Cassette assembly for robotic drive

Abstract

To provide a robotic drive system for driving one or more elongated medical devices.SOLUTION: A robotic drive system includes a robotic drive and a sterile cassette assembly. The robotic drive includes a first drive module, and a second drive module proximal to the first drive module. Each drive module is independently movable along a longitudinal axis of the robotic drive. A sterile cassette assembly includes a first cassette, and a second cassette coupled to the first cassette by means of a coupler. The first cassette and the second cassette are removably attached to the first drive module and the second drive module, respectively.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] "Cross - reference to Related Applications" This application claims priority based on U.S. Provisional Application No. 63 / 203,795, filed on July 30, 2021, the title of which is "Cassette assembly for robotic drive", and the disclosure of that application is incorporated herein by reference.

[0002] The present invention generally relates to the field of robotic medical treatment systems, and more particularly, to a cassette assembly for a robotic drive unit.

Background Art

[0003] When diagnosing and treating various vascular diseases, catheters and other elongated medical devices (EMDs) may be used for minimally invasive medical procedures. Examples of such vascular diseases include those known as neurovascular interventional procedures (NVIs) or neurointerventional surgeries, percutaneous coronary interventions (PCIs), and peripheral vascular intervention procedures (PVIs). In these procedures, typically, a guide wire is guided through the vasculature, and a catheter is advanced through the guide wire to deliver or perform a treatment. Such catheter procedures begin with obtaining access to an appropriate blood vessel, such as an artery or vein, using standard percutaneous techniques with an introducer sheath. Next, a sheath or guide catheter is advanced over a diagnostic guide wire through the introducer sheath to a primary position, which may be, for example, the internal carotid artery in an NVI, the coronary ostium in a PCI, or the surface of the femoral artery in a PVI. Next, a guide wire suitable for the vasculature is guided through the sheath or guide catheter to a target position within the vasculature. In certain situations, such as when the anatomical structure is tortuous, a support catheter or microcatheter may be inserted over the guide wire to assist in guiding the guide wire. The physician or operator may obtain images (cine) with contrast injection using an imaging system (e.g., a fluoroscope), and select a fixed frame to use as a roadmap for guiding the guide wire or catheter to the target (e.g., lesion) position.When the doctor transfers the guide wire or catheter, an image enhanced with contrast can also be obtained, by which it can be confirmed whether the device is moving along the correct path to the target position. While observing the anatomical structure using (X-ray) fluoroscopy, the doctor operates the proximal end of the guide wire or catheter to orient the distal end at the anatomical position of the lesion or target within the appropriate conduit, avoiding the distal end from branching (proceeding to the side branch) at that time.

[0004] The robotic catheter-based treatment system has been developed to assist physicians during catheter treatments (e.g., NVI, PCI, and PVI, etc.). Examples of NVI treatments include coil embolization of aneurysms, liquid embolization of arteriovenous malformations, and mechanical thrombectomy of large vessel occlusions in the context of acute ischemic stroke. In NVI treatments, the physician uses the robotic system to control the manipulation of neurovascular guide wires and micro-catheters to gain access to the target lesion, deliver the treatment, and restore normal blood flow. Access to the target is enabled by a sheath or guide catheter. However, in more distal regions, an intermediate catheter may be required to enable proper support of the micro-catheter and guide wire. The distal end of the guide wire may be guided into or through the lesion depending on the type of lesion and treatment. Also, to treat multiple aneurysms, the micro-catheter may be advanced to the lesion, the guide wire removed, and multiple thrombotic coils deployed within the aneurysm through the micro-catheter to block blood flow into the aneurysm. Also, to treat arteriovenous malformations, liquid embolics may be injected into the malformation through a micro-catheter. Mechanical thrombectomy for treating vascular occlusions can be achieved by the use of aspiration and / or a stent retriever. Depending on the location of the thrombus, aspiration may be performed through an aspiration catheter or, in the case of smaller arteries, through a micro-catheter. Once the aspiration catheter reaches the lesion, negative pressure may be applied to remove the clot (thrombus) through the catheter. Alternatively, the clot may be removed by placing a stent retriever (stent extractor) through the micro-catheter. When the thrombus is integrated with the stent retriever, the thrombus is retrieved by pulling the stent retriever and the micro-catheter (or intermediate catheter) into the guide catheter.

[0005] In PCI, the doctor may use a robotic system to manipulate a coronary guide wire to access the lesion, transfer the treatment site, and restore normal blood flow. This access is made possible by attaching a guide catheter at the coronary ostium. The distal end of the guide wire is guided through the lesion, and a microcatheter may be used to properly support the guide wire when the anatomical structure is complex. Blood flow is restored by delivering and deploying a stent or balloon to the lesion. The lesion may require preparation before stent implantation, such as delivering a balloon for pre-dilation of the lesion or performing an atherectomy, for example, using a laser or rotational atherectomy catheter and a balloon on the guide wire. Diagnostic imaging and physiological measurements may also be performed to determine the appropriate treatment by using an imaging catheter or fractional flow reserve (FFR) measurement.

[0006] In PVI, the doctor uses a robotic system to restore blood flow by the same technology as NVI for transferring the treatment. The distal end of the guide wire is guided through the lesion, and a microcatheter may be used to provide proper support for the guide wire against complex anatomical structures. Blood flow can be restored by delivering and deploying a stent or balloon to the lesion. Similar to PCI, lesion preparation and diagnostic imaging can also be used in the same way.

[0007] When support is required at the distal end of a catheter or guide wire, for example, to navigate a tortuous or calcified vasculature to reach a distal anatomical location or to cross a hard lesion, an over-the-wire (OTW) catheter or coaxial system may be used. Since the guide wire extends over the entire length of the catheter, the OTW catheter has a lumen (hollow or cavity). This provides a relatively stable system as the guide wire is supported along its entire length. However, this system has several drawbacks. For example, it has higher friction and a longer overall length compared to rapid or quick exchange catheters (see below). Typically, to remove or exchange an OTW catheter while maintaining the position of the indwelling guide wire, the exposed length of the guide wire (outside the patient) must be longer than the OTW catheter. For example, a guide wire with a length of 300 cm is usually sufficient for this purpose. This is sometimes referred to as an exchange length guide wire. However, due to the length of this guide wire, two operators are required to remove or exchange the OTW catheter. This is even more difficult in the case of triple coaxial (also known as a 3-axis system in the art, and the use of quadruple coaxial catheters is also known). However, due to its stability, the OTW system is often used in NVI and PVI procedures. On the other hand, in PCI procedures, rapid exchange (or monorail / single track) catheters are often used. The guide wire lumen in a rapid exchange catheter only passes through the distal portion of the catheter, which is also referred to as the monorail or rapid exchange (RX) section. When using an RX system, the operator manipulates the interventional devices parallel to each other (in contrast to the case where the devices are manipulated in a serial configuration in an OTW system), and the exposed length of the guide wire only needs to be slightly longer than the RX section of the catheter. The length of a rapid exchange guide wire is usually 180 cm - 200 cm.When a guide wire and a monorail of shorter length are used, the RX catheter can be exchanged by a single operator. However, when more distal support is required, the RX catheter is often incompatible. Summary of the Invention Means for Solving the Problems

[0008] In one aspect of the present invention, a robotic drive system for driving one or more elongated medical devices (EMDs) is provided. The robotic drive system includes a robotic drive unit and a sterilization cassette assembly. The robotic drive unit includes a first drive module and a second drive module proximal to the first drive module. The drive modules (the first drive module and the second drive module) are each independently movable along the longitudinal axis of the robotic drive unit. The sterilization cassette assembly includes a first cassette and a second cassette coupled to the first cassette using a coupler (via the coupler). The first cassette and the second cassette are removably attached together to the first drive module and the second drive module, respectively.

