U.S. patent application number 12/840880 was filed with the patent office on 2010-11-11 for methods and apparatus for performing procedures on target locations in the body.
This patent application is currently assigned to TRAXYZ MEDICAL, INC.. Invention is credited to Leslie Greengard, Matthew S. Kressy, Zachary S. Spigelman, Richard H. Theriault, Shekhar G. Wadekar, Steven B. Woolfson.
Application Number | 20100286509 12/840880 |
Document ID | / |
Family ID | 34826030 |
Filed Date | 2010-11-11 |
United States Patent
Application |
20100286509 |
Kind Code |
A1 |
Kressy; Matthew S. ; et
al. |
November 11, 2010 |
METHODS AND APPARATUS FOR PERFORMING PROCEDURES ON TARGET LOCATIONS
IN THE BODY
Abstract
A method of performing a medical procedure on target tissue
within the body includes immobilizing the target tissue with an
immobilization device, positioning an insertion tool (e.g., a
needle, a needle and marker wire, a needle gun, etc.) to be
inserted into the target tissue on the immobilization device based
on at least one reading of the target tissue, and inserting the
insertion tool into the target tissue. An immobilization device for
performing methods includes a frame assembly, a tissue
immobilization assembly coupled to the frame assembly, the tissue
immobilization assembly including a structure adapted to immobilize
tissue, and a needle assembly releasably connectable to the frame
assembly. The needle assembly includes a needle capable of being
inserted into the immobilized tissue.
Inventors: |
Kressy; Matthew S.;
(Wellesley, MA) ; Greengard; Leslie; (New York,
NY) ; Spigelman; Zachary S.; (Newton, MA) ;
Theriault; Richard H.; (Lincoln, MA) ; Wadekar;
Shekhar G.; (Westwood, MA) ; Woolfson; Steven B.;
(Boston, MA) |
Correspondence
Address: |
LANDO & ANASTASI, LLP
ONE MAIN STREET, SUITE 1100
CAMBRIDGE
MA
02142
US
|
Assignee: |
TRAXYZ MEDICAL, INC.
Needham
MA
|
Family ID: |
34826030 |
Appl. No.: |
12/840880 |
Filed: |
July 21, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
11041347 |
Jan 24, 2005 |
7787936 |
|
|
12840880 |
|
|
|
|
60539023 |
Jan 23, 2004 |
|
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Current U.S.
Class: |
600/427 |
Current CPC
Class: |
A61B 6/502 20130101;
A61B 17/3403 20130101; A61B 90/39 20160201; A61B 90/11 20160201;
A61B 6/4423 20130101; A61B 90/17 20160201; A61B 6/0414 20130101;
A61B 90/10 20160201 |
Class at
Publication: |
600/427 |
International
Class: |
A61B 5/05 20060101
A61B005/05 |
Claims
1. A method of performing a medical procedure on target tissue
within the body, the method comprising: immobilizing the target
tissue with an immobilization device; positioning an insertion tool
to be inserted into the target tissue on the immobilization device
based on at least one reading of the target tissue; and inserting
the insertion tool into the target tissue.
2. The method of claim 1, further comprising taking at least one
reading of a location of target tissue, which comprises taking a
first mammography reading.
3. The method of claim 2, wherein taking at least one reading of a
location of target tissue comprises taking a second mammography
reading.
4. The method of claim 3, further comprising plotting the first and
second mammography readings on an image grid, wherein a first
distance from a known reference point on the immobilization device
is determined from indicia on the image grid to position the
needle.
5. The method of claim 4, further comprising correcting for at
least one anomaly created by the first and second mammography
readings.
6. The method of claim 4, wherein the plotting of the first and
second mammography readings on the image grid is generated by a
PDA.
7. The method of claim 1, further comprising performing a medical
procedure on the target tissue.
8. The method of claim 7, wherein performing a medical procedure is
selected from a group comprising one of the following: needle
localization; needle aspiration; vacuum-assisted biopsy; virtual
guided breast surgery; open surgical biopsy; in-office biopsy;
sentinel node biopsy; and imaging correlation and implantation.
9. The method of claim 8, wherein the immobilization device is
attached to a unit to perform the medical procedure.
10. The method of claim 1, further comprising placing a marker wire
within the needle to mark the target tissue.
11. The method of claim 1, further comprising adjusting the
immobilization device to compress tissue surrounding the target
tissue.
12. The method of claim 1, further comprising performing at least
one diagnostic procedure to obtain the at least one reading of the
target tissue.
13. The method of claim 12, wherein the immobilization device is
attached to a mammography unit to take the at least one
reading.
14. The method of claim 1, further comprising determining a length
of a needle to be inserted into the target tissue.
15-27. (canceled)
28. A method for performing a medical procedure on target tissue,
the method comprising: immobilizing the target tissue; performing a
diagnostic procedure on the immobilized target tissue; and
performing a medical procedure on the immobilized target
tissue.
29. The method of claim 28, wherein performing a medical procedure
is selected from a group comprising one of the following: needle
localization; needle aspiration; vacuum-assisted biopsy; virtual
guided breast surgery; open surgical biopsy; in-office biopsy;
sentinel node biopsy; and therapeutic imaging correlation and
implantation.
30. The method of claim 29, wherein immobilizing the target tissue
comprises affixing an immobilization device to tissue surrounding
the target tissue, and adjusting the immobilization device to
compress the tissue surrounding the target tissue.
31. The method of claim 28, wherein performing a diagnostic
procedure comprises performing a scan of the target tissue.
32. The method of claim 31, wherein performing a scan of the target
tissue comprises taking at least one image of the target
tissue.
33. The method of claim 32, further comprising determining a
position of the target tissue based the at least one image of the
target tissue.
34. The method of claim 33, further comprising calculating a
location of the target tissue with respect to a known reference
point.
35. The method of claim 34, further comprising plotting the
location on an image grid.
36. The method of claim 28, wherein performing a medical procedure
comprises inserting a needle into the target tissue.
37. The method of claim 36, wherein inserting a needle into the
target tissue comprises determining a needle entry direction, a
needle entry location, and a depth of needle penetration.
38. The method of claim 37, further comprising placing a marker
wire within the target tissue.
39-48. (canceled)
49. A method of performing a procedure on an area of interest in a
breast, the method comprising steps of: placing an immobilization
device on the breast; taking a first image of the tissue in the
immobilization device from a first direction; taking a second image
of the tissue in the immobilization device from a second direction
at an angle different from the first direction; and removing the
immobilization device.
50. The method of claim 49, further comprising a step of:
performing a medical procedure on the breast, before the step of
removing the immobilization device.
51. The method of claim 49, further comprising a step of:
compressing the tissue of the breast in the immobilization
device.
52. The method of claim 49, further comprising a step of attaching
the immobilization device to an imaging unit.
Description
BACKGROUND OF INVENTION
[0001] 1. Field of Invention
[0002] The inventions described in this disclosure relate generally
to apparatus and methods for performing medical procedures and,
more particularly, to apparatus techniques for immobilizing tissue
or providing frame of reference for performance of medical
procedures.
[0003] 2. Discussion of Related Art
[0004] The inventions described in this application relate
generally to medical imaging and sensing of anatomical features,
procedures performed in connection with that imaging and sensing,
and the tools used for the procedures and sensing. The inventions
will be described in the context of medical imaging for surgical
procedures to be performed on soft tissue which is susceptible to
movement during a procedure, such as a woman's breast, and more
particularly related to marker placement (such as needle
localization of implanting or injecting a marker), biopsies and
open surgical removal of a suspected cancerous lesion within a
breast. While certain aspects of the present inventions are
uniquely well-suited to one or more of these applications, this is
not intended to be limiting with respect to all aspects of the
inventions described herein.
[0005] Mammography is presently the primary method for screening
for breast cancer. The primary role of mammography is to screen
asymptomatic women in order to detect breast cancer at an earlier
stage than would occur with only self-examination and/or clinical
breast examination. Detection at an earlier stage of the disease
has been shown to reduce or delay mortality from breast cancer.
[0006] Mammography uses X-rays to create an image of the interior
of the breast. Mammography typically requires careful positioning
of the patient by a highly skilled technician trained in
mammographic technique. Optimum results depend on pulling and
squeezing of the breast during the mammogram, which can be painful.
Accurate results are also highly dependent on interpretation of
films by a radiologist.
[0007] When a patient is screened by mammography, a "suspicious
mass" or lesion that is non-palpable (cannot be felt by touch) and
not visible to the naked eye is often identified. In these cases,
it must be determined whether the lesion is cancerous. This often
requires that the lesion or a piece of the lesion be removed for
further investigation. To do this, of course, there must be some
way that a surgeon can find the lesion in the breast (referred to
as "tumor localization" and also as "lesion localization").
[0008] A biopsy is a procedure for removing a portion of the lesion
for the purpose of determining whether the lesion is malignant.
There are at least three methods of biopsy: open surgical biopsy,
core needle biopsy and fine needle (aspiration) biopsy.
[0009] For open surgical biopsy, lesion location can be established
through a procedure called pre-operative needle localization.
Needle localization begins when a specially trained technician puts
the breast into a specialized mammography fixture. Several views of
the breast are taken using standard mammography to determine the
approximate location of the "suspicious mass."
[0010] To locate a lesion, frequently, the breast is squeezed
between plates horizontally and one image is taken. The plates are
removed and repositioned so that the breast is squeezed vertically
and another image is taken and the plates removed again. In
addition, multiple images may be taken until the lesion is located.
A trained specialist then uses the two (or more) two-dimensional
images to estimate where the lesion may be located in
three-dimensional space.
[0011] A needle is then placed into the breast at the estimated
lesion location. The placement of the needle is verified through
mammography, again using two or more two-dimensional images. Needle
insertion and verification may be repeated until the placement is
deemed appropriate by a radiologist. A small wire with a J hook is
then placed through the core of the needle. Alternatively, the wire
may be pre-loaded in the needle. The needle may be removed and the
wire remains. Otherwise, the wire remains in the needle. At this
point, the needle localization procedure is complete. The patient
is then moved to a surgical setting. During surgery, the wire is
used as a guide for the surgeon to cut to the "suspicious mass."
When the surgeon reaches the area where the wire terminates, a
tissue sample is taken. The sample is verified to be that of the
identified "suspicious mass" by comparing a mammogram of the tissue
sample with that of the original mammography.
[0012] In practice, depending on breast size, however, there is
often as much as a 1/2 inch movement of the wire before or during
the procedure. Accordingly, the sample tissue may not have come
from the "suspicious mass." In those cases, the surgeon may search
around the wire termination point and repeat the sample and
verification procedure until a match is found. The wire can drift
away from its original position in response to motion of the
breast. The extent of wire drift may increase as the length of time
between localization and surgery increases and as the breast moves.
Mammography is used repeatedly in many aspects of breast cancer
screening and diagnosis. For example, a dozen mammographic X-rays
may be required in support of a single open surgical biopsy.
[0013] In core biopsy procedures, a tool is positioned within the
breast. The breast is then imaged to determine location of the tool
with respect to the lesion. The tool may then be repositioned to
more closely target the lesion. This process can be cumbersome and
require multiple images of the breast.
