USRE42194EExpiredUtility

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

97
Assignee: MEDTRONIC NAVIGATION INCPriority: Sep 24, 1997Filed: Jun 12, 2006Granted: Mar 1, 2011
Est. expirySep 24, 2017(expired)· nominal 20-yr term from priority
A61B 17/7083A61B 17/7032A61B 2090/3983A61B 2017/00477A61B 2034/2072A61B 34/10A61B 2090/3945A61B 2034/2055A61B 34/20A61B 17/70A61B 2090/363A61B 90/11
97
PatentIndex Score
280
Cited by
767
References
73
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 clement 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 reference 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 clement 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. An implant system for facilitating percutaneous placement of an implant in an anatomy and adapted for use with a surgical navigation system to track positions of the implant system in space, said implant system comprising:
   an implant inserter adapted to releasably attach to the implant; and        a position identification structure rigidly and removably attached to said implant inserter;        wherein said position identification structure includes an assembly for providing position information to the surgical navigation system.     
     
     
       22. The implant system of  claim 21  wherein said position identification structure includes at least one optical emitter. 
     
     
       23. The implant system of  claim 21  wherein said position identification structure includes at least one light emitting diode. 
     
     
       24. The implant system of  claim 21 , wherein said position identification structure includes a selected geometrical shape. 
     
     
       25. The implant system of  claim 21 , wherein said position identification structure includes at least one of reflective spheres, acoustic emitters, magnets, eletromagnets, light emitting diodes, or combinations thereof. 
     
     
       26. The implant system of  claim 25 , wherein said reflectors can reflect at least one of visible light, infrared light, or combinations thereof. 
     
     
       27. The implant system of  claim 25 , wherein said magnets or electromagnets are operable to produce a magnetic field. 
     
     
       28. The implant system of  claim 21 , further comprising:
   a rod;        wherein said rod can form a portion of the surgical implant.     
     
     
       29. The implant system of  claim 28 , wherein said rod extends between a first end and a second end;
   wherein said implant inserter is releasably attached to at least one of said first end, said second end, or combinations thereof.     
     
     
       30. The implant system of  claim 28 , wherein said rod holder is operable to assist in moving a rod along a selected path. 
     
     
       31. The implant system of  claim 28 , wherein said rod holder is operably interconnected with the implant to determine a position of at least a portion of the implant. 
     
     
       32. The implant system of  claim 31 , wherein the implant includes
   a screw head and a rod;        wherein said position identification structure attached to said rod holder is operable to determine a position of the rod relative to the screw head.     
     
     
       33. The implant system of  claim 21 , wherein said implant inserter includes a rod holder. 
     
     
       34. The implant system of  claim 21 , further comprising:
   a bone screw;        wherein said bone screw can form a portion of the implant.     
     
     
       35. The implant system of  claim 34 , wherein said bone screw includes a slot operable to be aligned. 
     
     
       36. The implant system of  claim 35 , further comprising:
   a second screw having a slot operable to be aligned percutaneously with said bone screw.     
     
     
       37. The implant system of  claim 21 , further comprising:
   an imaging system operable to produce image data of the anatomy.     
     
     
       38. The implant system of  claim 37 , further comprising:
   a display;        wherein the position of the implant inserter, the position of the implant, or combinations thereof can be displayed on the display with the image data.     
     
     
       39. The implant system of  claim 38 , further comprising:
   a bone screw operable to be positioned in the anatomy;        wherein the geometry of the bone screw can be displayed on said display relative to the image data.     
     
     
       40. The implant system of  claim 39 , wherein the position of the implant, the geometry of the screw, and combinations thereof can be used intra- operably to determine bending of a rod.   
     
     
       41. The implant system of  claim 38 , wherein the display allows for substantially percutaneous placements of the implant relative to the anatomy. 
     
     
       42. The implant system of  claim 21 , further comprising:
   an optical tracking system; an acoustic tracking system; an electromagnetic tracking system; a micropulsed radar tracking system; acoustic tracking system; or combinations thereof.     
     
     
       43. An implant system for facilitating percutaneous placement of an implant in an anatomy and adapted use with a surgical navigation system to track positions in space, said implant system comprising:
   an implant inserter operably interconnected to the implant;        a position identification structure operably interconnected with said implant inserter;        wherein said position identification structure is trackable by the surgical navigation system having a position sensing unit to determine a position of at least one of said implant inserter, said implant, said reference structure, or combinations thereof.     
     
     
       44. The implant system of  claim 43 , further comprising:
   a rod;        wherein said rod can form a portion of the implant;        wherein said rod extends between a first end and a second end.     
     
     
       45. The implant system of  claim 44 , wherein said implant inserter is operable to be interconnected with at least one of said first end, said second end, or combinations thereof. 
     
