U.S. patent number RE42,194 [Application Number 11/451,594] was granted by the patent office on 2011-03-01 for percutaneous registration apparatus and method for use in computer-assisted surgical navigation.
This patent grant is currently assigned to Medtronic Navigation, Inc.. Invention is credited to John B. Clayton, Kevin T. Foley, Anthony Melkent, Michael Sherman.
United States Patent |
RE42,194 |
Foley , et al. |
March 1, 2011 |
**Please see images for:
( Certificate of Correction ) ** |
Percutaneous registration apparatus and method for use in
computer-assisted surgical navigation
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.
Inventors: |
Foley; Kevin T. (Germantown,
TN), Clayton; John B. (Superior, CO), Melkent;
Anthony (Memphis, TN), Sherman; Michael (Memphis,
TN) |
Assignee: |
Medtronic Navigation, Inc.
(Louisville, CO)
|
Family
ID: |
26739359 |
Appl.
No.: |
11/451,594 |
Filed: |
June 12, 2006 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
|
|
10423332 |
Apr 24, 2003 |
Re. 39133 |
|
|
|
60059915 |
Sep 24, 1997 |
|
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Reissue of: |
09148498 |
Sep 4, 1998 |
06226548 |
May 1, 2001 |
|
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Current U.S.
Class: |
600/426 |
Current CPC
Class: |
A61B
17/70 (20130101); A61B 17/7083 (20130101); A61B
34/20 (20160201); A61B 2017/00477 (20130101); A61B
2034/2072 (20160201); A61B 90/11 (20160201); A61B
2090/3945 (20160201); A61B 2090/363 (20160201); A61B
2090/3983 (20160201); A61B 17/7032 (20130101); A61B
2034/2055 (20160201); A61B 34/10 (20160201) |
Current International
Class: |
A61B
5/05 (20060101) |
Field of
Search: |
;600/407,426,427,429,414,417 ;606/60,61,65,104,130 ;604/236
;623/1.34 |
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|
Primary Examiner: Manuel; George
Attorney, Agent or Firm: Harness, Dickey
Parent Case Text
.Iadd.This application is a reissue of U.S. Pat. No. 6,226,548
issued on May 1, 2001 and also claims benefit under 35 U.S.C.
.sctn.120 as a continuation of U.S. patent application Ser. No.
10/423,332 filed on Apr. 24, 2003, now RE 39,133; which is a
reissue of U.S. Pat. No. 6,226,548 issued on May 1, 2001; which
claims rights under 35 U.S.C. .sctn.119 on provisional application
No. 60/059,915, filed on Sep. 24, 1997. Notice is also given that
concurrently filed is U.S. patent application Ser. No. 09/148,498
filed on Sep. 4, 1998; which is also is a reissue of U.S. Pat. No.
6,226,548 issued on May 1, 2001 and also claims benefit under 35
U.S.C. .sctn.120 as a continuation of U.S. patent application Ser.
No. 10/423,332 filed on Apr. 24, 2003; which is a reissue of U.S.
Pat. No. 6,226,548 issued on May 1, 2001; which claims rights under
35 U.S.C. .sctn.119 on provisional application No. 60/059,915,
filed on Sep. 24, 1997. The disclosures of the above applications
are incorporated herein by reference..Iaddend.
The present invention claims rights under 35 U.S.C. .sctn.119 on
provisional application No. 60/059,915, filed on Sep. 24, 1997, and
entitled "Percutaneous Registration Apparatus and Method for Use in
Computer-Assisted Surgical Navigation."
Claims
What is claimed is:
.[.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..].
.Iadd.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..Iaddend.
.Iadd.22. The implant system of claim 21 wherein said position
identification structure includes at least one optical
emitter..Iaddend.
.Iadd.23. The implant system of claim 21 wherein said position
identification structure includes at least one light emitting
diode..Iaddend.
.Iadd.24. The implant system of claim 21, wherein said position
identification structure includes a selected geometrical
shape..Iaddend.
.Iadd.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..Iaddend.
.Iadd.26. The implant system of claim 25, wherein said reflectors
can reflect at least one of visible light, infrared light, or
combinations thereof..Iaddend.
.Iadd.27. The implant system of claim 25, wherein said magnets or
electromagnets are operable to produce a magnetic
field..Iaddend.
.Iadd.28. The implant system of claim 21, further comprising: a
rod; wherein said rod can form a portion of the surgical
implant..Iaddend.
.Iadd.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..Iaddend.
.Iadd.30. The implant system of claim 28, wherein said rod holder
is operable to assist in moving a rod along a selected
path..Iaddend.
.Iadd.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..Iaddend.
.Iadd.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..Iaddend.
.Iadd.33. The implant system of claim 21, wherein said implant
inserter includes a rod holder..Iaddend.
