Cassette assembly for robot 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 to U.S. Provisional Application No. 63 / 203,795, filed July 30, 2021, entitled "Cassette assembly for robotic drive," the disclosure of which is incorporated herein by reference.

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

[0003] Catheters and other elongated medical device(s) (EMDs) may be used for minimally invasive medical procedures to diagnose and treat a variety of vascular conditions, including those known as neurovascular interventional procedures (NVI) or neurointerventional surgery, percutaneous coronary intervention (PCI), and peripheral vascular intervention procedures (PVI). These procedures typically involve the delivery or administration of treatment using a guide wire introduced through the vasculature and a catheter advanced over the guide wire. Such catheterization procedures begin with gaining access into the appropriate vessel, such as an artery or vein, using standard percutaneous techniques to introduce an introducer catheter into the appropriate vessel, such as an artery or vein. - A sheath (introducer sheath) is used. Next, -Through the sheath, a sheath or guide catheter is advanced over the diagnostic guide wire to a primary location, e.g., the internal carotid artery for NVI, the coronary ostium for PCI, or the surface of the femoral artery for PVI. A guide wire appropriate to the vasculature is then guided through the sheath or guide catheter to a target location within the vasculature. In certain circumstances, such as tortuous anatomy, a support catheter or microcatheter may be inserted over the guide wire to help guide the guide wire. The physician or operator may obtain images (cine) using an imaging system (e.g., fluoroscopy) with contrast injection, which may be used as a roadmap to guide the guide wire or catheter to the target (e.g., lesion) location by selecting a fixed frame. As the physician advances the guide wire or catheter, contrast-enhanced images may also be obtained to confirm whether the device is moving along the correct path to the target location. While viewing the anatomy using fluoroscopy, the physician manipulates the proximal end of the guidewire or catheter to orient its distal end within the appropriate vessel to the lesion or target anatomical location while avoiding the distal end bifurcation (advancing into a side branch).

[0004] Robotic catheter-based treatment systems have been developed to aid physicians in performing catheter procedures (e.g., 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 robotic systems to control the manipulation of neurovascular guide wires and microcatheters to gain access to the target lesion, deliver therapy, and restore normal blood flow. Access to the target is provided by a sheath or guide catheter. However, in more distal areas, intermediate catheters may be required to allow proper support of the microcatheter or 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. Alternatively, to treat multiple aneurysms, a microcatheter may be advanced to the lesion, the guide wire removed, and multiple thrombus coils may be deployed within the aneurysm through the microcatheter to block blood flow into the aneurysm. Also, to treat arteriovenous malformations, liquid emboli may be injected into the malformation via a microcatheter. Mechanical thrombosis to treat vascular occlusions can be accomplished by aspiration and / or the use of a stent retriever. Depending on the location of the thrombus, aspiration is performed through the aspiration catheter or, in the case of smaller arteries, through a microcatheter. 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 through the microcatheter. Once the thrombus is integrated with the stent retriever, it is retrieved by retracting the stent retriever and microcatheter (or intermediate catheter) into the guide catheter.

[0005] In PCI, the physician may use a robotic system to manipulate a coronary guide wire to gain access to the lesion, deliver the treatment, and restore normal blood flow. This access is achieved by placing a guide catheter in the coronary ostium. The distal end of the guide wire is guided through the lesion, and in complex anatomy, a microcatheter may be used to properly support the guide wire. A stent or balloon is delivered to the lesion and deployed, restoring blood flow. The lesion may require preparation before stenting, for example, a balloon may be delivered to pre-dilatate the lesion, or an atherectomy may be performed, for example, using a laser or rotational atherectomy catheter and a balloon over a guide wire. Diagnostic imaging and physiologic measurements may be performed to determine the appropriate treatment, for example, by using an imaging catheter or fractional flow reserve (FFR) measurements.

[0006] In PVI, the physician restores blood flow by techniques similar to NVI, using a robotic system to deliver the treatment. The distal end of a guidewire is guided through the lesion, and a microcatheter may be used to provide adequate support of the guidewire against the complex anatomy. Blood flow may be restored by delivering and deploying a stent or balloon to the lesion. As with PCI, lesion preparation and imaging may be used as well.

[0007] When support at the distal end of the catheter or guidewire is required, for example to navigate tortuous or calcified vasculature to reach a distal anatomical location or to cross a stiff lesion, an over-the-wire (OTW) catheter or coaxial system may be used. OTW catheters have a lumen because the guidewire extends the entire length of the catheter. This results in a relatively stable system because the guidewire is supported along its entire length. However, this system has some disadvantages, such as higher friction and a longer overall length compared to rapid or quick exchange catheters (see below). Typically, in order to remove or exchange an OTW catheter while maintaining the position of the indwelling guidewire, the exposed length of the guidewire (outside the patient) must be longer than the OTW catheter. For example, a guidewire that is 300 cm long is usually sufficient for this purpose. This is sometimes referred to as an exchange-length guidewire. However, due to the length of the guide wire, two operators are required to remove and exchange the OTW catheter. This becomes even more difficult with triple coaxial, known in the art as triaxial systems (although the use of quadruple coaxial catheters is also known). However, OTW systems are often used in NVI and PVI procedures because of their stability. On the other hand, rapid exchange (or monorail) catheters are often used in PCI procedures. The guide wire lumen in rapid exchange catheters runs only through the distal portion of the catheter, which is also called the monorail or rapid exchange (RX) section. With the RX system, the operator operates the interventional devices parallel to each other (as opposed to the devices operated in a serial configuration in the OTW system), and the exposed length of the guide wire is only slightly longer than the RX section of the catheter. The length of the rapid exchange guide wire is usually 180-200 cm.When shorter guidewire lengths and monorails are used, RX catheters can be exchanged by a single operator. However, when more distal support is required, RX catheters are often inadequate. Summary of the Invention [Means for solving the problem]

[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 and a sterile cassette assembly. The robotic drive includes a first drive module and a second drive module proximal to the first drive module. The drive modules (first drive module and second drive module) are each independently movable along a longitudinal axis of the robotic drive. The sterile cassette assembly includes a first cassette and a second cassette coupled to the first cassette with (via) a 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, the second arm being slidably connected to the first arm.