     
       46. The implant system of  claim 44 , wherein said implant inserter is operable to assist in moving said rod along a selected path. 
     
     
       47. The implant system of  claim 46 , further comprising:
   a bone screw;        wherein said bone screw can form a portion of the implant.     
     
     
       48. The implant system of  claim 47 , wherein the surgical navigation system assists in displaying a position of said rod relative to said bone screw to intra- operatively determine a configuration of said rod.   
     
     
       49. The implant system of  claim 67 , wherein said position data displayed on the display is determined with a processor. 
     
     
       50. The implant system of  claim 65 , further comprising:
   a rod implant;        a rod implant inserter;        a rod inserter reference structure operably interconnected with said rod inserter, wherein said rod inserter reference structure is operable with the surgical navigation system to determine a position of at least a portion of said rod implant;        wherein said implant inserter is operable to position said head relative to the anatomy percutaneously;        wherein said rod inserter is operable to position said rod implant relative to said head that has been positioned with said implant inserter.     
     
     
       51. The implant system of  claim 43 , wherein said position identification structure includes a selected geometrical shape. 
     
     
       52. The implant system of  claim 43 , wherein said position identification structure includes at least one of reflective spheres, acoustic emitters, magnets, electromagnets, emitting members, or combinations thereof. 
     
     
       53. The implant system of  claim 52 , wherein said emitting members include light emitting diodes. 
     
     
       54. The implant system of  claim 52 , wherein said reflectors can reflect at least one of visible light, infrared light, or combinations thereof. 
     
     
       55. The implant system of  claim 43 , further comprising:
   an imaging system operable to produce image data of the anatomy.     
     
     
       56. The implant system of  claim 55 , further comprising:
   a display;        wherein the position of the implant inserter, the position of the surgical implant, or combinations thereof can be displayed on the display with the image data.     
     
     
       57. The implant system of  claim 56 , further comprising:
   a bone screw operable to be positioned in the anatomy;        wherein the geometry of the bone screw can be displayed on said display relative to the image data.     
     
     
       58. The implant system of  claim 57 , wherein the position of the implant, the geometry of the screw, and combinations thereof can be used intra- operatively to determine bending of a rod.   
     
     
       59. The implant system of  claim 56 , wherein the display allows for substantially percutaneous placements of the implant relative to the anatomy. 
     
     
       60. The implant system of  claim 59 , wherein said implant is a screw. 
     
     
       61. The implant system of  claim 43 , wherein said reference structure is removably connected to said implant inserter. 
     
     
       62. The implant system of  claim 43 , further comprising:
   an optical tracking system; an acoustic tracking system; an electromagnetic tracking system; a micropulsed radar tracking system; acoustic tracking system; or combinations thereof.     
     
     
       63. An implant system for facilitating percutaneous placement of an implant in an anatomy that can be used with a surgical navigation system to track positions in space, the implant system comprising:
   an implant having a head and a body operable to be positioned relative to a selected portion of the anatomy;        an implant inserter operable to be interconnected to said head of said implant; and        a reference structure operable to be interconnected with said implant inserter;        wherein said reference structure is operable with the surgical navigation system having a position sensing unit to identify relative positions of reference points to be displayed at the reference structure to determine a position and produce position data of at least one of said implant inserter, said implant, said reference structure, or combinations thereof;        wherein said implant inserter is operable to move said implant relative to the anatomy.     
     
     
       64. The implant system of  claim 63 , wherein said implant includes a screw and said body includes a thread operable to engage the anatomy;
   wherein said implant inserter is operable to interconnect with at least the head of said screw.     
     
     
       65. The implant system of  claim 63 , further comprising:
   an imaging device that produces image data of the anatomy.     
     
     
       66. The implant system of  claim 65 , further comprising:
   a display;        wherein said display is operable to display the image data of the anatomy.     
     
     
       67. The implant system of  claim 66 , wherein the position data of said implant is determined by determining a position of the reference structure relative to the anatomy;
   wherein said implant position data is displayed on the display relative to the image data of the anatomy.     
     
     
       68. The implant system of  claim 67 , wherein said implant position data includes a position of said head. 
     
     
       69. The implant system of  claim 47 , wherein said head includes a slot. 
     
     
       70. The implant system of  claim 69 , wherein said implant position data includes a position of said slot. 
     
     
       71. The implant system of  claim 63 , wherein said implant is operable to be positioned percutaneously relative to the anatomy via said implant inserter;
   wherein said implant is operable to be manipulated percutaneously via said implant inserter and said referenced structure.     
     
     
       72. The implant system of  claim 71 , wherein the position image data of the implant is displayed on a display relative to image data of the anatomy to facilitate percutaneous placement of the implant relative to the anatomy. 
     
     
       73. The implant system of  claim 72 , wherein positioning of the implants includes positioning a head of a bone screw in a selected orientation relative to the anatomy.

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