Apparatus for fluid management in a robotic catheter-based surgical system

Abstract

The present invention relates to apparatus for fluid management in a robotic catheter-based surgical system. A cassette for use in a robotic drive of a catheter-based surgical 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 further includes a first tube connection point on the housing and above the longitudinal device axis. The first tube connection point is configured to receive a first tube. The cassette further includes a second tube connection point near a top edge of the housing and above the first tube connection point and the longitudinal device axis. The second tube connection point is configured to receive a second tube.

Description

Technical Field

[0001] This invention generally relates to the field of robotic medical surgical systems, and more particularly to a device for managing fluid connections to elongated medical devices in a cartridge within a robotic actuator of a catheter-based surgical system. Background Technology

[0002] Catheters and other elongated medical devices (EMDs) can be used in minimally invasive medical procedures to diagnose and treat a variety of vascular system diseases, including neurovascular intervention (NVI) (also known as neurointerventional surgery), percutaneous coronary intervention (PCI), and peripheral vascular intervention (PVI). These procedures typically involve guiding a guidewire through the vascular system and advancing a catheter via the guidewire to deliver treatment. Catheter insertion begins with the use of a guide sheath to enter the appropriate vessel, such as an artery or vein, using standard percutaneous techniques. The sheath or guide catheter is then advanced over the diagnostic guidewire to the primary location, such as the internal carotid artery for NVI, the coronary ostium for PCI, or the superficial femoral artery for PVI. A guidewire adapted to the vascular system is then guided through the sheath or guide catheter to the target location within the vascular system. In some cases, such as in convoluted anatomy, a support catheter or microcatheter is inserted over the guidewire to aid in its guidance. Physicians or operators can use imaging systems (such as fluorescein microscopes) to obtain images via angiography and select fixed frames as a roadmap to guide the guidewire or catheter to the target location, such as a lesion. As the physician advances the guidewire or catheter, enhanced images are also obtained, allowing the physician to verify that the device is moving along the correct path to the target location. When using fluoroscopy to visualize anatomical structures, the physician manipulates the proximal end of the guidewire or catheter to guide the distal tip toward the lesion or target anatomical location into the appropriate vessel and avoids advancing it into branch vessels.

[0003] Robotic catheter-based surgical systems have been developed to assist physicians in performing catheter insertion procedures such as, for example, NVI, PCI, and PVI. Examples of NVI procedures include coil embolization of aneurysms, liquid embolization of arteriovenous malformations, and mechanical thrombectomy for large vessel occlusion following acute ischemic stroke. In NVI procedures, physicians use a robotic system to access the target lesion by manipulating a neurovascular guidewire and microcatheter to deliver treatment and restore normal blood flow. Target access is made possible by a sheath or guide catheter, but intermediate catheters may be needed for more distant areas or to provide adequate support for the microcatheter and guidewire. Depending on the type of lesion and the treatment, the distal tip of the guidewire enters or passes through the lesion. To treat an aneurysm, the microcatheter is advanced into the lesion, the guidewire is removed, and several embolization coils are deployed into the aneurysm via the microcatheter to block blood flow into the aneurysm. To treat an arteriovenous malformation, a liquid embolic agent is injected into the malformation via the microcatheter. Mechanical thrombectomy for vascular occlusion can be performed via aspiration and / or the use of a stent retrieval device. Depending on the location of the clot, aspiration is performed via an aspiration catheter or via a microcatheter for smaller arteries. Once the aspiration catheter is at the lesion site, negative pressure is applied to remove the clot through the catheter. Alternatively, the clot can be removed by deploying a stent retrieval device via a microcatheter. Once the clot has integrated into the stent retrieval device, it is removed by retracting the stent retrieval device and the microcatheter (or intermediate catheter) into the guiding catheter.

[0004] In PCI, physicians use robotic systems to access the lesion, manipulating a coronary guidewire to deliver treatment and restore normal blood flow. Access is made possible by placing a guiding catheter in the coronary ostium. The distal tip of the guidewire is guided through the lesion, and for complex anatomy, a microcatheter can be used to provide adequate support for the guidewire. Blood flow is restored by delivering and deploying a stent or balloon at the lesion. The lesion may require preparation before stent placement, either by delivering a balloon for pre-dilation of the lesion or by performing atherosclerosis resection using a catheter and guidewire, such as a laser or rotational atherosclerosis resection catheter. Diagnostic imaging and physiological measurements can be performed using imaging catheters or fractional flow reserve (FFR) measurements to determine appropriate treatment.

[0005] In PVI, physicians use a robotic system to deliver treatment and restore blood flow using techniques similar to NVI. The distal tip of the guidewire is guided through the lesion, and microcatheters can be used to provide adequate support for the guidewire when used in complex anatomical structures. Blood flow is restored by delivering and deploying a stent or capsule to the lesion. As with PCI, lesion preparation and diagnostic imaging can also be used.

[0006] When support at the distal end of the catheter or guidewire is required, for example, to guide a tortuous or calcified vascular system to a distal anatomical location or through a hard lesion, an over-the-wire (OTW, integral exchangeable cyst catheter) or coaxial system is used. An OTW catheter has an inner lumen for the guidewire that extends the entire length of the catheter. This provides a relatively stable system because the guidewire is supported along its entire length. However, this system has some disadvantages compared to rapid exchange catheters, including higher friction and a longer overall length (see below). Typically, to remove or replace the OTW catheter while maintaining the indwelling guidewire position, the exposed length of the guidewire (outside the patient) must be longer than the OTW catheter. For this purpose, a 300 cm guidewire is usually sufficient and is often referred to as an exchange-length guidewire. Due to the length of the guidewire, two operators are required to remove or replace the OTW catheter. This becomes even more challenging if a triaxial system (known in the art as a triaxial system) is used (quadriaxial catheters are also known to be used). However, due to its stability, the OTW system is commonly used in NVI and PVI procedures. On the other hand, PCI procedures typically use rapid-exchange (or single-rail) catheters. In a rapid-exchange catheter, the guidewire lumen extends only through the distal segment of the catheter, known as the single-rail or rapid-exchange (RX) segment. Using the RX system, the operator manipulates interventional devices parallel to each other (as opposed to the OTW system, where multiple devices are arranged in a tandem configuration), and the exposed length of the guidewire only needs to be slightly longer than the RX segment of the catheter. Rapid-exchange guidewires are typically 180–200 cm long. Given a shorter guidewire and single rail, the RX catheter can be changed by a single operator. However, the RX catheter is often insufficient when more distal support is required. Summary of the Invention

[0007] According to one embodiment, a housing for use in a robotic actuator of a catheter-based surgical 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 elongated medical device. The housing also includes a first tube connection point located on the housing and above the longitudinal device axis. The first tube connection point is configured to receive a first tube. The housing further includes a second tube connection point located near the top edge of the housing and above the first tube connection point and the longitudinal device axis. The second tube connection point is configured to receive a second tube.

