Note: Descriptions are shown in the official language in which they were submitted.
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MEDICAL IMAGING DEVICE AND ASSOCIATED METHOD
Backr~round of the Invention
This i:wention relates to an imaging device or system. The imaging device or
system is
especially useful as a medical system. More particularly, this invention
relates to a device or
system which determines three-dimensional shapes of objects such as internal
organs of a
patient preferably by using ultrasonic pressure waves. This invention also
relates to a method
useful in medical operations.
In recent years, the escalation of medical costs has captured substantial
media and
regulatory attention. One reason for the escalating costs is the ever
increasing use of
expensive machines and testing techniques. Computed assisted tomography (CAT
scanning),
magnetic resonance imaging (MRI) and some radiological techniques have been in
the
forefront bf contributing to mounting medical costs. In addition to being
expensive, these
devices are heavy and bulky, making them ill suited to transport.
In this age of rapidly escalating medical costs, minimally invasive operations
have
become the method of choice for diagnosis and treatment. In many cases,
endoscopic,
iaparoscopic and radiographic techniques have superseded older diagnostic and
therapeutic
surgical techniques.
Summary of the Invention
An object of the present invention is to provide an imaging device or system
which is
relatively inexpensive and easy to transport.
It is another object of the present invention to provide an alternative to
conventional
medical imaging systems.
A further object of the present invention is to provide a medical imaging
system which
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2
exhibits reduced costs over conventional imaging systems such as CAT scanners
and MRI
machines.
A particular object of the present invention is to provide a medical imaging
system
which can be used during the performance of so-called minimally invasive
medical operations.
It is an additional object of the present invention to provide a medical
imaging system
which is portable.
Another object of the present invention is to provide a medical operating
method which
provides real time imaging in a cost effective manner.
These and other objects of the present invention, which will be apparent from
the
drawings and descriptions herein, are attained in a medical imaging device
comprising a flexible
web conformable to a patient, at least one electroacoustic transducer attached
to the web, an a-
c current source being operatively connected to the transducer for energizing
the transducer
with an electrical signal of a pre-established ultrasonic frequency to produce
a first pressure
wave. At least one acoustoelectric transducer is attached to the web, while an
analyzing
component is operatively connected to the acoustoelectric transducer for
determining three-
dimensional shapes of internal organs of the patient by analyzing signals
generated by the
acoustoelectric transducer in response to second pressure waves produced at
internal organs of
the patient in response to the first pressure wave. The web is provided with
at least one
aperture permitting traversal of the web by a medical instrument so that a
distal end of said
medical instrument lies inside the patient while said carrier is disposed
adjacent to a skin
surface of the patient.
According to a feature of the invention, a video monitor is linked to the
analyzing
component for displaying an image of the internal organs. Although
stereoscopic {3-D)
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3
medical viewing systems have been introduced, it is contemplated that the
image will generally
be a two-dimensional image. Accordingly, the system preferentially includes a
view selector
operatively connected to the analyzing component and the video monitor for
selecting the
image from among a multiplicity of possible images of the internal organs. In
addition, a filter
stage may be operatively connected to the analyzing component and the video
monitor for
eliminating a selected organ from the image. In one example of the use of the
filter, blood
moving through a vessel of the vascular system is deleted to enable viewing of
the blood vessel
walls on the monitor.
The web may be provided with a plurality of electroacoustic transducers
attached to the
web in a predetermined array. In that event, the system further comprises
circuitry for
energizing the electroacoustic transducers in a predetermined sequence. Where
the web carries
a plurality of acoustoelectric transducers attached to the web in a
predetermined array, the
system further comprises circuit components for receiving signals from the
acoustoelectric
transducers in a predetermined sequence.
In accordance with another feature of the present invention, the web is
provided with a
plurality of apertures each enabling traversal of the web by a medical
instrument. Thus, the
system may be used for performing a complex diagnostic or surgical operation.
The web may be provided with at least one chamber for holding a fluid. The
transducers are disposed in ultrasonic or pressure-wave communication with the
chamber,
thereby facilitating pressure wave transmission from the electroacoustic
transducer to the
patient and from the patient to the acoustoelectric transducer.
The web may take the form of a garment such as a vest surrounding the chest
region or
a girdle surrounding the abdominal region.
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A method for performing a medical operation, in accordance with the present
invention, utilizes a medical instrument and flexible web conformable to a
patient, the web also
having at least one electroacoustic transducer and at least one
acoustoelectric transducer
attached to the web. The web is disposed adjacent to a skin surface of the
patient so that the
web is in acoustic or pressure-wave-transmitting contact with the skin
surface. A distal end of
the medical instrument is inserted into the patient so that the distal end is
disposed inside the
patient while the web is disposed adjacent to the skin surface. After
disposition of the web
adjacent to the skin surface, the electroacoustic transducer is energized with
an electrical signal
of a pre-established ultrasonic frequency to produce a first pressure wave.
Signals generated
by the acoustoelectric transducer in response to second pressure waves
produced at internal
organs of the patient and at the distal end of the medical instrument in
response to the first
pressure wave are automatically analyzed to thereby determine three-
dimensional shapes of the
internal organs of the patient and a location of the distal end of the medical
instrument relative
to the internal organs, thereby enabling a real time manipulation of the
instrument to effectuate
a medical operation on a selected one of the internal organs.
It is contemplated that a video image will be generated of the patient's
internal organs
and the distal end of the medical instrument in response to the analysis of
signals generated by
the acoustoelectric transducer.
Preferably, the distal end of the medical instrument is inserted into the
patient after the
disposition of the web in contact with the patient's skin surface. Then, the
insertion of the
instrument into the patient can be guided in response to real-time three-
dimensional structural
data on the relative locations of the instrument and the internal organs of
the patient.
Where the web has a plurality of apertures, the medical instrument may be
passed into
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the patient through one of the apertures. In this way, laparoscopic surgery as
well as other
invasive operations, whether diagnostic or therapeutic, may be performed with
the aid of real-
time visual images produced upon the analysis of returning ultrasonic pressure
waves.
Laparoscopic surgery is simplified by eliminating the need for a laparoscope.
Laparoscope
elimination enables a reduction in the number of perforations made in the
patient or,
alternatively, enables the insertion of another laparoscopic instrument with
the same number of
perforations.
Multitudinous operations are facilitated with the use of ultrasonically
derived images of
internal organic structures. Such operations include liver biopsies, kidney
biopsies, and pleural
biopsies and the placement of tubular members, including drains and catheters,
for such
techniques as thoracentesis and abscess drainage and further include
diagnostic operations now
performed by using a flexible endoscope.
Where the web carries a plurality of electroacoustic transducers attached to
the web in
a predetermined array, the method further comprises energizing the
electroacoustic transducers
in a predetermined sequence. Where the web carries a plurality of
acoustoelectric transducers
attached to the web in a predetermined array, the method further comprises
receiving signals
from the acoustoelectric transducers in a pre-established sequence.
In accordance with an additional feature of the present invention, a printed
image of the
internal organs is generated in response to the analysis of signals generated
by the
acoustoelectric transducer. This printed image facilitates diagnosis by
providing a quick and
safe image.
Diagnosis is fi~rther facilitated by generating an electrical signal encoding
the
determined three dimensional shapes of the internal organs and wirelessly
transmitting the
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additional signal to a remote location. Thus, consultations with experts are
possible from
remote locations.
It is to be noted in this regard that an ultrasonic imaging device in
accordance with the
present invention is portable, at least signif cantly more portable than
conventional imaging
systems such as CAT scanners and MRI machines. Thus, imaging, diagnosis and
treatment is
possible even where patients do not have ready access to a hospital facility.
The images may
be transmitted from remote locations to global medical centers where experts
can view the
internal structures for diagnosis and therapeutic evaluation.
The above-related and other objects of the present invention are also attained
in a
medical imaging device comprising a container assembly defining a fluid- or
liquid-filled
chamber. The container assembly includes a flexible wall or panel which is
conformable to a
patient. The container assembly has at least one electroacoustic transducer in
operative
contact with the fluid-filled chamber so as to produce pressure waves in the
fluid disposed in
the chamber of the container assembly. An a-c current source is operatively
connected to the
1 _5 transducer for energizing the transducer with an electrical signal of a
pre-established ultrasonic
frequency to produce a first pressure wave in the fluid in the chamber. The
container assembly
is further provided with at least one acoustoelectric transducer which is in
operative contact
with the fluid-filled chamber for detecting or picking up pressure waves in
the fluid in the
chamber. An analyzing component is operatively connected to the
acoustoelectric transducer
for determining three-dimensional shapes of internal organs of the patient by
analyzing signals
generated by the acoustoelectric transducer in response to second pressure
waves produced at
internal organs of the patient in response to the first pressure wave and
transmitted through the
fluid in the chamber.
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Preferably, the container assembly includes a bag or bladder defining the
fluid-filled
chamber and further includes a plurality of substantially rigid walls or
panels which partially
surround and support the bag. The patient is placed on the fluid-filled bag,
the upper surface
of which is the flexible wall. The flexible wall deforms to receive and cradle
the patient and is
preferably coated with a liduid to facilitate ultrasonic pressure wave
transfer between the
patient and the bag.
A flexible web or sheet may be placed over the patient after disposition of
the patient
on the fluid-filled bag. The web or sheet may itself be provided with an
ultrasonic
electroacoustic and/or acoustoelectric transducer. Where the medical system is
to be used in
performing surgical operations under real-time visual feedback provided via
ultrasonic wave
generation, detection and analysis componentry, the web or cover sheet is
preferably provided
with a plurality of apertures enabling traversal of the web or sheet by
elongate medical
instruments, such as biopsy instruments or elongate instruments traditionally
used in
laparoscopic surgery.
