U.S. patent application number 11/338044 was filed with the patent office on 2006-06-08 for navigation of medical instrument.
Invention is credited to Wolfgang Daum, Axel Winkel.
Application Number | 20060122630 11/338044 |
Document ID | / |
Family ID | 46280081 |
Filed Date | 2006-06-08 |
United States Patent
Application |
20060122630 |
Kind Code |
A1 |
Daum; Wolfgang ; et
al. |
June 8, 2006 |
Navigation of medical instrument
Abstract
The subject invention pertains to a device for inserting medical
instruments into the human body. In a specific embodiment, the
subject device can be made from a material which is invisible under
Magnetic Resonance Imaging (MRI). The subject device can
incorporate three or more MRI compatible marks. The imaging of
these three or more markers can allow the determination of the
orientation of the device. A virtual image of the device can then
be shown in an MRI image.
Inventors: |
Daum; Wolfgang; (Groton,
MA) ; Winkel; Axel; (Zapel-Hof, DE) |
Correspondence
Address: |
SALIWANCHIK LLOYD & SALIWANCHIK;A PROFESSIONAL ASSOCIATION
PO BOX 142950
GAINESVILLE
FL
32614-2950
US
|
Family ID: |
46280081 |
Appl. No.: |
11/338044 |
Filed: |
January 23, 2006 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10632685 |
Aug 1, 2003 |
6989015 |
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11338044 |
Jan 23, 2006 |
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09954725 |
Sep 14, 2001 |
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10632685 |
Aug 1, 2003 |
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Current U.S.
Class: |
606/130 |
Current CPC
Class: |
A61B 2090/3937 20160201;
A61B 34/20 20160201; A61B 2017/3407 20130101; A61B 2090/067
20160201; A61B 2034/2055 20160201; A61B 90/11 20160201 |
Class at
Publication: |
606/130 |
International
Class: |
A61B 19/00 20060101
A61B019/00 |
Claims
1. An apparatus for inserting an instrument into a human body,
comprising: an element configured to be fixedly positioned relative
to a part of the human body, wherein at least a portion of the
element is invisible under magnetic resonance imaging; an
instrument insertion channel movably connected to the element,
wherein at least a portion of the instrument insertion channel is
invisible under magnetic resonance imaging; a means for determining
the relative position of the instrument insertion channel with
respect to the element such that once the position of the element
is known, the position of the instrument insertion channel is
known, or that once the position of the instrument insertion
channel is known, the position of the element is known; and at
least three positioning markers, wherein the at least three
positioning markers are each fixedly positioned relative to the
element, fixedly positioned relative to the instrument insertion
channel, or fixedly positioned relative to an instrument.
2. The apparatus according to claim 1, wherein the element is
configured to be fixedly positioned relative to a human head.
3. The apparatus according to claim 1, wherein the at least three
positioning markers are visible under magnetic resonance
imaging.
4. The apparatus according to claim 3, wherein under magnetic
resonance imaging, the at least three positioning markers allow
determination of the orientation of the element and determination
of the orientation of the instrument insertion channel.
5. The apparatus according to claim 3, wherein the at least three
positioning markers can be distinguished from one another by
magnetic resonance imaging.
6. The apparatus according to claim 5, wherein the at least three
positioning markers comprise coils.
7. The apparatus according to claim 5, wherein at least one of the
at least three positioning markers comprises a volume filled with a
material positively or negatively identifiable under magnetic
resonance imaging.
8. The apparatus according to claim 3, further comprising a means
for showing a virtual image of the instrument insertion channel in
a magnetic resonance image.
9. The apparatus according to claim 1, wherein the at least three
positioning markers comprise optically active or optically
reflecting positioning markers.
10. The apparatus according to claim 1, wherein the at least three
positioning markers are fixedly positioned relative to the element,
wherein the position of the element can be determined by monitoring
the at least three positioning markers fixedly positioned with
respect to the element such that the position of the instrument
insertion channel can be determined via the means for determining
the relative position of the instrument insertion channel with
respect to the element.
