Robotic control systems for cardiac diagnostic, therapeutic and imaging catheters

Abstract

A catheter body control system is provided that includes a first and a second robotic module and a manipulator device. The first robotic module is configured to couple with a guide catheter manipulator device to control advancement or angulation of the guide catheter within a heart chamber or to couple with a first control dial of a handle of a TEE probe to control advancement or angulation of a flexible shaft of a TEE probe within an esophagus. The second robotic module is configured to couple with a device catheter angulator to alter an angle of a tip of the device catheter within a heart chamber during a procedure or to couple with a second control dial of a handle of a TEE probe to control advancement or angulation of the flexible shaft of the TEE probe. The manipulator device is configured to advance a tip of the device catheter or TEE probe relative to anatomy of the patient.

Description

LAZA.037WO PATENT ROBOTIC CONTROL SYSTEMS FOR CARDIAC DIAGNOSTIC, THERAPEUTIC AND IMAGING CATHETERS CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of priority under 35 U.S.C. § 119(e) to U.S. Provisional Patent Application No. 63 / 615225, filed December 27, 2023, and U.S. Provisional Patent Application No. 63 / 637712, filed April 23, 2024. All of the above- mentioned applications are hereby incorporated by reference herein in their entireties. Any and all applications for which a foreign or domestic priority claim is identified in the Application Data Sheet as filed with the present application are hereby incorporated by reference under 37 CFR 1.57. BACKGROUND Technical Field

[0002] The present disclosure relates to systems for providing robotic control of catheter devices, such as structural heart therapy devices, including guide catheters, delivery catheters, imaging catheters for ICE, TEE, and intravascular imaging modalities, and systems for controlling the same. Description of the Related Art

[0003] Therapeutic, diagnostic, and imaging procedures that are performed on or used to image the heart are increasingly intricate and complex. Some of these procedures involve applying energy to tissue in and around the heart to alter electrical pathways, applying electrical energy to address arrhythmias, and implanting devices to improve heart function.

[0004] Innovators are developing additional novel cardiac therapies and implantable devices. Achieving a safe and effective implantable device is typically a very challenging task. Developing a delivery system that can traverse complex anatomic pathways adds a second degree of challenge to product development. Also, providing actionable imaging information of relevant anatomies in the course of a procedure requires great skill and coordination. An effective and safe implant will not gain wide adoption without a well- functioning delivery system. Adopting manual controls is one way to simplify the task of providing a functioning delivery system.

[0005] One implant in commercial use is the MitraClipTMdevice, a clip that provides transcatheter edge-to-edge repair (TEER). The clip is delivered through non-surgical access to the left atrium from the venous vasculature using a manual system. The manual system requires coordinate control of a guide catheter, a delivery catheter and a device that holds the clip. The system has three separate manually controlled devices for independently controlling these components of the delivery system. Manual control devices are also used to position catheter-based imaging systems. SUMMARY OF THE INVENTION

[0006] Cardiologists are familiar with manual manipulation of catheters. However, new technologies are requiring novel manual maneuvers to access and orient devices within heart chambers. Such maneuvers are requiring ever more complex controllers to be integrated into delivery systems. Manual operability of such controllers can expedite early clinical studies and can equip early adopters in advanced certain settings. Manual operability could be of use when more sophisticated systems are not available. Equipping such controllers to be operated under machine control would benefit patients by increasing the accuracy and precision of the performance of the procedure. Equipping such controllers to be operated under machine control would benefit less skilled clinicians by removing device specific skill and knowledge to successfully complete a procedure. Equipping such controllers to be operated under machine control would benefit the healthcare system by reducing the cost associated with training expert cardiologists on a new delivery system for every device they may wish to use. Providing for machine control of imaging probes would provide benefits to patients, clinicians and the healthcare system as discussed below.

[0007] In a first embodiment, a control system is provided that includes a first robotic controller and a second robotic controller. The first robotic controller is configured to couple with a first manual control element, such as a catheter manipulator which could be a knob, dial, slider, or the like. The second robotic controller module is configured to couple with a second manual control element, such as a catheter manipulator which could be a knob, dial, slider, or the like. One or both of the first and second manual control elements can act ona catheter, such as a guide catheter, device delivery catheter, and / or a component of an implantable device, and / or an end effector of the catheter.

[0008] In another embodiment, a catheter body control system is provided that includes a first robotic module, a second robotic module, and a manipulator device, e.g., an advancement device. The first robotic module and the second robotic modules are examples of robotic controllers. The first robotic module is configured to couple with a guide catheter manipulator to control advancement or angulation of the guide catheter within a heart chamber. The second robotic module is configured to couple with a device catheter angulator to alter an angle of a tip of the device catheter within a heart chamber during a procedure. The manipulator device is configured to advance the guide catheter or the tip of the device catheter toward cardiac anatomy.

[0009] In another embodiment, a method is provided in which a first robotic controller and a second robotic controller are used. The first robotic controller is coupled with a first manual control element, such as a catheter manipulator which could be a knob, dial, slider, or the like. The second robotic controller module is coupled with a second manual control element, such as a catheter manipulator which could be a knob, dial, slider, or the like. Thereafter, the first robotic controller receives an input to cause the first robotic controller to act on the first manual control element to cause the first manual control element to act on a catheter (e.g. a guide catheter, device delivery catheter) and / or a component of an implantable device, and / or an end effector of the catheter. Thereafter, the second robotic controller receives another input to cause the second robotic controller to act on the second manual control element to cause the second manual control element to act on the catheter (e.g. a guide catheter, device delivery catheter) and / or the component of an implantable device, and / or the end effector of the catheter.

[0010] In another embodiment, a method is provided. A cardiac interventional system is provided that comprises a catheter having a proximal end coupled with a manual manipulation system and a distal end having a therapeutic element. A robotic controller (e.g., a module) is coupled with a manual catheter manipulator to convert the control of a movement of or at the distal end of the catheter within a heart chamber from manual control to machine control. The catheter is advanced to engage the therapeutic element with cardiac anatomy.

[0011] In another embodiment, another method is provided. A cardiac interventional system is provided that has a catheter that has a distal end and a proximal end. The distal end has a therapeutic element. The proximal end has a first machine control component configured to control advancement and / or angulation of the distal end and a second machine control component. The second machine control component is configured to control a rotational orientation of the distal end. An input is received on a user interface to cause the first machine control component and / or the second machine control component to control advancement, angulation, and / or rotational orientation of the distal end of the catheter within a heart chamber. A signal is wirelessly transmitted to the first machine control component or to the second machine control component to facilitate a therapeutic procedure.

[0012] In another embodiment an ultrasound probe assembly is provided that includes a handle, a tip comprising an ultrasound element, a shaft, and a motor. The handle has a control dial. The shaft has a proximal end coupled with the handle and a distal end coupled with the tip. The has a control element having a proximal end coupled with the control dial and a distal end coupled with the tip. The motor is mounted on the handle. The motor has a transmission assembly coupled with an output shaft of the motor and with the control dial to apply torque to the control dial following movement of the motor.

[0013] A kit comprising a motor, a controller assembly, a housing, and a coupler. The motor has a transmission element configured to drive a control dial on a handle of an ultrasound probe. The motor is configured to be mounted on the handle. The controller assembly has a processor configured to drive the motor. The housing has a first mounting feature on a first end, a second mounting feature on a second end, and an enclosure disposed between the first end and the second end. The enclosure is configured to be disposed over the motor and over the controller assembly. The coupler is configured to slide over a distal end of the handle and over the second mounting feature to retain the housing over the motor and on the handle.

[0014] A TEE probe assembly comprising a manual TEE probe and a motor assembly. The manual TEE probe comprises a handle and an actuatable shaft. The handle includes a handle housing supporting one or more control dials configured to rotate about a rotational axis disposed transverse to the handle, a member having a protrusion at one end and an opposite end disposed on the rotational axis. The actuatable shaft includes a proximal endcoupled with the handle and a tip opposite the proximal end, the tip comprising an ultrasound element, the one or more control dials configured to actuate the actuatable shaft to deflect the tip. The motor assembly includes a motor housing enclosing one or more motors configured to apply a torque to the one or more control dials, the motor housing including a concave portion configured to be placed over the protrusion and to enclose at least a portion of a periphery of the protrusion.

[0015] A method of providing for robotic control of a TEE probe assembly. The method includes advancing a handle housing of a handle of the TEE probe assembly toward a motor assembly, the handle housing supporting one or more control dials configured to rotate about a rotational axis disposed transverse to the handle and a member having a protrusion at one end and an opposite end disposed on the rotational axis, the motor assembly comprising a motor housing enclosing one or more motors configured to apply a torque to the one or more control dials; placing a concave portion of the motor housing over the protrusion and to enclose at least a portion of a periphery of the protrusion; and securing the handle to the motor assembly.

[0016] A TEE probe assembly comprising a handle, an actuatable shaft, an actuator, a locking mechanism, and a securement mechanism. The actuatable shaft having a proximal end coupled with the handle and a distal end coupled with a tip. The tip comprises an ultrasound element. The actuator is operatively coupled to the actuatable shaft and configured to actuate the actuatable shaft. The locking mechanism is disposed on the handle and operatively coupled with the actuatable shaft. The locking mechanism is configured to selectively transition between a first state and a second state. The securement mechanism is configured to selectively engage the locking mechanism to prevent the locking mechanism from transitioning between the first state and the second state.

[0017] A method of converting a manual probe to robotic control. The method comprising placing a sheath around a handle, the sheath comprising one or more motors, coupling the one or more motors to a corresponding one of one or more control dials disposed on the handle, coupling a housing to the sheath for covering the one or more motors and the one or more control dials, securing a first mounting feature to a distal end of the sheath, and securing a second mounting feature to a proximal end of the sheath.BRIEF DESCRIPTION OF THE DRAWINGS

[0018] FIG. 1 is a schematic depiction of a catheter laboratory (“cath lab”) environment in which a cardiologist performs structural heart, electrophysiology and other cardiac procedures;

[0019] FIG. 2 is a perspective view of a mitral transcatheter edge-to-edge repair (TEER) system;

[0020] FIG. 3 is a schematic view of a robotic control system configured to adapt a manual control system configured for a TEER procedure to a machine or robotic control mode;

[0021] FIG. 4 is a flow chart illustrating a method of using the robotic control system of FIG.3;

[0022] FIG. 5 is a side view of a TEE probe assembly according to one embodiment;

[0023] FIG. 6 is a perspective view of a modified TEE probe handle of a probe system having one or more integrated motor controllers;

[0024] FIG.7 is a top perspective view of the modified TEE probe handle of FIG. 6 with a cover removed;

[0025] FIG.8 is a cross-sectional view of the TEE probe handle of FIG.6;

[0026] FIG. 9 is a partial assembly view showing a method of assembling an integration kit according to one embodiment; and

[0027] FIG. 10 is a top view of a portion of a TEE probe housing configured to facilitate connection to one embodiment of an integration kit.

