U.S. patent application number 10/842652 was filed with the patent office on 2005-07-21 for targeted biopsy delivery system.
Invention is credited to Lewis, Stephen, Olson, Bruce, Taylor, James D..
Application Number | 20050159676 10/842652 |
Document ID | / |
Family ID | 35394638 |
Filed Date | 2005-07-21 |
United States Patent
Application |
20050159676 |
Kind Code |
A1 |
Taylor, James D. ; et
al. |
July 21, 2005 |
Targeted biopsy delivery system
Abstract
This invention relates generally to the targeting and biopsy of
tissue for medical purposes, and more particularly to a targeted
biopsy system which allows planning of tissue to be sampled,
targeting of specific areas of tissue in reference to the plan,
capturing the tissue sample and recording the source location of
the tissue sample, particularly for use in collecting tissue
samples from the prostate gland. A further purpose of this
invention is to provide a targeted treatment system which allows
planning of tissue to be treated, targeting of specific areas of
tissue in reference to the plan, and delivering the treatment to
the targeted tissue.
Inventors: |
Taylor, James D.;
(Bridgeton, MO) ; Olson, Bruce; (Clayton, MO)
; Lewis, Stephen; (Florissant, MO) |
Correspondence
Address: |
Paul M. Denk
Ste. 170
763 S. New Ballas Road
St. Louis
MO
63141
US
|
Family ID: |
35394638 |
Appl. No.: |
10/842652 |
Filed: |
May 10, 2004 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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60494910 |
Aug 13, 2003 |
|
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|
Current U.S.
Class: |
600/567 ;
600/564; 606/167 |
Current CPC
Class: |
A61B 2090/378 20160201;
A61B 17/3421 20130101; A61B 10/0275 20130101; A61B 2017/3413
20130101; A61B 2017/00867 20130101; A61B 2017/3411 20130101; A61B
34/10 20160201; A61B 2018/00547 20130101; A61B 10/0241 20130101;
A61B 2017/00199 20130101; A61B 17/3403 20130101; A61B 2017/00274
20130101; A61B 10/0266 20130101; A61B 2034/107 20160201; A61B
2017/00862 20130101; A61B 2010/0225 20130101 |
Class at
Publication: |
600/567 ;
600/564; 606/167 |
International
Class: |
A61B 017/32; A61B
010/00 |
Claims
What is claimed is:
1. A targetable biopsy system comprising: a flexible biopsy needle
kit; a redirecting biopsy needle guide; an imaging means; a biopsy
planning and recording means; such that a specific area of tissue
may be accurately targeted for tissue collection.
2. The device of claim 1 whereby said flexible biopsy kit is
comprised of: a flexible stylet containing an extended specimen
notch; a flexible cannula;
3. The device of claim 1 whereby said stylet and said cannula are
manufactured with a pre-formed curve
4. The device of claim 1 whereby said stylet and said cannula are
manufactured from flexible material such as nitinol.RTM. or
plastic.
5. The device of claim 1 whereby said stylet and said cannula are
manufactured without a pre-formed curve.
6. The device of claim 1 whereby said stylet is assembled from two
or more sections each made of materials with different properties
to improve the flexibility.
7. The device of claim 1 whereby said cannula is assembled from two
or more sections each made of materials with different properties
to improve the flexibility.
8. The device of claim 1 whereby the length of said specimen notch
is increased to improve the flexibility of the stylet.
9. The device of claim 1 whereby multiple specimen notches are used
to improve the flexibility of the stylet.
10. The device of claim 1 whereby the depth of the specimen notches
varies to improve the flexibility of the stylet.
11. The device of claim 1 whereby said redirecting biopsy needle
guide is comprised of: an opening into which a biopsy needle kit
may be inserted; an opening through which a portion of the biopsy
needle kit exits; a means of redirecting said biopsy needle kit
such that the portion of the biopsy needle kit which has exited the
biopsy needle guide is angled relative to the portion of said
biopsy needle kit which has not been inserted into said biopsy
needle guide. a means of positioning the redirecting biopsy needle
guide relative to an ultrasound imaging device which remains
fixed.
12. The device of claim 1 whereby said means of redirecting the
biopsy needle physically bends a previously straight biopsy needle
kit.
13. The device of claim 1 whereby said means of redirecting
straightens a previously curved biopsy needle kit such that the
biopsy needle kit re-curve when leaving the redirecting means.
14. The device of claim 1 whereby said means of redirecting is
comprised of one or more static angled or curved channels.
15. The device of claim 1 whereby said means of redirecting
straightens is comprised of a movable device such that the opening
through which the needle kit exits may be moved relative to the
opening into which the biopsy needle kit is placed.
16. The device of claim 1 whereby said redirecting biopsy needle
guide is affixed to or associated with an ultrasound or imaging
system.
17. The device of claim 1 whereby said redirecting biopsy needle
guide may selectively positioned or rotated relative to the imaging
portion of the imaging means.
