Fluid Management Device of Robot Catheter Type Treatment System

Abstract

A cassette for use in a robotic drive of a catheter-based procedure system includes a housing configured to support a hemostasis valve having a base and a side port. The housing has a longitudinal device axis associated with an elongated medical device. The cassette also includes a first tube connection located on the housing above the longitudinal device axis. The first tube connection is configured to receive a first tube. The cassette also includes a second tube connection located adjacent a top edge of the housing and above the first tube connection and the longitudinal device axis. The second tube connection is configured to receive a second tube.

Description

Technical Field

[0001] Broadly speaking, the present invention relates to the field of robotic medical treatment systems, and more specifically, to an apparatus for managing a fluid connection (fluid coupling) to an elongate medical device within a cassette in a robotic drive of a catheter treatment system.

Background Art

[0002] Catheters and other elongate medical devices (EMDs) are used in minimally invasive medical procedures for the diagnosis and treatment of various vascular diseases, including neurovascular interventions (NVIs), also known as neurointerventional procedures, percutaneous coronary interventions (PCIs), and peripheral vascular interventions (PVIs). These procedures typically involve navigating a guidewire through the vasculature and using the guidewire to advance a catheter for treatment. Catheter-based procedures begin with accessing an appropriate blood vessel, such as an artery or vein, using a standard percutaneous technique and an introducer sheath. Through the introducer sheath, a diagnostic guidewire is then used to advance a sheath or guide catheter to a primary location, such as the internal carotid artery in the case of NVI, the coronary ostium in the case of PCI, or the superficial femoral artery in the case of PVI. A guidewire suitable for the vasculature is then navigated through the sheath or guide catheter to a target location within the vasculature. In situations such as tortuous anatomical structures, a support catheter or microcatheter is inserted over the guidewire to assist with guidewire navigation. An operator, such as a physician, can obtain cine by contrast injection using an imaging system (e.g., a fluoroscope) and select a stationary frame to use as a roadmap for navigating the guidewire or catheter to a target location, such as a lesion. Fluoroscopic images can also be obtained while the operator advances the guidewire or catheter, allowing the operator to confirm that the device is moving along the correct path towards the target location. The operator manipulates the proximal end of the guidewire or catheter while observing the anatomical structures using fluoroscopy, directing the distal tip into the appropriate blood vessel and towards the target anatomical location (such as a lesion), and avoiding entry into collateral branches.

[0003] A robotic catheter-based treatment system has been developed for assisting physicians performing catheter-based procedures such as NVI, PCI, and PVI. Examples of NVI procedures include coil embolization of aneurysms, liquid embolization of arteriovenous malformations, and mechanical thrombectomy of large vessel occlusions in the context of acute ischemic stroke. In an NVI procedure, the physician uses a robotic system to gain access to the target lesion by controlling the manipulation of a neurovascular guidewire and a microcatheter, and performs a treatment to restore normal blood flow. Access to the target is enabled by a sheath or a guiding catheter, but an intermediate catheter may be required for more distal regions or to provide proper support for the microcatheter and guidewire. The distal tip of the guidewire is navigated within the lesion or past the lesion depending on the type of lesion and treatment. When treating an aneurysm, the microcatheter is advanced into the lesion, the guidewire is removed, and several embolization coils are deployed into the aneurysm through the microcatheter and used to block blood flow into the aneurysm. When treating an arteriovenous malformation, a liquid embolization is injected into the malformation through the microcatheter. Mechanical thrombus removal for treating vascular occlusions is achieved by either or both of the use of aspiration and a stent retriever. Depending on the location of the thrombus, aspiration is performed either through an aspiration catheter or, in the case of a small artery, through a microcatheter. Once the aspiration catheter is in the lesion, negative pressure is applied to remove the thrombus through the catheter. Alternatively, the thrombus can also be removed by deploying a stent retriever through the microcatheter. After snaring the thrombus with Stent retriever the stent retriever and the microcatheter (or intermediate catheter) are retracted into the guiding catheter, the thrombus is retrieved.

[0004] In the case of PCI, the physician uses a robotic system to access the lesion by manipulating a coronary guidewire, perform treatment, and restore normal blood flow. Access is made possible by seating a guiding catheter at the coronary artery entry site. The distal tip of the guidewire is navigated to the tip of the lesion, and due to the complex anatomical structure, a microcatheter can be used to properly support the guidewire. Blood flow is restored by delivering and deploying a stent or balloon to the lesion. The lesion may require pretreatment before stent implantation, and a balloon may be delivered for pre-dilation of the lesion, or, for example, ablation is performed using a laser or a rotational atherectomy catheter and a balloon using a guidewire. Image diagnosis and physiological measurements can be performed to determine the appropriate treatment method by using an imaging catheter or a fractional flow reserve (FFR) measurement.

[0005] In the case of PVI, the physician performs treatment using a robotic system and restores blood flow using a technique similar to NVI. The distal tip of the guidewire is navigated to the tip of the lesion, and a microcatheter is used to properly support the guidewire for the complex anatomical structure. Blood flow is restored by delivering and deploying a stent or balloon to the lesion. Similar to the case of PCI, pretreatment of the lesion and image diagnosis are also used in the same manner.

[0006] Support at the distal end of a catheter or guidewire may be required, for example, for navigation of tortuous or calcified vasculature, to reach a distal anatomical location, or to cross a stenotic lesion. In such cases, an over-the-wire (OTW) catheter or coaxial system is used. An OTW catheter has a lumen for the guidewire, which extends along the entire length of the catheter. This provides support for the guidewire over its entire length, resulting in a relatively stable system. However, this system has several weaknesses compared to rapid exchange catheters (described below), such as greater friction and longer overall length. Typically, to remove or replace an OTW catheter while maintaining the position of the indwelling guidewire, the exposed length of the guidewire (exiting the patient) must be longer than the OTW catheter. A 300 cm guidewire is generally considered sufficient for this purpose and is often referred to as an exchange length guidewire. Due to the length of this guidewire, two operators are required to remove or replace the OTW catheter. This is further complicated when using a triple coaxial system known in the art as a triaxial system (although a quadruple coaxial catheter is also known to be used). 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) catheters are often used. The guidewire lumen of a rapid exchange catheter only passes through the distal portion of the catheter, called the monorail or rapid exchange (RX) section. Operators using the RX system manipulate the intervention device parallel to each other (in contrast to operating the device in a tandem configuration in the OTW system), and the exposed length of the guidewire only needs to be slightly longer than the RX section of the catheter. A rapid exchange guidewire typically has a length of 180 - 200 cm. Considering the short length of the guidewire and monorail, the RX catheter can be exchanged by a single operator. However, the RX catheter is often inappropriate when more distal support is required. SUMMARY OF THE INVENTION

[0007] In one aspect, a cassette for use in a robotic drive device of a catheter treatment system includes a housing configured to support a hemostatic valve having a base and side ports. The housing has a longitudinal device axis associated with an elongate medical device. The cassette also includes a first tube connection located above the longitudinal device axis in the housing. The first tube connection is configured to receive a first tube. The cassette further includes a second tube connection located proximate to an upper edge of the housing and above the first tube connection and the longitudinal device axis. The second tube connection is configured to receive a second tube.