.Iadd.34. The implant system of claim 21, further comprising: a
bone screw; wherein said bone screw can form a portion of the
implant..Iaddend.
.Iadd.35. The implant system of claim 34, wherein said bone screw
includes a slot operable to be aligned..Iaddend.
.Iadd.36. The implant system of claim 35, further comprising: a
second screw having a slot operable to be aligned percutaneously
with said bone screw..Iaddend.
.Iadd.37. The implant system of claim 21, further comprising: an
imaging system operable to produce image data of the
anatomy..Iaddend.
.Iadd.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..Iaddend.
.Iadd.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..Iaddend.
.Iadd.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..Iaddend.
.Iadd.41. The implant system of claim 38, wherein the display
allows for substantially percutaneous placements of the implant
relative to the anatomy..Iaddend.
.Iadd.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..Iaddend.
.Iadd.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..Iaddend.
.Iadd.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..Iaddend.
.Iadd.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..Iaddend.
.Iadd.46. The implant system of claim 44, wherein said implant
inserter is operable to assist in moving said rod along a selected
path..Iaddend.
.Iadd.47. The implant system of claim 46, further comprising: a
bone screw; wherein said bone screw can form a portion of the
implant..Iaddend.
.Iadd.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..Iaddend.
.Iadd.49. The implant system of claim 67, wherein said position
data displayed on the display is determined with a
processor..Iaddend.
.Iadd.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..Iaddend.
.Iadd.51. The implant system of claim 43, wherein said position
identification structure includes a selected geometrical
shape..Iaddend.
.Iadd.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..Iaddend.
.Iadd.53. The implant system of claim 52, wherein said emitting
members include light emitting diodes..Iaddend.
.Iadd.54. The implant system of claim 52, wherein said reflectors
can reflect at least one of visible light, infrared light, or
combinations thereof..Iaddend.
.Iadd.55. The implant system of claim 43, further comprising: an
imaging system operable to produce image data of the
anatomy..Iaddend.
.Iadd.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..Iaddend.
.Iadd.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..Iaddend.
.Iadd.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..Iaddend.
.Iadd.59. The implant system of claim 56, wherein the display
allows for substantially percutaneous placements of the implant
relative to the anatomy..Iaddend.
.Iadd.60. The implant system of claim 59, wherein said implant is a
screw..Iaddend.
.Iadd.61. The implant system of claim 43, wherein said reference
structure is removably connected to said implant
inserter..Iaddend.
.Iadd.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..Iaddend.
.Iadd.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..Iaddend.
.Iadd.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..Iaddend.
.Iadd.65. The implant system of claim 63, further comprising: an
imaging device that produces image data of the
anatomy..Iaddend.
.Iadd.66. The implant system of claim 65, further comprising: a
display; wherein said display is operable to display the image data
of the anatomy..Iaddend.
.Iadd.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..Iaddend.
.Iadd.68. The implant system of claim 67, wherein said implant
position data includes a position of said head..Iaddend.
.Iadd.69. The implant system of claim 47, wherein said head
includes a slot..Iaddend.
.Iadd.70. The implant system of claim 69, wherein said implant
position data includes a position of said slot..Iaddend.
.Iadd.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..Iaddend.
.Iadd.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..Iaddend.
.Iadd.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..Iaddend.
Description
FIELD OF THE INVENTION
The present invention relates generally to guiding, directing, or
navigating instruments or implants in a body percutaneously, in
conjunction with systems that use and generate images during
medical and surgical procedures, which images assist in executing
the procedures and indicate the relative position of various body
parts, surgical implants, and instruments. In particular the
invention relates to apparatus and minimally invasive procedures
for navigating instruments and providing surgical implants
percutaneously in the spine, for example, to stabilize the spine,
correct deformity, or enhance fusion in conjunction with a surgical
navigation system for generating images during medical and surgical
procedures.
BACKGROUND OF THE INVENTION
Typically, spinal surgical procedures used, for example, to provide
stabilization, fusion, or to correct deformities, require large
incisions and substantial exposure of the spinal areas to permit
the placement of surgical implants such as, for example, various
forms of screws or hooks linked by rods, wires, or plates into
portions of the spine. This standard procedure is invasive and can
result in trauma, blood loss, and post operative pain.
Alternatively, fluoroscopes have been used to assist in placing
screws beneath the skin. In this alternative procedure at least
four incisions must be made in the patient's back for inserting
rods or wires through previously inserted screws. However, this
technique can be difficult in that fluoroscopes only provide
two-dimensional images and require the surgeon to rotate the
fluoroscope frequently in order to get a mental image of the
anatomy in three dimensions. Fluoroscopes also generate radiation
to which the patient and surgical staff may become over exposed
over time. Additionally, the subcutaneous implants required for
this procedure may irritate the patient. A lever arm effect can
also occur with the screws that are not connected by the rods or
wires at the spine. Fluoroscopic screw placement techniques have
traditionally used rods or plates that are subcutaneous to connect
screws from vertebra to vertebra. This is due in part to the fact
that there is no fluoroscopic technique that has been designed
which can always adequately place rods or plates at the submuscular
region (or adjacent to the vertebrae). These subcutaneous rods or
plates may not be well tolerated by the patient. They also may not
provide the optimal mechanical support to the spine because the
moment arm of the construct can be increased, thereby translating
higher loads and stresses through the construct.
