Gear assembly for a hemostatic valve

Abstract

The present invention relates to a gear assembly for a hemostatic valve. An apparatus includes an outer surface comprising a driven element to interface with a drive element of a robotic driver, and an inner surface comprising a feature fixedly coupled to a rotator of a rotary hemostatic valve, such that driving the driven element with the drive element causes movement of the rotator.

Description

Background Technology

[0001] Vascular diseases can be treated in various ways. For example, coronary artery bypass surgery can be used to treat cardiovascular diseases. Some vascular diseases can be treated with catheter-based interventional procedures, such as angioplasty. Catheter-based interventions are generally considered safer and less invasive than surgical procedures.

[0002] Catheter-based interventional procedures typically involve guiding a guidewire through the patient's vascular system and advancing catheters, valves, stents, etc., via the guidewire to deliver treatment. In one type of catheter-based intervention, a guiding catheter is inserted into the patient's femoral artery and positioned near the coronary ostium close to the patient's heart. The guiding catheter is connected distal to a hemostatic valve. A guidewire is inserted proximal to the hemostatic valve and into the guiding catheter, and is subsequently manipulated through the patient's arterial system until it reaches the lesion site. For example, a working catheter, including a balloon and stent, is moved along the guidewire until it is positioned close to the lesion. The working catheter is deployed / activated to increase blood flow near the lesion.

[0003] Robotic catheter systems provide robotic manipulation of catheters, guidewires, and other elongated medical devices (EMDs) during catheter-based interventional procedures. Typically, one or more elements are coupled to the EMD, and these elements are driven by one or more drive elements of a robotic actuator to impart the desired motion to the EMD. This motion can consist of rotation, linear translation, and / or any other type of movement.

[0004] A rotary hemostatic valve may include a rotary Luer connector to which a catheter or other EMD is typically attached. In one example, a gear (i.e., the driven element) is attached to the rotary Luer connector of the hemostatic valve, and a second Luer connector is linearly coupled to the gear. A catheter is attached to the second Luer connector, and a robotic actuator operates its drive element to drive the gear to rotate the catheter.

[0005] Adding this gear and second Luer connector, aligned with the hemostatic valve, reduces the available or working length of any EMD (such as a guidewire) that passes through the hemostatic valve during the interventional procedure. For a given EMD, the loss of working length is cumulative based on the number of hemostatic valves the EMD passes through. Some interventional procedures use up to three hemostatic valves in tandem, resulting in a working length loss for the closest EMD that is at least three times the longitudinal length of the gear. This reduced working length leads to a decreased ability to reach distal targets during the procedure. Furthermore, because the gear is a separate component from the hemostatic valve, there is a risk of the gear disengaging from the hemostatic valve in high-torque scenarios.

[0006] Some rotary hemostatic valves include a rotary Luer connector into which the gear is integrated. The gear and the rotary Luer connector are a single, inseparable unit. While this arrangement prevents the gear from disengaging from the valve and avoids increasing the overall length of the rotary hemostatic valve, it requires specialized tooling and manufacturing techniques. Furthermore, this type of rotary hemostatic valve is only compatible with robot actuators that have a drive element that correctly matches the integrated gear.

[0007] The desired system is one that facilitates robotic control of common rotary hemostatic valves while maintaining the working length of the EMD. Attached Figure Description

[0008] The embodiments will be more fully understood from the following detailed description, taken in conjunction with the accompanying drawings, wherein the reference numerals refer to the same parts, wherein: Figure 1 This is a perspective view of a catheter-based surgical system according to some embodiments; Figure 2 This is a schematic block diagram of a catheter-based surgical system according to some embodiments; Figure 3 This is a perspective view of the robot actuator according to an embodiment; Figures 4A-4C This is a perspective view of an existing rotary hemostatic valve according to some embodiments; Figure 5 The illustration shows the attachment of a first portion of the device according to some embodiments to a rotator of a rotary hemostatic valve; Figure 6 The illustration shows the attachment of the second part of the device according to some embodiments to the rotator of the rotary hemostatic valve; Figures 7A-7E This is a perspective view of a device for attaching a rotary hemostatic valve to a rotary hemostatic valve according to some embodiments; Figures 8A-8D This is a perspective view of the second part of a device including a driven element and a biasing protrusion according to some embodiments; Figures 9A-9D This is a perspective view of a first portion of a device including a flexible element defining an opening, according to some embodiments; Figure 10 This is a cross-sectional view of a rotary hemostatic valve according to some embodiments during connection with the device; Figure 11 This is a cross-sectional view of a rotary hemostatic valve according to some embodiments during connection with the device; Figure 12 This is a cross-sectional view of a rotary hemostatic valve and a device connected thereto, according to some embodiments; Figure 13 This is a perspective sectional view of a rotary hemostatic valve and a device connected thereto, according to some embodiments; Figure 14 This is a cross-sectional view of a rotary hemostatic valve and a device connected thereto, according to some embodiments; Figure 15 This is a cross-sectional view of a rotary hemostatic valve and a device connected thereto, according to some embodiments; Figure 16 This is a perspective view of a rotary hemostatic valve according to some embodiments before it is inserted into the housing of a robot actuator; Figure 17 This is a perspective view of a rotary hemostatic valve inserted into a housing of a robot actuator according to some embodiments; Figure 18 This is a perspective view of the housing of a robot actuator according to some embodiments after the rotary hemostatic valve has been inserted; Figure 19 This is a side view of a rotary hemostatic valve and a device connected thereto, according to some embodiments; Figure 20 It is a side view of an existing technology system; Figure 21 This is a side view of a robot actuator according to some embodiments, which includes a housing supporting a rotary hemostatic valve; and Figure 22 This is a side view of a robot actuator, which includes a housing supporting a conventional rotary hemostatic valve. Detailed Implementation

[0009] The following description is provided to enable any person skilled in the art to make and use the described embodiments. However, various modifications will be apparent to those skilled in the art.

