USRE39133EExpiredUtility

Percutaneous registration apparatus and method for use in computer-assisted surgical navigation

84
Assignee: SURGICAL NAVIGATION TECHPriority: Sep 24, 1997Filed: Apr 24, 2003Granted: Jun 13, 2006
Est. expirySep 24, 2017(expired)· nominal 20-yr term from priority
A61B 17/7083A61B 17/7032A61B 2034/2072A61B 2090/3945A61B 34/10A61B 34/20A61B 90/11A61B 2090/3983A61B 2017/00477A61B 17/70A61B 2034/2055A61B 2090/363
84
PatentIndex Score
88
Cited by
507
References
63
Claims

Abstract

An apparatus and procedures for percutaneous placement of surgical implants and instruments such as, for example, screws, rods, wires and plates into various body parts using image guided surgery. The invention includes an apparatus for use with a surgical navigation system, an attaching device rigidly connected to a body part, such as the spinous process of a vertebrae, with an identification superstructure rigidly but removably connected to the attaching device. This identification superstructure, for example, is a reference arc and fiducial array which accomplishes the function of identifying the location of the superstructure, and, therefore, the body part to which it is fixed, during imaging by CAT scan or MRI, and later during medical procedures.

Claims

exact text as granted — not AI-modified
1. An apparatus for facilitating percutaneous placement of surgical instruments into the spine, adapted for use with a surgical navigation system employing an energy-detecting array in communication with a surgical navigation computer to track positions of instruments in three dimensional space relative to a known reference point, said apparatus comprising:
 a connector adapted to be rigidly attached to a portion of the spine;  
 at least one central post connected to said connector;  
 a position identification structure rigidly and removably connected to said central post at a predetermined position on said central post and adapted to be reconnected at the same said predetermined position, said identification structure being further adapted to allow a patient to be scanned with the structure connected to the central post, said structure including an assembly for communicating positioning information with respect to said assembly to the energy detecting array and surgical navigation computer; and  
 a connector assembly for said reconnecting of said structure substantially to said predetermined position on said central post.  
 
     
     
       2. The apparatus of  claim 1 , wherein the connector is a clamp having teeth adapted for biting into a spinous process. 
     
     
       3. The apparatus of  claim 1 , wherein the connector includes an elongated fixture with a central axis and a threaded end adapted to be inserted into the spinous process and a substantially rigid wire connected to the fixture with the central axis of the wire adapted to be implanted into the spinous process at an angle to elongated fixture to prevent the fixture from rotating. 
     
     
       4. The apparatus of  claim 1 , wherein said assembly for communication positioning information is a substantially H-shaped frame. 
     
     
       5. The apparatus of  claim 1 , wherein said assembly for communicating positioning information is a substantially W-shaped frame. 
     
     
       6. The apparatus of  claim 1 , wherein said assembly for communicating positioning information is a substantially U-shaped frame. 
     
     
       7. The apparatus of  claim 1 , wherein said assembly for communicating positioning information is a substantially X-shaped frame. 
     
     
       8. The apparatus of  claim 1 , wherein said assembly for communicating positioning information comprises:
 a fiducial array for registering the location of a spinal element with rigidly connected fiducials; and  
 a reference arc for signaling the position of a spinal element, said arc further comprising rigidly connected emitters.  
 
     
     
       9. The apparatus of  claim 1 , wherein said references point is on the spine. 
     
     
       10. A method for monitoring the location of an instrument, surgical implant and various portions of the body, to be operated on, using a surgical navigation system with a surgical navigation computer and a digitizer array for monitoring the location of instruments in three-dimensional space relative to a known reference point, said method comprising the steps of:
 attaching a fixture having a central post to a portion of the spine;  
 removably attaching an identification structure including a fiducial array and a reference arc to said central post;  
 providing a scanned three-dimensional image of a patient including said fiducial array rigidly attached to said central post of said fixture, said fixture being rigidly attached to the patient to identify the position of said fixture and said fiducial array on the scanned image;  
 using an image-guided system, by touching an image guided surgical pointer to one or more fiducials on the fiducial array to register the location of a spinal element fixed to said array; and  
 emitting a signal from said reference arc to indicate changes in position of the spinal element during a surgical procedure.  
 
