Systems, apparatus, and methods for supporting and actuating slender medical devices in robotic catheter-based surgical systems.

Abstract

A device for supporting an elongated medical device is disposed between a first device module and a second device module coupled to a linear member of a robotic actuator for a catheter-based surgical system. The second device module is located distal to the first device module along the linear member. The device includes a device support having a distal end and a proximal end. A segment of the device support is positioned within the first device module. The device also includes a connector attached to the distal end of the device support. The connector includes an attachment mechanism for engaging the proximal end of the second device module. The proximal end of the device support is configured to couple to the second device module.

Description

[0001] Cross-references to related applications

[0002] This application claims priority to U.S. Serial No. 62 / 874,222, filed July 15, 2019, entitled “System, apparatus, and method for supporting and driving a slender medical device in a robotic catheter-based surgical system,” the entire contents of which are incorporated herein by reference. Technical Field

[0003] This invention relates generally to the field of robotic medical surgical systems, and particularly to systems, apparatus, and methods for supporting and driving elongated medical devices in robotically controlled interventional procedures using catheter-based surgical systems. Background Technology

[0004] Catheters and other elongated medical devices (EMDs) are 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. The catheter insertion procedure begins by establishing access to the appropriate vessel, such as an artery or vein, using standard percutaneous techniques through a guidewire sheath. The 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 guidewire to the target location within the vascular system. In some cases, such as in convoluted anatomy, a support catheter or microcatheter is inserted through the guidewire to assist the navigation guidewire. Physicians or operators can use imaging systems (such as fluorescein microscopes) to obtain films with contrast agent injection and select a fixed frame as a roadmap to navigate the guidewire or catheter to the target location, such as a lesion. Contrast-enhanced images are also obtained while the physician delivers the guidewire or catheter, allowing the physician to verify that the device is moving along the correct path towards the target location. While observing anatomical structures using fluorescein, 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 avoid advance into collateral vessels.

[0005] 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 in cases of acute ischemic stroke. In NVI procedures, physicians use a robotic system to deliver treatment by manipulating a neurovascular guidewire and microcatheter to restore normal blood flow, thereby achieving access to the target lesion. The target access is achieved via a sheath or guide catheter, but intermediate catheters may also be needed for more distal 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 is navigated into or past the lesion. To treat an aneurysm, the microcatheter is advanced into the lesion, the guidewire is removed, and several embolization coils are deployed through the microcatheter into the aneurysm to block blood flow into it. 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 can be performed either via an aspiration catheter or via a microcatheter for smaller arteries. Once the aspiration catheter is located at the lesion site, negative pressure is applied to remove the clot through the catheter. Alternatively, the clot can be removed by deploying the 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) back into the guiding catheter.

[0006] In PCI, physicians use robotic systems to deliver treatment and restore normal blood flow through the coronary artery guidewire, thereby gaining access to the lesion. This access is achieved by placing a guiding catheter in the coronary ostium. The distal tip of the guidewire is navigated through the lesion, and for complex anatomy, microcatheters 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, or by delivering a balloon for pre-dilation of the lesion, or by performing atherosclerosis resection using, for example, a laser or rotational atherosclerosis resection catheter and a balloon on the guidewire. Diagnostic imaging and physiological measurements can be performed using imaging catheters or fractional flow reserve (FFR) measurements to determine appropriate treatment.

[0007] In PVI, physicians use a robotic system to deliver treatment and utilize techniques similar to NVI to restore blood flow. The distal tip of the guidewire is navigated across the lesion, and microcatheters can be used to provide adequate support for the guidewire when used in complex anatomy. Blood flow is restored by delivering and deploying a stent or balloon to the lesion. As with PCI, lesion preparation and diagnostic imaging can also be used.

[0008] When support is required at the distal end of the catheter or guidewire, for example, to navigate tortuous or calcified vascular systems to reach distal anatomical locations or through hard lesions, an over-the-wire (OTW) 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 quick-change catheters, including higher friction and a longer overall length (see below). Typically, to remove or change the OTW catheter while maintaining the position of the indwelling guidewire, the exposed length of the guidewire (outside the patient) must be longer than the OTW catheter. For this purpose, a 300 cm guidewire is often sufficient and is often referred to as the replacement-length guidewire. Due to the length of the guidewire, two operators are required to remove or change the OTW catheter. This becomes even more challenging if a triaxial system, known in the art (quadriaxial catheters are also known to be used), is used. However, due to its stability, the OTW system is often used in NVI and PVI procedures. On the other hand, PCI procedures often use quick-change (or single-rail) catheters. In a quick-change catheter, the guidewire lumen extends only through the distal segment of the catheter, called the single-rail or quick-change (RX) segment. Using the RX system, operators manipulate the interventional devices in parallel (unlike the OTW system, where devices are manipulated in a tandem configuration), and the exposed length of the guidewire only needs to be slightly longer than the RX segment of the catheter. Quick-change guidewire lengths are typically 180–200 cm. 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

[0009] According to an embodiment, a device for providing support to an elongated medical device between a first device module and a second device module, the first and second device modules being coupled to a linear member for a robotic actuator of a catheter. The second device module is located distal to the first device module along the linear member. The device includes a device support having a distal end and a proximal end. A segment of the device support is positioned within the first device module. The device also includes a connector attached to the distal end of the device support. The connector includes an attachment mechanism for engaging the proximal end of the second device module. The proximal end of the device support is configured to couple to the second device module.

[0010] According to another embodiment, a cassette in a robotic actuator for a catheter-based surgical system includes a housing having a distal and a proximal end; a device support having a longitudinal slit, a distal end, and a proximal end; a connector attached to the distal end of the device support; and a separator positioned at the distal end of the housing, the separator being located at an entry point from an elongated medical device into the device support. A section of the device support is positioned within the housing. In a first position, the connector is located proximal to the entry point, and in a second position, the connector is located distal to the entry point.

[0011] According to another embodiment, a device support for providing support for an elongated medical device between a first device module and a second device module coupled to a linear member of a robot actuator of a catheter-based surgical system, the device support comprising a first tube and a second tube, the first tube having a longitudinal slit configured to move between the first position and the second tube having a longitudinal opening, an inner diameter, and an outer diameter. The first tube has an inner diameter and an outer diameter. The second tube is disposed about the outer diameter of the first tube and configured to provide force on the first tube to hold the first tube in the first position.

[0012] According to another embodiment, a housing in a robotic actuator for a catheter-based surgical system includes: a housing having a distal end and a proximal end; an inlet point to a device support on the distal end of the housing; and a modular section of the housing located between the inlet point on the proximal and distal ends. The modular section is configured to receive a plurality of different adapters configured to support different elongated medical devices.

[0013] According to another embodiment, a device for providing support for an elongated medical device in a catheter-based surgical system includes a housing and an elongated medical device adapter. The housing includes a shell having a distal and a proximal end, an inlet point to a device support on the distal end of the shell, and a modular section of the shell between the inlet points on the proximal and distal ends. The modular section includes a central section and a recess positioned off-center from the longitudinal axis of the housing. The elongated medical device adapter includes a first section configured to receive a first elongated medical device and a second section configured to receive a second elongated medical device. The second section is positioned at an angle to the longitudinal axis of the first section. The first section of the elongated medical device adapter is positioned within the central section of the modular section, and the second section of the elongated medical device adapter is positioned within the recess of the modular section.

[0014] According to another embodiment, a cassette in a robotic actuator for a catheter-based surgical system includes a rigid support with an opening and an isolation interface positioned within the opening. The isolation interface includes a bracket for an elongated medical device. The recess and the isolation interface allow for a limited range of movement of the isolation interface relative to the rigid support in the x, y, and z directions.

[0015] According to another embodiment, a housing in a robot actuator for a catheter-based surgical system includes a rigid support section, an interface portion configured to support a hemostatic valve having a port, and a device for anchoring a fluid connector to the hemostatic valve. The device for anchoring the fluid connector includes a flexible tube having a first end and a second end, and a clamp attached to the rigid support section and the second end of the flexible tube. The first end of the flexible tube is configured to connect to the port of the hemostatic valve. Attached Figure Description

[0016] The invention will be more fully understood from the following detailed description taken in conjunction with the accompanying drawings, wherein reference numerals denote similar parts, wherein:

[0017] Figure 1 This is a perspective view of an exemplary catheter surgery system according to an embodiment;

[0018] Figure 2 This is a schematic block diagram of an exemplary catheter surgery system according to an embodiment;

[0019] Figure 3 This is a perspective view of a drive assembly for a catheter-based surgical system according to an embodiment;

[0020] Figure 4 It is a perspective view of a device support member having fixed front (or distal) and rear (or proximal) points to provide tension, according to an embodiment;

[0021] Figure 5 This is a top view of a box according to an embodiment, which has a device support in a retracted position to facilitate the replacement of an elongated medical device.

[0022] Figure 6 This is a top view of the box according to an embodiment, wherein the device support is in an extended position with both ends constrained;

[0023] Figure 7 This is a top view of two device modules having device supports according to an embodiment;

[0024] Figure 8 This is a top view illustrating a device module that is linearly translated forward relative to a device support member according to an embodiment.

[0025] Figure 9This is a top view illustrating a device module translated linearly in the opposite direction relative to a device support according to an embodiment.

[0026] Figure 10 This is a top view illustrating a device module translated linearly in the opposite direction relative to a device support according to an embodiment.

[0027] Figure 11 A simplified top view of four device modules and four device supports for a robot actuator according to one embodiment is shown;

[0028] Figure 12 A simplified top view is shown, illustrating the movement of the device module relative to the device support according to an embodiment;

[0029] Figure 13 A simplified top view is shown, illustrating an embodiment. Figure 11 The four device modules are in a forward position relative to their respective device supports;

[0030] Figure 14 A simplified top view is shown, illustrating an embodiment. Figure 11 The four device modules are in the retracted position relative to their respective device supports;

[0031] Figure 15 This is a side view of the proximal end of the extension of the device support member according to the embodiment and the rear constraint member to which the device support member is connected (or proximal side).

[0032] Figure 16 This is a side view of the proximal end of the device support member according to the embodiment and the rear constraint member to which the device support member is connected.

[0033] Figure 17 A simplified top view of a device module having a device support member stored on a linear shaft, according to an embodiment, is shown.

[0034] Figure 18 An exemplary winding tensioner according to an embodiment is shown;

[0035] Figure 19 A simplified top view of a device module with a drive device support according to an embodiment is shown;

[0036] Figure 20 An exemplary gear tensioner according to an embodiment is shown;

[0037] Figure 21 A simplified top view of a device module having a device support formed by a telescopic joint or a spring, according to an embodiment, is shown.

[0038] Figure 22 The illustration shows a compressed telescopic joint / spring according to an embodiment;

[0039] Figure 23 The illustration shows a stretched telescopic joint / spring according to an embodiment;

[0040] Figures 24(a)-(c) are perspective views of exemplary slit shapes for supporting a flexible tube according to an embodiment;

[0041] Figure 25 This is an exploded view of the device module and the elongated medical device according to the embodiment;

[0042] Figure 26a This is a perspective view of a box with a device support installed and in a retracted position according to an embodiment;

[0043] Figure 26b This is a perspective view of a box with a device support installed and in a retracted position according to an embodiment;

[0044] Figure 27 This is a top view of the device support and the connector extending from the box in front of the EMD inlet point according to an embodiment.