[0008] According to another embodiment, a device for providing fluid connection to a cassette used in a robotic actuator of a catheter-based surgical system includes: a cassette housing having a longitudinal device axis associated with an elongated medical device, and a hemostatic valve located within the cassette housing. The hemostatic valve has a base and side ports. The device further includes: a first tube connection point located on the cassette housing and above the longitudinal device axis; a first tube coupled to the side port of the hemostatic valve and located within the first connection point; a valve having a plurality of ports, one of which is coupled to the first tube; a second tube connection point located near the top edge of the cassette housing and above the first tube connection point and the longitudinal device axis; and a second tube coupled to one of the ports of the valve and located within the second tube connection point. Attached Figure Description

[0009] The invention will become more fully understood from the following detailed description taken in conjunction with the accompanying drawings, wherein reference numerals denote similar parts, wherein:

[0010] Figure 1 This is a perspective view of an exemplary catheter-based surgical system according to an embodiment;

[0011] Figure 2 This is a schematic block diagram of an exemplary catheter-based surgical system according to an embodiment;

[0012] Figure 3 This is a perspective view of a robot actuator for a catheter-based surgical system according to an embodiment;

[0013] Figure 4 This diagram illustrates the control axis of a slender medical device and its entry point into the patient.

[0014] Figures 5a and 5b illustrate the effect of the thickness of the robot actuator on the loss of working length.

[0015] Figure 6 This is a diagram illustrating an exemplary orientation that minimizes the loss of working length;

[0016] Figure 7 This is a perspective view of a device module having a vertically mounted box according to an embodiment;

[0017] Figure 8 This is a rear perspective view of a device module having a vertically mounted box according to an embodiment;

[0018] Figure 9 This is a front view of the distal end of a device module having a vertically mounted box according to an embodiment;

[0019] Figure 10 This is a front view of the distal end of a device module having a horizontally mounted box according to an embodiment;

[0020] Figure 11 This is a front view of a box including a fluid management element according to an embodiment;

[0021] Figure 12 This is a front view of a device for fluid management according to an embodiment;

[0022] Figure 13 This is a front view of a device for fluid management according to an embodiment; and

[0023] Figure 14 This is a perspective view of a device module having a vertically mounted box and a device for fluid management according to an embodiment. Detailed Implementation

[0024] The following definitions will be used throughout this document. The term “elongated medical device” (EMD) refers to, but is not limited to, catheters (e.g., guiding catheters, microcatheters, capsule / stent catheters), wire-based devices (guidewires, embolization coils, stent retrieval devices, etc.), and devices combining these. Wire-based EMDs include, but are not limited to, guidewires, microwires, proximal pushers for embolization coils, stent retrieval devices, self-deploying stents, and deflectors. Typically, wire-based EMDs do not have a hub or handle at their proximal end. In one embodiment, an EMD is a catheter having a hub at its proximal end and a flexible shaft extending from the hub toward the distal end of the catheter, wherein the shaft is more flexible than the hub. In one embodiment, the catheter includes an intermediate portion transitioning between the hub and the shaft, which has intermediate flexibility less rigid than the hub and more rigid than the shaft. In one embodiment, the intermediate portion is a strain reliever.

[0025] The terms "distal" and "proximal" define the relative positions of two distinct features. In the context of a robotic actuator, the terms distal and proximal are defined by the position of the robotic actuator relative to the patient in its intended use. When used to define relative positions, when the robotic actuator is in its intended use position, a distal feature is a feature of the robotic actuator that is closer to the patient than a proximal feature. Within a patient, any vascular system landmark further away from the access point along the path is considered farther than a landmark closer to the access point, where the access point is the point where the EMD enters the patient. Similarly, when the robotic actuator is in its intended use position, a proximal feature is a feature further away from the patient than a distal feature. When used to define orientation, when the robotic actuator is in its intended use position, distal orientation refers to something that is moving on or intended to move on, or something that is moving along its path from the proximal feature toward or toward the distal feature and / or the patient. Proximal orientation is the opposite of distal orientation.

[0026] The term "longitudinal axis of a component" (e.g., an EMD or other element in a catheter-based surgical system) refers to the orientation from the proximal portion of the component to the distal portion. For example, the longitudinal axis of a guidewire is the orientation from the proximal portion of the guidewire toward the distal portion, even if the guidewire may be non-linear in the relevant portion. The term "axial movement of a component" refers to the translation of the component along its longitudinal axis. An EMD is being advanced when its distal end moves axially in the distal direction along its longitudinal axis into or further into the patient. An EMD is being withdrawn when its distal end moves axially in the proximal direction away from or further away from the patient. The term "rotational movement of a component" refers to a change in the angular orientation of the component about its local longitudinal axis. Rotational movement of an EMD corresponds to clockwise or counterclockwise rotation of the EMD about its longitudinal axis due to applied torque.

[0027] The term "axial insertion" refers to inserting the first component into the second component along the longitudinal axis of the second component. The term "lateral insertion" refers to inserting the first component into the second component along a direction in a plane perpendicular to the longitudinal axis of the second component. This can also be referred to as radial loading or lateral loading. The term "clamping" refers to releasably securing the EMD to the component such that the EMD moves with the component when the component moves. The term "releasing" refers to releasing the EMD from the component such that the EMD and the component move independently when the component moves. The term "clamping" refers to releasably securing the EMD to the component such that the movement of the EMD is constrained relative to the component. The component can be fixed relative to a global coordinate system or a local coordinate system. The term "releasing clamping" refers to releasing the EMD from the component such that the EMD can move independently.

[0028] The term "clamping" refers to the application of a force or torque to the EMD via a drive mechanism, causing the EMD to move without slippage in at least one degree of freedom. The term "releasing clamping" refers to releasing the force or torque applied to the EMD via the drive mechanism, so that the position of the EMD is no longer constrained. In one example, when the tires move longitudinally relative to each other, the EMD clamped between the two tires will rotate about its longitudinal axis. The rotational motion of the EMD differs from the motion of the two tires. The position of the clamped EMD is constrained by the drive mechanism. The term "buckling" refers to the tendency of a flexible EMD to bend away from its longitudinal axis or the intended path being advanced along when under axial compression. In one embodiment, axial compression occurs in response to resistance guided in the vascular system. The distance the EMD can be driven along its longitudinal axis without support before buckling is referred to herein as the "device buckling distance". The device buckling distance depends on the device stiffness, geometry (including but not limited to diameter), and forces applied to the EMD. Buckling may cause the EMD to form an arcuate portion that deviates from the intended path. Knotting is a type of buckling in which the deformation of the EMD is inelastic, resulting in permanent shaping.