     
     
       11. The method of  claim 10 , further comprising:
 performing a surgical procedure percutaneously on a patient using an instrument and implant locatable relative to the spinal element and said structure in known positions identified in the surgical navigation system.  
 
     
     
       12. The method of  claim 10 , further comprising:
 inserting a threaded fixture having a substantially rigid wire into a spinal element; and  
 touching an image guided pointer to said threaded fixture and wire to positively register the location of said fixture and wire in a surgical navigation computer.  
 
     
     
       13. The method of  claim 10 , further comprising:
 implanting imageable devices into spinal elements to identify the location of the spinal elements in the surgical navigation computer.  
 
     
     
       14. The method of  claim 10 , further comprising:
 implanting imageable devices into a plurality of spinal elements; and  
 manipulating the patient's spine by viewing the location of the implanted devices, as communicated to the surgical navigation computer by touching an instrument with a tracking emitter to said implanted imageable devices to align the actual position of the spinal elements with the previously scanned image.  
 
     
     
       15. The method of  claim 10  further comprising:
 percutaneously implanting screws into spinal elements; and  
 locating the position of said screws using image guided surgical navigation techniques.  
 
     
     
       16. The method of  claim 15  further comprising:
 manipulating the orientation of the screw heads percutaneously using a head-positioning probe for communicating location containing an emitter, said probe communicating to the surgical navigation computer the orientation of the screw heads; and  
 using a head positioning tool for manipulating implants having an end portion that mates with the heads of the screws and rotating the screws to receive a connecting implant.  
 
     
     
       17. The method of  claim 16  further comprising:
 tracking the location and position of the connecting implant by means of an instrument affixed to the implant having emitters capable of communicating orientation and location to the surgical navigation computer.  
 
     
     
       18. A system for use in performing the percutaneous placement of surgical implants and instruments into the spine using image guided surgery and a surgical navigation computer and energy detecting array, said system comprising:
 means for attaching a fixture to a portion of the spine;  
 means for communicating position information to the surgical navigation computer and energy detecting array said means rigidly and removably connected to said means for attaching a fixture;  
 means for providing location information of said spinal portion to the surgical navigation system adapted to be connected to spinal elements;  
 means for indicating screw-head position said means electrically connected to the surgical navigation system and adapted to mate with the head of a screw implanted in one or more of said spinal elements.  
 
     
     
       19. The system of  claim 18  further comprising:
 an elongated implant adapted to be inserted into said implanted screws;  
 means for indicating the position of said elongated implant electrically connected to the surgical navigation system and adapted to mate with the elongated implant.  
 
     
     
       20. The system of  claim 18 , wherein said implanted screws have heads and the elongated implant is a rod adapted to be guided through holes in said implanted screw heads. 
     
     
       21. The apparatus of  claim 1 , wherein the connector includes an elongated fixture with a central axis and an end adapted to be inserted into the spinous process and a substantially rigid wire connected to the fixture with the central axis of the wire adapted to be implanted into the spinous process at an angle to said elongated fixture to prevent said fixture from rotating. 
     
     
       22. An apparatus for facilitating percutaneous placement of surgical instruments into the spine, adapted for use with a surgical navigation system employing an energy- detecting array in communication with a surgical navigation computer to track positions of instruments in three dimensional space relative to a known reference point, said apparatus comprising:      a connector adapted to be rigidly attached to a portion of the spine;        at least one post connected to said connector;        a position identification structure rigidly connected to said post at a predetermined position on said post, said identification structure being further adapted to allow a patient to be scanned with the structure connected to the post, said structure including an assembly for communicating positioning information with respect to said assembly to the energy detecting array and surgical navigation computer; and        a means for indicating a screw - head position said means electrically connected to the surgical navigation system and adapted to mate with the head of a screw implanted in the spine.     
     