[0010] Some embodiments include a device having: an outer surface including a driven element engaged with a drive element of a robot actuator; and an inner surface including a protruding feature fixedly coupled to a rotator of a rotary hemostat valve, such that driving the driven element with the drive element causes rotation of the rotary hemostat valve. Advantageously, some embodiments enable the rotary hemostat valve to be used by a robot actuator without increasing the effective length of the rotary hemostat valve.

[0011] In some embodiments, features on the inner surface of the device are fixedly coupled to protrusions of the rotator of the rotary hemostatic valve. These features enable torque transmission from the driven element of the device to the rotator. Compared to prior art systems, these features also tolerate higher torques, where the connections between the Luer joint and gear, and between the hemostatic valve and gear, are easily disengaged.

[0012] Some embodiments avoid the need for special tooling and / or manufacturing techniques to connect the driven element to the rotary hemostatic valve for use with a robot actuator. In a non-exhaustive example, the device includes a first part and a second part, each part including one or more features to securely connect the parts to each other when the features on the inner surface are fixedly engaged to a protrusion of the rotator.

[0013] As used herein, the term EMD refers to, but is not limited to, catheters (e.g., guiding catheters, microcatheters, balloon / stent catheters), wire-based devices (e.g., guidewires, microwires, proximal pushers for embolization coils, stent retrieval devices, self-expanding stents, flow shunts, etc.), and any combination thereof.

[0014] The terms “distal” and “proximal” define the relative positions of two distinct features. Relative to the robot actuator, the terms “distal” and “proximal” are defined by the position of the robot actuator relative to the patient in its intended use. When used to define relative positions, a distal feature is a feature of the robot actuator that is closer to the patient than a proximal feature when the robot actuator is in its intended use position. Within the patient, any vascular system landmark further away from the access point along the path is considered distal than a landmark closer to the access point, which is the point where the EMD enters the patient. Similarly, a proximal feature is a feature that is farther from the patient than a distal feature when the robot actuator is in its intended use position. When used to define orientation, a distal orientation refers to the path on which something moves or is intended to move, or the path along which something points or faces from the proximal feature toward the distal feature and / or the patient, when the robot actuator is in its intended use position. The proximal orientation is the opposite of the distal orientation.

[0015] The term "longitudinal axis" refers to the orientation between the proximal and distal portions. Axial movement refers to translation along the longitudinal axis. Rotational movement refers to rotation about the longitudinal axis, either clockwise or counterclockwise.

[0016] Figure 1This is a perspective view of a catheter-based surgical system 10 according to some embodiments. The catheter-based surgical system 10 can be used to perform catheter-based procedures, such as percutaneous interventional procedures (e.g., percutaneous coronary intervention for STEMI), peripheral vascular interventions (e.g., for emergency large vessel occlusion (ELVO)), and peripheral vascular interventions (e.g., for severe limb ischemia (CLI)). Catheter-based procedures may include diagnostic catheter insertion procedures, during which one or more catheters or other EMDs are used to aid in the diagnosis of the patient's condition. In some procedures, a contrast medium is injected through a catheter into one or more arteries, and images of the patient's vascular system are acquired while the contrast medium resides therein.

[0017] Catheter-based procedures may also include catheter-based therapeutic procedures (e.g., angioplasty, stent placement, treatment of peripheral vascular disease, clot removal, treatment of arteriovenous malformations, aneurysm treatment, etc.), during which a catheter (or other EMD) is used to treat the disease. For example, therapeutic procedures can be enhanced by including ancillary devices such as intravascular ultrasound (IVUS), optical coherence tomography (OCT), and fractional flow reserve (FFR). Certain specific percutaneous interventional devices or components (e.g., the type of guidewire, the type of catheter) 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 minor adjustments to accommodate the specific percutaneous interventional device to be used in the procedure.

[0018] Among other components, the catheter-based surgical system 10 includes a bedside unit 20 and a control station 26. The bedside unit 20 includes a robot actuator 24 and a positioning system 22 positioned adjacent to the patient table 18. The patient table 18 supports the patient 12.

[0019] Positioning system 22 is used to position and support robot actuator 24. For example, positioning system 22 may include a robotic arm, articulated arm, and retainer. For example, positioning system 22 may be attached at one end to a track, base, or trolley of patient table 18. The other end of positioning system 22 is attached to robot actuator 24. Positioning system 22 is movable (together with robot actuator 24) to allow patient 12 to be placed on patient table 18. Once patient 12 is positioned on patient table 18, positioning system 22 can be used to position or place robot actuator 24 relative to patient 12 for surgical procedures. In some embodiments, patient table 18 is operatively supported by a support 17 fixed to the floor and / or ground. Patient table 18 is capable of movement relative to support 17 in multiple degrees of freedom, such as tilt, pitch, and yaw.

