Systems, apparatus, and methods for supporting and driving elongate medical devices in robotic catheter-based surgical systems

Abstract

A cartridge assembly for use with a robotic system for driving a plurality of elongate medical devices, comprising: a first cartridge; a second cartridge; a third cartridge; and a fourth cartridge; first, second, third, and fourth device supports each having a proximal end and a distal end; each of the first, second, third, and fourth cartridges is configured to be attached to a corresponding drive module of the robotic system, and each of the first, second, third, and fourth cartridges includes a housing having a proximal end, a distal end, and a cartridge longitudinal device axis, and a channel; a fourth cartridge positioned distal to the third cartridge, the third cartridge positioned distal to the second cartridge, and the second cartridge positioned distal to the first cartridge; the first device support has a portion located within the channel of the first cartridge; a second device support having a portion located within the channel of the second cartridge; a third device support having a portion located within the passage of the third cartridge; and the fourth device support has a portion located within the passage of the fourth cartridge.

Description

[0001] This application is a divisional application of an application with an application date of July 14, 2020, application number 202080064594.6, and titled “Systems, apparatus, and methods for supporting and driving elongated medical devices in robotic catheter-based surgical systems.”

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority based on U.S. Serial No. 62 / 874,222, filed on July 15, 2019, and entitled “Systems, Apparatus, and Methods for Supporting and Driving Elongated Medical Devices in Robotic Catheter-Based Surgical Systems,” and is incorporated herein by reference in its entirety. Technical Field

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

[0004] Catheter and other elongated medical devices (EMD) can be used for minimally invasive medical procedures for diagnosing and treating various vascular system diseases, including neurovascular intervention (NVI) (also referred to as neurointerventional surgery), percutaneous coronary intervention (PCI) and peripheral vascular intervention (PVI). These operations typically include a navigation guide wire through the vascular system, and advancement of the catheter via the guide wire to deliver treatment. Catheterization surgery begins by obtaining access to appropriate blood vessels (such as arteries or veins) through an introducer sheath using standard percutaneous techniques. By the introducer sheath, the sheath or guiding catheter is then advanced to a primary position on the diagnostic guide wire, such as the internal carotid artery for NVI, the coronary ostium for PCI or the superficial femoral artery for PVI. Then, the guide wire suitable for the vascular system is navigated through the sheath or guiding catheter to the target position in the vascular system. In some cases, such as in a tortuous anatomical structure, a support catheter or microcatheter is inserted through the guide wire to assist in navigating the guide wire. The physician or operator can use an imaging system (e.g., a fluoroscope) to obtain a movie with contrast injection and select a fixed frame to use as a roadmap to navigate the guidewire or catheter to the target location, such as a lesion. While the physician delivers the guidewire or catheter, a contrast-enhanced image can also be obtained so that the physician can verify that the device is moving along the correct path to the target location. While observing the anatomy using fluoroscopy, 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 advancing into the side branches.

[0005] Robotic catheter-based surgical systems have been developed that can be used to assist physicians in performing catheterization 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 occlusions in the setting of acute ischemic stroke. In NVI procedures, physicians use a robotic system to deliver therapy by controlling the manipulation of a neurovascular guidewire and a microcatheter to restore normal blood flow and thereby gain access to the target lesion. Access to the target lesion is achieved through a sheath or guide catheter, but an intermediate catheter may also be required for more distal areas or to provide adequate support for the microcatheter and guidewire. Depending on the type of lesion and the treatment being treated, the distal tip of the guidewire is navigated into or through the lesion. To treat an aneurysm, a microcatheter is advanced into the lesion, the guidewire is removed, and several embolic coils are deployed into the aneurysm through the microcatheter and used to block blood flow into the aneurysm. To treat an arteriovenous malformation, a liquid embolic agent is injected into the malformation via the microcatheter. Mechanical thrombectomy for treating vascular occlusions can be accomplished by aspiration and / or using a stent retriever. Depending on the location of the clot, aspiration can be accomplished either through an aspiration catheter or through a microcatheter for smaller arteries. Once the aspiration catheter is located at the lesion, negative pressure is applied to remove the clot through the catheter. Alternatively, the clot can be removed by deploying a stent retriever through the microcatheter. Once the clot has been integrated into the stent retriever, the clot is removed by retracting the stent retriever and microcatheter (or intermediate catheter) into the guide catheter.

[0006] In PCI, physicians use a robotic system to gain access to the lesion by manipulating a coronary guidewire to deliver therapy and restore normal blood flow. Access is achieved by placing a guide catheter in the coronary ostium. The distal tip of the guidewire is navigated through the lesion, and for complex anatomies, a microcatheter can be used to provide adequate support for the guidewire. Blood flow is restored by delivering and deploying a stent or balloon at the lesion. The lesion may require preparation prior to stent placement, either by delivering a balloon for pre-dilation of the lesion, or by performing atherectomy using, for example, a laser or rotational atherectomy catheter and balloon over the guidewire. Diagnostic imaging and physiologic measurements can be performed using an imaging catheter or fractional flow reserve (FFR) measurements to determine appropriate treatment.

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

[0008] When support is required at the distal end of a catheter or guidewire, for example, to navigate tortuous or calcified vasculature to reach distal anatomical locations or through hard lesions, an over-the-wire (OTW) catheter or coaxial system is used. OTW catheters have 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, compared to rapid-exchange catheters, this system has some disadvantages, including higher friction and a longer overall length (see below). Typically, in order to remove or replace an OTW catheter while maintaining the position of an indwelling guidewire, the exposed length of the guidewire (outside the patient's body) must be longer than that of the OTW catheter. For this purpose, a 300-cm-long guidewire is generally sufficient and is often referred to as a replacement-length guidewire. Due to the length of the guidewire, two operators are required to remove or replace an OTW catheter. This becomes even more challenging if a triaxial system, known in the art, is used (quadruplex catheters are also known to be used). However, due to their stability, OTW systems are often used in NVI and PVI procedures. On the other hand, PCI procedures often use rapid exchange (or monorail) catheters. The guidewire lumen in a rapid exchange catheter extends only through the distal section of the catheter, called the monorail or rapid exchange (RX) section. With an RX system, the operator manipulates the interventional devices in parallel to each other (as opposed to an OTW system, in which the devices are manipulated in a serial configuration), and the exposed length of the guidewire only needs to be slightly longer than the RX section of the catheter. Rapid exchange length guidewires are typically 180-200 cm long. Given the shorter length guidewire and monorail, RX catheters can be changed by a single operator. However, when more distal support is needed, an RX catheter is often not enough. Summary of the Invention

[0009] According to an embodiment, an apparatus 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 member of a robotic actuator for a catheter. The second device module is positioned distally of the first device module along the linear member. The apparatus includes a device support having a distal end and a proximal end. A section of the device support is positioned within the first device module. The apparatus 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 cartridge for use in a robotic actuator for a catheter-based surgical system includes a housing having a distal end 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 cartridge housing, the separator being located at an entry point of 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 first and second device modules coupled to a linear member of a robotic actuator of a catheter-based surgical system includes a first tube and a second tube, the first tube having a longitudinal slit configured to move between a first position and a second position, 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 is configured to provide a force on the first tube to maintain the first tube in the first position.

[0012] According to another embodiment, a cartridge for use in a robotic actuator of a catheter-based surgical system includes a housing having a distal end and a proximal end; an access point to a device support at the distal end of the housing; and a modular section of the housing located between the access points at 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 cassette and an elongated medical device adapter. The cassette includes a housing having a distal end and a proximal end, an access point to a device support at the distal end of the housing, and a modular section of the housing located between the access points at the proximal and distal ends. The modular section includes a middle section and a recess positioned offset from a longitudinal axis of the cassette. 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 in the middle section of the modular section, and the second section of the elongated medical device adapter is positioned in the recess of the modular section.

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

[0015] According to another embodiment, a cartridge for use in a robotic actuator for a catheter-based surgical system includes a rigid support segment, 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 segment 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. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] The present invention will become more fully understood from the following detailed description taken in conjunction with the accompanying drawings, in which like parts are designated by reference numerals and in which: Figure 1 is a perspective view of an exemplary catheter surgery system according to an embodiment; Figure 2 is a schematic block diagram of an exemplary catheter surgery system according to an embodiment; Figure 3 is a perspective view of a drive assembly for a catheter surgery system according to an embodiment; Figure 4 is a perspective view of a device support having fixed anterior (or distal) and posterior (or proximal) points to provide tension, according to an embodiment; Figure 5 is a top view illustrating a cartridge according to an embodiment with a device support in a retracted position to facilitate replacement of an elongated medical device; Figure 6 is a top view showing a cartridge according to an embodiment with a device support in an extended position with restrained ends; Figure 7 is a top view of two device modules with device supports according to an embodiment; Figure 8 is a top view illustrating linear forward translation of a device module relative to a device support according to an embodiment; Figure 9 is a top view illustrating linear counter-translation of a device module relative to a device support according to an embodiment; Figure 10 is a top view illustrating linear counter-translation of a device module relative to a device support according to an embodiment; Figure 11shows a simplified top view of four device modules and four device supports for a robotic drive according to one embodiment; Figure 12 shows a simplified top view illustrating movement of a device module relative to a device support according to an embodiment; Figure 13 A simplified top view is shown illustrating a Figure 11 The four device modules are in a forward position relative to their respective device supports; Figure 14 A simplified top view is shown illustrating a Figure 11 The four device modules are in a retracted position relative to their respective device supports; Figure 15 is a side view of an extended proximal end of a device support and a rear restraint of a rear (or proximal) attachment point to which the device support is connected, according to an embodiment; Figure 16 is a side view of a partially retracted proximal end of a device support and a rear restraint of a rear (or proximal) attachment point to which the device support is connected, according to an embodiment; Figure 17 shows a simplified top view of a device module with a device support stored on a spool according to an embodiment; Figure 18 An exemplary winding tensioner according to an embodiment is shown; Figure 19 shows a simplified top view of a device module with a drive device support according to an embodiment; Figure 20 An exemplary gear tensioner according to an embodiment is shown; Figure 21 shows a simplified top view of a device module having a device support formed by telescopic joints or springs according to an embodiment; Figure 22 illustrates a compressed expansion joint / spring according to an embodiment; Figure 23 illustrates a stretched expansion joint / spring according to an embodiment; 24( a )-( c ) are perspective views of exemplary slit shapes for a device supporting a flexible tube, according to an embodiment; Figure 25 is an exploded view of a device module and an elongated medical device according to an embodiment; Figure 26a is a perspective view of a cartridge with a device support mounted and in a retracted position according to an embodiment; Figure 26bis a perspective view of a cartridge with a device support mounted and in a retracted position according to an embodiment; Figure 27 is a top view of a device support and a connector extending from a box in front of an EMD entry point according to an embodiment; Figure 28 is a top view of a device support and connector retracted behind an EMD entry point according to an embodiment; Figure 29 is an end view of a separator with a retaining device support open according to an embodiment; Figure 30 is a top view of a cartridge according to an embodiment with the device support connector retracted and offset from the device axis to facilitate loading of an EMD Figure 31 is a perspective view of a forward constraint and connector according to an embodiment; Figure 32 is a perspective view of a forward constraint with a cover according to an embodiment; Figure 33 is a perspective view of a distal support arm and a distal support connector according to an embodiment; Figure 34 is a perspective view of a distal support connector coupled to a device support and a connector according to an embodiment; Figure 35 is a side view of a distal support arm, a distal support connector, and an introducer hub support according to an embodiment; Figure 36 is a perspective view of an introducer hub support coupled to an introducer sheath according to an embodiment; Figure 37 is a perspective view of a movable distal support arm in a first position according to an embodiment; Figure 38 is a perspective view of a movable distal support arm in a second position according to an embodiment; Figure 39 is a top view of the movable distal support arm and the movable support arm in a first position according to an embodiment; Figure 40 is a top view of the movable distal support arm and the movable support arm in a second position according to an embodiment; Figure 41 is a top view illustrating the distal support arm and movement of the support arm from the second position to the first position according to an embodiment; Figure 42 is a perspective view of a catheter with an on-device adapter according to an embodiment; Figure 43 is a perspective view of a guidewire with an adapter on a device according to an embodiment; Figure 44is a perspective view of a cartridge with an elongated medical device mounted thereon with an on-device adapter, according to an embodiment; Figure 45 is an exploded view of a cartridge and an elongated medical device with an on-device adapter removed from the cartridge according to an embodiment; Figure 46 is a top view of a cartridge according to an embodiment; Figure 47 is an exploded view of an elongated medical device (EMD) adapter and cover according to an embodiment; Figure 48 is a perspective view of an EMD adapter and an EMD installed in a case according to an embodiment; Figure 49 is a top view of a cassette having a floating interface and a rigid support section according to an embodiment; Figure 50a is an end cross-sectional view of a floating (or isolation) interface and a rigid support section of a cartridge according to an embodiment; Figure 50b is an exploded isometric view of a cartridge according to an embodiment showing first and second components of a floating (or isolated) interface; Figure 51 is a bottom view of a floating (or isolated) interface of a cartridge according to an embodiment; Figure 52 shows a bracket supporting a rotation drive gear with a roller according to an embodiment; and Figure 53 illustrates a cassette with a support assembly for anchoring tubing and fluid connections according to an embodiment; Figure 54 is an end cross-sectional view of a device support according to an embodiment; and Figure 55 is an end cross-sectional view of a device support and separator according to an embodiment. DETAILED DESCRIPTION

