U.S. patent application number 15/076435 was filed with the patent office on 2016-07-14 for biopsy needle assembly.
The applicant listed for this patent is 3DBiopsy LLC. Invention is credited to Dave A. SCHECHTER, Nelson N. STONE.
Application Number | 20160199046 15/076435 |
Document ID | / |
Family ID | 54006197 |
Filed Date | 2016-07-14 |
United States Patent
Application |
20160199046 |
Kind Code |
A1 |
STONE; Nelson N. ; et
al. |
July 14, 2016 |
BIOPSY NEEDLE ASSEMBLY
Abstract
A biopsy needle assembly for excising a tissue specimen from a
target tissue includes a mandrel with a core bed having an inner
surface forming a projection for engaging the tissue specimen. One
or more projections are located between the edges of the core bed.
The projections are formed from the inner surface or extend from
the inner surface. The mandrel moves within a cannula whereby the
core bed is extended beyond the tip of the cannula into a target
tissue. The projection engages the target tissue holding the
tissues in place as the cannula is advanced over the core bed
cutting the tissue and separating the tissue specimen within the
core bed from the surrounding tissue.
Inventors: |
STONE; Nelson N.; (Vail,
CO) ; SCHECHTER; Dave A.; (LONGMONT, CO) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
3DBiopsy LLC |
Vail |
CO |
US |
|
|
Family ID: |
54006197 |
Appl. No.: |
15/076435 |
Filed: |
March 21, 2016 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14634679 |
Feb 27, 2015 |
9289192 |
|
|
15076435 |
|
|
|
|
61946366 |
Feb 28, 2014 |
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Current U.S.
Class: |
600/567 |
Current CPC
Class: |
A61B 8/463 20130101;
A61B 2090/395 20160201; A61B 10/02 20130101; A61B 8/483 20130101;
A61B 10/0241 20130101; A61B 90/39 20160201; A61B 10/0275 20130101;
A61B 34/25 20160201; A61B 8/12 20130101; A61B 2010/0208
20130101 |
International
Class: |
A61B 10/02 20060101
A61B010/02 |
Claims
1. A biopsy needle for excising a tissue specimen, the biopsy
needle comprising: a first component, comprising: a body extending
longitudinally between a proximal end and a distal end about a
longitudinally-extending central axis, wherein the body forms a
core bed adjacent the distal end for receiving a tissue specimen;
wherein the core bed forms a cavity with an inner surface extending
longitudinally between a first end and a second end, and laterally
between a first longitudinal edge and a second longitudinal edge;
and wherein the inner surface forms a projection for engaging the
tissue specimen.
2. The needle of claim 1, wherein the projection forms a ridge
extending between the first longitudinal edge and the second
longitudinal edge.
3. The needle of claim 2, comprising a plurality of ridges.
4. The needle of claim 1, wherein the projection forms a ridge
extending from the first longitudinal edge to the second
longitudinal edge.
5. The needle of claim 1, comprising a plurality of
projections.
6. The needle of claim 5, wherein the plurality of projections are
grouped adjacent the first end.
7. The needle of claim 5, wherein: a first set of a plurality of
projections is adjacent the first end; a second set of a plurality
of projections is adjacent the second end; and a third set of a
plurality of projections is disposed between the first set and
second set.
8. The needle of claim 1, wherein: the inner surface defines an
upwardly open lower cavity; and the first longitudinal edge and
second longitudinal edge form the upper edges of the lower
cavity.
9. The needle of claim 8, wherein the upwardly open cavity has a
C-shaped transverse cross-section.
10. The needle of claim 8, wherein the projection is below the
central axis.
11. The needle of claim 1, further comprising: a second component,
comprising: a tubular body extending longitudinally between a
proximal end and a distal end, wherein the distal end forms a
cutting face; and wherein the inner component travels within the
outer component.
12. The needle of claim 1, wherein the projection extends from the
inner surface.
13. A biopsy needle for excising a tissue specimen, the biopsy
needle comprising: an inner component, comprising: a body extending
longitudinally between a proximal end and a distal end about a
longitudinally-extending central axis, wherein the body forms a
core bed adjacent the distal end for receiving a tissue specimen;
wherein the core bed forms a cavity with an inner surface extending
longitudinally between a first end and a second end, and laterally
between a first longitudinal edge and a second longitudinal edge;
and wherein the inner surface forms a ridge for engaging the tissue
specimen; an outer component, comprising: a tubular body extending
longitudinally between a proximal end and a distal end, wherein the
distal end forms a cutting face; and wherein the inner component
travels within the outer component.
14. The needle of claim 13, wherein the inner component comprises a
plurality of ridges grouped adjacent the first end.
15. The needle of claim 13, wherein the inner surface defines an
upwardly open lower cavity.
16. The needle of claim 13, wherein the upwardly open cavity has a
C-shaped transverse cross-section.
17. The needle of claim 13, wherein the ridge extends from the
inner surface.
18. The needle of claim 13, wherein the inner component comprises:
a first set ridges adjacent the first end; a second set of ridges
adjacent the second end; and a third set of ridges disposed between
the first set and second set.
19. A biopsy needle for excising a tissue specimen, the biopsy
needle comprising: an inner component, comprising: a body extending
longitudinally between a proximal end and a distal end about a
longitudinally-extending central axis, wherein the body forms a
core bed adjacent the distal end for receiving a tissue specimen;
wherein the core bed forms a cavity with an inner surface extending
longitudinally between a first end and a second end, and laterally
between a first longitudinal edge and a second longitudinal edge;
and wherein the inner surface forms a projection extending between
the first longitudinal edge and the second longitudinal edge for
engaging the tissue specimen; an outer component, comprising: a
tubular body extending longitudinally between a proximal end and a
distal end, wherein the distal end forms a cutting face; and
wherein the inner component travels within the outer component.
20. The needle of claim 19, wherein the projection extends from the
first longitudinal edge to the second longitudinal edge.
21. The needle of claim 19, wherein the projection forms a
ridge.
22. The needle of claim 19, wherein the projection extends from the
inner surface.
23. The needle of claim 19, wherein the inner surface forms: a
first set of projections adjacent the first end; a second set of
projections adjacent the second end; and a third set of projections
disposed between the first set and second set.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of, and claims the
benefit of, U.S. Non-Provisional patent application Ser. No.
14/634,679, filed Feb. 27, 2015, which claims the benefit of U.S.
Provisional Application No. 61/946,366, filed Feb. 28, 2014. The
present application is also related to U.S. Non-Provisional patent
application Ser. No. 14/634,345, filed Feb. 27, 2015, now U.S. Pat.
No. 9,149,260, which claims the benefit of U.S. Provisional
Application No. 61/946,366, filed Feb. 28, 2014. The present
application is also related to U.S. Non-Provisional patent
application Ser. No. 14/634,576, filed Feb. 27, 2015, now
abandoned, which claims the benefit of U.S. Provisional Application
No. 61/946,366, filed Feb. 28, 2014.
BACKGROUND
[0002] The present disclosed subject matter relates generally to a
transperineal prostate needle biopsy system and method, and more
particularly to a biopsy needle used in conjunction with imaging
and planning software to identify and treat lesions of the
prostate.
[0003] Prostate cancer is the most frequently diagnosed solid tumor
in men and second leading cause of cancer death in the United
States. Early detection and treatment of such tumors has
progressively decreased the age--adjusted death rates. A diagnosis
of a prostate tumor may be confirmed by a biopsy and assessment of
the suspect tissue.
[0004] The standard biopsy needle used to confirm a diagnosis of
prostate cancer consists of a fixed length core bed. Such a needle,
and similar devices, are designed to be used in conjunction with a
transrectal ultrasound probe allowing real time imaging of the
prostate gland as biopsies are being performed. When transrectal
ultrasound was originally introduced large prostate cancer lesions
were easily identifiable by ultrasound imaging allowing an operator
to see a representative image of the prostate and lesions at the
time of biopsy. The wide application of prostate specific antigen
(PSA) screening has allowed for the detection of smaller and
smaller prostate cancer lesions thereby making visualization of
such discrete lesions unlikely when using ultrasound alone. Today,
the typical patient presents with an elevated PSA and no
discernible lesion on physical exam or by ultrasound exam.
[0005] During a typical needle biopsy procedure a urologist uses a
traditional transrectal ultrasound-guided approach taking multiple
individual biopsies trying to sample the lateral regions of the
gland in what amounts to a semi "blind" approach. A patient
undergoing this type of procedure has a 20-30% chance of having a
cancer diagnosed. A majority of these cancers are low grade. With
240,000 new cases of prostate cancer expected in the United States
in 2013, over 75% will be considered low risk cancers meaning these
cancers have a low likelihood of being the principle cause of a
patient's death. However, biopsy specimens retrieved using the
blind approach often leads to inconclusive results. For example, in
50-75% of the situations when a transrectal biopsy is followed by a
radical prostatectomy (removal of the entire prostate gland) the
pathology predicted by the biopsy is not representative of the
final specimen.
[0006] Data from radical prostatectomy specimens demonstrates a
high likelihood of bilateral and multifocal disease. In a study of
2,388 specimens, the incidence of multifocal lesions ranged from
33%-87% (average 67.6% for 12 studies). Of the more than 180,000
new prostate cancer diagnoses that are found to be low risk on
biopsy today, only a third would meet the criteria for observation
(no active treatment). The other two-thirds would be candidates for
complete or focal (partial) therapy. Identifying these candidates
based on transrectal biopsy is extraordinarily difficult, if not
impossible. In a study 538 low-risk prostatectomy specimens were
examined with the goal of looking for pretreatment characteristics
to accurately identify patients for focal therapy. A total of 6 to
16 cores were taken by transrectal biopsy and the median number of
positive cores was 1 (range, 1-12). When the prostatectomy
specimens were examined, upgrading to Gleason Score (GS) 8-10
occurred in 6.3%. Extracapsular extension was found in 19% and
seminal vesicle involvement in 2.4%. Although unilateral disease
was found by biopsy in 71% of the patients, it was present in only
22.5% of the prostatectomy specimens.
[0007] Based on current data, if accurate prostate biopsies could
be performed, a treatment algorithm for an estimated 240,000 new
prostate cancer cases (United States) as diagnosed by current
biopsy procedures would yield approximately 210,00 candidates with
a low grade lesion (GS 6-7) who would be candidates for
transperineal mapping (TPM) biopsies and approximately 30,000
candidates with higher grade lesions (GS 8-10) who would be
candidates for a radical prostatectomy (RP) or radiotherapy (RT)
(FIG. 1). Of the approximately 210,000 candidates undergoing TPM
for further examination, approximately 20,000 would yield high
grade lesions (GS 8-10) who would be candidates for RP or RT (FIG.
2). Of the remaining approximately 190,000 having undergone TPM,
approximately 33 percent would warrant active surveillance (AS),
approximately 33 percent would warrant RP or RT, and approximately
33 percent would warrant focal therapy. With improved tools and
technology a larger number of candidates could avoid RP or RT.
SUMMARY
[0008] A biopsy needle assembly for excising a tissue specimen from
a target tissue in an animal includes a mandrel with a core bed
with an inner surface forming a projection for marking the tissue
specimen at excision. The mandrel has a body extending
longitudinally between a proximal end and a distal end about a
longitudinally-extending central axis. The body forms a core bed
adjacent the distal end for containing the tissue specimen, the
core bed having an inner surface extending longitudinally between a
first a first end and a second end, and laterally between a first
longitudinal edge and an opposing second longitudinal edge.
[0009] In an embodiment, the projection is one or more adjacent
longitudinal ridges extending between the first longitudinal edge
and the second longitudinal edge. In an embodiment, the projections
present a contact surface for marking the tissue specimen. In an
embodiment, the contact surface includes a marking agent for
marking the tissue specimen. In an embodiment, the inner surface
defines an upwardly open lower cavity providing additional room for
containing the tissue specimen, with the first longitudinal edge
and second longitudinal edge forming the upper edges of the lower
cavity. In an embodiment, the upwardly open cavity has a C-shaped
cross sectional configuration. In an embodiment, the upwardly open
cavity has a box-shaped cross sectional configuration. In an
embodiment, the first and second longitudinal edges are disposed at
a horizontal plane coincident with the central axis, and the bottom
of the lower cavity is disposed below the central axis. In an
embodiment, the first and second longitudinal edges are disposed
above the horizontal plane, and the bottom of the lower cavity is
disposed below the central axis. In an embodiment, the first end of
the core bed forms a projection extending into the cavity
presenting a contact surface for marking the distal end of the
tissue specimen. In an embodiment, the marking left on the tissue
specimen by the projection aids a pathologist in proper
identification of the biopsy specimen during pathological
examination, and aid the pathologist in correlating the location
and orientation of the findings from the biopsy specimen in the
target tissue in vivo to aid in treatment of the target tissue.
[0010] A biopsy needle actuator assembly used with a biopsy needle
for excising a tissue specimen from a target tissue in an animal
includes a counter assembly for tracking the individual biopsy
event associated with the actuator assembly, and tracking the
cumulative number of firings of the actuator assembly to ensure the
actuator assembly is replaced prior to failure. The actuator
assembly includes a counter assembly that registers movement of the
biopsy needle during use.
[0011] In an embodiment, the counter assembly registers movement of
the biopsy needle between a rest position and a first position,
whereby the needle assembly is ready for firing when it is in the
first position. In an embodiment, the counter assembly includes a
register wheel for registering movement of a biopsy needle, where
the register wheel is operably connected to an index wheel for
recording the movement of the biopsy needle. In an embodiment, the
index wheel includes an event counter for sequentially recording
movement of the biopsy needle as it moves from the rest position to
the firing position, and a cumulative counter for contemporaneously
recording the needle movement. In an embodiment, a user can bypass
the event counter. In an embodiment, a mechanical lockout engages
when the cumulative counter registers a defined number of movements
of the biopsy needle preventing the actuator assembly from being
used beyond its useful life. In an embodiment, the counter assembly
aids an operator in proper identification of the biopsy specimen
during a biopsy event, and aids the user in correlating the
location and orientation of pathological findings of the biopsy
specimen in the target tissue in vivo to aid in treatment of the
target tissue.