[0020] Bedside unit 20 may also include controls and a display, as described below. For example, the controls and display may be located on the housing of robot actuator 24. Bedside unit 20, and in particular robot actuator 24, may include any number and / or combination of components to provide the functions described herein for bedside unit 20.

[0021] Typically, the robot actuator 24 may be equipped with percutaneous interventional devices and accessories suitable for a given procedure. Examples of percutaneous interventional devices include, but are not limited to, guidewires, catheters, microwires, microcatheters, and therapeutic devices (including embolization coils, stents, flow shunts, and stent retrieval devices). The robot actuator 24 is elongated along the longitudinal axis of the patient table 18.

[0022] The robot actuator 24 is configured as a mobile device module 32, which may include a drive module and a housing. The device module 32 may be arranged vertically or horizontally relative to the patient table 18. The device module 32 is configured to house and move a percutaneous device, including a hemostatic valve. In one embodiment, the housing is configured to house and drive the percutaneous device including the hemostatic valve. The percutaneous device may include an adapter for engaging with a housing element as described herein.

[0023] Operator 11 controls the robot actuator 24 to perform surgery by operating various control devices of control station 26. Bedside unit 20 communicates with control station 26, allowing signals generated by the control devices of control station 26 to be transmitted wirelessly or via wire to bedside unit 20 to control various functions of bedside unit 20, including the functions of robot actuator 24. Bedside unit 20 can also provide feedback signals (e.g., load, speed, operating status, warning signals, error codes, etc.) to control station 26, control computing system, or both.

[0024] Control station 26 may include, or be coupled to, a control computing system for bedside unit 20. Control station 26 includes input module 28, which includes control means configured according to some embodiments to receive user manipulation for controlling robot actuator 24 and / or various other components or systems of catheter-based surgical system 10. In the illustrated embodiment, control station 26 allows operator 11 to control bedside unit 20 to perform catheter-based medical procedures. Robot actuator 24 includes various actuation mechanisms to cause movement (e.g., linear and rotational movement) of components of bedside unit 20, including percutaneous interventional devices, in response to user manipulation of the control means of input module 28. For example, input module 28 may be configured to enable bedside unit 20 to perform various tasks using percutaneous interventional devices mounted in robot actuator 24. These tasks may include: advancing, retracting, or rotating guidewires; advancing, retracting, or rotating catheters; inflating or deflating balloons located on catheters; positioning and / or deploying stents; positioning and / or deploying stent retrieval devices; positioning and / or deploying coils; injecting contrast agents into catheters; injecting liquid embolic agents into catheters; injecting medications or saline into catheters; aspirating from catheters; or performing any other function that may be performed as part of a catheter-based medical procedure.

[0025] Input module 28 may include device selection buttons to allow operator 11 to select which percutaneous interventional devices are loaded into robot actuator 24 for user manipulation via input control. Automatic movement buttons may be used to enable algorithmic movement of the catheter-based surgical system 10 on percutaneous interventional devices without direct commands from operator 11.

[0026] Input module 28 may also include balloon or stent control devices configured to instruct balloon inflation or deflation and / or stent deployment. Input module 28 may include one or more buttons, scroll wheels, joysticks, touchscreens, etc., dedicated to instructing control of one or more specific components. Additionally, one or more touchscreens may display one or more icons (not shown) illustrating the relative positions of various components of input module 28 or catheter-based surgical system 10. Such one or more touchscreens may present a user interface for specifying and / or presenting the configuration of the control devices of input module 28 and one or more functions, including but not limited to linear and / or rotational locking functions.

[0027] Control station 26 may include displays 30. In some embodiments, control station 26 may include two or more displays 30. Displays 30 may be configured to display information or patient-specific data to an operator 11 located at control station 26. For example, displays 30 may be configured to display image data (e.g., X-ray images, MRI images, CT images, ultrasound images), hemodynamic data (e.g., blood pressure, heart rate), patient record information (e.g., medical history, age, weight), and lesion or treatment assessment data (e.g., IVUS, OCT, FFR). Additionally, displays 30 may be configured to display procedure-specific information (e.g., surgical examination forms, recommendations, procedure duration, catheter or guidewire position, amount of delivered medication or contrast agent). Displays 30 may include touchscreen capability to provide some user input capabilities for the system.

[0028] The catheter-based surgical system 10 also includes an imaging system 14. The imaging system 14 can be any medical imaging system (e.g., non-digital X-ray, digital X-ray, CT, MRI, ultrasound) that can be used in conjunction with catheter-based medical procedures. In one embodiment, the imaging system 14 is a digital X-ray imaging device that communicates with a control station 26. In one embodiment, the imaging system 14 may include a C-arm that allows the imaging system 14 to rotate partially or completely around the patient 12 to obtain images at different angular positions relative to the patient 12 (e.g., sagittal view, tail view, anterior-posterior view). The imaging system 14 may include a fluorescence fluoroscopy system comprising a C-arm having an X-ray source 13 and a detector 15, also referred to as an image intensifier.

[0029] Imaging system 14 may be configured to acquire X-ray images of appropriate areas of patient 12 during surgery. For example, imaging system 14 may be configured to acquire one or more X-ray images of the head to diagnose neurovascular conditions. Imaging system 14 may also be configured to take one or more X-ray images (e.g., real-time images) during catheter-based medical procedures to assist operator 11 of control station 26 in properly positioning guidewires, guiding catheters, microcatheters, stent retrieval devices, coils, stents, balloons, etc., during surgery. These one or more images may be displayed on display 30. For example, images may be displayed on display 30 to allow operator 11 to accurately move guiding catheters or guidewires into appropriate positions.

