Abstract:
Systems and methods are disclosed that include a guide catheter apparatus insertable through a external body passage of a subject. The guide catheter apparatus includes a substantially rigid shaft and a handle. The shaft has a proximal opening, a distal opening, and a lumen extending between the proximal opening and the distal opening. The handle has a structure to allow a position of the guide catheter to be controlled by some or all of three fingers of one hand of an operator of the handle. The structure of the handle is adapted to permit the operator to position a thumb and index finger of the hand to manipulate a working device inserted into the lumen of the guide catheter, where the working device is manipulable via a portion of the working device immediately adjacent to the handle.

Description:
CROSS-REFERENCE TO RELATED APPLICATION(S) AND CLAIM OF PRIORITY 
     The present application is related to U.S. Provisional Patent Application Ser. No. 61/127,848, filed May 16, 2008, entitled “APPARATUS, SYSTEM AND METHOD FOR CONTROLLING THE POSITION OF AND PROVIDING SUCTION IN A SURGICAL CATHETER OR GUIDE”. Provisional Patent Application Ser. No. 61/127,848 is assigned to the assignee of the present application and is hereby incorporated by reference into the present application as if fully set forth herein. The present application hereby claims priority under 35 U.S.C. §119(e) to U.S. Provisional Patent Application Ser. No. 61/127,848. 
    
    
     TECHNICAL FIELD 
     The present invention is generally directed to surgical devices and, in particular, to an apparatus, system and method for manipulating a surgical catheter and working device with a single hand. 
     BACKGROUND 
       FIG. 1  presents a schematic diagram of a typical surgical catheter (or guide)  100  that may be used to perform a procedure in a nasal, sinonasal, or oral passage or other external body passage. The catheter  100  includes a tube  102  having therein a duct  104 . The tube  102  may be introduced into the body passage and a guidewire or other working device inserted into the duct  104  via an opening  106  at a proximal end of the catheter  100 . The duct  104  then operates to guide the working device to an opening  108  at a distal end of the tube  102 . A handle  110  may be formed into or attached to the proximal end of the tube  102  to permit positioning of the catheter  100  by movement of the catheter  100  into and out of the body passage and rotation of the catheter  100  around a longitudinal axis with a first hand. Once a desired position is obtained, the catheter  100  with fingers of a second hand that also grasps an endoscope and held in position. The first hand may then be used to manipulate the working device inserted into the duct  104 . 
     SUMMARY 
     This disclosure provides an apparatus, system and method for manipulating a surgical catheter and working device with a single hand. 
     In one embodiment, a system includes a guide catheter, a working device and a handle coupled to the guide catheter. The guide catheter is insertable through an external body passage of a subject, and includes a substantially rigid shaft, a proximal opening, a distal opening and a lumen extending between the proximal opening and the distal opening. The working device is adapted to be insertable through the lumen of the guide catheter. The handle has a structure that allows a position of the guide catheter to be controlled by some or all of three fingers of one hand of an operator of the handle. The structure of the handle is adapted to permit the operator to position a thumb and index finger of the hand to manipulate the working device via a portion of the working device that is immediately adjacent to the handle. 
     In another embodiment, a method includes inserting a guide catheter through an external body passage of a subject, inserting a working device through the lumen of the guide catheter, and controlling a position of the guide catheter using a handle affixed to the guide catheter while substantially simultaneously manipulating the working device. The position of the guide catheter is controlled by some or all of three fingers of a hand and a thumb and index finger of the hand manipulate the working device via a portion of the working device immediately adjacent to the handle. 
     In still another embodiment, a guide catheter apparatus insertable through a external body passage of a subject includes a substantially rigid shaft and a handle. The shaft has a proximal opening, a distal opening, and a lumen extending between the proximal opening and the distal opening. The handle has a structure to allow a position of the guide catheter to be controlled by some or all of three fingers of one hand of an operator of the handle. The structure of the handle is adapted to permit the operator to position a thumb and index finger of the hand to manipulate a working device inserted into the lumen of the guide catheter, where the working device is manipulable via a portion of the working device immediately adjacent to the handle. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       For a more complete understanding of the present invention and its advantages, reference is now made to the following description taken in conjunction with the accompanying drawings, in which: 
         FIG. 1  presents a schematic diagram of a surgical catheter; 
         FIG. 2  presents a schematic diagram of a surgical catheter according to this disclosure; 
         FIG. 3  presents a schematic diagram of another surgical catheter according to this disclosure; 
         FIG. 4  presents a schematic diagram of a surgical catheter according to this disclosure with working devices inserted; 
         FIG. 5  presents a schematic diagram of a surgical catheter according to this disclosure held by a user; and 
         FIG. 6  presents a schematic diagram of still another surgical catheter according to this disclosure. 