[0045] Figure 28 This is a top view of the device support and the connector retracted behind the EMD inlet point according to the embodiment;

[0046] Figure 29 This is an end view of the separator with the retaining device support open according to the embodiment;

[0047] Figure 30 This is a top view of the box according to an embodiment, wherein the device support connector is retracted and offset from the device axis to facilitate loading of the EMD.

[0048] Figure 31 This is a perspective view of the forward constraint and connector according to an embodiment;

[0049] Figure 32 This is a perspective view of the front constraint with a cover according to an embodiment;

[0050] Figure 33 This is a perspective view of the distal support arm and the distal support connector according to an embodiment;

[0051] Figure 34 This is a perspective view of the distal support connector coupled to the device support and connector according to an embodiment;

[0052] Figure 35 This is a side view of the distal support arm, distal support connector, and guide interface support according to an embodiment;

[0053] Figure 36 This is a perspective view of a guide interface support connected to a guide sheath according to an embodiment;

[0054] Figure 37 This is a perspective view of the movable distal support arm in a first position according to an embodiment;

[0055] Figure 38 This is a perspective view of the movable distal support arm in the second position according to an embodiment;

[0056] Figure 39 This is a top view of the movable distal support arm and the movable support arm in a first position according to an embodiment;

[0057] Figure 40 This is a top view of the movable distal support arm and the movable support arm in the second position according to the embodiment;

[0058] Figure 41 This is a top view illustrating the movement of the distal support arm and the support arm from the second position to the first position according to an embodiment;

[0059] Figure 42 This is a perspective view of a conduit having an adapter on the device according to an embodiment;

[0060] Figure 43 This is a perspective view of a guidewire with an adapter on the device according to an embodiment;

[0061] Figure 44 This is a perspective view of a box according to an embodiment, which is fitted with an elongated medical device with an adapter on the device.

[0062] Figure 45 This is an exploded view of a box and an elongated medical device according to an embodiment, the elongated medical device having an on-device adapter that can be removed from the box;

[0063] Figure 46 This is a top view of the box according to an embodiment;

[0064] Figure 47 This is an exploded view of the elongated medical device (EMD) adapter and cover according to an embodiment;

[0065] Figure 48 This is a perspective view of the EMD adapter and EMD installed in the box according to an embodiment;

[0066] Figure 49 This is a top view of a box having a floating interface and a rigid support section according to an embodiment;

[0067] Figure 50a This is an end cross-sectional view of the floating (or isolated) interface and rigid support section of the box according to an embodiment;

[0068] Figure 50b This is an exploded isometric view of the box according to an embodiment, showing the first and second components of the floating (or isolated) interface;

[0069] Figure 51 This is a bottom view of the floating (or isolated) interface of the box according to an embodiment;

[0070] Figure 52 A bracket for supporting a rotary drive gear with rollers according to an embodiment is shown; and

[0071] Figure 53 The illustration shows a box with a support assembly for anchoring pipes and fluid connections according to an embodiment;

[0072] Figure 54 This is an end cross-sectional view of the device support member according to the embodiment; and

[0073] Figure 55 This is a cross-sectional view of the end of the device support and separator according to the embodiment. Detailed Implementation

[0074] The following definitions will be used in this document. The term Elongated Medical Device (EMD) refers to, but is not limited to, catheters (e.g., guiding catheters, microcatheters, balloon / stent catheters), wire-based devices (guidewires, embolization coils, stent retrieval devices, etc.), and devices having combinations of these. Wire-based EMDs include, but are not limited to, guidewires, microwires, proximal pushers for embolization coils, stent retrieval devices, self-expanding stents, and shunts. 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 that is less rigid than the hub but more rigid than the shaft. In one embodiment, the intermediate portion is a strain reliever.

[0075] The terms distal and proximal define the relative positions of two distinct features. In relation to 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 position, a distal feature is a feature of the robotic actuator that is closer to the patient than a proximal feature when the robotic actuator is in its intended use position. Within the patient, any vascular system landmark along the path away from the access point is considered distal than a landmark closer to the access point, where the access point is the point at which the EMD enters the patient. Similarly, when the robotic actuator is in its intended use position, a proximal feature is a feature farther from the patient than a distal feature. When used to define orientation, distal orientation refers to the path along which something is moving or intended to move when the robotic actuator is in its intended use position, or the path along which something points or faces from the proximal feature toward the distal feature and / or the patient. Proximal orientation is the opposite of distal orientation.

[0076] The term "longitudinal axis" refers to the orientation direction from the proximal portion of the component to the distal portion of the component. For example, the longitudinal axis of a guidewire is the orientation direction from the proximal portion of the guidewire to 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 along its longitudinal axis in a distal direction into or further into the patient's body. An EMD is being withdrawn when its distal end moves axially along its longitudinal axis in a proximal direction out of or further out of the patient's body. The term "rotational movement of a component" refers to a change in the angular orientation of the component about a local longitudinal axis. Rotational movement of an EMD corresponds to the clockwise or counterclockwise rotation of the EMD about its longitudinal axis due to applied torque.

[0077] The terms "axial insertion" and "lateral insertion" refer to inserting the first component into the second component along the longitudinal axis of the second component. "Lateral insertion" refers to inserting the first component into the second component along a plane perpendicular to the longitudinal axis of the second component. This can also be referred to as radial load or lateral load. "Clamping" refers to releasably securing the EMD to the component such that the EMD moves with the component when the component moves. "Releasing" refers to releasing the EMD from the component such that the EMD and the component move independently when the component moves. "Holding" refers to releasably securing the EMD to the component such that the movement of the EMD relative to the component is constrained. The component can be fixed relative to a global coordinate system or a local coordinate system. "Releasing from clamping" refers to releasing the EMD from the component, allowing the EMD to move independently.

[0078] The term "grip" refers to the application of force or torque to the EMD via a drive mechanism that enables the EMD to move without slipping in at least one degree of freedom. The term "release" refers to the release of 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 gripped between the two tires will rotate about its longitudinal axis. The rotational movement of the EMD differs from the movement of the two tires. The position of the gripped EMD is constrained by the drive mechanism. The term "buckling" refers to the tendency of a flexible EMD to bend away from its intended path or longitudinal axis of propulsion when subjected to axial compression. In one embodiment, axial compression occurs in response to resistance being navigated in a vascular system. The distance the EMD can be driven unsupported along its longitudinal axis before buckling is referred to herein as the device buckling distance. The device buckling distance is a function of device stiffness, geometry (including but not limited to diameter), and the forces applied to the EMD. Buckling can cause the EMD to form an arcuate portion that deviates from its intended path. Knotting is a type of buckling in which the deformation of the EMD is inelastic, resulting in permanent deformation.

[0079] The terms “top,” “up,” and “above” refer to a general direction away from the direction of gravity, while the terms “bottom,” “down,” and “below” refer to a general direction in the direction of gravity. The term “inward” refers to the internal portion of a feature. The term “outward” refers to the external portion of a feature. The term “sterile interface” refers to the interface or boundary between sterile and non-sterile units. For example, a cassette can be a sterile 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). Sterilizable units may come into contact with patients, other sterile devices, or any other items within a sterile area of ​​a medical procedure.

[0080] The term "device-on-adaptor" refers to a sterile device capable of releasably clamping an EMD to provide a drive interface. For example, an on-device adapter is also referred to as an end effector or EMD capture device. In one non-limiting embodiment, the on-device adapter is a chuck operably controlled by a robot to rotate the EMD about its longitudinal axis to clamp and / or release the EMD to the chuck, and / or translate the EMD along its longitudinal axis. In one embodiment, the on-device adapter is a hub-driven mechanism, such as a driven gear located on the hub of the EMD. The terms hub-driven or proximal drive refer to grasping and manipulating the EMD from a proximal position (e.g., a gear adapter on a catheter hub). In one embodiment, hub drive refers to applying force or torque to the hub of the catheter to translate and / or rotate the catheter. In hub drives, applying typical clinical loads often causes EMD buckling, and therefore hub drives often require buckling-resistant features in the drive mechanism. For devices that do not have a hub or other interface (e.g., a guidewire), a device adapter can be added to the device to act as a temporary hub. In one embodiment, the EMD handle includes mechanisms for manipulating intra-catheter features, such as a wire extending from the handle to the distal end of the catheter to deflect the distal end. In contrast, the hub is the rigid portion of the EMD at the proximal end and does not include control mechanisms for manipulating intra-catheter features. The term "axis (distal) drive" refers to gripping the EMD and manipulating it along its axis. For example, an on-device adapter may be positioned precisely on the proximal side of the hub or Y-connector into which the device is inserted. If the on-device adapter is located close to the insertion point (to the body or another catheter or valve), axis drive typically does not require buckling-resistance features (though it may include buckling-resistance features to improve actuation capability).

[0081] 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 (e.g., percutaneous coronary intervention (PCI) for STEMI treatment), neurovascular interventional procedures (NVI) for emergency large vessel occlusion (ELVO) for treatment, peripheral vascular interventional procedures (PVI) for severe limb ischemia (CLI), etc. Catheter-based medical procedures may 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, a 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 may 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. This can be achieved by including an auxiliary device 54 (such as...). Figure 2The catheter-based surgical system 10 can enhance the treatment procedure using techniques such as intravascular ultrasound (IVUS), optical coherence tomography (OCT), fractional flow reserve (FFR), etc. 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 can perform any number of catheter-based medical procedures with only minor adjustments to accommodate the specific percutaneous interventional device to be used during the procedure.

[0082] 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 positioned adjacent to the patient 12 and a positioning system 22. 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 can be, for example, a robotic arm, an articulated arm, a retainer, etc. One end of the positioning system 22 can be attached to, for example, a track, 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 placed on the patient table 18. Once the patient 12 is positioned on the patient table 18, the positioning system 22 can be used to position or position the 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 the ground. The patient table 18 is capable of movement relative to the base 17 in multiple degrees of freedom, such as roll, pitch, and yaw. Bedside unit 20 may also include controls and a display 46. Figure 2 (As shown). For example, controls and displays can be located on the housing of robot driver 24.

[0083] Typically, the robot actuator 24 can be equipped with appropriate percutaneous intervention devices and accessories 48 (such as...). Figure 2 (As shown) (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 media, drugs, hemostatic valve adapters, syringes, stopcocks, inflation devices, etc.) to allow a user or operator 11 to perform catheter-based medical procedures via the robotic system by operating various controls (such as controls and input devices located at control station 26). Bedside unit 20, and in particular robot actuator 24, may include any number and / or 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 (such as... Figure 3Multiple device modules 32a-d are shown. 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 artery of patient 12. One or more devices (such as EMDs) are inserted into the body (e.g., a blood vessel) of patient 12 at insertion point 16 via, for example, a guide sheath.

[0084] 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 (e.g., Figure 2 (As shown) or coupled to the bedside unit 20 via the control computing system 34. The bedside unit 20 can also connect to the control station 26, the control computing system 34 (as shown) Figure 2 (as shown) or both provide feedback signals (e.g., load, speed, operating conditions, warning signals, error codes, etc.). 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 The local control station 38 shown) or a remote station (e.g., Figure 2 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 subject (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 use communication systems and services 36 (such as...). Figure 2 Communication occurs (e.g., via the Internet). In embodiments, the remote site and the local (patient) site are geographically distant from each other, for example, in different rooms of the same building, in different buildings of the same city, in different cities, or in other different locations of the bedside unit 20 and / or patient 12 at the local site where the remote site cannot physically access them.