[0014] In many cases, where the lesion is determined to be
cancerous, the lesion must be surgically removed. When the breast
is to be largely preserved and only the lesion removed, the
procedure is called a lumpectomy. A lumpectomy sometimes requires
needle localization as described above. Instead of taking a piece
of the "suspicious mass" for analysis, however, the entire mass is
surgically removed.
[0015] Because the wire may move during or before the procedure due
to compression and/or re-compression of the tissue, the biopsy and
excision procedures often target the suspicious mass inaccurately.
As a result, the procedures may be lengthier than would otherwise
be required, occasionally unsuccessful due to failure to accurately
localize the lesion, and may result in the unnecessary removal of
healthy tissue from the breast. Some (but not all) embodiments of
the present invention address one or more of these issues as well
as having other advantages that would be apparent to one of
ordinary skill in the art based on the disclosure provided
herein.
SUMMARY OF INVENTION
[0016] One aspect of the invention is directed to a method of
performing a medical procedure on target tissue within the body,
the method comprising: immobilizing the target tissue with an
immobilization device; positioning an insertion tool (e.g., a
needle, a needle and marker wire, a needle gun, etc.) to be
inserted into the target tissue on the immobilization device based
on at least one reading of the target tissue; and inserting the
insertion tool into the target tissue.
[0017] In embodiments of the invention, the method further
comprises taking at least one reading of a location of target
tissue, and particularly, comprises taking a first mammography
reading. The step of taking at least one reading of a location of
target tissue comprises taking a second mammography reading. The
method further comprises plotting the first and second mammography
readings on an image grid, wherein a first distance from a known
reference point on the immobilization device is determined from
indicia on the image grid to position the needle, and correcting
for at least one anomaly created by the first and second
mammography readings. The plotting of the first and second
mammography readings on the image grid may be generated by a PDA.
The method further comprises performing a medical procedure on the
target tissue, wherein the step of performing a medical procedure
is selected from a group comprising one of the following: needle
localization; needle aspiration; vacuum-assisted biopsy; virtual
guided breast surgery; open surgical biopsy; in-office biopsy;
sentinel node biopsy; and imaging correlation and implantation. The
immobilization device may be attached to a unit to perform the
medical procedure. The method further comprises placing a marker
wire within the needle to mark the target tissue. The method
further comprises adjusting the immobilization device to compress
tissue surrounding the target tissue. The method further comprises
performing at least one diagnostic procedure to obtain the at least
one reading of the target tissue. The immobilization device may be
attached to a mammography unit to take the at least one reading.
The method further comprises determining a length of a needle to be
inserted into the target tissue.
[0018] In another aspect of the invention, an immobilization device
comprises a frame assembly, a tissue immobilization assembly
coupled to the frame assembly, the tissue immobilization assembly
including a structure adapted to immobilize tissue, and a needle
assembly releasably connectable to the frame assembly. The needle
assembly includes a needle adapted to be inserted into the
immobilized tissue.
[0019] In embodiments of the invention, the frame assembly includes
a frame member constructed and arranged to mount the immobilization
assembly thereon. Specifically, the frame assembly further includes
a seat configured to receive and secure the tissue immobilization
assembly, the seat being adjustably secured to the frame member to
adjust the position of the immobilization assembly with respect to
the frame assembly. The frame assembly further includes at least
one rod secured to the seat and adjustably secured to the frame
member. The structure of the immobilization assembly comprises a
bottom wall and two side walls formed with the bottom wall, the
bottom and side walls being sized to receive the tissue to be
immobilized, and a top wall slidably connected to the side walls.
The immobilization device further comprises means for securing the
top wall in place with respect to the side wall. Particularly, the
means for securing the top wall in place with respect to the side
wall comprises a serrated area formed on the top wall adapted to
mate with a serrated are formed on at least one of the side walls.
Each side wall has at least one slot formed therein.
[0020] The slot is adapted to receive a positioning detent, which
is formed along an edge of the top wall. The top wall is secured in
place by at least one inverted U-shaped member, the at least one
inverted U-shaped member being positioned adjacent a side wall and
formed with the top wall. An outwardly facing surface of the at
least one inverted U-shaped member has the serrated area adapted to
mate with the serrated area formed on the respective inner facing
surface of its respective side wall to secure the top wall in place
with respect to the side wall. The needle assembly comprises a
needle holder capable of being secured to the frame assembly. The
needle holder includes an outer sleeve having a clamping assembly
formed therewith adapted to be releasably clamped to the frame
assembly. The needle holder further includes a tubular member and a
needle portion adapted to be axially received within the outer
sleeve.
[0021] In yet another aspect of the invention, a method for
performing a medical procedure on target tissue comprises:
immobilizing the target tissue; performing a diagnostic procedure
on the immobilized target tissue; and performing a medical
procedure on the immobilized target tissue.
[0022] In embodiments of the invention, the step of performing a
medical procedure is selected from a group comprising one of the
following: needle localization; needle aspiration; vacuum-assisted
biopsy; virtual guided breast surgery; open surgical biopsy;
in-office biopsy; sentinel node biopsy; and therapeutic imaging
correlation and implantation. The step of immobilizing the target
tissue comprises affixing an immobilization device to tissue
surrounding the target tissue, and adjusting the immobilization
device to compress the tissue surrounding the target tissue. The
step of performing a diagnostic procedure comprises performing a
scan of the target tissue. The step of performing a scan of the
target tissue comprises taking at least one image of the target
tissue. The method further comprises determining a position of the
target to tissue based the at least one image of the target tissue.
The method further comprises calculating a location of the target
tissue with respect to a known reference point. The method further
comprises plotting the location on an image grid. The step of
performing a medical procedure comprises inserting a needle into
the target tissue, wherein inserting a needle into the target
tissue comprises determining a needle entry direction, a needle
entry location, and a depth of needle penetration. The method
further comprises placing a marker wire within the target
tissue.
[0023] In another aspect, a frame assembly, capable of supporting
an immobilization assembly and further adapted to be attached to a
device, comprises a frame member adapted to be attached to the
device, and a seat, coupled to the frame assembly. The seat is
adjustably secured to the frame member to adjust the position of
the immobilization assembly with respect to the frame assembly. The
frame assembly further includes at least one rod secured to the
seat and adjustably secured to the frame member.
[0024] Another aspect of the invention is directed to an
immobilization assembly for immobilizing tissue upon which a
medical procedure is to be applied. The immobilization assembly
comprises a bottom wall and two side walls formed with the bottom
wall, the bottom and side walls being sized to receive the tissue
to be immobilized, and a top wall slidably connected to the side
walls.
[0025] In embodiments of the invention, each side wall has at least
one slot formed therein, each slot being adapted to receive a
positioning detent, which is integrally formed along an edge of the
top wall. The top wall is secured in place by two inverted U-shaped
members, each member being positioned adjacent a respective side
wall and integrally formed with the top wall. An outwardly facing
surface of each inverted U-shaped member has a serrated area
adapted to mate with a serrated area formed on the respective inner
facing surface of its respective side wall to secure the top wall
in place with respect to the side walls. In another embodiment, the
serrated area is formed on the top wall adapted to mate with a
serrated are formed on at least one of the side walls to secure the
top wall in place with respect to the side walls.
[0026] A further aspect of the invention is directed to a needle
assembly adapted to be attached to an immobilization device, the
needle assembly comprising a needle holder including an to outer
sleeve having a clamping assembly formed therewith adapted to be
releasably clamped to a frame assembly of the immobilization
device, and a tubular member and a needle portion adapted to be
axially received within the outer sleeve.
[0027] In embodiments of the invention, the outer sleeve of the
needle holder includes a crease, the crease enabling the needle
holder to be flexed apart to remove the needle holder from the
tubular member and the needle portion without removing the needle
portion from the tissue.
[0028] Another aspect of the invention is directed to a kit for use
in a medical procedure on tissue. The kit comprises an
immobilization assembly, and a needle assembly comprising a needle
holder including an outer sleeve having a clamping assembly formed
therewith adapted to be releasably clamped to a frame assembly of
the immobilization device, and a tubular member and a needle
portion adapted to be axially received within the outer sleeve.
[0029] A further aspect of the invention is directed to a method of
performing a procedure on an area of interest in a breast. The
method comprises steps of: placing an immobilization device on the
breast; taking a first image of the tissue in the immobilization
device from a first direction; taking a second image of the tissue
in the immobilization device from a second direction at an angle
different from the first direction; and removing the immobilization
device.
[0030] In embodiments of the invention, the method further
comprises a step of performing a medical procedure on the breast,
before the step of removing the immobilization device. The method
further comprises a step of compressing the tissue of the breast in
the immobilization device. The method further comprises a step of
attaching the immobilization device to an imaging unit.
BRIEF DESCRIPTION OF DRAWINGS
[0031] The accompanying drawings are not intended to be drawn to
scale. In the drawings, each identical or nearly identical
component that is illustrated in various figures is represented by
a like numeral. For purposes of clarity, not every component may be
labeled in every drawing. In the drawings:
[0032] FIG. 1 is one embodiment of a method of performing a
diagnostic procedure on soft tissue.
[0033] FIG. 2 is one embodiment of a tissue immobilization device
and, more specifically, a breast immobilization device.
[0034] FIG. 3 is one embodiment of a breast immobilization device
including a harness.
[0035] FIG. 4 is one embodiment of a method for performing a
medical procedure using an immobilization device.
[0036] FIG. 5 is one embodiment of a method of performing a medical
procedure with respect to a reference frame, such as that provided
by an immobilization device.
[0037] FIG. 6 is one embodiment of a method using an automated
system to assist in locating an area of interest (such as a lesion)
in a patient.
[0038] FIG. 7 is one embodiment of a method for performing a
medical procedure using an immobilization device.
[0039] FIG. 8 is a perspective view of another embodiment of a
tissue immobilization device.
[0040] FIG. 8A is a perspective view of the tissue immobilization
device shown in FIG. 8 attached to a mammography machine.
[0041] FIG. 8B is a perspective view similar to FIG. 8A taken from
a different perspective.
[0042] FIG. 9 is a perspective view of a frame assembly of the
device illustrated in FIG. 8.
[0043] FIG. 10 is a perspective view of an immobilization assembly
of the device illustrated in FIG. 8.
[0044] FIG. 11 is a perspective view of a needle assembly of the
device illustrated in FIG. 8.
[0045] FIG. 12 is an embodiment of a method of calculating
reference points for positioning a needle assembly.
[0046] FIG. 12A is an embodiment of a method of performing a
medical procedure on soft tissue, using the embodiment of FIG.
8.
[0047] FIG. 12B is a view showing a PDA.
[0048] FIG. 13 is a view showing an image grid of an embodiment of
the present inventions.
[0049] FIG. 13A is a view showing the image grid of FIG. 13 with a
first reading plotted on the image grid.
[0050] FIG. 13B is a view of a coordinate system illustrating an
image taken by two image sources.
[0051] FIG. 14 is a view showing one embodiment of a step of
determining a needle length.
[0052] FIG. 15 is a view showing one embodiment of a step of
determining a posterior-anterior distance of a needle from a
reference point.
