U.S. patent application number 16/049706 was filed with the patent office on 2019-05-30 for system and method for image guidance during medical procedures.
This patent application is currently assigned to ViewRay Technologies, Inc.. The applicant listed for this patent is ViewRay Technologies, Inc.. Invention is credited to James F. Dempsey.
Application Number | 20190159845 16/049706 |
Document ID | / |
Family ID | 46314460 |
Filed Date | 2019-05-30 |
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United States Patent
Application |
20190159845 |
Kind Code |
A1 |
Dempsey; James F. |
May 30, 2019 |
SYSTEM AND METHOD FOR IMAGE GUIDANCE DURING MEDICAL PROCEDURES
Abstract
A surgical guidance system is disclosed that allows for
real-time imaging and patient monitoring during a surgical
procedure. The system can include an MRI system for generating
real-time images of the patient while surgery is being performed.
Prior to surgery, a surgical plan can be created using a planning
interface. A control unit receives the real-time image data and the
surgical plan, and monitors the image data based on parameters
included in the surgical plan. The control-unit monitoring occurs
in real-time while the surgical procedure is being performed. The
control unit can detect deviations from the surgical plan and/or
high-risk patient conditions and instruct an alert unit to issue an
alert based on the detected conditions.
Inventors: |
Dempsey; James F.;
(Atherton, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
ViewRay Technologies, Inc. |
Oakwood Village |
OH |
US |
|
|
Assignee: |
ViewRay Technologies, Inc.
Oakwood Village
OH
|
Family ID: |
46314460 |
Appl. No.: |
16/049706 |
Filed: |
July 30, 2018 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14332839 |
Jul 16, 2014 |
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16049706 |
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13333726 |
Dec 21, 2011 |
8812077 |
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14332839 |
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61425891 |
Dec 22, 2010 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 2034/256 20160201;
A61N 5/1045 20130101; A61B 2090/374 20160201; A61N 5/1049 20130101;
A61B 34/25 20160201; A61N 5/1067 20130101; A61B 34/30 20160201;
G01R 33/4808 20130101; A61N 2005/1055 20130101; G01R 33/3806
20130101; A61B 90/37 20160201 |
International
Class: |
A61B 34/00 20060101
A61B034/00; A61B 90/00 20060101 A61B090/00; A61N 5/10 20060101
A61N005/10 |
Claims
1. A surgical guidance system, comprising: a magnetic resonance
imaging (MRI) system configured for generating MRI data
representative of a portion of a patient; a planning interface for
generating a surgical plan based at least in part on pre-surgical
images and input information regarding surgical parameters for a
surgical procedure, the surgical parameters including one or more
position based parameters and one or more non-position based
parameters; a control unit for receiving image data based on the
MRI data acquired during the surgical procedure and for monitoring
the image data for conditions included in the surgical parameters
of the surgical plan; and an alert unit for issuing an alert based
on instructions from the control unit, wherein the control unit is
configured to instruct the alert unit to issue the alert based on
detecting at least one of the conditions included in the surgical
parameters of the surgical plan.
2. The surgical guidance system of claim 1, wherein the MRI
includes first and second main magnets separated by a gap.
3. The surgical guidance system of claim 1, wherein the MRI is
configured such that images are captured substantially
simultaneously with performance of the surgical procedure.
4. The surgical guidance system of claim 3, wherein the control
unit is configured to employ the image data for monitoring a
patient's response to the surgical procedure substantially
simultaneously with performance of the surgical procedure.
5. The surgical guidance system of claim 4, wherein the monitoring
of the patient's response to the surgical procedure includes
monitoring changes to a patient's anatomy substantially
simultaneously with performance of the surgical procedure.
6. The surgical guidance system of claim 5, wherein the control
unit is configured to instruct the alert unit to issue the alert
during the surgical procedure based on detecting at least one
condition associated with the changes to the patient's anatomy.
7. The surgical guidance system of claim 1, further comprising a
tracking unit for tracking a surgical instrument used for
performing the surgical procedure.
8. The surgical guidance system of claim 1, further comprising a
tracking unit for tracking a surgical robotic device performing the
surgical procedure.
9. The surgical guidance system of claim 1, wherein the alert unit
is configured to issue the alert in the form of at least one of
visual information and audible information.
10. The surgical guidance system of claim 1, further comprising an
image processing unit for receiving the MRI data from the MRI
system and generating the image data based on the MRI data.
11. The surgical guidance system of claim 10, wherein the MRI
system is configured for: obtaining MRI data representative of a
first quality of images before the start of the surgical procedure;
and obtaining MRI data representative of a second quality of images
during substantially simultaneous performance of the surgical
procedure, the second quality being lower than the first
quality.
12. The surgical guidance system of claim 11, wherein the image
processing unit is configured for generating image data
representative of volumetric images from MRI data generated during
the obtaining of MRI data representative of the second quality of
images, and wherein the generating of the image data representative
of volumetric images includes using deformable image
registration.
13. The surgical guidance system of claim 10, wherein the image
processing unit is configured for generating image data
representative of volumetric images based on the MRI data received
from the MRI system.
14. The surgical guidance system of claim 13, wherein the image
processing unit is configured for generating the image data
representative of volumetric images using deformable image
registration.
15. A surgical guidance system of claim 1, wherein the one or more
non-position based parameters include an extent of allowable
penetration into an organ, an allowable volume of tissue to be
resected, an allowable amount of organ motion, and an allowable
amount of blood pooling.
16. The surgical guidance system, comprising: a magnetic resonance
imaging (MRI) system configured for generating MRI data
representative of a portion of a patient substantially
simultaneously with performance of a surgical procedure on the
patient; a control unit for receiving image data representative of
volumetric images based on the MRI data acquired during the
surgical procedure and for monitoring the image data for
predetermined conditions, the predetermined conditions associated
with one or more position based parameters and one or more
non-position based parameters; and an alert unit for issuing an
alert based on instructions from the control unit, wherein the
control unit is configured to instruct the alert unit to issue the
alert based on detecting at least one of the predetermined
conditions.
17. The surgical guidance system of claim 16, further comprising a
planning interface for receiving at least one of the predetermined
conditions.
18. The surgical guidance system of claim 16, wherein the MRI is
configured such that MRI data is captured substantially
simultaneously with performance of the surgical procedure.
19. The surgical guidance system of claim 18, wherein the control
unit is configured to employ the image data for monitoring a
patient's response to the surgical procedure substantially
simultaneously with performance of the surgical procedure.
20. The surgical guidance system of claim 19, wherein the
monitoring of the patient's response to the surgical procedure
includes monitoring changes to a patient's anatomy substantially
simultaneously with performance of the surgical procedure.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation and claims the benefit of
priority under 35 U.S.C. .sctn.120 of U.S. patent application Ser.
No. 14/332,839, filed Jul. 16, 2014, entitled "System And Method
For Image Guidance During Medical Procedures", which claims the
benefit of priority of U.S. patent application Ser. No. 13,333/726,
filed Dec. 21, 2011, entitled "System And Method For Image Guidance
During Medical Procedures", which claims the benefit of priority
under 35 U.S.C. .sctn.119 of U.S. Provisional Application No.
61/425,891, filed Dec. 22, 2010, entitled "Devices And Methods For
Real-Time Image Guidance To Assist In Surgical Procedures". The
disclosures of these documents are incorporated herein by reference
in their entirety for all purposes.
BACKGROUND
1. Technical Field
[0002] The present disclosure relates to medical systems and
methods, and more particularly to systems and methods for imaging
the anatomy of a patient during medical treatment, particularly
where the resulting images can be used for enhancing the medical
treatment.
2. Related Art
[0003] Many types of medical treatments involve a pre-treatment
planning phase. Examples of medical treatments may include such
things as medications, physical therapy, radiation treatment,
and/or surgical procedures. Pre-treatment planning may include
medical imaging of patient anatomy, such as x-ray, computed
tomography (CT), and/or magnetic resonance imaging (MRI). The
images can then be used to assist a physician with deciding on a
course of treatment, and preparing a detailed plan for carrying out
the medical treatment.
[0004] For example, where a medical treatment involves a surgical
procedure, a surgical plan is commonly prepared prior to performing
the actual surgery. In some cases, a patient undergoes some form of
preoperative medical imaging so that the surgical team can review
images of the patient's anatomy as part of the surgical planning
process. Also, in some cases the preoperative images can be used
during the surgical procedure. Image-guided surgery (IGS) is a
general term used for a surgical procedure where the surgeon can
employ tracked surgical instruments in conjunction with
preoperative or intraoperative planar images in order to indirectly
guide the procedure. Most image-guided surgical procedures are
minimally invasive.
[0005] Surgery can include, but is not limited to, any one or more
of the following procedures:
[0006] Incision--puncturing or cutting into an organ, tumor, or
other tissue.
[0007] Excision--cutting out an organ, tumor, or other tissue.
[0008] Resection--partial removal of an organ or other bodily
structure.
[0009] Reconnection of organs, tissues, etc., particularly if
severed. Resection of organs, such as intestines, typically
involves reconnection. Internal suturing or stapling may be used
for the reconnection. Surgical connection between blood vessels or
other tubular or hollow structures, such as loops of intestine, is
called anastomosis.
[0010] Ligation--tying off blood vessels, ducts, or "tubes."
[0011] Grafting--severing pieces of tissue cut from the same (or
different) body, or flaps of tissue still partially connected to
the body, but resewn for rearranging or restructuring of an area of
the body in question. Although grafting is often used in cosmetic
surgery, it is also used in other surgery. Grafts may be taken from
one area of the patient's body and inserted to another area of the
body. An example is bypass surgery, where clogged blood vessels are
bypassed with a graft from another part of the body. Alternatively,
grafts may be from other persons, cadavers, or animals.
[0012] Insertion of prosthetic parts. Examples of prosthetic parts
can include pins or screws for setting and holding together bones;
prosthetic rods or other prosthetic parts for replacing sections of
bone; plates that are inserted to replace a damaged area of a
skull; so-called artificial parts, for example artificial hips,
used to replace damaged anatomy; heart pacemakers or valves; or
many other types of known prostheses.
[0013] Creation of a stoma, which is a permanent or semi-permanent
opening in the body.
[0014] Organ or tissue transplantation, where a donor organ (taken
out of a donor's body) is inserted into a recipient's body and
connected to the recipient in all necessary ways (blood vessels,
ducts, etc.).
[0015] Arthrodesis--surgical connection of adjacent bones so the
bones can grow together into one. Spinal fusion is an example of
arthrodesis, where adjacent vertebrae are connected allowing them
to grow together into one piece.