18. The device of claim 1 whereby said redirecting biopsy needle
guide is provided with demarcations or other indications of
position relative to the imaging portion of the imaging means.
19. The device of claim 1 whereby said imaging means records the
position of the biopsy sample.
20. The device of claim 1 whereby said imaging means may include a
biopsy plan specifying the preferred locations of the biopsies
relative to the position of the imaging portion of the imaging
means.
21. The device of claim 1 whereby said redirecting biopsy needle
guide may be positioned or rotated relative to the imaging portion
of the imaging consistent with the planned biopsy locations of the
biopsy plan.
22. A biopsy needle kit comprising: a flexible stylet containing an
extended specimen notch; a flexible cannula.
23. The device of claim 22 whereby said stylet and said cannula are
manufactured with a pre-formed curve from flexible material such as
nitinol.RTM. or plastic or other suitably flexible material.
24. The device of claim 22 whereby said stylet and said cannula are
manufactured without a pre-formed curve.
25. The device of claim 22 whereby said stylet is assembled from
two or more sections each made of materials with different
properties to improve the flexibility.
26. The device of claim 22 whereby said cannula is assembled from
two or more sections each made of materials with different
properties to improve the flexibility.
27. The device of claim 22 whereby the length of said specimen
notch is increased to improve the flexibility of the stylet.
28. The device of claim 22 whereby the cross section of said stylet
is reduced for a portion of the length of the stylet to improve the
flexibility of the stylet.
29. The device of claim 22 whereby the cross section of said stylet
alternates between areas where the cross section is reduced and
areas where the cross section is not reduced to improve the
flexibility of the stylet.
30. The device of claim 22 whereby the cannula is spiral cut to
improve flexibility.
31. The device of claim 22 whereby the body of the cannula is
spiral cut but the tip of the cannula body is not.
32. The device of claim 22 whereby the body of the cannula
alternates between spiral cut portions and non-spiral cut
portions.
33. A redirecting biopsy needle guide comprising: an opening into
which a biopsy needle kit may be inserted; an opening through which
a portion of the biopsy needle kit exits; a means of redirecting
said biopsy needle kit such that the portion of the biopsy needle
kit which has exited the biopsy needle guide is angled relative to
the portion of said biopsy needle kit which has not been inserted
into said biopsy needle guide.
34. The device of claim 33 whereby said means of redirecting the
biopsy needle physically bends a previously straight biopsy needle
kit.
35. The device of claim 33 whereby said means of redirecting
straightens a previously curved biopsy needle kit such that the
biopsy needle kit re-curve when leaving the redirecting means.
36. The device of claim 33 whereby said means of redirecting is
comprised of one or more static angled or curved channels.
37. The device of claim 33 whereby said means of redirecting is
comprised of a movable device such that the opening through which
the needle kit exits may be moved relative to the opening into
which the biopsy needle kit is placed.
38. The device of claim 33 whereby said biopsy needle guide may be
affixed to or associated with an ultrasound or imaging system.
39. The device of claim 33 whereby said biopsy needle guide may
selectively positioned or rotated relative to the imaging portion
of the ultrasound or imaging system.
40. A targeted medical deliver mechanism comprising: a flexible
delivery means; a flexible cannula; a redirecting cannula guide;
Whereby the cannula can be inserted into specific area of tissue
and said delivery means can be inserted through the cannula to said
specific area of tissue.
41. The device of claim 40 whereby said delivery means deposits a
material in said specific area of tissue.
42. The device of claim 40 whereby said delivery means deposits and
removes a material in said specific area of tissue.
43. The device of claim 40 whereby said delivery means removes a
previously-deposited material in said specific area of tissue.
44. The device of claim 41 whereby said material may be a solid,
liquid or gas.
45. The device of claim 42 whereby said material may be a solid,
liquid or gas.
46. The device of claim 43 whereby said material may be a solid,
liquid or gas.
47. The device of claim 43 whereby said material may be
organic.
48. The device of claim 43 whereby said material may be a living
organism.
49. The device of claim 40 whereby said delivery means is used to
apply energy to said specific area of tissue.
50. The device of claim 49 whereby said energy may be heat, cold,
visible or non-visible radiation.
51. A biopsy planning and recording means comprising: means of
receiving and displaying images generated by the imaging means;
means of projecting needle image path information onto said
displayed images; means of recording projected needle path
locations means of recording actual needle path locations
52. The device of claim 51 whereby said biopsy and planning means
can project a line which correlates with a needle path.
53. The device of claim 51 whereby said biopsy and planning means
can project a dot which correlates to the intersection of the
needle path with the imaging plane.
54. The device of claim 51 whereby said projected needle image path
information can be positioned relative to a landmark of the scanned
organ or tissue mass.
55. The device of claim 51 whereby said projected needle image path
information can be correlated to the redirecting guide positioning
selection.
