U.S. patent application number 09/970262 was filed with the patent office on 2002-02-14 for trajectory guide.
This patent application is currently assigned to Image-Guided Neurologics, Inc.. Invention is credited to Truwit, Charles L..
Application Number | 20020019641 09/970262 |
Document ID | / |
Family ID | 27489947 |
Filed Date | 2002-02-14 |
United States Patent
Application |
20020019641 |
Kind Code |
A1 |
Truwit, Charles L. |
February 14, 2002 |
Trajectory guide
Abstract
A surgical method and apparatus for accurately aligning the
trajectory of, guiding of, and introducing or withdrawal of an
instrument is disclosed. The apparatus includes a base which has a
movable member movably attached to the base. The movable member has
a passage therein which forms a portion of the trajectory path. A
positioning stem further includes a first locator and a second
locator. The first and second locators are associated with two
different portions of the positioning stem so that they are
essentially two points on a line. The first and second locators are
also locatable by a scanning or imaging system. The positioning
stem is removably attached to said movable member and used to
position the movable member. Moving the movable member also moves
the passage therein to different trajectories. Once the passage
within the movable member more or less is aligned with a target
within the body, a locking member locks the movable member into a
fixed position. The movable member can be moved to different
trajectories using a first hydraulic system. A second hydraulic
system can be used to introduce or withdraw an instrument to or
from the patient. A mechanical advancement tool can be substituted
for the second hydraulic system. The surgical instrument may also
be provided with a remote portion for controlling the instrument
from a remote location. The instrument can also be computer
controlled.
Inventors: |
Truwit, Charles L.;
(Wayzata, MN) |
Correspondence
Address: |
SCHWEGMAN, LUNDBERG, WOESSNER & KLUTH, P.A.
P.O. BOX 2938
MINNEAPOLIS
MN
55402
US
|
Assignee: |
Image-Guided Neurologics,
Inc.
|
Family ID: |
27489947 |
Appl. No.: |
09/970262 |
Filed: |
October 3, 2001 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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09970262 |
Oct 3, 2001 |
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09363510 |
Jul 29, 1999 |
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09363510 |
Jul 29, 1999 |
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09078913 |
May 14, 1998 |
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5993463 |
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09078913 |
May 14, 1998 |
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09058092 |
Apr 9, 1998 |
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6267769 |
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09058092 |
Apr 9, 1998 |
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08919649 |
Aug 28, 1997 |
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08919649 |
Aug 28, 1997 |
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08856664 |
May 15, 1997 |
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Current U.S.
Class: |
606/130 |
Current CPC
Class: |
A61B 90/11 20160201;
A61B 2017/00539 20130101; A61B 2017/00243 20130101; A61B 2017/00911
20130101; A61B 2090/3954 20160201; A61B 90/36 20160201; A61B 34/10
20160201; A61B 2017/00398 20130101 |
Class at
Publication: |
606/130 |
International
Class: |
A61B 019/00 |
Claims
What is claimed is:
1. A surgical device comprising: a base unit; an elongated guide
stem having a passage therein, a ball attached to one end of the
guide stem, said ball having a passage therein, said ball fitting
within the base unit, said ball capable of rotating with respect to
the base unit; and a guide stem cable mount associated with said
guide stem.
2. The surgical device of claim 1 further comprising a cable having
an end attached to said guide stem cable mount such that moving the
cable moves the guide stem.
3. The surgical device of claim 2, wherein the base unit includes a
recess for receiving a cable.
4. The surgical device of claim 2, further comprising a locking
member which engages the ball and fixes the position of the ball
and guide stem upon tightening the locking member when the ball is
properly positioned.
5. The surgical device of claim 2, further comprising a locking
member which engages the ball and fixes the position of the ball
and guide stem upon tightening the locking member when the ball is
properly positioned, said locking member having at least one slot
therein through which the cable passes.
6. The surgical device of claim 2, further comprising a positioning
stem, said positioning stem having an end which fits into the
passage within the guide stem, said positioning stem having a
locator visible in a scanning environment.
7. The surgical device of claim 1 wherein the guide stem cable
mount is attached to the guide stem.
8. The surgical device of claim 2 further comprising a surgical
instrument advancement assembly.
9. The surgical device of claim 1 further comprising a sleeve
placed over the guide stem between the base and the surgical
instrument advancement assembly, said sleeve placing the surgical
instrument advancement assembly in position to engage the guide
stem.
10. The surgical device of claim 8 wherein the surgical instrument
advancement assembly further comprises: a guide stem mounting
block; a surgical instrument lock; a cable for moving the surgical
instrument lock with respect to the guide stem mounting block.
11. The surgical device of claim 10 wherein the surgical instrument
advancement assembly further comprises a thumb ring attached at one
end of the cable; a finger ring attached near the end of the cable
having the thumb ring attached thereto, wherein the surgical
instrument lock moves with respect to the guide stem mounting block
in response to the thumb ring moving with respect to the finger
ring.
12. The surgical device of claim 10 wherein the guide stem has a
groove therein near the opposite end distant from the ball end,
said surgical device further comprising a sleeve placed over the
guide stem between the guide stem cable mount and the surgical
instrument advancement assembly, said guide stem mounting block
including a portion which engages the guide stem, said sleeve
placing the guide stem mounting block a selected distance away from
the locking member.
13. A surgical apparatus comprising: a first base unit; a first
elongated guide stem having a passage therein, a ball attached to
one end of the guide stem, said ball having a passage therein, said
ball fitting within the first base unit, said ball capable of
rotating with respect to the first base unit; a first guide stem
cable mount associated with said first elongated guide stem; a
second base unit; a second elongated guide stem having a passage
therein, a ball attached to one end of the guide stem, said ball
having a passage therein, said ball fitting within the second base
unit, said ball capable of rotating with respect to the second base
unit; a second guide stem cable mount associated with said second
elongated guide stem; and a cable connected at one end to the first
guide stem cable mount and connected at the other end to the second
guide stem cable mount, wherein the first elongated guide stem
moves in response to moving the second elongated guide stem.
14. The surgical apparatus of claim 13 wherein at least a portion
of said apparatus is used in an imaging environment, said cable
made of a material which is compatible in the imaging
environment.
15. The surgical apparatus of claim 13 wherein said cable is a
filament.
16. The surgical apparatus of claim 13 wherein said first base unit
has a recess for receiving said cable and said second base unit has
a recess for receiving said cable, said recesses acting as a cable
guide.
17. The surgical apparatus of claim 13 further comprising a
plurality of cables, each of said cables connected at one end to
the first guide stem cable mount and connected at the other end to
the second guide stem cable mount, wherein said first base unit has
a plurality of recesses for receiving said plurality of cables and
said second base unit has a plurality of recesses for receiving
said plurality of cables, said recesses acting as a cable
guides.
18. The surgical apparatus of claim 17 further comprising: a first
locking member for fixing the position of the first elongated guide
stem with respect to the first base unit; and a second locking
member for fixing the position of the second elongated guide stem
with respect to the second base unit, said first locking member and
said second locking member having slots therein to accommodate the
plurality of cables.
19. The surgical apparatus of claim 13 further comprising: a first
locking member for fixing the position of the first elongated guide
stem with respect to the first base unit; and a second locking
member for fixing the position of the second elongated guide stem
with respect to the second base unit.
20. The surgical apparatus of claim 13 wherein one of said first
base unit and first elongated guide stem, or said second base unit
and second elongated guide stem is located in an imaging
environment, and the other of said first base unit and first
elongated guide stem, or said second base unit and second elongated
guide stem is located outside an imaging environment.
21. The surgical apparatus of claim 20 further comprising: a
surgical instrument to be passed into the body of a patient
associated with the one of said first base unit and first elongated
guide stem, or said second base unit and second elongated guide
stem is located in an imaging environment; and a surgical
instrument advancement assembly.
22. The surgical apparatus of claim 21 wherein the surgical
instrument advancement assembly further comprises: a guide stem
mounting block for mounting on the elongated guide stem; a surgical
instrument lock; a cable for moving the surgical instrument lock
with respect to the guide stem mounting block.
23. The surgical apparatus of claim 22 wherein the surgical
instrument advancement assembly further comprises a thumb ring
attached at one end of the cable; and a finger ring attached near
the end of the cable having the thumb ring attached thereto,
wherein the surgical instrument lock moves with respect to the
guide stem mounting block in response to the thumb ring moving with
respect to the finger ring.
24. The surgical apparatus of claim 22 wherein said surgical
instrument lock further comprises: an elastomeric sleeve positioned
around the surgical instrument; a first substantially inelastic
end; and a second substantially inelastic end, wherein drawing the
first end toward the second end causes the elastomeric sleeve to
engage the surgical instrument.
25. The surgical apparatus of claim 22 further comprising a
surgical instrument advancement lock for locking the position of
the surgical instrument with respect to the guide stem.
26. The surgical apparatus of claim 25 further comprising: an
L-shaped surgical instrument advancement lock; and a locking pin
for holding the advancement lock in place.
27. The surgical apparatus of claim 23 further comprising the
surgical instrument advancement assembly further comprises a sleeve
between the thumb ring attached at one end of the cable and the
finger ring attached near the end of the cable, wherein the sleeve
has markings thereon corresponding to the movement instrument lock
moves with respect to the guide stem mounting block.
28. A method for introducing a surgical instrument into the body of
a patient, said patient positioned in a scanning environment, said
method comprising the steps of: selecting a target within a
patient; attaching a first base and first movable elongated guide
stem to the patient; connecting the first base and first movable
elongated guide stem to a second base and second movable elongated
guide stem using cables; placing a positioning stem within the
guide stem, said positioning stem having a first portion readable
within the scanning device and a second portion readable within the
scanning environment; and moving a second elongated guide stem with
respect to the second base, said second base and said second
movable elongated guide stem positioned outside the scanning
environment, wherein moving the second elongated guide stem with
respect to the second base causes movement of the first movable
elongated guide stem with respect to the first base.
29. The method of claim 28 further comprising the steps of:
aligning a passage in the first elongated guide stem with the
target within the patient; and locking the first elongated guide
stem with respect to the first base.
30. The method of claim 29 further comprising the steps of:
replacing the positioning stem with a surgical instrument at the
first guide stem; and introducing the surgical instrument into the
patient.
31. The method of claim 30 further comprising the steps of: locking
the surgical instrument into a position with respect to the guide
stem.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application is a continuation-in-part of U.S. patent
application Ser. No. 08/919,649 entitled "Surgical Instrument
Trajectory Guide Method and Apparatus", filed on Aug. 28, 1997
which in turn is a continuation-in-part of U.S. patent application
Ser. No. 08/856,664 entitled "Surgical Instrument Trajectory Guide
Method and Apparatus", filed on May 15, 1997. This application is
also a continuation-in-part of U.S. patent application Ser. No.
09/058,092 entitled Trajectory Guide Method and Apparatus for use
in Magnetic Resonance and Computerized Tomographic Scanners", filed
on Apr. 9, 1998.
FIELD OF THE INVENTION
[0002] The present invention is related to surgical working
platforms. More specifically, the present invention relates to a
working platform and method for using the same which facilitates
the alignment of surgical and observational instruments into a
patient.
BACKGROUND OF THE INVENTION
[0003] In the treatment of some diseases or defects associated with
a patient, it has been found necessary to access specific targets
within a patient. In the treatment of some diseases of or defects
of human beings, it has been found necessary to access specific
portions of the brain. Currently there are several methods for
inserting surgical and observational instruments into a patient's
brain.
[0004] U.S. Pat. No. 3,055,370 issued to McKinney et al. shows one
currently used method for placing a surgical instrument to access a
specific portion of the brain. The surgical instrument of the '370
patent includes a ball which has a bore. The direction of the bore
can be changed. The instrument has an elongated tube of a specific
length. A stylet is inserted within the tube to access the globus
pallidus and perform a pallidotomy. An opening or burr hole is made
in the skull at a specific landmark on the skull. Next, X-rays are
taken in the fore-and-aft (AP) and lateral positions, and the line
of the bar is projected downwardly by a ruler both in the
fore-and-aft (AP) and lateral positions, so that the direction of
the needle can be determined before it is inserted. When the
direction of the longitudinal axis of the tubular member is
determined to be satisfactory, a holder is threaded further into a
tap to force a surface against a ball and lock a tubular member
into place. Alignment of the trajectory is not measurable along a
specific line occurring at the intersection of two planes.
Alignment is dependent on placement of the burr hole at a specific
location to determine one plane. X-rays are used to determine
another plane-based use of common landmarks on the skull. The end
result is that an educated guess is being used to position the
stylet at the globus pallidus for the pallidotomy. One shortcoming
with the method of using X-ray imaging to direct a surgical or
observational instrument, is that many of the destinations within a
patient are not viewable via X-ray. Another shortcoming relates to
the slight shifting of intracranial contents, once a burr hole is
placed and the dura and arachnoid are penetrated. Once
cerebrospinal fluid is released via the burr hole, the intracranial
contents (i.e. brain) may shift one or more millimeters. In such a
case, the calculated trajectory is no longer accurate. Hence, there
is an inherent inaccuracy with the described scheme.
[0005] Several other methods are also used to place instruments,
catheters, or observational tools into patients. Currently,
surgical procedures are performed through craniotomy flaps or
craniotomy burr holes. A burr hole of about 14 mm is made in the
skull. Needles or probes are typically passed through the burr hole
into the brain using framed stereotaxy, frameless stereotaxy or
freehand without stereotaxy.
[0006] The freehand method depends very heavily on the knowledge
and judgment of the surgeon. In the freehand method, the surgeon
determines the insertion point with a couple of measurements from a
known landmark. The surgeon then looks at the measured point, makes
adjustments, determines the angle of insertion and then inserts the
surgical instrument or tool.
[0007] In framed stereotaxy, a ring frame is mounted to the
patient's skull by multiple (typically three or four) pins or
screws. This ring frame is used to determine a three dimensional
data set. From this data set, Cartesian coordinates are calculated
for both the lesion, the location of the pins or screws, and the
fiducial marks on the frame. The ring frame fits into a large
frame. A large frame is then attached to the patient in the
operating suite. The large frame provides known positions and
guides the surgical or observational instruments. The large frame
is used to position the instrument to be introduced into the
patient through a burr hole so that it intersects the target. In
frameless stereotaxy, the ring frame is replaced with several
markings on the patient's skull which can be used to determine
several known positions. The large frame is replaced by a camera.
The camera is usually infrared or some such device. Multiple
sensors readable by the camera are placed on the instrument. For
example, the surgical instrument or tool is provided with one or
more light emitting diodes ("LEDs") which are tracked by the
camera. The position of the surgical instrument can be calculated
from the information from the LEDs on the surgical instrument or
observational tool.
[0008] U.S. Pat. No. 4,955,891 and U.S. Pat. No. 4,805,615, both
issued to Carol, each discuss the use of stereotaxy surgery with
computerized tomographic ("CT") scanning. CT scanning is used to
determine the exact position of a lesion or specific portion of the
brain. After the exact position of the lesion or specific portion
of the brain is determined, a phantom fixture is set up. The
phantom fixture replicates the position of the ring frame on the
patient A phantom target is set up. The instrument can then be
positioned on the phantom such that it intersects the target. The
information from the phantom can then be used in actually
positioning the instrument in the operating suite.
[0009] U.S. Pat. No. 4,998,938 issued to Ghajar et al. shows
another surgical device for facilitating the insertion of an
instrument into a patient's cranial cavity through a burr hole. The
device includes a guide having an end configured to pass into the
burr hole. There is a separate locking member. A body member
includes alignment markings to help with insertion of a catheter or
stylet. Unlike the '370 patent, there is no movable member for
adjusting the path of the guide.
[0010] The methods currently in use all have a number of
shortcomings. Most of the techniques currently used to place a
surgical instrument or observational tool within a patient employ a
limited amount of accuracy. In particular, current framed,
frameless, and freehand methods compute or predict trajectories on
the basis of imaging data or anatomic landmarks that do not account
for the slight, but real shifting of the brain upon opening the
cranium and meninges to the level of the subarachnoid space. This
inherent inaccuracy inherently limits the success of these various
methodologies. In other words, these systems do not use any means
of updating the data files to include data obtained following the
placement of a surgical burr hole and opening of the meninges. In
addition, all the methods require large amounts of judgment on the
part of the surgeon placing the surgical instrument or tool, and in
particular, offer no direct feedback on the success or failure of
the trajectory to reach the target Very few of the techniques use
an imaging or scanning apparatus to aid in the placement of the
surgical instrument or observational tool. The only one that does
requires a phantom frame and target to be set up to simulate the
real geometry. In short, none of the apparatuses appear to use an
imaging or scanning apparatus as extensively as they could be used
to minimize the time and effort needed to accurately place a
surgical instrument into a patient, and to offer immediate data on
the success or failure of the trajectory to reach the target.
[0011] Still another disadvantage is that the apparatuses used
today are not remotely controlled or actuated. In some operating
environments, the patient is not accessible to the surgeon.
Therefore, it is advantageous to have remote control of the tool.
One such environment is within an MR magnet associated with an MR
operating suite. When the patient is in an open magnet, the surgeon
may have direct access to the patient. When in a closed magnet, the
surgeon probably will not have such direct access to the
patient.
SUMMARY OF THE INVENTION
[0012] A surgical method and apparatus for accurately aligning the
trajectory of, guiding of, and introducing or withdrawal of an
instrument is disclosed. The apparatus includes a base which has a
movable member movably attached to the base. The movable member has
a passage therein which forms a portion of the trajectory path. The
movable member also includes a guide stem which has an opening
therein. The guide stem is attached to said movable member such
that the opening in the guide stem substantially aligns with the
passage in the movable member. The movable member can include
either an integral guide stem for holding the positioning stem or a
removably attached guide stem. In the case of the former, a
positioning stem is inserted into the opening of the guide stem for
purposes of trajectory alignment. In the case of the latter, the
removably attached guide stem can be removed and replaced with a
positioning stem.