[0017] The following definitions will be used herein. The term elongated medical device (EMD) refers to, but is not limited to, catheters (e.g., guide catheters, microcatheters, balloon / stent catheters), devices based on wires (guidewires, embolic coils, stent retrievers, etc.), and devices with combinations of these. Wire-based EMDs include, but are not limited to, guidewires, microwires, proximal pushers for embolic coils, stent retrievers, self-expanding stents, and shunts. Typically, wire-based EMDs do not have a hub or handle at their proximal terminals. In one embodiment, the EMD is a catheter having a hub and a flexible shaft extending from the hub toward the distal end of the catheter at the proximal end of the catheter, wherein the shaft is more flexible than the hub. In one embodiment, the catheter includes a middle portion transitioning between the hub and the shaft, the middle portion having an intermediate flexibility that is less rigid than the hub and more rigid than the shaft. In one embodiment, the middle portion is a strain reliever.

[0018] The terms distal and proximal define the relative positions of two different features. With respect to a robotic actuator, the terms distal and proximal are defined by the position of the robotic actuator relative to a patient in its intended use. When used to define relative positions, 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 vasculature landmark along a path farther from an access point, where the access point is the point at which the EMD enters the patient, is considered more distal than a landmark closer to the access point. Similarly, a proximal feature is a feature farther from the patient than a distal feature when the robotic actuator is in its intended use position. When used to define a direction, a distal direction refers to the path along which something is moving or intended to move, or the path that something is pointing or facing from a proximal feature toward a distal feature and / or the patient, when the robotic actuator is in its intended use position. The proximal direction is the direction opposite to the distal direction.

[0019] The longitudinal axis of the term component (e.g., an EMD or other element in a catheter-based surgical system) is 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 toward the distal portion of the guidewire, even though the guidewire may be nonlinear in the relevant portion. The term "axial movement of a component" refers to the translation of the component along the longitudinal axis of the component. When the distal end of the EMD moves axially in a distal direction along its longitudinal axis into or further into the patient's body, the EMD is being advanced. When the distal end of the EMD moves axially in a proximal direction along its longitudinal axis out of the patient or further out of the patient, the EMD is being withdrawn. The term rotational movement of a component refers to the change in the angular orientation of the component around the local longitudinal axis of the component. Rotational movement of an EMD corresponds to a clockwise or counterclockwise rotation of the EMD around its longitudinal axis due to an applied torque.

[0020] The term "axial insertion" refers to the insertion of a first component into a second component along the longitudinal axis of the second component. The term "lateral insertion" refers to the insertion of a first component into a second component along a plane perpendicular to the longitudinal axis of the second component. This may also be referred to as radial loading or side loading. The term "clamping" refers to the releasable securing of the EMD to a component so that when the component moves, the EMD and the component move together. The term "unclamping" refers to the release of the EMD from a component so that when the component moves, the EMD and the component move independently. The term "clamping" refers to the releasable securing of the EMD to a component so that the movement of the EMD relative to the component is constrained. The component can be fixed relative to a global coordinate system or relative to a local coordinate system. The term "unclamping" refers to the release of the EMD from the component so that the EMD can move independently.

[0021] The term "grip" refers to applying a force or torque to the EMD by a drive mechanism that causes the EMD to move without slipping in at least one degree of freedom. The term "release grip" refers to releasing the force or torque applied to the EMD by a 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 is different 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 longitudinal axis or intended path along which it is being advanced when under axial compression. In one embodiment, axial compression occurs in response to resistance being navigated in the vascular system. Before the EMD buckles, the distance that the EMD can be driven along its longitudinal axis without support is referred to herein as the device buckling distance. The device buckling distance is a function of the device stiffness, geometry (including but not limited to diameter) and the force applied to the EMD. Buckling can cause the EMD to form an arched portion that is different from the intended path. Kinking is a case of buckling in which the deformation of the EMD is inelastic, resulting in permanent deformation.

[0022] The terms "top," "upward," and "up" refer to the general direction away from the direction of gravity, and the terms "bottom," "downward," and "down" refer to the general direction in the direction of gravity. The term "inward" refers to the interior portion of a feature. The term "outward" refers to the exterior portion of a feature. The term sterile interface refers to the interface or boundary between a sterile and a non-sterile unit. For example, a box can be a sterile interface between a robotic drive and at least one EMD. The term "sterilizable unit" refers to a device that can be sterilized (free of pathogenic microorganisms). This includes, but is not limited to, boxes, consumable units, drapes, device adapters, and sterilizable drive modules / units (which may include electromechanical components). A sterilizable unit may come into contact with a patient, other sterile devices, or any other item within the sterile field of a medical procedure.

[0023] On the term device, adapter refers to the sterile equipment that can releasably clamp EMD to provide drive interface.For example, on the device, adapter is also referred to as end effector or EMD capture device.In a non-limiting embodiment, on the device, adapter is a chuck, which is operably controlled by a robot to rotate the EMD around its longitudinal axis, so that the EMD is clamped to the chuck and / or unclamped, and / or the EMD is translated along its longitudinal axis.In one embodiment, on the device, adapter is a hub drive mechanism, such as a driven gear on the hub of the EMD. Term hub drive or proximal drive refers to grasping and manipulating EMD (for example, the gear adapter on the catheter hub) from the proximal position. In one embodiment, hub drive refers to giving force or torque to translate and / or rotate the catheter to the hub of the catheter. In hub drive, often applying typical clinical loads can cause EMD to buckle, and therefore hub drive often requires the anti-buckling feature in the drive mechanism. For devices without hub or other interfaces (for example guidewires), a device adapter can be added to the device to serve as a temporary hub. In one embodiment, the EMD handle includes a mechanism for manipulating features within the catheter, such as a wire that extends from the handle to the distal end of the catheter to deflect the distal end of the catheter. In contrast, the hub is the rigid portion of the EMD at the proximal end that does not include control mechanisms for manipulating features within the catheter. The term shaft (distal) drive refers to grabbing the EMD and manipulating the EMD along its axis. For example, an adapter on the device can be placed just proximal to the hub or Y-connector into which the device is inserted. If the location of the adapter on the device is close to the insertion point (to the body or another catheter or valve), the shaft drive generally does not require an anti-buckling feature (it may include an anti-buckling feature to improve driveability).

[0024] Figure 1 is a perspective view of an exemplary catheter-based surgical system 10 according to an embodiment. The catheter-based surgical system 10 can be used to perform catheter-based medical procedures, such as percutaneous interventional procedures (such as percutaneous coronary intervention (PCI) (e.g., to treat STEMI)), neurovascular interventional procedures (NVI) (e.g., to treat emergency large vessel occlusion (ELVO)), peripheral vascular interventional procedures (PVI) (e.g., for critical limb ischemia (CLI)), etc.). Catheter-based medical procedures can include diagnostic catheterization procedures during which one or more catheters or other elongated medical devices (EMDs) are used to help diagnose a patient's disease. For example, during one embodiment of a catheter-based diagnostic procedure, a contrast agent is injected into one or more arteries via a catheter and an image of the patient's vascular system is taken. Catheter-based medical procedures can also include catheter-based therapeutic procedures (e.g., angioplasty, stent placement, treatment of peripheral vascular disease, clot removal, arteriovenous malformation treatment, aneurysm treatment, etc.), during which a catheter (or other EMD) is used to treat the disease. The catheter-based medical procedures can be performed by including an auxiliary device 54 (e.g., Figure 2(as shown) to enhance therapeutic procedures, such as, for example, 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., type of guidewire, 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 in the procedure.

[0025] The catheter-based surgical system 10 includes, among other things, a bedside unit 20 and a control station 26. The bedside unit 20 includes a robotic actuator 24 and a positioning system 22 positioned adjacent to a patient 12. The patient 12 is supported on a patient table 18. The positioning system 22 is used to position and support the robotic actuator 24. The positioning system 22 may be, for example, a robotic arm, an articulated arm, a holder, or the like. One end of the positioning system 22 may be attached to, for example, a track, a base, or a cart on the patient table 18. The other end of the positioning system 22 is attached to the robotic actuator 24. The positioning system 22 can be removed (along with the robotic 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 the robotic actuator 24 relative to the patient 12 or for positioning the robotic actuator 24 for the procedure. In an embodiment, the patient table 18 is operably supported by a base 17, which is secured to a floor and / or ground. The patient table 18 is capable of moving relative to the base 17 in multiple degrees of freedom, such as roll, pitch, and yaw. The bedside unit 20 may also include controls and a display 46 ( Figure 2 For example, the controls and display may be located on the housing of the robot drive 24.

[0026] Typically, the robotic actuator 24 may be equipped with appropriate percutaneous access devices and accessories 48 (e.g., Figure 2 ) (e.g., guidewires, various types of catheters, including balloon catheters, stent delivery systems, stent retrievers, embolic coils, liquid embolic agents, suction pumps, devices for delivering contrast media, medications, 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 the control station 26. The bedside unit 20, and in particular the robotic drive 24, may include any number and / or combination of components to provide the functionality described herein to the bedside unit 20. The user or operator 11 at the control station 26 is referred to as the control station user or control station operator, and is referred to herein as the user or operator. The user or operator at the bedside unit 20 is referred to as the bedside unit user or bedside unit operator. The robotic drive 24 includes a controller mounted to a track or linear member 60 (e.g., Figure 31 . A plurality of device modules 32a-d are mounted on a track or linear member 60 (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 a guidewire. For example, the robotic drive 24 can be used to automatically feed a guidewire into a diagnostic catheter and a guide catheter in an artery of the patient 12. One or more devices (such as an EMD) enter the body (e.g., a blood vessel) of the patient 12 at the insertion point 16 via, for example, an introducer sheath.