[0029] The terms “top,” “upper,” “upper,” and “above” refer to a general direction away from the direction of gravity, while the terms “bottom,” “lower,” “lower,” and “below” refer to a general direction in the direction of gravity. The term “inward” refers to the interior of a feature. The term “outward” refers to the exterior of a feature. The term “front” refers to the side of a robot actuator (or an element of a robot actuator or other element of a catheterization system) facing the bedside user and away from the positioning system (such as an articulated arm). The term “rear” refers to the side of a robot actuator (or an element of a robot actuator or other element of a catheterization system) closest to the positioning system (such as an articulated arm). The term “sterilizable interface” refers to the interface or boundary between sterile and non-sterilizable units. For example, a cassette can be a sterilizable interface between a robot actuator and at least one EMD. The term “sterilizable unit” refers to a device capable of being sterilized (free from pathogenic microorganisms). This includes, but is not limited to, cassettes, consumable units, covers, device adapters, and sterilizable drive modules / units (which may include electromechanical components). The sterilizable unit may come into contact with the patient, other sterilization equipment, or any other items placed in the sterilization area of ​​a medical procedure.

[0030] The term "on-device adapter" refers to a sterilization device capable of releasably clamping an EMD to provide a drive interface. For example, an on-device adapter is also called an end effector or EMD capture device. In one non-limiting embodiment, the on-device adapter is a chuck operably and mechanically controlled to rotate the EMD about its longitudinal axis, clamp the EMD to and / or release it from the chuck, and / or translate the EMD along its longitudinal axis. In one embodiment, the on-device adapter is a hub drive mechanism, such as a driven gear located on the hub of the EMD.

[0031] Figure 1 This is a perspective view of an exemplary catheter-based surgical system 10 according to an embodiment. The catheter-based surgical system 10 can be used to perform catheter-based medical procedures, such as percutaneous interventional procedures, such as percutaneous coronary intervention (PCI) (e.g., treatment of STEMI), neurovascular interventional procedures (NVI) (e.g., treatment of emergency large vessel occlusion (ELVO)), peripheral vascular interventional procedures (PVI) (e.g., for severe limb ischemia (CLI), etc.). Catheter-based medical procedures can include diagnostic catheter insertion procedures, during which one or more catheters or other elongated medical devices (EMDs) are used to aid in the diagnosis of a patient's condition. For example, during one embodiment of a catheter-based diagnostic procedure, contrast agent is injected through a catheter onto one or more arteries, and images of the patient's vascular system are taken. Catheter-based medical procedures can also include catheter-based therapeutic procedures (e.g., angioplasty, stent placement, treatment of peripheral vascular disease, clot removal, treatment of arteriovenous malformations, aneurysm treatment, etc.), during which a catheter (or other EMD) is used to treat the condition. It can be achieved through auxiliary devices including, for example, intravascular ultrasound (IVUS), optical coherence tomography (OCT), fractional flow reserve (FFR) 54 ( Figure 2 (As shown in the diagram) to enhance the treatment procedure. However, it should be noted that those skilled in the art will recognize that certain specific percutaneous interventional devices or components (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 surgical system 10 is capable of performing any number of catheter-based medical procedures with only minor adjustments to accommodate the specific percutaneous interventional device to be used in the procedure.

[0032] In addition to other components, the catheter-based surgical system 10 includes a bedside unit 20 and a control station 26. The bedside unit 20 includes a robot actuator 24 and a positioning system 22 positioned adjacent to the patient 12. The patient 12 is supported on a patient table 18. The positioning system 22 is used to position and support the robot actuator 24. The positioning system 22 may be, for example, a robotic arm, an articulated arm, a retainer, etc. One end of the positioning system 22 may be attached to, for example, a rail, base, or trolley on the patient table 18. The other end of the positioning system 22 is attached to the robot actuator 24. The positioning system 22 can be removed (along with the robot actuator 24) to allow the patient 12 to be positioned 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 robot actuator 24 relative to the patient 12 for the procedure. In an embodiment, the patient table 18 is operatively supported by a base 17 fixed to the floor and / or ground. The patient table 18 is capable of moving relative to the base 17 with multiple degrees of freedom, such as roll, pitch, and yaw. The bedside unit 20 may also include controls and a display 46. Figure 2 (As shown in the diagram). For example, controls and displays can be located on the housing of the robot driver 24.

[0033] Typically, the robot actuator 24 may be equipped with appropriate percutaneous intervention devices and accessories 48. Figure 2 (as shown herein) (e.g., guidewires, various types of catheters, including balloon catheters, stent delivery systems, stent retrieval devices, embolization coils, liquid embolization agents, aspiration pumps, devices for delivering contrast agents, medications, hemostatic valve adapters, syringes, stopcocks, inflation devices, etc.) to allow a user or operator 11 to perform catheter-based medical procedures via a robotic system by operating various controls (such as controls and inputs located at control station 26). Bedside unit 20, and in particular robot actuator 24, may include any number and / or any combination of components to provide the functionality described herein to bedside unit 20. The user or operator 11 at control station 26 is referred to as control station user or control station operator, and is referred to herein as user or operator. The user or operator at bedside unit 20 is referred to as bedside unit user or bedside unit operator. Robot actuator 24 includes components mounted to a track or linear member 60 ( Figure 3 Multiple device modules 32a-d (shown in the diagram). A track or linear member 60 guides and supports the device modules. Each of the device modules 32a-d can be used to drive an EMD, such as a catheter or guidewire. For example, a robotic actuator 24 can be used to automatically feed a guidewire into a diagnostic catheter and a guiding catheter in the patient's artery 12. One or more devices (such as EMDs) are inserted into the patient's body (e.g., a blood vessel) at insertion point 16 via, for example, a guide sheath.

[0034] Bedside unit 20 communicates with control station 26, allowing signals generated by user input from control station 26 to be transmitted wirelessly or via hardwired to bedside unit 20 to control various functions of bedside unit 20. As discussed below, control station 26 may include control computing system 34. Figure 2 (as shown in the diagram) or coupled to the bedside unit 20 via the control computing system 34. The bedside unit 20 can also provide feedback signals (e.g., load, speed, operating conditions, warning signals, error codes, etc.) to the control station 26, the control computing system 34 (as shown in the diagram) or via the control computing system 34. Figure 2 (as shown) or both. Communication between the control computing system 34 and the various components of the catheter-based surgical system 10 can be provided via a communication link, which can be a wireless connection, a cable connection, or any other means that allows communication between components. The control station 26 or other similar control system can be located at a local site (e.g., Figure 2 At the local control station 38 shown or at a remote station (e.g., Figure 2 The remote control station and computer system 42 shown are illustrated. The catheterization system 10 can be operated by a control station at a local site, a control station at a remote site, or both simultaneously. At the local site, the user or operator 11 and the control station 26 are located in the same or adjacent room as the patient 12 and the bedside unit 20. As used herein, the local site is the location of the bedside unit 20 and the patient 12 or object (e.g., animal or cadaver), and the remote site is the location of the user or operator 11 and the control station 26 for remotely controlling the bedside unit 20. The control station 26 (and control computing system) at the remote site and the control computing system at the bedside unit 20 and / or the local site can utilize communication systems and services 36. Figure 2 The remote site and the local (patient) site communicate with each other, for example, via the Internet. In an embodiment, the remote site and the local (patient) site are geographically distant from each other, for example, in different rooms in the same building, in different buildings in the same city, in different cities, or in other different locations where the remote site cannot physically access the bedside unit 20 and / or the patient 12 at the local site.