A number of different types of surgical navigation systems have
been described that include indications of the positions of medical
instruments and patient anatomy used in medical or surgical
procedures. For example, U.S. Pat. No. 5,383,454 to Bucholz; PCT
Application No. PCT/US94/04530 (Publication No. WO 94/24933) to
Bucholz; and PCT Application No. PCT/US95/12894 (Publication No. WO
96/11624) to Bucholz et al., the entire disclosures of which are
incorporated herein by reference, disclose systems for use during a
medical or surgical procedure using scans generated by a scanner
prior to the procedure. Surgical navigation systems typically
include tracking means such as, for example, an LED array on the
body part, LED emitters on the medical instruments, a digitizer to
track the positions of the body part and the instruments, and a
display for the position of an instrument used in a medical
procedure relative to an image of a body part.
Bucholz et al. WO 96/11624 is of particular interest, in that it
identifies special issues associated with surgical navigation in
the spine, where there are multiple vertebral bodies that can move
with respect to each other. Bucholz et al. describes a procedure
for operating on the spine during an open process where, after
imaging, the spinous process reference points may move with respect
to each other. It also discloses a procedure for modifying and
repositioning the image data set to match the actual position of
the anatomical elements. When there is an opportunity for
anatomical movement, such movement degrades the fidelity of the
pre-procedural images in depicting the intra-procedural anatomy.
Therefore, additional innovations are desirable to bring image
guidance to the parts of the body experiencing anatomical
movement.
Furthermore, spinal surgical procedures are typically highly
invasive. There is, thus, a need for more minimally invasive
techniques for performing these spinal procedures, such as biopsy,
spinal fixation, endoscopy, spinal implant insertion, fusion, and
insertion of drug delivery systems, by reducing incision size and
amount. One such way is to use surgical navigation equipment to
perform procedures percutaneously, that is beneath the skin. To do
so by means of surgical navigation also requires apparatus that can
indicate the position of the spinal elements, such as, for example
the vertebrae, involved in the procedure relative to the
instruments and implants being inserted beneath the patient's skin
and into the patient's spine. Additionally, because the spinal
elements naturally move relative to each other, the user requires
the ability to reorient these spinal elements to align with earlier
scanned images stored in the surgical navigation system computer,
to assure the correct location of those elements relative to the
instruments and implants being applied or inserted
percutaneously.
In light of the foregoing, there is a need in the art for apparatus
and minimally invasive procedures for percutaneous placement of
surgical implants and instruments in the spine, reducing the size
and amount of incisions and utilizing surgical navigation
techniques.
SUMMARY OF THE INVENTION
Accordingly, the present invention is directed to 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. More
specifically, one object of the present invention is directed to
apparatus and procedures for the percutaneous placement of surgical
implants and instruments into various elements of the spine using
image guided surgery.
To achieve these objects and other advantages and in accordance
with the purpose of the invention, as embodied and broadly
described herein, the invention includes an apparatus for use with
a surgical navigation system and comprises 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 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.
In one aspect, the attaching device is a clamp with jaws and sharp
teeth for biting into the spinous process.
In another aspect, the fixture is a screw, having a head, wherein
the screw is implanted into the spinous process and a relatively
rigid wire is attached to the head of the screw and also implanted
into the spinous process at an angle to the axis of the screw to
prevent the screw from rotating in either direction.
In another aspect, the superstructure includes a central post, and
a fiducial array and a reference arc rigidly but removably attached
to the central post. The fiducial array is composed of
image-compatible materials, and includes fiducials for providing a
reference point, indicating the position of the array, which are
rigidly attached to the fiducial array, composed of, for example
titanium or aluminum spheres. The reference arc includes emitters,
such as, for example Light Emitting Diodes ("LEDs"), passive
reflective spheres, or other tracking means such as acoustic,
magnetic, electromagnetic, radiologic, or micropulsed radar, for
indicating the location of the reference arc and, thus, the body
part it is attached to, during medical procedures.