[0009] In one aspect, the coupler includes a first arm connected to the first cassette and a second arm connected to the second cassette, and the second arm is slidably connected to the first arm.

[0010] In one aspect, the first arm and the second arm are coupled such that relative movement therebetween is possible only along their respective longitudinal axes.

[0011] In one aspect, the robotic drive system further includes a first flexible support having a first distal end and a first proximal end, the first distal end being removably fixed to the first cassette, the first proximal end being fixed to the proximal end of the first arm, and a portion (part) between the first distal end and the first proximal end of the first flexible support being disposed within the second cassette.

[0012] In one aspect, the sterilization cassette assembly further includes a third cassette, and the coupler further includes a third arm slidably connected to the second arm, and the third cassette is connected to the third arm.

[0013] In one aspect, the second arm includes a first portion slidably engaging with the first arm and a second portion slidably engaging with the third arm.

[0014] In one aspect, the sterilization cassette assembly further includes a fourth cassette, the coupler further includes a fourth arm slidably connected to the third arm, and the fourth cassette is connected to the fourth arm.

[0015] In one aspect, the robot drive system further includes a second flexible support having a second distal end and a second proximal end, the second distal end of the second flexible support is removably fixed to the second cassette, the second proximal end is fixed to the proximal end of the second arm, and a portion between the second distal end and the second proximal end of the second flexible support is disposed within the third cassette.

[0016] In one aspect, the robot drive system further includes an initial flexible support having a leading distal end and a leading proximal end, the leading distal end is removably fixed to a distal connector (sheath connector) of the first cassette, the leading proximal end is fixed to the robot drive housing, and a portion between the leading distal end and the leading proximal end of the leading flexible support is disposed within the first cassette.

[0017] In one aspect, the first arm includes a first guide portion operably guiding a portion of the leading flexible support between a support anchor on the housing of the robot drive unit and a distal sheath connector.

[0018] In one aspect, the second arm includes a second guide portion that operably guides a portion of the first flexible support between the proximal end of the first flexible support and the first cassette.

[0019] In one aspect, the third arm includes a third guide portion that operably guides a portion of the second flexible support between the proximal end of the first flexible support and the second cassette.

[0020] In one aspect, each cassette includes a portion that is placed on the surface of the corresponding drive module when the cassette is attached to the corresponding drive module.

[0021] In one aspect, the first cassette includes a latch that releasably engages a tab in the drive module.

[0022] In one aspect, the first cassette includes a cylindrical cavity that can receive a cylindrical member of the drive module.

[0023] Further, in one aspect, a robotic drive system for driving one or more elongate medical devices (EMDs) is provided. The robotic drive system includes a robotic drive unit and a sterilization cassette assembly. The robotic drive unit includes a first drive module, a second drive module proximal to the first drive module, and a third drive module proximal to the second drive module, and each drive module (the first drive module, the second drive module, and the third drive module) is independently movable along the longitudinal axis of the robotic drive unit. The sterilization cassette assembly includes a first cassette having a first arm, a second cassette having a second arm, and a third cassette having a third arm. Further, a first flexible support having a proximal end and a distal end attached to the first cassette, a portion of which extends through the second cassette, is included. Further, a second flexible support having a proximal end and a distal end attached to the second cassette, a portion of which extends through the third cassette, is included. The first cassette, the second cassette, and the third cassette are movable independently of each other, and the first arm, the second arm, and the third arm are slidably connected to each other.

[0024] In one aspect, the second arm includes a second guide portion that operably guides a portion between a connector on the proximal end of the first arm of the first flexible support and the first cassette.

[0025] In one aspect, the robotic drive system further includes a leading flexible support having a proximal end fixed to the housing of the robotic drive unit and a distal end fixed to the sheath connector, and a portion of the leading flexible support can move through a channel (path) within the first cassette.

[0026] In one aspect, the cassette assembly can balance on a portion of the drive module in a non-engaged position (non-engaged state).

[0027] In one aspect, each cassette is provided with a latch that can releasably engage with a corresponding drive module.

[0028] In one aspect, a sterilization cassette assembly includes a first cassette, a second cassette, and a third cassette; and a coupler that couples the first cassette, the second cassette, and the third cassette. When the first cassette, the second cassette, and the third cassette are coupled together with the coupler, they are independently movable relative to each other, either towards each other or away from each other.

[0029] In one aspect, the sterilization cassette assembly further includes a third cassette, and the coupler couples the first cassette, the second cassette, and the third cassette. When the first cassette, the second cassette, and the third cassette are coupled together with the coupler, they are independently movable relative to each other, either towards each other or away from each other.

[0030] In one aspect, the coupler includes a first arm fixed to the first cassette, a second arm fixed to the second cassette, and a third arm fixed to the third cassette. The first arm, the second arm, and the third arm are slidably connected to each other.

[0031] In one aspect, it further includes a first flexible support having a proximal end and a distal end attached to the first cassette, with a part of it extending through the second cassette; and a second flexible support having a proximal end and a distal end attached to the second cassette, with a part of it extending through the third cassette.

[0032] The content of the present invention will become more apparent by referring to the following detailed description together with the accompanying drawings. It should be noted that the reference numbers refer to the same parts (components, elements).

Brief Description of the Drawings

[0033]

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Embodiments for Carrying Out the Invention

[0034] FIG. 1 is a perspective view of an exemplary catheter-based treatment system 10 according to one embodiment. A catheter-based treatment system 10 is used to perform catheter-based medical treatments, such as, for example, percutaneous coronary intervention (PCI) (e.g., treating STEMI), neurovascular interventional procedure (NVI) (e.g., treating emergent large vessel occlusion (ELVO)), peripheral vascular intervention procedure (PVI) (e.g., treating critical limb ischemia), etc. Catheter-based medical treatments can include diagnostic catheter procedures, in which one or more catheters or other elongated medical devices (EMDs) are used to assist in diagnosing a patient's illness. For example, in one embodiment of a catheter-based diagnostic procedure, a contrast agent is injected into one or more arteries through the catheter while an image of the patient's vascular structure is taken. Medical treatments using a catheter can also include treatment procedures using a catheter (e.g., angioplasty, stent placement, treatment of peripheral vascular lesions, blood clot removal, arteriovenous fistula therapy, treatment of aneurysms, etc.), in which a catheter (or other EMD) is used to treat a lesion. Treatment procedures may be enhanced, for example, by including additional devices 54 (see FIG. 2), such as intravascular ultrasound (IVUS), optical coherence tomography (OCT), fractional flow reserve (FFR), etc. However, those skilled in the art should understand that specific percutaneous intervention devices or components (e.g., type of guide wire, type of catheter, etc.) can be selected based on the type of procedure being performed.The catheter-based treatment system 10 can perform catheter-based medical treatments any number of times with minor adjustments to adapt to the specific percutaneous intervention device used in the treatment.