[0013] A positioning stem further includes a first locator and a
second locator. The first and second locators are associated with
two different portions of the positioning stem so that they are
essentially two points on a line. The first and second locators are
also locatable by a scanning or imaging system. The positioning
stem is either inserted into the guide stem that is integral to the
movable member, or is removably attached to said movable member and
used to position the movable member. Moving the positioning stem
while either within the guide stem or removably attached to the
movable member also moves the passage therein to different
trajectories. Once the passage within the movable member more or
less is aligned with a target within the body, a locking member
locks the movable member into a fixed position.
[0014] In one embodiment the first locator and the second locator
are readable by a magnetic resonance imaging apparatus. The locator
can include a fluid readable by a magnetic resonance imaging
apparatus or a source of radio frequency, such as a coil, which is
readable by a magnetic resonance imaging apparatus. In the latter
embodiment, the first and second locators may be small radio
frequency (RF) coils that detect an electromagnetic signal in a
magnetic resonance imaging environment. The electromagnetic signal
detected can be used to locate the first and second locators. The
line formed by the first locator and the second locator may be
substantially aligned with the centerline of the passage in the
movable member or may be offset from the centerline of passage in
the movable member. In other embodiments, the first and second
locators may be light emitting diodes which are readable by an
infrared camera.
[0015] The first and second locators may be located within an
essentially solid plastic positioning stem, or in another
embodiment, the first and second locators may be located within an
MR-visible chamber within the positioning stem. In the latter
embodiment, the chamber may be filled with an MR-visible fluid
(paramagnetic, for example), which can be used to afford a first
approximation of alignment. The first and second locators may be
either MR-visible (different than the MR-visible chamber) or may be
MR-invisible, in which case they would exhibit a negative image
against the background of the MR-visible fluid within the larger
chamber of the positioning stem. Advantageously, the fluid in the
chamber produces an image which can be easily located and can be
used to roughly align the positioning stem. The MR-visible or
MR-invisible fluid of the first and second locators can then be
used for fine or precise alignment.
[0016] In the embodiment where the guide stem and positioning stems
are removably attached to the movable member, the movable member
can include a threaded opening which receives either the guide stem
or the positioning stem. In this embodiment where the guide stem is
interchangeable with the positioning stem, one end of both the
guide stem and positioning stem is threaded. A portion of the
passage in the movable member has internal threads for receiving
the threaded end of either the guide stem or the positioning stem.
In the embodiment where the guide stem is formed as part of the
movable member, the positioning stem fits within the opening in the
guide stem. The movable member is a ball capable of swiveling with
respect to the base.
[0017] In another embodiment, the movable member may also include a
stage which allows for planar movement in a direction intersecting
the trajectory. A surgical instrument, such as a needle, probe
(cryotherapy probe, laser probe, RF ablation probe, microwave
interstitial therapy probe, or focussed ultrasound therapy probe),
catheter, endoscope, or electrode, can then be inserted through the
movable member and the opening in said guide stem to guide the
instrument toward the target position within the patient. In this
embodiment, it is possible to reposition the surgical instrument
without altering the trajectory itself, by first withdrawing it
from the targeted tissue and then adjusting the stage in a
direction intersecting the trajectory.
[0018] It is advantageous to have the trajectory guide operable
from a remote location. Among the advantages is that the patient
will not have to be moved in and out of an environment in order to
make adjustments to the trajectory guide. Adjustments or use of the
trajectory guide does not have to be interrupted when used in an
environment where a surgeon or technician does not have access to
the trajectory guide on the patient. This shortens the time spent
for the surgical procedure which is appreciated by both the surgeon
or technician as well as the patient. It should also be noted that
the trajectory guide is also adaptable to other environments such
as for use in a CT scan environment. In CT scanning, x-radiation is
used in order to form the images. Overexposure to x-rays is harmful
to patients who are undergoing procedures. Overexposure to x-rays
is a concern to surgeons or technicians who perform these
procedures. Therefore, it is advantageous to have the capability to
maneuver the trajectory guide from a remote location so that the
procedure can be done in a shorter amount of time and so that the
physicians and technicians that may be using the trajectory guide
can keep exposure to various imaging environments to a minimum.
[0019] In a first preferred embodiment of a remotely controlled
trajectory guide, there is the actual trajectory guide and a remote
trajectory guide. The remote trajectory guide is a duplicate of the
actual trajectory guide. The remote trajectory guide has the same
look and feel as the actual trajectory guide so that the surgeon or
technician used to using the actual guide can move the remote guide
as if it was the actual guide attached to the patient. The
objective is to make the movement of the remote feel as though it
was the actual guide. In this way, once the physician surgeon or
the technician learns to use the actual guide they do not have to
learn how to use the remote device. In the first embodiment, the
tilt or trajectory defined by the trajectory guide and the
advancement and of the surgical instrument is provided for by using
a mechanical device using a cable or filament.
[0020] In a second preferred embodiment of a remotely controlled
trajectory guide, a first hydraulic cylinder and a second hydraulic
cylinder control actuators which may be used to position the
positioning member. Once so positioned and after the movable member
locked is locked, thereby also locking in the trajectory, the first
and second hydraulic cylinder control actuators may be removed. A
third hydraulic cylinder and actuator may then be used to control
the insertion or withdrawal of an instrument. The hydraulic
cylinders are especially useful for positioning the movable member
and inserting or withdrawing the instrument when the patient is
positioned remotely from the surgeon. Although many scanning
devices allow access to a patient, there are many styles of
scanning devices that do not allow access to the patient during a
scanning operation. For example, in an MRI type scanning device,
the magnet producing the magnetic field can be of several shapes.
Some of the magnets are shaped such that a patient must be
positioned out of reach of the surgeon in order to be within the
homogeneous imaging volume of the magnetic field during a scanning
operation.
[0021] In operation, a target within a patient is initially
selected. A surgical opening into the body is made and the base is
inserted into and surgically secured to the opening. The movable
member and outer locking ring are also removably attached to the
base. The positioning stem is then used to move the movable member
and the passage therein to form a trajectory toward the target. The
first locator portion and the second locator portion are read by
the scanning device to determine the trajectory represented by the
line of the positioning stem. The positioning stem is moved until
the line represented by the positioning stem intersects the
selected target. The positioning stem can be moved manually or by
using the first hydraulic cylinder and actuator, and the second
hydraulic cylinder and actuator. The line of the positioning stem
may also be offset from the target in an alternate embodiment. Of
course, the determination of the position of the first and second
portions of the positioning stem is performed at least in part by
the central processing unit and the memory of the scanning device.
Once alignment is indicated, the movable member is locked into
position which locks the trajectory represented by the positioning
stem. The positioning stem is then removed either from the guide
stem that is integral to the movable member, or, when the guide
stem is not integral with the movable member, from the movable
member itself. In the latter case, a guide stem is then attached to
the movable member. The opening in the guide stem and the
substantially aligned passage in the movable member form a
trajectory in line with the selected target. The instrument is
passed therethrough.
[0022] The third hydraulic cylinder and associated actuator can be
used to control insertion or withdrawal of the instrument, if
remote operation is desirable. Insertion or withdrawal can also be
done manually. In situations where the target may be quite small,
if the surgical instrument, upon successfully reaching the quite
small target, reveals that the target selected, due to anatomic
variance, is indeed not the true target, repositioning of the
surgical instrument can be made by means of a slight offset. In
such a situation, a stage can be moved so that a parallel
trajectory can be followed. In such a situation, it may be
advantageous and safer to employ a stage in order to minimize
surgical trauma to the tissues.
[0023] The opening within the movable member and guide stem
(whether integral to the movable member or removably attached) are
designed to accommodate surgical instruments and observational
tools. As there is a wide variety of different surgical instruments
and observational tools, it is anticipated that multiple movable
members and guide stems with openings of different diameter for
such a wide array of surgical instruments and observational tools
will be employed. In addition, in the case of a guide stem that is
integral to the movable member, additional positioning stems of
similar diameters to fit appropriately into the guide stems will be
employed.
[0024] Advantageously, the scanning device used for diagnostic
purposes can be employed to place an instrument within the body of
a patient. There is no need for framed stereotaxy or unframed
stereotaxy, two procedures which require large amounts of time to
perform. Procedures that formerly required many hours can now be
performed in substantially less amounts of time with the trajectory
guide. Time is saved over framed or unframed stereotaxy since there
is no need to spend time placing a frame onto the patient or
calculating the location of several selected points before the
actual introduction of a surgical instrument. The procedure is not
only quicker, but provides for real time feedback as the surgical
instrument progresses into the body. The computer associated with
the scanning device also calculates the trajectory to determine if
the line defined by the first locator and the second locator is
collinear with the trajectory.
[0025] The surgical instrument can also be used in other
applications without a first and second locator. For example, the
movable member with a passage can be held by a clamp to guide
catheters and other surgical instruments into the human body. The
clamp includes a pair of cups for holding the movable member. The
clamp is spring loaded so that it engages the movable member when
the clamp is not held open. Several of the clamps can be held above
a patient by individual snake devices or by a support bar that
holds a plurality of clamps. A plate that holds several movable
members can also be held above the patient or even attached to a
patient to provide a platform from which to pass one or more
surgical instruments through corresponding movable members. Such
arrangements can be used for any type of surgery where it is
advantageous to use rigid or flexible type surgical instruments,
particularly as might be used in minimally-invasive surgical
procedures. The trajectory defined by the trajectory guide and the
advancement of the surgical instrument can be controlled from
outside the scanning environment.
BRIEF DESCRIPTION OF THE DRAWINGS
[0026] For a better understanding of the present invention,
reference may be made to the accompanying drawings in which:
[0027] FIG. 1 is a block diagram of a patient scanning system.
[0028] FIG. 2 is a side view of a patient on which the trajectory
guide is being used.
[0029] FIG. 3 is an exploded isometric view of the trajectory guide
with a removably attached guide member installed.
[0030] FIG. 4 is an exploded isometric view of the trajectory guide
with a removably attached positioning member installed.
[0031] FIG. 5a is a top view of the movable member or ball of the
trajectory guide.
[0032] FIG. 5b is a side view of the movable member or ball of the
trajectory guide.
[0033] FIG. 6a is a side view of the base of the trajectory
guide.
[0034] FIG. 6b is a top view of the base of the trajectory
guide.
[0035] FIG. 7a is a top view of the locking member of the
trajectory guide.
[0036] FIG. 7b is a cutaway side view of the locking member of the
trajectory guide, along line 7b-7b of FIG. 7a.
[0037] FIG. 8 is an exploded view showing a stage for attachment to
the base of the trajectory guide.
[0038] FIG. 9 is a cutaway side view of another preferred
embodiment of the movable member of the trajectory guide and a
positioning stem.
[0039] FIG. 10 is a side view of a hydraulic actuator used to move
the guide stem of the trajectory guide.
[0040] FIG. 11 is a top view of a guide stem of a trajectory guide
having two hydraulic actuators attached to the guide stem.
[0041] FIG. 12 is an isometric view of a first clamp for holding a
hydraulic cylinder.
[0042] FIG. 13 is an isometric view of a first clamp for holding a
hydraulic cylinder.
[0043] FIG. 14 is an exploded isometric view of the first clamp and
the second clamp for holding a hydraulic cylinder onto a surgical
instrument and a trajectory guide.
[0044] FIG. 15 is an attachment including a RF coil for the
base.
[0045] FIG. 16 is a cap for the attachment shown in FIG. 15.
[0046] FIG. 17 is an side view of an alternate embodiment of a
guide stem for the trajectory guide.
[0047] FIG. 18 is view of an image as seen on a display of a
nuclear magnetic imaging system.
[0048] FIG. 19 is a remotely controlled actuator mechanism used to
control movement of the movable member associated with the
patient.
[0049] FIG. 20 shows the set of intermediary hydraulic rams used to
interconnect the movable member associated with the patient and the
movable member associated with remote control.
[0050] FIG. 21 is a flow chart of the software program used to
control movement of the movable member.
[0051] FIG. 22 is a flow chart of the process for performing a
surgical procedure through a small opening within the body.
[0052] FIG. 23 is a top view of a surgical instrument for holding a
movable member.
[0053] FIG. 24 is a top view of a snake clamp for holding a movable
member.
[0054] FIG. 25 is a top view of a platform or bar which holds a
plurality of surgical instruments.
[0055] FIG. 26 is a top view of a plate which includes a plurality
of movable members attached to a pair of ribs.
[0056] FIG. 27 is a top view of a surgical instrument designed to
grip or be held within a burr hole a patient's skull.
[0057] FIG. 28 shows a top view of a doublet instrument which is a
combination of the instrument of FIG. 23 and a combination of the
instrument shown in FIG. 27.
[0058] FIG. 29 shows a side view of a doublet instrument which is a
combination of the instrument of FIG. 23 and a combination of the
instrument shown in FIG. 27.
[0059] FIG. 30 shows a perspective view of a preferred embodiment
of a mechanical remotely actuated trajectory guide mechanism.
[0060] FIG. 31 is a perspective view of one of the first or second
trajectory guides used as part of the mechanical remotely actuated
trajectory guide mechanism shown in FIG. 30.
[0061] FIG. 32 is a top view of the base of the trajectory guide
used as part of the mechanical remotely actuated trajectory guide
mechanism.
[0062] FIG. 33 is a side view of the guide stem of the trajectory
guide used as part of the mechanical remotely actuated trajectory
guide mechanism.
[0063] FIG. 34 is a top view of the locking member of the
trajectory guide used as part of the mechanical remotely actuated
trajectory guide mechanism.
[0064] FIG. 35 is a top view of the guide stem cable mount of the
trajectory guide used as part of the mechanical remotely actuated
trajectory guide mechanism.
[0065] FIG. 36 is an exploded perspective view of the mechanical
remotely actuated trajectory guide mechanism with the spacing
sleeve for spacing the surgical instrument advance mechanism up the
guide stem
[0066] FIG. 37 is an exploded perspective view of the surgical
instrument advance mechanism for use with the mechanical remotely
actuated trajectory guide mechanism.
[0067] FIG. 38 is a side view of a patient on which an externalizer
and trajectory guide are being used.
[0068] FIG. 39 is an exploded isometric view of the trajectory
guide with an externalizer and a removably attached guide member
installed.
[0069] FIG. 40 is an exploded isometric view of the trajectory
guide with an externalizer and a removably attached positioning
member installed.
[0070] FIG. 41a is a side view of the base of the trajectory
guide.
[0071] FIG. 41b is a top view of the base of the trajectory
guide.
[0072] FIG. 42 is an isometric view of another preferred embodiment
of the trajectory guide.
[0073] FIG. 43 is a block diagram of a computerized tomographic
type patient scanning system.
[0074] FIG. 44 is an isometric view of another preferred embodiment
of the trajectory guide having arched positioning bails.
[0075] FIG. 45 is an isometric view of yet another preferred
embodiment of the trajectory guide having arched positioning
bails.
[0076] FIG. 46 is a flow chart indicating the steps in using the
trajectory guide in a CT scanning environment.
[0077] FIG. 47 is a side view of the positioning stem of the
trajectory guide which includes light-emitting diodes.
[0078] FIG. 48 is a top view of a burr hole extension
apparatus.
[0079] FIG. 49 is a side view of the burr hole extension apparatus
shown in FIG. 10.
[0080] FIG. 50 is a top view of another embodiment of the burr hole
extension apparatus.
[0081] FIG. 51 is an end view of a patient positioned within a
magnet having a body type trajectory guide attached thereto.
[0082] FIG. 52 is a side view- of a patient positioned within a
magnet having a body type trajectory guide attached thereto.
[0083] FIG. 53 is a side view of a body type trajectory guide.
[0084] FIG. 54 is a cutaway side view of the body type trajectory
guide.
[0085] FIG. 55 is a top view of the body type trajectory guide.
DESCRIPTION OF THE EMBODIMENT
[0086] In the following detailed description of the embodiment,
reference is made to the accompanying drawings which form a part
hereof, and in which is shown by way of illustration specific
preferred embodiments in which the invention may be practiced.
These embodiments are described in sufficient detail to enable
those skilled in the art to practice the invention, and it is to be
understood that other embodiments may be utilized and that
structural, logical and electrical changes may be made without
departing from the spirit and scope of the present invention. The
following detailed description is, therefore, not to be taken in a
limiting sense, and the scope of the present invention is defined
only by the appended claims.
[0087] This application incorporates the following U.S.
applications by reference:
[0088] U.S. patent application Ser. No. 08/919,649 entitled
"Surgical Instrument Trajectory Guide Method and Apparatus", filed
on Aug. 28, 1997;
[0089] U.S. patent application Ser. No. 08/856,664 entitled
"Surgical Instrument Trajectory Guide Method and Apparatus", filed
on May 15, 1997; and
[0090] U.S. patent application Ser. No. 09/058,092 entitled
"Trajectory Guide Method and Apparatus for use in Magnetic
Resonance and Computerized Tomographic Scanners", filed on Apr. 9,
1998.
[0091] FIG. 1 is a block diagram of a patient scanning system 100.
