U.S. patent application number 11/153923 was filed with the patent office on 2006-01-12 for apparatus for imaging and treating a breast.
This patent application is currently assigned to TechniScan, Inc.. Invention is credited to David Borup, Barry K. Hanover, Steven A. Johnson, David Robinson, James Wiskin.
Application Number | 20060009693 11/153923 |
Document ID | / |
Family ID | 37761949 |
Filed Date | 2006-01-12 |
United States Patent
Application |
20060009693 |
Kind Code |
A1 |
Hanover; Barry K. ; et
al. |
January 12, 2006 |
Apparatus for imaging and treating a breast
Abstract
A system for imaging and treating a breast of a patient includes
a table configured to receive the patient thereon, having an
aperture formed therein configured to receive the breast of the
patient pendent therethrough and positionable over a bath
configured to contain a medium. Means for transmitting and
receiving ultrasound signals is disposed in the bath. A frame is
disposable out of the bath, and includes means for securing the
breast to the frame to substantially maintain a position and a
shape of the breast out of the bath as in the bath.
Inventors: |
Hanover; Barry K.; (Park
City, UT) ; Johnson; Steven A.; (Salt Lake City,
UT) ; Robinson; David; (Park City, UT) ;
Wiskin; James; (Salt Lake City, UT) ; Borup;
David; (Salt Lake City, UT) |
Correspondence
Address: |
THORPE NORTH & WESTERN, LLP.
8180 SOUTH 700 EAST, SUITE 200
SANDY
UT
84070
US
|
Assignee: |
TechniScan, Inc.
|
Family ID: |
37761949 |
Appl. No.: |
11/153923 |
Filed: |
June 15, 2005 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
10821407 |
Apr 8, 2004 |
|
|
|
11153923 |
Jun 15, 2005 |
|
|
|
60580416 |
Jun 16, 2004 |
|
|
|
Current U.S.
Class: |
600/407 |
Current CPC
Class: |
A61B 2090/378 20160201;
A61B 5/418 20130101; A61B 8/406 20130101; A61B 8/0825 20130101;
A61B 2017/008 20130101; A61B 90/17 20160201; A61B 90/11 20160201;
A61B 5/415 20130101; A61B 5/4312 20130101 |
Class at
Publication: |
600/407 |
International
Class: |
A61B 5/05 20060101
A61B005/05 |
Claims
1. A system for imaging and treating a breast of a patient,
including: a) a table configured to receive the patient thereon,
having an aperture formed therein configured to receive the breast
of the patient pendent therethrough and positionable over a bath
configured to contain a medium; b) means for transmitting and
receiving ultrasound signals in the bath; c) a frame, disposable
out of the bath, including means for securing the breast to the
frame to substantially maintain a position and a shape of the
breast out of the bath as in the bath.
2. A system in accordance with claim 1, wherein the frame is
disposable in the bath and maintains the position and the shape of
the breast both in and out of the bath.
3. A system in accordance with claim 1, wherein the frame is
removably securable to an underside of the table.
4. A system in accordance with claim 1, wherein the means for
securing includes: a breast magnet securable to the breast; and a
frame magnet, secured to the frame, and engagable with the breast
magnet.
5. A system in accordance with claim 4, further comprising: a bath
magnet, disposed in the bath, and engagable with the breast magnet
when the breast is in the bath.
6. A system in accordance with claim 1, wherein the frame includes:
at least one post extending from the table; and a cross member
extending from the post.
7. A system in accordance with claim 6, wherein the frame includes:
a ring, rotatably connected to the table, and supporting the at
least one post extending therefrom.
8. A system in accordance with claim 6, wherein the frame includes:
a frame magnet, coupled to the cross member.
9. A system in accordance with claim 6, wherein the frame includes:
a laser indicator, coupled to the at least one post.
10. A system in accordance with claim 6, wherein the cross member
is movably coupled to the at least one post, and movable towards
and away from the table; and further including a scale disposed on
the at least one post.
11. A system in accordance with claim 1, further comprising a
navigation system linked to a three-dimensional image of the
breast.
12. A system in accordance with claim 11, wherein the navigation
system includes: an infrared marker on a biopsy device, a marker
placement device, a needle, a surgical instrument or a probe; and a
camera, capable of visually sensing the infrared markers.
13. A system in accordance with claim 11, wherein the navigation
system includes: transmitters or receivers on a biopsy device, a
marker placement device, a needle, a surgical instrument or a
probe.
14. A system in accordance with claim 1, further comprising a
biopsy device insertable into the breast to remove a tissue sample;
and a navigation system linked to the three-dimensional image
including: a) the biopsy device attached to the frame acting as a
stereotactic frame; b) a camera visually sensing an infrared marker
on the biopsy device; or c) a transmitter and receiver system
coupled to the biopsy device.
15. A system in accordance with claim 1, further comprising a
marker placement device insertable into the breast and capable of
inserting at least one marker; and a navigation system linked to
the three-dimensional image including: a) the marker placement
device attached to the frame acting as a stereotactic frame; b) a
camera visually sensing an infrared marker on the marker placement
device; or c) a transmitter and receiver system coupled to the
marker placement device.
16. A system in accordance with claim 1, further comprising a
surgical instrument to remove the tumor; and a navigation
system-linked to the three-dimensional image including: a) the
surgical instrument attached to the frame acting as a stereotactic
frame; b) a camera visually sensing an infrared marker on the
surgical instrument; or c) a transmitter and receiver system
coupled to the surgical instrument.
17. A system in accordance with claim 1, further comprising a
needle to inject a drug into the tumor; and a navigation system
linked to the three-dimensional image including: a) the needle
attached to the frame acting as a stereotactic frame; b) a camera
visually sensing an infrared marker on the needle; or c) a
transmitter and receiver system coupled to the needle.
18. A system in accordance with claim 1, further comprising a probe
with a hot tip or a cold tip insertable into the tumor; and a
navigation system linked to the three-dimensional image including:
a) the probe attached to the frame acting as a stereotactic frame;
b) a camera visually sensing an infrared marker on the probe; or c)
a transmitter and receiver system coupled to the probe.
19. A system in accordance with claim 1, further comprising: an
ultrasound emitter capable of producing ultrasound energy
directable to a tumor in the breast.
20. A system for imaging and treating a breast of a patient,
including: a) a bath configured to contain a medium; b) transducer
arrays, disposable in the bath, configured to transmit and receive
ultrasound signals; c) a table, disposable over the bath,
configured to receive the patient thereon, having an aperture
formed in the table and positionable over the bath configured to
receive the breast of the patient pendent therethrough; d) a frame,
disposable under and carryable by the table, the frame including:
i) at least one post extending from the table; ii) a cross member
extending from the post; and iii) a frame magnet, coupled to the
cross member, and engageable with a breast magnet securable to the
breast.
21. A system in accordance with claim 20, wherein cross member is
movably coupled to the at least one post, and movable towards and
away from the table; and further including a scale disposed on the
at least one post.
22. A system for imaging and treating a breast of a patient,
including: a) a bath configured to contain a medium; b) transducer
arrays, disposable in the bath, configured to transmit and receive
ultrasound signals to generate a three-dimensional image of at
least a portion of the breast; c) a table, disposable over the
bath, configured to receive the patient thereon, having an aperture
formed in the table and positionable over the bath configured to
receive the breast of the patient pendent therethrough; d) a frame,
disposable under and carryable by the table; e) means for securing
the breast to the frame to substantially maintain a position and a
shape of the breast out of the base as in the bath; and f) a
navigation system linked to the three-dimensional image of at least
a portion of the breast.