[0016] Modification of tissues, e.g., the digestive tract in
bariatric surgery for weight loss.
[0017] Repair of a fistula, hernia, stoma, or prolapse.
[0018] Ablation or destruction of tissues through the use of heat,
cold, electrical current, radiation, or other cell-trauma inducing
technology.
[0019] Angioplasty, endoscopy, or implantation of devices.
[0020] Clearing clogged ducts, blood or other vessels.
[0021] Removal of calculi (stones).
[0022] Draining of accumulated fluids.
[0023] Debridement, which involves the removal of dead, damaged, or
diseased tissue.
[0024] Exploration to aid or confirm a diagnosis.
[0025] Sampling of tissue to aid or confirm a diagnosis.
[0026] Amputation, replantation, or reconstruction of tissues or
organs.
[0027] Some conventional ICS systems include a planar imaging
system and a hand-held surgical probe. The planar imaging system is
used to take a preoperative or intraoperative "snap shot" of the
patient's anatomy in order to locate the patient's anatomy and plan
the surgical procedure. During the surgical procedure, some IGS
systems include the ability to track the surgical probe position
relative to the planar, static image. In such cases, the IGS system
includes a display for displaying the static image beneath an image
representative of the surgical probe. In some IGS systems, the
probe location can be displayed over patient anatomy, where patient
anatomy is displayed as three orthogonal, planar image slices on a
workstation-based 3D imaging system.
[0028] An example of an IGS system is StealthStation.RTM., which is
a product offered by Medtronic, Inc. The Medtronic
StealthStation.RTM. IGS system utilizes electromagnetic and optical
tracking technology to determine the location of surgical
instruments within a patient during a surgical procedure. The
system uses previously-prepared coregistered sectional 2-D images,
which are combined using known algorithms to produce 3-D images.
The system can then superimpose the position of the instrument over
the images so that the surgeon can observe the location of the
instrument during a surgical procedure. Such IGS systems may use
any of a variety of different tracking techniques, including
mechanical, optical, ultrasonic, and electromagnetic technologies
to track the probe relative to the static images. Such systems have
followed a paradigm where the patient's anatomy is assumed to be
static and unmoving during a surgical procedure, and the focus has
been attempting to track the "proper" location of the surgical
probe or instrument. Such systems also assume that the surgeon will
be observing the images, rather than the patient, while positioning
the instrument.
[0029] As mentioned above, references to treatments can also
include medical treatments other than those involving surgical
procedures. Another example of a medical treatment is radiation
therapy. For example, disease caused by proliferative tissue
disorders such as cancer and coronary artery restenosis are
sometimes treated with radiation, where the portions of the patient
known to contain or suspected to contain disease are irradiated.
For this purpose, a radiotherapy planning system is used to first
acquire planning images of the diseased portion(s) and surrounding
regions.
[0030] Radiotherapy planning systems generally include a CT or MRI
simulator. CT or MRI radiography is carried out, typically on a
single day, before the beginning of therapy to acquire a plurality
of coregistered sectional 2-D images. These sectional images are
combined using known algorithms to produce 3-D images. These 3-D
simulation images are displayed and then analyzed to identify the
location of regions of suspected disease to be treated, such as a
radiographically evident tumor or regions suspected of microscopic
disease spread. These regions to be treated are called radiotherapy
targets.
[0031] In order to attempt to account for organ motions, the
concept of margins and planning target volumes (PTVs) was developed
to attempt to irradiate a volume that would hopefully contain the
target during most of the irradiation. PTVs include a geometric
margin to account for variations in patient geometry or motion.
Likewise, the 3-D simulation images are displayed and then analyzed
to identify important normal anatomy and tissues that may be
damaged by the radiation, such as the spinal cord and lung, to
evaluate the potential impact of radiation on the function of these
tissues. These regions to be spared or protected from excessive
radiation are called critical structures or organs at risk and may
also include a margin to account for variations in patient geometry
or motion. The delivery of radiation therapy is then traditionally
planned on a single static model of radiotherapy targets and
critical structures derived from a single set of CT and/or MRI
images.
[0032] Because the known art does not allow for simultaneous
volumetric imaging and therapy, the patient and all of their
internal organs need to be repositioned exactly for accurate IGS or
radiation dose delivery. However, it is known in the art that
exactly repositioning the patient is not possible due to several
factors including: the inability to reproduce the patient setup,
i.e., the geometry and alignment of the patient's body;
physiological changes in the patient, such as weight loss or tumor
growth and shrinkage; and organ motions in the patients including
but not limited to breathing motion, cardiac motion, rectal
distension, peristalsis, bladder filling, and voluntary muscular
motion. Note that the organ motions may occur on rapid time scales
such that changes may occur during a single dose delivery (e.g.,
breathing motion), termed "intra-fraction" organ motions, or they
may occur on slower time scales such that changes occur in between
dose deliveries or surgical procedures, termed "inter-fraction"
organ motions.
[0033] In both the fields of surgery and radiation therapy, patient
setup errors, physiological changes, and organ motions result in
increasing misalignment of the tracked surgical instrument or
treatment beams relative to the anatomical targets and critical
structures of a patient as the surgery or radiotherapy process
proceeds.
[0034] For example, in the field of radiation therapy, for years
practitioners have been acquiring hard-copy films of the patient
using the radiation therapy beam, technically referred to as a
"port film," to attempt to ensure that the beam position does not
significantly vary from the original plan. However, the port films
acquired are generally only single 2-D projection images taken at
some predetermined interval during the radiotherapy process
(typically 1 week). Port films cannot account for organ motion.
Additionally, port films do not image soft tissue anatomy with any
significant contrast, and only provide reliable information on the
honey anatomy of the patient. Accordingly, misalignment information
is only provided at the instants in time in which the port images
are taken, and may be misleading as the honey anatomy and soft
tissue anatomy alignment need not correlate and change with time.
With appropriate markers in the port image provided, the beam
misalignment may be determined and then corrected to some limited
degree.
[0035] More recently, some have disclosed acquiring the port images
electronically, referred to as electronic portal imaging. This
imaging technique employs solid state semiconductor, scintillator,
or liquid ionization chamber array technology to capture x-ray
transmission radiographs of the patient using the x-rays of the
linear accelerator or an associated kilovoltage x-ray unit. As with
the hard-copy technique, misalignment data is only provided at the
instants in time in which the port images are taken. Another recent
advance in electronic portal imaging includes the use of implanted
interstitial radio-opaque markers in an attempt to image the
location of soft tissues. These procedures are invasive and subject
to marker migration. Even when performed with the rapid acquisition
of many images, these procedures only result in finding the motion
of discrete points identified by the radio-opaque markers inside a
soft tissue, and cannot account for the true complexities of organ
motions and the dosimetric errors that they cause. Another recent
advance involves the acquisition of a volumetric cone-beam x-ray CT
image set or a helical tomotherapy megavoltage x-ray CT image set
before or after a daily delivery of radiation therapy, where the
image set can be used to create 3D volumetric image sets from the
2D electronic portal images. While this technology may account for
some patient setup errors, such as the geometry and alignment of
the patient's body, physiological changes in the patient, and
inter-fraction organ motions in the patient, it cannot account for
intra-fraction organ motions in the patients. Intrafraction organ
motions are very important and include, but are not limited to,
breathing motion, cardiac motion, rectal gas distension,
peristalsis, bladder filling, and voluntary muscular motion.
[0036] Radiation therapy has historically been delivered to large
regions of the body including the target volume. While some volume
margin is required to account for the possibility of microscopic
disease spread, much of the margin is required to account for
uncertainties in treatment planning and delivery of radiation.
Reducing the total volume of tissue irradiated is beneficial, since
this reduces the amount of normal tissue irradiated and therefore
reduces the overall toxicity to the patient from radiation therapy.
Furthermore, reduction in overall treatment volume may allow dose
escalation to the target, thus increasing the probability of tumor
control.
[0037] Clinical cobalt (.sup.60Co radioisotope source) therapy
units and MY linear accelerators (or linacs) were introduced nearly
contemporaneously in the early 1950's. The first two clinical
cobalt therapy units were installed nearly simultaneously in
October of 1951 in Saskatoon and London, Ontario. The first MV
linear accelerator installed solely for clinical use was at
Hammersmith Hospital in London, England, in June of 1952. The first
patient was treated with this machine in August of 1953. These
devices soon became widely employed in cancer therapy. The deeply
penetrating ionizing photon beams quickly became the mainstay of
radiation therapy, allowing the widespread noninvasive treatment of
deep seated tumors. The role of X-ray therapy slowly changed with
the advent of these devices from a mainly palliative therapy to a
definitive curative therapy. Despite similarities, cobalt units and
linacs were always viewed as rival technologies in external beam
radiotherapy. This rivalry would result in the eventual dominance
of linacs in the United States and Western Europe.
[0038] The cobalt unit was quite simplistic and was not technically
improved significantly over time. Of course, the simplicity of the
cobalt unit was a cause for some of its appeal; the cobalt units
were very reliable, precise, and required little maintenance and
technical expertise to run. Early on, this allowed cobalt therapy
to become the most widespread form of external beam therapy.
[0039] [The linac was the more technically intensive device. Linacs
were capable of accelerating high currents of electrons to energies
between 4 and 25 MeV to produce beams of bremsstrahlung photons or
scattered electrons. As such, the linac was a much more versatile
machine that allowed more penetrating beams with sharper penumbrae
and higher dose rates. As the linac became more reliable, the
benefits of having more penetrating photon beams coupled with the
addition of electron beams was seen as strong enough impetus to
replace the existing cobalt units.
[0040] [Cobalt therapy did not die away without some protests, and
the essence of this debate was captured in a famous paper in 1986
by Laughlin, Mohan, and Kutcher, which explained the pros and cons
of cobalt units and linacs. This was accompanied by an editorial
from Suit that pleaded for the continuance and further technical
development of cobalt units. The pros of cobalt units and linacs
have already been listed. The cons of cobalt units were seen as
less penetrating depth dose, larger penumbra due to source size,
large surface doses for large fields due to lower energy
contamination electrons, and mandatory regulatory oversight. The
cons for linacs increased with their increasing energy (and hence
their difference from a low energy cobalt beam), and were seen to
be increased builddown, increased penumbra due to electron
transport, increased dose to bone (due to increased dose due to
pair production), and most importantly the production of
photo-neutrons at acceleration potentials over 10 MV.
