U.S. patent application number 10/153241 was filed with the patent office on 2003-04-10 for ultrasound feedback in medically-treated patients.
Invention is credited to Makin, Inder Raj. S., Mast, T. Douglas.
Application Number | 20030069502 10/153241 |
Document ID | / |
Family ID | 23132036 |
Filed Date | 2003-04-10 |
United States Patent
Application |
20030069502 |
Kind Code |
A1 |
Makin, Inder Raj. S. ; et
al. |
April 10, 2003 |
Ultrasound feedback in medically-treated patients
Abstract
A method for ultrasound imaging of patient tissue. A first
signal is obtained of a first imaging ultrasound wave which has
been reflected back from a location in the patient tissue at a
first time. A second signal is obtained of a second imaging
ultrasound wave which has been reflected back from the location in
the patient tissue at a later second time wherein the patient has
received at least some medical treatment by the second time. An
image of the location is created using the first signal and the
second signal. In one example, the method is repeated for different
locations to image the patient tissue, wherein the image of the
patient tissue includes medically-treated locations and
medically-untreated locations.
Inventors: |
Makin, Inder Raj. S.;
(Loveland, OH) ; Mast, T. Douglas; (Cincinnati,
OH) |
Correspondence
Address: |
AUDLEY A. CIAMPORCERO JR.
JOHNSON & JOHNSON
ONE JOHNSON & JOHNSON PLAZA
NEW BRUNSWICK
NJ
08933-7003
US
|
Family ID: |
23132036 |
Appl. No.: |
10/153241 |
Filed: |
May 22, 2002 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60294135 |
May 29, 2001 |
|
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|
Current U.S.
Class: |
600/437 ;
600/459 |
Current CPC
Class: |
A61B 2090/3929 20160201;
A61B 10/0233 20130101; A61N 7/022 20130101; A61B 8/4488 20130101;
A61B 2090/3975 20160201; A61N 2007/0078 20130101; A61B 8/445
20130101; A61B 17/2202 20130101; A61B 2090/378 20160201; A61B 17/29
20130101; A61B 8/12 20130101; A61B 17/22012 20130101; A61B
2017/320093 20170801; A61B 2090/3784 20160201 |
Class at
Publication: |
600/437 ;
600/459 |
International
Class: |
A61B 008/00 |
Claims
What is claimed is:
1. A method for ultrasound imaging of patient tissue of a patient
comprising the steps of: a) obtaining a first signal of a first
imaging ultrasound wave which has been reflected back from a
location in the patient tissue at a first time; b) obtaining a
second signal of a second imaging ultrasound wave which has been
reflected back from the location in the patient tissue at a later
second time wherein the patient has received at least some medical
treatment by the second time; and c) creating an image of the
location using the first signal and the second signal.
2. The method of claim 1, wherein the medical treatment is
ultrasound medical treatment.
3. The method of claim 1, also including repeating steps a) through
c) for different locations to image the patient tissue, wherein the
image of the patient tissue includes medically-treated locations
and medically-untreated locations.
4. A method for ultrasound imaging of patient tissue of a patient
comprising the steps of: a) obtaining a first signal of a first
imaging ultrasound wave which has been reflected back from a
location in the patient tissue at a first time; b) obtaining a
second signal of a second imaging ultrasound wave which has been
reflected back from the location in the patient tissue at a later
second time wherein the patient has received at least some medical
treatment by the second time; and c) creating an image of the
location using at least the amplitude of the first signal and the
amplitude of the second signal.
5. The method of claim 4, wherein the first signal has a first
frequency, wherein the second signal has a second frequency, and
wherein the second frequency is different from the first
frequency.
6. The method of claim 4, wherein the medical treatment is
ultrasound medical treatment.
7. The method of claim 4, also including repeating steps a) through
c) for different locations to image the patient tissue, wherein the
image of the patient tissue includes medically-treated locations
and medically-untreated locations.
8. The method of claim 4, wherein step c) includes calculating the
difference in amplitude between the first and second signals.
9. The method of claim 8, wherein step c) uses the amplitude
difference and uses one of the amplitudes of the first and second
signals.
10. The method of claim 9, wherein step c) calculates the sum of
the one amplitude and a function of the amplitude difference.
11. A method for ultrasound imaging of patient tissue of a patient
comprising the steps of: a) obtaining a first signal of a first
imaging ultrasound wave which has been reflected back from a
location in the patient tissue at a first time; b) obtaining a
second signal of a second imaging ultrasound wave which has been
reflected back from the location in the patient tissue at a later
second time wherein the patient has received at least some medical
treatment by the second time; and c) creating an image of the
location using at least the phase of the first signal and the phase
of the second signal.
12. The method of claim 11, wherein the first signal has a first
frequency, wherein the second signal has a second frequency, and
wherein the second frequency is different from the first
frequency.
13. The method of claim 11, wherein the medical treatment is
ultrasound medical treatment.
14. The method of claim 11, also including repeating steps a)
through c) for different locations to image the patient tissue,
wherein the image of the patient tissue includes medically-treated
locations and medically-untreated locations.
15. The method of claim 11, wherein step c) includes calculating
the difference in phase between the first and second signals.
16. The method of claim 15, wherein step c) uses the phase
difference and uses one of the phases of the first and second
signals.
17. The method of claim 16, wherein step c) calculates the sum of
the one phase and a function of the phase difference.
18. A method for ultrasound imaging of patient tissue of a patient
comprising the steps of: a) obtaining a first signal of a first
imaging ultrasound wave which has been reflected back from a
location in the patient tissue at a first time; b) obtaining a
second signal of a second imaging ultrasound wave which has been
reflected back from the location in the patient tissue at a later
second time wherein the patient has received at least some medical
treatment by the second time; and c) creating an image of the
location using at least the amplitude and the phase of the first
signal and the amplitude and the phase of the second signal.
19. A method for ultrasound imaging of patient tissue of a patient
comprising the steps of: a) obtaining a first signal of a first
imaging ultrasound wave which has been reflected back from a
location in the patient tissue at a first time; b) obtaining a
second signal of a second imaging ultrasound wave which has been
reflected back from the location in the patient tissue at a later
second time wherein the patient has received at least some medical
treatment by the second time; and c) creating an image of the
location using the first signal and the second signal, wherein the
first signal has a first frequency, wherein the second signal has a
second frequency, and wherein the second frequency is different
from the first frequency.
Description
[0001] The present application claims priority of U.S. Provisional
Application Serial No. 60/294,135 filed May 29, 2001, the entire
disclosure of which is incorporated herein by reference.
FIELD OF THE INVENTION
[0002] The present invention relates generally to ultrasound, and
more particularly to an ultrasound medical system and/or to an
ultrasound medical method.
BACKGROUND OF THE INVENTION
[0003] Known ultrasound medical systems and methods include using
ultrasound imaging of patients to identify patient tissue for
medical treatment and include using ultrasound to medically destroy
identified patient tissue by heating the tissue. Imaging is done at
lower power and medical treatment is done at higher power. Low
power imaging ultrasound will not medically affect patient tissue.
High power medical-treatment ultrasound, when focused at a focal
zone a distance away from the ultrasound source, will substantially
medically affect patient tissue in the focal zone. However, focused
medical-treatment ultrasound will not substantially medically
affect patient tissue outside the focal zone such as patient tissue
located between the source and the focal zone.
[0004] In one known example, a transducer assembly includes a
single ultrasound transducer having a single transducer element, or
an array of transducer elements acting together, to ultrasonically
image the patient and to ultrasonically ablate identified patient
tissue. It is known to convert ultrasound imaging data into
temperature imaging data for ultrasound-treated patient tissue to
monitor the ultrasound treatment. A known transducer element
includes a transducer element having a concave shape or an acoustic
lens to focus ultrasound energy. A known array of transducer
elements includes a planar, concave, or convex array of transducer
elements to focus ultrasound energy. A known array of transducer
elements includes an array whose transducer elements are
electronically or mechanically controlled together to steer and
focus the ultrasound emitted by the array to a focal zone (which
may be large or which may be as small as, for example, a grain of
rice) to provide three-dimensional medical ultrasound treatment of
patient tissue. In some applications, the transducer is placed on
the surface of patient tissue for ultrasound imaging and/or
ultrasound medical treatment of areas within the patient tissue. In
other applications, the transducer is surrounded with a balloon
which is expanded to contact the surface of patient tissue by
filling with a fluid such as a saline solution to provide acoustic
coupling between the transducer and the patient tissue.
[0005] Known ultrasound medical systems and methods include
deploying an end effector having an ultrasound transducer outside
the body to break up kidney stones inside the body, endoscopically
inserting an end effector having an ultrasound transducer in the
colon to medically destroy prostate cancer, laparoscopically
inserting an end effector having an ultrasound transducer in the
abdominal cavity to medically destroy a cancerous liver tumor,
intravenously inserting a catheter end effector having an
ultrasound transducer into a vein in the arm and moving the
catheter to the heart to medically destroy diseased heart tissue,
and interstitially inserting a needle end effector having an
ultrasound transducer needle into the tongue to medically destroy
tissue to reduce tongue volume to reduce snoring. Known methods for
guiding an end effector within a patient include guiding the end
effector from x-rays, from MRI images, and from ultrasound images
obtained using the ultrasound transducer. Known ultrasound imaging
includes Doppler ultrasound imaging to detect blood flow, and a
proposed known use of ultrasound includes using an ultrasound
transducer outside the body to stop internal bleeding (by sealing
ruptured blood vessels) of a patient brought to an emergency room
of a hospital.
[0006] A Mammotome.RTM. Breast Biopsy System manufactured by
Ethicon Endo-Surgery, Inc. (a Johnson & Johnson Company)
inserts a tube into breast tissue, wherein the tube contains an end
effector having a biopsy cutting tool. A known electromagnetic
transponder and three-receiver system for calculating the position
of the transponder and for guiding the transponder (which is
attached to a heart catheter for monitoring the heart) inside a
patient is the CARTO.TM. EP Navigation System used with a
NAVI-STAR.RTM. catheter manufactured by Biosense Webster (a Johnson
& Johnson Company). Further, it is known that changes in
patient tissue because of medical treatment of patient tissue, such
as ultrasound medical treatment, affect the amplitude and/or phase
of ultrasound imaging signals.
[0007] What is needed is an improved ultrasound medical system
and/or an improved ultrasound medical method. This invention
addresses those needs lacking in an ultrasonic medical system
and/or an ultrasonic medical method.
SUMMARY OF THE INVENTION
[0008] One method of the invention is for ultrasound imaging of
patient tissue and includes steps a) through c). Step a) includes
obtaining a first signal of a first imaging ultrasound wave which
has been reflected back from a location in the patient tissue at a
first time. Step b) includes obtaining a second signal of a second
imaging ultrasound wave which has been reflected back from the
location in the patient tissue at a later second time wherein the
patient has received at least some medical treatment by the second
time. Step c) includes creating an image of the location using the
first signal and the second signal. In one example, steps a)
through c) are repeated for different locations to image the
patient tissue, wherein the image of the patient tissue includes
medically-treated locations and medically-untreated locations.