[0053] FIG. 16 is a view showing one embodiment of a step of
determining a needle entry direction.
[0054] FIG. 17 is a view showing one embodiment of a step of
determining a medio-lateral distance of a needle from a reference
point.
[0055] FIG. 18 is a view showing one embodiment of a step of
determining a depth of needle penetration.
[0056] FIG. 19 is a view showing one embodiment of a step of
inserting a needle to a correct depth.
[0057] FIG. 20 is a schematic view of an immobilization assembly of
another embodiment.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0058] This invention is not limited in its application to the
details of construction and the arrangement of components set forth
in the following description or illustrated in the drawings. The
invention is capable of other embodiments and of being practiced or
of being carried out in various ways. Also, the phraseology and
terminology used herein is for the purpose of description and
should not be regarded as limiting. The use of "including,"
"comprising," "having," "containing," or "involving", and
variations thereof herein, is meant to encompass the items listed
thereafter and equivalents thereof as well as additional items.
[0059] In one aspect of the inventions, improvements are made to
procedures for examining lesions within a breast. Application of
the inventions, however, is not limited to this context in every
aspect of the inventions. Various features of the inventions may be
applied to sensing or imaging or immobilizing any soft organ or
tissue, imaging hard features, and imaging external as well as
internal features. Certain embodiments of the invention are
particularly well suited for imaging a portion of the body that is
composed primarily of soft tissue, where the soft tissue can move
or change shape during the procedure (such as a lesion within a
breast moving in response to movement of the skin of the breast or
when the shape of the breast is changed through manipulation).
While the detailed description presents the invention in the
context of procedures for examination or removal of a lesion within
a breast, this is not intended as limiting for all embodiments.
[0060] While the inventions are also described with reference to
examples using X-ray localization of tumors, this is not intended
as limiting. MRI technology, PET, computer tomography, ultrasound,
"real-time" ultrasound and other diagnostic internal imaging
techniques may be used in the context of breast cancer diagnosis
and treatment as well as in other applications.
[0061] FIG. 1 is an illustration of one embodiment of using certain
aspects of the present invention. At step 11, the tissue being
examined (for example, a breast) is immobilized. In certain
embodiments, this may be done using the apparatus and procedures
described below.
[0062] At step 14, the diagnostic procedure is performed with
reference to the immobilized tissue. For example, a breast may be
immobilized at step 11 and then scanning procedures may be
performed to detect a lesion within the breast. In one embodiment,
the taking of two X-rays, at different, multiple (e.g., orthogonal)
angles is performed.
[0063] In many instances, in the prior art, the taking of these
X-rays at different angles is done with reference to soft tissue
that has been manipulated between the images. For example, plates
may be oriented horizontally and used to flatten the breast for one
image and then re-oriented vertically to squeeze the breast in the
opposite direction for a second image. The order of the images
(e.g., horizontal then vertical) may be changed for some
embodiments and is not intended as limiting; simultaneous imaging
is also possible in some embodiments. Indeed, one or more images
may be taken on a diagonal and the images may (but do not have to)
be from orthogonal angles.
[0064] According to certain aspects of the present invention, the
diagnostic is performed with reference to immobilized tissue. Thus,
where more than one image is taken of the immobilized tissue, that
tissue is kept as free from movement as is practical for each of
the two images. In certain embodiments, this reduces or eliminates
the amount of movement of the lesion within the breast between
images, permitting in some cases a more accurate estimation of
where a lesion is by maintaining the lesion as close as practical
to the same position for each of the two to images. In other
embodiments, an immobilization device is used to control movement
between images, such as when a breast is compressed more along one
axis for a first image and compressed on a different axis for a
second image. By more precisely controlling movement between
images, any movement of the lesion may be controlled and/or better
accounted for.
[0065] At step 16, the medical procedure is performed. As described
above, while this example includes biopsies performed with respect
to a lesion within a breast, many of the present inventions are
suitable for other medical procedures performed with respect to the
breast or other tissue. For example, the procedure may be any of
the procedures described herein, with reference to a medical
procedure performed on a breast.
[0066] According to certain embodiments of the present invention,
the tissue remains immobilized between the scanning or diagnostic
tests performed at step 14 and the performance of the medical
procedure at step 16. In these embodiments, the amount of possible
movement of the lesion between the time of scanning and the time of
performance the medical procedure can be reduced or eliminated.
[0067] In other embodiments, however, the scanning steps are used
to place a localization device within the breast. In these
embodiments, the immobilization device may be removed for
performance of a subsequent diagnostic test (e.g., biopsy) or other
surgical procedure. For example, the immobilization device may be
used to place a wire within the breast, where the tip of the wire
is located within the suspicious mass. Other localization devices
may include marker deposition for example by injecting a die. Such
localization procedure may be used to identify a point within the
breast where a subsequent procedure will be performed, such as
tissue removal, core biopsy, and/or vacuum-assisted biopsy.
[0068] FIG. 2 illustrates one embodiment of an immobilization
device 20. This particular immobilization device is suitable, for
example, for use in taking a biopsy of a lesion within a breast. In
this particular example, the immobilization device 20 is of a
square shape. Thus, the immobilization device is symmetric with
respect to two axes. This may, for example, correspond to the
direction of taking of two separate x-rays, one x-ray being taken
orthogonal to side 20a and the other being taken orthogonal to the
side 20b.
[0069] While the embodiment of FIG. 2 bears certain advantages for
some embodiments of the to present invention, other shapes could be
employed in an immobilization device. For example, an
immobilization device could be configured in a circular or
elliptical fashion. Similarly, the immobilization device may have
planar sides, such as the four-sided device of FIG. 2, or may have
more or fewer planar sides. Similarly, for embodiments with planar
sides, the edges where two planar sides meet may be rounded, to
reduce the risk of pinching during operation of the device as
described below.
[0070] Knobs 22a and 22b may be used to adjust the size of the
device 20. For example, the knobs 22a and 22b may be turned in
order to compress the breast. Thus, knob 22a could be turned
clockwise to cause the sides 20a to move closer together. Knob 22a
could be turned counterclockwise to cause the sides to move further
apart. The knobs may include a device (not shown) permitting the
knob to be locked in place. Such a mechanism may prevent
inadvertent loosening of the device after scanning or during the
medical procedure. Such a mechanism may include a push button,
latch or other device. The knob may also include a quick release
mechanism (not shown) that would allow the plates to quickly come
apart. This may be used for removal of the device quickly if the
patient experiences extreme discomfort, and also to ease removal of
device in the normal course of operation.
[0071] In the embodiment shown in FIG. 2, knob 22a causes sides 20a
to move in and knob 22b causes sides 20b to move closer together or
further apart. In another embodiment, a single knob could be used
causing both sides to move in and out together. This may be
advantageous in circumstances where it is desirable to have a
common distance between each of the sides 20a and sides 20b.
[0072] While the embodiment illustrated in FIG. 2 uses a simple
mechanical device for positioning sides, such as a bolt and screw,
an electromechanical device or other mechanism for causing the
sides to move relative to each other could be used, as would be
apparent to one of ordinary skill in the art based on the
disclosure provided herein. For example, current technology
includes a variety of mechanisms for precise automatic
computer-controlled movement, with open and closed loop control,
for pick and place machines used in various manufacturing
applications.
[0073] The embodiment of FIG. 2 uses a chamber frame as shown,
constructed of a rigid, nonmagnetic and radio-translucent material.
In this example, the chamber frame is rigid in order to minimize
the movement of the soft tissue (e.g., breast) during the procedure
in between scanning and procedures. Softer materials may be used in
any context in which the loss of accuracy (if any) caused by
permitting additional movement of the breast between scanning and
procedure is acceptable. Thus, in some context, an immobilization
device may be constructed using a semi-rigid material (such as
certain rubbers, which have some flexibility to deform in use but
also some rigidity to resist deformation once the device is affixed
to a patient), a flexible material, or a combination of rigid,
semi-rigid and flexible (e.g., portion of the chamber being rigid
such as a hard plastic and portions being flexible, such as cloth)
so long as the soft tissue is sufficiently immobilized for the
particular procedure being performed. In addition, certain soft
materials can be used to provide an exterior shell with materials
enclosed that have volume-filling properties such as various gels.
Additionally, certain materials that exhibit "memories" of shape
and volume may be used or materials which are malleable but can be
hardened, for example by change in temperature or by application of
an electric field, a chemical or exposure to air (e.g., by drying
to a hardened state). For the latter, the immobilization device may
be fitted to the patient in its more malleable form and then
"hardened" (made less malleable) to a less malleable form.
[0074] The chamber frame may be constructed of a material that does
not hinder one or more scanning modalities, for example, where the
chamber is configured in a way that portions of the chamber cover a
portion of the target area, the chamber being made of a material
that is translucent with respect to the imaging apparatus being
used. In the device 20 of FIG. 2, radio-opaque markings 27 are also
included on the chamber frame. These radio-opaque markings may
appear on the x-ray image and be visible to the medical
professional as well. Where this is done, a more precise
orientation of a medical instrument with respect to the chamber may
be made, with reference to radio-opaque markings on an x-ray or
other image.
[0075] The immobilization device 20 includes both rigid portions
(or semi-rigid portions) 24 and openings 25 between them. In this
example, the openings 25 are provided to provide access for
surgical instruments. For example, a biopsy needle may be inserted
through an appropriate opening. The configuration of the openings
in FIG. 2 is illustrative only and may be optimized for the
particular procedure or procedures that the immobilization device
20 is intended to support.
[0076] The immobilization device 20 may include a mechanism to
permit it to be attached to various medical equipment. For example,
slots 29 could be provided in an appropriate configuration to
permit the immobilization device to be attached to an x-ray imaging
system. This would permit the device 20, and therefore the breast,
to be more accurately and reproducibly positioned with respect to
the x-ray equipment. Additional mechanisms could be connected to
the device 20, for example, by using openings 28, to permit the
immobilizations device 20 to interface to different types of
equipment, such as other types of imaging equipment, as well as
surgical equipment.
[0077] By allowing the immobilization device 20 to be removably
connectable to different medical equipment, the immobilization
device can be connected to an apparatus for screening and connected
to a separate apparatus for performing a procedure, such as a
biopsy. An interface that allows mechanical or automated control to
coordinate any procedures may be further provided.
[0078] The immobilization device 20 may include an interface unit
26 for control of the device. For example, the device may be
equipped to sense pressure on the walls of the device, as a safety
measure to ascertain how hard a device is squeezing the breast.
This may be done by incorporating sensors into the immobilization
device 20. In the alternative, a liner may be used with the
immobilization device 20 which can assist with sterilization and
comfort. If so, in some embodiments, pressure sensing devices could
then be incorporated in the liner.
[0079] The interface may further include a mechanism to automate
the control of the tightening and loosening of the sides of the
immobilization device 20. Thus, for example, the knobs 22a and 22b
could be driven through the interface 26. Where this is done,
pressure sensing devices may further be used as a safety measure to
assure that too much pressure is not being applied to the
breast.
[0080] The immobilization device 20 may also have heating and/or
cooling elements built into the device, or incorporated into a
liner for use with the device. Where this is done, the heating and
cooling of the tissue within the immobilization device 20 may also
be controlled through interface 26.