56. The device of claim 51 whereby said biopsy and planning means
can be used to simulate the insertion of a needle into the targeted
organ or tissue mass.
57. The device of claim 51 whereby said received images can be used
to build a graphical representation of the targeted organ or tissue
mass showing the positions of the projected and actual needle paths
relative to the targeted organ or tissue mass.
58. The device of claim 51 whereby said recording projected and
actual needle paths can be recorded to an external medium or
transmitted to an external location.
Description
CROSS REFERENCE TO RELATED APPLICATION
[0001] This nonprovisional patent application claims priority to
the provisional patent application having Ser. No. 60/494,910,
which was filed on Aug. 13, 2003.
BACKGROUND OF THE INVENTION
[0002] Prostate health is a significant concern for men over the
age of fifty. If prostate cancer is suspected from either a
physical examination or because of a Prostate Specific Antigens
test, a biopsy is performed to collect tissue samples from the
prostate for evaluation by a pathologist. Prostate tumors are small
growths scattered about the prostate. For this reason, a physician
will take multiple tissue samples from different areas of the
prostate, typically between 9 and 18 samples.
[0003] The normal procedure for obtaining biopsy samples with
ultrasound guidance is called Transrectal Ultrasound (TRUS) Guided
Prostate Biopsy. An end-fire ultrasound probe is used, which
generates a pie-shaped image plane. Some end-fire probes are
manufactured with a biopsy needle channel, which passes through the
body of the probe at an angle, such that a biopsy needle set
inserted through the biopsy needle channel exits the channel at a
slight angle relative to the body of the probe. Most probes require
a needle set guide tube to be affixed to the probe body, such that
a needle set placed through the guide tube parallels the axis of
the probe and the needle set can be extended beyond the end of the
probe. In use for both, the physician inserts the ultrasound probe
into the rectum, and moves the probe around until the specific area
of the prostate to be sampled is identified. The physician then
bends the probe upward, pointing the biopsy needle channel or
biopsy needle set guide at the targeted area of the prostate. A
needle set is inserted into and through the needle channel or
guide, pushed through the rectum wall and into the prostate.
[0004] Standard coring biopsy needles sets are made from
substantially rigid, coaxially aligned, stainless steel wire and
tubing. They are comprised of two basic components; an inner solid
wire stylet with specimen notch and a hollow outer cutting cannula.
Once the needle set is correctly positioned relative to the area of
tissue to be sampled, the inner stylet is quickly advanced under
spring loaded or similar pressure into the prostate tissue. The
tissue to be sampled then "prolapses" into stylet's sample notch
cutout. Almost instantaneously the outer cutting cannula quickly
advances, also under spring loaded pressure, which serves to sever
and capture the tissue that had prolapsed into the stylet notch.
The needle set is then removed from the tissue/patient so that the
tissue sample can be extracted from the needle set and evaluated
for the presence of cancer. The physician then moves the probe
around within the rectum to identify the next area of the prostate
to be sampled, and the process is repeated. As noted, between 9 and
18 samples are typically taken from different areas of the
prostate.
[0005] Existing biopsy methods suffer from a number of
disadvantages. Because the probe must be physically moved about
within the rectum by hand to identify and target the different
areas of the prostate, it is difficult for physicians to precisely
targeted biopsy sample locations, often causing the need for
additional samples to be taken. Further, if a sample seems to
confirm cancer, it is difficult for the physician to accurately
know where in the prostate the sample was taken from, and so
difficult to re-biopsy the same tissue location to confirm the
cancer.
[0006] A number of systems or devices have been proposed for the
purpose of better targeting biopsies. Batten, et al, (U.S. Pat. No.
5,398,690) discloses a slaved biopsy device, analysis apparatus,
and process. In Batten, an ultrasound device is inserted into the
male urinary tract through the penis, with the biopsy and treatment
device inserted transrectally. Chin, et al, (U.S. Pat. No.
6,179,249) discloses an ultrasound guided therapeutic and
diagnostic device. Chin is a flexible ultrasound device used for
laproscopic surgery. Lin (U.S. Pat. No. 6,261,234) disclosed a
method and apparatus for ultrasound imaging with biplane instrument
guidance. Lin's ultrasound device uses two transducers to create
two image planes, and has a biopsy needle guide which directs a
biopsy needle at the intersection of the imaging planes. Burney, et
al (U.S. Pat. No. 6,447,477) discloses surgical and pharmaceutical
site access guide and methods. Burney shows a biopsy device in
which a thick needle with side exit ports is inserted into the
targeted tissue. Biopsy needles are then inserted into the thick
needle, exiting out the side to take samples. Further, a number of
systems have specified the use of flexible biopsy needle kits.
