Abstract:
A replica control tool ( 70 ) for remotely controlling a control handle ( 71 ) of an interventional tool (e.g., a probe, a catheter and a flexible scope) robotically controlled by a robotic actuator ( 50 ). The replica control tool ( 70 ) employs a replica control handle ( 71 ) substantially being a replica of a structural configuration of the control handle ( 71 ) of the interventional tool, and a control input device ( 72 ) (e.g., a joystick or a trackball) movable relative to the replica control handle ( 71 ). The replica control tool ( 70 ) further employs a robotic actuator controller ( 75 ) for remotely controlling the robotic actuator ( 50 ) in response to any movement of the control input device ( 72 ) relative to the replica control handle. The replica control tool ( 70 ) may further employ an electromechanical device ( 73 ) (e.g., an accelerometer) co-rotatable with the replica control handle ( 71 ) whereby the controller ( 75 ) remotely controls the robotic actuator ( 50 ) in response to a rotation of the electromechanical device ( 73 ).

Description:
FIELD OF THE INVENTION 
       [0001]    The present invention generally relates to transeesophageal echocardiography (“TEE”) probes. The present invention specifically relates to a remote robotic actuation of the TEE probe during an interventional procedure. 
       BACKGROUND OF THE INVENTION 
       [0002]    Transeesophageal echocardiography is commonly used to visualize cardiac anatomy and interventional devices during treatment for structural heart disease (“SHD”).  FIG. 1  shows a typical distribution of theatre staff within a lab room  10   a  having an ultrasound workstation  11  and an x-ray scanner, of which a c-arm  12  is shown. During a SHD operation, an echocardiographer  13  holds a TEE probe  14 , which passes through a mouth of a patient  16  into an esophagus to visualize a heart of patient  16 . A cardiologist  15  is located on an opposite side of x-ray c-arm  12  and an operating table  17 . Cardiologist  15  navigates interventional devices (not shown) (e.g., catheters and guidewires) from arterial incisions into the heart under x-ray guidance and ultrasound guidance via TEE probe  14  in order to perform different diagnostic or therapeutic procedures. Exemplar procedures, such as mitral clip deployments or transcatheter aortic valve replacements (“TAVR”), can be time consuming and complex. Moreover, ensuring appropriate visualization of the target anatomy during the procedure is the responsibility of echocardiographer  13 , who must make constant small adjustments to a position of a tip of TEE probe  14  for the duration of the procedure. 
         [0003]    In practice, the operating conditions of  FIG. 1  present several challenges. The first challenge is fatigue and poor visualization. Specifically, appropriate visualization includes both ensuring the relevant anatomical structures are within the field of view, and that the necessary contact force between the transducer head and esophageal wall, to achieve adequate acoustic coupling, is achieved. To this end, a position and an orientation of a head of TEE probe  14  requires constant, minute adjustments for the duration of the procedure in order to maintain appropriate visualization of the target structures. This can lead to fatigue and poor visualization by echocardiographer  13  during long procedures. 
         [0004]    The second challenge is x-ray exposure. Specifically, a length of TEE probe  14  results in the positioning of echocardiographer  13  in close proximity to the source of interventional x-ray system, thus maximizing the x-ray exposure of echocardiographer  13  over the course of the procedure. 
         [0005]    The third challenge is communication and visualization. During certain phases of a procedure, cardiologist  15  and echocardiographer  13  must be in constant communication as cardiologist  15  instructs echocardiographer  13  as to which structure to visualize. Given the difficultly interpreting a 3D ultrasound volume, and the different co-ordinate systems displayed by the x-ray and ultrasound systems, it can be challenging for echocardiographer  13  to understand the intentions of cardiologist  15 . 