23. A system in accordance with claim 22, wherein the navigation
system includes: a) a stereotactic frame secured to the breast; b)
a camera visually sensing an infrared marker on a biopsy device, a
marker placing device, an ultrasound emitter, a needle, a probe or
a surgical instrument; or c) a transmitter and receiver system
coupled to a biopsy device, a marker placing device, an ultrasound
emitter, a needle, a probe or a surgical instrument.
Description
PRIORITY CLAIM
[0001] Priority of U.S. Provisional Patent Application Ser. No.
60/580,416, filed Jun. 16, 2004, is claimed, and which is herein
incorporated by reference. This application is a
continuation-in-part of U.S. patent application Ser. No.
10/821,407, filed Apr. 8, 2004, which is herein incorporated by
reference.
RELATED APPLICATION(S)
[0002] This application is related to U.S. patent application Ser.
No. ______, filed Jun. 15, 2005, as TNW docket no. 23473.NP,
entitled "Method for Imaging and Treating a Breast," which is
herein incorporated by reference.
BACKGROUND
[0003] 1. Field of the Invention
[0004] The present invention relates generally to a method for
maintaining the position and the shape of a patient's breast during
scanning and treatment, such as biopsy, therapy and/or surgery.
[0005] 2. Related Art
[0006] Other than skin cancer, breast cancer is the most common
cancer among women, and is the second leading cause of cancer death
in women, after lung cancer. According to the American Cancer
Society, about 215,990 women in the United States will be found to
have invasive breast cancer in 2004, and about 40,110 women will
die from the disease.
[0007] Approximately 44.5 million women in the United States are
screened for breast cancer each year with 10% or 4.5 million
referred for a second diagnostic test. The latest American Cancer
Society Breast Cancer Statistics report indicates that 1 in 7 women
will get breast cancer during her lifetime. The current standard of
care has significant problems, generating unacceptably high rates
of false positive tests--between 8% and 10%--and upwards of 15%
false negative tests. The result is that many women suffer from
unnecessary and invasive biopsies. In addition, each year the U.S.
healthcare system spends an estimated $2.1 billion on biopsies,
which yield negative results more than 75% of the time.
[0008] Breast cancer is a malignant tumor that has developed from
cells of the breast. A malignant tumor is a group of cancer cells
that may invade surrounding tissues or spread (metastasize) to
distant areas of the body. The female breast is made up mainly of
lobules (milk-producing glands), ducts (milk passages that connect
the lobules to the nipple), and stroma (fatty tissue and connective
tissue surrounding the ducts and lobules, blood vessels, and
lymphatic vessels). Lymphatic vessels are like veins, except that
they carry lymph instead of blood. Lymph is a clear fluid that
contains tissue waste products and immune system cells (cells that
are important in fighting infections). Lymph nodes are small
bean-shaped collections of immune system cells that are found along
lymphatic vessels. Cancer cells can enter lymphatic vessels and
spread to lymph nodes. Most lymphatic vessels in the breast connect
to lymph nodes under the arm (axillary lymph nodes). Some lymphatic
vessels connect to lymph nodes inside the chest (internal mammary
nodes) and either above or below the collarbone (supra- or
infraclavicular nodes). When breast cancer cells reach the axillary
(underarm) lymph nodes, they may continue to grow, often causing
the lymph nodes in that area to swell. If breast cancer cells have
spread to the underarm lymph nodes, they are more likely to have
spread to other organs of the body as well. Thus, it is important
to find out if breast cancer has spread to the axillary lymph nodes
when choosing a treatment.
[0009] Most breast lumps are not cancerous, that is, they are
benign. Most lumps turn out to be fibrocystic changes. The term
"fibrocystic" refers to fibrosis and cysts. Fibrosis is the
formation of fibrous (or scar-like) connective tissue, and cysts
are fluid-filled sacs. Fibrocystic changes can cause breast
swelling and pain. This often happens just before a period is about
to begin. The breast may feel nodular, or lumpy, and, sometimes, a
clear or slightly cloudy nipple discharge is noticed. Benign breast
tumors such as fibroadenomas or papillomas are abnormal growths,
but they are not cancer and cannot spread outside of the breast to
other organs. They are not life threatening.
[0010] Although widespread use of screening mammography has
increased the number of breast cancers found before they cause any
symptoms, some breast cancers are not found by mammography, either
because the test was not done or because even under ideal
conditions mammography cannot find every breast cancer. The most
common sign of breast cancer is a new lump or mass. A painless,
hard mass that has irregular edges is more likely to be cancerous,
but some rare cancers are tender, soft, and rounded. For this
reason, it is important that a health care professional who is
experienced in diagnosing breast diseases check any new breast mass
or lump.
[0011] Other signs of breast cancer include a generalized swelling
of part of a breast (even if no distinct lump is felt), skin
irritation or dimpling, nipple pain or retraction (turning inward),
redness or scaliness of the nipple or breast skin, or a discharge
other than breast milk. Sometimes a breast cancer can spread to
underarm lymph nodes even before the original tumor in the breast
tissue is large enough to be felt.
[0012] If there is any reason to suspect breast cancer, other tests
must be performed. After a complete physical exam (including a
clinical breast exam), doctors often recommend a diagnostic
mammogram or a breast ultrasound. A clinical breast examination
(CBE) is an exam of the breasts by a health professional, such as a
doctor, nurse practitioner, nurse, or physician assistant. The
examiner first looks at the breasts for changes in size or shape.
Then, using the pads of the finger tips, the breasts are felt for
lumps.
[0013] Although mammograms are mostly used for screening, they can
also be used to examine the breast of a woman who has a breast
problem. This can be a breast mass, nipple discharge, or an
abnormality that was found on a screening mammogram. In some cases,
special images known as cone views with magnification are used to
make a small area of altered breast tissue easier to evaluate. A
diagnostic mammogram may show that a lesion (area of abnormal
tissue) has a high likelihood of being benign (not cancer). In
these cases, it is common to ask the woman to come back sooner than
usual for a recheck, usually in 4 to 6 months. On the other hand, a
diagnostic mammogram may show that the abnormality is not worrisome
at all, and the woman can then return to having routine yearly
mammograms. Finally, the diagnostic work-up may suggest that a
biopsy is needed to tell if the lesion is cancer.
[0014] Ultrasound, also known as sonography, uses high-frequency
sound waves to outline a part of the body. High-frequency sound
waves are transmitted into the area of the body being studied and
echoed back. A computer or dedicated electronic circuitry picks up
the sound wave echoes and changes them into an image that is
displayed on a computer screen. Breast ultrasound is sometimes used
to evaluate breast abnormalities that are found during mammography
or a physical exam. One of the most common abnormalities that women
have is fibrocystic disease. Ultrasound is useful for detecting
fibrocystic disease. It is the easiest way to tell if a cyst is
present without placing a needle into it to draw out fluid. It can
also find some breast masses. Conventional medical ultrasound uses
a single ultrasound array to both transmit and receive echoes and
thereby measure the ultrasound reflectivity and distance of various
objects under the skin surface. It assumes that the speed of sound
is constant through the tissue being imaged. It has difficulty
imaging objects with low reflectivity or high absorption of sound.
It produces images which are two-dimensional, distorted, grainy,
and contain speckle. Foreground objects tend to mask deeper
structures.