[0030] In some embodiments, the operator 11 and control station 26 are located in the same room or adjacent room as the patient 12 and bedside unit 20. In other embodiments, the control station 26 and bedside unit 20 are located remotely from each other, for example, in different rooms within the same building, in different buildings within the same city, in different cities, or in other different locations, where the operator at control station 26 cannot easily physically access bedside unit 20 and / or patient 12. In the latter embodiment, the operator 11 can communicate with personnel located near bedside unit 20 to perform any physical manipulation of the robot actuator 24 and / or EMD that may be required during surgery.

[0031] Figure 2 This is a block diagram of a catheter-based surgical system 10 according to some embodiments. Figure 2 The catheter-based surgical system 10 includes a control computing system 34. In various embodiments, the control computing system 34 is configured to receive and generate control signals based on user manipulation of the control device via the input module 28 of the control station 26 and / or based on information accessible to the control computing system 34, enabling the use of the catheter-based surgical system 10 to perform medical procedures.

[0032] The control computing system 34 may typically include a computer processing 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, a dedicated circuit, a general-purpose system programmed with the functions described herein, etc. Figure 1 Components of control station 26.

[0033] The control computing system 34 communicates with the bedside unit 20, the control station 26, the additional communication system 40 (e.g., a telepresence system), and the patient sensors 56 (e.g., an electrocardiogram (ECG) device, an electroencephalogram (EEG) device, a blood pressure monitor, a temperature monitor, a heart rate monitor, and a respiration monitor). The control computing system 34 also communicates with the imaging system 14, the patient table 18, the additional medical system 50, the contrast agent injection system 52, and the auxiliary devices 54 (e.g., IVUS, OCT, FFR). The bedside unit 20 includes the robot actuator 24 and the positioning system 22 as described above, and may include additional controls and a display 46. The additional controls and display 46 may be located on the housing of the robot actuator 24.

[0034] Interventional devices and accessories 48 (e.g., guidewires, catheters) are connected to bedside unit 20. In some embodiments, interventional devices and accessories 48 may include dedicated devices (e.g., EMDs, IVUS catheters, OCT catheters, FFR wires, diagnostic catheters for angiography, etc., including internal and external components as described herein), which are connected to their respective accessory devices 54 (i.e., IVUS systems, OCT systems, and FFR systems, etc.).

[0035] The catheter-based surgical system 10 may be connected to or configured to include any other systems and / or devices not explicitly shown. For example, the catheter-based surgical system 10 may include an image processing engine, a data storage and archiving system, an automated balloon and / or stent inflation system, a drug injection system, a drug tracking and / or recording system, a user log, an encryption system, a system for restricting access to or use of the catheter-based surgical system 10, etc.

[0036] As used herein, the term "box" generally refers to a component of a robot actuator that includes elements supporting and moving (e.g., rotating and / or translating) at least one EMD. A drive module generally refers to a component of a robot actuator that includes one or more motors having drive couplings that engage with the moving elements of the box's EMD. The box may provide a sterile interface between at least one EMD and the drive module, either directly or via a device adapter.

[0037] Figure 3 This is a perspective view of a robot actuator 24 according to some embodiments. The embodiments are not limited to... Figure 3 The robot actuator 24 includes a plurality of drive modules 206a-d coupled to the linear member 211. As will be discussed below, corresponding housings (not shown) may be mounted to each drive module 206a-d. In one embodiment, the housing coupled to the drive module is referred to as a device module. Each housing may be configured to house and drive a rotary hemostatic valve 100, with or without an adapter or device. During surgery, Figure 3 The drive modules 206a-d are vertically configured relative to the patient bed. Compared to other drive module configurations, this vertical orientation reduces the distance between the robot driver 24 and the patient, as well as the distance between the longitudinal axis of the robot driver 24 and the guide sleeve, thereby reducing the working length loss of all EMDs loaded into the drive modules 206a-d.

[0038] During surgery, the EMD can be loaded into one or more boxes. Each box may include an element that allows the EMD loaded therein to move with one or more degrees of freedom. Each drive module 206a-d includes at least one connector 209a-d for engaging with such an element in each box. Each drive module 206a-d also includes a motor (not shown) for rotating its corresponding connector 209a-d. Thus, rotating the connector 209a-d via the motor of its corresponding drive module 206a-d can cause the connector 209a-d to drive the mechanism mounted in its box, for example, to cause rotation of the EMD loaded in that box.

[0039] Each drive module 206a-d is coupled to the linear member 211 via a frame (or slider) 203a-d movably mounted to the track 204 of the linear member 211. The drive modules 206a-d can be connected to their frames 203a-d using connectors such as offset brackets 208a-d. In another embodiment, the drive modules 206a-d can be directly mounted to their frames 203a-d.

[0040] The robot actuator 24 may also include a device support connector 210 connected to a distal support arm 212. The distal support arm 212 extends away from the linear member 211 of the robot actuator 24 and may be attached to, for example, the frame of the robot actuator 24. The device support connector 210 and the distal support arm 212 are configured to provide a distal fixation point to support the distal end of a device support (not shown) mounted in a housing closest to the patient's drive module 206a. The device support connector 210 may also be coupled to a guide hub (not shown).