[0081] In some embodiments, temperature sensors may also be
incorporated, to monitor the temperature of the tissue. A feedback
loop may be formed to control heating and/or cooling of to the
tissue to maintain an appropriate temperature for either comfort or
the particular medical procedure being performed.
[0082] The immobilization device 20 may further include indicia for
the setting for the compression of the device, e.g., how close
together the sides are. Thus, where the immobilization device is
applied repeatedly over time, a medical practitioner could assure
that the device settings are the same each time, increasing the
chance that the immobilization device is placed on the patient in
the same configuration. Such indicia may include, for example,
markings on the knobs 22a and 22b, marking on the sides or edges of
the device, or some other mechanism that would be readily apparent
to one of ordinary skill in the art based on the disclosure
provided herein.
[0083] Whether used in conjunction with sensors (such as pressure
or temperature sensors) or not, a liner may be provided for use
with the immobilization device 20. Such a liner may be shaped for
use in connection with immobilization device 20 and may be
sterilized where a surgical procedure is being performed. Such
liners may be provided, and pre-sterilized, in packaged separate
units.
[0084] The openings 28 may also be used to attach the
immobilization device 20 to a mobile transfer unit. For example, if
a patient is to be transported between rooms in a wheelchair, the
wheelchair could be fitted with an interface that also permits the
immobilization device to be attached to the wheelchair.
[0085] In certain embodiments of this aspect of the inventions, a
unit is adapted to attach in a fixed manner to the wheelchair to
provide an interface on the wheelchair for an immobilization
device.
[0086] In certain embodiments, a wheelchair may be adapted
specifically to permit the patient to remain seated in the
wheelchair during the scanning and/or surgical procedure. This
promotes the reduction of relative movement between the patient and
the immobilization device, thereby reducing any movement of the
breast with respect to the immobilization device and/or the lesion
within the breast. Thus, for example, a wheelchair could be
designed or specially adapted to firmly fix the position of the
patient and the immobilization device in a manner restricting
movement of the patient relative to the immobilization device and
the wheelchair.
[0087] In other embodiments (or this one), the immobilization
device may be made of a lightweight material, to make the device
easier to hold in place when supported by the patient and to reduce
discomfort. As one example, a variety of plastics such as a
polycarbonate, a polyethylene or a polypropylene, may be used.
[0088] FIG. 3 illustrates one embodiment of another mechanism for
attaching an immobilization device 20 to a patient. In this
embodiment, a chest strap 31 is provided. The chest strap may be
positioned around the patient when the immobilization device has
been attached. The belt may be fastened or tightened as indicated
at 34 using for example a suitable mechanism. An opening 33 is
provided to accommodate the second breast of the patient and to
help maintain the immobilization device in a constant relationship
to the patient, to reduce movement of the breast in the
immobilization device and to reduce possible movement of the lesion
within the breast.
[0089] In this example, the belt 31 is attached to the
immobilization device through the slots 29. Openings 28 are used to
attach the immobilization device 21 either to a mobile transport
unit such as a wheelchair or instead to scanning equipment or
equipment that performs the surgical procedure.
[0090] FIG. 4 illustrates one embodiment of a method for using an
immobilization device, such as the one described above. In step 41,
the device is affixed to the patient. As described above, this may,
in some embodiments, involve the use of a belt or mobile device
permitting the patient to be moved from location to location (or
both).
[0091] In step 42, the device is adjusted for a snug fit with
respect to the patient. As described above, this may be done
manually or automatically. In some embodiments, as a safety measure
or to help assure the patient's comfort or to help assure a proper
fit, pressure sensors may be used to assure that a sufficient (but
not too large) amount of pressure is being applied to compress the
breast. An automatic release (or loosening) mechanism may be
provided where a pressure threshold is exceeded.
[0092] At step 43, a scanning and/or imaging procedure (or
procedures) is performed. As to described above, this may permit
isolation of a lesion within a breast (as one example). In certain
embodiments, the immobilization device 20 will include markings
that permit a technician or computer to analyze the position of the
lesion with reference to the immobilization device.
[0093] In some embodiments, it may be necessary or desirable to
take an asymmetric scan. For example, if the breast of the patient
being examined is compressed symmetrically, in some circumstances,
it may be possible that a clearer image cannot be taken through the
breast, without first reducing the thickness of the tissue through
which the x-rays pass. In this circumstance, the immobilization
device 20 may be adjusted out of an asymmetric position to permit
more than one shape during scanning. Thus, the device may be used
to flatten the breast horizontally for one scan, and then adjusted
to flatten the breast vertically for a second scan.
[0094] While use of an immobilization device in this fashion may
increase the possibility that the lesion moves during scanning, and
may in some circumstances reduce accuracy, the use of the
immobilization device is still preferable in some embodiments
because it reduces and better controls the amount of movement
between scans. By keeping the immobilization device affixed to the
patient during both, and adjusting it between scans, the relative
movement of a breast between scans and before the procedure may be
reduced and controlled. For the latter, a better feel for lesions
movement (or automated monitoring of lesion movement, or automated
estimation of lesion movement) may be maintained.
[0095] At step 44, the medical procedures performed are based on
the scan. In some embodiments, the immobilization device is
maintained on the patient during scanning at step 43 as well as the
medical procedure at step 44. Where the two are separated
substantially in time or location, however, there may be
circumstances where the immobilization device may be removed. If
so, use of the immobilization device may still assist
reproducibility, provided that the patient may be refitted with the
immobilization device for the medical procedure and the
practitioner (preferably) endeavors to attach the device in the
same position as it was affixed during the scanning procedure. Some
examples of techniques for performing this are provided below, but
are not intended to be limiting for all aspects of this embodiment
of the invention.
[0096] At step 45, after the medical procedure has been performed,
the immobilization device may be removed.
[0097] FIG. 5 illustrates one embodiment of a method for performing
a procedure. Any of a number of procedures could be performed using
this particular embodiment of the present invention. For example,
the procedure could be needle localization, needle aspiration,
vacuum-assisted biopsy, virtual guided breast surgery, in-office
biopsy, sentinel node biopsy or therapeutic imaging correlation and
implantation.
[0098] At step 51, the position of an area of interest is
determined using images. For example, if the images are two x-rays
taken to isolate a lesion within a breast, the three-dimensional
locations of the lesion may be determined or estimated. This
calculation may be made with reference to a frame of reference that
corresponds to one or more locations or markers on the
immobilization device. As described above, this can be done with
reference to radio-opaque markings on the immobilization device, at
least in certain embodiments.
[0099] At step 53, the location of the area of interest is
determined with respect to a reference frame. That reference frame
may correspond to the immobilization device or something whose
position is known relative to the immobilization device. Thus, the
location and three-dimensional space of the lesion with respect to
a reference point, such as one or more points on the immobilization
device, can be determined.
[0100] Using location and imaging techniques known in the prior art
and as described in, for example, U.S. Pat. No. 6,119,033, issued
Sep. 12, 2000 and naming Spigelman et al. as inventors, which is
fully incorporated herein by reference, an image may be displayed
during a medical procedure being performed on the area of
interest.
[0101] Returning to the embodiment disclosed in FIG. 5, at a step
55, the positioning parameters for an instrument may be determined.
This calculation may be performed by hand, or may be implemented on
a computer system using hardware and/or software. In this example,
at step 55, the positioning parameters may include a point of entry
and orientation for the surgical instrument as well as a depth.
Thus, for example, a medical practitioner or computer may calculate
a position on the breast (e.g., with reference to the
immobilization device) where a surgical instrument should enter,
and an angle (with respect to the to immobilization device) at
which the instrument or needle should be inserted. In addition, a
depth of insertion could also be calculated. If depth markings are
included on the surgical instrument, a calculation can be made
which permits relatively automated positioning and insertion of the
surgical instrument. In certain embodiments, positioning units or
tools such as guide ramps or tubes may be provided and directly or
indirectly attached to (or incorporated into) the immobilization
device at an appropriate place to help position and guide the tool.
For certain of these embodiments, the immobilization device may
include one or more interfaces for allowing positioning units or
tools to be (in some embodiments, adjustably) to be attached to the
immobilization device at one or more appropriate positions.
[0102] While this can be used to assist the hand insertion of the
surgical instrument, in other embodiments, the surgical instrument
may be inserted using an automated tool or mechanical arm.
[0103] At a step 57, the procedure is performed using the
calculated instrument position parameters.
[0104] As one of ordinary skill in the art would readily
appreciate, based on the disclosure provided herein, a number of
different mechanisms may be used both for specifying lesion
location with respect to a reference frame and for calculating the
parameters for positioning and insertion of the surgical
instrument. For example, xyz coordinates may be used to specify
location of the center of a lesion with respect to the
immobilization device. In other embodiments, polar coordinates
could be used. Any particular reference frame may be used.
[0105] As described above, the surgical instrument may include
markings so that the depth of insertion can be ascertained for
verification with reference to the desired insertion depth. In
other embodiments, the surgical instrument could be marked at the
desired insertion depth prior to performing the surgical procedure.
The instrument may then be inserted to the marked depth.
[0106] FIG. 6 illustrates one embodiment of a method for performing
needle localization. This embodiment illustrates certain
independent aspects of the present inventions.
[0107] At a step 61, an immobilization device, such as those
described according to one of the embodiments herein, is attached
to the patient.
[0108] At a step 62, the immobilization device is attached to a
mammography unit. This may be done, for example, using the openings
28. A top view, for example, scan is performed with the device
attached to the mammography unit. Side views and orthogonal views
may also be taken as well. Preferably, the attachment mechanism is
adapted to provide a secure fit with existing units. Optionally,
adapters may be provided for use with an immobilization device to
permit it to be used with more than one type of mammography unit,
or to other types of medical equipment such as other imaging
devices.
[0109] At step 63, the device is disengaged from the mammography
unit, to permit it to be rotated. The device is reattached at an
alternative side of the immobilization device to permit a lateral
image to be taken. At this step, the immobilization device may be
attached, for example, using slots 29.
[0110] At a step 64, the images may be input to an automated system
that assists in performance of the surgical procedure (at least
according to certain embodiments).
[0111] At step 65, instrument placement parameters may be
determined. As described above, this can be done with reference to
the immobilization device using calibration indicia located on the
device. Also as described above, this may be done either by a
medical practitioner or in an automated fashion.
[0112] At a step 66, according to certain embodiments of the
present inventions, instrument position guidance mechanisms are
affixed to the immobilization device. In other embodiments, the
mechanism may be already engaged to the immobilization device.
Here, a mechanism to fix the motion of the instrument relative to
the immobilization device, and therefore the lesion, may be
used.
[0113] At a step 67, according to certain embodiments, an image of
the instrument relative to the immobilization device and/or the
lesion can be displayed on a monitor. The technology for doing so
has been described in general in U.S. Pat. No. 6,119,033 cited
above. According to certain embodiments of the present inventions,
however, the portion of the body being viewed is immobilized rather
than being permitted to change shape. In this sense, the technology
for imaging can be simpler, because calculations for lesion
movement relative to changes in the shape of soft tissue (e.g., a
breast) may not need to be accounted for in certain embodiments. In
other embodiments, however, calculations about lesion movement
during multiple scanning procedures can be performed. For example,
if the shape of the breast is altered within the immobilization
device during two different scanning procedures, a calculation can
be made in an effort to more precisely identify the location of the
lesion. This calculation may be performed as described in the above
referenced patent.