[0010] In one embodiment, 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.

[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 and the first proximal end being fixed to the 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.

[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, the third cassette being connected to the third arm.

[0013] In one aspect, the second arm includes a first portion that slidably engages the first arm and a second portion that slidably engages 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 robotic 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 being removably fixed to the second cassette and the second proximal end being fixed to the proximal end of the second arm, and a portion of the second flexible support between the second distal end and the second proximal end is disposed within the third cassette.

[0016] In one aspect, the robotic drive system further includes an initial flexible support having a leading distal end and a leading proximal end, the leading distal end being removably fixed to a distal connector (sheath connector) of the first cassette and the leading proximal end being fixed to the robotic 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.

[0017] In one aspect, the first arm includes a first guide portion that operatively guides a portion of the leading flexible support between a support anchor on the housing of the robotic drive and a distal sheath connector.

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

[0019] In one aspect, the third arm includes a third guide portion that operatively 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 rests on a face of a corresponding drive module when the respective 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 embodiment, the first cassette includes a cylindrical cavity capable of receiving the cylindrical member of the drive module.

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

[0024] In one aspect, the second arm includes a second guide that operatively guides a portion between the 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 secured to the housing of the robotic drive and a distal end secured to the sheath connector, a portion of the leading flexible support capable of moving through a channel in the first cassette.

[0026] In one aspect, the cassette assembly can be balanced on a portion of the drive module in a disengaged position.

[0027] In one aspect, each cassette includes a latch releasably engageable with a corresponding drive module.

[0028] In one aspect, a sterilization cassette assembly includes a first cassette, a second cassette, a third cassette, and a coupler coupling the first cassette, the second cassette, and the third cassette, wherein the first cassette, the second cassette, and the third cassette are independently movable toward or away from each other when coupled together with the coupler.

[0029] In one aspect, the coupler comprises a first arm secured to the first cassette, a second arm secured to the second cassette, and a third arm secured to the third cassette, the first arm, the second arm, and the third arm being slidably connected relative to one another.

[0030] In one embodiment, the cassette further includes a first flexible support having a proximal end attached to the first cassette and a distal end, a portion of which extends through the second cassette; and a second flexible support having a proximal end attached to the second cassette and a distal end, a portion of which extends through the third cassette.

[0031] The present invention will become more apparent from the following detailed description taken in conjunction with the accompanying drawings, in which like reference numerals refer to like parts (components, elements), and in which: [Brief description of the drawings]

[0032] [Figure 1] FIG. 1 is a perspective view of an exemplary catheter treatment system according to one embodiment. [Diagram 2] FIG. 2 is a schematic block diagram of an exemplary catheter treatment system according to one embodiment. [Diagram 3] FIG. [Figure 4A] FIG. 2 is an exploded view of the cassette assembly. [Figure 4B] FIG. 13 is a perspective view of the cassette assembly in an extended orientation. [Figure 4C] The cassette assembly in the installation orientation. [Figure 5A] FIG. 13 is a side view of the robot drive and cassette assembly in the extended orientation. [Figure 5B] FIG. 13 is a side view of the robot drive and cassette assembly in an extended orientation with fluid lines extending downward. [Figure 6A] 6A is an enlarged view of a distal cassette of the cassette assembly taken generally along line 6A-6A of FIG. 5A. [Figure 6B] FIG. 6B is an enlarged view of a distal cassette of the cassette assembly taken generally along line 6B-6B of FIG. 5B. [Figure 7] 7 is a partial plan view of the cassette assembly taken generally along line 7-7 of FIG. 5A. [Figure 8] FIG. 13 is an exploded front perspective view of the cassette and associated drive module; [Figure 9] FIG. 13 is an exploded rear perspective view of the cassette and associated drive module; [Figure 10] FIG. [Figure 11] 11 is a cross-sectional side view of the cassette mounted in the drive module, taken generally along line 11-11 of FIG. 10. [Figure 12] FIG. 13 is a perspective view of the proximal side of the cassette. [Figure 13] 13 is a cross-sectional view of the cassette taken generally along line 13-13 of FIG. 12. [Figure 14] FIG. 4 is an enlarged view of a drive member of the drive module. [Figure 15] FIG. 1 is a perspective view of a robot drive including a drive module and a cassette assembly. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0033] FIG. 1 is a perspective view of an exemplary catheter-based procedure system 10, according to one embodiment. The catheter-based procedure system 10 may be used to perform catheter-based medical procedures, such as percutaneous coronary intervention (PCI) (e.g., to treat STEMI), neurovascular interventional procedures (NVI) (e.g., to treat emergency large vessel occlusion (ELVO), peripheral vascular intervention procedures (PVI) (e.g., to treat critical limb ischemia (CLI)), etc. Catheter-based medical procedures may include diagnostic catheterization procedures, in which one or more catheters or other elongated medical device(s) (EMDs) are used to aid in diagnosing a patient's condition. For example, one embodiment of a catheter-based diagnostic procedure involves the injection of contrast through a catheter into one or more arteries to obtain images of the patient's vasculature. Catheter-based medical procedures may also include catheter-based therapeutic procedures (e.g., angioplasty, placement of stents, treatment of peripheral vascular lesions, removal of blood clots, venous thrombosis, treatment of aneurysms, etc.) in which a catheter (or other EMD) is used to treat a lesion. Therapeutic procedures may be enhanced by the inclusion of additional devices 54 (see FIG. 2), such as, for example, intravascular ultrasound (IVUS), optical coherence tomography (OCT), fractional flow reserve (FFR), etc. However, it should be understood that one skilled in the art may select a particular percutaneous interventional device or component (e.g., type of guidewire, type of catheter, etc.) based on the type of procedure being performed.The catheter-based treatment system 10 can be used to perform any number of catheter-based medical procedures with minor adjustments to accommodate the particular percutaneous interventional device used in the procedure.