[0041] In the era before intensity modulated radiation therapy
(IMRT), the linac held definite advantages over cobalt therapy. The
fact that one could produce a very similar beam to cobalt using a 4
MV linac accelerating potential combined with the linac's ability
to produce either electron beams or more penetrating photon beams,
made the linac preferable. When the value of cobalt therapy was
being weighed against the value linac therapy, radiation fields
were only manually developed and were without the benefit of IMRT.
As IMRT has developed, the use of higher MY linac accelerating
potential beams and electron beams have been largely abandoned by
the community. This is partly due to the increased concern over
neutron production (and increased patient whole body dose) for the
increased beam-on times required by IMRT and the complexity of
optimizing electron beams, but most importantly because low MY
photon-beam IMRT could produce treatment plans of excellent quality
for all sites of cancer treatment.
[0042] IMRT represents a culmination of decades of improving 3D
dose calculations and optimization to the point that we have
achieved a high degree of accuracy and precision for static
objects. However, there is a fundamental flaw in our currently
accepted paradigm for dose modeling. The problem lies with the fact
that patients are essentially dynamic deformable objects that we
cannot and will not perfectly reposition for fractioned
radiotherapy. Even for one dose delivery, intra-fraction organ
motion can cause significant errors. Despite this fact, the
delivery of radiation therapy is traditionally planned on a static
model of radiotherapy targets and critical structures. The real
problem lies in the fact that outside of the cranium (i.e.,
excluding the treatment of CNS disease using Stereotactic
radiotherapy) radiation therapy needs to be fractionated to be
effective, i.e., it must be delivered in single 1.8 to 2.2 Gy
fractions or double 1.2 to 1.5 Gy fractions daily, and is
traditionally delivered during the work week (Monday through
Friday), taking 7 to 8 weeks to deliver a curative dose of 70 to 72
Gy at 2.0 or 1.8 Gy, respectively. This daily fractionation
requires the patient and all of their internal organs to be
repositioned exactly for accurate dose delivery. This raises an
extremely important question for radiation therapy: "Of what use is
all of the elegant dose computation and optimization we have
developed if the targets and critical structures move around during
the actual therapy?" Recent critical reviews of organ motion
studies have summarized the existing literature up to 2001 and have
shown that the two most prevalent types of organ-motion: patient
set-up errors and organ motions. While significant physiological
changes in the patient do occur, e.g., significant tumor shrinkage
in head-and-neck cancer is often observed clinically, they have not
been well studied. Organ motion studies have been further
subdivided into inter-fraction and intra-fraction organ motion,
with the acknowledgement that the two cannot be explicitly
separated, i.e., intra-fraction motions obviously confound the
clean observation of inter-fraction motions. Data on inter-fraction
motion of gynecological tumors, prostate, bladder, and rectum have
been published, as well as data on the intra-fraction movement of
the liver, diaphragm, kidneys, pancreas, lung tumors, and prostate.
Many peer-reviewed publications, spanning the two decades prior to
publication have demonstrated the fact that both inter- and
intra-fraction organ motions may have a significant effect on
radiation therapy dosimetry. This may be seen in the fact that
displacements between 0.5 and 4.0 cm have been commonly observed in
studies of less than 50 patients. The mean displacements for many
observations of an organ motion may be small, but even an
infrequent yet large displacement may significantly alter the
biologically effective dose received by a patient, as it is well
accepted that the correct dose per fraction must be maintained to
effect tumor control. In a more focused review of intra-fraction
organ motion recently published by Goitein (Seminar in Radiation
Oncology 2004 January; 14(1):2-9), the importance of dealing with
organ motion related dosimetry errors was concisely stated: "[I]t
is incontestable that unacceptably, or at least undesirably, large
motions may occur in some patients . . . ." It was further
explained by Goitein that the problem of organ motions has always
been a concern in radiation therapy: "We have known that patients
move and breathe and that their hearts beat and their intestines
wriggle since radiation was first used in cancer therapy. In
not-so-distant decades, our solution was simply to watch all that
motion on the simulator's fluoroscope and then set the field edge
wires wide enough that the target (never mind that we could not see
it) stayed within the field."
[0043] In an attempt to address the limitations imposed on
radiation therapy by patient setup errors, physiological changes,
and organ motion throughout the protracted weeks of radiation
therapy, imaging systems have been introduced that are capable of
acquiring a volumetric CT "snap shot" before and after each
delivery of radiation. This combination of a radiation therapy unit
with radiology imaging equipment has been termed image-guided
radiation therapy (IGRT), or preferably image guided IMRT (IGIMRT).
IGIMRT technology has the potential for removing patient setup
errors, detecting slow physiological changes, and detecting
inter-fraction organ motions that occur over the extended course of
radiation therapy. However, IGIMRT technology cannot account for
intra-fraction organ motion, which is a very significant form of
organ motion. IGIMRT devices are only being used to shift the gross
patient position. IGIMRT devices cannot capture infra-fraction
organ motion and are limited by the speed at which helical or
cone-beam CT imaging may be performed. Secondly, but perhaps
equally important, CT imaging adds to the ionizing radiation dose
delivered to the patient. It is well known that the incidence of
secondary carcinogenesis occurs in regions of low-to-moderate dose,
and the whole body dose will be increased by the application of
many CT image studies.
[0044] CT imaging and MRI units were both demonstrated in the
1970's. CT imaging was adopted as the "gold standard" for radiation
therapy imaging early on due to its intrinsic spatial integrity,
which comes from the physical process of X-ray attenuation. Despite
the possibility of spatial distortions occurring in MRI, it is
still very attractive as an imaging modality for radiotherapy. MRI
has a much better soft tissue contrast than CT imaging, and has the
ability to image physiological and metabolic information, such as
chemical tumor signals or oxygenation levels. The MRI artifacts
that influence the spatial integrity of the data are related to
undesired fluctuations in the magnetic field homogeneity and may be
separated into two categories: 1) artifacts due to the scanner,
such as field inhomogeneities intrinsic to the magnet design, and
induced eddy currents due to gradient switching; and 2) artifacts
due to the imaging subject, i.e., the intrinsic magnetic
susceptibility of the patient. Modem MRI units are carefully
characterized and employ reconstruction algorithms that may
effectively eliminate artifacts due to the scanner. At high
magnetic field strength, in the range of 1.0-3.0 T, magnetic
susceptibility of the patient may produce significant distortions
(which are proportional to field strength) that may often be
eliminated by first acquiring susceptibility imaging data.
Recently, many academic centers have started to employ MRI for
radiation therapy treatment planning. Rather than dealing with
patient-related artifacts at high field strength, many radiation
therapy centers have employed low-field MRI units with 0.2-0.3 T
for radiation therapy treatment planning, as these units diminish
patient-susceptibility spatial distortions to insignificant levels.
For dealing with intra- fraction organ motion, MRI is highly
favorable due to the fact that it is fast enough to track patient
motions in real-time, has an easily adjustable and orientable field
of view, and does not deliver any additional ionizing radiation to
the patient that may increase the incidence of secondary
carcinogenesis. Breath-controlled and spirometer-gated fast
multi-slice CT has recently been employed in an attempt to assess
or model intra-fraction breathing motion by many research groups.
Fast, single-slice MRI has also been employed in the assessment of
intra-fraction motions, and dynamic parallel MRI is able to perform
volumetric intra-fraction motion imaging. MRI holds a definite
advantage over CT for fast repetitive imaging due to the need for
CT imaging to deliver increasing doses to the patient. Concerns
over increased secondary carcinogenesis due to whole-body dose
already exist for IMRT and become significantly worse with the
addition of repeated CT imaging.
[0045] Two research groups appear to have simultaneously been
attempting to develop an MRI unit integrated with a linac. In 2001,
U.S. Pat. No. 6,198,957 was issued to Green, which teaches an
integrated MRI and linac device. In 2003, a group from the
University of Utrecht in the Netherlands presented their design for
an integrated MRI and linac device, and has since reported
dosimetric computations to test the feasibility of their device.
The significant difficulty with integrating an MRI unit with a
linac, as opposed to a CT imaging unit, is that the magnetic field
of the MRI unit makes the linac inoperable. It is well known that a
charged particle moving at a velocity, v, in the presence of a
magnetic field B, experiences a Lorentz force given by F=v.times.B.
The Lorentz force caused by the MRI unit will not allow electrons
to be accelerated by the linac as they cannot travel in a linear
path, effectively shutting the linac off. The high radiofrequency
(RF) emittance of the linac will also cause problems with the RF
transceiver system of the MRI unit, corrupting the signals required
for image reconstruction and possibly destroying delicate
circuitry. The integration of a linac with a MRI unit is a
monumental engineering effort and has not previously been
enabled.
[0046] Intensity modulated radiation therapy (IMRT) is a type of
external beam treatment that is able to conform radiation to the
size, shape, and location of a tumor. IMRT is a major improvement
as compared to other conventional radiation treatments. The
radiotherapy delivery method of IMRT is known in the art of
radiation therapy and is described in a book by Steve Webb entitled
"Intensity-Modulated Radiation Therapy" (IOP Publishing, 2001, ISBN
0750306998). This work of Webb is incorporated by reference into
the application in its entirety and hereafter referred to as "Webb
2001." The effectiveness of conventional radiation therapy is
limited by imperfect targeting of tumors and insufficient radiation
dosing. Because of these limitations, conventional radiation may
expose excessive amounts of healthy tissue to radiation, thus
causing negative side-effects or complications. With IMRT, the
optimal 3D dose distribution, as defined by criteria known in the
art (such as disclosed by Webb 2001), is delivered to the tumor and
dose to surrounding healthy tissue is minimized.
[0047] In a typical IMRT treatment procedure, the patient undergoes
treatment planning x-ray CT imaging simulation with the possible
addition of MRI simulation or a position emission tomography (PET)
study to obtain metabolic information for disease targeting. When
scanning takes place, the patient is immobilized in a manner
consistent with treatment so that the imaging is completed with the
highest degree of accuracy. A radiation oncologist or other
affiliated health care professional typically analyzes these images
and determines the 3D regions that need to be treated and 3D
regions that need to be spared, such as critical structures, e.g.
the spinal cord and surrounding organs. Based on this analysis, an
IMRT treatment plan is developed using large-scale
optimization.
[0048] IMRT relies on two advanced technologies. The first is
inverse treatment planning. Through sophisticated algorithms using
high speed computers, a treatment plan can be determined using an
optimization process. The treatment plan is intended to deliver a
prescribed uniform dose to a tumor while minimizing excessive
exposure to surrounding healthy tissue. During inverse planning a
large number (e.g. several thousands) of pencil beams or beamlets
that comprise the radiation beam are independently targeted to the
tumor or other target structures with high accuracy. Through
optimization algorithms, the non-uniform intensity distributions of
the individual beamlets are determined to attain certain specific
clinical objectives.