[0041] Each stage 203a-d can be independently actuated to move linearly along the track 204 of the linear member 211. Therefore, each stage 203a-d (and its corresponding drive module 206a-d) can move independently relative to each other and to the linear member 211. Each stage 203a-d is actuated using a drive mechanism. This drive mechanism includes independent stage translation motors 207a-d connected to each stage 203a-d and to the stage drive mechanism. For example, the stage drive mechanism may include one or more of a lead screw, rack, belt, and chain.

[0042] Figure 3 The test bench drive mechanism is a rack and pinion linear brake mechanism, which includes a rack 202 and a separate pinion for each test bench 203a-d. The teeth of each pinion (not shown) mesh with the teeth of the rack 202. To move the test benches 203a-d along the track 204, their pinions rotate in the appropriate direction to travel along the rack 202 and push their drive modules 206a-d in the direction of travel, while the rack 202 remains stationary.

[0043] To reduce the length of the linear member 211, offset brackets 208a-d can be configured to create an offset between the pedestals 203a-d and the drive modules 203a-d, thereby reducing the clearance size between the pedestals 203a-d on the linear member 211 when the drive modules are clustered together. The length of each drive module 208a-d (and its associated housing) limits the proximity of each pedestal to adjacent pedestals on the track 202.

[0044] Figures 4A-4C A perspective view of a rotary hemostatic valve 100 is illustrated. Devices according to some embodiments may be coupled to valve 100 to facilitate robotic control of an EMD coupled to valve 100. Valve 100 may include any known or becoming known rotary hemostatic valve. In some embodiments, valve 100 is an “off-the-shelf” valve that is generally available for use by various catheter-based interventional systems, including but not limited to manual catheter-based interventional systems (i.e., systems that do not use robotic actuators to manipulate the EMD). Embodiments may be implemented using any known or becoming known off-the-shelf hemostatic valve.

[0045] Valve 100 may include a polycarbonate body, but embodiments are not limited thereto. Valve 100 includes a proximal port 110 adjacent to a proximal end 112 and a distal port 120 adjacent to a distal end 122. Valve 100 defines a lumen extending between the proximal port 110 and the distal port 120 and having a longitudinal axis 125. This lumen is in fluid communication with the lumen of branch pipe 140 at valve portion 145 and is substantially perpendicular to the lumen of branch pipe 140. In other embodiments, branch pipe 140 may be disposed at other angles relative to branch pipe 140 and / or valve portion 145.

[0046] A controllable valve 114 is disposed within a proximal port 110. A valve actuator 130 is disposed at a proximal end 112 and is rotatable about an axis 125 to open and close the controllable valve 114. The valve 114 may comprise a material adapted to form a fluid-impermeable seal around an element (e.g., a guidewire) disposed in the proximal port 110 when closed. The controllable valve 114 may be controllable to gradually narrow or widen the opening within the proximal port 110. The controllable valve 114 may comprise any type of valve and may be actuated (i.e., opened and closed) using any suitable mechanism.

[0047] Valve 100 also includes a rotary Luer connector or rotator 150 at its distal end 122. Rotator 150 includes an outer surface 152 and an inner region 155 that presents a male Luer interface 158 to which the EMD can be releasably coupled. Luer connectors are known in the art for providing a fluid-impermeable connection between a catheter and a hemostatic valve. Luer connectors are covered by standards such as ISO 594 (including parts 594-1 and 594-2) and EN 1707.

[0048] Rotation of the rotator 150 causes rotation of the conduit connected to the Luer interface 158 about its longitudinal axis 125. This rotation can occur while the branch pipe 140 and the valve actuator 130 remain substantially stationary. The outer surface 152 of the rotator includes protrusions 154 that facilitate manual gripping and rotation of the rotator 150.

[0049] Figure 5 and Figure 6 The illustration shows the connection between a device and a rotator of a hemostatic valve according to some embodiments. The device includes a first portion 510 and a second portion 520, but the embodiments are not limited to a device consisting of only two portions. Portions 510 and 520 may be made of acetal, but are not limited to this material or a single material. In some embodiments, portions 510 and 520 are made of different materials.

[0050] Part 510 includes an outer surface 511 and a lower lip 512. The outer surface 511 may be generally curved relative to a horizontal plane and may follow the curvature of the outer surface 152. Part 510 includes notches 513a and 513b to provide flexibility to the locking part 514, the reason for which will become apparent. The locking part 514 defines an opening 515 for further providing flexibility to part 514, and for receiving a protrusion of part 520, as will be described below.

[0051] Part 520 has a generally cylindrical shape, corresponding to the curvature of the outer surface 152 and the generally cylindrical shape of the hemostatic valve 100. Part 520 includes an outer surface 524 and a gear 525. The teeth of the gear 525 may be integrally formed with, attached to, or otherwise coupled to the outer surface 524. As will be described below, the gear 525 is intended to engage with and be rotated by a drive element of a robot actuator. Embodiments are not limited to using a gear as a driven element or the shape, number, diameter, or arrangement of the gear teeth in the present figures.

[0052] like Figure 5 and Figure 6 As shown, portion 510 is placed on the rotator 150 of valve 100. In the illustrated embodiment, portion 510 is positioned between two protrusions 154 such that surfaces 516a and 516b of portion 510 ( Figure 5 and Figure 6 (Not shown) The inner (not shown) surface of the lower lip 512 contacts the side surface 153 and end surface 156 of the rotator 150 along their length.

