Abstract:
Apparatus for controlling force applied to and for manipulation of a surgical instrument. Movement and/or forces applied to the surgical instrument are preferably sensed within the apparatus. An actuator is preferably used to apply force to the surgical instrument for control and manipulation of the instrument. The apparatus applies variable force feedback to apply force to the surgical instrument in one or more degrees of freedom to provide an enhanced haptic experience to the user.

Description:
STATEMENT OF RELATED APPLICATION(S)  
       [0001]     The present application is a continuation-in-part of co-pending U.S. patent application Ser. No. 10/390,715, filed Mar. 19, 2003, by Gregory L. Merril et al. and entitled, “System and Method for Controlling Force Applied to and Manipulation of Medical Instruments,” which, in turn, is a divisional and claims priority based to U.S. patent application Ser. No. 09/811,358, now U.S. Pat. No. 6,817,973, filed Mar. 16, 2001, by Gregory L. Merril et al. and entitled, “Apparatus for Controlling Force For Manipulation of Medical Instruments,” which claims priority to Provisional Patent Application Ser. No. 60/189,838, filed on Mar. 16, 2000, by Gregory L. Merril et al. and entitled, “System and Method for Controlling Force Applied to and Manipulation of Medical Instruments,” all commonly owned herewith and hereby incorporated by reference herein. 
     
    
     BACKGROUND OF THE INVENTION  
       [0002]     Minimally invasive techniques for providing medical examinations and therapies frequently employ endoscopes, such as a bronchoscope, ureteroscope, or flexible sigmoidoscope. Endoscopes such as these typically employ fiber optic or CCD imaging devices to enable the practitioner to visually inspect otherwise inaccessible areas of the anatomy such as the lungs, the ureter and kidneys, the colon, etc. These endoscopes also typically contain a tube, called the working channel, through which solutions such as anesthetics can be administered and bodily materials such as mucus can be withdrawn, typically via suction. In addition to use in administering and removing liquids or other material, the working channel of an endoscope is used to pass slender instruments to perform other functions at the distal end of the scope, under visual guidance through the endoscope.  
         [0003]     Instruments typically used in this manner include forceps for grasping objects or for pinching and removing small tissue samples, biopsy needles for removing deep tissue samples in the lumen of a needle, snares or baskets for capturing and withdrawing objects such as an aspirated peanut from the lungs or a kidney stone from the calyxes of the kidney, and a wide variety of other tools.  
         [0004]     Manipulation of these tools requires simultaneous manipulation or stabilization of the endoscope, along with manipulation of the working channel tool itself. The endoscope can typically be maneuvered along three, four or more degrees of freedom, including insertion and withdrawal, rotation, and tip flexion in one or two dimensions (up/down and/or left/right). The working channel tool is maneuvered along an additional two or more degrees of freedom, including insertion/withdrawal, rotation, and tool actuation, etc. Tool actuation can include, for example, opening and closing the jaws of a biopsy forceps, controlling the plunge of a biopsy needle, actuating a cauterization or ablation tool, pulsing a laser, or opening and closing a snare or basket. The tasks of manipulating and stabilizing the three or more degrees of freedom of the endoscope, while simultaneously manipulating the multiple degrees of freedom of the working channel tool are difficult to perform, and frequently the practitioner uses an assistant to manipulate one or more of the degrees of freedom, such as working channel tool actuation.  
       BRIEF DESCRIPTION OF THE INVENTION  
       [0005]     The present invention relates to a device or system that extends the functionality of the working channel of an endoscope by adding devices for sensing motion of the working channel tool and for application of motive force to assist the practitioner in manipulation of the instrument in the working channel.  
