Steerable kink resistant sheath

Abstract

A steerable kink resistant access device is provided having an elongated body and a steerable portion. The access sheath has an outside diameter sufficiently small so that it may be inserted into a body cavity or conduit. The access sheath typically has two internal lumen, a first lumen sized and configured as an access to a surgical site and a second lumen sized and configured to contain a tensioning device that, when acted upon, will deflect the steerable portion. The tensioning device may be directly or remotely attached to an actuation device that operates to control the tensioning and loosening of the tensioning device.

1 . A surgical access device comprising: 
 an elongated body having a proximal end, a distal end, and a steerable region, the body including a primary lumen and a secondary lumen both extending through the body, the secondary lumen having a tensioning device extending through the secondary lumen and connected to the steerable region of the elongated body; and    an actuator connected to the tensioning device distally from the proximal end of the elongated body to control tension of the tensioning device.    
   
   
       2 . The surgical access device of  claim 1  further comprising a flexible body connected to the proximal end of the elongated body with the tensioning device extending through the flexible body and wherein the actuator is connected to the flexible body.  
   
   
       3 . The access device of  claim 1  wherein the tensioning device is at least one pull wire.  
   
   
       4 . The access device of  claim 1  wherein the tensioning device is a flexible flatten member.  
   
   
       5 . The access device of  claim 1  further comprises an enlarged entry at the proximal end of the body and adapted to receive one of a dilator and an ureteroscope.  
   
   
       6 . The access device of  claim 5  wherein the enlarged entry is funnel-shaped.  
   
   
       7 . The access device of  claim 1  wherein the secondary lumen has a diameter smaller than a diameter of the primary lumen.  
   
   
       8 . The access device of  claim 1  wherein the actuator further comprises one of a thumbwheel, a knob, a lever, a button, a handle, a t-bar, and a dial.  
   
   
       9 . The access device of  claim 8  wherein the actuator further comprises a hand engaging extension.  
   
   
       10 . The access device of  claim 9  wherein the actuator further comprises a directional indicator.  
   
   
       11 . The access device of  claim 1  wherein the actuator further comprises means for incrementally controlling tension of the tensioning device.  
   
   
       12 . The access device of  claim 1  wherein the actuator further comprises a movable component disposed within the actuator and connected to the tensioning device.  
   
   
       13 . The access device of  claim 12  wherein the actuator comprises: 
 a plurality of teeth connected to the movable component; and    a pawl operatively engaged with the first set of teeth.    
   
   
       14 . The access device of  claim 13  wherein the actuator further comprises an extension member connected between the tensioning device and the movable component.  
   
   
       15 . The access device of  claim 14  wherein the extension member operatively engages the plurality of teeth.  
   
   
       16 . The access device of  claim 12  wherein the actuator comprises: 
 a first set of teeth connected to the movable component;    a second set of teeth operatively engaged with the first set of teeth;    a pawl operatively engaged with the first set of teeth; and    a trigger extending from the actuator and operatively engaged with the pawl.    
   
   
       17 . The access device of  claim 1  wherein the actuator in a first position pulls the tensioning device and in a second position releases the tensioning device.  
   
   
       18 . The access device of  claim 1  further comprising a spring fixed within the secondary lumen and wherein the tensioning device extends through the spring.  
   
   
       19 . The access device of  claim 1  wherein the body further comprises at least one other secondary lumen disposed around the primary lumen.  
   
   
       20 . The access device of  claim 1  wherein the body comprises an inner plastic body, a spring coil and an outer plastic body.  
   
   
       21 . The access device of  claim 20  wherein the inner plastic body is surrounded by the spring coil and covered by the outer plastic body.  
   
   
       22 . The access device of  claim 1  wherein the steerable region includes a weakened portion extending along the steerable region.  
   
   
       23 . The access device of  claim 1  wherein the steerable region includes slots extending along the steerable region and slits extending along the steerable region on a generally opposing side of the slots, the slots being larger than the slits.  
   
   
       24 . The access device of  claim 1  wherein the steerable region includes means for increasing elasticity of the steerable region.  
   
   
       25 . The access device of  claim 1  wherein the tube is adapted to operate in a kidney.  
   
   
       26 . The access device of  claim 1  wherein the steerable region has a length adapted to use in a calyx.  
   
   
       27 . A surgical access device comprising: 
 a tube having a proximal end, a distal end, a steerable region, and an enlarged entry, the tube including a primary lumen and a secondary lumen both extending through the tube; and    means for deflecting the steerable region of the tube.    
   
   
       28 . The access device of  claim 27  wherein the means for deflecting the steerable region of the tube is situated remotely from the tube.  
   
   
       29 . The access device of  claim 27  wherein the means for deflecting the steerable region of the tube is situated offset from the tube.  
   
   
       30 . The access device of  claim 27  wherein the means for deflecting the steerable region further comprises means for transmitting tension extending through the secondary lumen and connected to the steerable region of the tube.  
   
   
       31 . The access device of  claim 30  wherein the means for deflecting the steerable region further comprises means for actuating connected to the means for transmitting tension.  
   
   
       32 . The access device of  claim 31  further comprises a flexible tubing connecting the means for actuating to the proximal end of the tube.  
   