[0035] The catheter-based treatment system 10 includes, among other things, a bedside device (clinical-side device) 20 and a control station (not shown). The bedside device 20 includes a robot drive unit (mechanical drive unit) 24 and a positioning system 22 disposed near the patient 12. The patient 12 is supported on a patient table 18. The positioning system 22 is used for positioning and supporting the robot drive unit 24. The positioning system 22 may be, for example, a robot arm, an articulated arm, a holder, or the like. One end of the positioning system 22 can be attached, for example, to the patient table 18 (see FIG. 1), a base, or a cart. The other end of the positioning system 22 is attached to the robot drive unit 24. The positioning system 22 can move outwards so as not to be obstructive (together with the robot drive unit 24) to enable the patient 12 to be placed on the patient table 18. When the patient 12 is placed on the patient table 18, the robot drive unit 24 can be positioned or arranged relative to the patient 12 using the positioning system 22 to perform the treatment. According to one embodiment, the patient table 18 is operably supported by a pedestal 17 fixed to the floor and / or the ground. The patient table 18 can move with multiple degrees of freedom (e.g., roll, pitch, yaw) relative to the pedestal 17. Also, the bedside device 20 can include a control device and a display (display device) 46 (shown in FIG. 2). For example, the control device and the display can be disposed on the housing of the robot drive unit 24.

[0036] Generally, the robot drive unit 24 includes a suitable percutaneous intervention device and accessories 48 (see FIG. 2) (for example, guide wires, various types of catheters, such as balloon catheters, stent delivery systems, stent retrievers, embolization coils, liquid embolics, suction pumps, contrast agent delivery devices, pharmaceuticals, hemostatic valve adapters, syringes, stopcocks, inflation devices, etc.) and performs various controls (such as control and input arranged at a control station) so that a user or operator can perform catheter-based medical procedures via the robot system. The bedside device 20, particularly the robot drive unit 24, can include components (parts) in any number and / or combination to provide the functions described herein to the bedside device 20. The robot drive unit 24 includes a plurality of device modules 32a - 32d attached to a rail or linear member (devices modularized). Each of the device modules 32a - 32d can be used to drive an EMD such as a catheter or guide wire. For example, using the robot drive unit 24, a guide wire can be automatically supplied into a diagnostic catheter and into a guide catheter within the artery of patient 12. One or more devices (apparatuses) such as an EMD enter the body (for example, a conduit) of patient 12 at the insertion point 16, for example, via an introducer sheath. Each device module 32a - 32d includes a drive module and a cassette removably attached to the drive module.

[0037] The bedside device 20 communicates with a control station (not shown), and can transmit a signal generated by a user input of the control station wirelessly or by wire to the bedside device 20 to control various functions of the bedside device 20. As will be described later, the control station may include a control computer system 34 (see FIG. 2), or may be coupled to the bedside device 20 via the control computer system 34. Further, the bedside device 20 may provide a feedback signal (e.g., loading, speed, operating conditions, warning signal, error code, etc.) to the control station, the control computer system 34 (see FIG. 2), or both. Communication between the control computer system 34 and various components of the catheter-based treatment system 10 can be provided via a communication link, but for example, a wireless connection, a cable (wired) connection, or any other means that enables communication between components can be used. The control station or other similar control system may be located at either a local site (e.g., the local control station 38 shown in FIG. 2) or a remote site (e.g., the remote (telemetry) control station and computer system 42 shown in FIG. 2). The catheter treatment system 10 may be operated simultaneously by a control station at a local site, a control station at a remote site, or both a local control station and a remote control station. At the local site, the user or operator and the control station are located in the same room or an adjacent room as the patient 12 and the bedside device 20. In the usage examples of this specification, the local site corresponds to the position of the bedside device 20 and the patient 12 or the subject (e.g., an animal or an anatomical cadaver), and the remote site corresponds to the position of the user or operator and the control station used to remotely control the bedside device 20. The control computer system at the local site and / or the control station (and the control computer system) at the remote site and the bedside device 20 can communicate using, for example, a communication system and service 36 (see FIG. 2) via the Internet.According to one embodiment, the remote site and the local (patient) site are separated from each other, for example, in multiple rooms within the same building, multiple buildings within the same city, multiple buildings in multiple cities, or other multiple locations, where the remote site does not have physical access to the bedside device 20 and / or the patient 12 at the local site.

[0038] The control station generally includes one or more input modules 28 configured to receive user input for operating various components or systems of the catheter-based treatment system 10. In the illustrated embodiment, the control station enables a user or operator to control the bedside device 20 to perform a catheter-based medical treatment. For example, the input module 28 may be configured to cause the bedside device 20 to perform various tasks (jobs) using a percutaneous intervention device (e.g., EMD) interfaced with the robot drive unit 24 (e.g., advancing, retracting, or rotating a guide wire, advancing, retracting, or rotating a catheter, inflating or deflating a balloon located on the catheter, positioning and / or deploying a stent, positioning and / or deploying a stent retriever, positioning and / or deploying a coil, injecting a contrast agent into the catheter, injecting a liquid embolism into the catheter, injecting a pharmaceutical or saline into the catheter, aspirating with the catheter, or performing any other function that can be performed as part of a catheter-based medical treatment). The robot drive unit 24 includes various drive mechanisms to cause movement (e.g., axial movement, rotational movement) of components of the bedside device 20 including the percutaneous intervention device.

[0039] In one embodiment, the input module 28 may include one or more touchscreens, joysticks, scroll wheels, and / or buttons. In addition to the input module 28, the control station may use additional user control units 44 (see FIG. 2) such as foot switches and microphones for voice commands. The input module 28 may be configured to advance, retract, or rotate various components and percutaneous intervention devices (e.g., guide wires and one or more catheters or micro-catheters). The buttons may include, for example, an emergency stop button, a multiplication button, a device selection button, and an automatic movement button. When the emergency stop button is pressed, the power supply (e.g., electricity) is cut off or removed from the bedside device 20. In the speed control mode, the multiplication button acts to increase or decrease the speed at which the associated components move in response to the operation of the input module 28. In the position control mode, the multiplication button changes the mapping between the input distance and the output command distance. The device selection button allows the user or operator to select which of the percutaneous intervention devices loaded in the robot drive unit 24 is to be controlled by the input module 28. The automatic movement button is used to enable the catheter-based treatment system 10 to perform algorithmic operations on the percutaneous intervention device without a direct command from the user or operator. In one embodiment, the input module 28 may include one or more control devices or icons (not shown) displayed on a touchscreen (which may or may not be part of the display), which, when actuated, cause the operation of the components of the catheter-based treatment system 10. Additionally, the input module 28 may include a balloon or stent control unit configured to inflate or deflate the balloon and / or deploy the stent. Each of the input modules 28 includes one or more buttons, scroll wheels, joysticks, touchscreens, etc., which are used to enable the control of specific components or a plurality of components to which dedicated controls are assigned.Furthermore, one or more touchscreens can display one or more icons (not shown) related to various parts of the input module 28 or one or more icons (not shown) related to various components of the catheter-based treatment system 10.