[0035] Control station 26 generally includes one or more input modules 28 configured to receive user input to operate various components or systems of catheter-based surgical system 10. In the illustrated embodiment, control station 26 allows a user or operator 11 to control bedside unit 20 to perform catheter-based medical procedures. For example, input modules 28 may be configured to cause bedside unit 20 to perform various tasks using a percutaneous interventional device (e.g., EMD) docked to robot actuator 24 (e.g., advancing, retracting, or rotating guidewires; advancing, retracting, or rotating catheters; inflating or contracting a balloon located on the catheter; positioning and / or deploying a stent; positioning and / or deploying a stent retrieval device; positioning and / or deploying an embolization coil; injecting contrast agent into the catheter; injecting liquid embolizing agent into the catheter; injecting medication or saline into the catheter; aspirating from the catheter; or performing any other function that may be performed as part of a catheter-based medical procedure). Robot actuator 24 includes various actuation mechanisms to cause movement (e.g., axial and rotational movement) of components of bedside unit 20, including the percutaneous interventional device.

[0036] In one embodiment, input module 28 may include one or more touchscreens, joysticks, scroll wheels, and / or buttons. In addition to input module 28, control station 26 may use additional user controls 44. Figure 2As shown in the diagram, input module 28 can be configured to advance, retract, or rotate various components and percutaneous interventional devices, such as guidewires and one or more catheters or microcatheters. Buttons may include, for example, an emergency stop button, a multiplier button, a device selection button, and an automated movement button. When the emergency stop button is pressed, power (e.g., electricity) to the bedside unit 20 is cut off or removed. In speed control mode, the multiplier button functions to increase or decrease the speed at which the associated component is moved in response to manipulation of input module 28. In position control mode, the multiplier button changes the mapping between the input distance and the output command distance. The device selection button allows the user or operator 11 to select which percutaneous interventional devices loaded into the robot actuator 24 are controlled by input module 28. The automated movement button enables algorithmic movement of the catheter-based surgical system 10 on percutaneous interventional devices without direct commands from the user or operator 11. In one embodiment, input module 28 may include one or more controls or icons (not shown) displayed on a touchscreen (which may or may not be part of display 30), which, when activated, cause operation of components of the catheter-based surgical system 10. Input module 28 may also include a capsule or stent control configured to inflate or deflate a capsule and / or deploy a stent. Each input module 28 may include one or more buttons, scroll wheels, joysticks, touchscreens, etc., which may be used to control one or more specific components dedicated to that control. Furthermore, one or more touchscreens may display one or more icons (not shown) associated with various parts of input module 28 or various components of the catheter-based surgical system 10.

[0037] Control station 26 may include display 30. In other embodiments, control station 26 may include two or more displays 30. Display 30 may be configured to display information or patient-specific data to a user or operator 11 located at control station 26. For example, display 30 may be configured to display image data (e.g., X-ray images, MRI images, CT images, ultrasound images, etc.), hemodynamic data (e.g., blood pressure, heart rate, etc.), patient record information (e.g., medical history, age, weight, etc.), lesion or treatment assessment data (e.g., IVUS, OCT, FFR, etc.). Furthermore, display 30 may be configured to display information for a specific procedure (e.g., procedure list, recommendations, procedure duration, catheter or guidewire position, volume of delivered medication or contrast agent, etc.). Additionally, display 30 may be configured to display information to provide information to the control computing system 34 ( Figure 2 (As shown in the diagram) Related functionality. Display 30 may include touchscreen capability to provide some user input capabilities for the system.

[0038] The catheter-based surgical system 10 also includes an imaging system 14. The imaging system 14 can be any medical imaging system that can be used in conjunction with catheter-based medical procedures (e.g., non-digital X-ray, digital X-ray, CT, MRI, ultrasound, etc.). In an exemplary embodiment, the imaging system 14 is a digital X-ray imaging device that communicates with a control station 26. In one embodiment, the imaging system 14 may include a C-arm (…). Figure 1 As shown in the diagram, the C-arm allows the imaging system 14 to rotate partially or completely around the patient 12 to obtain images at different angular positions relative to the patient 12 (e.g., sagittal view, caudal view, anterior and posterior view, etc.). In one embodiment, the imaging system 14 is a fluorescence fluoroscopy system including a C-arm with an X-ray source 13 and a detector 15, also referred to as an image intensifier.

[0039] Imaging system 14 can be configured to capture X-ray images of appropriate areas of the patient 12 during surgery. For example, imaging system 14 can be configured to capture one or more X-ray images of the head to diagnose neurovascular conditions. Imaging system 14 can also be configured to capture one or more X-ray images (e.g., real-time images) during catheter-based medical procedures to help the user or operator 11 of control station 26 properly position guidewires, guiding catheters, microcatheters, stent retrieval devices, coils, stents, capsules, etc., during surgery. One or more images can be displayed on display 30. For example, images can be displayed on display 30 to allow the user or operator 11 to accurately move the guiding catheter or guidewire into the appropriate position.

[0040] To define directions, a Cartesian coordinate system with X, Y, and Z axes is introduced. The positive X-axis is oriented in the longitudinal (axial) direction, that is, from the proximal end to the distal end, in other words, from the proximal side to the distal side. The Y and Z axes lie in the transverse plane of the X-axis, with the positive Z-axis oriented upwards, that is, in the direction opposite to gravity, and the Y-axis is automatically determined by the right-hand rule.