The specific scanning system shown is for a magnetic resonance
imaging ("MRI") system. An MRI scanning system 100 includes a
computer 102. The computer 102 includes a central processing unit
("CPU") 104 and memory 106. The CPU 104 and memory 106 has the
capacity to perform multiple calculations used to determine images
as well as positions of various organs, or portions or within an
image field. The computer 102 controls an image data processing
portion 110, a system controller and wave form generator portion
120, and an XYZ gradient producing portion 130. The XYZ gradients
are amplified and used to provide a gradient magnetic field in the
X, Y, and Z directions as part of a magnet system 140. The magnet
system 140 includes a magnet which produces a magnetic field
through which a patient can pass. The shape of the magnet varies
among MRI systems. The shape of the magnet and its relation to the
table upon which the patient lies, determines whether the patient
can be accessed by a surgeon while an MRI is being performed. There
are many styles of MRI devices that do not place the surgeon within
a close enough proximity to allow access to the patient during an
MRI scan operation.
[0092] The MRI system 100 also includes gradient amplifier 150.
Also included are a set of RF amplifiers 160 and RF coils 162 which
are used in conjunction with the magnet system 140 to produce and
transmit RF pulses in the magnetic field. Either the same RF coil
or another RF coil is used to detect the MR signals from the
interrogated tissues. This detected MR signal is then amplified by
a preamplifier 164 and received by a receiver 166 for transmission
to the data acquisition system 170 and then transmitted to the
image data processing computer system 110. The data acquisition
system is input to the system controllers and waveform generator
portion 120 of the computer 102 as part of a feedback loop. The
data is interpreted and placed on a display 180 associated with the
computer of the MRI system 100. The computer 102 and the CPU 104
and memory 106 can use data acquired from the MRI system 100 to
build up images of a portion of the patient which is being scanned.
The images are typically referred to as slices. For example, a
horizontal slice and a vertical slice can be made of the portion of
the body or patient being imaged. The computer can also recalculate
and build other slices for use by doctors and radiologists having
any selected orientation needed to facilitate study of various
items within a patient. For example, lesions can be found within
the body as well as certain organs. Different slices can be
requested to facilitate study of these targets. From the data
acquired, the position of the lesions or organs can also be very
accurately determined using a Cartesian or polar coordinate system.
The above description of the MR scanner is simply for demonstrative
purposes and multiple alternative MR scanning systems can be
described herein.
[0093] Within some parts of a patient, it is critical to very
accurately place a surgical instrument. For example, in
neurosurgery, it is very critical to have instruments, such as
catheters or needles, placed very accurately within the cranium or
head of a patient. FIG. 2 shows a side view of a patient on which
trajectory guide 200 is being used. The trajectory guide 200
includes a base unit 210, a movable member 220, a locking member
230 and a guide stem 240. The base unit 210 is attached to the
skull of the patient. In the particular embodiment shown, the
attachment is made by way of bone screws. However, it is
contemplated, that there may be any number of ways to attach the
base 210 to the skull. For example, the base 210 could also be
threaded to screw into a burr hole 250. The flange could also be
added to the base 210 to attach the base to the skull.
[0094] The movable member 220 has a passage therein 222 which is
shown in FIG. 2 as dotted lines. The guide stem 240 also has an
elongated opening 242 therein. The opening 242 is also shown as
dotted lines in FIG. 2. The passage 242 in the guide stem 240 and
the opening 222 in the movable member or ball 220 form a line or a
trajectory 260 which intersects with a target 270 within the
patient. The guide stem 240 and movable member or ball 220 form the
first part of the trajectory 260. A surgical instrument or
observational tool can be inserted into the opening 242 of the
guide stem 240 and passed through the passage in the movable member
220 and then further inserted into the patient a selected distance
to the target 270. The opening 242 in the guide stem 240 and the
passage 222 in the movable member 220 guide a surgical instrument
along the trajectory 260 to the target 270. Of course, the movable
member 220 is locked into place by locking member 230 before a
surgical instrument 280 is placed through the opening 242 in the
guide member 240.
[0095] FIG. 3 shows an exploded isometric view of the trajectory
guide 200 with a guide member installed. As shown in FIG. 3, the
trajectory guide 200 is comprised of a base 210, a movable member
220, a locking member 230, and a guide member 240. The base 210
includes a cylindrical portion 212 and a flange 214. The flange 214
includes a plurality of countersunk screw openings 215, 216, and
217. The countersunk screw openings 215, 216, and 217 receive bone
screws which are screwed into the skull bone or the bone of a
patient. The cylindrical portion 212 fits withing the burr hole 250
in the patient. The base also includes a semi-spherical seat 218.
Although not shown in FIG. 3, there is an opening in the base 210
having a first end which terminates at the seat 218 and another end
which terminates at the bottom of the base 210.
[0096] As shown in FIG. 3, the movable member 220 is essentially a
spherical member or a ball. The spherical member or ball fits
within the seat 218. The spherical member or ball moves freely
within the seat 218. The ball-shaped movable member 220 also has an
opening therein 222. The opening passes through the ball shaped
movable member. One end of the opening may have a set of internal
threads therein, which can be used to receive mating threads which
are placed onto the guide stem or member 240 or positioning stem
(discussed with respect to FIG. 4).
[0097] The locking member 230 also has an opening therethrough. The
locking member 230 includes a cylindrical bottom portion 232 and a
flange 234. The opening through the locking member 230 has
sufficient space to allow movement of movable member 220 when the
locking member is in an unlocked or untightened position. Although
not shown in FIG. 4, the bottom of the cylindrical portion 232 of
the locking member 230 includes a set of internal threads. The set
of internal threads engage a set of external threads on the base
unit 210 (shown in FIG. 7b). As will be detailed later, when the
internal threads of the locking member 230 are engaged with the
threads on the base 210, a portion of the locking member engages
the movable member 220 to fix the movable member and the passage
222 therethrough at a fixed position.
[0098] A guide stem or guide member 240 is also shown in FIG. 3.
The guide stem has an elongated opening 242 therein. The elongated
opening passes through the length of the guide stem 240. One end of
the guide stem includes a set of external threads which engage the
internal threads of the spherical, movable member 220. When the
external threads of the guide stem 240 engage the internal threads
of the movable member 220, the opening 242 is substantially aligned
with the passage 222 in the movable member. The opening 242 and
passage 222 form the first part or guide for the trajectory 260 to
the target 270 within the patient. It should be noted that the
movable member 220 need not necessarily be a spherical element,
although the spherical shape allows the ball to have a universal
joint type swivel action which is preferred. It should also be
noted that the movable element 220 and the guide stem 240 can be
formed as one piece. This would eliminate the need for the threaded
end of the guide stem 240 and the threaded inner diameter 222 of
the movable member 220.
[0099] In addition, the locking member 230 can be formed in most
any shape. A flange 234 is useful in that it allows additional
leverage for tightening or loosening the locking member. Any shape
capable of being turned or placed into a locking position with
respect to the movable member 220 is acceptable.
[0100] Positioning Member
[0101] Now turning to FIG. 4, an exploded isometric view of the
trajectory guide 200 with a positioning member 400 is shown. Many
of the parts of the trajectory guide 200 shown in FIG. 4 are the
same as those shown in FIG. 3. In the interest of time, a
discussion of the common elements will not be repeated. Several of
the basic elements will be numbered for the purposes of this
discussion. The difference between FIGS. 3 and 4 is that the guide
stem or guide member 240 has been replaced with a positioning stem.
The positioning stem 400 includes an end 410 which carries threads
for engaging internal threads within the passage 222 in the movable
element 220. The positioning stem 400 also includes a first locator
420 and second locator 430. The first locator 420 includes a small
opening 422 located at one end of the positioning stem 400. The
small opening 422, which is shown in phantom in FIG. 4, is filled
with a fluid or a substance that can be seen by a scanning device
such as the MRI scanning device 100 described and shown in FIG. 1.
After a fluid or substance is inserted into the opening 422 the end
is sealed with a cap and adhesive. Similarly, the second locator
430 includes an opening 432 which contains a substance which is
readable by a scanner such as an MRI scanner shown in FIG. 1. As
shown in FIG. 4, the first locator 420 and the second locator 430
are coaxial with the axis of the cylinder formed by the positioning
stem 400. It is contemplated that a first locator 420 and a second
locator 430 could also be formed in an offset position from the
axis of the cylinder formed by the positioning stem 400.
[0102] Now turning to FIG. 17, an alternate of embodiment of the
positioning stem 1700 is shown. The positioning stem 1700 includes
a chamber 1710 which is substantially hollow and sealed at both
ends by end caps 1712 and 1714. A fluid, which is readable by
nuclear magnetic resonance imaging system, is housed or kept in the
chamber 1710 of the alternate embodiment positioning stem 1700.
Within the chamber 1710 is a first locator 1720 and a second
locator 1722. The first locator 1720 and the second locator 1722
may include a fluid doped with a different material which is
discernable from the majority of fluid within the chamber 1710 by a
nuclear magnetic resonance imaging system. The chamber 1710 with a
first doped fluid can be easily located and is used for rough
alignment of the positioning stem. The first locator 1720 and the
second locator 1722 are used to more precisely align the
positioning stem 1700 so that the opening 222 within the movable
member 220 is on a straight line trajectory with a target within
the patient. The positioning stem 1700 includes a shaft end 1730
which is adapted to fit within the opening 222 in the movable
member 220 of the trajectory guide. Alternatively, the first and
second locators 1720 and 1722 may consist of a solid material that
appears on the MR image only by virtue of its absence of MR
visibility.
[0103] FIG. 18 shows the image that will be shown on the display
180 of a nuclear magnetic resonance imaging system 100. The image
1800 comprises two rectangles which reflect the shape of the
chamber 1710. Each of the rectangles image 1800 has another image
1820 and 1822 therein. The image 1820 and the image 1822 can be
used to precisely align the positioning stem and the opening 222
within the movable element 220 of the trajectory guide, so that the
opening in the movable element forms a trajectory that intersects a
target, such as 270, within the human body. This particular
embodiment of the positioning stem 1700 is advantageous in that the
main body of fluid within the hollow cylinder 1710 is more easily
found and can be used for rough alignment.
[0104] The fluid filled openings could be replaced with small coils
which detect a radio frequency readable by the scanning mechanism
100. Other transducers could be used for other scanning systems.
The different transducers or elements would serve as the first
locator 420 and the second locator 430 in another scanning system.
For example, in frameless stereotaxy, infrared cameras are used to
locate various points in space. It is contemplated that the first
locator 420 could include at least one LED or light emitting diode
readable by an infrared camera. Similarly, at least one LED or
light emitting diode could be used for the second locator 430.
Generally multiple LEDs or light emitting diodes are arranged in an
array. Within the array, the LEDs or light emitting diodes are
positioned so that the LEDs are at least a few degrees apart such
that the infrared camera can discern a locational difference. In an
embodiment that uses LEDs or light emitting diodes as locators, the
LEDs must be positioned in view of the infrared camera.
[0105] The first locator 420 and the second locator 430 need not be
the same type of readable transducer unit. For example, in an MR
imaging system the first locator 420 could be an opening 422 filled
with an MR readable substance while the second locator 430 could be
a coil which detects and/or emits radio frequencies. Both would be
readable on an MR imaging system.
[0106] Movable Member
[0107] FIGS. 5a and 5b show the movable member which will now be
discussed in slightly more detail. FIGS. 5a and 5b show that the
movable member 220 is substantially spherical in shape. The movable
member 220 has an opening 222 therein. The opening 222 includes a
smaller diameter portion 223 and a larger diameter portion 224. The
inside surface of the larger portion 224 of opening 222 is threaded
as indicated by reference numeral 225. The larger diameter portion
224 and the threads 225 receive the external threaded portion of
either the positioning stem 400 or the guide stem 240. The smaller
diameter portion 223 of the opening 222 is of a sufficient diameter
to allow an instrument, such as a needle, probe, catheter,
endoscope, or electrode to pass through the opening. The movable
member 220 is made of a biocompatible material such as delrin.
[0108] FIGS. 6a and 6b show a side and top view of the base 210 of
the trajectory guide 200. The base 210 includes the cylindrical
portion 212 and the flange 214. The flange 214 includes countersunk
openings 215, 216, and 217 as well as the seat 218 which receives
the movable member 220. The seat 218 is part of an opening 600
which includes an internally threaded portion 610. The internally
threaded portion 610 is dimensioned so as to receive the threads of
either the positioning stem 400 or the guide stem 240.
[0109] Now turning to FIGS. 7a and 7b, the locking member of the
trajectory guide 200 will now be discussed. The locking member 230
includes the cylindrical portion 232 and a flange 234. The external
surface of the flange 232 is threaded to form a threaded external
surface 700. The threads associated with the externally threaded
surface 700 are dimensioned so as to engage the internally threaded
surface 600 of the base 210. The locking member 230 also includes
an opening 710 which passes through the locking member 230. The
locking member also has a locking surface 720. In this particular
embodiment, the locking surface 720 is flat so that it engages a
flat face on the movable member 220. The flanges 234 are extended
so that the threads of the threaded surface 700 can be easily
engaged with the internal threads 600 of the base 210. It is
contemplated that other geometric shapes could be used for the
locking member and that other locking surfaces could be
employed.
[0110] In operation, a patient undergoes a scan with an apparatus
such as an MRI or magnetic resonance imaging system 100 as part of
a normal diagnostic medical procedure. A scan can be used to locate
a particular organ within a patient or to locate lesions or any
other target 270 within the patient. It should be noted that
targets are not necessarily limited to being within the head of a
patient. There can also be other areas of a patient where it would
be critical to accurately place a surgical or observational tool.
In addition, it should also be noted that the patient need not
necessarily be human. -A patient may include any living animal.
Once a target is found and located using an MRI or other scanning
system, the base 210 of the trajectory guide 200 can be attached to
the patient. The base is affixed to the patient in an area near the
target 270. The computer 102 of the scanning device 100 is used to
determine the exact location of the target 270. The exact location
can be found in any type of coordinate system, although normally a
Cartesian coordinate system is used. Once the base 210 is attached
to the patient, the remaining portions of the trajectory guide 200
are attached to the base 210. In otherwords, the movable member
220, the locking guide, the locking member 230 and a positioning
stem 400 are added to form a complete trajectory guide 200.
[0111] The first locator 420 and the second locator 430 of the
positioning stem 400 are read by the scanning system 100 and a line
defined by the first locator 420 and the second locator 430 is
calculated by the computer 102. The calculated line corresponds to
the center line of the passage 222 and the opening 242 of the guide
stem. If the line aligns with the target 270, the locking member is
used to lock the movable member 220 into position. If the line does
not intersect the target 270, the positioning stem 400 is moved
until a line is formed by the first locator 420 and the second
locator 430 intersects the target 270. If the patient and the
positioning stem 400 can be easily reached by a surgeon during a
scanning operation, positioning stem 400 can be moved or readjusted
manually. If the patient is remote from the surgeon or cannot be
reached by the surgeon, a hydraulic or other actuator may be used
to move the positioning stem 400. Once such a line is formed the
locking member 230 is secured.
[0112] After fixing the position of the movable member 220, the
positioning stem 400 is removed, and the guide stem 240 is attached
to the movable member 220. Once the guide stem 240 is attached to
the movable member 220 the trajectory 260 is formed by the opening
242 and the passage 222. The guide is then positioned so that an
instrument or an observational tool may be placed through the guide
opening to intersect the target 270.
[0113] Remote Actuation and Control--First Embodiment
[0114] FIGS. 30 to 32 detail a mechanical remote actuation and
control device 3000. The mechanical remote actuation and control
device 3000 includes a first or actual trajectory guide 3001 which
is attached to a patient and a second trajectory guide 3002 that is
remote from the patient. The second trajectory guide 3002 is
sometimes referred to as the remote trajectory guide 3002. The
second trajectory guide 3002 is a duplicate of the first trajectory
guide 3001. The first trajectory guide 3001 and the second
trajectory guide 3002 each have the same look and feel. In this
way, the physician surgeon or technician using a remote actuation
control device 3000 only has to learn how one particular trajectory
guide, such as the first trajectory guide 3001 or the second
trajectory guide 3002, works rather than learning the look and feel
of both the actual trajectory guide 3001 and the second or remote
trajectory guide 3002.
[0115] Typically, first trajectory guide 3001 is attached to a
patient that is within a scanning environment 3020. The scanning
environment 3020 can be an MR imaging suite as described above or
can be a CT scanning environment as will be discussed in more
detail below or can be in any other scanning or imaging
environment. The second trajectory guide 3002 is outside the
scanning environment. Using the remote actuation control device
3000, a surgeon or physician can then manipulate the first
trajectory guide 3001 that is within the scanning environment by
manipulating the second trajectory guide 3002 that is outside the
scanning environment. In many cases, the first trajectory guide
3001 is not accessible while the patient and the first trajectory
guide 3001 are located within the scanning environment. Being able
to manipulate the first trajectory guide 3001 by moving the second
trajectory guide 3002 positioned outside the scanning environment
allows the physician surgeon to make necessary adjustments to the
first trajectory guide 3001 without having to remove the patient
from the scanning environment. This saves time for the surgical
procedure as moving a patient in and out of a scanning environment
takes a large amount of time. In addition, since the procedure is
shortened, the exposure of the patient to any detrimental aspects
of the scanning environment is also lessened. In addition, the
physician surgeon is also not exposed to the scanning environment.
As an overview, MR and x-ray compatible cables 3030, 3032 and 3034
are used to translate the motion at the second trajectory guide
3002 or remote trajectory guide to the first trajectory guide 3001
which is attached or otherwise associated with the patient. The
term cable means any type of strong wires or other filaments that
can translate the motions of the second trajectory guide 3002 to
the first trajectory guide 3001. -The filaments or wires used in
the device are made of materials which are compatible with the
scanning environment. For example, if the remote actuation control
device 3000 is used in an MR environment, the material for the
cables must be made of a non-magnetic material as strong magnetic
fields are used in an MR environment. It should be noted that FIG.