Again, a video monitor is linked to the analyzing component for displaying an
image of
the internal organs, while a view selector is operatively connected to the
analyzing component
and the video monitor for selecting the image from among a multiplicity of
possible images of
the internal organs. In addition, a filter stage may be operatively connected
to the analyzing
component and the video monitor for eliminating a selected organ from the
image.
It is contemplated generally that acoustoelectric and electroacoustic
transducers are
disposed in or attached to the rigid walls or panels. However, the transducers
may be attached
to or embedded in one or more flexible walls of the fluid-filled chamber.
Specifically, some of
the transducers may be attached to or embedded in the flexible upper wall of
the fluid-filled
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chamber which conforms to and engages the patient.
With the patient received by the fluid-filled bag and covered by the flexible
web or
sheet, ultrasonic transducers may be disposed in an array virtually
surrounding the patient.
This disposition of transducers provides a dense stream of organ position and
configuration
S data to the analyzing component, thereby facilitating an enhancement of
image resolution and
the provision of multiple view angles.
The ultrasonic transducers may be disposed in a separate pad disposed, for
example,
beneath the fluid-filled bag prior to the placement of the patient on the bag.
A method for performing a medical operation, in accordance with the present
I O invention, utilizes a medical instrument and container assembly which
defines a fluid-filled
chamber having a flexible wall which is conformable to a patient. The
container assembly is
provided with at least one electroacoustic transducer and at least one
acoustoelectric
transducer which are in operative contact with the fluid-filled chamber so as
to respectively
generate and detect ultrasonic waves in the fluid. The flexible wall of the
fluid-filled chamber
I 5 is disposed adjacent to a skin surface of the patient so that the chamber
is in acoustic or
pressure-wave-transmitting contact with the skin surface. A distal end of the
medical
instrument is inserted into the patient so that the distal end is disposed
inside the patient while
the fluid-filled chamber is disposed adjacent to the skin surface. After
disposition of the
container assembly adjacent to the skin surface, the electroacoustic
transducer is energized
20 with an electrical signal of a pre-established ultrasonic frequency to
produce a first pressure
wave in the fluid in the chamber and accordingly in the patient. Signals
generated by the
acoustoelectric transducer in response to second pressure waves produced at
internal organs of
the patient and at the distal end of the medical instrument in response to the
first pressure wave
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are automatically analyzed to thereby determine three-dimensional shapes of
the internal
organs of the patient and a location of the distal end of the medical
instrument relative to the
internal organs, thereby enabling a real time manipulation of the instrument
to effectuate a
medical operation on a selected one of the internal organs.
An imaging device comprises, in accordance with the present invention, a
flexible
substrate, a flexible video screen disposed on the substrate, and a scanner
operatively
connected to the video screen for providing thereto a video signal encoding an
image of
objects located near the substrate. The scanner is preferably provided with an
analyzing
component, generally a specially programmed digital computer, for analyzing
scanner sensor
signals and determining therefrom three-dimensional shapes of the objects.
This imaging device is considered to be particularly advantageous in medical
diagnosis
and treatment procedures. The substrate with the video screen is disposed on a
selected body
portion of a patient, for example, the abdomen or a shoulder or knee, so that
the substrate and
the video screen substantially conform to the selected body portion and so
that the video
screen is facing away from the body portion. After the disposition of the
substrate and the
video screen on the selected body portion of the patient, the scanner is
operated to provide a
video signal to the video screen, the video signal encoding an image of
internal organs of the
patient. Preferably, the video screen is operated to reproduce the image so
that internal organ
representations as displayed on the video screen substantially overlie
respective corresponding
actual organs of the patient. Thus, for many purposes and applications, it
appears to the user
(generally a physician) that he or she is able to see through the skin and
other overlying tissues
to selected underlying organs.
To enable or facilitate an alignment of the displayed organ representations
and the
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respective underlying actual organs, it is recommended that markers be placed
in prespecified
locations on the patient. The markers are easily recognized by the analyzing
computer and
serve to define a reference frame whereby the position and orientation of the
video screen
relative to the patient's internal organs is detectable. Accordingly, the
position and orientation
5 of each portion or area of the video screen relative to the internal organs
of the patient is
determined to enable the display on the video screen of images of organs
underlying the
different portions of the screen. Where the screen is folded back on itself in
conforming to a
curved skin surface of the patient, two or more overlapping screen areas may
be provided with
the same image signal. However, only the uppermost screen portion of the
overlapping areas
10 will be visible to the user.
The imaging device or system is preferably provided with a number of ancillary
components or functional subcomponents for facilitating use of the system as a
medical
diagnostic and therapeutic tool. For example, the analyzing component may
include a module,
typically realized as a programmed general computer circuit, for highlighting
a selected feature
of the internal organs of the patient. The highlighting may be implemented by
changing the
color or intensity of the selected feature relative to the other features in
the displayed image,
thus providing a visual contrast of the selected feature with respect to the
other features of the
displayed image. An intensity change may be effectuated by essentially
blacking or whiting out
the other portions of the image so that the selected feature is the only
object displayed on the
video screen.
Another ancillary component for enhancing the usefulness of the imaging device
or
system is voice-recognition circuitry operatively connected to the analyzing
computer. Voice
recognition circuity is especially beneficial for medical applications in that
doctors must
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frequently have their hands (and even feet) available for operating medical
equipment. In
conventional medical procedures, voice control is exerted via attendant
personnel: the
assistants are requested by the lead physician to perform desired tasks. The
voice recognition
circuitry of the present invention is used, for instance, to request
highlighting of a selected
organ or removal of an organ from the image on the video screen. The removal
of selected
organs or tissues enables the user to view underlying organs. Viewing of the
patient's internal
structures may thus proceed in an ever more deeply penetrating sequence, with
successive
removal of different layers of tissues.
Yet another ancillary component is speech synthesis circuitry operatively
connected to
the analyzing computer. The voice recognition and speech synthesis circuitry
together enable
the user to interface with the imaging device as if the device were an
operating room assistant.
These ancillary components also free the physician's eyes to look at the
flexible video screen.
The analyzing computer's tasks may extend well beyond normal image analysis
and
construction. The computer may be programmed for automated diagnosis based on
pattern
recognition. For example, the computer may be programmed to recognize a
bloated appendix
by comparing the image data with prestored data identifying normal and
inflamed appendices.
The computed diagnosis may be communicated to the physician via the speech
synthesis
circuitry: "Enlarged appendix--possible appendicitis--recommend immediate
removal."
The substrate and the video screen are advantageously provided with a
plurality of
mutually aligned apertures enabling traversal of the substrate and the video
screen by medical
instruments. The distal ends of the medical instruments, inserted into the
patient in the field of
view of the imaging system, are displayed on the video screen together with
the selected
internal organs of the patient. In this way, laparoscopic surgery as well as
other invasive
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operations, whether diagnostic or therapeutic, may be performed with the aid
of real-time
visual images of the patient's internal organs displayed on the flexible video
screen.
Laparoscopic surgery is simplified by eliminating the need for a laparoscope.
Laparoscope
elimination enables a reduction in the number of perforations made in the
patient or,
alternatively, enables the insertion of another laparoscopic instrument with
the same number of
perforations. Other operations implemented by inserting instruments through
the flexible video
screen include liver biopsies, kidney biopsies, and pleural biopsies and the
placement of tubular
members, including drains and catheters, for such techniques as thoracentesis
and abscess
drainage.
An additional ancillary component for enhancing the usefulness of the imaging
device
or system in accordance with the present invention is a transceiver interface
for operatively
connecting the scanner, including the analyzing computer, to a long-distance
telecommunications link. The image data is transmitted over the
telecommunications link to a
video monitor at a remote location, thereby enabling observation of the
patient's internal
organs by specialists in distant cities. These specialists may provide
diagnostic and treatment
advice to people in the location of the patient. Also, a surgical procedure
may be exerted
robotically under the control of the distant experts, as disclosed in U.S.
Patents Nos. 5,217,003
and 5,217,453 to Wilk.
In accordance with a principal embodiment of the present invention, the
scanner utilizes
ultrasonic pressure waves to collect the three-dimensional structural data
from which the organ
images are derived or constructed. Such an ultrasonic scanner includes at
least one
electroacoustic transducer, an a-c current generator operatively connected to
the transducer
for energizing the transducer with an electrical signal of a pre-established
ultrasonic frequency
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to produce a first pressure wave, and at least one acoustoelectric transducer.
The analyzing
computer is operatively connected to the acoustoelectric transducer for
determining three-
dimensional shapes of the objects by analyzing signals generated by the
acoustoelectric
transducer in response to second pressure waves produced at the objects in
response to the
first pressure wave.
In a particular embodiment of the invention, at least one of the ultrasonic
transducers is
mounted to the substrate. Typically, the electroacoustic transducer is one of
a plurality of
electroacoustic transducers and the acoustoelectric transducer is one of a
plurality of
acoustoelectric transducers, all mounted to the substrate. This configuration
is especially
portable: it is compact and lightweight.
In accordance with another embodiment of the present invention, a medical
imaging
device comprises a planar substrate, a substantially flat video screen
provided on the substrate,
a flexible bag corulected to the substrate, and a scanner operatively
connected to the video
screen for providing a video signal thereto. The bag is disposed on a side of
the substrate
I 5 opposite the video screen and is filled with a fluidic medium capable of
transmitting ultrasonic
pressure waves. The video signal encodes an image of internal tissues of a
patient upon
placement of the flexible bag with the medium, the substrate and the video
screen against the
patent.