[0034] The catheter-based treatment system 10 includes, among other things, a bedside apparatus 20 and a control station (not shown). The bedside apparatus 20 includes a robotic drive 24 and a positioning system 22 that are disposed near the patient 12. The patient 12 is supported 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 articulated arm, a holder, or the like. The positioning system 22 may be attached at one end to, for example, the patient table 18 (see FIG. 1), a base, or a cart. The other end of the positioning system 22 is attached to the robotic drive 24. The positioning system 22 may be moved out of the way (together with the robotic drive 24) to allow the patient 12 to be placed on the patient table 18. Once the patient 12 is positioned on the patient table 18, the positioning system 22 can be used to position or position the robotic drive 24 relative to the patient 12 for performing a procedure. According to one embodiment, the patient table 18 is operably supported by a pedestal 17 that is fixed to the floor and / or ground. The patient table 18 can move with multiple degrees of freedom (e.g., roll, pitch, yaw) relative to the pedestal 17. The bedside device 20 can also include a controller and display 46 (shown in FIG. 2). For example, the controller and display can be located on a housing of the robotic drive 24.

[0035] Generally, the robotic drive 24 is coupled to suitable percutaneous interventional devices and accessories 48 (see FIG. 2) (e.g., guide wires, catheters of various types, e.g., balloon catheters, stent delivery systems, stent retrievers, etc.). -, embolic coils, liquid plugs, suction pumps, contrast delivery devices, medications, hemostasis valve adapters, syringes, stopcocks, inflation devices, etc., and various controls (e.g., controls and inputs located at a control station) to allow a user or operator to perform a catheter-based medical procedure via the robotic system. The bedside apparatus 20, and in particular the robotic drive 24, may include any number and / or combination of components to provide the bedside apparatus 20 with the functionality described herein. The robotic drive 24 includes a number of device modules 32a-32d mounted on a rail or linear member. Each of the device modules 32a-32d may be used to drive an EMD, such as a catheter or a guide wire. For example, the robotic drive 24 may be used to automatically feed a guide wire into a diagnostic catheter and into a guide catheter in an artery of the patient 12. One or more devices, such as EMDs, enter the body (e.g., a duct) of the patient 12 at an insertion point 16, for example, via an introducer sheath. · Modules 32a-32d include a drive module and a cassette removably attached to the drive module.

[0036] The bedside device 20 is in communication with a control station (not shown) such that signals resulting from user inputs at the control station can be transmitted, wirelessly or via wires, to the bedside device 20 to control various functions of the bedside device 20. As described below, 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. The bedside device 20 may also provide feedback signals (e.g., load, speed, operating conditions, warning signals, error codes, etc.) to the control station, the control computer system 34 (see FIG. 2), or both. Communication between the control computer system 34 and the various components of the catheter-based treatment system 10 may be provided via communication links, such as wireless connections, cable (wired) connections, or any other means that allows communication between the components. The control station or other similar control system may be located at either a local site (e.g., local control station 38 shown in FIG. 2) or a remote site (e.g., remote control station and computer system 42 shown in FIG. 2). The catheterization system 10 may be operated by a control station at a local site, a control station at a remote site, or by both a local control station and a remote control station simultaneously. At a local site, a user or operator and control station are located in the same room as the patient 12 and the bedside device 20 or in an adjacent room. In the examples used herein, a local site corresponds to the location of the bedside device 20 and the patient 12 or subject (e.g., an animal or cadaver), and a remote site corresponds to the location of a user or operator and control station used to remotely control the bedside device 20. The control computer system at the local site and / or the control station (and control computer system) at the remote site and the bedside device 20 may communicate using communication systems and services 36 (see FIG. 2), e.g., via the Internet.According to one embodiment, the remote site and the local (patient) site are separate from one another, for example, multiple rooms in the same building, multiple buildings in the same city, multiple buildings in multiple cities, or other locations where the remote site does not have physical access to the bedside device 20 and / or patient 12 at the local site.

[0037] The control station generally includes one or more input modules 28 configured to receive user inputs that operate various components or systems of the catheter-based procedure system 10. In the illustrated embodiment, the control station allows a user or operator to control the bedside device 20 to perform a catheter-based medical procedure. For example, the input module 28 may be configured to cause the bedside device 20 to perform various tasks using a percutaneous interventional device (e.g., EMD) interfaced with the robotic drive 24 (e.g., advance, retract, or rotate a guidewire, advance, retract, or rotate a catheter, inflate or deflate a balloon located on a catheter, position and / or deploy a stent, position and / or deploy a stent retriever, position and / or deploy a coil, inject contrast into the catheter, inject a liquid embolic into the catheter, inject a medicinal agent or saline into the catheter, aspirate through 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 effecting movement (eg, axial and rotational movement) of components of the bedside device 20, including the percutaneous intervention device.