     
       23. The apparatus of  claim 22  wherein said position identification structure is rigidly and removably connected to said post and adapted to be reconnected at said same predetermined position. 
     
     
       24. The apparatus of  claim 23  wherein said apparatus further includes a connector assembly for said reconnecting of said structure substantially to said predetermined position on said post. 
     
     
       25. The apparatus of  claim 22 , wherein the connector is a clamp having teeth adapted for biting into a spinous process. 
     
     
       26. An apparatus for facilitating percutaneous placement of surgical instruments into the spine, adapted for use with a surgical navigation system employing an energy- detecting array in communication with a surgical navigation computer to track positions of instruments in three dimensional space relative to a known reference point, said apparatus comprising:      a connector adapted to be rigidly attached to a portion of the spine;        at least one post connected to said connector;        a position identification structure rigidly connected to said post at a predetermined position on said post, said identification structure being further adapted to allow a patient to be scanned with the structure connected to the post, said structure including an assembly for communicating positioning information with respect to said assembly to the energy detecting array and surgical navigation computer; and        wherein the connector includes an elongated fixture with a central axis and a threaded end adapted to be inserted into the spinous process and a substantially rigid wire connected to the fixture, said wire adapted to be implanted into the spinous process at an angle to prevent the fixture from rotating.     
     
     
       27. The apparatus of  claim 22 , wherein said assembly for communicating positioning information is a substantially H- shaped frame.   
     
     
       28. The apparatus of  claim 22 , wherein said assembly for communicating positioning information is a substantially W- shaped frame.   
     
     
       29. The apparatus of  claim 22 , wherein said assembly for communicating positioning information is a substantially U- shaped frame.   
     
     
       30. The apparatus of  claim 22 , wherein said assembly for communicating positioning information is a substantially X- shaped frame.   
     
     
       31. The apparatus of  claim 1 , wherein said assembly for communicating positioning information comprises:
   a reference arc for signaling the position of a spinal element, said arc further comprising rigidly connected emitters.     
     
     
       32. The apparatus of  claim 31  wherein said assembly further includes a fiducial array for registering the location of a spinal element with rigidly connected fiducials. 
     
     
       33. The apparatus of  claim 32 , wherein said reference point is on the spine. 
     
     
       34. A method for monitoring the location of an instrument, surgical implant and various portions of the body, to be operated on, using a surgical navigation system with a surgical navigation computer and a digitizer array for monitoring the location of instruments in three- dimensional space relative to a known reference point, said method comprising:      attaching a fixture having a post to a portion of the body;        attaching a reference arc to said post;        providing a scanned three - dimensional image of a patient with the reference arc in place;        using an image - guided system to track instruments and implants relative to the reference arc and three - dimensional scan;        emitting a signal from said reference arc to indicate changes in position of the spinal element during a surgical procedure,        inserting a threaded fixture having a substantially rigid wire into a spinal element; and        touching an image guided pointer to said threaded fixture and wire to positively register the location of said fixture and wire in a surgical navigation computer.     
     
     
       35. A method for monitoring the location of an instrument, surgical implant and various portions of the body, to be operated on, using a surgical navigation system with a surgical navigation computer and a digitizer array for monitoring the location of instruments in three- dimensional space relative to a known reference point, said method comprising:      attaching a fixture having a post to a portion of the body;        attaching a reference arc to said post;        providing a scanned three - dimensional image of a patient with the reference arc in place;        using an image - guided system to track instruments and implants relative to the reference arc and three - dimensional scan; and        emitting a signal from said reference arc to indicate changes in position of the spinal element during a surgical procedure;        implanting imageable devices into a plurality of spinal elements; and        manipulating the patient's spine by viewing the location of the implanted devices, as communicated to the surgical navigation computer by touching an instrument with a tracking emitter to said implanted imageable devices to align the actual position of the spinal elements with the previously scanned image.     
     