[0007] However, all of these inventions suffer from a number of
disadvantages. All require specialized equipment, and do not make
use of existing ultrasound systems and technology. All require the
movement of the imaging device, making it more difficult to plan
and target areas of the prostate for biopsy. Further, the flexible
biopsy needles called out either require heating or additional
force to cause them to fire, and are impractical for use with
established prostate biopsy procedures and existing biopsy needle
set firing devices.
[0008] Therefore, users would benefit from a biopsy system to allow
a biopsy to be planned prior to the tissue sampling, to allow the
biopsy needle to be precisely inserted into a targeted area and
which is able to record the precise location from which the tissue
sample is collected while the imaging device remains stationary.
Users would also benefit from a flexible needle set which may be
easily "fired" while in a curved position. Further, users would
benefit from a means of precisely delivering a treatment to a
targeted area of an organ or tissue mass.
SUMMARY OF THE INVENTION
[0009] It is the principal object of this invention to provide a
device and method for precisely planning, undertaking and recording
a multi-sample biopsy of a targeted tissue mass such as a prostate,
improving physicians' ability to diagnose cancer.
[0010] Another object of the invention is to allow a biopsy plan to
be formulated identifying the specific quadrants and areas of the
prostate to be sampled.
[0011] Another object of the invention is to allow this biopsy plan
to be saved as a reference point.
[0012] Another object of the invention is to allow a physician to
adjust the biopsy needle guide to allow the physician to precisely
insert the needle into the tissue at the planned location.
[0013] Another object of the invention is to allow a physician to
monitor the needle set as it is inserted into the tissue, to verify
that the needle is in the planned location.
[0014] Another object of the invention is to provide a biopsy
needle guide which can be affixed to or associated with existing
side-imaging transrectal ultrasound probes.
[0015] A further object of the invention is to allow the
transrectal ultrasound probe to remain stationary while the biopsy
samples are gathered from different areas of the prostate, thereby
improving the accuracy of the procedure.
[0016] A further object of the invention is to allow the probe to
remain stationary while the needle guide is moved longitudinally
along the probe and is also rotated around the probe.
[0017] A further object of the invention is to provide a needle set
guide which can redirect the needle set such that the needle set
can be curved while still maintaining the freedom of movement to
allow the firing and collecting of tissue samples.
[0018] A further object of the invention is to provide a biopsy
needle set that may be redirected at an angle and further maintains
its ability to be fired and so collect the tissue samples.
[0019] An object of an alternative embodiment of the invention is
to allow a treatment plan to be formulated identifying the specific
areas of tissue or an organ to be treated.
[0020] A further object of an alternative embodiment of the
invention is to allow this treatment plan to be saved as a
reference point.
[0021] Another object of an alternative embodiment of the invention
is to allow a physician to precisely insert a needle or treatment
delivery means into the tissue at the planned location.
[0022] Another object of the invention is to allow a physician to
monitor the needle or treatment delivery method as it is inserted
into the tissue, to verify that the needle or treatment delivery
method is in the planned location.
[0023] These and other objects, advantages and features are
accomplished according to the devices and methods of the following
description of the preferred embodiment of the invention.
SUMMARY OF THE INVENTION
[0024] As noted the present invention relates to a biopsy targeting
system for use with ultrasound imaging devices, and particularly
for use in sampling prostate tissue. The biopsy targeting system
consists of a redirecting biopsy needle guide which works in
conjunction with a side-view or end-fire transrectal ultrasound
probe, a cooperating software program which can be loaded and
operated on a computer controlled ultrasound system, and a bendable
needle set.
[0025] In use, the transrectal ultrasound probe is placed in the
cradle of a stabilizer. The redirecting needle guide positioning
assembly is also affixed to the cradle. The physician then advances
and adjusts the cradle to allow the transrectal probe to be
inserted into the rectum of a patient. The physician generates an
ultrasound image while positioning the probe to insure that the
patient's prostate is viewable within the viewing area of the
probe. Once the probe is correctly positioned, the physician then
locks the probe in place in the stabilizer.
[0026] With the transectal probe in place, the physician initiates
a full 3D scan of the prostate. The multiple image slices are
captured by the ultrasound system. The physician then looks through
these saved images, to identify possible problem areas of the
prostate and further to decide which areas of the prostate to
sample. Typically, physicians collect 9 to 18 tissue samples from
different areas of the prostate. As part of this process, the
physician is able to use the software program to project potential
needle path lines onto the images of the prostate. These paths are
shown as lines in views parallel to the needle path and as circles
where the paths pierce the image plane. Each possible path is
described by the positional settings of the redirecting needle
guide. When the physician identifies a specific area to be sampled,
the physician moves a projected needle path line to intersect the
planed area to be biopsied. The physician continues to evaluate the
prostate and target additional areas for sampling, again saving
projected needle paths for each planned sample. Further, if the
physician does not identify any possible problem areas, but wishes
to take a standard biopsy, the physician can use a range of default
setting on the computer program to project between 9 and 18
projected needle paths with a standard distribution throughout the
prostate.
