Patent Document

RELATED APPLICATIONS 
       [0001]    This application is a continuation of pending U.S. patent application Ser. No. 12/111,119, filed Apr. 28, 2008, which is a continuation of U.S. application Ser. No. 10/270,743, filed Oct. 11, 2002, now U.S. Pat. No. 8,414,505, which claims the benefit of U.S. Provisional Application No. 60/332,287 filed Nov. 21, 2001, and is a continuation-in-part of U.S. application Ser. No. 10/216,067 filed Aug. 8, 2002, now abandoned, which claims the benefit of U.S. Provisional Application No. 60/313,497 filed Aug. 21, 2001, and is a continuation-in-part of U.S. application Ser. Nos. 10/023,024, now abandoned, Ser. No. 10/011,371, now U.S. Pat. No. 7,090,683, issued Aug. 15, 2006, Ser. No. 10/011,449, now abandoned, Ser. No. 10/010,150, now U.S. Pat. No. 7,214,230, issued May 8, 2007, Ser. No. 10/022,038, now abandoned, Ser. No. 10/012,586, now U.S. Pat. No. 7,371,210, all filed Nov. 16, 2001, and all of which claim the benefit of U.S. Provisional Application Nos. 60/269,200 filed Feb. 15, 2001, 60/276,217 filed Mar. 15, 2001, 60/276,086 filed Mar. 15, 2001, 60/276,152 filed Mar. 15, 2001, and 60/293,346 filed May 24, 2001. The entire teachings of the above applications are incorporated herein by reference. 
     
    
     BACKGROUND 
       [0002]    Catheters are used extensively in the medical field in various types of medical procedures, as well as other invasive procedures. In general, minimally invasive medical procedures involve operating through a natural body opening or orifice of a body lumen, or through small incisions, typically 5 mm to 10 mm in length, through which instruments are inserted. In general, minimally invasive surgery is less traumatic than conventional surgery, due, in part, because no incision is required in certain minimally invasive procedures, or the significant reduction in the incision size in other procedures. Furthermore, hospitalization is reduced and recovery periods are shortened as compared with conventional surgical techniques. 
         [0003]    Catheters may be provided in a variety of different shapes and sizes depending upon the particular application. It is typical for a clinician to manipulate the proximal end of the catheter to guide the distal end of the catheter inside the body, for example, through a vein or artery. Because of the small size of the incision or opening and the remote location of the distal end of the catheter, much of the procedure is not directly visible to the clinician. Although clinicians can have visual feedback from the procedure site through the use of a video camera or endoscope inserted into the patient, or through radiological imaging or ultrasonic imaging, the ability to control even relatively simple instruments remains difficult. 
         [0004]    In some procedures, such as electrophysiology, the surgeon manually places the distal end of an extension, such as a catheter, at a site of interest in the patient&#39;s body. The distal end of the catheter can be coupled to an energy generator to treat the site of interest. Alternatively, or additionally, the catheter can be connected to a detector which receives signals from the distal end of the catheter for diagnostic purposes. The catheter is typically connected to a handle that includes control devices such as dials that enable the surgeon to articulate the catheter, and thus, to maneuver the catheter through the patient. 
         [0005]    In view of the above, some have proposed using robotic tele-surgery to perform minimally invasive procedures. Typically, these robotic systems use arms that reach over the surgical table and manipulate the surgical instruments inserted into the patient, while the surgeon sits at a master station located a distance from the table and issues commands to the arms. 
       SUMMARY 
       [0006]    An apparatus for performing medical procedures on an anatomical body includes an extension with an element near its distal end to be extended into the body, and a driver that moves the extension axially into the body, and that causes flexure of the distal end of the extension. The movement and flexure of the extension is driven by the driver from the proximal end of the extension, and an electronic controller directs the operation of the driver. 