30 also shows the surgical instrument advancement assembly 3700
which will be more fully discussed below in the description of FIG.
37.
[0116] Now turning to FIG. 31, the details of the first trajectory
guide 3001 and the second trajectory guide 3002 will be discussed.
The first trajectory guide 3001 and the second trajectory guide
3002 are identical to one another so rather than describe the same
item twice for the sake of saving space, only one will be described
in detail. FIG. 31 is a perspective view of one of the first or
second trajectory guides, 3001 or 3002, used as part of the
mechanical remotely actuated trajectory guide mechanism shown in
FIG. 30. The trajectory guide 3001 includes a base 3200, a movable
element also called a guide stem 3300, a locking member 3400 and a
guide stem cable mount 3500. The guide stem 3300 has a ball or
rounded end 3310 which is received in an opening 3210 in the base
3200. The locking member 3400 fits over the ball end 3310 of the
guide stem 3300. The locking member has an outside threaded portion
3410 which engages an inside thread 3212 in the opening 3210 of the
base 3200. The ball end 3310 of the guide stem 3300 moves or
rotates freely within the opening 3210 of the base 3200 until the
locking member 3400 is screwed into engagement with the ball end
3310 and the base 3200. The guide stem cable mount 3500 fits over
the guide stem 3300 and sits atop the locking member 3400. The base
3200 has a plurality of recesses 3220, 3222, and 3224 which
accommodate the cables 3030, 3032, and 3034. When the locking
member 3400 is engaged with the base 3200 the recesses are covered
in part by the locking member 3400 to form routing paths for the
cables 3030, 3032, and 3034.
[0117] FIG. 32 is a top view of the base 3200 of the trajectory
guide 3001 used as part of the mechanical remotely actuated
trajectory guide mechanism 3000. As shown in FIG. 32, the base 3200
includes an opening 3210. The opening 3210 does not pass completely
though the base 3200 but is rather a pocket for receiving the ball
end 3310 of the guide stem 3300. The bottom of the opening 3210 is
chamfered so that the ball end 3310 contacts the opening on a line
about the ball end. The opening 3210 also has an inside threaded
portion shown by the dotted lines 3212. In addition, the base 3200
includes the recesses 3220, 3222, and 3224 for receiving cables.
Three recesses are shown. It should be understood that additional
recesses could be formed if the particular design required more
cables. In addition, it should also be understood that there could
be a lesser number of recesses if there were less numbers of cables
were used. It is also conceivable that the recesses could be
eliminated altogether and provided elsewhere other than on the base
3200. The base 3200 also includes openings 3230, 3232, and 3234
which could receive mounting screws or could be used to mount the
base 3200 to any other type of mount on the body of a patient.
[0118] FIG. 33 is a side view of the guide stem 3300 of the
trajectory guide 3001 used as part of the mechanical remotely
actuated trajectory guide mechanism 3000. The guide stem 3300 has a
ball shaped end 3310 and free end 3320. Near the free end 3320 is a
detente or groove 3330. The guide stem 3300 has an opening 3340
therein which runs the length of the guide stem 3300. The opening
3340 is dimensioned so that a surgical instrument can be received
and passed through the guide stem 3300. The opening 3340 is
positioned so that it is coaxial with the trajectory to the target
270 within the patient. The guide stem 3300 of the trajectory guide
3001 is the moveable member which is moved so that the opening is
coaxial or on target with the target 270 within the patient.
[0119] FIG. 34 is a top view of the locking member 3400 of the
trajectory guide 3001 used as part of the mechanical remotely
actuated trajectory guide mechanism 3000. The locking member has an
opening 3420 therein which passes all the way through the locking
member 3400. The opening 3420 is dimensioned to allow motion of the
guide stem 3300 so that the guide stem3300 can be repositioned to
align the opening 3340 therein with the trajectory to the target
within the patient. The opening is the inside of a tubular portion
3422 which has an outside threaded portion 3410. The locking member
3400 includes a disk shaped portion 3450 having a larger diameter
than the tubular portion 3422. The larger diameter of the disk
shaped portion 3450 makes it easier for an surgeon or technician to
tighten the locking member 3400. The outer diameter of the disk
shaped portion may be provided with frictional edge, such as a
knurled edge, to further enhance the ability to tighten the locking
member 3400 with respect to the base 3200. The disk shaped portion
3450 also has several large openings 3451, 3452, and 3453 therein.
The openings 3451, 3452, and 3453 provide clearance for the cables
3030, 3032 and 3034 which pass therethrough and are attached to the
guide stem cable mount 3500 which rests or sits adjacent the
locking member 3400.
[0120] FIG. 35 is a top view of the guide stem cable mount 3500 of
the trajectory guide 3001 used as part of the mechanical remotely
actuated trajectory guide mechanism 3000. The guide stem cable
mount 3500 includes a central opening 3510 which is dimensioned to
fit over the guide stem 3300 with an adequate clearance to allow
the guide stem 3300 to pass but with a small enough clearance to
exert a force on the guide stem 3300 when cables 3030, 3032 and
3034 are placed in tension by moving the other guide stem. The
guide stem cable mount 3500 includes several other openings 3520,
3522, and 3524 for receiving the ends of the cables 3030, 3032 and
3034. Each opening 3520, 3522, and 3524 is spaced a set distance
from the center of the guide stem cable mount 3500. Each opening
includes a larger diameter portion for receiving holding the end of
the cable. Each cable 3030, 3032 and 3034 has an enlarged end for
fitting within the openings 3520, 3522, and 3524.
[0121] FIG. 36 is an exploded perspective view of the mechanical
remotely actuated trajectory guide mechanism 3000 with the guide
spacing sleeve 3600 for spacing the surgical instrument advance
mechanism 3700 up the guide stem 3300. The cables, filaments or
wires 3030, 3032 and 3034 travel within cable sleeves 3630, 3632
and 3634. Each of the cable sleeves 3630, 3632 and 3634 has a first
turned end that fits within the recesses 3220, 3222, 3224 of the
first base 3200 of the first trajectory guide 3001, and a second
turned end that fits within the recesses 3220, 3222, 3224 of the
second base 3200 of the second trajectory guide 3002. After the
guide stem 3300 of the first trajectory guide 3001 is positioned
using the guide stem 3300 of the second trajectory guide 3002 so
that the opening 3340 is coaxial with the trajectory to the target
in the patient, the patient is removed from the scanning
environment 3020. While outside the scanning environment, the
locking member 3400 is tightened to affix the guide member 3300 in
place. The next step while the patient is outside the scanning
environment 3020, is to add the surgical instrument and the
surgical instrument advance mechanism 3700 (discussed in detail in
FIG. 37). Initially, several spacers are added for the proper
placement of the surgical instrument advance mechanism 3700. The
surgical instrument advance mechanism has a portion that locks or
snaps onto the detente or groove 3320 in the guide stem 3300. A
first guide marker cap 3602 is placed onto the locking member 3400.
The guide spacing sleeve 3600 is then placed onto the first guide
marker cap 3602 and over the guide stem 3300. The final spacer is a
second guide marker cap 3604. Once these spacers are in place the
surgical instrument advance mechanism 3700 is placed onto the guide
stem and the surgical instrument. The surgical instrument, the
trajectory guide 3001, and a portion of the surgical instrument
advance mechanism 3700 are then placed back into the scanning
environment 3020.
[0122] FIG. 37 is an exploded perspective view of the surgical
instrument advance mechanism 3700 for use with the mechanical
remotely actuated trajectory guide mechanism 3000. The surgical
instrument advance mechanism 3700 includes an advancement guide
mount 3710 which locks onto the detent or groove 3320 in the guide
stem 3300, an instrument guide mount 3720, an instrument lock
mechanism 3730, an advancement sleeve 3740, a cable 3750 and a
mechanism for moving the cable 3760.
[0123] The instrument lock mechanism 3730 includes a top instrument
lock 3732, a bottom instrument lock 3734, and a lock tube 3736. The
lock tube 3736 is placed between the top instrument lock 3732 and
the bottom instrument lock 3734. The exterior of the lock tube 3736
is surrounded and constrained by the top instrument lock 3732 and
the bottom instrument lock 3734. The top instrument lock 3732 and
the bottom instrument lock 3734 threadably engage one another. In
operation, the instrument lock mechanism 3730 is placed over the
instrument. The top instrument lock 3732 and the bottom instrument
lock 3734 are moved toward each other by threading one of either
the top instrument lock 3732 or the bottom instrument lock 3734
into the other of the top instrument lock 3732 and the bottom
instrument lock 3734. The lock tube 3736 is elastomeric so as the
top and bottom are brought closer together, the elastomeric tube
bulges and captures or locks onto the surgical instrument. This
also locks the surgical instrument into an opening 3722 in the
instrument guide mount 3720.
[0124] The outer advancement sleeve 3740 is attached to the
instrument guide mount 3720. The instrument guide mount has a
second opening 3724 therein which corresponds to the opening in the
advancement sleeve 3740. There is also an inner advancement sleeve
3742 which is attached to the advancement guide mount 3710 which
locks onto the detent or groove 3320 in the guide stem 3300. The
inner advancement sleeve 3742 fits within the outer advancement
sleeve 3740. The cable 3750 is attached to one end of the inner
advancement sleeve 3742. Pulling or pushing the filament or the
cable 3750 allows the inner sleeve 3742 to move with respect to the
outer advancement sleeve 3740.
[0125] The advancement guide mount 3710 includes an advancement
lock 3712 and a locking pin 3714. The advancement lock 3712 has an
end which fits into the detent or groove 3320 in the guide stem
3300. The locking pin 3714 keeps the advancement lock 3712 in
place. After the advancement guide mount 3710 is locked into place
it does not move with respect to the guide stem 3300.
[0126] The mechanism for moving the cable 3760 includes an inner
sleeve 3762, an outer sleeve 3764, a syringe ring 3766, and a thumb
ring 3768. The cable is attached to one end of the inner sleeve
3762. By moving the thumb ring 3768 with respect to the syringe
ring 3766, the inner sleeve 3762 moves with respect to the outer
sleeve 3762 and in turn moves the cable 3750 on the other end.
Moving the thumb ring 3768 away from the syringe ring 3766 causes
the instrument guide mount 3720 to move toward the advancement
guide mount 3710. Since the surgical instrument is attached to the
instrument guide mount 3720, the surgical instrument is advanced
into the patient. When the thumb ring 3768 is moved toward the
syringe ring 3766, the surgical instrument is withdrawn from the
patient body. The the thumb ring 3768 and the syringe ring 3766 are
positioned outside the scanning environment 3020 so that the
surgeon or technician can control the advancement or withdrawal of
the instrument into and out of the trajectory guide in the scanning
environment. In the first or actual trajectory guide 3001 the outer
advancement sleeve 3740 includes markings thereon indicative of
units of measure such as centimeters, millimeters, or inches. On
the second trajectory guide 3002 the the outer sleeve 3762 includes
markings thereon indicative of units of measure such as
centimeters, millimeters, or inches. In this way the surgeon can
advance the surgical instrument from outside the environment by
moving the thumb ring 3768 toward the syringe ring 3766 a certain
number of units of measure to get the surgical instrument
relatively close to the target. The surgeon can advance the
instrument to the target while watching the surgical instrument
from outside the environment using an available scanning apparatus.
The needle can be advanced to just the exact position of the body
organ.
[0127] It should be noted that this advancement mechanism can be
adapted for use with any base or for use with any trajectory guide.
For example, a hydraulic mechanism for moving the guide stem 3300
from side to side, which is discussed below, could be used with
this advancement mechanism. In addition, this advancement mechanism
can be used with any base or on any variation of the trajectory
guide.
[0128] Hydraulic Actuator for Remote Actuation and Control--Second
Embodiment
[0129] Now turning to FIG. 10, a hydraulic actuator 1000 is shown.
The hydraulic actuator 1000 includes a cylinder 1010, a plunger
1020, a hydraulic line 1030 and an attachment mechanism 1040. The
plunger 1020 has a seal 1022 located on one end of the plunger. The
seal 1022 prevents the flow of liquid from the cylinder to a
position past the plunger 1020. When fluid is forced or fluid
pressure is placed on the fluid in the hydraulic line 1030, the
fluid passes into the cylinder 1010. When more fluid is passed into
the cylinder 1010, the plunger 1020 moves in a direction to allow
for an increased volume between the seal 1022 and the bottom of the
cylinder 1010. If the fluid in the hydraulic line 1030 is drawn
away from the cylinder, the plunger and the end with the seal 1022
move closer to the bottom of the cylinder 1010 so that a smaller
volume is formed within the cylinder. As a result, the plunger 1020
moves in response to fluid being pressed into the cylinder 1010 or
being removed from the cylinder 1010. The attachment mechanism 1040
is used to attach the plunger to the guide stem or other surgical
instrument that needs to be moved or adjusted. The attachment
mechanism 1040 is attached to the plunger 1020. In this instance,
the attachment mechanism 1040 is a hoop which can be used to
encircle the guide stem 240. Other attachment mechanisms could also
be used such as hooks or clamps. The hoop arrangement shown allows
the guide stem to be moved or adjusted when the plunger 1020 moves
in and out of the cylinder 1010. All of the pieces of the hydraulic
actuator 1000 can be made of a material that is not affected by a
magnetic field. A hydraulic cylinder such as the one shown can then
be used in an MRI scanning environment. It is contemplated that
other actuators could be formed and made from non-magnetic parts so
they too could perform in an MRI environment.
[0130] FIG. 11 is a top view of a guide stem 240 of a trajectory
guide 100 which has two hydraulic actuators 1000 and 1000 attached
thereto. Hydraulic actuators 1000 and 1000' one used to move the
guide stem when it is remote from the surgeon. The attachment
mechanism 1040 from the actuator 1000 passes around the guide stem
of the trajectory guide 100. Similarly, the attachment mechanism
1040' is also attached around the guide stem 240. The plunger 1020
and the plunger 1020' are at approximately 90.degree. with respect
to each other. Each of the plungers can then move the guide stem
240 to adjust its trajectory toward a target within the human body.
Each of the hydraulic cylinders 1010 and 1010' is attached or
affixed to a solid base 1100. As shown in FIG. 11, both of the
cylinders 1010 and 1010' are attached to a base 1100 which is shown
schematically. Any number of arrangements can be used to attach the
cylinders to a base 1100. For example, it is contemplated that the
base 1100 could be the base 210 of the trajectory guide 100. It is
also contemplated that the base 1100 could be a ring configuration
which holds the cylinders 1010 and 1010' solid with respect to the
guide stem 240.
[0131] In operation, the hydraulic cylinders 1000 and 1000' are
attached to the guide stem 240 by the attachment mechanism 1040 and
the attachment mechanism 1040'. The guide stem 240 can then be
moved by moving either plunger 1020 or 1020'. By moving these
plungers, the attitude or the trajectory of the guide stem can be
changed before the locking member is used to lock the movable
member into position. Once the hydraulic cylinders 1000 and 1000'
move the guide stem 240 to a position in line with the target, the
patient is moved to a point where the locking member can be used to
immobilize the movable member. The hydraulic system described thus
far is used to position the guide stem so that a trajectory may be
selected.
[0132] Remote Actuation and Control--Second Preferred
Embodiment
[0133] FIG. 19 shows a remotely controlled actuator mechanism which
is used to control the movement of the movable member 220
associated with the trajectory guide system 200. To remotely
control the movable member 220 there is provided a duplicate or
remote movable member 1920 having an opening 1922 therein. The
movable member 220 has a series of subactuators 1950, 1952, 1954,
and 1956 which are attached to the movable member 220 and have one
end embedded in a base of a trajectory guide. The base 210 shown in
FIG. 19 is schematically depicted as a ring to which the
subactuators 1950, 1952, 1954, and 1956 are attached. Attached to
each subactuator is a hydraulic line. Attached to subactuator 1950
is hydraulic line 1960, attached to subactuator 1952 is hydraulic
line 1962, attached to subactuator 1954 is hydraulic line 1964, and
attached to subactuator 1956 is hydraulic line 1966. The
subactuators 1950, 1952, 1954, and 1956 are positioned so that the
movable member 220 can be adjusted in or about at least two
orthogonal axes. It should be noted, that only two subactuators are
really required to produce movement about two orthogonal axes. Four
are shown in FIG. 19. Four are used since many of the movements are
very small and precise. Therefore it is advantageous to have one
subactuator offset another subactuator to effectuate the precise,
small motions of the movable member 220. The movable member 220 is
associated with the patient.
[0134] Attached to the movable member 220 and the base 210 is a
duplicate or remote actuator 1970. The remote actuator 1970
includes movable member 1920 and a ring 1910 or base in which the
movable member 1920 is able to rotate. Attached to the movable
member 1920 are a series of four subactuators 1980, 1982, 1984, and
1986. A hydraulic line 1990 is attached to subactuator 1980.
Similarly, a hydraulic line 1992 is attached to subactuator 1982,
hydraulic line 1994 is attached to subactuator 1984 and hydraulic
line 1996 is attached to subactuator 1986. The hydraulic lines
1960, 1962, 1964, and 1966 are attached to an intermediary actuator
device 2000. Also attached to the intermediary actuator device 2000
are hydraulic lines 1990, 1992, 1994, and 1996. Within the
intermediary actuator device 2000 the hydraulic line associated
with a subactuator on a patient is attached to an opposite
hydraulic subactuator on the remote 1970. In other words, the
hydraulic line 1960 associated with subactuator 1950 is attached to
hydraulic line 1994 associated with subactuator 1984. Similarly,
hydraulic line 1964 is attached to hydraulic 1990, and hydraulic
line 1966 is attached to hydraulic line 1992. By attaching the
hydraulic lines to subactuators that are opposite on the remote
when compared to the movable member 220, movement of the movable
member 1920 mirrors movement of the movable member 220. In other
words there is a direct relation between moving movable member 1920
on the remote device and moving the movable member 220 associated
with the patient.