[0015] A biopsy is done when mammograms, ultrasound, or the
physical examination finds a tumor. A biopsy is the only way to
tell if cancer is really present. All biopsy procedures remove a
tissue sample for examination under a microscope. There are several
types of biopsies, such as fine needle aspiration biopsy, core
(large needle) biopsy, and surgical biopsy. Each type of biopsy has
distinct advantages and disadvantages. The choice of which to use
will depend on the specific situation. Some of the factors the
doctor will consider include how suspicious the lesion appears, how
large it is, where in the breast it is located, how many lesions
are present, other medical problems the patient may have, and the
patient's personal preferences. Statistically, three of four
biopsies are benign.
[0016] In addition, high rates of recall are currently being
experienced in lumpectomy breast surgery. As many as 30-40% of
excisional breast biopsies must be repeated due to post-surgical
histological findings of malignant cells unacceptably close to the
margin of excised breast tissue. The subsequent surgery is
extremely costly as well as traumatic to the patient. Current
methods in widespread use for guiding the surgeon to the outer
margins of a malignant lesion are extremely crude and inaccurate.
These methods generally involve the placement of one or more barbed
wires under ultrasonic guidance or with no real-time guidance
followed by post-placement positional checking with x-rays. Often
the lesion cannot be clearly delineated from surrounding tissue and
the wire(s) can be anywhere within or near the lesion. The relative
position of the wire(s) is communicated verbally or in a report to
the surgeon who must translate this information into removal of the
malignant tissue while trying to preserve as much normal tissue as
possible. The difference in the shape of the breast during wire
placement and surgery can result in significant geometrical errors
that substantially contribute to "dirty" margins and repeat
surgeries.
[0017] One relatively new approach to improving surgery staging
involves using contrast-enhanced MRI subtraction imaging to
determine the location of malignant lesions in 3D. With the patient
remaining in the MRI breast retention system, multiple MRI-safe
wires are placed, with access to only the lateral side of each
breast, at the outer poles of the lesion to guide the surgeon. The
method has the benefit of more accurately defining the margins of
the lesion and translating that information to the surgeon through
the use of multiple wires that remain in position regardless of
breast distortion. The downside to such a procedure is the cost of
both the initial investment to purchase MRI equipment and,
subsequently, the necessity of upgrading that MRI system to enable
this procedure. In addition, the time required to image the patient
and place the wires routinely exceeds one hour. Notwithstanding
these potential barriers to use of MRI-guided wire placement, this
procedure is gaining acceptance and local hospitals are budgeting
to acquire the enabling MRI hardware and software upgrades at
significant cost.
[0018] In order to facilitate diagnosis of breast cancer and reduce
unnecessary biopsies, an improved and advanced tomography or
ultrasonic scanning technology has been developed, referred to as
Ultrasound CT.TM. by Techniscan Medical Systems of Salt Lake City,
Utah. In addition, the Ultrasound CT.TM. system is intended to
decrease the incidence of recall surgery due to inadequate margins.
Ultrasound CT.TM. is ultrasound computerized tomography, and is
intended to be used as an adjunct to mammography. The Ultrasound
CT.TM. technology generates information using transmission
ultrasound which produces two unique images: one of the speed of
sound and one of the attenuation (absorption of sound at a sub
millimeter resolution) throughout the breast. The underlying
proposition is that these unique measurements will correlate to
specific tissue properties. Radiologists then use the information
to distinguish breast cancer from benign tumors or normal
tissues.
[0019] Ultrasound CT.TM. produces a stack of tomography (2-D planar
slice) images, similar in appearance and spatial resolution to CT
or MR imaging methods, but at a much lower cost. These images are
produced using two different techniques--Ultrasound Reflective
Tomography (URT) and Ultrasound Inverse Scattering Tomography
(UIST). Compared with conventional projection mammography
Ultrasound CT.TM. images are more detailed, easier to read, and do
not use potentially harmful ionizing radiation. Unlike conventional
ultrasound, Ultrasound CT.TM. images completely penetrate and
sample the entire breast for uniform and better overall resolution.
These images are not dependent on the system operator for image
quality and consistency. For example, see U.S. Pat. Nos. 4,662,222;
5,339,282; 5,588,032; 6,005,916; 6,587,540; and 6,636,584.
[0020] Once Ultrasound CT.TM. has been utilized to identify breast
cancer, therapy and/or surgery can be utilized to neutralize or
remove the tumor. However, a further biopsy may be required.
Multiple testing or treatments, such as a mammogram, an Ultrasound
CT.TM. scan, a possible biopsy, and therapy or surgery, can be
stressful for the patient. In addition, the tumor or lesion needs
to be relocated at each interval.
SUMMARY OF THE INVENTION
[0021] It has been recognized that it would be advantageous to
develop a method to facilitate further treatment of the breast or
tumor after performing a scan or creating a tomography of the
breast. In addition, it has been recognized that it would be
advantageous to develop a method to facilitate biopsy, therapy
and/or surgery after an ultrasound computer topography scan. In
addition, it has been recognized that it would be advantageous to
develop a pre-biopsy, pre-therapy or pre-surgical staging method
that uses inverse scattering ultrasound technology to accurately
model in situ malignant breast legions in three-dimensions, and
coordinates placement of a biopsy device, marker placement device,
needle, probe, and/or surgical instrument.
[0022] The invention provides a system for imaging and treating a
breast of a patient, including a table configured to receive the
patient thereon, having an aperture formed therein configured to
receive the breast of the patient pendent therethrough and
positionable over a bath configured to contain a medium. Means for
transmitting and receiving ultrasound signals is disposed in the
bath. A frame is disposable out of the bath and includes means for
securing the breast to the frame to substantially maintain a
position and a shape of the breast out of the bath as in the bath.
Maintaining the position and the shape of the breast out of the
bath as in the bath allows for the tumor or lesion to be more
easily located for further treatment, and allows three-dimensional
image to be utilized to guide treatment instruments.
[0023] In accordance with a more detailed aspect of the present
invention, the frame can also be disposable in the bath and can
maintain the position and the shape of the breast both in and out
of the bath.
[0024] In accordance with a more detailed aspect of the present
invention, the frame can be removably securable to an underside of
the table.
[0025] In accordance with a more detailed aspect of the present
invention, the means for securing can include a breast magnet
securable to the breast, and a frame magnet secured to the frame
and engagable with the breast magnet. In addition, a bath magnet
can be disposed in the bath, and can engage the breast magnet when
the breast is in the bath.
[0026] In accordance with a more detailed aspect of the present
invention, the frame can include at least one post extending from
the table, and a cross member extending from the post. In addition,
a ring can be rotatably connected to the table, and can supporting
the at least one post extending therefrom. A frame magnet can be
coupled to the cross member. A laser indicator also can be coupled
to the post. Furthermore, the cross member can be movably coupled
to the at least one post, and movable towards and away from the
table. A scale can be disposed on the at least one post to position
the cross member.
[0027] In accordance with a more detailed aspect of the present
invention, the system can include a navigation system linked to a
three-dimensional image of the breast. In one aspect, the
navigation system can include an infrared marker on a biopsy
device, a marker placement device, a needle, a surgical instrument
or a probe; and a camera capable of visually sensing the infrared
markers. In another aspect, the navigation system can include
transmitters or receivers on a biopsy device, a marker placement
device, a needle, a surgical instrument or a probe.
[0028] In accordance with a more detailed aspect of the present
invention, the system can include a treatment device for performing
a biopsy, therapy and/or surgery. In one aspect, a biopsy device
can be insertable into the breast to remove a tissue sample. In
another aspect, a marker placement device can be insertable into
the breast and capable of inserting at least one marker. In another
aspect, a surgical instrument can be used to remove the tumor. In
another aspect, a needle can be used to inject a drug into the
tumor. In another aspect, a probe with a hot tip or a cold tip can
be insertable into the tumor. A navigation system can include the
frame attached to the biopsy device, the marker placement device,
the surgical instrument, the needle or the probe. In another
aspect, the navigation system can include a camera visually sensing
an infrared marker on the biopsy device, the marker placement
device, the surgical instrument, the needle or the probe. In
another aspect, the navigation system can include a transmitter and
receiver system coupled to the biopsy device, the marker placement
device, the surgical instrument, the needle or the probe.