[0053] To connect portion 520 to portion 510 and to rotator 150, portion 520 is moved from the distal end 122 of valve 100 toward the proximal end 112 onto rotator 150. This movement causes surfaces 521a and 521b to contact and slide along corresponding surfaces 516a and 516b. The inner surface 522 of portion 520 defines a channel 523 that receives and engages a protrusion 154 as portion 520 slides toward the proximal end 112. Embodiments may provide any other suitable features to engage with protrusion 154. According to some embodiments, in addition to or alternative to protrusion 154, the outer surface 152 of rotator 150 defines a recess / recess that engages with a protruding feature of the inner surface 522 when portion 520 is connected to portion 510. Once the inner flange 529 of part 520 contacts the stop 517 of part 510, the connection between part 520 and part 510 is completed.

[0054] Figures 7A-7D The diagram illustrates valve 100, to which a device comprising portions 510 and 520 is coupled. When portions 510 and 520 are coupled to valve 100, the device comprising portions 510 and 520 does not extend beyond the end of Luer connector 158. Advantageously, portions 510 and 520 allow valve 100 to be used by a robot actuator without increasing the effective length of valve 100.

[0055] Figures 7A-7D The following description of the system depicted in [the document] will also refer to [the document]. Figures 8A-8D The elements of portions 510 and 520 shown in 9A-9D. For example, channel 523 is fixedly coupled to (e.g., biased against) protrusion 154 of rotator 150, wherein channel end 523a is fixedly coupled to end of protrusion 154. The inner surface 518 of lower lip 512 is fixedly coupled to side surface 153 and end surface 156 of rotator 150. Surfaces 521a and 521b are also biased against surfaces 516a and 516b.

[0056] Part 520 includes a protrusion 530 extending from an inner surface 522. As described herein, the protrusion 530 is beveled to engage with the bevel 514a of the flexible part 514 during sliding of part 520 onto part 510. As sliding continues, when parts 510 and 520 are coupled to the rotator 150, the protrusion 530 enters and remains fixedly therein in the opening 515 of the flexible part, as... Figures 7A-7E As shown in the image.

[0057] Given the connections between the various surfaces and elements of the aforementioned portions 510 and 520 and with the surfaces and elements of the rotator 150, portions 510, 520, and the rotator 150 are fixedly connected to each other. When in this arrangement, the drive gear 525 will thus cause the rotator 150 to rotate about the axis 125.

[0058] Figure 10-12 This is a cross-sectional view of a rotary hemostatic valve according to some embodiments during the connection of a device to the rotary hemostatic valve. Figure 10 The first portion 510, as described above, is connected to the rotator 150, and the middle portion 520, which has slid approximately onto the rotator 150, is shown. Next, in Figure 11 In the middle, part 520 has slid further along the rotator 150, thereby biasing the protrusion 530 against the inclined surface 514a of the flexible part 514. As shown, this bias causes the flexible part 514 to bend away from the protrusion 530.

[0059] Finally, Figure 12 In the middle, part 520 has slid further until protrusion 530 has entered opening 515. Flexible part 514 is no longer as... Figure 11 The portion 530 is bent away from the protrusion 530. Instead, the protrusion 530 is fixedly residing within the opening 515. In some embodiments, the flexible portion 514 can be manually pressed down to release the protrusion 530 from the opening 515 and allow the portion 520 to slide away from the portion 510.

[0060] The embodiments are not limited to portions 510 and 520 or their aforementioned connections. The embodiments cover any system that connects the driven element to a rotary valve rotator. Such systems may utilize adhesives, friction, threads, or any other connection mechanism.

[0061] Figure 10-12 A cross-section of the thread 540 of the Luer connector 158 is also shown. Thread 540 can be used to facilitate the attachment of the EMD with the Luer connector to the valve 100. The embodiments are not limited to threaded Luer connectors.

[0062] Figure 13 This is a cross-sectional perspective view of valve 100, portion 510, and portion 520 according to some embodiments. The inner cavity 105 extends between the proximal port 110 and the distal port 120. Although the branch pipe 140 and its inner cavity are arranged perpendicular to the inner cavity 105, the embodiments are not limited thereto.

[0063] Figure 14 and Figure 15This is a cross-sectional view of portions 510 and 520 connected to a rotary hemostatic valve according to some embodiments. The channel 523 of portion 520 is fixedly connected to the protrusions 154a, 154b of the rotator 150.

[0064] The outer surface 524 of portion 520 includes a groove 526 defined by an inner lip 527 and an outer lip 528. As will be described below, elements of a robot actuator may engage with the groove 526, the inner lip 527 and the outer lip 528 to longitudinally bias (and thereby move) portion 520, portion 510 and valve 100.

[0065] The box can be installed into each drive module 206a-d of the robot drive 24. Figure 16 This is a view of a housing 220 according to some embodiments. Housing 220 includes features (not shown) that enable housing 220 to be mounted to a drive module of a robot actuator. Housing 220 includes a distal end 222, a bracket 223, a proximal end 224, and a longitudinal device axis 225. Housing 220 may include any configuration suitable for supporting the EMD and imparting linear and rotational motion to the EMD.