[0027] Once the biopsy is planned, the physician initiates the
biopsy. All of the needle paths for a given longitudinal image are
displayed on the ultrasound monitor. The display shows the
coordinates of the planned needle paths which correlate to the
positional setting of the redirecting needle guide. The physician
then advances and/or rotates the redirecting needle guide to the
correlating coordinates for the first planned needle path. The
physician then inserts a flexible biopsy needle kit into the
redirecting needle guide's needle insertion point. The needle set
is advanced by hand through the needle set channel, including
through the redirecting curve within the needle guide. This
redirecting curve causes the needle to exit the needle guide,
within the rectum of the patient, at an angle relative to the
transrectal probe. The physician pushes the needle guide through
the tissue of the rectal wall and into the prostate, monitoring the
progress of the needle on the ultrasound system and insuring that
the actual path of the needle matches the planned needle path being
projected on the image. When the biopsy needle set has achieved the
correct depth of penetration, the physician uses a standard biopsy
firing gun to "fire" the needle set, causing the stylet and cannula
to quickly extend in sequence, cutting and capturing a slice of
prostate tissue in the specimen notch of the needle set. Because
the specimen notch is substantially longer than in standard biopsy
needles and the cannula body is flexible, the needle set is very
flexible and able to be fired even though bent. The specimen notch
is extended to the curved portion of the needle set within the
redirecting needle set guide, allowing the stylet to be quickly
moved in reference to the cannula without binding. With the needle
still in the prostate, the physician saves the ultrasound image(s)
on the computer program, creating a permanent record of the biopsy
tissue location. The physician then removes the biopsy needle with
captured tissue sample. Once removed, the cannula is retracted from
the stylet, allowing the tissue sample to be placed into a tissue
specimen dish. The physician then advances or moves the redirecting
biopsy needle guide to the next planned needle path location, and
repeats the procedure.
BRIEF DESCRIPTION OF THE DRAWINGS
[0028] FIG. 1 is a perspective view of targetable biopsy system in
conjunction with an ultrasound imaging system and stabilizer.
[0029] FIG. 2 is a perspective view of the redirecting needle set
guide mounted on a side-imaging transrectal ultrasound probe.
[0030] FIG. 3 is a side view of the redirecting needle set guide
mounted on a side-imaging transrectal ultrasound probe, showing the
guide positioning assembly.
[0031] FIG. 4 is a planning software interface displayed on the
monitor.
[0032] FIG. 5 is a schematic of the biopsy planning process.
[0033] FIG. 6 is a schematic of the biopsy procedure.
[0034] FIG. 7 is a side view of an embodiment of the targetable
biopsy guide.
[0035] FIG. 8 is a side cutaway view of an embodiment of the
targetable biopsy guide designed to be manufactured with an
insertable metal tube.
[0036] FIG. 9 is a side cutaway view of an alternative embodiment
of the targetable biopsy guide.
[0037] FIG. 10 is a side cutaway view of an alternative embodiment
of the targetable biopsy guide with an enlarged bend channel.
[0038] FIG. 11 shows a side view of a biopsy stylet with extended
specimen notch.
[0039] FIG. 12 shows a side view of an alternative embodiment of
the stylet with dual extended specimen notches.
[0040] FIG. 13 shows a side view of an alternative embodiment of
the stylet with a tiered specimen notch.
[0041] FIG. 14 shows a side view of an alternative embodiment of
the stylet with multiple notches to facilitate bending.
[0042] FIG. 15 shows a side view of an embodiment of the cannula in
which the cannula tube has been ground down along its length to
leave a flexible spine.
[0043] FIG. 16 shows a side view of an embodiment of the cannula in
which the cannula tube has been spiral-cut along its length to
facilitate bending of the cannula.
[0044] FIG. 17 shows a side view of an alternative embodiment of
the cannula in which the tip of the cannula tube is uncut while the
body of the cannula tube has been spiral-cut.
[0045] FIG. 18 shows a side view of an alternative embodiment of
the cannula in which sections of the cannula tube alternate between
cut and uncut.
[0046] FIG. 19 shows a side view of an embodiment of the cannula in
which the cannula tube is encased in flexible tubing.
[0047] FIG. 20 shows a perspective view of an embodiment of the
flexible needle set.
[0048] FIG. 21 is a side view of the traditional method of taking a
prostate biopsy with a biopsy needle channel.
[0049] FIG. 22 is a side view of the bendable needle and biopsy
targeting system mounted on a side-fired probe taking a biopsy.
[0050] FIG. 23 is a side view of the redirecting guide with a
flexible needle set inserted and extending out of the guide such
that the needle set is bent by the needle set channel bend.