     
    
    
     DETAILED DESCRIPTION 
       FIG. 2  depicts a schematic diagram of a surgical catheter  200  according to the present disclosure. The catheter  200  includes a tube  202  having therein a duct  204  with an opening  208  at a distal end. A handle  210  may be formed into or attached to the proximal end of the tube  202 . A Y-shaped section  212  is coupled to a proximal end of the tube  202  at a distal end of the section  212 . The section  212  includes a second handle  218  and an opening  216  at a proximal end of the section  212 . The section  212  includes a duct  214  that mates with the duct  204  of the tube  202 . As described for the catheter  100 , working devices may be inserted in the opening  216  and guided to the opening  208  at the distal end of the tube  202  by the duct  214  and the duct  204 . 
     The section  212  further includes a branch section  212 A having a branch duct  214 A. Suction may be applied to the catheter  200  via the branch section  212 A. Where both the opening  216  and the opening  208  are left uncovered, the suction will be conducted to the opening  216  via the ducts  214 A and  214  and to the opening  208  via the ducts  214 A,  214  and  204 . Because the tube  202  is inserted into a body passage and, possibly, through a hole in a membrane of the body, the opening  208  may be sealed off from the ambient air pressure outside the catheter  200 . In such a situation, the suction applied to the branch section  212 A will primarily result in air being drawn through the opening  216  and into the duct  214 A. 
     Partially or completely blocking the opening  216 , however, will result in the suction drawing blood, mucous, and other materials into the opening  208  and along the ducts  204 ,  214  and  214 A, resulting in removal of the materials from the vicinity of the distal end of the tube  202 . An operator of the catheter  200  may vary the mount of blockage of the opening  216  with a finger or valve, in order to control the amount of suction delivered to the opening  208 . In this way, materials produced by the body in response to operation of the working devices (or freed from the body by the operation of the working devices) may be removed from vicinity of the distal end of the tube  202  by way of a controlled amount of suction. Such removal may provide a clearer view for an endoscope inserted into the catheter  200 , a clearer working area for a cutter, or other similar benefits. 
     A coupling  220  at a proximal end of the branch section  212 A couples a tube  222  having a duct  224  to the branch section  212 A and the duct  214 A, respectively. The tube  222  may conduct the suction to the section  212  from a suction canister or other suction source. Where the tube  222  is stiff, the coupling  220  may permit rotation of the branch section  212 A relative to the tube  222 , to reduce interference by the tube  222  with an operator&#39;s positioning of the catheter  200 . 
     In another embodiment, a coupling  226  at a proximal end of the tube  222  may couple a second tube  228  having a duct  230  to the tube  222  and the duct  224 , respectively. The coupling  220  does not permit rotation of the tube  222  relative to the branch section  214 A, nor does the coupling  226  permit rotation of the tube  228  relative to the tube  222 . However, where the tube  228  is stiff, a flexible tube  222  may be employed to reduce interference by the tube  228  with an operator&#39;s positioning of the catheter  200 . 
     While the section  212  is shown and described as separate from the tube  202 , it will be understood that in other embodiments, the section  212  may be formed integrally with the tube  202 . In still other embodiments, the coupling  220  may be mounted directly to a side of the section  212 , rather than to the branch section  212 A. While the section  212  is shown fixedly attached to the tube  202 , in other embodiments the section  212  may move relative to the tube  202 , in order to further free tethering and increase a user&#39;s free and unencumbered movements in space, while leaving the tube  202  in a substantially fixed position relative to the patient&#39;s body. In such embodiments, the section  212  may rotate freely or be moved to a desired position and then locked into place via a suitable locking mechanism. 
       FIG. 3  presents a schematic diagram of a second surgical catheter  300  according to the disclosure. The catheter  300  includes a body having a handle  350 . At a distal end of the catheter  300  is a guide coupling  310 , which may be a rotating ‘female’ luer lock. The guide coupling  310  accepts and locks a guide  302 . The coupling also operates to permit the guide  302  to be rotated to a desired position relative to the handle  350  and locked in that position for use. The guide coupling  310  may include detents to allow the guide  302  to be positioned only at predetermined positions relative to the handle  350 . 
     The handle  350  may include concavities  356  adapted to provide a secure grip on the handle  350  by some or all of the middle, ring and little fingers of a user&#39;s hand, as will be described in greater detail with reference to  FIG. 5 . The handle  350  may include a protrusion  352  adapted to a secure grip on the handle  350  by a user when the upper portion of the handle  350  is positioned between the middle and ring fingers while grasping the lower portion of the handle  350  with the ring and little fingers. 
     The handle  350  includes a duct  314  that passes from the guide coupling  310  to an opening  318  at a distal end of the handle  350 . The duct  314  is aligned with a duct in the guide  302  when the guide  302  is mounted in the guide coupling  310 , so that an endoscope, guidewire or other working device may be inserted into the opening  318 , pass through the duct  314  and the guide  302  to emerge from a distal end of the guide  302 . A branch section  314   a  of the duct  314  extends through the handle  350  to a handle coupling  320 . A source of suction may be attached to the handle  350  at the handle coupling  320  to provide suction at the distal end of the guide  302 , as described with reference to  FIG. 2 . 