[0027] The bedside unit 20 is in communication with the control station 26, thereby allowing signals generated by user inputs to the control station 26 to be transmitted wirelessly or via hardwiring to the bedside unit 20 to control various functions of the bedside unit 20. As discussed below, the control station 26 may include a control computing system 34 (e.g., Figure 2 ) or coupled to the bedside unit 20 via the control computing system 34. The bedside unit 20 can also provide communication to the control station 26, the control computing system 34 ( Figure 2 ) 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 capable of allowing communication between the components. The control station 26 or other similar control system can be located at a local site (e.g., Figure 2 local control station 38 shown) or a remote site (e.g., Figure 2 The catheter surgery system 10 may be operated by a control station at a local site, a control station at a remote site, or both. At the local site, the user or operator 11 and the control station 26 are located in the same room as the patient 12 and the bedside unit 20 or in an adjacent room. As used herein, the local site is the location of the bedside unit 20 and the patient 12 or subject (e.g., an animal or a 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 may use communication systems and services 36 (e.g., Figure 2 In embodiments, the remote site and the local (patient) site are located remotely from one another, e.g., in different rooms in the same building, in different buildings in the same city, in different cities, or other locations where the remote site cannot physically access the bedside unit 20 and / or the patient 12 at the local site.

[0028] The control station 26 typically includes one or more input modules 28 that are configured to receive user input to operate various components or systems of the catheter-based surgical system 10. In the illustrated embodiment, the control station 26 allows the user or operator 11 to control the bedside unit 20 to perform a catheter-based medical procedure. For example, the input module 28 can be configured to cause the bedside unit 20 to use a percutaneous interventional device (e.g., an EMD) that is interfaced with the robotic actuator 24 to perform various tasks (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 retriever; positioning and / or deploying a coil; injecting contrast media into a catheter; injecting a liquid embolic agent into a catheter; injecting medication or saline into a catheter; applying suction on a catheter; or performing any other function that may be performed as part of a catheter-based medical procedure). The robotic actuator 24 includes various drive mechanisms to cause movement (e.g., axial and rotational movement) of components of the bedside unit 20, including the percutaneous interventional device.

[0029] In one embodiment, the input module 28 may include one or more touch screens, joysticks, scroll wheels, and / or buttons. In addition to the input module 28, the control station 26 may use additional user controls 44 (e.g., Figure 2), such as a foot switch and a microphone for voice commands. The input module 28 can be configured to advance, retract or rotate various components and percutaneous interventional devices, such as, for example, a guidewire and one or more catheters or microcatheters. The 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 pushed, the power supply (e.g., electricity) to the bedside unit 20 is cut off or removed. When in speed control mode, the multiplier button is used to increase or decrease the speed of movement of the associated component in response to manipulation of the input module 28. When in position control mode, the multiplier button changes the mapping between input distance and output instruction distance. The device selection button allows the user or operator 11 to select which percutaneous interventional devices loaded into the robotic drive 24 are controlled by the input module 28. The automatic movement button is used to implement algorithmic movements that the catheter-based surgical system 10 can perform on percutaneous interventional devices without direct commands from the user or operator 11. In one embodiment, the input module 28 may include one or more controls or icons (not shown) displayed on a touch screen (which may or may not be part of the display 30) that, when activated, cause operation of the components of the catheter-based surgical system 10. The input module 28 may also include a balloon or stent control that is 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, touch screens, etc., which may be used to control one or more specific components to which the control is dedicated. In addition, the one or more touch screens may display one or more icons (not shown) related to various portions of the input module 28 or various components of the catheter-based surgical system 10.

[0030] The control station 26 may include a display 30. In other embodiments, the control station 26 may include two or more displays 30. The display 30 may be configured to display information or patient-specific data to a user or operator 11 located at the control station 26. For example, the 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, the display 30 may be configured to display procedure-specific information (e.g., procedure checklist, recommendations, procedure duration, catheter or guidewire position, volume of medication or contrast agent delivered, etc.). Furthermore, the display 30 may be configured to display information to provide information related to the control computing system 34 ( Figure 2 The display 30 may include touch screen capabilities to provide some user input capabilities for the system.

[0031] 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 a catheter-based medical procedure (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 can include a C-arm ( Figure 1 ), the C-arm allows the imaging system 14 to be partially or fully rotated about the patient 12 to obtain images at different angular positions relative to the patient 12 (e.g., sagittal view, caudal view, anteroposterior view, etc.). In one embodiment, the imaging system 14 is a fluoroscopy system that includes a C-arm having an X-ray source 13 and a detector 15, also referred to as an image intensifier.

[0032] The imaging system 14 can be configured to take X-ray images of appropriate areas of the patient 12 during surgery. For example, the imaging system 14 can be configured to take one or more X-ray images of the head to diagnose neurovascular conditions. The imaging system 14 can also be configured to take one or more X-ray images (e.g., real-time images) during a catheter-based medical procedure to help a user or operator 11 at the control station 26 properly position a guidewire, guide catheter, microcatheter, stent retriever, coil, stent, balloon, etc. during the procedure. The one or more images can be displayed on the display 30. For example, the images can be displayed on the display 30 to allow the user or operator 11 to accurately move a guide catheter or guidewire into the appropriate position.

[0033] To clarify the orientation, a rectangular coordinate system with X, Y, and Z axes is introduced. The positive X axis is oriented in the longitudinal (axial) distal direction, i.e., from the proximal end to the distal end, in other words, from the proximal side to the distal side. The Y and Z axes lie in a plane transverse to the X axis, with the positive Z axis oriented upward, i.e., in the direction opposite to gravity, and the Y axis is automatically determined by the right-hand rule.

[0034] Figure 2 is a block diagram of a catheter-based surgical system 10 according to an exemplary embodiment. The catheter surgical system 10 may include a control computing system 34. The control computing system 34 may be physically located at, for example, a control station 26 (e.g., Figure 1The control computing system 34 is typically an electronic control unit adapted to provide the various functions described herein for the catheter-based surgical system 10. For example, the control computing system 34 may be an embedded system, dedicated circuitry, a general-purpose system programmed with the functions described herein, or the like. The control computing system 34 communicates with the bedside unit 20, communication systems and services 36 (e.g., the internet, a firewall, a cloud service, a session manager, a hospital network, etc.), a local control station 38, additional communication systems 40 (e.g., a telepresence system), a remote control station and computing system 42, and patient sensors 56 (e.g., an electrocardiogram (ECG) device, an electroencephalogram (EEG) device, a blood pressure monitor, a temperature monitor, a heart rate monitor, a respiratory monitor, etc.). The control computing system also communicates with the imaging system 14, the patient table 18, additional medical systems 50, a contrast agent injection system 52, and accessory devices 54 (e.g., IVUS, OCT, FFR, etc.). The bedside unit 20 includes a robotic drive 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 robotic drive 24. Interventional devices and accessories 48 (e.g., guidewires, catheters, etc.) are docked to the bedside system 20. In embodiments, the interventional devices and accessories 48 may include specialized devices (e.g., IVUS catheters, OCT catheters, FFR wires, diagnostic catheters for angiography, etc.) that dock to their respective accessory devices 54, i.e., IVUS systems, OCT systems, FFR systems, etc.

[0035] In various embodiments, the control computing system 34 is configured to control the computer system 34 based on user interaction with the 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 catheter-based surgical system 10 may be used to perform a medical procedure by interacting with the local control station 38 and / or generating control signals based on information accessible to the control computing system 34 so that a medical procedure can be performed using the catheter-based surgical system 10. 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 similar components 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 desired functionality. The additional user controls 44 may include, for example, one or more foot input controls. The foot input controls may be configured to allow a user to select functions of the imaging system 14, such as turning X-ray on and off and scrolling through different stored images. In another embodiment, the foot input device may be configured to allow a user to select which devices are mapped to a scroll wheel included in the input module 28. Additional communication systems 40 (e.g., audio conferencing, video conferencing, telepresence, etc.) may be used to help the operator interact with the patient, medical staff (e.g., vascular laboratory staff), and / or equipment near the bedside.

[0036] The catheter-based surgical system 10 may be connected 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 expansion system, a drug injection system, a drug tracking and / or recording system, a user log, an encryption system, a system for limiting access to or use of the catheter-based surgical system 10, and the like.

[0037] As described above, the control computing system 34 communicates with the bedside unit 20, including the robotic drive 24 and the positioning system 22, and may include additional controls and a display 46, and may 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 robotic drive 24. Figure 3 is a perspective view of a robotic actuator for a catheter-based surgical system 10 according to an embodiment. Figure 3 In, the robotic drive 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 that is 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 the corresponding device modules 32a-d coupled to the platforms 62a-d) can move independently relative to each other and the linear member 60. A drive mechanism is used to actuate each platform 62a-d. In Figure 3 In the illustrated embodiment, the drive mechanism includes an independent platform translation motor 64a-d and a platform drive mechanism 76 coupled to each platform 62a-d, for example, a leadscrew 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 motor 64a-d itself can be a linear motor. In some embodiments, the platform drive mechanism 76 can be a combination of these mechanisms, for example, each platform 62a-d can employ a different type of platform drive mechanism. In embodiments where the platform drive mechanism is a leadscrew and a rotating nut, the leadscrew can be rotated, and each platform 62a-d can engage and disengage the leadscrew to move, for example, to advance or retract. Figure 3 In the illustrated embodiment, the platforms 62a-d and device modules 32a-d are in a serial drive configuration.

[0038] Each device module 32a-d includes a drive module 68a-d and a cartridge 66a-d mounted and coupled to the drive module 68a-d. Figure 3 In the illustrated embodiment, each box 66a-d is mounted to the drive module 68a-d with a vertical orientation. In other embodiments, each box 66a-d can be mounted to the drive module 68a-d with other mounting orientations. Each box 66a-d is configured to dock with the proximal portion (not shown) of the EMD and supports the proximal portion. In addition, each box 66a-d can include an element that also provides one or more degrees of freedom except the linear motion provided by the actuation of the corresponding platform 62a-d to move linearly along the linear member 60. For example, the box 66a-d can include an element that can be used for rotating the EMD when the box 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 box 66a-d, thereby providing additional degree of freedom. Each box 66a-d also includes a channel, in which the device supports 79a-d are positioned, and each device supports 79a-d is used to prevent the EMD from buckling. Support arms 77a, 77b and 77c are attached to each device module 32a, 32b and 32c respectively to provide a fixing point for supporting the proximal end of device supports 79b, 79c and 79d respectively. The robot drive 24 can 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 is used to provide a fixing point for supporting the proximal end of the farthest device support 79a accommodated in the farthest device module 32a. In addition, an introducer interface support (steering gear) 74 can be connected to the device support connector 72 and the EMD (e.g., an introducer sheath). The configuration of the robot drive 24 has the benefit of reducing the volume and weight of the drive robot drive 24 by using an actuator on a single linear member.