BRIEF DESCRIPTION OF THE DRAWINGS
[0029] Additional features and advantages of the invention will be
apparent from the detailed description which follows, taken in
conjunction with the accompanying drawings, which together
illustrate, by way of example, features of the invention; and,
wherein:
[0030] FIG. 1a is a perspective view of a frame for maintaining a
position and a shape of a breast in accordance with an embodiment
of the present invention disposed on a scanning system;
[0031] FIG. 1b is a partial perspective view of the frame of FIG.
1;
[0032] FIG. 1c is a side view of the frame and scanning system of
FIG. 1h;
[0033] FIG. 1d is a partial side view of the frame of FIG. 1;
[0034] FIG. 2a is a side schematic view of the scanning system of
FIG. 1 with the breast physically secured and maintained in a
repeatable position and in a repeatable shape;
[0035] FIG. 2b is a side schematic view of the frame of FIG. 1 with
the breast maintained in the position and the shape as during
scanning;
[0036] FIG. 3a is a side view of the frame of FIG. 1 shown disposed
in a bath of the scanning system;
[0037] FIG. 3b is a top schematic view of the frame of FIG. 1;
[0038] FIG. 4a is a side view of the scanning system of FIG. 1 with
an electromechanical navigation system and a treatment instrument
in accordance with an aspect of the present invention;
[0039] FIGS. 4b and 4c are front views of a display of the
navigation system of FIG. 4a;
[0040] FIG. 5 is a side view of the scanning system of FIG. 1 with
a camera navigation system and a treatment instrument in accordance
with an aspect of the present invention;
[0041] FIG. 6a is a perspective view of the scanning system of FIG.
1 with an ultrasonic emitter in accordance with an aspect of the
present invention;
[0042] FIG. 6b is a partial perspective view of the frame with the
ultrasonic emitter of FIG. 6a;
[0043] FIG. 7a is a perspective view of the scanning system of FIG.
1 with a treatment instrument in accordance with an aspect of the
present invention;
[0044] FIG. 7b is a partial perspective view of the frame with the
treatment instrument of FIG. 7a;
[0045] FIG. 8a is a perspective view of the scanning system of FIG.
1;
[0046] FIG. 8b is a partial perspective view of the scanning system
of FIG. 8a;
[0047] FIG. 8c is a cross-sectional side view of the scanning
system of FIG. 8a with the table in a raised configuration;
[0048] FIG. 8d is a cross-sectional side view of the scanning
system of FIG. 8a with the table in a lowered configuration;
[0049] FIG. 9a is a perspective view of a bath of the scanning
system of FIG. 1; and
[0050] FIG. 9b is a cross-sectional side view of the bath of FIG.
9a.
DETAILED DESCRIPTION OF EXAMPLE EMBODIMENT(S)
[0051] Reference will now be made to the exemplary embodiments
illustrated in the drawings, and specific language will be used
herein to describe the same. It will nevertheless be understood
that no limitation of the scope of the invention is thereby
intended. Alterations and further modifications of the inventive
features illustrated herein, and additional applications of the
principles of the inventions as illustrated herein, which would
occur to one skilled in the relevant art and having possession of
this disclosure, are to be considered within the scope of the
invention.
[0052] The present invention includes a method for further treating
a tumor or a lesion of a breast while maintaining a position and a
shape of the breast with respect to the chest wall of the patient
as during scanning. Maintaining the position and the shape of the
breast during further treatment allows for the tumor or legion to
be more easily located, and allows three-dimensional image to be
utilized to guide treatment instruments. Scanning can include an
ultrasound computerized tomography, such as Ultrasound Reflective
Tomography (URT) and Ultrasound Inverse Scattering Tomography
(UIST). The further treatment can include biopsy; marker placement;
therapy and/or surgery. Therapy can include ultrasound ablation;
injecting a drug into the tumor; injecting an ultrasound activated
drug into the patient and directing ultrasound energy at the tumor
to activate the ultrasound activated drug; and/or thermally
treating the tumor by inserting a probe with a hot tip or a cold
tip into the tumor. Furthermore, biopsy, therapy and/or surgery can
be facilitated with a navigation system linked to a
three-dimensional image or model of the breast generated from the
scanning. The surgical navigation can utilize a sterotactic frame,
a camera, or electro-magnetical signals to coordinate the position
of a biopsy device, a marker placement device, a needle, a probe
and/or a surgical instrument with respect to the three-dimensional
image or model, and thus with respect to the breast and the
tumor.
[0053] Referring to FIGS. 1a-2b, a breast retention mechanism or
frame, indicated generally at 10, in accordance with the present
invention is shown for maintaining the position and the shape of
the breast as during scanning. The frame 10 can be part of a breast
scanning and/or imaging system 100 shown for imaging or scanning a
breast, as discussed in greater detail below. Generally, the system
100 includes a table 104 to receive a patient thereon and having an
aperture 108 formed therein and disposable over bath 112 of medium
so that the patient's breast 116 is pendent through the aperture
and received in the bath. Transducer arrays 120 and 124 are
disposed in the bath to transmit and receive ultrasound signals.
The breast can be physically secured and maintained in a repeatable
position and in a repeatable shape with respect to a chest wall of
the patient, as described below.
[0054] The frame 10 can be disposed under the table 104 and carried
by the table. The frame 10 can be removably attached to the table,
such as with snap attachments or magnets or the like. Thus, the
frame 10 can be secured to the table 104 when the table is elevated
and the breast is removed from the bath, as shown in FIGS. 1a and
1c. The frame can be attached to the table and around the breast,
and the breast can be secured to the frame. The frame can be
configured to maintain the same position and the same shape of the
breast as during scanning in the bath. Alternatively, the frame can
be disposed in the bath and can maintain the position and the shape
of the breast both in and out of the bath, as shown in FIGS. 3a and
3b.
[0055] A breast magnet 204 can be securable to the breast 116, such
as at the nipple with an adhesive or the like. The frame can
include a frame magnet 208 secured to the frame and engagable with
the breast magnet 204. The breast and frame magnets 204 and 208 are
an example of means for securing the breast to the frame. Other
means for securing the breast to the frame could be used, including
for example, snaps, a temporary adhesive, etc. While in the bath,
the breast can be secured to a structure within the bath, such as
with the breast magnet 204 engaging a bath magnet 210 secured on a
rod.
[0056] As described below, the relative position of the breast or
breast magnet 204 is determined while the breast is in the bath for
scanning. The frame 10 can position the frame magnet 208 so that
the frame and frame magnet maintain the breast in the same
configuration as in the bath during scanning. Thus, the frame
magnet 208 attached to the frame 10 can attach to the breast magnet
204 and position the nipple at the same relative position to the
chest wall as during scanning.
[0057] The frame 10 mounted to the table 104 can permit the breast
to remain in a known position for stereotaxic guided biopsy,
surgery or therapy, as discussed below. The frame 10 can be mounted
to the table 104, and the magnets 204 and 208 can immobilize the
breast.