[0049] The second technology relied on for IMRT involves the used
of multi-leaf collimators (MLC). MLC technology allows for delivery
of the treatment plan derived from the inverse treatment planning
system. A separate optimization, referred to as leaf sequencing, is
used to convert the set of beamlet fluences to an equivalent set of
leaf motion instructions or static apertures with associated
fluences. The MLC is typically composed of computer-controlled
tungsten leaves that shift to form specific patterns, thereby
blocking the radiation beams according to the intensity profile
from the treatment plan. As an alternative to MLC delivery, an
attenuating filter may also be designed to match the fluence of
beamlets.
[0050] After the treatment plan is generated and quality control
checking has been completed, the patient is immobilized and
positioned on the treatment couch. Positioning of the patient
includes attempting to reproduce the patient positioning from
during the initial x-ray CT or magnetic resonance imaging.
Radiation is then delivered to the patient via the MLC instructions
or attenuation filter. This process is then repeated for many weeks
until the prescribed cumulative dose is assumed to be
delivered.
[0051] Magnetic resonance imaging (MRI) is an advanced diagnostic
imaging procedure that creates detailed images of internal bodily
structures without the use of ionizing radiation, which is used in
x-ray or megavoltage x-ray CT imaging. The diagnostic imaging
method of MRI is known in the arts of radiology and radiation
therapy and is described in the books by E. M. Haacke, R. W. Brown,
M. R. Thompson, R. Venkatesan entitled Magnetic Resonance Imaging:
Physical Principles and Sequence Design (John Wiley & Sons,
1999, ISBN 0-471-35128-8) and by Z.-P. Liang and P. C. Lauterbur
entitled Principles of Magnetic Resonance Imaging: A Signal
Processing Perspective. (IEEE Press 2000, ISBN 0-7803-4723-4).
These works of Haacke et al. and Liang and Lauterbur are
incorporated herein by reference in their entirety, and are
hereafter referred to as "Haacke et al. 1999" and "Liang and
Lauterbur 2001," respectively. MRI is able to produce detailed
images through the use of a powerful main magnet, magnetic field
gradient system, radiofrequency (RE) transceiver system, and an
image reconstruction computer system. Open Magnetic Resonance
Imaging (Open MRI) is an advanced form of MRI diagnostic imaging
that uses a main magnet geometry that does not completely enclose
the patient during imaging. MRI is a very attractive imaging
modality for radiotherapy as it has a much better soft tissue
contrast than CT imaging and the ability to image physiological and
metabolic information, such as spectroscopic chemical tumor signals
or oxygenation levels. Many tracer agents exist and are under
development for MRI to improve soft tissue contrast (e.g.
Gadopentate dimeglumine for kidney or bowel enhancement, or
Gadoterate meglumine for general contrast). Novel contrast agents
are currently under development that will allow for the metabolic
detection of tumors, similar to PET imaging, by employing either
hyperpolarized liquids containing carbon 13, nitrogen 15, or
similar stable isotopic agents or paramagnetic niosomes. All of
these diagnostic MRI techniques enhance the accurate targeting of
disease and help assess response to treatment in radiation
therapy.
[0052] CT scanning for IMRT treatment planning is performed using
thin sections (2-3 mm), sometimes after intravenous injection of an
iodine-containing contrast medium. CT scanning has the advantage of
being more widely available, cheaper than magnetic resonance
imaging (MRI), and it may be calibrated to yield electron density
information for treatment planning. Some patients who cannot be
examined by MRI (due to claustrophobia, cardiac pacemaker, aneurism
clips, etc.) may be scanned by CT.
[0053] The problem of patient setup errors, physiological changes,
and organ motions during various medical treatments, including
radiation treatment and IGS, is currently a topic of great interest
and significance. For example, in the field of radiology, it is
well known that the accuracy of conformal radiation therapy is
significantly limited by changes in patient mass, location,
orientation, articulated geometric configuration, and
inter-fraction and intra-fraction organ motions (e.g. during
respiration), both during a single delivery of dose (intrafraction
changes, e.g., organ motions such as rectal distension by gas,
bladder filling with urine, or thoracic breathing motion) and
between daily dose deliveries (interfraction changes, e.g.,
physiological changes such as weight gain and tumor growth or
shrinkage, and patient geometry changes). No single effective
method has previously been known to account for all of these
deviations simultaneously during each and every actual dose
delivery. Current state-of-the-art imaging technology allows taking
2D and 3D megavoltage and orthovoltage x-ray CT "snap-shots" of
patients before and after a medical treatment, or may allow for
taking time-resolved 2D radiographs that have no soft tissue
contrast during radiation delivery.
[0054] Great advances have been made in a number of medical fields
that involve various types of medical therapies, including
conformal radiation therapy and IGS. However, their true efficacy
is not realized without improved real-time imaging guidance and
control.
SUMMARY
[0055] The present disclosure includes detailed descriptions of
embodiments that allow for real-time monitoring of patient anatomy
during various types of medical treatments. For example, disclosed
embodiments can include a device and/or a process for performing
high temporal- and spatial-resolution magnetic resonance imaging
(MRI) of the anatomy and target tissues of a patient during various
forms of medical therapy, which can include, for example, radiation
therapy and/or various types of surgical procedures.
[0056] According to one aspect of the present disclosure, a
surgical guidance system can comprise a magnetic resonance imaging
(MRI) system configured for generating MRI data representative of a
portion of a patient, a planning interface for generating a
surgical plan based at least in part on pre-surgical images and
input information regarding surgical parameters for a surgical
procedure, a control unit for receiving image data based on the MRI
data acquired during the surgical procedure and for monitoring the
image data for conditions included in the surgical parameters of
the surgical plan, and an alert unit for issuing an alert based on
instructions from the control unit, wherein the control unit is
configured to instruct the alert unit to issue the alert based on
detecting at least one of the conditions included in the surgical
parameters of the surgical plan.
[0057] The MRI can include first and second main magnets separated
by a gap. The MRI system can be configured for generating MRI data
representative of the portion of the patient positioned in the
gap.
[0058] The MRI can be configured such that images may be captured
substantially simultaneously with performance of the surgical
procedure. The control unit can be configured to employ the image
data for monitoring patient's response to the surgical procedure
substantially simultaneously with performance of the surgical
procedure. The monitoring of the patient's response to the surgical
procedure can include monitoring changes to the patient's anatomy
substantially simultaneously with performance of the surgical
procedure. The control unit can be configured to instruct the alert
unit to issue the alert during the surgical procedure based on
detecting at least one condition associated with the changes to the
patient's anatomy.
[0059] The surgical guidance system can further comprise a tracking
unit for tracking a surgical instrument used for performing the
surgical procedure.
[0060] The surgical guidance system can further comprise a tracking
unit for tracking a surgical robotic device performing the surgical
procedure.
[0061] The alert unit can be configured to issue the alert in the
form of at least one of visual information and audible
information.
[0062] The surgical guidance system may further comprise an image
processing unit for receiving the MRI data from the MRI system and
generating image data based on the MRI data. The MRI system can be
configured for obtaining MRI data representative of a first quality
of images before the start of the surgical procedure, and for
obtaining MRI data representative of a second quality of images
during substantially simultaneous performance of the surgical
procedure, the second quality being lower than the first quality.
The image processing unit can be configured for generating image
data representative of volumetric images from MRI data generated
during the obtaining of MRI data representative of the second
quality of images, wherein the generating of the image data
representative of volumetric images can include using deformable
image registration.
[0063] The image processing unit can be configured for generating
image data representative of volumetric images based on the MRI
data received from the MRI system. The image processing unit can be
configured for generating the image data representative of
volumetric images using deformable image registration.
[0064] According to another aspect of the present disclosure, a
surgical guidance system can comprise an MRI system configured for
generating MRI data representative of a portion of a patient
substantially simultaneously with performance of a surgical
procedure on the patient. The surgical guidance system can also
comprise a control unit for receiving image data representative of
volumetric images based on the MRI data acquired during the
surgical procedure and for monitoring the image data for
predetermined conditions, and an alert unit for issuing an alert
based on instructions from the control unit. The control unit can
be configured to instruct the alert unit to issue the alert based
on detecting at least one of the predetermined conditions.
[0065] The surgical guidance system can further comprise a planning
interface for receiving at least one of the predetermined
conditions.
[0066] The MRI can be configured such that images may be captured
substantially simultaneously with performance of the surgical
procedure. The control unit can be configured to employ the image
data for monitoring patient's response to the surgical procedure
substantially simultaneously with performance of the surgical
procedure. The monitoring of the patient's response to the surgical
procedure can include monitoring changes to the patient's anatomy
substantially simultaneously with performance of the surgical
procedure.
[0067] The control unit can be configured to instruct the alert
unit to issue the alert during the surgical procedure based on
detecting at least one condition associated with the changes to the
patient's anatomy.
[0068] The surgical guidance system can further comprise an image
processing unit for receiving MRI data from the MRI system and
generating image data representative of the volumetric images based
on the MRI data. The MRI system can be configured for obtaining MRI
data representative of a first quality of images before the start
of the surgical procedure, and obtaining MRI data representative of
a second quality of images during substantially simultaneous
performance of the surgical procedure, the second quality being
lower than the first quality. The image processing unit can be
configured for generating image data representative of the
volumetric images from MRI data generated during the obtaining of
MRI data representative of the second quality of images, wherein
the generating of the image data representative of volumetric
images can include using deformable image registration.
[0069] The image processing unit can be configured for generating
image data representative of the volumetric images using deformable
image registration.
[0070] According to a further aspect of the present disclosure, a
surgical guidance a surgical guidance method comprises generating
MRI data representative of a portion of a patient; generating image
data based on the MRI data; generating a surgical plan based at
least in part on pre-surgical images and input information
regarding surgical parameters for a surgical procedure; monitoring
the image data for conditions included in the surgical parameters
of the surgical plan; and issuing an alert based on detecting at
least one of the conditions included in the surgical parameters of
the surgical plan. The image data can be representative of
volumetric images based on the MRI data.
[0071] These and other features, aspects, and embodiments are
described below in the section entitled "Detailed Description of
the Drawings."
BRIEF DESCRIPTION OF DRAWINGS
[0072] There are shown in the drawings, embodiments which are
presently contemplated, it being understood, however, that the
present disclosure is not limited to the precise arrangements and
instrumentalities shown.