11. The apparatus according to claim 10, wherein one of the at
least three positioning markers comprises a titanium screw.
12. The apparatus according to claim 10, wherein at least one of
the at least three positioning markers are within the element.
13. The apparatus according to claim 1, wherein the at least three
positioning markers are fixedly positioned relative to the
instrument insertion channel, wherein the position of the
instrument insertion channel can be determined by monitoring the at
least three positioning markers such that the position of the
element can be determined via the means for determining the
relative position of the instrument insertion channel with respect
to the element.
14. The apparatus according to claim 1, wherein the at least three
positioning markers comprise six positioning markers, wherein three
of the six positioning markers are fixedly positioned relative to
the element and three of the six positioning markers are fixedly
positioned relative to the instrument insertion channel.
15. The apparatus according to claim 14, wherein the three of the
six positioning markers fixedly positioned relative to the element
are distinguishable from the three of the six positioning markers
fixedly positioned relative to the instrument insertion
channel.
16. The apparatus according to claim 15, wherein the three of the
six positioning markers fixedly positioned relative to the element
and the three of the six positioning markers fixedly positioned
relative to the instrument insertion channel correspond to
different wavelengths.
17. The apparatus according to claim 15, wherein the three of the
six positioning markers fixedly positioned relative to the element
and the three of the six positioning markers fixedly positioned
relative to the instrument insertion channel correspond to a
different codification.
18. The apparatus according to claim 15, wherein the three of the
six positioning markers fixedly positioned relative to the element
and the three of the six positioning markers fixedly positioned
relative to the instrument insertion channel correspond to
different geometrically designed reflectors.
19. The apparatus according to claim 1, wherein two of the at least
three positioning markers are fixedly positioned relative to the
element, and wherein one of the at least three positioning markers
is fixedly positioned relative to the instrument insertion
channel.
20. The apparatus according to claim 19, wherein at least one of
the two of the at least three positioning markers fixedly
positioned relative to the element comprises a titanium screw.
21. The apparatus according to claim 1, wherein the at least three
positioning markers comprise: a first positioning marker fixedly
positioned relative to the instrument insertion channel, a second
positioning marker fixedly positioned relative to the element, and
a third positioning marker fixedly positioned relative to a distal
end of the instrument.
22. The apparatus according to claim 1, wherein the means for
determining the relative position of the instrument insertion
channel with respect to the element comprises: a means for
measuring an azimuth angle that the instrument insertion channel
makes with respect to an axis parallel to a plane of the element,
and a means for measuring a zenith angle that the instrument
insertion channel makes with respect to the plane of the
element.
23. The apparatus according to claim 22, wherein the means for
measuring the azimuth angle comprises a scaling on a top piece
attached to the element, and wherein the means for measuring the
zenith angle comprises a scaling on the element.
24. The apparatus according to claim 1, further comprising: a means
for positioning the instrument insertion channel with respect to
the element configured to be fixedly positioned relative to a part
of the human body.
25. The apparatus according to claim 24, wherein the means for
positioning the instrument insertion channel with respect to the
element configured to be fixedly positioned relative to a part of
the human body comprises: a tilting means, wherein the tilting
means comprises: a first movable lamina having a first opening, and
a second movable lamina having a second opening, wherein the first
movable lamina is positioned relative to the element configured to
be fixedly positioned relative to a human skull and the second
movable lamina is positioned relative to the first movable lamina
such that the instrument insertion channel extends through the
first opening of the first movable lamina and the second opening of
the second movable lamina, wherein the first opening is shaped such
that the first movable lamina allows the instrument insertion
channel to tilt in a first plane, wherein the second opening is
shaped such that the second movable lamina allows the instrument
insertion channel to tilt in a second plane orthogonal to the first
plane.
26. The apparatus according to claim 25, further comprising a means
for actuating a tilting motion.