An imaging device comprises, in accordance with another embodiment of the
present
invention, a plurality of substantially planar substrates, at /east one
flexible connection coupling
the substrates to one another so that the substrates are extendable at a
variable angle with
respect to one another, a plurality of video screens each attached to one of
the substrates, and
a scanner operatively connected to the video screens for providing respective
video signals
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thereto, the video signals each encoding an image of objects located near a
respective one of
the substrates.
It is contemplated that the scanner is an ultrasonic scanner and includes at
least one
electroacoustic transducer and at least one acoustoelectric transducer. Where
a flexible bag
filled with a fluidic medium is attached to the substrate or substrates, the
transducers are both
attached at least indirectly to the substrates) so that ultrasonic pressure
waves can travel
through the fluidic medium from the electroacoustic transducer and to the
acoustoelectric
transducer.
The scanner is preferably provided with an analyzing component, generally a
specially
programmed digital computer, for analyzing scanner sensor signals and
determining therefrom
three-dimensional shapes of objects being scanned.
The imaging device of the present invention is considered to be particularly
advantageous in medical diagnosis and treatment procedures. The substrate or
substrates with
one or more video screens are disposed on a selected body portion of a
patient, for example,
the abdomen or a shoulder or knee, so that the substrate and the video screen
overlie the
selected body portion and so that the video screen or screens are facing away
from the body
portion. After the disposition of the substrate and the video screen, or the
multiple substrates
and the multiple video screens next to the patient, the scanner is operated to
generate one or
more video signals and transmit those signals to the video screens. The video
signals encode
images of internal tissues of the patient. Preferably, the video screens are
operated to
reproduce the images so that representations of internal tissues (e.g.,
organs) as displayed on
the video screens substantially overlie respective corresponding actual
tissues (organs) of the
patient. Thus, for many purposes and applications, it appears to the user
(generally a
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physician) that he or she is able to see through the skin and other overlying
tissues to selected
underlying tissues.
To enable or facilitate an alignment of the displayed tissue representations
and the
respective underlying actual tissues, it is again recommended that markers be
placed in
5 prespecified locations on the patient. Also, the imaging device or system is
preferably
provided with a number of ancillary components or functional subcomponents for
facilitating
use of the system as a medical diagnostic and therapeutic tool. For example,
the analyzing
component may include a module for highlighting a selected feature of the
internal organs of
the patient, voice-recognition circuitry, speech synthesis circuitry, computer
implemented
10 diagnosis, and a telecommunications transceiver
Where the imaging device comprises multiple video screens, the device is
advantageously provided with a plurality of apertures, for example, in the
interstitial spaces
between the video screens, enabling traversal of the device by medical
instruments. The distal
ends of the medical instruments, inserted into the patient in the field of
view of the imaging
15 system, are displayed on the video screens together with internal target
tissues of the patient.
In this way, laparoscopic surgery as well as other invasive operations,
whether diagnostic or
therapeutic, may be performed with the aid of real-time visual images of the
patient's internal
tissues displayed on the video screens. Laparoscopic surgery is simplified by
eliminating the
need for a laparoscope. Laparoscope elimination enables a reduction in the
number of
perforations made in the patient or, alternatively, enables the insertion of
another laparoscopic
instrument with the same number of perforations. Other operations implemented
by inserting
instruments through the flexible video screen include liver biopsies, kidney
biopsies, and pleural
biopsies and the placement of tubular members, including drains and catheters,
for such
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techniques as thoracentesis and abscess drainage.
In a particular embodiment of the invention, at least one of the ultrasonic
transducers is
mounted to the substrate or to one of the substrates. Typically, the
electroacoustic transducer
is one of a plurality of electroacoustic transducers and the acoustoelectric
transducer is one of
a plurality of acoustoelectric transducers, all mounted to the substrate or
substrates. This
configuration is especially portable: it is compact and lightweight.
Where the imaging device is used to diagnose or treat a limb or a joint, the
planar
substrates and the video screens attached thereto have sizes and possibly
shapes which
facilitate substantial conformity with the limb or joint.
A medical method in accordance with the present invention utilizes an imaging
device
including a plurality of planar substrates fastened to one another by flexible
connectors, each of
the substrates carrying a respective video screen, a scanner being operatively
connected to the
video screens. Pursuant to the method, the substrates with the video screens
are disposed on a
body portion of a patient so that the substrates and the video screens
substantially conform to
the body portion of the patient and so that the video screens are facing away
from the body
portion of the patient. After the disposition of the substrates and the video
screens on the body
portion of the patient, the scanner is operated to provide video signals to
the video screens, the
video signals encoding images of internal tissues of the patient.
Preferably, the video screens are operated to reproduce the images so that
internal
tissue representations as displayed on the video screens substantially overlie
respective
corresponding actual tissues of the patient.
The method also contemplates the placing of markers on the patient for
facilitating the
reproducing of the images so that the internal tissue representations on the
video screens
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substantially overlie respective corresponding actual tissues of the patient.
Brief Description of the Drawings
Fig. I is a block diagram of a medical diagnostic system, which may utilize or
incorporate an ultrasonographic imaging device in accordance with the present
invention.
Fig. 2 is a flow-chart diagram illustrating steps in a mode of operation of
the diagnostic
system of Fig. 1.
Fig. 3 is a flow-chart diagram illustrating steps in another mode of operation
of the
diagnostic system of Fig. 1.
Fig. 4 a block diagram of a fizrther medical diagnostic system.
Fig. 5 is a diagram showing the composition of a data string or module used in
the
system of Fig. 4
Fig. 6 is a block diagram of a computerized slide scanning system.
Fig. 7 is a block diagram of a device for measuring a diagnostic parameter and
transmitting the measurement over the telephone lines.
Fig. 8 is a diagram of an uitrasonography device
Fig. 9 is a diagram showing a modification of the device of Fig. 8.
Fig. 10 is a block diagram of an ultrasonographic imaging apparatus similar to
the
device of Figs. 8 and 9, for use in diagnostic and therapeutic procedures.
Fig. 11 is a block diagram showing a modification of the apparatus illustrated
in Fig.
I 0.
Fig. 12 is partially a schematic perspective view and partially a block
diagram showing
use of an ultrasonographic imaging device in a minimally invasive diagnostic
or therapeutic
procedure.
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Fig. 13 is a partial schematic perspective view including a block diagram
showing use
of an ultrasonographic imaging device in another minimally invasive diagnostic
or therapeutic
procedure.
Fig. 14 is a schematic perspective view of yet another ultrasonographic
imaging device
which includes a sensor vest in a closed, use configuration.
Fig. 15 is a schematic perspective view of the sensor vest of Fig. 14, showing
the vest
in an open configuration.
Fig. 16 is partially a schematic perspective view and partially a block
diagram of an
ultrasonic diagnostic imaging device.
Fig. 17 is partially a schematic perspective view and partially a block
diagram of the
ultrasonic diagnostic imaging device of Fig. 16, showing the device in use
with a patient.
Fig. 18 is partially a schematic perspective view and partially a block
diagram of
another ultrasonic diagnostic imaging device, showing the device in use with a
patient.
Fig. 19 is partially a schematic perspective view and partially a block
diagram of the
ultrasonic diagnostic imaging device of Figs. 17 and I 8, showing a
modification of the device
of those figures.
Fig. 20 is partially a schematic exploded perspective view and partially a
block diagram
of an ultrasonographic device or system related to the present invention.
Fig. 21 is a schematic perspective view showing use of the system of Fig. 20
in
performing a laparoscopic operation.
Figs. 22A and 22B are schematic perspective views showing use of another
ultrasonographic device related to the present invention.
Fig. 23A is a schematic perspective view of a further ultrasonographic device
related to
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the present invention.
Fig. 23B is a schematic perspective view showing use of the ultrasonographic
device of
Fig. 23A.
Fig. 24 is a schematic perspective view of an ultrasonographic device in
accordance
with the present invention.
Fig. 25 is a schematic perspective view of another ultrasonographic device in
accordance with the present invention.
Fig. 26 is a schematic perspective view of the ultrasonographic device of Fig.
25,
showing the device in use on a patient.
Fig. 27A is a schematic front elevational view of a video screen display
configuration
utilizable in the ultrasonographic device of Figs. 25 and 26.
Fig. 27B is a schematic front elevational view of a further video screen
display
configuration utilizable in the ultrasonographic device of Figs. 25 and 26.
Fig. 28 is a schematic partial perspective view of a modification of the
ultrasonographic
device of Figs. 25 and 26, showing a mode of use of the device in a surgical
treatement or a
diagnostic procedure.
Description of the Preferred Embodiments
The present invention is directed chiefly to an imaging device and
particularly to an
ultrasonographic imaging device utilizable in diagnostic and therapeutic
procedures. The
ultrasonographic imaging device of the present invention is described
generally hereinafter with
reference to Figs. 8 et .seg. and particularly with reference to Figs. 20 et
seq. The
ultrasonographic imaging device, and particularly image derivation or
construction portions
thereof, can be employed as an image generating apparatus or scanner 42 in the
medical
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diagnostic system of Fig. 1 or a diagnostic image generating apparatus 78a,
78b, 78i in the
medical diagnostic system of Fig. 4. Alternatively or additionally, the
ultrasonographic
imaging device can be employed in carrying out certain minimally invasive
diagnostic or
therapeutic operations, examples of which are illustrated schematically in
Figs. 12 and 13.