[0073] FIG. 1 shows a schematic view of a radiation therapy system
according to the present disclosure;
[0074] FIG. 2 shows another schematic view of the radiation therapy
system shown in FIG. 1, where a radiation source and collimator
have been rotated from the position shown in FIG. 1;
[0075] FIG. 3 shows a top view of the radiation therapy system
shown in FIG. 1;
[0076] FIG. 4 shows a side view of the radiation therapy system
shown in FIG. 1;
[0077] FIG. 5 shows a detailed schematic view of the co-registered
isotopic radiation source of the radiation therapy system shown in
FIG. 1;
[0078] FIG. 6 shows a perspective view of collimators of the
radiation therapy system shown in FIG. 1;
[0079] FIG. 7 shows a beams-eye view of the radioisotopic source
and collimators of the radiation therapy system shown in FIG.
1;
[0080] FIG. 8 shows axial dose distributions from a single
head-and-neck IMRT case planned using commissioned cobalt
beamlets;
[0081] FIG. 9 shows DVH data derived from the single head-and-neck
IMRT case shown in FIG. 8;
[0082] FIG. 10 shows cobalt beamlet dose distributions in water
with and without a 0.3 Tesla magnetic field;
[0083] FIG. 11 shows cobalt beamlets dose distributions in water
and lungs with and without a 0.3 Tesla magnetic field;
[0084] FIG. 12 shows cobalt beamlets dose distributions in water
and air with and without a 0.3 Tesla magnetic field;
[0085] FIG. 13 shows a block diagram of a surgical guidance system
according to the present disclosure;
[0086] FIG. 14 shows a perspective view of an embodiment of the
surgical guidance system shown in FIG. 13; and
[0087] FIG. 15 shows a perspective view of an alternative
embodiment of the surgical guidance system shown in FIG. 13.
DETAILED DESCRIPTION OF THE DRAWINGS
[0088] Aspects of the present disclosure are more particularly
described in the following examples that are intended to be
illustrative only since numerous modifications and variations
therein will be apparent to those skilled in the art. As used in
the specification and in the claims, the singular form "a," "an,"
and "the" may include plural referents unless the context clearly
dictates otherwise.
[0089] The present disclosure includes detailed descriptions of
embodiments that allow for real-time monitoring of patient anatomy
during various types of medical treatments. For example, disclosed
embodiments can include a device and/or a process for performing
high temporal- and spatial-resolution magnetic resonance imaging
(MRI) of the anatomy and disease of a patient during various forms
of medical therapy, which can include, for example, radiation
therapy and/or various types of surgical procedures. Specific,
non-limiting embodiments disclosed herein include embodiments that
include radiation therapy systems and embodiments that include
surgical guidance systems.
[0090] Thus, according to some embodiments, a radiation therapy
device and a process are provided for performing high temporal- and
spatial-resolution MRI of the anatomy and disease of a patient
during intensity modulated radiation therapy (IMRT) to directly
measure and control the highly conformal ionizing radiation dose
delivered to the patient. In a beneficial embodiment, a radiation
therapy system comprises an open MRI that allows for axial access
with IMRT radiation beams to the patient, a multileaf-collimator or
compensating filter-based IMRT delivery system, and cobalt-60
teletherapy radiation source or sources in a single co-registered
and gantry-mounted system.
[0091] As mentioned, prior systems do not simultaneously image the
internal soft tissue anatomy of a person in real time during the
delivery of radiation therapy while the radiation beams are
striking the patient. Rather, in prior systems, an image is
generated prior to and/or after the radiation delivery, and these
images do not reflect any movement and/or natural changes that may
occur in the patient during radiation delivery. As such, targeted
radiation without the devices described here may not be successful
if, after taking an initial image, the portion of the body to be
treated either changes in size naturally, or changes in location
due to the shifting of the patient prior to treatment; i.e., the
occurrence of patient setup errors or errors in the geometry and
alignment of the patients anatomy; physiological changes in the
patient, such as weight loss or tumor growth and shrinkage; and
organ motions in the patient including, but not limited to,
breathing motion, cardiac motion, rectal distension, peristalsis,
bladder filling, and voluntary muscular motion.
[0092] Aspects of the present disclosure allow for a system and
method that help to eliminate problems of prior systems by allowing
for real-time MRI of the patient substantially simultaneous to
radiation delivery. The targeted radiation can be readjusted if the
region to be treated suffers from any type of dosimetric error
caused patient setup error, physiological change, and/or
inter-fraction or intra-fraction organ motion. Many actions may be
taken including, but not limited to: shifting the patient position
to account for changes in size and/or position of targets and
anatomy; stopping treatment altogether to permit additional
calculations to be determined before restarting treatment or allow
for the cessation of transitory motion; adding extra delivery
fractions to increase the probability of tumor control or limiting
the number of delivery fractions to decrease the probability of
side effect; any of the beneficial process embodiments previous
described; and reoptimizing the IMRT treatment plan on a variety of
time scales, e.g., reoptimization for every delivery, every beam,
or every segment in the IMRT plan is performed.
[0093] Real-time imaging as referred to herein can refer to
repetitive imaging that may be acquired fast enough to capture and
resolve any intra-fraction organ motions that occur and that can
result in significant changes in patient geometry during a medical
treatment, for example while a dose of radiation is being
delivered. The data obtained by real-time imaging can allow for the
determination of the actual dose deposition in the patient. This
can be achieved by applying known techniques of deformable image
registration and interpolation to sum the doses delivered to the
moving tissues and targets. This data can be collected over the
course of an entire multi-session radiotherapy treatment program,
where data is accumulated while the radiation beams are striking
the patient and delivering the radiation dose, thereby allowing for
the quantitative determination of 3D in vivo dosimetry. Hence, the
present disclosure enables an effective means of assessing and
controlling, or eliminating, organ-motion related dose-delivery
errors.
[0094] Reference is now made with specific detail to the drawings
in which like reference numerals designate like or equivalent
elements throughout the several views, and initially to FIG. 1.
[0095] In FIG. 1, an embodiment of the present disclosure includes
an open MRI 15 and an IMRT cobalt therapy unit 20. The system shown
in FIG. 1 also includes a means to perform IMRT in the IMRT cobalt
therapy unit 20, such as an MFC or compensation filter unit, and a
gantry 25 that may be used for rotating the IMRT cobalt therapy
unit 20 while keeping the MRI 15 stationary. A patient 35 is
positioned on an adjustable, stationary couch 30.
[0096] FIG. 2 shows the system in use, and where the gantry 25 has
been rotated approximately 90 degrees clockwise relative to its
position in FIG. 1. As such, the IMRT cobalt therapy unit 20 is in
position to treat the patient 35 in one of many selectable
locations. FIG. 3 shows a top view of the system shown in FIG. 1,
and FIG. 4 shows a side view of the system shown in FIG. 1.
[0097] FIG. 5 shows a detailed schematic view of a co-registered
isotopic radiation source with a multi-leaf collimator, which
serves as an embodiment of the IMRT cobalt therapy unit in FIG. 1.
A radioisotopic source 115 is shown with a fixed primary collimator
120, a secondary doubly-divergent multileaf collimator 125, and a
tertiary multi-leaf collimator 130 for blocking interleaf leakage
from the secondary multi-leaf collimator 125. FIG. 6 shows a
perspective view of the secondary doubly-divergent multi-leaf
collimator 125 and the tertiary multi-leaf collimator 130. As
mentioned, the tertiary multi-leaf collimator 130 is provided for
blocking interleaf leakage from the secondary multi-leaf collimator
125. FIG. 7 shows a beams-eye view of the radioisotopic source 115,
the secondary doubly divergent multi-leaf collimator 125, and the
tertiary multi-leaf collimator 130.
[0098] [A beneficial embodiment of the present disclosure can thus
include a computer-controlled cone-beam cobalt therapy unit 20,
such as a cobalt-60 therapy unit, equipped with a multileaf
collimator or an automated compensating filter system mounted on a
rotational gantry 25 along with an orthogonally mounted "Open" MRI
unit 15. The IMRT cobalt unit 20 projects its cone-beam geometry
radiation down the center of the opening of the axial open MRI unit
15. The IMRT cobalt unit 15 rotates on a gantry 25 axially (about
the longitudinal (cranial-caudal) axis of the patient) about a
patient 35. An adjustable treatment couch 30 may be used to support
the patient 35 in a stationary position while the gantry 25 rotates
to change the beam angle.
[0099] The present embodiment can use cobalt teletherapy as the
radiation therapy. While some IMRT use a linear electron
accelerator for delivering a more penetrating radiation therapy,
the accelerator itself produces a treatment beam that is highly
variable in regards to the level of radiation emitted. As such, it
becomes difficult to accurately determine the amount of radiation
that is being used on the patient and to coordinate the motion of
an MLC for IMRT delivery. Gamma-rays are electromagnetic radiation
emitted by the disintegration of a radioactive isotope and have
enough energy to produce ionization in matter, typically from about
100 keV to well over 1 MeV. The most useful gamma-emitting
radioactive isotopes for radiological purposes are found to be
cobalt (Co 60), iridium (Ir 192), cesium (Cs 137), ytterbium (Yb
169), and thulium (Tm 170). As such, the disintegration of a
radioactive isotope is a well-known phenomena and, therefore, the
radiation emitted by cobalt teletherapy is more consistent and,
therefore, easier to calculate in terms of preparing a treatment
regimen for a patient.
[0100] Enablement of the present embodiment's cobalt IMRT has been
demonstrated via computational analysis. Simulations have been
performed of IMRT delivery with a commercially available cobalt
therapy unit and a MLC. A 3D image-based radiation therapy
treatment planning system with a cobalt beamlet model was
commissioned and validated using measured radiochromic film data
from a Theratronics 1000C cobalt therapy unit. An isotropic
4.times.4.times.4 mm.sup.3 dose voxel grid (effectively
Shannon-Nyquist limited for 7-ray IMRT source penumbra) was
generated. This beamlet model was fitted to published data and
validated with radiochromic film measurements of 1.times.1 cm.sup.2
beamlets formed by a Cerrobend block and measured using a
previously reported methodology. The calculation depths were then
determined for the same voxels with standard three-dimensional
ray-tracing of the structures. Density scaling to the depths
computed was used to better account for tissue heterogeneities in
the dose model. The CPLEX, ILOG Concert Technologies industrial
optimization solver using an implementation of the barrier
interior-point method with dense column handling for IMRT
optimization was used to solve for optimal IMRT plans. Beamlet
fluences were discretized for each beam angle to 5% levels for leaf
sequencing. The resulting plan dose distribution and histograms
were computed by summing the dose values weighted by the
deliverable discretized intensities. Leaf-transmission leakage
intensities were conservatively estimated at 1.7% for otherwise
zero intensity beamlets. Finally, standard methods of heuristic
leaf-sequencing optimization to create delivery instructions for
the treatment plans were employed. We adopted the Virginia Medical
College simultaneous integrated boost (SIB) target dose-level
scheme as it is the largest maximum to minimum clinical
prescription dose ratio advocated in the literature, making it the
most difficult dose prescription scheme to satisfy. Head-and-neck
IMRT provides an excellent basis for testing IMRT optimization for
several reasons: 1) there are well defined treatment goals of
sparing salivary glands and other structures while maintaining
homogeneous target coverage; 2) attempting to achieve these goals
tests IMRT optimization to its technical limits; and 3) a large
phase I/II multi-institutional trial, the Radiation Therapy
Oncology Group (RTOG)'s H-0022 Phase I/II Study of Conformal and
Intensity Modulated Irradiation for Oropharyngeal Cancer, has
defined a common set of planning criteria. The case examined was
run with 7 equispaced beams having International Electrotechnical
Commission (IEC) gantry angles of 0.degree., 51.degree.,
103.degree., 154.degree., 206.degree., 257.degree., and
309.degree.. The treatment planning system generated 1,289 beamlets
to adequately cover the targets from the seven beam angles, and the
4 mm isotropic voxel grid generated 417,560 voxels. FIG. 8 and FIG.