[0028] FIG. 11 is a perspective view of another embodiment of a modified TEE probe handle of a probe system having one or more integrated motor controllers;

[0029] FIG. 12 is a side view of another embodiment of a modified TEE probe handle of a probe system having one or more integrated motor controllers;

[0030] FIG. 13 is a front perspective view of the modified TEE probe handle of FIG.11.

[0031] FIG. 14 is a front perspective view of the modified TEE probe handle of FIG.11.

[0032] FIG.15 is a perspective view of a TEE probe handle.

[0033] FIG. 16 is a flow chart of a method for converting a TEE probe handle to robotic or semi-robotic control.

[0034] FIG.17A is a view of a modified TEE probe handle without an enclosure.

[0035] FIGS.17B-17C are side views of a TEE probe handle being retrofitted with one or more motors.

[0036] Embodiments of the present disclosure and their advantages are best understood by referring to the detailed description that follows. It should be appreciated that like reference numerals are used to identify like elements illustrated in one or more of the figures, wherein showings therein are for purposes of illustrating embodiments of the present disclosure and not for purposes of limiting the same. DETAILED DESCRIPTION

[0037] While new therapeutic devices may be initially developed using manual delivery and / or manipulation devices, such devices are not able to be quickly adopted by a full range of clinicians as quickly as would be systems that incorporate at least some degree of machine control. Manual systems also suffer from lower precision and / or accuracy and from more user-to-user variability. As a first example, in a conventional TEER procedure, a control system is provided that relies upon manual manipulation, e.g., manual movement of a number of dials and actuators. A subset of these dials and actuators allows for degrees of freedom of movement of a guide catheter. Another subset of these dials and actuators allows for degrees of freedom of movement of a TEER device deliver catheter. A further structure of the manual control system allows for degrees of freedom of and articulation of the TEER device. As a second example discussed further below a conventional transesophageal echocardiogram (TEE) probe can be modified to provide machine control to one or a plurality of degrees of freedom of operation.

[0038] Some advances disclosed herein enables one or more of the subsets of dials and actuators to be converted to machine control. Variations disclosed herein would enable all dials and actuators to be converted to machine control. In one implementation, a systemwith a user interface enables a cardiologist to perform a structural heart procedure, such as a TEER procedure or a left atrial appendage (LAA) closure procedure, or an electrophysiology procedure by interacting with the user interface device. In one implementation, a system with a user interface enables a cardiologist to perform an imaging procedure, such as a TEE procedure, an intracardiac echocardiography (ICE) procedure or an intravascular imaging procedure by interacting with the user interface device. The cardiologist can direct the performance of one or more, e.g., all, steps of a procedure from the user interface. The advances disclosed herein enable the coordinate control of one or more robotic systems that can work independently in some phases and that can work in unison in other phases of the procedure to facilitate a therapy.

[0039] The disclosed technology will now be described in more detail.

[0040] FIG. 1 shows a typical catheter lab or cath lab 100 within which advanced cardiac therapeutic procedures can be performed. One such procedure is a TEER procedure. However, the cath lab 100 is a versatile environment in which many different procedures can be performed. Other procedures that can be performed in the cath lab 100 include LAA procedures, heart valve replacement or repair procedures, and electrophysiology procedures. To facilitate complex procedures, the cath lab 100 typically includes a C-arm for x-ray imaging, a console for obtaining a transesophageal echocardiogram (TEE) from a TEE probe. The TEE probe is typically controlled by one cardiologist, known as a sonographer, while the interventional procedure equipment is controlled by another cardiologist. However, as discussed further below a TEE imaging procedure can be streamlined by adapting a TEE probe for machine control of one or more degrees of freedom. The cardiologist controlling the interventional procedure equipment is typically restricted in position to where the device is inserted into the patient, e.g., adjacent to the femoral vein, because the manual control system is positioned close to this location. An anesthesiologist and other support medical professionals are typically also in the cath lab 100 to support the procedure. Needless to say, with all these highly trained personnel involved, the procedure requires a great degree of coordination. It would be an improvement to enable the cardiologist controlling the interventional procedure equipment to be able to be positioned elsewhere in the cath lab 100 and / or to be able to move around during the procedure.

[0041] FIG. 2 shows a TEER delivery system 200 and an approach to modify the system 200 according to the present disclosure. The TEER delivery system 200 includes a TEER device 204 and a manual system 208. The TEER device 204 is a clip device, which may be similar to the MitraClipTMdevice. The TEER device 204 can have arms that engage each of the leaflets of the mitral valve of a patient. In one approach, it is desired that the TEER device 204 be placed toward the center of the line of coaptation of the mitral valve, thus creating two smaller apertures between the clip and each end of the line of coaptation. The intent is to improve the closure of the valve and to reduce backflow during ventricular systole.

[0042] The manual system 208 includes a TEER device catheter 212 that is disposed through a guide catheter system 216. The guide catheter system 216 includes a guide catheter body 220 with a deflection zone 224 toward a distal end thereof and a proximal section 228. A length between the deflection zone 224 and the distal end is bendable relative to the proximal section 228 so that the opening at the distal end can be oriented or aimed in a selected direction. The orienting of the opening is achieved by a guide catheter manipulator 232. The guide catheter manipulator 232 is an example of a manipulator device. The guide catheter manipulator 232 is a first manipulator of the manual system 208. The guide catheter manipulator 232 can be a distal-most of a plurality of manipulators.

[0043] A device catheter angulator 236 can be a second manipulator disposed proximal of the guide catheter manipulator 232. The device catheter angulator 236 is an example of a manipulator device. The guide catheter manipulator 232 is an example of a manipulator device. The device catheter angulator 236 can change the angle of the TEER device catheter 212 in one or more degrees of freedom. The device catheter angulator 236 can have a first deflector 248 that can bend the TEER device catheter 212 in an anterior or posterior direction. The device catheter angulator 236 can have a second deflector 252 that can bend the TEER device catheter 212 in a medial or lateral direction.

[0044] The manual system 208 can also include a TEER device manipulator 240 is an example of a manipulator device that can enable the location or rotational orientation of the TEER device 204 to be selectively adjusted. The TEER device manipulator 240 can enable the TEER device 204 to be advanced distally and retracted proximally along an axis extending through the opening of the guide catheter body 220 and / or along the longitudinal axis of the catheter body holding the TEER device 204 prior to deployment. Proximal and distalmovement of the TEER device 204 can be achieved by proximal and distal movement of the TEER device manipulator 240. A rotational position of the TEER device 204 can be achieved by applying a torque to the TEER device manipulator 240. The manipulators of the manual system 208 can be supported by a bracket that is mounted or is mountable to a table, e.g., to the patient procedural table or to a separate table nearby.

[0045] FIG. 2 shows that the TEER delivery system 200 can be augmented by providing one or more robotic modules that can engage the manipulators of the manual system 208. For example, a first manipulator adaptor 260 can be coupled with a manual adjuster, such as a guide catheter dial 244. The first manipulator adaptor 260 can be part of a first robotic module 312 (see FIG. 3) configured to provide machine control of the guide catheter manipulator 232. The first robotic module 312 can include or can be coupled to the processor, motor or other force generator, and / or the manipulator adaptor.

[0046] The first manipulator adaptor 260 can include a roller that would apply a controlled torque to a surface of the guide catheter dial 244. The first manipulator adaptor 260 can apply a rolling contact and a frictional engagement with a peripheral surface of the guide catheter dial 244. The first manipulator adaptor 260 can be advanced over a projection of the guide catheter dial 244 such that a temporary inserted configuration is provided whereby a torque can be applied between overlapping surfaces. In addition to having one of these or another dial interface element, the first manipulator adaptor 260 can comprise a motor or other force generator configured to generate torque or rotational or other movement to the interface element. The motor or other force generator can be connected to a controller or processor that can drive the motor or other force generator to achieve a selected position or angulation of the distal portion of the guide catheter body 220.

[0047] A second manipulator adaptor 264 can be coupled with a first deflector 248 and a third manipulator adaptor 268 can be coupled with a second deflector 252 of the manual system 208. The second manipulator adaptor 264 can engage the first deflector 248 in the same manner as the first manipulator adaptor 260 engages the guide catheter dial 244. That is, the second manipulator adaptor 264 can include a manipulator adaptor that can apply a torque to a peripheral surface through rolling contact, overlapping surfaces or otherwise to the first deflector 248. The third manipulator adaptor 268 can include a manipulator adaptor that can apply a torque to a peripheral surface through rolling contact, overlapping surfaces orotherwise to the second deflector 252. The second manipulator adaptor 264 and the third manipulator adaptor 268 can be coupled with motors or other force generators and with a controller or processor to provide selective control of the first deflector 248 or the second deflector 252. The second manipulator adaptor 264 can be coupled to a second robotic module 316 of the robot controller 308. The second robotic module 316 can include or can be coupled to the processor, motor or other force generator, and / or the manipulator adaptor of the second manipulator adaptor 264. The third manipulator adaptor 268 can be coupled to the second robotic module 316. In one variation, the third manipulator adaptor 268 is connected to a robotic module that is separate from the second robotic module 316, e.g., can be applied separately to the TEER delivery system 200 or not at all. If a separate robotic module is provided, the separate robotic module can include or can be coupled to the processor, motor or other force generator, and / or the manipulator adaptor of the third manipulator adaptor 268.

[0048] FIG. 2 shows that a further improvement can be provided by coupling the manual system 208 with one or more actuators, e.g., an actuator 272A and an actuator 272B. The actuators 272A, 272B can be rotated in opposite directions (as indicated by the curved arrows) to generate proximal and distal motion of the TEER device 204. In one further variation not shown, a second set of actuators can act directly on the TEER device manipulator 240 to rotate it about an axis aligned with the longitudinal axis of the device delivery catheter. The actuator 272A, the actuator 272B and (if provided) these additional actuators can provide machine control of the TEER device manipulator 240. A third robotic module 320 can be coupled with one or both of the actuator 272A and the actuator 272B. The third robotic module 320 can include or can be coupled to the processor, motor, or other force generator, and / or the actuator 272A and / or the actuator 272B. An additional or nthrobotic module 324 can be coupled with additional actuators if they are provided, e.g., for rotational position control.

[0049] Further actuators can be provided to articulate movable members of the TEER device 204, e.g., to deflect one or more arms thereof.

