Robot drive system for catheter type treatment system

Abstract

To provide a robot drive system for a catheter type treatment system.SOLUTION: A robot drive system includes a linear member, and a device module connected to the linear member. The device module can be independently controlled and includes a drive module. The drive module includes a housing with a surface side part having a recessed part, a motor with a shaft, and a capstan directly attached to the shaft of the motor. The motor is arranged inside the housing, the shaft is positioned inside the recessed part of the surface side part of the housing, and a cassette is attached to the drive module. The cassette includes a surface side part and is configured to support a thin and long medical device with a device axis in a longitudinal direction. The cassette is attached to the drive module in a vertical direction so that the surface side part of the cassette is in parallel with the surface side part of the drive module, and the cassette is connected to the capstan.SELECTED DRAWING: Figure 11a

Description

[Technical field]

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

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

[0004] In PCI, the physician uses a robotic system to manipulate a coronary guidewire to access the lesion, perform treatment, and restore normal blood flow. Access is achieved by seating a guide catheter at the coronary ostium. The distal tip of the guidewire is navigated past the lesion, and for complex anatomy, a microcatheter can be used to properly support the guidewire. Blood flow is restored by delivering and deploying a stent or balloon at the lesion. The lesion may require pretreatment prior to stent placement, and a balloon is delivered to predilatate the lesion, or atherectomy is performed, for example, using a laser or a rotational atherectomy catheter and balloon over the guidewire. Imaging and physiologic measurements can be performed to determine the appropriate treatment using imaging catheters or fractional flow reserve (FFR) measurements.

[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 to the lesion and deployed to restore blood flow. As with PCI, pre-treatment of the lesion and imaging are also used.

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

[0007] A robotic drive system of a catheter-based treatment system according to one embodiment includes a positioning system coupled to a patient table having a front side and a back side. The back side of the patient table is provided with a rail. The robotic drive system further includes a linear member connected to the positioning system at a connection and at least three device modules coupled to the linear member. Each device module is independently controllable and includes a drive module having a front side and a cassette attached to the drive module. The cassette has a front side and is configured to support an elongated medical device having a longitudinal device axis. The cassette is attached to the drive module in an upright position such that the front side of the cassette is parallel to the front side of the drive module. Furthermore, a width defined between the longitudinal device axis of the elongated medical device and the connection of the linear member to the positioning system is equal to or less than a distance between an insertion point of the elongated medical device into the patient and the rail on the back side of the patient table.

[0008] A robotic drive system for a catheter-based treatment system according to another embodiment includes a linear member and at least one device module coupled to the linear member. The at least one device module is independently controllable and includes a drive module and a cassette attached to the drive module. The drive module includes a housing having a front side including a recess, a motor having a shaft, and a capstan attached directly to the shaft of the motor. The motor is disposed within the housing, and the shaft is located within the recess in the front side of the housing. The cassette has a front side and is configured to support an elongated medical device having a longitudinal device axis. The cassette is mounted to the drive module in an upright position such that the front side of the cassette is parallel to the front side of the drive module, and the cassette engages with the capstan.