9 show results of the treatment. Note that our system normalized
plans to ensure 95% coverage of the high dose target. FIG. 8 shows
axial dose distributions from the single head-and-neck IMRT case
planned using the commissioned cobalt beamlets. Excellent target
coverage and tissue sparing may be observed. FIG. 9 shows the DVH
data derived from the leaf sequenced and leakage corrected plan
(i.e., deliverable plan) using the 4 mm voxels and 1 Gy dose bins.
The cobalt source based IMRT created an excellent IMRT treatment
plan for a head-and-neck patient. The y-ray IMRT was able to
clearly spare the right parotid gland (RPG) and keep the left
parotid (LPG) and right submandibular glands (RSMG) under 50%
volume at 30 Gy, while covering more than 95% of the target volumes
(CTV and GTV) with the prescription dose or higher. All other
structures were below tolerance. The unspecified tissue (SKIN) was
kept below 60 Gy, with less than 3% of the volume above 50 Gy. The
optimization model used was the same as published in Romeijn et al.
and was not modified for the cobalt beams. For sites with larger
depths such as prostate and lung it is known in the art that the
addition of extra beams or isocenters allows for the creation of
treatment plans using cobalt IMRT that may achieve the same
clinical quality criteria as linac-based IMRT. This enabling
demonstration shows that a cobalt therapy unit is capable of
providing high quality IMRT.
[0101] Enablement of the present embodiment's dose computation for
cobalt IMRT in the presence of the magnetic field has been
demonstrated via computational analysis. In addition, by using
cobalt teletherapy, better calculations can be made based upon the
magnetic field of the MRI. When the radiation therapy is performed
while the patient is stationed within the MRI, the magnetic field
will cause a slight deflection of the targeted radiation. As such,
the calculations used to determine the treatment regimen need to
take this deflection into account. A charged particle moving in a
vacuum at a velocity, v, in the presence of a magnetic field, B,
experiences a Lorentz force given by F=v.times.B. This force is not
significant enough to significantly change the physics of the
interactions of ionizing photons and electrons with matter;
however, it may influence the overall transport of ionizing
electrons and hence the resulting dose distribution. The impact of
magnetic fields on the transport of secondary electrons has been
well studied in the physics literature, starting more than 50 years
ago. Recent studies have employed Monte Carlo simulation and
analytic analysis in an attempt to use a localized magnetic field
to help focus or trap primary or secondary electrons to increase
the local dose deposition in the patient. All of these studies have
examined aligning the direction of the magnetic field lines along
the direction of the beam axis to laterally confine the electron
transport with the Lorentz force (called "longitudinal" magnetic
fields, where the term longitudinal refers to the beam and not the
patient). For high field MRI, with magnetic fields between about
1.5-3.0 T is known that the initial radius of gyration is small
with respect to the MFP of large-angle scattering interactions for
the secondary electrons (bremsstrahlung, elastic scatter, and hard
collisions) and this condition results in the desired trapping or
focusing of the electrons. As the electrons lose energy the radius
decreases as it is proportional to |v| and, in the absence of
large-angle scattering interactions (CSDA) the electrons would
follow a spiral with decreasing radius until they stop. Although
this spiraling may change the fluence of electrons it is known that
it does not produce any significant synchrotron radiation. In the
present embodiment, the magnetic field is preferably orthogonal to
the radiation beams in order allow parallel MRI for real-time
imaging. Recent work has shown that a 1.5 T magnetic field
perpendicular to the beam axis of a 6 MV linac beam may
significantly perturb the dose distribution to water for a 6 MV
linac beamlet. Both to avoid such dose distribution distortions and
to prevent MRI artifacts that could compromise the spatial
integrity of the imaging data, a beneficial embodiment of the
present disclosure uses a low field open MRI design that allows the
magnetic field to be directed along the superior-inferior direction
of the patient (see FIG. 1). Simple estimates of the radii of
gyration for secondary electrons from cobalt y rays indicate that
the radii of gyration are much greater than the MFP for large-angle
scattering interactions for electrons. This is easily understood as
the Lorentz force is proportional to the magnitude of the magnetic
field, |B| and the radius of gyration is inversely proportional to
the magnetic field. We have pursued modeling a beamlet from a
cobalt y-ray source in a slab phantom geometry using the
well-validated Integrated Tiger Series (ITS) Monte Carlo package
and its ACCEPTM subroutine for transport in magnetic fields. For
the simulations we employed 0.1 MeV electron and 0.01 MeV photon
transport energy cutoffs, the standard condensed history energy
grid (ETRAN approach), energy straggling sampled from Landau
distributions, mass-collisional stopping powers based on Bethe
theory, default electron transport substep sizes, and incoherent
scattering including binding effect. Three pairs of simulations
were run where each pair included the run with and without a 0.3 T
uniform magnetic field parallel to the beam direction. A 2 cm
circular cobalt y-ray beamlet was modeled on the following
geometries: a 30.times.30.times.30 cm.sup.3 water phantom; a
30.times.30.times.30 cm.sup.3 water phantom with a 10 cm lung
density (0.2 g/cc) water slab at 5 cm depth; and a
30.times.30.times.30 cm.sup.3 water phantom with a 10 cm air
density (0.002 g/cc) water slab at 5 cm depth. Simulations were run
with between 30 and 100 million histories on a P4 1.7 GHz PC for
between 8 and 30 hours to obtain less than a percent standard
deviation in the estimated doses. The results are displayed in
FIGS. 10-12. FIG. 10 clearly demonstrates that a 0.3 T
perpendicular uniform magnetic field, as would exist in a
beneficial embodiment of the current disclosure, will not
measurably perturb the dose distribution in soft tissue or bone. A
very useful treatment site for the present embodiment will be lung
and thorax, which contain the most significant tissue
heterogeneities in the body. As seen in FIG. 11, adding a 12 cm
lung density (0.2 g/cc) water slab to the phantom causes a very
small yet detectable perturbation in the dose at the interfaces of
the high and low density regions. These perturbations are small
enough to allow acceptable clinical application without correction.
In FIG. 12, we finally observe significant perturbations, which
exist largely in the low-density and interface regions. This
demonstrates that air cavities will hold the greatest challenge for
accurate dosimetry. However, other than at interfaces with lower
density media there should be no significant perturbations in soft
tissue and bone (where the MFP shortens even more than soft
tissue). This data demonstrates that in a beneficial embodiment of
the present disclosure with a low (0.2-0.5 Tesla) field MRI, dose
perturbation will be small except inside of air cavities were
accurate dosimetry is not required due to an absence of tissue. By
using a known radiation source, such as a cobalt teletherapy unit,
the amount of deflection may be easily determined if the strength
of the MRI field is known. However, even if the strength of the
field is known, if a linear accelerator is used, the unknown energy
spectrum of the radiation makes the calculations much more
difficult.
[0102] Alternate sources of radiation that do not interfere
significantly with the operations of the MRI unit such as protons,
heavy ions, and neutrons that are produced by an accelerator or
reactor away from the MRI unit and transported by beam to patient
can also be included in alternative embodiments.
[0103] In addition, the strength of the MRI field will factor into
the calculations and, as a result, the use of open MRIs offers
advantages over closed MRIs. In an open MRI, the strength of the
field generated is generally less than the field of a closed MRI.
As such, the images resulting from an open MRI have more noise and
are not as clear and/or defined as images from a higher field
closed MRI. However, the stronger field of the closed MRI causes
more of a deflection of the radiation treatment than the weaker
field of an open MRI. Accordingly, depending on the characteristics
most beneficial to a given treatment regimen, a closed MRI could
alternatively be used. However, due to ease of calculation and/or
the fact that a slightly less clear image during treatment is
sufficient for adjusting most treatment regimens, an open MRI of
the geometry shown in FIG. 1 is preferably used with the cobalt
teletherapy to eliminate significant dose perturbations, prevent
spatial imaging distortions, and allow for fast parallel phased
array MRI.
[0104] By using an open MRI and cobalt teletherapy, three
dimensional (3D) imaging of a patient can be accomplished during
the radiation therapy. As such, by using the 3D images of the
target region and the planning images of the target region, a
displacement can be determined that can be updated based upon the
continuous 3D images received during the radiotherapy process.
Using the information obtained, the patient may then be then
translated relative to the treatment beam to reduce the
displacement during the irradiation process, such as if the
measured displacement is outside a predetermined limit. Irradiation
may then continue after translation. Alternatively, the treatment
beam may be moved. The translation may occur during treatment or
treatment may be stopped and then translation may occur.
[0105] By using 3D images during treatment and using these images
to rapidly position and/or adjust the patient during the
radiotherapy process, treatment accuracy may be substantially
improved. If the patient becomes misaligned while radiation is
being applied, the misalignment may be mitigated through positional
adjustment. In addition to possible dose escalation, improved
positional accuracy permits treatment of tumors that are currently
considered not treatable with radiation using conventional systems.
For example, primary spinal cord tumors and spinal cord metastases
are typically not treated by conventional radiation systems due to
the high accuracy needed to treat lesions in such important
functional anatomic regions. The increased precision provided by 3D
imaging during treatment makes it feasible to treat these types of
tumors. Improvements are also expected for targets located in the
lung, upper thorax, and other regions where intra-fraction organ
motions are known to cause problems with radiotherapy
dosimetry.
