Devices and methods for positioning a spinal fixation element

Abstract

Methods for delivering a spinal fixation element to a surgical site are provided herein. More specifically, the method includes delivering a plurality of percutaneous access devices to a corresponding number of spinal locations, inserting a spinal fixation element through tissue, and manipulating the element through opposed sidewall openings formed in each access device. In an exemplary embodiment, the method can be optimized for position of large-scale fixation elements (e.g., greater than about 95 mm in length). In addition, a manipulation instrument configured to position such spinal fixation elements is also provided herein.

1 . A method for delivering a spinal fixation element to a surgical site, comprising:
 engaging a plurality of percutaneous access devices to a corresponding number of spinal locations, each access device being delivered to the respective spinal location via a respective incision such that at least a first access device is delivered via a first incision, each percutaneous access device having a distal end disposed adjacent to a spinal anchor and a proximal end positioned outside a patient's body;   releasably engaging a proximal end of a spinal fixation element to a manipulation instrument;   delivering a distal portion of the spinal fixation element through the first incision;   manipulating the distal portion of the spinal fixation element through opposed sidewall openings of the first percutaneous access device;   guiding the distal portion of the spinal fixation element through opposed side wall openings of each percutaneous access device;   placing the spinal fixation element within the plurality of spinal anchors such that at least a portion of the spinal fixation element resides within each of the plurality of spinal anchors; and   releasing the spinal fixation element from the manipulation instrument following the placing step.   
   
   
       2 . The method of  claim 1 , wherein the spinal fixation element is a rod. 
   
   
       3 . The method of  claim 1 , wherein the spinal fixation element has a length configured to provide a three-level spinal fixation. 
   
   
       4 . The method of  claim 1 , wherein the spinal fixation element has a length configured to provide at least a four-level spinal fixation. 
   
   
       5 . The method of  claim 1 , wherein three percutaneous access devices are utilized. 
   
   
       6 . The method of  claim 1 , wherein at least four percutaneous access devices are utilized. 
   
   
       7 . The method of  claim 1 , wherein the proximal end of at least one percutaneous access device is closed. 
   
   
       8 . The method of  claim 1 , wherein the proximal end of at least one percutaneous access device is open. 
   
   
       9 . The method of  claim 1 , wherein the releasably engaging step comprises:
 disposing the proximal end of the spinal fixation element within an opening formed in a distal portion of the manipulation instrument; and   securing the spinal fixation element to the manipulation instrument by engaging a distal end of an engagement element to a notch formed in a proximal portion of the spinal fixation element, the engagement element being disposed within a distal portion of the manipulation instrument.   
   
   
       10 . The method of  claim 9 , wherein the releasing step comprises:
 applying an actuation force to an actuator coupled to the manipulation instrument wherein the actuation force disengages the distal end of the engagement element from the notch formed in the proximal portion of spinal fixation element.   
   
   
       11 . A minimally invasive method for delivering a spinal fixation element to a surgical site, comprising:
 inserting a plurality of access devices into a body through a percutaneous incision for each access device such that a proximal end of each access device is positioned outside the body and a distal end engages a spinal anchor disposed in a vertebra;   engaging a proximal portion of a spinal fixation element to a distal portion of a manipulation instrument;   inserting the spinal fixation element through one of the percutaneous incisions for one of the access devices such that a distal portion of the spinal fixation element is positioned adjacent an outer portion of a first percutaneous access device;   manipulating the spinal fixation element such that the spinal fixation element passes through the opposed sidewall openings of each percutaneous access device;   placing the spinal fixation element in the plurality of spinal anchors such that at least a portion of the spinal fixation element resides within each bone anchor; and   disengaging the spinal fixation element from the manipulation instrument following the placing step.   
   
   
       12 . The method of  claim 11 , wherein the spinal fixation element is a rod. 
   
   
       13 . The method of  claim 11 , wherein the spinal fixation element has a length configured to provide a three-level spinal fixation. 
   
   
       14 . The method of  claim 11 , wherein the spinal fixation element has a length configured to provide at least a four-level spinal fixation. 
   