[0009] A robotic drive system of a catheter-based treatment system according to another embodiment includes a positioning system coupled to a patient table. The patient table has a top side and a bottom side, and the bottom side of the patient table has a rail. The robotic drive system further includes a linear member coupled to the positioning system at a connection point. The linear member has a distal end and a proximal end. The robotic drive system further includes at least three device modules coupled to the linear member. The device modules are each independently controllable and configured to support an elongated medical device having a longitudinal device axis. The positioning system is configured to position the linear member and the at least three device modules at a pitch angle defined between a horizontal axis parallel to the patient table and a proximal end of the linear member. The pitch angle is less than or equal to 10 degrees. [Brief description 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. [Diagram 2] 1 is a schematic block diagram of a catheter-based treatment system according to an embodiment. [Diagram 3] FIG. 2 is a perspective view of a robot drive device of a catheter-based treatment system according to an embodiment. [Figure 4] FIG. 1 illustrates the operating axis and insertion point within a patient of an elongated medical device. [Diagram 5] 5A and 5B are diagrams illustrating the effect of the thickness of the robot drive on the loss of working length. [Figure 6] FIG. 13 is a diagram for explaining an example of an orientation that minimizes loss of working length. [Figure 7] FIG. 13 is a perspective view of a device module including cassettes mounted upright in a vertical direction according to an embodiment. [Figure 8] FIG. 13 is a rear perspective view of a device module with cassettes mounted upright in an upright position according to an embodiment. [Figure 9]FIG. 13 is an end view of the distal end of a device module with cassettes mounted upright, according to an embodiment. [Figure 10] FIG. 13 is an end view of the distal end of a device module with a cassette mounted horizontally, according to an embodiment. [Figure 11a] FIG. 2 is a perspective view of a robot drive unit including device modules mounted vertically according to an embodiment. [Figure 11b] FIG. 2 is a perspective view of a rack and pinion drive mechanism of one drive module of a robotic drive according to an embodiment. [Figure 12] FIG. 2 is a front view of a robot driving device including device modules attached in a vertical direction according to an embodiment. [Figure 13] FIG. 2 is a front view of a robot driving device including device modules attached in a vertical direction according to an embodiment. [Figure 14] 1 is a front view of a cassette and an elongated medical device, according to an embodiment. [Figure 15] FIG. 2 is a perspective view of a bedside unit of a catheter-based treatment system placed on a patient table according to an embodiment. [Figure 16] FIG. 2 is a top view of a bedside unit of a catheter-based treatment system placed on a patient table, according to an embodiment. [Figure 17] FIG. 2 is a front view of a bedside unit of a catheter-based treatment system placed on a patient table according to an embodiment. [Figure 18] FIG. 2 is a rear cross-sectional view of a robot drive unit with device modules mounted vertically according to an embodiment. [Figure 19] FIG. 19a is a perspective view of a drive module according to an embodiment, FIG. 19b is a diagram of a motor shaft in a recess of the drive module according to an embodiment, and FIG. 19c is a perspective view of a capstan of a coupler of the drive module according to an embodiment. [Figure 20] FIG. 11 is a front view of a robot driving device illustrating a pitch angle according to an embodiment. [Figure 21]FIG. 2 is a top view of a bedside unit of a catheter-based treatment system placed on a patient table, according to an embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0011] The following definitions are used herein: Elongated medical device (EMD) refers to devices having, but are not limited to, catheters (guide catheters, microcatheters, balloon / stent catheters, etc.), wire-based devices (guidewires, embolic coils, stent retrievers, etc.), and combinations thereof. Wire-based EMDs include, but are not limited to, guidewires, microwires, proximal pushers for embolic coils, stent retrievers, self-expanding stents, and flow diverters. Typically, wire-based EMDs do not have a hub or handle at their proximal end. In one embodiment, an EMD includes a catheter having a hub at the catheter proximal end and a flexible shaft extending from the hub toward the catheter distal end, the shaft being more flexible than the hub. In one embodiment, the catheter includes a transition section that transitions between the hub and the shaft, the flexibility of the transition section being softer than the hub and harder 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 part is the part of the robotic drive that is closer to the patient than the proximal part when the robotic drive is in the intended placement. Within the patient, vascular landmarks that are further along a path from an access point are considered more distal than landmarks closer to the access point. The access point is the point at which the EMD enters the patient. Similarly, the proximal part is the part of the robotic drive that is further from the patient than the distal part when the robotic drive is in the intended placement. When used to define direction, the distal direction refers to the path that something is moving or moving to, or the path that something is pointing or pointing from the proximal part to the distal part and / or the patient when the robotic drive is in the intended placement. The proximal direction is the opposite direction of the distal direction.

[0013] The longitudinal axis (longitudinal axis, long axis) of a member (EMD or other element of a catheter-based treatment system) is the direction going from the proximal portion of the member to the distal portion of the member. In one example, the longitudinal axis of a guidewire is the direction going from the proximal portion of the guidewire to the distal portion of the guidewire, even if the guidewire is non-linear in the relevant portion. Axial motion of a member refers to the translation (translation) of the member along the longitudinal axis of the member. 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 motion of a member refers to the change in angular orientation of the member about the local longitudinal axis of the member. The rotational motion of the EMD corresponds to a 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 a 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 releasably securing an EMD to a member such that the EMD and member move together when the member moves. "Unpinch" means releasing an EMD from a member such that the EMD and member move independently when the member moves. "Clamp" means releasably securing an EMD to a member such that movement of the EMD is constrained relative to the member. The member may be fixed with respect to a global coordinate system or with respect to a local coordinate system. "Unclamp" means releasing an EMD from a member such 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 removal of the application of a force or torque to the EMD by the drive mechanism such 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 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. "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, the axial compression occurs in response to resistance due to navigation within the vasculature. The distance that the EMD can be driven along its longitudinal axis without support before it buckles is referred to herein as the device buckling distance. The device buckling distance is related to the device 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 differs from the desired path. A "kink" is an example of buckling when deformation of the EMD creates a distortion that is inelastic and cannot be corrected.