In addition, the invention further comprises a method for
monitoring the location of an instrument, surgical implants and the
various portions of the body, for example, vertebrae, to be
operated on in a surgical navigation system comprising the steps
of: attaching a fixture to the spinous process; attaching a
superstructure including a fiducial array with fiducials and a
reference arc to the fixture; scanning the patient using CT, MRI or
some other three-dimensional method, with fiducial array rigidly
fixed to patient to identify it on the scanned image; and
thereafter, in an operating room, using image-guided technology,
touching an image-guided surgical pointer or other instrument to
one or more of the fiducials on the fiducial array to register the
location of the spinal clement fixed to the array and emitting an
audio, visual, radiologic, magnetic or other detectable signal from
the reference arc to an instrument such as, for example, a
digitizer or other position-sensing unit, to indicate changes in
position of the spinal element during a surgical procedure, and
performing a surgical or medical procedure percutaneously on the
patient using instruments and implants localable relative to spinal
elements in a known position in the surgical navigation system.
In another aspect, the method includes inserting screws or rigid
wires in spinal elements in the area involved in the anticipated
surgical procedure before scanning the patient, and after scanning
the patient and bringing the patient to the operating area,
touching an image-guided or tracked surgical pointer to these
screws and wires attached to the vertebrae to positively register
their location in the surgical navigation computer, and
manipulating either the patient's spine or the image to align the
actual position of the spinal elements with the scanned image.
In another aspect, the method includes percutaneously implanting
screws into spinal elements, which screws are located using image
guided surgical navigation techniques, and further manipulating the
orientation of the screw heads percutaneously using a
head-positioning probe containing an emitter, that can communicate
to the surgical navigation computer the orientation of the screw
heads and position them, by use of a specially designed
head-positioning tool with an end portion that mates with the heads
of the screws and can rotate those screw heads to receive a rod,
wire, plate, or other connecting implant. If a rod is being
inserted into the screw heads for example, the method further
includes tracking the location and position of the rod,
percutaneously using a rod inserter having one or more emitters
communicating the location and orientation of the rod to the
surgical navigation computer.
The objects of the invention are to provide a user, such as a
surgeon, with the system and method to track an instrument and
surgical implants used in conjunction with a surgical navigation
system in such a manner to operate percutaneously on a patient's
body parts, such as spinal vertebrae which can move relative to
each other.
It is a further object of this invention to provide a system and
method to simply and yet positively indicate to the user a change
in position of body parts, such as spinal vertebrae segments, from
that identified in a stored image scan, such as from an MRI or CAT
scan, and provide a method to realign those body parts to
correspond with a previously stored image or the image to
correspond with the actual current position of the body parts.
It is a further object of this invention to provide a system or
method for allowing a fiducial array or reference arc that is
removable from a location rigidly fixed to a body part and
replaceable back in that precise location.
It is another object of this invention to provide a system and
method for positively generating a display of instruments and
surgical implants, such as, for example screws and rods, placed
percutaneously in a patient using image-guided surgical methods and
techniques.
It is another object of this invention for a percutaneous reference
array and fiducial array, as described in this appplication, to be
used to register and track the position of the vertebrae for the
purposes of targeting a radiation dose to a diseased portion of
said vertebrae using a traditional radiosurgical technique.
Additional objects and advantages of the invention will be set
forth in part in the description which follows, and in part will be
obvious from the description, or may be learned by practice of the
invention. The objects and advantages of the invention will be
realized and attained by means of the elements and combinations
particularly pointed out in this description.
It is to be understood that both the foregoing general description
and the following detailed description are exemplary and
explanatory only and are not restrictive of the invention.
BRIEF DESCRIPTION OF THE DRAWINGS
The accompanying drawings, which are incorporated in and constitute
a part of this specification, illustrate one embodiment of the
invention and together with the description, serve to explain the
principles of the invention.
FIG. 1 is a schematic diagram of one preferred embodiment of a
superstructure for use in the current invention, including a
reference arc, center post and fiducial array and rigid Kirschner
wires ("K wires") and screws placed in the spine for use with a
surgical navigation system for percutaneous spinal surgical
procedures.
FIG. 1A is an enlarged view of the superstructure depicted in FIG.
1 engaging a vertebra by a clamp and also K wires implanted in
adjacent vertebrae in the superior and inferior positions of the
spinous process.
FIG. 2 is a diagram of the preferred embodiment of a clamp fixture
for rigid connection to the spinous process of a single vertebrae
with an H-shaped fiducial array attached to a center post rigidly
attached to the clamp and a mating connector at the tip of the post
for mating with a reference array, and a reference array for use in
the current invention.
FIG. 2A is a side view of FIG. 2 FIG. 2B is another side view of
FIG. 2.
FIG. 2C is a top view of FIG. 2.
FIG. 2D is an exploded view of FIG. 2 without the reference
arc.
FIG. 2E is an exploded view of the interface of the center post and
clamp of FIG. 2.
FIG. 3 is a diagram of a W-Shaped fiducial array mounted to a
central post with generally spherical fiducials attached to the
array, for mounting to a single vertebrae.
FIG. 3A is a side view of FIG. 3.