[0114] At step 68, a marker wire may be placed to show where the
surgical instrument was positioned for the procedure. The position
of the marker wire may be held constant within the soft tissue
(e.g. a breast) using the immobilization device.
[0115] At a step 69, a confirmatory mammogram or mammograms may be
taken to establish that the procedure was performed within the
lesion. The method for performing one or more confirmatory
mammograms may include maintaining the breast within the
immobilization device during the performance of confirmatory
scans.
[0116] In the method described in FIG. 6, previously taken
screening mammograms (e.g., top and lateral view of the breast) may
also serve as controls during performance of the procedure. Needle
aspiration may be performed using a similar method to that
illustrated in FIG. 6, according to certain embodiments of the
present inventions. Similarly, vacuum-assisted biopsies may be
performed, using a vacuum-assisted device rather than a needle
aspiration device.
[0117] According to alternative embodiments of the present
inventions, the medical procedure can be guided virtually, using a
monitor to display an initial tool position and lesion location or
orientation and with respect to the immobilization device and/or
breast. In one embodiment, the patient can remain attached to the
imaging machine, such as a mammography unit. This may permit images
to be taken during the procedure, or for certain equipment, a
continuous display. In other embodiments, the immobilization device
may be attached to a fixed surface other than the imaging
equipment. Doing so will reduce the risk that patient movement
during the procedure can adversely affect the outcome.
[0118] As described above, for these procedures as well as others,
heating and/or cooling may be applied to either assist in
performance of the procedure or to make the patient more
comfortable, or both.
[0119] FIG. 7 illustrates one embodiment of such a procedure.
[0120] According to this embodiment, at step 71, an immobilization
device is attached to the patient. As described, the immobilization
device may be attached to a breast for performance of a medical
procedure, such as a biopsy on a lesion.
[0121] At step 72, the immobilization device is attached to a
scanning unit. This may be done using an interface on the
immobilization device adapted to be attached to the scanning unit.
One or more scans may then be performed to locate a lesion within
the breast.
[0122] At step 73 the device may be disengaged from the scanning
unit and the patient may be moved. As described above, the medical
procedure may then be performed on the patient in a different
location.
[0123] According to the embodiment shown in FIG. 7, the device is
attached at step 74, to a procedure unit. The procedure unit may
simply be a fixture that prevents movement of the immobilization
device during the medical procedure, to reduce the risk of patient
movement adversely affecting the procedure.
[0124] In another embodiment, the procedure unit may include an
interface permitting imaging of the medical procedure, or use
automated control tools, as described above with reference to FIG.
6. Thus, at step 75, the medical procedure may be performed with
reference to an image being displayed in coordination with the
immobilization device as attached to a procedure unit.
[0125] One application suited for this particular type of surgery
would be an in-office biopsy.
[0126] As described above, the immobilization device may be
attached to the patient using a harness or other mechanism.
According to certain embodiments, the immobilization device may
also be fitted onto an ambulatory device such as a wheelchair, to
further reduce the risk of movement of the breast with respect to
the immobilization device between scanning and procedure.
[0127] In another embodiment, markings may be placed on the breast
or other soft tissue to confirm that the tissue has not moved with
respect to the immobilization device. For example, one or more
openings may be included on the device for this purpose. Once the
immobilization device is fitted to the patient, a medical
practitioner could use a marker to outline or fill in (for example)
a circular opening. If this is done in one or more places on the
immobilization device, one can look at the opening and see if that
portion of the tissue moved with respect to the immobilization
device. If so, the medical practitioner can detect the risk to that
the position of the immobilization device has moved and, therefore,
the reference frame for performing the procedure has moved.
[0128] In this circumstance, the patient may return for new imaging
to reduce the risk of lesion movement affecting the outcome of the
procedure. In alternative circumstances, however, the amount of
movement of the device with respect to the soft tissue can be
ascertained by examination of the degree of movement of the markers
on the breast with reference to the immobilization device, and any
change in lesion location determined automatically or manually
(e.g., by estimation). This would permit greater accuracy in the
performance of the medical procedure when a new image is not taken,
would permit confirmation that the immobilization device has not
moved, and can increase the confidence and likelihood that the
medical procedure will be performed on the appropriate location in
the tissue.
[0129] In some circumstances, such as where the imaging is being
done remotely in time or place from the medical procedure, it may
be necessary or desirable to remove the immobilization device.
Removal of the device can create risk that the lesion will move and
can make it more difficult to locate a lesion within the breast
over time. It also makes it more difficult to track changes of the
internal structure of the soft tissue over time.
[0130] Toward this end, if permanent or semi-permanent markings are
placed on the breast with reference to the immobilization device in
one or more positions, the device can be attached again to the
patient in a manner which reduces the risk that the immobilization
device is positioned differently than before.
[0131] As can be appreciated, one or more of the inventions
described herein can be applied in a number of other applications.
These applications include therapeutic implantations, where one or
more devices capable of delivering chemicals, radiation or other
therapeutic modalities are implanted in the body. Another
application would include a sentinel node biopsy. In a sentinel
node biopsy, a radioactive or other trackable dye is injected into
the target site prior to the biopsy. The techniques described
herein can be used, during such procedures, both for positioning of
the sentinel node and/or for tracking of the procedure being
performed.
[0132] In other embodiments of the present inventions, the tools
and techniques disclosed herein can be used for diagnostic and
historical tracking purposes. Thus, if the immobilization to device
is used during routine screening mammograms (or any other regularly
performed series of scans), the appropriate images may be stored in
a database and tracked by patient and time of diagnostic. In the
alternative or in addition, certain parameters can be ascertained
from each scan and stored. For example, the volume of the breast or
a medical anomaly within the breast, e.g., the lesion, may be
tracked over time, so that changes in volume can be determined
Marker locations may also be stored.
[0133] In one embodiment, temperature sensors and/or
heating/cooling elements can be applied in this context. This can
be done to assure that, at the time that the volume measurement is
being made, the tissue is at the same approximate temperature.
[0134] As one might appreciate, certain adjustments might be made
to the immobilization device illustrated in FIG. 2 to allow more
accurate volume measurements to be taken. For example, for this
(and certain other applications) it may be desirable to have a
closing surface on the immobilization device (e.g., an end wall),
so that the chest, sides of the immobilization device and closing
surface form a three dimensional enclosed space.
[0135] Where historical patient information is being tracked,
different images may be overlaid and changes in the internal image
structure may be tracked.
[0136] As described above, markers or other mechanisms may be used
to assure that the immobilization device is positioned as closely
as possible each time, with respect to the breast. Even when such
markers are not employed, use of the immobilization device can
assist in more uniform imaging of the breast. Thus, for example,
using a consistent interface between the immobilization device and
the scanning unit may allow more uniform imaging angles over
time.
[0137] In other embodiments, the immobilization device includes
radio opaque markings, or other types of markings which will be
visible on the digital image. A computer system may then use these
images of the radio opaque markings to assist in correlation of
images taken at separate points and time.
[0138] In other embodiments, the immobilization device can
facilitate multimodal imaging correlation. For these, the
immobilization device may be adapted to be mounted to more than one
medical imaging device. This can be done using the same or
different interfaces built into to the immobilization device to
attach to the different types of imaging equipment. In an
alternative embodiment, the immobilization device has an interface
that permits an adapter to be mounted to it. An appropriate adapter
may then be selected or configured for each of the different types
of imaging equipment that may be used with the immobilization
device.
[0139] Where an immobilization device is used with different forms
of scanning, use of the immobilization device can assist in
overlaying of the different images taken. This can be done in one
(or both) of at least two ways. First, by having a common frame of
reference using the immobilization device, the relative angles and
orientation of the scans may be determined fairly reliably in
advance. (As described above, markers may also be used to assure
that there is no movement of the tissue with respect to the
immobilization device between scans.) Since the relative scanning
positions of all of the images may be known in advance in this
fashion, correlation of the images may be produced more
readily.
[0140] In other embodiments, radio opaque (or other visible)
markings on the immobilization device can be used manually or by
computer software to correlate images.
[0141] In other embodiments, these types of images whether taken
from multimodal sources or multiple scans of a singular source may
be used to construct a three-dimensional image or model on a
computer screen. One may also be constructed using
three-dimensional modeling techniques, in an automated fashion.
[0142] In another embodiment of the present invention, the devices
may be used to assist in therapeutic radiological planning In these
embodiments, using historical tracking of volume, an internal
structure of the breast can be used to better plan and focus
application of an external beam, permitting more accurate planning
of a cone for a lesion to be irradiated.
[0143] Referring now to FIGS. 8-12, and more specifically to FIGS.
8, 8A and 8B, there is generally indicated at 101 an immobilization
unit of another embodiment of the inventions. In this example, the
immobilization unit is described with respect to use for needle
localization in a patient's breast, e.g., a procedure where a
needle is placed in the breast so that the tip of the needle is
located at or within the area of interest, permitting another
procedure (e.g., a biopsy) to be performed later at that location.
This device is suitable, however, for other forms of localization,
such as placement of a marker or injection of a dye and is suitable
for other to procedures such as direct placement of a biopsy needle
within the breast. A biopsy gun containing a biopsy needle or some
other suitable attachment can also be employed.
[0144] The immobilization unit 101, as with device 20, is suitable,
for example, for use in performing medical procedures on tissue
requiring immobilization, such as taking a biopsy of a lesion
within a breast or placing a guide wire in association with
performing another medical procedure such as a biopsy. The assembly
105 may be less bulky than device 20, and fabricated from
lightweight materials to reduce the device's overall weight.
Possible materials include (but are not limited to) plastics such
as a polycarbonate, a polyethylene or a polypropylene, semi-rigid
or rigid rubbers, light-weight metals and other materials that
could be readily selected by one of skill in the art based on the
disclosure provided herein. As shown, the unit 101 includes a frame
assembly, generally indicated at 103, a tissue immobilization
assembly, generally indicated at 105, and a needle assembly,
generally indicated at 107. In some embodiments, the frame assembly
may be made of a metal, for a more rigid configuration. As one
example, though, other assemblies may be attached to the frame
assembly for different procedures. For example, an interface may be
provided to allow attachment of a biopsy gun to the frame.
[0145] The term "immobilization device," as used herein may refer
to a device for immobilizing tissue and may include a device that
permits adjustment of shape breast between images or during the
procedure (as well as those that do not), or an immobilization
assembly with or without a frame.
[0146] Turning to FIG. 9, the frame assembly 103 is constructed to
support the immobilization assembly 105 and the needle assembly
107. The frame assembly 103 includes an inverted U-shaped frame
member fabricated from three lengths of stock material, indicated
at 109a, 109b and 109c, e.g., lightweight aluminum or an aluminum
alloy, plastic, or some other suitable polymeric material,
connected to one another by a pair of elbow connectors 117, 119.