[0085] Control station 26 typically includes one or more input modules 28 configured to receive user input to operate various components or systems of the 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 enable bedside unit 20 to perform various tasks using a percutaneous interventional device (e.g., EMD) docked with robot actuator 24 (e.g., advancing, retracting, or rotating a guidewire; advancing, retracting, or rotating a catheter; inflating or deflating a balloon located on a catheter; positioning and / or deploying a stent; positioning and / or deploying a stent retrieval device; positioning and / or deploying a coil; injecting contrast agent into a catheter; injecting a liquid embolizing agent into a catheter; injecting medication or saline into a catheter; aspirating from a 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.

[0086] In one embodiment, the input module 28 may include one or more touchscreens, joysticks, scroll wheels, and / or buttons. In addition to the input module 28, the control station 26 may use additional user controls 44 (such as…). Figure 2As shown), such as a foot switch and a microphone for voice commands. 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 automatic movement button. When the emergency stop button is pressed, the power supply (e.g., electricity) to bedside unit 20 is cut off or removed. In speed control mode, the multiplier button is used to increase or decrease the speed of movement of associated components in response to manipulation of input module 28. In position control mode, the multiplier button changes the mapping between input distance and output command distance. The device selection button allows the user or operator 11 to select which percutaneous interventional devices loaded into robot actuator 24 are controlled by input module 28. The automatic movement button is used to implement algorithmic movement of catheter-based surgical systems 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 balloon or stent controls configured to inflate or deflate a balloon and / or deploy a stent. Each input module 28 may include one or more buttons, scroll wheels, joysticks, touchscreens, etc., which can be used to control one or more specific components dedicated to that control. Additionally, 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.

[0087] 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.). Additionally, display 30 may be configured to display surgery-specific information (e.g., surgery list, recommendations, surgery duration, catheter or guidewire position, volume of delivered medication or contrast agent, etc.). Furthermore, display 30 may be configured to display information to provide information to the control computing system 34 ( Figure 2 (As shown) Related functions. Display 30 may include touchscreen capability to provide some user input capabilities for the system.

[0088] 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, 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 that includes a C-arm with an X-ray source 13 and a detector 15, also referred to as an image intensifier.

[0089] Imaging system 14 can be configured to take X-ray images of appropriate areas of the patient 12 during surgery. For example, imaging system 14 can be configured to take one or more X-ray images of the head to diagnose neurovascular conditions. Imaging system 14 can also be configured to take 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 correctly position guidewires, guiding catheters, microcatheters, stent retrieval devices, coils, stents, balloons, 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.

[0090] To define orientation, 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 to the distal end. 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.

[0091] 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 (e.g., Figure 1(As shown) Part of the control computing system 34. The control computing system 34 can typically be an electronic control unit, which is adapted to provide the various functions described herein for the catheter-based surgical system 10. 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 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 agent 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 described above, additional controls and displays may be located on the housing of the robot actuator 24. Interventional devices and accessories 48 (e.g., leads, catheters, etc.) are connected to the bedside system 20. In embodiments, interventional devices and accessories 48 may include dedicated devices (e.g., IVUS catheters, OCT catheters, FFR wires, diagnostic catheters for angiography, etc.) that are connected to their respective accessory devices 54, i.e., IVUS systems, OCT systems, and FFR systems, etc.

[0092] In various embodiments, the control computing system 34 is configured based on the user and input module 28 (e.g., a control station 26 such as a local control station 38 or a remote control station 42). Figure 1 The interaction and / or information accessible to the control computing system 34, as shown in the diagram, generate control signals to enable 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 may be different and customized based on their required functionality. The additional user controls 44 may include, for example, one or more foot pedal input controls. The foot pedal input controls may 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 pedal input device may 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.) may be used to assist the operator in interacting with patients, medical personnel (e.g., vascular unit staff), and / or bedside devices.

[0093] 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 balloon and / or stent inflation 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.

[0094] As described above, the control computing system 34 communicates with the bedside unit 20, which includes the robot actuator 24 and the positioning system 22, and may include additional controls and a display 46. It may also 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 provided 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 platform 62a-d movably mounted to the linear member 60. The device modules 32a-d can be connected to the platforms 62a-d using connectors such as offset brackets 78a-d. In another embodiment, the device modules 32a-d are directly mounted to the platforms 62a-d. Each platform 62a-d can be independently actuated to move linearly along the linear member 60. Therefore, each platform 62a-d (and its corresponding device module 32a-d coupled to it) can move independently relative to each other and to the linear member 60. A drive mechanism is used to actuate each platform 62a-d. Figure 3 In the illustrated embodiment, the drive mechanism includes independent platform translation motors 64a-d coupled to each platform 62a-d and a platform drive mechanism 76, such as a lead screw via a rotating nut, a rack via a pinion, a belt via a pinion or pulley, a chain via a sprocket, or the platform translation motors 64a-d themselves may be linear motors. In some embodiments, the platform drive mechanism 76 may be a combination of these mechanisms; for example, each platform 62a-d may employ a different type of platform drive mechanism. In embodiments where the platform drive mechanism is a lead screw and a rotating nut, the lead screw can rotate, and each platform 62a-d can engage and disengage with the lead screw to move, such as advance or retract. Figure 3 In the embodiment shown, the platform 62a-d and the device module 32a-d are in a serial drive configuration.

[0095] Each device module 32a-d includes a drive module 68a-d and a housing 66a-d that is mounted and coupled to the drive module 68a-d. Figure 3 In the illustrated embodiment, each housing 66a-d is mounted to the drive module 68a-d in a vertical orientation. In other embodiments, each housing 66a-d may be mounted to the drive module 68a-d in other mounting orientations. Each housing 66a-d is configured to abut and support a proximal portion (not shown) of the EMD. Additionally, each housing 66a-d may include elements that provide one or more degrees of freedom in addition to the linear motion provided by the actuation of the corresponding platform 62a-d to move linearly along the linear member 60. For example, housing 66a-d may include elements that can be used to rotate the EMD when the housing is coupled to the drive module 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 in which device supports 79a-d are positioned, and each device support 79a-d is used to prevent buckling of the EMD. Support arms 77a, 77b, and 77c are attached to each device module 32a, 32b, and 32c, respectively, to provide anchor 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 anchor points for supporting the proximal end of the distal device support 79a housed in the distal device module 32a. Additionally, a guide interface support (steering mechanism) 74 may be connected to the device support connector 72 and an EMD (e.g., a guide sheath). This configuration of the robot actuator 24 has the advantage of reducing the size and weight of the driven robot actuator 24 by using an actuator on a single linear member.

[0096] To prevent pathogen contamination of patients, healthcare staff should ensure that bedside units 20 accommodate patients 12 or subjects (e.g., ...). Figure 1 Aseptic 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 vascular room. Aseptic techniques include the use of sterile barriers, sterile equipment, appropriate patient preparation, environmental control, and contact guidelines. Therefore, all EMDs and interventional accessories are sterilized and can only come into contact with sterile barriers or sterile equipment. In an embodiment, a sterile drape (not shown) is placed on the non-sterile robotic actuator 24. Each cartridge 66a-d is sterilized and serves as a sterilization interface between the draped robotic actuator 24 and at least one EMD. Each cartridge 66a-d can be designed to be disposable and sterile, or to be resterilized wholly or partially, so that cartridge 66a-d or its components can be used in multiple procedures.

[0097] As described above, the robot actuator 24 may include device supports 79a-d between each device module 32a-d and between the distal device module 32a and device support connector 72. Each device support 79a-d is configured to prevent the elongated medical device from buckling when it is advanced outside the patient's body and before being advanced into the more distal EMD. In an embodiment, each device support 79a-d may be a flexible tube with longitudinal slits and used in conjunction with a separator on the cassette. Each device support 79a-d is fixed or constrained at both ends such that the device support can be kept taut, thus limiting the amount of displacement in which the flexible tube can buckle. Buckling of the elongated medical device limits the magnitude of the force that can be applied and can permanently damage the elongated medical device. Compressive loads can be caused by several factors, including friction between the EMD and the device support, and the device support and the cassette (e.g., a separator in the cassette, referred to below). Figure 27-29 The discussion includes friction between components. Keeping the device support taut eliminates the need for additional breaking strength and allows for smaller, more flexible device supports. In one embodiment where the device support is a flexible tube, tension can be provided by fixing or constraining the front (or distal) and rear (or proximal) points or positions of the flexible tube. Figure 3 The device supports 79a-d shown are one embodiment of a device support with fixed front and rear points. In another embodiment, the device support may be a telescopic joint type or spring type support that provides appropriate tension. Each of these different embodiments of the device support will be discussed further below.

[0098] Figure 4 It is a perspective view of a device support having fixed front (or distal) points and rear (or proximal) points according to an embodiment to provide appropriate tension. Figure 4 The diagram shows... Figure 3 The illustrated device support embodiment. In Figure 4 In this configuration, the first device module 102 includes a first housing 106 having a first device support 128, such as a flexible tube, positioned within a channel 124 of the housing 106. The first housing 106 and the first device support 128 are movable relative to each other. Figure 4In this configuration, a first device support 128 extends from the distal end of a first housing 106, and a first end of the first device support 128 is connected to the proximal end of a second device module 104 at a first front (or distal) fixing point 110. The second device module 104 is located distal to the first device module 102. The second device module 104 includes a second housing 108 and a support arm 116, which extends from the second device module 104 proximally toward the first housing 106. A second end of the first device support 128 extends from the proximal end of the first housing 106 and is connected to a first rear (or proximal) fixing point 112 on the proximal end of the support arm 116 of the second device module 104. The first device support 128 is held in place by the fixed (or constrained) first front point 110 and rear point 112. The first front fixing point 110 and the first rear fixing point 112 maintain a constant distance from each other. The first front fixing point 110 and the first rear fixing point 112 may be rigid or may have a certain degree of elasticity to accommodate manufacturing and assembly tolerances. The first device module 102 also includes a support arm 114, which can be used to provide a rear (or proximal) fixing point for a device support member of a box (not shown) located near the first box 106.

[0099] The second device module 104 is the most distal module and closest to the patient (not shown). The second housing 108 of the second device module 104 includes a second device support 130, such as a flexible tube, positioned within a channel 126 of the second housing 108. The second housing 108 and the second device support 130 are movable relative to each other. Since there is no device module or housing in front of the second device module 104, a distal support connector 132, mounted to the distal support arm 134, provides a second anterior (or distal) fixation point 120 for the distal end of the second device support 130. The distal support connector 132 and the distal support arm 134 will be referenced below. Figure 33-41 Further description. A second end of the second device support 130 extends from the proximal end of the second housing 108 and connects to a second rear (or proximal) fixing point 122 on the proximal end of a support arm 118, which is connected to a distal support arm 134. The second device support 130 is held taut by fixed second front points 120 and rear points 122. The second front points 120 and the second rear points 122 maintain a constant distance from each other. The second front fixing point 120 and the second rear fixing point 122 may be rigid or may have a degree of elasticity to accommodate manufacturing and assembly tolerances.