[0039] To prevent pathogens from contaminating the patient, the medical staff can place the bedside unit 20 and the patient 12 or subject (e.g. Figure 1 Aseptic technique is used in a room (not shown) that houses the bedside unit 20 and the patient 12. The room that houses the bedside unit 20 and the patient 12 can be, for example, a catheterization laboratory or a vascular laboratory. Aseptic technique includes the use of sterile barriers, sterile equipment, appropriate patient preparation, environmental controls, 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 over the non-sterile robotic drive 24. Each box 66a-d is sterilized and acts as a sterile interface between the robotic drive 24 covered with the drape and at least one EMD. Each box 66a-d can be designed to be disposable and sterile, or be resterilized in whole or in part, so that the box 66a-d or its components can be used in multiple procedures.

[0040] As described above, the robotic drive 24 can include device supports 79a-d between each device module 32a-d and between the distal-most device module 32a and the device support connector 72. Each device support 79a-d is configured to prevent the elongated medical device from buckling as the elongated medical device is advanced outside the patient's body and before being advanced into the more distal EMD. In an embodiment, each device support 79a-d can be a flexible tube having a longitudinal slit and is used in conjunction with a separator on the box. Each device support 79a-d is fixed or constrained at both ends so that the device support can be maintained in tension so that the flexible tube is limited in the amount of displacement it can buckle. Buckling the elongated medical device limits the amount of force that can be applied and can permanently damage the elongated medical device. The compressive load can be caused by several factors, which may include friction between the EMD and the device support, the device support and the box (e.g., the separator in the box (see below) Figures 27-29 (discussed)) friction between the device support, etc. Holding the device support in tension can eliminate the need for additional breaking strength and allow for a smaller, more flexible device support. In one embodiment where the device support is a flexible tube, tension can be provided by securing or constraining the flexible tube at front (or distal) and rear (or proximal) points or locations. Figure 3 The device supports 79a-d shown in FIG are one embodiment of a device support having fixed front and rear points. In another embodiment, the device support can be a telescoping or spring-type support that provides appropriate tension. Each of these different embodiments of the device support will be discussed further below.

[0041] Figure 4 is a perspective view of a device support having fixed anterior (or distal) and posterior (or proximal) points to provide proper tension, according to an embodiment. Figure 4 Pictured Figure 3 The device support embodiment shown. Figure 4 In FIG, the first device module 102 includes a first cassette 106 having a first device support 128, such as a flexible tube, positioned in a channel 124 of the cassette 106. The first cassette 106 and the first device support 128 are movable relative to each other. Figure 4106, a first device support 128 extends from the distal end of the first housing 106, and a first end of the first device support 128 is connected to the proximal end of the second device module 104 at a first front (or distal) fixation 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 extending proximally from the second device module 104 toward the first housing 106. The 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) fixation 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 the first rear point 112. The first front fixation point 110 and the first rear fixation point 112 are maintained at a constant distance from each other. The first front fixing point 110 and the first rear fixing point 112 can be rigid or can have some elasticity to account for manufacturing and assembly tolerances. The first device module 102 also includes a support arm 114 that can be used to provide a rear (or proximal) fixing point for a device support member of a box (not shown) located proximal to the first box 106.

[0042] The second device module 104 is the most distal module and is closest to the patient (not shown). The second cartridge 108 of the second device module 104 includes a second device support 130, such as a flexible tube, positioned in the channel 126 of the second cartridge 108. The second cartridge 108 and the second device support 130 are movable relative to each other. Since there are no device modules or cartridges in front of the second device module 104, a distal support connector 132 mounted to a distal support arm 134 is used to provide a second front (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 described below with reference to Figure 33-41 Further described. The second end of the second device support 130 extends from the proximal end of the second box 108 and is connected to the second rear (or proximal) fixing point 122 on the proximal end of the support arm 118, which is connected to the distal support arm 134. The second device support 130 is maintained in tension by the fixed second front point 120 and the second rear point 122. The second front point 120 and the second rear point 122 are maintained at a constant distance from each other. The second front fixing point 120 and the second rear fixing point 122 can be rigid or can have a certain degree of flexibility to account for manufacturing and assembly tolerances.

[0043] 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 separated or disconnected, as further discussed below, to facilitate loading and unloading of the EMD before, during, and after surgery. Figure 5is a top view illustrating a cartridge according to an embodiment with a device support in a retracted position to facilitate replacement of an elongated medical device. Figure 5 140 has been separated from the front (or distal) fixing point 150 and is in a retracted position that 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 distal to the cassette 140. For clarity, Figure 5 140 is shown on the lid of the cassette 140. A first (or distal) end 144 of the device support 142 is located at the distal end of the cassette 140. A second (or proximal) end 146 of the device support 142 has been moved past a rear (or proximal) fixation point 152. As described above, the rear fixation point 152 is located distal to the cassette 140, for example, on a support arm of the cassette, drive module, or platform. Additionally, the fixed rear point 152 can be attached to the frame of a robotic drive. Figure 6 1 is a top view of a cartridge 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 fixing point 150 and the second end 146 is constrained by the rear fixing point 152. As described above, the front fixing point 150 and the rear fixing point 152 are fixed relative to the device module into which the distal end of the EMD 148 is entering. For clarity, the device support 142 is shown in FIG. Figure 6 A device support 142 on the lid of the box 140 is shown in FIG.

[0044] Constraining (fixing) each equipment support on both ends allows relative motion between all equipment modules in the robotic drive. Figure 7 1 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 that is constrained at a first front (or distal) fixation point 172 at the proximal end of the second device module 162 and a first rear (or proximal) fixation 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 that is constrained at a second front (or distal) fixation point (not shown) and a second rear (or proximal) fixation point 175 located in the proximal end of a support arm 173 of a device module (not shown) distal to the second device module 162. The first device module 160 can translate forward from a first position 164. The second device module 162 is located at a first position 176. Figure 817 is a top view illustrating the linear forward translation of a device module relative to a device support according to an embodiment. As first device module 160 moves forward toward the patient from first position 164 (as indicated by arrow 177) to second position 166, first posterior fixation point 174 supports the loads (e.g., friction between the cartridge and first device support 168) generated as the cartridge of first device module 160 (and the device module) moves along first device support 168. Consequently, first device support 168 will not buckle between the distal end of the cartridge on first device module 160 and the proximal end or rear portion of the cartridge on second device module 162. As first device module 160 is advanced distally toward second device module 162 (in this example, second device module 162 is stationary at its first position 176), it moves relative to first device support 168, as indicated by reference points A and B located along the length of first device support 168. When first device module 160 is in first position 164, reference points A and B are located near the distal end of first device module 160. As the first equipment module 160 is advanced along the first equipment support 168, the first equipment support 168 remains stationary because the second equipment module 162, to which it is coupled via the first anterior fixation point 172 and the first posterior fixation point 174, is also stationary. When the first equipment module 160 is in the second position 166, the reference points A and B are off-axis and proximal to the first equipment module 160. The first equipment module 160 can also translate posteriorly from the second position 166 to the first position 164.

[0045] Figure 917 is a top view illustrating linear counter-translation of a device module relative to a device support according to an embodiment. As first device module 160 moves rearward (retracted) from second position 166 away from the patient (as indicated by arrow 179) to first position 164, first anterior fixation point 172 withstands the loads (e.g., friction between the cartridge and first device support 168) generated as the cartridge of first device module 160 (and the device module) moves along first device support 168. Consequently, first device support 168 will not flex between the cartridge on first device module 160 and first posterior fixation point 174. As first device module 160 moves proximally away from second device module 162 (in this example, second device module 162 is stationary at its first position 176), it moves relative to first device support 168, as indicated by reference points A and B positioned along the length of first device support 168. When first device module 160 is in second position 166, reference points A and B are offset from the axis and proximal to 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 anterior fixation point 172 and the first posterior fixation point 174, is also stationary. When the first device module 160 is in the first position 164, reference point A and reference point B are located near the distal end of the first device module 160.

[0046] Figure 101 is a top view illustrating linear counter-translation of a device module relative to a device support according to an embodiment. As the second device module 162 moves rearwardly from a first position 176, away from the patient (as indicated by arrow 169), to a second position 178, a second anterior attachment point (not shown) distal to the second device module 162 bears the loads (e.g., friction between the cartridge and the second device support 170) generated as the cartridge of the second device module 162 (and the device module) moves along the second device support 170. Consequently, the second device support 170 will not buckle between the cartridge and the second posterior attachment point 175 on the second device module 162. Because device supports 168 and 170 are each supported between two known points, the length of each device support does not need to change. As the second device module 162 moves proximally toward the first device module 160 (in this example, while 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 the first front and rear attachment points 172, 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 at the first position 176, reference points A and B are located near the distal end of the first device module 160, as shown. Figure 7 As 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 a more distal device module (not shown) that is stationary in this example. However, the first device support 168 moves proximally with the second device module 162 to which it is coupled via the first anterior attachment point 172 and the first posterior attachment point 174. At the second position 178 of the second device module 162, reference points A and B are offset from the axis and proximal to the first device module 160.

[0047] Figure 11A simplified top view of four device modules and four device supports for a robotic actuator according to an embodiment is shown. The first device module 202 includes a first device support 204, one end of which is connected to a support arm 218 and one end of which is connected to a distal support point. The second device module 206 includes a second device support 208, one end of which is connected to a support arm 220 and one end of which is connected to the first device module 202. The third device module 210 includes a third device support 212, one end of which is connected to a first front (or distal) attachment point 226 on the second device module 206 and the other end of which is connected to a first rear (or proximal) attachment point 228 on the support arm 222. The fourth device module 214 includes a fourth device support 216, one end of which is connected to a second front (or distal) attachment point 230 on the third device module 210 and the other end of which is connected to a second rear (or proximal) attachment point 232 on the support arm 224. In various embodiments, support arms 218, 220, 222, and 224 can be connected to a box of a device module or a drive module. In another embodiment, support arms 218, 220, 222, and 224 can be foldable, retractable, or use other methods to shorten the length of the support arms when not in operation. Figure 12A simplified top view is shown illustrating the movement of device modules relative to a device support according to an embodiment. The third device module 210 begins in 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 (toward the patient), it moves along the third device support 212, which is secured 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 portion of the device support 212 that moves through the third device module 210 changes, while the first front fixation point 226 and the first rear fixation point 228 do not move. The length of a first section 242 of the device support 212 spanning between the second device module 206 and the third device module 210 decreases, while the length of a second section 244 of the device support 212 spanning between the third device module 210 and the rear fixation point 228 increases. This allows the third equipment module 210 (and associated EMD) to remain fully supported between the spans of the third equipment module 210 and the second equipment module 206 during linear motion. Another relative motion that occurs during movement of the third equipment module 210 between the first position 234 and the second position 236 involves the fourth equipment support 216 of the fourth equipment module 214 and the second front (or distal) point 230 and second rear (or proximal) point 232 of the fourth equipment support 216. The fourth equipment support 214 is secured to the third equipment module 210 at the second front fixation point 230 and to the support arm 224 extending from the third equipment module 210 at the second rear fixation point 232. As the third equipment module 210 moves, the second front fixation point 230 and the second rear fixation point 232 also move. First section 238 of fourth equipment support 216 slides through fourth equipment module 214 , thereby increasing in length over the span between fourth equipment module 214 and third equipment module 210 , while second section 240 of fourth equipment support 216 decreases in length over the span between fourth equipment module 214 and rear fixing point 232 .