[0135] FIG. 20 shows the intermediary actuator device 2000. The
intermediary actuator device 2000 includes a set of intermediate
double hydraulic rams which are used to interconnect the movable
member 1920 and the movable member 220. As shown in FIG. 20,
hydraulic ram 2010 is removably attached to another identical
hydraulic ram 2010', with identical subunits 2012' and 2014'. Four
hydraulic rams 2010, 2020, 2030, and 2040 are thus removably
attached to identical mirror-related hydraulic rams 2010', 2020',
2030', and 2040', hence four double hydraulic rams. One such double
hydraulic ram will be described. The remaining double hydraulic
rams are the same. Intermediary actuator device 2000, including
four double hydraulic rams, each of which comprises dual,
mirror-related hydraulic rams, includes hydraulic rams 2010 and
2010' that include shafts 2012 and 2012' respectively. On each end
of shafts 2012 and 2012' are seals 2014 and 2014' respectively. The
seals 2014 and 2014' can also be thought of as plungers. The seals
2014 and 2104' keep hydraulic fluid on the away from the shafts
2012 and 2012' and outside of the plungers, 2014 and 2014'. For
example, the hydraulic rams 2010 and 2010' have no or are devoid of
fluid in the area adjacent to cylinders 2012 and 2012'. The seals
2014 and 2014' maintain the fluid on the outside of the cylinders
2012 and 2012'. Fluid is depicted by the gray areas on the outside
of the seals 2014 and 2014'.
[0136] In operation, when fluid is forced toward the hydraulic ram
2010 in the hydraulic line 1992 due to a movement of microactuator
1982 (FIG. 19), the cylinders 2012' and 2012 and the seals 2014'
and 2014 move in the direction of the fluid pressure. In other
words, when the fluid is moved in the direction shown by the arrow
adjacent hydraulic line 1992, additional fluid is forced into the
hydraulic ram 2010' near the seal 2014' to which the hydraulic line
1992 is added and this forces the cylinders 2012' and 2012 and the
seals 2014' and 2014 to move in the same direction as the arrow.
The other double hydraulic rams 2020/2020', 2030/2030', and
2040/2040' work in the same manner.
[0137] Advantageously, the intermediary actuator device 2000
provides a break in the various hydraulic lines so that the movable
member 220 and base 210 are disposable, while the movable member
1920 and the base 1910 which are used to control the trajectory
guide associated with the patient, can be reused. The intermediary
actuator device 2000 is also part of the reusable portion. In other
words, a new sterile movable member 220 and base 210 as well as
sterile hydraulic line 1960, 1962, 1964, and 1966, and hydraulic
rams 2010, 2020, 2030, and 2040 can be used on a patient. After the
use, the movable member 220 and base 210 and the hydraulic lines
1960, 1962, 1964, and 1966 can be discarded. A new assembly
including movable member 220 and base 210 and the associated
hydraulic lines and hydraulic rams can then be attached to the
appropriate mirror-related hydraulic rams 2010', 2020', 2030', and
2040' of the intermediary actuator device 2000 for the next
use.
[0138] Of course it is not necessary that hydraulics be used. A
small mechanical device can also work equally well. In such a
design, hydraulics would be replaced by wires or other filaments
that would translate the motion at the remote end to the device in
are associated with the patient. An MR-compatible deflection device
could also be used. The deflection device is a laminated composite
material including at least one piezoelectric layer.
[0139] Now turning to FIGS. 12, 13 and 14, a hydraulic system for
introduction or insertion of a surgical instrument through the
opening 242 in the guide stem 240 and through the opening 222 in
the movable member 220 will now be discussed.
[0140] FIG. 12 shows a clamp 1200 which is used to clamp onto one
of either the surgical instrument 1400 or the guide means 240. In
FIG. 14, clamp 1200 is attached to the surgical instrument 1400.
The clamp 1200 includes a first wing 1210 and a second wing 1220.
The first wing 1210 and the second wing 1220 have an arcuate shape
that conforms with either the surgical instrument 1400 or the
outside body of the guide means 240 The wings 1210 and 1220 are
spring loaded such that the wings 1210 and 1220 tend to urge toward
each other. One wing 1210 includes a C-shaped holder 1212 and a
P-shaped tab 1214. The C-shaped holder 1212 holds a portion of a
plunger 1020 of a hydraulic actuator 1000. The tab 1214 provides an
end stop for the plunger 1220. The C-shaped holder 1212 also serves
to limit the range of motion of the end of the plunger 1220. The
end of the plunger has a disk-shaped end 1025.
[0141] Now turning to FIG. 13, there is shown a second clamp 1300.
The second clamp 1300 includes a first wing 1310 and a second wing
1320. The first wing 1310 and the second wing 1320 are assembled
such that the wings urge toward one another. The shape of the wings
1310 and 1320 conform the clamp to the outer body of the guide
means 240. The clamp 1300 also includes a holder 1312 which is used
to hold the cylindrical body 1010 of the hydraulic cylinder
1000.
[0142] In operation, the hydraulic system for inserting or
introducing a surgical instrument 1400 into the trajectory guide
100 is used as described below. Clamp 1200 is applied to one of
either the surgical instrument 1400 or the guide means 240. The
other clamp 1300 is applied to the other of the surgical instrument
or the guide means 240. As shown in FIG. 14, the clamp 1200 is
applied to the surgical instrument 1400 while the clamp 1300 is
applied to the guide means 240 of the trajectory guide 100. It
should be noted that the clamps 1200 and 1300 are made of a
lightweight material and furthermore are made of a material that
can be used in an MR or magnetic environment. Once the clamps are
put in place, a hydraulic cylinder is attached to the holder 1212
of clamp 1200 and to the holder 1312 of clamp 1300. The holder 1212
grips or holds the plunger 1220 while the holder 1312 holds the
cylinder 1010 of the hydraulic actuator 1000. Once the clamps 1200
and 1300 have been placed and once the hydraulic actuator 1000 has
been placed onto the clamps, fluid can be passed into the hydraulic
cylinder 1010 or removed from the cylinder 1010 to move the clamps
1200 and 1300 with respect to one another. As shown in FIG. 14,
fluid would be removed from the cylinder 1010 via hydraulic line
1030 which would draw the clamp 1200 attached to the surgical
instrument 1400 toward the clamp 1300 on the guide stem 240. This
would result in an insertion of the surgical instrument 1400 into
the guide means and into the body of a patient. It should be noted
that the clamps must be lightweight so as not to produce an
excessive torque on the guide means 240 or the surgical instrument
1400. If too large a torque is placed on the guide means or the
surgical instrument 1400, the guide means may be repositioned out
of alignment due to torque placed on the guide stem 240 or the
surgical instrument 1400. In addition, it should be noted that it
is not necessary to use clamps 1200 and 1300. The holders 1212 and
1312 as well as the tab 1214 could be formed integral with the
surgical instrument 1400 and the guide stem 240. It is also
contemplated that a pair of clamps could be used to prevent a
torque in a sideways mode or bending mode. In other words, if two
hydraulic actuators 1000 were used side by side, the surgical
instrument 1400 would be less likely to bend with respect to the
guide stein 240.
[0143] In an actual operation using the hydraulically controlled
guide, the position of the tip of the surgical instrument with
respect to the target is monitored or tracked in real time using
fast MR imaging techniques, so-called MR fluoroscopy. The position
of the plunger and therefore the surgical instrument can be
controlled through a precision fluid pump in a remote location
inside or outside of the MR magnet. This controlling mechanism can
also be a manual control 1420, as shown in FIG. 14, or may be
interfaced to a computer that may also control the advancement of
withdrawal of the hydraulic assembly can be bi-directional for the
purpose of both insertion and extraction of a surgical instrument
within a targeted tissue in the MR imaging volume. It should be
noted that a manual controller may include one or more hydraulic
actuators. In other words, one may move small amounts of hydraulic
fluid for fine adjustment while the other may move large amounts of
hydraulic fluid for course adjustment
[0144] It should be noted that two embodiments of remote actuation
of trajectory guides have been discussed. This invention covers
many other types of remote actuation which could be substituted for
either of the two embodiments discussed so far. In other words,
variations could be made to the two remote actuation devices
discussed so far that would be within the scope of this
invention.
[0145] Stage
[0146] The base 210 of the trajectory guide 200 can also be fitted
with a stage 800 as is shown in FIG. 8. The stage 800 is used to
move the guide opening within a plane that intersects the center
line of the trajectory line 260 defined by the opening 242 in the
guide member or stem 240 and the opening 222 in the movable member
220. FIG. 8 shows an exploded view of a stage 800 for attachment to
the base 210 of the trajectory guide (shown in FIG. 2). The stage
800 includes a suspension tube 810, a first or lower suspended
platform 820, a middle or second suspended platform 830 and an
upper or third suspended platform 840. The suspension tube 810
includes an outside thread which mates with the inner thread of the
base 210. The outside thread is located near one end 812 of the
suspension tube. On the other end of the suspension tube is another
outside threaded portion 814 which mates with inside threads formed
in the first or lower suspended platform 820. The suspension tube
810 has a flanged body which allows the movable member and attached
guide stem 240 to have freedom of motion within the suspension tube
810. The first suspended platform 820 is threadably attached to the
threaded end 814 of the suspension tube 810. The first suspended
platform includes geared areas 822 and 824. The geared areas 822
and 824 mesh with geared areas 832 and 834 of the second or middle
suspended platform 830. The second or middle suspended platform 830
is attached to the first or lower suspended platform 820 via the
geared areas 822, 824, 832 and 834. The result is that the middle
or second suspended platform is able to move with respect to the
first suspended platform 820 in a plane that includes the geared
areas 822, 824, 832 and 834. The second suspended or middle
platform 830 also includes geared areas 836 and 838 which enmesh
with geared areas 846 and 848 of the third or top suspended
platform 840. The geared areas 836, 838, 846 and 848 allow the
third suspended platform 840 to move with respect to the second
suspended platform 830. The movement of the third suspended
platform 840 with respect to the first suspended platform 830 is
transverse in a direction transverse to the movement of the second
suspended platform 830 with respect to the first suspended platform
820. The stage is useful in allowing for slight adjustments when
using the trajectory guide means 100. Sometimes when the trajectory
guide means is used, the instrument 1400 is placed at the target
within the body only to discover either that the target has shifted
slightly due to tissue changes, such as edema or swelling, or that
the anatomic target selected from the MR or other images is not, in
fact, the physiological target. In such situations, the trajectory
may be proper, however, it is linearly displaced slightly. By
moving the trajectory guide means in a linear fashion using the
stage 800, the trajectory is maintained. A parallel trajectory is
thus formed so that the surgical instrument can be re-inserted into
the human body and hit a target. There are numerous types of
gearing mechanisms that can enable the stage to operate, with
linear, curvilinear or other movements, to reposition the
trajectory in a parallel fashion.
[0147] FIG. 9 shows a cross sectional view of a movable element 920
that has a ball end 910 and a guide stem end 930. The movable
element 920 fits within the base 210 and locking member 230. As
shown, the movable element 920 has a passageway 922 therein which
traverses the length of the movable element 920. FIG. 9 also shows
a positioning stem 400. The positioning stem 400 is dimensioned so
that it fits snugly within thepassageway922. The positioning stem
includes the first locator 420 and the second locator:430 but has
no threaded end. In order to correctly position the movable element
920, the positioning stem 400 is placed into the passageway 922.
The movable element 920 with the positioning stem 400 is moved
until the computer 102 determines that the line formed by the first
locator 420 and the second locator 430 align with the target 270.
Once alignment is achieved, the locking member 230 is used to lock
the movable element 920 into place. Once locked, the positioning
stem 400 is removed. Passageway 922 then corresponds or is
collinear with the trajectory 260 to the target 270 within the
patient.
[0148] Computer Control
[0149] The remote actuators can be controlled by a computer program
that, once calibrated, can be used to perform the alignment, and
even the introduction of a device through the guiding stem. Several
methodologies for enabling this are available. Using the MR imaging
coordinates of a target, and the MR imaging coordinates of the two
or more micro coils on the alignment or guiding stem, a computer
program can be written to direct the remotely actuated trajectory
guide to align with the target. One essential component of such a
software program is the ability of the system to accurately and
efficiently measure both MR position on the images and physical
position in the bore of the MR scanner. Various linear
transformations are required to correctly reference all positional
points of reference and achieve precise spatial registration. In
addition, geometric distortions inherent in the MR images need to
be quantified and corrected.
[0150] FIG. 21 shows a flow-chart of computer software used to
implement computer control of the alignment of the opening 222
within the movable member 220 with a selected target 270 within the
body. The first step is to find the position of the selected target
within the patient, as depicted by reference numeral 2110. The
position of the target 270 within the patient may be in a
coordinate system specific to the nuclear magnetic resonance system
and may have to be converted to another coordinate system. For
example, a coordinate system associated with a particular nuclear
magnetic resonance imaging system may have to be converted into
polar coordinates or into Cartesian coordinates with an "x", "y"
and "z." The next step is to find the position of one end of the
passageway with respect to the first or second locator which is
closest to the selected target, as denoted by reference number
2112. Many times the first or second locator will be associated
with or co-linear with one end of the opening 222 in the movable
member 220. At other times, the first or second locator will be
offset from the opening. Therefore, the position of the first or
second locator will have to be mathematically moved or corrected so
that it corresponds to the position of one end at the opening 222
and the movable member 220. The next step is to determine the
formula for a line defined by the selected target within the
patient and the end of the opening 222 and the movable member 220.
Once the formula of the line is known and the distance between the
first locator and second locator is known, the exact position of
the first or second locator most distant from the selected target
can be calculated. If the most distant first or second locator is
offset from the opening or a line co-linear with the passageway
through the movable member, this too can be mathematically
corrected for. The next step is to move the movable member such
that the second locator is in the calculated or determined
position, as depicted by reference numeral 2116. After the second
locator is in its determined position, the system checks whether
the opening is aligned with the target, as shown by the decision
box carrying the reference numeral 2118. If the passageway is not
aligned with the target, the movable member is repositioned, or the
step depicted by reference numeral 2112 is repeated and steps 2114
and 2116 are repeated. If the passageway is aligned with the
target, the program ends, as depicted by reference numeral 2120.
After the adjustment of the movable member 220 is complete, a clamp
or other means is used to firmly affix the movable member so that a
surgical instrument can be passed through the opening 222 in the
movable member.
[0151] Base With RF Coil
[0152] FIG. 15 shows an attachment 1500 to the base. The attachment
is flat, may be rigid or flexible, may be round or other geometric
or non-geometric shape. The attachment is designed to be screwed
into the base much like the locking component. The attachment 1500
has a threaded end 1510 which engages the base member 210. Within
the attachment 1500 is a radio frequency coil 1520 for imaging the
subjacent tissues by using an MR scanner. Leads 1522 and 1524 from
the coil 1520 are attached to the MR scanning system. In the
figure, the coil 1520 is circular, but it is not limited to that
design. There are numerous different coil designs that could be
used to enable the detection of signals from the subjacent tissues.
Not shown in the figures are the typical preamplifier and other
electrical components required to enable the coil 1520 to function.
In one embodiment, these components could be designed on a silicon
chip such that they are quite small and only two wires would need
to exit the attachment for connection to the MR scanner. In another
embodiment, the electrical components could be physically included
within the attachment in a more traditional manner. In either
embodiment, both imaging and spectroscopy of the subjacent tissue
could be enabled in order to monitor the deliver of a therapy, such
as a drug or a thermal therapy. In addition, the coil or coils
included in the attachment could function in conjunction with a
coil or coils on a delivery device implanted in the subjacent
tissue as described above, when using the guide stem and movable
member.
[0153] Turning to FIG. 16, a cap 1600 with a plug 1610 may be used
to seal the base 210 in the event that it is desirable to leave the
base 210 in place. Typically, the cap 1600 would include a plug
1610, so as to fill the space of the surgical opening to prevent
escape of tissues or bodily fluids. The cap 1600 and plug 1610 can
be attached to the base by any number of means, such as a threaded
connection or force fit connection. It is also envisioned that the
cap and plug could be used in conjunction with an implantable
medical device, such as a drug delivery device, in which case the
cap 1600 and plug 1610 might include a reservoir and pump
mechanism. In another embodiment, the cap 1600 and plug 1610 might
serve as a connector to the drainage tubing of a cerebrospinal
fluid shunt, in the case where the trajectory guide were used to
enable the placement of a shunt catheter into the cerebral
ventricles.
[0154] Small Incision Procedure
[0155] Currently, many surgical procedures are now performed
through a twist drill hole of approximately 2 mm. This is much
smaller than the burr hole previously discussed above. If a 2 mm
hole is used in a surgical procedure there is no requirement for a
suture at the end of a procedure. A drill hole of this small size
can be made with a minor incision or scalp or upper body area and
with minimal trauma. Many times the small hole approach is used
when performing biopsies on areas that present a relatively large
target within the patient. In other words, the use of a 2 mm hole
is typically used in applications where the target is relatively
large. A fixation device is attached to a therapy table. The
fixation device may include a flexible snake which are easily
repositioned by hand or by remote control. Once a remote button is
released, a snake retains its last position.