[0012] A pathology specimen cassette includes a cartridge assembly
having a media retained between a base and a lid. A biopsy tissue
specimen is applied to the media and retained within the closed
cartridge assembly preserving the tissue until it is removed for
pathological examination. The base is hingedly connected to the
lid. The base forms a cavity with openings in its lower wall. The
lid includes a middle wall forming openings. The openings allow
fluids to move in and out of the closed cartridge assembly. A fluid
transfer element, bound by the media and a semi-permeable membrane,
is retained within the cartridge assembly. The fluid transfer
element absorbs fluid allowing the tissue specimen on the media to
be constantly immersed in the fluid. The media facilitates handling
and examination of the tissue specimen without a need to remove the
specimen from the media. The cartridge assembly with tissue is put
in a collection vial containing a preservative and stored in a
collection tray. The tray includes unused cartridge assemblies and
vials, and unique markings identifying the patient and specimen
locations.
[0013] In an embodiment, a tissue specimen is placed on the media
where the specimen includes markings made by the projections on a
biopsy needle aiding a pathologist in proper identification of the
biopsy specimen during pathological examination, and aiding the
pathologist in correlating the location and orientation of the
pathological findings from the biopsy specimen in the target tissue
in vivo to aid in treatment of the target tissue.
[0014] A system, method, and apparatus for planning and performing
biopsies on a target tissue located within an animal includes a
three-dimensional imaging system for imaging and mapping of a
target tissue for the planning and performing biopsies of the
target tissue, and for planning and performing treatments of the
target tissue.
[0015] A three-dimensional biopsy mapping and focal therapy system,
method, and apparatus uses an imaging system to: generate and store
a three-dimensional image of the target tissue based on an
ultrasound image of the target tissue, store a user generated
contour of the target tissue and surrounding anatomical structures,
and calculate the volume of the target tissue and surrounding
anatomical structures; plan the location and orientation of the
biopsy sites; generate and store a three-dimensional image of the
location, orientation, and volume of tissue biopsied from the
target tissue, store a map of diseased tissue based on the
three-dimensional image and user inputs of diseased tissue
identified by pathological examination. During biopsy planning, the
system calculates the recommended number of biopsy sites and biopsy
needle core lengths needed, and calculates probabilities for
encountering lesions of a particular size. The system generates a
visual representation of the location and orientation of the biopsy
needles and sites in the three-dimensional target tissue. The
system is used to identify and log the biopsies. A pathologist
identifies lesions in each biopsy specimen and uses the stored
images of the patient target tissue in the system to identify the
size and location of the lesion according to each biopsy site.
Based on the pathology information and biopsy sites, the volume of
the overall tumor is calculated and represented in the
three-dimensional image. The three-dimensional image of the target
tissue and lesion tissue is used to provide localized therapy to
the diseased tissue.
BRIEF DESCRIPTION OF THE DRAWINGS
[0016] The drawings constitute a part of this specification and
include exemplary embodiments of the disclosed subject matter and
illustrate various objects and features thereof.
[0017] FIG. 1 is a schematic of a treatment algorithm.
[0018] FIG. 2 is a schematic of a treatment algorithm.
[0019] FIG. 3A is a side elevation view of an embodiment of a
mandrel.
[0020] FIG. 3B is a side elevation view of an embodiment of a
mandrel.
[0021] FIG. 3C is a cross section view of the mandrel taken along
line 3C-3C in FIG. 3B.
[0022] FIG. 3D is a side elevation view of an embodiment of a
mandrel.
[0023] FIG. 3E is a cross section view of the mandrel taken along
line 3E-3E in FIG. 3D.
[0024] FIG. 4 is a side elevation view of an embodiment of a
mandrel.
[0025] FIG. 5 is a plan view of an embodiment of a mandrel.
[0026] FIG. 6 is an enlarged plan view of the mandrel of FIG.
5.
[0027] FIG. 7 is an isometric view of an embodiment of a
mandrel.
[0028] FIG. 7A is an isometric view of an alternative embodiment of
a mandrel.
[0029] FIG. 8 is a side elevation view of an embodiment of a
cannula.
[0030] FIG. 9 is a side elevation view of an embodiment of a needle
assembly.
[0031] FIG. 10 is a plan view of an embodiment of an actuator
assembly.
[0032] FIG. 11 is a plan view of an embodiment of an actuator
assembly.
[0033] FIG. 12 is a side elevation view of an embodiment of an
actuator assembly showing a first carriage assembly and associated
firing pin.
[0034] FIG. 13A is a side elevation view of an embodiment of an
actuator assembly showing a first and second carriage assembly and
associated firing pins.
[0035] FIG. 13B is a side elevation view of an embodiment of an
actuator assembly showing a device cocking mechanism.
[0036] FIG. 14A is a plan view of an embodiment of an actuator
assembly showing a safety release.
[0037] FIG. 14B is a view of an embodiment of an actuator assembly
showing a counter assembly
[0038] FIG. 14C is a plan view of the counter assembly.
[0039] FIG. 15 is a side elevation view of an embodiment of an
actuator assembly showing a safety release and a firing pin.
[0040] FIG. 16 is a schematic showing a side elevation view of a
needle assembly and a target tissue.
[0041] FIG. 17 is a schematic showing a side elevation view of a
mandrel within a target tissue.
[0042] FIG. 18 is a schematic showing a side elevation view of a
cannula within a target tissue.
[0043] FIG. 19 is an isometric view of an embodiment of a cartridge
assembly in an open position.
[0044] FIG. 20 is an isometric view of an embodiment of a cartridge
assembly in a closed position.
[0045] FIG. 21 is a plan view of an embodiment of the cartridge
assembly of FIG. 20.
[0046] FIG. 22 is a bottom view of the cartridge assembly of FIG.
20.
[0047] FIG. 23 is a front elevation view of the cartridge assembly
of FIG. 20.
[0048] FIG. 24 is a side elevation view of the cartridge assembly
of FIG. 20.
[0049] FIG. 25 is a section view taken generally along line 25-25
in FIG. 24.
[0050] FIG. 26 is an exploded view of a lid of an embodiment of a
cartridge assembly.
[0051] FIG. 27 is an exploded view of a base of an embodiment of a
cartridge assembly.
[0052] FIG. 28 is a plan view of an embodiment of a tray.
[0053] FIG. 29 is a front elevation view of an embodiment of a
tray.
[0054] FIG. 30 is a plan view of an embodiment of a tray.
[0055] FIG. 31 is a front elevation view of an embodiment of a
tray.
[0056] FIG. 32 is a side elevation view of an embodiment of a
tray.
[0057] FIG. 33 is an illustration of a patient positioned for a
prostate biopsy procedure.
[0058] FIG. 34 is an illustration of a graphical user interface
according to some embodiments of the disclosed subject matter for
selecting a module.
[0059] FIG. 35 is an illustration of a graphical user interface
according to some embodiments of the disclosed subject matter for
creating and accessing patient files.
[0060] FIGS. 36-40 are illustrations of a graphical user interface
according to some embodiments of the disclosed subject matter for
aligning a biopsy template grid and an ultrasound grid about an
image of the target tissue site.
[0061] FIGS. 41-49 are illustrations of a graphical user interface
according to some embodiments of the disclosed subject matter for
contouring structures of the tissue site and ultra sound
hardware.
[0062] FIGS. 50-52 are illustrations of a graphical user interface
according to some embodiments of the disclosed subject matter for
viewing the three-dimensional images created from the contour
images generated during contouring.
[0063] FIGS. 53-56 are illustrations of a graphical user interface
according to some embodiments of the disclosed subject matter for
aligning the three-dimensional image to the ultrasound image of the
target tissue site.
[0064] FIGS. 57-60 are illustrations of a graphical user interface
according to some embodiments of the disclosed subject matter for
planning a biopsy procedure of the target tissue site.
[0065] FIGS. 61-64 are illustrations of a graphical user interface
according to some embodiments of the disclosed subject matter for
viewing the paths of the biopsy needles.
[0066] FIGS. 65-71 are illustrations of a graphical user interface
according to some embodiments of the disclosed subject matter for
viewing information about the individual biopsy sites.
[0067] FIGS. 72-73 are illustrations of a graphical user interface
according to some embodiments of the disclosed subject matter for
viewing pathological information about the biopsy sites.
[0068] FIG. 74 is an illustration of a graphical user interface
according to some embodiments of the disclosed subject matter for
viewing the lesions in the three-dimensional images.
[0069] FIG. 75 is a diagram of a process of planning a biopsy
procedure according to some embodiments of the disclosed subject
matter.
[0070] FIG. 76 is a diagram of a process of image acquisition
according to some embodiments of the disclosed subject matter.
[0071] FIG. 77 is a diagram of a process of contouring images
according to some embodiments of the disclosed subject matter.
[0072] FIG. 78 is a diagram of a process of planning a biopsy site
according to some embodiments of the disclosed subject matter.
[0073] FIG. 79 is a diagram of a process of acquiring biopsy tissue
specimens according to some embodiments of the disclosed subject
matter.
[0074] FIG. 80 is a diagram of a process of examining tissue
specimens according to some embodiments of the disclosed subject
matter.
[0075] FIG. 81 is a diagram of a process of treating lesions
according to some embodiments of the disclosed subject matter.
[0076] FIG. 82 is a block diagram of an exemplary hardware
configuration model for a device implementing the system described
in reference to FIGS. 33-81.
DETAILED DESCRIPTION
[0077] As required, detailed aspects of the disclosed subject
matter are disclosed herein; however, it is to be understood that
the disclosed aspects are merely exemplary of the disclosed subject
matter, which may be embodied in various forms. Therefore, specific
structural and functional details disclosed herein are not to be
interpreted as limiting, but merely as a basis for the claims and
as a representative basis for teaching one skilled in the art how
to variously employ the disclosed technology in virtually any
appropriately detailed structure.
[0078] Certain terminology will be used in the following
description for convenience in reference only and will not be
limiting. For example, up, down, front, back, right and left refer
to the disclosed subject matter as orientated in the view being
referred to. The words, "inwardly" and "outwardly" refer to
directions toward and away from, respectively, the geometric center
of the aspect being described and designated parts thereof.
Forwardly and rearwardly are generally in reference to the
direction of travel, if appropriate. Said terminology will include
the words specifically mentioned, derivatives thereof and words of
similar meaning.
[0079] A needle biopsy system includes a biopsy needle assembly
used in conjunction with an actuator assembly to remove a tissue
specimen from a target tissue, storage of the tissue specimen in a
pathology specimen cassette until pathological examination, and a
three-dimensional tissue mapping system for planning the biopsy
procedure, guiding removal of the tissue specimen, identifying and
recording pathological remarks, and conducting targeted tissue
treatment. Target tissue may be any animal tissue type or organ,
including humans. Tissue types include, but are not limited to,
epithelial tissue, connective tissue, muscle tissue, nervous
tissue. Organs include, but are not limited to, prostate, breast,
kidney, and liver.
[0080] Needle Assembly
[0081] A needle assembly 100 is used to excise a tissue specimen
from a target tissue site. Referring to FIGS. 3A-E, and 8-9, the
needle assembly 100 includes an inner component 102 or mandrel that
travels within an outer component 152 or cannula. Referring to
FIGS. 3A-4, the mandrel or inner needle includes an elongated
cylindrical body 104, extending from a proximal end 106 to a distal
end 114. The body 104 has an outer diameter. In some embodiments
the body 104 outer diameter is from about 0.1842 mm to about 4.572
mm, preferably from to about 1.27 mm to about 2.77 mm. The body 104
is manufactured from a surgically suitable material, including
stainless steel. A generally rectangular first connecting element
108 forming an offset aperture 110 is located at the proximal end
106 for connecting the inner component 102 to an actuating
assembly. The first connecting element 108 is molded to the
proximal end 106 forming a collar 111 about the body 104. The
distal end 114 forms a tip 130 terminating at a point 134. The body
104 forms an adjacent core bed 116 extending between a first end
118, and a second end 120 located adjacent the tip 130, providing a
cavity 121 for retaining a tissue specimen. In some embodiments,
the second end 120 is about 5 mm from the point 134. The core bed
116 presents an inner surface 117 bound laterally by a first
longitudinal edge 137 and an opposite second longitudinal edge 138,
and extending from a distal end by the second end 120, and from a
proximal end by the first end 118.
[0082] The core bed 116 has a longitudinal length between the first
end 118 and second end 120 from about 1 mm to about 200 mm,
preferably from about 20 mm to about 60 mm. The use of a mandrel
with a core bed 116 of substantial length can result in poor
stiffness, in particular, when the inner surface 117 lies below the
central axis 141 of the body 104, the needle can deflect or break
during use. In an embodiment, the core bed 116 forms an upwardly
open lower cavity 139 whereby a substantial portion of the inner
surface 117 lies below the central axis 141 between adjacent first
and second longitudinal edges 137, 138 (FIGS. 3B-E). Longitudinal
edges 137, 138 are at or above a horizontal plane coincident with
the central axis thereby improving the stiffness of the body 104 at
the core bed, and thus the cross sectional moment of inertia.
Referring to FIGS. 3B-C, and embodiment of the cavity 139 is formed
from a core bed 116 having a C-shaped cross sectional configuration
presenting a trough-shaped cavity 142 with the bottom of the cavity
142 disposed below the central axis 141. Referring to FIGS. 3D-E,
an embodiment of the cavity 139 is formed from a core bed 116
having a rounded bottom box-shaped cross sectional configuration
presenting a rectangular cavity 144 with the bottom of the cavity
144 disposed below the central axis 141.
[0083] In some embodiments, the core bed 116 forms one or more
projections 122 with a contact surface 123 for one or more of
marking, securing, impressing, engaging, orientating, and scoring
the tissue specimen within the core bed 116. In some embodiments
the projection 122 includes a plurality of adjacent longitudinal
ridges 124 formed by the inner surface 117 extending the length of
the core bed 116 between the first end 118 and second end 120 (FIG.
5-6) that contact the tissue specimen. In some embodiments the
retaining member 122 includes a plurality of adjacent transverse
ridges 126 formed by the inner surface 117 extending between the
first longitudinal edge 137 and second longitudinal edge 138 spaced
between the first end 118 and the second end 120 (FIG. 7) that
contact the tissue specimen.
[0084] In some embodiments, ridges 126 are grouped at one end of
the core bed 116 leaving the remainder of the inner surface 117
free from ridges 126. In an embodiment, ridges 126 are grouped at
each end of the core bed 116 leaving the inner surface 117 between
free from ridges.
[0085] In some embodiments the projections 122 include one or more
projections 128 formed by, and extending from, one or both the
first end 118 and second end 120 that contact the ends of the
tissue specimen. In an embodiment, the projections 128 extend
generally longitudinally into the cavity 121 (FIG. 7A). In an
embodiment, the projections 128 extend upward into the cavity 121.