[0008] According to another aspect, an apparatus for providing a fluid connection to a cassette for use in a robotic drive device of a catheter treatment system includes a cassette housing having a longitudinal device axis associated with an elongate medical device and a hemostatic valve located within the cassette housing. The hemostatic valve has a base and side ports. The apparatus further includes a first tube connection located above the longitudinal device axis in the cassette housing, a first tube connected to the side port of the hemostatic valve and located at the first tube connection, a valve having one of a plurality of ports connected to the first tube, a second tube connection located proximate to an upper edge of the cassette housing and above the first tube connection and the longitudinal device axis, and a second tube connected to one of the plurality of ports of the valve and located at the second tube connection. BRIEF DESCRIPTION OF THE DRAWINGS

[0009] The present invention will be more fully understood from the following detailed description taken in conjunction with the accompanying drawings, in which like reference numerals refer to like parts, and in which:

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Mode for Carrying Out the Invention

[0010] The following definitions are used herein. An elongate medical device (EMD) refers to a catheter (such as a guide catheter, microcatheter, balloon / stent catheter, etc.), a wire-based device (such as a guide wire, embolization coil, stent retriever, etc.), and a device having a combination thereof (but not limited thereto). The wire-based EMDs include, but are not limited to, a guide wire, a micro wire, a proximal pusher for an embolization coil, a stent retriever, a self-expanding stent, and a flow diverter. Typically, the wire-based EMD does not have a hub or a handle at its proximal end. (However, not limited thereto) In one embodiment, the EMD has a catheter having a hub at the proximal end of the catheter and a flexible shaft extending from the hub towards the distal end of the catheter, and the shaft is more flexible than the hub. In one embodiment, the catheter includes a transition portion that transitions between the hub and the shaft, and the flexibility of this transition portion is softer than the hub and harder than the shaft. In one embodiment, the transition portion is a stress relaxation portion.

[0011] "Distal" and "proximal" define the relative positions of two separate parts. With respect to a robotic drive device, "distal" and "proximal" are defined by the arrangement of the robotic drive device according to the purpose of use for the patient. When used to define relative positions, the distal part is the part of the robotic drive device that is closer to the patient than the proximal part when the robotic drive device is in the intended arrangement for use. Inside the patient's body, a vascular landmark that is farther along the path from the access point is considered to be distal to a landmark closer to the access point. The access point is the point where the EMD is inserted into the patient. Similarly, the proximal part is the part that is farther from the patient than the distal part when the robotic drive device is in the intended arrangement for use. When used to define a direction, the distal direction refers to the path along which something is moving or is moving towards, or the path along which something is aimed or directed from the proximal part towards the distal part and / or the patient when the robotic drive is in the intended arrangement for use. The proximal direction is the opposite direction of the distal direction.

[0012] The longitudinal axis (vertical axis, longitudinal axis) of a member (EMD or other element of a catheter-based treatment system) is the direction going from the proximal portion of the member to the distal portion of the member. By way of example, the longitudinal axis of a guidewire is the direction going from the proximal portion of the guidewire to the distal portion of the guidewire, even if the guidewire is non-linear in the relevant portion. Axial movement of a member means a translation of the member along the longitudinal axis of the member. When the distal end of the EMD is axially moved distally along the longitudinal axis of the EMD, into or further into the patient, the EMD is advancing. When the distal end of the EMD is axially moved proximally along the longitudinal axis of the EMD, out of or further out of the patient, the EMD is being withdrawn (retracted). Rotational movement of a member refers to a change in the angular direction of the member around the local longitudinal axis of the member. Rotational movement of the EMD corresponds to a clockwise or counterclockwise rotation of the EMD around the longitudinal axis of the EMD due to an applied torque.

[0013] "Axial insertion" means inserting a first member into a second member along the longitudinal axis of the second member. "Lateral insertion" means inserting a first member into a second member along a direction in a plane intersecting the longitudinal axis of the second member. With regard to lateral insertion, it may also be referred to as radial loading or side loading. "Pinch" means removably fixing the EMD to the member such that the EMD and the member operate together when the member moves. "Unpinch" means releasing the EMD from the member such that the EMD and the member move independently when the member moves. "Clamp" means removably fixing the EMD to the member such that the movement of the EMD is constrained with respect to the member. The member may be fixed with respect to a global coordinate system or with respect to a local coordinate system. "Unclamp" means releasing the EMD from the member such that the EMD can move independently.

[0014] "Grip" refers to applying force or torque to the EMD by a drive mechanism that operates the EMD without slip in at least one degree of freedom. "Ungrip" means releasing the application of force or torque to the EMD by the drive mechanism so that the position of the EMD is no longer constrained. In one example, an EMD gripped between two tires can rotate about the longitudinal axis of the EMD as the tires move longitudinally relative to each other. The rotational movement of the EMD is different from the movement of the two tires. The position of the gripped EMD is constrained by the drive mechanism. "Buckling" refers to the tendency of a flexible EMD that is axially compressed to bend away from the longitudinal axis or away from the intended path of travel. In one embodiment, the axial compression occurs in response to resistance due to intravascular navigation. The distance that the EMD can be driven along the longitudinal axis without support until it buckles is herein referred to as the device buckling distance. The device buckling distance is related to the stiffness of the device, the shape (including but not limited to the diameter), and the force applied to the EMD. Buckling can cause the EMD to form an arcuate portion different from the intended path. "Twisting" is an example of buckling that occurs when the deformation of the EMD results in a non-elastic and non-reversible strain.

[0015] "Upper, upper end, upper part, above" refer to the general direction opposite to the direction of gravity, and "lower, lower end, lower part, below" refer to the general direction of the direction of gravity. "Inner, inwards, inside" means the part within a specific portion. "Outer, outwards, outside" means the part outside a specific portion. "Front" refers to the side facing the user beside the bed, which is the side of the robot drive device (or an element of the robot drive device, or another element of the catheter treatment system) opposite to the positioning system such as the multi-joint arm. "Rear" means the side of the robot drive device (or an element of the robot drive device, or another element of the catheter treatment system) closest to the positioning system such as the multi-joint arm. "Sterile interface" means the interface or boundary between a sterile unit and a non-sterile unit. For example, the cassette can be a sterile interface between the robot drive device and at least one EMD. "Sterilizable unit" refers to a device that can be sterilized (free of pathogenic microorganisms). This includes, but is not limited to, cassettes, disposable units, drapes, device adapters, and sterilizable drive modules / units (which may include electromechanical components). Sterilizable units have the potential to come into contact with patients, other sterile devices, or items placed in the sterile field of a medical procedure.

