Abstract:
A remote control catheterization system comprising: a propelling device, which controllably inserts a flexible, elongate probe into the body of a patient; and a control unit, in communication with the propelling device, and comprising user controls which are operated by a user of the system remote from the patient to control insertion of the probe into the body by the propelling device, wherein the user controls include an intuitive user interface comprising a handle that can be moved longitudinally, forward and back along a longitudinal axis, and also can be moved rotationally, in rotation around the longitudinal axis; the intuitive user interface comprising motion sensors that detect longitudinal motion and rotational motion of the handle and convert them to signals; and signal communication circuitry that communicates the signals to the control unit for commanding the propelling device to move the probe in respective direction and distance as the handle.

Description:
FIELD OF THE INVENTION 
       [0001]    The present invention relates generally to invasive medical probes and methods, and specifically to intravascular catheterization and catheterization techniques. 
       BACKGROUND OF THE INVENTION 
       [0002]    Catheters are used for many medical procedures, including inserting a guide wire, delivering a stent, and delivering and inflating a balloon. 
         [0003]    Catheterization procedures are very commonly performed for diagnosis and treatment of diseases of the heart and vascular system. The catheterization procedure is generally initiated by inserting a guide wire into a blood vessel in the patient&#39;s body. The guide wire is then guided to the desired location, most commonly in one of the heart vessels or elsewhere in the vascular system. At this point the catheter is slid over the guide wire into the blood vessel and/or heart. Once the catheter is in the desired position, the guide wire can then be removed, leaving the catheter in location. Alternatively, in some procedures, the catheter is inserted without using a guide wire. The catheter may be used to pass ancillary devices into the body, such as an angioplasty balloon, or to perform other diagnostic or therapeutic procedures. 
         [0004]    In order to facilitate the guide wire insertion and the subsequent catheter application, the physician generally performs the procedure with the assistance of a fluoroscope, as is well known in the art. The fluoroscope produces a real-time image showing the continued progress of the guide wire, or the catheter, through the patient&#39;s body. 
         [0005]    The fluoroscope generates a high level of X-ray radiation, which poses a significant danger to medical personnel exposed thereto, as is well known in the art. In order to provide protection from radiation exposure, the attending medical personnel generally wear a heavy, cumbersome protective lead garment which covers the entire body and neck, or use various lead shields including transparent glass face and eye shields. 
         [0006]    It is desirable to know the precise linear and rotational state of the catheter. Japanese patent no. 2000-010467 (2000) by Tokai Rika Co Ltd. et al, “CATHETER OPERATION SIMULATOR AND SIMULATION METHOD USING THE SAME” mentions a catheter operation simulator characterized by having an insertion/rotation detection sensor which outputs detected insertion/rotation data, providing the amount of insertion and rotation of a catheter tube. However the Tokai Rika patent is focused on simulation and provides only position feedback—not active means for controlling position. 
         [0007]    One way to improve control of the catheter is to provide a control system that moves the catheter via motors. One such system is described in PCT publication no. WO/99/45994 (1999), by Dalia Beyar “REMOTE CONTROL CATHETERIZATION”, which describes a remote control catheterization system including a propelling device, which controllably inserts a flexible, elongate probe into the body of a patient. A control console, in communication with the propelling device, includes user controls which are operated by a user of the system remote from the patient to control insertion of the probe into the body by the propelling device. 
         [0008]    It is an object of some aspects of the WO/99145994 invention to provide apparatus and methods of catheterization that allow medical personnel to be distanced from the vicinity of the fluoroscope and its resultant radiation, thereby reducing radiation exposure of the personnel. It is a further object of some aspects of the WO/99145994 invention to provide a mechanism for remote control performance of catheterization procedures. 
         [0009]    The present invention is intended to provide an intuitive user interface to a remote control catheterization system, such as WO99/45994. The present invention is based on a handle element that provides the user with an experience that closely resembles actual insertion and rotation of a catheter or guide wire. More specifically, the present invention enables the user to move the handle along a longitudinal axis and around that axis, thereby emulating the primary types of motion associated with insertion of a catheter or guide wire (herein “catheter” applies equally for a catheter or a guide wire). 
         [0010]    In a preferred embodiment of the present invention, the user&#39;s movement of the handle is translated by the system to movement of the catheter. 
         [0011]    In a preferred embodiment of the present invention, feedback from the catheter is converted by the invention to tactile forces acting on the handle. 