FIG. 3B is another side view of FIG. 3.
FIG. 3C is a top view of FIG. 3.
FIG. 4 is a diagram of a reference arc and fiducial attached to a
center post for use in the current invention in mounting to a
single vertebrae.
FIG. 4A is a side view of FIG. 4.
FIG. 4B is a back view of FIG. 4.
FIG. 4C is a top view of FIG. 4.
FIG. 4D is an expanded view of FIG. 4.
FIG. 4E is an expanded side view of FIG. 4.
FIG. 4F is an expanded view of the array foot and shoe of FIG.
4E.
FIG. 5 is a diagram of an alternative embodiment of a fixture for
use in the current invention using a cannulated screw for insertion
into a vertebrae, with Kirschner wire mounted on a central post and
including an alternate embodiment of a fiduciary array and
reference arc combined on a single structure.
FIG. 6 is a side view of the screw and Kirschner wire fixture of
FIG. 5 implanted in a spinous process of a vertebrae.
FIG. 7 is a diagram of a screw-head positioning probe and
multiaxial screw for insertion into a single vertebrae.
FIG. 7A is a diagram of the screw of FIG. 7.
FIG. 8 is a diagram of a head positioning probe, multiaxial screw
and spinal segment.
FIG. 9 is a diagram of a rod inserter with an LED.
FIG. 10 is a diagram of an alternative embodiment of the invention
depicting a cannulated tube and attachment for holding a reference
arc.
FIG. 11 is a diagram of the cannulated tube of FIG. 10 with a
reference arc and screw for attachment to a spinal process.
FIG. 12 is a posterior view of spinal segment and implanted screws
before alignment.
FIG. 13 is a posterior view of spinal segment and implanted screws
after alignment.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
Reference will now be made in detail to the present preferred
embodiment of the invention, an example of which is illustrated in
the accompanying drawings. Wherever possible, the same reference
numbers will be used throughout the drawings to refer to the same
or like parts. The following example is intended to be purely
exemplary of the invention.
As generally described in PCT/US95/12894, the entire disclosure of
which is incorporated herein by reference, a typical surgical
navigation system is shown in FIG. 1 adopted to be used in the
present invention. A computer assisted image-guided surgery system,
indicated generally at 10, generates an image for display on a
monitor 106 representing the position of one or more body elements,
such as spinal elements fixedly held in a stabilizing frame or
device such as a spinal surgery frame 125 commonly used for spinal
surgery. A reference arc 120 bearing tracking means or emitters,
such as for example LED emitters 122, is mounted to the spinous
process by a central post 150. The structures 20 and K wires 260 of
FIG. 1 are depicted in more detail in FIG. 1A. The image 105 is
generated from an image data set, usually generated preoperatively
by a CAT scanner or by MRI for example, which image 105 has
reference points for at least one body element, such as a spinal
element or vertebrae. The reference points of the particular body
element have a fixed spatial relation to the particular body
element.
The system includes an apparatus such as a digitizer or other
Position Sensing Unit (PSU), such as for example sensor array 110
on support 112 for identifying, during the procedure, the relative
position of each of the reference points to be displayed by
tracking the position of emitters 122 on arc 120. The system also
includes a processor 114 such as a PC or other suitable workstation
processor associated with controller 108 for modifying the image
data set according to the identified relative position of each of
the reference points during the procedure, as identified by
digitizer 110. The processor 114 can then, for example, generate an
image data set representing the position of the body elements
during the procedure for display on monitor 106. A surgical
instrument 130, such as a probe or drill or other tool, may be
included in the system, which is positioned relative to a body part
and similarly tracked by sensor array 110.
In summary, the general operation of a surgical navigating system
is well known in the art and need not further be described
here.
In accordance with the preferred embodiment of the present
invention, with further reference to FIGS. 1 through 6, a
registration device 20 is rigidly fixed to a spinal element by, for
example, a device such as a bone clamp 30 depicted in FIG. 2.
Alternatively, a screw retention device 40, such as the cannulated
screw 42 depicted in FIG. 5, and described in more detail below,
can be used.
With reference now to FIG. 2, bone clamp 30 is fixedly attached to
the spinous process. The clamp 30 includes at least two blades (or
jaws) 32 with tips or teeth 34, which are preferably sharp, for
driving together and penetrating soft tissue or more dense bone for
rigid fixation to the spinous process. The teeth 34 are also
preferably sized to accommodate the bulb shape of the spinous
process. The driving mechanism 40 is, for example, a screw driven
into a sleeve 41 and is also preferably located such that it will
be accessible in a percutaneous manner. Attached to the clamp 30 is
a superstructure 20. The superstructure 20 includes a central post
150 which is relocatable, that is, it fixes to the clamp 30 in a
rigid fashion, for example, as depicted in FIGS. 2D and 2E, by
being inserted into a V-shaped wedge 44 orienting the post 150
front to back and providing a mating hole 48 along the wedge 44 for
insertion of post 150 in a single orientation and also providing
fasteners such as screw 43 for lightning to lock the post 150 in
place. The post 150 can be removed and reapplied by loosening and
tightening screw 43, such that the original geometry and
orientation is maintained. The central post 150 has at its apex a
connector 60 with unique geometrical configuration, such as, for
example, a starburst, onto which a spinal reference arc 120 of the
superstructure 20 attaches. Any such standard reference arc 120 can
be used, such as depicted in FIGS. 1A, 4, and 11, preferably
including emitters 122, such as for example LEDs or reflective
spheres for providing a positive indication of movement to the
surgical navigation system during a procedure.