PARTS NUMBERS
[0051] Rectum 1
[0052] Prostate 2
[0053] redirecting guide 10
[0054] alternative redirecting guide 10A
[0055] positioning assembly 11
[0056] targeting software system 12
[0057] flexible needle set 13
[0058] cradle 15
[0059] stabilizer 16
[0060] ultrasound system 17
[0061] ultrasound system CPU 18
[0062] side view transrectal probe 19
[0063] monitor 20
[0064] probe tip 22
[0065] probe imaging window 23
[0066] guide body 30
[0067] needle set channel 31
[0068] needle set insertion point 32
[0069] needle set exit point 33
[0070] front body guide extensions 34A, 34B
[0071] imaging cutout 35
[0072] needle set channel bend 36
[0073] enlarged bend channel 37
[0074] insertable metal tube 38
[0075] rotational adjustment collar 40
[0076] fixed collar 41
[0077] longitudinal slides 42
[0078] longitudinal position controller 43
[0079] needle path location registry 50
[0080] needle path lines 51
[0081] needle path dots 52
[0082] flexible stylet 60
[0083] flexible cannula 61
[0084] tip 62
[0085] extended specimen notch 63
[0086] stylet body 64
[0087] cutting tip 65
[0088] cannula body 66
[0089] counter bore and taper 67
[0090] bending notches 70
[0091] tiered specimen notch 71
[0092] segmented specimen notch 72
[0093] removable needle set guide insert 75
[0094] stylet hub 76
[0095] cannula hub 77
[0096] strip 78
[0097] depth markings 79
[0098] cannula sheath 81
[0099] spiral cut 82
[0100] non-spiral cut portion 83
[0101] beveled edge 84
[0102] Biopsy attachment angle selector 201 and display
[0103] Biopsy attachment depth selector 202 and display
[0104] needle path coordinates display 204 window
[0105] Finished with Biopsy Planning 206 button
[0106] Remove selected biopsy location 207 from plan button
[0107] Add selected biopsy location to 208 plan button
[0108] Select pre-planned template 209
[0109] Sagittal image plane selector 210
[0110] Transverse image plane selector 211
[0111] Transverse image display 212
[0112] Sagittal Image display 213
DESCRIPTION OF THE PREFERRED EMBODIMENT
[0113] As seen in FIG. 1, the targeted biopsy system is comprised
of a redirecting guide 10, positioning assembly 11, targeting
software system 12 (loaded on CPU 18) and flexible needle set 13
(best seen in FIG. 20). The positioning assembly 11 is affixed to
cradle 15, which is a part of stepper and stabilizer 16. Working in
conjunction with the targeted biopsy system is ultrasound system
17, which is comprised of ultrasound system CPU 18, side view
transrectal probe 19 and monitor 20. Side view transrectal probe is
comprised of probe tip 22 and probe imaging window 23. As seen in
FIGS. 2 and 7, the redirecting guide 10 consists of guide body 30,
needle set channel 31, needle set insertion point 32, and needle
set exit point 33, front body guide extensions 34A and 34B, imaging
cutout 35. As seen in FIG. 10, needle set channel 31 may be
provided with enlarged bend channel 37. As seen in FIG. 8, the
redirecting guide 10 may be provided with insertable metal tube 38.
In an alternative embodiment, the redirecting guide may contain one
or more pathways may be used for insertion of the biopsy needle
kit. The redirecting guide may be comprised of a movable device
such that the opening through which the needle kit exits may be
moved relative to the opening into which the biopsy needle kit is
placed. In a further alternative embodiment, the redirecting guide
may straighten a previously curved biopsy needle kit such that the
biopsy needle kit re-curve when leaving the redirecting guide.
[0114] As best seen in FIG. 3, positioning assembly 11 is comprised
of rotational adjustment collar 40, fixed collar 41, longitudinal
slides 42 and longitudinal position controller 43.
[0115] As best seen in FIG. 4, targeting software system 12 is
comprised of transverse image display 212, Sagittal Image display
213, longitudinal projected needle path 51 and transverse projected
needle path 52, in addition to various controls.
[0116] As best seen in FIG. 20 flexible needle set 13 consists of
flexible stylet 60 and flexible cannula 61. Stylet 60 may be
affixed to stylet hub 76, with cannula 61 affixed to cannula hub
77. Further, cannula 61 may be provided with depth markings 79. As
seen in FIG. 11, the preferred Flexible stylet 60 consists of tip
62, extended specimen notch 63 and stylet body 64. As seen in FIG.
12, an alternative preferred Flexible stylet 60 consists of tip 62
and segmented specimen notches 72a and 72b. Alternative embodiments
of flexible stylet 60, as seen in FIGS. 13 and 14, contain bending
notches 70 and tiered specimen notch 71.
[0117] As seen in FIG. 19, the preferred embodiment of cannula 61
consists of cutting tip 65, cannula body 66 and cannula sheath 81.