     Where the opening  318  is provided with a one-way valve to prevent air being drawn into the opening  318  by suction in the branch section  314   a , an opening  354  may be provided between the branch section  314   a  and the exterior of the handle  350  to allow the user to control the amount of suction present at the distal end of the guide  302 . 
     The handle  350  may be provided with a locking screw  358 . Once a user has inserted a guide catheter through the duct  314  to a desired position within the patient, the user may operate the locking screw  358  to hold the guide wire in position while inserting another working device, such as a balloon catheter, along the guide wire. Once the second working device reaches the position of the locking screw  358 , the locking screw  358  may be operated to withdraw it from the duct  314  and allow the second working device to continue along the duct  314 . 
     With reference to  FIG. 4 , a balloon catheter  454  has been inserted into the opening  318  and through the guide  302 . The balloon catheter  454  includes a tube  452  coupled to an inflation device. Operation of the inflation device causes an inflation segment  456  of the balloon catheter  454  to inflate. The handle  350  may be designed so that the distance between the opening  318  and the guide coupling  310  (indicated by the letter a), when added to the length of the guide  302  (indicated by the letter b), totals less than the distance between the attachment of the tube  452  at a proximal end of the balloon catheter  454  and the inflation segment  456  (indicated by the letter c). 
     Furthermore, the distance between the opening  318  and the guide coupling  310  may be selected based upon a distance between a shoulder feature of the proximal end of the balloon catheter  454  and the inflation segment  456 . The distance may be selected to allow the shoulder feature to engage the opening  318  while the inflation segment  456  extends past the distal end of the guide  302  substantially only far enough to inflate without interference from the distal end of the guide  302 . In this way, motion of the inflation segment  456  towards or away from the guide  302  during inflation may be minimized to reduce the likelihood that the inflation segment  456  will slip out of position when inflated. 
     A suction tube  428  may be attached to the handle coupling  320  by a tube coupling  422 . Where the suction tube  428  is stiff, the tube coupling  422  (or the handle coupling  320 ) may be flexible and/or rotate to reduce interference by the stiff tube  428  with positioning the surgical catheter  300 . 
       FIG. 5  illustrates the surgical catheter  300  in use. A surgeon or other user holds the handle  350  in a hand by some or all of the small finger, the ring finger and the middle finger. Gripped in this way, the surgeon may move the guide  302  in the direction of its longitudinal axis, may rotate the guide  302  about its longitudinal axis, or may rotate the guide  302  about an axis other than its longitudinal axis (‘yaw’). The fore finger and thumb are left free to manipulate a working device inserted into the opening  318  or to cover the opening  318  to redirect suction to the distal end of the guide  302 , as described with reference to  FIG. 2 . As described with reference to  FIG. 4 , flexibility and/or rotation of the couplings  320  and/or  422  may reduce the interference of a stiff suction tube  428  on such motion. 
     The lower portion of the handle  350 , which is grasped by the fingers, makes an angle with the upper portion of the handle, and with the guide  302 , that facilitates the user&#39;s manipulation of working devices with the thumb and forefinger of a hand while grasping the handle with some or all of the remaining fingers of the hand. That is, the angle may be selected to place the user&#39;s thumb and forefinger in comfortable proximity to the opening  318 , and the handle shaped to permit easy motion of the thumb and forefinger towards and away from the opening  318  while securely grasping a working device inserted through the handle  350  into the guide  302 . As shown in the figures, that angle may be approximately sixty (60) degrees, although other angles that are less than ninety (90) degrees and more than zero (0) degrees may be employed. 
     Using the handle  350 , the user is enabled to control the position of the guide  302  by positioning the arm and wrist of the hand that is grasping the handle, while simultaneously controlling the position of a working device inserted into the guide  302  with the thumb and forefinger of the same hand. This leaves the user&#39;s other hand free for other activities, such as holding an endoscope in position to view the distal ends of the guide  302  and the working device. In this way, the user is able to simultaneously control the position of the distal end of the guide  302  adjacent to a desired region of the patient and manipulate the working device with one hand. 
       FIG. 6  illustrates a handle  650  according to the present disclosure wherein the upper portion of the handle  650  comprises a pivot  652 . The upper portion includes an opening  618  and a main duct and guide coupling (not shown, but similar to the duct  314  and the guide coupling  310 ) are in a fixed position relative to each other and to the pivot  652 . The duct branch in the handle  650  (not shown, but similar to the branch duct  314   a ) is pivotally coupled to the main duct, to allow suction applied to a handle coupling  620  to be applied to the opening  318  and a guide attached to the guide coupling. The pivot  652  allows the handle  650  to be rotated to a desired angular position relative to the upper portion and locked into the desired position. 
     Although the present invention and its advantages have been described in the foregoing detailed description and illustrated in the accompanying drawings, it will be understood by those skilled in the art that the invention is not limited to the embodiment(s) disclosed but is capable of numerous rearrangements, substitutions and modifications without departing from the spirit and scope of the invention as defined by the appended claims.