[0040] The catheter-based treatment system 10 also includes an imaging system 14. The imaging system 14 can be any medical imaging system that can be used in connection with catheter-based medical treatments (e.g., non-digital X-ray, digital X-ray, CT, MRI, ultrasound, etc.). In an exemplary embodiment, the imaging system 14 is a digital X-ray imaging device in communication with a control station. In one embodiment, the imaging system 14 can include a C-shaped arm (see FIG. 1) that can rotate partially or completely around the patient 12, thereby obtaining images at different angular positions (e.g., sagittal view, caudal view, anteroposterior view, etc.) with respect to the patient 12. In one embodiment, the imaging system 14 is a fluoroscopy system that includes a detector 15, also known as an intensifier, and an X-ray source 13 in a C-shaped arm.

[0041] The imaging system 14 may be configured to take X-ray images of the appropriate area of the patient 12 during the treatment. 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. Also, the imaging system 14 may take one or more X-ray images (e.g., real-time images) during a catheter-based medical treatment to assist the user or operator at the control station in properly positioning a guide wire, guide catheter, microcatheter, stent retriever, coil, stent, balloon, etc. during the treatment. One or more images can be displayed on the display 30. For example, an image may be displayed on the display 30 to enable the user or operator to accurately move a guide catheter or guide wire to the appropriate position.

[0042] To clarify the directions, a Cartesian coordinate system having an X-axis, a Y-axis, and a Z-axis is introduced. The positive X-axis is oriented in the longitudinal (axial) distal direction, i.e., in the direction from the proximal end to the distal end, or in other words, in the direction from the proximal side to the distal side. The Y-axis and the Z-axis are in a plane perpendicular to the X-axis, and the positive Z-axis is oriented upward, i.e., in the direction opposite to gravity. The Y-axis shall be automatically determined by the right-hand rule.

[0043] Figure 2 is a block diagram of a catheter-based treatment system 10 according to an exemplary embodiment. The catheter treatment system 10 may include a control computer system 34. Physically, the control computer system 34 may be, for example, part of a control station. The control computer system 34 may generally be an electronic control unit suitable for providing the catheter-based treatment system 10 with various functions described herein. For example, the control computer system 34 may be an embedded system, a dedicated circuit, a general-purpose system programmed to have the functions described herein, etc. The control computer system 34 communicates with a bedside device 20, a communication system and service 36 (e.g., the Internet, a firewall, a cloud service, a session manager, a hospital network, etc.), a local control station 38, an additional communication system 40 (e.g., a telepresence system), a remote control station and computer system 42, and a patient sensor 56 (e.g., an electrocardiogram (ECG) device, an electroencephalogram (EEG) device, a blood pressure monitor, a temperature monitor, a heart rate monitor, a respiration monitor, etc.). Also, the control computer system communicates with an imaging system 14, a patient table 18, an additional medical system 50, a contrast agent injection system 52, and an additional device 54 (e.g., IVUS, OCT, FFR, etc.). The bedside device 20 includes a robot drive unit 24, a positioning system 22, and may further include an additional control device and display 46. As described above, the additional control device and display can be arranged on the housing of the robot drive unit 24. An intervention device (interventional device) and accessories 48 (e.g., a guide wire, a catheter, etc.) interface (connect) with the bedside system 20. According to one embodiment, the intervention device and accessories 48 may include dedicated devices (e.g., an IVUS catheter, an OCT catheter, an FFR wire, a diagnostic catheter for contrast, etc.) that interface with their respective additional devices 54, i.e., an IVUS system, an OCT system, and an FFR system, etc.

[0044] In various embodiments, the control computer system 34 is configured to generate control signals that enable a medical procedure to be performed using the catheter-based treatment system 10 based on user interaction with an input module 28 (such as a control station like the local control station 38 or the remote control station 42) and / or information accessible to the control computer system 34. 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 computer system 42 can include components similar to those of the local control station 38. The remote control station 42 and the local control station 38 can be adjusted to be different depending on the required functionality. The additional user controls 44 can include, for example, one or more foot input control devices. The foot input control is configured such that the user can select functions of the imaging system 14, and for example, turn X-rays on and off for imaging, or enable scrolling through various stored images. In another embodiment, the foot input device can be configured such that the user can select which device is mapped to the scroll wheel included in the input module 28. An additional communication system 40 (such as audio conferencing, video conferencing, telepresence, etc.) can be used to assist an operator in interacting with a patient, medical staff (such as staff at an angiography facility), and / or equipment near the patient's bedside.

[0045] The catheter-based treatment system 10 may be connected or configured to include any other systems and / or devices not explicitly shown herein. For example, the catheter-based treatment system 10 may include an image processing engine, a data storage and archive system, an automatic balloon and / or stent inflation system, a pharmaceutical injection system, a pharmaceutical tracking and / or logging system, a user log, an encryption system, a system that restricts access to or use of the catheter-based treatment system 10, and the like.

[0046] As described above, the control computer system 34 communicates with the bedside device 20, which includes a robot drive unit 24 and a positioning system 22, and may further include an additional control device and display 46. The control computer system 34 can supply a control signal to the bedside device 20 to control the operation of the motor and drive mechanism used to drive a percutaneous intervention device (e.g., a guide wire, catheter, etc.). Various drive mechanisms can be provided as part of the robot drive unit 24.

[0047] Referring to FIGS. 3 and 15, the cassette assembly 100 includes a plurality of cassettes 102 coupled together with a coupler 104 (also referred to as a connector or coupler). As used herein, the term "cassette assembly" includes an assembly consisting of at least two cassettes. Referring to FIGS. 4A, 4B, and 4C, the cassette assembly 100 is an assembly consisting of at least a first cassette 112 and a second cassette 116. In one embodiment, the robot drive unit 24 includes a drive module to which the cassette assembly 100 is removably attached. The drive module corresponds to a part of the capital non-sterile portion of the robot drive unit 24. The cassette assembly 100 corresponds to a part of the sterile portion of the catheter-based treatment system 10. Each cassette 102 within the cassette assembly is attached to a respective drive module.

[0048] For each use of the robot drive unit 24, it is necessary to attach each cassette 102 to its respective drive module. In the procedure of using a plurality of cassettes 102, the cassette assembly 100 uses a single loading step, in which all the cassettes 102 of the cassette assembly 100 are loaded into their respective drive modules. In one embodiment, the coupler 104 is removably attached to the cassette 102 and is removed when each cassette is attached to its respective drive module. The drive module is moved along the longitudinal axis of the robot drive unit 24 to the loading configuration. The drive modules are positioned relative to each other at predetermined intervals. Also, the cassettes 102 of the cassette assembly 100 are positioned relative to each other at a predetermined interval in the loading position so that each cassette 102 can be aligned with its respective drive module during loading of the cassette assembly 100 into the robot drive unit 24.