[0048] Figure 13 A simplified top view is shown illustrating a Figure 11 The four device modules are in a forward position relative to their respective device supports. Figure 13 , the first equipment module 202 , the second equipment module 206 , the third equipment module 210 , and the fourth equipment module 214 are each shown in a maximum forward position along their respective equipment supports 204 , 208 , 212 , and 216 . Figure 14 A simplified top view is shown illustrating the apparatus according to an embodiment in a retracted position relative to their respective device supports. Figure 11The four device modules. Figure 14 , the first device module 202, the second device module 206, the third device module 210, and the fourth device module 214 are shown in a maximum extended (rear) position along their respective device supports 204, 208, 212, and 216. In an embodiment, the device support length is determined by the linear 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 an embodiment, each device support 204, 208, 212, and 214 can include compliance to protect the device support, thereby facilitating relaxation when transitioning between forward and reverse directions.

[0049] As discussed above, each device support is constrained at a rear (or proximal) fixation point connected to a support arm extending from a device module in front of (e.g., distal to) the device module associated with the device support. In embodiments, the rear (or proximal) fixation point includes a rear restraint that can be configured to react only to tension. Figure 15 is a side view of a proximal end of an extended device support and a rear restraint for a rear (or proximal) attachment point to which the device support is attached, according to an embodiment, and Figure 16 2 is a side view of a partially retracted proximal end of a device support and a rear (or proximal) restraint for a rear fixation point to which the device support is attached, according to an embodiment. The proximal end 252 of the support arm includes a retaining clip 254 that holds the proximal end of the device support 250. A hard stop 256 is positioned on the end of the device support and is configured to hold the device support taut as the device support moves forward and to allow the device support to be retracted for device loading (as described above with respect to FIG. Figure 5 and 6 (See Figure 25A for details). The forward movement and retraction of the device support 250 is indicated by arrow 258. The operator can pull the device support 250 back without removing it from the retaining clip 254. The rear restraint formed by the retaining clip 254 and the hard stop 256 only reacts to the pulling force. The device support will not buckle because the retaining clip 254 cannot react to the compressive force.

[0050] In another embodiment, the tension on the device support provided by the front (or distal) and rear (or proximal) fixation points connecting the device support to the more distal device modules is generated by storing the proximal end of the device support on a spool or reel at each cassette. In this embodiment, the support arm would not be required to provide a fixation point on the proximal end of the device support. Figure 17 shows a simplified top view of a device module with a device support stored on a spool according to an embodiment, and Figure 18 An exemplary winding tensioner according to an embodiment is shown. Figure 17In FIG, each device module 260 includes a spool or reel 262 upon which the device support can be wound. Figure 18 An exemplary winding tensioner is shown in FIG, which includes a reel 262 on which the flexible tube of the device support 264 is wound. The proximal end of the device support is fixed to the reel 262. The distal or "free" end of the device support can be pulled out by an operator, or automatically actuated by a robotic drive, and attached to a front fixing point on the distal box. Torque can be applied to the reel 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 shown) controlled by a motor (not shown). Figure 19 shows a simplified top view of a device module with a driven device support according to an embodiment, and Figure 20 An exemplary gear tensioner according to an embodiment is shown. Figure 19 , each device module 270 includes a drive mechanism 274 that interacts or engages with the 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 can engage the device support via friction on the wall of the flexible tube of the device support 272. In another embodiment, the device support can have radial holes along one side that are then engaged by a pin drive gear, also known as a tractor feed. In another embodiment, the device support is a ribbed or convoluted tube and the drive mechanism is a gear that engages and tensions the ribbed or convoluted tube. Figure 20 An exemplary gear tensioner 276 is shown in FIG. 2 , engaging a convoluted flexible tube 278 .

[0051] In another embodiment, the device support may be a telescoping joint or a spring. Figure 21 1 shows a simplified top view of a device module with a device support formed by telescopic joints or springs according to an embodiment. Figure 21 In FIG. 2 , the device support between the device modules 280 is formed by a telescoping joint element 286 and two linear guides 284 positioned parallel to each other on opposite sides of the telescoping joint element 286. The EMD 282 passes through each segment 294 (e.g., Figure 23 ) in the opening 292 (as shown) Figure 23(as shown). The telescoping joint-based device support is always taut. In one embodiment, the telescoping joint device support has built-in compliance that enables it to handle relative translational motion between the two device modules 280. Even though the telescoping joint member acts as a tension spring and is generally held taut, it may still deviate from the device axis when an axial load is applied. Figure 21 The linear guide (or guide rail) 284 shown in FIG2 constrains the telescoping 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 the more distal second device module, and the other end of the linear guide 284 is free to slide through the telescoping joint and the first device module. Embodiments with four telescoping joints to support four device modules can have offset telescoping joint linear guides so that the linear guides do not interfere with each other when the device modules are closed. Figure 22 The expansion joint element 286 is shown in a compressed state 288. For clarity, Figure 22 The linear guides are not shown. Figure 23 The telescoping joint element 286 is shown in a stretched state 280. For clarity, the linear guides are not shown. The telescoping joint element 286 includes a plurality of segments 294, each segment 294 including an opening 292 through which the EMD can be positioned. The number of segments 294 and the length of the segments 294 can be optimized so that the unsupported distance between the discrete segments 294 is such that the EMD will not buckle under the maximum load experienced during surgery. The telescoping joint device support has multiple flexures that automatically balance to give equal spacing regardless of the total tension so that a single gap across the length of the segment 294 will 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, which allows the telescoping joint element 286 to reach higher loads before buckling.

[0052] The profile of the device support formed by the flexible tube should support being opened and closed, 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 forced apart (for example, using a separator discussed further below), the device support can be advanced to encapsulate the EMD, and when closed, the EMD is sufficiently supported and retained so as not to pop out and buckle. Figures 24(a)-(c) are perspective views of exemplary slit shapes of device support flexible tubes according to embodiments. 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 can 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 can have a wavy slit 306 along the longitudinal direction of the tube that is similar to a sine wave. The slit of the device support 300 can be formed by a wedge or separator (in Figures 27-29 The wedge or separator is positioned near the entry point of the EMD into the device support (shown in Figure 1 and discussed further below). The wedge or separator expands the opening wide enough 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 retaining the EMD. Sawtooth shapes and sinusoidal shapes can be used to cause material overlap in the slit area to improve EMD retention in the device support.

[0053] The EMDs utilized in robotic actuators for interventional procedures can vary in size, for example, the various EMDs that can be used can vary from a 9 FR to a 2 FR, or even a .010" guidewire. For example, in a multi-axis robotic actuator configured for an endovascular procedure to treat acute ischemic stroke, it is contemplated that the first EMD in the device stack would be between 6 and 9 FR. The second and third EMDs in the device stack would be between 2.5 and 6 FR. The fourth EMD would be a wire-based EMD with a diameter between .010" and .038". In order to properly support and hold EMD devices of varying sizes, the stack may be configured to have a plurality of guidewires. In an embodiment, a different device support can be provided for each EMD, where the device support for each EMD is designed to work with an EMD of a corresponding size. For example, by minimizing the diametrical gap between the EMD and the device support tube, any device that buckles within the tube will store less energy and have less linear motion hysteresis. In an embodiment, the device support for each cassette can be designed to be modular so that the correct size device support can be added to the cassette based on the EMD supported by the cassette. Additionally, separators and device support connectors designed to work with specific sizes of EMDs (both of which will be referenced below) can be provided. Figures 27-29Further discussion) can also be modular and switched based on the specific size of the EMD supported by the box. In another embodiment, a different version of the box can be provided for each subset of device sizes, where the box has the appropriately sized device supports pre-installed. The appropriate box design for an EMD of a specific size or size range can be installed to the drive of the robotic drive and can be removed when a different design is required for an EMD of a different size or size range. For example, the box can be designed to support a range of sizes of wire-based EMDs that can vary between .010" and 0.38".

[0054] As above reference Figure 3 As discussed, the device module 32 of the robotic drive 24 includes a drive module 68 and a cartridge 66 mounted on and releasably coupled to the drive module 68 . Figure 25 is an exploded view of a device module and an elongated medical device according to an embodiment. Drive module 310 includes a mounting surface 312 and a coupler 314. A motor and drive belt (not shown) can be housed in drive module 310 and connected to coupler 314. The motor and belt are used to control the rotational position of coupler 314. Drive module 310 can include an encoder (not shown) for device position feedback. Figure 25 The drive module 310 is shown with one coupler 314, however, it should be understood that the drive module 310 can 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 an EMD positioned in a cassette 316, which can be mounted on the mounting surface 312 so as to interface with the coupler 314. For example, when an EMD 324 is positioned in the cassette 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.

[0055] As described above, the cartridge 316 can be positioned on the mounting surface 312 of the driver module 310 and used to interface with the EMD 324 positioned in the cartridge 316. The cartridge 316 includes a housing 318. In an embodiment, the cartridge housing 318 can be releasably attached to the driver module 310. The driver module 310 can also include one or more additional elements 313 on the mounting surface 312, such as, for example, locating pins, alignment pins, etc., to interact with elements on the cartridge 316 (e.g., connection points, slots, channels, etc.) to enable the cartridge 316 to be releasably attached to the driver module 310. In one embodiment, the cartridge housing 318 is releasably connected to the driver module 310 using a quick release mechanism 321. In one embodiment, the quick release mechanism 321 includes a spring-biased member in the cartridge housing 318 that is actuated by a latch release 323 that releasably engages a quick-release locking pin 315 secured to the driver module 1010.

[0056] The cartridge housing 318 includes a bracket 320 configured to receive an EMD 324. A bevel gear 322 is configured to interface with the coupler 314 of the drive module 310 and interface with the EMD 324 to rotate the EMD 324. In one embodiment, the EMD 324 is provided with an on-device adapter 326 (described below). Figures 42-44 ), to dock the EMD 324 to the box 316, such as to the bevel gear 322. Figure 25 In the example shown, the EMD is a guide wire, 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 box 316 (e.g., via the coupler 314), the gear 322 in the box interacts with the gear 327 on the chuck to rotate the guide wire 324. The device support 328 is positioned in the box and is located in the channel 342, which can be covered by the housing 318. As discussed above, the device support 328 and the box 316 are configured to move relative to each other. The device support 328 includes a connector 330 for connecting to the device module (e.g., other elements of the box, the device module, or elements positioned in the device module) on the far side (or in front of it) of the box 316 in the robot drive. The connector 330 includes a recess 332. In the withdrawn or retracted position, the connector 330 is positioned in the recess 336 in the housing 318 on the far end 334 of the box 316. As discussed above, the connector 330 and device support 328 can be pulled outward from the cartridge 316 so that the connector can be attached to a device module (e.g., a cartridge of a device module) further distal in the robotic drive. In one embodiment, a forward constraint 340 is provided on the proximal end 338 of the cartridge 316 and is used to connect to a connector of a device support on another cartridge proximal to (or behind) the cartridge 316 in the robotic drive. Figure 26a 316 is a perspective view of a cartridge with a device support mounted thereon and in a 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 cartridge 316. Figure 26b 3 is a perspective view of a cartridge with a device support installed and in a retracted position, according to an embodiment. Device support 328 is positioned in channel 342 of the cartridge. Cartridge 316 includes a proximal support member 331 positioned at a proximal end 338 of the cartridge 316. Proximal support member 331 includes an opening and is configured to provide support for device support 328. Device support 328 is positioned in and passes through opening 333. Opening 333 is sized so that the device support can move through opening 333 as device support 328 is advanced and retracted.