       SUMMARY OF THE INVENTION 
       [0006]    The present invention provides a remote robotic actuation system to address these challenges. Generally, as shown in  FIG. 2 , a new distribution of theatre staff within a lab room  10   b  with the remote robotic actuator system employing a robotic workstation  20 , a robotic actuator  30 , and a replica TEE control tool  31  and for remote actuation of between two (2) degrees of freedom and (4) degrees of freedom of TEE probe  14  which adjust the ultrasound imaging volume of TEE probe  14 . Additionally, as will be further described herein, replica TEE control tool  31  may have the ability to be employed for use with existing and various types of robotic actuators  30 , and may have the ability to be rapidly disengaged from robotic actuator  30  should echocardiographer  13  decide to return to manual operation of TEE probe  14  for any reason. 
         [0007]    One form of the present invention is a replica control tool for remotely controlling a robotic actuator that robotically controls a control handle of an interventional tool (e.g., a probe, a catheter, flexible scopes, etc.), which in turn actuates a distal end of the interventional tool. The replica control tool employs a replica control handle substantially being a replica of a structural configuration of the control handle of the interventional tool, and a control device (e.g., a joystick or a trackball) movable relative to the replica control handle. The replica control tool further employs a robotic actuator controller for remotely controlling the robotic actuator responsive to any movement of the control device relative to the replica control handle. The replica control tool may further employ an electromechanical device (e.g., an accelerometer) co-rotatable with the replica control handle whereby the robotic actuator controller further remotely controls the robotic actuator in response to a rotation of the electromechanical device. 
         [0008]    For purposes of the present invention, the term “controller” broadly encompasses all structural configurations of an application specific main board or an application specific integrated circuit housed within or linked to a computer or another instruction execution device/system for controlling an application of various inventive principles of the present invention as subsequently described herein. The structural configuration of the application controller may include, but is not limited to, processor(s), computer-usable/computer readable storage medium(s), an operating system, peripheral device controller(s), slot(s) and port(s). Examples of a computer include, but are not limited to, a server computer, a client computer, a workstation and a tablet. 
         [0009]    A second form of the present invention is a robotic actuation system employing the robotic actuator and the replica control tool. 
         [0010]    The foregoing forms and other forms of the present invention as well as various features and advantages of the present invention will become further apparent from the following detailed description of various embodiments of the present invention read in conjunction with the accompanying drawings. The detailed description and drawings are merely illustrative of the present invention rather than limiting, the scope of the present invention being defined by the appended claims and equivalents thereof. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0011]      FIG. 1  illustrates an exemplary manual actuation of a TEE probe as known in the art. 
           [0012]      FIG. 2  illustrates an exemplary embodiment of a remote controlled actuation of a TEE probe in accordance with the present invention. 
           [0013]      FIG. 3  illustrates an exemplary embodiment of a robotic actuation system in accordance with the present invention. 
           [0014]      FIG. 4  illustrates an exemplary mapping of various movements of a probe of an TEE probe and a replica TEE control tool in accordance with the present invention. 
           [0015]      FIG. 5  illustrates an exemplary embodiment of a robotic actuator and a replica TEE control tool in accordance with the present invention. 
           [0016]      FIG. 6  illustrates an exemplary embodiment of the replica TEE control tool shown in  FIG. 5  in accordance with the present invention. 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0017]    To facilitate an understanding of the present invention, exemplary embodiments of a robotic actuation system of the present invention and various components therefore will now be described in the context of a remote control actuation of a TEE probe as shown in  FIG. 3 . From these descriptions, those having ordinary skill in the art will appreciate how to apply the principles of a robotic actuation system of the present invention to any suitable designs of ultrasound probes for any type of procedure as well as other tendon driven flexible interventional tools (e.g., a catheter, an endoscope, a colonoscope, a gastroscope, a bronchosope etc.). 
         [0018]    For purposes of the present invention, the terms of the art including, but not limited to, “deflection”, “joystick”, “accelerometer”, “light emitting diode”, “actuation”, “robotic”, “robotic actuator”, “workstation”, “input device” and “electromechanical device” are to be interpreted as known in the art of the present invention. 