In some embodiments the projection 122 includes a plurality of
adjacent ridges formed by the inner surface 117 spaced between the
first end 118 and the second end 120 that are disposed at an angle
that is between longitudinal and transverse. In some embodiments
the projection 122 includes a plurality of spaced ridges formed by
the inner surface 117 that are curvilinear across the core bed 116.
The projection 122 creates a marking or impression on the excised
tissue specimen providing a visual indication to the user of the
orientation of the tissue specimen in the core bed. Because the
orientation and location of the core bed 116 and cavity are known
by the user, the marking or impression by the projections on the
excised tissue specimen provide a visual indication to the user of
the orientation of the tissue specimen in the target tissue prior
to removal. The marking or impression on the excised tissue
specimen and core bed 116 location and orientation can be
correlated by a user allowing the pathological characteristics of
the tissue specimen to be correlated with the target tissue.
[0086] In an embodiment, the projections 122, 128 include a marking
agent 129 that is transferred to the tissue specimen, including an
FDA approved ink or coloring agent, India ink, or a biocompatible
natural or synthetic pigment capable of marking hard or soft
tissue. In an embodiment, the marking agent further includes a
biocompatible membrane that is transferred to and adheres to the
tissue specimen. The marking agent is applied to the projection at
the time of manufacture, or prior to use. The projection may be
treated to releasably accept the marking agent. In an embodiment,
the projection is mechanically treated, including etching or
ablation, to releasably accept the marking agent. In an embodiment,
the projection is chemically treated, including etching, ablation,
or application of a releasing agent, to releasably accept the
marking agent. The marking agent provides a visual indication to
the user of the orientation of the tissue specimen in the core
bed.
[0087] The tip 130 extends from a base 132 at a proximal end to the
point 134 at a distal end. A cutting face 136 at the tip 130 allows
the inner component 102 to cut tissue as it passes through the
body. In some embodiments, one or more marks 140 at intervals along
the body 104 enhance visibility of the inner component 102 when it
is used with the imagining system 1032. In some embodiments, the
one or more marks 140 appear at 5.0 cm intervals along the length
of the body 104 between the tip 130 and first connecting element
108.
[0088] Referring to FIG. 8, the outer component 152 or outer needle
includes an elongated tubular body 154 forming a sidewall 156 that
extends from a proximal end 158 to a tip 168 at a distal end 166.
The interior diameter of the body 154 is equal to or greater than
the corresponding outer diameter of the mandrel body 104 used
therewith thereby allowing the inner component 102 to freely travel
therein. The body 154 is manufactured from a surgically suitable
material, including stainless steel. A generally rectangular second
connecting element 160 forms an offset aperture 162 located at the
proximal end 158 for connecting the outer component 152 to an
actuating assembly. The second connecting element 160 is molded to
the proximal end 158 forming a collar 165 about the body 154. The
end of the second connection element 160 forms a first opening 164,
such as a Luer lock tip, allowing access to the interior of the
body 154.
[0089] The opening 164 allows the distal end 114 of the inner
component 102 to be inserted into the proximal end 158 of the outer
component 152 thereby allowing the tip 130, core bed 116, and body
104 to extend beyond the tip 168 through a second opening 176. The
tip 168 extends from a base 170 at a proximal end to a point 172 at
the distal end 166. A cutting face 174 at the tip 168 allows the
outer component 152 to cut tissue as it passes. In some
embodiments, one or more marks 178 at intervals along the body 154
enhance visibility of the outer component 152 when it is used with
the imagining system 1032, and allow the location of the outer
component 152 to be viewed within the body by an imagining system
1032. In some embodiments, the one or more marks 178 appear at 5.0
cm intervals along the length of the body 154 between the tip 168
and second connecting element 160. The opening 164 also allows an
operator to introduce a liquid or a solid, such as medication or
other agents, into the outer component 152 for depositing at the
location of the tip 168. Other agents include a marker that is
visible using an imaging system, such as ultrasound, allowing an
operator subsequently identify the location of the removed biopsy
tissue specimen for manipulation or treatment of the target
tissue.
[0090] The inner component 102 and outer component 152 cooperate to
remove a tissue specimen from a target tissue site. The needle
assembly 100 is prepared for use by first inserting the inner
component 102 into the outer component 152 as described above (FIG.
9). The overall length of each component 102, 152 is determined by
the depth of the target tissue site from the exterior of the body,
however, the overall length of the selected interior component 102
will be greater than the overall length of the selected outer
component 152. In some embodiments, the length of the outer
component 152 between the proximal end of the second connecting
element 160 and the point 172 is equal to about less than the
distance between the distal end of the first connecting element and
the first end 118 of the core bed 116. In some embodiments, the
length of the core bed 116 is greater than the length of the tissue
intended to be excised.
[0091] The length of the inner component 102 between the collar 111
and the point 134 is greater than the length of outer component 152
between the collar 165 and point 172. In some embodiments, the
second end 120 of the core bed 116 is approximately 6 cm beyond the
point 172 when the collar 111 abuts the first opening 164.
[0092] In use, the needle assembly 100 is arranged in a first
position whereby the first connecting element 108 and second
connecting element 160 are mounted in an actuator assembly so that
the tip 130 extends just beyond tip 168 to allow the needle
assembly 100 to cut tissue as it is advanced into the body toward a
target tissue site. Because the inner component 102 is designed to
be of greater length than the outer component 152, the first
connecting element 108 and second connecting element 160 are offset
a distance when in the first position allowing the inner component
102 to travel within the outer component 152.
[0093] The needle assembly 100 is advanced toward the target tissue
site until the tip 130 reaches an area adjacent the tissue to be
removed. The maximum length of the tissue specimen capable of being
excised is equal to the length between the first end 118 and second
end 120 of the core bed 116. For an inner component 102 having a
core bed 116 of great length, an operator can use the needle
assembly 100 to excise tissues of varying lengths by limiting the
length of core bed 116 that is exposed beyond the point 172 of the
outer component 152. The target tissue is prepared for excision by
first transitioning the needle assembly 100 from the first position
to a second position. The transition occurs by advancing the inner
component 102 within the outer component 152 exposing the desired
length of core bed 116 beyond the point 172. In the second position
the core bed 116 is exposed to the tissue to excise and the
projection 122 engages the tissue, and alternatively holding it in
place. The projection 122 and/or marking agents leave identifiers
on the tissue specimen providing identification and orientation of
the tissue specimen, and allowing any pathological characteristics
of the tissue specimen to be correlated with the target tissue.
[0094] The tissue specimen is removed from the target tissue site
by next transitioning the needle assembly 100 from the second
position to a third position. The transition occurs by advancing
the outer component 152 along the inner component 102 a sufficient
distance whereby the point 172 advances from a position proximal
the first end 118 of the cored bed 116 to a position distal the
second end 120 of the core bed 116. The cutting face 174 cuts the
tissue exposed above the core bed 116 as the point 172 advances
encapsulating a portion of tissue between the inner component 102
and the outer component 152. The needle assembly 100 is then
withdrawn from the tissue site, with the selected tissue specimen,
to the exterior of the body.
[0095] The tissue specimen may be removed from the needle assembly
100 by transitioning the needle assembly 100 from the third
position to a fourth position. The transition occurs by advancing
the inner component 102 within the outer component 152 a sufficient
distance to expose the core bed 116 beyond the point 172 of the
outer component 152 thereby exposing the tissue within the core bed
116. The excised tissue may then be transferred to a medium until
pathological evaluation. Alternatively, the tissue specimen may be
removed from the needle assembly 100 by withdrawing the inner
component 102 from the outer component 152 thereby exposing the
tissue within the core bed 116.
[0096] The needle assembly 100 can be used with various target
tissue types, including breast tissue, kidney tissue, liver tissue,
and prostate tissue. In an embodiment, the needle assembly 100 is
used to excise or biopsy a tissue specimen from a prostate gland,
whereby the prostate gland is the target tissue. Biopsies of the
prostate gland can take place with the patient in various
positions. An approach to a procedure for removing biopsies from
the prostate gland is shown in FIG. 33, whereby a patient 1002 is
positioned in a lithotomy position whereby the prostate is
orientated above or anterior the rectum, the rectum is orientated
below or posterior the prostate, the base of the prostate
orientated toward the head of the patient and the apex of the
prostate opposite, and the prostate is accessed in a transperineal
manner. During a transperineal biopsy procedure, the needle
assembly 100 is arranged in the first position whereby the core bed
116 is orientated to face posterior or toward the rectum. The
needle assembly 100 is advanced into the prostate from the apex
toward the base until the tip 130 reaches an area adjacent the
tissue to be removed. The inner component 102 is advanced into the
prostate with the core bed 116 facing downward, and the projections
contacting the target tissue. The projection 122 and/or marking
agents leave identifiers on the tissue specimen providing the user
with identification and orientation information after the tissue
specimen is removed and processed. For example, use of an inner
component 102 with transverse ridges 126 and projections 128
extending into the cavity 121 from the second end 120, and where
the ridges 126 and projections 128 include marking agents, the
excised tissue specimen would have visible marks on the base end of
the specimen from the projections 128, and would have visible marks
on the anterior end of the specimen adjacent the base end from the
ridges 126. The markings on the tissue specimen allow a user to
correlate any pathological findings associated with the tissue
specimen to their location in the target tissue.
[0097] In some embodiments, the inner component 102 can be used for
the introduction of a liquid or a solid, such as medication or
other agents, or an elongated flexible element, such as a fiber or
wire for manipulating tissue structures when the needle assembly
100 is in either the first position or the second position. Other
agents include a marker that is visible using an imaging system,
such as ultrasound, allowing an operator subsequently identify the
location of the removed biopsy tissue specimen for manipulation or
treatment of the target tissue. In some embodiments, the body 104
is a hollow tubular member forming a passage extending between an
opening at a proximal end 106 and an opening at the first end 118
for introducing the liquid, solid, or elongated flexible member. In
some embodiments, the tip 130 is a hollow tubular member forming a
passage extending between an opening at the second end 120 and an
opening at the cutting face 136 allowing further extension of the
elongated flexible element past the tip 130.
[0098] It will be appreciated that the bodies 104, 154 can be used
with or without connecting elements, and may be used with the core
bed 116 in any orientation with respect to an aspect of the target
tissue.
[0099] It will be appreciated that the components of the needle
assembly 100 can be used for various other applications. Moreover,
the needle assembly 100 can be fabricated in various sizes and from
a wide range of suitable materials, using various manufacturing and
fabrication techniques.
[0100] Actuator Assembly
[0101] In some embodiments, an actuator assembly 200 is used with
the needle assembly 100 to excise the tissue specimen from the
target tissue site. Referring to FIG. 10, an embodiment of the
actuator assembly 200 includes a body 202 extending from a proximal
end 204 to a distal end 206 forming sidewalls 208, including a
front wall 210 at the distal end 206, and a rear wall 212 at the
proximal end 204. An opening 214 in the front wall 210 allows the
needle assembly 100 to extend from the actuator assembly 200. A
cover 216 is movable on the body 202 allowing access to the
interior of the actuator assembly 200.
[0102] The actuator assembly 200 includes an actuator for axially
moving each of a mandrel and a cannula. A first actuator member 220
for moving the mandrel or inner component 102 includes a first
guide 222 extending from a proximal end 204 at the rear wall 212,
to a distal end 206 at the front wall 210. A first carriage
assembly 230 moves axially along the first guide 222 for moving the
inner needle within the cannula or outer component 152. A biasing
member, such as a spring 236, is disposed between the first
carriage assembly 230 and the rear wall 212, and when compressed,
biases the first carriage assembly 230 toward the distal end 206 of
the actuator assembly 200. A pin 232 extending from the first
carriage assembly 230 receives the first connecting element 108 of
the mandrel. A notch 234 in the first carriage assembly 230
receives a first firing pin 242 when the first carriage assembly
230 is moved to the distal end 206. A first carriage stop 238
disposed between the first carriage assembly 230 and the front wall
210 limits the forward movement of the first carriage assembly 230
along the first guide 222.
[0103] A second actuator member 254 for moving the outer component
152 is disposed adjacent the first actuator member 220. The second
actuator member 254 includes a second guide 256 extending from a
proximal end 258 at the rear wall 212, to a distal end 260 at the
front wall 210. A second carriage assembly 264 moves axially along
the second guide 256 for moving the outer component 152 about the
inner component 102. A biasing member, such as a spring 270, is
disposed between the second carriage assembly 264 and the rear wall
212, and when compressed, biases the second carriage assembly 264
toward the distal end 206 of the actuator assembly 200. A pin 266
extending from the second carriage assembly 264 receives the second
connecting element 160 of the cannula. A notch 268 in the second
carriage assembly 264 receives a second firing pin 276 when the
second carriage assembly 264 is moved to the distal end 206. A
second carriage stop 272 disposed between the second carriage
assembly 264 and the front wall 210 limits the forward movement of
the second carriage assembly 230 along the second guide 256.
[0104] An adjusting member 288 allows an operator to move the first
carriage stop 238 and second carriage stop 272. The adjusting
member 288 includes an externally threaded member 290 disposed
between the first guide 222 and second guide 256, and extend
between a proximal end 292 rotatably disposed adjacent the rear
wall 212, and a distal end 294 rotatably disposed at the front wall
210. A wheel 296 at the exterior of the body 202 is operably
connected to the threaded member 290 for rotating the threaded
member 290. A threaded surface 240 on the first carriage stop 238,
and a threaded surface 274 on the second carriage stop 272
interface with the threaded member 290 whereby rotation of the
threaded member 290 moves the threaded members along their
respective guides. The distance between the distal edge of the
first carriage assembly 230 and proximal edge of the first carriage
stop 238 can be adjusted in some embodiments from about 0 mm to
about 70 mm, and in some embodiments from about 20 mm to about 60
mm. An indicator on the wheel 296 or at another location on the
actuator assembly 200, provides an indication of the distance
between the first carriage assembly 230 and first carriage stop
238, and thus, the distance an inner component 102 will travel
through a target tissue, discussed in more detail below.
[0105] In some embodiments, the first carriage stop and second
carriage stop is a unitary stop 302 (FIG. 11). The unitary stop 302
includes a first carriage stop 304 and second carriage stop 306
connected by a bridge 308, with the first and second carriage stops
304, 306 and bridge 308 forming an internally threaded passage that
is received on the threaded member 290.