[0009] The present invention has, without limitation, application
in conventional endoscopic and open surgical instrumentation as
well as application in robotic-assisted surgery.
BRIEF DESCRIPTION OF THE DRAWINGS
[0010] FIG. 1 is a perspective view of a first embodiment of the
present invention showing an ultrasound medical treatment system
which includes a tissue-retaining device;
[0011] FIG. 2 is an enlarged view of the end effector of the
ultrasound medical treatment system of FIG. 1;
[0012] FIG. 3 is a view of the end effector of FIG. 2 retaining an
intervertebral disk of a patient;
[0013] FIG. 4 is a perspective view of a first alternate end
effector which can be used in the ultrasound medical treatment
system of FIG. 1;
[0014] FIG. 5 is a perspective view of a second alternate end
effector which can be used in the ultrasound medical treatment
system of FIG. 1;
[0015] FIG. 6 is a perspective view of a third alternate end
effector which can be used in the ultrasound medical treatment
system of FIG. 1;
[0016] FIG. 7 is a side elevational view of a second embodiment of
the present invention showing another ultrasound medical treatment
system which includes a tissue-retaining device;
[0017] FIG. 8 is an enlarged, partially-cutaway view of the end
effector of the ultrasound medical treatment system of FIG. 7;
[0018] FIG. 9 is a perspective view of a third embodiment of the
present invention showing an ultrasound medical system which
includes flexible fingers, wherein each finger includes an
ultrasound transducer;
[0019] FIG. 10 is an enlarged view of the tube and the flexible
fingers of the ultrasound medical system of FIG. 9 showing the
flexible fingers in a deployed fan-like state;
[0020] FIG. 11 is a view of the flexible fingers of FIG. 10 shown
in a stowed state;
[0021] FIG. 12 is a perspective view of an alternate flexible
finger arrangement which can be used in the ultrasound medical
system of FIG. 9, showing the flexible fingers in a deployed
claw-like state surrounding patient tissue;
[0022] FIG. 13 is a perspective view of a fourth embodiment of the
present invention showing an ultrasound medical system which
includes an ultrasound transducer assembly which includes at least
two ultrasound transducers;
[0023] FIG. 14 is an enlarged view of the ultrasound transducer
assembly of the ultrasound medical system of FIG. 13;
[0024] FIG. 15 is a cross-sectional view of the transducer assembly
of FIG. 14;
[0025] FIG. 16 is a cross-sectional view of a first alternate
transducer arrangement which can be used in place of the
arrangement of FIG. 15;
[0026] FIG. 17 is a cross-sectional view of a second alternate
transducer arrangement which can be used in place of the
arrangement of FIG. 15;
[0027] FIG. 18 is a perspective view of a fifth embodiment of the
present invention showing an ultrasound medical treatment system
which includes a cutting tool and an ultrasound medical-treatment
transducer assembly;
[0028] FIG. 19 is an enlarged, cross-sectional view of the tube of
FIG. 18 showing a cutting tool that has been introduced into the
lumen of the tube;
[0029] FIG. 20 is an enlarged, cross-sectional view of the tube of
FIG. 18 showing an ultrasound medical-treatment transducer assembly
that has been introduced into the lumen of the tube;
[0030] FIG. 21 is a block diagram of an eighth method of the
present invention which includes ultrasound staging of medical
treatment of patient tissue in the gastrointestinal area;
[0031] FIG. 22 is a block diagram of an eleventh method of the
present invention which includes ultrasound medical treatment of a
lesion on or in the lung of a patient;
[0032] FIG. 23 is a block diagram of a thirteenth method of the
present invention which includes ultrasound medical treatment of a
blood vessel to stop the supply of blood to a lesion from the blood
vessel;
[0033] FIG. 24 is a perspective view of a sixth embodiment of the
present invention showing a portion of an ultrasound medical
treatment system which includes receivers for locating the position
of the transducer assembly of the system;
[0034] FIG. 25 is a perspective view of a seventh embodiment of the
present invention showing a portion of another ultrasound medical
treatment system which includes receivers for locating the position
of the transponder of the system;
[0035] FIG. 26 is a block diagram of a seventeenth method of the
present invention which includes aiming the transducer assembly;
and
[0036] FIG. 27 is a block diagram of a twentieth method of the
present invention which includes creating an image after starting
medical treatment using an imaging ultrasound wave before medical
treatment and an imaging ultrasound wave after starting medical
treatment.
DETAILED DESCRIPTION OF THE INVENTION
[0037] Before explaining the present invention in detail, it should
be noted that the invention is not limited in its application or
use to the details of construction and arrangement of parts
illustrated in the accompanying drawings and description. The
illustrative embodiments of the invention may be implemented or
incorporated in other embodiments, variations and modifications,
and may be practiced or carried out in various ways. Furthermore,
unless otherwise indicated, the terms and expressions employed
herein have been chosen for the purpose of describing the
illustrative embodiments of the present invention for the
convenience of the reader and are not for the purpose of limiting
the invention.
[0038] It is understood that any one or more of the
following-described embodiments, expressions of embodiments,
examples, methods, etc. can be combined with any one or more of the
other following-described embodiments, expressions of embodiments,
examples, methods, etc. For example, and without limitation, any of
the end effectors can be used in any of the methods, any of the
transducer arrangements can be used in any of the end effectors,
and any appropriate methods can be combined such as combining the
seventeenth and twentieth methods, etc.
Ultrasound Medical Treatment Using Tissue-Retaining Devices
[0039] Tissue-Retaining System for Ultrasound Medical Treatment
[0040] Referring now to the drawings, FIGS. 1-3 illustrate a first
embodiment of the present invention. A first expression of the
first embodiment of the present invention is for an ultrasound
medical treatment system 10 including an end effector 12 insertable
into a patient 14. The end effector 12 includes a tissue-retaining
device 16. The tissue-retaining device 16 includes a first
tissue-retaining member 18 having an (i.e., at least one)
ultrasound medical-treatment transducer 20 (also called "transducer
20") and includes a second tissue-retaining member 22. The first
and second tissue-retaining members 18 and 22 are operatively
connected together to retain patient tissue 24 between the first
and second tissue-retaining members 18 and 22 and to release
patient tissue 24 so retained.
[0041] It is noted that an ultrasound medical-treatment transducer
is an ultrasound transducer adapted at least for ultrasound medical
treatment of a patient such as, but not limited to, a human
patient. An ultrasound medical-treatment transducer includes either
a single ultrasound medical-treatment transducer element or an
array of ultrasound medical-treatment transducer elements, as is
known to those skilled in the art. An ultrasound medical-treatment
transducer may or may not also be adapted for ultrasound imaging of
a patient. Likewise, an ultrasound imaging transducer is an
ultrasound transducer adapted at least for ultrasound imaging of a
patient and may or may not also be adapted for ultrasound
medical-treatment of a patient.
[0042] Advantages of retaining patient tissue between two
tissue-retaining members during ultrasound medical treatment by one
of the tissue-retaining members include having a single instrument
which ultrasonically medically treats patient tissue and at the
same time immobilizes patient tissue against undesired movement
during the treatment. It is also noted that in one application the
tissue-retaining device is a clamp which retains and holds tissue
and that in another application the tissue-retaining device retains
tissue against movement, but does not hold tissue, and therefore is
not a clamp.
[0043] In one variation, not shown, the second tissue-retaining
member 22 has an ultrasound imaging and/or medical treatment
transducer. In the same or a different variation, not shown, the
tissue-retaining device 16 has at least one additional
tissue-retaining member. Mechanisms, not shown, for remotely moving
two (or more) members toward and away from each other are within
the ordinary level of skill of the artisan and include, without
limitation, the use of pivotal member attachments and the use of
cables or motors. In the same or a different variation, the
retained patient tissue 24 is retained between the ultrasound
medical-treatment transducer 20 and the second tissue-retaining
member 22. In the same or a different variation, the ultrasound
medical-treatment transducer 20 focuses ultrasound energy, such
focusing being known to those skilled in the art. In the same or a
different variation, not shown, the second tissue-retaining member
22 is substantially ultrasonically non-reflective.
[0044] A second expression of the first embodiment of the present
invention is for an ultrasound medical treatment system 10
including an end effector 12 insertable into a patient 14. The end
effector 12 includes a tissue-retaining device 16. The
tissue-retaining device 16 includes a first tissue-retaining member
18 having an (i.e., at least one) ultrasound imaging and
medical-treatment transducer 26 (also called "transducer 26") and
includes a second tissue-retaining member 22. The first and second
tissue-retaining members 18 and 22 are operatively connected
together to retain patient tissue 24 between the first and second
tissue-retaining members 18 and 22 and to release patient tissue 24
so retained.
[0045] It is noted that an ultrasound imaging and medical-treatment
transducer is an ultrasound transducer adapted at least for both
ultrasound imaging and ultrasound medical treatment of a patient.
An ultrasound imaging and medical-treatment transducer includes
either a single ultrasound imaging and medical-treatment transducer
element or an array of ultrasound medical transducer elements
(including an array having at least one separate element for
imaging and at least one separate element for medical treatment or
an array having at least two elements each adapted for both imaging
and medical treatment), as is known to those skilled in the art. In
one variation, the retained patient tissue 24 is retained between
the imaging and medical-treatment transducer 26 and the second
tissue-retaining member 22. In the same or a different variation,
the ultrasound imaging and medical-treatment transducer 26 focuses
ultrasound energy. In the same or a different variation, not shown,
the second tissue-retaining member 22 is substantially
ultrasonically non-reflective.
[0046] A third expression of the first embodiment shown in FIGS.
1-3 is for an ultrasound medical treatment system 10 including an
end effector 12 insertable into a patient 14. The end effector 12
includes a tissue-retaining device 16. The tissue-retaining device
16 includes a first tissue-retaining member 18 having an (i.e., at
least one) ultrasound medical-treatment transducer 20 and includes
a second tissue-retaining member 22 having an (i.e., at least one)
ultrasound reflector 28. The first and second tissue-retaining
members 18 and 22 are operatively connected together to retain
patient tissue 24 between the first and second tissue-retaining
members 18 and 22 and to release patient tissue 24 so retained.
[0047] Advantages of retaining patient tissue between two
tissue-retaining members during ultrasound medical treatment by an
ultrasound medical-treatment transducer of a first tissue-retaining
member and an ultrasound reflector of a second tissue-retaining
member include having a single instrument which ultrasonically
medically treats patient tissue by direct ultrasound, which
enhances the ultrasound medical treatment by reflected ultrasound,
and which at the same time immobilizes patient tissue against
undesired movement during the treatment.
[0048] It is noted that an ultrasound reflector 28 is a material
which reflects ultrasound at least to a degree that would
substantially medically affect patient tissue over a treatment
period by direct ultrasound which is being reflected back by the
ultrasound reflector. Choices of ultrasound reflecting materials
include, without limitation, acoustically-rigid materials such as
stainless steel (which reflects about 100%) and aluminum (which
reflects about 80%) and acoustically-softer materials such as
corporene (which reflects about 90%). An ultrasound reflecting
material is contrasted with an ultrasound absorbing material such
as, without limitation, rubber or plastic. In one variation, the
retained patient tissue 24 is retained between the ultrasound
medical-treatment transducer 20 and the ultrasound reflector 28. In
the same or a different variation, the ultrasound medical-treatment
transducer 20 and the ultrasound reflector 28 each focus ultrasound
energy, such ultrasound reflector focusing being accomplished by
the shape of, or by shaping, the reflector surface as is within the
ordinary level of skill of the artisan.