[0050] FIG. 3 shows a robotic control system 300 that can be used to convert a manual actuated delivery system such as the TEER delivery system 200 to a machine or robotic controlled system. The robotic control system 300 can include a user interface 304 and a robot controller 308. The user interface 304 can include any suitable user interface that allows a cardiologist to provide input to commence one or more steps of a procedure. The user interface304 can be a touchscreen interface or another user interface device, e.g., one accepting spoken instructions or manual inputs or such as clicking a button. The robot controller 308 can include one or a plurality of robotic modules to drive control elements. The robot controller 308 can be configured as a monolithic unit with a plurality of modules or can include a plurality of separately mounted modules that can be applied to all or a subset of control elements of the TEER delivery system 200 (or other similar system). Dotted line between modules and control elements show that the robotic control system 300 can be applied to the TEER delivery system 200 after shipment, e.g., in the cath lab 100 just prior to or during the procedure.

[0051] The robotic control system 300 can include a first robotic module 312 that is configured to engage a first control element. The first robotic module 312 can engage the guide catheter manipulator 232 as an example of a first control element. The first robotic module 312 can include a clamshell housing or other clamp or snap-on arrangement that provides secure mechanical engagement of the first manipulator adaptor 260 with the guide catheter dial 244. The clamshell housing, clamp on or snap-on arrangement can be configured to be removably coupled to a housing within which the guide catheter manipulator 232 is enclosed to enable the manual system 208 to be converted into a machine control system. The robotic control system 300 can include a second robotic module 316 and a third robotic module 320. The second robotic module 316 can include a clamshell housing or other clamp or snap- on arrangement that provides secure mechanical engagement of the second manipulator adaptor 264 with the first deflector 248. The second robotic module 316 can include a clamshell housing or other clamp or snap-on arrangement that provides secure mechanical engagement of the third manipulator adaptor 268 with the second deflector 252. The second robotic module 316 can be applied in the same step where the first robotic module 312 is applied or can be applied separately. If a separate robotic module is provided for the third manipulator adaptor 268, the separate robotic module can be applied along with the first robotic module 312 or the second robotic module 316 or can be applied separately from one or both of these modules.

[0052] The robotic control system 300 can include a third robotic module 320 that can be coupled to a third control element, e.g., to the TEER device manipulator 240. The third robotic module 320 can include a clamshell housing or other clamp or snap-on arrangement that provides secure mechanical engagement of the actuator 272A and actuator 272B with theTEER device manipulator 240. The robot controller 308 can cause the manual system 208 to provide linear actuation of the device catheter by operation of the actuator 272A and the actuator 272B. In one variation a fourth robotic module is provided that engages the TEER device manipulator 240 to provide rotational motion thereof. The robotic module 324 can be a fourth module and can be coupled with the TEER device manipulator 240 to provide such rotational control, similar to the controls described above. There can be more than four robotic modules, such that the robotic module 324 is an “nth” module.

[0053] FIG. 3 shows that the robotic control system 300 can be coupled with the TEER delivery system 200 such that manipulation of the TEER device 204 is achieved with inputs to the user interface 304. The modules are coupled with control elements of the manual system 208. Actuation of the modules causes the control elements of the manual system 208 to be moved, which results in a change in position and / or orientation of the TEER device 204.

[0054] In one variation, the robot controller 308 comprises software on a computer that is connected to the user interface 304. The modules, i.e., the first robotic module 312, the second robotic module 316, the third robotic module 320, and the nth robotic module 324 are separate units that are separately connected to functionally distinct parts of a manual procedure system, e.g., a manual device delivery system such as the manual system 208 for the TEER device 204. The computer operating the robot controller 308 can be in wireless control with the modules 312, 316, 320, 324. The robot controller 308 can provide for coordinate motion of the modules 312, 316, 320, 324 such that the control dials and actuators that these modules cause to move may be moved sequentially during at least some parts of the procedure, such that one motion by one module is completed before a motion by another module is commenced. The robot controller 308 can provide for coordinate motion of the modules 312, 316, 320, 324 such that the control dials and actuators that these modules cause to move may be moved simultaneously during at least some parts of the procedure. The robot controller 308 can also support an arrangement where one or more aspects of control of the manual system 208 can be performed manually while one or more aspects is controlled using a robotic module.

[0055] The techniques described herein enable an adaptability for different delivery systems, such as the TEER delivery system 200. For example, one or more of the user interface 304, robot controller 308, device controller 208, and so on, may communicateaccording to discrete protocols (e.g., different layers). Example description of such layers follows.

[0056] In the illustrated embodiment, a user interface 304 may be used to present information and respond to user input associated with control of a procedure. The user input may be translated into communication information (e.g., commands or messages) interpretable by the robot controller 308, such that the robot controller 308 may cause adjustments, or other control, of the device controller 208.

[0057] In some embodiments, the user interface 304 may be presented via an application or software associated with a particular protocol. For example, different applications or software (applications) may be used which follow the particular protocol. In this example, the different applications may represent different front-ends which are usable by medical professionals to implement the techniques described herein. Each of the applications may provide messages or commands downstream to the robot controller 308 according to the particular protocol. For example, the user interface 304 may be analogous to an application- layer protocol. As an example, a medical professional may provide user input associated with adjusting the TEER device 204. This user input may be interpreted, for example according to the particular protocol, into one or more commands or messages which are provided downstream to the robot controller 308. Advantageously, the user input may be arbitrarily complex. For example, the medical professional may provide user input to cause arbitrary complex movement or actions of the device 204. The particular protocol may convert this into a form interpretable by the robot controller 308. Thus, different applications may allow for customized user experiences while enabling control of a TEER delivery system.

[0058] Similarly, the robot controller 308 may respond to communications via the above-described application-layer protocol. In some embodiments, the robot controller 308 may implement the user input provided by the medical professional to the user interface 304. For example, the user input may indicate that the TEER device 204 is to perform a series of adjustments in position, rotation, and so on. The robot controller 308 may receive this information and determine adjustments to controller 208 to effectuate the series of adjustments.

[0059] In some embodiments, capabilities of the TEER delivery system 200 may be identified. For example, the robot controller 308 may ascertain how finely it can control the system 200 or the types of adjustments it can make. For example, the TEER deliverysystem 200 may be associated with metadata or other information which informs the capabilities. As another example, the robot control system 300 may perform one or more tests of the system 200 to determine the capabilities. This information may be used to interpret the communications received from the user interface 304. Additionally, the information may be provided to the user interface 304 such that the medical professional, or application presenting the user interface 304, can determine any constraints associated with the user input.

[0060] While use of an application-layer protocol is described above, as may be appreciated other protocols may be used and fall within the scope of the present disclosure. For example, the robot controller 308 may communicate with the robotic modules 312-324 via a different protocol. This different protocol may be analogous to a layer lower than the application-layer (e.g., the transport layer or network layer). In this way, the user input may be converted into lower-level information from user input commands to actual control of control elements 232-234. In some embodiments, the robot controller 308 may instruct specific robotic modules 312-324 to perform specific actions (e.g., according to the different protocol).

[0061] In this way, different user interfaces, robot controllers, robotic modules, may be used with different TEER delivery systems. For example, different robotic modules 312-324 may be able to respond to information from the robot controller 308. In this example, the medical profession may thus swap robotic modules 312-324 and have the overall operation not be adjusted. Similarly, the robot controller 308 may be adjusted without negative effect on the overall operation. As an example, the robot controller 308 may be swapped for one with finer control capabilities. For this example, the robot controller 308 may thus interpret commands or messages from the user interface 304 to allow for finer adjustment of the TEER device 204. Additionally, different user interfaces 304 may be used according to the medical professional’s preference.

[0062] FIG.4 shows one process 400 that can be provided by the devices disclosed herein. At block 404, a robotic module is engaged with a control element of a delivery system, such as the manual system 208. As discussed in connection with FIG. 3, the first robotic module 312 can be engaged with the guide catheter dial 244 of the guide catheter manipulator 232. This can be achieved by closing a clam-shell housing around the guide catheter manipulator 232 or otherwise affixing the first robotic module 312 to the guide cathetermanipulator 232. At block 408, additional modules can be coupled with additional control elements to provide machine control of one or more additional aspects of operation of a manual system. For example, the second robotic module 316 can include a first manipulator adaptor 260 to be coupled with a first deflector 248 of a device catheter angulator 236. The second robotic module 316 can be configured to be coupled with either one or both of the first deflector 248 and the second deflector 252 of the device catheter angulator 236. The second robotic module 316 can include a second manipulator adaptor 264 configured to be coupled with a second deflector 252 of the device catheter angulator 236. The second robotic module 316 can include a third manipulator adaptor 268 configured to be coupled with the second deflector 252. At block 408, the third robotic module 320 can be coupled with the TEER device manipulator 240. The third robotic module 320 can include actuator 272A and actuator 272B. The actuator 272A and / or the actuator 272B can be coupled with the TEER device manipulator 240. A fourth and up to an nthrobotic module 324 can be coupled to the TEER device manipulator 240, e.g., to rotate the manipulator and / or to actuate the TEER device 204.

[0063] At block 412, the process 400 can proceed such that a distal end of an interventional catheter is advanced into a patient’s vasculature. The interventional catheter can be the guide catheter system 216 and / or the TEER device catheter 212. The interventional catheter can be advanced into a femoral vein. The process 400 can be initiated by or can proceed by an input to the robotic control system 300, for example to the user interface 304. If the distal end of the guide catheter body 220 is disposed in the right atrium, a block 416 can include receiving at the user interface 304 an instruction to perform an interventional step, e.g., for the distal end of the interventional catheter (e.g., the guide catheter body 220) to cross the intra-atrial septum into the left atrium. The input to the user interface 304 can cause instructions saved in memory connected to a processor to be executed to cause the guide catheter body 220 to be advanced through the septum. Such advancement may involve activating a linear actuator of the first robotic module 312.

[0064] If the interventional step performed at the block 416 completes the procedure, then the interventional catheter can be removed from the patient. If the step performed at block 416 does not complete the procedure, the process 400 can repeat the block 416 where additional inputs are received at the user interface 304. The additional input can direct the manual system 208 to perform an additional step under machine control. Theadditional step can involve acting on the TEER delivery system 200 to improve the position or orientation of a portion thereof for a subsequent step. For example, the additional step at the block 416 can involve activating guide catheter manipulator 232 to alter the orientation of a distal portion of the guide catheter body 220 such that the open distal end of oriented along an axis extending through the mitral valve of the patient. In another example, the additional step can involve acting on the anatomy of the patient, e.g., advancing a left atrial appendage closure device into the left atrial appendage.

[0065] In one method, a mixed procedure can involve some steps proceeding under machine control and other steps proceeding under manual control. For example, if the distal end of the guide catheter body 220 is oriented such that the open distal end is along the axis extending through the mitral valve, the cardiologist can act to move the TEER device 204 through the mitral valve by activating the TEER device manipulator 240 manually. In another approach, the block 416 can be repeated again in which the user interface 304 can received an input from a cardiologist to cause the TEER device 204 to be advanced through the mitral valve by the actuator 272A and / or the actuator 272B of the third robotic module 320 acting on TEER device manipulator 240.