[0016] "On-device adapter" means a sterile device that can releasably pinch an EMD to provide a drive interface. For example, an on-device adapter is also known as an end effector or an EMD capture device. By way of a non-limiting example, an on-device adapter is a collet that is robotically actuated to rotate the EMD about the longitudinal axis of the EMD, pinch and / or unpinch the EMD in the collet, and / or translate the EMD parallel to the longitudinal axis of the EMD. In one embodiment, the on-device adapter is a hub drive mechanism such as a driven gear disposed on the hub of the EMD.

[0017] FIG. 1 according to an embodiment is a perspective view showing an example of a catheter-based treatment system 10. The catheter-based treatment system 10 is used to perform catheter-based medical treatments, such as percutaneous intervention treatments such as percutaneous coronary intervention (PCI) (e.g., for treating STEMI), neurovascular intervention treatments (NVI) (e.g., for treating acute large vessel occlusion (ELVO)), peripheral vascular intervention treatments (PVI) (e.g., for severe lower limb ischemia (CLI)), etc. Catheter-based medical treatments include diagnostic catheterization procedures that use one or more catheters and other elongated medical devices (EMDs) to assist in diagnosing a patient's disease. For example, in one embodiment of a catheter-based diagnostic procedure, a contrast agent is injected through a catheter into one or more arteries to obtain an image of the patient's vasculature. Catheter-based medical treatments also include catheter-based treatment procedures (e.g., angioplasty, stent placement, treatment of peripheral vascular diseases, thrombus removal, treatment of arteriovenous malformations, treatment of aneurysms, etc.) that treat diseases using a catheter (or other EMD). The treatment procedure can be enhanced, for example, by including an auxiliary device 54 (shown in FIG. 2) such as intravascular ultrasound (IVUS), optical coherence tomography (OCT), fractional flow reserve (FFR), etc. However, it is natural for those having ordinary knowledge in the art to recognize that a specific percutaneous intervention device or component (e.g., the type of guidewire, the type of catheter, etc.) can be selected based on the type of procedure to be performed. The catheter-based treatment system 10 can accommodate dedicated percutaneous intervention devices used in the treatment with minor adjustments and can perform any catheter-based medical treatment.

[0018] The catheter treatment system 10 includes, among a plurality of elements, in particular, a bedside unit 20 and a control station 26. The bedside unit 20 includes a robot drive device 24 and a positioning system 22 located beside the patient 12. The patient 12 is lying on the patient table 18. The positioning system 22 is used to position and support the robot drive device 24. The positioning system 22 is, for example, a robotic arm, an articulated arm, a holder, etc. The positioning system 22 can be attached at one end, for example, to the rails, base, or cart of the patient table 18. The robot drive device 24 is attached to the other end of the positioning system 22. The positioning system 22 (together with the robot drive device 24) can be retracted to place the patient 12 on the patient table 18. After placing the patient 12 on the patient table 18, the positioning system 22 is used to position (fix) the robot drive device 24 relative to the patient 12 for treatment. In one embodiment, the patient table 18 is supported and operated by a pedestal 17 installed on the floor and / or the ground. The patient table 18 can be operated relative to the pedestal 17 with multiple degrees of freedom, for example, roll, pitch, yaw. The bedside unit 20 may also include control equipment and a display 46 (shown in FIG. 2). For example, the control equipment and the display can be arranged in the housing of the robot drive device 24.

[0019] Generally, the robot drive device 24 includes a suitable percutaneous intervention device and accessory equipment 48 (shown in FIG. 2) (for example, various catheters including guide wires, balloon catheters, stent delivery systems, stent retrievers, embolization coils, liquid plugs, suction pumps, delivery devices for contrast agents and drugs, hemostatic valve adapters, syringes, stopcocks, inflation devices, etc.). The operator (user) 11 can perform a catheter-based medical procedure using the robot system by operating various control devices such as the control device and input device arranged at the control station 26. The bedside unit 20, particularly the robot drive device 24, can include any component and / or combination thereof for imparting the functions described herein to the bedside unit 20. The operator 11 of the control station 26 is referred to as the control station operator (user), and herein refers to the operator (user). The operator (user) of the bedside unit 20 is referred to as the bedside unit operator (user). The robot drive device 24 includes a plurality of device modules 32a-d attached to a rail or linear member 60 (shown in FIG. 3). The rail or linear member 60 guides and supports the device modules. Each of the device modules 32a-d can be used to drive an EMD such as a catheter or a guide wire. For example, the robot drive device 24 can be used to automatically feed a guide wire into a diagnostic catheter and into a guide catheter in the artery of the patient 12. One or more devices, such as an EMD, enter the patient 12's body (e.g., blood vessel) from the insertion point 16, for example, through an introducer sheath.

[0020] The bedside unit 20 communicates with the control station 26, and the control station 26 is capable of wirelessly or wiredly transmitting a signal generated by a user input of the control station 26 to the bedside unit 20 to control various functions of the bedside unit 20. As will be described later, the control station 26 includes a control computing system 34 (shown in FIG. 2) or is connected to the bedside unit 20 via the control computing system 34. The bedside unit 20 can also provide a feedback signal (e.g., loading, speed, operating conditions, warning signal, error code, etc.) to the control station 26 or the control computing system 34, or both. Communication between the control computing system 34 and each component of the catheter treatment system 10 is provided via a communication link that can be a wireless connection, a wired connection, or any other means that enables communication between components. The control station 26 or other similar control systems are located at either a local site (e.g., the local control station 38 in FIG. 2) or a remote site (e.g., the remote control station and computing system 42 in FIG. 2). The catheter treatment system 10 can be operated by the control station at the local site or the control station at the remote site, or simultaneously by both the local control station and the remote control station. At the local site, the operator 11 and the control station 26 are located in the same room or an adjacent room as the patient 12 and the bedside unit 20. The local site as used herein is the location of the bedside unit 20 and the patient 12 or the subject (e.g., an animal or a cadaver), and the remote site is the location of the control station 26 and the operator 11 used to remotely control the bedside unit 20. The control station 26 (and the control computing system) at the remote site and the bedside unit 20 and / or the control computing system at the local site communicate via a communication system and service 36 (shown in FIG. 2), for example, via the Internet.In one embodiment, the remote site and the local (patient) site are separated from each other. For example, they are in separate rooms within the same building, separate buildings within the same city, separate cities, or other separate locations where the remote site does not have physical access to the bedside unit 20 and / or the patient 12 at the local site.