[0016] "Top, upper, upper part, upward" refers to the general direction against the direction of gravity, and "bottom, lower, downward" refers to the general direction in the direction of gravity. "Inside, inner, inside" refers to a portion within a particular part. "Outside, outer, outside" refers to a portion outside a particular part. "Front" refers to the side of the robotic drive (or element of the robotic drive, or other element of the catheterization system) that faces the user at the side of the bed 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 the catheterization system) that is closest to a positioning system such as an articulated arm. "Sterile interface" refers to an interface or boundary between a sterile unit and a non-sterile unit. For example, a cassette may be a sterile interface between a robotic drive and at least one EMD. "Sterilizable unit" refers to a device that can be sterilized (free of 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" refers to 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 an EMD capture device. In one non-limiting example, the on-device adapter is a collet that is robotically actuated to rotate the EMD about the EMD's longitudinal axis, pinch and / or unpinch the EMD into the collet, and / or translate the EMD along the EMD's 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 according to an embodiment is a perspective view showing an example of a catheter-based treatment system 10. The catheter-based treatment system 10 is used to perform catheter-based medical procedures, such as percutaneous interventional procedures such as percutaneous coronary intervention (PCI) (e.g., for treating STEMI), neurovascular interventional procedures (NVI) (e.g., for treating emergency large vessel occlusion (ELVO)), peripheral vascular interventional procedures (PVI) (e.g., for critical limb ischemia (CLI)), and the like. Catheter-based medical procedures include diagnostic catheterization procedures that use one or more catheters or other elongated medical devices (EMDs) to assist in diagnosing a patient's disease. For example, in one embodiment of a catheter-based diagnostic procedure, a contrast agent is injected through a catheter into one or more arteries to obtain images of the patient's vascular system. Catheter-based medical procedures also include catheter-based therapeutic procedures that use a catheter (or other EMD) to treat a disease (e.g., angioplasty, stent placement, treatment of peripheral vascular disease, thrombectomy, treatment of arterial venous malformation, treatment of aneurysms, etc.). The therapeutic procedure may be enhanced by the inclusion of auxiliary devices 54 (shown in FIG. 2), such as, for example, intravascular ultrasound (IVUS), optical coherence tomography (OCT), fractional flow reserve (FFR), etc. However, one of ordinary skill in the art will recognize that the particular percutaneous interventional device or component (e.g., guidewire type, catheter type, etc.) may be selected based on the type of procedure to be performed. The catheter-based treatment system 10 can accommodate, with minor adjustments, the specialized percutaneous interventional device used in the procedure and can perform any catheter-based medical procedure.

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

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

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

[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 intervention device (e.g., EMD) in conjunction with the robotic drive 24 (e.g., advance, retract, or rotate a guidewire, advance, retract, or rotate a catheter, inflate or deflate a balloon placed in the catheter, place and / or deploy a stent, place and / or deploy a stent retriever, place and / or deploy a coil, inject contrast into the catheter, inject liquid emboli into the catheter, inject drugs or saline into the catheter, aspirate the catheter, or perform any other function that may be performed as part of a catheter-based medical procedure). The robotic drive 24 includes various drive mechanisms for moving (eg, axial and rotational) the components of the bedside unit 20, including the percutaneous interventional devices.

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

[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.), pathology or treatment evaluation data (e.g., IVUS, OCT, FFR, etc.). Additionally, the display 30 may be configured to display procedure-specific information (e.g., procedure checklists, recommendations, duration of procedure, catheter or guidewire location, amount of drug or contrast delivered, etc.). The display 30 may also be configured to display information to provide functionality associated with the control computing system 34 (shown in FIG. 2). The display 30 may also have touch screen capabilities to provide some of the user input functionality of the system.

[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 rotate partially or fully around the patient 12 to obtain images of various angular positions relative to the patient 12 (e.g., sagittal, caudal, anterior-posterior, etc.). In one embodiment, the imaging system 14 is a fluoroscopy system that includes a C-arm having an x-ray source 13 and a detector 15, also known as an image intensifier.

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

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

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

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

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

[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 intervention devices (e.g., guidewires, catheters, etc.). Each drive mechanism may be provided as part of the robotic drive 24. FIG. 3 is a perspective view of the robotic drive of the catheter-based treatment system 10 according to an embodiment. In FIG. 3, the robotic drive 24 includes a plurality of device modules 32a-d coupled to a linear member 60. Each of the device modules 32a-d is coupled to the linear member 60 via a stage 62a-d that is 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 actuated to move linearly along the linear member 60. Thus, each stage 62a-d (and corresponding device modules 32a-d coupled to the stages 62a-d) can be independently actuated with respect to each other and with respect to the linear member 60. A drive mechanism is used to actuate each stage 62a-d. In the embodiment shown in FIG. 3, the drive mechanism can have individual stage translation motors 64a-d and stage drive mechanisms 76 coupled to each stage 62a-d, or the stage translation motors 64a-d themselves can be linear motors. The stage drive mechanisms 76 can be, for example, a lead screw via a rotating nut, a rack via a pinion, a belt via a pinion or pulley, or a chain via a sprocket. In one embodiment, the stage drive mechanisms 76 are a combination of these mechanisms. For example, different types of stage drive mechanisms can be employed for each of the stages 62a-d.In embodiments where 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 it, e.g., 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 and coupled to 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 66a-d in such an orientation that the cassette 66a-d is mounted to 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 connect with and support a proximal portion of an EMD (not shown). Additionally, each cassette 66a-d may include elements that provide one or more degrees of freedom in addition to the linear motion provided by the linear movement along the linear member 60 upon actuation of the corresponding stage 62a-d. For example, the cassettes 66a-d may include elements that are used to rotate the EMD in the cassette coupled to the drive modules 68a-d. Each drive module 68a-d includes at least one coupler to provide a drive interface to the mechanism within each cassette 66a-d to provide an additional degree of freedom. Additionally, each cassette 66a-d includes a channel in which the 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 of the device modules 32a, 32b, and 32c to provide fixed points that support the proximal ends of the 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 connector 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 connector 72 and to the EMD (e.g., introducer sheath). This configuration of the robotic drive 24 has the advantage that the use of actuators on a single linear member can reduce the volume and weight of the robotic drive 24.