         [0019]    Referring to  FIG. 3 , a TEE probe  40  as known in the art employs an elongated probe  41  and a control handle  42  having a yaw actuation dial  43  for adjusting a yaw degree freedom of a distal tip of probe  41  and a pitch actuation dial  44  for adjusting a pitch degree freedom of the distal tip of probe  41 . 
         [0020]    A robotic actuator  50  as known in the art provides a mechanical control of yaw actuation dial  43  and pitch actuation dial  44  for deflecting the distal tip of probe  41  in an anterior direction, a posterior direction, a lateral left direction, a lateral right direction or a combination thereof. 
         [0021]    Robotic actuator  50  as known in the art may further provide a mechanical control of a translation along and/or a rotation about a longitudinal axis of TEE probe  40  as symbolically shown by the dashed line extending through TEE probe  40 . 
         [0022]    A robotic workstation  62  as known in the art has controller(s) installed therein for communicating control commands to robotic actuator  50  via an operator&#39;s use of an interface platform  61 . Typically, the operator will interact with interface platform  61  to strategically navigate probe  41  via selective deflections, translations and/or rotations of probe  41  within a patient as illustrated by on overlay of probe  41  on a x-ray image or other volume image displayed by a monitor  60 . 
         [0023]    The present invention provides a replica TEE control tool  70  having a replica control handle  71  substantially being a replica of a structural configuration of TEE control handle  42 . In practice, replica control handle  71  may be constructed in the same manner as TEE control handle  42  with the inside of replica control handle  71  being hollowed out for placement of electronic, electromechanical, mechanical and/or other components for implementing the inventive principles of the present invention. 
         [0024]    One such inventive principle of the present invention is the replacement of dials  43  and  44  with a control input device  72  including, but not limited to, duplicates of dials  43  and  44 , a two-axis thumb joystick and/or a two-axis tracker ball. Control input device  72  allows for an easy and more intuitive control of probe  41 . Specifically, lateral left-right motion of control input device  72  is mapped to a lateral left-right deflection of probe  41 , and an up-down motion of control input device  72  is mapped to an anterior-posterior deflection of probe  41 . 
         [0025]    For example, referring to  FIG. 4  with control input device  72  in the form of a joystick:
       (1) an up +Z motion of the joystick is mapped to an anterior deflection of probe  41  as shown (or alternatively mapped to a posterior deflection of probe  41 )   (2) a down −Z motion of the joystick is mapped to the posterior deflection of probe  41  as shown (or alternatively mapped to the anterior deflection of probe  41 );   (3) a lateral left −X motion of the joystick is mapped to a lateral left deflection of probe  41  as shown;   (4) a lateral left +X motion of the joystick is mapped to a lateral right deflection of probe  41  as shown;   (5) a left upward motion of the joystick is mapped to a left anterior deflection of probe  41  as shown (or alternatively mapped to a left posterior deflection of probe  41 );   (6) a right upward motion of the joystick is mapped to a right anterior deflection of probe  41  as shown (or alternatively mapped to a right posterior deflection of probe  41 );   (7) a left downward motion of the joystick is mapped to a left posterior deflection of probe  41  as shown (or alternatively mapped to a left anterior deflection of probe  41 ); and   (8) a right upward motion of the joystick is mapped to a right posterior deflection of probe  41  as shown (or alternatively mapped to a right anterior deflection of probe  41 ).       
 
         [0034]    Referring back to  FIG. 3 , in practice, the mapping is stored within robotic workstation  62  whereby motion of the control input device  72  is communicated to robotic workstation  62  for the further communication of control commands to robotic actuator  50  for mapped movement of probe  41 . Concurrently or alternatively, the mapping is stored within replica TEE control tool  70  whereby mapping data is communicated to robotic workstation  62  for the further communication of control commands to robotic actuator  50  for mapped movement of probe  41 . 