         [0012]    In a preferred embodiment of the present invention, the translation (handle to catheter) ratio and the tactile feedback (catheter to handle) ratio are user-controlled. 
         [0013]    In a preferred embodiment of the present invention, indicators and controls, are included on the base of the handle or in proximity. 
         [0014]    In a preferred embodiment of the present invention, a safety mechanism is provided to ensure that the handle does not move the catheter accidentally. 
         [0015]    In summary, it is a main object of the present invention to provide a user interface for remote control catheterization with the following several objects and advantages:
       easy to grasp   provides operator with safe, intuitive, precise control of linear and rotational movement of the catheter   provides the operator with tactile feedback regarding forces acting on the catheter   provides operator with means for varying the scaling of the control signals sent and feedback received   provides operator with easy access to controls for catheter operations, such as injecting a contrasting agent or inflating a balloon.       
 
         [0021]    Still further objects and advantages will become apparent from a consideration of the ensuing description and drawings. 
       BRIEF DESCRIPTION OF THE INVENTION 
       [0022]    There is thus provided, in accordance with some preferred embodiments of the present invention, a remote control catheterization system comprising: a propelling device, which controllably inserts a flexible, elongate probe into the body of a patient; and a control unit, in communication with the propelling device, and comprising user controls which are operated by a user of the system remote from the patient to control insertion of the probe into the body by the propelling device, wherein
       the user controls include an intuitive user interface comprising a handle that can be moved longitudinally, forward and back along a longitudinal axis, and also can be moved rotationally, in rotation around the longitudinal axis;   the intuitive user interface comprising motion sensors that detect longitudinal motion and rotational motion of the handle and convert them to signals; and signal communication circuitry that communicates the signals to the control unit for commanding the propelling device to move the probe in respective direction and distance as the handle.       
 
         [0025]    Furthermore, in accordance with some preferred embodiments of the present invention, the intuitive user interface is further provided with positioners that move the handle longitudinally, forward and back along its longitudinal axis, and move it rotationally, in rotation around its longitudinal axis, and wherein:
       the remote control catheterization system includes at least one sensor that detects forces acting longitudinally or rotationally upon the probe and communicates this feedback information to the control console;   the control console is adapted to convert the feedback to commands for the positioners and send the commands to the signal communication circuits; and   the signal communication circuits are adapted to receive the commands from the processing device and send them to the positioners, which apply longitudinal or rotational forces upon the handle that replicate the longitudinal or rotational forces experienced by the probe.       
 
         [0029]    Furthermore, in accordance with some preferred embodiments of the present invention, the intuitive user interface is further provided with a fail-safe mechanism that, when activated, allows communication between the intuitive user interface and the control console and that, when deactivated, prevents the communication. 
         [0030]    Furthermore, in accordance with some preferred embodiments of the present invention, the fail-safe mechanism is implemented as a switch that is activated when the handle is lifted up. 
         [0031]    Furthermore, in accordance with some preferred embodiments of the present invention, the fail-safe mechanism is implemented as two contacts in the handle that are activated when brought into contact. 
         [0032]    Furthermore, in accordance with some preferred embodiments of the present invention, the system is further equipped with a return mechanism that, upon operator release of the handle, returns the handle to an initial longitudinal and rotational position. 
         [0033]    Furthermore, in accordance with some preferred embodiments of the present invention, the return mechanism is engaged by operator-controlled switching. 
         [0034]    Furthermore, in accordance with some preferred embodiments of the present invention, the intuitive user interface is further equipped with a support base. 
         [0035]    Furthermore, in accordance with some preferred embodiments of the present invention, the intuitive user interface is further equipped with operator-controlled amplification circuitry that can adjust the ratio of handle movement command sent to the probe and the force feedback from the probe to the handle. 
         [0036]    Furthermore, in accordance with some preferred embodiments of the present invention, the intuitive user interface is further equipped with operator-controlled switches that move the handle in precise, operator-defined steps. 
         [0037]    Furthermore, in accordance with some preferred embodiments of the present invention, the intuitive user interface is further equipped with operator-controlled switches for controlling the handle&#39;s stiffness. 
         [0038]    Furthermore, in accordance with some preferred embodiments of the present invention, the intuitive user interface is further equipped with operator-controlled switches for controlling the ratio of handle speed to catheter speed. 