[0021] The control station 26 generally includes one or more input modules 28 configured to receive user input for operating each component or system of the catheter-based treatment system 10. In the case of the embodiment shown herein, the control station 26 enables the operator 11 to control the bedside unit 20 to perform a catheter-based medical treatment. For example, the input module 28 is configured to cause the bedside unit 20 to perform various tasks using a percutaneous intervention device (e.g., EMD) in conjunction with the robotic drive 24 (e.g., advancing, retracting, or rotating a guidewire, advancing, retracting, or rotating a catheter, inflating or deflating a balloon disposed with the catheter, deploying and / or placing a stent, deploying and / or placing a stent retriever, deploying and / or placing a coil, injecting a contrast agent into the catheter, injecting a liquid plug into the catheter, injecting a drug or saline into the catheter, aspirating with the catheter, or performing other functions that can be implemented as part of a catheter-based medical treatment). The robotic drive 24 includes various drive mechanisms for operating the components of the bedside unit 20 that include the percutaneous intervention device (e.g., axial and rotational movements).

[0022] In one embodiment, the input module 28 includes one or more touchscreens, joysticks, scroll wheels, and / or buttons. In addition to the input module 28, the control station 26 can use additional user control devices 44 (shown in FIG. 2), such as foot switches and microphones for voice commands. The input module 28 is configured to move various components and various percutaneous intervention devices, such as guidewires and one or more catheters or microcatheters, forward, backward, or rotationally. The buttons include, for example, an emergency stop button, magnification buttons, device selection buttons, and an auto-operation button. When the emergency stop button is pressed, power (e.g., electricity) is cut off or removed from the bedside unit 20. In the speed control mode, the magnification buttons act 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 magnification buttons change the mapping between the input distance and the output command distance. The device selection buttons allow the operator 11 to select which of the percutaneous intervention devices loaded in the robot drive 24 is to be controlled by the input module 28. The auto-operation button is used to execute an algorithm-based operation that the catheter treatment system 10 can perform with the percutaneous intervention device without receiving a direct command from the operator 11. In one embodiment, the input module 28 includes one or more controllers or icons (not shown) displayed on a touchscreen (which may or may not be part of the display 30), which, when activated, operate the components of the catheter treatment system 10. The input module 28 can also include a balloon or stent controller configured to inflate or deflate a balloon and / or deploy a stent. Each of the input modules 28 includes one or more buttons, scroll wheels, joysticks, touchscreens, etc., which can be used to specifically control one or more specific components.Furthermore, one or more touchscreens display one or more icons (not shown) associated with each part of the input module 28 or each component of the catheter treatment system 10.

[0023] The control station 26 includes a display 30. In one embodiment, the control station 26 can also include two or more displays 30. The display 30 is configured to display information or patient-specific data to the operator 11 located at the control station 26. For example, the display 30 can be configured to display image data (e.g., X-ray images, MRI images, CT images, ultrasound images, etc.), hemodynamic data (e.g., blood pressure, heart rate, etc.), patient chart information (e.g., medical history, age, weight, etc.), lesion or treatment evaluation data (e.g., IVUS, OCT, FFR, etc.). Furthermore, the display 30 can also be configured to display procedure-specific information (e.g., procedure checklists, recommendations, duration of the procedure, position of the catheter or guidewire, amount of drug or contrast agent delivered, etc.). Also, the display 30 may be configured to display information for providing functions related to the control computing system 34 (shown in FIG. 2). The display 30 may have a touchscreen function to provide part of the system's user input function.

[0024] The catheter-based treatment system 10 also includes an imaging system 14. The imaging system 14 can be any medical imaging system (e.g., non-digital X-ray, digital X-ray, CT, MRI, ultrasound, etc.) that can be used in conjunction with catheter-based medical treatments. In one embodiment, the imaging system 14 is a digital X-ray imaging device that communicates with a control station 26. In one embodiment, the imaging system 14 includes a C-arm (shown in FIG. 1) that allows the imaging system 14 to rotate partially or completely around the patient 12 in order to obtain images of the patient 12 at various angular positions (e.g., sagittal images, coronal images, anteroposterior images, etc.). In one embodiment, the imaging system 14 is a fluoroscopy system that includes a C-arm having an X-ray source 13 and a detector 15, also known as an image intensifier.

[0025] The imaging system 14 is configured to capture X-ray images of the appropriate region of the patient 12 during the treatment. For example, the imaging system 14 can be configured to capture one or more X-ray images of the head to diagnose a neurovascular condition. The imaging system 14 can also be configured to assist the operator 11 at the control station 26 by capturing one or more X-ray images (e.g., real-time images) during the catheter-based medical treatment to properly position a guidewire, guide catheter, microcatheter, stent retriever, coil, stent, balloon, etc. during the treatment. One or more images are displayed on the display 30. For example, the images are displayed on the display 30 to allow the operator 11 to accurately move the guide catheter or guidewire to the appropriate position.

[0026] For clarity of direction, a Cartesian coordinate system is presented with X, Y, and Z axes. The positive X-axis is oriented in the distal direction of the longitudinal (axial) direction, i.e., the direction from the proximal end to the distal end, or in other words, the proximal-to-distal direction. The Y-axis and Z-axis are within the cross-section with respect to the X-axis, Positive Z-axis is upward, i.e., in the opposite direction of gravity, and the Y-axis is automatically determined by the right-hand rule.

[0027] FIG. 2 according to one embodiment is a block diagram of a catheter-based treatment system 10. The catheter treatment system 10 includes a control computing system 34. The control computing system 34 can physically be, for example, part of a control station 26 (shown in FIG. 1). The control computing system 34 is typically an electronic control unit suitable for providing a catheter-based treatment system 10 with each of the functions described herein. For example, the control computing system 34 can be an embedded system, a dedicated circuit, a general-purpose system programmed with the functions described herein, etc. The control computing system 34 communicates with a bedside unit 20, a communication system and service 36 (such as the Internet, a firewall, a cloud service, a session manager, a hospital network, etc.), a local control station 38, an additional communication system 40 (such as a telepresence system), a remote control station and computing system 42, and a patient sensor 56 (such as an electrocardiogram (ECG) device, an electroencephalogram (EEG) device, a blood pressure monitor, a temperature monitor, a heart rate monitor, a respiration monitor, etc.). The control computing system also communicates with an imaging system 14, a patient table 18, an additional medical system 50, a contrast agent injection system 52, and an auxiliary device 54 (such as IVUS, OCT, FFR, etc.). The bedside unit 20 includes a robot drive 24 and a positioning system 22, and can also include additional control equipment and a display 46. As described above, the additional control equipment and the display can be arranged in the housing of the robot drive 24. An intervention device and accessory 48 (such as a guide wire, a catheter, etc.) are connected to the bedside system 20. In one embodiment, the intervention device and accessory 48 include dedicated devices (such as an IVUS catheter, an OCT catheter, an FFR wire, a diagnostic catheter for contrast imaging, etc.) for connecting to their respective auxiliary devices 54, namely an IVUS system, an OCT system, an FFR system, etc.

