U.S. patent application number 10/649214 was filed with the patent office on 2004-06-17 for method and apparatus for electromagnetic navigation of a surgical probe near a metal object.
Invention is credited to Jascob, Bradley, Kessman, Paul, Simon, David, Smith, Aaron.
Application Number | 20040116803 10/649214 |
Document ID | / |
Family ID | 25361970 |
Filed Date | 2004-06-17 |
United States Patent
Application |
20040116803 |
Kind Code |
A1 |
Jascob, Bradley ; et
al. |
June 17, 2004 |
Method and apparatus for electromagnetic navigation of a surgical
probe near a metal object
Abstract
A method and apparatus for electromagnetic navigation of a
surgical probe near a metal object. The electromagnetic navigation
system includes a transmitter coil array and a shield. The
transmitter coil array has a plurality of transmitter coils and is
operable to generate the electromagnetic field to navigate the
probe. The shield is positioned adjacent the metal object and is
operable to shield the metal object from the electromagnetic field
generated by the transmitter coil array, such that the shield
substantially reduces distortion of the electromagnetic field by
the metal object.
Inventors: |
Jascob, Bradley;
(Broomfield, CO) ; Simon, David; (Boulder, CO)
; Kessman, Paul; (Boulder, CO) ; Smith, Aaron;
(Denver, CO) |
Correspondence
Address: |
HARNESS, DICKEY & PIERCE, P.L.C.
P.O. BOX 828
BLOOMFIELD HILLS
MI
48303
US
|
Family ID: |
25361970 |
Appl. No.: |
10/649214 |
Filed: |
January 9, 2004 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10649214 |
Jan 9, 2004 |
|
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09873604 |
Jun 4, 2001 |
|
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6636757 |
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Current U.S.
Class: |
600/424 ;
324/207.11 |
Current CPC
Class: |
A61B 2034/2051 20160201;
A61B 2090/0481 20160201; A61B 2017/00725 20130101; A61B 90/36
20160201; A61B 2034/2072 20160201; A61B 2090/376 20160201; A61B
34/20 20160201 |
Class at
Publication: |
600/424 ;
324/207.11 |
International
Class: |
A61B 005/05 |
Claims
What is claimed is:
1. A method for calibrating an electromagnetic navigation system
having a transmitter coil array that generates an electromagnetic
field, said method comprising: (a) positioning the electromagnetic
navigation system in a working environment to account for metallic
distortion caused by a metallic object adjacent to the
electromagnetic field; (b) positioning a calibration sensor at a
first calibration point; (c) energizing a first coil in the
transmitter coil array to generate a first field; (d) sensing a
first field strength of the first field with the calibration
sensor; and (e) repeating steps (b), (c) and (d) at a second
calibration point, wherein effects of metallic distortion caused by
the metallic object is taken into account during the calibration
process and wherein the metallic object is a medical device.
2. The method as defined in claim 1 further comprising energizing a
plurality of coils sequentially in the transmitter coil array to
generate a plurality of fields and sensing field strengths of each
of the plurality of fields with the calibration sensor.
3. The method as defined in claim 1 further comprising repeating
step (e) to generate about eight thousand calibration points.
4. The method as defined in claim 1 wherein positioning the
calibration sensor at a first calibration point further comprises
utilizing a robotic unit to position the calibration sensor at the
first calibration point.
5. The method as defined in claim 1 wherein the medical device is
selected from a group consisting of operating room table,
fluoroscope, microscope, ultrasound hand piece, high-intensity
focused ultrasound systems, computer topography imaging (CT),
interoperative computer topography, magnetic resonance imaging
(MR), interoperative magnetic resonance and surgical robot.
6. The method as defined in claim 5 wherein at least one of
function and movement of the medical device is simulated during the
calibration process.
7. The method as defined in claim 1 further comprising navigating a
probe through the electromagnetic field by using the stored field
strengths sensed by the calibration sensor.
8. The method as defined in claim 7 further comprising comparing
the stored field strengths sensed by the calibration sensor with
field strengths measured by the probe.
9. The method as defined in claim 8 further comprising using the
stored field strengths sensed by the calibration sensor to
interpolate fields at a guess point in space.
10. The method as defined in claim 9 further comprising computing
the difference in field strengths between the guess point with the
field strength measured by the probe.
11. The method as defined in claim 10 further comprising using the
measured difference to refine the guess point during a minimization
process to select a new guess point that is closer to the probe
location.
12. The method as defined in claim 11 further comprising minimizing
the error between the guess point and the actual location of the
probe to an acceptable value.
13. The method as defined in claim 1 further comprising creating a
look-up table for a plurality of calibration points which is
operable to be used during navigation process, where the look-up
table stores field strengths for the plurality of calibration
points that take into affect the metallic distortion caused by the
metallic object adjacent to the electromagnetic field.
14. The method as defined in claim 1 further comprising energizing
the plurality of coils in the transmitter coil array in at least
one of a time division multiplex manner, frequency division
multiplex manner, or a combination of both.
15. The method as defined in claim 7 wherein navigating the probe
includes navigating a probe selected from at least one of a
surgical probe, catheter, steerable catheter, endoscope, shunt,
drill guide, awl/tap, orthopedic instrument and a combination
thereof.
16. The method as defined in claim 7 further comprising providing a
dynamic reference arc that is affixed relative to a patient and
used as a reference point for the probe.
17. A method for navigating an instrument in an electromagnetic
navigation system having a transmitter coil array that generates an
electromagnetic field, said method comprising: (a) referencing a
look-up table of calibration field strengths that account for
metallic distortion caused by a metallic object adjacent to the
electromagnetic field; (b) selecting a guess point where the
instrument is located; (c) energizing the transmitter coil array to
generate the electromagnetic field adjacent to the metallic object;
(d) sensing the electromagnetic field with the instrument; (e)
interpolating the field strength at the guess point using the
look-up table; (f) calculating the difference in field strengths
between the guess point and the field sensed by the instrument; and
(e) refining the guess point.