         [0035]    Still referring to  FIG. 3 , another inventive principle of the present invention is to install an electromechanical device  73  within replica control handle  71  to co-rotate with replica control handle  71  (i.e., a synchronized rotation of replica control handle  71  and electromechanical device  73  about a longitudinal axis of replica control handle  71  as symbolically shown by the dashed line extending through replica control handle  71 ). In practice, the co-rotation of electromechanical device  73  is communicated to robotic workstation  62  for the further communication of control commands to robotic actuator  50  for a corresponding rotation of probe  41  as exemplary shown in a (9) axial rotation of  FIG. 4 . Concurrently or alternatively, replica TEE control tool  70  generates rotation data indicative of a co-rotation of electromechanical device  73  whereby the rotation data is communicated to robotic workstation  62  for the further communication of control commands to robotic actuator  50  for corresponding rotation of probe  41  as exemplary shown in a (9) axial rotation of  FIG. 4 . 
         [0036]    An unlimited example of electromechanical device is a three-axis accelerometer whereby a rotation of replica control handle  71  may be calculated using the data obtained from the three-axis accelerometer. This calculation may happen either on a microcontroller (not shown) within replica control handle  71  or within the robotic workstation  62 . 
         [0037]    The present invention provides multiple rotation modes, three (3) of which are now described herein. 
         [0038]    Vertical Base Mode. 
         [0039]    If replica control handle  71  is rotated to a certain delineated angle to vertical (e.g., 90° as shown in  FIG. 4 ), then robot actuator  50  rotates probe  41  a corresponding rotational direction. If, for example, replica control handle  71  is rotated clockwise and reaches the desired threshold angle θ, then probe  41  is rotated clockwise, and if replica control handle  71  is rotated counter-clockwise and reaches the delineated threshold angle θ, then probe  41  is rotated counter-clockwise. 
         [0040]    Fail Safe Mode. 
         [0041]    To prevent an accidental rotation of replica control handle  71 , a fail-safe (aka “dead man&#39;s switches”) may be integrated into delineated degree mode of replica control handle  71 . In this mode, robotic actuator  50  does not rotate probe  41  until replica control handle  71  is rotated past the delineated threshold angle and the fail safe is activated. 
         [0042]    Relative Roll Mode. 
         [0043]    A rotation activation of replica control handle  71  records a current roll position of replica control handle  71 , but probe  41  is not actuated at that time. After rotation activation, when replica control handle  71  is then rotated past a delineated threshold angle from that recorded roll angle (e.g., 30°), then robotic actuator  50  rotates probe  41  in the corresponding direction (clockwise or counter-clockwise). 
         [0044]    To facilitate a further understanding of the present invention, embodiments  50   a  and  70   a  of respective robot actuator  50  and replica control tool  70  will now be described herein. 
         [0045]    Referring to  FIG. 5 , robotic actuator  50   a  employs a deflection actuator  51 , an axial translation actuator  52 , and an axial rotation actuator  53 . 
         [0046]    Deflection actuator  51  is mechanically engaged as known in the art with dials  43  and  44  of TEE probe  40 . Workstation  62  provides control commands to motor controller(s) (not shown) of deflection actuator  51  for actuating dials  43  and  44  to execute a deflection of a probe  41  (not shown) of TEE probe  40  corresponding to a mapped motion of control input device  72  of replica control tool  70 . 
         [0047]    Axial translation actuator  52  and axial rotation actuator  53  are mechanically coupled to deflection actuator  51 . 
         [0048]    Axial translation actuator  52  as known in the art may be actuated to translate TEE control handle  42  along its longitudinal axis. Workstation  62  provides control commands to a motor controller (not shown) of axial translation actuator  52  to actuate an axial translation of TEE control handle  42 . 
         [0049]    Axial rotation actuator  53  as known in the art may be actuated to rotate TEE control handle  42  along its longitudinal axis. Workstation  62  provides control commands to a motor controller (not shown) of axial rotation actuator  53  to execute a rotation of TEE control handle  42  corresponding to a mapped rotation of electromechanical device  73  of replica control tool  70 . 