With reference to connector 117, the connector has an opening 121
formed therein, which extends through a boss 123 formed on the
connector. As shown, two rods 125, 127 are received within
respective openings of the connectors 117, 119, each opening being
sized to receive the rod therethrough. Knobs 128, made of a softer
material, are included on the end of rods 125, 127 to for the
comfort of a patient, should she lean forward into the ends of
those rods. For each connector 117, 119, a locking mechanism is
further provided for securing the rod in place. Specifically, each
locking mechanism includes an outwardly projecting tab 129 adapted
to be pressed downward to release the rod 125, 127 from the
connector 117, 119. In its pressed, unlocked position, the rod can
be axially slid to its desired position. When released, the rod is
locked in place by any suitable device contained within the locking
mechanism.
[0147] The rods 125, 127 may include indicia on each in order to
precisely position the U-shaped frame along one axis with reference
to an immobilization device attached to the frame portions 109a,
109b and 109c. Since (in this embodiment) the needle assemble 107
is attached to the U-shaped frame, positing the U-shaped frame will
precisely position the needle assembly along one axis, with
reference to a breast in the immobilization device. In an
embodiment described below, a computer, PDA or other device may
calculate a position for location of the U-shaped frame for
performance of the procedure, and the output specifying where to
place a needle (107 in FIG. 8) may then include a reference to
where along the rods 125, 127 the U-shaped member 109a-109c should
be positioned with reference to the indicia on rods 125, 127.
[0148] For a similar reason, the frame parts 109a, 109b and 109c
may include indicia calibrated to allow the needle assembly 107 to
be positioned along the length of that axis. Thus, by positioning
the U-shaped frame 109a-c along one axis and the needle assembly
107 on one of the bars 109a-c, the needle procedure can be
specified along 2 axes. By controlling the insertion depth, a point
may be determined in a three-dimensional space. As one might
appreciate based on the disclosure provided herein, other
mechanisms could be adapted to specify and control a point in
3-dimensional space. For example, whether or not a circular
immobilization device is used, polar coordinates could be used to
precisely specify needle position and the mechanisms designed
appropriately.
[0149] A horizontally disposed bar 131 secures the ends of the rods
125, 127 to a seat 133. As shown, the seat bar 133 is suitably
secured by a pair of fasteners, such as machine screws, to the bar
131. The seat bar 133 extends downwardly from the bar 131, and in
this embodiment is "S` shaped. In another embodiment, the seat-bar
133 may be L-shaped. This may be done, for example, to allow more
room for a patient's breast that is compressed and extending out of
the end of immobilization device 105. As shown, the seat 133 of the
frame assembly 103 is adapted to secure the immobilization assembly
105 thereto in a manner that precisely registers the immobilization
device with reference to the frame assembly 103 and, since the
frame assembly is coupled to the mammography machine and bucky,
also with respect to the machine.
[0150] In this example, the bottom of the seat bar 133 has tab seat
134. The tab seat 134 (as well as the bottom U-shaped frame member
parts 109a and 109c, for purposes of stability) are designed to
rest precisely on top of a bucky 136 of a mammography machine when
interface plate 187 is attached to the frame assembly 103 and a
mammography machine (see FIGS. 8A and 8B). Multiple forms of
interface plate 187 (or other mechanism) can be supplied, each
adapted to permit a common frame assembly 103 to be attached to
different machines.
[0151] A tab (not shown) on a immobilization device can be inserted
into a slot formed by an opening in the bottom of tab seat 134 and
the bucky 136. The tab and tab seat 134 may be formed to assist in
proper registration, for example by having a ball bearing in the
tab and a corresponding depression in tab seat. The tabs may be
removable to quickly disengage the immobilization assembly from the
frame assembly.
[0152] The frame assembly 103 of the immobilization unit 101 may
include a suitable mechanism to permit it to be attached to various
medical equipment. For example, the frame assembly 103 could be
provided in an appropriate configuration to permit the
immobilization unit 101 to be attached to an x-ray imaging system
using interface plate 187 and configured so that the bottom of rods
109a and 109c, and the tab seat 134 rest on the bucky 136 when it
is so attached. Additional mechanisms could be provided to permit
the immobilization unit 101 to interface to different types of
equipment, such as other types of imaging equipment, as well as
surgical equipment.
[0153] By allowing the immobilization unit 101 to be removably
connectable to different medical equipment, the immobilization
device can be connected to an apparatus for screening, and
connected to a separate apparatus for performing a procedure, such
as a biopsy. An interface that allows mechanical or automated
control to coordinate any procedures may be further provided.
[0154] In addition, when the bucky 136 on a mammography machine is
rotated to take (for example) a second image from the side, the
frame assembly would also be rotated. Since the immobilization unit
101 can be detached from the assembly, this rotation can be
straightforward. For example, the immobilization device can be
removed from the assembly frame, the bucky (and frame) rotated and
then the immobilization device attached again (using a different
tab, as described below).
[0155] Referring to FIG. 10, the immobilization assembly 105 of
this example is generally square shaped in construction to receive
the tissue to be immobilized, e.g., a breast. In this example, the
top piece 147 is curved. In this example, compression is achieved
by pushing down on the top piece as described below.
[0156] The immobilization assembly 105 includes a bottom wall 137
and two side walls 139, 141 integrally formed with the bottom wall.
The bottom and side walls 137, 139, 141 are sized to receive the
tissue to be immobilized. The immobilization assembly 105 may be
sized appropriately for compression of a breast. As breast sizes
vary, it may be desirable to provide more than one standard size,
e.g., correlating size to breast or bra size. As shown, the
interior surfaces formed by the bottom and side walls 137, 139, 141
are smooth to reduce the risk of pinching the tissue during
operation of the unit 101.
[0157] With reference to FIGS. 8A and 8B, in addition to FIG. 10,
each side wall 139, 141 has a tab portion 146 formed at the rear of
the side wall 137 or 139 and also on the bottom (not shown in these
drawing figures). As described above, the tab portion may be
secured to the tab seat 134 of the frame assembly 103 by a suitable
fastening method. By including a tab portion on the bottom and each
side, a top, left or right side view may be taken by rotating the
bucky of a mammography machine (with a frame assembly 103 attached)
and then using the corresponding tab portion with tab seat 134 to
secure and register the device to the machine.
[0158] Each of the tab portions may further include a corresponding
radio-opaque marking. This would permit someone reading an X-ray to
readily ascertain which view was taken.
[0159] The immobilization assembly 105 further includes a top wall
147 slidably connected to the side walls 139, 141. Specifically, at
the top of each side wall 139, 141, two vertical slots, each
indicated at 149, are formed therein. Each slot 149 is adapted to
receive a positioning detent, each indicated at 151, which is
formed along an edge of the top wall. The top wall 147 is secured
in place by two inverted U-shaped members 153, 155, each member
being to positioned adjacent a respective side wall 139, 141 and
formed with the top wall so that it projects perpendicularly from
the top wall. The outwardly facing surface of each inverted
U-shaped member 153, 155 has a serrated area (not shown) adapted to
mate with a serrated area 159 formed on the respective inner facing
surface of its respective side wall 139, 141 to secure the top wall
147 in place with respect to the side walls. By applying inwardly
directed pressure to each member at 161, 163, the serrated areas of
the members 153, 155 disengage their respective serrated areas 159
of the side walls 139, 141 to enable the top wall 147 to move up
and down between the two side walls with the detents 151 sliding in
their respective slots 149.
[0160] The arrangement is such that upon placing tissue within the
immobilization assembly 105, e.g., breast tissue, downward pressure
can be applied to the tissue by moving the top wall 147 downwardly
within the assembly. The serrated areas, once the top wall 147 is
positioned to secure and immobilize the tissue, retain the top wall
in place with respect to the side walls 139, 141 to maintain
pressure on the tissue. As shown, the inwardly facing surface of
the top wall that engages the tissue is slightly arced to provide
additional comfort to the patient.
[0161] By sizing the immobilization device appropriately, one can
appreciate that the downward pressure on the top result in
compression of the breast along two dimensions. In some
embodiments, immobilization assembly 105 may be provided in
standard sizes intended correlate to breast size, such as cup size
of the breast and an appropriate sized unit selected for the
particular patient.
[0162] It should be understood that although the top wall has four
such positioning detents 151 received within four slots 149, any
number of detents and slots can be provided for guiding the top
wall 147 with respect to the side walls 139, 141 to immobilize the
tissue and other suitable securing mechanisms can also be readily
designed based on the disclosure herein. In addition, although the
side walls 139, 141 shown in FIG. 10 have slots 149 that extend
down from the top edge approximately one-third the way down their
respective side walls, the slots can extend further down the side
walls to further reduce the volume defined by the bottom, side and
top walls 137, 139, 141, 147.
[0163] The immobilization assembly 105 can be fabricated by any
suitable rigid, nonmagnetic and radio-translucent material, for
example. In this example, the immobilization assembly 105 is rigid
in order to minimize the movement of the soft tissue (e.g., a
breast) during the to procedure in between scanning and procedures.
Softer materials may be used in any context in which the loss of
accuracy (if any) caused by permitting additional movement of the
breast between scanning and procedure is acceptable. As with device
20, the immobilization assembly 105 of the immobilization unit 101
may be constructed using a semi-rigid material, a flexible material
or a combination thereof. In addition, certain soft materials can
be used to provide an exterior shell with materials enclosed that
have volume-filling properties, such as various gels.
[0164] In some embodiments, as a safety measure or to help assure
the patient's comfort or to help assure a proper fit, pressure
sensors may be used to assure that a sufficient (but not too large)
amount of pressure is being applied to compress the breast. An
automatic release (or loosening) mechanism may be provided where a
pressure threshold is exceeded.
[0165] In one embodiment, holes are included in appropriate places
in portions of the immobilization device to allow insertion of a
needle. The hole may be molded in or drilled and the positioning of
the holes may be coordinated to correspond to the calibration
markings on the frame assembly.
[0166] In this example, the holes may be positioned in the top and
each side wall to permit a needle to be inserted from the top or
either side since (in this example) a rigid or semi-rigid material
completely surrounds the sides of the breast. In this example, and
using this embodiment of a frame assembly, insertion of the needle
is always made at about a right angle to the surface of the
immobilization device. The holes may vary in shape and size in
order to accommodate certain medical procedures or instruments. For
example, the holes may be constructed to enable the procedure of a
"biopsy in a circle" when it is desirable to move the needle with
respect to the frame assembly and/or the immobilization assembly.
Also, the holes may be configured to accommodate a biopsy gun,
which is capable of pivoting about a fixed or movable point on the
frame assembly (or the immobilization assembly, as the case may
be). The immobilization device may be further configured to
interface with other tools for precisely aligning the device with a
machine upon which it is attached.
[0167] In this example, if holes are not included at the edges of
in the immobilization device, and even where they are, it may not
be preferable to endeavor to perform a procedure on an area of
interest that is near a corner or side of the immobilization
device. Where this is the case, the device can be positioned on the
patient at an angle. When the device is positioned on a screening
device, the patient may then have to angle her body to one side so
that the device is fitted squarely into the bucky.