18. The method as defined in claim 17 wherein selecting the guess
point includes selecting an arbitrary start guess point.
19. The method as defined in claim 17 further comprising energizing
the plurality of coils in the transmitter coil array in at least
one of a time division multiplex manner, frequency division
multiplex manner, or a combination of both.
20. The method as defined in claim 17 wherein interpolating the
field at the guess point includes using at least one interpolation
method selected from linear interpolation, spline interpolation,
and polynomial curve fitting.
21. The method as defined in claim 17 wherein refining the guess
point includes performing a minimization process to select a new
guess point that is closer to the actual instrument location.
22. The method as defined in claim 21 further comprising minimizing
the error between the guess point and the actual instrument
location to an acceptable value.
23. The method as defined in claim 17, wherein the metallic object
is selected from a group consisting of operating room table,
fluoroscope, microscope, ultrasound hand piece, high-intensity
focused ultrasound systems, computer topography imaging (CT),
interoperative computer topography, magnetic resonance imaging
(MR), interoperative magnetic resonance and surgical robot.
24. The method as defined in claim 17 wherein navigating the probe
includes navigating a probe selected from at least one of a
surgical probe, catheter, strobe catheter, endoscope, shunt, drill
guide, awl/tap, orthopedic instrument and a combination
thereof.
25. The method as defined in claim 17 wherein the transmitter coil
array is controlled via a wireless channel.
26. The method as defined in claim 17 wherein the instrument senses
the electromagnetic field and operates via a wireless channel.
27. An electromagnetic navigation system for use in navigating an
instrument through an electromagnetic field positioned near a metal
object, said electromagnetic navigation system comprising: (a) a
transmitter coil array having a plurality of transmitter coils,
said transmitter coil array operable to generate the
electromagnetic field to navigate the instrument; and (b) a shield
positioned adjacent the metal object, said shield operable to
substantially shield the metal object from the electromagnetic
field generated by said transmitter coil array, said transmitter
coil array being attached to said shield, wherein shield
substantially reduces distortion of the electromagnetic field by
the metal object, thereby enabling accurate navigation of the
instrument in the electromagnetic field.
28. The electromagnetic navigation system as defined in claim 27
wherein said transmitter coil array is integrally formed
transmitting coils positioned about a perimeter of said shield.
29. The electromagnetic navigation system as defined in claim 27
wherein said transmitter coil array is displaced from said
shield.
30. The electromagnetic navigation system as defined in claim 29,
wherein said transmitter coil array includes at least three sets of
transmitter coils which are displaced from said shield.
31. The electromagnetic navigation system as defined in claim 30
wherein said three sets of transmitter coils are displaced from
said shield by an extension member.
32. The electromagnetic navigation system as defined in claim 30,
wherein each set of transmitter coils includes three sets of coils
positioned orthogonal to one another.
33. The electromagnetic navigation system as defined in claim 27
wherein said transmitter coil array is driven in at least one of a
time division multiplexed manner, a frequency division multiplexed
manner or a combination of both.
34. The electromagnetic navigation system as defined in claim 27
wherein the metal object is a fluoroscope.
35. The electromagnetic navigation system as defined in claim 34
wherein said fluoroscope is a C-arm fluoroscope.
36. The electromagnetic navigation system as defined in claim 27
wherein at least one of said shield and transmitter coil array is
removably attached to said metal object.
37. The electromagnetic navigation system as defined in claim 34
wherein said shield is integral with said fluoroscope.
38. The electromagnetic navigation system as defined in claim 27
wherein said instrument includes at least one electromagnetic
sensor attached at a distal end of said instrument.
39. The electromagnetic navigation system as defined in claim 38
wherein the instrument is non-rigid and may bend during navigation
and the instrument includes a plurality of electromagnetic sensors
to provide further location information regarding the
instrument.
40. The electromagnetic navigation system as defined in claim 27
wherein said transmitter coil array is controlled over a wireless
channel.
41. The electromagnetic navigation system as defined in claim 27
wherein said instrument operates over a wireless channel.
42. The electromagnetic navigation system as defined in claim 27
wherein the field strength of each coil in the transmitter coil
array is stored on a memory medium where each field strengths takes
into account interference from the metal object.
43. The electromagnetic navigation system as defined in claim 42
wherein the memory medium is a flash ROM.
44. An electromagnetic navigation system for use in navigating an
instrument through an electromagnetic field positioned near a
fluoroscope, said electromagnetic navigation system comprising: (a)
a transmitter coil array having a plurality of transmitter coils,
said transmitter coils array operable to generate the
electromagnetic field to navigate the instrument; and (b) a shield
attached to the fluoroscope, said shield operable to substantially
shield the fluoroscope from the electromagnetic field generated by
said transmitter coil array, wherein said shield substantially
reduces distortion of the electromagnetic field by the fluoroscope,
thereby enabling accurate navigation of the instrument in the
electromagnetic field.
45. The electromagnetic navigation system as defined in claim 44
wherein at least one of said transmitter coil array is integrally
formed transmitting coils positioned about a perimeter of said
shield.
46. The electromagnetic navigation system as defined in claim 44
wherein said transmitter coil array is displaced from said
shield.
47. The electromagnetic navigation system as defined in claim 46
wherein said transmitter coil array includes at least three sets of
transmitter coils which are displaced from said shield.
48. The electromagnetic navigation system as defined in claim 47
wherein said three sets of transmitter coils are displaced from
said shield by an extension member.
49. The electromagnetic navigation system as defined in claim 44
wherein each set of transmitter coils includes three sets of coils
positioned orthogonal to one another.
50. The electromagnetic navigation system as defined in claim 44
wherein said transmitter coil array is driven in at least one of a
time division multiplexed manner, frequency division multiplexed
manner or a combination of both.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 09/873,604 filed on Jun. 4, 2001, entitled
"Method and Apparatus for Electromagnetic Navigation of a Surgical
Probe Near a Metal Object". The disclosure of the above application
is incorporated herein by reference.