         [0006]     In one mode of use, the system uses drive wheels driven by a motor or other device to permit the practitioner to quickly exchange working channel tools, by smoothly moving the current tool out of the working channel, and then quickly moving in the new tool to a point just short of exiting the working channel. At this point the practitioner takes over and performs the fine motor skills necessary to move the tool out of the endoscope and into a position to interact with the anatomy. In another mode of operation the physician manipulates tools manually and is provided with tactile guidance via a set of driven or braked drive wheels. One form of guidance is the provision of notification that the tool is approaching the end of the endoscope and is about to emerge from the endoscope. A braking or other tactile force would signal nearing the end of the working channel, enabling the user to move the tool quickly within the working channel without danger of moving the tool too rapidly out of the working channel, thereby reducing the risk of damage or injury to tissue adjacent the distal end of the endoscope.  
         [0007]     In another embodiment, the sensor and drive assembly is coupled to a catheter through which instruments and tools are passed into the vascular system. For instance, in the process of implantation of a heart pacing lead, the cardiologist must make a number of fine adjustments in the position of a guide catheter, then attempt to stabilize it while inserting an additional element through the lumen of the stabilized catheter. In one mode, the sensor/drive assembly is commanded to maintain a position using passive or active braking force. In another mode, the tip of the catheter is instrumented and an active mechanism commands insertion/retraction and roll increments to stabilize the actual position of the distal end.  
         [0008]     In yet another embodiment, the sensor and drive assembly is instrumented with strain gauges or other devices to detect forces encountered at the distal end of the catheter or working channel tool. These forces are then amplified and displayed to the user via a motor or other motive mechanism.  
         [0009]     In another embodiment, the sensor and drive assembly detect and modify motions, for example detecting and filtering out high frequency jitter caused by the user. This superstabilization mode is useful in situations where fine motor control is required.  
         [0010]     In another embodiment, signals from a device inserted in the working channel are used to command the motive device to maintain a particular quality of electrical contact with the anatomy. In this situation, electrical impedance is changed by the force of contact. A desired quality of contact is initially attained by the physician, then the device is commanded to control contact force automatically to maintain the particular quality of contact.  
         [0011]     The above and still further features and advantages of the present invention will become apparent upon consideration of the following detailed description of specific embodiments thereof, particularly when taken in conjunction with the accompanying drawings wherein like reference numerals in the various figures are utilized to designate like components. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0012]     The accompanying drawings, which are incorporated into and constitute a part of this specification, illustrate one or more embodiments of the present invention and, together with the detailed description, serve to explain the principles and implementations of the invention.  
         [0013]     In the drawings:  
         [0014]      FIG. 1   a  illustrates an unmodified endoscope with working channel and working channel tool.  
         [0015]      FIG. 1   b  illustrates an endoscope modified to provide a sensor and control element in accordance with the present invention.  
         [0016]      FIG. 2  illustrates an endovascular tool inserted into the vascular anatomy, combined with a sensor and control element in accordance with the present invention.  
         [0017]      FIG. 3  illustrates an axial motion sensor control element in accordance with the present invention.  
         [0018]      FIG. 4  illustrates addition of a rotational motion sensor and control element to the device in  FIG. 3 .  
     