         [0039]    Furthermore, in accordance with some preferred embodiments of the present invention, the intuitive user interface is further equipped with operator-controlled switches that send control signals via the signal communication circuits to command probe operations, including:
       inflating a balloon;   injecting contrast agent.   deploying a stent       
 
     
    
     
       BRIEF DESCRIPTION OF THE FIGURES 
         [0043]    The invention is described herein, by way of example only, with reference to the accompanying Figures, in which like components are designated by like reference numerals. 
           [0044]      FIG. 1  is a view of the intuitive user interface of a remote control catheterization system, in accordance with a preferred embodiment of the present invention. 
           [0045]      FIG. 2  is an external view of the intuitive user interface of a remote control catheterization system, in accordance with a preferred embodiment of the present invention. 
           [0046]      FIG. 3  is a view of the primary components of the intuitive user interface of a remote control catheterization system, in accordance with a preferred embodiment of the present invention. 
           [0047]      FIG. 4  is a block diagram for a method of intuitive user operation of a remote control catheterization system, in accordance with a preferred embodiment of the present invention. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0048]    The present invention discloses a remote control catheterization system and method employing an intuitive user interface. Such a system controllably inserts an elongate probe, typically a catheter, into a patient&#39;s body. For the purpose of the present invention “catheter” and “probe” are used to refer to any type of device that is inserted in a patient&#39;s body in a catheterization process. 
         [0049]    The present invention provides a remote control catheterization system or method, such as that of PCT publication no. WO/99/45994 (1999), by Dalia Beyar “REMOTE CONTROL CATHETERIZATION”, which is included herein by reference. The innovation of the present invention is the user interface that it provides. While the user interface of the present invention is particularly suited for integration with WO/99/45994, it can generally be used with any remote control catheterization system or method. 
         [0050]    Reference is now made to  FIG. 1 , which is a simplified, pictorial illustration of a remote control catheterization system  20 , in accordance with a preferred embodiment of the present invention. The invention of WO/99/45994 is summarized as follows: 
         [0051]    System  20  comprises a guiding catheter  26 , which is fed via a cannula  42  into a blood vessel  44  leading to a target location in a vessel or a heart  24  of a patient  22 . 
         [0052]    Preferably, the catheter is fed over a guide wire, which is omitted in  FIG. 1  for simplicity. 
         [0053]    Catheter  26  is fed through a catheter propelling device  28 , and then coupled proximally with a catheter interface  30 . 
         [0054]    Interface  30  may be used to perform various therapeutic and/or diagnostic catheter procedures, such as balloon inflation or injection of contrast media, or any other such catheter-based treatments known in the art. A fluoroscope  32  is used to capture images showing the position of catheter  26  in the patient&#39;s body. (For simplicity, the X-ray tube associated with the fluoroscope is not shown in the figure.) Propelling device  28 , interface  30  and fluoroscope  32  all communicate with a control console  34 . The various elements of system  20  relay operative information to console  34 , and receive operative instructions from the console. Preferably, device  28  relays to console  34  force measurements associated with insertion of the catheter and an indication of the distance that the catheter has traveled; interface  30  relays applicable data from the catheter regarding the therapeutic and/or diagnostic procedures being performed; and fluoroscope  32  conveys X-ray images. 
         [0055]    The data are preferably displayed on console  34  via a pair of displays, monitors  36 . Preferably, one of monitors  36  displays fluoroscopic images, and the other monitor displays data [RECEIVED] from propelling device  28  and interface  30 . 
         [0056]    Alternatively, the data may be presented using dials, meters, or any means known and used in the art. 
         [0057]    Console  34  also includes a user-interface peripheral device  38  and a speed-direction interface device (which replaces all or part of tactile control unit 40 of WO/99145994). Medical personnel operating system  20  use device  38 , preferably a keyboard, to send directional commands, for example to control table and fluoroscope motions, and to operate interface  30  and fluoroscope  32 . intuitive user interface device  50 , preferably a handle with tactile and speed feedback, sends directional and speed instructions to propelling device  28 . Optionally, it can include all or some of the controls that are otherwise implemented in peripheral device  38 . 
         [0058]    In order to prevent exposure by medical staff to the fluoroscope&#39;s high levels of radiation, console  34  is preferably located outside of the catheterization room or in an area of the room that is shielded from radiation generated by the fluoroscope X-ray tube. The present invention, via this usage of remote control communication with console  34 , thus furnishes the medical staff with all the relevant information, and all the relevant remote control means, to perform the catheterization operation without danger of radiation exposure. 