[0041] Figure 2 This is a block diagram of a catheter-based surgical system 10 according to an exemplary embodiment. The catheter-based surgical system 10 may include a control computing system 34. The control computing system 34 may be physically, for example, a control station 26. Figure 1As shown in the diagram, the control computing system 34 is generally an electronic control unit adapted to provide the various functionalities described herein for the catheter-based surgical system 10. For example, the control computing system 34 may be an embedded system, a dedicated circuit, a general-purpose system programmed with the functionalities described herein, etc. The control computing system 34 communicates with the bedside unit 20, communication systems and services 36 (e.g., the Internet, firewall, cloud services, session manager, hospital network, etc.), local control station 38, additional communication systems 40 (e.g., telepresence system), remote control station and computing system 42, and patient sensors 56 (e.g., electrocardiogram (ECG) device, electroencephalogram (EEG) device, blood pressure monitor, temperature monitor, heart rate monitor, respiratory monitor, etc.). The control computing system also communicates with the imaging system 14, patient table 18, additional medical systems 50, contrast injection system 52, and auxiliary devices 54 (e.g., IVUS, OCT, FFR, etc.). The bedside unit 20 includes a robot actuator 24, a positioning system 22, and may include additional controls and a display 46. As mentioned above, additional controls and displays may be located on the housing of the robot actuator 24. Interventional devices and accessories 48 (e.g., guidewires, catheters, etc.) interface with the bedside system 20. In embodiments, interventional devices and accessories 48 may include dedicated devices (e.g., IVUS catheters, OCT catheters, FFR lines, diagnostic catheters for angiography, etc.) that interface with their respective auxiliary devices 54, i.e., the IVUS system, OCT system, and FFR system, etc.

[0042] In various embodiments, the control computing system 34 is configured to be user-based (e.g., control station 26 such as local control station 38 or remote control station 42). Figure 1 The input module 28 (shown in the diagram) interacts with and / or generates control signals based on information accessible to the control computing system 34, enabling the use of the catheter-based surgical system 10 to perform medical procedures. The local control station 38 includes one or more displays 30, one or more input modules 28, and additional user controls 44. The remote control station and computing system 42 may include components similar to the local control station 38. The remote control station 42 and the local control station 38 can be different and customized based on their required functionality. The additional user controls 44 may include, for example, one or more foot input controls. Foot input controls can be configured to allow the user to select functions of the imaging system 14, such as turning X-rays on and off and scrolling through different stored images. In another embodiment, the foot input device can be configured to allow the user to select which devices are mapped to a wheel included in the input module 28. An additional communication system 40 (e.g., audio conferencing, video conferencing, telepresence, etc.) can be used to assist the operator in interacting with patients, medical personnel (e.g., angiography room personnel), and / or bedside devices.

[0043] The catheter-based surgical system 10 may be connected to or configured to include any other systems and / or devices not explicitly shown. For example, the catheter-based surgical system 10 may include an image processing engine, a data storage and archiving system, an automated capsule and / or stent expansion system, a drug injection system, a drug tracking and / or recording system, a user log, an encryption system, a system for restricting access to or use of the catheter-based surgical system 10, etc.

[0044] As mentioned, the control computing system 34 communicates with the bedside unit 20, which includes a robot actuator 24, a positioning system 22, and may include additional controls and a display 46, and can provide control signals to the bedside unit 20 to control the operation of motors and drive mechanisms used to drive percutaneous interventional devices (e.g., guidewires, catheters, etc.). Various drive mechanisms may be configured as part of the robot actuator 24. Figure 3 This is a perspective view of a robot actuator for a catheter-based surgical system 10 according to an embodiment. Figure 3 In this embodiment, the robot actuator 24 includes a plurality of device modules 32a-d coupled to a linear member 60. Each device module 32a-d is coupled to the linear member 60 via a stage 62a-d movably mounted to the linear member 60. The device modules 32a-d can be connected to the stages 62a-d using connectors such as offset brackets 78a-d. In another embodiment, the device modules 32a-d are directly mounted to the stages 62a-d. Each stage 62a-d can be independently actuated to move linearly along the linear member 60. Therefore, each stage 62a-d (and its corresponding device module 32a-d coupled to the stage 62a-d) can move independently relative to each other and to the linear member 60. A drive mechanism is used to actuate each stage 62a-d. Figure 3 In the illustrated embodiment, the drive mechanism includes independent stage translation motors 64a-d coupled to each stage 62a-d and a stage drive mechanism 76, such as a lead screw via a rotating nut, a rack via a pinion, a conveyor belt via a pinion or pulley, a chain via a sprocket, or the stage translation motors 64a-d themselves may be linear motors. In some embodiments, the stage drive mechanism 76 may be a combination of these mechanisms; for example, each stage 62a-d may employ a different type of stage drive mechanism. In embodiments where the stage drive mechanism is a lead screw and a rotating nut, the lead screw can be rotated, and each stage 62a-d can engage and disengage with the lead screw to move, such as advance or retract. Figure 3 In the embodiment shown, the stations 62a-d and the device modules 32a-d are in a series drive configuration.

[0045] Each device module 32a-d includes a drive module 68a-d and a housing 66a-d mounted on and connected to the drive module 68a-d. Figure 3 In the illustrated embodiment, each box 66a-d is mounted to the drive module 68a-d in a specific orientation such that the box 66a-d is mounted on the drive module 68a-d by moving the box 66a-d vertically downward onto the drive module 68a-d. When the box 66a-d is mounted on the drive module 68a-d, the top or side surface of the box 66a-d is parallel to the top or side surface (i.e., the mounting surface) of the drive module 68a-d. As used herein, Figure 3 The mounting orientation shown is referred to as horizontal orientation. In other embodiments, each box 66a-d may be mounted to drive modules 68a-d with a different mounting orientation. See below for reference. Figure 7-10 Various mounting orientations are further described. Each housing 66a-d is configured to abut and support a proximal portion of an EMD (not shown). In addition to the linear motion provided by the actuation of the corresponding stages 62a-d for linear movement along the linear member 60, each housing 66a-d may include elements that provide one or more degrees of freedom. For example, housing 66a-d may include elements that can be used to rotate the EMD when the housing is coupled to drive modules 68a-d. Each drive module 68a-d includes at least one coupler to provide a drive interface to the mechanism in each housing 66a-d, thereby providing additional degrees of freedom. Each housing 66a-d also includes a channel therein for device supports 79a-d, and each device support 79a-d is used to prevent buckling of the EMD. Support arms 77a, 77b, and 77c are attached to each device module 32a, 32b, and 32c, respectively, to provide fixation points for supporting the proximal ends of device supports 79b, 79c, and 79d. The robot actuator 24 may also include a device support connector 72, a distal support arm 70, and a support arm 770 connected to the device support 79. The support arm 770 provides a fixing point for supporting the proximal end of the distal device support 79a housed in the distal device module 32a. Furthermore, a guide interface support (steering mechanism) 74 may be connected to the device support connector 72 and the EMD (e.g., a guide sheath). The configuration of the robot actuator 24 offers the advantage of reducing the size and weight of the robot actuator 24 by using an actuator on a single linear member.