[0100] In one embodiment, the distal end of the first device support 128 connected to the first front fixation point 110 and the distal end of the second device support 130 connected to the second front fixation point 120 can be detached or disconnected, as discussed further below, to facilitate loading and unloading of the EMD before, during and after surgery. Figure 5This is a top view showing a box according to an embodiment, the box having a device support in a retracted position for easy replacement of an elongated medical device. Figure 5 In the middle, the device support 142 of the housing 140 has been separated from the front (or distal) fixing point 150 and is in a retracted position, which exposes the EMD 148 to facilitate loading and unloading of the EMD. As discussed above, the front fixing point 150 is located on the device module on the distal side of the housing 140. For clarity, in Figure 5 The diagram shows a device support 142 on the cover of housing 140. A first (or distal) end 144 of the device support 142 is located at the distal end of housing 140. A second (or proximal) end 146 of the device support 142 has been moved past a rear (or proximal) anchor point 152. As described above, the rear anchor point 152 is located on the distal side of housing 140, on a support arm of, for example, a housing, drive module, or platform. Additionally, the anchored rear point 152 can be attached to the frame of a robot actuator. Figure 6 This is a top view of the box according to an embodiment, wherein the device support is in an extended position with both ends constrained. When the device support 142 is pulled onto the EMD 148, the first end 144 is attached to the front anchor point 150, and the second end 146 is constrained by the rear anchor point 152. As described above, the front anchor point 150 and the rear anchor point 152 are fixed relative to the device module being inserted into the distal end of the EMD 148. For clarity, in Figure 6 The image shows a device support 142 on the lid of box 140.

[0101] Constraining (fixing) each device support at both ends allows for relative movement between all device modules in the robot actuator. Figure 7 This is a top view of two device modules with device supports according to an embodiment. The first device module 160 has a first device support 168, which is constrained at a first front (or distal) fixing point 172 at the proximal end of the second device module 162 and at a first rear (or proximal) fixing point 174 located on the proximal end of a support arm 171 of the second device module 162. The second device module 162 has a second device support 170, which is constrained at a second front (or distal) fixing point (not shown) and a second rear (or proximal) fixing point 175 in the proximal end of a support arm 173 of a device module (not shown) located distal to the second device module 162. The first device module 160 can be translated forward from a first position 164. The second device module 162 is located at a first position 176. Figure 8This is a top view illustrating a device module linearly translated forward relative to a device support according to an embodiment. As the first device module 160 moves forward toward the patient from a first position 164 (as indicated by arrow 177) to a second position 166, the first rear fixation point 174 bears the load (e.g., friction between the box and the first device support 168) generated as the housing of the first device module 160 (and the device module) moves along the first device support 168. Therefore, the first device support 168 will not buckle between the distal end of the box on the first device module 160 and the proximal or rear portion of the box on the second device module 162. As the first device module 160 is advanced distally toward the second device module 162 (in this example, the second device module 162 is stationary at its first position 176), it moves relative to the first device support 168, as indicated by reference points A and B positioned along the length of the first device support 168. When the first device module 160 is in the first position 164, reference points A and B are located near the distal end of the first device module 160. As the first device module 160 advances along the first device support 168, the first device support 168 remains stationary because the second device module 162, to which it is coupled via the first front fixing point 172 and the first rear fixing point 174, is also stationary. When the first device module 160 is in the second position 166, reference points A and B are off-axis and proximal to the first device module 160. The first device module 160 can also be translated rearward from the second position 166 to the first position 164.

[0102] Figure 9This is a top view illustrating a device module linearly reverse-translated relative to a device support according to an embodiment. When the first device module 160 moves rearward (retracted) from a second position 166 away from the patient (as indicated by arrow 179) to a first position 164, the first anterior fixation point 172 bears the load (e.g., friction between the box and the first device support 168) generated as the housing of the first device module 160 (and the device module) moves along the first device support 168. Therefore, the first device support 168 will not buckle between the box on the first device module 160 and the first rear fixation point 174. As the first device module 160 moves proximally away from the second device module 162 (in this example, the second device module 162 is stationary at its first position 176), it moves relative to the first device support 168, as indicated by reference points A and B positioned along the length of the first device support 168. When the first device module 160 is in the second position 166, reference points A and B are off-axis and proximal to the first device module 160. As the first device module 160 moves proximally (retracts) along the first device support 168, the first device support 168 remains stationary because the second device module 162, to which it is coupled via the first front fixing point 172 and the first rear fixing point 174, is also stationary. When the first device module 160 is at the first position 164, reference points A and B are located near the distal end of the first device module 160.

[0103] Figure 10This is a top view illustrating a linear reverse translation of a device module relative to a device support according to an embodiment. When the second device module 162 moves rearward from a first position 176 away from the patient (as indicated by arrow 169) to a second position 178, a second anterior fixation point (not shown) distal to the second device module 162 bears the load (e.g., friction between the box and the second device support 170) generated as the housing of the second device module 162 (and the device module) moves along the second device support 170. Therefore, the second device support 170 will not buckle between the box and the second rear fixation point 175 on the second device module 162. Since device supports 168 and 170 are each supported between two known points, the length of each device support does not need to be changed. When the second device module 162 moves proximally toward the first device module 160 (in this example, the first device module 160 is stationary at its first position 164), the second device module 162 moves relative to the second device support 170. Additionally, the first device support 168 (coupled to the second device module 162 via a first front fixing point 172 and a rear fixing point 174) moves relative to the first device module 160, as indicated by reference points A and B positioned along the length of the first device support 168. When the second device module 162 is located at the first position 176, reference points A and B are located near the distal end of the first device module 160, as shown in the image. Figure 7 As shown, when the second device module 162 moves proximally (retracts) along the second device support 170, the second device support 170 remains stationary because it is coupled to the device module (not shown) that is stationary on the more distal side in this example. However, the first device support 168, coupled to the second device module 162 via the first front fixing point 172 and the first rear fixing point 174, moves proximally. At the second position 178 of the second device module 162, reference points A and B are off-axis and proximally to the first device module 160.

[0104] Figure 11A simplified top view of four device modules and four device supports for a robot actuator according to an embodiment is shown. A first device module 202 includes a first device support 204, one end of which is connected to a support arm 218, and the other end to a distal support point. A second device module 206 includes a second device support 208, one end of which is connected to a support arm 220, and the other end to the first device module 202. A third device module 210 includes a third device support 212, one end of which is connected to a first front (or distal) anchor point 226 on the second device module 206, and the other end to a first rear (or proximal) anchor point 228 on the support arm 222. A fourth device module 214 includes a fourth device support 216, one end of which is connected to a second front (or distal) anchor point 230 on the third device module 210, and the other end to a second rear (or proximal) anchor point 232 on the support arm 224. In various embodiments, support arms 218, 220, 222, and 224 may be connected to the housing of the device module or drive module. In another embodiment, support arms 218, 220, 222, and 224 may be foldable, telescopic, or have their length shortened using other methods when not in operation. Figure 12A simplified top view is shown, illustrating the movement of the device module relative to the device support according to an embodiment. The third device module 210 starts at a first position 234 (shown in dashed lines) and moves to a second position 236 (as indicated by arrow 246). As the third device module 210 moves forward (towards the patient), it moves along the third device support 212, which is fixed to the second device module 206 at a first front fixation point 226 and to a support arm 222 extending from the second device module 206 at a first rear fixation point 228. As the third device module translates, the movement changes through a portion of the device support 212 of the third device module 210, while the first front fixation point 226 and the first rear fixation point 228 do not move. The length of the first segment 242 of the device support 212 spanning between the second device module 206 and the third device module 210 decreases, while the length of the second segment 244 of the device support 212 spanning between the third device module 210 and the rear fixation point 228 increases. This allows the third device module 210 (and the associated EMD) to remain fully supported between the third device module 210 and the second device module 206 during linear movement. Another relative movement occurring during the movement of the third device module 210 between the first position 234 and the second position 236 involves the fourth device support 216 of the fourth device module 214 and the second front (or distal) point 230 and the second rear (or proximal) point 232 of the fourth device support 216. The fourth device support 214 is secured to the third device module 210 at the second front fixing point 230 and to the support arm 224 extending from the third device module 210 at the second rear fixing point 232. Because the third device module 210 is moving, the second front fixing point 230 and the second rear fixing point 232 are also moving. The first segment 238 of the fourth device support 216 slides through the fourth device module 214, thereby increasing its length over the span between the fourth device module 214 and the third device module 210, while the second segment 240 of the fourth device support 216 decreases its length over the span between the fourth device module 214 and the rear fixing point 232.

[0105] Figure 13 A simplified top view is shown, illustrating an embodiment. Figure 11 The four device modules are positioned forward relative to their respective device supports. Figure 13 In the diagram, the first device module 202, the second device module 206, the third device module 210, and the fourth device module 214 are each shown in their maximum forward position along their respective device supports 204, 208, 212, and 216. Figure 14 A simplified top view is shown, illustrating the retracted position of the respective device supports according to an embodiment. Figure 11The four device modules. Figure 14 In the diagram, the first device module 202, the second device module 206, the third device module 210, and the fourth device module 214 are shown in their maximum extended (rear) positions along their respective device supports 204, 208, 212, and 216. In this embodiment, the length of the device support is determined by the straight length of the device support and the S-shaped spline that offsets the device support from the longitudinal device axis of the device module and guides it toward the longitudinal axis of the support arm. In one embodiment, each device support 204, 208, 212, and 214 may include compliance to protect the device support, thereby facilitating relaxation during transitions between forward and reverse directions.

[0106] As discussed above, each device support is constrained at a rear (or proximal) anchor point connected to a support arm extending from the front (e.g., distal) of the device module associated with the device support. In an embodiment, the rear (or proximal) anchor point includes a rear constraint that can be configured to react only to tension. Figure 15 This is a side view of the proximal end of the extended device support according to an embodiment and the rear constraint member for the rear (or proximal) fixing point to which the device support is connected. Figure 16 This is a side view of the proximal end of a partially retracted device support according to an embodiment, and a rear (or proximal) constraint for connection of the device support to a rear fixing point. The proximal end 252 of the support arm includes a retaining clip 254 for holding the proximal end of the device support 250. A rigid stop 256 is positioned on the end of the device support and configured to hold the device support taut as it moves forward, and to allow the device support to retract for device loading (as described above regarding...). Figure 5 and 6 (As described). The forward movement and retraction of the device support 250 are indicated by arrow 258. The operator can pull back the device support 250 without removing it from the retaining clamp 254. The rear constraint formed by the retaining clamp 254 and the hard stop 256 only reacts to tensile forces. The device support will not buckle because the retaining clamp 254 does not react to compressive forces.