         [0050]    Referring to  FIG. 6 , generally, a solid replica  70   a  of TEE control handle  42  is made by splitting an upper half  71   a  and a lower half  71   b  of TEE control handle  42  whereby electronic components  75   a  and  76   a  may be fitted and placed inside lower half  71   b . Additionally, a hole  78  is made in a top cover  71   c  of lower half  71   b  to allow for a thumb joystick  72   a  to pass there through. 
         [0051]    Lower half  71   b  contains cut-outs to house the electronics including a robotic actuator controller and a communication controller. Specifically, a printed circuit board (“PCB”)  75   a  holds thumb joystick  72  (e.g., a two axis 30KΩ potentiometer) and a three-axis accelerometer (not shown) (e.g., a three-axis accelerometer from STMicroelectronics). PCB  75   a  also contains a robotic actuator controller in the form of a microcontroller chip (e.g., microcontroller manufactured by Renesas) to interpret signals from thumb joystick  72  and the accelerometer and to output data in appropriate format for workstation  62  (e.g., an I 2 C format.) PCB  75   a  may be held securely in place by a PCB holder (not shown for clarity) that is inserted onto a keyed boss (not shown for clarity) on lower half  71   b  of replica control handle  70   a . The PCB holder also holds two membrane switches  74   a  at a 90° angle from the joystick/accelerometer for use as buttons to replicate buttons  45  on TEE probe handle  42  ( FIG. 5 ). 
         [0052]    A second area of lower half  71   b  houses a communication controller  76   a  (e.g., a Teensy 3.0 microcontroller board). Communication controller  76   a  processes the I 2 C input from the joystick, accelerometer, and buttons and output the data over a universal serial bus (“USB”) to workstation  62  either as a simulated serial port or as a game controller, the latter allowing for easy integration into any software application. A channel and hole (not shown) is cut out an end of lower half  71   b  to allow wires to pass from controller  76   a  to workstation  62  and to house a USB connector. 
         [0053]    Alternatively, the communication between replica control handle  70   a  and workstation  62  occurs through a wireless communication instead of wired USB. In the wireless mode, communication controller  76  is implemented as a wireless module (e.g., Bluetooth or Wi-Fi) and a battery pack. This embodiment allows for more freedom of motion and positioning. 
         [0054]    Also alternatively, communication controller  76   a  may be omitted and PCB  75   a  may be equipped with communication components, and the controllers may be installed within workstation  62 . 
         [0055]    In practice, bosses (not shown) may be utilized to properly align cover  71   c  with lower half  71   b , which may be secured to lower half  71   b  via screws. 
         [0056]    Also, upper half  71   a  of replica control handle  70   a  may be solid and integrated with lower half  71   b , or may be hollow and directly attached to lower half  71   b  via a threaded screw connector (not shown). The hollow embodiment of upper half  71   a  prevents replica control handle  70   a  from being top heavy. 
         [0057]    Further, an LED or laser  77  may be placed within a hollow upper half  71   a  (e.g., with in a screw connector) whereby LED or laser  77  lights up to indicate to the user a specific event has occurred. For example, the LED/laser  77  may light up when a button  74   a  is pressed. A multi-color LED may be used to indicate different events. For example, one color may be used to indicate a button  74   a  has been pressed and another color may indicate the delineated threshold angle has been surpassed and TEE probe  40  is being rotated. 
         [0058]    Still further, a vibration mechanism (not shown) may be the assembly to give the clinician/technician haptic feedback. This feedback can be used when specific events are triggered. For example, the replica can be made to vibrate when a button  74   a  is pressed, TEE probe  40  is being actuated, or when the force measure on TEE probe  40  exceeds a chosen threshold. For this embodiment, force feedback requires a force sensing technique implement by TEE probe  40 , either through physical force sensors or by estimation of current forces using the measured currents drawn by the actuating motors. 
         [0059]    Referring to  FIGS. 1-6 , those having ordinary skill in the art will appreciate numerous benefits of the present invention including, but not limited to, an intuitive remote control of a robotic actuator of an interventional tool of any type. 