[0168] In this embodiment, the immobilization device 105 includes
an area of thin material (e.g., scored) along the bottom running
from a center of the bottom portion proximal the patient to the
center distal end. In this example, this channel permits the device
to be broken or snapped apart for quick removal. This channel is
not meant to break during use, but instead is intended to hinge
apart for quick removal from the patient. For example, the bottom
wall 137 may include a crease 138 to enable the bottom wall to
hinge apart along an axis defined by the crease upon flexing the
side walls 139, 141 apart from each other. The purpose of the
crease 138 will be described in greater detail below.
[0169] The needle assembly 107 is illustrated in FIG. 11, and
comprises a needle holder 165 capable of being secured to the frame
assembly 103. As shown, the needle holder 165 includes an sleeve
169 having a clamping assembly 171 configured to permit the needle
holder to be securely attached to the frame assembly as described
generally above. The clamping assembly 171 should be configured,
and a suitable material selected, to avoid play or rocking of the
holder during use. Referring back to FIG. 8, the clamping assembly
171 is capable of releasably clamping onto a frame member portion
109a, 109b or 109c to position the needle holder 165 adjacent the
immobilization assembly 105.
[0170] The needle holder 165 of this example further includes an
outer sleeve 173 sized to fit within the sleeve 169 by suitable
means. The outer sleeve 173 has internal threads (not shown) formed
therein and a longitudinal slot 175 best illustrated in FIG.
11.
[0171] The needle assembly further includes a tubular member 177
adapted to be slidably received within the inner sleeve 173. A
needle portion 179 suitably secured to the tubular member 177. A
pointer etched on the needle portion may be provided to indicate
the orientation of the needle opening. The arrangement is such that
the tubular member 177 is capable of axially moving with respect to
the inner sleeve 173 so that the needle can be inserted through the
outer sleeve 173, through a hole in the immobilization device and
into the to patient to finely position the needle portion 179. The
tubular member 177 may also be rotated to assist in achieving the
insertion of the needle portion 179 into the tissue.
[0172] The tubular member 177 may include calibrated markings along
the length of the tubular member. A positioning element or clamp
181 may be secured to the tubular member by pinching a pair of tab
portions 183, 185 adapted to be pressed together to unclamp the
positioning element and axially move the positioning element with
respect to the tubular member. By releasing the tab portions 183,
185, the positioning element 181 is spring-loaded to clamp onto the
tubular member 177. To insert a needle, the needle portion 179 and
the tubular member 177 are slide into the outer sleeve 173 and down
until the positioning element 181 engages a top portion of the
outer sleeve. Thus, the positioning of the positioning element 181,
with reference to the markings on the tubular member 177 can
precisely determine the depth of the insertion of the needle
portion 179 into the tissue. As might be appreciated, therefore,
the positioning of the U-shaped pieces 109a-c along the rods 125,
127 of the frame assembly, the position of the needle assembly 107
along one of the pieces 109a-c and the insertion depth (determined
in this example by the location of the positioning element 181) can
specify precisely in three-dimensional space where the tip (or any
other part) of the needle portion 179 is positioned.
[0173] Still referring to FIG. 11, the outer sleeve 169 and sleeve
173 of the needle holder 165 may be formed with a crease 186 to
flex the needle portion along an axis defined by the crease upon
spreading apart the outer sleeve and the sleeve via slot 175. This
construction enables the needle holder 165 to be removed from the
tubular member 177 and needle portion 179 without removing the
needle from the tissue.
[0174] The immobilization unit 101 may include a mechanism to
permit it to be attached to various medical equipment, as described
above. For example, a plate 187 (see FIGS. 8, 8A, 8B and 9) secured
to the horizontal bar 131 could be provided in an appropriate
configuration to permit the immobilization unit 101 to be attached
to an x-ray imaging system or a mammography machine, for example.
This would permit the unit 101, and therefore the breast, to be
more accurately and reproducibly positioned with respect to the
x-ray equipment. Additional mechanisms could be provided to permit
the immobilization device to interface to the same equipment
supplied by a different manufacturer, different types of equipment,
such as other types of imaging equipment, as well as surgical
equipment.
[0175] In addition, the immobilization assembly 105 can be removed
from the immobilization tissue prior to performing the procedure by
removing the top wall 147 (by pinching members 153, 155), and
lifting the top wall away from the side walls 139, 141. For
example, if the needle is inserted through an opening in a side
wall (e.g., side wall 139) as described above, the other side wall
(e.g., side wall 141) can be flexed apart via crease 138 in the
bottom wall 137. Once the side wall (e.g., side wall 141) and
one-half the bottom wall 137 are moved away from the immobilized
tissue, the other side wall (e.g., side wall 139) can be removed by
slipping the wall over the needle and/or marker.
[0176] By allowing the immobilization unit 101 to be removably
connectable to different medical equipment, the immobilization
device can be connected to a device for screening and connected to
a separate device for performing a procedure such as a biopsy. The
provision of an interface allows mechanical or automated control to
coordinate any procedures since the frame of reference or each
materials is known.
[0177] The immobilization unit 101 may include an interface unit
(not shown), similar to the interface unit 26 for immobilization
device, for control of the device. For example, the unit 101 may be
equipped to sense pressure on the walls of the device, as a safety
measure to ascertain how hard a device is squeezing the tissue.
This may be done by incorporating sensors into the immobilization
unit 101. In the alternative, a liner may be used with the
immobilization unit 101 which can assist with sterilization and
comfort. If so, in some embodiments of the invention, pressure
sensing devices could then be incorporated in the liner. The
interface may further include a mechanism to automate the control
of the movement of the top wall of the immobilization unit 101.
[0178] The immobilization unit 101 may also have heating and/or
cooling elements built into the device, or incorporated into a
liner for use with the device. Where this is done, the heating and
cooling of the tissue within the immobilization unit 101 may also
be controlled through an interface. In some embodiments,
temperature sensors may also be incorporated, to monitor the
temperature of the tissue. A feedback loop may be formed to control
heating and/or cooling of the tissue to maintain an appropriate
temperature for either comfort or the particular medical to
procedure being performed.
[0179] Whether used in conjunction with sensors (such as pressure
or temperature sensors), a liner may be provided for use with the
immobilization unit 101. Such a liner may be shaped for use in
connection with immobilization unit 101 and may be sterilized where
a surgical procedure is being performed. Such liners may be
provided, and pre-sterilized, in packaged separate units.
[0180] In another embodiment, the immobilization device and needle
assembly may be packaged as a pre-sterilized kit or separate kits.
Such a kit may be intended to be disposable after a single use.
[0181] In other embodiments (or this one), the immobilization unit
101 may be made of a lightweight material in some embodiments, to
make the device easier to hold in place when supported by the
patient and to reduce discomfort. As one example, a variety of
thermoplastic material, such as Lexan may be used to fabricate the
immobilization assembly 105, and a lightweight alloy may be used to
fabricate the frame assembly 103. (While the term "assembly" is
used to describe various components of embodiments of the present
invention, this term is intended to include an integrally formed
component that is not actually assembled.)
[0182] Turning now to FIGS. 12-22, and more particularly to FIG.
12, a method according to an embodiment of the inventions for using
the immobilization device is further described. In this example,
and with reference to FIG. 12, the immobilization unit 101 is used
to perform needle localization. Mammography readings from two
directions are taken and the results input to a PDA (step 190). The
PDA then calculates a reference point on the frame assembly, e.g.,
a posterior-anterior position along the rods 125, 127 for the frame
member (step 191), the medial-lateral position on the appropriate
portion of the frame assembly portions 109a, 109b or 109c (step
192), and the location for placement of the positioning element 181
on the tubular member 177 (step 193), to fix the depth of
insertion. These calculations are based on information inputted by
the technician or appropriate medical practitioner. For example the
length of the needle may be inputted or as identified herein
selected from a menu of needle lengths (step 194). Also, the needle
entry direction may also be inserted (step 195). In one example,
the reference markings on 109a, 109b and 109c may have different
designations, so that the user is reminded during the procedure to
place the needle assembly 107 on the correct to portion 109a, 109b
or 109c. Similarly, the reference markings on each of the other
elements (rods 125, 127 and the tubular member 177) may be
different to reduce the change that a user may transpose
designations when performing the procedure.
[0183] With reference to FIG. 12A, at step 201, an immobilization
device, such as those described according to one or more
embodiments disclosed herein, is attached to the patient to
immobilize the tissue having the target tissue or mass (or a
targeted area or area of interest).
[0184] In step 203, after the immobilization device is affixed to
the patient and, in some embodiments, to a bucky of a mammography
machine as depicted in FIGS. 8A and 8B, and described herein, a
first mammography reading is taken with respect to one direction
(e.g., from the top). At this time or at another time, the reading
is input into a computer system having firmware and/or software to
perform a calculation of the location of the legion. Such a
"computer system" may be any computational device including
personal computers, PDAs, or special hardward provided for this
purpose. Such a system may allow automated reading of the mammogram
or the data may be read by a qualified medical professional. The
mammogram reading may be read or input to a computer such as a PDA
(of course, automated calculations are not required for use of an
immobilization device and are present only in accordance with some
aspects of the present inventions).
[0185] The first mammography reading may be input with reference to
an image grid 301, which is illustrated in FIG. 13. Specifically,
the direction of the first image is indicated by selecting a "top,"
"left" or "right" button contained on the image grid 301. As shown,
FIG. 13 illustrates the image grid 301 for recording the location
of a lesion to be treated.
[0186] In addition, radio-opaque reference markings that are on the
tab seat 134 of the frame assembly also appear on the mammogram.
When the data is input, the data determines the x-y position on the
mammogram and, by implication, the x-y position of the lesion (or
area of interest) with reference to the immobilization device.
[0187] At the top of this grid 301, one of three boxes 303 must be
checked to ascertain whether the image corresponds to a top, left
or right view. As described above, a radio-opaque marking may be
included in each respective tab of the immobilization device to
create a radio-opaque marking with a position that corresponds to
the location where a user inputs the type of view. For example, a
dot may be placed in the tab, creating a dot at the top of the
mammogram, to where the location of the dot in the tab and
mammogram is in the center (for a top view), left of center (left
view) or right of center (right view).
[0188] At the left side of the display, a user may input into a box
305 the Y coordinate as read by a medical professional. At the
bottom, a user may input into a box 307 the X reading.
[0189] At step 205, in some embodiments, the immobilization device
is disconnected from the mammogram machine bucky, and the bucky
rotated to take a second reading from a different direction (e.g.,
from the left) and a second mammography reading is taken. The
result is input in a similar manner as the first mammography
reading. As described above, in some embodiments, it may be
necessary or desirable to take an asymmetric scan. For example, if
the breast of the patient being examined is compressed
symmetrically, in some circumstances, it may be possible that a
clearer image cannot be taken through the breast, without first
reducing the thickness of the tissue through which the x-rays pass.
In this circumstance, the immobilization device may be adjusted out
of an asymmetric position to permit more than one shape during
scanning. Thus, the device may be used to flatten the breast
horizontally for a first scan, and then manipulated to flatten the
breast vertically for a second scan. In other embodiments, however,
the immobilization device is not changed, avoiding movement of the
area of interest during the process.