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

[0034] As shown in FIG. 1, one or more EMDs are introduced into the patient (e.g., blood vessel) at an insertion point 16, for example, using an introducer and introducer sheath. The introducer sheath is typically oriented at an angle, usually less than 45 degrees, with respect to the axis of the blood vessel of the patient 120 (shown in FIGS. 4-6). The height difference between the height at which the EMD enters the body (proximal opening 126 of the introducer sheath shown in FIG. 4) and the height of the longitudinal drive axis of the robotic drive 124 will directly affect 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 shows the working axis of the elongated medical device and the introduction point into the patient. FIG. 4 shows 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, and 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 to create a curve with endpoints that are tangentially aligned. The length of this curve represents the length of the elongated medical device 121 before it can be driven further forward by the robotic drive 124 and into the introducer sheath 122 where it will become misaligned. 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 are diagrams illustrating 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, which 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 a shorter (d) 123, which is thinner as indicated by the distance (X) 129 between the top and bottom surfaces of the robotic drive 124. By reducing the thickness of the robotic drive 124 to be closer to the patient and the introducer sheath, the distance 123 between the introducer sheath and the device axis is shortened, reducing the loss of working length of the elongated medical device. FIG. 6 is a diagram illustrating an orientation to minimize the loss of working length. 6, the robot drive 124 is oriented such that the longitudinal device axis 125 of the robot drive 124 is aligned with the axis of the introducer sheath 122. This eliminates loss of working length due to angular and vertical differences in the elongated medical device. However, this orientation of the robot drive 124 is not practical given the length and size of the robot drive 124. Also, orienting the robot drive at an acute angle makes loading and unloading the elongated medical device, as well as adjustment and handling of the robot drive, difficult, affecting ease of use.

[0036] To reduce the distance between the robotic drive and the patient, and between the longitudinal device axis of the robotic drive and the introducer sheath, the cassettes 66a-d of the device module 32 (shown in FIG. 3) are mounted to the drive module 68a-d in an orientation such that the cassettes 66a-d are mounted to the drive module 68a-d by moving the cassettes 66a-d horizontally onto the drive module 68a-d. FIG. 7 shows a perspective view of a device module with a top-to-bottom mounted cassette, according to one embodiment, and FIG. 8 shows a rear perspective view of a device module with a top-to-bottom mounted cassette, according to one embodiment. In FIGS. 7 and 8, the device module 132 includes a cassette 138 mounted to the drive module 140 such that a front side (or lateral side) 139 of the cassette 138 is parallel to a front side (or lateral side) 141 (i.e., mounting surface) of the drive module 140. As used herein, the mounting orientation shown in FIGS. 7 and 8 is referred to as a top-to-bottom orientation. 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 moving the cassette 138 horizontally onto the mounting surface 141 such that the cassette is coupled 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 disposed 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 elongate 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 elongate medical device 144 and the patient.Only a portion of the cassette 138 is between the elongated medical device 138 and the patient. The top-to-bottom mounting of the cassette 138 reduces the distance 146 between the elongated medical device and the bottom of the device module 132, moving the robotic drive closer to the patient and reducing the loss of working length in the elongated medical device. For comparison, an example is shown in FIG. 10, which is 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 on the bottom or below 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 mounted to the drive module at any angle. In one embodiment, the cassette can be mounted horizontally below the drive module, so that the drive module does not have to be located between the device axis and the patient.

[0037] FIG. 11a is a perspective view of a robotic drive with device modules mounted vertically, according to one embodiment. In FIG. 11a, the robotic drive 200 includes a plurality of drive modules 206a-d coupled to a linear member 211. As described above, a cassette (not shown) is mounted to each drive module 206a-d. In the robotic drive 200, each drive module 206a-d is configured to allow a cassette to be mounted vertically to the drive module 206a-d. As described above with reference to FIGS. 7-9, the vertical orientation of the drive modules 206a-d and the corresponding cassettes (not shown) mounted to each drive module 206a-d allows the robotic drive 200 and the drive modules 206a-d to be closer to the patient and reduces the working length loss of the EMD. Each of the drive modules 206a-d includes at least one coupler 209a-d to provide a drive interface to a mechanism within the respective cassette and to provide power, such as power to rotate the EMD, using the mechanism within the cassette. Each of the drive modules 206a-d also includes a motor (not shown) that is used to rotate the couplers 209a-d. Each drive module 206a-d is coupled to the linear member 211 via a stage (or slide) 203a-d that is operatively coupled to the linear member 211 using, for example, rails 204. The drive modules 206a-d are connected to the stages 203a-d using connectors such as offset brackets 208a-d. In one embodiment, the drive modules 206a-d can be directly attached to the stages 203a-d. The robot drive 200 also includes a device support connection 210 that is connected to a distal support arm 212. The distal support arm 212 extends from the linear member 211 of the robot drive 200 and is attached, for example, to a frame of the robot drive 200. The device support connection 210 and distal support arm 212 are configured to provide a distal fixation point for supporting the distal end of a device support (not shown) of a cassette mounted on the distal-most drive module 206a closest to the patient, and the device support connection 210 is also connected to an introducer sheath hub (not shown).