[0106] The actuator assembly 200 is prepared for use by actuating
the adjusting member 288 to set the distance between the first
carriage stop 238 and the first carriage assembly 230 when the
first carriage assembly 230 is in a first position or firing
position. A needle assembly 100 with body 104 positioned within
body 154 is loaded into the actuator assembly 200 by opening the
cover 216 and inserting pin 232 into aperture 110 and inserting pin
266 into aperture 162, with the needle assembly 100 exiting from
the body 202 through the opening 214. The cover 216 is closed and
the first and second carriage assemblies 230, 264 are moved to
their first position or firing position. The first carriage
assembly 230 is moved to a first position by moving it toward the
rear wall 212, such as by pushing or pulling it into position by a
first cocking mechanism 330. The mechanism 330 includes a third
guide 334 extending between the front wall 210 and rear wall 212. A
first biasing arm 332 extends outward to the exterior of the body
202 and moves axially along the third guide 334 within a channel in
the sidewall 208 for moving the first carriage assembly 230 to the
first position. Moving the first biasing arm 332 from a start
position toward the proximal end 204 compresses spring 236, until
the protrusion 246 of the first firing pin 242 engages the notch
234. Moving the first biasing arm 332 compresses a spring 336 (FIG.
12), wherein upon engagement of the first firing pin 242 and the
notch 234, the spring 336 biases the first biasing arm 332 to the
neutral starting position (FIG. 13). In the first position the
first firing pin 242 ceases rearward movement of the first carriage
assembly 230 and prevents forward movement of the inner needle. The
first firing pin 242 includes an arm 244 extending from the
interior of the body 202 through the rear wall 212 to the exterior
of the actuator assembly 200. A spring 250 biases against the arm
244 causing the protrusion to engage the notch 234. A pivot 248
connected to the arm 244 inside the body 202 allows the first
firing pin 242 to be actuated between an engaged position and a
disengaged position from the exterior of the body 202. The first
carriage assembly 230 includes a marking 252 that are visible
through a window 218 in the cover 216 showing a user that the first
carriage assembly 230 is ready for firing.
[0107] The second carriage assembly 264 is moved to a first
position by moving it toward the rear wall 212, such as by pushing
or pulling it into position by a second cocking mechanism. The
second mechanism includes a fourth guide, adjacent the third guide,
extending between the front wall 210 and ear wall 212. A second
biasing arm extends outward to the exterior of the body 202 and
moves axially along the fourth guide within a channel in the
sidewall 208 for moving the second carriage assembly 264 to the
first position. Moving the second biasing arm from a start position
toward the proximal end 204 compresses spring 270, until the
protrusion 280 of the second firing pin 276 engages the notch 268.
Similar to above, moving the second biasing arm compresses a
spring, wherein upon engagement of the second firing pin 276 and
the notch 268, the spring biases the second biasing arm to the
neutral starting position. In the first position the second firing
pin 276 ceases rearward movement of the second carriage assembly
264 and prevents forward movement of the outer needle. The second
firing pin 276 includes an arm 278 extending from the interior of
the body 202 through the rear wall 212 to the exterior of the
actuator assembly 200. A spring 284 biases against the arm 278
causing the protrusion to engage the notch 266. A pivot 282
connected to the arm 278 inside the body 202 allows the second
firing pin 276 to be actuated between an engaged position and a
disengaged position from the exterior of the body 202.
[0108] The length of travel of the inner component 102 is
determined by the distance of the first carriage assembly 230 in
its first position from the first carriage stop 238. As described
above, forward movement of the first carriage assembly 230 is
limited by the location of the first carriage stop 238. The
distance between the first carriage stop 238 and the first carriage
assembly 230 in its first position, or needle throw length,
determines the length of forward movement of the inner needle and
thus the length of the core bed 116 exposed beyond the point 172 of
the cannula. The needle throw length can be adjusted in some
embodiments from about 0 mm to about 70 mm. In some embodiments,
the needle throw length is from about 20 mm to about 60 mm. In some
embodiments, the adjusting member 288 is indexed whereby the needle
throw length is about 25 mm, about 30 mm, and about 35 mm. The
needle throw length determines the length of the tissue specimen
removed from the target tissue site. Forward movement of the second
carriage assembly 264 is limited by the location of the second
carriage stop 272. The distance between the second carriage stop
272 and the second carriage assembly 264 in its first position
determines the throw length.
[0109] Once the inner and outer needles are in their first
positions in the actuator assembly 200 the variable throw biopsy
device is ready for use to excise tissue. As described above, the
tip of the needle assembly 100 is advanced from outside the body
toward the target tissue site until the tip 130 reaches an area
adjacent the tissue to be removed. At this time, the throw length
can be adjusted before firing by actuating the adjusting member 288
to set the distance between the first carriage stop 238 and the
first carriage assembly 230. An adjustment to the throw length may
be made, for example, after viewing the position of the needle
assembly 100 in the body by an imaging system, such as an
ultrasound image. Referring to FIG. 16, the needle assembly 100 is
shown being advanced toward a schematic of a target tissue site,
such as a prostate gland 320, with the tip 130 at the apex 322 of
the prostate gland 320 and the core bed 116 facing upward. As
discussed above, the core bed 116 can be manufactured for use with
an actuator assembly 200 whereby the core bed 116 faced downward or
posteriorly when used with the actuator 200 as shown in FIGS.
16-18. The inner needle or mandrel is fired or moves from its first
position to a second position by actuation of the first firing pin
242. When the first firing pin 242 is actuated, disengaging the
protrusion 246 from the notch 234, the first carriage assembly 230
is no longer held stationary against the biasing force of the
compressed spring 236, and the spring 236 rapidly decompresses
forcing the first carriage assembly 230 and biopsy needle forward
toward the first carriage stop 238 and exposing a corresponding
length of the core bed 116 (FIG. 17). The length of core bed 116
exposed to the tissue for removal from the prostate gland 320
includes tissue extending from the apex 322 to the base 324 of the
prostate gland 320 in a region above the urethra 126. In some
embodiments, as described above, the projections 122 engage the
tissue specimen holding it in place within the core bed 116. In
some embodiments, as described above, the projections 122 engage
the tissue specimen leaving marks on the tissue specimen for later
identification and proper orientation of the tissue specimen
relative to its position in the target tissue.
[0110] Referring to FIG. 18, the tissue specimen is excised from
the target tissue by firing the cannula. Referring to FIG. 17, the
cannula is fired or moves from its first position to a second
position by actuation of the second firing pin 276. When the second
firing pin 276 is actuated disengaging the protrusion 280 from the
notch 268, the second carriage assembly 264 is no longer held
stationary against the biasing force of the compressed spring 270,
and the spring 270 rapidly decompresses, forcing the second
carriage assembly 264 forward toward the second carriage stop 272
covering the exposed length of the core bed 116. As the outer
component 152 moves along the inner component 102 the point 172
advances from a position adjacent the first end 118 of the cored
bed 116 to a position distal the second end 120 of the core bed
116. The cutting face 174 cuts the tissue exposed above the core
bed 116 as the point 172 advances, encapsulating a portion of
tissue between the inner component 102 and the outer component 152.
The needle assembly 100 is then withdrawn from the target tissue
site to the exterior of the body.
[0111] The tissue specimen is removed from the needle assembly 100
by first moving the second carriage assembly 264 from its second
position to a third position by returning the second carriage
assembly 264 to its first position, re-exposing the core bed 116.
The tissue within the core bed 116 may then be transferred to a
medium, such as a medium in a pathology specimen cassette, or into
a vial with preservative, until pathological examination.
[0112] In some embodiments, the first and second firing pins 242,
276 are connected by a bridge 298. The bridge 298 operates to
immediately disengage the second firing pin 276 from the second
carriage assembly 264 immediately after the first carriage assembly
230 contacts the first carriage stop 238. In such an arrangement, a
trigger 300 connected to the first firing pin 242 at the exterior
of the body 202 is actuated to initiate the firing sequence.
[0113] In some embodiments, a safety release 312 obstructs movement
of the first firing pin 242 from the engaged position to the
disengaged position relative to the first carriage assembly 230. To
fire the needles, the safety release 312 is moved from a position
obstructing movement of the first firing pin 242 to a position that
does not obstruct movement of the first firing pin 242.
[0114] In some embodiments, the actuator assembly includes a
counter that records the number of actuations of the biopsy needle
assembly. Referring to FIGS. 14B-14C, an embodiment of a counter
assembly 352 for use with the actuator assembly 200 is shown and
described whereby the counter assembly 532 registers movement of
the biopsy needle component connected to the second carriage
assembly 264, here the outer component 152 or cannula. In an
embodiment, the counter assembly 352 registers movement of the
biopsy needle component connected to the first carriage assembly
230, here the inner component 102 or mandrel.
[0115] The counter assembly 352 includes a cumulative counter 358
and a resettable event counter 360. The counters each comprise a
row of index wheels with numbers visible through an opening 356 in
a housing 354, whereby the wheels are operably connected to a
register wheel 362 within the actuator assembly 200. In an
embodiment, the wheel 362 is configured to register unidirectional
movement of the biopsy needle assembly. In an embodiment, the wheel
362 includes a toothed exterior that contacts the end of a lever
368 connected to the second carriage assembly 264, where the lever
368 extends from the second carriage assembly 264 toward the rear
wall of the body 202 when the second carriage assembly 264 is at
the rest position. As the second carriage assembly 264 moves from
rest to its first position or firing position, the lever 368
contacts and rotates the wheel 362 rotating an index wheel of the
cumulative counter 358 and event counter 360, advancing and
increasing the numerical value of the counter by one whole number.
A biasing member 370 or spring extends the lever 368 into the path
of the wheel 362 when the second carriage assembly 264 is moved
from rest to the first position. Upon the firing or movement of the
second carriage assembly 264 from the first position to a second
position, the biasing member 370 allows the lever 368 to move away
from the wheel 362 and to pass by the wheel 362 without arresting
movement of the second carriage assembly 264. Thus the firing of
the cannula is recorded by each arming of the actuator assembly
200. A bypass 364 button is adapted for allowing the carriage
assembly 264 to move from rest to the first position without
advancing event counter 360. In an embodiment, the wheel 362 is
moved out of the path of lever 368 to avoid rotating the wheel 362
or an index wheel. Allowing a biopsy to be taken without advancing
the event counter 360 is useful when an operator desires to excise
an additional tissue specimen from a target tissue from the same
sample site. Upon completion of a biopsy procedure, the event
counter 360 can be resent to zero by actuation of the event counter
reset 366 button.
[0116] The cumulative counter 358 records the cumulative number of
firings of the cannula, and the event counter 360 simultaneously
records each arming of the actuator assembly 200. Tracking the
cumulative number of firings of the cannula with the cumulative
counter 358 is important to ensure the actuator assembly is used
for no more than the manufacturer's recommendation number of biopsy
events, thereby decreasing the likelihood the actuator assembly
would be used under conditions whereby the mechanical components of
the device would malfunction during a biopsy procedure due to use
beyond its recommended number of firings. In an embodiment, the
cumulative counter 358 engages a lockout device that prevents
actuation of the carriage assemblies 230, 264 when the counter 358
reaches a number specified by the manufacturer, thereby requiring
return or servicing of the actuator assembly.
[0117] Tracking the number of firings of the cannula with the event
counter 360 is important to ensure the operator properly accounts
for each biopsy event during a biopsy procedure. For example, an
operator using an actuator assembly with the three-dimensional
tissue mapping system below can correlate actuator assembly in use
and the value represented by the event counter 360, with the
location of the biopsy needle in the template 1018 and biopsy site
number assigned by the software. For example, if the biopsy site
number assigned by the software indicates the next biopsy event is
biopsy number fifteen, the operator ensures they are holding an
actuator that is ready for firing, and the event counter 360
presents the number "15" in the opening 356.
[0118] In an embodiment, the counter assembly 352 includes a firing
detector that registers the firing of the cannula, the actuator in
use, the value of the cumulative counter 358, and the value of the
event counter 360, and transmits a data signal to a device or
system external to the actuator assembly 200 for registering the
data. In an embodiment, the system external to the actuator
assembly 200 is the three-dimensional imaging system 1102 discussed
below.
[0119] In an embodiment, the firing detector includes the wireless
transmission of the data signal from the actuator assembly 200 to
the imaging system 1102. In an embodiment, the firing detector
includes circuitry connecting a processor, a power source, a firing
sensor, a cumulative counter sensor, an event counter sensor, a
memory, and a transceiver. The firing sensor detects the firing of
the cannula and sends a signal to the processor. The cumulative
counter sensor detects the numerical value represented by the
cumulative counter and sends a signal to the processor. The event
counter sensor detects the numerical value represented by the event
counter and sends a signal to the processor. The memory includes
the unique ID of the actuator assembly, instructions for processing
the signals received by the processor, and instructions for
transmitting the data signal from the actuator assembly 200 to the
imaging system 1102 using the transceiver.
[0120] In use, an operator prepares to use an actuator assembly,
for example an actuator assembly with the unique ID of "A-01," with
a cumulative counter value of "52," an event counter value of "3,"
and the cannula carriage assembly at rest. The operator moves the
carriage assembly from the rest position to the firing position,
actuating the cumulative counter 358 and changing the value from
"52" to "53," and actuating the event counter 360 and changing the
value from "3" to "4." The firing detector registers the new
counter values and communicates the values and the unique actuator
assembly device ID A-01 to the imaging system 1102 where the
information is registered as associated with biopsy number 4. Upon
firing of the cannula, the sensor detects the firing of the cannula
and sends a data signal to the imaging system 1102 where the
information is registered as associated with biopsy number 4.
[0121] In an embodiment, the operator alternates use of two
actuator assemblies, each with a unique device ID, to conduct a
biopsy procedure, where the value of the event counter is staggered
so that the alternating use of the actuators corresponds to a
sequential progression of numerical values.
[0122] Referring to FIG. 14C, an embodiment of the actuator
assembly 200 includes a lever 338 forming an ergonomic handle at
the bottom or posterior of the actuator assembly 200, operably
connected to the actuator members 220, 254 for moving the actuator
members 220, 254 from rest to the first position. In addition, the
lever 338 may be formed to fit comfortably in the hand of the
operator whereby the lever 338 induces the operator to orientate
the needle assembly 100 loaded therein to present the core bed 116
in the proper direction. In an embodiment, the actuator assembly
200 orientates the core bed 116 upward. In an embodiment, the
actuator assembly 200 orientates the core bed 116 downward. By
dictating the orientation of the core bed 116 the operator is able
to correlate the subsequent pathological characteristics of the
tissue specimen to the target tissue. Such correlation is enhanced
by use of a needle assembly employing one or more projections 122,
128, and marking agents, as described above.