[0106] In an alternative embodiment, a separate guidance system can
be used to track the patient location. The guidance system can be
used to correlate the actual patient position with the imaging
information obtained during both planning and radiotherapy. This
may significantly improve the ease of patient positioning by
providing updateable image correlation and positioning information
throughout the patient set-up and treatment delivery phases, even
when the patient is moved to positions that are not perpendicular
to the coordinate system of the therapy machine. This ability to
monitor patient position at non-coplanar treatment positions may be
a significant improvement over conventional radiotherapy systems.
In one beneficial embodiment, the guidance system may include an
adjustable bed or couch for the patient to be placed upon. In an
alternative beneficial embodiment, the guidance system may include
a gantry that permits substantially simultaneous movement of the
MRI and the cobalt therapy unit. Some beneficial embodiments
include both the gantry and the adjustable bed or couch.
[0107] The initial radiation treatment and/or any changes to the
treatment regimen can be determined based upon the use of a
computer program that takes into account various factors including,
but not limited to, the area of the patient to be treated, the
strength of the radiation, the strength of the MRI field, the
position of the patient relative to the radiation unit, any change
in the patient during treatment, and/or any positional changes
necessary of the patient and/or the radiation unit during
treatment. The resulting IMRT is then programmed and the treatment
is started.
[0108] One embodiment for determining a treatment plan for
intensity modulated radiation treatment (IMRT) includes dividing a
three dimensional volume of a patient into a grid of dose voxels,
wherein each dose voxel is to receive a prescribed dose of
radiation from a plurality of beamlets each having a beamlet
intensity, and providing a convex programming model with a convex
objective function to optimize radiation delivery. The model is
solved to obtain a globally optimal fluence map, the fluence map
including beamlet intensities for each of the plurality of
beamlets. This method is described in greater detail in U.S. Patent
Application Publication No. 2005/0207531, filed Jan. 20, 2005,
titled "RADIATION THERAPY SYSTEM USING INTERIOR-POINT METHODS AND
CONVEX MODELS FOR INTENSITY MODULATED FLUENCE MAP OPTIMIZATION,"
which is hereby incorporated herein by reference.
[0109] In general, the method used for determining a treatment
plan, in one beneficial embodiment, is the interior point method
and variants thereof. This method is beneficial due to its high
efficiency and resulting generally short computational times. The
interior point method is described in a book by Steven J. Wright
entitled "Primal-Dual Interior-Point Methods" (SIAM, Publications,
1997, ISBN 089871382X). Primal-dual algorithms have emerged as the
most beneficial and useful algorithms from the interior-point
class. Wright discloses the major primal-dual algorithms for linear
programming, including path-following algorithms (short- and
long-step, predictor-corrector), potential-reduction algorithms,
and infeasible-interior-point algorithms.
[0110] Once the treatment plan is determined, the clinician is able
to ensure that the treatment plan is followed. The patient to be
treated is placed in the MRI. An image of the area to be treated is
taken and the MRI continues to transmit a 3D image of the area. The
treatment plan is input into the cobalt radiation teletherapy unit
and treatment commences. During treatment, a continuous image of
the area being treated is observed. If the location of the area to
be treated changes, such as if the patient moves or the area to be
treated changes in size, the treatment plan is recalculated and/or
the patient or radiation unit is adjusted without interrupting
treatment. Alternatively, treatment can be stopped, then the
treatment plan can be recalculated, and then the position of the
patient and/or the radiation unit can be readjusted before
recommencing treatment.
[0111] Multiple process embodiments may be used in improving the
accuracy of the patient's therapy. One process embodiment can
include taking the MRI data and applying methods known in the art
for deformable image registration and dose calculation to the
delivered IMRT cobalt unit fluences to determine the dose delivered
to the target and critical structures during each delivery
fraction. Corrections to the patient's treatment could then be
taken to add or subtract delivery fractions to improve tumor
control or reduce side effects, respectively. Along with the
dosimetric assessment, the size and progression of the patient's
disease would also be assessed on a daily basis.
[0112] A second process embodiment can include taking the MRI data
and performing a reoptimization of the IMRT treatment plan before
each single radiation delivery to improve the accuracy of the
treatment delivery. This process can be combined with the previous
process to assess the dose delivered to the target and critical
structures during each delivery fraction.
[0113] A third process embodiment can include taking the MRI data
and performing a reoptimization of the IMRT treatment plan on a
beam-by-beam basis before the delivery of each radiation beam in a
single radiation delivery to improve the accuracy of the treatment
delivery. This process can include that the first process be
performed rapidly before each beam delivery.
[0114] A fourth process embodiment can include taking the MRI data
and performing reoptimization of the IMRT treatment plan on a
moment-by-moment basis during the delivery of each part of each
radiation beam in a single radiation delivery to improve the
accuracy of the treatment delivery. This process can also include
that the first process be performed in real-time simultaneously
with the radiation delivery. The process can include the use of
parallel computation that employs one or more computers
beneficially connected via a low latency local network or a secure
connection on a wide area network to greatly enhance the speed of
the algorithms known in the art for MRI image reconstruction,
deformable image registration, dose computation, and IMRT
optimization.
[0115] According to alternative embodiments, a surgical guidance
device and a process are provided for performing temporal- and
spatial-resolution MRI of the anatomy and disease of a patient
during various types of surgical procedures. Descriptions above of
imaging systems for radiation treatment systems are also applicable
to the following embodiments that involve surgical guidance
systems. In a beneficial embodiment, a surgical guidance system
comprises an open MRI that allows for access to the patient for
performance of a surgical procedure, be it performed by a surgeon
or by an automated device, such as a surgical robotic device.
[0116] Referring to FIG. 13, an embodiment of a surgical guidance
system 200 includes an MRI unit 210, or an alternative imaging
source, that preferably allows for noninvasive and nonionizing
radiation-based imaging of a patient's internal anatomy. FIG. 13
also shows an image processing unit 220, which can optionally be
used to receive data generated by the MRI unit 210 and provide
real-time image processing for converting the data into images that
can be used for monitoring patient anatomy. The information
produced by the image processing unit 220 can be provided to a
control unit 230. Alternatively, data taken directly from the MRI
unit 210, which may be referred to herein as "image data," may be
interpreted or analyzed directly using methods known in the art to
detect motions or changes in anatomy before or without passing the
data to the image processing unit 220. The control unit 230 can
receive information about a planned or ongoing surgical procedure
from the surgeon or other personnel via a planning interface 235.
The control unit 230 can optionally also receive information about
an ongoing surgical procedure by receiving information about a
trackable surgical instrument 240 and/or an automated surgical
robotic device 250 via a tracking unit 260. Additionally, or
alternatively, the control unit 230 can infer information about an
ongoing surgical procedure based on imagery provided from the image
processing unit 220. The control unit 230 can provide information
to personnel monitoring the surgical procedure via an alert unit
270. Information provided via the alert unit 270 can include
information indicative of one or more pre-defined conditions, and
the information can be provided in one or more of a variety of
different forms including, but not limited to, visual information
and/or audible information. The visual information can include, for
example, images and/or textual information. The audible information
can include, for example, synthesized voice, voice recordings,
and/or alarms.
[0117] The units depicted in FIG. 13 and described herein are for
purposes of illustrating various functions, and as such the various
units are not necessarily representative of separate elements. For
example, a computer or other processor-based system can be used for
performing the operations described herein of one or more of the
image processing unit 220, the control unit 230, the planning
interface 235, the tracking unit 260, and/or the alert unit 270.
Also, one or more of the image processing unit 220, the control
unit 230, the planning interface 235, the tracking unit 260, and/or
the alert unit 270 can be integrally combined as a single device
and/or can be integrally combined with the MRI unit 210.
[0118] The present disclosure thus includes a surgical guidance
system for monitoring and/or guiding surgical interventions using
noninvasive and non-ionizing radiation-based imaging by an MRI unit
210 or the like. The MRI unit 210 provides rapid volumetric
imaging. The resulting images can be processed using deformable
image registration in order to provide for real-time volumetric
imaging, for example so that one can see a heart beat, lungs expand
and contract, organ movement, arteries, formation of blood pools,
etc. The real-time imaging can then be monitored by computerized
control unit 230, which can continually analyze the imaging data in
real time, determine if there are risks or deviations from the
surgical plan, and if so, issue appropriate warnings or alerts to
the surgeon and/or other personnel via the alert unit 270.
[0119] As shown in FIG. 14, the MRI unit 210 can include a split
main magnet, where each have of the main magnet is housed in a
respective one of the first and second main magnet housings 280a
and 280b. The MRI unit 210 can also include split gradient coils,
split RF shield, split T/R coil, and/or T/R surface coils (not
shown). For example, the MRI unit 210 can include coils and/or
shielding as disclosed in copending U.S. patent application Ser.
No. 12/951,976, filed Nov. 22, 2010, titled "SELF-SHIELDED GRADIENT
COIL," which is hereby incorporated herein by reference.
[0120] The split-magnet MRI unit 210 can image the anatomy of a
patient, particularly the portions of the patient's anatomy that
are positioned in the gap between the first and second main magnet
housings 280a and 280b. The split-magnet MRI unit 210 also allows
unobstructed access to the region of the patient being imaged
(inside the imaging field of view) simultaneously to the
performance of the surgical procedure. This allows the MRI unit 210
to continuously image the patient as surgery is being performed,
where the images are of the region of the patient where the surgery
is being performed. This also allows the surgical guidance system
200 to image a patient during surgery, as the surgical procedure is
being performed, without repositioning the patient and/or imaging
equipment.
[0121] A non-limiting example of a use of the surgical guidance
system 200 can involve the use of the surgical guidance system 200
in connection with a surgical procedure. The process can begin with
the surgical procedure being planned and images being acquired on
as many high-resolution imaging devices as can be useful to the
procedure (e.g., PET-CT, SPECT, 3 or 7 T MRI, etc.), as well as on
the system 200 just before the surgical procedure commences. These
image sets can be fused via a deformable image registration
algorithm to form a primary planning image set.
[0122] The planning interface 235 provides a means for the surgeon,
clinician, or other personnel to prepare a surgical plan. The
planning interface 235 can include, for example, a computer or
other processor-based system. In some embodiments, the planning
interface 235 can include known surgical planning software and/or
surgical planning capabilities. The planning interface 235 can
include a keyboard, touch-screen, cursor-control device (e.g.,
trackball or mouse), or other such means for allowing a user to
prepare a surgical plan. The planning interface 235 can then
provide the surgical guidance system 200 with surgical parameters
based on the surgical plan. The surgical plan thus will preferably
include parameters that should be monitored by the system 200
during the surgical procedure. The parameters can vary depending on
several factors, and can include threshold values that, if
satisfied, can cause the system 200 to issue an alert via the alert
unit 270.