[0058] The frame 10 can include one or more posts 212 extending
downwardly from the table, and a cross member 216 extending
horizontally between the posts. The frame magnet 208 can be
attached to the cross member 216. The cross member 216 can be
movably coupled to the posts 212 to vertically position the frame
magnet 208, and thus the breast magnet and breast. A scale 220 can
be disposed on the posts 212 to facilitate proper positioning of
the cross member, and thus the frame magnet. A ring 224 can be
rotatably connected to the table, and can support and suspend the
posts. The ring 224 can circumscribe the aperture 108 in the table.
In addition, the ring 224 can be coupled to the table by a bearing
228 so that the ring and the frame can rotate in order to position
the posts out of the way.
[0059] The frame 10 maintains the position and the shape of the
breast after scanning, such as with the table raised and the breast
elevated from the bath for treatment. Accurate placement of a
treatment instrument, indicated by 300, can be achieved while the
breast is constrained in the frame 10 attached to the underside of
the elevated tabletop. Orientation of the frame can be mechanical-
or laser-guided by computer-generated coordinates to provide the
radiologist with the correct orientation and entry point for the
treatment instrument. The depth for the treatment instrument can
also be provided by computer and controlled mechanically or
manually by the radiologist. Access to all sides of the breast is
provided, unlike the lateral-only access provided with the
MRI-based system. The position of treatment instrument could also
be checked using scanning in order to verify the position. The
treatment instrument 300 is shown generically in the figures and
represents a biopsy device, a marker placement device, a needle, a
probe or a surgical instrument.
[0060] In an alternative embodiment, as shown in FIGS. 3a and 3b,
the breast retention mechanism or frame can be used for maintaining
the position and the shape of the breast during both scanning in
the bath, and during treatment. Thus, the patient's breast can be
held or immobilized by securing the nipple or breast magnet 204 to
the patient's nipple or breast, inserting the breast through the
aperture 108 in the table 104, and magnetically coupling the nipple
or breast magnet 204 to the frame magnet 208 of the frame 10. The
patient's breast can be immobilized prior to insertion into the
bath, and with the table elevated. Another bearing can be inserted
between the magnets, or between the frame magnet and the frame. The
bearing 228 can allow the frame 10, or posts 212 and cross-member
216, to rotate about the breast, thus rotating out of interference
with the arrays during operation, and without twisting the
patient's breast. The frame 10 can be pivoted when abutted by the
arrays. Alternatively, magnets can be disposed between the frame
and arrays to resist interference between the two.
[0061] Alternatively, the breast retention mechanism or the frame
can be an extension of a rod movably disposed in the bath, and
capable of being elevated out of the bath. Alternatively, the frame
can be disposed on the rod.
[0062] Maintaining the position and the shape of the breast during
further treatment allows for the tumor or lesion to be more easily
located, and allows three-dimensional image to be utilized to guide
treatment instruments. The system 100 can include a navigation
system linked to a three-dimensional image or model of the breast.
Thus, the navigation system can aid in directing the treatment
instrument 300 for biopsy, marker placement, therapy and/or
surgery. The navigation system can track or sense the location and
orientation of the treatment instrument 300 with respect to the
three-dimensional image or model of the breast. In addition, the
navigation system can display the location and orientation of the
treatment instrument along with the three-dimensional image or
model (and the tumor), such as on a monitor 304 (FIG. 4b and 4c).
Such a display can be three-dimensional (FIG. 4b), or can include
two or more two-dimensional images (FIG. 4c).
[0063] The navigation system can use a mechanical reference, such
as the frame 10 as a stereotactic frame. Thus, the treatment
instrument 300 can be attached or coupled to the frame 10, as shown
in FIGS. 1a-d. Thus, the position of the treatment instrument 300
with respect to the breast and tumor is known because the position
of the frame with respect to the breast and tumor is known.
[0064] Referring to FIG. 4a, the navigation system can use an
electromagnetic signal system. For example, a transmitter 330 can
be attached to the system at a known location with respect to the
frame, and thus the breast and tumor, such as on a lower surface of
the table adjacent the frame. One or more receivers 334 can be
disposed on a treatment instrument 338. Thus, the receivers 334 can
receive or sense a signal from the transmitter to determine the
position of the treatment instrument 338 with respect to the
transmitter, and thus the breast and the tumor. In addition, one or
more reference receivers can be disposed on the breast, the table
or the frame to position the breast, table or frame. Furthermore,
the system can be calibrated by touching the treatment instrument
at known locations, such as the frame or other point.
Alternatively, one or more transmitters can be disposed on the
treatment instrument and a receiver can be disposed on the
table.
[0065] Referring to FIG. 5, the surgical navigation system can use
an infrared camera or the like. For example, a camera 350 can be
attached to the system at a known location with respect to the
frame, and thus the breast and tumor, such as on a lower surface of
the table adjacent the frame. One or more infrared markers or
"dots" 354 can be disposed on a treatment instrument 338. Thus, the
camera 350 can see or sense the dots 354 to determine the position
of the treatment instrument 338 with respect to the camera, and
thus the breast and the tumor. In addition, one or more reference
dots can be disposed on the breast, the table or the frame to
position the breast, table or frame. Furthermore, the system can be
calibrated by touching the treatment instrument at known locations,
such as the frame or breast magnet.
[0066] As described above, the further treatment can include
biopsy, marker placement, therapy or surgery, and the treatment
instrument 300 or 338 can be a biopsy device, a marker placement
device, a needle, a probe or a surgical instrument. The treatment
instrument can be a biopsy device that can be used to obtain a
tissue sample of the tumor. For example, a needle can be used to
obtain a tissue sample. The treatment instrument can be a marker
placement device that can be insertable into the breast and capable
of inserting at least one marker at the margins of the tumor. Such
markers can be wires, dye, or clips. For example, a needle can be
used to place markers. A syringe can be filled with a visible dye
that would be injected using stereotactic guidance in small "spots"
immediately prior to excisional surgery. This dye could also
contain components that would allow it to be imaged ultrasonically
in order to check the position of the "spots" by scanning as
described above.
[0067] Referring to FIGS. 6a and 6b, therapy can include ultrasound
ablation and the treatment instrument can be an ultrasound emitter
380 capable of producing ultrasound energy directable to a tumor in
the breast. The ultrasound emitter 380 can be coupled to the
ultrasound transducers 120 and 124, and can be operated in the
bath, using the medium to transmit the ultrasound energy to the
breast and the tumor. Alternatively, the ultrasound emitter can be
coupled to the frame. Alternatively, an ultrasound emitter can be
positioned against the breast while the breast is out of the bath
and table elevated (represented by 300 in FIGS. 1a-d).
[0068] Therapy can include a thermal probe with a hot tip or a cold
tip insertable into the breast. The thermal probe (represented by
300 in FIGS. 1a-d) can be coupled to the frame.
[0069] Referring to FIGS. 7a and 7b, the treatment instrument 300
can be disposed in, and operated in, the bath 112. Again, the
treatment instrument 300 represents a biopsy device, a marker
placement device, a needle, a probe or a surgical instrument.
[0070] A method for using the system 100 and the frame 10 described
above, and for imaging and treating a breast of a patient, includes
disposing the breast 116 into a bath 112 of medium. The patient can
be positioned on the table with the breast pendent through the
aperture 108 in the table. The breast 116 is physically secured and
maintained in a repeatable position and in a repeatable shape with
respect to a chest wall of the patient. For example, a breast
magnet 204 can be secured to the breast, and can engage a bath
magnet 210 disposed on a rod in the bath, as described below. The
breast is scanned with ultrasound signals from transducer arrays
120 and 124 to create a three-dimensional image or model of the
breast, and to locate a position of a tumor or a lesion in the
breast with respect to the three-dimensional image or model. The
tumor or lesion is further treated while maintaining the position
and the shape of the breast with respect to the chest wall of the
patient as during scanning. Maintaining the position and the shape
of the breast allows the image or model of the breast created from
ultrasonic scanning to correspond substantially to the actual
position and shape of the breast during treatment where the image
or model is used for guiding a treatment instrument. The patient
can be maintained on the table 104 with the breast pendent through
the aperture 108 while the tumor or the lesion is further
treated.