[0156] Initially as is shown in FIG. 22 a target is selected within
the patient as depicted by step 2202. The movable member of the
trajectory guide is positioned near the body of the patient and
near the target within the patient using the snake to hold the
trajectory guide 200, as depicted by step 2204. The next step,
depicted by reference no. 2206, is to align the passage within the
movable member with the target within the body. This can be done
using nuclear magnetic resonance imaging or a CT scanner or
infrared lights or any other suitable means. The methods discussed
above are used in aligning the passage of the movable member with
the target within the body of the patient. As shown in FIG. 22,
step 2208 is to locate a first locator, and step 2210 is to locate
a second locator. The trajectory of the opening in the movable
member is based on the position of the first locator and the second
locator, as shown by step 2212. The next step is to move the
movable member 220 until the trajectory of the opening 222 aligns
with the target within the patient, as depicted by step 2214. Once
aligned a twist drill is passed through the opening 222, as
depicted by step 2216. An opening is then drilled within the body,
as depicted by step 2218. The twist drill is removed, as depicted
by step 2220 and then the surgical instrument is passed through the
opening 222, and through the opening within the body to the target
Another snake secures the guiding instrument, which will permit
passage of a surgical drill, a biopsy needle, an observational
tool, or other surgical instruments, a thermal therapy probe, or
other diagnostic or therapeutic device into the body of the
patient. The other snake holds a clamp which holds a hydraulic
piston which can either introduce or withdraw the surgical
instrument from a remote location. In this way, the device very
easily can be used remotely from outside the bore of a standard MR
scanner in order to introduce a surgical instrument to either a
predetermined depth or to a point visualized on the MR scan
obtained, while the instrument is being advanced. This simple
device can be used with great precision and accuracy. It has no
specific parts that are introduced into the body and can be used
for repeat intervention. The device is completely external, and the
only component that is, in fact, introduced into the body is the
surgical instrument itself
[0157] The device should be fully MR compatible, as well as x-ray
translucent. Initially, an alignment stem is placed into the
guiding component. The alignment stem is filled with fluid, but is
easily visualized under routine MR, CT, or other radiographic
procedures. The fluid, for MR purposes, can be normal saline or
other fluid. For x-ray purposes, it might be doped with barium or
other such compound.
[0158] Procedures that formerly required many hours can now be
performed in substantially less amounts of time with the trajectory
guide 200. For example, previously procedures to require
considerable set up time including MR or CT scan, computer
reconstruction of data with fiducial markers, calculation of
trajectory, placement of stereotactic frame apparatus. Now with the
trajectory guide 200, these procedures can be done in a matter of
minutes. Furthermore the procedure is much more accurate and safer
since the positioning stem can be seen by the MRI or other scanning
device after the placement, whereas stereotactic systems have only
retrospective data and have no such capability after placement. In
a stereotactic procedure, the calculations are done and the
placement procedure is performed based solely on the calculations.
It is presumed to be accurate and there is really no way to
determine if a surgical instrument was inserted to the target or
missed the target. If the target is missed, the set up steps must
be repeated. In other words, the stereotactic procedure does not
have the benefit of immediate or near immediate feedback with
respect to the target being missed or met. In the procedure
described which uses the scan readable device, immediate or near
immediate feedback can be obtained. The feedback comes with the
next image calculated in an MRI scanning system, for example. The
procedure described herein is also more accurate since the target
270 is also locatable by the scanning device 100 and the computer
102 associated with the scanning device is calculating the
trajectory to determine if the line defined by the first locator
420 and the second locator 430 is collinear with the trajectory
260.
[0159] Many uses are contemplated for this new trajectory guide
200. For example, a surgical instrument can be used to access
certain portions of the body of the patient. Using the head of a
human patient as an example, the trajectory guide 200 can be used
to deliver an instrument to an area of the brain for biopsy. An
instrument can also be used to access the ventricular area of the
brain and cerebrospinal fluid for placement of a ventricular shunt
or drain. The trajectory guide can also be used to enable a
neurosurgeon to perform ventricular endoscopy. The instrument in
such endoscopy typically includes a fiber optic for viewing a
portion of the brain. The instrument can be rigid or flexible. The
trajectory guide 200 can also be used in treating or researching
various other disorders or diseases of the brain, such as
Alzheimer's disease, multiple sclerosis, Huntington's chorea,
Parkinson's disease and other neurodegenerative diseases. The
globus pallidus is one key to controlling the tremors that patients
with Parkinson's disease have. In some treatments, electrodes are
used to deliver electrical signals to this organ to reduce or
eliminate the effect of Parkinson's disease. In addition, a
surgical instrument can be used to perform a pallidotomy (i.e.
lesion the globus pallidus). Similarly, other targets include the
thalamus and subthalamic nucleus. Depending on the surgeon,
additional targets could be considered, including nuclear and
non-nuclear regions of the brain stem. Another surgical procedure
is the removal of tumor material in the brain. The tumor can be
located and eliminated using an instrument delivered with the help
of the trajectory guide 200. Still other procedures second arm 2320
has a handle 2322 on one end and a cup 2324 on the other end. A
movable member 220 with a passage or opening 222 therein is held
between the cups 2314 and 2324. The movable member 220 is a ball or
is substantially spherical in shape. The cups 2314 and 2324 have a
radius that is close to the radius of the substantially spherically
shaped movable member 220. The cups 2314 and 2324 may also be lined
with an elastomeric or other material to enhance the gripping of
the cups on the movable member 220. It should be noted that the
size of the movable member 220 is not limited to one size and that
larger and smaller spherically shaped movable members may require
specialized surgical instruments 2300 having cups 2314 and 2324
with radii that are near the radius of the movable member 220.
Located between the handles 2312 and 2322 is a bias or spring
element 2340. The spring element 2340 is held in compression
between the handle 2312 and the handle 2322. The spring element
2340 therefore biases the arm 2312 away from the arm 2322 which in
turn biases cup 2314 toward cup 2324. The surgical instrument 2300
is designed so that in the absence of a force which counteracts the
spring or bias element 2340, the cups 2314 and 2324 will engage the
movable member 220 to fix it in one position so that surgical
instruments may be passed through the opening 222 in the movable
member 220. The spring element or bias element 2340 can be mounted
on an arcuate portion which is attached to one of either the first
arm 2312 or the second arm 2322. The spring or bias element 2340
can be placed over the arcuate member. A mating or receiving member
can be attached to the opposite arm. The opposite arm also may
include an opening for allowing the arcuate member to pass through
the opening. A stop is typically provided on the surgical
instrument 2300. The stop 2350 limits the amount of motion that can
take place between the movable member 220 and the cups 2314 and
2324. By limiting the amount of motion between the cups 2314 and
2324, the spherical movable member 220 cannot be removed from the
surgical instrument 2300. This would prevent an inadvertent drop of
the movable member 220 during a critical portion of an operation.
The stop 2350 can be incorporated within the bias are removal of
lesions which are formed in the brain due to strokes or other
medical conditions.
[0160] Other Uses of the Trajectory Guide
[0161] Described above are procedures associated with the brain.
There are numerous other surgical procedures that can also be
performed on other than the brain that would benefit from accurate
placement of a surgical tool. In particular, it is anticipated that
cardiac and pulmonary conditions will be ameliorated by minimally
invasive therapies that can be made possible with the trajectory
guide. In such procedures, the trajectory guide is more of a body
portal and may or may not be used to lock into a specific
trajectory toward a target. Moreover, such procedures may require
use of more than one trajectory guide or may require a multiple
body portal configuration in which each of the portals include one
or more trajectory guides. In such therapies, surgical instruments
or observational tools may be inserted to enable the surgeon in
performing surgical procedures. Similarly, probes may be delivered
to specific targets or general targets by the trajectory guide for
the performance of cryotherapy, laser therapy, radio frequency
ablation, microwave interstitial therapy, focussed ultrasound
therapy and other therapies. These therapies are all currently done
on various parts of the body in conjunction with an imaging device,
such as an MR scanning device. A CT scanner could similarly be
employed. The trajectory guide makes delivery of the instruments to
the various targets easier in all of these therapies.
[0162] FIG. 23 is a top view of a surgical instrument for holding a
movable member. The surgical instrument 2300 can be used for other
surgical procedures as discussed above. The surgical instrument
2300 includes a first arm 2310 and a second arm 2320. The first arm
2310 is pivotally connected to the second arm 2320 at a pivot point
2330. The first arm 2310 has a handle 2312 on one end and a cup
2314 on the other end. The cup 2314 doesn't necessarily have to be
attached to the end of the arm 2310 but may be close to the end of
the arm. The element 2340, or can be incorporated at any location
along arm 2322 or arm 2312, as shown in FIG. 23. In other words,
stop 2350 limits the amount of potential loosening of cups 2314 and
2324 with respect to movable member 220, while spring element 2340
maintains tension such that movable member 220 is held in
position.
[0163] FIG. 24 shows another clamp for holding a movable member
220. This clamp is commonly known as a snake clamp. The clamp 2400
includes a snake end 2410 and a jaw end 2420. The jaw end 2420
includes a set of two or more jaws which can be opened and closed
slightly to allow a movable member 220 positioned between the jaws
to be moved. As shown in FIG. 24, there are two jaws 2422 and 2424
associated with the jaw end 2420 of the clamp 2400. The snake end
2410 includes a plurality of articulated sections which are
connected together to allow the clamp to be moved and adjusted and
positioned to a selected position. The snake end 2410 includes a
clamp for clamping onto an operating table or other fixed
structure. In operation, the surgical instrument 2400 can be
clamped to a table. The snake end 2410 can be moved so that the jaw
end 2410 can be positioned to a desired location with respect to
the patient. The individuals jaws 2424 and 2422 can be opened to
allow for movement of the movable member 220 located between the
individual jaws.
[0164] FIG. 25 is a top view of a platform or bar 2500 which holds
a plurality of surgical instruments such as2300 or 2400. The bar
2500 is fastened to a solid object such as a frame of a surgical
table 2510. The bar 2500 can be attached at one or both ends to
provide a solid platform to attach surgical instruments 2300 or
2400 thereto.
[0165] FIG. 26 is a top view of a plate 2600 which includes a
plurality of movable member 220. The plate 2600 as shown in FIG. 26
is attached to a pair of human ribs 2602 and 2604. The plate 2600
has openings 2610 and 2612 or fasteners that pass into the rib
2602. The other end of the plate 2600 has a pair of openings 2620
and 2622 which allow fasteners to pass there through and into the
second rib 2604. The openings 2610 and 2620 are spaced apart such
that the spacing corresponds to the spacing between the ribs 2602
and 2604. Similarly, the spacing between the openings 2612 and 2622
are also spaced such that they correspond to the spacing between
the ribs 2602 and 2604. The plate 2600 includes several cups 2630,
2632 and 2634, each of which receives a movable member 220. The
cups 2630, 2632, and 2634 may have different radii to receive
movable members having corresponding radii. Locking members may
also be provided which are used to lock the movable members in
place. The plate 2600 is contemplated for use in cardiac surgery,
although it could be adapted for other uses.
[0166] FIG. 27 is a top view of a surgical instrument 2700 designed
to grip or be held within a burr hole a patient's skull. Burr holes
typically have a radius of 14 mm. Currently, many surgical
procedures are performed through craniotomy flaps or craniotomy
burr holes. Needles or probes are typically passed through the burr
hole into the brain. The surgical instrument 2700 is typically used
other surgical instruments, as shown and discussed with respect to
FIG. 28. The surgical instrument 2700 includes a first arm 2710 and
a second arm 2720. The first arm 2710 is pivotally connected to the
second arm 2720 at a pivot point 2730. The first arm 2710 has a
handle 2712 on one end and a tubular half2714 on the other end. The
cup 2714 does not necessarily have to be attached to the end of the
arm 2710 but may be close to the end of the arm. The second arm
2720 has a handle 2722 on one end and a tubular half 2724 on the
other end. The tubular halves 2714 and 2724 have an outside radius
that is close to the radius of the burr hole. Located between the
handles 2712 and 2722 is a bias or spring element 2740. The spring
element 2740 is held in compression between the handle 2712 and the
handle 2722. The spring element 2740 therefore biases the arm 2712
away from the arm 2722 which in turn biases tubular half 2714 and
tubular half 2724 toward the edge of the burr hole. The surgical
instrument 2700 is designed so that in the absence of a force which
counteracts the spring or bias element 2740, the tubular halves
2714 and 2724 will engage the edge of the burr hole to fix it in
one position with respect to the burr hole. The instrument 2700
also has a stop 2750 to limit the amount of motion between the
handles.
[0167] FIG. 28 shows a top view and FIG. 29 shows a side view of a
doublet instrument 2800 which is a combination of the instrument
2300 of FIG. 23 and a combination of the instrument 2700 shown in
FIG. 27. The instrument 2700 and the instrument 2300 are attached
to one another via a common pivot axis 2830. The instrument 2700
holds the doublet within the burr hole in the patient's skull. The
cups 2314 and 2324 of instrument 2300 hold the movable member 220
above the tubular halves 2714 and 2724 of the instrument 2700 and
above the burr hole in the patient's head. Once the instrument 2700
is positioned within the burr hole, the handles of the instrument
2300 can be forced open so that the movable member 220 can be
adjusted to a selected angle or trajectory. Other instruments can
then be passed through the opening 222 in the movable member,
between the tubular halves 2714 and 2724, and through the burr hole
in the patient's skull.
[0168] Within some parts of a patient, it is critical to very
accurately place a surgical instrument. For example, in
neurosurgery, it is very critical to have instruments, such as
catheters or needles, placed very accurately within the cranium or
head of a patient. FIG. 38 shows a side view of a patient on which
a trajectory guide 3800 is being used. The trajectory guide 3800
includes a base unit 3810, a movable member 220, a locking member
230 and a guide stem 240. The base unit 3810 is attached to the
skull of the patient. In the particular embodiment shown, the
attachment is made by way of bone screws. A burr hole is not
required in the patient In this particular embodiment, the movable
member 220 is held away from the patient's body such that a burr
hole is not required.
[0169] The movable member 220 has a passage therein 222 which is
shown in FIG. 2 as dotted lines. The guide stem 240 also has an
elongated opening 242 therein. The opening 242 is also shown as
dotted lines in FIG. 38. The passage 242 in the guide stem 240 and
the opening 222 in the movable member or ball 220 form a line or a
trajectory 260 which, when the guide stem 240 and movable member
220 are positioned correctly, intersects with a target 270 within
the patient. The guide stem 240 and movable member or ball 220 form
the first part of the trajectory 260. The base unit 3810 includes a
seat 3818 or socket which allows the movable member 220 to move
freely. The seat 3818 is positioned away from a flange 3814 on the
base 3810. The seat 3818 is elevated with respect to the flange
3814. Below the seat is an opening through which instruments may
pass. The elevated seat 3818 and opening below serve as a
substitute for a burr hole in the skull.
[0170] After aligning the opening 242 and the opening 222 to form
the trajectory 260, a twist drill is then used to make a small
opening in the patient. The twist drill is passed through the
opening 242 and opening 222 along trajectory 260. After a drill
hole is formed in the patient, a surgical instrument or
observational tool can be inserted into the opening 242 of the
guide stem 240 and passed through the passage in the movable member
220 and through the drill hole formed along the trajectory 260.
Further insertion of the surgical instrument or observational tool
into the patient for a selected distance will strike or place the
tool near or at the target 270. The opening 242 in the guide stem
240 and the passage 222 in the movable member 220 guide a surgical
instrument along the trajectory 260 to the target 270. Of course,
the movable member 220 is locked into place by locking member 230
before a surgical instrument 280 is placed through-the opening 242
in the guide member 240.
[0171] FIG. 39 shows an exploded isometric view of the trajectory
guide 3800 with a guide member installed. As shown in FIG. 3, the
trajectory guide 3800 is comprised of a base 3810, a movable member
220, a locking member 230, and the guide member 240. The guide
member 240 may be threadably attached or the guide member can be
made integral with the movable member 220. The base 3810 includes
acylindrical portion 3812 and a flange 3814. The flange looks like
a series of ears. Each of the ears of the flange 3814 includes a
plurality of countersunk screw openings 3815, 3816, and 3817. The
countersunk screw openings 3815, 3816, and 3817 receive bone screws
which are screwed into the skull bone or the bone of a patient. The
flange 3814 also may include markings 219 used to position the
guide member 240. The base also includes a semi-spherical seat 3818
on the end of the base opposite the flange 3814. The flange 3814 is
in a plane away from the seat 3818. Although not shown in FIG. 3,
there is an opening in the base 3810 having a first end which
terminates at the seat 3818 and another end which terminates at the
bottom of the base 3810. This opening is essentially a substitute
burr hole.
[0172] As shown in FIG. 39, the movable member 220 is essentially a
spherical member or a ball. The spherical member or ball fits
within the seat 3818. The spherical member or ball moves freely
within the seat 3818. The ball-shaped movable member 220 also has
an opening therein 222. The opening passes through the ball shaped
movable member. One end of the opening may have a set of internal
threads therein, which can be used to receive mating threads which
are placed onto the guide stem or member 240 or positioning stem
(discussed with respect to FIG. 40).
[0173] The locking member 230 also has an opening therethrough. The
locking member 230 includes a cylindrical bottom portion 232 and a
flange 234. The opening through the locking member 230 has
sufficient space to allow movement of movable member 220 when the
locking member is in an unlocked or untightened position. Although
not shown in FIG. 4, the bottom of the cylindrical portion 232 of
the locking member 230 includes a set of internal threads. The set
of internal threads engage a set of external threads on the base
unit 3810 (shown in FIG. 7b). As will be detailed later, when the
internal threads of the locking member 230 are engaged with the
threads on the base 3810, a portion of the locking member engages
the movable member 220 to fix the movable member and the passage
222 therethrough at a fixed position.