[0049] A fourth expression of the first embodiment shown in FIGS.
1-3 is for an ultrasound medical treatment system 10 including an
end effector 12 insertable into a patient 14. The end effector 12
includes a tissue-retaining device 16. The tissue-retaining device
16 includes a first tissue-retaining member 18 having an (i.e., at
least one) ultrasound imaging and medical-treatment transducer 26
and includes a second tissue-retaining member 22 having an (i.e.,
at least one) ultrasound reflector 28. The first and second
tissue-retaining members 18 and 22 are operatively connected
together to retain patient tissue 24 between the first and second
tissue-retaining members 18 and 22 and to release patient tissue 24
so retained. In one variation, the retained patient tissue 24 is
retained between the ultrasound imaging and medical-treatment
transducer 26 and the ultrasound reflector 28. In the same or a
different variation, the ultrasound imaging and medical-treatment
transducer 26 and the ultrasound reflector 28 each focus ultrasound
energy.
[0050] In one example of the previously-described third and fourth
expressions of the first embodiment, the ultrasound reflector 28 is
disposed to receive ultrasound energy from the transducer 20 and 26
and is oriented to reflect the received ultrasound energy back into
patient tissue 24 retained by the tissue-retaining device 16. In
the same or a different example, the ultrasound reflector 28 is
oriented to reflect the received ultrasound energy away from the
transducer 20 and 26 when the patient tissue 14 is retained by the
tissue-retaining device 16. An advantage of this arrangement is
that it avoids damage to the transducer from the reflected
ultrasound. In the same or a different example, one of the first
and second tissue-retaining members 18 and 22 is controllably
orientatable relative to the other of the first and second
tissue-retaining members 18 and 22 such as, without limitation, by
being orientatable along the double-headed arrows shown in FIG. 2.
In one modification, the second tissue-retaining member 22 is
controllably orientatable relative to the first tissue-retaining
member 18 to reflect the received ultrasound energy back along
different directions. A first alternate end effector 30 is shown in
FIG. 4 wherein the second tissue-retaining member 32 is
controllably orientatable relative to the first tissue-retaining
member 34 as shown by the double-headed arrows in FIG. 4.
Mechanisms, not shown, for remotely controlling the orientation of
one member relative to another member are within the ordinary level
of skill of the artisan and include, without limitation, the use of
pivotal member attachments and the use of cables or motors. In one
application, the transducer 20 and 26 generates wide-focused
ultrasound (shown by the two single-headed arrows coming from the
first tissue-retaining member 18 in FIG. 3) and the ultrasound
reflector 28 generates narrow-focused ultrasound (shown by the two
single-headed arrows coming from the second tissue-retaining member
22 in FIG. 3).
[0051] In one example of the previously-described first through
fourth expressions of the first embodiment, the end effector 12 is
an open-surgery end effector, an endoscopic end effector, a
laparoscopic end effector (as shown in FIG. 1), a catheter end
effector (such as, but not limited to, an intravascular catheter
end effector), or a needle end effector, as can be appreciated by
those skilled in the art. In one application, the end effector 12
is used to retain a blood vessel and then to ultrasonically treat
the blood vessel to seal the blood vessel stopping the flow of
blood in the retained blood vessel. In another application, the end
effector 12 is used to retain patient tissue and then to
ultrasonically ablate at least a portion of the retained patient
tissue.
[0052] In one design of the previously-described first through
fourth expressions of the first embodiment, the end effector 12 has
a longitudinal axis 35, and one of the first and second
tissue-retaining members 18 and 22 at all times faces along a
direction which is substantially perpendicular to the longitudinal
axis 35. If the one tissue-retaining member were planar, this means
that the longitudinal axis would be substantially parallel to the
plane of the one tissue-retaining member. In one enablement, the
one tissue-retaining member is the first tissue-retaining member
18. A second alternate end effector 36 has first and second
tissue-retaining members 38 and 40 which are hinged together to
relatively move as indicated by the double-headed arrow and which
are shown in a partially open configuration in FIG. 5. The second
alternate end effector 36 has a longitudinal axis 42, and one of
the first and second tissue-retaining members 38 and 40 at all
times faces along a direction which is substantially parallel to
the longitudinal axis 42. If the one tissue-retaining member were
planar, this means that the longitudinal axis would be
substantially perpendicular to the plane of the one
tissue-retaining member. In one enablement, the one
tissue-retaining member is the first tissue-retaining member 38. A
third alternate end effector 37 having first and second
tissue-retaining members 39 and 41 with one member longitudinally
movable with respect to the other member (as indicated by the
double-headed arrow) is shown in FIG. 6. The third alternate end
effector 37 has a longitudinal axis 43, and one of the first and
second tissue-retaining members 39 and 41 at all times faces along
a direction which is substantially parallel to the longitudinal
axis 43. In one enablement, the one tissue-retaining member is the
first tissue-retaining member 39.
[0053] In one enablement, as shown in FIG. 1, the ultrasound
medical treatment system 10 also includes a handpiece 44
operatively connected to the end effector 12 and to an ultrasound
controller 46 operatively connected to a foot-pedal power switch
47, as can be appreciated by those skilled in the art.
[0054] A first method of the invention is for ultrasound medical
treatment of a patient and uses the ultrasound medical treatment
system as previously described in the first, second, third or
fourth expression of the first embodiment with or without the
previously-described variations, etc. thereof. The first method
includes steps a) through e). Step a) includes endoscopically
inserting the end effector into an ear, nose, or throat of the
patient. Step b) includes guiding the end effector in the patient.
Step c) includes identifying patient tissue for medical treatment
such as optionally at least in part from ultrasound imaging using
the transducer. Other ways of identifying patient tissue for
medical treatment include, without limitation, using x-rays and/or
MRI imaging, as are known to the artisan. Step d) includes
retaining the identified patient tissue using the tissue-retaining
device. Step e) includes medically treating the retained patient
tissue with ultrasound using the transducer or using the transducer
and the ultrasound reflector. In one implementation, one
tissue-retaining member at all times faces along a direction which
is substantially parallel to the longitudinal axis of the end
effector (as seen in FIGS. 5 and 6).
[0055] A second method of the invention is for ultrasound medical
treatment of a patient and uses the ultrasound medical treatment
system as previously described in the first, second, third or
fourth expression of the first embodiment with or without the
previously-described variations, etc. thereof. The second method
includes steps a) through c). Step a) includes inserting the end
effector 12 into the patient. Step b) includes retaining an
intervertebral disk 48 (see FIG. 3) of the patient with the
tissue-retaining device, wherein the intervertebral disk 48
includes tissue. Step c) includes medically treating the retained
intervertebral disk 48 with ultrasound to shrink the tissue using
the transducer or using the transducer and the ultrasound
reflector. In one implementation, one tissue-retaining member at
all times faces along a direction which is substantially
perpendicular to the longitudinal axis of the end effector (as seen
in FIGS. 2 and 4). In one application of the second method of the
invention, the intervertebral disk 48 includes connective and nerve
tissue.
[0056] A third method of the invention is for ultrasound medical
treatment of a patient and uses the ultrasound medical treatment
system as previously described in the first, second, third or
fourth expression of the first embodiment with or without the
previously-described variations, etc. thereof. The third method
includes steps a) through c). Step a) includes inserting the end
effector into the patient. Step b) includes retaining a joint of
the patient with the tissue-retaining device, wherein the joint
includes tissue. Step c) includes medically treating the retained
joint with ultrasound to shrink the tissue using the transducer or
using the transducer and the ultrasound reflector. In one
implementation, one tissue-retaining member at all times faces
along a direction which is substantially perpendicular to the
longitudinal axis of the end effector (as seen in FIGS. 2 and 4).
In one application of the third method of the invention, the joint
includes connective and nerve tissue.
[0057] As previously mentioned, one application of the ultrasound
medical treatment system 10 of the previously-described first
through fourth expressions of the first embodiment uses the
tissue-retaining device to retain a blood vessel and uses the
transducer, or the transducer and the ultrasound reflector, to
substantially stop the flow of blood within the blood vessel.
[0058] Referring again to the drawings, FIGS. 7-8 illustrate a
second embodiment of the present invention which is an ultrasound
medical treatment system 50 including an end effector 52 insertable
into a patient. The end effector 52 includes a tissue-retaining
device 54. The tissue-retaining device 54 includes a first
tissue-retaining member 56 having an ultrasound imaging and
medical-treatment transducer 58 and includes a second
tissue-retaining member 60 having an ultrasound reflector 62. The
first and second tissue-retaining members 56 and 60 are operatively
connected together to retain patient tissue between the first and
second tissue-restraining members and to release patient tissue so
retained. The first and second tissue-retaining members 56 and 60
always maintain a substantially parallel alignment.
[0059] Advantages of having a substantially parallel alignment
between the tissue-retaining members include, in one example,
having the transducer and the ultrasound reflector maintain a
substantially parallel alignment for improved reflected ultrasound
medical treatment enhancement for any thickness of patient tissue
retained by the tissue-retaining members.
[0060] In one example of the second embodiment, the first
tissue-retaining member 56 is a distal end portion 64 of a first
tube 66. The ultrasound medical treatment system 50 also includes a
second tube 68, first and second link members 70 and 72, and a
cable 74. The second tube 68 is oriented substantially parallel to
the first tube 66. The first and second link members 70 and 72 are
pivotally attached to the second tissue-retaining member 60 and to
the second tube 68 at pivot points 76-82 creating a hinged
parallelogram defined by a proximal portion 84 of the second
tissue-retaining member 60, a distal portion 86 of the second tube
68, and the first and second link members 70 and 72. The ultrasound
reflector 62 is disposed at a distal portion 88 of the second
tissue-retaining member 60 and faces the transducer 58. The cable
74 is operatively connected to the hinged parallelogram to move the
second tissue-retaining member 60 toward and away from the first
tissue-retaining member 56.
[0061] In one variation, the ultrasound medical treatment system 50
also includes an outer tube 90. The cable 74 and the first and
second tubes 66 and 68 are disposed in the outer tube 90. In one
modification, the ultrasound medical treatment system 50 also
includes a handpiece 92. The cable 74 and the first, second, and
outer tubes 66, 68 and 90 are operatively connected to the
handpiece 92. In one design, the orientation of the first tube 66
about the longitudinal axis of the first tube 66 is controlled by a
step motor (not shown) disposed in, and actuated by, the handpiece
92. In the same or another design, the first tube 66 is a hollow
tube allowing for transducer wiring (not shown), and the second
tube is a solid tube (not shown). Depending on use, the tubes 66,
68, and 90 may be rigid or flexible which also is true for any tube
arrangement (specifically disclosed as rigid or flexible, or not so
specifically disclosed) of any end effector and for any end
effector itself of any of the previous or following embodiments of
the invention.