[0066] In the case of the TEER procedure, inputs to the user interface 304 at subsequent repeating of the block 416 can involve angling the TEER device 204 by user input to cause the second robotic module 316 to activate the second manipulator adaptor 264 engaged with the first deflector 248 and / or to activate the third manipulator adaptor 268 engaged with the second deflector 252. Inputs received by the user interface 304 at subsequent repeating of the block 416 can cause rotation of the TEER device 204 by action of the third robotic module 320 to activate the actuators engaged with the catheter device surface to rotate or torque the catheter about its longitudinal axis.

[0067] In the case of an LAA, the user interface 304 can receive inputs in connection with the block 416 to cause angulation of the LAA device by action of the second robotic module 316 to activate the second manipulator adaptor 264 engaged with the first deflector 248 and / or to activate the third manipulator adaptor 268 engaged with the second deflector 252. Once the angle of the LAA device is proper, inputs to the user interface 304 can cause the LAA device to be advanced, e.g., by activating the actuator 272A, 272B to cause distal motion of the LAA implant. The LAA is a blind recess in the left atrium that opens atan ostium into the greater volume of the left atrium. An LAA closure device will be at least partially advanced through the ostium of the LAA such that a distal portion thereof will be positioned beyond a plane of the ostium. Inputs to the user interface 304 at subsequent repeating of the block 416 can involve rotating the LAA device if it is not rotationally symmetric by user input to cause the third robotic module 320 to activate the actuators engaged with the catheter device surface to rotate or torque the catheter about its longitudinal axis.

[0068] Other procedures can be performed using machine control as applied to a delivery system, a catheter placements system, and / or an imaging catheter or probe system. FIG. 5 shows one embodiment of an imaging probe system 500 that can be used with a TEE ultrasound console (not shown). The probe system 500 includes a handle 504, an electrical interface 508, and a cable 552 coupling the handle 504 to the electrical interface 508. The electrical interface 508 is configured to electrically connect the cable 552 with an ultrasound console configured to be operably coupled with the probe system 500. The probe system 500 also includes a flexible shaft 520 extending distally from the handle 504 to a tip 556. The tip 556 has an ultrasound transducer disposed thereon. The ultrasound transducer is configured to capture imaging information from a remote site, e.g., from a heart of the patient. The imaging information is transmitted through the flexible shaft 520 and the handle 504 to the cable 552 and through the tip 556 to the console.

[0069] The tip 556 is articulated by one or more controllers disposed on the handle 504. In one embodiment, a first control dial 532 is provided on the handle 504. The first control dial 532 can be manually manipulated. The handle 504 can also have a second control dial 536 disposed thereon. Movement of the first control dial 532 can cause movement of the tip 556, e.g., anterior and posterior deflection or left and right lateral deflection. Movement of the second control dial 536 can cause movement of the tip 556, e.g., anterior and posterior deflection or left and right lateral deflection. While manual operation of the dials 532, 536 is convenient in certain settings, this application also discloses modified embodiments in which the control dials 532, 536 are at least partially machine controlled, such that the movement of the tip 556 is achieved under machine control of a suitable input to one or both of the first control dial 532 and the second control dial 536. The first control dial 532 can be coupled with a motor to provide machine control. The second control dial 536 can be coupled with a motor to provide machine control.

[0070] FIGS. 6-8 illustrate various embodiments of a handle 504A of a probe system. The handle 504A is equipped, e.g., can be re-configured or retro-fitted, with a compact motor assembly including a first motor 580 and a second motor 580A. The first motor 580 and the second motor 580A can be coupled with a body of the handle 504A to provide some degree of motor control of the position of a first control dial 532A and a second control dial 536A of the handle 504A. The first control dial 532A and the second control dial 536A can replace the first control dial 532 and the second control dial 536 while still employing the mechanisms that enable the tip 516 to be deflected, as discussed above.

[0071] The first control dial 532A includes an engagement surface 544 which can be coupled with a transmission wire 588 (see FIG. 7) configured to couple to the motor 580. In some embodiments, the transmission wire 588 can include a wire rope, a round cable, a flat ribbon, a toothed timing belt, a v-shaped timing belt, a string of beads, or any other flexible, tension bearing element. The motor 580 and the motor 580A can be housed within a cover 560 coupled to the body of the handle 504A. The cover 560 can be coupled at one end by placing a lower engagement surface 564 over a protrusion 540 of the handle 504A. The protrusion 540 can have a free end, e.g., pointing in an upward or in a proximal direction. The protrusion 540 can form a hook. The lower engagement surface 564 can form a loop to extend over and / or around the protrusion 540. In other embodiments, the lower engagement surface 564 can form a hook to engage the protrusion 540 which can comprise a loop or other concavity. The cover 560 can be coupled by placing an upper engagement surface 562 over a portion of the first control dial 532A. The cover 560 can be coupled to the body of the handle 504A by a securement element 568, which can include a flexible clip configured to slide over a distal tapered surface of the handle 504A.

[0072] In some embodiments, the protrusion 540 can be a locking mechanism for preventing movement of the tip 516. The locking mechanism can be configured to selectively transition the handle 504A between a locked state and an unlocked state. In some embodiments, the locking mechanism can be referred to as a pose-locking mechanism configured to lock the pose or orientation and configuration of the flexible shaft. In some embodiments, the protrusion 540 can be a lever configured to pivot between a first position and a second position. In some embodiments, the protrusion 540 may be configured to axially translate between a first position and a second position. The first position can correspond tothe locked state and the second position can correspond to the unlocked state. In the locked state, the locking mechanism may prevent the tip 516 from moving. For example, in the locked state one or more internal mechanisms of the handle 504A may be prevented from moving such that motion of the dials 532 is not transmitted through the flexible shaft 520. In contrast, the shaft 520 can be manipulated in the unlocked state to orient the tip 516 to a desired position. Accordingly, the protrusion 540 can transition from the unlocked state to the locked state to fix the tip 516 in place.

[0073] Transitioning the handle 504A between a locked state and an unlocked state may present safety risks to a patient in robotic or semi-robotic embodiments. For example, in an emergency, a robotically or semi-robotically controlled shaft may need to be removed from the patient. If the shaft is in a locked state to maintain the orientation of the tip 516, the withdrawal of the shaft in a rigid position may injure the patient. Accordingly, a securement mechanism may be provided to selectively engage the locking mechanism. The securement mechanism can be configured to prevent the locking mechanism from transitioning between the locked state and the unlocked state. In some embodiments, the securement mechanism may engage the locking mechanism when the locking mechanism is in the unlocked state to prevent the locking mechanism from transitioning to the locked state. The securement mechanism can be any device capable of selectively engaging and preventing the locking mechanism from transitioning between the locked state and the unlocked state. For example, the lower engagement surface 564 can be configured to fence in the protrusion 540A. In such embodiments, the lower engagement surface 564 can prevent the protrusion 540 from transitioning from the unlocked state to the locked state. The lower engagement surface 564 is shown as part of a cover 560 of a kit for affixing motors to a TEE probe handle, certain features of the cover 560 could be integrated into a robotic assembly, e.g., into a motor assembly, configured to receive a TEE probe handle. In some such arrangements, the motor assembly can receive the TEE probe assembly and at the same time a concave portion of the robotic assembly, e.g., of a motor housing, can be placed over the protrusion 540. The concave portion can enclose at least a portion of a periphery of the protrusion, e.g., the entire protrusion in a blind recess. In the case of the cover 560, the blind recess can be formed in a protrusion of the lower engagement surface 564 that comprise an internal surface that is larger than but a substantial negative surface of the protrusion 540.

[0074] Modifying a probe system to include the motors 580, 580A can provide machine control. Machine control can implement drive assist features such as power steering. For example, drive assist can be achieved by including the motors 580, 580A with a transmission. For example, a cycloid motor may be mounted to the probe system such that the output of the cycloid motor is operatively coupled to the first control dial 532A and the second control dial 532B. Accordingly, the actuation of the cycloid motor can control the corresponding actuation of a control dial 532A, 532B. Adding the one or more motors 580, 580A for machine control can provide additional value to a traditional probe system by providing drive assist to a human user. Furthermore, adding the one or more motors 580, 580A can provide additional value to a traditional probe system by providing a fully robotic system. A fully robotic system may combine the modified probe system with a robot to provide additional controls.

[0075] FIG. 8 shows the motor 580 disposed close to the first and second control dials 532A, 532B. The motor 580 is disposed between the dials 532A, 532B and the motor 580A. The motor 580A is disposed distal of the motor 580. The motor 580A is disposed closer to a distal end of the handle 504A than is the motor 580. The motor 580A is disposed between the distal end of the handle 504A and the motor 580. The motor 580 is disposed closer to the proximal end of the handle 504A than is the motor 580A. The motor 580 is disposed between the proximal end of the handle 504A and the motor 580A. As discussed above, the transmission wire 588 is shown extending from the motor 580 to the first control dial 532A. Another transmission wire can be provided to couple the output of the motor 580A with the second control dial 536A. FIG. 8 shows that the motor 580 and the motor 580A can be very compact in the direction about with the first control dials 532A, 536A rotate. The motor 580 and the motor 580A can have a housing (discussed further below in connection with one example embodiment) that includes a bottom surface configured to be supported at or near the body of the handle 504A and a top surface opposite to the bottom surface. The top surface of the motor 580 and the motor 580A can be below a plane that intersects the top of the first control dial 532A and that is disposed transverse, e.g., perpendicular, to the axis of rotation of the first control dial 532A. The axis of rotation of the first control dial 532A is generally perpendicular to the longitudinal axis of the body of the handle 504A. The compact dimensions of the motor 580 and motor 580A can be provided in any various ways. For example, acompact arrangement is provided by employing a multistage high gear ratio powertrain or transmission to provide a suitable output for driving the dials 532A, 536B.

[0076] It will be appreciated that FIGS. 8-10 show a kit and a technique for re- configuring the handle 504 of the TEE probe 502 for machine control. In one arrangement, a standard manual probe is provided with a housing body that has an upper and a lower portion. To reconfigure the handle 504, the first control dial 532 and the second control dial 536 can be removed and the upper portion of the body of the handle 504 can be replaced with a probe body upper cover 592A. In some cases, a cover for the lower portion of the body of the handle 504 can be mated with the upper cover 592A. In other cases, the cover of the lower portion of the body of handle 504 can be replaced with a housing lower cover 592B. The upper cover 592A and the lower cover 592B can be mated to form a complete enclosure around inner components of the handle 504.