[0174] A guide stem or guide member 240 is also shown in FIG. 39.
The guide stem has an elongated opening 242 therein. The elongated
opening passes through the length of the guide stem 240. One end of
the guide stem includes a set of external threads which engage the
internal threads of the spherical, movable member 220. When the
external threads of the guide stem 240 engage the internal threads
of the movable member 220, the opening 242 is substantially aligned
with the passage 222 in the movable member. The opening 242 and
passage 222 form the first part or guide for the trajectory 260 to
the target 270 within the patient. It should be noted that the
movable member 220 need not necessarily be a spherical element,
although the spherical shape allows the ball to have a universal
joint type swivel action which is preferred. As mentioned
previously, the movable element 220 and the guide stem 240 can be
formed as one piece. This would eliminate the need for the threaded
end of the guide stem 240 and the threaded inner diameter 222 of
the movable member 220.
[0175] In addition, the locking member 230 can be formed in most
any shape. A flange 234 is useful in that it allows additional
leverage for tightening or loosening the locking member. Any shape
capable of being turned or placed into a locking position with
respect to the movable member 220 is acceptable.
[0176] Positioning Member
[0177] Now turning to FIG. 40, an exploded isometric view of the
trajectory guide 3800 with a positioning member 400 is shown. The
positioning member 400 may also be referred to as a positioning
stem. Many of the parts of the trajectory guide 3800 shown in FIG.
4 are the same as those shown in FIG. 39. In the interest of time,
a discussion of the common elements will not be repeated. Several
of the basic elements will be numbered for the purposes of this
discussion. The difference between FIGS. 39 and 40 is that the
guide stem or guide member 240 has been replaced with the
positioning stem 400. The positioning stem 400 includes an end 410
which carries threads for engaging internal threads within the
passage 222 in the movable element 220.
[0178] Movable Member
[0179] FIGS. 5a and 5b show the movable member which is used as the
movable member in the trajectory guide 3800.
[0180] FIGS. 41a and 41b show a side and top view of the base 3810
of the trajectory guide 3800. The base 3810 includes the
cylindrical portion 3812 and the flange 3814. The flange 3814
includes ears with countersunk openings 3815, 3816, and 3817 as
well as the seat 3818 which receives the movable member 220. It
should be noted that the flange 3814 can be of any shape. As shown,
the seat 3818 is in a plane substantially parallel to the plane of
the flange 3814. The seat 3818 is elevated with respect to the
flange 3814. The seat 3818 is on one end of the base 3810 and the
flange 3814 is on the opposite end of the base 3810. Between the
seat and the flange is an opening 4100 which includes an internally
threaded portion 610. The internally threaded portion 4110 is
dimensioned so as to receive the threads of either the positioning
stem 400 or the guide stem 240. The flange 3814 may include a first
arched bail 4410 and a second arched bail 4420 (arched bails are
shown in FIGS. 44 and 45) which are used to align the positioning
stem 400 so that it defines a trajectory 260 which intersects the
target 270 within the patient. It should be noted, that although
the flange 214 is shown as having a triangular shape, the flange
could be most any shape.
[0181] FIGS. 7a and 7b show the locking member 230 as used in the
trajectory guide 3800.
[0182] Integral Guide Stem and Movable Member
[0183] FIG. 42 shows an isometric view of a movable element 4220
that has a ball end 4210 and a guide stem end 4230. The movable
element 220 fits within the base 3810 and locking member 230. As
shown, the movable element 4220 has a passageway 4222 therein which
traverses the length of the movable element 4220. In other words,
the passageway 4222 passes through the guide stem end 4230 and
through the ball end 4210. FIG. 42 also shows a positioning stem
400. The positioning stem 400 is dimensioned so that it fits snugly
within the passageway 4222.
[0184] The various guide stems and positioning stems shown in FIGS.
1-42 can be used with any type of body scanner. The positioning
stems can be provided with MR viewable portions and positioned with
the aid of an MR imaging device similar to the one discussed in the
U.S. patent application entitled "Surgical Instrument Trajectory
Guide Method and Apparatus" filed Aug. 28, 1997 and having serial
number 08/919,649. The guide stems shown in FIGS. 1-42 can also be
adapted for use with a CT scanner. CT scanners are widely available
around the world.
[0185] CT Scanner
[0186] FIG. 43 is a block diagram of a patient scanning system
4300. The specific scanning system shown is a computerized
tomography ("CT") system. An CT scanning system 4300 includes a
computer 4302. The computer 4302 includes a central processing unit
("CPU") 4304 and memory 4306. The CPU 4304 and memory 4306 have the
capacity to perform multiple calculations used to determine images
as well as positions of various organs, or portions or within an
image field. The computer 4302 controls an image data processing
portion 4310. The computer 4302 also reconstructs an image along a
desired plane. An X-ray tube 4320 is pulsed at many times per
second. Across from the x-ray tube are a plurality of detectors
4330. Most commonly, the detectors 4330 are photo diodes.
[0187] The data is interpreted and placed on a display 4340
associated with the computer of the CT system 4300. The computer
4302 and the CPU 4304 and memory 4306 can use data acquired from
the CT system 4300 to build up images of a portion of the patient
which is being subjected to x-radiation. The images are typically
referred to as slices. For example, a horizontal slice and a
vertical slice can be made of the portion of the body or patient
being imaged. The computer can also recalculate and build other
slices for use by doctors and radiologists having any selected
orientation needed to facilitate study of various items within a
patient. For example, lesions can be found within the body as well
as certain organs. Different slices can be requested to facilitate
study of these targets. From the data acquired, the position of the
lesions or organs can also be very accurately determined using a
Cartesian or polar coordinate system.
[0188] In operation, x-ray beams of a computerized tomography
scanner pass through a human body or an object and are collected
with an array of detectors; the beam is rotated to produce the
equivalent of a "slice" through the area of interest. The x-ray
information collected during the rotation is then used by a
computer to reconstruct the "internal structures," and the
resulting image is displayed on a television screen. This technique
represents a noninvasive way of seeing internal structures, and has
in many ways revolutionized diagnostic approaches. In the brain,
for example, computerized tomography can readily locate tumors and
hemorrhages, thereby providing immediate information for evaluating
neurological emergencies.
[0189] Basically, the scanner gantry is composed of an x-ray tube,
an array of detectors opposite the tube, and a central aperture in
which the person (or object) is placed. X-rays are generated in
short bursts, usually lasting 2-3 ms; the x-ray beam contains an
"invisible image" of the internal structures. The role of the
detectors is to collect this information, which is then fed into a
computer. The computer reconstructs the image from the information
collected by the detectors. In order to obtain enough information
to calculate one image, the newer scanners can take as many as
90,000 readings (300 pulses and 300 detectors). CT scanning devices
are widely available throughout the world. The above description of
the CT scanning device 4300 is simply for demonstrative
purposes.
[0190] For use with CT scanning system 4300, the positioning stem
400 of FIG. 40 is modified by doping with a dopant that is
detectable with x-radiation. The dopant can be a liquid carrying
barium which is housed with a tubular cavity of the position stem.
The dopant can also be made within the material of the positioning
stem. Since it is detectable, the positioning stem 400 is viewable
as a result of the CT scan. One dopant which could be used is
barium. The entire positioning stem 400 or selected portions of the
positioning stem may be doped so as to produce a detectable image
on the display 4380 of the CT scanning device 4300. For example,
rather than dope the entire positioning stem 400, the ends 420 and
430 of the positioning stem may be doped. The two ends of the
positioning stem could be detected by the CT scanning device 4300
and used to define a line corresponding to the current trajectory
through the opening 222 in the movable member 220.
[0191] Now turning to FIG. 44, the further modification of the
device shown in FIG. 40 will be discussed. The modifications
provide for an alignment instrument which can be used where only CT
scanners are available. In the alternative, if CT scanning
equipment is available, it can be used as an alternative to more
expensive methods, such as MR scanning. The positioning stem 400 is
doped as discussed above. A ring 4450 is attached to the
cylindrical portion 3812 of the base 3810. The ring 4450 moves with
respect to the cylindrical portion 3812. Attached to the ring 4450
is a first arched bail 4410 and a second arched bail 4420. The
arched bails 4410 have physical markings 4412 thereon. The arched
bail 4420 has physical markings 4422 thereon. At least one of the
bails 4410 or 4420 is also doped at least three points so that the
three points determine a plane viewable on a CT scan. The arched
bails 4410 and 4420 are secured to the flange 3814 with a fastener
which can be securely tightened to prevent movement of the bail
4410 and 4420. The bails 4410 and 4420 are also made so that they
extend a distance above the movable member 220 to allow clearance
for the locking member 230.
[0192] Also for use with a CT scanning system 100, the positioning
stem 400' of the trajectory guide 200', shown in FIG. 42 is doped
with a dopant that is detectable with x-radiation. Since it is
detectable, the positioning stem 400' is viewable as a result of
the CT scan. One dopant which could be used is barium. The entire
positioning stem 400' or selected portions of the positioning stem
may be doped so as to produce a detectable image on the display
4380 of the CT scanning device 4300. For example, rather than dope
the entire positioning stem 400', the ends 420' and 430' of the
positioning stem may be doped. The two ends of the positioning stem
could be detected by the CT scanning device 4300 and used to define
a line corresponding to the current trajectory through the opening
guide member end 4230 and the opening 4222 in the ball end
4210.
[0193] The first end 420 and the second end 430' of the positioning
stem 400' do not need to be doped with the same material. This may
enable the computer 4302 associated with the CT scanning device to
more easily discern end 420' from end 430'. In this embodiment, the
positioning stem 400' is inserted into the guide stem end 4230. The
movable member 4220 and more specifically the opening 4222 in the
movable member 4220 is moved until it is aligned to the desired
trajectory 260 to the target 270. Once aligned, a locking member
230 (not shown in FIG. 42 to more clearly illustrate this
embodiment) locks the ball end 4210 in place. The positioning stem
400' is removed and the surgical instrument is passed into the
guide member end.
[0194] In still another embodiment, portions of the movable member
4220 are doped with a dopant that makes it x-radiation readable and
viewable. Movable member 4220 includes a ball as well as an
extended guide stem end 4230. All or part of the guide stem end
4230 may be doped. The ends of the opening 4222 in the movable
member 4220 may also be doped. The ends could then be used in
locating the line or trajectory 260 defined by the opening 4222. In
this embodiment, there would be no real need for positioning stem
400'. When the movable member 4220 is determined to be properly
aligned, the movable member 4220 would be locked into place and the
surgical instrument or tool would be passed directly into the
opening 4222.
[0195] FIG. 45 shows the trajectory guide 200' having a base 3810
that has a ring 4450. The arched bail 4410 and the arched bail 4420
are attached to the ring 4450. The arched bails are attached to the
ring 4450 so that they can be rotatably moved with respect to the
base 3810. The bails 4410 and 4420 can then be rotated with respect
to the ring 4450. The attachment also allows them to be tightened
so the bails 4410 and 4420 stay in one position. The bails 4410 and
4420 are positioned so that there is clearance so the locking
member 230 can be loosened to adjust the position of the at least
one of the bails 4410 or 4420. At least one of the bails 4410 or
4420 includes a CT readable portion that defines a plane.
Preferably, one edge of the bail, 4410 or 4420, will be readable
via CT scan. The edge of the bail 4410 or 4420 will be an arcuate
line which defines a plane. The bail 4410 will have markings 4412
and the bail 4420 will have markings 4422. The bails 4410 and 4412
would enable a person to reposition the movable member 4220 to make
adjustments to the trajectory guide so that the opening 4222 in the
movable member aligns with the trajectory 260.
[0196] Method for Using CT Scans and Trajectory Guide
[0197] In operation, a patient undergoes a CT scan with a CT
scanning device 4300 to locate a particular organ within a patient
or to locate lesions or any other target 270 within the patient. It
should be noted that targets are not necessarily limited to being
within the head of a patient. There can also be other areas of a
patient where it would be critical to accurately place a surgical
or observational tool. In addition, it should also be noted that
the patient need not necessarily be human. A patient may include
any living animal.
[0198] Once the target 270 is found and located using the CT
scanning system 4300, the base 3810 of the trajectory guide 3800
can be attached to the patient. The base is affixed to the patient
in an area near the target 270. The computer 4302 of the scanning
device 4300 is used to determine the exact location of the target
270. The exact location can be found in any type of coordinate
system, although normally a Cartesian coordinate system is used.
Once the base 3810 is attached to the patient, the remaining
portions of the trajectory guide 3800 are attached to the base
3810. In other words, the movable member 3820, the locking guide,
the locking member 3830 and a positioning stem 400 are added to
form a complete trajectory guide 3800.
[0199] Now turning to FIG. 46, as shown by step 4600, the
positioning stem 400 or 400' is initially positioned. As depicted
by step 4602, a CT scan is performed to initially locate the
positioning stem 400 or 400' and the target 270. The line or
trajectory formed by the positioning stem 400 or 400' is read by
the CT scanning system 4300. The trajectory 260 is determined by
determining a line between the end 430 or 430' of the positioning
stem 400 or 400' nearest the patient and the target 270. The
computer 4302 determines the difference between the trajectory 260
and the line formed by the doped positioning stem 400, 400'. The
computer 4302 determines the adjustment that the surgeon must make
to reposition the positioning stem 400 or 400' so that it
corresponds to the trajectory 260. The adjustment corresponds to
the increments 4412, 4422 on the arched bails 4410, 4420 attached
to the base 3810.
[0200] The computer 4302 also determines the plane corresponding to
the edge of one of the bails 4410 or 4420. The computer can then
output an adjustment that can be made by the surgeon or person
doing the procedure. Given the plane defined by the edge of one of
the arched bails 4410 or 4420, the position of the other bail 4420
or 4410 can be determined.
[0201] The physician is instructed to leave one bail 4410 in a
fixed position. In fact, one bail 4410 could remain in a fixed
position. The edge of the other bail 4410 is moved to a mark 4412
on the fixed bail 4410. The edge with the markings 4422 is moved to
a mark 4412. The bail 4420 is then secured into position. The
surgeon then moves the positioning stem 400 or 400' to a mark 4422
on the second bail 4420 to reposition the positioning stem 400 or
400' so that it corresponds to the trajectory 260. This series of
steps corresponds to the step of adjusting the position of the
positioning stem so the trajectory aligns with the target 4604.
[0202] The instrument is then inserted using the guide stem. In the
instance of the trajectory guide 3800, the positioning stem is
replaced by the guide stem. In the instance of the trajectory guide
3800', the positioning stem 400' is removed and then the instrument
is placed in the movable member. The instrument is inserted to a
selected distance into the patient, as depicted by step 4607. The
selected distance is the distance to the target 270 along the
trajectory 260.
[0203] Another CT scan is then done, as depicted by step 4606, to
confirm that the instrument is at the target 270. If the instrument
has not reached the target 270, the needle is inserted another
selected distance (step 4605).
[0204] The procedure for repositioning the positioning stem 400 or
400' may be modified slightly depending on the size of the target
270 and whether a burr hole opening will be made. The trajectory
guides 3800 and 3800' do not need a burr hole, but they can be used
with burr holes. If a burr hole is formed, the contents within the
cranium shift may shift slightly as a result of fluid loss through
the burr hole. If the target 270 is large, such as a tumor, it may
not be necessary to recheck the trajectory 260. If the target is
small, it may require a recheck of the trajectory even if only a
twist drill opening is made in the skull.
[0205] Frameless Stereotaxy Environment
[0206] In an environment where there are detectors for
light-emitting diodes ("LEDs"), the trajectory guide 3800 as shown
in FIG. 40 or the trajectory guide 200' as shown in FIG. 42 can be
used to accomplish this procedure. FIG. 47 shows the positioning
guide 400 of the trajectory guide 3800 provided with two or more
LEDs 4710 and 4720 which are located along the length of the
positioning stem 400. Rather than use the arched bails 4410 and
4420 to reposition the positioning stem 400, one or more LED
detectors 4730 and 4740 are used to locate the LEDs 4710 and 4720.
The step of adjusting the position of the positioning stem 4604 so
that it aligns with the trajectory 260 to the target 270 is
accomplished by moving the positioning stem 400 manually until the
LEDs 4710 and 4720 form a line which is collinear with the
trajectory 260. The computer 4302 determines the trajectory 260 by
determining the formula for a line between the target 270 and the
end of the positioning stem 400 closest to the patient. The
positioning stem 400 is moved until the LEDs 4710 and 4720 are
aligned with the trajectory 260. The positioning stem can be moved
manually (directly or remotely) or by automated control, such as
under control of a computer. The LED's position can be determined
by the detectors 4730 and 4740 at a relatively high frequency rate
such that movement of the positioning stem 400 can be monitored in
real time. Once the LEDs 4710 and 4720 are aligned with the
trajectory 260, the computer 4302 will output a signal indicating
that the positioning stem 400 is correctly positioned. The same
procedure would be followed for a trajectory guide 200'. The
positioning stem 400' would be provided with the LEDs 4710 and
4720. Once the positioning stem 400' is correctly positioned, a
signal from computer 4302 indicates the correctly positioned
positioning stem 400'. The movable member 4220 is then locked into
position. The positioning stem 400' is removed and the instrument
is passed into the opening 4222 in the movable member 4220.
[0207] Of course, this procedure may be modified slightly depending
upon the particulars of the procedure. The trajectory guides 200
and 200' do not need a burr hole, but can be used with burr holes.