Also rigidly attached to the central post 150, as part of the
superstructure 20 preferably at a location closer to the skin, or
possibly collocated with or also performing the function of the
reference arc 120, is a fiducial array 170, which can be of various
different shapes, such as, for example the H-shaped frame 170
depicted in FIG. 2, the W-shaped frame 170' as depicted in FIG. 3,
the U-shaped frame 170'' as depicted in FIG. 4 or the X-shaped
frame 120', 170''' depicted in FIG. 5 (depicting a structure that
is both a fiducial array and a reference arc). As depicted in FIGS.
2 and 3, this array can include fiducial points 29 or spheres 17,
rigidly attached to fiducial array 170, 170' and is, for example,
as depicted in FIG. 3, substantially in the shape of spheres 17 and
of a material detectable by the CAT scan or MRI, preferably
titanium or aluminum. This fiducial array such as 170 indicates to
the surgical navigation system the location of the bone structure
to which the clamp 30 and central post 150 are attached by touching
a pointed surgical tracker to fiducial points 29 or a cup-shaped
probe to fiducial spheres 17, thereby indicating the center of the
fiducial to the surgical navigation controller 114. The array 170
and central post 150 are also attached to the clamp 30, as
described above, in such a way that they can be removed and
replaced in the same geometric orientation and location, for
example, by means of a uniquely shaped interface, for example, a
triangle, or a single unique shape or a combination of unique
angles or pins with the clamp 30 such that the post 150 can only be
reinserted the same way it was removed.
Additionally, the fiducial array 170, can be located at various
heights on the post 150 to accomodate variations in patient tissue
depth and size, preferably as close to the patient's body as
possible, and then fixed at that specific height by the use of pins
or indents matched to boles 19 (shown in FIG. 2) in the central
post 150 or by placing the rods 39 of H-shaped array 170 in
different holes 31. The fiducial array 170 also has, for example,
divots 29 (shown in FIG. 2) shaped to interface with an instrument
such as a surgical pointer 130 which can touch that divot 29 to
register the location of the divot 29 and, thus, the location of
the fiducial array 170 and likewise the spinal element in the
surgical navigation system. Multiple divots can be registered to
further increase accuracy of the registration system. In one
preferred embodiment of the array, the fiducials 17 or 29 can be
mounted in a manner such that they can be adjusted, for example by
mounting them on a rotatable or collapsible arm 66 (as depicted in
FIG. 3) that pivots and folds together, to get the maximum distance
between fiducials while not dramatically increasing the field of
view required at the time of scanning.
Alternatively, rather than using clamp 30, a screw 42 and rigid
wire 45 attachment, as depicted in FIGS. 5 and 6, may be used to
rigidly attach the central post of the superstructure 20 to a body
element, such as, for example, a vertebrae. As depicted in FIG. 6,
screw 42 is screwed into the spinal process of spinal element 100.
A rigid wire 45, post, or other sufficiently rigid fastener such as
for example a Kirschner wire (K-wire), is inserted through the
cannulation in the center of post 150 and the screw 42 or is
otherwise fixed to the screw 42, and exits the tip of the screw 42
at some angle, and is also implanted into the spinal element 100 to
prevent the screw 42 from rotating in either direction.
Another embodiment for preventing the superstructure 20 from
rotating as depicted in FIGS. 10 and 11 includes the insertion of a
screw 85 through a cannulated tube 86 which has teeth 89 in the end
(or V-shaped end) that would bite into the tip of the spinous
process, preventing rotation.
Having described the preferred embodiment of this apparatus of the
present system, the method of using this apparatus to practice the
invention of registering a single vertebrae will now be discussed.
The operation of a surgical navigating system is generally well
known and is described in PCT/US95/12894. In the preferred method
of operation, clamp 30 of FIG. 2 or screw 42 and K-Wire 45 of FIG.