[0057] Figure 27 346 is a top view of the device support and connector extending from the box in front of the EMD entry point, according to an embodiment. The device support 328 and the connector 330 extend from a recess in the distal end 334 of the box housing. As the device support 328 moves in and out of the recess 336 and the channel 342, the guide 344 and the 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, which is 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 that the device support can be forced apart (e.g., by using a separator as described below) and closed to allow the device support to encapsulate the EMD as the device support is advanced. As shown in FIG. Figure 29 As shown, connector 330 holds the end of the device support tube open, allowing it to pass through separator 348. Figure 27 and 29346, when the connector 330 and the device support 328 pass through the separator 348 and the EMD entry point 346, the separator 348 holds the slit in the device support 328 open when the EMD 324 is encapsulated by the device support 328. The end of the device support tube 328 is positioned in the recess 332 of the connector 330. Using the separator 348 to hold the device support 328 open on both sides of the EMD entry point 346 reduces or eliminates friction on the EMD 324. For example, this prevents the walls of the device support 328 tube from rubbing against the EMD 324, which could damage the EMD 324 at the entry point 346 and introduce noise into a load sensing system (not shown) that can be used to read the force or torque applied to the EMD. The EMD 324 passes through the cavity 352 in the center of the separator 348. The connector 330 and separator 348 are designed to remain open when the device support 328 passes through the gap between the proximal and distal sections of the separator 348. The separator 348 is also designed so that the unsupported length of the EMD 324 at any point will not catastrophically buckle. The guide 344 is configured to guide the device support 328 across the gap and retain the device support 328 on the separator 348. As described above, the separator 348 can be designed for a specific EMD and device support size range. Figure 28 is a top view of the device support and connector retracted behind the EMD entry point according to an embodiment, and Figure 30 316, wherein the device support connector is withdrawn and away from the device axis to facilitate loading of the EMD. Figure 25 ), before loading the EMD 324, the device support 328 and connector 330 are retracted into the recess 336. Figure 28 and 30 As shown, the connector 330 can be retracted onto the separator 348 and the guide 344 and behind (or proximal to) the EMD entry point 346. In addition, the retracted (or withdrawn) position of the connector 330 is offset from the longitudinal EMD axis 350. This allows the EMD to be placed into the box 316, for example, to load a side-loaded EMD. Retracting the connector 330 behind the EMD entry point also reduces the unsupported EMD length and reduces working length loss.

[0058] As discussed above, the connector 330 and device support 328 can be pulled outward from the cartridge 316 so that the connector can be attached to a device module further distal in the robotic drive (e.g., a cartridge of a device module). Figure 25) can be provided on the proximal end 338 of the first cartridge and used to connect to a connector of a device support on a second cartridge proximal to (or behind) the first cartridge in the robotic drive. Figure 31 is a perspective view of a forward restraint and connector according to an embodiment. The forward restraint 340 includes a latch mechanism 354, such as a spring latch. The connector 330 of the device support 328 from the proximal box (not shown) is attached to the spring latch 354. In one embodiment, the connector 330 is connected to the latch mechanism 354 by pushing the connector 330 into the forward restraint 340. In an embodiment, the latch mechanism 354 may not require auxiliary movement other than axial translation to engage the latch mechanism 354, but one or more additional movements may be required to disengage the latch mechanism 354 and remove the connector from the forward restraint 340. For example, a release button, lever, or knob may be required before the connector 330 is disengaged. The connector 330 can be disengaged manually or using the control computing system 34 (such as Figure 2 The connector 330 is attached to the forward restraint 340 approximately along the longitudinal EMD axis 350 of the EMD (not shown) contained in the device support 328. This prevents shearing of the EMD by moving perpendicular to the latch mechanism 354. In another embodiment, a secondary latch or fastening mechanism can be provided to further secure the connector 330 and reduce play. Figure 32 is a perspective view of a forward restraint with a cover according to an embodiment. Figure 32 In the embodiment of the present invention, the cover 356 is connected to the forward restraint 340, for example using a pivot. The cover 356 can be closed and locked on the connector 330 to further restrain the connector 330 in the forward restraint 340.

[0059] As mentioned above Figure 4 As discussed, a distal support connector mounted to a distal support arm can be used to provide a front (or distal) attachment point to support the distal end of the device support in the cassette of the distal-most device module (i.e., the device module closest to the patient) in the robotic drive. Figure 333 is a perspective view of a distal support arm and distal support connector according to an embodiment. Cartridge 362 is mounted to drive module 364, which is connected to platform 366 using offset brackets 368. Platform 366 is movably mounted to a track or linear member 360 and can move linearly along track 360. Distal support arm 370 can be attached to a frame of a robotic actuator, such as the frame of track 360. In one embodiment, distal support arm 370 can be rigidly attached to the frame. In another embodiment, distal support arm 370 can be attached to a patient table or patient. Distal support arm 370 extends away from the robotic actuator and connects to device support connector 372 to provide a distal attachment point for the device support at the introduced sheath hub. In one embodiment, distal support arm 370 also serves to provide distal definition for cartridge 362 and drive module 364. Distal definition defines the distal-most aspect of the distal-most device of the robotic actuator (e.g., cartridge 362 and drive module 364). In another embodiment, distal restraint can be provided using a separate distal restraint arm (not shown) that can be coupled to, for example, the frame of a robotic actuator. The distal support connector 372 can also be coupled to the introducer sheath hub. The introducer interface support 376 can be connected to the device support connector 372. The connector 374, such as that described above with reference to FIG. Figures 27-30 The connector on the distal end of the device support may be attached to the device support connector 372 to provide a front (or distal) fixation 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 34 372 is a perspective view of a distal support connector coupled to a device support and a connector according to an embodiment. Device support 378 is shown as a dashed line enclosing EMD 379 and extending between cartridge 362 and device support connector 372. Connector 374 is attached to device support connector 372. Device support connector 372 may be, for example, the device support connector 372 previously described with reference to FIG. Figure 31 and 32 A device support connector 1072 is mounted to the distal support arm 370 and can be connected to the introducer hub support 376. Figure 35 FIG is a side view of a distal support arm, distal support connector, and introducer interface support according to an embodiment. The introducer interface support 376 is configured to support the device support 378 (e.g., Figure 34 ) and the EMD 379 between the introducer sheath 375 (as shown in FIG. Figure 34376, and the introducer sheath 375 is connected to the distal end of the introducer interface support 376, as discussed further below. The introducer interface support 376 ensures that the EMD 379 does not buckle or prolapse between the distal end of the device support 378 and the hub of the introducer sheath 375. In embodiments, the introducer interface support 376 can also be used to redirect the EMD from a position axially aligned with the robotic drive axis 365 to a position axially aligned with the introducer sheath 375 or other support member.

[0060] Introducer sheath 375 is inserted into the vascular system of patient at access point (for example femoral artery), and this will guide EMD to arrive the target site (for example lesion) in patient's body.Introducer sheath 375 should remain in proper position so that it can not come out from patient's body.In one embodiment, distal support arm 370 and device support connector 372 can be used for fixing the position of introducer sheath 375, and can react to the force on introducer sheath 375, and this force is produced by the friction between introducer sheath 375 and the EMD that moves in introducer sheath 375.In another embodiment, introducer sheath 375 can be supported by the structure separated from distal support arm 370 and device support connector 372, for example, introducer sheath 375 can be attached to patient or patient table using known method.

[0061] Figure 36 376 is a perspective view of the introducer interface support member connected to the introducer sheath according to an embodiment. The introducer interface support member 376 is connected to the device support connector 372 at its proximal end 380, and the device support connector 372 is connected to the distal support arm 370. The introducer sheath 375 is connected to the distal end 382 of the introducer interface support member 376. The introducer interface support member 376 can be configured to receive the introducer sheath 375 with a side port (not shown). The side port and its pipeline (not shown) can allow the administration of medicine, contrast agent or saline injection or the extraction of a blood sample. The EMD (not shown) enters the patient's body by the introducer sheath 375 inserted in the blood vessel (normally an artery). In one embodiment, the introducer interface support member 376 is opened to allow the EMD to be placed in the introducer interface support member 376. In another embodiment, the EMD can be axially inserted in the introducer interface support member 376. In another embodiment, the EMD and the introducer interface support 376 can be friction fit such that the introducer interface support 376 does not need to be opened or axially inserted into the EMD. As described above, the introducer interface support 376 can be configured to move the EMD from a position axially aligned with the robot drive axis 365 (e.g., Figure 35375) to a position axially aligned with the introducer sheath 375 or other support member. The introducer interface support 376 also provides support for the EMD over the distance between the connector 372 and the introducer sheath 375. The introducer interface support 376 can be rigid (e.g., Figure 36 For example, the introducer interface support 376 can be made of a flexible material, or the introducer interface support 376 can have a joint near the device support connector 372 that allows a limited range of motion of the distal end 382 (where the introducer sheath 375 is retained) to account for perturbations of the robotic drive or patient movement.

[0062] In another embodiment, the distal support arm 370 can be movably connected to the robotic actuator. The movable distal support arm 370 can have one or more degrees of freedom to account for excess exposed EMD length that may not need to be actuated. For example, with a shorter patient and / or a less tortuous patient, more of the first guide catheter may be exposed because it will never need to enter the patient. If the distal support arm (and therefore the device support connector 372) can be moved forward, it can account for excess length of guide catheter that does not need to be actuated. This can also help to reduce the length of the track or linear member 361 (and Figure 33 and 35 The total length of the track 360 shown. Figure 37 is a perspective view of a 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 39, distal support arm 370 is in a first position 394, wherein distal support connector 372 is located near the distal end of device module 392. Platform 390 can be moved along track 361 manually or automatically to change the position of distal support arm 370. Figure 38 is a perspective view of the movable distal support arm in a second position according to an embodiment. Figure 38 , the platform 390 and distal support arm 370 have been linearly moved from the device module 392 to a second, more distal position 396. Thus, the device support connector 372 and the device module 392 are separated by a distance 395. Figure 37 and 38 In the illustrated embodiment, distal support arm 370 has one degree of freedom. In another embodiment, distal support arm 370 can be an articulated arm or a driven arm with multiple degrees of freedom.

[0063] As discussed above, each end of the device support can be connected to a fixation point (front (or distal) and back (or proximal)) to provide appropriate tension to the device support between device modules or between the most distal device module and the device support connector to prevent EMD buckling. The device support connector 372 described above provides a front (or distal) fixation point for the device support of the most distal cartridge in the robotic driver. Using a support arm (e.g., Figure 4 In the embodiment of the present invention, the device support of the most distal box can be provided with a rear (or proximal) fixing point, such as the support arm 118 shown in FIG. 1 , the device support of the most distal box can be provided with a rear (or proximal) fixing point. For a movable distal support arm, the support arm will also be movable. Figure 39 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 4. In the embodiment of the present invention, the distal support arm 410 is in a first position 414. The device module 406 is connected to the track or linear member 400 using the first platform 402. The device support 408 is positioned in the device module 406 (e.g., in the device module's box), and the distal end of the device support 408 is connected to the device connection point 411 (front (or distal) fixation point) that is 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) fixation point 409. The second platform 403 is connected to the track 400 (or a different track in the system (not shown)) and can be moved along the track 400 manually or automatically to change the position of the distal support arm 410 and the support arm 412. Figure 40 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 , the second platform 403, distal support arm 410, and support arm 412 have moved linearly to a second position 416 further distal from the device module 406. The support arm 412 moves with the device support connector 411 so that there is always the same length of the device support 408 between the device support connector 411 and the rear fixation point 409. Figure 41 is a top view illustrating the distal support arm and the movement of the support arm from the second position to the first position according to an embodiment. Figure 41 4, the device support link 411, support arm 412, distal support arm 410, and second platform 403 begin at a second position 416 (indicated by a dashed line). The second platform 403 can be actuated to move linearly along the track 400 to a first position 414, as indicated by arrow 418. The first positions of the device support link, support arm, distal support arm, rear fixation point, and second platform are indicated by reference numerals 411', 412', 410', 409', and 403', respectively.