         [0007]    In some embodiments, the driver includes control devices which may include conventional handle dials. A first control device is coupled to a first control wire, and a second control device is coupled to a second control wire. The first and second control wires extend along the length of the extension, and the terminal ends of the first and second control wires are coupled to the distal end of the extension. The first and second control devices are operated to control the flexure movements of the distal end of the extension with at least two degrees-of-freedom. The first and second control devices can be part of a handle which is a plug-in module that is removable from the driver. 
         [0008]    In certain embodiments, the driver moves the extension with a rotational movement. The driver may include a first drive mechanism and a second drive mechanism that are coupled to a motor array. The motor array in turn may be coupled to the controller, which directs the operation of the motor array and consequent operation of the drive mechanisms to move the extension with the axial and rotational movements. 
         [0009]    In some embodiments, the element may receive RF energy from an RF generator for delivery to a target site in the body. In particular embodiments, the element provides signals from the target site to a detector. The signals are typically related to properties of the target site. 
         [0010]    Since the movements of the driver are under the direction of the controller, these movements may be gentler than those produced by the surgeon when the instrument is manually driven through the patient. Furthermore, with the assistance of the driver, the surgeon is less likely to become fatigued during the procedure. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0011]    The foregoing and other objects, features and advantages of the invention will be apparent from the following more particular description of preferred embodiments of the invention, as illustrated in the accompanying drawings in which like reference characters refer to the same parts throughout the different views. The drawings are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the invention. 
           [0012]      FIG. 1  illustrates a manual catheter system; 
           [0013]      FIG. 1A  a close-up view of the terminal end of the catheter shown in  FIG. 2 ; 
           [0014]      FIG. 2  is a block and schematic diagram of a catheter drive system in accordance with the present invention; 
           [0015]      FIG. 2A  is a variation of the configuration shown in  FIG. 3 ; 
           [0016]      FIG. 3  is a block and schematic diagram of another version of a catheter drive system in accordance with the present invention; 
           [0017]      FIG. 4  is a perspective view of an illustrative embodiment of the catheter drive system of  FIG. 3 ; 
           [0018]      FIG. 4A  is a top view of the catheter drive system of  FIG. 4 ; and 
           [0019]      FIG. 4B  is a front view of the catheter drive system of  FIG. 4 . 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0020]    A description of preferred embodiments of the invention follows. 
         [0021]    The present invention provides a drive system that can be used to manipulate a surgical implement from its proximal end. For example, a manually operable instrument can be coupled to the drive system without requiring any modification to the instrument. The drive system can be operated by a surgeon at a master station of a master-slave telerobotic system. In some embodiments, the drive apparatus is in the form of a housing in which the instrument is inserted, which is then driven as the surgeon manipulates the housing. 
         [0022]    In electrophysiology procedures, as shown in  FIG. 1 , a extension such as a catheter  30  is used for diagnostic purposes or sensing conditions at a predetermined target site  31  as the catheter  30  extends through an artery or vein  34 . The distal end  36  of the catheter  30  can be considered as an operative segment of the catheter and thus is capable of flexing or bending to assist guiding the catheter through the anatomic body, and curving to a desired location, for example, to lean against an inner surface of the heart. In this regard, there is schematically illustrated wiring  40  that may extend along the length of the catheter  30  that transmits mechanical inputs of a manual handle  60 . As shown in  FIG. 1A , there can be additional wiring  61   a,    61   b,  and  61   c  that are connected to respective electrophysiology elements  62   a,    62   b,  and  62   c  and extend from the distal end  36  to an RF generator  45 , as well as a detector  50 , associated with the handle  60  ( FIG. 1 ). 
         [0023]    In some embodiments, the RF generator  45  couples energy through the handle  60  by way of the catheter  30  to the elements  62   a,    62   b,  and  62   c  at the distal end  36  for the application of RF energy at the target site  31  for therapeutic purposes. In association with the RF generator  45 , the detector  50  may receives signals from a probe, such as the elements  62   a,    62   b,  and  62   c,  positioned at the target site. Typically, these signals are related to physiological properties at the target site. 