5 are implanted percutaneously through a small incision in the skin
and rigidly attached to the spinal process. This attachment occurs
with the clamp 30, by driving the blades 32 of the clamp 30
together to hold the spinous process rigidly. The central post 150
is then rigidly fixed to the clamp 30 or screw 42 and the fiducial
array 170 is rigidly fixed to the central post 150. The patient is
then scanned and imaged with a CAT scan or MRI with a field of view
sufficiently large to display the spinal anatomy and the clamp 30
or screw 42 and the fiducial array 170. This scan is loaded into
the surgical navigation system processor 104.
After scanning the patient, the array 120 and post 150 can be
removed from the patient, while leaving in place the rigidly
connected clamp 30 or screw 42. For example, as depicted in FIGS.
4D and 4E, a foot 55 located below array 170'' engages with shoe 56
and rigidly connected by screws 57 and 58. Before the surgical
procedure, the post 150, array 120 and other remaining portions of
the superstructure 20, once removed, may be sterilized. The patient
is then moved to the operating room or similar facility from, for
example, the scanning room.
Once in the operating room, the patient may be positioned in an
apparatus, such as, for example, a spinal surgery frame 125 to help
keep the spinal elements in a particular position and relatively
motionless. The superstructure 20 is then replaced on the clamp 30
or screw 42 in a precise manner to the same relative position to
the spinal elements as it was in the earlier CAT scan or MRI
imaging. The reference arc 120 is fixed to the starburst or other
interface connector 60 on the central post 150 which is fixed to
the clamp 30 or screw 42. The operator, for example a surgeon, then
touches an instrument with a tracking emitter such as a surgical
pointer 130 with emitters 195 to the divots 29 on the fiducial
array 170 to register the location of the array 170 and, thus,
because the spinal process is fixed to the fiducial array 170, the
location of the spinal element is also registered in the surgical
navigation system.
Once the superstructure 20 is placed back on the patient, any
instrument 130 fitted with tracking emitters thereon such as, for
example, a drill or screw driver, can be tracked in space relative
to the spine in the surgical navigation system without further
surgical exposure of the spine. The position of the instrument 130
is determined by the user stepping on a foot pedal 116 to begin
tracking the emitter array 190. The emitters 195 generate infrared
signals to be picked up by camera digitizer array 110 and
triangulated to determine the position of the instrument 130.
Additionally, other methods may be employed to track reference
arcs, pointer probes, and other tracked instruments, such as with
reflective spheres, or sound or magnetic emitters, instead of
LED's. For example, reflective spheres can reflect infrared light
that is emitted from the camera array 110 back to the camera array
110. The relative position of the body part, such as the spinal
process is determined in a similar manner, through the use of
similar emitters 122 mounted on the reference frame 120 in
mechanical communication with the spinal segment. As is well known
in this art and described generally in PCT/US95/12894, based upon
the relative position of the spinal segment and the instrument 130
(such as by touching a known reference point) the computer would
illustrate a preoperative scan--such as the proper CAT scan
slice--on the screen of monitor 106 which would indicate the
position of the tool 130 and the spinal segment for the area of the
spine involved in the medical procedure.
For better access by the operator of various areas near the central
post 150, the fiducial array 170 can be removed from the central
post 150, by, for example, loosening screw 42 and sliding the array
170 off post 150, leaving the reference arc 120 in place or
replacing it after removal of array 170. By leaving the reference
arc 120 in place, the registration of the location of the spinal
process is maintained. Additionally, the central post 150,
reference arc 120, and fiducial array 170 can be removed after the
spinal element has been registered leaving only the clamp 30 or
screw 42 in place. The entire surgical field can then be sterilized
and a sterile post 150 and reference arc 170 fixed to the clamp 30
or screw 42 with the registration maintained.
This surgical navigation system, with spinal element registration
maintained, can then be used, for example, to place necessary and
desired screws, rods, hooks, plates, wires, and other surgical
instruments and implants percutaneously, using image-guided
technology. Once the location of the spinal element 100 involved in
the procedure is registered, by the process described above, in
relation to the image data set and image 105 projected on monitor
106, other instruments 130 and surgical implants can be placed
under the patient's skin at locations indicated by the instrument
130 relative to the spinal element 100.
Additionally, the location of other spinal elements, relative to
the spinal element 100 containing the fiducial array 170, can be
registered in the surgical navigation system by, for example,
inserting additional screws 250, rigid wires 260, or other rigid
implants or imageable devices into the spinal segment.