[0038] Each of the stages 203a-d can be individually actuated to move linearly along the rails 204 of the linear member 211. That is, each stage 203a-d (and the corresponding drive modules 206a-d coupled to the stages 203a-d) can be moved individually relative to each other and relative to the linear member 211. A drive mechanism is used to actuate each stage 203a-d. In the embodiment shown in FIG. 11a, the drive mechanism includes independent stage translation motors 207a-d and a stage drive mechanism for each of the stages 203a-d. In FIG. 11a, the stage drive mechanism is a rack-and-pinion linear actuator mechanism including a rack 202 and an individual pinion (shown in FIG. 11b) for each of the stages 203a-d. The rails 204 are positioned above the rack 202 so that the rack 202 can receive a moment. FIG. 11b, according to one embodiment, is a perspective view of a rack-and-pinion drive mechanism of one drive module of a robot drive. FIG. 11b shows the rack and pinion drive mechanism of one drive module 206 (e.g., one of the drive modules 206a-d shown in FIG. 11a). The drive module 206 is coupled to the stage 203 with an offset bracket 208. The stage 203 is operatively coupled to a rail 204. In one embodiment, the stage 203 is configured to be as frictionless as possible. The pinion 213 is attached directly to the motor 207, for example to the shaft (not shown) of the motor 207. Using well-known methods, the pinion 213 can be attached directly to the motor shaft, for example by threading. Attaching the pinion 213 directly to the shaft of the motor 207 reduces the height (thickness) of the robot drive 200 (shown in FIG. 11), as described below. The pinion 213 meshes with the rack 202 (e.g., the teeth of the pinion 213 mesh with the teeth of the rack 202). To actuate the stage 203 to move forward (i.e., distally towards the patient) along the rails 204, the pinion 213 rotates (e.g., counterclockwise when viewed from the bottom as shown in FIG. 11b) and moves along the rack 202, which is stationary, pushing the drive module 206 forward.In one embodiment, the teeth of rack 202 and pinion 213 may be straight, helical, or any other standard shape.

[0039] As discussed above, each drive module 206a-d is coupled to the stage 203a-d using a connector such as an offset bracket 208a-d. FIG. 12, according to one embodiment, is a front view of a robot drive with vertically mounted device modules. Each drive module 206a-d is secured to an offset bracket 208a-d that is used to couple the drive module to the stage 203a-d. To shorten the overall length 214 of the linear member 211 of the robot drive 200, the offset brackets 208a-d can be used to create an offset between the stage 203a-d and the drive modules 206a-d (and the cassettes (not shown) attached to each drive module) to reduce the gap between the stages 203a-d on the linear member 211 (e.g., on the rail 204) when the drive modules 206a-d are gathered together. The distance of each of the drive modules 206a-d (and associated cassettes) defines how close one stage can be to another on the rail 204 (e.g., how close stage 203b can be to stage 203a). The four stages 203a-d define an occupied rail length that affects the overall length 214 required for the rail 204 and linear member 211. The occupied rail length and the overall length 214 of the rail 204 (and linear member 211) are reduced by using offsets and offset brackets. Each of the offset brackets 208a-d defines an offset distance from the center of the stage 203a-d to which it is coupled to the center of the drive module 206a-d attached to the stage 203a-d or the center of the cassette (not shown) attached to the drive module 206a-d. The offset allows the stages 203a-d to be closer to the center of the rail 204, thereby reducing the overall length of the robot drive 200. 12, each of the offset brackets 208a-d located along the rail 204 (and linear member 211) extends distally (i.e., forward) toward the patient. This configuration allows the linear member 211 (and other elements of the robotic drive) to be positioned farther away from the patient's access site and the imaging system of the catheterization system.FIG. 13 is a front view of a robotic drive with vertically mounted device modules according to one embodiment. In the embodiment of FIG. 13, a linear member 211 is disposed within a housing 216. The offset provided by the offset brackets 208a-d is used to minimize the length of the linear member and the required length 219 of the housing 216 by limiting the dead space between the stages (as shown in FIGS. 11a and 12). As a result, the length of the linear member 211 and the housing 216 of the linear member 211 can be reduced while the linear range of motion of the most distal drive module 206a can be advanced beyond the distal end of the linear member 211 and the housing 215 towards the patient. For example, the most distal drive module 206a can go beyond the distal end of the housing 216 a distance 218 defined by the length of the distal support arm. This has the advantage that, for example, interference of the straight member 211 and the housing 216 with a C-arm (for example, the detector 15 of the C-arm shown in FIG. 1) of an imaging system (for example, a fluoroscopic imaging system) can be avoided. Furthermore, by using the offset brackets 208a-d, the length of the straight member 211 (and the frame of the robot driving device) can be shortened, so that the weight of the robot driving device 200 can be reduced.