As illustrated in Fig. 1, a medical diagnostic system comprises a device 20
for
monitoring and measuring a biological or physiological parameter. Monitoring
and measuring
device 20 is juxtaposable to a patient for collecting individualized medical
data about the
patient's condition. Device 20 may take the form of an electronic thermometer,
an electronic
blood pressure gauge, a pulmonary function apparatus, a Doppler study
apparatus, an EEG
10 machine, an EKG machine, an EMG machine, or a pressure measurement device,
etc., or
include a plurality of such components.
Monitoring and measuring device 20 is connected at an output to a digitizer 22
which
converts normally analog type signals into coded binary pulses and transmits
the resulting
digital measurement signal to a computer 24. Digitizer 22 may be incorporated
into a housing
I 5 (not shown) enclosing all or part of the monitoring and measuring device
20. Moreover,
digitizer may be an integral part of monitoring and measuring device 20.
Computer 24 receives instructions and additional input from a keyboard 26.
Keyboard
26 is used to feed computer 24 information for identifying the patient, for
example, the
patient's age, sex, weight, and known medical history and conditions. Such
medical conditions
20 may include past diseases and genetic predispositions.
Computer 24 is also connected to an external memory 28 and an output device 30
such
as a printer or monitor. Memory 28 stores medical data for a multiplicity of
previously
diagnosed medical conditions which are detectable by analysis of data provided
by monitoring
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21
and measuring device 20.
As illustrated in Fig. 2, monitoring and measuring device 20 detects a
magnitude of a
predetermined biological or physiological parameter in a step 32. Digitizer 22
converts the
detected magnitude into a pre-established digital format in a step 34 and
transmits the digital
signal to computer 24 in a step 36. Computer 24 is operated in a step 38 to
compare the
digitized data from monitoring and measuring device 20 with the data stored in
memory 28 and
to derive a diagnosis as to the patient's condition. The diagnosis is then
communicated to the
user (operator) and to the patient via output device 30 in a step 40.
If monitoring and measuring device 20 measures a physiological function
characterized
I0 by a plurality of different variables, for example, the electric potential
at different points on the
patient's body (EEG, EKG, EMG), these variables may be broken down by computer
24 into
one or more parameters, e.g., a frequency packet. The measured values of the
pre-established
parameters are then compared with parameter ranges stored in memory 28 for the
type of
parameter and the kind of patient, as characterized by sex, age, weight, etc.
If the measured
values of the pre-established parameters fall within expected ranges, as
stored in memory 28,
then computer 28 communicates a "normalcy" finding via printer 30. If, on the
contrary, the
measured values of one or more parameters fall outside the normal ranges, then
a diagnosis of
a possible medical condition is printed out.
As further illustrated in Fig. 1, the medical diagnostic system may comprise,
in addition
to or alternatively to monitoring and measuring device 20, image generating
apparatus or
scanner 42 for generating in electrically encoded form a visually readable
image of an organic
part of the patient. Scanner 42 may take the form of an MItI apparatus, a CAT
scanner, an
X-ray machine, an ultrasonography apparatus (see Figs. 8-15 and 20), or a
video camera with
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or without magnification optics for magnifying a sample on a slide. The video
camera can be
used for obtaining an image of a portion of a patient's skin.
Scanner 42 is connected via an interface 44 to computer 24.
As shown in Fig. 3, scanner 42 obtains an image of a tissue or organ in a step
46. The
image is digitized, either by scanner 42 or interface 44 in a step 48, and is
transmitted to
computer 24 in a step 50. Computer 24 is operated in a step 52 to analyze the
image from
scanner 42 and determine specific values for a multiplicity of predetermined
parameters. For
example, in the event that scanner 42 takes the particular form of a video
camera for
dermatological diagnosis, an image of a skin surface of a patient is analyzed
by computer 24 to
derive such parameters as percentage of skin covered by abnormal condition,
the range of sizes
of individual ulcers, the range of color variation (e.g., whether bleeding is
symptomatic).
The specific values of pre-established parameters calculated by computer 24
from
electrically encoded images transmitted from scanner 42 are compared by
computer 24 with
previously determined parameter ranges stored in memory 28. For example, if a
pregnant
woman's fetus is being scanned by ultrasonography, the lengths of the fetal
appendages, arms,
legs, fingers, etc., are compared with each other and with respective fetal
appendage ranges
recorded in memory 28 for the stage of pregnancy, weight of the fetus, and
possibly weight of
the mother. In the event that any appendages are missing or are of abnormal
length, a
diagnosis as to possible deformity is printed out. Organs internal to the
fetus may be similarly
examined automatically by scanner 42 and computer 24. In more advanced stages
of
pregnancy, physiological functions such as the heart rate of the fetus may be
automatically
monitored for abnormal conditions.
The analysis performed by computer 24 on the image from scanner 42 will depend
in
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part on the region of the patient's body being scanned. If a woman's breast or
a person's cortex
is being monitored for tumorous growths, computer 24 is programmed to separate
the tissue
image into regions of different textures. The different textured regions are
parameterized as to
size, shape and location and the derived parameters are compared to values in
memory 30 to
determine the presence of a tumor. Additional analysis is undertaken to detect
lines in an
image which may indicate the presence of an organic body.
A similar analysis is undertaken to evaluate a tissue specimen on a slide. The
texture
and line scanning may be repeated at different magnification levels if, for
example, the tissue
sample is a slice of an organ wall. On a high magnification level, the texture
and line analysis
can serve to detect microorganisms in blood.
Memory 28 may store entire images related to different diseases. For example,
memory may store images of skin conditions in the event that scanner 42 takes
the form of a
video camera at a dermatological diagnosis and treatment facility. In a step
54 (Fig. 3),
computer 24 compares the image of a patient's skin with previously stored
images in memory
28, for example, by breaking down the current image into sections and
overlaying the sections
with sections of the stored images, at variable magnification levels.
In the event that scanner 42 takes the form of an MRI apparatus, a CAT scanner
or an
ultrasonographic scanner such as those described hereinafter with references
to Figs. 8-15 and
20, the images stored in memory 28 are of internal organic structures. In step
54 (Fig. 3),
computer 24 compares images of a person's internal organs with previously
stored organ
images in memory 28. Computer 24 partitions the image from the MRI apparatus
or CAT
scanner into subareas and overlays the subareas with sections of the stored
images, at variable
magnification levels.
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In a final step 40 (Fig. 3 ), computer 24 communicates the results of its
diagnostic
evaluation to a user or patient.
As illustrated in Fig. 4, a medical diagnostic system comprises a plurality of
remote
automated diagnostic stations 60a and 60b connected via respective
telecommunications links
62a and 62b to a central computer 64. Each diagnostic station 60a, 60b may
take the form
shown in Fig. 1, local computer 24 communicating via link 62a, 62b with
central computer 64.
Alternatively, each diagnostic station 60a, 60b may take the form shown in
Fig. 4 and include a
respective plurality of monitoring and measuring devices 66a, 66b, ... 66n
operatively
connected to a local computer 68 via respective digitizer output units 70a,
70b, ... 70n.
Computer 68 is fed instructions and data from a keyboard 72 and communicates
diagnostic
results via a monitor 74 or printer 76. As discussed hereinabove with
reference to monitoring
and measuring device 20 of Fig. l, each monitoring and measuring device 66a,
66b, ... 66n is
juxtaposable to a patient for collecting individualized medical data about the
patient's
condition. Monitoring and measuring devices 66a, 66b, ... 66n may respectively
take the form
of an electronic thermometer, an electronic blood pressure gauge, a pulmonary
function
apparatus, a Doppler study apparatus, an EEG machine, an EKG machine, an EMG
machine,
or a pressure measurement device, etc.
Digitizers 70a, 70b, ... 70n convert normally analog type signals into coded
binary
pulses and transmit the resulting digital measurement signals to computer 68.
Digitizers 70a,
70b, ... 70n may be incorporated into the housings or casing (not shown)
enclosing all or part
of the respective monitoring and measuring devices 66a, 66b, ... 66n.
Keyboard 72 is used to feed computer 68 information for identifying the
patient, for
example, the patient's age, sex, weight, and known medical history and
conditions. Such
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medical conditions may include past diseases and genetic predispositions.
As fizrther illustrated in Fig. 4, a plurality of diagnostic image generating
apparatuses or
scanners 78a, 78b, ... 78i are also connected to central computer 64 via
respective hard-wired
or wireless telecommunications links 80a, 80b, ... 80i. Scanners 78a, 78b, ...
78i each generate
5 in electrically encoded form a visually readable image of an organic part of
the patient.
Scanners 78a, 78b, ... 78i may each take the form of an NiRI apparatus, a CAT
scanner, an
X-ray machine, an ultrasonography apparatus (Figs. 8-1 S and 20), or a video
camera with or
without magnification optics for magnifying a sample on a slide.
Because of the enormous quantity of data necessary for storing images, central
10 computer 64 is connected to a bank of memories 82 at a central storage and
information
processing facility 84. Diagnosis of patient conditions may be undertaken by
central computer
64 alone or in cooperation with local computers 24 or 68.
As illustrated in Fig. 5, local computers 24 and 68 transmit information to
central
computer 64 in data packets or modules each include a first string of binary
bits 86
1 S representing the transmitting station 60a, 60b, a second bit string 88
identifying the patient, a
bit group 90 designating the parameter which is being transmitted, another bit
group 92 coding
the particular measured value of the parameter, a set of bits 94 identifying
the point on the
patient at which the measurement was taken, and another bit set 96 carrying
the time and date
of the measurement. Other bit codes may be added as needed.