[0077] FIG.10 shows that the upper cover 592A can be configured for mating with components facilitating machine control. The upper cover 592A can have a recess 596. The upper cover 592A can have the protrusion 540 formed thereon. The control dials can have inner and outer portions. In particular, as seen in FIG. 10, the housing upper cover 592A can have, be coupled with, or in some cases extend under an inner dial portion 600A of the first control dial 532 and an inner dial portion 600B of the second control dial 536. The inner dial portion 600A can be configured to mate with an outer dial portion 604A that is configured to engage the first motor 580. Each of the inner dial portion 600A and the inner dial portion 600B can have notches 602 configured for mating with an outer dial portion. For example, the notches 602 can mate in a lock-and-key manner with protrusions extending inwardly from the outer dial portion 604A. The outer dial portion 604A can fit concentrically around the inner dial portion 600A to form the first control dial 532A. The outer dial portion 604A can have the engagement surface 544 for mating with the transmission wire 588 as discussed above.

[0078] In one technique, prior to coupling the outer dial portions with the inner dial portion 600A and the inner dial portion 600B, the first motor 580 and the second motor 580A are coupled with the upper cover 592A. In one kit, the first motor 580 and the second motor 580A are pre-connected to the upper cover 592A. A circuit board 584 for controlling the first motor 580 and a circuit board 584a for controlling the second motor 580A can be pre- connected to the upper cover 592A. In assembling the upper cover 592A to the lower cover592B, the mechanical transmission elements for conveying torque on the control dials to the control elements within the handle pass through the upper cover 592A. Thereafter, the inner dial portion 600A and the inner dial portion 600B can be coupled to these mechanical transmission elements.

[0079] FIGS.6 and 8 show that the cover 560 extends to a lower elevation than at least a portion of the second control dial 536A and in some cases at least partially under the second control dial 536A. Accordingly, in one technique the cover 560 can be positioned over the upper cover 592A before the inner dial portion 600B and the inner dial portion 600A are connected. In another technique the cover 560 is configured to be advanced over the inner dial portion 600A and the inner dial portion 600B. In another technique the cover 560 is configured to be advanced under the inner dial portion 600A and the inner dial portion 600B. Thereafter, the outer dial portion 604A can be coupled to the inner dial portion 600A and another outer dial portion can be coupled to the inner dial portion 600B forming the first control dial 532A and the second control dial 536A. A transmission wire 588 can be coupled with each dial at a torque plane 608A, 608B. A transmission wire 588 can extend into a gearbox housing (not shown) coupled with or comprising a portion of the first motor 580 and the second motor 580A. A pulley or other transmission element (not shown) can be disposed in the gearbox housing.

[0080] After the lower engagement surface 564 and the upper engagement surface 562 have been engaged with the upper cover 592A and the first control dial 532A respectively, the cover 560 can be secured to the upper cover 592A. In one embodiment, a securement element 568, sometimes referred to herein as a coupler, is provided in a kit for re-configuring the handle 504 for machine control. The securement element 568 can comprise a generally C- shaped clip configured to be advanced over a distal portion of the handle 504, e.g., over a tapered distal portion of the cable 552. The securement element 568 can have a lower portion 570 with an arcuate shape for engaging a bottom surface of the housing lower cover 592B. An upper portion of the securement element 568 is configured to engage and hold the cover 560, e.g., by flexing upon proximal movement relative to an outside surface of the handle 504. The securement element 568 can have a C-shaped cross-section such that such that an end of the coupler engages the side surface of the motor housing and a concavity of the coupler engages a surface of the handle 504 opposite of a surface upon which the motor housing is disposed. Sliding the securement element 568 toward the first end of the motor housing causes thesecurement element 568 to flex when engaging a tapered portion of the handle. clip configured to be advanced over a distal portion of the handle 504, e.g., over a tapered distal portion of the cable 552. The upper portion can include one or a plurality of elongate proximal ridges 572 that can slide over and compress against a side surface of the cover 560. The upper portion can include one or a plurality of angled distal edges 574 that can engage and compress against a distal surface of the cover 560. Relative motion of the securement element 568 to the cover 560 and the lower cover 592B as indicated by arrow A in FIG. 9 can cause the securement element 568 to engage these components to hold the cover 560 against the housing upper cover 592A. For example, as the securement element 568 moves over the tapered distal portion of the cable 552 the C-shaped body of the securement element 568 can be expanded. The elongate proximal ridges 572 can apply a force to the side surfaces of the cover 560 holding it against the housing upper cover 592A. The angled distal edges 574 can apply a force to the distal surfaces of the cover 560 holding the cover against the housing upper cover 592A. In some cases, the elongate proximal ridges 572 can apply a force to the side surfaces of the cover 560 and the angled distal edges 574 can apply a force to the distal surfaces of the cover 560 holding the cover 560 against the housing upper cover 592A. In one embodiment, the securing position of the securement element 568 relative to the housing upper cover 592A and the housing lower cover 592B is shown in FIG.6.

[0081] FIG.11 illustrates another embodiment of a handle 504A of a probe system. As shown in FIG. 11, the handle 504A can be substantially similar to the handle 504A described herein with reference to FIGS. 6-10 with the addition of a second compact motor assembly 560B. The second compact motor assembly 560B can be positioned on a side of the handle 504A opposite the first compact motor assembly 560A. The second compact motor assembly can be equipped, e.g., can be re-configured or retro-fitted onto the handle 504A. Accordingly, the handle 504A can include a first compact motor assembly 560A and a second compact motor assembly 560B. In some embodiments, the first compact motor assembly 560A can include one or more motors and the second compact motor assembly 560B can include one or more motors. For example, the first compact motor assembly 560A can include the first motor 580 and the second compact motor assembly 560B can include the second motor 580A. In some cases, the second compact motor assembly 560B can further include the lower engagement surface 564 for preventing a protrusion, or a distal probe tip pose locking devicefrom transitioning to a locked state. As further shown in FIG. 11, the first control dial and / or the second control dial can be accessible in a space 576 between the first compact motor assembly 560A and the second compact motor assembly 560B.

[0082] FIG. 12 illustrates another embodiment of a handle 504 of a probe system. The handle 504 can be equipped, e.g., can be re-configured or retro-fitted, with a probe handle adapter 700. The probe handle adapter 700 can include a sheath 702, a proximal collar 704A, a distal collar 704B, and a housing 706. The sheath 702 can be placed around the handle 504 and secured together with the proximal collar 704A and the distal collar 704B. The probe handle adapter 700 can be configured to adapt a manual probe system into a robotic or semi- robotic probe system.

[0083] The sheath 702 can include a proximal portion 702A and a distal portion 702B. The proximal portion 702A can be configured to engage with a proximal end of the handle 504. The distal portion 702B can be configured to engage with a distal end of the handle 504. In some cases, the proximal portion 702A can be configured to couple to the distal portion 702B via a mating interface 705. The mating interface 705 can include one or more interlocking tabs.

[0084] The proximal collar 704A can be a first mounting feature configured to secure the proximal end of the proximal portion 702A to a proximal end of the handle 504. The proximal collar 704A can include an annular ring configured to surround a proximal portion of the handle 504 and a proximal end of the proximal portion 702A. The inner diameter of the proximal collar 704A can be less than the outer dimension of the electrical interface 508. Accordingly, the proximal collar 704A can be applied to the proximal end of the handle 504 by including a slot 714 in the proximal collar 704A configured to receive the cable 552 as described herein with reference to FIGS. 13-14. Accordingly, the proximal collar 704A can bypass the electrical interface 508 and slide distally to the proximal end of the handle 504.

[0085] The distal collar 704B can be a second mounting feature configured to secure the distal end of the distal portion 702B to a distal end of the handle 504. The distal collar 704B include an annular ring configured to surround a distal portion of the handle 504 and a distal end of the distal portion 702B. The inner diameter of the distal collar 704B can be greater than the outer dimension of the tip 516 and / or the flexible shaft 520. Accordingly, the distal collar 704B can be applied to the distal end of the handle 504 by passing the tip 516through the distal collar 704B and sliding the distal collar 704B proximally along the flexible shaft 520 until the distal collar 704B reaches the distal end of the handle 504.

[0086] The housing 706 can couple to the sheath 702. In some embodiments, the housing 706 can be positioned along a surface of the handle 504 corresponding to the first control dial 532A and the second control dial 536A. For example, the housing 706 can extend radially outward from the proximal portion 702A and the distal portion 702B in a direction configured to cover the first control dial 532A and the second control dial 536A.

[0087] The housing 706 can include an outer enclosure (e.g., an outer wall, a housing, an outer surface). The outer enclosure can include proximal end and a distal end, each configured to cover a respective motor. In some embodiments, the distal end can be configured to cover a first motor 580 and the proximal end can be configured to cover a second motor 580A, or vice versa. The housing can include one or more central openings through which a corresponding transmission element coupled with the first motor 580 and / or the second motor 580A can extend. In some cases, the one or more central openings can be arranged along a plane orthogonal to the longitudinal axis of the handle 504. For example, the one or more central openings can extend along a width of the housing 706.

[0088] In some embodiments, the outer housing can optionally include one or more transparent sections 710. The one or more transparent sections 710 can permit a user to visually inspect the interior of the housing 706. In some embodiments, the one or more transparent sections 710 can be positioned axially inward from the proximal end and the distal end of the outer housing. In some embodiments, the one or more transparent sections 710 may be opaque. In some embodiments, the outer housing may not include the one or more transparent sections 710.

[0089] In some embodiments, the housing 706 can include a window 712. The window 712 can be an opening in the outer housing of the housing 706. The window 712 can be configured to provide access to the first control dial 532A and / or the second control dial 536A. For example, the window 712 can be configured to permit an operator to manually engage the first control dial 532A and / or the second control dial 536A. As shown in FIG.12, the window 712 can be arranged along the center of the housing 706. For example, the window 712 can be positioned between two transparent sections 710.

[0090] The first motor 580 can be coupled to one of either the first control dial 532A or the second control dial 536A. The second motor 580A can be coupled to the other of the first control dial 532A or the second control dial 536A. For example, a transmission wire 588 can extend between a control dial and a corresponding motor. The transmission wire 588 can be coupled with each dial at a torque plane as described herein with reference to FIG. 8. The transmission wire 588 can extend into a gearbox housing (not shown) coupled with or comprising a portion of the first motor 580 and the second motor 580A. A pulley or other transmission element (not shown) can be disposed in the gearbox housing.

[0091] FIGS. 13-14 illustrate a front perspective view of the proximal end of the handle 504. As shown in FIGS. 13-14, the proximal collar 704A can be an annular ring extending around the proximal end of the proximal portion 702A. In some cases, the proximal collar 704A can also extend around an adapter 720 configured to engage the cable 552. The adapter 720 can include one or more openings 721A, 721B. The one or more openings 721A, 721B of the adapter 720 can be configured to receive one or more electrical wires 722 and / or a hanger tab 724 of the handle 504 as described in greater detail herein with reference to FIGS. 14-15.

[0092] The proximal collar 704A can include a plurality of radial protrusions 716. The plurality of radial protrusions 716 can extend radially inward and engage with a corresponding groove located at the proximal end of the proximal portion 702A. The plurality of radial protrusions 716 can be configured to prevent the proximal collar 704A from rotating around the proximal end of the proximal portion 702A.