27. The apparatus according to claim 24, wherein the means for
positioning the instrument insertion channel with respect to the
element configured to be fixedly positioned relative to a part of
the human body comprises: a worm wheel movable attached to the
instrument insertion channel, wherein the worm wheel provides a
tilting motion and a rotating motion.
28. The apparatus according to claim 27, further comprising a means
for actuating the tilting motion and the rotating motion.
29. The apparatus according to claim 1, further comprising: a
stabilization channel removably positioned within the instrument
insertion channel such that upon inserting an instrument into the
instrument insertion channel, the instrument is inserted through
the stabilization channel.
30. The apparatus according to claim 29, further comprising: a
mounting for shifting in an axial direction with respect to the
instrument insertion channel, wherein the stabilization channel
extends through the mounting.
31. The apparatus according to claim 30, further comprising a means
for actuating movement of the mounting in the axial direction.
32. A method for inserting an instrument into a human body,
comprising: positioning an apparatus at a location relative to a
part of a human body, wherein the apparatus comprises: i) an
element configured to be fixedly positioned relative to the part of
a human body, ii) an instrument insertion channel, and iii) at
least three positioning markers at a location relative to the part
of a human body, wherein the at least three positioning markers are
each fixedly positioned relative to the element, fixedly positioned
relative to the instrument insertion channel, or fixedly positioned
relative to an instrument, wherein positioning the apparatus at a
location relative to a part of a human body comprises: positioning
the element with relative to the part of a human body, and
positioning the instrument insertion channel with respect to the
element; and determining the orientation of the apparatus with
respect to the part of a human body, wherein determining the
orientation of the apparatus with respect to the part of a human
body comprises: monitoring the at least three positioning markers,
and determining the relative position of the instrument insertion
channel with respect to the element.
33. The method according to claim 32, wherein the element comprises
a self-cutting thread, wherein fixedly attaching the element to the
part of a human body comprises screwing the element into a human
skull.
34. The method according to claim 32, wherein monitoring the at
least three positioning markers comprises imaging the at least
three positioning markers with a magnetic resonance imaging
system.
35. The method according to claim 32, wherein monitoring the at
least three positioning markers comprises imaging the at least
three positioning markers with a respective camera system.
36. The method according to claim 32, wherein determining the
relative position of the instrument insertion channel with respect
to the element comprises: monitoring a means for measuring an
azimuth angle that the instrument insertion channel makes with
respect to an axis parallel to a plane of the element, and
monitoring a means for measuring a zenith angle that the instrument
insertion channel makes with respect to the plane of the
element.
37. The method according to claim 36, further comprising indicating
the azimuth angle and the zenith angle in an MR image.
38. The method according to claim 37, further comprising adjusting
the orientation of the MR image to the orientation of the apparatus
with respect to the part of a human body.
39. The method according to claim 37, further comprising adjusting
the position of the instrument insertion channel with respect to
the orientation of the MR image.
40. The method according to claim 32, further comprising creating a
virtual image of the apparatus in a MR image.
41. The method according to claim 32, wherein determining the
orientation of the apparatus with respect to the part of a human
body determines the orientation of an instrument inserted through
the instrument insertion channel.
Description
CROSS REFERENCE TO A RELATED APPLICATION
[0001] This application is a divisional of U.S. patent application
Ser. No. 10/632,685; filed Aug. 1, 2003, which is a continuation of
U.S. Ser. No. 09/954,725; filed Sep. 14, 2001, now abandoned.
BACKGROUND OF THE INVENTION
[0002] With the German patent specification DE 198 44 767 A1, a
method attaching markers to a medical instrument that are
detectable under MRI is already known. The orientation of the
instrument within the MRI device can be determined with these
points. However, the respective allocation of the measured markers
to the instrument markers is impeded due to the similarity of the
signal-emitting substance to the instrument material. The
non-availability of an instrument fixation to the patient proves to
be a further disadvantage. Such fixation could be achieved by use
of trocars. FIGS. 2, 3, 4, and 5 show a device ensuring a
minimally-invasive approach to the brain through a hole in the top
of the skull. Such trocar is already known from patent
specification DE 197 26 141 and prevents the risk of the so-called
Brain Shift, which signifies the uncontrolled shifting of the brain
inside the surrounding skull during an operation. This problem is
not limited to the neuro field, but occurs whenever shifting tissue
is punctured. The disadvantages of this kind of trocars are the
following points:
[0003] The adjustment of a navigation system adapting the devices
to MRI imaging to such a neuro trocar is difficult.