Ultrasound Medical Treatment Using Specific Transducer
Arrangements
[0062] Deployable Ultrasound Medical Transducers
[0063] Referring to the drawings, FIGS. 9-11 illustrate a third
embodiment of the present invention. A first expression of the
third embodiment of the present invention is for an ultrasound
medical system 94 including a tube 96 and a plurality of
resiliently flexible fingers 98. The tube 96 has a distal end 100
insertable into a patient and has a lumen 102 with a distal opening
104. The fingers 98 are extendable out of the distal opening 104 of
the lumen 102 creating a deployed state (seen in FIG. 10) and which
are at-least-partially retractable into the distal opening 104 of
the lumen 102 creating a stowed state (seen in FIG. 11). Each
finger 98 includes an ultrasound transducer 106. The distance
between the ultrasound transducers 106 of adjacent fingers 98 is
greater in the deployed state than in the stowed state. It is noted
that an ultrasound medical system is a medical system which at
least provides ultrasound imaging or ultrasound medical treatment
of a patient.
[0064] Advantages of the tube and extendable/retractable
flexible-finger array arrangement include, when the transducers are
ultrasound medical-treatment transducers having a common focal zone
in the deployed state, providing faster medical treatment times by
allowing for more transducer ultrasound-emitting surface area which
can be simply stowed into a compact shape for transport within a
patient to and from the site of patient tissue receiving ultrasound
medical treatment.
[0065] In one variation, the fingers 98 are only partially
retracted into the distal opening 104 of the lumen 102 in the
stowed state (as seen in FIG. 11). In another variation, not shown,
the fingers 98 are completely retracted into the distal opening 104
of the lumen 102 in the stowed state. By the fingers 98 being
extendable out of the distal opening 104 of the lumen 102 creating
the deployed state and being at-least-partially retractable into
the distal opening 104 of the lumen 102 creating the stowed state
means the fingers 98 protrude more out of the distal opening 104 of
the lumen 102 in the extended state than (if at all) in the stowed
state. Mechanisms, not shown, for remotely extending and retracting
fingers in a tube include, without limitation, a common shaft
attached to the proximal ends of the fingers, disposed in the lumen
of the tube, and spring-biased to move forward upon squeezing of a
handpiece and to return backward upon relaxing of the handpiece, as
is within the ordinary level of skill of the artisan. In one
modification, the distal opening 104 of the lumen 102 coincides
with the distal end 100 of the tube 96. In another modification,
not shown, the distal opening of the lumen is spaced apart from the
distal end of the tube. In one implementation, the distal opening
104 of the lumen 102 faces in the same direction as the distal end
100 of the tube 96. Other implementations are left to the artisan,
such as, without limitation, the distal opening of the lumen facing
perpendicular to the distal end of the tube. In one example, at
least one of the transducers 106 is an ultrasound imaging
transducer. In the same or a different example, at least one of the
transducers 106 is an ultrasound medical-treatment transducer. In
the same or a different example, at least one of the transducers
106 is an ultrasound imaging and medical-treatment transducer.
[0066] A second expression of the third embodiment is for an
ultrasound medical treatment system 108 including a tube 96 and
including an end effector 110 having a plurality of fingers 98. The
tube 96 has a distal end 100 insertable into a patient and has a
lumen 102 with a distal opening 104. The fingers 98 are extendable
out of the distal opening 104 of the lumen 102 creating a deployed
state (seen in FIG. 10) and are at-least-partially retractable into
the distal opening 104 of the lumen 102 creating a stowed state
(seen in FIG. 11). Each finger 98 includes an ultrasound
medical-treatment transducer 112. The distance between the
ultrasound medical-treatment transducers 112 of adjacent fingers 98
is greater in the deployed state than in the stowed state.
[0067] A third expression of the third embodiment is for an
ultrasound medical treatment system 108 including a tube 96 and
including an end effector 110 having a plurality of fingers 98. The
tube 96 has a distal end 100 insertable into a patient and has a
lumen 102 with a distal opening 104. The fingers 98 are extendable
out of the distal opening 104 of the lumen 102 creating a deployed
state (seen in FIG. 10) and are at-least-partially retractable into
the distal opening 104 of the lumen 102 creating a stowed state
(seen in FIG. 11). Each finger 98 includes an ultrasound imaging
and medical-treatment transducer 114. The distance between the
ultrasound imaging and medical-treatment transducers 114 of
adjacent fingers 98 is greater in the deployed state than in the
stowed state.
[0068] It is noted that the variations, modifications, and
implementations, etc. previously discussed for the first expression
of the third embodiment are equally applicable to the second and
third expressions of the third embodiment.
[0069] In one example of the first, second and third expressions of
the third embodiment, the transducers 106, 112 and 114 each have an
ultrasound-emitting concave surface 116. In another example, not
shown, the transducers have a planar ultrasound-emitting surface.
In one arrangement, each concave surface 116 is concave as one
moves along the corresponding finger 98 (as best seen in FIG. 10).
In another arrangement, not shown, each concave surface is concave
as one moves across the corresponding finger or is concave as one
moves both along and across the corresponding finger (such as, for
example, with a hemispherically-concave surface). In one design,
the concave surfaces 116 together have a substantially common focal
zone when the fingers 98 are in the deployed state. The end
effector 110 is seen with its fingers 98 facing the patient tissue
119 in FIG. 10. In another design, not shown, the focal zones are
not common. In one configuration, the fingers 98 define an
open-hand finger array 118 in the deployed state. An alternate
flexible finger arrangement in the form of a substitute end
effector 120 is shown in FIG. 12, wherein the fingers 122 define a
clawed-hand finger array 124 in the deployed state. The substitute
end effector 120 is seen with its fingers 122 surrounding the
patient tissue 126 for imaging and/or medical treatment by the
ultrasound transducers 128 in FIG. 12. In other transducer
arrangements, not shown, one or more or all of the ultrasound
transducers face outward rather than facing inward.
[0070] In the same or another example of the first, second and
third expressions of the third embodiment, the fingers 98 are at
least four in number. In the same or yet another example of the
second and third expressions of the third embodiment, the end
effector 110 (as well as the substitute end effector 120) is an
open-surgery end effector, an endoscopic end effector, a
laparoscopic end effector (as shown in FIG. 9), a catheter end
effector (such as, but not limited to, an intravascular catheter
end effector), or a needle end effector, as can be appreciated by
those skilled in the art.
[0071] In one enablement, as shown in FIG. 9, the ultrasound
medical treatment system 108 also includes a handpiece 130
operatively connected to the end effector 110 and to an ultrasound
controller 132 operatively connected to a foot-pedal power switch
133, as can be appreciated by those skilled in the art.
[0072] Faceted Ultrasound Medical Transducer Assembly
[0073] A fourth embodiment of the present invention is shown in
FIGS. 13-15. A first expression of the fourth embodiment of the
present invention is for an ultrasound medical system 134 including
an ultrasound transducer assembly 136 insertable into a patient.
The ultrasound transducer assembly 136 has a longitudinal axis 138.
The ultrasound transducer assembly 136 includes a plurality P of
ultrasound transducers 140. Each transducer 140 has an
ultrasound-emitting surface 142 oriented at an angle of
substantially 360/P degrees apart from the ultrasound-emitting
surface 142 of an adjacent transducer 140 when viewed in a cross
section (see FIG. 15) of the transducer assembly 136 taken by a
cutting plane which is perpendicular to the longitudinal axis
138.
[0074] Advantages of such a transducer configuration include, in
one example, providing directed or focused medical-treatment
ultrasound which is not possible with a cylindrical ultrasound
transducer, as can be appreciated by those skilled in the art.
[0075] It is noted that an ultrasound transducer assembly 136
insertable into a patient is an ultrasound imaging transducer
assembly, an ultrasound medical-treatment transducer assembly, or
an ultrasound imaging and medical-treatment transducer assembly. An
ultrasound imaging transducer assembly has at least one ultrasound
imaging transducer, and an ultrasound medical-treatment transducer
assembly has at least one ultrasound medical-treatment transducer.
An ultrasound imaging and medical-treatment transducer assembly has
at least one ultrasound imaging transducer and at least one
ultrasound medical-treatment transducer or has at least one
ultrasound imaging and medical-treatment transducer.
[0076] A second expression of the fourth embodiment of the present
invention is for an ultrasound medical-treatment system 144
including an end effector 146 insertable into a patient. The end
effector 146 includes an ultrasound medical-treatment transducer
assembly 148. The ultrasound medical-treatment transducer assembly
148 has a longitudinal axis 138. The ultrasound medical-treatment
transducer assembly 148 includes a plurality P of ultrasound
medical-treatment transducers 150. Each transducer 150 has an
ultrasound-emitting surface 142 which faces away from the
longitudinal axis 138 and which is oriented at an angle of
substantially 360/P degrees apart from the ultrasound-emitting
surface 142 of an adjacent transducer 150 when viewed in a cross
section (see FIG. 15) of the transducer assembly 148 taken by a
cutting plane which is perpendicular to the longitudinal axis 138.
In one example, at least one of the ultrasound medical-treatment
transducers 150 is also adapted for ultrasound imaging.
[0077] A fourth method of the present invention is for ultrasound
medical treatment of a patient and uses the ultrasound medical
treatment system 144 as previously described in the second
expression of the fourth embodiment. The fourth method includes
steps a) through b). Step a) includes inserting the end effector
146 into the liver of the patient. Step b) includes medically
treating a lesion in the liver with ultrasound from the ultrasound
medical-treatment transducer assembly 148. In one example, step a)
interstially inserts the end effector 146 into the lesion. In
another example, step a) endoscopically inserts the end effector
146 into the liver through the hepato-biliary duct system.
[0078] A third expression of the fourth embodiment of the present
invention is for an ultrasound medical treatment system 144
including an end effector 146 insertable into a patient. The end
effector 146 includes an ultrasound imaging and medical-treatment
transducer assembly 152. The ultrasound imaging and
medical-treatment transducer assembly 152 has a longitudinal axis
138. The ultrasound imaging and medical-treatment transducer
assembly 152 includes a plurality P of ultrasound imaging and
medical-treatment transducers 154. Each transducer 154 has an
ultrasound-emitting surface 142 which faces away from the
longitudinal axis 138 and which is oriented at an angle of
substantially 360/P degrees apart from the ultrasound-emitting
surface 142 of an adjacent transducer 154 when viewed in a cross
section (see FIG. 15) of the transducer assembly 152 taken by a
cutting plane which is perpendicular to the longitudinal axis
138.
[0079] A fifth method of the present invention is for ultrasound
medical treatment of a patient and uses the ultrasound
medical-treatment system 144 as previously described in the third
expression of the fourth embodiment. The fourth method includes
steps a) through c). Step a) includes inserting the end effector
146 into the liver of the patient. Step b) includes identifying a
lesion in the liver for medical treatment at least in part from
ultrasound imaging using the ultrasound imaging and
medical-treatment transducer assembly 152. Step c) includes
medically treating the lesion with ultrasound from the ultrasound
imaging and medical-treatment transducer assembly 152. In one
example, step a) interstially inserts the end effector 146 into the
lesion. In another example, step a) endoscopically inserts the end
effector 146 into the liver through the hepato-biliary duct
system.