[0064] Figure 42 is a perspective view of a catheter with an adapter on a device according to an embodiment, and Figure 43 is a perspective view of a guidewire with an on-device adapter according to an embodiment. As used herein, an on-device adapter is a sterile device that can be releasably clamped to an EMD to provide a drive interface. Figure 42 In FIG, the catheter 420 includes a hemostatic valve or hub (e.g., a rotary hemostatic valve) 424 on the proximal end 426 of the catheter 420. The adapter 422 is positioned on the catheter 420 distal to the hemostatic valve 424 on the proximal end 426 of the catheter. Figure 42 In the embodiment of the present invention, 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 mate with the gear 322 of the cartridge (e.g., Figure 26a shown) interactions, such as Figure 26a 4. Box 316 shown. When power is transferred to the gear in the box from the device module (not shown) (for example, via a coupler), the gear in the box interacts with the gear 422 on the conduit 420 to rotate the conduit. In another embodiment, the rotation of the adapter 422 on the device can be configured to clamp / unclamp conduit 420. In an embodiment, the inner surface of the adapter 422 on the device is firmly attached to the standard Luer section of the elongated medical device (for example, conduit 420). In another embodiment, the inner surface of the adapter on the device is clamped to the lateral surface of the proximal end of the elongated medical device. In another embodiment, the adapter is attached to the cylindrical section (shaft) of the EMD on the device. In yet another embodiment, the adapter is not directly attached to the EMD on the device, but is attached to the EMD via an interface. Power can be transferred to the adapter on the device from the box in different ways, such as, for example, gears (as described above) or friction surfaces (for example, tires and rollers), belts, pneumatic or magnetic / electromagnetic coupling.

[0065] exist Figure 43 In FIG, a guidewire 430 is shown with an adapter 432 on the device. Figure 43 In an embodiment of the present invention, the adapter 432 on the device is a collet having a gear 434 on a proximal end 436 of the collet. The collet 432 is configured to grasp the guide wire 430. As used herein, the term collet is a device to which a portion of an EMD is releasably secured. In one embodiment, the collet 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 of the collet 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 26aWhen power is transmitted from the device module (not shown) to the gear in the box (e.g., via a coupler), the gear in the box interacts with the gear 434 on the guidewire 430 to rotate the guidewire 430. In another embodiment, the rotation of the adapter 432 on the device via the gear 436 can be configured to clamp / loosen the guidewire 430. Figure 44 As shown, the elongated medical device and the adapter on the device can be positioned in the box. Figure 44 4, a guidewire 430 and a collet 432 are positioned in a cradle 442 of a cartridge 440. The elongated medical device and the adapter on the device can be removed from one cartridge and moved to another unfilled cartridge. Figure 45 Guidewire 430 and collet 432 are shown with gear 434 removed from cartridge 440. When the cartridges are similar and an on-device adapter is used to dock an elongated medical device to the cartridge, the device and on-device adapter can be moved between unpopulated cartridges, thereby enabling the number of devices and the configuration of the robotic actuator to be changed.

[0066] Figure 46 4 is a top view of a box according to an embodiment. Box 450 has a distal end 452 and a proximal end 454 and is typically used to dock with an EMD such as a guidewire or catheter. The area between the distal end 452 and the proximal end 454 includes a bracket 456, an intermediate section 458, and an off-axis recess 460 that is positioned at an angle away from the longitudinal device axis 461 of the box. The intermediate section 458 and the off-axis recess 460 can be configured to receive an EMD adapter to dock the box with an EMD having an atypical proximal end, such as a balloon guide catheter (which includes an integrated y-shaped connector) or a rapid exchange device, such as a rapid exchange balloon. Figure 47 is an exploded view of an elongated medical device (EMD) adapter and cover according to an embodiment. Figure 47 The illustrated EMD adapter 462 is a quick-change EMD adapter. The EMD adapter includes a cap 464, a first section 466, and a second section 468. The first section is configured to receive a guidewire. The second section 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 section 468 is positioned at an angle to the longitudinal axis of the first section 466. The second section also includes a clip 472 for retaining the proximal end of the EMD 470. Figure 484 is a perspective view of an EMD adapter and an EMD installed in a box according to an embodiment. The first section 466 of the EMD adapter 462 is positioned in the bracket 456 and the middle section 458 of the box 450. The second section 468 of the EMD adapter 462 is positioned in the off-axis recess 460. A quick-change EMD 470 (e.g., a quick-change balloon) is positioned in the second section of the EMD adapter 462, and a clip 472 is used to clamp the proximal end of the EMD 470 into place. The first section 466 of the EMD adapter 462 can be used to receive a guide wire (not shown) from a proximal device module (not shown). The guide wire can pass through the box 450 and be driven by a more proximal device module. The EMD adapter 462 provides flexion support for the guide wire. In another embodiment, the EMD adapter can be configured to dock with a balloon guide catheter. For the balloon guide catheter, the EMD adapter can be configured to constrain the proximal end of the balloon guide catheter to perform linear motion, but does not allow the balloon guide catheter to rotate.

[0067] It may be expected that by using a load sensing system, the device module in the robot driver is used to measure the load applied to the EMD driven by the hub. In order to accurately sense the linear force on the EMD hub, the components to be sensed in the device module (for example EMD and EMD hub) should be isolated from external forces. When the device support is tightened, redirected by the box and separated, it gives force on the box. The connection of the connector of the device support and the forward constraint of another box also gives force. In an embodiment, the box of the device module can be configured to separate the part of the box supporting the EMD from the rest of the box to isolate the linear force on the EMD hub. Figure 495 is a top view of a cassette having a floating (or isolated) interface and a rigid support section according to an embodiment. The cassette 500 includes a floating (or isolated) interface (or component) 506 positioned within the cassette to provide support for an EMD 502 positioned within the floating interface 506. The remainder of the cassette 500 (e.g., the housing) forms a rigid support 508. The EMD 502 includes a rotational drive element 504 (e.g., an adapter on a device such as a gear) configured to interface with a drive mechanism (e.g., a bevel gear (not shown)) within the floating interface 506. The rotational drive element 504 is supported within a rotational drive element bracket 510 of the floating interface 506. The floating interface 506 floats relative to the rigid support 508 portion of the cassette 500. For example, the floating (or isolated) interface 506 can move 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 be isolated from loads other than the actual load acting on the EMD 502. The rigid support 508 reacts to forces such as, for example, forces from a device support connected to the cartridge. To reduce measurement noise of rotational forces, the bracket 510 supporting the rotating 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 can include, for example, Figure 52 The roller 534 is shown. For example, the roller 534 can be a sliding bearing or a rolling bearing.

[0068] Figure 50a FIG is an end cross-sectional view of a floating (or isolating) interface and a rigid support section of a cartridge according to an embodiment. The floating (or isolating) interface 506 positions a recess or opening 536 (e.g., Figure 50b 506a and 506b, and is separated from the rigid support member 508 by the first slot 514 and the second slot 515 and is restricted in 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 Floating interface 506 is loosely contained within recess 536 (e.g., Figure 50b The range of motion of the floating interface 506 allows the floating interface 506 to be mounted to a drive module (eg, Figure 25510 ) and, in particular, the load sensing portion of the drive module, while allowing for tolerances between the docking 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 captured 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 proximate to the first slot and a second protrusion 523 on the second side 520 of the rigid support 508 proximate to 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 in the recess 524 of the floating interface 506. The first protrusion 522 is loosely positioned over 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 member 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 can assist in the usability and setup of the robotic actuator. The contactless, frictionless interface between the floating interface 506 and the rigid support 508 is achieved by floating the floating interface 506 in the z-direction. When the floating interface 506 is mounted to a drive module (e.g., Figure 25 For example, the positioning pin 313 on the driving module 310 (in Figure 25 50 ). In one embodiment, the floating interface 506 is raised relative to the rigid support 508 to a height at which a contactless interface is achieved, as shown in FIG50 . In one embodiment, the height is 1 mm. In other embodiments, the height is less than 1 mm, and in other embodiments, the height is greater than 1 mm.

[0069] The bottom surface 516 of the floating (or isolated) interface 506 is configured to couple to a driver module. Figure 51 is a bottom view of a floating interface of a cartridge according to an embodiment. The bottom surface 516 of the floating (or isolating) interface 506 includes a connector 530 and a connection point 532. The connector 530 is used to receive a coupler (e.g., Figure 25 The coupler 314 shown in FIG. 3 is a schematic diagram of a coupling 532 configured to receive various types of connection members of the drive module. For example, the positioning pin 313 (e.g., Figure 25532) can be assembled into a series of holes and slots in the bottom surface 516 of the floating interface 506. The locating pins 313 can be used to constrain the floating interface 506 and the drive module in the X and Y directions. In an 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.

[0070] As described above, the floating (or isolated) interface 506 includes a first component 506a and a second component 506b. Figure 50b is an exploded isometric view of a cartridge according to an embodiment showing the first and second components of the floating (or isolated) interface. When the cartridge is in a use position secured to the driver module 310, the first component 506a is positioned along a line toward the driver module 310 (e.g., Figure 25 The first component 560a is placed in the recess 536 of the rigid support section (or cartridge housing) 508 of the cartridge in a direction (as shown). The second component 506b is placed in the recess 536 from a direction away from the driver module 310 toward the first component 560a. When the floating interface 506 is connected to the driver module, the floating (or isolated) interface 506 is positioned in at least one direction within the rigid support 508 and separated from the rigid support 508. The rigid support (or cartridge housing) 508 includes two longitudinally oriented rails 507 located in the recess 536. In an embodiment, the rails 507 act as protrusions 522 and 523 (see above). Figure 50a 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 25 310 is shown. Note that although the assembly orientation of the first and second components 506a, 506b of the floating interface 506 is described relative to the in-use position, the first and second components 506a, 506b of the floating interface 506 are mounted away from the driving 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 cartridge to the bottom surface of the cartridge, which is generally perpendicular to the longitudinal axis of the cartridge housing.

[0071] The first and second components 506a, 506b of the floating interface 506 are secured to one another. In one embodiment, a mechanical fastener or 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 and second components 506a, 506b may be secured together using, for example, magnets or an adhesive. The first and second components 506a, 506b may be releasably secured to one another or non-releasably secured to one another.

[0072] In the use position, the second part 506b of the floating interface 506 is releasably fixed to the drive module (eg, Figure 25 506a and the second component 506b are spaced apart from the track 507 of the rigid support 508 so that the first component 506a and the second component 506b are in a non-contacting relationship with the rigid support 508. In one embodiment, the box includes a box cover 505, which is pivotally coupled to the floating interface 506 by a hinge 503 and is separated from and does not contact the rigid support 508. For example, the cover 505 can be pivotally coupled to the first component 506a by the hinge 503. In another embodiment, the cover 505 can be connected to the first component 506a by other connection mechanisms (such as a snap fit).