20 As shown in Fig. 6, a computerized slide scanning system comprises a slide
carrier 100
mountable to a microscope stage and a slide positioning device 102
mechanically linked to the
slide carrier 100 for shifting the carrier along a path determined by a
computer 104. Computer
104 may be connected to an optional transport or feed assembly 106 which
delivers a series of
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slides (not shown) successively to slide carrier 100 and removes the slides
after scanning.
Computer 104 is also connected to an optical system 108 for modifying the
magnification power thereof between successive slide scanning phases. Light
emerging from
optical system 108 is focused thereby onto a charge coupled device ("CCD") 110
connected to
computer 104 for feeding digitized video images thereto.
Computer 104 performs a line and texture analysis on the digitized image
information
from CCD 110 to determine the presence of different organic structures and
microorganisms.
The different textured regions are parameterized as to size, shape and
location and the derived
parameters are compared to values in a memory to identify microscopic
structures. The
texture and line scanning is repeated at different magnification levels.
Computer 104 may be connected to a keyboard 112, a printer 114, and a modem
16.
Modem 116 forms part of a telecommunications link for connecting computer 104
to a remote
data processing unit such as computer b4 in Fig. 4
Image generating apparatus 42 in Fig. 1 may take the form of the computerized
slide
scanning system of Fig. 6.
As shown in Fig. 7, a device for measuring a diagnostic parameter and
transmitting the
measurement over the telephone lines comprises a monitoring and measuring
device 118 which
may take the form, for example, of an electronic thermometer, an electronic
blood pressure
gauge, a pulmonary function apparatus, a Doppler study apparatus, an EEG
machine, an EKG
machine, an EMG machine, or a pressure measurement device, etc., or include a
plurality of
such components. Monitoring and measuring device 118 is connected at an output
to a
digitizer I20 which in turn is coupled to a modulator 122. Modulator 122
modulates a carrier
frequency from a frequency generator 124 with the data arriving from
monitoring and
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measuring device 118 via digitizer 120 and transmits the modulated signal to
an electroacoustic
transducer 126 via an amplifier 128. Transducer 126 is removably attachable
via a mounting
element 130 to the mouthpiece of a telephone handset (not shown) and generates
a pressure
wave signal which is converted by a microphone in the handset mouthpiece back
to an
S electrical signal for transmission over the telephone lines. Of course,
transducer 126 may be
omitted and modulator 122 connected directly to a telephone Line.
The system of Fig. 7 enables the transmission of specialized medical data
directly over
the telephone lines to a central computer (e.g. computer 64 in Fig. 4) which
utilizes the
incoming data to perform a diagnostic evaluation on the patient.
Monitoring and measuring device 118 may include traditional medical
instrumentation
such as a stethoscope or modern devices such as a CCD.
Fig. 8 shows an ultrasonographic image generating apparatus which may be used
in the
medical diagnostic system of Fig. 1 (see reference designation 42) or in the
medical diagnostic
system of Fig. 4 (see reference designations 78a, 78b, ... 78i). A flexible
web 132 carnes a
I 5 plurality of piezoelectric electroacoustic transducers 134 in a
substantially rectangular array.
Transducers 134 are each connectable to an ultrasonic signal generator 136 via
a switching
circuit 138. Switching circuit 138 is operated by a control unit 140 to
connect tranducers 134
to signal generator 136 in a predetermined sequence, depending on the area of
a patient's body
which is being ultrasonically scanned.
Web 132 also carries a multiplicity of acoustoelectric transducers or sensors
142 also
arranged in a substantially rectangular array. Sensors 142 are connected to a
switching circuit
144 also operated by control unit 140. An output of switching circuit 144 is
connected to a
sound or pressure wave analyzer 146 via an amplifier 148.
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Web 132 is draped over or placed around a portion of a patient's body which is
to be
monitored ultrasonically. Control unit 140 then energizes signal generator 136
and operates
switching circuit 138 to activate transducers 134 in a predetermined sequence.
Depending on
the transducer or combination of transducers 134 which are activated, control
unit 140
S operates switching circuit 144 to connect a predetermined sequence of
sensors 142 to pressure
wave analyzer 146. Pressure wave analyzer 146 and control unit 140 cofunction
to determine
three dimensional structural shapes from the echoes detected by sensors 142.
Control unit 140 is connected to ultrasonic signal generator 136 for varying
the
frequency of the generated signal.
Fig. 9 shows a modified ultrasonography web 1 SO having a limited number of
electroacoustic transducers 152 and generally the same number and disposition
of sensors 1 S4
as in web 132.
Web 132 or 1 SO may be substantially smaller than illustrated and may
corresponding
carry reduced numbers of transducers 134 and 1 S2 and sensors 142 and 1 S4.
Specifically, web
1 S 132 or 1 S0, instead of being a sheet large enough to wrap around a torso
or arm of a patient,
may take a strip-like form which is periodically moved during use to
different, predetermined
locations on the patient. Control unit 140 and pressure wave analyzer 146 are
programmed to
detect internal organic structures from the data obtained at the different
locations that the web
132 or I 50 is juxtaposed to the patient.
Fig. 10 illustrates a modification of the ultrasonography apparatus of Figs. 8
and 9
which is employable in diagnostic or therapeutic operations involving the
insertion of an
instrument into a patient. A control unit 1 S6 for performing operations of
control unit 140 is
connected at an output to a video monitor 1 S8. As discussed hereinafter with
reference to
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Figs. 12 and 13, a diagnostician, surgeon or other medical specialist inserts
a distal end of a
medical instrument into a patient in response to video feedback provided by
the
ultrasonography apparatus including video monitor 158.
As further illustrated in Fig. 10, an a-c current or ultrasonic signal
generator 160 is
connected via a switching circuit 162 to different piezoelectric type
electroacoustic transducers
164 in seriatum. Transducers 162 are mounted in interspaced fashion to a
flexible web 166
which also carries an array of spaced piezoelectric type acoustoelectric
transducers 168.
Web is placed adjacent to a skin surface of a patient. In some cases, it may
be
beneficial to provide a layer of fluid between the skin surface of the patient
and the web 166 to
facilitate ultrasonic wave transmission from web 166 to the patient and from
the patient back
to the web. In response to the periodic energization of transducers 162,
ultrasonic pressure
waves are reflected from internal organic structures of the patient and sensed
by
acoustoelectric transducers 168. Electrical signals generated by transducers
168 in response to
the reflected pressure waves are fed via a switching circuit 170 to control
unit 156.
I S As discussed hereinabove with reference to control unit 140 in Fig. 8,
control unit 156
controls switching circuits 162 and 170 to energize emitting transducers 164
in a
predetermined sequence and and to selectively couple receiving transducers 168
in a pre-
established sequence to a pressure wave or ultrasonic frequency analyzer 172
in control unit
156. The sequencing depends on the portion of the patient being monitored.
In addition to pressure wave or ultrasonic frequency analyzer 172, control
unit 156
includes a view selector 174 and a filter stage 176. View selector 174 is
operatively connected
at an input to analyzer 172 and at an output to video monitor 158 for
selecting an image for
display from among a multiplicity of possible images of the internal organs
detected by
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analyzer 172. View selector 174 may be provided with an input 178 from a
keyboard (not
shown) or other operator interface device for enabling an operator to select a
desired view.
For example, during the insertion of a medical diagnostic or treatment
instrument into the
patient or during manipulation of that instrument to effect an operation on a
targeted internal
5 organ of the patient, the medical practitioner may sequentially select views
from different
angles to optimize the practitioner's perception of the spatial relation
between the distal tip of
the instrument and the patient's internal organs.
Filter stage 176 is operatively connected to analyzer 172 and video monitor
158 for
optionally eliminating a selected organ from the displayed image. Filter stage
176 is provided
10 with an input 180 from a keyboard (not shown) or other operator interface
device for enabling
an operator to select an organ for deletion from the displayed image. In one
example of the
use of filter stage 176, blood moving through a vessel of the vascular system
is deleted to
enable viewing of the blood vessel walls on monitor I 58. This deletion is
easily effected
starting from conventional techniques such as the Doppler detection of moving
bodies.
I 5 Filter stage 176 may also fi~nction to highlight selected organs. The
pattern recognition
techniques discussed above are used to detect selected organs. The
highlighting may be
implemented exemplarily through color, intensity, cross-hatching, or outlines.
As further illustrated in Fig. 10, control unit I 56 is optionally connected
at an output to
a frame grabber 182 for selecting a particular image for reproduction in a
fixed hard copy via a
20 printer 184. In addition, as discussed hereinabove with respect to the
telecommunications links
80a, 80b ... 80i in Fig. 4, ultrasonically derived real-time image information
may be encoded by
a modulator 186 onto a carrier wave sent to a remote location via a wireless
transmitter 188.
Fig. 11 depicts the ultrasonography apparatus of Fig. 10 in a form wherein
control unit
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156 (Fig. 10) is realized as a specially programmed general purpose digital
computer 190. A
switching circuit or multiplexer 192 relays signals incoming from respective
acoustoelectric
transducers 168 (Fig. 10) in a predetermined intercalated sequence to an
analog-to-digital
converter 194, the output of which is stored in a computer memory 196 by a
sampling circuit
S 198 of computer 190. A wave analysis module 200 of computer 190 retrieves
the digital data
from memory 196 and processes the data to determine three dimensional organic
structures
inside a patient. This three-dimensional structural data is provided to a view
selection module
202 for deriving two-dimensional images for display on monitor 158 (Fig. 10).