FIELD OF THE INVENTION
[0002] This invention relates generally to navigation of a probe
and, more particularly, to a method and apparatus for
electromagnetic navigation of a surgical probe near a metal
object.
BACKGROUND OF THE INVENTION
[0003] Various systems currently exist, which assist in guiding and
navigating a surgical probe through a patient undergoing a surgical
procedure. These systems include, for example, fluoroscopic,
ultrasonic, conductive, optical and electromagnetic type navigation
systems.
[0004] Various electromagnetic type navigation systems have already
been proposed, such as that disclosed in U.S. Pat. No. 4,821,731 to
Martinelli, et al., U.S. Pat. No. 5,592,939 to Martinelli and U.S.
Pat. No. 5,913,820 to Bladen, et al., which are each hereby
incorporated by reference. Advantages of such electromagnetic
tracking navigation systems are significant over existing
navigation systems. For example, low-frequency electromagnetic
waves are not attenuated by the body and therefore, there are no
"line-of-sight" issues as with existing optical systems. The
transmitter coil array may also be placed underneath or above the
patient and the navigated surgical instrument or probe may be used
above or below the transmitter coil array. The receiver coils
utilized in the surgical instrument or probe are also generally
much smaller than existing type navigation systems, which may
enable surgical procedures that were previously impossible due to
instrument size. The small size of the receiver coils also enable
the receiver coils to be placed near the tip of the instrument
providing further accuracy and the ability to navigate non-rigid
instruments.
[0005] However, electromagnetic type navigation systems do have the
disadvantage that the electromagnetic field may be distorted by
metal objects, sometimes referred to as metallic distortions. In
this regard, metal objects that are generally large in size cause
the magnetic field to bend, thereby possibly causing inaccuracy in
the reported probe position. The other effect of positioning a
metal object near the electromagnetic field being navigated is
conduction effects. For example, a metal object positioned near or
in the electromagnetic field, such as a fluoroscope (C-arm) or an
OR table, may create a virtual coil along the metal surface that
creates an interference back into the magnetic field. Again, this
may create an inaccuracy in the reported probe position because the
exact field strengths in the previously known electromagnetic
fields have been altered due to the metal object.
[0006] In order to reduce or eliminate the effects of distortion
due to metal objects, known mathematical models of the
electromagnetic fields produced by the transmitter coil array may
be utilized. If these mathematical models are accurate, they can be
used to represent a set of "known" fields used during the
navigation process. However, the disadvantage with using
mathematical models for the transmitted fields is that there are
inherent inaccuracies in the manufacturing process of the
transmitting coils in the transmitting coil array, which can lead
to incorrect field values, which are mathematically modeled. These
incorrect field values may lead to inaccuracy in the overall
navigation process. The mathematical models are also generally very
mathematically complex and may, therefore, take an unreasonable
amount of time for a computer to calculate and process.
[0007] What is needed then is a method and apparatus for
electromagnetic navigation of a surgical probe near a metal object,
which does not suffer from the above-mentioned disadvantages. This
will, in turn, provide electromagnetic navigation of a surgical
probe near a metal object that has greater accuracy, provide a
shield to reduce or eliminate the effects of the metal object,
provide a universal connection to connect the shield to the metal
object, provide a calibration process that takes into effect either
the shield or the metal object, provide a set of transmitting
coils, which may be attached to the shield, integrated into the
shield or integrated into the metal object itself, and provide
wireless communications in the electromagnetic navigation system
for ease of assembly into existing hardware. It is, therefore, an
object of the present invention to provide such a method and
apparatus for electromagnetic navigation of a surgical probe near a
metal object.
SUMMARY OF THE INVENTION
[0008] In accordance with the teachings of the present invention, a
method and apparatus for electromagnetic navigation of a surgical
probe near a metal object is provided.
[0009] In one embodiment, an electromagnetic navigation system for
use in navigating a probe through an electromagnetic field
positioned near a metal object includes a transmitter coil array
and a shield. The transmitter coil array has a plurality of
transmitter coils and is operable to generate the electromagnetic
field to navigate the probe. The shield is positioned adjacent the
metal object and is operable to shield the metal object from the
electromagnetic field generated by the transmitter coil array,
wherein the shield substantially reduces distortion of the
electromagnetic field by the metal object.
[0010] In another embodiment, an electromagnetic navigation system
for use in navigating a probe through an electromagnetic field
during a surgical procedure includes a metal instrument and a
transmitter coil array. The metal instrument is used during a
surgical procedure and is formed at least in part by metallic
material. The transmitter coil array has a plurality of transmit
coils and is operable to generate the electromagnetic field used to
navigate the probe. The transmitter coil array is integrated into
the metal instrument, wherein the effects of metallic distortion on
the electromagnetic field by the metal instrument is characterized
during a calibration process to provide substantially accurate
navigation of the probe during the surgical procedure.
[0011] In another embodiment, a method for calibrating an
electromagnetic navigation system having a transmitter coil array
that generates an electromagnetic field is provided. This method
includes positioning the electromagnetic navigation system in a
working environment to account for metallic distortion caused by a
metallic object adjacent to the electromagnetic field, positioning
a calibration sensor at a first calibration point, energizing a
first coil in the transmitter coil array to generate a first field,
sensing the first field strength in the first field with the
calibration sensor, and repeating the positioning, energizing and
sensing at a second calibration point, wherein effects of metallic
distortion caused by the metallic object is taken into account
during the calibration process.
[0012] Use of the present invention provides a method and apparatus
for electromagnetic navigation of a probe through an
electromagnetic field near a metal object. As a result, the
aforementioned disadvantages associated with the currently
available techniques have been substantially reduced or eliminated.