[0066] The bracket 223 is configured to receive EMDs, such as catheters, guidewires, stents, stent retrieval devices, microwires, microcatheters, etc. The bracket 223 extends longitudinally along the longitudinal device axis 225. The bracket may also receive clamps or similar device adapters. The bracket 223 may receive a rotary hemostatic valve and may include an actuation element 226 and a support member 227b. Mounting the housing 220 onto the drive modules 206a-d causes the drive element 226 to engage with the connectors 209a-d of the drive modules 206a-d. In some embodiments, the drive element 226 may include a bevel gear or a helical gear. The support member 227b has a surface perpendicular to or substantially perpendicular to the longitudinal axis of the device.

[0067] Support member 227a is configured as a groove 526 of receiving portion 520, and support member 227b is configured as a portion 135 of receiving valve 100. Cover 228 is shown in the open position and includes rib 229. Rib 229 is disposed in groove 526 when cover 228 is closed.

[0068] The housing 220 may also include at least one channel 221 in which device supports (not shown) are positioned, wherein each device support may be a flexible tube with longitudinal slits and is used to prevent EMD buckling. In one embodiment, the system includes a plurality of drive modules having at least one housing attached thereto. A portion of the device support is positioned within the channel of each housing, and a portion of the device support is capable of extending between the housings to support at least one EMD positioned within the device support. In one embodiment, the distal end of the device support may be connected to the proximal end of the housing.

[0069] Channel 221 may be angled, bent, or offset relative to the longitudinal device axis 225. As it moves into and out of channel 221, guide 235 and separator 236 may be positioned on opposite sides of the path of the device support. The connector keeps the ends of the device support open, thereby allowing it to pass over separator 236, which opens a slot in the device support and allows the device support to surround any EMD passing through bracket 223. Each device support is secured or constrained at both ends so that the device support can be kept taut and the amount of displacement that may buckle is limited.

[0070] Figure 17 The illustration shows valve 100 and portions 510 / 520 loaded into housing 220. Specifically, support 227a supports slot 526 of portion 520, and support 227b supports portion 135. When slot 526 is supported by support 227a and portion 135 is supported by support 227b, drive element 226 is positioned to engage gear 525. Therefore, operating the drive motors of drive modules 206a-d to which housing 220 is mounted causes rotation of corresponding connectors 209a-d, rotation of drive element 226 of housing 220, rotation of gear 525, rotation of rotator 150 of valve 100, and rotation of EMD that can be attached to Luer connector 158.

[0071] The dimensions of support 227a allow slot 526 to rotate slightly freely when support 227a supports slot 526. Conversely, the dimensions of support 227b allow portion 135 to be securely positioned (e.g., snapped into) within support 227b during rotation of rotator 150 or valve actuator 130 and during longitudinal movement of cartridge 220. In some embodiments, drive element 226 is positioned at a distance from distal end 222, which allows the operator to control valve 100 when it is in a certain position. Figure 17 When in the position depicted, attach the EMD to or remove it from the rotary Luer connector 158.

[0072] As described above, drive modules 206a-d are movable in the longitudinal direction. Movement of drive modules 206a-d, to which housing 220 is connected, in the distal direction along axis 225 biases the support member 227a and rib 229 against the surface 526a of portion 520, and biases the inner surface 518 of the lower lip 512 against the end surface 156 of the rotator 150, thereby causing the valve 100 and the EMD attached thereto to move in the distal direction. Furthermore, movement of drive modules 206a-d in the proximal direction along axis 225 biases the support member 227a and rib 229 against the surface 526b of portion 520, and biases the channel end 523a of portion 520 against the ends of ribs 154a and 154b of the rotator 150, thereby causing the valve 100 and the EMD attached thereto to move in the proximal direction.

[0073] During the procedure, the housing 220 can be moved proximally along axis 225 to retract the EMD attached to the Luer connector 158. This movement results in a force pulling portion 520 distally (via support 227a and rib 229 abutting the outer lip 528) and a force pulling portion 510 proximally (via end surface 156 of rotator 150 abutting the inner surface 518 of lower lip 512). The embodiment is able to withstand these opposing forces without separation of portion 510 from portion 520 by means of a locking mechanism of protrusion 530 and locking portion 514.

[0074] Figure 18 The cap 228 is shown in the closed position. When the cap 228 is closed, the branch pipe 140 remains exposed, allowing the connection of a pipe (not shown) to facilitate fluid (e.g., brine) flow back and forth between the valve 100 and the EMD attached thereto. The valve actuator 130 also remains exposed, allowing an operator to rotate the actuator 130 to open the valve 114, insert the EMD into the valve 114 and into the EMD (e.g., a conduit) attached to the Luer connector 158, and rotate the actuator 130 to close the valve 114 around the inserted EMD.

[0075] Figure 19 This is a side view of a rotary hemostatic valve 100 and a device connected thereto, according to some embodiments. Figure 20 This is a side view of a prior art system using the same rotary hemostatic valve 100.

[0076] Figure 20The system includes a gear assembly 2000 coupled to a rotary Luer connector 158 of valve 100. Gear assembly 2000 includes a gear 2010, a slot 2015, and a Luer connector 2020. Gear 2010 is intended to be driven by a drive element of a robot drive housing, thereby causing rotation of rotator 150. Slot 2015 is intended to engage with a support member of the housing, as described above with respect to slot 526. A conduit or other EMD is coupled to Luer connector 2020 during operation and rotates with rotator 150.