[0038] In one embodiment, the input module 28 may include one or more touch screens, joysticks, scroll wheels, and / or buttons. In addition to the input module 28, the control station may use additional user controls 44 (see FIG. 2), such as a foot switch, a microphone for voice commands, and the like. The input module 28 may be configured to advance, retract, or rotate various components and percutaneous interventional devices (e.g., guide wires, and one or more catheters or microcatheters, etc.). The buttons may include, for example, an emergency stop button, a multiplication button, a device selection button, and an auto move button. When the emergency stop button is pressed, power (e.g., electrical power) is cut off or removed from the bedside device 20. In a speed control mode, the multiplication button acts to increase or decrease the speed at which an associated component moves in response to manipulation of the input module 28. In a position control mode, the multiplication button changes the mapping between an input distance and an output commanded distance. The device selection button allows the user or operator to select which of the percutaneous interventional devices loaded on the robotic drive 24 will be controlled by the input module 28. The auto move button is used to enable algorithmic operations that the catheter-based treatment system 10 can execute on the percutaneous interventional device without direct command from the user or operator. In one embodiment, the input module 28 may include one or more controls or icons (not shown) displayed on a touch screen (which may or may not be part of the display) that, when activated, cause the operation of the 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 may include one or more buttons, scroll wheels, joysticks, touch screens, etc., that allow for control of a particular component or components to which dedicated controls are assigned.Additionally, the one or more touch screens may display one or more icons (not shown) associated with various portions of the input module 28 or one or more icons (not shown) associated with various components of the catheter-based treatment system 10.

[0039] The catheter-based treatment system 10 also includes an imaging system 14. The imaging system 14 may be any medical imaging system that may be used in connection with a catheter-based medical treatment (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 imager in communication with a control station. In one embodiment, the imaging system 14 may include a C-arm (see FIG. 1 ) that allows the imaging system 14 to rotate partially or fully around the patient 12 to obtain images at different angular positions (e.g., sagittal view, caudal view, anterior-posterior view, etc.) relative to the patient 12. In one embodiment, the imaging system 14 is a fluoroscope system that includes a C-arm having a detector 15, also known as an image intensifier, and an x-ray source 13.

[0040] The imaging system 14 may be 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 a user or operator at the control station in properly positioning a guide wire, guide catheter, microcatheter, stent retriever, coil, stent, balloon, etc., during a procedure. An image or multiple images may be displayed on the display 30. For example, images may be displayed on the display 30 to enable a user or operator to accurately move a guide catheter or guide wire to the appropriate position.

[0041] For directional clarity, a Cartesian coordinate system is introduced with X, Y and Z axes. The positive X axis is oriented in the longitudinal (axial) distal direction, i.e. from the proximal end to the distal end, in other words from the proximal side to the distal side. The Y and Z axes are in a plane perpendicular to the X axis, and the positive Z axis is oriented upwards, i.e. opposite to the direction of gravity. The Y axis is assumed to be automatically determined by the right-hand rule.

[0042] FIG. 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. The control computer system 34 may be physically part of, for example, 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 the various functions described herein. For example, the control computer system 34 may be an embedded system, a dedicated circuit, a general-purpose system programmed with the functions described herein, etc. The control computer system 34 is in communication with the bedside devices 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 computer 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 computer system is also in communication with the imaging system 14, the patient table 18, the additional medical system 50, the contrast injection system 52, and the additional devices 54 (e.g., IVUS, OCT, FFR, etc.). The bedside apparatus 20 includes the robotic drive 24, the positioning system 22, and may 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 accessories 48 (e.g., guide wires, catheters, etc.) interface with the bedside system 20. According to one embodiment, the interventional devices and accessories 48 may include dedicated devices (e.g., IVUS catheters, OCT catheters, FFR wires, contrast diagnostic catheters, etc.) that interface with the respective additional devices 54, i.e., IVUS systems, OCT systems, FFR systems, etc.

[0043] 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 procedure system 10 based on user interaction with the input modules 28 (e.g., a control station such as a local control station 38 or a 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 may include similar components as the local control station 38. The remote control station 42 and the local control station 38 may be configured differently depending on the functionality required. The additional user controls 44 may include, for example, one or more foot input controls. The foot input controls may be configured to allow a user to select a function of the imaging system 14, such as to turn x-rays on and off to capture, scroll through various stored images, etc. In another embodiment, the foot input device may be configured to allow a user to select which device is mapped to a scroll wheel included in the input module 28. Additional communication systems 40 (e.g., audio conferencing, video conferencing, telepresence, etc.) may be used to help the operator interact with the patient, medical staff (e.g., angiography lab staff), and / or equipment near the bedside.

[0044] The catheter-based treatment system 10 may be connected or configured to include any other systems and / or devices not expressly shown herein, such as, for example, 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 to or use of the catheter-based treatment system 10, etc.

[0045] As mentioned above, the control computer system 34 is in communication with the bedside device 20, which includes the robotic drive 24, the positioning system 22, and may further include additional controls and a display 46, and the control computer system 34 may provide control signals to the bedside device 20 for controlling the operation of motors and drive mechanisms used to drive percutaneous interventional devices (e.g., guide wires, catheters, etc.). Various drive mechanisms may be provided as part of the robotic drive 24.