Further areas of applicability of the present invention will become
apparent from the detailed description provided hereinafter. It
should be understood that the detailed description and specific
examples, while indicating the preferred embodiment of the
invention, are intended for purposes of illustration only and are
not intended to limit the scope of the invention.
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] Still other advantages of the present invention will become
apparent to those skilled in the art after reading the following
specification and by reference to the drawings in which:
[0014] FIG. 1 is an electromagnetic navigation system block diagram
according to the teachings of one embodiment of the present
invention;
[0015] FIG. 2 is an electromagnetic navigation system block diagram
according to the teachings of another embodiment of the present
invention;
[0016] FIG. 3 is a perspective view of a shield having extended
transmitter coils according to the teachings of one embodiment of
the present invention;
[0017] FIG. 4 is a perspective view of a shield having integrated
transmitter coils according to the teachings of another embodiment
of the present invention;
[0018] FIG. 5 is a perspective view of a shield having integrated
transmitter coils according to the teachings of another embodiment
of the present invention;
[0019] FIG. 6 is a perspective view of a fluoroscope (C-arm)
employing the shield of FIG. 4 according to the teachings of the
present invention;
[0020] FIG. 7 is a side view of an operating room (OR) table having
a transmitter coil array (TCA) positioned atop the OR table with a
shield positioned between the OR table and transmitter coil array
(TCA) according to the teachings of another embodiment of the
present invention;
[0021] FIG. 8 is a diagram illustrating the transmitter coil array
configuration of FIG. 7 in further detail;
[0022] FIG. 9 is an illustration of a calibration process according
to the teachings of the present invention;
[0023] FIG. 10 is a two dimensional grid of robotically measured
calibration points used in the calibration process according to the
teachings of the present invention;
[0024] FIG. 11 is an illustration of a navigation process according
to the teachings of the present invention;
[0025] FIG. 12 is a graph illustrating two interpolation methods
utilized in the navigation process according to the teachings of
the present invention;
[0026] FIG. 13 is an electromagnetic navigation system block
diagram according to the teachings of another embodiment of the
present invention; and
[0027] FIG. 14 illustrates the electromagnetic navigation system of
FIG. 13 associated with a fluoroscope (C-arm) and an OR table.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0028] The following description of the preferred embodiments
concerning a method and apparatus for electromagnetic navigation of
a surgical probe near a metal object is merely exemplary in nature
and is not intended to limit the invention or its application or
uses. Moreover, while the present invention is described in detail
in association with a fluoroscope (C-arm) or an operating room (OR)
table, those skilled in the art will readily understand that the
present invention may be employed in many other environments having
metal objects.
[0029] Referring to FIG. 1, an electromagnetic navigation system 10
according to the teachings of one embodiment of the present
invention is shown. The electromagnetic navigation system 10 is
implemented utilizing a transmitter coil array (TCA) 12, which
emits low energy, low frequency AC signals to generate an
electromagnetic field or region 14 adjacent to the transmitter coil
array 12. The transmitter coil array 12 includes a plurality of
coils, further discussed herein, which are driven by a coil array
controller (CAC) 16. The coil array controller 16 sources AC
current to drive each coil housed within the transmitter coil array
12, via transmission lines 18. The coil array controller 16 may
drive the coils housed within the transmitter coil array 12 either
sequentially, via time division, or simultaneously, via frequency
division, or a combination of both. The electromagnetic field 14
generated by the transmitter coil array 12 provides very accurate
known magnetic field strengths over the field of view (FOV) of the
electromagnetic navigation system 10. Because the low-frequency
electromagnetic waves generated by the transmitter coil array 12
are not attenuated by the body of a patient, there are no
line-of-sight issues as with currently available optical
systems.
[0030] An instrument 20, such as, but not limited to, a surgical
probe, catheter, steerable catheter, endoscope, shunt, drill guide,
awl/tap, orthopedic implant instrument, etc. located or positioned
within the electromagnetic field 14 is able to detect the
electromagnetic signal and measure the magnetic field strength by
way of small loops of wire or receive coils attached to the
instrument 20. The receive coils may be any diameter but are
generally made small, for example, about one millimeter to about
two millimeters in diameter, which provides for a much smaller
instrument 20 than other existing instruments used in navigation
systems, such as optically navigated systems. Because of the
reduced size of the receiver coils, this enables the receiver coils
to be placed near the distal tip of the instrument 20, thereby
further reducing accuracy concerns that exist when the receiver
coils are positioned more proximally in the instrument 20, since
the instrument 20 may bend during navigation. The instrument 20 may
include a single receiver coil consisting of multiple loops of wire
or a single loop of wire and may also include multiple receiver
coils to provide further positional information regarding the
instrument 20, as is known in the art and further discussed
herein.
[0031] The magnetic field strengths sensed by the instrument 20 are
received by a navigation probe interface (NPI) 22, via a
transmission line 24. The navigation probe interface 22 gathers the
magnetic field strengths received by the instrument 20 and
processes this information in order to identify the magnetic field
strength generated by each coil in the transmitter coil array 12.
The navigation probe interface 22 is able to track up to any number
of coils, located in the transmitter coil array 12 based on the
number of input ports provided, at a sampling rate of about thirty
frames per second. The navigation probe interface 22 also directs
or triggers the coil array controller 16 to drive each coil located
in the transmitter coil array 12 either in a time multiplexed
manner, frequency multiplexed manner or a combination of both. The
navigation probe interface 22 is generally configured as a digital
signal processor (DSP), but may also be configured as discrete
logic circuits or any other type of electrical processor. The
navigation probe interface 22 is also capable of supporting
multiple instruments 20 in a multiplexed manner should this be
desirable for the particular surgical procedure.