[0028] In one embodiment, the control computing system 34 is configured to generate a control signal based on a control signal based on user interaction with an input module 28 (of a control station 26 (shown in FIG. 1), such as a local control station 38 or a remote control station 42) and / or information accessible to control the control computing system 34 to perform a medical procedure using the catheter treatment system 10. The local control station 38 includes one or more displays 30, one or more input modules 28, and additional user control devices 44. The remote control station and computing system 42 may include components similar to those of the local control station 38. The remote control station 42 and the local control station 38 can be made different according to the functions required for each. The additional user control device 44 includes, for example, one or more foot input controllers. The foot input controller can be configured to enable an operator to select functions of the imaging system 14, such as turning X-rays on / off and scrolling through multiple stored images. In one embodiment, the foot input device can be configured to enable an operator to select a device that is mapped to a scroll wheel included in the input module 28. An additional communication system 40 (such as voice conversation, video conversation, telepresence, etc.) can be employed to assist an operator in communicating with a patient, medical staff (such as angio suite staff), and / or devices near the bedside.

[0029] The catheter treatment system 10 can be connected or configured to include any other system and / or device not explicitly stated. For example, the catheter treatment system 10 can include an image processing engine, a data storage and archival system, an automatic balloon and / or stent inflation system, a drug infusion system, a drug tracking and / or logging system, a user log, an encryption system, a system that restricts access to or use of the catheter treatment system 10, and the like.

[0030] As described above, the control computing system 34 communicates with the bedside unit 20 that includes the robot drive device 24 and the positioning system 22 and may include additional control devices and a display 46, and provides a control signal to the bedside unit 20 to operationally control the motors and drive the mechanisms used to drive a percutaneous intervention device (e.g., a guide wire, a catheter, etc.). Each drive mechanism can be provided as part of the robot drive device 24. FIG. 3 according to an embodiment is a perspective view of the robot drive device of the catheter treatment system 10. In FIG. 3, the robot drive device 24 includes a plurality of device modules 32a-d connected to a linear member 60. Each of the device modules 32a-d is connected to the linear member 60 via a stage 62a-d movably attached to the linear member 60. Each individual device module 32a-d is connected to the stage 62a-d using a connector such as an offset bracket 78a-d. In one embodiment, the device modules 32a-d are directly attached to the stage 62a-d. Each stage 62a-d can be operated independently to move linearly along the linear member 60. Thus, each stage 62a-d (and the corresponding device module 32a-d connected to the stage 62a-d) can be operated individually relative to each other and relative to the linear member 60. A drive mechanism is used to operate each stage 62a-d. In the embodiment shown in FIG. 3, the drive mechanism has individual stage translation motors 64a-d connected to each stage 62a-d and a stage drive mechanism 76, or the stage translation motors 64a-d themselves can be linear motors. The stage drive mechanism 76 is, for example, a feed screw via a rotating nut, a rack via a pinion, a belt via a pinion or a pulley, or a chain via a sprocket. In one embodiment, the stage drive mechanism 76 is a combination of these mechanisms. For example, different types of stage drive mechanisms can be employed for each of the stages 62a-d.In the case of an embodiment where the stage drive mechanism is a feed screw and a rotating nut, the feed screw is rotated to engage and disengage each stage 62a-d with respect to the feed screw, and is operated, for example, to move forward or backward. In the embodiment illustrated in FIG. 3, the stages 62a-d and the device modules 32a-d have a columnar drive structure.

[0031] Each device module 32a-d includes drive modules 68a-d and cassettes 66a-d mounted on and connected to the drive modules 68a-d. In the embodiment illustrated in FIG. 3, each of the cassettes 66a-d is mounted on the drive module 68a-d in an orientation such that the cassette 66a-d is lowered onto the drive module 66a-d with the cassette 66a-d facing downward in the vertical direction. The upper surface (or side surface) of the cassette 66a-d is parallel to the upper surface (or side surface) (i.e., the mounting surface) of the drive module 68a-d when the cassette 66a-d is mounted on the drive module 68a-d. The direction when mounted as shown in FIG. 3 is referred to herein as the horizontal direction. In other embodiments, each cassette 66a-d may be attached to the drive module 68a-d in other mounting directions. With respect to FIGS. 7-10, various mounting directions are disclosed below. Each cassette 66a-d is configured to connect to and support a proximal portion of an EMD (not shown). Further, each cassette 66a-d can include elements that provide one or more degrees of freedom in addition to the linear motion provided by moving linearly along the linear member 60 by the actuation of the corresponding stage 62a-d. For example, the cassette 66a-d can include elements used to rotate the EMD in a cassette connected to the drive module 68a-d. Each drive module 68a-d includes at least one coupler to provide a drive interface to the mechanisms within each cassette 66a-d to add degrees of freedom. Also, each cassette 66a-d includes a channel in which a device support 79a-d is disposed, and each device support 79a-d is used to prevent buckling of the EMD. Support arms 77a, 77b, 77c are attached to each of the device modules 32a, 32b, 32c, respectively, and fixed points are provided to support the proximal ends of the device supports 79b, 79c, 79d, respectively. The robot drive 24 also includes a device support connection 72 connected to the device support 79, the distal support arm 70, and the support arm 770. The support arm 770 is used to provide a fixed point to support the proximal end of the most distal device support 79a housed in the most distal device module 32a.Further, an introducer interface support (redirector) 74 can be connected to the device support connector 72 and the EMD (e.g., an introducer sheath). This configuration of the robotic drive device 24 has the advantage that the volume and weight of the robotic drive device 24 can be reduced by using an actuator in a single linear member.

[0032] To prevent pathogen infection of the patient, healthcare staff use aseptic technique in the room where the bedside unit 20 and the patient 12 or subject (shown in FIG. 1) are housed. The room housing the bedside unit 20 and the patient 12 is, for example, a catheter lab or an angiography suite. Aseptic technique consists of using sterile barriers, sterile instruments, appropriate patient preparation, environmental management, and contact guidelines. That is, all EMDs and intervention accessories are sterilized and contact is permitted only with either a sterile barrier or a sterile instrument. In one embodiment, a sterile drape (not shown) is placed over the non-sterile robotic drive device 24. Each cassette 66a-d is sterilized and functions as a sterile interface between the drape-covered robotic drive device 24 and at least one EMD. Each cassette 66a-d is designed to be sterilizable for single use or is designed such that all or part of the cassette 66a-d or its components can be resterilized for use in multiple procedures.