[0046] To prevent pathogen contamination of patients, healthcare staff will house bedside units 20 and patient 12 or other relevant facilities. Figure 1Aseptic techniques are used in the room shown. The room housing the bedside unit 20 and the patient 12 can be, for example, a catheterization lab or an angiography suite. Aseptic techniques include the use of sterilization barriers, sterilization equipment, proper patient preparation, environmental control, and contact guidelines. Therefore, all EMDs and interventional accessories are sterilized and can only come into contact with sterilization barriers or sterilization equipment. In an embodiment, a sterile cover (not shown) is placed over the non-sterile robotic actuator 24. Each cartridge 66a-d is sterilized and acts as a sterilization interface between the covered robotic actuator 24 and at least one EMD. Each cartridge 66a-d can be designed to be sterilized for single use or to be resterilized wholly or partially, allowing cartridge 66a-d or its components to be used in multiple procedures.

[0047] like Figure 1 As shown, one or more EMDs can be inserted into the patient's body (e.g., a blood vessel) at insertion point 16 using, for example, a guide and a guide sheath. The guide sheath is typically attached to the patient at 120 ( Figure 4-6 As shown in the diagram, the axes of blood vessels in the body are oriented at an angle (usually less than 45 degrees). The EMD enters the body where... Figure 4 Any height difference between the proximal opening 126 of the guide sheath shown and the longitudinal drive axis of the robot actuator 124 will directly affect the working length of the elongated medical device. The greater the difference in displacement and angle that the elongated medical device needs to compensate for when the robot actuator is in its maximum distal (forward) position, the less likely the elongated medical device is to enter the body. It is beneficial to have the robot actuator at the same height and angle as the guide sheath. Figure 4 This diagram illustrates the control axis of a slender medical device and its entry point into the patient. Figure 4 The height difference (d) 123 between the proximal end 126 of the guide sheath 122 and the longitudinal device axis is shown, as well as the angle difference (θ) 128 between the guide sheath 122 and the longitudinal device axis 125 of the robot actuator 124. The elongated medical device 121 is constrained on each axis, creating a curve with tangentially aligned endpoints. The length of this curve represents the length of the elongated medical device 121 that cannot be further driven forward by the robot actuator 124 and cannot enter the guide sheath 122 due to misalignment. A larger angle (θ) 128 also results in higher device friction. Generally, smaller angular misalignment (θ) 128 and linear misalignment d 123 cause reduced friction and reduced working length loss. Although Figure 4 The illustration shows a simplified example of one linear offset and one rotational offset, but it should be understood that the problem arises in three dimensions, i.e., three linear offsets and three rotational offsets. The thickness of the robot actuator 124 also plays a role in determining the position of the longitudinal device axis 125 relative to the guide sheath 122.

[0048] Figures 5a and 5b are diagrams illustrating the effect of the thickness of the drive module or robot actuator as a whole on the loss of working length. Figure 5a shows the position of the longitudinal device axis 125 of the robot actuator 124 relative to the guide sheath 122, indicated by d 123, when the robot actuator 124 is as thick as the distance (X) 129 between the upper and lower surfaces of the robot actuator 124. Figure 5b shows the position of the longitudinal device axis 125 of the robot actuator 124 relative to the guide sheath 122, indicated by the shorter d 123, when the robot actuator 124 is as shallow as the distance (X) 129 between the upper and lower surfaces of the robot actuator 124. Reducing the thickness of the robot actuator 124 to be closer to the patient and the guide sheath reduces the distance 123 between the guide sheath axis and the device axis, and reduces the loss of working length of the elongated medical device. Figure 6 This is a diagram illustrating an exemplary orientation that minimizes work length loss. Figure 6 In this configuration, the robot actuator is positioned to align the longitudinal axis 125 of the robot actuator 124 with the longitudinal axis of the guide sheath 122. This eliminates the loss of working length caused by angular and linear misalignment of the elongated medical device. However, this position of the robot actuator 124 may not be practical due to its length and dimensions. Orienting the robot actuator at an acute angle also affects usability, as it makes loading and unloading elongated medical devices, as well as adjusting and manipulating the robot actuator, difficult.

[0049] To reduce the distance between the robot actuator and the patient, as well as the distance between the longitudinal axis of the robot actuator and the guide sheath, device module 32 ( Figure 3 The box 66a-d (shown in the figure) can be installed onto the drive module 68a-d in a certain orientation, such that the box 66a-d is installed onto the drive module 68a-d by moving the box 66a-d onto the drive module 66a-d in the horizontal direction. Figure 7 This is a perspective view of a device module having a vertically mounted box according to an embodiment, and Figure 8 This is a rear perspective view of a device module having a vertically mounted box according to an embodiment. Figure 7 and Figure 8 In this embodiment, device module 132 includes a housing 138 mounted to drive module 140 such that the front or side 139 of housing 138 is parallel to the front or side 141 (i.e., mounting surface) of drive module 140. As used herein, Figure 7 and Figure 8The mounting orientation shown is referred to as vertical orientation. Device module 132 is connected to stage 136, which is movably mounted to track or linear member 134. Drive module 140 includes coupler 142 for providing a power interface to cartridge 138 to, for example, rotate an elongated medical device (not shown) located within the cartridge. Coupler 142 rotates about axis 143. As mentioned, cartridge 138 is mounted to drive module 140 by moving it horizontally onto mounting surface 141, such that the cartridge is coupled to coupler 142 of drive module 140. By vertically mounting cartridge 138, drive module 140 to which cartridge 138 is attached is positioned to one side and is no longer located between cartridge 138 and patient. Figure 9 This is a front view of the distal end of a device module having a vertically mounted box according to an embodiment. Figure 9 The image shows the distance 146 between the device axis of the elongated medical device 144 and the bottom surface of the device module 132. The vertical mounting orientation of the housing 138 eliminates the need to place the drive module 140 below the device axis and between the elongated medical device 144 and the patient. Instead, only a portion of the housing 138 is positioned between the elongated medical device 138 and the patient. Vertical mounting of the housing 138 also reduces the distance 146 between the elongated medical device and the bottom surface of the device module 132, allowing the robotic actuator to be closer to the patient and reducing the loss of working length in the elongated medical device. In contrast, Figure 10 This is a front view of the distal end of a device module having a horizontally mounted box according to an embodiment. Figure 10 The diagram shows device module 132, in which a housing 138 is horizontally mounted to drive module 140. When housing 138 is mounted on drive module 140, the top or side surface 145 of housing 138 is parallel to the top or side surface 147 (i.e., mounting surface) of drive module 140. Drive module 140 is located below or under housing 138, increasing the distance 148 between the device axis of elongated medical device 144 and the bottom surface of device module 132. This prevents the device axis from being too close to the guide (not shown). Drive module 140 located below housing 138 may also interfere with the patient. In various other embodiments, housing can be mounted to drive module at any angle. In yet another embodiment, housing can be horizontally mounted on the underside of drive module to eliminate the need for drive module between device axis and patient.