[0004] The neuro trocar is manufactured of titanium alloy, so that
it is depicted as a homogenous formation with indistinct rim
demarcation in the MR image. A three-dimensional orientation is
difficult to assess. This, however, is highly essential, with the
neuro trocar, unlike a stereotactic system, having no own reference
point as it is fixed to the patient.
[0005] The invention presented herein aims to solve these and other
problems.
BRIEF SUMMARY OF THE INVENTION
[0006] The subject invention pertains to a device for inserting
medical instruments into the human body. In a specific embodiment,
the subject device can be made from a material which is invisible
under Magnetic Resonance Imaging (MRI). The subject device can
incorporate three or more MRI compatible markers. The imaging of
these three or more markers can allow the determination of the
orientation of the device. A virtual image of the device can then
be shown in an MRI image.
DETAILED DESCRIPTION OF THE FIGURES
[0007] FIG. 1 shows a problem of navigation.
[0008] FIG. 2 shows navigation points at a device in accordance
with an embodiment of the present invention.
[0009] FIG. 3 shows navigation points at the instrument insertion
channel of a device in accordance with an embodiment of the present
invention.
[0010] FIG. 4 shows angle measurement between instrument insertion
channel and device in accordance with and embodiment of the present
invention.
[0011] FIG. 5 shows navigation with active and passive material
contrast in accordance with and embodiment of the present
invention.
[0012] FIG. 6 shows a device with a stabilization channel in
accordance with an embodiment of the present invention.
[0013] FIG. 7 shows attachment of MRI markers to the combination of
device, instrument and angle measuring system in accordance with an
embodiment of the present invention.
[0014] FIG. 8 shows linear propulsion at the instrument insertion
channel in accordance with an embodiment of the present
invention.
[0015] FIG. 9a shows a device ensuring tilting motions of the
instrument insertion channel in accordance with an embodiment of
the present invention.
[0016] FIG. 9b shows a sectional image of an embodiment of a device
ensuring tilting motions.
[0017] FIG. 10 shows a device with double-walled and contrast
medium-filled top on the instrument insertion channel in accordance
with an embodiment of the present invention.
[0018] FIG. 11 shows adevice with motor-powered adjustable
instrument insertion channel in accordance with an embodiment of
the present invention.
DETAILED DISCLOSURE OF THE INVENTION
[0019] The problem of the conventional neuro trocar being not
sufficiently identifiably with regard to its orientation within the
MRI, as described in patent DE 197 26 141, can be solved by
designing a device of a material that is totally invisible under
MRI. If then a minimum of three MRI compatible points are marked on
it, an exact orientation can be determined by these three points;
its position in the MRI procedure can be precisely assessed, and a
virtual image of the trocar can be shown in the MRI picture.
[0020] Various systems for the technical realization of these
points are described below.
[0021] The problem is shown in FIG. 1. The medical instrument 1
with its reactive coordination system x'y'z' shall be determined in
its position relative to the patient coordination system xyz.