[0093] As described herein, the proximal collar 704A can include a slot 714. The slot 714 can be a discontinuity in the annular structure of the proximal collar 704A. As shown in FIG. 13, the slot 714 can be a radial discontinuity in a radial protrusion 718. The radial protrusion 718 can be similar to the plurality of radial protrusions 716 with the addition of a circular securing element positioned radially inward from the annular structure of the proximal collar 704A. Accordingly, the slot 714 can be configured to allow the proximal collar 704A to radially expand (e.g., to increase the distance of the opposing sides of the slot 714). The proximal collar 704A can be secured in a minimum dimension by securing the radial protrusion 718 inside a corresponding groove located at the proximal end of the proximal portion 702A.

[0094] FIG.14 further illustrates one or more electrical wires 722 extending along the cable 522 through an opening 721A in the adapter 720. The one or more electrical wires 722 can be operatively coupled to one or more sensors, the first motor 580, and / or the second motor 580A. In some embodiments, the one or more electrical wires 722 may be power wires and / or control wires for controlling the first motor 580 and / or the second motor 580A. In some embodiments, the one or more electrical wires 722 can be operatively coupled to one or more sensors for transmitting sensed forces to a processor. In some embodiments, the sensors can be optical sensors, force sensors, torque sensors, or other sensors used to measured forces and / or positions of the tip 516.

[0095] FIG. 14 further illustrates a hanger tab 724 positioned within an opening 721B in the adapter 720. As described in greater detail herein with reference to FIG. 15, the hanger tab 724 may be a component of the handle 504.

[0096] FIG. 15 illustrates a proximal end of a handle 504. As shown in FIG. 15, the handle 504 can include a first control dial 532A and a second control dial 536A. The handle 504 can further include the cable 552 extending proximally to an electrical interface 508. The handle 504 can include a hanger tab 724. The hanger tab 724 can be configured to facilitate hanging the handle 504. In some embodiments, the hanger tab 724 can extend radially outward from the handle 504 and include an opening 726. The opening 726 can receive a key ring for facilitating hanging the handle 504 when not in use. In some embodiments, the hanger tab 524 may be rotatably coupled to the handle 504.

[0097] FIG. 5-14 shows techniques for adapting a manual TEE probe 502 to be operated at least partially under machine control. The first motor 580 and the second motor 580A including or coupled to gearbox and transmission elements can be components of a layer of a system for providing machine control to an application or for providing machine control to a plurality of applications. For example, and as described in Figure 3, the motors may form part of a lower-level layer which may be adjusted by robot controller 308. These mechanical components can be provided as a kit to re-configure an otherwise manual system. The first motor 580 and second motor 580A can be locally controlled by software that can also be mounted to the handle 504A, e.g., stored in memory connect to the circuit boards 584. These components can be connected to a network of computing devices that can play a role incontrolling these mechanical components. In some cases, the network can also include additional robotic controllers.

[0098] A robotic control system similar to that of FIG.3 can be used to control the TEE probe 502 as modified. The first robotic module 312 and the second robotic module 316 can correspond to the first motor 580 and the circuit board 584 connected thereto. The first control dial 532 can correspond to the manipulator 232. Connecting these components can modify the first control dial 532 into the machine controlled first control dial 532A. With continued reference to FIG. 3, the second robotic module 316 can correspond to the second motor 580A and the circuit board 584 connected thereto. The second control dial 536 can correspond to the angulator 236. Connecting the second motor 580A and circuit board 584 (the second robotic module 316) to the second control dial 536 (the device catheter angulator 236) can re-configured the second control dial 536 to provide machine control in the second control dial 536A.

[0099] In one application, the TEE probe 502 can be mated with a robotic system that can include the third robotic module 320 and a fourth robotic module, which in FIG. 3 is the nth robotic module 324. The robotic system can include a cradle configured to receive the TEE probe 502 and configured to manipulate the probe in additional degrees of freedom not provided by the first motor 580 and the second motor 580A. As described in Figure 3, a particular layer can be provided in the robotic control system 300 that determines how and when to transmit data from the two robotic modules coupled with the handle 504 and the two robotic modules disposed in the robotic system. The above-described layer may represent the lower-level lower described in Figure 3.

[0100] In one application, and as described in FIG. 3, an application-layer is provided where data from the robot controller 308 and / or from the manual system 208 are configured into actionable information in a format that can be presented to a user. The application-layer can also respond to user input as described above.

[0101] FIG. 16 is a flow chart illustrating a method 800 for converting a manual probe to robotic or semi-robotic control. For example, a probe handle adapter can be a kit for converting a manual probe to robotic control. In such embodiments, the method 800 can be a method for re-configuring or retro-fitting the manual probe with the probe handle adapter 700A described herein.

[0102] The method 800 can begin with block 802 where a sheath is placed (e.g., fitted, disposed, or applied) around a handle of the manual probe. In some embodiments, the sheath may include one or more portions. The one or more portions can be configured to be placed around a particular geometry of the handle. In some embodiments, multiple portions can be secured together. For example, a proximal portion of the sheath can be configured to be positioned around a proximal end of the handle and a distal portion can be configured to be positioned around a distal end of the handle. In some embodiments, the proximal portion of the sheath can be slidably disposed around the proximal end of the handle and the distal portion of the sheath can be slidably disposed around the distal end of the handle. In some embodiments, the proximal portion of the sheath can be radially pressed onto the proximal end of the handle and the distal portion of the sheath can be radially pressed onto the distal end of the handle. The proximal portion and the distal portion can be secured together via a mating interface. The mating interface can include one or more interlocking tabs.

[0103] The method 800 can then move to block 804, where one or more motors are coupled to a corresponding one of one or more control dials disposed on the handle. In some embodiments, the one or more motors can be included with the sheath. In some embodiments, the one or more motors can be coupled to the sheath as described herein with reference to elements 580, 580A in FIGS. 7, 8 and 12. Coupling the one or more motors to the corresponding one of the one or more control dials disposed on the handle can include operatively coupling a transmission assembly between an output of the one or more motors and the corresponding one of the one or more control dials. In some embodiments, a wire can be wrapped around the output of a motor and around the corresponding control dial.

[0104] The method 800 can then move to block 806, where a housing is coupled to the sheath for covering the one or more motors and the one or more control dials. The housing can include engagement features configured to couple with the sheath. In some embodiments, the housing can be radially placed onto the sheath. In an assembled state, the housing can cover, at least in part, the one or more motors and the one or more control dials.

[0105] The method 800 can include block 808, where a first mounting feature is secured to a distal end of the sheath. Securing the first mounting feature to the distal end of the sheath can include inserting a tip of the manual probe through an opening of the first mounting feature and passing the first mounting feature proximally along a flexible shaft ofthe manual probe to the distal end of the sheath. Accordingly, the first mounting feature can be proximally guided to the distal end of the sheath.

[0106] The method 800 can include block 810, where a second mounting feature is secured to a proximal end of the sheath. Securing the second mounting feature to the proximal end of the sheath can include radially inserting a cable of the manual probe into an opening of the second mounting feature and passing the second mounting feature distally along the cable to the proximal end of the sheath. For example, the second mounting feature can include a slot for radially expanding the second mounting feature to receive the cable. Accordingly, the second mounting feature can be distally guided to the proximal end of the sheath.

[0107] The order of the blocks is not intended to limit the order of performing the operations of the methods 800. In some embodiments, blocks 806 and 808 can be performed after block 802. In some embodiments, block 806 can be performed before block 808, and vice versa.

[0108] FIGS. 17A-17C illustrate views of interior components of a modified TEE probe handle with an enclosure not shown. For example, as shown in FIGS.17A-17C, a handle 504 of a manual TEE probe can include a first control dial 532A, a second control dial 536A, a flexible shaft 520 extending distally from the handle 504 to a tip 556, and a cable 552 coupling the handle 504 to the electrical interface 508. In some embodiments, the handle 504 can further include a dial cover 730. The dial cover 730 can be configured to extend around a control dial of the handle 504. In some embodiments, the dial cover 730 can include engagement elements for interfacing with a transmission wire 588.

[0109] As described herein, the handle 504 can be retrofitted with one or more motors to convert the manual TEE probe to robotic or semi-robotic control. As described herein, one or more motors can be operatively coupled to the handle 504. As shown in FIGS. 17A-17C, the one or more motors can be coupled to a base plate 728. The base plate 728 can form a base that is coupled to the handle 504. In some embodiments, the base plate 728 can include an opening sized to receive the control dials of the handle 504. For example, the inner dimension of the opening can exceed the outer dimensions of the control dials of the handle 504.

[0110] In some examples, one or more motors can be positioned on one side of the handle 504 as described herein with reference to FIGS. 6-10. As shown FIGS. 17A-17C, oneor more motors can be positioned on both sides of the handle 504. In some embodiments, a first motor 580 can be coupled to a first side of the handle 504 and a second motor 580A can be coupled to a second side of the handle 504 opposite the first side. For example, the first motor 580 can be coupled to the distal side of the handle 504 and the second motor 580A can be coupled to the proximal side of the handle 504, or vice versa.

[0111] Each of the one or more motors can include a transmission element 734. The transmission element 734 can be an output. In some embodiments, the transmission element 734 can be a pulley, output shaft, or other mechanism configured to provide a rotational output from the motor.

[0112] As described herein, transmission wires 588 can extend between the one or more motors and the control dials of the handle 504. In some embodiments, the transmission wire 588 can be operatively coupled to a transmission element 734 of a corresponding motor 580, 580A. As shown in FIGS. 17A-17C, a transmission element 588 can extend around a control dial 532A and around a transmission element 734 of the motor 580A. As described herein, the transmission wire 588 can include a wire rope, a round cable, a flat ribbon, a toothed timing belt, a v-shaped timing belt, a string of beads, or any other flexible, tension bearing element. Accordingly, the transmission wire 588 can be configured to transfer rotational movement of the transmission element 734 to the corresponding control dial of the handle.

[0113] One or more pulleys 732 can be provided for direct the transmission wire 588. In some examples, the one or more pulleys 732 can be coupled to the base plate 728. The one or more pulleys 734 can be positioned radially outward from control dials of the handle 504. The transmission wire 588 can be configured to be positioned between the one or more pulleys 732 and the corresponding control dial of the handle 504. Accordingly, the one or more pulleys 732 can direct the transmission wire 588 radially inward and / or can be configured to tension the transmission wire 588. In such embodiments, the one or more pulleys 732 may increase the engagement of the transmission wire 588 with the control dial of the handle 504.

[0114] FIG.17B illustrates a side view of a handle 504 with the base plate 728 not yet mounted to the handle 504. Accordingly, the one or more motors are not operatively coupled with the control dials of the handle 504 via the transmission wires 588.