A filter module
204 is provided for removing selected organs from the image presented on the
visual display or
video montiro 158. Sampling circuit 198, wave analysis module 200, view
selection module
202, and filter module 204 are program-modified generic digital circuits of
computer 190.
Fig. 12 shows a use of a flexible ultrasonic sensor web 206 which may be any
of the
flexible ultrasonic sensor webs described herein, except that web 206 is
additionally provided
with a plurality of apertures or perforations 208. Upon the placement of web
206 in pressure-
wave transmitting contact with a skin surface of a patient P, elongate
diagnostic or therapeutic
instruments such as laparoscopic surgical instruments 210 and 212 are inserted
through
respective openings 208 to perform a surgical operation on a designated
internal organ of the
patient P 1. This operation is effectuated by viewing a real time image of the
distal ends of the
instruments 210 and 212 in relation to the patient's internal organic
structures as determined
by control unit 156 or computer 190. Generally, the image on monitor 158 is
viewed during
insertion of instruments 210 and 212 to enable a proper employment of those
instruments.
Also, the video images on monitor 158 are viewed to enable a proper carrying
out of the
"laparoscopic" surgical operation on the designated internal organ of the
patient P 1. Strictly
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speaking, this operation is not a laparoscopic operation, since a laparoscope
is not used to
provide a continuing image of the patient's internal organic structures and
the distal ends of
instruments 210 and 212.
There are multiple advantages to using sonographic web 206 instead of a
laparoscope.
Fewer perforations need be made in the patient for the same number of surgical
instruments.
In addition, multiple views of the patient's internal organic structures are
possible, rather than
a single view through a laparoscope. Generally, these multiple views may
differ from one
another by as little as a few degrees of arc. Also, particularly if web 206 is
extended
essentially around patient P 1, viewing angles may be from under the patient
where a
laparoscopic could not realistically be inserted.
Web 206 may be used to insert tubular instruments such as catheters and
drainage
tubes, for example, for thoracentesis and abscess drainage. The tubes or
catheters are inserted
through apertures 208 under direct real time observation via monitor 158.
In addition to treatment, web 206 may be used to effectuate diagnostic
investigations.
In particular, a biopsy instrument 214 may be inserted through an aperture 208
to perform a
breast biopsy, a liver biopsy, a kidney biopsy, or a pleural biopsy.
As illustrated in Fig. 13, a flexible ultrasonic sensor web 216, which may be
any of the
flexible ultrasonic sensor webs described herein, may be used in a diagnostic
or therapeutic
operation utilizing a flexible endoscope-like instrument 218. Instrument 218
has a steering
control 220 for changing the orientation of a distal tip 222 of the
instrument. Instrument 218
also has a port 224 connected to an irrigant source 226 and another port 228
connected to a
suction source. In addition, instrument 218 is provided a biopsy channel (not
shown) through
which an elongate flexible biopsy instrument or surgical instrument 230 is
inserted.
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Instrument 218 is considerably simplified over a conventional endoscope in
that
instrument 218 does not require fiber-optic light guides for carrying tight
energy into a patient
P2 and image information out of the patient. Instead, visualization of the
internal tissues and
organ structures of patient P2 is effectuated via monitor 158 and control unit
156 or computer
190. As discussed above with reference to Fig. 12, the sonographic imaging
apparatus if web
216 is extended essentially around patient P2, images may be provided from
multiple angles,
not merely from the distal tip 222 of instrument 218.
View selector 174 and organ filter stage 176 or view selection module 202 and
filter
module 204 may function in further ways to facilitate viewing of internal
organic structures. In
addition to organ removal and highlighting, discussed above, a zoom capability
may be
provided. The zoom or magnification factor is limited only by the resolution
of the imaging,
which is determined in part by the frequency of the ultrasonic pressure waves.
Figs. 14 and 15 depict a specialized ultrasonic sensor web 232 in the form of
a garment
such as a vest. Sensor vest 232 has arm holes 234 and 236, a neck opening 238
and fasteners
240 for closing the vest about a patient. In addition, sensor vest 232 is
provided with a
plurality of elongate chambers 242 which receive fluid for expanding the vest
into
conformation with a patient's skin surface, thereby ensuring contact of the
vest with a patient's
skin surface and facilitating the transmission of ultrasonic pressure waves to
and from
ultrasonic transducers 244. Fig. 14 shows a computer 246, a video monitor 248
and a printer
250 used as described above.
Sensor vest 232 may be understood as a container assembly having fluid-filled
chambers 242 with flexible inwardly facing walls (not separately designated)
which conform to
the patient.
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As illustrated in Fig. 16, an ultrasonography apparatus comprises a container
assembly
302 including a substantially rigid plate 304 attached to a flexible bladder
or bag 306. Bladder
or bag 306 is filled with a liquid and is sufficiently flexible to
substantially conform to a patient
when the container assembly 302 is placed onto a patient PT1, as illustrated
in Fig. 17. A
liquid may be deposited on the patient prior to the placement of container
assembly 302 on
patient PT 1.
Plate 304 is provided with multiple ultrasonic pressure wave generators and
detectors
308 as described above with respect to Figs. 8 and 9 and Figs. 14 and 15.
Generators and
detectors 308 are connected to a computer 310 having essentially the same
functional
structures and programming as computer 190 for implementing sequential
generator
energization and sequential detector sampling, as described above. Computer
310 is connected
to a monitor 312 for displaying images of internal organs of patient PT 1.
Computer 310 has
the capability of alternately displaying organ images from different angles,
as discussed above.
Fig. 18 depicts another ultrasonography apparatus useful for both diagnostic
investigations and minimally invasive surgical operations. The apparatus
comprises a container
assembly 314 which includes a fluid-filled sack or bag 316 for receiving a
patient PT2. Sack or
bag 316 include a flexible upper wall 318 which deforms to conform to the
patient PT2 upon
placement of the patient onto the bag. Bag 316 is supported on tow or more
sides by
substantially rigid walls or panels 320 and 322. Panels 320 and 322 are either
integral with bag
316 or separable therefrom. Panels 320 and 322, as well as an interconnecting
bottom panel
324, may be provided with multiple ultrasonic pressure wave generators and
detectors (not
shown) as described above with respect to Figs. 8 and 9, Figs. 14 and 15, and
Fig . I6. These
generators and detectors are connected to a computer 326 having essentially
the same
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functional structures and programming as computer 190 for implementing
sequential generator
energization and sequential detector sampling, as described above. Computer
326 is connected
to a monitor 328 for displaying images of internal organs of patient PT2.
Computer 326 has
the capability of alternately displaying organ images from different angles,
as discussed above.
5 The ultrasonic pressure wave generators and detectors may be provided in a
separate
carrier 330 disposable, for example, between bottom panel 324 and bag 316, as
shown in Fig.
18.
As illustrated in Fig. 19, the ultrasonography apparatus of Fig. 19 may be
used in
conjunction with a flexible web or cover sheet 332 identical to web 132, 150,
or 206 (Fig. 8, 9,
10 or 12). Web or cover sheet 332 is operatively connected to computer 326 for
providing
ultrasonically derived organ position and configuration data to the computer
for displaying
organ images on monitor 328. The use of web or sheet 332 enables the
disposition of
ultrasonic wave generators and detectors in a 360° arc about a patient
PT3 (diagrammatically
illustrated in Fig,. 19), thereby facilitating image production. Where web or
sheet 332 takes
15 the form of web 206, the sheet is provided with apertures (see Fig. 12 and
associated
description) for enabling the introduction of minimally invasive surgical
instruments into the
patient PT3.
As discussed above, contact surfaces are advantageously wetted with liquid to
facilitate
ultrasonic pressure wave transmission over interfaces.
20 As discussed hereinafter with reference to Fig. 20, video monitor 158
(Figs. 10, 12, and
13) or monitor 328 (Fig. 19) may take the form of a flexible video screen
layer attached to web
132, 150, 166 or 206 (Fig. 8, 9, 10, 12) or web 332 (Fig. 19). This
modification of the
ultrasonographic imaging devices discussed above is considered to be
particulary advantageous
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in medical diagnosis and treatment procedures. The web or subtrate with the
video screen is
disposed on a selected body portion of a patient, for example, the abdomen
(Figs. 12 and 21)
or a shoulder (Figs. 22A, 22B) or knee (Fig. 23B), so that the substrate and
the video screen
layer substantially conform to the selected body portion and so that the video
screen is facing
S away from the body portion.
As shown in Fig. 20, an ultrasonographic device or system comprises a flexible
substrate or web 350 which carries a plurality of piezoelectric
electroacoustic transducers 352
and a plurality of piezoelectric acoustoelectric transducers 354. A flexible
video screen 356 is
attached to substrate or web 350 substantially coextensively therewith. Video
screen 356 may
be implemented by a plurality of laser diodes (not shown) mounted in a planar
array to a
flexible carrier layer (not separately designated). The diodes are protected
by a cover sheet
(not separately illustrated) which is connected to the carrier layer.
Energization componentry
is operatively connected to the diodes for energizing the diodes in accordance
with an
incoming video signal to reproduce an image embodied in the video signal. In a
video monitor,
I 5 the laser diodes are tuned to different frequency ranges, so as to
reproduce the image in color.
The protective cover sheet may function also to disperse light emitted by the
laser diodes, to
generate a more continuous image.
Substrate or web 350 and video screen 356 comprise an ultrasonic video
coverlet or
blanket 358 which may be used with the control hardware depicted in Figs. 10
and 11.