[0032] Once the magnetic field strengths of all the transmitting
coils in the transmitter coil array 12 are measured and processed
by the navigation probe interface 22, this field strength
information is forwarded to the coil array controller 16, via
transmission line 26. A general purpose computer or PC incorporated
into the coil array controller 16 is then applied to "look-up" the
single point in space where the field strengths detected by the
receiver coil in the instrument 20 is equivalent to the known field
strengths transmitted by the transmitter coil array 12. In this
regard, the magnetic field strengths measured by the instrument 20
identify a unique position and orientation in space to determine
the X, Y, Z point and the angle and azimuth of the receiver coil
located in the instrument 20. Should rotation about the axis of the
receiver coil positioned in the instrument 20 be desired, a second
receiver coil may be required in the instrument 20. The process
used by the coil array controller 16 employs known minimization
techniques, such as Newton's method, further discussed herein.
[0033] Thus, the electromagnetic navigation system 10 is able to
support electromagnetic navigation of the instrument 20 by
generating electromagnetic fields from the transmitter coil array
12 throughout the region 14. Instrument 20 measures the magnetic
field strengths by way of an electromagnetic sensor or receiver
coil. Through design of these electromagnetic fields generated by
each coil in the transmitter coil array 12, every position and
orientation of each field generated has a unique set of
electromagnetic field strengths that is known in the art. These
electromagnetic levels or magnetic field strengths generate a
system of equations that can be solved mathematically to determine
the position and orientation of the instrument 20, as is known in
the art.
[0034] The localized information which is determined in the coil
array controller 16 is then forwarded to an application specific
user interface/display 28. The user interface/display 28 may
consist of a general purpose computer and a video display to
provide image guidance to a surgeon with real time visual feedback
of the surgery or navigation being performed. The user
interface/display 28 may be configured to provide application
specific interfaces for various surgical procedures, such as, but
not limited to, cranial, 3-D spine, virtual fluoroscopy, cranial
biopsies, tumor resections, craniotomies/craniectomies,
thalamotomies/pallidotomies, spinal implant procedures, such as
pedicle screw placement, sinus procedures, such as maxillary
antrostomies, ethmoidectomies, sphenoidotomies/sphenoid
explorations, turbinate resections, and frontal sinusotomies,
cardiac mapping procedures, cardiac lead placements, orthopedic,
interventional radiology, etc.
[0035] Turning to FIG. 2, the electromagnetic navigation system 10
according to the teachings of another embodiment of the present
invention is shown. In this regard, like reference numerals will be
used to identify like elements, as set forth in FIG. 1. The
electromagnetic navigation system 10 includes the transmitter coil
array 12, which is driven by the coil array controller 16 to
generate an electromagnetic field or region 14. This
electromagnetic field 14 is sensed by the instrument 20 and the
navigation probe interface 22 processes the magnetic field
strengths sensed by the instrument 20. Again, the navigation probe
interface 22 forwards this information to the coil array controller
16, which then determines the position of the instrument 20 in the
field or region 14. The location of the instrument 20 is again
forwarded to the user interface/display 28 for use by the surgeon
during the surgical procedure being performed to provide real time
visual feedback of the instrument 20 during the surgical
procedure.
[0036] The electromagnetic navigation system 10, as shown in FIG.
2, is substantially the same as the electromagnetic navigation
system 10, shown in FIG. 1, except that this system employs
wireless communications between each element. In this regard, the
transmitter coil array 12 includes a wireless receiver 30, which
receives control information, via a wireless transmitter 32 coupled
to the coil array controller 16. In this configuration, the
transmitter coil array 12 will include the amplifiers that are
normally positioned in the coil array controller 16 to drive the
coils and the coil array controller 16 will simply control the
operation of the transmitter coil array 12, via the wireless
communication channel 34. Likewise, the instrument 20 includes a
wireless transmitter 36 that transmits information over a wireless
channel 38 to a wireless receiver 40 in the navigation probe
interface 22. The navigation probe interface 22 also includes a
wireless transmitter 42, which transmits information to the coil
array controller 16, via a wireless receiver 44 over communication
channel 46. Finally, the coil array controller 16 forwards
navigation information to the user interface/display 28, via a
wireless transmitter 48, wireless receiver 50 and wireless channel
52.
[0037] The wireless communication or transmission may be
accomplished through many types of wireless mediums, such as analog
or digital methods. The analog transmission methods may include
amplitude modulation (AM), frequency modulation (FM) or phase
modulation (PM). Various digital communication standards may also
be used such as Ethernet, Blue Tooth or any other type of
appropriate digital communication protocol. For example, the
wireless communications system, as set forth in Surgical
Communications in Power Systems, filed Oct. 28, 1999, U.S. Ser. No.
09/428,722, may be used as one form of wireless communications,
which is hereby incorporated by reference. By providing this type
of wireless communication of the electromagnetic navigation system
10, as shown in FIG. 2, the transmission lines, as shown in FIG. 1
are substantially eliminated, thereby reducing the amount of
cabling required in an operating room environment. This also
enables the electromagnetic navigation system 10 to be retrofitted
to existing hardware structures without requiring significant
modifications to the existing structures. It should further be
noted that the electromagnetic navigation system 10 may selectively
use both transmission lines and wireless communication.
[0038] The electromagnetic navigation system 10 provides
significant advantages over existing navigation systems, as
discussed above, however, the electromagnetic navigation system 10
must account for electromagnetic navigation near metal objects that
may distort the electromagnetic field. This environment typically
exists in the operating room and other surgical environments
because the metal structure causes or creates distortions in the
magnetic field needed for the navigation process. These metal
objects, devices or instruments may include, but are not limited to
operating room (OR) tables, fluoroscope (C-arms), microscope,
ultrasound hand-piece, high-intensity focused ultrasound systems,
computer topography imaging (CT), interoperative CT, magnetic
resonance imaging (MR), interoperative MR, surgical robot imaging,
etc. In order to take into account the distortions caused by such
metal objects, the current electromagnetic navigation system 10 may
either utilize a shield positioned adjacent to the transmitter coil
array 12 to shield the effect of the metal object or the
transmitter coil array 12 may be incorporated directly into the
metal object and the distortion effect characterized during the
calibration process itself since the distortions will generally
remain static, further discussed herein.