The cannula sheath may have beveled edges. As seen in FIG. 15, a
portion of the body of flexible cannula 61 has been removed. As
seen in FIG. 16, cannula body 66 may be provided with spiral cut 82
to facilitate bending. As seen in FIG. 17, in an alternative
embodiment of cannula 61, cannula body 66 may be provided with
non-spiral cut portion 83 at cutting tip 65, to facilitate the
straight entry of the cannula into the tissue. As seen in FIG. 18,
in a further alternative embodiment of cannula 61, cannula body 66
may be provided with non-spiral cut portions 83 interspersed with
spiral cuts 82. In an alternative embodiment of flexible cannula 61
consists of a cutting tip inserted into the flexible cannula
body.
[0118] It should be noted that both the stylet cannula can be made
from a range of flexible materials, including combinations of one
or more materials, to facilitate the bendability. This may include
traditional materials used in medical devices, such as stainless
steel, as well as materials such an nitinol.RTM.. Furthermore, the
cannula design may mirror the stylet, such that portion or portions
of the metal cannula tube are removed to create a metal component
which has a metal cutting tip, a long spine consisting of only a
portion of the cannula wall in the flexible part of the cannula and
then the full tubular cannula. Furthermore, the machine cannula may
be partially or wholly incased in a cannula sheath, which may be
plastic or some other material.
[0119] FIG. 21 shows a biopsy being performed using the standard
method, using an end-fire ultrasound probe with a biopsy needle
channel. The probe is inserted into the rectum, and then angled
upward until the probe tip is pointed at the desired portion of the
prostate. A needle set is then inserted through the biopsy needle
channel guide into the prostate 2.
[0120] In use of the preferred embodiment of the invention, as seen
in FIGS. 1 and 22, side view transrectal probe 19 is mounted on the
cradle 15 of a stabilizer 16. Redirecting guide 10 is also mounted
on the cradle 15, such that guide body 30 sits atop probe tip 22.
As seen in FIG. 2, front body extensions 34a and 34b partially wrap
around probe tip 22 to help maintain the guide body 30 on the probe
tip 22. The cradle 15 is moved forward, with the probe tip 22
inserted into patient's rectum 1. Probe tip 22 is generating
ultrasound images, which are displayed on monitor 20. The physician
uses this image to insure that the entirety of prostate 2 is
viewable by probe imaging window 23. Once the probe tip 22 is
correctly positioned, the physician locks in place cradle 15.
[0121] The biopsy planning process is illustrated in FIG. 5. A
representative display of the biopsy information to the user is
shown in FIG. 4. The process begins with the planning software
obtaining a set of volumetric data 101. The volumetric data
consists of two sets of sampled images. One set is of longitudinal
images sampled at a regular angular spacing, and the other is a set
of transverse images sampled at regular depth spacing. If only one
of the two sets is available, one may be interpolated from the
other. The physician starts the planning process by pressing button
203 to satisfy step 102 of FIG. 4. For 103, the planning system
overlays a series of lines 51a, b, c, etc. and dots 52a, b, c, etc.
on the images in panes 212 and 213. These lines and dots represent
the available needle paths selectable with controls 40 and 43, and
show where the needle intersects with image planes. Each line and
dot combination is labeled with a coordinate 50 corresponding to a
unique pair of setting for controls 40 and 43. The user can review
the stored images using controls 210 and 211 to change the image
viewed. For 104, the user can "simulate" the effect of controls 40
and 43 using on-screen controls 201 and 202 to adjust the selected
needle path. The current path is displayed by changing the color of
the appropriate line and dot (51 and 52, respectively). The user
adds a specific needle path to the biopsy plan (105) by selecting
button 208. Each time a path is selected, a record is placed into
needle path coordinates display window 204 showing the coordinates
of the path. The user may also remove a specific path from the plan
by selecting button 207. When the plan is complete, the user clicks
on the button 206 to send the planning process (106).
[0122] Once the biopsy planning process has been completed, the
physician or technician may then proceed with the biopsy procedure,
to complete the series of precision located biopsy's to be taken
through the usage of this instrument. For example, as can be noted
in FIG. 6, once a biopsy procedure has been completed, the
physician then determines whether any more biopsies are needed, and
where the biopsy locations may be determined. This can be seen at
301. If no additional biopsies are required, this is the end of the
procedure. If additional biopsies are considered as needed, the
physician then adjusts the redirection of the guide 10, and the
longitudinal controller 40, to mass the desired biopsy coordinates,
as provided upon the scanner. This can be noted at 302. Then, the
user inserts a needle set 13 into the channel 32, to prepare for
additional biopsies. The physician then inserts the needle into the
patient, moving the needle in and out to adjust for depth, as
determined by the scanner, as can be seen at 304. Then, the
physician can determine if the needle tip is at the correct depth,
at 305. If it is not, then the physician may move the needle and
adjust its depth further. If it is, the physician then fires the
needle of the biopsy instrument, as at 306. Then the physician
removes the needle set 13 from the patient, having taken the biopsy
as required. Then, the tissue sample is removed from the biopsy
needle notch, for further analysis by the lab. This can be noted at
308. When this is completed, this concludes the conduct of biopsies
upon the patient.