Reference numerals used in Figs. 10 and 11 are repeated in Fig. 20 to
designate the same
functional components.
Electroacoustic transducers 352 are connected to a-c or ultrasonic signal
generator 160
for receiving respective a-c signals of different frequencies. Generator 160
produces different
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frequencies which are directed to the respective electroacoustic transducers
352 by switching
circuit 162. Pressure waveforms of different ultrasonic frequencies have
different penetration
depths and resolutions and provide enhanced amounts of information to a
digital signal
processor or computer 360. As discussed above with reference to computer 190
ofFig. 11,
computer 360 is a specially programmed digital computer wherein functional
modules are
realized as generic digital processor circuits operating pursuant to
preprogrammed instructions.
As discussed above with reference to Fig. 1 l, switching circuit or
multiplexer 192
relays signals incoming from respective acoustoelectric transducers 354 in a
predetermined
intercalated sequence to analog-to-digital converter 194, the output of which
is stored in
computer memory 196 by sampling circuit 198. Wave analysis module 200
retrieves the digital
data from memory 196 and processes the data to determine three dimensional
organic
structures inside a patient. This three-dimensional structural data is
provided to view selection
module 202 for deriving two-dimensional images for display on video screen
256. Filter
module 204 serves to remove selected organs, for example, overlying organs,
from the image
presented on video screen 356. Sampling circuit 198, wave analysis module 200,
view
selection module 202, and filter module 204 are program-modified generic
digital circuits of
computer 360.
Computer 360 contains additional functional modules, for example, an organ
highlighter 362 and a superposition module 364. The functions of organ
highlighter 362 are
discussed above with reference to organ filter 176 and 204 in Figs. 10 and 11.
Organ
highlighter 362 operates to provide a different color or intensity or cross-
hatching to different
parts of an image to highlight a selected image feature. For example, a gall
bladder or an
appendix may be shown with greater contrast than surrounding organs, thereby
facilitating
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perception of the highlighted organ on video screen 356. After organ filter
204 has removed
one or more selected organs from an electronic signal representing or encoding
an image of
internal organs, highlighter 362 operates to highlight one or more features of
the encoded
image.
Superposition module 364 effects the insertion of words or other symbols on
the image
displayed on video screen 356. Such words or symbols may, for example, be a
diagnosis or
alert signal produced by a message generator module 366 of computer 360 in
response to a
diagnosis automatically performed by a determination module 368 of computer
360. Module
368 receives the processed image information from waveform analysis module 200
and
consults an internal memory 370 in a comparison or pattern recognition
procedure to
determine whether any organ or internal tissue structure of a patient has an
abnormal
configuration. The detection of such an abnormal configuration may be
communicated to the
physician by selectively removing organs, by highlighting organs or tissues,
or superimposing
an alphanumeric message on the displayed image. Accordingly, message generator
366 may be
I 5 connected to organ filter 204 and organ highlighter 362, as well as to
superposition module
364. The communication of an abnormal condition may be alternatively or
additionally
effectuated by printing a message via a printer 372 or producing an audible
message via a
speech synthesis circuit 374 and a speaker 376.
As discussed above, the ultrasonically derived three-dimensional structural
information
from waveform analysis module 200 may be transmitted over a telecommunications
link (not
shown in Fig. 20) via a modulator 378 and a transmitter 380. The transmitted
information may
be processed at a remote location, either by a physician or a computer, to
generate a diagnosis.
This diagnosis may be encoded in an electrical signal and transmitted from the
remote location
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to a receiver 382. Receiver 382 is coupled with message generator module 366,
which can
communicate the diagnosis or other message as discussed above.
Computer 360 is connected at an output to a video signal generator 384 (which
may be
incorporated into the computer). Video signal generator 384 inserts horizontal
and vertical
synchs and transmits the video signal to video screen 3 56 for displaying an
image of internal
patient organs thereon.
Fig. 21 diagrammatically depicts a step in a "laparoscopic" cholecystectomy
procedure
utilizing the ultrasonographic device or system of Fig. 20. Coverlet or
blanket 358 is disposed
on the abdomen of a patient P2 in pressure-wave transmitting contact with the
skin. The skin
is advantageously wetted with liquid to facilitate ultrasonic pressure wave
transmission.
Laparoscopic surgical instruments 210 and 212 (same as in Fig 12) are inserted
through
respective openings 386 in coverlet or blanket 358 to perform a surgical
operation a gall
bladder GB of the patient P2. This operation is effectuated by viewing a real
time image of the
distal ends of the instruments 210 and 212 in relation to the patient's
internal organic
I S structures as determined by computer 360. Generally, the image on video
screen 356 is
viewed during insertion of instruments 210 and 212 to enable a proper
employment of those
instruments.
As illustrated in Fig. 21, the gall bladder GB is highlighted (e.g., with
greater contrast
in screen intensities) relative to other organs such as the liver LV, the
stomach ST and the
large intestine LI. One or more of these organs may be deleted entirely by
organ filter 204.
Computer 360 is instructed as to the desired display features via a keyboard
(not illustrated in
Fig. 20) or a voice recognition circuit 388 operatively connected to various
modules 202, 204
and 362. (It is to be noted that speech synthesis circuit 374 and voice
recognition circuit 388
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enable computer 360 to carry on a conversation with a user. Thus the user may
direct the
computer to answer questions about the appearance of certain organs selected
by the user.)
Generally, the images of the different organs GB, LV, ST and LI, etc., are
displayed on
video screen 356 so as to substantially overlie the actual organs ofthe
patient P2. To
5 effectuate this alignment of image and organ, markers 390, 392, 394 are
placed on the patient
P2 at appropriate identifiable locations such as the xyphoid, the umbilicus,
the pubis, etc. The
markers are of a shape and material which are easily detected by ultrasonic
wave analysis and
provide computer 360 with a reference frame for enabling the alignment of
organ images on
screen 356 with the corresponding actual organs. During an operation, view
selector 202 may
10 be utilized (via keyboard command or voice recognition circuit 388) to
adjust the relative
positions of image and organs to facilitate the performance of an invasive
surgical operation.
As discussed above with reference, for example, to Fig. 13, the
ultrasonographic device or
system of Fig. 20 may be used in other kinds of procedures.
As illustrated in Fig. 22A, an ultrasonographic coverlet or blanket 396 with
attached
1 S video screen (not separately designated) and connected computer 398 has a
predefined shape
conforming to a shoulder SH. The coverlet or blanket 396 is flexible and thus
deforms upon
motion of the shoulder (Fig. 22B). The coverlet or blanket 396 has a memory so
that it returns
to the predefined shape when it is removed from the shoulder SH. The
flexibility of the
coverlet or blanket 396 enables the display in real time of a filtered video
image showing the
20 shoulder joint SJ during motion of the shoulder. This facilitates a
diagnostic appraisal of the
joint.
Fig. 23A illustrates an ultrasonic video cuff400 with a computer 402. The
cuffis
attachable in pressure-wave transmitting contact to a knee KN, as depicted in
Fig. 23B. Cuff
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400 conforms to the knee KN and follows the knee during motion thereof. A knee
joint KJ is
imaged on the cuff during motion of the knee KN, thereby enabling a physician
to study the
joint structure and function during motion. Cuff 400 has a memory and returns
to its
predefined shape (Fig. 23A) after removal from knee KN.
Video screen 356, as well as other video monitors disclosed herein, may be a
lenticular
lens video display for presenting a stereographic image to a viewer. The
ultrasonic processor,
e.g., computer 190 or 360, operates to display a three-dimensional image of
the internal organs
on the lenticular lens video display. 118. Because of the stereoscopic visual
input a surgeon is
provided via video display 356, he or she is better able to manipulate
instruments and 212
during a surgical procedure.
Electroacoustic transducers 134, 164, 352 in an ultrasonographic coverlet or
blanket
132, 166, 206, 216, 358 as described herein may be used in a therapeutic mode
to dissolve clot
in the vascular system. The coverlet or blanket is wrapped around the relevant
body part of a
patient so that the electroacoustic transducers surround a target vein or
artery. First, a scan is
effectuated to determine the location of the clot. Then, in a clot dissolution
step, the
electroacoustic transducers are energized to produce ultrasonic pressure waves
of frequencies
selected to penetrate to the location of the clot. With a sufficiently large
number of
transducers transmitting waves to the clot site simultaneously, the clot is
disrupted and forced
away from the clot site. It is recommended that a filter basket be placed in
the pertinent blood
vessels downstream of the clot site to prevent any large clot masses from
being swept into the
brain or the lungs where an embolism would be dangerous.
The monitors disclosed herein, such as monitors 158, 248, 3 i2, 328 and video
screen
356, may be provided with a lenticular lens array (not shown) for generating a
three-
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dimensional or stereoscopic display image when provided with a suitable dual
video signal.
Such a dual signal may be generated by the waveform analysis computer 190,
310, 326, 360
with appropriate programming for the view selection module 202 to select two
vantage points
spaced by an appropriate distance. Lenticular lens video displays, as well as
the operation
thereof with input from two cameras, are disclosed in several U.S. patents,
including U.S.
Patent No. 4,214,257 to Yamauchi and U. S. Patent No. 4,164,748 to Nagata, the
disclosures
of which are hereby incorporated by reference.
It is to be noted that any of the ultrasonography devices or systems disclosed
herein
may be used in a robotic surgical procedure wherein one or more surgeons are
at a remote
location relative to the patient. The performance of robotic surgery under the
control of the
distant experts is disclosed in U.S. Patents Nos. 5,217,003 and 5,217,453 to
Wilk, the
disclosures of which are hereby incorporated by reference. Video signals
transmitted to the
remote location may be generated by the analysis of ultrasonic waves as
disclosed herein.