[0080] In one example of the previously-described first, second and
third expressions of the fourth embodiment, the transducer assembly
136, 148, and 152 has a distal tip 156 and has a tip transducer
158. In one design, the tip transducer is a forward facing tip
transducer. In another design, the tip transducer is a sideways
facing tip transducer. In one variation, the tip transducer is an
ultrasound imaging tip transducer. In another variation, the tip
transducer is an ultrasound medical-treatment tip transducer. In a
further variation, the tip transducer is an ultrasound imaging and
medical-treatment tip transducer. In an additional variation, the
tip transducer is a transponder which emits electromagnetic waves
or mechanical waves or both.
[0081] In the same or a different example of the
previously-described first, second and third expressions of the
third embodiment, each ultrasound-emitting surface 142 is
substantially straight when viewed in the cross section, as seen in
FIG. 15. In one variation, as seen in FIG. 14, each
ultrasound-emitting surface 142 has a substantially concave shape
as one moves along the ultrasound-emitting surface 142 in a
direction parallel to the longitudinal axis 138, and each
ultrasound-emitting surface 142 has a focal zone. In a first
alternate transducer arrangement seen FIG. 16, each
ultrasound-emitting surface 162 has a substantially planar shape.
In a second alternate transducer arrangement seen in FIG. 17, each
ultrasound-emitting surface 164 has a substantially concave shape
when viewed in the cross section, and each ultrasound-emitting
surface 164 has a focal zone. In one modification, each
ultrasound-emitting surface 164 also has a substantially concave
shape as one moves along the ultrasound-emitting surface 164 in a
direction parallel to the longitudinal axis (such as, for example,
by the ultrasound-emitting surface 164 having a
hemispherically-concave shape). Such ultrasound-emitting surface
shapes are equally applicable to any ultrasound transducer
mentioned in any other embodiment of the invention.
[0082] In the same or a different example of the
previously-described first, second and third expressions of the
third embodiment, P is no greater than four. In one variation, P
equals three as seen in FIGS. 15 and 17. In another variation, P
equals two as seen in FIG. 16.
[0083] In the same or a different example of the
previously-described second and third expressions of the third
embodiment, the end effector 146 is an open-surgery end effector,
an endoscopic end effector, a laparoscopic end effector (as shown
in FIG. 13), a catheter end effector (such as, but not limited to,
an intravascular catheter end effector), or a needle end effector,
as can be appreciated by those skilled in the art. In one
enablement, as shown in FIG. 13, the ultrasound medical treatment
system 144 also includes a handpiece 166 operatively connected to
the end effector 146 and to an ultrasound controller 168
operatively connected to a foot-pedal power switch 169, as can be
appreciated by the artisan.
Ultrasound Medical Treatment Applications
[0084] Excisional and Ultrasound Medical Treatment System
[0085] A fifth embodiment of the present invention is shown in
FIGS. 18-20. In a first expression of the fifth embodiment of the
present invention, an ultrasound medical treatment system 170
includes a tube 172, a first end effector 174, and a second end
effector 176. The tube 172 has a distal end 178 insertable into a
patient 180 and has a lumen 182. The first end effector 174 has a
cutting tool 184, is introducible into the lumen 182 of the
inserted tube 172 from outside the patient 180, and is translatable
through the lumen 182 of the inserted tube 172 to inside the
patient 180. The second end effector 176 has an ultrasound
medical-treatment transducer assembly 186, is introducible into the
lumen 182 of the inserted tube 172 from outside the patient 180,
and is translatable through the lumen 182 of the inserted tube 172
to inside the patient 180. In one variation, the first and second
end effectors are introduced into the lumen through separate
openings in the lumen or through separate branch channels leading
to the lumen. In another variation, the first and second end
effectors are introduced into the lumen through the same opening in
the lumen. In one modification, a lumen opening is disposed at the
end of the tube. In another modification, a lumen opening is spaced
apart from the end of the tube.
[0086] A second expression of the fifth embodiment of the present
invention is for an ultrasound medical treatment system 170
including a tube 172, a first end effector 174, and a second end
effector 176. The tube has a distal end 178 insertable into a
patient 180 and has a lumen 182 with a distal opening 188 and a
proximal opening 190. The first end effector 174 has a cutting tool
184, is introducible into the proximal opening 190, and is
translatable through the lumen 182 to the distal opening 188. The
second end effector 176 has an ultrasound medical-treatment
transducer assembly 186, is introducible into the proximal opening
190, and is translatable through the lumen 182 to the distal
opening 188.
[0087] In one example of the first and second expressions of the
fifth embodiment of the present invention, the lumen 182 is sized
to allow introduction of only one of the first and second end
effectors 174 and 176 at a time. In the same or another example,
the distal end 178 of the tube 172 is interstitially insertable
into patient tissue 192 of the patient 180. In the same or a
different example, the cutting tool 184 is a biopsy cutting tool
194 or other excisional cutting tool.
[0088] A third expression of the fifth embodiment of the present
invention is for an ultrasound medical treatment system 170
including a tube 172, a first end effector 174, and a second end
effector 176. The tube 172 has a distal end 178 interstitially
insertable into breast tissue 196 of a patient 180 and has a lumen
182 with a distal opening 188 and a proximal opening 190. The first
end effector 174 has a biopsy cutting tool 194 (or other excisional
cutting tool), is introducible into the proximal opening 190, and
is translatable through the lumen 182 to the distal opening 188.
The second end effector 176 has an ultrasound medical-treatment
transducer assembly 186, is introducible into the proximal opening
190, and is translatable through the lumen 182 to the distal
opening 188. The lumen 182 is sized to allow introduction of only
one of the first and second end effectors 174 and 176 at a time. In
one design, the first end effector also includes a suction
mechanism to draw in patient tissue to be biopsied by the biopsy
cutting tool 194. In one application, the tube 172 and the first
end effector 174 (with the biopsy cutting tool 194 including a
suction mechanism) are based on components of a Mammotome.RTM.
Breast Biopsy System manufactured by Ethicon Endo-Surgery, Inc. (a
Johnson & Johnson Company).
[0089] A sixth method of the invention is for ultrasound medical
treatment of a patient 180 and uses the ultrasound medical
treatment system 170 as previously described in the third
expression of the fifth embodiment of the present invention. The
sixth method includes steps a) through h). Step a) includes
identifying possibly cancerous breast tissue 196 of the patient.
Step b) includes interstitially inserting the distal end 178 of the
tube 172 into the patient 180 with the distal opening 188 disposed
proximate the breast tissue 196 and with the proximal opening 190
disposed outside the patient. Step c) includes introducing the
first end effector 174 into the proximal opening 190 and
translating the first end effector 174 through the lumen 182 to the
distal opening 188. Step d) includes obtaining a biopsy sample of
the breast tissue 196 with the biopsy cutting tool 194. Step e)
includes removing the first end effector 174 from the lumen 182,
Step f) includes introducing the second end effector 176 into the
proximal opening 190 and translating the second end effector 176
through the lumen 182 to the distal opening 188. Step g) includes
identifying an area of hemorrhaging in the breast tissue where the
biopsy sample was obtained. Step h) includes medically treating the
identified area with ultrasound using the transducer assembly 186
to substantially stop the hemorrhaging. In one application, the
sixth method of the invention also includes the steps of testing
the biopsy sample for cancer and substantially ablating any
remaining cancer in the breast tissue with ultrasound using the
transducer assembly 186. Advantages of such an ultrasound medical
treatment system and method include the ease of obtaining a breast
biopsy and the control of hemorrhaging caused by the biopsy
procedure coupled together in a minimally invasive manner.
[0090] In a fourth expression of the fifth embodiment of the
present invention, an ultrasound medical treatment system 170
includes a tube 172, a first end effector 174, and a second end
effector 176. The tube 172 has a distal end 178 insertable into a
patient 180 and has a lumen 182. The first end effector 174 has a
cutting tool 184, is introducible into the lumen 182 of the
inserted tube 172 from outside the patient 180, and is translatable
through the lumen 182 of the inserted tube 172 to inside the
patient 180. The second end effector 176 has an ultrasound imaging
and medical-treatment transducer assembly 198, is introducible into
the lumen 182 of the inserted tube 172 from outside the patient
180, and is translatable through the lumen 182 of the inserted tube
172 to inside the patient 180. In one variation, the first and
second end effectors are introduced into the lumen through separate
openings in the lumen or through separate branch channels leading
to the lumen. In another variation, the first and second end
effectors are introduced into the lumen through the same opening in
the lumen. In one modification, a lumen opening is disposed at the
end of the tube. In another modification, a lumen opening is spaced
apart from the end of the tube.
[0091] A fifth expression of the fifth embodiment of the present
invention is for an ultrasound medical treatment system 170
including a tube 172, a first end effector 174, and a second end
effector 176. The tube has a distal end 178 insertable into a
patient 180 and has a lumen 182 with a distal opening 188 and a
proximal opening 190. The first end effector 174 has a cutting tool
184, is introducible into the proximal opening 190, and is
translatable through the lumen 182 to the distal opening 188. The
second end effector 176 has an ultrasound imaging and
medical-treatment transducer assembly 198, is introducible into
proximal opening 190, and is translatable through the lumen 182 to
the distal opening 188.
[0092] In one example of the fourth and fifth expressions of the
fifth embodiment of the present invention, the lumen 182 is sized
to allow introduction of only one of the first and second end
effectors 174 and 176 at a time. In the same or another example,
the distal end 178 of the tube 172 is interstitially insertable
into patient tissue 192 of the patient 180. In the same or a
different example, the cutting tool 184 is a biopsy cutting tool
194 or other excisional cutting tool.
[0093] A sixth expression of the fifth embodiment of the present
invention is for an ultrasound medical treatment system 170
including a tube 172, a first end effector 174, and a second end
effector 176. The tube 172 has a distal end 178 interstitially
insertable into breast tissue 196 of a patient 180 and has a lumen
182 with a distal opening 188 and a proximal opening 190. The first
end effector 174 has a biopsy cutting tool 194 (or other excisional
cutting tool), is introducible into the proximal opening 190, and
is translatable through the lumen 182 to the distal opening 188.
The second end effector 176 has an ultrasound imaging and
medical-treatment transducer assembly 196, is introducible into the
proximal opening 190, and is translatable through the lumen 182 to
the distal opening 188. The lumen 182 is sized to allow
introduction of only one of the first and second end effectors 174
and 176 at a time. In one application, the tube 172 and the first
end effector 174 (with the biopsy cutting tool 194 including a
suction mechanism) are based on components of a Mammotome.RTM.
Breast Biopsy System manufactured by Ethicon Endo-Surgery, Inc. (a
Johnson & Johnson Company).
[0094] A seventh method of the invention is for ultrasound medical
treatment of a patient 180 and uses the ultrasound medical
treatment system 170 as previously described in the sixth
expression of the fifth embodiment of the present invention. The
seventh method includes steps a) through h). Step a) includes
identifying possibly cancerous breast tissue 196 of the patient.