[0039] An exemplary shield 54, shown in FIG. 3, may be used to
shield metal objects, such as a fluoroscope (C-arm) (see FIG. 5).
The shield 54 is designed to be removably coupled to the C-arm or
any other metal object or device requiring shielding by way of a
universal band clamp 56. The mounting mechanism or band clamp 56 is
able to be adjustably engaged around an intensifier tube 58 of a
conventional C-arm 60, which usually has a diameter of about 9 to
about 12 inches (see FIG. 5). The shield 54 is substantially
conically shaped to substantially reduce or eliminate the effects
of the C-arm 60, along with its associated components, such as the
intensifier 58. The shield 54 can also be configured in any other
shape to create a virtual surface or infinite plane to reflect or
shield any type of metal object desired. Reflecting or shielding of
these fields prevents field distortion, and thus prevents
disturbances by objects on the opposite side of the shield 54.
[0040] The shield 54 is formed from a conductive or semi-conductive
material, such that the shield's effect on the magnetic field
should dominate the effect of the item, such as the C-arm 60 being
shielded. The shield 54 may be constructed from materials, such as
sheet metal, aluminum, copper, titanium, mu-metal, conductive
mylar, etc. The shield 54 may also be formed as a solid shield, a
mesh or be modified with holes or slots to reduce the overall
weight of the shield 54. Since electromagnetic navigation is
generally performed at relatively low frequencies (less than about
one megahertz), these frequencies represent long wavelengths that
do not pass through the openings, such that the shield 54
essentially acts as a solid shield to these low frequency signals.
Therefore, by adding holes or a mesh, the performance of the shield
54 will not be degraded.
[0041] Positioned adjacent to or about the periphery of the
conically shaped shield 54 is the transmitter coil array 12 which
is formed by three sets of transmitting coils 62, which are
displaced from the shield 54 by an extension member 64. Each set of
transmitting coils 62 consists of three sets of coils 66, each
positioned orthogonal to one another and consisting of about fifty
wire loops positioned about a cube 68. Offsetting the set of
transmitting coils 62 from the shield 54 creates less interference
or canceling of the electromagnetic field because of the shield 54
to provide enhanced performance.
[0042] Another embodiment of the shield 54 is shown in FIG. 4,
where the shield 54 includes three sets of integrally formed
transmitting coils 70, also positioned about the perimeter of the
shield 54. The transmitting coils 70 are formed substantially
adjacent to, or integral with, the shield 54, as opposed to being
somewhat displaced from the shield 54, as shown in FIG. 3. While
this may create some canceling of the electromagnetic field, this
also provides a smaller package should clearance concerns exist in
particular applications. The transmitting coils 70 each may include
multiple coils configured substantially similar to the set of
transmitting coils 62, shown in FIG. 3 or in any other type of
configuration. It should further be noted that while the shield 54
shown in FIGS. 3 and 4 include three sets of three orthogonal coils
providing for a total of nine coils for navigation purposes, any
number of coils or coil configurations may be used. In this regard,
generally a minimum of five coils is required to identify the six
degrees of freedom (X, Y, Z, angle, azimuth). These coils may be
configured with either five transmit coils or more and one receiver
coil, or three transmit coils and three receiver coils or any other
type of combination. Moreover, should only three degrees of freedom
(i.e., X, Y, Z) be desired, only three coils would be required, as
is known in the art.
[0043] An additional embodiment of the shield 54 is shown in FIG.
5, where the shield includes several integrally formed transmitting
coils 71, located about the shield 54. In this regard, the
transmitting coils 71 are wrapped and formed integral with the
shield 54 with multiple coils extending about the top and bottom
perimeter of the shield 54, as well as transmitting coils 71
extending radially from the shield 54. Here again, the coil
configuration may be arranged in any manner, as long as each coil
has a unique orientation relative to the other coils.
[0044] Turning briefly to FIG. 6, the C-arm 60 is shown, which
incorporates the shield 54 of the electromagnetic navigation system
10 to generate the electromagnetic field or region 14 for
navigating the instrument 20. By using the shield 54, which may be
formed integral with the C-arm 60, the distortion created by the
C-arm 60 is substantially reduced or attenuated so that accurate
navigation of the instrument 20 within the region 14 may be
achieved. It should further be noted that either the three sets of
transmitting coils 62 or the three sets of transmission coils 70
may be incorporated directly into the C-arm 60. With the three sets
of transmitting coils 62 and 70 being an integral part of the C-arm
60, the calibration process may be completed with the entire
assembly. If the calibration process is completed in this manner, a
separate shield is not required. In this embodiment, the effect of
distortion caused by the C-arm 60 or any other metal object on the
transmitted fields, would be taken into account and characterized
during the calibration process and since these distortions are
generally static, accurate navigation is achieved.
[0045] Referring to FIGS. 7 and 8, another embodiment of the
transmitter coil array 12 is shown incorporated over an operating
room (OR) table 72. Positioned between the transmitter coil array
12 and the operating room table 72 is a planar shield 74 having an
upturned peripheral lip 76. The shield 74 again acts as an infinite
plane to reflect and shield the electromagnetic field or region 14
generated by the transmitter coil array 12 from the metal operating
room table 72. The upturned lip 76 also directs the electromagnetic
field or region 14 in the vicinity of the patient 78. The OR table
72, shield 74 and transmitter coil array 12 may be separate
components or attached to one another.
[0046] The configuration of the transmitter coil array 12 used with
the OR table is shown in further detail in FIG. 8. The transmitter
coil array 12 includes nine discrete coils 80 positioned about the
transmitter coil array 12. Each coil 80 is located or positioned at
a different orientation relative to the remaining coils 80, such
that each coil 80 generates its own unique electromagnetic field.