The ultrasonography devices or systems disclosed herein may be used in
conjunction
with other kinds of scanning devices, for example, spectral diagnosis and
treatment devices
described in U.S. Patents Nos. 5,305,748 to Wilk and 5,482,041 to Wilk et al.
(those
disclosures incorporated by reference herein). It may be possible to
incorporate the
electromagnetic wave generators and sensors of those spectral diagnosis and
treatment devices
into the coverlet or blanket of the present invention.
As illustrated in Fig. 24, a medical imaging device comprises a planar firm
substrate
404, a substantially flat video screen 406 provided on the substrate, and a
flexible bag 408
connected to the substrate. Flexible bag 408 contains a fluidic medium such as
water or gel
capable of transmitting pressure waves of ultrasonic frequencies and is
disposed on a side of
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the substrate opposite the video screen. As discussed above, a scanner 410
including an
ultrasonic waveform generator 412 and a computer-implemented ultrasonic signal
processor
414 is operatively connected to video screen 406 for providing a video signal
thereto. The
video signal encodes an image of internal tissues of a patient PT4 upon
placement of medium-
containing bag 408, substrate 404, and video screen 406 against the patient.
The images of
internal tissues and organs off the patient, including the stomach SH, the
heart HT, the lungs
LG, the small intestine SE, and the large intestine LE, are displayed on
screen 406 at positions
generally overlying the respective actual tissues and organs of the patient
PT4.
Video screen 406 and substrate 404 may be provided with aligned apertures 415
for
enabling the traversal of the video screen and the substrate by medical
instruments as discussed
above with reference to Fig. 21.
Figs. 25 and 26 show another medical imaging device comprising a flexible bag
416
containing a fluidic medium such as water or gel. A multiplicity of
substantially rigid planar
substrates or carrier pads 418 together with respective flat video screens 420
attached thereto
are mounted to an upper surface of bag 416. Bag 416 serves in part to movably
mount pads
418 with their respective video screens 420 to one another so that the
orientations or relative
angles of the video screen can be adjusted to conform to a curving surface of
a patient PTS, as
shown in Fig. 26. Again, a scanner 422 including an ultrasonic waveform
generator 424 and a
computer-implemented ultrasonic signal processor 426 is operatively connected
to video
screens 420 for providing respective video signals thereto. The video signals
encode
respective images of internal tissues of a patient PTS upon placement of
medium-containing
bag 416, substrates 418 and video screens 420 against the patient. As
illustrated in Fig. 27A,
the video images displayed on screen 420 may be substantially the same, with
differences in the
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angle of view of a target organ ORG, depending on the locations and
orientations of the
respectme screens 420. Alternatively, in an enlarged view, a single image of
the target organ
ORG may be displayed, with each screen 420 displaying only a part of the total
image. The
technology for implementing these displays over video screens 420 is
conventional and well
S known.
Scanners 410 and 422 are ultrasonic scanners with the same components as other
ultrasonic scanners discussed herein, for example, with reference to Fig. 21.
Briefly, scanners
410 and 422 each includes a plurality of electroacoustic transducers and a
plurality of
acoustoelectric transducers disposed in respective arrays along the respective
bag 408 or 416
so that ultrasonic pressure waves can travel through the fluidic medium in the
respective bag
from the electroacoustic transducers and to the acoustoelectric transducers.
Computers or
processors 414 and 426 analyze incoming digitized ultrasonic sensor signals
which are
produced in response to ultrasonic pressure waves reflected from various
tissue interfaces in
the patient PT4 or PTS. From these incoming ultrasonic sensor signals,
computers or
processors 414 and 426 determine three-dimensional shapes of tissue interfaces
and organs
inside the patient PT4 or PTS.
As discussed above with reference to Fig. 21, it is recommended that markers
be placed
in prespecified locations on the patient to enable or facilitate an alignment
of the displayed
tissue representations and the respective underlying actual tissues. The
markers are easily
recognized by computer 426 and serve to define a reference frame whereby the
positions and
the orientations of the multiple video screens 420 relative to the patient's
internal tissues are
detectable. Thus, the position and the orientation of each video screen 420
relative to the
internal tissues and organs of the patient PTS are determined to enable the
display on the video
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screens 420 of images of selected target tissues of the patient. The reference
markers
facilitate the display on screens 420 of respective views of the same organ or
tissues from
different angles depending on the positions and orientations of the various
screens 420.
As discussed above, for example, with reference to Figs. 20 and 21, computers
or
5 processor 414 and 426 may include a module 362, typically realized as a
programmed general
computer circuit, for highlighting a selected feature of the internal organs
of patient PT4 or
PTS. The highlighting is achievable by modifying the color or intensity of the
selected feature
relative to the other features in the displayed image, thus providing a visual
contrast of the
selected feature with respect to the other features of the displayed image. An
intensity change
10 may be effectuated by essentially blacking or whiting out the other
portions of the image so
that the selected feature is the only object displayed on the video screen.
The imaging devices of Figs. 24 and 26 are optionally provided with a voice-
recognition circuit 388 and a speech synthesis circuit 374 (Fig. 20)
operatively connected to
computer or processor 414 and 426. Advantages and uses of these components are
discussed
15 above with reference to Fig. 20. As further described above, computers or
processors 414 and
426 are possibly programmed for automated diagnosis based on pattern
recognition, with the
computed diagnosis being communicated to the user physicians via speech
synthesis circuit
374
As illustrated in Fig. 28, the imaging device of Figs. 26 and 27 is
advantageously
20 provided with a plurality of apertures or passageways 428 extending through
bag 416 in the
interstitial spaces between video screens 420. Passageways 428 receive
respective tubular
cannulas 430 which extend both through the passageways and respective openings
(not shown)
in the skin and abdominal wall of the patient PTS. Medical instruments such as
a laparoscopic
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forceps 432 are inserted through passageways 428 for performing an operation
on internal
target tissues of patient PTS essentially under direct observation as afforded
by video screens
420. The distal ends of the medical instruments 432, inserted into patient PTS
in the field of
view of the imaging system, are displayed on one or more video screens 420
together with
internal target tissues of the patient. The uses of the imaging device of
Figs. 25 and 26 with
passageways 428 as illustrated in Fig. 28 are substantially identical to the
uses and modes of
operation described above with reference to Figs. 20 and 21.
It is to be noted that bag 416 may be replaced by a plurality of bags (not
illustrated) all
filled with a fluidic medium through which ultrasonic pressure waves may be
transmitted. Each
planar substrate or carrier pad 418 and its respective video screen may be
attached to a
respective fluid-filled bag. In this modification of the ultrasonographic
device of Figs. 25 and
26, apertures performing the function of passageways 428 (Fig. 28) are
naturally formed as
gaps or spaces between adjacent bags. Separate coupling elements (not
illustrated) must be
provided between adjacent video screens 420 for forming an integral structure
while enabling
at least limited flexing between adjacent video screens 420.
It is to be additionally understood that substrates 418 may be formed as
carrier layers
for active picture elements of video screens 420 and may be visually
indistinguishable from the
video screens 420.
The imaging devices of Figs. 24 and 25, 26 may include a transmitter 380 and a
receiver 382 (Fig. 20) for operatively connecting scanners 410 and 422 and
particularly
computers or processors 414 and 426 to a long-distance hard-wired or wireless
telecommunications link. As pointed out above, image data transmitted over the
telecommunications link to a video monitor at a remote location will enable
observation of the
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patient's internal tissues by distant specialists who may also operate on the
patients robotically
via the telecommunications link.
Where the imaging device of Figs. 25-28 is used to diagnose or treat a limb or
a joint,
planar substrates 418 and video screens 420 have sizes and two-dimensional
shapes which
facilitate substantial conformity with the limb or joint. To facilitate the
use of the imaging
device in invasive surgical procedures, the images provided on video screens
420 may be
stereoscopic or holographic. Thus, manipulation of medical instrument 432 so
that its distal
end engages desired internal tissues is facilitated. The imaging device thus
may include
elements for providing a stereoscopic or holographic image to a viewer, the
scanner including
means for energizing the elements to produce the stereoscopic or holographic
image.
Although the invention has been described in terms of particular embodiments
and
applications, one of ordinary skill in the art, in light of this teaching, can
generate additional
embodiments and modifications without departing from the spirit of or
exceeding the scope of
the claimed invention. It is to be noted, for example, that multiple images
may be provided on
a single video screen, pursuant to conventional windows-type overlay
techniques. Thus, one
window or video image may show an organ from one point of view or angle, while
another
window on the same screen may show the same organ from a different vantage
point.
Alternatively, one window may show a first organ, while another window
displays one or more
organs underlying the first organ. In this case, the underlying organs may be
shown in
phantom line in the first window, while the overlying organs is shown in
phantom lines in the
second window. Of course, all such operating modes apply to multiple video
screens as well
as to a single screen. Thus, one screen may display an overlying organ from
one angle, while
an adjacent organ displays an underlying organ from a different angle. A
display window on a
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video screen of the present invention may be used alternatively for the
display of textual
information pertaining to the tissues and organs displayed in other video
windows. Such
information may include diagnostic information determined by the analyzing
computer.
Accordingly, it is to be understood that the drawings and descriptions herein
are
proferred by way of example to facilitate comprehension of the invention and
should not be
construed to limit the scope thereof.