If a burr hole is formed during the procedure, the contents of the
cranium shift slightly as a result of fluid loss through the burr
hole. If the target 270 is large, such as a tumor, it may be
unnecessary to recheck the trajectory 260. If the target is small,
such as when the target is the globus pallidus interna, it may be
necessary to recheck the trajectory before inserting a tool or an
instrument to the target 270. Once the trajectory 260 is
determined, the instrument or tool is inserted a selected distance
into the trajectory guide 200 or 200'. The selected distance is
equal to the distance between the trajectory guide and the target
270. The position of the instrument or tool can then be checked
using x-radiation to determine if the tool or instrument has
reached the target 270.
[0208] Magnetic Resonance Imaging Procedure
[0209] The trajectory guide 3800 or 3800' can also be used in an MR
imaging environment. In such an environment, the positioning stem
400 or 400' is provided with a dopant that can be read by an MR
imaging device. The procedure set forth above for the frameless
stereotaxy environment is similar to the procedure used here. The
MR imaging device is used to determine the position of the
positioning stem 400 and to determine the trajectory between the
portion of the positioning stem nearest the patient and the actual
target 270. The positioning stem 400 is moved either manually or
with the aid of a remote device. The positioning stem 400 is moved
until it is positioned so that it is collinear with the trajectory
260 between target 270 and the end of the positioning stem 400
nearest the patient.
[0210] The basic procedure set forth in FIG. 48 varies at a step
4604, which is to adjust the position of the positioning stem. When
using CT scanning equipment only, the positioning stem 400 is
adjusted using the arched bails 4410 and 4420. When the trajectory
guide is used in an MR environment, the MR scanning device is used
to locate the position of the positioning stem 400. In either
environment, the positioning stem 400 may be used in association
with frameless stereotaxy, in which case LED detectors are used to
find the position of the positioning stem. Once the positioning
stem is properly located collinearly with the trajectory 260, the
instrument is inserted through the trajectory guide 200 or 200'
toward the target 270 to a specific distance. Another scan is then
taken to confirm that the instrument is at the target. These are
the steps as shown and described previously and correspond to steps
4606 and 4608 in FIG. 46.
[0211] FIGS. 10-14, 19-22 and 30-37 show and describe remote
controlled versions of trajectory guides 200' that could be used
under MR guidance.
[0212] Burr Hole Externalizer Adapter for Other Tools
[0213] Turning now to FIGS. 48-50, the burr hole externalizer will
be detailed. FIG. 48 is a top view of a burr hole extension
apparatus 4800. FIG. 49 is a side view of the burr hole
externalizer 4800. The burr hole externalizer 4800 is made of a
tubular body 4810 with a set of flanges 4820, 4822, and 4824
attached thereto. The tubular body 4810 is approximately 1 cm in
height. The tubular body 4810 has a height that allows clearance
between the tubular body and the tool to allow insertion of the
tool into the patient's body. The tubular body 4810 has a flange
end 4812 and a burr hole end 4814. The flanges 4820, 4822, and 4824
are used to attach the burr hole externalizer 4800 to the patient.
The flanged end 4812 is the end of the burr hole externalizer 4800
that contacts the patient. The burr hole end 4814 is positioned a
distance from the patient's body. The burr hole externalizer 4800
basically provides a substitute opening for a burr hole that used
to have to be made in the patient. The burr hole end 4814 of the
tubular body is dimensioned so that it replicates a burr hole. The
inner diameter of the burr hole end 4814 is the same as a standard
burr hole. It should be pointed out that the Europeans have one
standard diameter and the rest of the world has another standard
diameter. The burr hole end 4814 may also include an inside thread
4816 so that tools which thread into a burr hole can also thread
into the burr hole end 4814 of the externalizer 4800. It should be
noted that an inside thread is not necessary. Thus the externalizer
4800 can also be thought of as a universal adapter for tools that
normally are attached to a burr hole.
[0214] In operation, a physician/surgeon will initially position
the burr hole externalizer 4500 onto the patient's body. For the
sake of example, the physician surgeon will initially position the
externalizer on the patient's head. The burr hole externalizer is
held in place using several bone screws. The bone screws pass
through openings in each of the flanges 4820, 4822, and 4824. A
selected tool is then attached to the burr hole end 4514 of the
burr hole externalizer 4800. The tool attached can be a trajectory
guide such as described above or such as described in U.S. patent
application Ser. No. 08/919649 filed Aug. 28, 1997 and entitled
"Surgical Instrument Trajectory Guide Method and Apparatus". The
tool can be any tool that previously required attachment to a burr
hole in the body of the patient. The advantages associated with
using the burr hole externalizer 4800 stem from the fact that the
surgeon no longer has to make a burr hole in the patient. Not
having to make a burr hole means that the procedure takes less
time. It also results in less fluid loss from the spine and the
cranium which results in less shifting of the target or contents of
the head. In addition to several small bone screws, the only
opening made in the patient's body is a small twist drill hole. A
twist drill hole has a diameter of approximately 2 mm. This is much
smaller than the 12-15 mm burr hole previously discussed above. A
drill hole of this small size can be made with a minor incision or
scalp or upper body area and with minimal trauma Thus, there is
less trauma and less discomfort for the patient when the burr hole
externalizer is used.
[0215] FIG. 50 is a top view of another embodiment of the burr hole
externalizer 4800. Most of the components are the same and are
numbered the same as the externalizer 4800 shown in FIG. 48. The
difference is that the flanges are replaced with a first headband
5010 and a second headband 5012. This produces four long legs when
compared to the externalizer 4800 shown in FIG. 48. Three elongated
legs could also be used to provide adequate attachment of the
externalizer to the patient's body. In the ends of each head band
are openings for body screws. The body screws may not have to be
used to secure the burr hole externalizer 4800 to the patient. It
should be noted that the embodiments shown are just two examples of
ways of attaching the burr hole externalizer 4800 to the patient.
There are many ways of stably attaching the burr hole externalizer
4800. In addition, although a burr hole is normally used for
entering the cranial cavity, this externalizer 4800 could easily be
used for similar operations on other portions of the patient's
body. Procedures that formerly required many hours can now be
performed in substantially less amounts of time with the burr hole
externalizer and the trajectory guide 3800.
[0216] Many uses are contemplated for this new trajectory guide
3800. For example, a surgical instrument can be used to access
certain portions of the body of the patient. Using the head of a
human patient as an example, the trajectory guide 3800 can be used
to deliver an instrument to an area of the brain for biopsy. An
instrument can also be used to access the ventricular area of the
brain and cerebrospinal fluid for placement of a ventricular shunt
or drain. The trajectory guide can also be used to enable a
neurosurgeon to perform ventricular endoscopy. The instrument in
such endoscopy typically includes a fiber optic for viewing a
portion of the brain. The instrument can be rigid or flexible. The
trajectory guide 3800 can also be used in treating or researching
various other disorders or diseases of the brain, such as
Alzheimer's disease, multiple sclerosis, Huntington's chorea,
Parkinson's disease and other neurodegenerative diseases. The
globus pallidus is one key to controlling the tremors that patients
with Parkinson's disease have. In some treatments, electrodes are
used to deliver electrical signals to this organ to reduce or
eliminate the effect of Parkinson's disease. In addition, a
surgical instrument can be used to perform a pallidotomy (i.e.,
lesion the globus pallidus). Similarly, other targets include the
thalamus and subthalamic nucleus. Depending on the surgeon,
additional targets could be considered, including nuclear and
non-nuclear regions of the brain stem. Another surgical procedure
is the removal of tumor material in the brain. The tumor can be
located and eliminated using an instrument delivered with the help
of the trajectory guide 3800. Still other procedures are removal of
lesions which are formed in the brain due to strokes or other
medical conditions.
[0217] Other Uses of the Trajectory Guide
[0218] Described above are procedures associated with the head and
brain. There are numerous other surgical procedures that can also
be performed on other than the brain that would benefit from
accurate placement of a surgical tool. In particular, it is
anticipated that cardiac and pulmonary conditions will be
ameliorated by minimally invasive therapies that can be made
possible with the trajectory guide. In such procedures, the
trajectory guide is more of a body portal and may or may not be
used to lock into a specific trajectory toward a target. Moreover,
such procedures may require use of more than one trajectory guide
or may require a multiple body portal configuration in which each
of the portals include one or more trajectory guides. In such
therapies, surgical instruments or observational tools may be
inserted to enable the surgeon in performing surgical procedures.
Similarly, probes may be delivered to specific targets or general
targets by the trajectory guide for the performance of cryotherapy,
laser therapy, radio frequency ablation, microwave interstitial
therapy, focussed ultrasound therapy and other therapies. These
therapies are all currently done on various parts of the body in
conjunction with an imaging device, such as the CT scanning device
4300. The trajectory guide 3800 makes delivery of the instruments
to the various targets easier in all of these therapies. In
addition, the use of the burr hole externalizer 4500 further speeds
procedures that require the entry of tools into the patient's
body.
[0219] FIGS. 51-55 show a trajectory guide 5100 which can be used
as a body portal. FIG. 51 is an end view of a patient positioned
within a MR scanner 5100. The patient has a body portal type
trajectory guide 5110 attached and positioned on their body. FIG.
52 is a side view of a patient positioned within a conventional MR
scanner 5100. As shown in FIG. 52, the body portal type trajectory
guide is positioned at an angle with respect to the body of the
patient so that the total overall height of the body portal type
trajectory guide 5110 will fit within the conventional MR scanner
5100. The movable element 4220, if positioned perpendicular with
respect to the body, may interfere with the MR scanner 5100. Most
certainly if the movable element 4220 is positioned perpendicular
with respect to the body, a surgical instrument could not be placed
within the movable element 4220. A surgical instrument such as a
catheter extends through a longitudinal opening or passageway 4222
in the movable element 4220. When perpendicular to the patient,
there would not be enough room between the MR scanner 5100 and the
surgical instrument being placed within the passageway 4222 of the
movable element 4220. It should be noted that the body portal type
trajectory guide 5110 may be equipped with a movable element 4220
or a guide member 240 or a positioning member 400. The movable
member 4220 is rotatable with respect to the patient so that a
surgical instrument may be placed within the movable member 4220
from any position the surgeon may take with respect to the patient.
In a scanning environment that has an open magnet, an angled base
is not necessary. The base for the body portal type positioner
could be made with a vertical surface or a surface substantially
parallel to the patient's body.
[0220] FIGS. 53-55 show the body portal type trajectory guide 5110
in more detail. FIG. 53 is a side view of the body portal type
trajectory guide 5110 and FIG. 54 is a cutaway side view of the
body portal type trajectory guide 5110. The movable element 4220
includes passageway 4222. The movable element 4220 also has a guide
stem end 4230 and a base end 4210. The base end 4210 is ball
shaped. The body portal type trajectory guide 5110 includes a base
5120 which has an opening or passageway 5122 therein. The
passageway 5122 allows the surgical instrument to pass into the
body of the patient and to a target 270 within the patient. At one
end of the passageway 5122 is a cup 5124. The cup 5124 is
dimensioned such that the cup grips the ball end 4210 of the
positioning member 4220. The cup 5124 may also include portions
which extend beyond the largest diameter of the ball end 4210 to
further grip the ball end 4210 of the movable member 4220. The base
5120 also includes an angled portion 5126 and a flat base portion
5128. The flat base portion 5128 is circular and includes a first
flange 5130 and a second flange 5132. A plastic ring 5140 includes
a finger 5142 which engages the slot between the first flange 5130
and the second flange 5132 of the flat base. The plastic finger
5142 engages the slot between the first flange 5130 and the second
flange 5132 so that the base 5120 can rotate or swivel with respect
to the plastic ring 5140. The plastic ring 5140 is merged or
attached to a flexible adhesive patch 5150. The flexible adhesive
patch is made from a flexible material which can conform to various
body portions or parts of a patient. An adhesive material is placed
on one side of the flexible adhesive patch. The adhesive is placed
on surface 5152 which is opposite the side of the flexible adhesive
patch 5150 closest to the angled base portion 5126. The flexible
adhesive patch 5150 is made of a biocompatible material such as
might be used to affix a colostomy bag to a patient or a similar
material. FIG. 55 shows an embodiment that includes a quick locking
mechanism 5400. The base is provided with a high pitch thread. The
locking mechanism 5400 is provided with a matching high pitch
thread. The locking mechanism 5400 is also provided with a single
arm or knob 5410 for turning the locking mechanism 5400 with
respect to the threaded base portion. The knob 5410 is positioned
away from the patient so that the surgeon has easy access to the
knob 5410. Because a high pitch thread length is used, the knob
needs to be turned only slightly to lock the movable element 4220
into position with respect to the base.
[0221] FIG. 55 is a top view of the body portal type trajectory
guide 5110. The movable member 4220 includes the guide stem end
4230 and the ball end 4210 which is positioned within the cup 5124.
The base is angled through the angled base portion 5126 and is
attached to the flat base portion 5128. The flat base portion is
attached to the plastic ring portion 5140 which in turn is merged
with a flexible body patch 5150.
[0222] In operation, the body portal type trajectory guide 5110 is
used as follows. Initially, the surgeon determines the approximate
location of the target 270 within the body of the patient. An
incision is made in the patient near the target 270. The body
portal type trajectory guide 5110 is then placed over the incision
so that the passageway 5122 in the base 5120 is positioned over the
incision that is made in the patient. The passageway 5122 is
roughly aligned with a line between the target and the incision
within the patient. The flexible adhesive patch 5150 is attached to
the patient to seal the incision as well as to provide a stable
attachment point for the body portal type trajectory guide 5110.
The movable member 4220 can be repositioned with respect to the cup
5124 within the base 5120 of the trajectory guide 5110. The entire
base 5120 can be moved with respect to the plastic ring 5140 and
the flexible adhesive patch 5150. By moving the base with respect
to the flexible adhesive patch, a surgeon is afforded the
flexibility to work from a variety of positions with respect to the
patient and with respect to the MR scanner which is positioned
around the patient. Initially, the physician will roughly position
the base 5120 with respect to the target. The base 5120 can be
rotated with respect to the plastic ring and flexible adhesive
patch to enable the surgeon to take any position with respect to
the incision and the patient. The movable member 4222 can then be
moved to assure that the surgical instrument that will be placed
within the opening or passageway 4222 in the movable member 4220
will intersect with the target 270. The movable member can be
equipped with RF micro coils to aid in positioning the movable
member, similar to those described in U.S. patent application Ser.
No. 08/919,649 filed Aug. 8, 1997 and entitled "Surgical Instrument
Trajectory Guide Method and Apparatus".
[0223] It should be noted that the body portal type trajectory
guide 5110 will be used when the targets 270 are relatively large.
In other words, a trajectory guide 5110 can be used to take a
biopsy of a liver, which is a relatively large organ. Thus, if the
guide member 4220 is slightly out of position, the sample will come
from just a slightly different portion of the liver but will still
be valid. Although a locking member could be provided, the body
portal type trajectory guide 5110 shown does not feature a locking
member for the movable member 4222. The cup 5124 holds the ball end
4210 of the movable member 4220 tightly such that it will not move
under most conditions. As stated before, the body portal type
trajectory guide 5110 is used on relatively large targets 270 and,
therefore, slight movement of the movable member due to respiratory
excursion will not affect the placement of the surgical instrument
within the large target 270. Once the surgical instrument has been
inserted through the passageway 4222 and the passageway 5122 and to
the target 270 and the operation has been performed, the surgical
instrument is removed. The body patch 5150 can then also be
removed. By removing the body patch 5150, the entire trajectory
guide 5110 is also removed. The incision is then sewn or bandaged
by the surgeon to end the operation. The main advantages of the
body portal type trajectory guide 5110 is that the operation can be
done relatively quickly in either a CT or MR environment. The body
patch 5150 also keeps the area clear and clean. Operations that
used to be difficult or impossible or used to take large amounts of
time can now be performed easily and efficiently.
[0224] There are many other uses contemplated for the body portal
type trajectory guide 5110. The trajectory guide 5110 can be used
to biopsy or provide therapy to organs in or near the abdomen or
pelvis. Among the uses are liver biopsies, renal biopsies,
pancreatic biopsies, adrenal biopsies. In addition, some procedures
require both a biopsy as well as a therapy. The biopsy needle is
used first and then an instrument used in therapy is substituted
for the biopsy needle. The instrument for applying therapy includes
instruments for thermal ablation, and instruments for providing
shunts to various organs such as TIPS (transjugular interhepatic
portal systemic shunts). The trajectory guide 5110 can also be used
to conduct biliary drainages, and used to conduct other biopsies
and treatments at or near the abdomen of the pelvis. The trajectory
guide 5110 can also be used for procedures on the back and near the
spine of a patient. Nerve blocks epidural injections, facet
injections, sacroiliac joint injections, and spinal cordotomy are
just a few of the procedures possible with the trajectory guide
5110. Non-brain treatments and biopsies in the head and neck can
also be accomplished using the trajectory guide 5110. Trigeminal
neuralgia can be treated using the trajectory guide 5110. Biopsies
of the pleura, the lung, and the mediastinum and removal of
emphysematous to reduce the volume of the lung can be done
percutaneously using the trajectory guide. The trajectory guide
5110 can also be used for fetal surgery such as for diversion of
fetal hydrocephalus, and for treatment of fetal hydronephrosis.
These are just a sampling of the possible procedures that can be
done using the body portal type trajectory guide 5110. Numerous
other procedures will be accomplished using this device. In
addition, the device will give rise to other future surgical
procedures.
[0225] It is to be understood that the above description is
intended to be illustrative, and not restrictive. Many other
embodiments will be apparent to those of skill in the art upon
reviewing the above description. The scope of the invention should,
therefore, be determined with reference to the appended claims,
along with the full scope of equivalents to which such claims are
entitled.
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