[0033] As shown in FIG. 1, for example, using an introducer and an introducer sheath, at the insertion point 16, one or more EMDs are inserted into the patient's body (e.g., a blood vessel). The introducer sheath is Patient 120 (shown in FIGS. 4-6) at a predetermined angle, usually less than 45 degrees, with respect to the axis of the is directed toThis is a general case. The height difference between the height where the EMD enters the body (the proximal opening 126 of the introducer sheath shown in FIG. 4) and the height of the longitudinal drive shaft of the robot drive device 124 will directly affect the working length of the slender medical device. The greater the need for a slender medical device to compensate for the difference in position and angle, the fewer slender medical devices can be inserted into the body when the robot drive device is in its most distal (front) position. It is beneficial to have a robot drive device with the same height and angle as the introducer sheath. FIG. 4 is a diagram showing the operating axis of the slender medical device and the introduction point to the patient. FIG. 4 shows the height difference (d) 123 between the height of the proximal end 126 of the introducer sheath 122 and the height of the longitudinal device axis 125, and the angle difference (θ) 128 between the introducer sheath 122 and the longitudinal device axis 125 of the robot drive device 124. The slender medical device 121 is constrained to each axis and creates a curve with endpoints that align tangentially. The length of this curve represents the length at which the robot drive device 124 cannot drive further forward and cannot enter the misaligned introducer sheath 122. elongated medical device 121 represents the length. When the angle (θ) 128 is large, the friction of the device also increases. Generally, the smaller the angle difference (θ) 128 and the height difference (d) 123, the more it leads to a reduction in friction and a reduction in the loss of the operating length. FIG. 4 illustrates a simple example explaining one straight line and one rotational offset, but it should be understood that this problem occurs in three dimensions, i.e., three straight line offsets and three rotational offsets. Also, the thickness of the robot drive device 124 is a factor that determines the position of the longitudinal device axis 125 relative to the introducer sheath 122.

[0034] Figures 5A and 5B are diagrams explaining the influence of the overall thickness of the drive module or the robot drive device on the loss of working length. Figure 5A shows the position of the longitudinal device axis 125 of the robot drive device 124 with respect to the introducer sheath 122, as indicated by (d) 123. This robot drive device 124 is thick as indicated by the distance (X) 129 between the upper and lower surfaces of the robot drive device 124. Figure 5B shows the position of the longitudinal device axis 125 of the robot drive device 124 with respect to the introducer sheath 122, as indicated by a shorter (d) 123. This robot drive device 124 is thin as indicated by the distance (X) 129 between the upper and lower surfaces of the robot drive device 124. By reducing the thickness of the robot drive device 124 to approach the patient and the introducer sheath, the distance 123 between the introducer sheath and the device axis is shortened, and the loss of working length of the elongated medical device is reduced. Figure 6 is a diagram illustrating the orientation for minimizing the loss of working length. In Figure 6, the robot drive device 124 is arranged such that the longitudinal device axis 125 of the robot drive device 124 is aligned with the axis of the introducer sheath 122. Thereby, the loss of operating length due to the angular difference and height difference of the elongated medical device is eliminated. However, this posture of the robot drive device 124 is not practical considering the length and size of the robot drive device 124. Also, directing the robot drive device at an acute angle makes it difficult to load and unload the elongated medical device, and to adjust and handle the robot drive device, affecting its usability.

[0035] To reduce the distance between the robot drive device and the patient and the distance between the longitudinal device axis of the robot drive device and the introducer sheath, the cassettes 66a-d of the device module 32 (shown in Figure 3) are attached to the drive modules 68a-d in an orientation such that the cassettes 66a-d are attached to the drive modules 68a-d by horizontally moving the cassettes 66a-d onto the drive modules 68a-d. Figure 7 according to one embodiment is a perspective view of a device module provided with a cassette mounted in the vertical direction, One embodimentFIG. 8 related thereto is a rear perspective view of a device module with a cassette mounted in the vertical direction. In FIGS. 7 and 8, the device module 132 includes a cassette 138 mounted to a drive module 140 such that the front (or side) surface 139 of the cassette 138 is parallel to the front (or side) surface 141 (i.e., the mounting surface) of the drive module 140. The mounting direction shown in FIGS. 7 and 8 is referred to as the vertical direction when used herein. The device module 132 is connected to a stage 136 movably attached to a rail or linear member 134. The drive module 140 includes, for example, a coupler 142 used to provide a power interface to the cassette 138 for rotating an elongated medical device (not shown) disposed within the cassette. The coupler 142 rotates about an axis 143. As described above, the cassette 138 is attached to the drive module 140 by horizontally moving the cassette 138 onto the mounting surface 141, such that the cassette is coupled to the coupler 142 of the drive module 140. By mounting the cassette 138 in the vertical direction, the drive module 140 to which the cassette 138 is mounted is located laterally displaced and is no longer disposed between the cassette 138 and the patient. FIG. 9 related to one embodiment is an end view of the distal end of a device module with a cassette mounted vertically upright. FIG. 9 shows the distance 146 between the device axis of the elongated medical device 144 and the bottom surface of the device module 132. By mounting the cassette 138 in the vertical direction, there is no need to dispose the drive module 140 between the elongated medical device 144 and the patient below the device axis. Only a portion of the cassette 138 is between the elongated medical device 138 and the patient. By mounting the cassette 138 in the vertical direction, the distance 146 between the elongated medical device and the bottom surface of the device module 132 can be reduced, bringing the robotic drive closer to the patient and reducing the loss of working length in the elongated medical device. For comparison, FIG. 10 shows an example in which the cassette is mounted in the horizontal direction (left - right direction). In the device module 132 shown in FIG. 10, the cassette 138 is mounted to the drive module 140 in the horizontal direction.The upper surface (or side surface) 145 of the cassette 138 becomes parallel to the upper surface (or side surface) 147 (i.e., the mounting surface) of the drive module 140 when the cassette 138 is mounted on the drive module 140. The drive module 140 is located below the lower surface or below the cassette 138, increasing the distance 148 between the device axis of the elongated medical device 144 and the bottom surface of the device module 132. This prevents the device axis from approaching the introducer (not shown here) as close as possible. The drive module 140 disposed under the cassette 138 may also interfere with the patient. In one embodiment, the cassette can be attached to the drive module at any angle. In one embodiment, the cassette can be horizontally attached to the lower surface of the drive module so that it is not necessary to position the drive module between the device axis and the patient.