[0071] Maintaining the position and the shape of the breast can
include securing the breast 116 to the frame 10 suspended from the
table 104 supporting the patient. As described above, the breast
magnet 204 secured to the breast can engage the frame magnet 208 on
the frame.
[0072] It will be appreciated that further treating the breast can
be facilitated by removing the breast from the bath for the further
treatment. For example, the table 104 can be elevated, thus
elevating the breast from the bath. The position and the shape of
the breast can be substantially maintained with respect to the
chest wall of the patient out of the bath as in the bath during
scanning using the frame. The frame 10 can be suspended from the
table 104 after the breast is removed from the bath, and after the
table is elevated. Then the breast can be secured to the frame.
[0073] As stated above, a biopsy can be performed by inserting a
biopsy device (represented by 300 in FIGS. 1a-d) into the tumor or
lesion and removing a tissue sample. The biopsy device can be
guided by a navigation system linked to the three-dimensional image
or model of the breast. The navigation system can mechanically
linked to the image or model using the frame 10 as a stereotactic
frame. Alternatively, the navigation system can use an infrared
camera 350 (FIG. 5) visually sensing an infrared marker or dot on
the biopsy device (represented by 338 in FIG. 5). In addition, an
infrared reference marker can be disposed on the breast, the frame,
or the table. Alternatively, the navigation system can use an
electromagnetic transmitter and receiver system coupled to the
biopsy device (represented by 330 in FIG. 4a). In addition, the
transmitter and receiver system can be coupled to a reference on
the breast, the frame, or the table. Furthermore, one or more
markers can be inserted into the breast using the biopsy device to
mark a margin of the tumor to guide a surgeon during surgery to
remove the tumor.
[0074] As stated above, ultrasound ablation can be performed by
directing ultrasound energy at the tumor. An ultrasound emitter 380
(FIGS. 6a and 6b) can be coupled to the ultrasound transducers 120
and 124 and can be operable in the bath with the ultrasound energy
transmittable through the medium. The breast can be disposed back
into the bath of medium while substantially maintaining the
position and the shape of the breast with respect to the chest wall
of the patient as during scanning, prior to performing ultrasound
ablation, as shown in FIGS. 6a and 6b Thus, the breast magnet can
be reconnected to the bath magnet, as described below. In addition,
an ultrasound activated drug can be injected into the patient.
Ultrasound energy from the emitter can activate the drug, while
directing the ultrasound energy can limit activation to the tumor.
The ultrasound emitter can be directed using a navigation system as
described herein.
[0075] A drug, such as a chemotherapy drug, can be injected into
the tumor using a needle (represented by 300 in FIGS. 1a-d, or 338
in FIGS. 4a and 5). The needle can be coupled to the frame. In
addition, the needle can be guided by a navigation system as
described herein.
[0076] As stated above, the tumor can be thermally treated by
inserting a probe (represented by 300 in FIGS. 1a-d, or 338 in
FIGS. 4a and 5) with a hot tip or a cold tip into the tumor. The
probe can be coupled to the frame. In addition, the probe can be
guided by the navigation system as described herein.
[0077] As stated above, one or more markers can be inserted into
the breast to mark the margins of the tumor to guide a surgeon
during surgery to remove the tumor. The markers can be inserted by
a marker insertion device (represented by 300 in FIGS. 1a-d, or 338
in FIGS. 4a and 5), such as a needle. The markers can be wires,
dye, or clips.
[0078] As stated above, surgery can be performed to remove the
tumor using a surgical instrument (represented by 300 in FIGS.
1a-d, or 338 in FIGS. 4a and 5). The surgical instrument can be
guided by a navigation system linked to the three-dimensional image
or model of the breast. The navigation system can be mechanically
linked to the image or model using the frame 10 as a stereotactic
frame. Alternatively, the navigation system can use an infrared
camera 350 (FIG. 5) visually sensing an infrared marker or dot on
the surgical instrument (represented by 338 in FIG. 5). In
addition, an infrared reference marker can be disposed on the
breast, the frame, or the table. Alternatively, the navigation
system can use an electromagnetic transmitter and receiver system
coupled to the surgical instrument (represented by 330 in FIG. 4a).
In addition, the transmitter and receiver system can be coupled to
a reference on the breast, the frame, or the table.
[0079] Alternatively, the breast can remain in the bath during
further treatment, as shown in FIGS. 3a and 3b. A treatment
instrument 300 can operate in the bath.
[0080] The system can be a non-invasive, diagnostic tool to provide
detailed information about the physiology (i.e. bulk tissue
properties) and anatomy (i.e. physical architecture) of the breast.
The system can be used as an adjunct to mammography to aid
physicians in diagnosing breast cancer by providing information
about tissue properties that help to more clearly differentiate
normal or benign from malignant tissue in the breast. The system
can replace other diagnostic testing, such as diagnostic
mammograms, breast ultrasound, and other imaging technologies
currently used between a screening mammogram and a biopsy.
[0081] In general, the system 100 can use ultrasound inverse
scattering technology to produce a 3-D stack of tomography (2-D
planar slice) images (similar in appearance and spatial resolution
to CT or MR imaging methods). Direct 3-D imaging is a further
feature of the system 100. These images can be produced using two
different techniques, namely Ultrasound Reflective Tomography (URT)
and Ultrasound Inverse Scattering Tomography (UIST). Compared with
conventional projection mammography, URT images can be more
detailed, easier to read, and do not use potentially harmful
ionizing radiation. Unlike conventional ultrasound, ultrasound
images using inverse scattering technology completely penetrate and
sample the entire breast for uniformity and better overall
resolution. In addition, such images are quantitative
representations of ultrasound tissue properties, and therefore are
not dependent on the system operator for image quality and
consistency. The images can be reconstructed in three dimensions
providing an important visualization tool for diagnosis, biopsy and
surgery staging.
[0082] The system 100 can use two ultrasound arrays that rotate
around the breast, generating true 3-D images and diagnostic
information in a commercially viable timeframe, such as less than
20 minutes per exam. The breast can be disposed in a bath 112 of
medium, such as liquid, water or gel. The use of water will be
described throughout for illustrative purposes. The system 100 can
include two opposing ultrasound transducer arrays 120 and 124
movably disposed in the bath 112 to obtain both reflection and
transmission information used to generate images and diagnostic
information. The arrays 120 and 124 are mechanically designed to
rotate and move up and down generating a complete 3-D data set for
the area of interest or even for the entire breast. Ultrasound
pulses can be used for two imaging modalities: reflective and
transmissive. For reflective images, the system emits a pulse from
one array and receives the reflected energy back in the same array.
The array can emit a pulse at 20 positions (every 18 degrees)
around the breast. During the same rotation sequence, the
transmitting array can emit an ultrasound signal into and through
the breast at 180 different locations (every 2 degrees) around the
entire breast. The resulting waveforms are received by the opposing
array. This allows the system to simultaneously generate data for
both reflection and transmission sound properties of the breast.
Alternatively, the arrays can move and/or emit continuously. The
arrays 120 and 124 are one example of means for transmitting and
receiving ultrasound signals in the bath. Other means for
transmitting and receiving ultrasound signals in the bath include,
for example, ring arrays, a tank lined with arrays, etc.