         [0024]    As can be seen in  FIG. 1 , the handle  60  has wheels or dials  62  and  64  that can be manually operated by the surgeon during a procedure. Manipulation of the dials  62  and  64  are transmitted through the control wiring  40  to the distal end  36  to control the flexing or bending of the distal end in respective orthogonal directions. 
         [0025]    In a particular embodiment, as shown in  FIG. 2 , the operation of the drive system of  FIG. 1  is automated. That is, the system shown in  FIG. 2  modifies the construction of that shown in  FIG. 1  by providing for automatic control of a catheter  130 , which at its distal end is substantially the same as the catheter  30  shown in  FIGS. 1 and 1A . 
         [0026]    Like the catheter  30 , the catheter  130  is able to move at its end with at least two degrees-of-freedom under control of wires  128   a  and  128   b.  In addition, the catheter  130  is coupled at its distal end to a support block  132  that includes wheels  134  that provide linear translation of the catheter  130  in the direction  136 . A further mechanism  137  provides rotational motion of the catheter  130 , such as depicted by the arrow  138 . Moreover, there are also wires extending through the catheter  130  associated with the RF generator  145  and the detector  150   
         [0027]    In the embodiment illustrated in  FIG. 2 , a guide wire is not used, nor is a guide wire used in the device shown in  FIGS. 1 and 1A . Accordingly, only a single support block  132  is used with this catheter construction. However, the particular catheter  130  is provided with the flex control, and hence is provided with control wires that extend through the catheter  130  like those described previously in reference with  FIG. 1 . 
         [0028]    As shown in  FIG. 2 , the support or drive block  132  is coupled to an electromechanical drive member or motor array  120 . Also included in the system is an input device  124  at which a surgeon provides control actuations. The input device  124  is coupled to a controller  122  which in turn is coupled to the motor array  120 . Thus, instructions from the input device  124  are received by the controller  122  which then directs the operation of the motor array  120 . 
         [0029]    As mentioned previously, movement of the motors of the array  120  is transmitted to the catheter  130  through mechanically cabling extending through the catheter. In particular, a mechanical cabling  126  coupled directly to the block  132  controls the rotational and linear degrees-of-freedom of the catheter  130  through the mechanism  137  and wheels  134 , respectively. In addition, there is a cabling  128  from the motor array  120  to the block  132  which controls the bending and flexing movement of the catheter  130 . As such, one cable  128   a  may be used to control the bending movements of the catheter with one degree-of-freedom, and another cable  128   b  may control the bending movements with a second degree-of-freedom. 
         [0030]    The input device  124  may include separate manipulators for the different movements of the catheter  130 . As described in connection with  FIG. 1 , the input device can take on one of many different forms including joysticks, wheels, dials, and other types of manual interfaces. For the control desired in  FIG. 2 , one input member controls the mechanical cabling  126  for providing the two degrees-of-freedom of action of the catheter  130 , in particular, the linear and rotational movement. Another input member in input device  124  controls the flexing and bending of the catheter  130  by way of the mechanical cabling  128 . The input instructions from the input device  124  are transmitted to the motor array  120  by way of the controller  122  which may be a microprocessor. 
         [0031]    In an alternative arrangement, as shown in  FIG. 2A , an intermediate drive device  59  may be interposed between the motor array  120  and the catheter  130 . In such an arrangement, the motor array  120  communicates with the drive device  59  over the lines  128 , which may be electrical. In turn, the drive device  59  is coupled to the cabling extending through the length of the catheter, and actuates the cabling to cause the distal end of the catheter  130  to bend and flex with one or more degrees-of-freedom. 