[0123] In an embodiment, the actuator assembly 200 includes a
bubble level assembly on its upper surface providing an indication
to a user during use that the actuator assembly 200, and thereby
the needle assembly 100, is level and plumb, and not obliquely
orientated thereby creating a misalignment of the biopsy tissue
specimen excised from the target tissue.
[0124] It will be appreciated that the components of the actuator
assembly 200 can be used for various other applications. Moreover,
the actuator assembly 200 can be fabricated in various sizes and
from a wide range of suitable materials, using various
manufacturing and fabrication techniques.
[0125] Pathology Specimen Cassette
[0126] Referring to FIGS. 19-27, a pathology specimen cassette for
retaining a biopsy tissue specimen, such as a tissue specimen
obtained using the needle assembly 100, includes a cartridge
assembly 400 having a media 478 retained between a base 402 and a
lid 430. The biopsy specimen is applied to the media 478 and
retained within the closed cartridge assembly 400 until the biopsy
specimen is removed for pathological examination.
[0127] The base 402 includes sidewalls 410 forming a generally
rectangular body 404 extending between a front wall 405 at a first
end 406 and a back wall 407 at a second end 408. The body 404 forms
a cavity 414 that is bound by an inner surface 411 of walls 405,
407, 410, a top surface 424 of a lower wall 422. The cavity 414 can
be from about 5 mm to about 30 mm in width between the sidewalls
410, and from about 10 mm to about 100 mm in length between the
front wall 405 and back wall 407. The cavity 414 is open at the
top, and is intermittently open at the bottom by way of one or more
openings 428 passing through the top surface 424 and a bottom
surface 426 of the lower wall 422. The openings 428 allow fluids to
move in and out of the closed cartridge assembly 400. In some
embodiments the body 404 forms a hinge element 416 at the first end
406 allowing movable connection of the lid 430 to the base 402. In
some embodiments the body 404 forms a lip 418 that extends outward
from the second end 408 and includes an outwardly-open notch 420
for receiving a latch 472 connected to the lid 430.
[0128] The lid 430 includes sidewalls 438 forming a generally
rectangular body 432 extending between a first end 434 and a second
end 436. The body 432 includes a middle wall 454 with a lower wall
440, a lip 448, and an upper wall 462 extending therefrom. The
middle wall 432 extends between the sidewalls 438 and the first and
second ends 434, 436 forming one or more openings 460 extending
between a bottom surface 456 and a top surface 458. The openings
460 allow fluids to move into and out of the closed cartridge
assembly 400. The lower wall 440 depends from the bottom surface
456 and extends between the sides and the first and second ends
434, 436, forming a bottom surface 422, and inner surface 444, and
an outer surface 446. The inner surface 444 forms a cavity that is
open at the bottom, and is bound by the lower wall 440 at the first
end 434, second end 436, sides, and the bottom surface 456. A lip
448 extends outward from the middle wall 454 forming a bottom
surface 450 and a top surface 452. The upper wall 462 extends
upward from top surfaces 458 and 452 forming a top surface 465.
[0129] In some embodiments, the body 432 forms a hinge element 468
at the first end 434 that cooperates with hinge element 416
allowing movable connection of the base 402 to the lid 430, thereby
securing the base 402 to the lid 430 when the cartridge assembly
400 is in an open position (FIG. 19) or closed position (FIG. 20).
In some embodiments the body 432 forms a tab 470 that extends
outward from the second end 436 and includes a latch 472 depending
therefrom forming a protrusion 474 for engaging the notch 420,
thereby securing the base 402 to the lid 430 when the cartridge
assembly 400 is in a closed position.
[0130] The base 402 and lid 430 are manufactured from material,
including plastic that is resistant to corrosion, including
corrosion from aqueous and non-aqueous solvents such as
formaldehyde.
[0131] Referring to FIGS. 25-27, a fluid transfer element 484,
bound by a media 478 and a first membrane 490, is retained within
cavity 414. The fluid transfer element 484 comprising a suitable
porous material, is retained within cavity 414. The fluid transfer
element 484 absorbs a fluid, described further below, allowing the
tissue specimen on the media 478 to be constantly immersed in the
fluid. The porous material can comprise, for example, an open-cell,
closed-cell, large-cell, or small cell foam material. The foam
material can comprise, for example, a hydrophilic material, a
hydrophobic material, polyurethane ester, polyvinyl acetate, and
rubber. The fluid transfer element 484 includes a top surface 486
and a bottom surface 488.
[0132] The first membrane 490, comprises a suitable semi-permeable
material for selectively admitting fluid into the cartridge
assembly 400. The first membrane 490 includes a top surface 492 and
a bottom surface 494. The top surface 492 is in contact with bottom
surface 488, and the bottom surface 494 is in an opposing
relationship with top surface 424 and exposed to openings 428.
[0133] The media 478 facilitates handling and examination of the
biopsy tissue specimen during examination without a need to remove
the specimen from the media 478. The media 478 includes a top
surface 480 exposed to the top of the base 402 for receiving the
tissue specimen, and a bottom surface 482 in contact with the top
surface 486. The media 478 comprises, for example, a single
material or an amalgam of materials including, cellulose filter
media, plastic filter media, polymer formulations, and biopolymer
formulations. The thickness of the media 478 is from about 0.1 mm
to about 10 mm. The density of the media 478 includes the same
density as paraffin polymers used in routine histology labs to
facilitate tissue processing and sectioning through without removal
of the biopsy tissue core. The media 478 may be treated to improve
adherence of the tissue specimen including chemical coating or
infusion, biopolymer coating or infusion, and exposure to high
temperature coronal plasma. Markings, such as perforations or
lines, on the top surface 480 or incorporated within the media 478,
facilitate spacial orientation and location identification of the
beginning and end of any lesions identified during the pathological
examination, and subsequent segmentation of the media 478 and
attached tissue specimen during pathological examination. In some
embodiments, the markings are delineated in cm or mm increments
providing a guide to the distance between the first end and second
end of the tissue specimen.
[0134] A second membrane 496 is retained by cavity 466. The second
membrane 496 comprises, for example, a suitable semi-permeable
material for selectively admitting fluid into the cartridge
assembly 400. The second membrane 496 includes a top surface 498
and a bottom surface 500. The top surface 496 is an opposing
relationship with bottom surface 456 and exposed to openings 460,
and the bottom surface 500 is exposed to the bottom of the lid
430.
[0135] The first and second membranes 490, 496 are manufactured
from a material, including plastic, that is resistant to corrosion,
including corrosion from aqueous and non-aqueous solvents such as
formaldehyde.
[0136] The aforementioned features of the cartridge assembly 400
aid in a more precise examination of a biopsy tissue specimen
excised from a target tissue site. Moreover, the careful
orientation, transfer, and placement of a biopsy tissue core
specimen from a biopsy needle to the media 478 allows an examining
pathologist to accurately identify the biopsy specimen and to
identify the anatomic location and orientation of the specimen in
relationship to the target tissue.
[0137] In use, the cartridge assembly 400 is orientated to an open
position (FIG. 19) whereby the lid 430 and base 402 are separated
so that the media 478 is accessible. The biopsy tissue specimen is
orientated and placed on the media 478 so that tissue located at
the second end 120 of the core bed 116 is adjacent the first end
406 of the base 402, and the tissue located at the first end 118 of
the core bed 116 is adjacent the second end 408 of the base 402.
Any markings made on the tissues by the projections or marking
agents may additionally facilitate orientation and identification
of the tissue specimen. In some embodiments, the cartridge assembly
400 may be labeled to indicate the proper orientation of the biopsy
needle. In some embodiments, the base of the tissue is marked with
a pathological compatible ink allowing the pathologist to properly
determine the location of any lesions on the specimen, and in turn,
lesions in the target tissue. Once the biopsy tissue specimen is in
contact with the media 476 the cartridge assembly 400 is orientated
to a closed position (FIG. 20) whereby the lid 430 and base 402 are
joined, effectively capturing the specimen there between. In the
closed position, top surface 424 and bottom surface 450 are in an
opposing relationship, and bottom surface 442 and top surface 480
are in an opposing relationship. In some embodiments, the
protrusion 474 engages the notch 420 securing the base 402 to the
lid 430. The closed cartridge assembly 400 with tissue specimen is
then placed in a collection vial 502 containing a fluid, including
a preservative, until the cartridge assembly 400 is removed prior
to pathological examination. At the time of pathological
examination, the cartridge assembly 400 is orientated in an opened
position and the media 478 with the tissue specimen is removed for
examination.
[0138] Referring to FIGS. 28-32, the collection vial 502 has a
sidewall forming an upwardly open cylinder extending from a lower
closed bottom 504 to an upper opening 506. The vial includes a cap
508 that creates a sealing relationship with the vial 502. In use,
a vial 502 is selected having a length, and a diameter greater than
the largest cross-sectional dimension and length of the selected
closed cartridge assembly 400. The cap 508 is removed and the first
end 406 of the closed cartridge assembly 400 containing a tissue
specimen is inserted into the vial 502 until it is at the base 504.
The vial 502 may include a preservative prior to insertion of the
cartridge assembly 400, or a preservative may be added after
insertion of the cartridge assembly 400. The cap 508 is replaced
and the vial 502 remains sealed until pathological examination. In
some embodiments, a label providing is applied to the vial 502
including information associating the specimens as belonging to an
individual patient
[0139] In some embodiments, a plurality of vials 502 and a
plurality of cartridge assemblies 400 may be assembled in a
collection tray 520 (FIGS. 28-32). The tray 520 includes a vacuum
formed base with a plurality of vial wells 526 in an upper surface
524, and an adjacent cartridge assembly well 530. The tray 520 may
be manufactured from plastic and plastic copolymers. The vial wells
526 are dimensioned to receive the bottom 504 of a corresponding
vial 502 so that the vial 502 is supported in an upright position.
The cartridge assembly well 530 is dimensioned to receive a
plurality of cartridge assemblies 400 in an open position. The
cartridge assemblies 400 may be sterile, and the cartridge assembly
well 530 is bound by a sealing surface 534 for receiving a seal 532
for retaining the cartridge assemblies 400 in a sterile environment
therein. One or more labels 538 on the tray 520 provide information
identifying the specimens in the vials 502 as belonging to an
individual patient. The tray 520 includes a vertical sidewall 522
at its base. The sidewall 522 includes a sealing surface 540 for
engaging a cover 536, such as in a labyrinth seal arrangement, for
retaining the vials 502 in a sterile environment therein and for
containing spills. In some embodiments the tray 520, vials 502, and
cartridge assemblies 400 are enveloped by a plastic bag 542 and
sealed therein for retaining a sterile environment therein and for
containing spills.
[0140] Common biopsy procedures may require at least twenty biopsy
tissue specimens to adequately sample a target tissue. In some
embodiments, the collection tray 520 includes twenty five vials 502
and twenty five cartridge assemblies 400. In some embodiments the
vials are pre-filled with 10 percent neutral buffered formalin.
[0141] In some embodiments, a printer connected to software being
used in conjunction with performing the biopsy will print a label
adapted for application to the vials 502 for identifying the
specimen contained therein. The label may include patient
identifying information, including a specimen identification number
and associated patient record data. Each vial 502 containing a
tissue specimen receives a unique identification number allowing
the specimen to be associated with a biopsy site. Providing a
unique identification number will greatly minimize specimen
labeling mistakes and facilitate incorporation of remarks related
to the pathological findings into biopsy mapping software.
[0142] Upon pathological examination, the distal end or base of
each tissue specimen will be marked with tissue marking dye of a
color. Each subsequent length of tissue, from about 10 mm to about
15 mm may be marked with a different color of tissue marking dye.
The tissue specimen and the media 478 are sectioned, such as with a
dissection blade. The tissue and media 478 segments will be placed
into a labeled histopathology cassette for subsequent tissue
processing according to standard histopathology practice. For media
478 of higher density than paraffin, the tissue specimens are
removed from the media 478 when orientating and embedding the
tissue specimens on the histopathology cassette.
[0143] It will be appreciated that the components of the cartridge
assembly 400 can be used for various other applications. Moreover,
the cartridge assembly 400 can be fabricated in various sizes and
from a wide range of suitable materials, using various
manufacturing and fabrication techniques.
[0144] Three-Dimensional Mapping and Focal Therapy System and
Method
[0145] Embodiments of the disclosed subject matter include systems,
methods, and apparatus that are improvements to the field of
planning and performing biopsies. Some embodiments of the disclosed
subject matter include systems, methods, and apparatus for a
three-dimensional imaging system 1102 providing advantages in the
imaging and mapping of a target tissue for planning and performing
biopsies of the target tissue, and for planning and performing
treatments of the target tissue. The three-dimensional imaging and
mapping of a target tissues provides a technological benefit of a
higher degree of accuracy of sampling tissue specimens and
reconstruction of the location and mass of lesions of the target
tissue thereby providing for a higher degree of accuracy of the
identification of the existing pathology of the target tissue and
allowing a more accurate identification of appropriate therapies
for patient treatment. The disclosed subject matter can be used
with any manner of target tissue types, including human
tissues.
[0146] FIG. 33 illustrates a patient 1002 positioned for a
procedure, specifically a procedure where the target tissue is a
prostate gland. The patient 1002 is in a lithotomy position on a
procedure table whereby the prostate gland is accessed in a
transperineal manner. In the representative embodiment, the biopsy
of the prostate is performed with the aid of a grid or template
1018 positioned adjacent the perineum of the patient 1002. An
imaging system 1032, such as an ultrasound system 1034 with a
transrectal ultrasound (TRUS) probe 1036 is used to provide
transverse and sagittal images of the target tissue on a graphical
user interface (GUI) 1104. The relative position between the probe
1036 and the template 1018 is known allowing for a correlation
between the image produced by the TRUS probe 1036 and the position
of the template 1018. The template 1018 is connected to a mount
1026, and the probe 1036 is connected to the mount 1026 by an index
mechanism 1028 such as a stepper system. The mount 1026 provides
for proper support and positioning of the template 1018 and probe
1036, and the index mechanism 1028 provides for registered movement
of the probe 1036 allowing the imaging system 1032 to acquire
images of the prostate that are a fixed distance apart.
[0147] Once the patient 1002 is positioned to begin the procedure,
the system 1102 can be used to acquire images of a target tissue
for planning a biopsy procedure, conducting the biopsy procedure
and obtaining tissue specimens, correlating pathology results of
the tissue specimens to a virtual and ultrasound image of the
target tissue, and plan and implement treatments of the target
tissue.