[0077] During operation, if the torque applied to gear 2010 is greater than the torque applied to the connection between gear 2010 and connector 158, the connection may disengage. Conversely, the connection between portion 520, including gear 525, and rotator 150 can tolerate significantly higher torques applied to gear 525 to transmit to rotator 150.

[0078] from Figure 20 The length L2 from the end to the proximal end 112 of the connector 2020 in the system is greater than that from the end to the proximal end 112. Figure 19 The length L1 from the distal end 122 to the proximal end 112 of the system. Therefore, for a given EMD, Figure 19 The system is more Figure 20 The system provides more EMD working length. Furthermore, it supports... Figure 20 The features of the system's 135 and slot 2015 box are definitely more than the support. Figure 19 The slots 526 and the housing features of the system 135 are further apart from each other, which potentially reduces the available space inside the housing for manually attaching the EMD to the Luer connector.

[0079] Figure 21 This is a side view of a robot actuator according to some embodiments, including housings 220a-d supporting rotary hemostatic valves. Each housing 220a-d includes the aforementioned system consisting of valve 100 and portions 510 / 520, and a corresponding EMD attached thereto. Embodiments are not limited to four housings or the use of valve 100 and portions 510 / 520 in each housing 220a-d. In some embodiments, valve 100 and portions 510 / 520 are present in fewer than all available housings.

[0080] Figure 22 This is a side view of the robot actuator, which includes its respective supports. Figure 20 The rotary hemostatic valve housings 230a-d. Each housing 230a-d is wider than each housing 220a-d to accommodate the distance between slot 2015 and portion 135. This increased width reduces the effective working length of the EMD loaded into the housing 230a-d.

Claims

1. An apparatus comprising: The outer surface includes a driven element for contact with the drive element of a robot actuator; as well as The inner surface includes a feature portion of a rotator fixedly connected to a rotary hemostatic valve, such that the driven element drives the driven element to cause movement of the rotator.

2. The apparatus according to claim 1, wherein, The motion includes the rotation of the rotator.

3. The apparatus according to claim 2, wherein, The motion includes the longitudinal movement of the rotator.

4. The apparatus according to claim 1, wherein, The motion includes the longitudinal movement of the rotator.

5. The apparatus according to claim 1, wherein, When the feature portion of the inner surface is fixedly connected to the rotator, the device does not extend beyond the end of the male Luer connector of the rotary hemostatic valve.

6. The apparatus according to claim 1, wherein, The device includes a first part and a second part, the first part and the second part including one or more features, such that the first part and the second part are fixedly connected when the features on the inner surface are fixedly connected to the rotator.

7. The apparatus according to claim 6, wherein, The first part includes the driven element and a first surface that contacts the first end of the rotator.

8. The apparatus according to claim 7, wherein, The first portion includes a second surface to engage with the end of a protrusion extending from the surface of the rotator.

9. The apparatus according to claim 6, wherein, The first portion includes a protrusion extending from the inner surface, and The second part includes a flexible portion that defines an opening, in which the protrusion is fixedly residing when the feature portion of the inner surface is fixedly connected to the rotator.

10. The apparatus according to claim 9, wherein, As the first portion slides on the second portion, the protrusion biases the flexible portion to bend away from the protrusion.

11. The apparatus according to claim 6, wherein, The first part includes a feature portion that is fixedly connected to the rotator.

12. The apparatus according to claim 1, wherein, The driven element includes a gear that rotates the rotator, and a feature that engages with the robot driver to longitudinally bias the device.

13. The apparatus of claim 1, comprising a first surface in contact with a first end of the rotator, and a second surface in contact with an end of a protrusion extending from the surface of the rotator.

14. An apparatus comprising: The outer surface includes a driven element for contact with the drive element of a robot actuator; as well as The inner surface includes a first feature portion for connection to a second feature portion of a rotator of a rotary hemostatic valve, such that the driven element drives the driven element to cause movement of the rotator. When the first feature of the inner surface is connected to the rotator, the device does not extend beyond the end of the male Luer connector of the rotary hemostatic valve.

15. The apparatus according to claim 14, wherein, The device includes a first part and a second part, each of the first part and the second part including one or more features to fix the first part and the second part together when the first feature on the inner surface is coupled to the second feature of the rotator.

16. The apparatus according to claim 15, wherein, The first part includes the driven element and a first surface that contacts the first end of the rotator, and The first portion includes a second surface for contacting the end of one of the second features of the rotator.

17. The apparatus according to claim 14, wherein, The first portion includes a protrusion extending from the inner surface, and The second part includes a flexible portion that defines an opening, in which the protrusion is fixedly residing when the first feature of the inner surface is attached to the second feature of the rotator.

18. The apparatus according to claim 17, wherein, As the first portion slides on the second portion, the protrusion biases the flexible portion to bend away from the protrusion.

19. A method comprising: Connect the first part of the device to the rotator of the rotary hemostatic valve; Connect the second part of the device to the first part and the rotator connected to the rotary hemostatic valve; as well as Insert the rotary hemostatic valve into the robot actuator to connect the driven element of the second part to the drive element of the robot actuator; as well as Operate the driving element to drive the driven element. The driven element causes the rotator to move.

20. The method according to claim 19, wherein, Connecting the second part of the device to the first part includes sliding the second part on the first part such that a protrusion extending from the second part is biased against a flexible portion of the first part until the protrusion is fixedly residing within an opening in the flexible portion.

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