Step b) includes interstitially inserting the distal end 178 of the
tube 172 into the patient 180 with the distal opening 188 disposed
proximate the breast tissue 196 and with the proximal opening 190
disposed outside the patient. Step c) includes introducing the
first end effector 174 into the proximal opening 190 and
translating the first end effector 174 through the lumen 182 to the
distal opening 188. Step d) includes obtaining a biopsy sample of
the breast tissue 196 with the biopsy cutting tool 194. Step e)
includes removing the first end effector 174 from the lumen 182,
Step f) includes introducing the second end effector 176 into the
proximal opening 190 and translating the second end effector 176
through the lumen 182 to the distal opening 188. Step g) includes
identifying an area of hemorrhaging in the breast tissue where the
biopsy sample was obtained from ultrasound imaging using the
transducer assembly 198. Step h) includes medically treating the
identified area with ultrasound using the transducer assembly 198
to substantially stop the hemorrhaging. In one application, the
seventh method of the invention also includes the steps of testing
the biopsy sample for cancer and substantially ablating any
remaining cancer in the breast tissue with ultrasound using the
transducer assembly 198. Advantages of such an ultrasound medical
treatment system and method include the ease of obtaining a breast
biopsy and the imaging and control of hemorrhaging caused by the
biopsy procedure coupled together in a minimally invasive
manner.
[0095] In one enablement, as shown in FIG. 18, the ultrasound
medical treatment system 170 also includes a handpiece 199 which is
attached to the tube 172, which contains the first end effector 174
for extending the cutting tool 184 into, and withdrawing it from,
the lumen 182, and which is operatively connected to an ultrasound
controller 201 via a first cable 203. The second end effector 176,
in this enablement, is operatively connected to the ultrasound
controller 201 via a second cable 205 and is inserted into the
lumen 182 from outside the handpiece 199 as shown in FIG. 18.
[0096] Staging Medical Treatment Using Ultrasound
[0097] An eighth method of the invention is shown in block diagram
form in FIG. 21 and is for medical treatment of a patient. The
eighth method includes steps a) through f). Step a) is labeled
"Obtain Transducer Assembly" in block 200 of FIG. 21. Step a)
includes obtaining an ultrasound imaging transducer assembly. Step
b) is labeled "Insert Assembly Into Gastrointestinal Area" in block
202 of FIG. 21. Step b) includes inserting the transducer assembly
into a gastrointestinal area of the patient. Step c) is labeled
"Guide Assembly" in block 204 of FIG. 21. Step c) includes guiding
the transducer assembly within the gastrointestinal area. Step d)
is labeled "Identify Patient Tissue For Treatment" in block 206 of
FIG. 21. Step d) includes identifying patient tissue in the
gastrointestinal area for medical treatment. Step e) is labeled
"Stage Treatment From Ultrasound Imaging" in block 208 of FIG. 21.
Step e) includes staging the medical treatment from ultrasound
imaging using the transducer assembly. Step f) is labeled as
"Medically Treat Patient" in block 210 of FIG. 21. Step f) includes
medically treating the patient tissue according to the staging of
step e). It is pointed out that in the eighth method the medical
treatment need not include ultrasound medical treatment with the
transducer assembly used for staging and/or need not include
ultrasound medical treatment with any other ultrasound transducer
assembly. In one procedure depending on the pathology size and
site, a first transducer assembly is used endoscopically to stage
the medical treatment in step e) and a second transducer assembly
is used laparoscopically to medically treat the patient tissue with
ultrasound in step f). In one variation, the first transducer
assembly is used laparoscopically to stage the medical treatment in
step e) and the second transducer assembly is used endoscopically
to medically treat the patient tissue with ultrasound in step f).
In another procedure, the medical treatment in step f) is
radio-frequency, laser, microwave, or chemical ablation medical
treatment. Other types of medical treatment are left to the
artisan.
[0098] It is noted that the gastrointestinal (GI) area of a human
patient includes, without limitation, the esophagus and the stomach
of the upper GI area and the rectum and the colon of the lower GI
area. It further is noted that the liver is also considered to be
in the GI area for purposes of this method.
[0099] By "staging the medical treatment from ultrasound imaging"
is meant at least using ultrasound images to determine the
three-dimensional size and shape of the patient tissue that is to
receive medical treatment. For example, and without limitation,
upper and lower GI tumors can be visualized with high frequency
(6-30 MHz) ultrasound imaging using a cylindrical, side-firing, or
half-convex ultrasound array or single-element transducer
introduced endoscopically into the GI tract. All layers of the GI
tract can be visualized including all layers of the esophagus,
stomach, duodenum, colon, etc. In one procedure, a
three-dimensional representation of the GI structures is created by
collating a series of two-dimensional scans generated by axially
advancing the ultrasound transducer. Any neoplastic growth, its
morphological characteristics, as well as the tumor's size and
shape can easily be determined from the three-dimensional
representation.
[0100] Advantages of such medical-treatment staging from ultrasound
imaging include, in one example, providing a non-invasive
medical-treatment staging technique which has greater resolution
and which is more practical compared to conventional extracorporeal
medical-treatment staging techniques such as using x-rays or MRI
imaging or compared to using conventional endoscopic optical
techniques.
[0101] A ninth method of the invention is for ultrasound medical
treatment of a patient and includes steps a) through f). The ninth
method uses the same block diagram of FIG. 21 as does the eighth
method but with "end effector" replacing "transducer assembly" in
block 200 and with "end effector" replacing "assembly" in blocks
202 and 204. Step a) includes obtaining an end effector having an
ultrasound imaging and medical-treatment transducer assembly. Step
b) includes inserting the end effector into a gastrointestinal area
of the patient. Step c) includes guiding the transducer assembly
within the gastrointestinal area. Step d) includes identifying
patient tissue in the gastrointestinal area for medical treatment.
Step e) includes staging the medical treatment from ultrasound
imaging using the transducer assembly. Step f) includes medically
treating the patient tissue with ultrasound using the transducer
assembly according to the staging of step e).
[0102] A tenth method of the invention is for ultrasound medical
treatment of a patient and includes steps a) through f). The tenth
method uses the same block diagram of FIG. 21 as does the eighth
method but with "end effector" replacing "transducer assembly" in
block 200 and with "end effector" replacing "assembly" in blocks
202 and 204. Step a) includes obtaining an end effector having an
ultrasound imaging and medical-treatment transducer assembly. Step
b) includes inserting the end effector into a gastrointestinal area
of the patient. Step c) includes guiding the transducer assembly
within the gastrointestinal area. Step d) includes identifying
patient tissue in the gastrointestinal area for medical treatment
at least in part from ultrasound imaging using the transducer
assembly. Step e) includes staging the medical treatment from
ultrasound imaging using the transducer assembly. Step f) includes
medically treating the patient tissue with ultrasound using the
transducer assembly according to the staging of step e). In one
procedure, large GI tumors are staged through a laparoscopic access
to the GI area, whereby the tumors are identified, staged and
treated using an end effector having an ultrasound imaging and
medical-treatment transducer assembly.
[0103] In one example of the ninth and tenth methods of the
invention, the patient tissue is gastroesophageal tissue containing
a lesion, and step f) ultrasonically substantially ablates the
lesion. In one modification, the gastroesophageal tissue contains a
blood vessel supplying blood to the lesion, and step f)
ultrasonically treats the blood vessel to substantially stop the
supply of blood to the lesion from the blood vessel.
[0104] In another example of the ninth and tenth methods of the
invention, the patient tissue is liver tissue containing a lesion
and a blood vessel supplying blood to the lesion, and step f)
ultrasonically treats the blood vessel to substantially stop the
supply of blood to the lesion from the blood vessel.
[0105] In an additional example of the ninth and tenth methods of
the invention, the patient tissue is liver tissue containing a
lesion, and step f) ultrasonically substantially ablates the
lesion. In one modification, the liver tissue contains a blood
vessel supplying blood to the lesion, and step f) also
ultrasonically treats the blood vessel to substantially stop the
supply of blood to the lesion from the blood vessel. In one
procedure, an end effector having an ultrasound imaging and
medical-treatment transducer assembly is introduced endoscopically
into the GI tract, is advanced retrogradely through the ampulla of
Vater up the common bile duct, and is advanced further into the
hepatic duct system where liver parenchyma requiring medical
treatment (such as cholangio-carcinomas) are identified, staged,
and treated using the end effector.
[0106] Treatment of Lung Lesions Using Ultrasound
[0107] An eleventh method of the invention is shown in block
diagram form in FIG. 22 and is for ultrasound medical treatment of
a patient. The eleventh method includes steps a) through f). Step
a) is labeled "Obtain End Effector" in block 212 of FIG. 22. Step
a) includes obtaining an end effector having an ultrasound
medical-treatment transducer assembly. Step b) is labeled "Insert
End Effector" in block 214 of FIG. 22. Step b) includes inserting
the end effector into the patient. Step c) is labeled "Guide End
Effector To Lung" in block 216 of FIG. 22. Step c) includes guiding
the end effector within the patient to a lung of the patient. Step
d) is labeled "Identify Lesion" in block 218 of FIG. 22. Step d)
includes identifying a lesion on or in the lung for medical
treatment. Step e) is labeled "Position Transducer Assembly" in
block 220 of FIG. 22. Step e) includes positioning the transducer
assembly on or in the lesion. Step f) is labeled "Medically Treat
Lesion" in block 222 of FIG. 22. Step f) includes medically
treating the lesion with ultrasound using the transducer
assembly.
[0108] A twelfth method of the invention is for ultrasound medical
treatment of a patient and includes steps a) through f). The
twelfth method uses the same block diagram of FIG. 22 as does the
eleventh method. Step a) includes obtaining an end effector having
an ultrasound imaging and medical-treatment transducer assembly.
Step b) includes inserting the end effector into the patient. Step
c) includes guiding the end effector within the patient to a lung
of the patient. Step d) includes identifying a lesion on or in the
lung for medical treatment at least in part from ultrasound imaging
using the transducer assembly. Step c) includes positioning the
transducer assembly on or in the lesion. Step f) includes medically
treating the lesion with ultrasound using the transducer
assembly.
[0109] In one example of the eleventh and twelfth methods, step f)
ultrasonically substantially ablates the lesion. In one
application, the end effector is an endoscopic end effector and
step b) transbronchial-endoscopically inserts the end effector into
the patient. In another application, the end effector is a needle
end effector and step b) interstitially inserts the end effector
into the patient. In one implementation, step e) positions the
transducer assembly on the lesion. In another implementation, step
e) positions the transducer assembly in the lesion. In one practice
of the eleventh and twelfth methods, step c) a bronchoscope is used
to guide the end effector to a lung of the patient.
[0110] Ultrasound medical treatment of the lung has conventionally
been avoided because such ultrasound is prevented from reaching a
lesion within the lung by the alveoli of the lung which contain air
which reflect back most of the ultrasound preventing the ultrasound
from effectively penetrating the lung to the lesion. Using higher
power ultrasound for effective penetration of the lung to reach the
lesion would injure or destroy the alveoli which are needed for
breathing. Applicants theorized that positioning the ultrasound
transducer on or in a lesion of the lung would allow ultrasound
medical treatment of the lesion (such as a tumor or an infarct)
without injury to the alveoli. It is noted that Applicants' method
is applicable to surface lesions as well as non-surface lesions.