[0148] FIG. 34 illustrates an example of a GUI 1104 according to
some embodiments of the system 1102. The GUI 1104 displays a list
of modules performed by the system 1102 pertaining to the several
phases of the system 1102. Specifically, FIG. 34 illustrates five
modules: a planning module 1106 for a planning phase, a biopsy
module 1108 for a biopsy phase, a pathology module 1110 for a
pathology phase, a treatment module 1112 for a treatment phase, and
a review module 1114 for a review phase.
[0149] Planning Phase
[0150] The planning module 1106 allows a user to obtain ultrasound
images of the target tissue, align the hardware used to obtain
biopsy specimens with the ultrasound images, construct a
three-dimensional image of the target tissue, and prepare a plan
for obtaining biopsy tissue specimens of the target tissue. The
three-dimensional imaging system improves the biopsy procedure by
allowing an operator to generate a biopsy site plan from a
three-dimensional model of the prostate.
[0151] FIG. 35 illustrates an exemplary embodiment of a graphical
user interface used for creating new patient files and for
accessing existing patient files. The GUI 1104 includes an image
frame 1152: bound at the top by a menu bar 1154, a tool bar 1166, a
thumbnail frame 1202; bound at the side by a preview frame 1228, an
outline object structure frame 1260, a biopsy control frame 1280,
and a pathology control frame 1302; and bound below by an image
control frame 1312.
[0152] The image frame 1152 displays the interactive icons, and
interactive images of the biopsy plan. The interactive icons
include creating a new patient file with a real-time image data
1118, a new patient file with existing image data 1120, access to
existing patient files 1122, and access to recent patient files
1124. The following example of the functionality of the system 1102
is first shown and described in an embodiment where the user
selects creating a new patient file with a real-time image data
1118 in the planning module 1106.
[0153] The menu bar 1154 includes menu items that provide access to
file, view, phase, and help functionality. The file 1156 menu item
opens a new or existing file, adds an existing biopsy plan, imports
data files from other imaging modalities and allows export of data
files in various formats. The view 1158 menu item creates
two-dimensional or three-dimensional views, allows for the addition
of toolbars, and allows for adjustment of screen image size. The
phase 1160 menu item puts the user in the planning, biopsy,
pathology, or treatment phases. The help 1162 menu item includes
instructions and software license information.
[0154] The tool bar 1166 includes tool buttons that provide
software input and output elements. The new file 1168 button
creates a new patient study or procedure. The open file 1170 button
opens data files for an existing patient study or procedure. The
save file 1172 button saves the active patient study or procedure.
The save folder 1173 button saves the active patient study or
procedure with a new name. The three-dimensional reconstruct 1174
button adds a three-dimensional view of the structures. The toggle
probe dropdown button 1176 switches the views in the image frame
1152 between axial to sagittal views. The grid 1178 button brings
up the software grid 1344 in the image frame 1152, allowing
calibration of the software grid 1344 to the ultrasound grid 1332.
The capture device dropdown 1180 button allows a user to select
preferences for the capture device, including setting the capture
device, setting the capture interface and frame rate, and setting
the aspect ratio. In some embodiments the capture device is set as
a universal serial bus (USB) image capture device. In some
embodiments the capture interface is set as separate video
(S-Video) at 720.times.480 pixel resolution, 16 bits per pixel
(bpp), 19.8 mebibyte per second (Mib/s), and picture encoding YUY2.
In some embodiments the aspect ratio is set at 4:3. The outline
tool 1182 button allows a user to create and edit an outline or
contour of a tissue or structure in the image frame 1152. The
outline dropdown 1184 button allows a user to set outline details
such as turn on or turn off the outline, and allows adjustment of
the outline parameters, including intensity, color, size, etc. The
fill outline 1186 button fills the entire outline in. The node
contour 1188 button shows the outline control points and allows
adjustment of the contour edge by adding nodes to the contour edge
and pulling or pushing notes across the image. Notes may also be
removed from the image with the noted contour 1188 button. The
single outline 1192 button shows only the selected outline in the
image frame 1152. The adjacent outline 1194 button shows the
selected outline and any adjacent outlines in the image frame 1152.
The all outlines 1196 button shows all of the saved outlines in the
image frame 1152. The clear 1198 button clears the selected outline
being constructed in the image frame 1152. The clear all 1200
button clears all outlines constructed in the image frame 1152.
[0155] Referring to FIGS. 36-38, a transverse ultrasound image 1040
of the target tissue is generated in the image frame 1152. The
image 1040 is an axial image or a transverse cross section of a
prostate gland 1008 generated by real-time image data 1118 received
from the ultrasound system 1034, namely data generated by a TRUS
probe 1036 positioned within the rectum 1004 of a patient 1002.
[0156] The system 1102 displays an ultrasound grid 1332 of dots
over the image 1040. The ultrasound grid 1332 is generated by the
ultrasound system 1034 and consists of a coordinate system 1334 of
horizontal rows of spaced dots along an x-axis 1336 and a vertical
row of spaced dots along a y-axis 1338 representing the same
number, arrangement, and spacing of the apertures 1020 of the
template 1018. Thus the apertures 1020 of the template 1018 are
represented by the dots of the ultrasound grid 1332. The ultrasound
probe 1036 is represented by an arch of a circle at the bottom of
the image 1040, and is centered on a horizontal row of spaced index
markers 1342 below the bottom row of dots of the x-axis 1336. The
index markers 1342 provide a fixed reference point for aligning a
software grid 1344, representing a biopsy site plan, generated by
the system 1102. In some embodiments, the elements of the
ultrasound image 1040 are represented by gradations of white on a
black background, and ultrasound grid is represented by white
dots.
[0157] The software grid 1344 of circles consists of a coordinate
system 1345 of horizontal rows of spaced circles along an x-axis
1346 and a vertical row of spaced circles along a y-axis 1348. The
software gird 1344, when aligned with the ultrasound gird 1332,
allows for coordination between the ultrasound system 1034 and the
system 1102. When the coordinate systems 1334 and 1345 are aligned
the system 1002 is able to accurately capture the image 1040 and
any contours, and accurately represent the features of the
three-dimensional prostate image 1472. In some embodiments, the
elements of the software grid 1344 are represented by circles, and
the color of the circles is determined by the user by changing the
display preferences.
[0158] Referring to FIG. 37, the scale and location of the software
grid 1344 is aligned with the scale and location of the ultrasound
grid 1332 so that the top and bottom horizontal rows of dots of the
ultrasound grid 1332 x-axis 1336 fall within the center of the
corresponding top and bottom horizontal rows of circles of the
software gird 1344 x-axis 1346, and the left and right vertical
rows of dots of the ultrasound grid 1332 y-axis 1338 fall within
the center of the corresponding left and right vertical rows of
circles of the software grid 1344 y-axis 1348. The software grid
1344 is repositioned by selecting a corner handle 1352 or side
handle 1354, represented by squares, by a cursor controlled by an
input device, such as a mouse or stylus, and dragging the
coordinate system 1345 across the image 1040. The software gird
1344 is resized by selecting a corner handle 1352 or side handle
1354 and squeezing or expanding the coordinate system 1345 across
the image 1040. The sweep angle of the ultrasound probe 1036 and
contour of the probe height 1358 are aligned by selecting the boxes
at the end of the probe angle 1360 lines and pulling the probe
angle 1360 lines to match the sweep angel of the ultrasound probe
1036, and by adjusting the height of the probe view to match the
ultrasound image 1040. In some embodiments, the probe angle 1360
and probe height 1358 are represented by green lines. The center of
the ultrasound probe 1036, and the center of the image 1040
generated by the ultrasound probe 1036 is represented by a probe
centerline 1362.
[0159] The image 1040 of the target tissue in the image frame 1152
automatically switches between a transverse image and a sagittal or
axial image when the data from the ultrasound system 1034 is
switched between a transverse image and a sagittal or axial image.
This functionality is initialized by selecting the configure
auto-plane 1364 tab. Referring to FIG. 38, a flashing rectangular
box appears in the image frame 1152, and it is selected by the
cursor and moved over the letter "T," representing the transverse
view. In FIG. 38, the "T" is in the upper right hand corner of the
image frame 1152, and is displayed as "8558/T." Next the view of
the target tissue in the image frame 1152 switched from a
transverse image to a sagittal image. Next another flashing
rectangular box appears in the image frame 1152, and it is selected
by the cursor and moved over the letter "S," representing the
sagittal view. In FIG. 39, the "S" is in the upper right hand
corner of the image frame 1152, and is displayed as "8558/S." Next
the user selects the done configuring 1134 button.
[0160] Referring to FIG. 40, a sagittal image or a longitudinal
cross section of the prostate gland 1008 from the base 1012 to apex
1010 is shown in the image frame 1152. As above, the software grid
1344 is displayed over the ultrasound image 1040 of the prostate
1008, and the scale and location of the software grid 1344 needs to
be adjusted. The software grid 1344 is repositioned by selecting a
corner handle 1352 or side handle 1354, represented by squares, by
a cursor controlled by an input device, such as a mouse or stylus,
and dragging the coordinate system 1345 across the image 1040 The
software gird 1344 is resized by selecting a corner handle 1352 or
side handle 1354 and squeezing or expanding the coordinate system
1345 across the image 1040. The software grid 1344 is further
positioned by aligning the probe height 1374 with the image of the
ultrasound probe 1036 in the image 1040. In some embodiments, the
probe height 1374 is represented by a green lines. The scale of the
software grid 1344 in the sagittal view is also determined by the
location of the base 1012 and apex 1010 of the prostate 1008. In
this view, a vertical base alignment 1370 line is projected
adjacent the left edge of the software grid 1344 and a vertical
apex alignment 1372 line is projected adjacent the right edge of
the software gird 1344. The base alignment 1370 line is moved to
align with the base 1012 of the prostate 1008 and the apex
alignment 1372 is moved to align with the apex 1010 of the prostate
1008.
[0161] When grids 1332 and 1344 are aligned, and probe height 1358
and probe angle 1360 are set in the transverse view, and grid 1344,
probe height 1374, and base and apex alignment 1370, 1372 are set,
the virtual grid image adjustments are complete for setting up the
system 1102 for use with the imaging system 1032 for the particular
patient 1002. The above settings are stored by the system 1102 and
the above steps do not need to be repeated for subsequent patients
if the system 1102 is used with the same imaging system 1032.
[0162] Contouring
[0163] After the system 1102 is aligned, identification and line
contouring of the structures of the target tissue and surrounding
structures are performed. The system 1102 is used to construct a
three-dimensional model of the target tissue using a plurality of
line contours of tissue structural elements appearing in each
transverse ultrasound image 1040 of the target tissue. Referring to
FIG. 41, elements, such as structures and organs, are named and
given a line color using the outline object frame 1260. Selecting
the add object 1264 button allows a user to input an element name
and select a line color. Selecting the delete object 1266 button
removes an element. In an embodiment, the structures of the
prostate are identified, including the prostate 1268 as a red line,
the urethra 1270 as a green line, the rectum 1271 as a blue line, a
first seminal vesicle 1272 as an orange line, a second seminal
vesicle 1273 and an orange line, a first anchor needle 1274 as a
yellow line, and a second anchor needle 1276 as a yellow line. The
above text and line colors can be adjusted by selecting an element
and selecting the settings 1262 button. Any number of elements can
be included and any number of colors assigned.
[0164] Various contour tools may be used to create a contour line
of an element represented by the image 1040. The tool bar 1166
includes an outline tool 1184 button for initiating a contour line,
a sweep contour 1188 button for creating a continuous contour line
with the cursor, and a node contour 1190 button for creating a
contour with the cursor moving to individual nodes at the edge of
the element. To begin constructing a first contour image, the
ultrasound probe 1036 is advanced inward until it is at a first
position adjacent the base 1012 of the prostate 1008 whereby a
first transverse image 1040 is displayed in the image frame 1152.
In some embodiments, the first element selected for contouring from
the list in the outline object frame 1260 is the prostate 1268.
Upon selecting the prostate 1268 outline object the system 1102
prompts the user to identify a first point on the first transverse
image 1040 as the center of the prostate by selecting the location
on the image frame 1152 with the cursor (FIG. 41). A dot is then
displayed on the first transverse image 1040 at the first point and
the user drags a line from the first point to a second point at an
outer edge of the prostate 1008 shown on the image 1040 to initiate
outlining the element (FIG. 42). The user then traces the edge of
the prostate 1008 shown on the image 1040, stopping at the second
point, creating a prostate contour line 1378 (FIG. 43). The edge of
the contour can be adjusted by selecting the node contour 1190
button and selecting a point on the contour line 1378 and moving
the cursor. The image 1040 and the overlaid contour can be enlarged
to aid fine tuning of the contour line 1378 by moving the cursor
along the zoom 1320 bar within the image control pane 1312. The
entire contour can be deleted by selecting the clear 1198 button
and the contour begun again.
[0165] In some embodiments, the second element selected for
contouring is the urethra 1014. Upon selecting the urethra 1270
from the outline object frame 1260 the user then traces the inner
edge of the urethra 1014 shown on the first transverse image 1040
creating a urethra contour line 1380. In some embodiments, the
contour of the urethra 1014 can be selected as a circle and sized
and positioned accordingly. In some embodiments, the third element
selected for contouring is the rectum 1004. Upon selecting the
rectum 1271 from the outline object frame 1260 the user then traces
the portion of the rectum 1004 shown on the first transverse image
1040 creating a rectum contour line 1382.
[0166] The contour lines of the elements of the first transverse
image are saved as a first captured image 1204 by the system 1102
by selecting the capture image 1190 button in the lower left
portion of the image frame 1152. The first captured image 1204
appears at the left in the thumbnail frame 1202 and is referenced
by the number 0 (FIG. 44). The first captured image 1204 is also
shown as a first slice 1232 of a three-dimensional image 1472 in
the preview pane 1228. The three-dimensional image 1472 is shown as
two images, a plan image 1256 of the prostate 1008 with the base
1012 shown at the top, and a side elevation image 1258 of the
prostate 1008 with the base 1012 shown at the left. The edges of
the contour may be adjusted as described above (FIG. 45).
[0167] The ultrasound probe 1036 is then moved out of the rectum
1004 one unit distance toward the apex of the prostate to show a
second transverse image 1040 is displayed in the image frame 1152
(FIG. 46). The unit distance is determined by the index mechanism
1028. In some embodiments, one unit distances is about 5 mm. In
some embodiments, the index mechanism 1028 is mechanically actuated
and the system 1102 moves the probe 1036 after capturing of each
contour. The unit distance separating each transverse image 1040
may be programmed into the system 1102. The elements of the second
transverse image 1040 are contoured and modified as above (FIG.