     
       36. The method of  claim 35 , further comprising:
   performing a surgical procedure percutaneously on a patient using an instrument and implant locatable relative to the spinal element and said structure in known positions identified in the surgical navigation system.     
     
     
       37. The method of  claim 35 , further comprising:
   implanting imageable devices into spinal elements to identify the location of the spinal elements in the surgical navigation computer.     
     
     
       38. The method of  claim 35  further comprising:
   percutaneously implanting screws into spinal elements; and        locating the position of said screws using image guided surgical navigation techniques.     
     
     
       39. A method for monitoring the location of an instrument, surgical implant and various portions of the body, to be operated on, using a surgical navigation system with a surgical navigation computer and a digitizer array for monitoring the location of instruments in three- dimensional space relative to a known reference point, said method comprising:      attaching a fixture having a post to a portion of the body;        attaching a reference arc to said post;        providing a scanned three - dimensional image of a patient with the reference arc in place;        using an image - guided system to track instruments and implants relative to the reference arc and three - dimensional scan;        emitting a signal from said reference arc to indicate changes in position of the spinal element during a surgical procedure;        percutaneously implanting screws into spinal elements;        locating the position of said screws using image guided surgical navigation techniques;        manipulating the orientation of the screw heads percutaneously using a head - positioning probe for communicating location containing an emitter, said probe communicating to the surgical navigation computer the orientation of the screw heads; and        using a head positioning tool for manipulating implants having an end portion that mates with the heads of the screws and rotating the screws to receive a connecting implant.     
     
     
       40. The method of  claim 39  further comprising:
   tracking the location and position of the connecting implant by means of an instrument affixed to the implant having emitters capable of communicating orientation and location to the surgical navigation computer.     
     
     
       41. A system for use in performing the percutaneous placement of surgical implants and instruments into the spine using image guided surgery and a surgical navigation computer and energy detecting array, said system comprising:
   means for attaching a fixture to a portion of the spine;        means for communicating position information to the surgical navigation computer and energy detecting array said means rigidly connected to said means for attaching a fixture;        means for providing location information of said spinal portion to the surgical navigation system adapted to be connected to spinal elements; and        a means for indicating screw - head position said means electrically connected to the surgical navigation system and adapted to mate with the head of a screw implanted in one or more of said spinal elements.     
     
     
       42. The system of  claim 41  further comprising:
   an elongated implant adapted to be inserted into said screw;        means for indicating the position of said elongated implant electrically connected to the surgical navigation system and adapted to mate with the elongated implant.     
     
     
       43. The system of  claim 41  wherein energy detecting array is removably connected to said means for attaching a fixture. 
     
     
       44. A system for use in performing the percutaneous placement of surgical implants and instruments into the spine using image guided surgery and a surgical navigation computer and energy detecting array, said system comprising:
   means for attaching a fixture to a portion of the spine;        means for communicating position information to the surgical navigation computer and energy detecting array said means rigidly connected to said means for attaching a fixture;        means for providing location information of said spinal portion to the surgical navigation system adapted to be connected to spinal elements; and        wherein a screw has a head and the elongated implant is a rod adapted to be guided through holes in said implanted screw head.     
     
     
       45. An apparatus for use with a surgical navigation system to track a position of at least one object in three- dimensional space relative to a patient's body, said apparatus comprising:      an anchor operable to be attached to a portion of the body;        a position identification structure rigidly and removably connected to said anchor at a pre - determined position and adapted to be reconnected at said same pre - determined position, said position identification structure being further adapted to allow the patient to be scanned with said position identification structure connected to said anchor, said position identification structure including an assembly for providing position information to the surgical navigation system;        a connector assembly associated with said position identification structure operable to reconnect said position identification structure substantially to said pre - determined position; and        a means for indicating a member position said means electrically connected to the surgical navigation system and adapted to mate with said member implanted in the body.     
     
     
       46. The apparatus as defined in  claim 45  wherein the anchor is a clamp having teeth adapted for biting into a patient's body. 
     