[0046] 3 and 15, the cassette assembly 100 includes a plurality of cassettes 102 coupled together with couplers 104. As used herein, the term "cassette assembly" includes an assembly of at least two cassettes. With reference to FIGS. 4A, 4B, and 4C, the cassette assembly 100 includes at least a first cassette 112 and a second cassette 116. In one embodiment, the robotic drive 24 includes a drive module to which the cassette assembly 100 is removably attached. The drive module is a portion of the non-sterile portion of the robotic drive 24. The cassette assembly 100 is a portion of the sterile portion of the catheter-based treatment system 10. Each cassette 102 in the cassette assembly is attached to a respective drive module.

[0047] For each use of the robot drive 24, it is necessary to mount each cassette 102 to its respective drive module. In procedures using multiple cassettes 102, the cassette assembly 100 uses a single loading step in which all cassettes 102 of the cassette assembly 100 are loaded into their respective drive modules. In one embodiment, the couplers 104 are removably attached to the cassettes 102 and are removed once each cassette is attached to its respective drive module. The drive modules are moved along the longitudinal axis of the robot drive 24 to the loading configuration. The drive modules are positioned relative to one another at a predetermined interval. Also, the cassettes 102 of the cassette assembly 100 are positioned relative to one another at a predetermined interval in the loading position to allow each cassette 102 to align with its respective drive module during loading of the cassette assembly 100 into the robot drive 24.

[0048] In one embodiment, the coupler 104 includes an arm 108 that remains attached to the cassette during operation of the catheter-based treatment system 10. With reference 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, the second arm 114 being 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 coupled to each other such that relative movement between the first arm 110 and the second arm 114 is only possible along their respective longitudinal axes. It is contemplated that other coupling devices may be used to couple the at least two cassettes together while allowing the at least two cassettes to move relative to one another while still in the coupled state. In one embodiment, each of the first arms is connected to a corresponding cassette. Each arm may be integrally formed with the cassette housing or may be attached to the cassette housing as a separate part.

[0049] 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 secured to the first cassette 112, and the first proximal end 122 is secured to a 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.

[0050] 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 that is removably connected to the second proximal end of the second cassette 116 and a second proximal end 134 that is 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.

[0051] 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 that is removably connected to the proximal end of the third cassette 126 and a third proximal end 144 that is fixed to the proximal end of the third arm 128. The portion of the third flexible support 140 between the third distal end 142 and the third proximal end 144 is 4th Cassette 136 is placed inside.

[0052] In one embodiment, cassette assembly 100 includes a leading flexible support 146 having a leading proximal end 148 and a leading distal end 150. Leading distal end 150 is secured to a sheath connection 152, which connects leading flexible support 146 to an introducer sheath. Leading proximal end 148 is secured to a support anchor 154, which is attached to the housing of robotic drive 24.

[0053] 4A and 5A, in one embodiment, a first guide 156 included in the first arm 110 orients the leading flexible support 146 toward a support anchor 154, which connects a leading proximal end 148 of the flexible support 146 to the housing of the robot drive 24.

[0054] A second guide 158 included in the second arm 114 orients the first flexible support 118 toward a first connector 160 on the proximal end of the first arm 110. 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.

[0055] A third guide 162 included in the third arm 128 orients the second flexible support 130 toward a second connector 164 on the proximal end of the second arm 114. A second distal end 132 of the second flexible support 130 is removably fixed to the second cassette 116. A second proximal end 134 of the flexible support 130 is fixed to the second connector 164.

[0056] A fourth guide 166 included in the fourth arm 138 orients the third flexible support 140 toward a third connector 168 on the proximal end of the third arm 128. A third proximal end 144 of the third flexible support 140 is fixed relative to the third connector 168. Referring to FIG. 6A, it is illustrated that the fourth guide (director) 166 changes the orientation of the third flexible support 140 from a first orientation shown as region A through the fourth guide shown as region B toward the third connector 168 shown as region C.

[0057] 4A and 7, the first arm 110 is secured to a first cassette flange 170. In one embodiment, the first cassette 112, the second arm 114, the third cassette 126, and the fourth cassette 136 each include a corresponding first cassette flange 170, a second cassette flange 172, a third cassette flange 174, and a fourth cassette flange 176. In one embodiment, each flange is identical and has four different connection regions. The first connection region is furthest from the longitudinal axis of the cassette assembly 100. In one embodiment, the first connection region includes two openings through which two fasteners connect the first arm 110 to the first flange 170. Similarly, the second connection region, second furthest from the longitudinal axis of the cassette assembly 100, includes two openings through which two fasteners connect the second arm 114 to the flange 172 of the second cassette. The third connection region, third furthest from the longitudinal axis of the cassette assembly 100, includes two openings through which two fasteners connect the third arm 128 to the flange 174 of the third cassette. And the fourth connection region, closest to the longitudinal axis of the cassette assembly 100, includes two openings through which two fasteners connect the fourth arm 138 to the flange 176 of the fourth cassette. It should be noted that these connection regions may use other fastening systems, such as other mechanical, chemical or material fastening systems known in the art.

[0058] In one embodiment, first arm 110, second arm 114, third arm 128 and fourth arm 138 are stacked on top of one another such that their respective longitudinal axes are spaced apart from and substantially parallel to the longitudinal axis of cassette assembly 100. Referring to FIG. Z They are stacked along the axis.

[0059] 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 may each be formed from an extrusion material. The cross-section of the first arm 110 has a generally S-shaped configuration that defines a first cavity 178 and a second cavity 180. 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 between the free end of the first wall 182 and the second wall 184 toward the connecting wall 186. A tab 190 extends from the guide wall 188 away from the second wall 184 to form a pocket 192. The second cavity 180 is formed by a 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 away from the third wall, and a fifth wall 198 extending from the fourth wall 196 toward the connecting wall 186. Each arm is identical and each portion of each arm may be similarly characterized.