[0107] In another embodiment, tension is generated on the device support by storing the proximal end of the device support on a spool or reel at each housing, provided by the front (or distal) and rear (or proximal) fixing points that connect the device support to the more distal device module. In this embodiment, it is not necessary for the support arm to provide a fixing point at the proximal end of the device support. Figure 17 A simplified top view of a device module having a device support member stored on a linear shaft, according to an embodiment, is shown. Figure 18 An exemplary winding tensioner according to an embodiment is shown. Figure 17In this device module 260, each device module 260 includes a spool or reel 262, and the device support can be wound around the spool or reel 262. Figure 18 An exemplary winding tensioner is shown, comprising a spool 262 on which a flexible tube of a device support 264 is wound. The proximal end of the device support is secured to the spool 262. The distal end, or "free" end, of the device support can be pulled out by an operator or automatically actuated by a robot actuator and attached to a front anchor point on the distal housing. Torque can be applied to the spool to apply tension to the device support 264. The torque can be applied by a separate mechanical device, such as a constant torque spring or a rack and pinion. In another embodiment, the torque can be applied by, for example, a control computing system 34 (such as...). Figure 2 The motor (not shown) controlled by the motor is applied. Figure 19 A simplified top view of a device module with a driven device support according to an embodiment is shown, and Figure 20 An exemplary gear tensioner according to an embodiment is shown. Figure 19 In each device module 270, a drive mechanism 274 interacts with or engages with a device support 272 to provide tension on the device support and allow the device support 272 to move forward and backward. The drive mechanism can be, for example, a wheel or gear. In one embodiment, the drive mechanism 274 may engage the device support via friction on the wall of a flexible tube of the device support 272. In another embodiment, the device support may have radial holes along one side, which are then engaged by a pin-driven gear, also known as a traction feeder. In yet another embodiment, the device support is a ribbed or spiral tube, and the drive mechanism is a gear that engages and tensions the ribbed or spiral tube. Figure 20 An exemplary gear tensioner 276 is shown, which engages a spiral flexible tube 278.

[0108] In another embodiment, the device support may be a telescopic joint or a spring. Figure 21 A simplified top view of a device module having a device support formed by a telescopic joint or spring, according to an embodiment, is shown. Figure 21 In the device, the device support between the device modules 280 is formed by a telescopic joint element 286 and two linear guides 284, which are positioned parallel to each other on opposite sides of the telescopic joint element 286. The EMD 282 passes through each segment 294 of the telescopic joint element 286 (e.g., ...). Figure 23 The opening 292 in the shown) (as shown) Figure 23(As shown) Positioning. The device support based on the expansion joint is always tensioned. In one embodiment, the expansion joint device support has built-in compliance, enabling it to handle relative translational movement between the two device modules 280. Even though the expansion joint member acts as a tension spring and is generally kept tensioned, it may still deviate from the device axis when an axial load is applied. Figure 21 The linear guide (or guide rail) 284 shown constrains the telescopic joint, thereby limiting its deflection away from the device axis. In one embodiment, the linear guide 284 of the first device module is mounted to the proximal end of a more distal second device module, and the other end of the linear guide 284 slides freely through the telescopic joint and the first device module. An embodiment with four telescopic joints to support four device modules may have offset telescopic joint linear guides such that the linear guides do not interfere with each other when the device modules are closed. Figure 22 The diagram illustrates the compressed state 288 of the expansion joint element 286. For clarity, Figure 22 Linear guides are not shown. Figure 23 The diagram illustrates the stretched state 280 of the expansion joint element 286. For clarity, the linear guide is not shown. The expansion joint element 286 comprises multiple segments 294, each segment 294 including an opening 292 through which the EMD can be positioned. The number and length of the segments 294 can be optimized such that the unsupported distance between the discrete segments 294 prevents the EMD from buckling under the maximum load experienced during the procedure. The expansion joint assembly support has multiple flexures that automatically balance to provide equal spacing, independent of the total tension, so that a single gap across the length of the segments 294 does not become large enough to buckle. In other words, the gap across the length of each segment 294 is desired to be the same across all segments 294. This helps to minimize the unsupported distance the EMD needs to travel, allowing the expansion joint element 286 to reach higher loads before buckling.

[0109] The profile of the device support formed by the flexible tube should support opening and closing, for example, to allow the EMD to be loaded into the device support. When the slit at the distal end of the device support flexible tube is forcibly separated (e.g., using a separator discussed further below), the device support can be advanced to encapsulate the EMD, and when closed, the EMD is adequately supported and held so as not to pop out or buckle. Figures 24(a)-(c) are perspective views of exemplary slit shapes of the device support flexible tube according to an embodiment. In Figure 24(a), a device support flexible tube 300 is shown having a straight slit 302 along the longitudinal direction of the tube. In another example, as shown in Figure 24(b), the device support flexible tube 300 may have a serrated slit 304 along the longitudinal direction of the tube. In yet another example, as shown in Figure 24(c), the device support flexible tube 300 may have a sine-like wave slit 306 along the longitudinal direction of the tube. The slit of the device support 300 can be opened by a wedge or a separator (in... Figure 27-29 (As shown in the diagram and discussed further below) the wedge or separator is positioned near the entry point of the EMD to the device support. The wedge or separator widens the opening sufficiently to clear the EMD. The elasticity of the flexible tube causes the slit to recover and close on the other side of the EMD, thereby encapsulating and securing the EMD. Serrated shapes and sinusoidal shapes can be used to allow material overlap in the slit region to improve EMD retention within the device support.

[0110] The EMDs used in robotic actuators for interventional procedures can vary in size; for example, various EMDs can be used ranging from 9 FR to 2 FR, or even .010” guidewires. For instance, in a multi-axis robotic actuator configured for endovascular treatment of acute ischemic stroke, the first EMD in the device stack can be expected to be between 6 and 9 FR. The second and third EMDs in the device stack can be between 2.5 and 6 FR. Between FR. The fourth EMD can be a wire-based EMD with a diameter between .010” and .038”. To properly support and hold EMD devices of different sizes, different device supports can be provided for each EMD, wherein the device support for each EMD is designed to work with the corresponding size EMD. For example, by minimizing the diameter gap between the EMD and the device support tube, any device buckling within the tube will store less energy and have less linear motion hysteresis. In embodiments, the device support for each box can be designed to be modular, allowing the correct size device support to be added to the box based on the EMD supported by the box. Additionally, a separator and device support connector (both will be referred to below) are designed to work with EMDs of specific sizes. Figure 27-29(Further discussion) It can also be modular and switchable based on the specific size of the EMD supported by the box. In another embodiment, different versions of the box can be provided for each subset of device sizes, wherein the box has a pre-installed device support of the appropriate size. An appropriate box design for a specific size or size range of EMDs can be mounted to the drive of the robot actuator and can be removed when different sizes or different size ranges of EMDs require different designs. For example, the box can be designed to support a size range of wire-based EMDs that can vary between .010” and 0.38”.

[0111] As per the above reference Figure 3 The device module 32 of the robot actuator 24 discussed includes a drive module 68 and a housing 66, which is mounted on the drive module 68 and releasably coupled to the drive module 68. Figure 25 This is an exploded view of a device module and an elongated medical device according to an embodiment. The drive module 310 includes a mounting surface 312 and a coupler 314. A motor and drive belt (not shown) may be housed in the drive module 310 and connected to the coupler 314. The motor and belt are used to control the rotational position of the coupler 314. The drive module 310 may include an encoder (not shown) for device position feedback. Figure 25 The drive module 310 shown has one coupler 314; however, it should be understood that the drive module 310 may have more than one coupler 314 and more than one motor (e.g., one motor per coupler or one motor driving multiple couplers). Rotation of the coupler 314 can be used to provide another degree of freedom for the EMD positioned in a housing 316, which may be mounted on a mounting surface 312 to mate with the coupler 314. For example, when the EMD 324 is positioned in the housing 316, the coupler 314 can be used to rotate the EMD 324. If the drive module 310 has two or more couplers 314, each coupler can be used to provide a degree of freedom for the EMD.

[0112] As described above, the housing 316 can be positioned on the mounting surface 312 of the drive module 310 and is used to mate with the EMD 324 positioned within the housing 316. The housing 316 includes a shell 318. In an embodiment, the shell 318 can be releasably attached to the drive module 310. The drive module 310 may also include one or more additional elements 313 on the mounting surface 312, such as locating pins, alignment pins, etc., to interact with elements on the housing 316 (e.g., connection points, slots, channels, etc.) to allow the housing 316 to be releasably attached to the drive module 310. In one embodiment, the shell 318 is releasably connected to the drive module 310 using a quick-release mechanism 321. In one embodiment, the quick-release mechanism 321 includes a spring-biased member in the shell 318 actuated by a latch release member 323 that releasably engages with a quick-release locking pin 315 fixed to the drive module 1010.

[0113] The housing 318 includes a bracket 320 configured to receive the EMD 324. A bevel gear 322 is used to mate with a coupler 314 of the drive module 310 and with the EMD 324 to rotate the EMD 324. In one embodiment, the EMD 324 is provided with an on-device adapter 326 (see below). Figures 42-44 (Further discussion) to mate EMD 324 to housing 316, for example, to the bevel gear 322. Figure 25 In the example shown, the EMD is a guidewire, and the adapter 326 on the device is a chuck with a gear 327. When power is transmitted from the device module 310 to the gear 322 in the housing 316 (e.g., via coupler 314), the gear 322 in the housing interacts with the gear 327 on the chuck to rotate the guidewire 324. The device support 328 is positioned in the housing, located in a channel 342, which may be covered by the housing 318. As discussed above, the device support 328 and the housing 316 are configured to move relative to each other. The device support 328 includes a connector 330 for connection in a robot actuator to a device module (e.g., the housing, other elements of the device module, or elements positioned within the device module) located distal to (or in front of) the housing 316. The connector 330 includes a recess 332. In the retracted or withdrawn position, the connector 330 is positioned in a recess 336 in the housing 318 on the distal end 334 of the housing 316. As discussed above, connector 330 and device support 328 can be pulled outward from housing 316, allowing the connector to be attached to a device module (e.g., a housing of a device module) on a more distant side of the robot actuator. In one embodiment, forward constraint 340 is disposed on the proximal end 338 of housing 316 and is used to connect to a connector on a device support on another housing proximal to (or behind) housing 316 in the robot actuator. Figure 26a This is a perspective view of a housing with a device support mounted and in the retracted position according to an embodiment. In the retracted position, the connector 330 is positioned in a recess 336 of the housing 318 at the distal end 334 of the housing 316. Figure 26b This is a perspective view of a box with a device support mounted and in a retracted position according to an embodiment. The device support 328 is positioned in a channel 342 of the box. The box 316 includes a proximal support member 331 positioned on a proximal end 338 of the box 316. The proximal support member 331 includes an opening and is configured to provide support to the device support 328. The device support 328 is positioned in and through the opening 333. The opening 333 is sized such that the device support can move through the opening 333 when the device support 328 is advanced and retracted.