     
       47. The apparatus as defined in  claim 45  wherein the anchor is an elongated fixture having a central axis and a threaded end adapted to be inserted into the patient's body. 
     
     
       48. The apparatus as defined in  claim 47  wherein said elongated fixture further includes a substantially rigid wire adapted to be implanted at an angle to said elongated fixture to prevent said fixture from rotating. 
     
     
       49. The apparatus as defined in  claim 45  wherein the object is a surgical instrument. 
     
     
       50. The apparatus as defined in  claim 45  wherein the object is an implant. 
     
     
       51. The apparatus as defined in  claim 45  wherein said position identification structure includes a fiducial array operable to register a location of the patient's body; and
   a reference arc operable to identify a position of the patient's body.     
     
     
       52. The apparatus as defined in  claim 51  wherein said fiducial array includes a plurality of rigidly connected fiducials and said reference arc includes a plurality of rigidly connected emitters. 
     
     
       53. The apparatus as defined in  claim 45  wherein a portion of the patient's body is the spine. 
     
     
       54. The apparatus as defined in  claim 45  wherein said position identification structure includes a fiducial array selected from a group comprising a W- shaped frame, a U - shaped frame, an X - shaped frame, and an H - shaped frame.   
     
     
       55. A method for monitoring the location of an object relative to a patient's body using a surgical navigation system, said method comprising:
   attaching an anchor to a portion of the body;        movably attaching an identification structure having a fiducial array and a reference arc to said anchor;        providing a three - dimensional image of a patient, including said fiducial array attached to said anchor, said anchor being attached to the body to identify the position of said fiducial array on the three - dimensional image;        using the fiducial array to register a location of the body fixed to said fiducial array; and        using the reference arc to identify changes in position of the body during a surgical procedure;        inserting a threaded anchor into a spinal element; and        touching an image guided pointer to said threaded anchor to positively register a location of said fixture with the surgical navigation system.     
     
     
       56. The method as defined in  claim 55  further comprising using an image guided system and touching an image guided surgical pointer to one or more fiducials on the fiducial array to register a location of the body to the array. 
     
     
       57. The method as defined in  claim 55  further comprising emitting a signal from the reference arc to identify changes in position of the body during the surgical procedure. 
     
     
       58. The method as defined in  claim 55  further comprising performing a surgical procedure percutaneously on a spine of the patient. 
     
     
       59. The method as defined in  claim 58  further comprising locating an implant relative to the spine and an instrument associated with the implant. 
     
     
       60. The method as defined in  claim 59  further comprising percutaneously implanting screws into spinal elements; and
   locating the position of the screws.     
     
     
       61. The method as defined in  claim 60  further comprising manipulating an orientation of screw heads associated with the screws percutaneously using a head- positioning probe, which is adapted to communicate with the surgical navigation system to orient the screw head.   
     
     
       62. The method as defined in  claim 55  further comprising:
   implanting imageable devices into spinal elements of the body to identify the location of the spinal elements with the surgical navigation system.     
     
     
       63. A method for monitoring the location of an object relative to a patient's body using a surgical navigation system, said method comprising:
   attaching an anchor to a portion of the body;        movably attaching an identification structure having a fiducial array and a reference arc to said anchor;        providing a three - dimensional image of a patient, including said fiducial array attached to said anchor, said anchor being attached to the body to identify the position of said fiducial array on the three - dimensional image;        using the fiducial array to register a location of the body fixed to said fiducial array;        using the reference arc to identify changes in position of the body during a surgical procedure;        performing a surgical procedure percutaneously on a spine of the patient;        locating an implant relative to the spine and an instrument associated with the implant;        comprising percutaneously implanting screws into spinal elements;        locating the position of the screws;        manipulating an orientation of screw heads associated with the screws percutaneously using a head - positioning probe, which is adapted to communicate with the surgical navigation system to orient the screw head;        tracking a location and position of a connecting implant by use of an instrument attached to the connecting implant that include emitters capable of communicating orientational location to the surgical navigation system; and        attaching the connecting implant to the screw heads percutaneously.

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