47), and the contours of the elements of the second transverse
image 1040 are saved as a second captured image 1206 by the system
1102 by selecting the capture image 1190 button. The second
captured image 1206 appears to the right of the first captured
image 1204 in the thumbnail frame 1202 and is referenced by the
number 5 representing the distance the second captured image 1206
is spaced from the first captured image 1204. The second captured
image 1206 is shown as a second slice 1234 of the three-dimensional
image 1472 in the preview pane 1228. The second slice 1234 is
positioned below the first slice 1232 in the plan image 1256, and
to the right of the first slice 1232 in the elevation image
1258.
[0168] The ultrasound probe 1036 is then advanced one unit distance
out of the rectum 1004, as described above, to show a third
transverse image 1040 in the image fame 1152 (FIG. 48). The
elements of the third transverse image 1040 are contoured and
modified as above, and the contours of the elements of the third
transverse image 1040 are saved as a third captured image 1208 by
the system 1102 by selecting the capture image 1190 button. The
third captured image 1208 appears to the right of the second
captured image 1206 in the thumbnail frame 1202 and is referenced
by the number 10 representing the distance the third captured image
1208 is spaced from the first captured image 1204. The third
captured image 1208 is shown as a third slice 1236 of the
three-dimensional image 1472 in the preview pane 1228. The third
slice 1236 is positioned below the second slice 1234 in the plan
image 1256, and to the right of the second slice 1234 in the
elevation image 1258.
[0169] Additional captured images are generated and saved to the
system 1102 as described above by advancing the ultrasound probe
1036 one unit, contouring elements on the transverse image 1040,
and creating captured images of the contours of the image elements.
Accordingly, a fourth, fifth, sixth, seventh, eighth, ninth, tenth,
and eleventh contoured image 1210, 1212, 1214, 1216, 1218, 1220,
1222, and 1224 are created and used to create a fourth, fifth,
sixth, seventh, eighth, ninth, tenth, and eleventh slice,
respectively, with the eleventh contoured image 1224 at an eleventh
position at the apex 1010 of the prostate 1008 (FIG. 49). The
aforementioned contoured images are arranged in order adjacent to
each other in the thumbnail frame 1202, plan image 1256, and
elevation image 1258 as described above.
[0170] In some embodiments, capturing two or more images completes
capture of a sufficient number of images and slices to render the
three-dimensional plan image 1256 and three-dimensional elevation
image 1258. In some embodiments, the margin of the tissue
structures are filled in between each slice by automatically
interpolating the proper contour.
[0171] Selection of any image in the thumbnail frame 1202 outlines
the image in a box, highlights the corresponding slice in the plan
image 1256 and elevation image 1258, and displays the captured
image in the image frame 1152 allowing a user to check the contours
and make any modifications to the contours desired. When the user
is done capturing images and editing the contours of the captured
images the contouring is completed by selecting the done contouring
1384 button at the bottom of the image frame 1152. The system 1102
calculates the target tissue volume 1254, here the volume of the
prostate 1008, and displays the value below the images 1256, 1258.
In some embodiments, the volume value is represented in a metric
volume, including cubic centimeters.
[0172] Three-Dimensional Model
[0173] The tool bar 1166 includes a three-dimensional
reconstruction 1174 button that presents the three-dimensional
image of the target tissue generated from the contour images in a
three-dimensional image graphical user interface (3DGUI) 1402.
Referring to FIGS. 50-52, three-dimensional images of the prostate
are rendered in the 3DGUI 1402 frame from the plurality of contour
images generated above, including an isometric, three-dimensional
image of the prostate 1472 rendered in an image frame 1440. The
image frame 1440 is: bound at the top by a tool bar 1404, and a
front view window 1430, a top view window 1434, and an elevation
view window 1438; and bound at the side by an image control frame
1442, and a grid control frame 1460, and a background control frame
1468.
[0174] The image frame 1440 displays an interactive
three-dimensional image of the prostate 1472 and related
structures. The image of the prostate 1472 includes lines and
shading. The intensity of the lines and shading can be manipulated
by increasing or decreasing the tones of the colors associated with
the contour elements. The prostate model and related structures can
be studied by the viewer, and the model may be rotated in any
direction by selecting a point on the image and moving the
cursor/pointing device.
[0175] The tool bar 1404 includes tool buttons that add windows
showing three-dimensional images of a virtual prostate from
different vantage points, constructed of the outer contour of the
tissue structures as a wire frame. The file drop down 1406 button
offers a section of three views, a front view, a top view, and a
side view. The wire frame 1408 button converts the
three-dimensional prostate image 4172 into a wire frame contour
image. The shading 1410 button and the shading button 1412 control
the color intensity of the image. The shading controls 1414 button
controls the contrast of the three-dimensional prostate image 1472.
The home drop down 1416 button sets the images in one of the front
view window 1430, top view window 1434, and elevation view window
1438. The back 1418 button returns to the previous image. The
forward 1420 button moves to the next image. The rotate 1422 button
switches the image perspective. The anchor 1424 button sets anchor
points on the image. The camera 1426 button captures the scene and
save it to the file.
[0176] The front view window 1430 includes the same buttons as
found on the tool bar 1404 and displays an image of the front of
the prostate 1472. The top view window 1434 includes the same
buttons as found on the tool bar 1404 and displays an image of the
top of the prostate 1472. The elevation view window 1438 includes
the same buttons as found on the tool bar 1404 and displays an
image of the side of the prostate 1472. Selection of any image in
the thumbnail frame 1202 is shown as a highlighted slice in the top
view window 1434 and elevation view window 1438. The corresponding
contour line or lines are highlighted on the prostate 1472
image.
[0177] The image control frame 1442 allows the intensity of the
color of the various tissues and elements created in the object
frame 1260 displayed in the windows to be adjusted. In this
embodiment, the structure of the prostate 1444 is represented in
red, the urethra 1446 is represented in green, the rectum 1448 is
represented in blue, the first seminal vesicle 1450 is represented
in orange, the second seminal vesicle 1452 is represented in
orange, the first anchor needle 1454 is represented in yellow, and
the second anchor needle 1456 is represented in yellow. Slider
controls adjacent the labels above may be moved from left to right
to vary the intensity of the color. As above, the system 1102
calculates the volume of the prostate 1472, and displays the value
above the image control frame 1442.
[0178] The grid control frame 1460 controls a three-dimension grid.
A grid 1462 checkbox turns a grid overlying the prostate 1472,
represented by a gridlines displayed as a three-dimensional graph,
on or off. A slider control next to the grid 1462 checkbox may be
moved from left to right to vary the intensity of the of the grid
lines. A "Use A-M instead of A-G" 464 checkbox turns on a probe box
displaying the ultrasound probe, and a slider control next to the
checkbox may be moved from left to right to vary the intensity of
the image of the ultrasound probe.
[0179] The background control frame 1468 allows the color 1470 of
the image frame 1440 to be white, black, or any variation in
between by moving the slider control adjacent the color 1470 label
from left to right, respectively. The size of the prostate image
1472 in the image frame 1440 can be changed from small to large by
moving the image size slider control from left to right
respectively.
[0180] Referring to FIG. 51, the prostate 1472 is shown with the
apex of the prostate in the foreground, and the base of the
prostate in the background. The prostate is represented by a
prostate margin 1474, shown in some embodiments as a red,
translucent, hollow, spheroid, with an opening at each end. The
urethra is represented by a urethra margin 1476, shown in some
embodiments as a green, translucent, hollow, tube, with an opening
at each end. The prostate margin 1474 reflects the outer margin of
the prostate tissue. The urethra margin 1476 reflects both the
interior margin of the prostate tissue and the outer margin of the
urethra as it passes through the prostate tissue. Therefore, the
volume of the prostate 1472 is calculated by the system 1102 by
calculating the volume of the tissue between the prostate margin
1474 and the urethra margin 1476. Referring to FIG. 52, the
prostate 1472 is shown with apex of the prostate at the left, the
base of the prostate at the right, and the rectum represented by a
rectum margin 1478, shown in some embodiments as a blue,
translucent, hollow, tube with an opening at each end.
[0181] Three-Dimensional Image Alignment
[0182] After the three-dimensional prostate image 1472 is
generated, the alignment of the image 1472 may need to be realigned
with the ultrasound image 1040 of the prostate 1008 before biopsy
planning can begin. Referring to FIG. 53, the sagittal image 1040
or a longitudinal cross section of the prostate 1008 from the base
1012 to the apex 1010 is shown in the image frame 1152 with a
sagittal image or longitudinal cross section image 1482 of the
three-dimensional prostate image 1472 overlaying the image of the
prostate 1008. The cross section image 1482 includes vertical lines
representing the slices generated above. Referring to FIG. 54,
selecting the grid 1178 button brings up the software grid 1344.
The user then aligns the prostate margin 1474, urethra margin 1476,
and rectum margin 1478 of the cross section image 1482 with the
corresponding tissue structures of the image 1040 in the image
frame 1152. The scale of the cross section 1482 may be adjusted
along a horizontal axis 1484, and may be adjusted along a vertical
axis 1486. The location of the base 1012 and apex 1010 of the
prostate 1008 needs to be determined so the base alignment 1488
line and apex alignment 1490 line can be aligned to the base and
apex of the prostate in the ultrasound image 1040. A vertical base
alignment 1488 line is project adjacent the left edge of the cross
section 1482 and a vertical apex alignment 1490 line is projected
adjacent he right edge of the cross section 1482. Referring to FIG.
55, the base alignment 1488 line is moved to align it with the base
1012 of the prostate 1008 by selecting the grab box at the bottom
of the line, and the apex alignment 1490 is moved to align with the
apex 1010 of the prostate 1008 by selecting the grab box at the
bottom of the line. Once the features of the cross section 1482 are
aligned with the features in the image frame 1152.
[0183] Referring to FIG. 56, the biopsy planning phase continues by
generating a biopsy site plan. A biopsy site plan is generated
using the biopsy control frame 1280 in the GUI 1104. Selecting the
generate plan 1286 button brings up a biopsy plan graphical user
interface (BPGUI) 1494 frame. Referring to FIG. 57, the BPGUI 1494
enables a user to specify the parameters of the biopsy plan. By way
of example, the BPGUI 1494 shows a biopsy plan for the prostate
1008. The minimum section 1496 text box allows a user to specify
the minimum length of the tissue specimen to be taken. In some
embodiments the minimum length is 1.00 cm. The value displayed in
the minimum section 1496 text box may be adjusted by 0.01 cm
increments by selecting the up arrow adjacent the text box to
increase the value, and the value may be decreased by selecting the
down arrow adjacent the text box. In this example, the length of
the minimum section determines how close to the prostate capsule or
contoured perimeter of the gland a biopsy will be taken. The closer
to the edge of the prostate 1008 the lower the minimum section 1496
value should be. In turn, the closer to the edge of the prostate
1008 biopsies are taken the greater the number of total biopsies of
the prostate 1088 will be taken. The needle lengths 1498 text box
allows a user to specify the length of the biopsy tissue specimen
removed. The system 1102 calculates the specific length necessary
depending upon the location of the biopsy in prostate 1008. The
designated tissue specimen length is rounded to the nearest 0.1 cm.
The next selection determines if the entire tissue specimen length
will be inside the capsule, if a small amount of the biopsy core
will be outside the capsule, or if the biopsy core is to be as
close to the capsule as possible. Selecting the use closest 1500
radio button causes the system 1102 to designate needle lengths
that are as close to the capsule as possible. Selecting the inside
capsule 1502 radio button causes the system 1102 to select needle
lengths that are always inside the capsule. Selecting the outside
capsule 1504 radio button causes the system 1102 to select needle
lengths that may end up outside of the capsule, and would require
the use of more biopsy needles, require the biopsy of longer core
bed lengths, or both. The next selection allows the use of biopsy
needles having a core bed length that is less than the longest core
length required to be taken. Selecting the allow multiple inline
biopsies 1506 box allows a user to use standard biopsy needles
having a fixed core length from about 17 mm to about 20 mm. A
biopsy schematic 1508 below the selections provides an
interpretation of the selections, and a written instructions 1510
portion below the biopsy schematic 1508 provides an explanation of
the selections above. Selecting a clear biopsies first 1512 box in
the bottom left of the BPGUI 1494 clears each biopsy site from view
on the image frame 1152 after the biopsy is taken. Selecting the
generate 1514 button in the bottom right corner of the BPGUI 1494
generates the biopsy plan.
[0184] Referring to FIG. 58, the biopsy plan is shown over the
sixth contour image 1214 or sixth slice located at about the
mid-point of the prostate 1008. The biopsy plan is represented by
an array of dots 1516 indicating the intended biopsy needle
positions. The biopsy control frame 1280 indicates the number of
biopsy sites 1290 represented by the array of dots 1516. In the
example shown in FIG. 58, 56 biopsy sites are shown, as well as the
length of the core, and the number of biopsy needles with a given
core length needed to complete the biopsy plan. The number of
biopsy sites and the various core lengths and number of needles are
determined by the system 1102 by the length specified by the
minimum section 1496, the needle lengths 1498, the capsule radio
button selected, and whether allow multiple inline biopsies 1505 is
selected. For example, because in the example shown in FIG. 57 the
selections were a minimum section 1496 of 2.0 cm, needle lengths
1498 of 2.5 cm, 3.0 cm, 4.0 cm, 4.5 cm, and 5.0 cm, and use closest
1500, the biopsy plan 1286 generated a plan requiring 5 biopsy
needles with a core length of 2.5 cm, 3 biopsy needles with a core
length of 3.0 cm, 8 biopsy needles with a core length of 3.5 cm, 6
biopsy needles with a core length of 4.0 cm, 12 biopsy needles with
a core length of 4.5 cm, and 21 biopsy needles with a core length
of 5.0 cm are needed. In some embodiments, the system 1102 will
calculate and display the probability of encountering a lesion of a
particular size within the prostate 1008 using a given biopsy plan
and an array of biopsy needle positions.
[0185] Referring to FIG. 59, scrolling down below the biopsy sites
1290 displays the skipped sites 1292 and the total tissue volume
skipped. For example, 10 sites were skipped totaling 7.24 cm.sup.3.