[0123] For example, using the planning interface 235, the surgeon
can define segmented anatomy for protection, resection,
anastomosis, etc. The MRI unit 210 and image processing unit 220
can produce high-quality planning scans that are displayed by the
planning interface 235. A clinician can interact with the planning
scans using the planning interface 235 to create a plan for
segmenting anatomy, set targets for excision, plan an anastomosis
procedure, or any of many other known surgical procedures. Also,
the planning interface 235 can be used to define surgical pathways
as regions that represent routes that the surgeon intends to follow
for entering the patient's body with surgical instruments. The
planning interface 235 can be used to mark organs as targets of the
surgical procedure (e.g., a tumor may be marked for excision). The
planning interface 235 can be used to mark margins around organs
for the surgical procedure (e.g., margins may be marked around a
tumor for excision). The planning interface 235 can be used to
define the extent of allowable puncture or penetration into an
organ. The planning interface 235 can be used to mark organs or
regions for preservation from invasion by surgical instruments
(e.g., regions containing major nerves or arteries can be marked
for preservation). The planning interface 235 can be used to define
the volume of tissue to be resected, including margins if required.
Any of these and other surgical planning parameters can be defined
using the planning interface 235 and electronically stored as a
surgical plan for the surgical procedure. It will be appreciated
that these parameters include alert threshold values that can be
expressly indicated by a surgeon, clinician, or other personnel
using the planning interface 235, and/or can include alert
threshold values that are inferred by the planning interface 235
based on planning information that is input into the planning
interface 235 by a surgeon, clinician, or other personnel.
[0124] For example, a surgical plan can be created for a surgery to
resect a tumor, which may include removal of a portion of a kidney.
Pre-surgical images of the region surrounding the tumor can be
provided to the planning interface 235. The surgeon can interact
with the planning interface 235 to identify the portion of the
kidney to be removed, for example by circling, marking, or
otherwise identifying the portion to be removed. The surgeon may
also observe a potentially hazardous region, such as a nearby
artery that should be avoided. The surgeon can then also identify
the artery, again by circling, marking, or otherwise identifying
the artery using the planning interface 235. The surgeon can also
use the planning interface 235 to identify other nearby organs, for
example the liver and bowel, that the surgeon does not want to
damage. All of this information can then become part of the
surgical plan that will be monitored by the surgical guidance
system 200 during the surgery. In this example, the surgical
guidance system 200 would monitor the surgery in real time and
issue alerts if the surgeon nears the artery or the bowel, or if
the surgeon is at or near the limit of the amount of kidney to be
removed. The surgical guidance system 200 can also watch for other
conditions, such as pooling blood, irregular heart beating, or
irregular breathing. Also, since the surgical guidance system 200
can track the movement of tissue using volumetric, deformable image
registration imaging in real time during surgery, the control unit
230 can track movement of the tissue associated with the tumor as
the surgeon is operating in order to allow the surgeon to stay on
the surgical path and ensure that all of the tumor is safely
removed.
[0125] Thus, the surgical guidance system 200 can allow a surgeon
to input a plan for a surgery, and then track the surgery in real
time and alert the surgeon as to their progress, for example if
they are about to or have just violated some requirement or safety
constraint. In order to accomplish this, the parameters that are
defined using the planning interface 235 can be monitored by the
control unit 230. Also, or alternatively, the control unit 230 can
monitor predefined or default parameters that may not necessarily
be specified via the planning interface 235. For example, the
control unit 230 can be configured to monitor surgical procedures
for undesirable conditions, such as excessively large motions,
pooling of blood, and/or lack of blood flow. The control unit 230
can track organ motion and identify such conditions as blockages or
blood pooling based on changes in data received from the MRI or
images received from the image processing unit 220 through, for
example, using known algorithms for detecting and/or tracking
variations in image intensity and/or data representative of patient
anatomy.
[0126] During the surgical procedure, the control unit 230 can
continuously receive data representative of real-time images of
patient anatomy generated by the MRI unit 210 and, optionally,
image processing unit 220. The control unit 230 can monitor the
parameters of the surgical plan using the received image data and
deformable image registration during the surgical procedure to aid
the surgeon in performing a safe and successful surgical procedure
by alerting the surgeon or other personnel in the event that one or
more alert threshold values has been met or exceeded (e.g., a
surgical tool is at or near a defined margin).
[0127] Thus, the surgical guidance system 200 allows for real-time
MRI-based guidance during surgical procedures. The surgical
guidance system 200 has the ability to perform fast volumetric
and/or planar imaging during surgical procedures. Imaging may be
performed by the image processing unit 220 at a spatial and
temporal resolution that allows for the tracking of the movement
and deformation of the patient's tissue during the surgical
procedure. In some embodiments, the MRI unit 210 can generate MRI
data, for example k-space data, and the image processing unit 220
can rapidly generate image data representative of images that have
been reconstructed based on the MRI data generated by the MRI unit
210. In some embodiments, the image processing unit 220 can
include, for example, a computer or other processor-based system.
Also, in some embodiments, the image processing unit 220 can
include an imaging system and/or operate according to image
reconstruction methods as disclosed in U.S. Patent Application
Publication No. 2010/0322497, filed Jun. 17, 2010, titled "SYSTEM
AND METHOD FOR PERFORMING TOMOGRAPHIC IMAGE ACQUISITION AND
RECONSTRUCTION," which is hereby incorporated by reference.
Volumetric imaging can thus be employed over the surgical region of
the patient's body at a resolution that allows for determining the
spatial location of the anatomy with the resolution required by the
surgeon. The temporal refresh rate for imaging is preferably
acquired at the rate of human reflex and response, i.e., between U
and 1/5 of a second. The rate can be lowered or raised to capture
slower or faster physiological processes occurring in the patient.
The imaging for anatomy tracking and monitoring can be of a lower
signal to noise and spatial resolution than diagnostic imaging, and
deformable image registration can be employed to correlate higher
resolution, signal to noise and contrast imaging to the real-time
tracking images. Thus, in some embodiments, the quality of the
pre-surgical images produced by the MRI unit 210 for creating the
surgical plan can be of a higher quality than the images produced
by the MRI unit 210 during the surgical procedure for real-time
tracking.
[0128] The segmented anatomy and regions can optionally be
continuously tracked and auto-contoured by the image processing
unit 220 using deformable image registration on the stream of real
time image data based on MRI data generated by the MRI unit 210.
Anatomy that is defined to be critical for sparing of damage,
incision, or excision, can be monitored with low latency, e.g.,
less than a second, to warn the surgeon via the alert unit 270 with
audible and/or visual signals of the risk of damaging the critical
structure. Criteria for a safe procedure can be rapidly computed
and, if a violation is detected or is extrapolated to be imminent,
audio and visual warnings can be provided to the surgeon or other
personnel. If requested or required, planar images and metrics can
be displayed to show the surgeon or other personnel what issues are
causing the alarm. In some embodiments, the alert unit can include
display means for continuously displaying images based on image
data generated by the MRI unit 210 and image processing unit 220,
thereby allowing the surgeon or other personnel to monitor the
progress of the surgical procedure. The control system 230 and/or
alert unit 270 can be configured such that characteristics of
alerts can change based on the type and/or severity of the
conditions that triggered the alert. For example, sounds, symbols,
colors, or other indicators issued by the alert unit 270 can vary
such that the degree of a warning issued by the alert unit can be
increased with increases in the extent of damage, penetration, or
excision of an organ in question.
[0129] As illustrated in FIG. 13, the surgical guidance system 200
can include a tracking unit 260 configured for tracking one or more
surgical instruments 240. Referring to FIG. 14, it should be
appreciated that a large magnetic field is present at the location
where the surgical procedure is taking place due to the ongoing MRI
imaging that is occurring during the surgical procedure. Thus, any
surgical instrument 240 used during a surgical procedure should be
formed of materials that are very weakly, or not significantly,
affected by being placed in the presence of an externally applied
magnetic field, e.g., paramagnetic materials. However, in some
embodiments, the surgical instruments 240 can include markers, or
otherwise be visible to the MRI unit 210. The position of a
surgical instrument 240 can then be distinguished and tracked by
the control unit 230 based optionally on the appearance of the
surgical instrument 240 in images generated by the image processing
unit 220. Alternatively, the position of the surgical instrument
240 can be inferred based on such things as organ motion and/or
deformation, and/or other changes to the appearance of anatomical
structures that appear in the images generated by the MRI unit 210
where such changes are indicative of surgical intervention. In some
embodiments, in addition to continuous monitoring of a surgical
instrument 240, the control system 230 can detect deviations from a
surgical path that was previously defined using the planning
interface 235, and compute a new trajectory, which can then be
visually and/or audibly relayed to the surgeon.
[0130] It will thus be appreciated based on the present disclosure
that the disclosed devices and methods have the ability to account
for deformations and motions of the patient's anatomy during
surgery through real-time imaging. This ability is advantageous,
since most organs in the human body inherently and naturally
experience motions continuously. The surgical instrument itself can
also cause deformations and displacements of organs during the
procedure as it punctures, cuts, or presses against the patient's
tissues. The disclosed devices and methods also have the ability to
provide warnings to a surgeon, without necessarily requiring the
surgeon to regularly watch a monitor displaying images. In
addition, pointing devices are not required to find the "correct"
plane or projection in which to view a procedure.
[0131] As shown in FIG. 15, an automated surgical robotic device
250 can also be employed for performing a surgical procedure with,
or in place of, a surgeon. For example, surgical robotic devices
are known that can be used for performing a surgical procedure,
including robotic devices having varying degrees of automation. The
surgical guidance system 200 can provide feedback as described
above to an operator and/or to the robotic device 250 during a
surgical procedure. As discussed above, the feedback can include
alerts based on a surgical plan input via the planning interface
235. The feedback can also include data used to control a surgical
path of the robotic device 250. It will be appreciated that the
surgical robotic device 250 can be any type of medical robot, and
should preferably be capable of operating within a magnetic
resonance imaging (MRI) scanner for the purpose of performing or
assisting in image-guided interventions.
[0132] Although the illustrative embodiments of the present
disclosure have been described herein with reference to the
accompanying drawings and examples, it is to be understood that the
disclosure is not limited to those precise embodiments, and various
other changes and modifications may be affected therein by one
skilled in the art without departing from the scope or spirit of
the disclosure. All such changes and modifications are intended to
be included within the scope of the disclosure as defined by the
appended claims.
* * * * *