[0060] 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.

[0061] 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. This staggered arrangement of arms minimizes relative arm movement in all directions, with the exception of movement along the longitudinal axes of the arms.

[0062] With reference to FIG. 4C, the cassette assembly 100 is illustrated in an as-shipped configuration with the proximal end of the leading flexible support 146 and the support anchor 154 positioned adjacent to the fourth cassette 136.

[0063] In one embodiment, the flexible support is a tube having a longitudinal slit that extends substantially along the entire length of the tube. Each cassette operates a percutaneous device that is connected to the distal end of each cassette and to the proximal cassette and / or sheath. vinegarThe percutaneous device is supported between the flexible support and the connector. The manner in which each percutaneous device moves in and out of the lumen of the corresponding flexible support is described in International Application Publication No. WO / 2021 / 011551, entitled "Systems, apparatus and methods for supporting and driving elongated medical devices in a robotic catheter-based procedure system," the disclosure of which is incorporated herein by reference. In this disclosure, the flexible support tube supports the percutaneous devices as cassettes that move independently of one another, with splitters in each cassette allowing the percutaneous devices to move in and out of the lumen of the flexible support tube. The flexible support allows the cassettes to move relative to one another without buckling the percutaneous devices within the lumen of the flexible support tube. This can be achieved by automatically adjusting the length of the flexible support between the cassettes. For example, referring to FIG. 5A, as the second cassette 116 moves proximally towards the first cassette 112, a portion of the first flexible support 118 passes through a channel in the second cassette 116 towards the first proximal end 122 of the first arm 110. Note that the second cassette 116 is secured to a drive module of the robot drive 24. The cassette 116 and its associated drive module form a device module that moves together. This can be accomplished by securing the first flexible support 118 at a proximal end of the first flexible support 118 to a proximal end of the body of the first cassette 112 and at a distal end of the first flexible support 118 to a proximal end of the first arm 110. As the second cassette 116 moves towards the first cassette 112, the connection at the first proximal end 122 is in tension to prevent the first flexible support 118 from buckling.Similarly, the connection at the proximal end of the first flexible support 118 places the first flexible support 118 in tension as the second cassette 116 moves away from the first cassette 112. Note that multiple cassettes can move together at the same or different speeds and / or the orientation and length of the flexible supports between multiple cassettes can be automatically adjusted.

[0064] Because 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, the flexible support 118 remains in tension as the second cassette 116 moves relative to the first cassette 112. As each cassette moves along the cassette assembly 100, the flexible support extending through each cassette remains in tension because the flexible support is supported at both its distal and proximal ends. The locations of the distal and proximal ends are fixed distances relative to each other. In the example of the first flexible support 118, the second flexible support 130, and the third flexible support 140, the distal and proximal ends of each support are fixed to the same cassette / arm configuration. The proximal and distal ends of the leading flexible support 146 are secured to a sheath connection portion 152 and a support anchor 154, respectively. The sheath connection portion 152 and the support anchor 154 are at a fixed distance from each other in a deployed, use position of the catheter-based treatment system 10.

[0065] 15, the first cassette 112, the second cassette 116, the third cassette 126, and the fourth cassette 136 are secured to the corresponding first drive module 111, the second drive module 115, the third drive module 125, and the fourth drive module 135, respectively, in a similar manner. With reference to FIGS. 8, 9, 10, 11, and 14, in one embodiment, the connections of each cassette to the corresponding drive module are 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 slides from a disengaged position to an engaged position. A portion of the latch 210 releasably engages with 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 218 that defines 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 219. The second drive module 115 includes an outwardly extending cylindrical wall 220 that is received within the cavity as the cassette 116 moves toward the second drive module 115. The location of the outwardly extending cylindrical wall 220 within the cavity helps to minimize movement between the mounted and engaged first flexible support 118 and the second drive module 115. The driven member 214 is held within the drive module 115 by a resilient spring such as the portion of the second concentric cylindrical wall 219. In other words, the second concentric cylindrical wall 219 is provided with resilient finger portions that retain the driven member 214 within the drive module 115 by an upper lip at the free end of each finger portion.

[0066] The first flexible support 118 includes a stationary wall portion 222 that can rest or rest on a wall portion 224 of the second drive module 115 when the cassette assembly 100 is moved to a first installation position. The stationary wall portion of each cassette of the cassette assembly 100 can rest 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 a user or operator does not need to hold the cassette assembly 100 when installing the cassette assembly 100 on the robot drive 24. In other words, the cassette assembly 100 is balanced on the drive module, so that a user can remove both hands from the cassette assembly before latching the cassette to the drive module. Each cassette is provided with a locating groove 226 that can receive a locating pin 228. The user moves the cassette assembly 100, once placed on the support surface, towards the drive module 115 so that the tabs are located in the recesses and the cylindrical walls are located in the cavities. In the engaged position, the latches move from a disengaged position to an engaged position so that the cassette is locked to the corresponding drive module.

[0067] 12 and 13, the proximal end of the body of the second cassette 116 is illustrated to include a first roller 200 and a second roller 202 to help guide the portion of the first flexible support 118 as it moves through the second cassette 116 via the second guide 158 toward the first connector 160. In one embodiment, an additional roller 204 can be provided to facilitate smooth movement of the first flexible support 118 through the second cassette 116. The rollers 200 can pivot about a pin 206 as the first flexible support 118 moves through the second cassette 116.