         [0032]    Details of an automated catheter drive system are describe in the U.S. Application entitled “Coaxial Catheter System,” by Weitzer, Rogers, and Solbjor, Ser. No. 10/270,740, filed herewith, the entire contents of which are incorporated herein by reference. Details of a imaging system that aids the movement of the catheter through an anatomic body are describe in the U.S. application entitled “Catheter Tracking System,” by Weitzner and Lee, Ser. No. 10/216,669, filed herewith, the entire contents of which are incorporated herein by reference. 
         [0033]    Referring now to  FIG. 3 , there is shown a further embodiment of a catheter drive system. In  FIG. 3 , like reference characters are used to identify like features shown in  FIG. 2 . Thus, in the embodiment of  FIG. 3 , there is an input device  124 , a controller  122 , and a motor array  120 .  FIG. 3  also depicts the support block  132  which provides both linear and rotational movement of the catheter  130 . As before, these movements are provide by wheels  134  for the linear translation as noted by the arrow  136 , and the member or mechanism  137  for the rotational translation as noted by the arrow  138 . 
         [0034]    In the embodiment of  FIG. 3 , the handle  60  is depicted with its pair of actuating wheels or dials  62  and  64  shown earlier in  FIG. 1 . Rather than replacing the handle  60 , as in the embodiment of  FIG. 2 , the handle  60  here remains intact so that the wheels  62  and  64  are used to control the flexing and bending of the catheter  130 . For this purpose, there are included drive pieces  63  and  65  associated, respectively, with the wheels  62  and  64 . Each of the drive pieces engages its corresponding wheel to drive the wheels in either direction to provide the appropriate flex control of the catheter  130 . Note in  FIG. 3 , the separate lines  127  and  129 , which may be mechanical or electrical, coupling the drive pieces  65  and  63  to the motor array  120 . Hence, actuation of respective drive units in the motor array  120  results in a consequent actuation of the wheels  62  and  64  via the control line  129  and drive piece  63 , and the control line  127  and drive piece  65 , respectively. Note that with this embodiment the proper support and housings are provided such that the drive pieces  63  and  65  maintain proper engagement with the wheels  62  and  64 . 
         [0035]    With the particular arrangement shown in  FIG. 3 , the existing catheter construction need not be modified. Rather, the drive system shown in  FIG. 3  is simply coupled to an existing catheter system, such as the handle  60  and catheter  130  combination. 
         [0036]    Although the motor array  120  is illustrated as having two separate lines for two separate drive pieces, in other embodiments, the handle  60  may have only a single control dial. In such implementations, there may be only a single line and associated drive piece that couples the motor array  120  to the handle  60 . Thus, unlike the handle  60  with wheels  62  and  64  which provide flex control in orthogonal planes, if only a single wheel is used, the catheter typically flexes only in a single plane. However, in arrangements in which the catheter support block  132  provides for rotational movement of the catheter  130 , the movement of the catheter is not limited to this single plane, since as the catheter is being rotated it moves out of this plane. 
         [0037]    A particular embodiment of the system of  FIG. 3  is illustrated in  FIGS. 4 ,  4 A, and  4 B, where like reference characters are used to identify like features shown in  FIG. 3 . In this embodiment, the handle  60  is clamped in a clamp or vise  200  with a screw  202 . The clamp  200  is connected to a shaft  201  supported in a carriage  202  that moves back and forth on a guide bar  204  mounted in the drive block  132 . Associated with the shaft  201  is a set of gears  206  that engage with another set of gears  208  of the rotary drive mechanism  137 . The drive mechanism  137  includes a motor  210  driven by the array  120  located in the drive block  132  and under the direction of the controller  122  as it receives instructions from the user through the input device  124 . Thus, as the motor  210  rotates the gears  208 , a consequent rotary motion is induced in the gears  206  to rotate the clamp  200 , and hence the handle  60  and catheter  130 , in the rotational direction  138 . 