[0022] Both the adjustment of the instrument insertion channel 10
and the adjustment of the device 3, which essentially corresponds
to the devices 1 and 2, can be correlated to each other by an angle
adjustment (see FIG. 4). An angle adjustment for the azimuth angle
14 and an angle adjustment for the zenith angle 15 are possible on
the device 3. When the position of the device 3 is known, the
position of the instrument insertion channel 10 will also be known
automatically. By an automatic pick-off of angular movement not
shown in FIG. 4, azimuth and zenith angle could be directly
measured and included into the MR image. The MR image could then
always adjust to the orientation of the instrument insertion
channel 10 so that the operation site 16 will always be optimally
in the sight vane in the imaging of the MRI device. In such case,
markers 20', 20'', and 20''' according to the principles stated
herein could be adapted in the device 3 or in a top for angle
measurement 21. Reversedly, it is also possible to measure the
angle within the MR image and then to adjust at the device, i.e.,
the device follows the MR image.
[0023] The fixation of the instrument insertion channel 10 in a
certain position can be achieved by tightening a fixing screw 22 as
shown in FIG. 5.
[0024] Through the instrument insertion channel 10, a tube can be
inserted deep into the operation site, which will then serve as a
channel for inserting further instruments as shown in FIG. 6, the
advantage being a stabilization of the instruments inserted under
navigation. The stabilization channel 23 then holds the inserted
instruments. FIGS. 8 and 9 show a possibility where the instrument
or the stabilization channel 23 can be cramped into a mounting 6,
which is shifting in axial direction on the instrument insertion
channel 10. Such mounting 6 can be lowered manually or
automatically by a motor, electrically, hydraulically, by pneumatic
power or by wire pull.
[0025] The orientation of the instrument insertion channel can be
achieved by tilting. To allow this, two movable laminas 7 and 8,
relative to the device 2 and shifting to each other (as shown in
FIG. 9), are attached to the device. The instrument insertion
channel 10 is guided through an oblong opening 9 in each lamina. By
mechanical manual or automatic shifting of the laminas to each
other, the instrument insertion channel is tiltable in various
directions. Electrical, hydraulic or pneumatic actuations are
possible for automatic shifting.
[0026] A further possibility of adjustment of the instrument
insertion channel 10, as shown in FIG. 11, is to position the
instrument insertion channel by means such as a rotating and
tilting motion via a worm wheel 11 mechanically or by motor,
pneumatically, or by wire pull.
[0027] The orientation of the instrument is directly readable by
the scaling at the positioning unit. It could also be monitored via
the above-mentioned markers in the MR image.
[0028] In order to adapt the device to the imaging of the MRI
device, a navigation system is to be integrated into the device
itself. FIG. 2 shows a device 2 with an instrument insertion
channel 10 and three laterally extended reflectors 12. The three
mountings 13 for the reflectors 12 can be manufactured from one
piece or can be three separate parts. The reflectors 12 could also
be active optical light-emitting diodes. In such arrangement, the
three reflectors or sending elements 12 can be monitored by an
external camera system, and, due to the relative position of these
three elements to each other, the spatial orientation of the device
can be calculated and then be integrated in the MR image. Better
still is the application of markers which are directly identified
by the "magnet" (MRI), since this will prevent inaccuracies upon
matching the coordination systems.
[0029] FIG. 3 shows that this navigation device can also be
directly connected to the instrument insertion channel 10. There
could also be a navigation system for the device 2 a well as for
the instrument insertion channel 10, resulting in having two
navigation systems working with either different wavelengths or
different codification or with different geometrically designed
reflectors 12. The device can be manufactured of a material that is
not depictable under MRI or with other radiological imaging
methods. Single parts or areas of the device could be designed of a
material that is actively or passively identifiable under MRI. For
instance, the entire device for the operation under MRI could be
manufactured of plastics such as PEEK, and only certain parts would
be designed of titanium. The device could also be designed to have
hollow spaces containing a liquid which will emit active signals,
such as liquids with unpaired proton spin, for instance a
gadolinium-based liquid. FIG. 10 shows a double-walled top filled
with a signal-emitting liquid.