[0068] 5A, 5B, 6A, and 6B, in one embodiment, a fluid line 238 is in fluid communication with the hemostasis valve 234 via a port 236, as known in the art. In one embodiment, a fluid line 238 is connected to the port 236 of each hemostasis valve to allow for the transfer of fluids, such as contrast, saline, therapeutic agents, or other fluids known in the art, to the hemostasis valve. The fluid line 238 is generally tubular in shape with a lumen therethrough. With reference to FIGS. 6A and 6B, the fourth and most proximal cassettes of the cassette assembly include fluid lines, however, in one embodiment of the system, the fourth or most proximal cassette may include a wire-based device that may be coupled to the cassette using a collet rather than a hemostasis valve. The most proximal device may include a catheter and a hemostasis valve. The description of the fluid line for the most proximal cassette may also be applied to the fluid lines for the more distal cassettes. Similarly, it is contemplated that not all cassettes will include fluid lines with hemostasis valves, In other words, in one embodiment, some, but not all, of the cassettes in a cassette assembly may include fluid lines.

[0069] 5A and 6A, in one embodiment, the fluid lines 238 extend from the ports 236 in a generally upward direction along the positive Z axis. In this embodiment, the fluid lines 238 extend from the hemostasis valve in a direction away from the patient table 18. A cover 230 is pivotally attached to each drive module near a bottom portion 230a of the cover 230. A top portion 230b restricts a portion of the fluid lines 238 such that the fluid lines 238 are oriented upward along the positive Z axis, away from the patient table 18.

[0070] 5B and 6B, in one embodiment, the fluid line 238 extends from the port 236 in a first direction along the positive Y-axis, generally across the patient table, and then the flexible fluid line 238 extends toward the patient table 18 under the influence of gravity. An opening 230c on the proximal side of the cover 230 allows the fluid line 238 to extend through the cover 230. The opening 230c includes a lower edge, an opposing upper edge, and a distal edge. The opening 230c is completely open at the proximal end. The lower and upper edges of the opening 230c help guide 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 hemostasis valve body. However, it is also contemplated that the fluid line 238 is fluidly connected to one leg of a Y-connector that extends at an angle relative to the longitudinal axis of the hemostasis valve. In one embodiment, the fluid line 238 is releasably fluidly connected to one leg of a Y-connector that extends at an angle relative to the longitudinal axis of the hemostasis 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 downwardly directed 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 a closed position relative to the bottom 230a. 4B and 5B, all fluid lines 238 are directed away from arms 110, 114, 128, and 138 to avoid entangling the fluid lines with associated couplings (e.g., stopcocks, etc.) known in the art. In other words, all fluid lines 238 are oriented away from or not near arms 110, 114, 128, and 138. In one embodiment (not shown), cover opening 230c does not have a top edge, thereby eliminating the need for the fluid lines to travel through a side port proximal to opening 230c when fluid lines 238 are positioned within cover 230.Some commercially available hemostasis valves are provided with a port 236 that removably receives the end of a fluid line, while other commercially available hemostasis valves are provided with a fluid line that is integrally connected to the port 236 such that it cannot be readily removed. R In one embodiment, the fluid lines are provided with connectors so that they can be removed. In one example of a fluid line that is not readily removable from the port 236, no connector is provided. Removable and integrated fluid lines are envisioned as alternative embodiments. If the fluid lines are not integrated, a cover that can be pivoted from an open position to a closed position can be used, avoiding encountering the side port of the Y-connector of the hemostasis valve. If the fluid lines are integrated with the port 236, there is an advantage in that the cover 230 can be pivoted from a fully open position to a fully closed position without encountering the fluid lines 238. In some procedures, such as neurovascular interventional procedures, each fluid line can be connected with tubing routed from a pressurized saline bag. Typically, the saline bag hangs from a pole that is attached to a rail on the left side of the patient table. Additionally, the fluid lines and tubing can be routed below the robotic drive, allowing access to the bedside user to operate the stopcock or roller clamp (or associated coupling). In one embodiment, the cover 230 does not extend into the space into which the side ports protrude. The cover 230 does not contact the fluid lines as the cover moves from the open position to the closed position.

[0071] As used herein, terms such as "couple," "coupled," "coupler," "coupling," and the like, may apply to flexible couplers, rigid couplers, sliding couplers, releasable couplers, or other types of couplers. Note that separate cassettes may be positioned together such that each is positioned with respect to a corresponding drive module at the same time.

[0072] Hemostatic valves are known in the art. A conventional hemostatic valve has a rotating seal at the end that can be opened and closed whenever a wire, microcatheter, or guidewire is inserted and removed. In other words, in one embodiment, the seal itself does not rotate, but rather the proximal end may be rotated to compress a Tuohy-Borst valve. Not all hemostatic valves have Tuohy-Borst valves. These may be used to seal and minimize fluid loss during interventional and diagnostic procedures. Hemostatic valves allow catheters and other instruments, such as EMDs, to pass through the valve by opening it, and automatically close as soon as the instrument is removed. Note that when the EMD is withdrawn, a cross-cutting elastic valve (or similar) closes. Not all hemostatic valves have cross-cutting elastic valves. The hemostatic valve includes a first leg having a distal end and a proximal end. A second leg extends from the first leg and is in fluid communication with the first leg to allow fluid to be introduced to 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. The distal end of the first leg may include a luer connector that may be rotatably coupled to the distal end of the first leg. The rotatable luer connector includes an exterior surface and an interior region that includes a luer female interconnect for releasably coupling a guide catheter. Luer connectors that allow for tight fluid communication between a guide catheter and a hemostatic valve are known in the art. Luer connectors are covered by ISO standard 80369-7. A rotating hemostasis valve (RHV) is attached to the proximal hub of a catheter to allow insertion of additional equipment while maintaining a seal. The RHV has side ports to allow connection to syringes, heparinized saline lines, contrast injection systems, manual / pump suction, or manifolds.The luer connector at the distal end of the RHV can rotate independently of the rest of the RHV so that the side port does not rotate when the catheter device rotates.