    
     DETAILED DESCRIPTION  
       [0019]      FIG. 1   a  illustrates an unmodified endoscope of the prior art, showing the endoscope body  2  attached to the endoscope tube assembly  3 . Working channel tool  4  is inserted into working channel orifice  6  in endoscope body  2 . Working channel tool  4  slides through working channel tube  1  and exits the distal end of endoscope tube assembly  3  through working channel orifice  5 .  
         [0020]      FIG. 1   b  illustrates one embodiment of a motion sensor and control element  10  of the present invention, which is affixed to the working channel orifice  6  of an endoscope. Working channel tool  4  passes through motion sensor and control element  10  and through working channel orifice  6 . Normal manipulation and operation of the working channel to possible through the body of motion sensor and control element  10 . Motion sensor and control element  10  can assist in the control of the working channel tool  4 , as exemplified in the embodiments presented below.  
         [0021]     The working tool  4  may be any of a variety of medical instruments used in endovascular procedures, endoscopy or other medical procedures. For example, the working tool can be a guidewire, a catheter, a heart pacing lead, or a stylet. The tool end that enters and operates on or interacts with the body can include one or more of any of a variety of tools, such as a blade, a serrated edge, a biopsy tool, a trocar tip, an ultrasonic tool, a needle, a vibrating tip, a suturing tool, a retractor, an electrosurgical cutter, an electrosurgical coagulator, a forceps, a needle holder, scissors, an irrigator, an aspirator, a medicator, a laser tool, a cryogenic tool, a flexible steering or guiding tip, and/or a camera. For simplicity, the term “working channel” as used herein is intended to refer to any tube that can guide a medical tool, including catheters, tubes, endoscopic working channels, or other channels.  
         [0022]      FIG. 2  illustrates an endovascular application of the motion sensor and control element  10  of the present invention. Motion sensor and control element  10  is coupled to introducer sheath  7  (which can be considered a “working channel” herein), which pierces skin  8  and the wall of blood vessel  9 . Elongated endovascular tool  4  passes through motion sensor and control unit  10 , through introducer sheath  7 , and into the lumen of blood vessel  9 .  
         [0023]      FIG. 3  illustrates one embodiment of sensor and control element  10  which measures the motion of and applies force to the body of the working channel tool  4  in its translational degree of freedom. Motion sensor and control element  10  contains a sensor device for measuring translational motion of the body of working channel tool  4 . As the elongate portion of working channel tool  4  passes between motion sensing and control wheel  18  and idler wheel  13 , it causes rotation of each wheel. Wheel  18  is affixed to shaft  15  of an actuator  12  that is supported by bracket  20 . In turn, transparent optical encoder disk  14  is affixed to the opposite end of motor shaft  15 . Encoder reader  16  passes light through transparent encoder disk  14 . As transparent encoder disk  14  rotates, marks imprinted on the surface pass in front of the light source, occluding alternately light passing through the disk. A plurality of light sensors in encoder reader  16  measure the varying light and dark patterns and determine the amount and direction of rotational motion of encoder disk  14 . Control unit  24  receives motion signals from encoder reader  16  corresponding to translational motion of working channel tool  4 .  
         [0024]     Actuator  12  is operative to provide forces on the working channel tool  4  in its translational degree of freedom, as transmitted by control wheel  18  to the tool  4 . The actuator  12  is controlled by control signals from the control unit  24 . In some embodiments, the control unit  24  can determine the amount of force to be output from actuator  12  by examining the current signals from the encoder reader  16  indicating the current position or motion of the tool  4 , and then control the actuator  12  to output that force. For example, the current position of the tool  4  may indicate when force is to be output and/or the amount of force to be output, as described below.  
         [0025]     Control unit  24  can include a microprocessor, ASIC, or other type of processor or controller, for example. Other types of sensors, besides the optical type of sensor described above, can also be used to sense the position and/or amount of motion of working channel tool  4  to determine insertion distance; for example, analog potentiometers, other types of optical sensors, magnetic sensors, etc., can be used. Some embodiments may use absolute sensors instead of the relative sensor described above; for example, successive markings can be placed on the tool  4  and detected by an optical or other type of detector when the markings are moved past the sensor to determine the position of the tool. Actuator  12  is an electronically-controlled device that modifies the force on the tool  4 . For example, actuator  12  can be a DC motor, stepper motor, moving magnet actuator, voice coil, hydraulic or pneumatic actuator, or a variety of other types of actuators able to output a force on the working tool  4 . Actuator  12  can also be a passive actuator, such as a magnetic particle brake, fluid brake, or other form of brake, which causes a controllable resistance to motion of the tool  4  based on control signals from control unit  24 . Multiple actuators  12  may also be used, of same or differing types.  
         [0026]     In one mode of the present invention, the total distance of insertion of the working channel tool is measured and controlled by the motion sensor and control element. For example, control unit  24  can be provided with, or can measure (using the sensor) the total insertion distance of working channel tool  4 . This distance can be used in assisting control of the tool  4 . For example, the user or practitioner can manually move the tool  4  within the working channel. However, when a preset limit, point, or distance is approached by the front (distal) end of the tool, such as the exit point of the channel, control signals can be transmitted to actuator  12  to produce torque necessary to slow and then halt further motion of motion sensing and control wheel  18 , thereby slowing and then halting further insertion of working channel tool  4 .  