[0114] Figure 27 This is a top view of a device support and connector extending from the housing in front of the EMD entry point according to an embodiment. The device support 328 and connector 330 extend from a recess in the distal end 334 of the housing. As the device support 328 moves into and out of the recess 336 and channel 342, a guide 344 and a separator 348 are positioned in the recess 336 on opposite sides of the path of the device support 328. In the extended position, the device support encapsulates the EMD 324. The EMD enters the device support 328 at the EMD entry point 346 located between the proximal and distal sections of the separator 348. The proximal and distal sections of the separator are shown in dashed lines. As described above, the device support 328 includes a longitudinal slit, so the device support can be forcibly separated (e.g., by using a separator as described below) and closed to allow the device support to encapsulate the EMD as the device support advances. Figure 29 As shown, the end of the connector 330 retaining device support tube is open, thereby allowing it to pass through the separator 348. (Reference) Figure 27 and 29As connector 330 and device support 328 pass through separator 348 and EMD inlet point 346, and as EMD 324 is enclosed by device support 328, separator 348 keeps the slit in device support 328 open. The end of device support tube 328 is positioned in recess 332 of connector 330. Keeping device support 328 open on both sides of EMD inlet point 346 using separator 348 reduces or eliminates friction on EMD 324. For example, this prevents the walls of device support tube 328 from rubbing against EMD 324, which could damage EMD 324 at inlet point 346 and introduce noise into a load sensing system (not shown) used to read the force or torque acting on EMD. EMD 324 passes through cavity 352 in the center of separator 348. Connector 330 and separator 348 are designed to remain open when device support 328 passes through the gap between the proximal and distal sections of separator 348. Separator 348 is also designed such that the unsupported length of EMD 324 does not catastrophically buckle at any point. Guide 344 is configured to guide device support 328 across the gap and hold device support 328 to separator 348. As described above, separator 348 can be designed for a specific range of EMD and device support sizes. Figure 28 This is a top view of the device support and connector retracted behind the EMD entry point according to the embodiment, and Figure 30 This is a top view of the box according to an embodiment, wherein the device support connector is retracted and moved away from the device axis to facilitate loading the EMD. This is to facilitate loading the EMD 324 into the box 316 (e.g., Figure 25 As shown), before loading the EMD 324, the device support 328 and connector 330 retract into the recess 336. Figure 28 and 30 As shown, connector 330 can retract onto separator 348 and guide 344, and is located behind (or near) EMD inlet point 346. Additionally, the retracted (or withdrawn) position of connector 330 is offset from the longitudinal EMD axis 350. This allows the EMD to be placed in cassette 316, for example, a load-side loaded EMD. Retracting connector 330 behind the EMD inlet point also reduces the length of the unsupported EMD and minimizes working length loss.

[0115] As discussed above, connector 330 and device support 328 can be pulled outward from housing 316, allowing the connector to be attached to a more distal device module (e.g., the housing of the device module) in the robot actuator. In an embodiment, forward constraint 340 ( Figure 25(As shown) can be located on the proximal end 338 of the first box and is used to connect to the device support on the second box on the proximal side (or rear) of the first box in the robot drive. Figure 31 This is a perspective view of the forward constraint and connector according to an embodiment. The forward constraint 340 includes a latching mechanism 354, such as a spring latch. A connector 330 from a device support 328 of a proximal housing (not shown) is attached to the spring latch 354. In one embodiment, the connector 330 is connected to the latching mechanism 354 by pushing the connector 330 into the forward constraint 340. In an embodiment, the latching mechanism 354 may not require auxiliary movement other than axial translation to engage the latching mechanism 354, but one or more additional movements may be required to disengage the latching mechanism 354 and remove the connector from the forward constraint 340. For example, a release button, lever, or knob may be required before the connector 330 disengages. The connector 330 can be disengaged manually or using a control computing system 34 (such as...) Figure 2 (As shown) Disengagement. Connector 330 is attached to forward constraint 340 approximately along the longitudinal EMD axis 350 of the EMD (not shown) contained in device support 328. This prevents shearing of the EMD by moving perpendicular to latching mechanism 354. In another embodiment, an auxiliary latch or fastening mechanism may be provided to further secure connector 330 and reduce play. Figure 32 This is a perspective view of the forward restraint member with a cover according to an embodiment. Figure 32 In this configuration, cover 356 is connected to forward constraint 340, for example, using a pivot. Cover 356 can be closed and locked on connector 330 to further constrain connector 330 within forward constraint 340.

[0116] As referenced above Figure 4 The distal support connector discussed, mounted to the distal support arm, can be used to provide a front (or distal) fixation point to support the distal end of the device support in the box of the most distal device module (i.e. the device module closest to the patient) of the robot actuator. Figure 33This is a perspective view of the distal support arm and distal support connector according to an embodiment. The housing 362 is mounted to the drive module 364, which is connected to the platform 366 using an offset bracket 368. The platform 366 is movably mounted to a track or linear member 360 and can move linearly along the track 360. The distal support arm 370 may be attached to the frame of the robot actuator, such as the frame of the track 360. In one embodiment, the distal support arm 370 may be rigidly attached to the frame. In another embodiment, the distal support arm 370 may be attached to a patient table or patient. The distal support arm 370 extends remotely from the robot actuator and connects to the device support connector 372 to provide a distal fixation point for the device support at an introduced sheath hub. In one embodiment, the distal support arm 370 may also be used to provide distal definition for the housing 362 and the drive module 364. The distal definition defines the distal aspect of the distal device of the robot actuator (e.g., housing 362 and drive module 364). In another embodiment, a separate distal limiting arm (not shown) can be used to provide distal limiting, which can be coupled to, for example, a robot actuator frame. The distal support connector 372 can also be coupled to the guide housing hub. The guide interface support 376 can be connected to the device support connector 372. A connector 374, as shown above, is also included. Figure 27-30 The connector on the distal end of the device support can be attached to the device support connector 372 to provide a front (or distal) fixing point and support for the distal end of the device support. Figure 33 The device support is not shown, but as... Figure 34 As shown, the device support will be positioned by box 362. Figure 34 This is a perspective view of the distal support connector coupled to the device support and connector according to an embodiment. The device support 378 is shown as a dashed line extending between the encapsulated EMD 379 and the housing 362 and the device support connector 372. The connector 374 is attached to the device support connector 372. The device support connector 372 can be, for example, as previously referenced. Figure 31 and 32 The described forward constraint member. The device support connector 1072 is mounted to the distal support arm 370 and can be connected to the guide interface support 376. Figure 35 This is a side view of the distal support arm, distal support connector, and guide interface support according to an embodiment. The guide interface support 376 is configured to support the device support 378 (e.g., Figure 34 EMD 379 (as shown) between guide sheath 375 and guide sheath 375 Figure 34As shown), the guide sleeve 375 is connected to the distal end of the guide interface support 376, as discussed further below. The guide interface support 376 ensures that the EMD 379 does not buckle or sag between the distal end of the device support 378 and the hub of the guide sleeve 375. In embodiments, the guide interface support 376 can also be used to redirect the EMD from a position axially aligned with the robot drive axis 365 to a position axially aligned with the guide sleeve 375 or other support members.

[0117] The guide sheath 375 is inserted into the patient's vascular system at an access point (e.g., the femoral artery), which guides the EMD to a target site (e.g., a lesion) within the patient's body. The guide sheath 375 should be held in place so that it does not exit the patient's body. In one embodiment, the distal support arm 370 and the device support connector 372 can be used to fix the position of the guide sheath 375 and to react to forces on the guide sheath 375 generated by friction between the guide sheath 375 and the EMD moving within the guide sheath 375. In another embodiment, the guide sheath 375 may be supported by a structure separate from the distal support arm 370 and the device support connector 372; for example, the guide sheath 375 may be attached to the patient or patient table using known methods.

[0118] Figure 36 This is a perspective view of a guide interface support connected to a guide sheath according to an embodiment. The guide interface support 376 is connected at its proximal end 380 to a device support connector 372, which is connected to a distal support arm 370. A guide sheath 375 is connected to the distal end 382 of the guide interface support 376. The guide interface support 376 can be configured to receive a guide sheath 375 having a side port (not shown). The side port and its conduit (not shown) can allow administration of medications, contrast agents, or saline injections, or aspiration of blood samples. An EMD (not shown) is inserted into the patient through the guide sheath 375, which is inserted into a blood vessel (typically an artery). In one embodiment, the guide interface support 376 is opened to allow placement of the EMD within the guide interface support 376. In another embodiment, the EMD can be inserted axially into the guide interface support 376. In another embodiment, the EMD and the guide interface support 376 can be frictionally engaged, so that the guide interface support 376 does not need to be opened or the EMD axially inserted. As described above, the guide interface support 376 can be configured to axially align the EMD from a position aligned with the robot actuator axis 365 (e.g., Figure 35(As shown) Redirected to a position axially aligned with the guide sleeve 375 or other support member. The guide interface support 376 also provides support for the EMD over the distance between the connector 372 and the guide sleeve 375. The guide interface support 376 can be rigid (e.g., Figure 36 (As shown) or flexible. For example, the guide interface support 376 may be made of a flexible material, or the guide interface support 376 may have a joint near the device support connector 372 that allows a limited range of motion of the distal end 382 (where the guide sheath 375 is held) to accommodate disturbances from robot actuators or patient movement.

[0119] In another embodiment, the distal support arm 370 may be movably connected to the robot actuator. The movable distal support arm 370 may have one or more degrees of freedom to account for excess EMD length that may not need to be actuated. For example, for shorter and / or less flexed patients, more of the first guiding catheter may be exposed because it will never need to be inserted into the patient. If the distal support arm (and therefore the device support connector 372) can be moved forward, it can address excess length of the guiding catheter that does not need to be actuated. This can also help reduce the size of the track or linear member 361 (and... Figure 33 and 35 The total length of the track shown is 360°. Figure 37 This is a perspective view of the movable distal support arm in a first position according to an embodiment. The distal support arm 370 can be movably connected to the track or linear member 361 using a platform 390. Figure 37 In the first position 394, the distal support arm 370 is positioned, with the distal support connector 372 located near the distal end of the device module 392. The platform 390 can be moved manually or automatically along the track 361 to change the position of the distal support arm 370. Figure 38 This is a perspective view of the movable distal support arm in the second position according to an embodiment. Figure 38 In the middle, platform 390 and distal support arm 370 have been linearly moved from device module 392 to a second, more distal position 396. Therefore, device support connector 372 and device module 392 are separated by a distance 395. Figure 37 and 38 In the illustrated embodiment, the distal support arm 370 has one degree of freedom. In another embodiment, the distal support arm 370 may be a hinged arm or a driven arm with multiple degrees of freedom.

[0120] As discussed above, each end of the device support can be connected to a fixed point (front (or distal) and rear (or proximal)) to provide appropriate tension to the device support between device modules or between the distal device module and the device support connector, thereby preventing EMD buckling. The aforementioned device support connector 372 provides a front (or distal) fixed point for the device support of the distal box in the robot actuator. A support arm connected to the distal support arm 370 (e.g., Figure 4 As shown in the diagram, the support arm 118, the device support of the farthest box, may be provided with a rear (or proximal) fixing point. For movable farthest support arms, the support arm will also be movable. Figure 39 This is a top view of the movable distal support arm and the movable support arm in a first position according to an embodiment. Figure 39 In the first position 414, the distal support arm 406 is connected to the track or linear member 400 using the first platform 402. A device support 408 is positioned within the device module 406 (e.g., in a housing of the device module), and the distal end of the device support 408 is connected to the device connection point 411 (front (or distal) fixing point) connected to the distal support arm 410. The proximal end of the device support 408 is connected to the proximal end of the support arm 412 at the rear (or proximal) fixing point 409. A second platform 403 is connected to the track 400 (or a different track in the system, not shown) and can be moved manually or automatically along the track 400 to change the positions of the distal support arm 410 and the support arm 412. Figure 40 This is a top view of the movable distal support arm and the movable support arm in the second position according to an embodiment. Figure 40 In this configuration, the second platform 403, the distal support arm 410, and the support arm 412 have been linearly moved to a second position 416 further away from the device module 406. The support arm 412 moves with the device support connector 411, so there is always a device support 408 of the same length between the device support connector 411 and the rear fixing point 409. Figure 41 This is a top view illustrating the distal support arm and the movement of the support arm from a second position to a first position according to an embodiment. Figure 41 In the diagram, the device support connector 411, support arm 412, distal support arm 410, and second platform 403 begin at a second position 416 (indicated by dashed lines). The second platform 403 can be actuated to move linearly along track 400 to a first position 414, as indicated by arrow 418. The first positions of the device support connector, support arm, distal support arm, rear fixing point, and second platform are indicated by reference numerals 411', 412', 410', 409', and 403', respectively.