For example, as depicted in FIG. 1, and in more detail FIG. 1A,
additional screws 250 or rigid and pointed wires 260 are placed in
the vertebrae adjacent to the vertebrae containing the clamp 30 and
post 150 prior to scanning. On the image 105 provided by monitor
106, the surgeon can see the clamp 30 or screw 42 and fiducial
array 170 and also the additional screws 250, wires 260 or other
imageable devices. When screws 250 or other devices are used, these
screws 250 (as depicted in FIG. 7) may contain a divot 256 or other
specially shaped interface on the head 255 so that a pointer probe
130 can be used to point to the head 255 of the screw 250 (or wire)
and indicate the orientation of the screw 250 or wire 260 to the
surgical navigation system by communicating to the controller 114
or by emission from LEDs 195 on probe 130 to digitizer 110. The
image of these additional screws 250 also appear in the scan. Once
the patient is then moved to the operating facility, rather than
the scanning area, the image of the screw 250 can be compared to
the actual position of the screw 250 as indicated by the pointer
probe 130 that is touched to the head 255 of the screw 250 or wire
260. If necessary, the operator can manipulate the position of the
patient to move the spinal element and thus the location of the
screw 250 or wire 260 to realign the spinal elements with the
earlier image of the spine. Alternatively, the operator can
manipulate the image to correspond to the current position of the
spinal segments.
For additional positioning information, the operator can place
additional rigid wires 260 or screws 250 into the vertebrae, for
example, located at the superior (toward the patient's head) and
inferior (towards the patient's feet) ends of the spinal process to
more accurately position those vertebrae relative to the other
vertebrae and the image data. Additionally, the wires 260 and
screws 250 implanted to provide positioning information can also be
equipped with emitters, such as, for example, LEDs, to provide
additional information to the surgical navigation system on the
location of the wire 260 or screw 250, and thus the vertebra to
which they are affixed.
Alternatively, the patient can be placed in a position stabilizing
device, such as a spinal surgery frame 125 or board, before a scan
is taken, and then moved to the operating facility for the
procedure, maintaining the spine segments in the same position from
the time of scanning until the time of surgery. Alternatively, a
fluoroscope can be used to reposition the spinal segments relative
to the earlier image from the scan. An ultrasound probe can be used
to take real-time images of the spinal segment which can be
portrayed by monitor 106 overlayed or superimposed on image 105.
Then the operator can manually manipulate the spinal elements and
take additional images of these elements with the fluoroscope to,
in an iterative fashion, align the spinal elements with the
previously scanned image 105.
Alternatively, a clamp 30 or screw 42 and superstructure 20 can be
rigidly fixed to each vertebra involved in the surgical or medical
procedure to register the position of each vertebra as explained
previously for a single vertebra:
After the spinal elements are registered in the spine, various
medical and surgical procedures can be performed on that patient.
For example, spinal implants, endoscopes, or biopsy probes can be
passed into the spine and procedures such as, for example, spinal
fusion, manipulation, or disc removal can be performed
percutaneously and facilitated by the surgical navigation
image-guiding system. Additionally, a radiation dose can be
targeted to a specific region of the vertebrae.
One such procedure facilitated by the apparatus and methods
described above is the percutaneous insertion of screws and rods,
fixed to different vertebra in a spine to stabilize them. Once
screws, for example multiaxial screws 250, (as depicted in FIG. 12,
before manipulation) are implanted through small incisions they can
be manipulated by a head-positioning probe 280. The final position
of screws 250 and heads 255 are depicted in FIG. 13. This probe
280, as depicted in FIG. 7, includes a head 285 that mates in a
geometrically unique fashion with the head 255 of the screw 250. An
emitter, such as for example an LED array 380 on the probe 280,
indicates the location and orientation of the screw head 255 to the
computer 114 of the surgical navigation system by providing an
optical signal received by digitizer 110. The screw head 255 can
then be rotatably manipulated under the patient's skin by the head
positioning probe 280 to be properly oriented for the receipt of a
rod 360 inserted through the rotating head 255. The operator can
then plan a path from the head 255 of each screw 250 to the other
screws 250 to be connected. Then, with reference now to FIG. 9, an
optically tracked rod inserter 245 also equipped with emitters,
such as, for example LEDs 247, can be placed through another small
incision to mate with and guide a rod 360 through the holes or
slots in the screw heads 245, through and beneath various tissues
of the patient, with the rod inserter 245, and, therefore, the rod
360, fixed to the inserter 245, being tracked in the surgical
navigation system. The operator can also use the computer 114 to
determine the required bending angles of the rod 360. For greater
visualization, the geometry of the screws 250 could be loaded into
the computer 114 and when the position and orientation of the head
255 is given to the computer 114 via the probe 280, the computer
114 could place this geometry onto the image data and
three-dimensional model. The rod 360 geometry could also be loaded
into the computer 114 and could be visible and shown in real time
on monitor 106 as the operator is placing it in the screw heads
255.
In an alternative procedure, one or more plates and/or one or more
wires may be inserted instead of one or more rods 360.
It will be apparent to those skilled in the art that various
modifications and variations can be made in the present invention
and in construction of this surgical navigation system without
departing from the scope or spirit of the invention. Other
embodiments of the invention will be apparent to those skilled in
the art from consideration of the specification and practice of the
invention disclosed herein. It is intended that the specification
and examples be considered as exemplary only.
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