[0036] The EMD (e.g., catheter) within the cassette can be connected to various tubes for purposes such as supplying a drip of physiological saline, enabling injection of a contrast agent, enabling suction, etc. In one embodiment, the catheter can be connected to a hemostatic valve (e.g., a rotary hemostatic valve) having a side port to which the tube can be connected (e.g., removably connected or connected so as not to come off). In an example of a fluid management system, a closed system (closed system) using a manifold is used to provide connections to all of the necessary fluid lines (pipes). In the closed system, all of the necessary fluid lines (e.g., physiological saline, contrast agent, waste bag) are connected to the side ports of the manifold through a series of stopcocks (stop plugs). A syringe is connected to the proximal end of the manifold, and a tube is connected to the distal end of the manifold. The other end of the tube is connected to the side port of the hemostatic valve that is in fluid communication with the catheter. After setup, the connections are not removed so that air does not enter the system. That is, the closed system requires a plurality of dedicated fluid lines to the manifold for injecting fluid into the catheter or suctioning fluid from the catheter. If there are a plurality of catheters that require fluid connections within the system, it is necessary to set up a closed system with a manifold and all of the necessary fluid lines for each catheter. In the case of an intervention procedure that requires a plurality of catheters, setting up a closed system for each catheter is a burden and not necessary.

[0037] In a robot driving device that linearly operates an EMD, a hemostatic valve and a tube connected to the hemostatic valve are translated in parallel with a catheter when being advanced and retracted by the robot driving device during a treatment. During the movement of the catheter, the tube may be caught or snagged by one or more elements of the robot driving device. The possibility of the tube being caught is increased in the above-described robot driving device. This is because the operator usually operates the robot driving device from a control station at a local site or a remote site, rather than observing and managing the tube at the bedside. When the tube is snagged or caught, resistance may occur in the movement of the robot driving device, the tube may be broken, the tube may come off, or the hemostatic valve or catheter may become detached from the robot system. Therefore, it is beneficial to provide a device for grasping tube connections and managing fluid connections to prevent unintended movement or damage of the catheter when the tube is caught or snagged during the operation of the robot driving device. Furthermore, it is beneficial to provide an open system for fluid (infusion) management.

[0038] As described above, the catheter disposed within the cassette can be connected to a fluid tube via a hemostatic valve. FIG. 11 according to one embodiment is a front view of a cassette including a fluid management element, and FIG. 12 according to one embodiment is a front view of a fluid management device. In FIG. 11, a hemostatic valve 152 (e.g., a rotary hemostatic valve) and a catheter 176 are disposed within a housing 151 of a cassette 150. The catheter 176 defines a longitudinal device axis 172 of the cassette 150. The hemostatic valve 152 is connected to the catheter 176. The hemostatic valve 152 includes a base 153 having a lumen used to receive other EMDs, e.g., an EMD from another cassette that is more proximal within another robotic drive device (e.g., the robotic drive device 24 described above with respect to FIGS. 1 and 3). In one embodiment, the distal end (not shown) of the base 153 includes a rotary connector (not shown), e.g., a rotary luer connector, that is rotatably connected to the distal end of the base 153. In one embodiment, the outer surface of the rotary luer connector has a gear (not shown) driven, e.g., by a robotic drive device. The hemostatic valve 150 also includes a side port 154 used to connect a fluid tube that travels to and from the catheter 176. In one embodiment, the side port 154 can be oriented such that when the cassette 150 (e.g., the cassette 150 shown in FIGS. 13 and 14) is configured to be mounted vertically to a drive module, the open end faces upward toward the upper side of the cassette 150. A support 155 is connected to the cassette housing 151 and includes a connector 157. The connector 157 is configured to receive a syringe, as will be described later with respect to FIG. 13.

[0039] The cassette 150 also includes a first tube connection portion 156 and a second tube connection portion 160. The first tube connection portion 156 is located on the housing 151 at a position above the longitudinal device axis 172. The second tube connection portion 160 is close to the upper edge portion 182 of the cassette housing 151 and is located on the housing 151 above the first tube connection portion 156 and the longitudinal device axis 172. The first tube connection portion 156 and the second tube connection portion 160 are shown in a horizontal arrangement. According to one embodiment, however, the first tube connection portion 156 and the second tube connection portion 160 may be arranged vertically or at various angles. As shown in FIG. 12, the first tube connection portion 156 is configured to receive the first tube 162. Referring to FIG. 12, one end of the first tube 162 is connected to the side port 154 of the hemostatic valve 152, and the other end of the first tube 162 is connected to a valve which is, for example, a three-way stopcock (three-way valve) 158. In one embodiment, the first tube 162 is removably connected to the side port 154, or the first tube 162 is connected (e.g., adhered) to the side port 154 so as not to come off. The three-way stopcock 168 has a first port 164, a second port 166, and a third port 168. In the embodiment of FIG. 12, the first tube 162 is connected to the first port 164 of the stopcock 158. In one embodiment, the first tube 162 is removably connected to the first port 164 of the stopcock 158, or the first tube 162 is connected (e.g., adhered) to the first port 164 of the stopcock 158 so as not to come off. The stopcock 158 is not firmly attached to the cassette 150 and is maintained loosely (not fixed). The first tube connection portion 156 receives the first tube 162 in the axial direction of the first tube 162. The first tube connection portion 156 is, for example, a clip. The second tube connection portion 160 is configured to receive the second tube 170. One end of the second tube 170 is connected to the second port 166 of the stopcock 158.In one embodiment, the second tube 170 is removably coupled to the second port 166 of the stopcock 158, or the second tube 170 is coupled (e.g., adhesively) to the second port 166 of the stopcock 158 so as not to become detached. The other end of the second tube 170 is connected to a fluid source (not shown) as will be described later. The second tube 170 is in fluid communication with the first tube 162 and the hemostatic valve 152 via the stopcock 158.

[0040] The first tube connection portion 156 fixes the first tube 162 to the cassette housing 151 (e.g., prevents radial and axial movement of the first tube 162) and is configured to provide strain relief for the first tube 162 and the hemostatic valve 152. In one embodiment, the first tube 162 includes a collar 159 configured to lock onto the first tube connection portion 156 and prevent axial movement of the first tube 162. In one embodiment, the collar 159 is on the outer surface of the first tube 162 and includes an upper flange 163 and a lower flange 165. The first tube connection portion 156 is configured to prevent pinching or snagging of the first tube 162 or the second tube 170 when the hemostatic valve 152 is being attached or when the hemostatic valve 151 is being pulled out of the cassette 150.