         [0027]     In other modes of operation, if the practitioner inserts a tool into the working channel, the actuator  12  can be used to move the tool  4  into and through the working channel, to a point just short of exiting the channel, so that the tool is then ready for manual use by the practitioner, i.e. the practitioner then moves the tool out of the endoscope and into a position to interact with the anatomy. The control unit  24  can use the signals from sensor of the element  10  to determine the position of the tool. In some embodiments, the drive wheel driven by actuator  12  can permit the practitioner to quickly exchange working channel tools, by smoothly moving a current tool out of the working channel, and then quickly moving in the newly-inserted tool to a point just short of exiting the working channel at its other end.  
         [0028]     In yet another mode of operation, the physician can manipulate the tools manually and is provided with tactile guidance via the actuator  12 . One form of guidance is the provision of a haptic notification that the tool is approaching or has approached a desired location or has traveled a predetermined distance. For example, the haptic notification can indicate that the tool has reached the end of the working channel or catheter and is about to emerge from the channel. A braking or resistive force, or other tactile force, can signal that the tool is nearing the end of the working channel, enabling the user to move the tool quickly within the working channel without danger of moving the tool too rapidly out of the working channel, thereby reducing the risk of damage or injury to tissue adjacent the distal end of the endoscope. The notification can take a variety of forms, from a single pulse of resistance, a barrier force (continuing resistive force), a vibration, damping force (having a magnitude based on velocity of the tool in one or more directions), spring force, a series of particular jolts or actuated detents, etc. In another embodiment, the notification can indicate each increment or predetermined distance that the tool has been moved by the user. For example, a detent, vibration, or jolt can be output by actuator  12  for each 10 centimeters that the tool is moved into the working channel, or the notification can occur at half or quarter points along the channel.  
         [0029]     In another embodiment, the sensor and control element  10  can provide forces on a catheter through which instruments and tools are passed into the vascular system. For instance, in the process of implantation of a heart pacing lead, the cardiologist must make a number of fine adjustments in the position of a guide catheter, then attempt to stabilize it while inserting an additional element (such as a lead tool) through the lumen of the stabilized catheter. In one mode, the sensor and control element  10  can be commanded to output forces on the catheter to maintain it at a desired position using passive or active force from actuator  12 . In another embodiment, the tip of the catheter can be instrumented and an active mechanism may command insertion/retraction and roll increments of the catheter to stabilize the actual position of the distal end.  
         [0030]     In another embodiment, the sensor and control element  10  can detect and modify motions of the working tool  4 . For example, the sensor of element  10  can detect high frequency jitter caused by the user, based on short, undesired motions or oscillations the user may be conveying to the tool. These motions can then be filtered out after being detected by providing a force in the opposite direction by actuator  12  to cancel or reduce the magnitude of the jitter. This superstabilization mode can be useful in situations where fine motor control is required.  
         [0031]     In another embodiment, signals from a device or tool inserted in the working channel are used to command the motive device/tool to maintain a particular quality of electrical contact with the anatomy, e.g. in a heart pacing lead application. For this type of situation, electrical impedance is typically changed if the magnitude of the force of contact of the tool with the anatomical part is changed. The present invention can be used to maintain or achieve a desired quality of contact (or contact force). For example, a desired quality of contact can be initially attained by the physician using the tool manually. Then, the sensor and control element  10  can be commanded to control the contact force automatically to maintain that particular quality of contact by detecting the electrical impedance resulting from the desired contact; if the electrical impedance goes above or below a desired threshold, the force on the tool from actuator  12  is adjusted to provide the desired electrical contact. Other embodiments may use a force sensor on the distal end of the tool to detect the current contact force and maintain a desired contact force.  
         [0032]     In another embodiment of the invention, the forces on the working channel tool  4  applied by the user are measured and used in force determination, where motion sensing and control unit  10  can effectively amplify or reduce forces applied by the user to tool  4 . In this embodiment, handle  17  can be disposed adjacent force-torque sensor  19  which in turn is disposed adjacent working channel tool  4  such that translational force applied by the user to working channel tool  4  via handle  17  is sensed by force-torque sensor  19 . A control algorithm described below and residing in control unit  24  receives signals resulting from applied force measured by force-torque sensor  19  and in response produces control signals which are transmitted to actuator  12  to control the motion of wheel  18 . Wheel  18  can be moved either by force applied by actuator  12  or by frictional forces applied via working channel tool  4 . When working channel tool  4  is held motionless by the user, force applied to wheel  18  via shaft  15  of actuator  12  is opposed by, and therefore sensed by, torque sensor  22  which is attached to bracket  20  which is in turn fastened to base  11  of sensing and control element  10 .  
         [0033]     Force applied to working channel tool  4  by control wheel  18  is sensed by torque sensor  22  and denoted F W . This force is added to force applied by the user (F U ) to produce the effective force at the distal end of the working channel tool F WC , as expressed in the following equation of equilibrium: 
 