   
       33 . The access device of  claim 31  further comprises means for incrementally controlling the means for transmitting tension and coupled to the means for actuating.  
   
   
       34 . The access device of  claim 27  wherein the tube further comprises means for assisting deflection of the tube.  
   
   
       35 . The access device of  claim 27  wherein the tube further comprises means for increasing elasticity of the tube.  
   
   
       36 . The access device of  claim 27  wherein the tube is adapted to operate in a kidney.  
   
   
       37 . The access device of  claim 27  wherein the means for deflecting is adapted to operate in a calyx.  
   
   
       38 . A surgical access device comprising: 
 a tube having a substantially rigid portion having a first diameter and a substantially flexible portion having a second diameter and extending from the substantially rigid portion, the first diameter being smaller than the second diameter, the tube including a primary lumen and a secondary lumen both extending through the tube, the secondary lumen having a pull wire extending through the secondary lumen and connected to the flexible portion of the elongated body;    a connector having a distal end connected to the tube and a proximal end including a funnel-shaped portion, the pull wire extending through the connector from the distal end to the proximal end;    a plastic tubing connected to the connector through which the pull wire extends through; and    a handle connected to the plastic tubing and including an axle disposed within the handle and a knob connected to and outside the handle, the axle connected to the pull wire and the knob.    
   
   
       39 . The access device of  claim 38  further comprises: 
 a pawl connected to the handle;    a trigger connected to the handle and the pawl; and    a first set of teeth connected to the axle and operatively engaging with the pawl;    wherein the trigger when actuated causes the pawl to move to disengage the pawl from the first set of teeth.    
   
   
       40 . The access device of  claim 39  further comprising an extension member connected between the axle and the pull wire and having a second set of teeth and operatively engaging the first set of teeth.  
   
   
       41 . A method of using a surgical access device with a dilator, the access device comprising an elongated body having a proximal end, a distal end, and a steerable region, the body including a primary lumen and a secondary lumen both extending through the body, the secondary lumen having a tensioning device extending through the secondary lumen and connected to the steerable region of the elongated body, and an actuator connected to the tensioning device distally from the proximal end of the elongated body to control tension of the tensioning device, the method comprising: 
 inserting the dilator through the primary lumen of the access device;    removing the dilator from the access device after the access device is inserted into the patient; and    manipulating the actuator to a first position to deflect the steerable region to form an arc.    
   
   
       42 . The method of  claim 41  further comprising: 
 placing the actuator out of a surgical site; and    inserting a surgical instrument into the access device.    
   
   
       43 . The method of  claim 41  further comprising incrementally controlling the deflection of the steerable region.  
   
   
       44 . The method of  claim 41  further comprising: 
 inserting an ureteroscope into the body;    inserting the body into the kidney; and    manipulating the actuator to a position to deflect the steerable region into a calyx.    
   
   
       45 . The method of  claim 44  further comprising removing the ureteroscope while the steerable region remains deflected in a position substantially identical to a position prior to removal of the ureteroscope.  
   
   
       46 . A method of manufacturing an access device, the method comprising: 
 wrapping a first wire around a mandrel;    resting a first tube on the first wire, the first tube extending further in length than the first wire along the mandrel;    inserting the mandrel through a second tube; and    heating the second tube, the mandrel, the first wire and the first tube.    
   
   
       47 . The method of  claim 46  further comprises wrapping a second wire around the first tube, first wire and mandrel.  
   
   
       48 . The method of  claim 46  further comprises coating the mandrel with a plastic material.  
   
   
       49 . The method of  claim 46  further comprises fusing a tip around the distal end of the second wire.  
   
   
       50 . The method of  claim 46  further comprises attaching a pull wire to a distal end of the second wire.  
   
   
       51 . The method of  claim 50  wherein the second tube comprises of silicon.  
   
   
       52 . The method of  claim 46  further comprising assembling a plurality of ring-shaped members around the first wire and the first tube.  
   
   
       53 . The method of  claim 52  wherein the plurality of ring-shaped members include at least one of plastic rings, metallic rings, un-reinforced plastic rings and metal reinforced plastic rings assembled along the first tube.  
   
   
       54 . The method of  claim 46  wherein the first tube comprises a semi-rigid tube extending partially through the first tube.  
   
   
       55 . The method of  claim 54  wherein the first tube is more flexible than the semi-rigid tube.  
   
   
       56 . A method of manufacturing an access device, the method comprising: 
 assembling a plurality of first ring-shaped members around a mandrel;    resting a first tube on the first connecting member;    inserting the mandrel through a second tube; and    heating the second tube, the mandrel, the first connecting member and the first tube.    
   
   
       57 . The method of  claim 56  further comprising wrapping a wire around the first ring-shaped members and the first tube.  
   
   
       58 . The method of  claim 56  further comprising assembling a plurality of second ring-shaped members around the first ring-shaped members and the first tube.  
   
   
       59 . The method of  claim 58  wherein the plurality of first and second ring-shaped members include at least one of plastic rings, metallic rings, un-reinforced plastic rings and metal reinforced plastic rings assembled along the first tube.