[0040] As discussed above, the cassettes are mounted to respective drive modules 206a-d of the robotic drive 200. FIG. 14 is a front view of the cassette and elongated medical device according to one embodiment. The cassette 220 is configured for vertical mounting to a drive module (e.g., drive modules 206a-d shown in FIGS. 11a, 12, and 13) and includes portions that allow the cassette 220 to be vertically mounted to a drive module of the robotic drive (e.g., vertical mounting as described above with reference to FIGS. 7-9). The cassette 220 has a distal end 222, a proximal end 224, and a longitudinal device axis 238 that is associated with and defined by an elongated medical device (EMD) 230 disposed within the cassette housing 228. In one embodiment, the EMD 230 is a catheter. The catheter 230 is connected to a hemostasis valve (e.g., a rotating hemostasis valve (RHV)) 232, which is also disposed within the cassette housing 228. The hemostasis valve 232 includes a side port 234 that is connected to a tube (not shown) for flowing fluid (e.g., saline) into and out of the hemostasis valve 232 and the catheter 230. The cassette 220 also includes a cover 226 that is connected to the cassette housing 228 with a connection mechanism 236 (e.g., a hinge). The connection mechanism 236 is located below a longitudinal device axis 238. In FIG. 14, the cover 226 is closed. The connection mechanism 236 allows the cover 226 to be operated between a closed state and an open state.

[0041] FIG. 15 is a perspective view of a bedside unit of a catheter-based treatment system mounted on a patient table, according to one embodiment. The bedside unit includes a robotic drive 302 (e.g., the robotic drive 200 shown in FIG. 11a) and a positioning system 304. The robotic drive 302 includes a housing 322 and four device modules 324, each configured to manipulate an EMD. In one embodiment, each of the device modules 324 includes a top-bottom mounted drive module and a top-bottom mounted cassette. The robotic drive 302 includes a front side 314, a back side (or rear side) 316, a proximal end 318, and a distal end 320. The positioning system 304 (e.g., a robotic arm, articulated arm, holder, etc.) can be attached to one side of the patient table, such as to a back rail 312 of the patient table 306. The robotic drive 302 is attached to the other end of the positioning system 304. The positioning system 304 is used to secure or position the robotic drive 302 relative to a patient (not shown) on a patient table 306 during a procedure. The patient table 306 is supported and operated by a pedestal 308 that is mounted to the floor and / or ground. In one embodiment, the width of the robotic drive 302 is limited to avoid interference with other devices that may be mounted to a back rail 312, for example. FIG. 16, according to one embodiment, is a top view of a bedside unit of a catheter-based treatment system mounted on a patient table. In FIG. 16, the width 331 of the robotic drive is defined as the distance between the attachment or connection point 335 of the positioning system 304 to the robotic drive 302 and the longitudinal device axis 337 of the device module 324. The longitudinal device axis 337 is associated with and defined by the EMD disposed on the device module 324. In one embodiment, width 331 is less than or equal to distance 333 between insertion point 332 where the introducer sheath enters the patient's femoral artery and back rail 312 of patient table 306. In the case of Figure 16, insertion point 332 is at the left femoral artery and back rail 312 of the patient table is the left rail.In another embodiment, the robotic drive 302, positioning system 304, and patient (not shown) are set up such that the insertion point is at the right femoral artery, and the robotic drive 302 and positioning system 304 are attached to the front rail 310. In one embodiment, the width 331 of the robotic drive is on the order of 15 cm. By having the width 331 as narrow as possible, the robotic drive 302 can be parallel to other devices attached to the back rail 312 of the patient table 306 and still be able to enter the EMD into the patient's femoral artery at the insertion point 332. By limiting the width 331 to less than or equal to the distance 333 between the insertion point 332 and the back rail 312, the robotic drive 302 can fit into the area between the patient's groin (i.e., femoral artery) and the back rail 312 and not interfere with other devices (e.g., IV / intravenous, etc.) on the back rail 312, such as devices attached to connection point 330 on the back rail 312. Fig. 17 is a front view of a bedside unit of a catheter-based treatment system mounted on a patient table according to one embodiment. In Fig. 17, an example of a device attached to the patient table 306 along with the positioning system 304 and the robotic drive 302 is an IV pole 336. The IV pole 336 is attached to a back rail (not shown) of the patient table 306.