[0190] Since the first (e.g., top) reading is in two-dimensions and
the second (e.g., side) reading is in two-dimensions, the inputs
can be cross-checked to ascertain whether there is an anomaly in
the data. If so, the user may be warned and the magnitude of the
anomaly calculated and displayed. For example, the software and/or
hardware are configured to correct for the effects of parallax. The
accuracy of the position of the lesion is dependent on the accuracy
of the data provided. The software and/or hardware create two
theoretically intersecting vectors based on the data input for the
x and y coordinates provided by the use of each image and the know
characteristics of the imaging system. If the data points provided
are accurate and close to the lesion image on the reading, then it
is reasonable to assume the calculations below accurately reflect
the three-dimensional location of the lesion within the
immobilization device.
[0191] In another embodiment, and with reference to FIG. 13A, when
the second reading data is input, a mammogram chart is displayed
along with a line on the screen showing where on the mammogram the
region should be, to correspond to the data input on the screen.
For example, if x-y are input from a reading from the top, the
x-reading from the side should correspond to the y-reading from the
top. As would be appreciated from the discussion with reference to
FIG. 13B below, "corresponds" may not be a one-to-one relationship.
That is, where parallax error may be introduced with particular
imaging systems, a geometrical calculation may be applied to
translate the x-y reading from the top (for example) to a line on a
side view showing where on the reading the x-reading should be. As
shown in FIG. 13A, line 309 represents the x-reading taken from the
first mammography reading. Thus, the position of the lesion should
be located along this line 309 after inputting the second reading
data, and specifically the y-reading.
[0192] Displaying this line can assist a person reading the x-rays
in selecting from among multiple possible areas of interest where,
for example, multiple lesions exist within a breast or the area of
interest is a grouping of many small lesions.
[0193] When two sets of data are input (e.g., x-y reading from a
top and side view), the correspondence between measurement (for
purposes of calculating anomalies or displaying a line) may not be
linear. In some imaging equipment, the source of radiation may be a
point or fan source. The result may be a distortion of the
2-dimensional image, sometimes referred to as parallax error.
[0194] This distortion may be corrected or otherwise accounted for,
for example, by calibrating the system to a particular imaging
device . Specifically, the accuracy of the data can be verified by
plotting the distance of the lesion against four known reference
points generated by the intersection of the x-ray source along a
known plane. As illustrated in FIG. 13B, a beebee labeled B0 is the
origin of the coordinate system, e.g., a corner of the
immobilization device. The distance from the lateral image plane B0
is assumed to be known and input. The distance from the frontal
image plane to B0 is also assumed to be known and input. It is
assumed that the other three beebees, beebees B1, B2 and B3, are at
locations 0,0,L3, 0,L2,0 and L1,0,0, respectively, all also known.
In one embodiment, the four beebees may be provided on the
immobilization assembly 105, for example, or on a frame attached to
the assembly. In other embodiments, two beebees may be provided on
the frame assembly 103, e.g., on tab seat 134. These two beebees
are identified by A and B on FIGS. 13A and to 13B. It is assumed
that the x-ray source is at a distance DL from the image plane in
lateral view (positive or negative) and DF from the image plane in
frontal view. The location of the lesion should be within the space
defined by the four beebees B0, B1, B2 and B3, e.g., when these are
at the extremities of the device (although they may also be
positioned within the device so long as the lesion is located
within the beebees).
[0195] After the data has been input, the system has sufficient
information to ascertain the degree and form of parallax error for
the particular imaging system, and the point in three-dimensional
space where a lesion is located, with reference to the
immobilization device.
[0196] After the degree and form of parallax error has been
ascertained, future measurement of parallax error (e.g.,
measurements of the beebees that define the coordinate system) may
not be necessary. Since the immobilization assembly can be
registered in the same position each time with respect to the
imaging unit, this date would be essentially the same and,
therefore, does not have to be measured and input each time.
Instead, the system may adjust for parallax error based only on the
data input for the lesion. Where this is done, the two-dimensional
image still needs to be correlated or registered with respect to
the immobilization device. Radio-opaque markings on the
immobilization assembly or the frame assembly may serve that
purpose, e.g., markings in tab seat 134.
[0197] Other methods would for adjusting for possible parallax
error in the context of the present inventions could be determined
and implemented based on the disclosure provided herein.
[0198] Referring again to FIG. 12A, at step 207, and with reference
to FIG. 14, the length of the needle portion 179 is taken from the
tip of the needle portion to the base of the needle portion that
connects to the tubular member 177. Preferably, the length of the
needle portion 179 is measured in millimeters. This measurement is
input. The system may include a variety of default options for
standard needles as well as an opportunity for a user to input a
measurement for a custom needle.
[0199] With reference to FIG. 16, the user inputs the needle entry
direction, based on their judgment as to the appropriate entry
direction. As shown in FIG. 16, the technician can choose from one
of three entry directions--from top wall 147, from side wall 139,
and from side wall to 141.
[0200] Finally (although the order of input is not important), in a
system where more than one size immobilization device may be used,
an entry may be made to indicate which size unit is used.
[0201] FIG. 12B illustrates a PDA of an embodiment of the present
invention. A PDA may be used to receive the input of data read from
the mammograms and any other data to be input (e.g., entry
direction, needle length or immobilization device size) and output
lesion location and/or settings for performing the procedure (such
as where on the frame assembly to attach a needle assembly for
performing needle localization).
[0202] Once this is done, the system has all of the data required
to ascertain how to insert a needle with reference to an
immobilization device to hit an area of interest identified on
mammograms.
[0203] Consequently, at step 209, and with reference to FIG. 15, a
first distance (e.g., a posterior-anterior distance (P-A)) is
calculated and the corresponding setting on the marked indicia is
output. The frame member portions 109a, 109b and 109c may then be
positioned accordingly and locked in place using the locking tabs
129.
[0204] In step 213, and with reference to FIG. 17, a second
distance (e.g., a medio-lateral distance (M-L)) of the needle
assembly 107 is set. This may specify the position that the needle
assembly 107 should be attached to along the appropriate portion
109a, 109b or 109c. As shown in FIG. 17, the needle assembly 107 is
attached to the frame member via the clamping assembly 171. The
needle assembly 107 can be moved anywhere along the length of the
frame member portions 109a, 109b or 109c.
[0205] At step 215, and with reference to FIG. 18, the depth of the
needle portion 179 penetration is set by selecting where the
clamping assembly 171 should be attached to the tubular member 177
(with reference to the indicia on the tubular member) for insertion
at the appropriate depth.
[0206] At step 217, and with reference to FIG. 19, the needle
portion 179 of the needle assembly 107 is then inserted or plunged
to the correct depth. In this position, the medical procedure may
be performed. Such medical procedures include needle localization,
needle to aspiration, vacuum-assisted biopsy, virtual guided breast
surgery, in-office biopsy, sentinel node biopsy or therapeutic
imaging correlation and implantation, for example.
[0207] Where needle localization is being performed, it may be
desirable to remove the needle assembly in order to take a
confirmatory mammogram. A formation may be included in the outer
sleeve to permit a user to manually hold the needle in place while
the needle is disconnected (e.g., unscrewed) from the tubular
member. Once done, the remainder of the needle assembly may be
removed and one or more confirmatory mammograms may be taken. The
procedure may then be performed before or after removal of the
immobilization device.
[0208] As one would appreciate based on this disclosure, various
concepts described with reference to the embodiment of FIG. 1 may
also be applied to the embodiment of FIG. 8. For example,
historical reading may be taken to measure breast size or a
pre-sterilized liner may be included.
[0209] In the embodiment of FIG. 8, the immobilization device
provides relatively uniform compression around the entire breast,
forming the breast into generally square-shape. Changing of breast
shape is not preferred, however, during the procedure. In some
embodiments, asymmetrical compression may be required.
[0210] The embodiment of FIG. 20 illustrates an alternative
immobilization device that may be used. In FIG. 20, the
immobilization device 401 is not symmetric and the breast 408 is
flattened when the top piece 402 is pushed down toward the bottom
404. A variable density filler, such as a radiolucent or
translucent material or a radio-opaque material depending on the
particular application, may be disposed below the bottom 404. This
filler material may be manipulated to achieve a desired angle of
image, e.g., a 45.degree. offset. Sides 403 may be configured to be
rounded at the corners. A first image may be taken from direction
405, and the width of the tissue being imaged is only square-root
of two times the width of a flattened breast (where the device is
at a 45.degree. offset from the direction of orthogonal images).
Similarly, a second image can be taken at a right angle and also
have a similar width (e.g., along direction 406). This width may be
less than the width of a uniformly compressed breast, however, and
allow for lower radiation dosages in certain circumstances.
[0211] This design may be used with a frame as described above,
suitably adapted for use with this immobilization device. The
immobilization device 401 and frame (not shown) may be adapted so
that needle insertion is from one location (orthogonal to the top
402) or from either of the same direction as the images are taken
(e.g., along line 405 or 406) (or all of these).
[0212] It some circumstances, it can be preferable that the area of
interest not be located near an edge of the breast; the width of
the breast in the device is varied at the extreme edges and the
image quality may be inferior for that reason. Also, there may be
some movement of the breast at the very edges.
[0213] Where a screening mammogram is available, a user can assure
that the area of interest is not near an edge by having the patient
angle her body an appropriate amount so that the lesion is located
more toward the center of the top 402 or bottom 404 of the
immobilization unit 101.
[0214] In another embodiment, the edges of the breast may be
compressed as well, with the compression not being uniform, causing
the breast to assume a rectangular, pancake shape rather than a
more squared shape as described with reference to FIG. 8.
[0215] In another embodiment, padding or some other soft material
may be provided at the edges. This material may also be x-ray
transparent.
[0216] As one would appreciate based on the disclosure provided
herein, various alternatives described with respect to the previous
embodiments may be applied to the embodiment of FIG. 20 as well,
including use of a PDA or other device to calculate settings to
insert a medical instrument to the appropriate location and
providing the immobilization device and a medical instrument part
(e.g., the parts of a needle assembly or all of a needle assembly
except for the needle, where the needle assembly can be attached to
one or more available, standard, pre-sterilized needles) in a
pre-sterilized disposable package.
[0217] As can be appreciated by those skilled in the art, the
apparatus and methods disclosed herein can be utilized for a
variety of medical procedures. For example, the immobilization
devices described herein can be employed in a sentinel node process
in which a dye is injected into tissue surrounding a lymph node.
This procedure may be referred to as nuclear localization. In
addition, the apparatus may be used for antibody localization. The
apparatus and methods may further be utilized in procedures
requiring separate devices, such as a wheelchair or an operating
table, for example, and the apparatus can be specifically tailored
to accommodate such separate devices.
[0218] Having thus described several aspects of at least one
embodiment of this invention, it is to be appreciated various
alterations, modifications, and improvements will readily occur to
those skilled in the art. Such alterations, modifications, and
improvements are intended to be part of this disclosure, and are
intended to be within the spirit and scope of the invention.
Accordingly, the foregoing description and drawings are by way of
example only.
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