[0050] The EMD (e.g., catheter) in the kit can be connected to various tubes for purposes such as supplying saline drips, allowing contrast agent injections, allowing aspiration, etc. In embodiments, the catheter can be coupled to a hemostatic valve (e.g., a rotary hemostatic valve) having a side port that can be coupled (e.g., releasably or permanently) to the tube. In some systems for fluid management, a closed system utilizing a manifold can be used to provide connections to all necessary fluid lines. In a closed system, all necessary fluid lines (e.g., saline, contrast agent, waste bag) are connected to the side port of the manifold via a series of stopcocks. 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, which is in fluid communication with the catheter. Once set up, no connections are removed to ensure that air does not enter the system. Therefore, a closed system requires multiple fluid lines dedicated to the manifold to inject fluid into or aspirate fluid from the catheter. If there is more than one catheter in the system requiring fluid connections, a closed system with a manifold and all necessary fluid lines will be required for each catheter. For interventional procedures that require multiple catheters, setting up a closure system for each catheter is cumbersome and unnecessary.

[0051] In a robotic actuator of a linearly manipulated EMD, as the catheter is advanced and retracted by the robotic actuator during surgery, the hemostatic valve and any tubing connected to it translate along with the catheter. During catheter movement, the tubing may become caught or hooked onto one or more components of the robotic actuator. The likelihood of tubing jamming is likely higher in robotic actuators such as those described above because the user typically does not view and control the tubing at the bedside, but rather operates the robotic actuator from a control station at a local or remote site. A jammed or hooked tube can cause resistance to the movement of the robotic actuator, tube breakage, disconnection of the connection to the tube, or the hemostatic valve and catheter being abruptly pulled out of the robotic system. Therefore, it would be advantageous to consider tubing connections and provide a device for managing fluid connections to prevent accidental catheter movement or damage in the event of tubing jamming or hooking during operation of the robotic actuator. Furthermore, providing an open system for fluid management would be advantageous.

[0052] As mentioned, the catheter located in the box can be connected to the tube used for fluid via a hemostatic valve. Figure 11 This is a front view of a box including a fluid management element according to an embodiment, and Figure 12 This is a front view of a device for fluid management according to an embodiment. Figure 11In this configuration, a hemostatic valve 152 (e.g., a rotary hemostatic valve) and a catheter 176 are located within the housing 151 of the housing 150. The catheter 176 defines a longitudinal device axis 172 of the housing 150. The hemostatic valve 152 is coupled to the catheter 176. The hemostatic valve 152 includes a base 153 having a lumen that can be used to accommodate other EMDs, such as those from robot actuators (e.g., referenced above). Figure 1 and Figure 3 The robot actuator 24 described is an EMD of another, more proximal box. In an embodiment, the distal end (not shown) of the base 153 may include a rotary connector (not shown), such as a rotary Luer connector, which is rotatably connected to the distal end of the base 153. In an embodiment, the outer surface of the rotary Luer connector includes a gear (not shown), which may be driven by, for example, the robot actuator. The hemostatic valve 150 also includes a side port 154, which may be used to provide a connection to a tube for fluid inflow and outflow from the conduit 176. In an embodiment, the side port 154 is rotated such that, when located in the box 150, the open end points upward toward the top side of the box 150, which is configured to be vertically mounted on the drive module, for example, Figure 13 and 14 The box 150 is shown. A support 155 is connected to the box housing 151 and includes a connector 157. The connector 157 is configured to receive a syringe, as shown in the following reference. Figure 13 Further discussion is needed.

[0053] The housing 150 also includes a first tube connection point 156 and a second tube connection point 160. The first tube connection point 156 is located on the housing 151 above the longitudinal device axis 172. The second tube connection point 160 is located on the housing 151 near the top edge 182 of the housing 151 and above the first tube connection point 156 and the longitudinal device axis 172. Although the first tube connection point 156 and the second tube connection point 160 are shown positioned horizontally, in various other embodiments, the first tube connection point 156 and the second tube connection point 160 may be positioned vertically or at different angles. The first tube connection point 156 is configured to receive the first tube 162, as... Figure 12 As shown. Now refer to Figure 12 One end of the first tube 162 is connected to a side port 154 of the hemostatic valve 152, and the other end of the first tube 162 is connected to a valve, such as a three-way stopcock valve 158. In various embodiments, the first tube 162 may be releasably connected to the side port 154, or the first tube 162 may be permanently connected (e.g., coupled) to the side port 154. The three-way stopcock valve 168 has a first port 164, a second port 166, and a third port 168. Figure 12In one embodiment, the first tube 162 is connected to the first port 164 of the stopcock valve 158. In various embodiments, the first tube 162 may be releasably coupled to the first port 164 of the stopcock 158, or the first tube 162 may be permanently coupled (e.g., bonded) to the first port 164 of the stopcock 158. The stopcock 158 is not rigidly mounted to the housing 150, but remains loose. A first tube connection point 156 is connected to the first tube 162 along its length. The first tube connection point may be, for example, a clamp. A second tube connection point 160 is configured to receive a second tube 170. One end of the second tube 170 may be connected to the second port 166 of the stopcock valve 158. In various embodiments, the second tube 170 may be releasably coupled to the second port 166 of the stopcock 158, or the second tube 170 may be permanently coupled (e.g., bonded) to the second port 166 of the stopcock 158. The other end of the second tube 170 may be connected to a fluid source (not shown), as discussed further below. The second tube 170 is in fluid communication with the first tube 162 and the hemostatic valve 152 via a stopcock valve 158.

[0054] The first tube connection point 156 is configured to anchor the first tube 162 to the housing 151 (e.g., to prevent radial and axial movement of the first tube 162) and provide strain relief for the first tube 162 and the hemostatic valve 152. In an embodiment, the first tube 162 may include a collar 159 that engages with the first tube connection point 156 and is configured to prevent axial movement of the first tube 162. In an 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 point 156 is configured to prevent the first tube 162 or the second tube 170 from hooking or jamming, thereby preventing the hemostatic valve 152 from being pulled or the hemostatic valve 151 from being pulled out of the housing 150.

[0055] Figure 13 This is a front view of a device for fluid management according to an embodiment. As mentioned above, the stopcock valve 158 is not rigidly mounted to the housing 150, but remains loose, which allows the user to easily and comfortably manipulate the stopcock valve 158 to degas or connect a syringe to the stopcock valve 158. Figure 13 In this embodiment, syringe 174 is connected to the third port 168 of stopcock valve 158. Syringe 174 can be used, for example, to inject contrast agents, inject saline, or for aspiration. In an embodiment, syringe 174 can be located on support 155 and within connector 157. Support 155 is coupled to housing 151. Connector 157 can be, for example, a clip or other connection mechanism. Support 155 and connector 157 are configured to provide support for syringe 174 and prevent movement of syringe 174 when it is connected to stopcock valve 158 (e.g., during surgery). Furthermore, when housing 150 (and associated drive module (not shown)) moves along linear member 60 during surgery... Figure 3 As shown in the diagram, during linear movement, the support 155 and connector 157 hold the syringe 174 in place.