Three sets of coils 80 are generally driven at a time so that there
are three sets of three coils 80 driven sequentially with each coil
80 in each set of three driven at its own unique frequency to
identify that particular field. Here again, other types of coil
arrangements and numbers of coils may be utilized in the
electromagnetic navigation system 10. Moreover, as shown herein,
the transmitter coil array 12 may be configured in any number of
ways to accommodate for its particular application and the use in
association with the C-arm 60 and the OR table 72 are merely
exemplary in nature.
[0047] Turning now to FIGS. 9 and 10, the calibration process 82
according to the teachings of the present invention is disclosed in
further detail. The calibration process 82 is conducted at the
factory and is implemented by simulating the environment in which
the electromagnetic navigation system 10 will be employed. In this
regard, should a shield 56 or 74 be used, as is shown in FIGS. 6
and 7, that particular configuration with the C-arm 60 or the OR
table 72 will be calibrated at the factory prior to shipment of the
electromagnetic navigation system 10 to characterize the effects of
the particular metal object or surgical device being used.
Likewise, should the transmitter coil array 12 be integrally formed
or incorporated directly into the surgical device having metallic
portions rather than retrofitting the surgical device with the
shield, the surgical device with the incorporated electromagnetic
navigation system 10 will also be calibrated prior to shipment or
delivery. This calibration process 82 assumes that the distortion
from the metal object or device will remain static.
[0048] The calibration process 82 starts by moving a calibration
sensor 84 to a point in the electromagnetic field or region 14 at
step 86. Preferably, the starting point will be identified as the
origin (i.e., equals zero) and all other measured points will be
referenced back to this origin. In this regard, a robotic
calibration arm or unit 88 having the calibration sensor 84 (see
FIG. 10) is employed to measure the magnetic field strength of each
energized coil, along a pre-determined grid of calibration points
90. As shown in FIG. 10, a two-dimensional grid is illustrated
having a plurality of calibration grid points 90 disposed equally
throughout the two-dimensional grid. For example, each grid point
90 may be separated every 15 millimeters. During the calibration
process 82, a three-dimensional grid will be employed to measure
the magnetic field strength of each calibration point 90 throughout
the region 14 for each coil in the transmitter coil array 12. For
example, a one meter cubed (m.sup.3) region 14 may be separated
into several calibration grid points 90, such as eight thousand
grid points 90, which are sensed by the calibration sensor 84 on
the robotic unit 88 as the calibration sensor 84 is positioned at
each one of these discrete grid points 90.
[0049] Referring back to FIG. 9, with the calibration sensor 84
positioned at the first grid point 90 or origin at step 86, one of
the coils in the transmitter coil array 12 is energized at step 92
and the magnetic field strength generated is sensed or read at this
grid point 90 with the calibration sensor 84 at step 94. Again, the
navigation probe interface 22 instructs the coil array controller
16 to drive a particular coil in the transmitter coil array 12.
With the magnetic field sensed by the calibration sensor 84, the
magnetic field strength is determined for that particular
calibration point 90 by the navigation probe interface 22. Each
coil in the transmitter coil array 12 is then driven by the coil
array controller 16 at that particular calibration point 90, via
step 96. With the magnetic field strength values known for each
coil in the transmitter coil array 12, these magnetic field
strengths are then stored to memory at step 98. In this regard,
these magnetic field strengths are forwarded from the navigation
probe interface 22 through the general purpose computer in the
control array controller 16 and stored on a flash ROM or any other
type of memory housed within the transmitter coil array 12. In this
way, the transmitter coil array 12 may be operated by any coil
array controller 16, since the calibration values are stored with
the transmitter coil array 12.
[0050] The calibration process 82 continues by moving to a next
calibration point 90 at step 100 to again determine the magnetic
field strengths from each coil. With the navigation probe interface
22 synchronizing the coil array controller 16 to drive each coil in
the transmitter coil array 12 and with the robotic unit 88
positioning the calibration sensor 84 at each calibration point 90
within the three-dimensional calibration grid, the calibration
process 82 continues until all of the field strengths for all of
the coils at each calibration point 90 in the calibration grid is
stored. Accordingly, the calibration process 82 stores actual
measurements of the magnetic field strength generated by the
transmitter coil array 12, while taking into account or
characterizing the distortion effects of either the particular
shield, coupled to the surgical device or the transmitter coil
array 12 incorporated directly into the surgical device. In this
way, any metallic distortions caused by the metal object or device,
such as the C-arm 60 or the OR table 74 is taken into account by
performing the real time measurements with these objects in place.
Therefore, any distortions caused by utilizing the electromagnetic
navigation system 10 in its environment are already accounted for
during the factory calibration process to provide accurate
navigation of the instrument.
[0051] Referring now to FIGS. 10-12, the navigation process 102
will be described in further detail. The navigation process 102 is
a minimization process, as is known in the art, such as Newton's
method, which begins at step 104. At step 104, an arbitrary
starting point is selected, which is generally the center of volume
of the region 14 (i.e., 0, 0, 0). Once the arbitrary start point or
guess point 110 is selected at step 104, the navigation process 102
continues to step 106 where the coils in the transmitter coil array
12 are energized, either sequentially or by frequency multiplexing
and the magnetic field strength values are received by the sensor
located in the instrument 20. Once these values are determined at
step 106, the navigation process continues to step 108 where the
previously stored calibration data or field strengths for the
calibration points 90 in the calibration grid are used to
interpolate the fields at the guess point 110 in space. In this
regard, should the guess point 110 not be one of the known
calibration grid points 90, the guess point 110 is interpolated
using known interpolation techniques. These techniques, for
example, may include linear interpolation or spline interpolation
as shown in FIG. 12. The location of the guess point 110 may be
determined from the known calibration grid points 90 using these
known interpolation methods to determine the magnetic field
strengths between the known calibration grid points 90.