[0049] In one embodiment, the coupler 104 includes an arm 108, and the arm 108 remains attached to the cassette during operation of the catheter-based treatment system 10. Referring to FIGS. 4A, 4B, and 4C, the coupler 104 includes a first arm 110 connected to a first cassette 112 and a second arm 114 connected to a second cassette 116, and the second arm 114 is slidably connected to the first arm 110. The first arm 110 and the second arm 114 each have a longitudinal axis. As described herein, the first arm 110 and the second arm 114 are connected to each other such that relative movement between the first arm 110 and the second arm 114 is possible only along each longitudinal axis. It is also conceivable to use other coupling devices to couple at least two cassettes and to allow the at least two cassettes to move relative to each other while remaining coupled. In one embodiment, the first arm is connected to the corresponding cassette, respectively. Each arm may be integrally formed with the cassette housing or may be attached to the cassette housing as a separate part.

[0050] The cassette assembly 100 includes a first flexible support 118 having a first distal end 120 and a first proximal end 122. The first distal end 120 is removably fixed to the first cassette 112, and the first proximal end 122 is fixed to the proximal end 124 of the first arm 110. A portion of the first flexible support 118 between the first distal end 120 and the first proximal end 122 is disposed within the second cassette 116.

[0051] In one embodiment, the cassette assembly 100 includes a third cassette 126 having a third arm 128. A second flexible support 130 has a second distal end 132 removably connected to the second proximal end of the second cassette 116 and a second proximal end 134 fixed to the proximal end of the second arm 114. A portion of the second flexible support 130 between the second distal end 132 and the second proximal end 134 is disposed within the third cassette 126.

[0052] In one embodiment, the cassette assembly 100 includes a fourth cassette 136 having a fourth arm 138. A third flexible support 140 has a third distal end 142 removably connected to the proximal end of the third cassette 126 and a third proximal end 144 fixed to the proximal end of the third arm 128. A portion of the third flexible support 140 between the third distal end 142 and the third proximal end 144 is disposed within the third cassette 126.

[0053] In one embodiment, the cassette assembly 100 includes a leading flexible support 146 having a leading proximal end 148 and a leading distal end 150. The leading distal end 150 is fixed to a sheath connection portion 152 by which the leading flexible support 146 is connected to an introducer sheath. The leading proximal end 148 is fixed to a support anchor 154 which is attached to the housing of the robot drive unit 24.

[0054] Referring to FIGS. 4A and 5A, in one embodiment, the direction of the leading flexible support 146 is oriented towards the support anchor 154 by a first guide (guide part) 156 included in the first arm 110, and by that support anchor 154, the proximal end 148 of the leading end of the flexible support 146 is connected to the housing of the robot drive unit 24.

[0055] The direction of the first flexible support 118 is oriented towards a first connector (connection part) 160 on the proximal end of the first arm 110 by a second guide (guide part) 158 included in the second arm 114. The first flexible support 118 includes a first distal end 120 and a first proximal end 122. The first proximal end 122 is fixed to the first connector 160 on the first arm 110. The first distal end 120 is removably fixed to the cassette 112.

[0056] The direction of the second flexible support 130 is oriented towards a second connector 164 on the proximal end of the second arm 114 by a third guide 162 included in the third arm 128. The second distal end 132 of the second flexible support 130 is removably fixed to the second cassette 116. The second proximal end 134 of the flexible support 130 is fixed to the second connector 164.

[0057] The direction of the third flexible support 140 is oriented towards a third connector 168 on the proximal end of the third arm 128 by a fourth guide 166 included in the fourth arm 138. The third proximal end 144 of the third flexible support 140 is fixed to the third connector 168. Referring to FIG. 6A, it is illustrated that the direction of the third flexible support 140 is changed from the first direction shown as region A, through the fourth guide shown as region B, towards the third connector 168 shown as region C by the fourth guide (director) 166.

[0058] Referring to FIGS. 4A and 7, the first arm 110 is fixed to the flange 170 of the first cassette. In one embodiment, the first cassette 112, the second arm 114, the third cassette 126, and the fourth cassette 136 each include a corresponding flange 170 of the first cassette, a flange 172 of the second cassette, a flange 174 of the third cassette, and a flange 176 of the fourth cassette. In one embodiment, each flange is identical and has four different connection regions. The first connection region is the farthest from the longitudinal axis of the cassette assembly 100. In one embodiment, the first connection region includes two openings, and two fasteners passing through them connect the first arm 110 to the first flange 170. Similarly, the second connection region, which is the second farthest from the longitudinal axis of the cassette assembly 100, includes two openings, and two fasteners passing through them connect the second arm 114 to the flange 172 of the second cassette. Also, the third connection region, which is the third farthest from the longitudinal axis of the cassette assembly 100, includes two openings, and two fasteners passing through them connect the third arm 128 to the flange 174 of the third cassette. And the fourth connection region, which is the closest to the longitudinal axis of the cassette assembly 100, includes two openings, and two fasteners passing through them connect the fourth arm 138 to the flange 176 of the fourth cassette. It should be noted that other fixing systems, such as other mechanical, chemical, or material fixing systems known in the art, can be used for these connection regions.

[0059] In one embodiment, the first arm 110, the second arm 114, the third arm 128, and the fourth arm 138 are stacked on top of each other, so that their respective longitudinal axes are spaced apart from the longitudinal axis of the cassette assembly 100 and are substantially parallel. Referring to FIG. 5A, each arm is stacked along the Z-axis.

[0060] Referring to FIG. 7, the first arm 110, the second arm 114, the third arm 128, and the fourth arm 138 each have a similar cross-section and can each be formed from an extruded material. The cross-section of the first arm 110 has a substantially S-shaped configuration, by which the first cavity 178 and the second cavity 180 are defined. The first cavity is formed from a first wall 182, a second wall 184, and a connecting wall 186. A guide wall 188 extends from the first wall 182, and this guide wall 188 extends towards the connecting wall 186 between the free end of the first wall 182 and the second wall 184. A tab 190 extends from the guide wall 188 in a direction away from the second wall 184 so as to form a pocket 192. The second cavity 180 is formed from the connecting wall 186, a third wall 194 extending from the connecting wall 186 in a direction away from the first wall 182, a fourth wall 196 extending in a direction away from the third wall, and a fifth wall 198 extending from the fourth wall 196 towards the connecting wall 186. Each arm is identical, and each part of each arm can be characterized similarly.

[0061] Each arm is slidably coupled or connected to an adjacent arm. The guide wall and tab of the second arm 114 are received within the second cavity 180 of the first arm 110, and the fifth wall 198 of the first arm 110 is disposed within the first cavity of the second arm 114.

[0062] The guide wall and tab of the third arm 128 are received within the second cavity of the second arm 114. The guide wall and tab of the fourth arm 138 are received within the second cavity of the third arm 128. By this alternating arrangement of the plurality of arms, relative arm movement is minimized in all directions, with the exception of movement along the longitudinal axis of the arms.