[0056] As mentioned above, the second tube 170 can be used to supply fluid (e.g., saline) from a fluid source (e.g., a pressurized saline bag) to the first tube 162 and the hemostatic valve 152. In an embodiment, when the catheter is in use, a fluid such as saline can be used to flush the lumen of the catheter 176 to ensure that blood does not remain inside the lumen, which could otherwise lead to clotting. The pressurized bag or other fluid source is typically located on the rear or non-operating side of the patient table. Figure 14 As shown, the second tube 170 can cover the robot actuator to reach the box. Figure 14 This is a perspective view of a device module with a vertically mounted box and an apparatus for fluid management, according to various embodiments. Figure 14 In the diagram, housing 150 is shown vertically mounted to drive module 178. Drive module 178 is coupled to stage 184, which is movably coupled to track 180. A stopcock valve 158 is connected to a first tube 162 via a first port 162 and to a second tube 170 via a second port 166. A third port 168 can be connected to, for example, a syringe (not shown). The first port 164, second port 166, and third port 168 each have an inner cavity to allow fluid communication with attached tubing (or fluid lines) or devices (e.g., syringes). The second tube 170 is located in a second tube connection point 160, which is located near the top edge 182 of housing 151. The second tube connection point 160 guides the second tube 170 upwards and away from the longitudinal device axis 172 to prevent the second tube 170 from contacting components of the robot actuator (e.g., [missing information]). Figure 3 The support rails 79a-d shown may become entangled or hooked. During loading and replacement of EMDs (such as catheter 176), the hemostatic valve 152 can be removed from the housing 150. Desiredly, when the loosened second tube 170 is disconnected from the hemostatic valve 152, it is prevented from falling back onto the rear side of the drive module. Therefore, the second tube connection point 160 is also configured to restrict the second tube 170 to prevent it from dislodging when it is not connected to the hemostatic valve 152 and the stopcock valve 158. In an embodiment, the distal end of the second tube 170 below the second tube connection point 160 may include a shoulder that prevents the second tube 170 from sliding through the second tube connection point 160 and falling when it is not connected to the stopcock valve 158. The second tube connection point 160 may be, for example, a clamp or a ring. The second tube connection point 160 is also configured to allow the second tube 170 to move or slide axially within the second tube connection point 160. This second tube 170 is connected to the hemostatic valve via a stopcock valve 158 and is manipulated to allow for easy control, for example, to remove air bubbles.

[0057] The control computing system described herein may include a processor with processing circuitry. The processor may include a central purpose processor, a dedicated processor (ACIC), circuitry containing one or more processing units, a group of distributed processing components configured to process, etc., a group of distributed processing components configured to provide functionality for the modules or subsystem components discussed herein, or a group of distributed computers. A memory unit (e.g., a memory device, storage device, etc.) is a means for storing data and / or computer code to perform and / or facilitate the various processes described herein. A memory unit may include volatile memory and / or non-volatile memory. A memory unit may include database components, object code components, script components, and / or any other type of information structure for supporting the various activities described herein. According to exemplary embodiments, any distributed and / or local memory devices, past, present, or future, may be utilized with the systems and methods of this disclosure. According to exemplary embodiments, a memory unit may be communicatively connected to one or more associated processing circuits. This connection may be via circuitry or any other wired, wireless, or network connection and includes computer code for performing one or more processes described herein. A single memory unit may include various individual memory devices, chips, disks, and / or other storage structures or systems. A module or subsystem component can be computer code (e.g., object code, procedural code, compiled code, script code, executable code, or any combination thereof) used to perform the respective functions of each module.

[0058] This written description uses examples to disclose the invention, including the best mode, and also enables any person skilled in the art to make and use the invention. The patentable scope of the invention is defined by the claims, but may include other examples that would occur to a person skilled in the art. Such other examples are intended to be within the scope of the claims if they have structural elements that are not different from the literal language of the claims, or if they include equivalent structural elements that are not substantially different from the literal language of the claims. According to alternative embodiments, the order and sequence of any process or method steps may be varied or reordered.

[0059] Many other changes and modifications can be made to this invention without departing from its spirit. The scope of these and other changes will become clear from the appended claims.

Claims

1. A housing for use in a robotic actuator of a catheter-based surgical system, the housing comprising: A housing configured to support a hemostatic valve having a base and side ports, the housing having a longitudinal device axis associated with an elongated medical device; A first tube connection point, located on the housing and above the longitudinal device axis, is configured to receive a first tube and anchor the first tube to the housing. and The second tube connection point is located near the top edge of the housing and above the first tube connection point and the longitudinal device axis, and is configured to receive the second tube.

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

3. The box according to claim 2, wherein, The first tube connection point is a clamp.

4. The box according to claim 1, wherein, The second tube connection point is a clamp.

5. The box according to claim 1, wherein, The second pipe connection point is a ring.

6. An apparatus for providing fluid connection to a cartridge used in a robotic actuator of a catheter-based surgical system, the apparatus comprising: The outer casing has a longitudinal device axis associated with an elongated medical device, wherein the elongated medical device includes a catheter and a guidewire; A hemostatic valve located in the housing of the box, the hemostatic valve having a base and a side port; The first tube connection point is located on the outer casing of the box and above the longitudinal device axis; The first tube is connected to the side port of the hemostatic valve and is located at the first tube connection point; A valve having multiple ports, wherein one of the multiple ports is connected to the first pipe; The second pipe connection point is located near the top edge of the housing and above the first pipe connection point and the longitudinal device axis; and The second pipe is connected to one of the multiple ports of the valve and is located at the second pipe connection point.

7. The device according to claim 6, wherein, The first tube connection point is configured to provide strain relief for the first tube.

8. The device according to claim 7, wherein, The first tube connection point is a clamp.

9. The device according to claim 6, wherein, The valve is a plug valve.

10. The device according to claim 9, wherein, The multiple ports include three ports.

11. The device according to claim 6, wherein, The second tube connection point is a clamp.

12. The device according to claim 6, wherein, The second pipe connection point is a ring.

13. The device according to claim 6, wherein, The second pipe connection point is configured to allow axial movement of the second pipe.

14. The device according to claim 13, wherein, The second tube includes a shoulder at the distal end of the second tube.

15. The device according to claim 6, wherein, The second pipe is connected to the fluid source.

16. The device according to claim 15, wherein, The fluid source includes brine.

17. The device according to claim 6, wherein, The hemostatic valve is a rotary hemostatic valve.

18. The device according to claim 6, wherein, The first tube includes a collar configured to engage the first tube connection point.

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