[0123] As alternative to the procedure in FIG. 4, preplanned biopsy
selection menu 209 allows the user to select a pre-determined
needle pattern, typically 9-12 needle paths, without having to
select each needle path manually. The needle paths generated could
need to be adjusted for the specific size of the organ. The size of
the organ can be input by various means. The planning process
allows the physician to modify the needle paths as needed and to
approve that they are correct.
[0124] Projected needle paths 51a, 51b, etc, include needle path
location registry 50, which indicate the horizontal and rotational
position of the needle path in reference to the probe. Working from
the saved biopsy plan, displayed in 204, the physician rotates
redirecting guide 10 using rotational adjustment collar 40, and
then advances the redirecting guide using longitudinal position
controller 40, both of which have position information which
correlates to the needle path location registry 50. As seen in FIG.
18, the physician inserts flexible needle set 13 into needle set
insertion point 32 and into needle set channel 31. When the needle
set 13 reaches needle set channel bend 36, the needle set 13 is
redirected at an angle away from the axis of probe tip 22. Needle
set 13 exits needle set exit point 33. Because of imaging cutout
35, the physician is able to see the needle set in the ultrasound
image as it exits exit point 33, allowing the physician to insure
that the needle set 13 is in the path marked by projected needle
path 51a. The physician monitors the depth of the needle set 13 as
it is pushed through the rectum wall and into the prostate 2. Once
the desired depth is reached, the physician stops inserting the
needle set 13. Using a standard biopsy gun, the needle set 13 is
"fired". This causes flexible stylet 60 to rapidly advance a short
distance, such that tissue from the prostate two prolapses into
extended specimen notch 63. Almost instantaneously flexible cannula
61 quickly advances, also under spring loaded pressure or other
motivational means, which serves to sever and capture the tissue
that had prolapsed into the extended specimen notch 63. Because the
extended specimen notch 63 extends to the point where flexible
needle set 13 is bent in needle set channel bend, the stylet and
cannula are able to fire without the two pieces binding together,
allowing the specimen to be effectively captured. The physician
then removes the flexible needle set 13 with the captured specimen.
The specimen is removed from the flexible needle set, and the
physician then resets the redirecting guide to the coordinates of
the next saved projected needle path 51b. The process is repeated
until the physician has captured all of the samples as planned
using the targeting software system 12.
[0125] FIG. 23 provides a side cut-away view of the redirecting
guide with a flexible needle set inserted and extending out of the
guide such that the extended specimen notch is bent by the needle
set channel bend.
[0126] In an alternative embodiment of the invention, the invention
is used to plan and perform a targeted treatment of an organ or
tissue mass. With the device in place, the process begins with the
planning software obtaining a set of volumetric data. The planning
system overlays a series of needle path lines and needle path dots
on the images in panes 212 and 213, which represent the available
needle paths with coordinates that match the coordinates on
rotational adjustment collar 40 and longitudinal position
controller 43 of positioning assembly 11. The user selects specific
needle paths, which are saved the treatment plan. Preplanned
treatment selections allow the user to select a pre-determined
needle pattern without having to select each needle path
manually.
[0127] Working from the saved treatment plan, the physician rotates
redirecting guide using rotational adjustment collar, and then
advances the redirecting guide using longitudinal position
controller, both of which have position information which
correlates to the needle path location registry. The physician then
inserts a flexible needle set or treatment delivery means into
needle set insertion point 32 and into needle set channel 31. When
the needle set or treatment delivery means reaches the needle set
channel bend, the needle set or treatment delivery method is
redirected at an angle away from the axis of probe tip 22. Needle
set 13 exits needle set exit point 33. Because of imaging cutout
35, the physician is able to see the needle set or treatment
delivery method in the ultrasound image as it exits exit point 33.
The physician monitors the depth of the needle set or treatment
delivery method as it is pushed into the targeted organ or tissue
mass. Once the desired depth is reached, the physician is able to
undertake the preferred activity. This may include using the
delivery means to inject a solid, gas or liquid material or other
treatment apparatus into the targeted organ or tissue mass.
Further, the physician may insert an organism into the targeted
organ or tissue mass. The material may be deposited and left in the
targeted organ or tissue mass. Further, material previously
deposited may be removed. The use of the deposited material may be
as a treatment, a marker, or other uses. Further, the delivery
means may be used to apply energy to a targeted organ or tissue
mass, including but not limited to heat, cold, light and radiation.
Once the treatment or marking is delivered, the physician then
removes the flexible needle set or treatment delivery method, and
then resets the redirecting guide to the coordinates of the next
saved projected needle path. The physician has the option of saving
the image of the treatment needle in the targeted organ or tissue
mass, to record the location of the treatment as delivered. The
process is repeated until the physician has treated or marked all
of the targeted areas of the organ or tissue mass.
* * * * *