[0041] FIG. 13 according to one embodiment is a front view of a fluid management device. As described above, the stopcock 158 is not rigidly attached to the cassette 150 and is kept loose, whereby the operator can easily and comfortably operate the stopcock 158 during degassing or when connecting a syringe to the stopcock 158. In FIG. 13, the syringe 174 is connected to the third port 168 of the stopcock 158. The syringe 174 is used, for example, for injecting a contrast agent, injecting physiological saline, or aspiration. In one embodiment, the syringe 174 is disposed at the connector 157 on the support 155. The cassette housing 151 is connected to the support 155. The connector 157 can be, for example, a clip or other connection mechanism. The support 155 and the connector 157 are configured to support the syringe 174, for example, during a procedure, and to prevent movement of the syringe 174 when it is connected to the stopcock 158. Further, the support 155 and the connector 157 hold the syringe 174 in place when the cassette 150 (and associated drive module (not shown)) moves linearly along the linear member 60 (shown in FIG. 3) during a procedure.

[0042] As described above, using the second tube 170, fluid (e.g., physiological saline) is supplied from a fluid source such as a pressurized physiological saline bag to the first tube 162 and the hemostatic valve 152. In one embodiment, fluid such as physiological saline is used to flush the lumen of the catheter 176 in use, ensuring that blood stasis in the lumen that could cause coagulation does not occur. The pressurized bag or other fluid source is typically located behind or on the non-operating side of the patient table. The second tube 170 is suspended above the robotic drive device and reaches the cassette, as shown in FIG. 14. FIG. 14 according to one embodiment is a perspective view of a device module with a vertically mounted cassette and a fluid management device. In FIG. 14, the cassette ....... It should be noted that the original text seems to be incomplete at the end. If you can provide the full text, I will be able to give a more complete translation.Accordingly, the second tube connection portion 160 is also configured to restrain the second tube 170 so that the second tube 170 does not fall off when the second tube 170 is not connected to the hemostatic valve 152 and the stopcock 158. In one embodiment, the distal end of the second tube 170 below the second tube connection portion 160 includes a shoulder (flange portion) that prevents the second tube 170, which is not connected to the stopcock 158, from slipping through the second tube connection portion 160 and sliding down. The second tube connection portion 160 is, for example, a clip or a loop. Further, the second tube connection portion 160 is configured such that the second tube 170 can move or slide axially within the second tube connection portion 160. This facilitates handling when the second tube 170 is connected to the hemostatic valve via the stopcock 158 and is operated, for example, to enable degassing.

[0043] The control computing system described herein may include a processor having a processing circuit. The processor may include a central processing unit, an application specific processor (ASIC), a circuit including one or more processing components, a group of distributed processing components, a group of distributed computers configured for processing, etc., and is configured to provide the functions of the modules or subsystem components described herein. A memory unit (e.g., a memory device, a storage device, etc.) is a device for storing data and / or computer code to perform and / or facilitate the various processes disclosed herein. The memory unit includes volatile memory and / or non-volatile memory. The memory unit can include a database component, an object code component, a script component, and / or any other type of information structure for supporting the various activities disclosed herein. According to one embodiment, any past, present, or future distributed and / or local memory devices can be utilized in the systems and methods disclosed herein. According to one embodiment, the memory unit is commonly connected with one or more associated processing circuits. This connection can be made via any wired, wireless, or network connection of the circuit or otherwise, and includes computer code for executing one or more of the processes described herein. One memory unit can include various individual memory devices, chips, disks, and / or other storage structures or systems. A module or subsystem component can be computer code (e.g., object code, program code, compiled code, script code, executable code, or any combination thereof) for performing the functions of each module.

[0044] In the description set forth herein, examples have been used in order to disclose the invention, including the best mode, and to enable a person of ordinary skill in the art to make and use the invention. The scope of the present invention is defined by the claims and includes other examples that would be apparent to a person of ordinary skill in the art. Such other examples are intended to be within the scope of the claims if they have elements that do not depart from the scope of the claims, or if they have equivalent elements that do not materially differ from the claimed elements. The order of the process or method steps and Procedure both may be changed or rearranged according to alternative embodiments.

[0045] Many other changes and modifications can be made to the present invention without departing from the spirit of the invention. The scope of these and other changes will be apparent from the claims.

Claims

1. A cassette for use in a robotic drive device of a catheter treatment system, comprising: a housing configured to support a hemostatic valve having a base and a side port, the housing having a longitudinal device axis associated with an elongate medical device; a first tube connection portion disposed on the housing above the longitudinal device axis, positioned above the longitudinal device axis, and configured to hold the outside of a first tube connected to the side port; a second tube connection portion disposed adjacent to an upper edge portion of the housing above the first tube connection portion and the longitudinal device axis, and configured to hold the outside of a second tube in communication with the first tube.

2. The cassette according to claim 1, wherein the first tube connection portion is configured to provide strain relief for the first tube.

3. The cassette according to claim 2, wherein the first tube connection portion is a clip.

4. The cassette according to claim 1, wherein the second tube connection portion is a clip.

5. The cassette according to claim 1, wherein the second tube connection portion is a loop.

6. An apparatus for providing a fluid connection to a cassette for use in a robotic drive device of a catheter treatment system, the cassette having a cassette housing having a longitudinal device axis associated with an elongate medical device, the cassette housing being configured to receive a hemostatic valve having a base and a side port for the elongate medical device, the apparatus comprising: a first tube connection portion disposed on the cassette housing above the longitudinal device axis; a first tube connected to the side port of the hemostatic valve and having its outside held by the first tube connection portion; a valve having a plurality of ports, one of the plurality of ports being connected to the first tube; a second tube connection portion disposed adjacent to an upper edge portion of the cassette housing above the first tube connection portion and the longitudinal device axis; and a second tube connected to one of the plurality of ports of the valve and having its outside held by the second tube connection portion.

7. The apparatus according to claim 6, wherein the first tube connection portion is configured to provide strain relief for the first tube. ​ ​ Claim 8 The apparatus according to claim 7, wherein the first tube connection part is a clip. Claim 9 The apparatus according to claim 6, wherein the valve is a stopcock. Claim 10 The apparatus according to claim 9, wherein the plurality of ports are three ports. Claim 11 The apparatus according to claim 6, wherein the second tube connection part is a clip. Claim 12 The apparatus according to claim 6, wherein the second tube connection part is a loop. Claim 13 The apparatus according to claim 6, wherein the second tube connection part is configured such that the second tube can operate in the axial direction. Claim 14 The apparatus according to claim 13, wherein the second tube includes a shoulder at the distal end of the second tube. Claim 15 The apparatus according to claim 6, wherein the second tube is connected to a fluid source. Claim 16 The apparatus according to claim 15, wherein the fluid source contains physiological saline. Claim 17 The apparatus according to claim 6, wherein the hemostatic valve is a rotary hemostatic valve. Claim 18 The apparatus according to claim 6, wherein the first tube includes a collar configured to lock to the first tube connection part.

Images