[0121] Figure 42 This is a perspective view of a conduit with an adapter on the device according to an embodiment, and Figure 43 This is a perspective view of a guidewire with an on-device adapter according to an embodiment. As used herein, the on-device adapter is a sterile device capable of being releasably clamped to an EMD to provide a drive interface. Figure 42 In this device, catheter 420 includes a hemostatic valve or hub (e.g., a rotary hemostatic valve) 424 on its proximal end 426. An adapter 422 is positioned on catheter 420 distal to the hemostatic valve 424 on the proximal end 426. Figure 42 In one embodiment, the outer surface of the adapter on the device is formed as a gear. The gear feature of the adapter 422 on the device is configured to engage with the gear 322 of the housing (e.g., Figure 26a (As shown) interactions, for example Figure 26a The housing 316 is shown. When power is transmitted from the device module (not shown) to the gears in the housing (e.g., via a coupler), the gears in the housing interact with the gears 422 on the catheter 420 to rotate the catheter. In another embodiment, rotation of the on-device adapter 422 can be configured to clamp / release the catheter 420. In one embodiment, the inner surface of the on-device adapter 422 is securely attached to a standard Luer section of an elongated medical device (e.g., catheter 420). In another embodiment, the inner surface of the on-device adapter is clamped to a lateral surface proximal to the elongated medical device. In another embodiment, the on-device adapter is attached to a cylindrical section (shaft) of the EMD. In yet another embodiment, the on-device adapter is not directly attached to the EMD, but is attached to the EMD via an interface. Power can be transmitted from the housing to the on-device adapter in various ways, such as, for example, gears (as described above), or friction surfaces (e.g., tires and rollers), belts, pneumatic, or magnetic / electromagnetic coupling.

[0122] exist Figure 43 In the diagram, guidewire 430 is shown with adapter 432 on the device. Figure 43 In one embodiment, the adapter 432 on the device is a chuck with a gear 434 on its proximal end 436. The chuck 432 is configured to grip the guide wire 430. As used herein, a chuck is a device for releasably securing a portion of an EMD thereto. In one embodiment, the chuck includes at least two members that move relative to each other to releasably secure the EMD to at least one of the two members. Secure means that there is no intentional relative movement between the chuck and the EMD during operating parameters. The gear 434 is configured to engage with a cartridge (e.g., Figure 26a The gear 322 (as shown in the box 316) Figure 26a(As shown) interacts. When power is transmitted from the device module (not shown) to the gear in the housing (e.g., via a coupler), the gear in the housing interacts with the gear 434 on the guide wire 430 to rotate the guide wire 430. In another embodiment, the adapter 432 on the device can be configured to clamp / release the guide wire 430 via rotation of the gear 436. Figure 44 As shown, the elongated medical device and its adapter can be positioned within a housing. Figure 44 In this configuration, the guidewire 430 and clamp 432 are positioned within the bracket 442 of the cassette 440. The elongated medical device and its on-device adapter can be removed from one cassette and moved to another unfilled cassette. Figure 45 Guide wire 430 and chuck 432 are shown, with gear 434 removed from cassette 440. When cassettes are similar and on-device adapters are used to mate elongated medical devices to cassettes, the devices and on-device adapters can move between unfilled cassettes, thereby enabling changes in the number of devices and the configuration of the robot actuators.

[0123] Figure 46 This is a top view of the cartridge according to an embodiment. The cartridge 450 has a distal end 452 and a proximal end 454 and is typically designed for docking with an EMD such as a guidewire or catheter. The region between the distal end 452 and the proximal end 454 includes a bracket 456, an intermediate section 458, and an off-axis recess 460 positioned at an angle away from the cartridge's longitudinal assembly axis 461. The intermediate section 458 and the off-axis recess 460 can be configured to receive an EMD adapter to allow the cartridge to dock with EMDs having a non-typical proximal end, such as balloon guiding catheters (which include an integrated Y-connector) or quick-change devices, such as quick-change balloons. Figure 47 This is an exploded view of the elongated medical device (EMD) adapter and cover according to an embodiment. Figure 47 The EMD adapter 462 shown is a quick-change EMD adapter. The EMD adapter includes a cap 464, a first segment 466, and a second segment 468. The first segment is configured to receive a guidewire. The second segment is configured to receive an EMD, such as a quick-change EMD 470. In one example, the EMD 470 is a quick-change balloon. The second segment 468 is positioned at an angle to the longitudinal axis of the first segment 466. The second segment also includes a clip 472 for securing the proximal end of the EMD 470. Figure 48This is a perspective view of the EMD adapter and EMD installed in the housing according to an embodiment. A first segment 466 of the EMD adapter 462 is positioned in the bracket 456 and intermediate segment 458 of the housing 450. A second segment 468 of the EMD adapter 462 is positioned in an off-axis recess 460. A quick-change EMD 470 (e.g., a quick-change balloon) is positioned in the second segment of the EMD adapter 462, and the proximal end of the EMD 470 is clamped into place using a clip 472. The first segment 466 of the EMD adapter 462 can be used to receive a guidewire (not shown) from a proximal device module (not shown). The guidewire can pass through the housing 450 and be driven by a more proximal device module. The EMD adapter 462 provides flexure support for the guidewire. In another embodiment, the EMD adapter can be configured to dock with a balloon guiding catheter. For a balloon guiding catheter, the EMD adapter can be configured to constrain the proximal end of the balloon guiding catheter for linear movement but not allow rotation of the balloon guiding catheter.

[0124] It may be desirable to measure the load applied to the hub-driven EMD using a device module in a robot actuator by employing a load sensing system. To accurately sense the linear force on the EMD hub, the components to be sensed in the device module (e.g., the EMD and its hub) should be isolated from external forces. The device support exerts a force on the housing when it is tensioned, reoriented through the housing, and separated. The connection between the connector of the device support and the forward constraint of another housing also exerts a force. In an embodiment, the housing of the device module may be configured to separate the portion of the housing supporting the EMD from the rest of the housing to isolate the linear force on the EMD hub. Figure 49This is a top view of a box with a floating (or isolated) interface and a rigid support section according to an embodiment. Box 500 includes a floating (or isolated) interface (or component) 506 located within the box to provide support for an EMD 502 positioned within the floating interface 506. The remainder of box 500 (e.g., a housing) forms a rigid support 508. EMD 502 includes a rotary drive element 504 (e.g., an adapter such as a gear) configured to engage with a drive mechanism (e.g., a bevel gear (not shown)) in the floating interface 506. The rotary drive element 504 is supported in a rotary drive element bracket 510 of the floating interface 506. The floating interface 506 is partially floating relative to the rigid support 508 of box 500. For example, the floating (or isolated) interface 506 may be movable within and / or relative to the rigid support 508. In an embodiment, the floating interface 506 is isolated from the rigid support such that the floating interface 506 is not fixed to the rigid support 508. As discussed further below, the floating interface 506 is configured to isolate from loads other than the actual load acting on the EMD 502. The rigid support 508 reacts to forces, such as those from device supports connected to the housing. To reduce measurement noise of rotational forces, the bracket 510 supporting the rotational drive element 504 (e.g., a gear) of the EMD 502 can be formed of a low-friction static material. In another embodiment, the bracket 510 may include, for example... Figure 52 The roller 534 is shown. For example, roller 534 can be a sliding bearing or a rolling bearing.

[0125] Figure 50a This is an end cross-sectional view of the floating (or isolating) interface and rigid support section of the box according to an embodiment. The floating (or isolating) interface 506 positions a recess or opening 536 in the housing of the box 500 (e.g., Figure 50b (As shown) and separated from the rigid support 508 by the first groove 514 and the second groove 515, and confined to a limited range of motion. In an embodiment, the floating interface 506 includes a first component 506a and a second component 506b, as shown below. Figure 50b Further discussion. The floating interface 506 is loosely contained within the recess 536 (e.g. Figure 50b (As shown). The range of motion of the floating interface 506 allows the floating interface 506 to be mounted to the drive module (e.g., Figure 25The drive module 310 shown, particularly the load sensing portion of the drive module, allows for tolerances between mating components. The first slot 514 and the second slot are configured to allow limited movement of the floating interface 506 in the X and Y directions. The floating interface 506 is also floating (or isolated), but is trapped in the first slot 514 and the second slot 515 in the z-direction due to a first protrusion 522 on the first side 518 of the rigid support 508 near the first slot and a second protrusion 523 on the second side 520 of the rigid support 508 near the second slot 515. The floating interface 506 includes a first recess 524 on the first side 526 of the floating interface 506 and a second recess 525 on the second side 528 of the floating interface 506. The protrusion 522 is loosely positioned within the recess 524 of the floating interface 506. The first protrusion 522 is loosely positioned on the first recess 524 of the floating interface 506, and the second protrusion 523 is loosely positioned in the second recess 525 of the floating component 506. In one embodiment, the floating interface 506 and the rigid support 508 exist as a single unit, rather than two completely separate parts, which facilitates the availability and setup of the robot actuator. The contactless, frictionless interface between the floating interface 506 and the rigid support 508 is achieved by allowing the floating interface 506 to float in the z-direction. When the floating interface 506 is mounted to the drive module (e.g., Figure 25 When the drive module 310 is shown, a contactless interface is implemented. For example, the positioning pin 313 on the drive module 310 (in...) Figure 25 (As shown in Figure 50) The floating interface 506 is raised to a height relative to the rigid support 508, at which a non-contact interface is achieved, as shown in Figure 50. In one embodiment, this height is 1 mm. In other embodiments, the height is less than 1 mm, and in still other embodiments, the height is greater than 1 mm.

[0126] The bottom surface 516 of the floating (or isolated) interface 506 is configured to couple to the drive module. Figure 51 This is a bottom view of the floating interface of the box according to an embodiment. The bottom surface 516 of the floating (or isolated) interface 506 includes a connector 530 and a connection point 532, the connector 530 being used to receive a coupler of the drive module (e.g., Figure 25 The coupler 314 shown), and the connection point 532 are configured to receive various types of connection components of the drive module. For example, the locating pin 313 (such as...) Figure 25(As shown) can be fitted into a series of holes and slots in the bottom surface 516 of the floating interface 506. Locating pins 313 can be used to constrain the floating interface 506 and the drive module in the X and Y directions. In one embodiment, the floating interface 506 can also be constrained in the Z direction by using magnets positioned in one or more connection points 532. In another embodiment, the floating interface 506 is constrained in the Z direction by friction with the connection points 532. In one embodiment, the slots are used to interact with the locating pins 313 of the drive module to constrain the floating interface 506.