[0063] Referring to FIG. 4C, an example of the configuration of the cassette assembly 100 at the time of shipment is illustrated, in which the proximal end of the leading flexible support 146 and the support anchor 154 are disposed in proximity to the fourth cassette 136.

[0064] In one embodiment, the flexible support is a tube having a longitudinal slit, and the longitudinal slit extends substantially along the entire length of the tube. Each cassette operates a percutaneous device, and the percutaneous device is supported between the distal end of each cassette and the proximal cassette and / or the sheath connector. The manner in which each percutaneous device enters and exits the lumen (hollow or inner cavity) of the corresponding flexible support is described in the publication of International Application No. WO / 2021 / 011551, the title of which is "Systems, apparatus and methods for supporting and driving elongated medical devices in a robotic catheter-based procedure system", and the disclosure of that application is incorporated herein by reference. In this exemplary disclosure, the flexible support tube supports the percutaneous device as a plurality of cassettes, and the cassettes move independently of each other to allow the percutaneous device to enter and exit the lumen of the flexible support tube by splitters within each cassette. The flexible support allows the cassettes to move relative to each other without the percutaneous device buckling within the lumen of the flexible support tube. This can be achieved by automatically adjusting the length of the flexible support between the plurality of cassettes. For example, referring to FIG. 5A, when the second cassette 116 moves proximally towards the first cassette 112, a portion of the first flexible support 118 passes through a channel (path) within the second cassette 116 towards the first proximal end 122 of the first arm 110. Note that the second cassette 116 is fixed to the drive module of the robotic drive unit 24. The cassette 116 and its associated drive module together form a device module that moves together. This can be achieved by fixing the first flexible support 118 to the proximal end of the body of the first cassette 112 at the proximal end of the first flexible support 118 and to the proximal end of the first arm 110 at the distal end of the first flexible support 118.When the second cassette 116 moves towards the first cassette 112, the connection of the first proximal end 122 is placed in a tension state so that the first flexible support 118 does not buckle. Similarly, when the second cassette 116 moves away from the first cassette 112, the connection of the proximal end of the first flexible support 118 places the first flexible support 118 in a tension state. Note that the plurality of cassettes can move together at the same speed or at different speeds, and / or the direction and length of the flexible supports between the plurality of cassettes can be automatically adjusted.

[0065] The first flexible support 118 is fixed to the proximal end of the body of the first cassette 112 and the proximal end of the first arm 110, so that when the second cassette 116 moves relative to the first cassette 112, the flexible support 118 remains in a tension state. When each cassette moves along the cassette assembly 100, the flexible supports extending through the respective cassettes remain in a tension state. The reason is that the flexible support is supported at both its distal end and proximal end. The positions of the distal end and proximal end are at a fixed distance from each other. In the example of the first flexible support 118, the second flexible support 130, and the third flexible support 140, the distal end and proximal end of each support are fixed to the same cassette / arm configuration. The proximal end and distal end of the leading flexible support 146 are fixed to the sheath connection 152 and the support anchor 154, respectively. The sheath connection 152 and the support anchor 154 are in a fixed distance relationship at the use position of the installation of the catheter-based treatment system 10.

[0066] Referring to FIG. 15, the first cassette 112, the second cassette 116, the third cassette 126, and the fourth cassette 136 are each fixed to the corresponding first drive module 111, second drive module 115, third drive module 125, and fourth drive module 135 in a similar manner. Referring to FIGS. 8, 9, 10, 11, and 14, in one embodiment, the connection of each cassette to its corresponding drive module is the same. Thus, the attachment of the second cassette 116 to the second drive module 115 is the same as the attachment of the other cassettes to their corresponding drive modules. The second cassette 116 includes a latch 210 that moves in a sliding (sliding) manner from a disengaged position to an engaged position. A portion of the latch 210 releasably engages a tab on the drive module 115. The second cassette 116 includes a driven member 214 that releasably engages a drive member 216 of the second drive module 115. Referring to FIG. 14, the driven member 214 is surrounded by an outer cylindrical wall (cylindrical member) 218, thereby defining a cavity between the driven member 214 and the outer cylindrical wall 218. In one embodiment, the cavity is formed by the outer cylindrical wall 218 and a second concentric cylindrical wall (cylindrical member) 219. The second drive module 115 includes an outwardly extending cylindrical wall 220 that is received within the cavity when the cassette 116 moves toward the second drive module 115. The position of the outwardly extending cylindrical wall 220 within the cavity helps to minimize movement between the first flexible support 118 that is mounted and engaged and the second drive module 115. The driven member 214 is held within the drive module 115 by an elastic spring such as a portion of the second concentric cylindrical wall 219. In other words, the second concentric cylindrical wall 219 is provided with elastic finger-like portions, and the upper lips provided at the free ends of each finger portion hold the driven member 214 within the drive module 115.

[0067] The first flexible support 118 includes a stationary wall portion 222 that can be stationary or placed on the wall portion 224 of the second drive module 115 when the cassette assembly 100 is moved to the first installation position. The stationary wall portions of each cassette of the cassette assembly 100 can be placed on all corresponding support wall portions of each drive module. In one embodiment, the cassette assembly 100 is fully supported on the drive module in the initial installation position, so that the user or operator does not need to hold the cassette assembly 100 when installing the cassette assembly 100 on the robot drive unit 24. In other words, since the cassette assembly 100 is balanced on the drive module, the user can release both hands from the cassette assembly before latching the cassette to the drive module. Each cassette is provided with a positioning groove (recess) 226 that can receive a positioning pin 228. The user moves the cassette assembly 100 toward the drive module 115 once it is placed on the support surface. As a result, each tab is disposed within each recess and each cylindrical wall is disposed within each cavity. In this engaged position, each latch moves from the disengaged position to the engaged position, and as a result, each cassette is latched to the corresponding drive module.

[0068] Referring to FIGS. 12 and 13, the proximal end of the body of the second cassette 116 includes a first roller 200 and a second roller 202 to assist in guiding a portion of the first flexible support 118 as the portion of the first flexible support 118 moves through the second cassette 116 and through the second guide portion 158 toward the first connector 160. In one embodiment, additional rollers 204 can be provided to facilitate the smooth movement of the first flexible support 118 through the second cassette 116. As the first flexible support 118 moves through the second cassette 116, the roller 200 may pivot about the pin 206.

[0069] Referring to FIGS. 5A, 5B, 6A, and 6B, in one embodiment, as is known in the art, there is a fluid line 238 that communicates with the hemostatic valve 234 via port 236. In one embodiment, the fluid line 238 is connected to the port 236 of each hemostatic valve to enable the transfer of contrast agent, saline, therapeutic agent, or other fluids known in the art to the hemostatic valve. The fluid line 238 generally has a tubular shape and has a lumen therethrough. Referring to FIGS. 6A and 6B, within the cassette assembly, the fourth cassette and the most proximal cassette include fluid lines. In one embodiment of the system, the fourth cassette or the most proximal cassette can include a wire-based device, and in that case, it can be coupled to the cassette using a collet regardless of the hemostatic valve. Note that the most proximal device can include a catheter and a hemostatic valve. Note that the description of the fluid line for the most proximal cassette is also applicable to the fluid lines for more distal cassettes. Similarly, it is conceivable that not all cassettes include a fluid line with a hemostatic valve. In other words, in one embodiment, some, but not all, of the plurality of cassettes within the cassette assembly may include fluid lines.