   
       15 . The method of  claim 11 , wherein the releasably engaging step comprises:
 disposing the proximal end of the spinal fixation element within an opening formed in a distal portion of the manipulation instrument; and   securing the spinal fixation element to the manipulation instrument by engaging a distal end of an engagement element to a notch formed in a proximal portion of the spinal fixation element, the engagement element being disposed within a distal portion of the manipulation instrument.   
   
   
       16 . The method of  claim 15 , wherein the releasing step comprises:
 applying an actuation force to an actuator coupled to the manipulation instrument wherein the actuation force disengages the distal end of the engagement element from the notch formed in the proximal portion of spinal fixation element.   
   
   
       17 . A method for delivering a spinal fixation element to a surgical site, comprising:
 engaging a plurality of percutaneous access devices to a corresponding number of spinal locations, each access device being delivered to the respective spinal location via a respective incision such that at least a first access device is delivered via a first incision, each percutaneous access device having a distal end disposed adjacent to a spinal anchor and a proximal end positioned outside a patient's body;   releasably engaging a proximal portion of a spinal fixation element to a distal portion of a manipulation instrument, the manipulation instrument having a handle portion coupled to an elongate shaft via an offset;   delivering a distal portion of the spinal fixation element through the first incision;   manipulating the distal portion of the spinal fixation element through opposed sidewall openings of the first percutaneous access device;   guiding the distal portion of the spinal fixation element through opposed side wall openings of each percutaneous access device;   placing the spinal fixation element within the plurality of spinal anchors such that at least a portion of the spinal fixation element resides within the spinal anchors; and   releasing the spinal fixation element from the manipulation instrument following the above placing step.   
   
   
       18 . The method of  claim 17 , wherein a distal portion of the elongate shaft is angled relative to a proximal portion of the elongate shaft. 
   
   
       19 . The method of  claim 17 , further comprising:
 contacting a distal end of the manipulation instrument to a distal portion of a first percutaneous access device, the distal end of the manipulation instrument configured to prevent passage of the instrument through the opposed side-wall openings, the contacting step performed prior to the releasing step.   
   
   
       20 . A device for releasably engaging a spinal fixation element and positioning the element percutaneously into a spinal anchor, comprising:
 a handle having a proximal end and a distal end;   an offset having a proximal end and a distal end, the proximal end of the offset coupled to the distal end of the handle and the distal end of the offset extending into an elongate shaft; and   an opening formed in the distal end of the elongate shaft, the opening being configured to receive and releasably engage a proximal end of a spinal fixation element.   
   
   
       21 . The device of  claim 20 , wherein the distal portion of the elongate shaft is configured to prevent passage of the shaft within a sidewall opening of a percutaneous access device attached to a spinal anchor. 
   
   
       22 . The device of  claim 20 , further comprising:
 an actuator coupled to the shaft, the actuator configured to release an engaged spinal fixation element from the distal end of the device.   
   
   
       23 . The device of  claim 20 , wherein a distal portion of the elongate shaft is angled relative to a proximal portion of the elongate shaft. 
   
   
       24 . A device for releasably engaging a spinal fixation element and positioning the element percutaneously into a plurality of spinal anchors, comprising:
 a handle having a proximal end and a distal end, the distal end of the handle being coupled to an elongate shaft by an offset;   a distal end of the elongate shaft having an opening configured to receive a proximal end of a spinal fixation element, the distal end also being configured to prevent passage of the manipulation instrument through a side-wall opening of a percutaneous access device; and   an actuator coupled to the distal shaft of the instrument, the actuator being in communication with an engagement disposed within an inner lumen of the elongate shaft and being capable of moving the engagement element into and out of contact with a portion of the spinal fixation element disposed within the opening of the elongate shaft thereby retaining or releasing the spinal fixation element from the device upon actuation.   
   
   
       25 . The device of  claim 24 , wherein a distal portion of the elongate shaft is angled relative to a proximal portion of the elongate shaft.