         [0060]    Furthermore, as one having ordinary skill in the art will appreciate in view of the teachings provided herein, features, elements, components, etc. described in the present disclosure/specification and/or depicted in the  FIGS. 1-6  may be implemented in various combinations of electronic components/circuitry, hardware, executable software and executable firmware, particularly as application modules of a controller as described herein, and provide functions which may be combined in a single element or multiple elements. For example, the functions of the various features, elements, components, etc. shown/illustrated/depicted in the  FIGS. 1-6  can be provided through the use of dedicated hardware as well as hardware capable of executing software in association with appropriate software. When provided by a processor, the functions can be provided by a single dedicated processor, by a single shared processor, or by a plurality of individual processors, some of which can be shared and/or multiplexed. Moreover, explicit use of the term “processor” should not be construed to refer exclusively to hardware capable of executing software, and can implicitly include, without limitation, digital signal processor (“DSP”) hardware, memory (e.g., read only memory (“ROM”) for storing software, random access memory (“RAM”), non-volatile storage, etc.) and virtually any means and/or machine (including hardware, software, firmware, circuitry, combinations thereof, etc.) which is capable of (and/or configurable) to perform and/or control a process. 
         [0061]    Moreover, all statements herein reciting principles, aspects, and embodiments of the invention, as well as specific examples thereof, are intended to encompass both structural and functional equivalents thereof. Additionally, it is intended that such equivalents include both currently known equivalents as well as equivalents developed in the future (e.g., any elements developed that can perform the same or substantially similar function, regardless of structure). Thus, for example, it will be appreciated by one having ordinary skill in the art in view of the teachings provided herein that any block diagrams presented herein can represent conceptual views of illustrative system components and/or circuitry embodying the principles of the invention. Similarly, one having ordinary skill in the art should appreciate in view of the teachings provided herein that any flow charts, flow diagrams and the like can represent various processes which can be substantially represented in computer readable storage media and so executed by a computer, processor or other device with processing capabilities, whether or not such computer or processor is explicitly shown. 
         [0062]    Furthermore, exemplary embodiments of the present invention can take the form of a computer program product or application module accessible from a computer-usable and/or computer-readable storage medium providing program code and/or instructions for use by or in connection with, e.g., a computer or any instruction execution system. In accordance with the present disclosure, a computer-usable or computer readable storage medium can be any apparatus that can, e.g., include, store, communicate, propagate or transport the program for use by or in connection with the instruction execution system, apparatus or device. Such exemplary medium can be, e.g., an electronic, magnetic, optical, electromagnetic, infrared or semiconductor system (or apparatus or device) or a propagation medium. Examples of a computer-readable medium include, e.g., a semiconductor or solid state memory, magnetic tape, a removable computer diskette, a random access memory (RAM), a read-only memory (ROM), flash (drive), a rigid magnetic disk and an optical disk. Current examples of optical disks include compact disk read only memory (CD-ROM), compact disk read/write (CD-R/W) and DVD. Further, it should be understood that any new computer-readable medium which may hereafter be developed should also be considered as computer-readable medium as may be used or referred to in accordance with exemplary embodiments of the present invention and disclosure. 
         [0063]    Having described preferred and exemplary embodiments of novel and inventive replica control tools, (which embodiments are intended to be illustrative and not limiting), it is noted that modifications and variations can be made by persons having ordinary skill in the art in light of the teachings provided herein, including the  FIGS. 1-6 . It is therefore to be understood that changes can be made into the preferred and exemplary embodiments of the present disclosure that are within the scope of the embodiments disclosed herein. 
         [0064]    Moreover, it is contemplated that corresponding and/or related systems incorporating and/or implementing the device or such as may be used/implemented in a device in accordance with the present disclosure are also contemplated and considered to be within the scope of the present invention. Further, corresponding and/or related method for manufacturing and/or using a device and/or system in accordance with the present disclosure are also contemplated and considered to be within the scope of the present invention.