[0073] Typically, an EMD in a cassette (e.g., a catheter) can be connected to various tubing via a side port connected to a hemostasis valve of the EMD, for example, to supply a saline drip, allow contrast injection, allow aspiration, etc. In a robotic drive that linearly manipulates the EMD, it would be advantageous to consider the tubing connections, particularly to provide a support assembly so that the tubing does not obstruct or pull on the hemostasis valve. Figure 53 A cassette with a support assembly for anchoring tubing and fluid connectors is illustrated, according to an embodiment. The support assembly for tubing and fluid connectors includes a flexible section of tubing 544, one end of which is attached to a side port 542 of a hemostatic valve positioned in a cassette 540. The second end of the flexible section of tubing 544 is attached to a clip 548 mounted on a support member 546. The support member 546 is connected to the cassette 540. The second end of the tubing 544 and the clip 548 can be configured to provide a connector (e.g., a female port) for attachment to tubing or other fluid connectors. The support assembly creates strain relief so that if the tubing 544 is pulled, the force will be reacted through the connection to the support member 546 rather than the hemostatic valve 542. In another embodiment, the strain relief tubing 544 can also terminate in a multi-port stopcock manifold, which would allow multiple tubing connectors to remain in place during surgery.

[0074] As described above, the profile of the device support formed from a flexible tube having longitudinal slits should support being opened and closed, for example, to allow an EMD to be loaded into the device support and retained in the device support so as not to pop out and buckle. Figure 54 is an end cross-sectional view of a device support according to an embodiment. Figure 54 In the embodiment, device support 550 includes a first (or inner) flexible tube 552 and a second (or outer) flexible tube 556. Inner tube 552 includes a longitudinal slit 554, an outer diameter 558, and an inner diameter 560. In an embodiment, inner tube 552 is a thin-walled tube to allow longitudinal slit 554 to be more easily opened and closed. Outer tube 556 includes an outer diameter 562 and an inner diameter 564. In addition, outer tube 556 includes a longitudinal opening defined by a first side 566 and a second side 568. Outer tube 556 is disposed around outer diameter 558 of inner tube 552. Outer tube 556 can be formed of a material that provides sufficient force to maintain slit 554 of inner tube 552 in a "closed" position, e.g., such that the sides of slit 554 touch and EMD 570 positioned in inner tube 552 is retained within inner tube 552. The material used to form outer tube 556 should also be configured to allow the slit of the inner tube to be forced open when a force is applied, such as from a separator. In an embodiment, the inner diameter 564 of the outer tube 556 is smaller than the outer diameter 558 of the inner tube 552 .

[0075] As described above, separators or wedges may be used to separate the longitudinal slits of the device support to allow the device support to encapsulate the EMD. Figure 55 is an end cross-sectional view of a device support and separator according to an embodiment. Figure 55 , 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 member 576 and a second arm member 578. In an embodiment, the inner tube 572 is a thin-walled tube to allow the longitudinal slit 582 to be more easily separated and closed. 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 the first side of the opening, and the second arm 578 contacts the second side 590 of the opening. The first arm 576 and the second arm 578 provide a surface that can travel over a separator (e.g., separator 584) as the device support 580 advances over the separator 584 to force the slit 582 of the inner tube 572 apart to enclose the EMD 586. As the device support 580 advances over the separator 584, the first arm 576 and the second arm 578 prevent the separator 584 from contacting (e.g., rubbing against) the EMD 586. Thus, the first arm 576 and the second arm 578 can reduce or eliminate frictional forces acting on the EMD 586 that could damage the EMD 586.

[0076] According to the above method, computer executable instructions for supporting and driving an elongated medical device in a catheter-based robotic surgical system can be stored on 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 memory technology, compact disk read-only memory (CD-ROM), digital versatile disk (DVD) or other optical storage, cassettes, magnetic tape, disk storage or other magnetic storage devices, or can be used to store the desired instructions and can be used by system 10 (such as Figure 1 any other medium accessible by means of the Internet or other computer network.

[0077] The control computing system described herein may include a processor having a processing circuit. The processor may include a central processing unit, an application-specific integrated circuit (ASIC), a circuit containing one or more processing components, a distributed processing component group, a distributed computer group configured for processing, etc., which is configured to provide the functions of the modules or subsystem components discussed herein. A storage unit (e.g., a memory device, a storage device, etc.) is a device for storing data and / or computer code to complete and / or facilitate the various processes described in this disclosure. The memory unit may include volatile memory and / or non-volatile memory. The memory unit may include a database component, an object code component, a script component, 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 device, past, present, or future, may be used with the system and method of the present disclosure. According to exemplary embodiments, the memory unit is communicatively connected to one or more associated processing circuits. The connection may be via a circuit or any other wired, wireless, or network connection and includes computer code for executing one or more processes described herein. A single memory unit may include various separate memory devices, chips, disks, and / or other storage structures or systems. The modules or subsystem components may be computer codes (eg, object codes, program codes, compiled codes, script codes, executable codes, or any combination thereof) for executing the corresponding functions of each module.

[0078] This written description uses examples to disclose the invention, including the best mode, and also to enable any person skilled in the art to make and use the invention. The patentable scope of the invention is defined by the claims and may include other examples that occur to those skilled in the art. Such other examples are intended to be within the scope of the claims if they have structural elements that do not differ from the literal language of the claims, or if they include equivalent structural elements with insubstantial differences from the literal language of the claims. The order and sequence of any process or method steps may be changed or reordered according to alternative embodiments.

[0079] Numerous other changes and modifications may be made to the present invention without departing from the spirit of the invention. The scope of these and other variations will become apparent from the appended claims.

Claims

1. A cartridge assembly for use with a robotic system for driving a plurality of elongated medical devices (EMDs), the cartridge assembly comprising: First box; Second box; The third box; and Box 4; a first device support having a proximal end and a distal end; a second device support having a proximal end and a distal end; a third device support having a proximal end and a distal end; a fourth device support having a proximal end and a distal end; each of the first, second, third, and fourth cartridges is configured to be attached to a corresponding drive module of a robotic system, and each of the first, second, third, and fourth cartridges comprises a housing and a channel, the housing having a proximal end, a distal end, and a cartridge longitudinal device axis; the fourth cartridge being positioned distally of the third cartridge, the third cartridge being positioned distally of the second cartridge, and the second cartridge being positioned distally of the first cartridge; the first device support having a portion positioned within the channel of the first cassette; the second device support having a portion positioned within the channel of the second cassette; the third device support having a portion positioned within the channel of the third cassette; and The fourth device support has a portion located within the channel of the fourth cassette.

2. The cartridge assembly according to claim 1, wherein: At least the first, second, and third device supports include a connector configured to attach to at least one of the cassettes.

3. The cartridge assembly according to claim 1, wherein: Each device support is configured to support an EMD.

4. The cartridge assembly of claim 1, further comprising four support arms, each support arm connected to one of the device supports.

5. The cartridge assembly according to claim 1, wherein: The first device support is capable of sliding within the channel of the first box, the second device support is capable of sliding within the channel of the second box, the third device support is capable of sliding within the channel of the third box, and the fourth device support is capable of sliding within the channel of the fourth box.

6. The cartridge assembly of claim 1, wherein the first cartridge, the second cartridge, the third cartridge, and the fourth cartridge each comprise a separator.

7. The cartridge assembly according to claim 1, wherein: Each of the first, second, third, and fourth cartridges is configured to be attached to a corresponding first, second, third, and fourth drive module of the robotic system.

8. The cartridge assembly according to claim 4, wherein: Each support arm includes a fixing point positioned above each respective cartridge, and each fixing point is configured to constrain a proximal end of each of the four device supports.

9. The cartridge assembly according to claim 6, wherein: Each separator is positioned at a distal end of each of the first, second, third, and fourth cartridges.

10. The cartridge assembly according to claim 2, wherein: Each cassette includes a forward restraint configured to attach to a connector of the device support.

11. The cartridge assembly according to claim 2, wherein: Each connector is configured to attach to a proximal end of a corresponding cassette.

12. The cartridge assembly according to claim 1, wherein: Each of the first box, the second box, the third box and the fourth box is configured to be attached to the corresponding first drive module, the second drive module, the third drive module and the fourth drive module of the robotic system when the first drive module, the second drive module, the third drive module and the fourth drive module of the robotic system are in a vertical orientation.

13. The cartridge assembly according to claim 1, wherein: Each of the first box, the second box, the third box and the fourth box is configured to be attached to the corresponding first drive module, the second drive module, the third drive module and the fourth drive module of the robotic system when the first drive module, the second drive module, the third drive module and the fourth drive module of the robotic system are in an orientation different from the vertical orientation.

14. A cartridge assembly for use with a robotic system for driving a plurality of elongated medical devices (EMDs), the cartridge assembly comprising: First box; Second box; a first device support having a proximal end and a distal end, the first device support configured to support the EMD; a second device support having a proximal end and a distal end, the second device support configured to support the EMD; Each of the first and second cartridges is configured to be attached to a corresponding drive module of a robotic system oriented in a non-vertical orientation, and each of the first and second cartridges includes a housing and a channel, the housing having a proximal end, a distal end, and a cartridge longitudinal device axis; the second cartridge being positioned distal to the first cartridge; the first device support having a portion positioned within the channel of the first cassette; as well as The second device support has a portion located within the channel of the second cassette.

15. The cartridge assembly according to claim 14, wherein: The first device support is configured to be attachable to the second cartridge.

16. The cartridge assembly of claim 14, further comprising a first support arm and a second support arm, wherein: The first cassette is coupled to the first support arm, and the second cassette is coupled to the second support arm.

17. The cartridge assembly according to claim 14, wherein: Each of the first and second cartridges includes a bracket configured to receive an elongated medical device along the cartridge longitudinal device axis.

18. The cartridge assembly according to claim 14, wherein: The channels of the first and second cartridges are angled relative to the cartridge longitudinal device axis.

19. The cartridge assembly of claim 14, further comprising a recess at the distal end of the first cartridge, wherein the recess has a portion substantially along the cartridge longitudinal device axis and a portion substantially along the channel.

20. The cartridge assembly of claim 14, further comprising a guide and a separator positioned in the recess on opposite sides of the path.

21. The cartridge assembly according to claim 14, wherein: The first device support and the second device support have longitudinal slits.

22. A cartridge assembly for use with a robotic system for driving a plurality of elongated medical devices (EMDs), the cartridge assembly comprising: First box; Second box; a first device support having a proximal end and a distal end, the first device support configured to support the EMD; a second device support having a proximal end and a distal end, the second device support configured to support the EMD; each of the first and second cartridges is configured to be attached to a corresponding drive module of a robotic system, and each of the first and second cartridges includes a channel; the second cartridge being positioned distal to the first cartridge; the first device support having a portion positioned within the channel of the first cassette; the second device support having a portion positioned within the channel of the second cassette, wherein the first device support is configured to move between a first position and a second position, Wherein in the first position, the proximal end of the first device support is located more proximally, and in the second position, the proximal end of the first device support is located more distally.

23. The cartridge assembly of claim 22, wherein: The first device support includes a connector, and in the second position, the connector is closer to the second cassette than in the first position.

24. The cartridge assembly of claim 22, wherein: The connector is coupled to the distal end of the first device support.

25. The cartridge assembly of claim 24, wherein: In the second position, the connector of the first device support is attached to the second cassette.

26. The cartridge assembly of claim 22, wherein: The first cartridge includes a recess at a distal end of the first cartridge.

27. The cartridge assembly of claim 26, wherein: The first position is a retracted position, and in the first position the connector is located in the recess.

28. The cartridge assembly of claim 26, further comprising: a separator positioned in the recess; and a guide positioned in the recess on an opposite side of the path of the device support from the separator.

Images