Additionally, any other type of interpolation method may also be
used such as polynomial curve fitting, etc.
[0052] Once the field strengths are determined for the guess point
110 at step 108, the navigation process 102 continues to step 114
where computation of the field gradients or the difference in field
strengths between the guess point 110 and the measured fields at
the instrument location are determined. These field gradients or
errors are then used at step 116 to refine the guess point 110
during the minimization process to select a new guess point 110
which is closer to the actual sensor location. Once the refined
guess point 110 is determined, this process is continued without
requiring additional measurements from the instrument 20 until the
error between the guess point 110 and the actual instrument
location is minimized to an acceptable value at step 118. If the
error value is not acceptable, the navigation process 102 again
continues with a new guess point 110 selected which is closer to
the actual instrument location and the error again computed, via
the steps in blocks 108, 114 and 116. Should the error be
acceptable, as determined in step 118, the navigation process 102
ends with the guess point 110 now representing the actual
instrument location or navigated point 120. In this way, navigation
of the instrument 20 is performed very accurately without having
metal objects effect the overall navigation since the calibration
process has already taken into effect the metal object during
creation of the look-up table for the calibration grid points 90,
which is used during the navigation process 102.
[0053] Finally, referring to FIGS. 13 and 14, an electromagnetic
navigation system 122 according to the teachings of another
embodiment of the present invention is shown. The electromagnetic
navigation system 122 is substantially similar to the
electromagnetic navigation systems 10, shown in FIGS. 1 and 2,
except that the electromagnetic navigation system 122 includes an
additional transmitter coil array and a dynamic reference arc. In
this regard, the electromagnetic navigation system 122 includes a
coil array controller 124 which drives a first transmitter coil
array 126, as well as a second transmitter coil array 128. Both
transmitter coil arrays 126 and 128 generate an electromagnetic
field or region 130 where the instrument 132 is navigated and a
dynamic reference arc 133 is positioned. Here again, instrument 132
provides the received magnetic field strengths to navigation probe
interface 134 for processing and forwarding to the coil array
controller 124 and the dynamic reference arc 133 is used for a
reference by the instrument 132, further discussed herein. The coil
array controller 124 again forwards the navigation information to a
user interface/display 136 for use during the surgical procedure
being performed.
[0054] The electromagnetic navigation system 122 is shown
configured in FIG. 14 in association with a C-arm 138 and an OR
table 140. Here again, the transmitter coil array 126 may be
configured within shield 142 of the C-arm 138 or incorporated
directly into the C-arm 138. The transmitter coil array 128 is
shown positioned above the OR table 140 with a shield 144
positioned therebetween.
[0055] By providing both the transmitter coil array 126 and the
transmitter coil array 128 to generate the electromagnetic field or
region 130 about the patient 146, each transmitter coil array 126
and 128 may be driven simultaneously, sequentially or independent
from one another. In this regard, the coil array controller 124 is
capable of driving the transmitter coil arrays 126 and 128
simultaneously at different frequencies so that the particular
fields may be identified. Alternatively, the transmitter coil
arrays 126 and 128 may be time multiplexed or driven sequentially,
via the coil array controller 124. In other situations, it may be
desirable to initially drive the transmitter coil array 126 located
on the C-arm 138 during the surgical procedure while the C-arm 38
generates a fluoroscopic image. However, the C-arm 138 may be in
the way for certain portions of the surgical procedure. If so, the
C-arm 138 may be rotated or moved our of the way after the image is
captured to provide for further surgical clearance while still
conducting navigation, via the second transmitter coil array 128
associated with the OR table 140.
[0056] In this way, navigation handoff can be performed between
both transmitter coil arrays 126 and 128 without requiring the
surgeon to have to stop during the overall surgical procedure
should one of the particular metal or surgical instruments be in
the way. The dynamic reference arc 133 is substantially similar to
the instrument 132 in that it includes receive coils capable of
providing six degrees of freedom information. However, the dynamic
reference arc 133 is used as a reference and is fixed relative to
the patient being navigated to provide a reference point for the
instrument 132. In other words, the instrument 132 may be
referenced back to either transmitter coil array 126 or 128 and the
dynamic reference arc 133 may be also referenced back to the
transmitter coil arrays 126 and 128 to determine the relative
positions of each. By having this information, the instrument 132
may then be simply referenced back to the dynamic reference arc 133
by simple subtraction of the fields, as is known in the art, which
removes the transmitter coil arrays 126 and 128 out of the
calculation process, thereby enabling unobstructed hand-offs
between the transmitter coil array 126 and the transmitter coil
array 128. Use of the dynamic reference arc 133 may also be
employed with the navigation system 10, shown in FIGS. 1 and 2
should this be desired. An example of such hand off technology is
set forth in System For Translation of Electromagnetic and Optical
Localization Systems, filed Oct. 28, 1999, U.S. Ser. No.
09/429,568, which is hereby incorporated by reference. Moreover, it
should be further noted that the calibration process 82 will be
performed with both the C-arm 138 and the OR table 140 in proximity
to one another, as shown in FIG. 14 to take into effect the entire
surgical environment, thereby providing further accuracy and
surgical versatility.
[0057] The electromagnetic navigation systems 10 and 122,
therefore, provide for very accurate surgical navigation of the
instruments 20 and 132 during the surgical procedure because the
calibration process 82 takes into account and characterizes the
distortion effect of the surgical device used during the surgical
procedure. This accuracy is achieved by using the information
determined during the calibration process 82 in the navigation
process 102. In this way, accurate navigation of the instruments 20
and 132 are achieved in an efficient, cost effective and versatile
manner that also takes into effect the tolerance of the transmitter
coil array and the surrounding environment.
[0058] The description of the invention is merely exemplary in
nature and, thus, variations that do not depart from the gist of
the invention are intended to be within the scope of the invention.
Such variations are not to be regarded as a departure from the
spirit and scope of the invention.
* * * * *