[0115] FIG. 17C illustrates a side view of the handle 504 with the base plate 728 mounted to the handle 504. As shown in FIG. 17C, the one or more motors are operativelycoupled with the control dials of the handle 504 via the transmission wires 588. An enclosure can be placed around the one or more motors. Additionally, a window may be provided between the one or more motors. As described herein, the window may make the control dials of the handle assessable to a user for manual control.

[0116] Although the foregoing system is described as being well suited to convert a manual control system into one that is at least partially machine controlled, the robotic modules could also be integrated into an implant delivery system or a catheter placement system that is designed for machine control. The robotic modules can be integrated into a housing where actuators are located to act on a catheter body to deflect, advance, rotate or otherwise manipulate an end portion in space. In an integrated configuration, some features can be eliminated, such as dials that are configured for manual manipulation. In a further variation, a system can be pre-assembled with robotic modules that enable machine control for one, a plurality or all maneuvers but can be re-configured in the cath lab 100 to allow manual control of one or more maneuvers. Additional Terminology

[0117] All of the processes described herein may be embodied in, and fully automated, via software code modules executed by a computing system that includes one or more computers or processors. The code modules may be stored in any type of non-transitory computer-readable medium or other computer storage device. Some or all the methods may be embodied in specialized computer hardware.

[0118] Many other variations than those described herein will be apparent from this disclosure. For example, depending on the embodiment, certain acts, events, or functions of any of the algorithms described herein can be performed in a different sequence or can be added, merged, or left out altogether (for example, not all described acts or events are necessary for the practice of the algorithms). Moreover, in certain embodiments, acts or events can be performed concurrently, for example, through multi-threaded processing, interrupt processing, or multiple processors or processor cores or on other parallel architectures, rather than sequentially. In addition, different tasks or processes can be performed by different machines and / or computing systems that can function together.

[0119] The various illustrative logical blocks, modules, and engines described in connection with the embodiments disclosed herein can be implemented or performed by a machine, such as a processing unit or processor, a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field programmable gate array (FPGA) or other programmable logic device, discrete gate or transistor logic, discrete hardware components, or any combination thereof designed to perform the functions described herein. A processor can be a microprocessor, but in the alternative, the processor can be a controller, microcontroller, or state machine, combinations of the same, or the like. A processor can include electrical circuitry configured to process computer-executable instructions. In another embodiment, a processor includes an FPGA or other programmable device that performs logic operations without processing computer-executable instructions. A processor can also be implemented as a combination of computing devices, for example, a combination of a DSP and a microprocessor, a plurality of microprocessors, one or more microprocessors in conjunction with a DSP core, or any other such configuration. Although described herein primarily with respect to digital technology, a processor may also include primarily analog components. For example, some or all of the signal processing algorithms described herein may be implemented in analog circuitry or mixed analog and digital circuitry. A computing environment can include any type of computer system, including, but not limited to, a computer system based on a microprocessor, a mainframe computer, a digital signal processor, a portable computing device, a device controller, or a computational engine within an appliance, to name a few.

[0120] Conditional language such as, among others, “can,” “could,” “might” or “may,” unless specifically stated otherwise, are understood within the context as used in general to convey that certain embodiments include, while other embodiments do not include, certain features, elements and / or steps. Thus, such conditional language is not generally intended to imply that features, elements and / or steps are in any way required for one or more embodiments or that one or more embodiments necessarily include logic for deciding, with or without user input or prompting, whether these features, elements and / or steps are included or are to be performed in any particular embodiment.

[0121] Disjunctive language such as the phrase “at least one of X, Y, or Z,” unless specifically stated otherwise, is understood with the context as used in general to present that an item, term, etc., may be either X, Y, or Z, or any combination thereof (for example, X, Y,and / or Z). Thus, such disjunctive language is not generally intended to, and should not, imply that certain embodiments require at least one of X, at least one of Y, or at least one of Z to each be present.

[0122] Any process descriptions, elements or blocks in the flow diagrams described herein and / or depicted in the attached figures should be understood as potentially representing modules, segments, or portions of code which include one or more executable instructions for implementing specific logical functions or elements in the process. Alternate implementations are included within the scope of the embodiments described herein in which elements or functions may be deleted, executed out of order from that shown, or discussed, including substantially concurrently or in reverse order, depending on the functionality involved as would be understood by those skilled in the art.

[0123] Unless otherwise explicitly stated, articles such as “a” or “an” should generally be interpreted to include one or more described items. Accordingly, phrases such as “a device configured to” are intended to include one or more recited devices. Such one or more recited devices can also be collectively configured to carry out the stated recitations. For example, “a processor configured to carry out recitations A, B and C” can include a first processor configured to carry out recitation A working in conjunction with a second processor configured to carry out recitations B and C.

[0124] It should be emphasized that many variations and modifications may be made to the above-described embodiments, the elements of which are to be understood as being among other acceptable examples. All such modifications and variations are intended to be included herein within the scope of this disclosure. The foregoing descriptions of specific embodiments of the present invention have been presented for purposes of illustration and description. They are not intended to be exhaustive or to limit the invention to the precise forms disclosed, and obviously many modifications and variations are possible in light of the above teaching. The embodiments were chosen and described in order to best explain the principles of the invention and its practical application, to thereby enable others skilled in the art to best utilize the invention and various embodiments with various modifications as are suited to the particular use contemplated. It is intended that the scope of the invention be defined by the Claims appended hereto and their equivalents.Example Clauses

[0125] Examples of the implementations of the present disclosure can be described in view of the following example clauses. The features recited in the below example implementations can be combined with additional features disclosed herein. Furthermore, additional inventive combinations of features are disclosed herein, which are not specifically recited in the below example implementations, and which do not include the same features as the specific implementations below. For sake of brevity, the below example implementations do not identify every inventive aspect of this disclosure. The below example implementations are not intended to identify key features or essential features of any subject matter described herein. Any of the example clauses below, or any features of the example clauses, can be combined with any one or more other example clauses, or features of the example clauses or other features of the present disclosure.

[0126] Clause 1. A catheter body control system, comprising: a first robotic controller configured to couple with a guide catheter manipulator to control advancement or angulation of the guide catheter within a heart chamber; a second robotic controller configured to couple with a device catheter angulator to alter an angle of a tip of the device catheter within a heart chamber during a procedure; and a manipulator device configured to advance the guide catheter or the tip of the device catheter toward cardiac anatomy.

[0127] Clause 2. The catheter body control system of Clause 1 wherein the first robotic controller is configured to be removably coupled to a housing within which the guide catheter manipulator is enclosed to enable a manual system to be converted into a machine control system.

[0128] Clause 3. The catheter body control system of Clause 1 further comprising a user interface device configured to receive an input from a user to activate the first robotic controller and the second robotic controller.

[0129] Clause 4. The catheter body control system of Clause 3, wherein the user interface device is configured to receive a first input from the user to activate the first robotic controller and a second input from the user to activate the second robotic controller after the first robotic controller has completed a task.

[0130] Clause 5. The catheter body control system of Clause 1, further comprising a third robotic controller configured to activate the advancement guide catheter through an intra-atrial septum.

[0131] Clause 6. The catheter body control system of Clause 1, further comprising a third robotic controller configured to activate the advancement tip of the device catheter toward an ostium of a left atrial appendage.

[0132] Clause 7. The catheter body control system of Clause 1, further comprising a third robotic controller configured to activate the advancement tip of the device catheter through a mitral valve.

[0133] Clause 8. The catheter body control system of Clause 1, further comprising a third robotic controller configured to be removably coupled to a manual advancement device to convert the manual advancement device from a manual manipulator to a machine control configuration.

[0134] Clause 9. The catheter body control system of Clause 1, further comprising a processor and a user interface and wherein the first robotic controller and the second robotic controller each comprise a housing configured to be separately coupled with a manual control components of a manual catheter system and at least one of the first robotic controller and the second robotic controller comprises a wireless receiver configured to communicate with the processor to receive control instructions following inputs to the user interface.

[0135] Clause 10. A method, comprising: providing a cardiac interventional system comprising a catheter having a proximal end coupled with a manual manipulation system and a distal end having a therapeutic element; coupling a robotic controller with a manual catheter manipulator to convert control of a movement of or at the distal end of the catheter within a heart chamber from manual control to machine control; and advancing the catheter to engage the therapeutic element with cardiac anatomy.

[0136] Clause 11. The method of Clause 10, where the robotic controller is a first robotic controller, the first robotic controller being coupled with a first control element of the manual catheter manipulator and further comprising coupling a second robotic controller with a second control element of the manual catheter manipulator, receiving a first input to cause the first robotic controller to act on the first control element to perform a first movement of or at the distal end of the catheter and receiving a second input to cause the second roboticcontroller to act on the second control element to perform a second movement of or at the distal end of the catheter.

[0137] Clause 12. A method, comprising: providing a cardiac interventional system comprising a catheter having a distal end having a therapeutic element and a proximal end having a first machine control component configured to control advancement and / or angulation of the distal end and a second machine control component configured to control rotational orientation of the distal end; receiving an input on a user interface to cause the machine control components to control advancement, angulation, and / or rotational orientation of the distal end of the catheter within a heart chamber; and wirelessly transmitting a signal to the first machine control component or to the second machine control component to facilitate a therapeutic procedure.

[0138] Clause 13. An ultrasound probe assembly, comprising: a handle having a control dial; a tip comprising an ultrasound element; a shaft having a proximal end coupled with the handle and a distal end coupled with the tip, the shaft having a control element having a proximal end coupled with the control dial and a distal end coupled with the tip; and a motor mounted on the handle, the motor having a transmission assembly coupled with an output shaft of the motor and with the control dial to apply torque to the control dial following movement of the motor.

[0139] Clause 14. The ultrasound probe assembly of Clause 13, wherein the transmission assembly comprising a gear element having a cycloidal profile.

[0140] Clause 15. The ultrasound probe assembly of Clause 13, wherein the control dial comprises a first control dial and further comprising a second control dial, the motor comprises a first motor, the transmission assembly comprises a first transmission assembly, and the output shaft comprises a first output shaft, and further comprising a second motor mounted on the handle, the second motor having a second transmission assembly coupled with a second output shaft of the second motor and with the second control dial to apply torque to the second control dial following movement of the second motor.

[0141] Clause 16. The ultrasound probe assembly of Clause 15, wherein the first transmission assembly comprises a wire extending from a pulley coupled with the first motor, the second transmission assembly disposed at an elevation between the wire and a body of the handle.

[0142] Clause 17. A kit comprising: a motor having a transmission element configured to drive a control dial on a handle of an ultrasound probe, the motor configured to be mounted on the handle; a controller assembly comprising a processor configured to drive the motor; a housing having a first mounting feature on a first end, a second mounting feature on a second end, and an enclosure disposed between the first end and the second end, the enclosure configured to be disposed over the motor and over the controller assembly; and a coupler configured to slide over a distal end of the handle and over the second mounting feature to retain the housing over the motor and on the handle.