         [0059]    Alternatively or additionally, console  34 , or certain elements thereof, may be in a remote location, even in a different city from the patient, and communicate with the other elements of system  20  over telecommunication channels. As noted above with reference to  FIG. 1 , cannula  42  is inserted into blood vessel  44 . Preferably a guide wire (not shown) is threaded through cannula  42  into vessel  44 . Once the guide wire is in a desired position, catheter  26  is slipped over guide wire  46  and guided to a desired position, for example, in one of the chambers of heart  24  or in one of the coronary arteries. 
         [0060]    Once catheter  26  is in place, guide wire  46  may be withdrawn if desired. An ancillary instrument (not shown), such as an angioplasty balloon, may be passed through the catheter, into the heart or arteries. The guide wire, catheter and ancillary instrument are themselves substantially similar to devices of these types known in the art. 
         [0061]    The intuitive user interface device  50  of the present invention electronically communicates with the control console  34 . A primary use of device  50  is to convert an operator&#39;s movements into signals to the control console  34  from whence they are translated into control signals to catheter propelling device  28 , thereby controlling movement of the catheter  26  inside patient  22 . 
         [0062]    If the catheter is equipped with sensors that detect forces on the catheter, these can be relayed by the control console  34  to the device of the present invention  50 , which can be further equipped to translate those signals into calibrated forces on the device, thereby transmitting to the device operator a tactile sense of what is happening to the catheter. 
         [0063]    The device can be further equipped with controls enabling the operator to activate various catheter functions, such as balloon inflation, guide wire delivery, or stent insertion. 
         [0064]    The components of intuitive user interface device  50  are now described with reference to  FIG. 2  (external view) and  FIG. 3  (internal view). 
         [0065]    The primary component of device  50  is an element that is capable of translating to the catheter an operator&#39;s linear movement along its longitudinal axis as well an operator&#39;s rotational movement around about that axis. In a preferred embodiment, this element is a handle  7 , and the operator is a human operator  25 , such as a skilled physician. However, operation of the device could equally be incorporated into an automated system. 
         [0066]    Handle  7  is grasped by operator  25  at one end, herein the proximal end. The distal end of handle  7  engages other device components that translate handle  7  motion effected by the operator  25  to predetermined movement of catheter  26  (which comprises catheter and system that moves catheter). In a preferred embodiment of this invention, this translation is implemented as follows:
       linear movement towards the handle&#39;s distal end causes the catheter to be proportionally inserted further into the patient;   linear movement away from the handle&#39;s distal end causes the catheter to be proportionally retracted from the patient;   rotational movement in either direction causes the catheter to be proportionally moved in the same rotational direction.       
 
         [0070]    The two types of movement can be effected simultaneously. For example, the operator can turn the handle while at the same time inserting it, and both these motions will translated simultaneously to the catheter. 
         [0071]    The proportion of handle distance moved to catheter distance moved is operator-controlled. 
         [0072]    Intuitive user interface  50  sends data to control console  34  concerning movement of handle  7 . Control console  34  generates drive signals to catheter interface  30  and receives tactile feedback back from interface  30 . Interface circuits between control console  34  and Intuitive user interface  50  device&#39;s several sensors and motors are represented in  FIG. 3  as circuit board  3 . 
         [0073]    Handle  7  can include a fail-safe release that provides a measure of safety by disengaging the system from the handle when not in use. In other words, when the safety is engaged, movement of the handle is not translated to the catheter. This prevents inadvertent or unintended movement of the catheter. In a preferred embodiment of the present invention, the fail-safe release is implemented as a metal fail-safe contact  1  physically connected to handle  7 . When handle  7  is not in use, contact  1  lies in contact with fail-safe sensor  2 , thereby closing the fail-safe circuit, which disengages the handle from the system. When operator  25  operates the handle, he (he refers herein to he or she) lifts up the handle, thereby breaking the fail-safe circuit and reengaging the system. A secondary aspect of reengaging the system is for control console  34  to start measuring handle movement (via feedback from transducers  4  and  5  as described later). 
         [0074]    In an alternative preferred embodiment of the present invention, the fail-safe activation circuit can be implemented as one of controls  15 . 