Advantages of Applicants' eleventh and twelfth methods for
ultrasound medical treatment include, in one example, the
destruction of lung cancer lesions in cases which otherwise would
be inoperable or incurable.
[0111] Ultrasound-Based Occlusive Procedure for Medical
Treatment
[0112] A thirteenth method of the invention is shown in block
diagram form in FIG. 23 and is for ultrasound medical treatment of
a patient. The thirteenth method includes steps a) through e). Step
a) is labeled "Obtain End Effector" in block 224 of FIG. 23. Step
a) includes obtaining an end effector having an ultrasound
medical-treatment transducer assembly. Step b) is labeled "Insert
End Effector" in block 226 of FIG. 23. Step b) includes inserting
the end effector into the patient. Step c) is labeled "Guide End
Effector" in block 228 of FIG. 23. Step c) includes guiding the end
effector within the patient to a region of patient tissue
containing a lesion. Step d) is labeled "Identify Blood Vessel
Supplying Lesion" in block 230 of FIG. 23. Step d) includes
identifying a blood vessel in the region which supplies blood to
the lesion. Step e) is labeled "Stop Blood Supply Using Ultrasound"
in block 232 of FIG. 23. Step e) includes medically treating the
blood vessel with ultrasound from the transducer assembly to
substantially seal the blood vessel to stop the supply of blood to
the lesion from the blood vessel. One implementation of the
thirteenth method of the invention also includes the step of
medically treating the lesion with ultrasound from the transducer
assembly to substantially ablate the lesion.
[0113] A fourteenth method of the invention is for ultrasound
medical treatment of a patient and includes steps a) through g).
The fourteenth method is similar to the thirteenth method. Step a)
includes obtaining an end effector having an ultrasound imaging and
medical-treatment transducer assembly. Step b) includes inserting
the end effector into the patient. Step c) includes guiding the end
effector within the patient to a region of patient tissue
containing a lesion. Step d) includes identifying the lesion at
least in part from ultrasound imaging using the transducer
assembly. Step e) includes identifying a blood vessel in the region
which supplies blood to the lesion from ultrasound imaging using
the transducer assembly. Step f) includes medically treating the
blood vessel with ultrasound from the transducer assembly to
substantially seal the blood vessel to substantially stop the
supply of blood to the lesion from the blood vessel. Step g)
includes medically treating the lesion with ultrasound from the
transducer assembly to substantially ablate the lesion. It is noted
that Doppler ultrasound imaging alone, gray-scale ultrasound
imaging alone, and a combination of Doppler and gray-scale
ultrasound imaging are known ultrasound techniques to image blood
flow in blood vessels.
[0114] In one application of the thirteenth and fourteenth methods,
the end effector is an open-surgery end effector. In another
application, the end effector is an endoscopic end effector. In a
further application, the end effector is a laparoscopic end
effector. In an additional application, the end effector is a
catheter end effector (such as, but not limited to, an
intravascular catheter end effector). In a different application,
the end effector is a needle end effector.
[0115] A broadened thirteenth method of the invention eliminates
the inserting into and guiding within steps of the above-described
thirteenth method and includes steps a) through c). Step a)
includes obtaining an end effector having an ultrasound
medical-treatment transducer assembly. Step b) includes identifying
a blood vessel in the patient which supplies blood to a lesion.
Step c) includes medically treating the blood vessel with
ultrasound from the transducer assembly to substantially seal the
blood vessel to substantially stop the supply of blood to the
lesion from the blood vessel.
[0116] A broadened fourteenth method of the invention eliminates
the inserting into and guiding within steps of the above-described
fourteenth method and includes steps a) through e). Step a)
includes obtaining an end effector having an ultrasound imaging and
medical-treatment transducer assembly. Step b) includes identifying
a lesion in the patient at least in part from ultrasound imaging
using the transducer assembly. Step c) includes identifying a blood
vessel which supplies blood to the lesion from ultrasound imaging
using the transducer assembly. Step d) includes medically treating
the blood vessel with ultrasound from the transducer assembly to
substantially seal the blood vessel to substantially stop the
supply of blood to the lesion from the blood vessel. Step e)
includes medically treating the lesion with ultrasound from the
transducer assembly to substantially ablate the lesion.
[0117] In one example of the broadened thirteenth and fourteenth
methods, the end effector is an extracorporeal end effector. In
another example, the end effector is an intracorporeal end
effector. In a further example, the end effector can be used in
both an extracorporeal mode and in an intracorporeal mode.
[0118] Advantages of Applicants' thirteenth and broadened
thirteenth methods for ultrasound medical treatment include, in one
example, the indirect destruction of cancer lesions by ultrasound
hemostasis in blood vessels supplying the cancer lesions in cases
which otherwise would be inoperable or incurable because the
location of the cancer lesions prevents medical treatment of the
lesions themselves. Advantages of Applicants' fourteenth and
broadened fourteenth methods for ultrasound treatment include, in
one example, direct destruction of cancer lesions by ultrasound
ablation of the cancer lesions together with the indirect
destruction of any cancer lesions missed in the ultrasound ablation
step by ultrasound hemostasis in blood vessels supplying blood to
the missed cancer lesions.
Guiding and Targeting Ultrasound End Effectors
[0119] Guiding Ultrasound End Effector for Medical Treatment
[0120] A sixth embodiment of the present invention is shown in FIG.
24. In a first expression of the sixth embodiment of the present
invention, an ultrasound medical treatment system 234 (only a
portion of which is shown in FIG. 24) includes an end effector 236
and at least three receivers 238. The end effector 236 has a
transducer assembly 240 including a transducer 242 having at least
one transducer element 244 adapted for emitting medical-treatment
ultrasound waves and for emitting mechanical waves. It is noted
that the terminology "mechanical waves" includes ultrasound and
non-ultrasound compression (acoustic) waves and ultrasound and
non-ultrasound shear waves, and that waves include wave pulses. The
receivers 238 are spaced apart from the transducer assembly 240,
and the receivers 238 are adapted to receive the emitted mechanical
waves for use in locating the position of the transducer assembly
240. Conventional methods (including triangulation methods) for
locating the position of a transponder emitting waves which are
received by three receivers are well known. A second expression of
the sixth embodiment is identical to the first expression of the
sixth embodiment except that the at-least-one transducer element
244 is also adapted for emitting imaging ultrasound waves. In one
variation of the first and second expressions of the sixth
embodiment, the end effector and the receivers are disposable
outside (including in one modification on) the patient. In another
variation, the end effector is insertable into the patient and the
receivers are disposable outside (including in one modification on)
the patient.
[0121] A seventh embodiment of the present invention is shown in
FIG. 25. In a first expression of the seventh embodiment of the
present invention, an ultrasound medical treatment system 246 (only
a portion of which is shown in FIG. 25) includes an end effector
248 and at least three receivers 250. The end effector 248 has an
ultrasound medical-treatment transducer assembly 252 and has a
transponder 254 The transponder 254 is adapted to emit waves, and
the waves include electromagnetic waves or mechanical waves or
both. The receivers 250 are spaced apart from the transducer
assembly 252, and the receivers 250 are adapted to receive the
emitted waves for use in locating the position of the transponder
254. In a second expression of the seventh embodiment, the
ultrasound medical-treatment transducer assembly 252 is an
ultrasound imaging and medical-treatment transducer assembly
256.
[0122] In one application of the first and second expressions of
the seventh embodiment, the end effector 248 is insertable into a
patient, the transponder 254 is adapted to emit electromagnetic
waves, and the receivers 250 are disposable outside the patient. In
one variation, the receivers 250 are disposable on the patient. In
another application, the end effector is disposable outside
(including in one modification on) the patient and the receivers
are disposable outside (including in one modification on) the
patient.
[0123] In one example of the first and second expressions of the
seventh embodiment, the end effector 248 is an endoscopic end
effector, a laparoscopic end effector, a catheter end effector
(such as, but not limited to, an intravascular catheter end
effector), or a needle end effector. In one design of the first and
second expressions of the seventh embodiment, the end effector 248
has a distal tip 260, and the transponder 254 is disposed at the
distal tip 260 of the end effector 248. In one variation, the
transducer assembly 252 and 256 is disposed proximate the
transponder 254.
[0124] A fifteenth method of the invention uses the ultrasound
medical treatment system of the first expression of the seventh
embodiment and includes steps a) through h). Step a) includes
inserting the end effector 248 into the patient. Step b) includes
disposing the receivers 250 outside the patient. Step c) includes
emitting electromagnetic waves from the transponder 254. Step d)
includes receiving the electromagnetic waves with the disposed
receivers 250. Step e) includes calculating the position of the
transponder 254 from the received electromagnetic waves. Step f)
includes guiding the end effector within the patient to a desired
location from the calculated position of the transponder 254. Step
g) includes, after step f), identifying patient tissue for medical
treatment. Step h) includes medically treating the identified
patient tissue with ultrasound using the transducer assembly
252.
[0125] A sixteenth method of the invention uses the ultrasound
medical treatment system of the second expression of the seventh
embodiment and includes steps a) through h). Step a) includes
inserting the end effector 248 into the patient. Step b) includes
disposing the receivers 250 outside the patient. Step c) includes
emitting electromagnetic waves from the transponder 254. Step d)
includes receiving the electromagnetic waves with the disposed
receivers 250. Step e) includes calculating the position of the
transponder 254 from the received electromagnetic waves. Step f)
includes guiding the end effector within the patient to a desired
location from the calculated position of the transponder 254. Step
g) includes, after step f), identifying patient tissue for medical
treatment at least in part from ultrasound imaging using the
transducer assembly 256. Step h) includes medically treating the
identified patient tissue with ultrasound using the transducer
assembly 256.
[0126] A known electromagnetic transponder and three-receiver
system for calculating the position of the transponder and for
guiding the transponder (which is attached to a heart catheter for
monitoring the heart) inside a patient is the CARTO.TM. EP
Navigation System used with a NAVI-STAR.RTM. catheter manufactured
by Biosense Webster (a Johnson & Johnson Company).
[0127] Advantages of an end effector with ultrasound medical
treatment and position-location capabilities include, in one
example, more accurately guiding the end effector inside a patient
to patient tissue for ultrasound medical treatment of the patient
tissue.
[0128] Method for Aiming Ultrasound for Medical Treatment
[0129] A seventeenth method of the invention is shown in block
diagram form in FIG. 26 and is for ultrasound medical treatment of
a patient. The seventeenth method includes steps a) through f).
Step a) is labeled "Obtain End Effector" in block 262 of FIG. 26.