[0070] Referring to FIGS. 5A and 6A, in one embodiment, the fluid line 238 extends generally upward along the positive Z-axis from port 236. In this embodiment, the fluid line 238 extends from the hemostatic valve in a direction away from the patient table 18. A cover 230 is pivotally attached to each drive module, and is attached near the bottom 230a of the cover 230. The top 230b restricts a portion of the fluid line 238 such that the fluid line 238 is oriented upward along the positive Z-axis in a direction away from the patient table 18.

[0071] Referring to FIGS. 5B and 6B, in one embodiment, the fluid line 238 extends from the port 236 in a first direction generally across the patient table along the positive Y-axis and then, under the influence of gravity, extends toward the patient table 18. The proximal opening 230c of the cover 230 allows the fluid line 238 to extend through the cover 230. The opening 230c includes a lower edge, an upper edge opposite thereto, and a distal edge. The opening 230c is completely open at the proximal end side. The lower and upper edges of the opening 230c assist in guiding the fluid line 238 as it extends from the port 236. In one embodiment, the port 236 is a side port that extends directly from the hemostatic valve body. However, it is also contemplated that the fluid line 238 may be fluidly connected to one leg of a Y-connector that extends at an angle with respect to the longitudinal axis of the hemostatic valve. In one embodiment, the fluid line 238 is releasably fluidly connected to one leg of a Y-connector that extends at an angle with respect to the longitudinal axis of the hemostatic valve. In one embodiment, the direction of the side port with the fluid line is 90 degrees (parallel to the patient table), and in one embodiment, the direction of the side port with the fluid line is a direction that droops toward the patient table. The open proximal side of the cover opening 230c allows the fluid line 238 to be easily positioned within the opening 230c of the cover 230 when the cover 230 is rotated to the closed position with respect to the bottom 230a. Referring to FIGS. 4B and 5B, all of the fluid lines 238 are away from the arms 110, 114, 128, and 138, avoiding entanglement of the fluid lines with associated connectors (e.g., plugs, etc.) known in the art. In other words, all of the fluid lines 238 are oriented such that they are away from or do not pass near the arms 110, 114, 128, and 138. In one embodiment (not shown), the cover opening 230c does not have an upper edge portion, eliminating the need for the fluid line to move through the side port on the proximal side of the opening 230c when the fluid line 238 is disposed within the cover 230.Among commercially available hemostatic valves, some have a port 236 that removably accepts the end of a fluid line, while other commercially available hemostatic valves have a fluid line integrally connected to the port 236 so that it cannot be removed immediately. In one embodiment, a connector is provided on the fluid line so that it can be removed. In an example of a fluid line that cannot be removed immediately from the port 236, no connector is provided. A removable fluid line and an integrated fluid line can be envisioned as alternative embodiments. When the fluid line is not integrated, a cover that can be rotated (pivoted) from an open position to a closed position can be used, and in that case, it may be avoided that the cover meets the side port of the Y-shaped connector of the hemostatic valve. When the fluid line is integrated with the port 236, there is an advantage in that the cover 230 can be rotated from a fully open position to a fully closed position without meeting the fluid line 238. In some procedure such as a neurovascular intervention procedure, each fluid line can be connected to a tube retrieved from a pressurized saline bag. Typically, the saline bag is suspended from a pole attached to a rail on the left side of the patient's table. Further, since the fluid line and the tube are retrieved below the robotic drive unit, it may be possible for a bedside user to access the operation of a stopper or a roller clamp (or a related coupler). In one embodiment, the cover 230 does not extend into the space where the side port protrudes. This cover 230 does not contact the fluid line when the cover moves from the open position to the closed position.

[0072] As used herein, terms such as "couple," "coupled," "coupler," "coupling," etc. are applicable to flexible couplers, rigid couplers, sliding couplers, releasable couplers, or other types of couplers. Note that separate cassettes may be arranged together so that each is arranged with respect to a corresponding drive module at the same time.

[0073] Hemostatic valves are known in the art. Conventional hemostatic valves have a rotating seal at the end, and each time a wire, micro-catheter, or guide wire is inserted or removed, the rotating seal can be opened and closed. In other words, in one embodiment, the seal itself does not rotate. Instead, the proximal end may be rotated to compress a Tuohy-Borst valve (which may have other readings such as Tuoyi-Borst valve or Twoi-Borst valve, etc.). Note that not all hemostatic valves have a Tuohy-Borst valve. These can be used to seal and minimize fluid loss during interventional and diagnostic procedures. The hemostatic valve allows devices such as catheters and other EMDs to open the valve and pass through, and automatically closes as soon as the device is removed. Note that it should be noted that when the EMD is withdrawn, a cross-cut elastic valve (or similar) closes. However, not all hemostatic valves have a cross-cut elastic valve. The hemostatic valve includes a first leg having a distal end and a proximal end. The second leg extends from the first leg and communicates with the first leg to allow fluid to be introduced into the proximal end of the second leg. The first leg of the hemostatic valve defines a longitudinal axis extending from the proximal end of the first leg to the distal end of the first leg. A luer connector may be included at the distal end of the first leg, and this luer connector may be rotatably coupled to the distal end of the first leg. The rotary luer connector includes an outer surface and an internal region, and the internal region is provided with a female interconnection of the luer for releasably coupling a guide catheter. In the art, luer connectors that allow for a secure flow between the guide catheter and the hemostatic valve are known. The luer connector is covered by ISO standard 80369-7. A rotating hemostasis valve (RHV) is attached to the proximal hub of the catheter and allows another device to be inserted while maintaining the seal. The RHV is equipped with a side port to allow connection to a syringe, heparinized saline line, contrast agent injection system, manual / pump suction, or manifold.The luer connector at the distal end of the RHV can rotate independently of the rest of the RHV, so the side port does not rotate when the catheter device rotates.

[0074] In one embodiment, the hemostatic valve device comprises one or more valves within a body having a lumen. The body has a proximal end and a distal end. The hemostatic valve device is connected to the proximal hub of the catheter. In one embodiment, the hemostatic valve device is removably connected to the proximal hub of the catheter. In one embodiment, the hemostatic valve device is adhered to the catheter device. In one embodiment, the hemostatic valve device is designed such that when the catheter is rotated, it comprises a rotary connector that seals fluid. An elongate medical device (EMD) extends through the hemostatic valve device. In one embodiment, the hemostatic valve device comprises a side port between the valve and the distal end of the hemostatic valve device. In one embodiment, the side port is not essential to the hemostatic valve device. The side port may be a separate component attached to the catheter device on the distal side of the hemostatic valve. In one embodiment, the valve is an elastomer (or elastomeric body) having a cross-cut (or other) shape, forming an opening that allows the EMD to be inserted and, when the EMD is removed, closing or sealing (based on the properties of the material). In one embodiment, the valve is a chewable boost valve that, when compressed, closes around the EMD or seals when the EMD is removed. When not compressed, the chewable boost valve has an open opening. Compression of the chewable boost valve is typically performed by rotating the proximal end of the hemostatic valve clockwise (CW). Also, closing of the chewable boost valve is typically performed by rotating the proximal end of the hemostatic valve counterclockwise (CCW).