[0073] 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 a proximal hub of a 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 glued to the catheter device. In one embodiment, the hemostatic valve device comprises a rotating connector designed to allow the catheter to be rotated, providing a fluid seal. An elongated 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 integral to the hemostatic valve device. The side port may be a separate piece attached to the catheter device distal to the hemostatic valve. In one embodiment, the valve is an elastomer (or elastic) having a cross-cut (or other) shape that forms an opening that allows the EMD to be inserted and closes or seals (based on the material properties) when the EMD is removed. In one embodiment, the valve is a Chewy-Borst valve that, when compressed, closes around the EMD or seals when the EMD is removed. When not compressed, the Chewy-Borst valve has an opening that remains open. Compression of the Chewy-Borst valve is typically achieved by rotating the proximal end of the hemostatic valve clockwise (CW), and closure of the Chewy-Borst valve is typically achieved by rotating the proximal end of the hemostatic valve counterclockwise (CCW).

[0074] The present disclosure has been described above with reference to examples of embodiments, but those skilled in the art will recognize that modifications can be made to the form and details of the above examples without departing from the scope and technical spirit of the present subject matter. For example, in the examples of several embodiments, one or more features having one or more advantages are described, but in the illustrated embodiments and alternative embodiments, the described features can be replaced 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 the changes in the technical idea in advance. Therefore, the disclosed contents are intended to be interpreted as broadly as possible. For example, unless otherwise specified, a description of a single specific component also covers the application of multiple 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 a first flexible support having an internal lumen for receiving a first elongate medical device, the first flexible support having a distal end attached to the first cassette and a proximal end, a portion of the first flexible support extending through a portion of the second cassette; the first cassette and the second cassette are removably attached to the first drive module and the second drive module, respectively; and 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; Robot drive system.

2. 2. The robot drive system of claim 1, 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.

3. 3. The robot drive system of claim 2, further comprising the 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.

4. 3. The robotic drive system of claim 2, 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.

5. The robot drive system of claim 4 , wherein the second arm includes a first portion that slidably engages the first arm and a second portion that slidably engages the third arm.

6. 5. The robotic drive system of claim 4, 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.

7. a second flexible support having an internal lumen for receiving the second elongate medical device, the second flexible support having a second distal end and a second proximal end; 5. The robot drive system of claim 4, wherein the second distal end of the second flexible support is removably fixed to the second cassette, the second proximal end is 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 is disposed within the third cassette.

8. a leading flexible support having an internal lumen in which the further elongate medical device is received, the leading flexible support having a leading distal end and a leading proximal end; 3. The robotic drive system of claim 2, wherein the lead distal end is removably secured to a sheath connector disposed distally relative to the first cassette, the lead proximal end is secured to a robot drive housing, and a portion of the lead flexible support between the lead distal end and the lead proximal end is disposed within the first cassette.

9. 9. The robotic drive system of claim 8, 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.

10. 4. The robotic drive system of claim 3, wherein the second arm includes a second guide portion that operatively guides a portion of the first flexible support between the proximal end of the first flexible support and the first cassette.

11. 8. The robot drive system of claim 7, 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 second flexible support and the second cassette.

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

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

14. The robotic drive system of claim 1 , wherein the first cassette comprises a cylindrical cavity capable of receiving a cylindrical member of the first drive module.

15. 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 removably attached to the first drive module and having a first arm; a second cassette removably attached to the second drive module and having a second arm; a third cassette removably attached to the third drive module, the third cassette having a third arm; a first flexible support having an internal lumen for receiving a first elongate medical device, the first flexible support having a distal end attached to the first cassette and a proximal end, a portion of the first flexible support extending through a portion of the second cassette; a second flexible support having an internal lumen for receiving a second elongate medical device, the second flexible support having a distal end attached to the second cassette and a proximal end, a portion of the second flexible support extending through a portion of 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.

16. 16. The robotic drive system of claim 15, 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.

17. 17. The robot drive system of claim 16, further comprising a leading flexible support having a proximal end secured to a housing of the robot 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, the sheath connector being a separate member from the first cassette, the second cassette and the third cassette and configured to be attached to the robot drive.

18. 16. The robotic drive system of claim 15, wherein each cassette of the sterilization cassette assembly is supported on a corresponding drive module in a non-engaged position with the corresponding drive module such that a user does not need to hold the sterilization cassette assembly when placing the sterilization cassette assembly on the robot drive.

19. The robotic drive system of claim 18 , wherein each cassette is provided with a latch releasably engageable with a corresponding drive module.

20. 16. A sterilization cassette assembly adapted for use with the robotic drive of claim 15, comprising: a first cassette removably attached to the first drive module and having a first arm; a second cassette removably attached to the second drive module and having a second arm; a third cassette removably attached to the third drive module, the third cassette having a third arm; a first flexible support having an internal lumen for receiving a first elongate medical device, the first flexible support having a distal end attached to the first cassette and a proximal end, a portion of the first flexible support extending through a portion of the second cassette; a second flexible support having an internal lumen for receiving a second elongate medical device, the second flexible support having a distal end attached to the second cassette and a proximal end, a portion of the second flexible support extending through a portion of 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; Sterile cassette assembly.

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