[0030] FIG. 5 shows a device 4 designed completely of plastics,
preferably PEEK (polyetheretherketone). This device 4 is screwed
into the skull with a self-cutting thread 19. Owing to the hardness
of the plastic material, the device can be manufactured with a
self-cutting thread. Such plastic device 4 is preferably designed
as a disposable. Two navigation points, which could be placed
inside the device either separated from one another or together,
shall be exemplarily described at the device. As one possibility,
the adjusting screw 17 in this PEEK instrument could be made of
titanium. Titanium is imaged negatively, as a black spot, in the
MRI device, so that the position of the device 4 is recognizable.
With two further titanium points, the orientation of the device 4
can be identified in a similar way as with the navigation system of
FIG. 3 or 2. A gadolinium-containing liquid is filled into a hollow
space 18 in this device. This liquid is an active liquid for the
MRI device, to be imaged as a white spot in the MR image. With
three such hollow spaces filled with a gadolinium-containing
liquid, here also the position of the device 4 can be determined.
It is now possible to combine such active spots such as the hollow
spaces 18 with the respective active or passive points 17, or
self-reflecting or luminous marker points 12, which will be
identified by the MRI device or a navigation system connected to
the MRI device. In this way, the localization and navigation of the
device within the MRI is ensured. By use of various positioning
points depicted differently in the MR image, it is possible to
achieve an exact allocation of the measured points to the points at
the device.
[0031] A so-called TrackPointer, as described in patent
specification 298 21 944.1, can also be connected to the device by
implanting it in the instrument insertion channel 10.
[0032] The orientation of the instrument with regard to the
operation system, or, in other words, the adaptation of the image
to the device presented herein via the MRI device, can also be
realized with the markers 20, according to the principle stated
herein, not only attached to the device 3 itself, but also to the
instrument 24, being inserted into the minimally-invasive channel 2
for a certain procedure, and to the angle measuring system 25 (FIG.
7).
[0033] FIG. 7 shows the process of pushing an instrument 24 through
the device 3 into the operation area. A marker 20' is placed at its
distal end 20', a second marker 20'' in the insertion center of the
device 3 as shown in FIG. 5. The third marker 20''' is positioned
on the angle measuring system 25, which is freely adjustable around
the device. The plane visible in the MR image will then be extended
by the three points 20', 20'', and 20'''. Thus one will always see
the instrument with its inserted length in the brain region, which
is determined by the third point placed on the circular angle
measuring system 25. Such marking points could also be designed as
small coils, as, for example, laid open with number 200 in patent
application U.S. Pat. No. 5,353,795 by Sven P. Souza in FIG. 2.
Such an element is an active coil sending with a certain frequency
and being deflected according to the system presented in the
above-mentioned patent.
[0034] Such a device can be used to insert probes, for mechanical
and mechanical-surgical instruments or endoscopes. The instrument
insertion channel 10 could also be designed in form of several
lumens, resulting in several channels instead of only one. The
device can also be used to insert larger instruments in open OP's.
Such a device could be designed as either reusable or disposable
instrument.
[0035] A system as presented herein can be used not only for
surgical interventions and procedures, but also for the insertion
of electrodes to fight Parkinson's disease. It could also be
applied as a shunt.
REFERENCE NUMBERS
[0036] 1. Device [0037] 2. Device, general for adaptation to a
navigation system [0038] 3. Device [0039] 4. Plastic Device [0040]
5. Double-walled top filled with contrast medium [0041] 6. Mounting
[0042] 7. Movable lamina [0043] 8. Movable lamina [0044] 9. Opening
[0045] 10. Instrument insertion channel [0046] 11. Worm wheel
[0047] 12. Reflector/optically emitting elements [0048] 13.
Reflector fitting [0049] 14. Angle adjustment azimuth angle [0050]
15. Angle adjustment zenith angle [0051] 16. Operation site [0052]
17. Titanium screw [0053] 18. Hollow space filled with
gadolinium-containing liquid [0054] 19. Self-cutting thread [0055]
20. MRI markers according to one principle presented herein [0056]
21. Top with angle adjustment [0057] 22. Fixing screw [0058] 23.
Stabilization channel [0059] 24. Instrument [0060] 25. Angle
measuring system
* * * * *