[0127] As described above, the floating (or isolated) interface 506 includes a first component 506a and a second component 506b. Figure 50b This is an exploded isometric view of the box according to an embodiment, showing the first and second components of the floating (or isolated) interface. When the box is in the use position fixed to the drive module 310, the first component 506a is oriented towards the drive module 310 (e.g., Figure 25 The first component 560a is positioned in the direction shown above within the recess 536 of the rigid support section (or housing) 508 of the box. The second component 506b is positioned in the recess 536 from a direction away from the drive module 310 toward the first component 560a. When the floating interface 506 is connected to the drive module, the floating (or isolating) interface 506 is positioned within and separated from the rigid support 508 in at least one direction. The rigid support (or housing) 508 includes two longitudinally oriented tracks 507 located within the recess 536. In an embodiment, the tracks 507 act as protrusions 522 and 523 (see above). Figure 50a (Discussed). The first component 506a is located on the top surface of the track 507, closer to the top surface with the rigid support 508, and the second component 506b is located near the bottom surface e of the track 507, closest to the drive module (e.g., Figure 25 (See drive module 310). Note that although the assembly direction of the first component 506a and the second component 506b of the floating interface 506 is described relative to the usage position, the first and second components 506a and 506b of the floating component 506 are mounted away from the drive module. In other words, the first component 506a of the floating interface 506 is inserted into the recess 536 in a direction from the top surface of the box to the bottom surface of the box, which is approximately perpendicular to the longitudinal axis of the box housing.

[0128] The first component 506a and the second component 506b of the floating interface 506 are secured to each other. In one embodiment, a mechanical fastener or multiple fasteners may be used to secure the first component 506 to the second component 506b of the floating interface 506. In other embodiments, the first component 506a and the second component 506b may be secured together using, for example, a magnet or an adhesive. The first component 506a and the second component 506b may be releasably secured to each other or non-releasably secured to each other.

[0129] In the usage position, the second component 506b of the floating interface 506 is releasably fixed to the drive module (e.g., Figure 25 The drive module 310 shown has a first component 506a and a second component 506b spaced apart from the track 507 of the rigid support 508, such that the first component 506a and the second component 506b are in a non-contact relationship with the rigid support 508. In one embodiment, the box includes a lid 505, which is pivotally coupled to the floating interface 506 via a hinge 503 and is separate from and does not contact the rigid support 508. For example, the lid 505 can be pivotally coupled to the first component 506a via the hinge 503. In another embodiment, the lid 505 can be connected to the first component 506a via other connecting mechanisms, such as snap-fit.

[0130] Typically, the EMD (e.g., catheter) in the cartridge can be connected to various tubing via a side port of a hemostatic valve attached to the EMD for purposes such as supplying saline drips, allowing contrast agent injections, and allowing aspiration. In robotic actuators that linearly manipulate the EMD, it will be advantageous to consider tubing connections, particularly by providing support components, so that the tubing does not obstruct or pull on the hemostatic valve. Figure 53 The illustration shows a housing with a support assembly for anchoring tubing and fluid connections according to an embodiment. The support assembly for tubing and fluid connections includes a flexible section of tubing 544, one end of which is attached to a side port 542 of a hemostatic valve positioned in the housing 540. A second end of the flexible section of tubing 544 is attached to a clip 548 mounted on a support 546. The support 546 is connected to the housing 540. The second end of tubing 544 and clip 548 can be configured to provide a connector (e.g., a female port) for attachment to tubing or other fluid connections. The support assembly provides strain relief such that if tubing 544 is pulled, the force is counteracted through the connection to the support 546 rather than the hemostatic valve 542. In another embodiment, the strain-relieving tubing 544 may also terminate in a multi-port stopcock valve manifold, which would allow multiple tubing connections to remain in place during surgery.

[0131] As described above, the profile of the device support formed by the flexible tube with longitudinal slits should support opening and closing, for example, to allow the EMD to be loaded into and held in the device support so as not to pop out or buckle. Figure 54 This is a cross-sectional view of the end of the device support member according to an embodiment. Figure 54 In this embodiment, the device support 550 includes a first (or inner) flexible tube 552 and a second (or outer) flexible tube 556. The inner tube 552 includes a longitudinal slit 554, an outer diameter 558, and an inner diameter 560. In this embodiment, the inner tube 552 is a thin-walled tube to allow the longitudinal slit 554 to open and close more easily. The outer tube 556 includes an outer diameter 562 and an inner diameter 564. Additionally, the outer tube 556 includes a longitudinal opening defined by a first side 566 and a second side 568. The outer tube 556 is disposed around the outer diameter 558 of the inner tube 552. The outer tube 556 can be formed using a material that provides sufficient force to hold the slit 554 of the inner tube 552 in a “closed” position, for example, such that the sides of the slit 554 are in contact, and the EMD 570 positioned within the inner tube 552 is held within the inner tube 552. The material used to form the outer tube 556 should also be configured to allow the slit of the inner tube to be forced open when a force from, for example, a separator is applied. In this embodiment, the inner diameter 564 of the outer tube 556 is smaller than the outer diameter 558 of the inner tube 552.

[0132] As described above, a separator or wedge can be used to separate the longitudinal slits of the device support to allow the device support to encapsulate the EMD. Figure 55 This is a cross-sectional view of the end of the device support and separator according to an embodiment. Figure 55 In this embodiment, the device support 580 includes a first (or inner) flexible tube 572 and a second (or outer) flexible tube 574. The inner tube 572 includes a longitudinal slit 582, a first arm element 576, and a second arm element 578. In this embodiment, the inner tube 572 is a thin-walled tube to allow the longitudinal slit 582 to open and close more easily. The outer tube 574 includes a longitudinal opening defined by a first side 588 and a second side 590. The outer tube 574 is disposed around the outer diameter of the inner tube 572. The first arm 576 and the second arm 578 of the inner tube 572 are disposed within the opening of the outer tube 574. Figure 55In the illustrated embodiment, the first arm 576 contacts a first side of the opening, and the second arm 578 contacts a second side 590 of the opening. The first arm 576 and the second arm 578 provide a surface that can travel on the separator (e.g., separator 584) when the device support is advanced on the separator 584 to force the slit 582 of the inner tube 572 to open to encapsulate the EMD 586. When the device support 580 is advanced on the separator 584, the first arm 576 and the second arm 578 prevent the separator 584 from contacting (e.g., rubbing) with the EMD 586. Therefore, the first arm 576 and the second arm 578 can reduce or eliminate the frictional forces acting on the EMD 586 that could damage it.

[0133] According to the above method, computer-executable instructions for supporting and driving elongated medical devices in a catheter-based robotic surgical system can be stored in the form of a computer-readable medium. Computer-readable media include volatile and non-volatile, removable and non-removable media implemented in any method or technology for storing information such as computer-readable instructions, data structures, program modules, or other data. Computer-readable media include, but are not limited to, random access memory (RAM), read-only memory (ROM), electrically erasable programmable ROM (EEPROM), flash memory or other storage technologies, optical disc read-only memory (CD-ROM), digital versatile disc (DVD) or other optical storage, cassette tape, magnetic tape, disk storage or other magnetic storage devices, or other devices that can be used to store the required instructions and can be accessed by system 10 (such as...). Figure 1 (as shown) any other medium for access, including access via the Internet or other computer networks.

[0134] The control computing system described herein may include a processor with processing circuitry. The processor may include a central processing unit (CPU), an application-specific integrated circuit (ASIC), circuitry containing one or more processing units, a distributed group of processing units, a distributed computer group configured for processing, etc., configured to provide the functionality of the modules or subsystem components discussed herein. A storage unit (e.g., a memory device, storage unit, etc.) is a means for storing data and / or computer code to perform and / or facilitate the various processes described in this disclosure. A memory unit may include volatile memory and / or non-volatile memory. A memory unit may include database components, object code components, scripting components, and / or any other type of information structure for supporting the various activities described in this disclosure. According to exemplary embodiments, any distributed and / or local memory devices of the past, present, or future may be used 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 circuitry. 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, program code, compiled code, script code, executable code, or any combination thereof) used to perform the corresponding function of each module.

[0135] 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 changed or reordered.

[0136] 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 apparent from the appended claims.

Claims

1. A device for providing support for an elongated medical device between a first device module and a second device module, the first device module and the second device module being coupled to a linear member for a robot actuator of a catheter-based surgical system, the second device module being located distal to the first device module along the linear member, the device comprising: A device support having a distal end and a proximal end, wherein a section of the device support is positioned within the first device module; and A connector attached to the distal end of the device support, the connector including an attachment mechanism for engaging the proximal end of the second device module; The device support is coupled to the support arm, and The support arm is coupled to the second device module and extends from the second device module proximally toward the first device module, providing a fixing point for supporting the proximal end of the device support; and The device support is under tension between the distal end and the proximal end.

2. The device according to claim 1, wherein, The device support is configured to move relative to the first device module.

3. The device according to claim 2, wherein, The device support is configured to move through the channel of the first device module.

4. The device according to claim 1, wherein, The device support is a tube with a longitudinal slit, and the connector is configured to keep the distal end of the device support open.

5. The device according to claim 1, wherein, The connector's attachment mechanism is configured to engage a forward constraint on the proximal end of the second device module.

6. The device according to claim 5, wherein, The connector is attached to the forward constraint along the longitudinal axis of the slender medical device positioned within the device support.

7. A device support for providing support for an elongated medical device between a first device module and a second device module, the first and second device modules being coupled to a linear component of a robot actuator of a catheter-based surgical system. The device support has a distal end and a proximal end, wherein... A section of the device support is positioned within the first device module; and The device support has a connector attached to the distal end of the device support, the connector including an attachment mechanism for engaging the proximal end of the second device module. The device support is coupled to the support arm and The support arm is coupled to the second device module and extends from the second device module proximally toward the first device module, providing a fixing point for supporting the proximal end of the device support; and The device support is under tension between the distal end and the proximal end, and the device support further includes: A first tube having a longitudinal slit configured to move between a first position and a second position, the first tube having an inner diameter and an outer diameter; and A second tube, having a longitudinal opening, an inner diameter, and an outer diameter, is disposed around the outer diameter of the first tube and configured to provide a force on the first tube to hold the first tube in the first position. The first device module and the second device module include a separator configured to move the slit between the first position and the second position.

8. The device support according to claim 7, wherein, The inner diameter of the outer tube is smaller than the outer diameter of the inner tube.

9. The device support according to claim 7, wherein, The inner tube also includes a first arm and a second arm positioned in the longitudinal opening of the second tube.

10. The device support according to claim 9, wherein, The first arm and the second arm are configured to receive a splitter.

11. The device support according to claim 7, wherein, The first tube is formed of a flexible material.

12. The device support according to claim 11, wherein, The first tube is configured to provide low friction on the elongated medical device.

13. The device support according to claim 7, wherein, The second tube is formed of a flexible material.

14. The device support according to claim 10, wherein, The separator is configured to provide force on the longitudinal slit of the first tube to hold the first tube in the first position.

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