[0042] As discussed above, the robotic drive (200, 302) can be configured to minimize the width of the robotic drive and allow the robotic drive to be located close to the patient. FIG. 18 is a rear cross-sectional view of a robotic drive with a vertically mounted device module, according to one embodiment. In FIG. 18, the cassette 340 is mounted vertically (upright) on the drive module 354. The cover 342 of the cassette 340 is shown in a closed position. The drive module 354 is coupled to a stage 346 that is movably coupled to rails 348. In one embodiment, the drive module 354 is coupled to the stage 346 using an offset bracket 359. The drive module 354 is also coupled to a motor 353 that is used to rotate an EMD (not shown) located in the cassette 340, for example, using a coupler as described above. The drive mechanism for the stage 346 includes a rack 344 and a pinion 356. As discussed above, the pinion 356 is directly fixed (e.g., to a motor shaft) to the motor 345 associated with the stage 346. A motor 345 is provided to drive a pinion 344 that meshes with a rack 344 to linearly move the stage 346. The width 352 of the robotic drive 302 is defined as the distance between the attachment point 341 of the positioning system 304 to the robotic drive 302 and the longitudinal device axis 347 of the device module (i.e., cassette 340 and drive module 354). The longitudinal device axis 347 is associated with and defined by an EMD (not shown) disposed in the cassette 340 of the device module. In one embodiment, the longitudinal device axis 347 is below or lower than the centerline of the cassette 340, such that the longitudinal device axis is closer to the patient. The distance 350 between the longitudinal device axis 347 and the bottom of the device module (e.g., bottom of cassette 340) can be small due to the vertical mounting of the cassette 340 and drive module 354. For vertical mounting, it is beneficial that the drive module is not below the device axis and is not between the device axis and the patient.As a result, the longitudinal device axis 347 can be brought closer to the patient, and in particular, 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 linear member 211 (shown in FIG. 11a)) as close to the patient as possible. In one embodiment, the cassette 340 is configured to make the distance 350 as short as possible. The distance 358 between the longitudinal device axis 347 and the positioning system interface (connection point) 343 is also shown in FIG. 18. The positioning system interface 343 is connected, for example, to the back side of the robotic drive and to the arm of the positioning system. The positioning system interface 343 is used to adjust the pitch angle of the robotic drive.

[0043] One element that can be configured to minimize the width of the robot drive is the coupler of the drive module. FIG. 19a shows a perspective view of the drive module according to one embodiment, FIG. 19b shows a view of the motor shaft in a recess of the drive module according to one embodiment, and FIG. 19c shows a perspective view of the coupler of the drive module according to one embodiment. The drive module 360 ​​includes a housing 362. A locating pin 364 is located on the front side (e.g., mounting surface) of the drive module 360. A coupler 366 is located in a recess 368 of the housing 362. The locating pin 364 serves to align the coupler 366 of the drive module 362 with a mating coupler of, for example, a cassette (not shown) before the couplers are fully engaged. The coupler 366 can be protected from external radial loads by being located in the recess 368, which can increase the life of the motor bearings. As described above, the coupler 366 is used to connect with a cassette (not shown) mounted to the drive module 360 ​​and rotate the EMDs in the cassette. For example, the cassette may include a bevel gear that engages with the coupler 366 of the drive module 360, which meshes with a mating bevel gear that acts on the EMDs in the cassette to rotate the EMDs. To reduce the width of the robot drive, the coupler 366 (e.g., a capstan) is attached directly to a shaft 370 of a motor in the drive module 360, as shown in FIG. 19b. In one embodiment, the capstan 366 is attached directly to the motor shaft 370, for example, using laser welding and / or adhesives or other permanent or non-permanent methods. In one embodiment, the coupler 366 (e.g., a capstan) includes an opening 372 into which the motor shaft 370 is inserted, as shown in FIG. 19c.

[0044] The angle at which the robot drive (e.g., robot drive 200 shown in FIG. 11a and robot drive 302 shown in FIG. 15) is fixed affects the maneuverability of the robot drive. For example, the height of the more proximal device modules (e.g., device modules 324c, 324d) can affect loading and unloading of EMDs, especially when retracting the more proximal device modules toward the proximal end of the robot drive. In addition, the angle at which the robot drive is fixed can make it difficult to adjust and handle the robot drive. It also affects how close the most distal device module of the robot drive can be to the patient. FIG. 20 is a front view of a robot drive illustrating the pitch angle, according to one embodiment. In FIG. 20, the pitch angle 371 of the robot drive 302 is shown between a horizontal line 374 parallel to the patient table 306 and the proximal end of the rail 327. The device modules 324a-d are coupled to stages 325a-d that are movably coupled to the rail 327. In one embodiment, the pitch angle 371 is less than 10 degrees. In another embodiment, the pitch angle 371 is in the range of 3 degrees-6 degrees. For long robotic drive systems using multiple device modules and EMDs, it is advantageous to have the pitch angle 371 as small as possible. The pitch angle 371 of the robotic drive 302 should also be selected so that the robotic drive does not interfere with or contact the patient's feet. By having the pitch angle 371 as small as possible, a convenient loading height for the device can be provided. As mentioned above, limiting the width of the robotic drive ensures that the yaw of the robotic drive does not cause the robotic drive to interfere with other devices mounted on the back rail of the patient table 306. FIG. 21, according to one embodiment, is a top view of a bedside unit of a catheter-based treatment system placed on a patient table. In FIG. 21, yaw is represented by the angle 380 between the longitudinal axis 382 of the back rail of the patient table 306 and the longitudinal axis 384 of the robotic drive 302. It is desirable to minimize the yaw of the robotic drive 302 to avoid contact with other devices mounted on the back rail of the patient table.

[0045] The control computing system described herein may include a processor having a processing circuit. The 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. The memory unit (e.g., memory device, 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 database components, object code components, script components, and / or any other type of information structure to support the various activities disclosed herein. According to an embodiment, any distributed and / or local memory device, past, present, or future, may be utilized in the systems and methods disclosed herein. According to an 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 includes 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 a function for the module.