         [0075]    In another alternative embodiment of the present invention, handle  7  can be implemented as two strips that also perform the fail-safe function. When operator  25  squeezes the handle, bringing the strips into contact, it activates a circuit that engages the system. 
         [0076]    Rotational movement of handle  7  is detected by rotation transducer  4  (which can be a potentiometer, encoder, or other device measuring movement and translating the movement into an electrical signal), which sends a corresponding signal via circuits  3  to control console  34 . 
         [0077]    Linear movement of handle  7  turns linear movement detector wheel  9 , which in turn moves linear transducer  5  (which can be a potentiometer, encoder, or other device measuring movement and translating the value into an electrical signal), which sends a corresponding signal via circuits  3  to control console  34 . 
         [0078]    In a preferred embodiment of the present device, catheter propelling device  28  is equipped to detect forces acting on the distal end of the catheter  26  (inside the patient) during the catheterization procedure. Feedback motors (or other positioner device)  21  and  22 , on the handle&#39;s  7  linear and rotational axes of movement, provide feedback to the operator  25 , transferring forces detected on the catheter to the handle. The feedback motor mechanism can be activated/deactivated by operator  25 , through controls  15  or similar means. 
         [0079]    Feedback motors  21  and  22  enable the operator  25  to feel what is happening to the catheter as he or she navigates it. The feedback force translation can be a ratio of 1:1 or scaled. For example, if the operator  25  wants to more easily detect small forces acting on the catheter, the motors can multiply the force translated to the handle. 
         [0080]    In addition to providing feedback about the catheter, motors  21  and  22  can be calibrated by the operator  25  to determine the handle&#39;s  7  level of stiffness along each axis of movement (linear and rotational). For example, the stiffness can be calibrated to increase proportionally to the amount of opposing force experienced by the catheter. 
         [0081]    Handle  7  is optionally further equipped with return components which return the handle to its original position when the operator  25  releases the handle. The return can be effected with dedicated components, such as motors or springs, or integrated into the feedback motors and their control circuit. In a preferred embodiment, return component is implemented as springs  13  and  14 . Return of the handle to its original position does not have to be coupled to the catheter, in other words, the catheter is not moved when the handle returns to its zero. However, this type of linkage can be left to operator discretion, as expressed via controls  15  or similar means. 
         [0082]    Handle  7  is further equipped with handle controls  15  for operator  25  interaction with control console  34  and catheter  26 . Controls can include:
       Engaging handle—acting as a safety switch that must be activated for the handle to affect the catheter   Controlling linkage of handle and catheter, for example, determining that catheter is not affected when return mechanism returns handle to zero.   Determining the amount of force feedback for each type of movement (linear and rotational)   Determining the amount of stiffness   Determining the ratio of catheter movement to handle movement. For example, the operator  25  could choose a 1:10 ratio in which case a 1 cm handle movement would move the catheter 1 mm.   Determining the ratio of catheter speed to handle speed. For example, the operator  25  could choose a 10:1 ratio, in which case 1 cm/s of handle speed is translated into 1 mm of catheter speed.   Moving in incremental steps of operator-determined size, for example, moving the handle (and catheter) 1 cm on each activation of the control.   Activating catheter operations, for example, injecting contrast agent.   Activating a device in the catheter, for example, inserting a stent or inflating a balloon.   Inserting a guide wire.   Changing the target of the device activation function from one device to another, for example, from a guide wire to a stent.       
 
         [0094]    Device operation is now described with reference to  FIG. 4 . 
         [0095]    Operator  25  moves handle  7  in desired linear and/or rotational direction. Linear transducer  4  and rotational transducer  5  each transmit a signal via integration circuit  3  to control console  34 , which translates the movement to motorized catheterization system  26 . The translated movement can be scaled, according to how operator  25  sets controls  15 . As catheter  26  moves, it encounters forces from obstacles and other characteristics of its path. Catheterization system  26  relays this information to control console  34 , which translates the signals into control signals for linear feedback motor  21  and rotary feedback motor  22 , which apply feedback force in same direction as that experienced by catheter to handle  7 . Again, the feedback force can be direct or scaled, according to operator  25  preference. 
         [0096]    It should be clear that the description of the embodiments and attached Figures set forth in this specification serves only for a better understanding of the invention, without limiting its scope as covered by the following Claims. 
         [0097]    It should also be clear that a person skilled in the art, after reading the present specification could make adjustments or amendments to the attached Figures and above described embodiments that would still be covered by the following Claims.