[0143] Clause 18. The kit of Clause 17, wherein the housing comprises an opening facing the first end through which a transmission element coupled with the motor can extend.

[0144] Clause 19. The kit of Clause 17, wherein the enclosure of the housing is configured to cover a portion of the control dial while another portion of the control dial is disposed outside the enclosure.

[0145] Clause 20. The kit of Clause 17, wherein the first mounting feature comprises an aperture configured to be advanced over a projection of an outside surface of the handle of the ultrasound probe.

[0146] Clause 21. The kit of Clause 17, wherein the first mounting feature comprises a hook configured to engage a portion of a projection of an outside surface of the handle of the ultrasound probe, the portion of the projection of the outside surface of the handle facing away from the second end.

[0147] Clause 22. The kit of Clause 17, wherein the second mounting feature is disposed along a side surface of the housing and the coupler comprises a C-shaped cross- section such that an end of the coupler engages the second mounting feature along the side surface of the housing and a concavity of the coupler engages a surface of the handle opposite of a surface upon which the housing is disposed, and wherein sliding the coupler toward the first end causes the coupler to flex when engaging a tapered portion of the handle.

Claims

WHAT IS CLAIMED IS:

1. An ultrasound probe assembly, comprising: a handle having a control dial; a tip comprising an ultrasound element; a shaft having a proximal end coupled with the handle and a distal end coupled with the tip, the shaft having a control element having a proximal end coupled with the control dial and a distal end coupled with the tip; and a motor mounted on the handle, the motor having a transmission assembly comprising a wire coupled with an output shaft of the motor and with the control dial to apply torque to the control dial following movement of the motor.

2. The ultrasound probe assembly of Claim 1, wherein the motor is axially aligned with the handle.

3. The ultrasound probe assembly of Claim 1, wherein the motor is axially aligned with the control dial.

4. The ultrasound probe assembly of Claim 1, wherein the transmission assembly further comprises a gear element having a cycloidal profile.

5. The ultrasound probe assembly of Claim 1, wherein the control dial comprises a first control dial and further comprising a second control dial, the motor comprises a first motor, the transmission assembly further comprises a first transmission assembly, wherein the wire comprises a first wire, the output shaft comprises a first output shaft, and further comprising a second motor mounted on the handle, the second motor having a second transmission assembly comprising a second wire coupled with a second output shaft of the second motor and with the second control dial to apply torque to the second control dial following movement of the second motor.

6. The ultrasound probe assembly of Claim 5, wherein the first wire extends from a pulley coupled with the first motor, the second wire disposed at an elevation between the first wire and a body of the handle.

7. The ultrasound probe assembly of Claim 5, wherein the first motor and the second motor are axially aligned with the handle.

8. The ultrasound probe assembly of Claim 5, wherein the first motor and the second motor are axially aligned with the first control dial and the second control dial.

9. The ultrasound probe assembly of Claim 5, wherein the first motor is positioned between the second motor and the second control dial.

10. A TEE probe assembly, comprising: a manual TEE probe comprising: a handle comprising a handle housing supporting one or more control dials configured to rotate about a rotational axis disposed transverse to the handle, a member having a protrusion at one end and an opposite end disposed on the rotational axis; an actuatable shaft having a proximal end coupled with the handle and a tip opposite the proximal end, the tip comprising an ultrasound element, the one or more control dials configured to actuate the actuatable shaft to deflect the tip; and a motor assembly comprising a motor housing enclosing one or more motors configured to apply a torque to the one or more control dials, the motor housing including a concave portion configured to be placed over the protrusion and to enclose at least a portion of a periphery of the protrusion.

11. The TEE probe assembly of Claim 10 wherein the protrusion is located proximal of the one or more control dials.

12. The TEE probe assembly of Claim 10 wherein relative rotation is prevented when the concave portion is placed over the protrusion.

13. The TEE probe assembly of Claim 12 wherein relative rotation that is prevented is between the motor housing and the handle housing.

14. The TEE probe assembly of Claim 10 wherein the concave portion of the motor housing provides securement between the motor housing and the protrusion.

15. The TEE probe assembly of Claim 14 wherein the securement provided between the motor housing and the protrusion is provided by a loop formed in the motor housing.

16. The TEE probe assembly of Claim 10 wherein the concave portion of the motor housing is placed over the protrusion by relative motion between the protrusion and the concave portion of the motor housing along a direction aligned with the rotation axis.

17. The TEE probe assembly of Claim 10 wherein the member comprises a lever configured to be moved relative to the handle by applying a force to the protrusion prior to the concave portion of the motor housing being placed over the protrusion.

18. The TEE probe assembly of Claim 17 wherein movement of the lever causes a locking mechanism to be in a locked state or an unlocked state, the locked state fixing an orientation of the tip, the unlocked state allowing deflection of the tip.

19. The TEE probe assembly of Claim 18 wherein the concave portion is configured to fence in the protrusion prevent moving the lever to the locked state.

20. The TEE probe assembly of Claim 19 wherein the concave portion comprises a loop.

21. The TEE probe assembly of Claim 19 wherein the concave portion comprises a blind recess comprising a substantial negative shape of the shape of the protrusion.

22. A method of providing for robotic control of a TEE probe assembly, comprising: advancing a handle housing of a handle of the TEE probe assembly toward a motor assembly, the handle housing supporting one or more control dials configured to rotate about a rotational axis disposed transverse to the handle and a member having a protrusion at one end and an opposite end disposed on the rotational axis, the motor assembly comprising a motor housing enclosing one or more motors configured to apply a torque to the one or more control dials; placing a concave portion of the motor housing over the protrusion and to enclose at least a portion of a periphery of the protrusion; and securing the handle to the motor assembly.

23. The method of Claim 22, wherein the TEE probe assembly includes an actuatable shaft having a proximal end coupled with the handle and a tip opposite the proximal end, the tip comprising an ultrasound element, the one or more control dials configured to actuate the actuatable shaft to deflect the tip, the member comprising a lever configured to activate a pose-locking mechanism to limit deflection of the tip from a selected orientation, placing the concave portion of the motor housing over the protrusion prevents the lever from activating the pose-locking mechanism.

24. The method of Claim 22, wherein placing the concave portion of the motor housing over the protrusion comprises placing a loop over the protrusion.

25. The method of Claim 22, wherein placing the concave portion of the motor housing over the protrusion comprises placing a blind recess over the protrusion.

26. The method of Claim 22, wherein securing the handle to the motor assembly comprises applying a load to a side of the handle opposite to a side of the handle supporting the concave portion of the motor housing.

27. A TEE probe assembly, comprising: a handle; an actuatable shaft having a proximal end coupled with the handle and a distal end coupled with a tip comprising an ultrasound element; an actuator operatively coupled to the actuatable shaft and configured to actuate the actuatable shaft; a locking mechanism disposed on the handle and operatively coupled with the actuatable shaft, wherein the locking mechanism is configured to selectively transition between a first state and a second state; and a securement mechanism configured to selectively engage the locking mechanism to prevent the locking mechanism from transitioning between the first state and the second state.

28. The TEE probe assembly of Claim 27, wherein the first state is a locked state and the second state is an unlocked state.

29. The TEE probe assembly of Claim 27, wherein in the first state the locking mechanism prohibits movement of the actuatable shaft and in the second state the locking mechanism permits movement of the actuatable shaft.

30. The TEE probe assembly of Claim 27, wherein the actuatable shaft further comprises a control element for controlling movement of the shaft, wherein the actuator and the locking mechanism are operatively coupled to the control element.

31. The TEE probe assembly of Claim 30, wherein in the first state the locking mechanism engages the control element and in the second state the locking mechanism does not engage the control element.

32. The TEE probe assembly of Claim 27, wherein the securement mechanism is configured to maintain the locking mechanism in the second state.

33. The TEE probe assembly of Claim 27, wherein the securement mechanism maintains the actuatable shaft in an unlocked state.

34. The TEE probe assembly of Claim 27, wherein the securement mechanism comprises a lower engagement surface configured to fence in the locking mechanism and prevents the locking mechanism from transitioning from the first state to the second state.

35. A kit comprising: a motor having a transmission element configured to drive a control dial on a handle of an ultrasound probe; a controller assembly comprising a processor configured to drive the motor; a probe handle adapter having a sheath configured to enclose the handle, a first mounting feature on a first end of the sheath, a second mounting feature on a second end of the sheath, and a housing coupled to the sheath and disposed between the first end and the second end, the housing configured to be disposed over the motor and over the controller assembly; wherein: the motor is positioned between the sheath and the housing and configured to be mounted on the handle in an assembled state; and the first mounting feature is configured to slide over a proximal end of the handle and engage the first end of the sheath to retain the sheath on the handle.

36. The kit of Claim 35, wherein the housing comprises a central opening through which a transmission element coupled with the motor can extend.

37. The kit of Claim 35, wherein the housing comprises a window, wherein a portion of the control dial is covered by the housing while another portion of the control dial is assessable through the window.

38. The kit of Claim 35, wherein the control dial comprises a first control dial and further comprising a second control dial, the motor comprises a first motor, the transmission element comprises a first transmission element, and further comprising a second motor positioned between the sheath and the housing and configured to be mounted on the handle in the assembled state, the second motor having a second transmission element coupled with thesecond control dial to apply torque to the second control dial following movement of the second motor.

39. The kit of Claim 38, wherein the first motor and the second motor are axially aligned with the first control dial and the second control dial, and wherein the first motor is positioned on a first side of the control dial and the second motor is positioned on a second side of the control dial opposite the first side.

40. The kit of Claim 35, wherein the first mounting feature comprises a slot.

41. The kit of Claim 35, wherein the first mounting feature is configured receive and to extend annularly around a cable of the ultrasound probe.

42. A method of converting a manual probe to robotic control, the method comprising: placing a sheath around a handle, the sheath comprising one or more motors; coupling the one or more motors to a corresponding one of one or more control dials disposed on the handle; coupling a housing to the sheath for covering the one or more motors and the one or more control dials; securing a first mounting feature to a distal end of the sheath; and securing a second mounting feature to a proximal end of the sheath.

43. The method of Claim 42, wherein coupling the one or more motors to a corresponding one of the one or more control dials comprises providing a transmission wire between a corresponding output shaft of the one or more motors and the corresponding one of the one or more control dials.

44. The method of Claim 42, wherein securing the first mounting feature to the distal end of the sheath comprises inserting a tip of the manual probe through an opening of the first mounting feature and passing the first mounting feature proximally along a flexible shaft of the manual probe to the distal end of the sheath.

45. The method of Claim 42, wherein securing the second mounting feature to the proximal end of the sheath comprises radially inserting a cable of the manual probe into an opening of the second mounting feature and passing the second mounting feature distally along the cable to the proximal end of the sheath.

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