[0083] The imaging system produces three separate images using two
different imaging techniques: 1) transmission information generates
images representing bulk tissue properties of speed of sound and
attenuation of sound at each point in the breast; and 2) data
generated from reflection information generates detailed reflective
tomographic images that are refraction corrected. These imaging
techniques are combined to effectively produce a three-dimensional
stack of "slices" of the breast. Data from the ultrasound source is
analyzed, and a quantitative map of tissue properties is rendered.
In the "transmission mode" the energy propagates through the breast
(or other soft tissue). In the "reflection mode", the energy
reflects back to the receivers. In both cases, the energy of the
acoustic wave is refracted and scattered from the tissue it
encounters. In this process multiple physical phenomena take place:
reflection, refraction, diffraction, and multiple scattering
events. These effects are generally ignored in present ultrasound,
which seriously degrades the image, therefore rendering it useful
only in differentiating architectural or structural properties
within the breast. In present ultrasound it is impossible to
acquire quantitative values at a level sufficient for diagnosis of
tissue characteristics using standard reflection ultrasound or
imaging.
[0084] Further details of inverse scattering technology and imaging
are disclosed in U.S. Pat. Nos. 4,662,222; 5,339,282; 6,005,916;
5,588,032; 6,587,540 and 6,636,584, which are herein incorporated
by reference in their entirety.
[0085] The transducer arrays 120 and 124 can be disposed in the
bath 112, and carried by an armature 424, also disposed in the bath
112. The armature 424 can include a u-shaped member disposed on a
vertical column that extends through a bottom of the bath. Each
vertical arm of the u-shaped member can carry one of the arrays.
The u-shaped member can be sized to position the arrays around the
breast. The arrays 120 and 124 can be rotatable around an axis of
rotation, and displaceable vertically. For example, the armature
can rotate around the vertical column, thus rotating the arrays. A
rotational motor can be coupled to the armature 424 to rotate the
armature. For example, the rotational motor can be a rotational
step motor coupled to the armature or vertical column by a belt. In
addition, a linear motor can be coupled to the armature to linearly
displace the armature, and thus the transducer arrays. For example,
the vertical column can be carried by a platform on a plurality of
rods. One of the rods can be threaded. The linear motor can engage
the threaded rod such that rotation of the motor can raise and
lower the platform, and thus the vertical column along with the
rotational motor. A rotational and/or sliding seal can be formed
between the bath and the armature, or vertical column, to seal the
bath where the armature or vertical column passes through the
bottom of the bath. In addition, one or more bearings or rotational
bearings can be disposed between the vertical column and the
platform to facilitate rotation and reduce frictional forces. Thus,
the platform can carry the armature and related motors to move the
armature.
[0086] The transducer arrays 120 and 124 can be off-set, or
non-concentric, with respect to an axis of rotation. The armature
424 can also be offset or non-concentric with respect to the axis
of rotation.
[0087] The transducer arrays 120 and 124 can send and receive
ultrasound signals at a plurality of elevational locations along
the breast, and at a plurality of rotational orientations around
the breast at each elevational location. The linear motor can move
(raise or lower) the transducer arrays sequentially through a
plurality of different elevational locations along the breast. The
rotational motor can sequentially move (or rotate) the transducer
arrays through a plurality of different angular orientations around
the breast at each elevational location. As described above, arrays
can emit a pulse at 20 positions (every 18 degrees) around the
breast. During the same rotation sequence, the transmitting array
can emit an ultrasound signal into and through the breast at 180
different locations (every 2 degrees) around the entire breast. The
resulting waveforms are received by the opposing array. The arrays
can then be moved to a different location along the breast and the
sequence repeated. Alternatively, the arrays can emit during a
continuous motion. Thus, the movement of the arrays and armature
can be discrete, or stepwise through discrete position, or
continuous.
[0088] In addition, the arrays 120 and 124 can be tilted, or
rotatable to have tilted orientation to allow imaging closer to the
chest wall. For example, the arrays can be angled or directed in an
upwardly angled direction so that the arrays emit upwardly at an
angle and receive downwardly at an angle.
[0089] Alternatively, transducers can be configured or arrayed
differently to have different movement, or even no movement. For
example, transducers can be vertically oriented along the length of
the breast, and can be rotated around the breast, without the need
to move the transducers vertically. Alternatively, transducers can
be horizontally oriented around the circumference of the breast,
and can be moved vertically along the length of the breast, without
the need to rotate the transducers. Furthermore, the transducers
can be disposed around the breast, and along the length of the
breast, so that the transducers do not have to be moved or
rotated.
[0090] The bath 112 can be cylindrical and transparent, or can have
a bath wall that is cylindrical and transparent. The bath can be
any desired shape, but cylindrical is believed to be the most
efficient because it matches or allows the rotational motion of the
arrays while minimizing volume. The transparent wall allows the
breast to be viewed during the scan, and allows a technician to
observe operation of the armature. Alternatively, the bath wall can
be opaque or translucent, and can have a window formed therein. The
bath can include one or more holes therein forming inlet and/or
outlet openings to allow fluid to enter and/or exit the bath. An
upper end of the bath can be open to receive the breast, as
described in greater detail below.
[0091] The bath 112 can be supported by or disposed on a base. The
base can include a framework and can contain various components of
the system, as described in greater detail below. A skin or skirt
can be disposed around the base, or portions thereof, to protect
and restrict access to the various components. The bath 112 can be
disposed at one end of the system or base to increase the viewing
angle or viewing perimeter. The base can include controls, such as
an emergency shut-off or stop button. In addition, the base can
include various input/output connections, such as for controls.
[0092] A horizontal table 104 can be disposable over the bath 112
and the base to receive the patient thereon. The table 104 can be
rigid, but can have a padded upper surface for patient comfort. The
table 104 can be supported or carried by the base. An aperture 108
can be formed in the table 104 and positionable over the bath 112.
In use, the patient's breast is received pendent through the
aperture, and into the bath. The aperture 108 can be located nearer
one end of the table. The end of the table with the aperture can be
broadly curved to circumscribe the bath and/or the aperture. The
curved end of the table facilitates access to the bath and/or
breast, and facilitates viewing the bath and/or breast.
[0093] The table 104 and the bath 112 can be linearly vertically
displaceable with respect to one another. For example, the table
104 can be movable upward and downward, away from and towards the
bath. The table 104 can have a lowered position, as shown in FIGS.
1b and 1d, and a raised position, as shown in FIGS. 1a and 1c. In
the lowered position, the table 104 is adjacent the bath to
position the breast within the bath. In the raised position, the
table 104 is spaced-above the bath to elevate the breast above the
bath. The raised position allows access to the breast by a
technician or physician. For example, a technician can center the
breast in the aperture, and/or draw the breast further through the
aperture.
[0094] One or more columns can support the table. For example, a
pair of columns can be disposed on each side of the base. One or
more motors can be coupled to the columns to raise and lower the
columns, and thus the table. The motors can be located within the
columns, and can be rotational motors providing relative rotational
movement between a threaded screw and a threaded nut to provide
linear motion. The column(s) and motor are one example of means for
maintaining the table in the raised position with the table
spaced-above the bath, and means for raising and lowering the
table.
[0095] The table can also be displaceable horizontally, as shown in
dashed lines, so that the aperture can be displaced away from the
bath to allow further access to the breast for additional
procedures, such as biopsies. For example, the table can be
linearly displaceable, such as longitudinally in a forward
direction. A linear slider can be disposed between the columns and
the table to allow the table to slide. As another example, the
table can be rotationally or pivotally disposed on the base. A
rotational bearing can be disposed between the columns and table to
allow the table to pivot or rotate.