[0075] As described above, the present disclosure has been explained with reference to examples of embodiments. However, those skilled in the art will recognize that it is possible to make changes to the forms and details of the above examples without departing from the scope and technical idea of the subject matter of the present invention. For example, in the examples of a plurality of embodiments, one or more features having one or more advantages are described. However, in the illustrated embodiments and alternative embodiments, the described features can be exchanged with each other or combined with each other. Since the technical idea of the present disclosure is relatively complex, it is difficult to anticipate all changes in the technical idea in advance. Therefore, the described present disclosure is intended to be construed as broadly as possible. For example, unless otherwise specified, the description of a single specific component shall also cover the application of a plurality of such components.

Claims

1. 1. A robotic drive system for driving one or more elongated medical devices, comprising: a robot drive; a sterilization cassette assembly; Including, The robot driving unit includes: A first drive module; a second drive module proximal to the first drive module; and the first drive module and the second drive module are each independently movable along a longitudinal axis of the robot drive; The sterilization cassette assembly comprises: A first cassette; a second cassette coupled to the first cassette using a coupler; and the first cassette and the second cassette are removably attached to the first drive module and the second drive module, respectively. Robot drive system.

2. 2. The robot drive system of claim 1, wherein the coupler includes a first arm connected to the first cassette and a second arm connected to the second cassette, the second arm being slidably connected to the first arm.

3. 3. The robot drive system of claim 2, wherein the first arm and the second arm are coupled to each other such that relative movement between the first arm and the second arm is permitted only along their respective longitudinal axes.

4. 4. The robot drive system of claim 3, further comprising a first flexible support having a first distal end and a first proximal end, the first distal end being removably fixed to the first cassette and the first proximal end being fixed to a proximal end of the first arm, and a portion of the first flexible support between the first distal end and the first proximal end being disposed within the second cassette.

5. 4. The robotic drive system of claim 3, wherein the sterilization cassette assembly further includes a third cassette, the coupler further includes a third arm slidably connected to the second arm, and the third cassette is connected to the third arm.

6. The robot drive system of claim 5 , wherein the second arm includes a first portion that slidably engages the first arm and a second portion that slidably engages the third arm.

7. 6. The robotic drive system of claim 5, wherein the sterilization cassette assembly further includes a fourth cassette, the coupler further includes a fourth arm slidably connected to the third arm, and the fourth cassette is connected to the fourth arm.

8. 6. The robot drive system of claim 5, further comprising a second flexible support having a second distal end and a second proximal end, the second distal end of the second flexible support being removably fixed to the second cassette and the second proximal end being fixed to a proximal end of the second arm, and a portion of the second flexible support between the second distal end and the second proximal end being disposed within the third cassette.

9. 4. The robot drive system of claim 3, further comprising a leading flexible support having a leading distal end and a leading proximal end, the leading distal end being removably secured to a distal sheath connector of the first cassette and the leading proximal end being secured to a robot drive housing, and a portion of the leading flexible support between the leading distal end and the leading proximal end being disposed within the first cassette.

10. 10. The robotic drive system of claim 9, wherein the first arm comprises a first guide that operably guides a portion of the leading flexible support between a support anchor on the robotic drive housing and the distal sheath connector.

11. 5. The robotic drive system of claim 4, wherein the second arm includes a second guide portion that operably guides a portion of the first flexible support between the proximal end of the first flexible support and the first cassette.

12. 9. The robotic drive system of claim 8, wherein the third arm includes a third guide portion that operatively guides a portion of the second flexible support between a proximal end of the first flexible support and the second cassette.

13. The robot drive of claim 1 , wherein each cassette comprises a portion that rests on a surface of a corresponding drive module when the respective cassette is attached to the corresponding drive module.

14. The robot drive of claim 1 , wherein the first cassette comprises a latch that releasably engages a tab in the drive module.

15. The robot drive of claim 1 , wherein the first cassette comprises a cylindrical cavity capable of receiving a cylindrical member of the drive module.

16. 1. A robotic drive system for driving one or more elongated medical devices, comprising: a robot drive; a sterilization cassette assembly; Including, The robot driving unit includes: A first drive module; a second drive module proximal to the first drive module; and a third drive module proximal to the second drive module; and the first drive module, the second drive module, and the third drive module are each independently movable along a longitudinal axis of the robot drive; The sterilization cassette assembly comprises: a first cassette having a first arm; a second cassette having a second arm; a third cassette having a third arm; a first flexible support having a proximal end attached to the first cassette and a distal end, a portion of the first flexible support extending through the second cassette; a second flexible support having a proximal end attached to the second cassette and a distal end, a portion of the second flexible support extending through the third cassette; Including, the first cassette, the second cassette, and the third cassette are independently movable relative to one another; the first arm, the second arm, and the third arm are slidably connected to one another; Robot drive system.

17. 17. The robotic drive system of claim 16, wherein the second arm includes a second guide that operably guides a portion of the first flexible support between a connector on the proximal end of the first arm and the first cassette.

18. 20. The robotic drive system of claim 17, further comprising a leading flexible support having a proximal end secured to a housing of the robotic drive and a distal end secured to a sheath connector, a portion of the leading flexible support moving through a channel in the first cassette.

19. The robotic drive system of claim 16 , wherein the cassette assembly is capable of balancing on a portion of the drive module in a disengaged position.

20. 20. The robotic drive system of claim 19, wherein each cassette is provided with a latch releasably engageable with a corresponding drive module.

21. 1. A sterilization cassette assembly comprising: A first cassette; A second cassette; a third cassette; and a coupler that couples the first cassette, the second cassette, and the third cassette; wherein the first cassette, the second cassette and the third cassette are independently movable towards or away from each other when coupled together with the coupler.

22. further comprising a third cassette, the combiner combining the first cassette, the second cassette, and the third cassette; 22. The sterilization cassette assembly of claim 21, wherein the first cassette, the second cassette and the third cassette are independently movable towards or away from each other when coupled together with the coupler.

23. The coupler includes: a first arm fixed to the first cassette; a second arm fixed to the second cassette; a third arm fixed to the third cassette; Equipped with 23. The sterilization cassette assembly of claim 22, wherein the first arm, the second arm and the third arm are slidably connected relative to one another.

24. a first flexible support having a proximal end attached to the first cassette and a distal end, a portion of the first flexible support extending through the second cassette; a second flexible support having a proximal end attached to the second cassette and a distal end, a portion of the second flexible support extending through the third cassette; 24. The sterilization cassette assembly of claim 23, further comprising:

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