         [0038]    The linear drive mechanism  134  of this embodiment includes a motor  212  connected to a screw drive  214 . The motor  212  and screw drive  214  are mounted to the drive block  132  in a manner to allow the screw drive  214  to rotate. The screw drive  214  has threads  215  about its periphery that engage with the carriage  202 . Accordingly, under the direction of the controller  122  via the array  120 , the motor  212  rotates the screw drive  214  to induce the carriage  202 , and hence the handle  60  and catheter  130 , to move back and forth in the linear direction  136 . 
         [0039]    As previously mentioned, the drive pieces  63  and  65  engage with the dials or wheels  62  and  64  of the handle  60  so that upon instructions from the user through the input device  124 , the drive pieces  63  and  65  manipulate the dials  62  and  64  to control the desired bending and flexing movements of the catheter  130 . 
         [0040]    This invention can be implemented and combined with other applications, systems, and apparatuses, for example, those discussed in greater detail in U.S. Provisional Application No. 60/332,287, filed Nov. 21, 2001, the entire contents of which are incorporated herein by reference, as well as those discussed in greater detail in each of the following documents, all of which are incorporated herein by reference in their entirety: 
         [0041]    U.S. application Ser. No. 09/783,637 filed Feb. 14, 2001, which is a continuation of PCT application Serial No. PCT/US00/12553 filed May 9, 2000, which claims the benefit of U.S. Provisional Application No. 60/133,407 filed May 10, 1999; U.S. application entitled “Articulated Apparatus for Telemanipulator System,” by Brock and Lee, Ser. No. 10/208,087, filed Jul. 29, 2002, which is a continuation of U.S. application Ser. No. 09/827,503 filed Apr. 6, 2001, which is a continuation of U.S. application Ser. No. 09/746,853 filed Dec. 21, 2000, which is a divisional of U.S. application Ser. No. 09/375,666 filed Aug. 17, 1999, now U.S. Pat. No. 6,197,017 which issued on Mar. 6, 2001, which is a continuation of U.S. application Ser. No. 09/028,550 filed Feb. 24, 1998, which is now abandoned; PCT application Serial No. PCT/US01/11376 filed Apr. 6, 2001, which claims priority to U.S. application Ser. No. 09/746,853 filed Dec. 21, 2000, and U.S. application Ser. No. 09/827,503 filed Apr. 6, 2001; U.S. application Ser. Nos. 10/014,143, Ser. No. 10/012,845, Ser. No. 10/008,964, Ser. No. 10/013,046, Ser. No. 10/011,450, Ser. No. 10/008,457, and Ser. No. 10/008,871, all filed Nov. 16, 2001 and all of which claim benefit to U.S. Provisional Application No. 60/279,087 filed Mar. 27, 2001; U.S. application Ser. No. 10/077,233 filed Feb. 15, 2002, which claims the benefit of U.S. Provisional Application No. 60/269,203 filed Feb. 15, 2001; U.S. application Ser. No. 10/097,923 filed Mar. 15, 2002, which claims the benefit of U.S. Provisional Application No. 60/276,151 filed Mar. 15, 2001; U.S. application Ser. No. 10/034,871 filed Dec. 21, 2001, which claims the benefit of U.S. Provisional Application No. 60/257,816 filed Dec. 21, 2000; U.S. application Ser. No. 09/827,643 filed Apr. 6, 2001, which claims the benefit of U.S. Provisional Application No. 60/257,869 filed Dec. 21, 2000, and U.S. Provisional Application No. 60/195,264 filed Apr. 7, 2000. 
         [0042]    While this invention has been particularly shown and described with references to preferred embodiments thereof, it will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the scope of the invention encompassed by the appended claims. For example, the catheter need not be limited for use in electrophysiology procedures. That is, there may be other types of probes or end effectors located at the distal end of the catheter. The end effector may be, for example, an articulated tool such a grasper, scissor, needle holder, micro dissector, staple applier, tacker, suction irrigation tool, and clip applier. The end effector can also be a non-articulated tool, such as a cutting blade, probe, irrigator, catheter or suction orifice, and dilation balloon.

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