 F   WC   =F   U   +F   W   (1) 
 
         [0034]     The control algorithm described below and contained in controller  24  dynamically modifies the force applied by the wheel  18 , F W , to control working channel tool force, F WC  in response to force applied by the user F U . In particular, if the desired relationship between user applied forces and working tool forces is expressed by function f( ) as: 
 
 F   WC   =f ( F   U )  (2) 
 
         [0035]     Combining these equations and solving for Fw provides the following control algorithm: 
 
 F   w   =f ( F   u )− F   U   (3) 
 
         [0036]     Control unit  24  receives signals corresponding to user applied force F.sub.U and control wheel force F.sub.W and adjusts control signals transmitted to actuator  12  to implement the control algorithm of equation 3.  
         [0037]     In a different embodiment, the sensor and control element  10  can be instrumented with strain gauges or other devices to detect or measure forces encountered at the distal end of the catheter or working channel tool. These forces can then be amplified and displayed to the user via actuator  12  or other motive mechanism to allow the practitioner to more easily control or determine the behavior of the distal end of the moved catheter or tool.  
         [0038]      FIG. 4  illustrates another embodiment of the sensing and control element  10  of the present invention, in which rotation and torque of the tool  4  is sensed and controlled in addition to sensing translation and controlling axial force as described in  FIG. 3 . In  FIG. 4 , as the elongated portion of working channel tool  4  rotates between motion sensing and control wheel  28  and idler wheel  26 , it causes rotation of each wheel. Wheel  28  is affixed to shaft  29  of actuator  30 . In turn, transparent optical encoder disk  34  is affixed to the opposite end of motor shaft  29  of actuator  30 . In turn, transparent optical encoder disk  34  is affixed to the opposite end of motor shaft  29 . Encoder reader  38  passes light through transparent encoder disk  34 . As transparent encoder disk rotates, marks imprinted on the surface pass in front of the light source, occluding alternately light passing through the disk. A plurality of light sensors in encoder reader  38  measure the varying light and dark patterns and determine the amount and direction of rotational motion of encoder disk  34 . Control unit  24  receives motion signals from encoder reader  38  corresponding to rotational motion of working channel tool  4 . Control unit  24  measures the rotation of working channel tool  4  using these signals.  
         [0039]     Actuator  30  can be similar to actuator  12 , where control unit  24  provides control signals to actuator  30  to output a force in the rotational degree of freedom of the tool  4 . As described above, both the sensor  34 / 38  and actuator  30  can take a variety of different forms.  
         [0040]     In one embodiment, when a preset limit to rotation is approached by the tool  4 , a control signal is produced by control unit  24  and transmitted to actuator  30  to produce torque necessary to slow and then halt further motion of motion sensing and control wheel  28 , thereby slowing and then halting further rotation of working channel tool  4 . Other embodiments can be similar to those described above for the translational sensing and actuation of the tool  4 ; for example, a haptic indication can be output to the user when the tool  4  is rotated a predetermined rotational distance (e.g., number of degrees).  
         [0041]     In some embodiments of element  10  of  FIG. 4 , the torque applied by the user to working channel tool  4  can be measured, and motion sensing and control unit  10  can be used to amplify or reduce the torques applied by the user to tool  4 . In  FIG. 4 , the handle  17  is disposed adjacent a force-torque sensor  19  which in turn is disposed adjacent working channel tool  4  such that rotational force applied by the user to working channel tool  4  via handle  17  is sensed by force-torque sensor  19 . A control algorithm described below and residing in control unit  24  receives signals resulting from applied force measured by force-torque sensor  19  and in response produces control signals which are transmitted to actuator  30  to control the motion of wheel  28 . Wheel  28  can be moved either by force applied by motor  12  or by frictional forces applied via working channel tool  4 . When working channel tool  4  is held motionless by the user, force applied to wheel  28  via shaft  29  of actuator  30  is opposed by, and therefore sensed by torque sensor  32  which is attached to bracket  36  which is in turn fastened to base  11  of sensing and control element  10 . Torque applied to working channel tool  4  by control wheel  28  is sensed by torque sensor  32  and denoted T W . This torque is added to torque applied by the user (T U ) to produce the effective torque at the distal end of the working channel tool T WC , as expressed in the following equation of equilibrium: 
 
 T   WC   =T   U   +T   W   (4) 
 
         [0042]     The control algorithm described below and contained in controller  24  dynamically modifies the torque applied by the wheel  28 , T W , to control working channel tool torque, T WC , in response to force applied by the user T U . In particular, if the desired relationship between user applied torque and working tool torque is expressed by function q( ) as: 
 
 T   WC   =q ( T   U )  (5) 
 
         [0043]     Combining these equations and solving for T w  provides the following control algorithm: 
 
 T   W   =q ( T   U )− T   U   (6) 
 
         [0044]     Control unit  24  receives signals corresponding to user applied torque T U  and control wheel torque T W  and adjusts control signals transmitted to motor  30  to implement the control algorithm of equation 6.  
         [0045]     The sensor  19  can include two sensors in appropriate embodiments: one sensor to measure the axial force applied by the user to the tool  4 , and another sensor to measure the torque applied to the user to the tool  4 .  
         [0046]     Thus, sensing and control unit  10  as shown in  FIG. 4  can provide rotational or translational position control, as well as translational force and rotational torque control to working channel tools. As shown in  FIG. 2 , sensing and control unit  10  can be used to control any elongated medical instrument, such as a catheter used in interventional radiology.  
         [0047]     While this invention has been described in terms of several preferred embodiments, it is contemplated that alterations, permutations, and equivalents thereof will become apparent to those skilled in the art upon a reading of the specification and study of the drawings. For example, many different types of sensors and actuators can be used to sense tool position or motion and to output tactile sensations to the user. Furthermore, many of the features described in one embodiment can be used interchangeably with other embodiments. Furthermore, certain terminology has been used for the purposes of descriptive clarity, and not to limit the present invention.