Step a) includes obtaining an end effector having an ultrasound
medical-treatment transducer assembly. Step b) is labeled "Aim
Transducer Assembly" in block 264 of FIG. 26. Step b) includes
aiming the transducer assembly to focus ultrasound energy at a
desired focal zone of patient tissue. It is noted that, in one
example, to aim a transducer assembly means to focus ultrasound
energy at a particular distance from the transducer assembly and
along a particular direction. Step c) is labeled "Activate
Transducer Assembly" in block 266 of FIG. 26. Step c) includes
activating the aimed transducer assembly to emit ultrasound energy
sufficient to achieve a temperature increase in the patient tissue
essentially without medically affecting the patient tissue. Step d)
is labeled "Detect Actual Focal Zone" in block 268 of FIG. 26. Step
d) includes after step c) detecting, from reflected ultrasound
energy, an actual focal zone of patient tissue having a temperature
increase. Step e) is labeled "Correct For Any Aiming Error" in
block 269 of FIG. 26. Step e) includes correcting for any error
between the desired focal zone and the actual focal zone. Step f)
is labeled "Medically Treat Patient Tissue" in block 270 of FIG.
26. Step f) includes after step e), medically treating the patient
tissue with ultrasound using the transducer assembly. In one
application, step d) uses one or more additional ultrasound
transducer assemblies, separate from the ultrasound transducer
assembly used in steps a) through c) and e) through f), to detect,
from reflected ultrasound energy, the actual focal zone. In another
application, the same ultrasound transducer assembly is used for
steps a) through f). In one example of the seventeenth method, the
end effector is an extracorporeal end effector. In another example,
the end effector is an intracorporeal end effector. In a further
example, the end effector can be used in both an extracorporeal
mode and in an intracorporeal mode.
[0130] An eighteenth method of the invention is for ultrasound
medical treatment of a patient and includes steps a) through f).
The eighteenth method uses the same block diagram of FIG. 26 as
does the seventeenth method. Step a) includes obtaining an end
effector having an ultrasound imaging and medical-treatment
transducer assembly. Step b) includes aiming the transducer
assembly to focus ultrasound energy at a desired focal zone of
patient tissue. Step c) includes activating the aimed transducer
assembly to emit ultrasound energy sufficient to achieve a
temperature increase in the patient tissue essentially without
medically affecting the patient tissue. Step d) includes after step
c) detecting, from reflected ultrasound energy using the transducer
assembly, an actual focal zone of patient tissue having a
temperature increase. Step e) includes correcting for any error
between the desired focal zone and the actual focal zone. Step f)
includes after step e), medically treating the patient tissue with
ultrasound using the transducer assembly. In one example, the end
effector is an extracorporeal end effector. In another example, the
end effector is an intracorporeal end effector. In a further
example, the end effector can be used in both an extracorporeal
mode and in an intracorporeal mode.
[0131] A nineteenth method of the invention is for ultrasound
medical treatment of a patient and includes steps a) through i).
The nineteenth method uses the same block diagram of FIG. 26 as
does the seventeenth method but with three extra steps added
between block 262's step a) and block 264's step b) of the
seventeenth method. In the nineteenth method, step a) includes
obtaining an end effector having an ultrasound imaging and
medical-treatment transducer assembly. Step b) includes inserting
the end effector into the patient. Step c) includes guiding the end
effector inside the patient. Step d) includes identifying a desired
focal zone of patient tissue at least in part from ultrasound
imaging using the transducer assembly. Step e) includes aiming the
transducer assembly to focus ultrasound energy at the desired focal
zone of patient tissue. Step f) includes activating the aimed
transducer assembly to emit ultrasound energy sufficient to achieve
a temperature increase in the patient tissue essentially without
medically affecting the patient tissue. Step g) includes after step
f) detecting, from reflected ultrasound energy using the transducer
assembly, an actual focal zone of patient tissue having a
temperature increase. Step h) includes correcting for any error
between the desired focal zone and the actual focal zone. Step i)
includes after step h), medically treating the patient tissue with
ultrasound using the transducer assembly.
[0132] In one example of the seventeenth through nineteenth
methods, the end effector is an endoscopic end effector. In another
example, the end effector is a laparoscopic end effector. In a
further example, the end effector is a catheter end effector (such
as, but not limited to, an intravascular catheter end effector). In
an additional example, the end effector is a needle end
effector.
[0133] It is noted that the achieved temperature increase will
decrease over time so that the detected temperature increase may
not exactly equal the achieved temperature increase. In one
implementation of the seventeenth through nineteenth methods, the
temperature increase detected in the detecting step is equal
substantially to the temperature increase achieved in the
activating step. In one application of the seventeenth through
nineteenth methods, the detected temperature increase is not
greater than about five degrees Celsius. In one variation, the
detected temperature increase is not greater than about two degrees
Celsius.
[0134] It is noted that conventional methods are known to the
artisan to convert ultrasound image data into temperature images.
In one variation of the seventeenth through nineteenth methods, the
correcting step is performed automatically by a feedback control on
the same mechanism used to aim the transducer assembly in the
aiming step, as can be appreciated by the artisan. As previously
noted, mechanisms for aiming an ultrasound medical-treatment
transducer assembly include conventional electronic and/or
mechanical techniques as are known to those skilled in the art.
[0135] Advantages of correcting for any error between the desired
and actual focal zones before medical treatment include more
precise ultrasound medical treatment of patient tissue. In one
example, better targeting maximizes the ablation of a lesion (and
any appropriate margin) while minimizing medical treatment of
patient tissue outside the lesion (and outside any appropriate
margin).
Ultrasound Imaging of Patient Tissue
[0136] Ultrasound Feedback in Medically-Treated Patients
[0137] A twentieth method of the invention is shown in block
diagram form in FIG. 27 and is for ultrasound imaging of patient
tissue of a patient. The twentieth method includes steps a) through
c). Step a) is labeled "Obtain A First Signal From A Location At A
First Time" in block 272 of FIG. 27. Step a) includes obtaining a
first signal of a first imaging ultrasound wave which has been
reflected back from a location in the patient tissue at a first
time. Step b) is labeled "Obtain A Second Signal From The Location
At A Later Second Time" in block 274 of FIG. 27. Step b) includes
obtaining a second signal of a second imaging ultrasound wave which
has been reflected back from the location in the patient tissue at
a later second time wherein the patient has received at least some
medical treatment by the second time. Step c) is labeled "Create An
Image Of The Location Using The Two Signals" in block 276 of FIG.
27. Step c) includes creating an image of the location using the
first signal and the second signal. It is understood that the
terminology "creating an image" includes, without limitation,
creating an image in visual form displayed, for example, on a
monitor and creating an image in electronic form which, for
example, is used by a computer without being displayed in visual
form on a monitor. In one enablement of the twentieth method of the
invention, the image of the location is visually displayed at a
pixel location on a monitor.
[0138] In one example of the twentieth method of the invention,
step c) includes creating an image of the location using at least
the amplitude of the first signal and the amplitude of the second
signal. In one variation, step c) calculates the difference in the
amplitudes between the first and second signals. In one
modification, step c) uses the calculated amplitude difference and
uses one of the amplitudes of one of the first and second signals.
In one implementation, step c) calculates the sum of the one
amplitude and a function of the calculated amplitude difference. In
one illustration for a first signal amplitude of 6 and a second
signal amplitude of 7, step c) calculates the amplitude difference,
adds the difference to the second signal amplitude creating a
processed amplitude of 8, and creates the image of the location
using the processed amplitude. Other algorithms for using the
amplitude of the first and second signals to enhance any amplitude
difference in creating the image of the location after medical
treatment are left to the artisan.
[0139] In another example of the twentieth method of the invention,
step c) includes creating an image of the location using at least
the phase of the first signal and the phase of the second signal.
In one variation, step c) calculates the difference in the phase
between the first and second signals. In one modification, step c)
uses the calculated phase difference and uses one of the phases of
one of the first and second signals. In one implementation, step c)
calculates the sum of the one phase and a function of the
calculated phase difference. In one illustration of a first signal
phase of 6 degrees and a second signal phase of 7 degrees, step c)
calculates the phase difference, adds the difference to the second
signal phase creating a processed phase of 8 degrees, and creates
the image of the location using the processed phase. Other
algorithms for using the phase of the first and second signals to
enhance any phase difference in creating the image after medical
treatment are left to the artisan.
[0140] In an additional example of the twentieth method of the
invention, step c) includes creating an image of the location using
at least the amplitude and the phase of the first signal and the
amplitude and phase of the second signal. In one variation step c)
combines the discussions in the previous two paragraphs, as is
within the ordinary level of skill of the artisan.
[0141] In one application of the twentieth method and examples,
etc. thereof, the first signal of step a) has a first frequency
(e.g., a first center frequency having a sigma) and the second
signal of step b) has a second frequency (e.g., a second center
frequency having a sigma) which is different from the first
frequency (meaning, for example, that the center frequencies are
different). In the same or a different application, the medical
treatment is ultrasound medical treatment. In the same or a
different application, steps a) through c) are repeated for
different locations to image the patient tissue, wherein the image
of the patient tissue includes medically-treated locations and
medically-untreated locations. In one enablement of the twentieth
method of the invention, the image of the patient tissue is
visually displayed on a monitor. In another enablement, the image
remains as an image map in a computer without being displayed on a
monitor. In one extension of the twentieth method, additional
signals are obtained between steps a) and b) which are also used in
creating the image of the location in step c).
[0142] Applicants were the first to realize that changes in patient
tissue because of medical treatment of patient tissue, such as
ultrasound medical treatment, which affect the amplitude and/or
phase of ultrasound imaging signals can be used to enhance the
ultrasound image differences of medically-treated patient tissue
from surrounding untreated tissue. Applicants have theorized that
using different frequencies for the two signals can enhance
amplitude and/or phase differences for medically treated and
untreated tissue and can be used to enhance the ultrasound image
differences of medically-treated patient tissue from surrounding
untreated tissue. Advantages of the twentieth method and examples,
etc. thereof include, in one application, better ultrasound image
contrast between treated and untreated patient tissue providing
better monitoring during patient treatment.
[0143] Other medical treatments applicable to the twentieth method
include, without limitation, other thermal ablation techniques such
as radio-frequency, laser, and microwave medical treatments and
chemical ablation techniques such as ethanol and chemo-therapeutics
(including anti-cancer drugs). Other optional steps in the
twentieth method include using signal smoothing techniques, as are
known to those skilled in the art.
[0144] It is understood that any one or more of the
previously-described embodiments, expressions of embodiments,
examples, methods, etc. can be combined with any one or more of the
other previously-described embodiments, expressions of embodiments,
examples, methods, etc. For example, and without limitation, any of
the end effectors can be used in any of the methods, any of the
transducer arrangements can be used in any of the end effectors,
and any appropriate methods can be combined such as combining the
seventeenth and twentieth methods, etc.
[0145] The foregoing description of several expressions of
embodiments and methods of the invention has been presented for
purposes of illustration. It is not intended to be exhaustive or to
limit the invention to the precise forms and procedures disclosed,
and obviously many modifications and variations are possible in
light of the above teaching. For example, as would be apparent to
those skilled in the art, the disclosures herein of the ultrasonic
systems and methods have equal application in robotic assisted
surgery taking into account the obvious modifications of the
invention to be compatible with such a robotic system. It is
intended that the scope of the invention be defined by the claims
appended hereto.
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