[0046] The written description uses examples to disclose the invention, including the best mode, and to enable any person of ordinary skill 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 of ordinary skill 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 recitations of the claims, or if they have equivalent elements that do not differ substantially from the recitations 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 robot drive system for a catheter-based treatment system, comprising: a positioning system coupled to a patient table having a top section and a bottom section with a bottom rail; a linear member connected to the positioning system at a connection point; at least three device modules coupled to the linear member; Each of the device modules is individually controllable and includes a drive module having a front side and a cassette mounted to the drive module; the cassette has a front side and is configured to support an elongated medical device having a longitudinal device axis, and the cassette is vertically mounted to the drive module such that the front side of the cassette is parallel to the front side of the drive module; A robotic drive system, wherein a width defined between a longitudinal device axis of the elongated medical device and a connection point of the linear member to the positioning system is equal to or less than the distance between an insertion point of the elongated medical device into a patient and a back rail of the patient table.

2. The robot drive system according to claim 1 , wherein the linear member includes a drive mechanism for linearly moving each of the device modules, the drive mechanism being a linear actuator consisting of a rack and pinion.

3. The robot drive system of claim 1 , wherein the linear member includes a drive mechanism for linearly moving each of the device modules, the drive mechanism being of a screw type.

4. The robot drive system of claim 2 , wherein the linear member further includes a rail located above a rack of the rack and pinion.

5. further comprising a plurality of stages operatively coupled to the rail; The robot drive system of claim 4 , wherein each of the stages is coupled to one of the device modules.

6. the rack and pinion linear actuator includes a plurality of pinions, each of which is coupled to one of the stages; The robot drive system of claim 5 , wherein each of the stages includes a motor that drives the pinion of each of the stages.

7. The robotic drive system of claim 1 , wherein the distance between a bottom surface of each of the device modules and the longitudinal device axis is 20 mm or less.

8. The robotic drive system of claim 1 , wherein the insertion point of the elongated medical device is a femoral artery of a patient.

9. A robot drive system for a catheter-based treatment system, comprising: A straight member; at least one device module coupled to the linear member; the at least one device module is independently controllable and includes a drive module; The drive module includes: a housing including a front side having a recess; a motor having a shaft; a capstan mounted directly on the shaft of the motor; the motor is disposed within the housing, the shaft being positioned within a recess in a front side of the housing; a cassette mounted to the drive module, the cassette having a front side and configured to support an elongated medical device having a longitudinal device axis, the cassette being mounted vertically to the drive module such that the front side of the cassette is parallel to the front side of the drive module, and the cassette is coupled to the capstan.

10. The capstan is attached directly to the shaft of the motor using laser welding.

10. The robot drive system of claim 9 .

11. a positioning system coupled to the patient table; the patient table has a top side and a bottom side, the bottom side of the patient table being provided with a bottom rail; the linear member is coupled to the positioning system at a connection point; 10. The robotic drive system of claim 9, wherein a width defined between a longitudinal device axis of the elongated medical device and a connection point of the linear member is equal to or less than a distance between an insertion point of the elongated medical device into a patient and a back rail of the patient table.

12. The robot drive system according to claim 9 , wherein the linear member includes a drive mechanism for linearly moving each of the device modules, the drive mechanism being a linear actuator consisting of a rack and pinion.

13. The robotic drive system of claim 9 , wherein the linear member includes a drive mechanism for linearly moving each of the device modules, the drive mechanism being screw-type.

14. A robot drive system for a catheter-based treatment system, comprising: a positioning system coupled to a patient table having a top section and a bottom section with a bottom rail; a linear member coupled to the positioning system at a connection point and having a distal end and a proximal end; at least three device modules coupled to the linear member; each of the device modules is individually controllable and configured to support an elongated medical device having a longitudinal device axis; a robotic drive system, wherein the positioning system is configured to fix the linear member and the at least three device modules at a pitch angle defined between a horizontal line parallel to the patient table and a proximal end of the linear member, the pitch angle being less than or equal to 10 degrees.

15. Each of the device modules comprises: a drive module having a front side; a cassette attached to the drive module; 15. The robotic drive system of claim 14, wherein the cassette has a front side and is configured to support an elongated medical device having a longitudinal device axis, and the cassette is vertically mounted to the drive module such that the front side of the cassette is parallel to the front side of the drive module.

16. The robot drive system of claim 14 , wherein the linear member includes a drive mechanism for linearly moving each of the device modules, the drive mechanism being a linear actuator comprising a rack and pinion.

17. 15. The robotic drive system of claim 14, wherein a width defined between a longitudinal device axis of the elongated medical device and a connection point of the linear member to the positioning system is equal to or less than a distance between an insertion point of the elongated medical device into a patient and a back rail of the patient table.

18. The robotic drive system of claim 17 , wherein the insertion point of the elongated medical device is the patient's left femoral artery.

19. 15. The robot drive system of claim 14, wherein the pitch angle is in the range of 3 degrees to 6 degrees.

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