[0096] As discussed above, the bath 112 contains a medium, such as
liquid or water. The liquid or water can have characteristics, such
as purity and the like, to facilitate transmission of the signals
from the arrays, or to resist interference with such transmission.
For example, the liquid or water can be purified, filtered,
de-ionized, degassed, etc. In addition, the liquid or water can
have known qualities, such as temperature, to facilitate data
calculations or conversions, and to provide patient comfort. For
example, the liquid or water can have a temperature similar to
normal body temperature (or approximately 30.degree. C.).
[0097] A breast retention assembly can be used to secure the breast
within the bath. For example, a pair of magnets, including a breast
magnet 204 attached to the breast and a bath magnet 210 (FIGS. 2a,
6a-7b and 9b) disposed in the bath, can be used to hold the breast.
The breast magnet 204 can have a breast connector to secure the
breast magnet to the breast of the patient. The breast connector
can use an adhesive similar to that used to secure other medical
sensors to the skin. The bath magnet and the breast magnet
magnetically couple when the table is in the lowered position. A
beveled cup can be associated with one of the breast or bath
magnets, such as the bath magnet, to center the breast and bath
magnets with respect to one another. The beveled cup can be plastic
and can mechanically center the magnets. The bath magnet 210 can be
movable within the bath, and can be vertically moved between a
raised and a lowered position. The raised position of the bath
magnet can correspond to the raised position of the table, and can
allow a technician to secure the bath and breast magnets prior to
lowering the table and immersing the breast in the bath. The bath
magnet 210 can be disposed on and carried by a rod 430 (FIGS. 2a,
6a-7b and 9b) vertically movable within the bath. The rod 430 can
extend through a hollow interior of the armature, or vertical
column thereof. A seal can be formed around the rod.
[0098] The rod 430 can be raised and lowered by a motor, such as a
stepper motor. The stepper motor can be rotational and can cause
relative rotation between a threaded rod and nut to raise and lower
the rod. The stepper motor can indicate the position of the rod to
control electronics, and thus the tip or nipple of the breast.
Similarly, the position of the table can be determined using the
motors. Thus, the length and position of the breast can be
determined. Alternatively, sensors can be used.
[0099] The magnets and/or rod are one example of means for securing
the breast within the bath. Other means for securing the breast
within the bath can include, for example, attaching a shaft, wire,
spring, weight, magnet, or the like at or near the nipple. As
another example, means for securing the breast within the bath can
include a retention device mounted to the table permitting the
ultrasound tank to be lowered out of the way (or the patient
raised) with the breast remaining in a known position for
stereotaxic guided biopsy or other medical procedures. The
retention device can include a frame rotatably mounted to the
table. The frame can include a ring circumscribing the hole and
rotatably coupled to the table by a bearing. A pair of posts can
extend downwardly from the ring to a cross-member can extend
between the posts. A magnetic coupling can include a frame magnet
pivotally coupled to the cross-member or brace by bearings, and a
nipple or breast magnet coupled to the patient's breast or nipple,
and magnetically coupled to the frame magnet. The bearings allow
the frame, or posts and cross-member to rotate about the breast,
thus rotating out of interference with the arrays during operation,
and without twisting the patient's breast. The frame can be pivoted
when abutted by the arrays. Alternatively, magnets can be disposed
between the brace and arrays to resist interference between the
two.
[0100] As another example, means for securing the breast within the
bath can include a special bra or other membrane could be could be
worn over the breast to help hold the breast in position. The bra
could include a device for attaching a shaft, wire, spring, weight
or magnet as described above. A membrane can be provided in the
shape of a cone to receive the breast therein. The membranes can
include a proximal, larger opening to receive the breast, and a
distal smaller opening through which suction can be applied to draw
the breast into and against the membrane. An ultrasound gel can be
disposed between the breast and the membrane for lubrication and
coupling.
[0101] A light source, such as a laser pointer, can project a light
beam (such as a fan beam) onto the breast at an area of interest.
The area of interest can be marked prior to immersing the breast
into the bath. The area of interest can be determined beforehand by
reference to breast examinations, mammograms, etc. The laser
pointer can be mounted to the armature, and be positioned at the
arrays. Thus, the armature and arrays can be raised or lowered
until the light beam from the laser pointer aligns with the mark on
the breast corresponding to the area of interest. This position can
be saved in the system as a center of the area of interest, and the
scan can begin and end at a predetermined distance above and below
the center of interest. It will be appreciated that the position of
the armature, and thus the arrays, can be determined from the
motors used to position the armature, or from other sensors.
[0102] In addition, a camera can be positioned to provide an image
of the breasts and arrays. The camera can be coupled to the system
and/or a display or control module associated with the system. The
camera can be mounted on the armature and positioned at the arrays.
A horizontal line, or cross-hair, can be provided on the display,
camera, or system to align the camera, and thus the arrays, with
the mark on the breast corresponding to the area of interest. The
camera can also include a light source, such as one or more
LEDs.
[0103] A method for preparing a breast of a patient for scanning
can include cleaning and drying a portion of the breast, such as
the nipple. The breast magnet 204 can be secured to the breast with
the breast connector 450 (FIG. 9b). In addition, an area of
interest can be identified and marked on the breast.
[0104] The patient can be positioned on the horizontal table 104.
The table can be initially positioned at the lowered position, and
raised after the patient is on the table. The table can then be
raised. Thus, the table can be initially raised to a higher
elevation and subsequently lowered to a lower position. The breast
can be disposed through the aperture 108 in the table. The gap
between the table and the bath in the raised position allows the
technician to center and pull the breast through the aperture. The
table 104 can be displaced linearly vertically towards the bath to
immerse the breast into the water.
[0105] After the breast is immersed in the bath, the breast is
secured within the bath. The rod 430 can be raised until the bath
magnet 210 docks with, or magnetically couples to, the breast
magnet 204. The beveled cup can assist in centering the magnets,
and thus the breast. In addition, the rod 430 and the bath magnet
210 can be lowered to pull on and exert a degree of tension to the
breast. Alternatively, the bath magnet can be coupled to the breast
magnet prior to the breast being immersed within the bath. Thus,
the table and rod can be lowered together into the bath. A length
of the breast can be determined based on the position of the rod
and the position of the table.
[0106] The arrays can be positioned so that a beam of light from
the laser pointer is projected onto the breast at the mark
corresponding to the area of interest to be scanned. The position
of the arrays can be determined by the system so that the system or
technician can determine what portion of the breast to scan. The
arrays can be raised or lowered a predetermined amount in order to
scan the entire area of interest. Similarly, arrays can be
positioned so that the cross-hairs associated with the camera align
with the mark.
[0107] The arrays 120 and 124 and the armature 424 can initially be
in a lowered position. The arrays and armature can be raised and
the breast scanned with ultrasound signals from the transducer
arrays. As described above, the arrays can send and receive
ultrasound signals at a plurality of elevational locations along
the breast, and at a plurality of rotational orientations around
the breast at each elevational location. Thus, the transducers can
be sequentially moved through a plurality of different elevational
locations along the breast. In addition, the transducers arrays can
be sequentially moved through a plurality of different angular
orientations around the breast at each elevational location.
[0108] While the forgoing examples are illustrative of the
principles of the present invention in one or more particular
applications, it will be apparent to those of ordinary skill in the
art that numerous modifications in form, usage and details of
implementation can be made without the exercise of inventive
faculty, and without departing from the principles and concepts of
the invention. Accordingly, it is not intended that the invention
be limited, except as by the claims set forth below.
* * * * *