The number of skipped sites is calculated based on the input
criteria. For example, if the minimum section 1496 is increased,
then less of the prostate is available for biopsy. The skipped
sites 1292 information allows a user to evaluate the biopsy plan
and make changes to the biopsy plan to increase the amount of
tissue included in the biopsy plan. The user can refer to the
probability calculation above to determine if any changes to the
biopsy plan improve the biopsy plan. For example, the higher the
probability of encountering a lesion of the tissue of a certain
size is an improvement in the biopsy plan. Referring to FIG. 60, a
minimum section 1496 of 1.0 cm, needle lengths 1498 of 2.5 cm, 3.0
cm, 4.0 cm, 4.5 cm, and 5.0 cm, and outside capsule 1504 was
selected, and the biopsy plan 1286 generated a plan requiring 7
biopsy needles with a core length of 2.5 cm, 4 biopsy needles with
a core length of 3.0 cm, 8 biopsy needles with a core length of 3.5
cm, 6 biopsy needles with a core length of 4.0 cm, 12 biopsy
needles with a core length of 4.5 cm, and 21 biopsy needles with a
core length of 5.0 cm are needed, totaling 59 biopsy sites. As a
result, the number of skipped sites 1292 decreased from 10 to 7,
and the total tissue volume skipped dropped from 7.24 cm.sup.3 to
1.79 cm.sup.3.
[0186] After generating a biopsy plan and making adjustments to the
variables as necessary, a user can view the orientation of the
biopsy needles 1480 in the three-dimensional prostate image 1472.
Returning to the 3DGUI 1402 frame (FIGS. 61-64), three-dimensional
images of the prostate with needle 1480 paths determined by the
biopsy plan are rendered in the 3DGUI 1402 frame from the plurality
of contour images generated above, including a rotatable,
isometric, three-dimensional image of the prostate with needles
image 1518 rendered in the image frame 1440. Accordingly, the front
view window 1430 displays an image of the front of the prostate
with needles image 1518, the top view window 1434 displays an image
of the top of the prostate with needles image 1518, and the
elevation view window 1438 displays an image of the side of the
prostate with needles image 1518. In FIG. 61, the prostate with
needles image 1518 is viewed with the apex in the foreground and
the base in the background. In FIG. 62, the prostate with needles
image 1518 is viewed from above the prostate with the rectum below,
and the path of biopsy needles that pass through the prostate above
the urethra. The prostate with needles image 1518 can be rotated in
three dimensions about a central axis using a cursor to view the
biopsy plan from all angles. In FIG. 63, the slider control for the
prostate 1444 has been moved from the middle of the slider to the
right of the slider to increase the intensity of the color of the
prostate margin 1474 causing it to become opaque, providing
contrast for the portions of the needles 1480 of the plan that
extend outside of the prostate margin 1474, represented by straight
lines 1520. In FIG. 64, the slider control for the prostate 1444
has been moved to the left of the slider to decrease the intensity
of the color of the prostate margin 1474 causing it to become
transparent, and the slider control for the urethra 1446 has been
moved from the middle of the slider to the right of the slier to
increase the intensity of the color for the urethra margin 1475
causing it to become opaque, allowing a user to evaluate the
positions of the needles 1480 around the urethra and make any
adjustments to the biopsy plan based on the relationship between
the needles 1480 and the urethra.
[0187] The three-dimensional representation of the prostate with
needle image 1518 provides an operator with visualizations, and the
ability to perform calculations, not otherwise attainable.
[0188] Biopsy Phase
[0189] Upon completion of the planning phase, biopsies may be taken
in conjunction with the system 1102. A user returns to the biopsy
plan in the image frame 1440. In the image frame 1440, the
plurality of biopsy sites are represented by dots 1516. The biopsy
sites of the biopsy plan are orientated so that biopsy site number
1 1524 is the most anterior and left site, with biopsy site number
2 1526 to the right of biopsy site number 1 1524. Biopsy site
number 11 1528 is shown with a callout box 1530. When a user places
a cursor over a biopsy site a callout box is displayed showing the
biopsy site number and coordinates. The biopsy site number and
coordinates represent the position on the software grid 1344 which
corresponds to the same location on the coordinate system 1022 on
the template 1018, allowing a user to biopsy needle into the
correct aperture 1020 of the template 1018 so the needle enters the
prostate as viewed on the ultrasound image 1040. The callout box
1530 for biopsy site number 11 shows the site is number "11," and
the coordinates are "B.5,4," referring to coordinate position "B.5"
on the x-axis of the coordinate system 1022, and coordinate
position "4" on the y-axis of the coordinate system 1022.
[0190] Selecting a biopsy site with the cursor opens a biopsy site
editing graphical user interface (BSEGUI) 1536 frame. Referring to
FIG. 66, a BSEGUI 1536 for biopsy site number 1 1524 is shown in
line with the probe centerline 1362. The BSEGUI 1536 displays a
biopsy site label 1538 corresponding to the biopsy site selected,
here, a "1" for biopsy site number 1 1524. The new page button 1540
is for adding a new biopsy site to the biopsy plan. The copy button
1542 is for copying an existing site to the biopsy plan. The close
button 1544 is for closing the biopsy site window. The probe angle
1546 is shown indicating the position of the biopsy site that
deviated from the location 1548, wherein a probe angle 1546 of "0"
indicates no deviation. In FIG. 66, the biopsy site location 1548
is at the "D" position so the probe angle 1546 is "0." If the
biopsy site is to the left of the midline location 1548 "D" the
probe angle 1546 would be represented by a negative number and
conversely if it was to the right of the midline location 1548 "D"
the probe angle 1546 would be a positive number. The probe angle
1546 represents how far to rotate the ultrasound probe 1036
(discussed below) so the intended biopsy needle is in the field of
view of the probe 1036 when imaging is switched from axial to
sagittal view. In some embodiments, a guide line represented by a
probe centerline 1362 is shown on the image frame 1152 allowing the
user to rotate the ultrasound probe 1036 so the probe centerline
1362 is in the "0" position or passing through the "D" position.
The coordinate location 1548 of the biopsy site corresponds to the
coordinate system 1022 on the template 1018 indicating the location
of the aperture 1020 along the x-axis and the y-axis where the user
will insert the biopsy needle assembly to take the biopsy tissue
specimen. Here the coordinate location 1548 is "D, 5." The snap
1550 box is for locking the position of the biopsy needle
presenting the needle from being moved. The start depth 1552 of the
biopsy site corresponds to the depth within the prostate that the
biopsy specimen will be taken calculated by the system 1102. The
length 1554 is the required length of the core bed of the biopsy
needle calculated by the system 1102 to take a biopsy tissue
specimen at the selected biopsy site.
[0191] To take the first biopsy a user selects a biopsy needle
assembly having a biopsy needle with a core bed length specified by
the length 1554. In some embodiments, the user may select the
needle assembly 100 above wherein the inner component 102 core bed
116 length between the first end 118 and second end 120 is equal to
or greater than length 1554. In an embodiment, the actuator
assembly 200 is used with the needle assembly 100 to excise a
biopsy specimen specified by the length 1554 by setting the length
of travel of the inner component 102. The user advances a biopsy
needle assembly through the aperture 1020 corresponding to the
biopsy site label 1538. Referring to FIG. 67, when a biopsy needle
is inserted through the designated aperture in the template 1018 it
may enter the prostate 1008 at a slightly different location than
indicated on the BSEGUI 1536. This may be caused by the location of
the apertures 1020 of template 1018 when it is placed against the
perineum not being perfectly aligned to the ultrasound grid 1332.
In addition, as the biopsy needle assembly enters the prostate 1008
from the perineum, it moves the gland away from its position within
the patient's 1002 body thereby what was, for example, coordinate
location "D, 5" may now be essentially coordinate location "C .93,
4.92", meaning the actual coordinate of the biopsy needle indented
for "D, 5" is 0.07 cm to the left of D at position 0.08 cm below
5.
[0192] As the user advances the biopsy needle assembly toward the
prostate 1008 the view in the image frame 1152 is changed to a
sagittal image or a longitudinal cross section of the prostate 1008
from the base 1012 to the apex 1010 is shown in the image frame
1152, and a sagittal image or longitudinal cross section 1482 of
the three-dimensional prostate image 1472 overlays the image 1040
of the prostate 1008 (FIG. 68). The length 1554 and location of the
biopsy is shown on the ultrasound image 1040 as a virtual biopsy
specimen 1586. The virtual biopsy site specimen 1586 extends
between a first end adjacent the base 1012 of the prostate 1008, a
second end adjacent the apex 1010 of the prostate 1008, and
includes a cross sectional width. In some embodiments, the virtual
biopsy specimen 1586 is represented as a yellow line having a
height representing the cross sectional width, and extends between
a vertical first end line 1592 representing the first end and a
vertical second end line 1594 representing the second end. The user
may then examine the cross section and evaluate the intended biopsy
site. When the biopsy needle is viewed on the ultrasound image
1040, and it is not perfectly superimposed with the virtual biopsy
specimen 1586, the user selects the site and moves a yellow dot
that is superimposed on the inserted biopsy needle. The new
location 1548 of "C.93, 4.92" now represents the true position of
the biopsy needle in the three-dimensional prostate image 1472. The
user can decided if the new location is acceptable and whether any
changes need to be made to the biopsy sites of the surrounding
needles.
[0193] Referring to FIG. 68, an assessment of biopsy site number 1
1524 indicates the suggested length 1554 of 2.5 cm for the biopsy
specimen is of insufficient length to extend between the margin of
the prostate 1008 from a first point adjacent the apex 1010 and a
second point adjacent the base 1012. The user may change the
recommended length of the biopsy core to a revised length of the
biopsy core.
[0194] Referring to FIG. 69, the biopsy core length was changed
from a recommended length of 2.5 cm to a revised length of 3.5 in
the BSEGUI 1536 by changing the length 1554 from 2.5 to 3.5. The
length selected will depend on the appearance of the virtual biopsy
specimen 1586 on the ultrasound image 1040. Adjusting the length of
the biopsy core taken allows the biopsy core to sample tissue from
the full length of the prostate 1008 at that site. In addition to
adjusting the length of the biopsy specimen, the vertical location
or height of the virtual biopsy specimen 1586 can be adjusted on
the ultrasound image 1040 by selecting the virtual biopsy specimen
1586 and moving it up or down along the y-axis, and the horizontal
location of the virtual biopsy specimen 1586 can be adjusted as
well by moving it right or left along the z-axis. Repositioning of
the virtual biopsy specimen 1586 ensures the that the ultrasound
image of the biopsy needle and the virtual biopsy specimen 1586 are
superimposed ensuring the virtual biopsy specimen 1586 accurately
reflects the position of the biopsy removed from the prostate.
[0195] Because the length 1554 was changed, in some embodiments,
use of the needle assembly 100 allows the user to adjust the length
of travel of the inner component 102 to excise a biopsy core
corresponding to the revised length, regardless of whether the
needle assembly 100 is in the patient 1002 or not. The biopsy
tissue specimen is taken and the tissue specimen is removed from
the prostate 1008 for pathological examination. The user selects
the biopsy taken 1582 box and the biopsy site dot turns to a red
dot 1596 in the image frame 1152 (FIG. 70).
[0196] In some embodiments, the system 1102 prints a label using a
printer connected to the computer after selecting the biopsy taken
1582 box. The label includes information identifying the patient,
including the patient's name, the patient's identifying number, a
medical record number, date of birth, and other identifying
information designated by the user, including the biopsy site
number. The label is applied to the biopsy specimen container for
the corresponding biopsy tissue specimen. In some embodiments, the
label is applied to a collection vial 502 containing a cartridge
assembly 400 enclosing the corresponding biopsy tissue
specimen.
[0197] To take each subsequent biopsy to complete the biopsy
procedure the user follows the steps above for identifying a biopsy
site, selecting a needle, inserting the needle into the appropriate
aperture 1018, adjusting the biopsy site values, excising the
biopsy specimen, and depositing the specimen in a cartridge
assembly and labeled collection vial.
[0198] As the biopsy procedures progresses, adjustments to the
position of the probe centerline 1362 may need to be performed to
keep the virtual image aligned with the ultrasound image of the
prostate 1008. Referring to FIG. 71, biopsy site number "3" 1527
has been selected as indicated by the biopsy site label 1538 in the
BSEGUI 1536. Biopsy site number "3" 1527 is located lateral to the
midline of the image. In order to keep the virtual image aligned to
the ultrasound image the ultrasound probe 1036 will need to be
rotated to the left aligning the probe centerline 1362 with biopsy
site number "3" 1527. The user may then switch the view to sagittal
and the virtual representation of the needle will now be
represented in the proper location respective to the virtual image
of the prostate 1008.
[0199] Upon completion of the biopsy phase the patient is
discharged from the healthcare facility and returns for treatment
using the system 1102 after completion of the pathology phase.
[0200] Pathology Phase
[0201] After the biopsy phase is complete the biopsy specimens are
evaluated in a pathology phase and the results are recorded by the
system 1102 in the pathology module 1110. Upon examination of a
tissue specimen by a medical professional, including a pathologist,
test results and remarks regarding the biopsy tissue specimen can
by entered for each biopsy tissue specimen using the pathology
module 1110. In an embodiment, markings made on the biopsy
specimens from projections in the core bed 116 aid the medical
professional in proper identification and orientation of the biopsy
specimen and biopsy site. When lesions, such as cancerous tumors,
are identified in a biopsy specimen the pathologist can report the
Gleason score, and the locations, size, and regions of the tissue
specimen presenting lesions.
[0202] To enter pathology remarks for a specimen, a user selects a
biopsy site on the image frame 1152 bringing up the BSEGUI 1536.
Referring to FIG. 72, the BSEGUI 1536 for biopsy site "5" 1529 is
shown. Returning to FIG. 66, remarks for a first pathology remark
are entered in a first tumor frame 1556, and remarks for a second
pathology remark, if necessary, are entered in a second tumor frame
1566. For a first tumor, a Gleason value 1558, a Gleason start
1560, and a Gleason end 1562 may be entered. For a second tumor, a
Gleason value 1568, a Gleason start 1570, and a Gleason end 1572
may be entered. A preview frame 1574 includes a virtual image of
the biopsy core, with the base of the core at the left, and the
apex of the core at the right, with any regions of the biopsy
specimen associated with the pathology remarks. The Gleason value
1558, 1568 ranges from about 1, representing the lowest grade to
about 10, representing the highest grade. The Gleason start 1560,
1570 is the distance a given remark begins from the base, and the
Gleason end 1562, 1572 is the distance the given remark ends from
the base. In some embodiments, the Gleason start 1560, 1570 and the
Gleason end 1562, 1572 are represented by numerical positions
beginning from the base (left end) of the core, such as a Gleason
start of 3 mm from the base of the core and a Gleason end of 10 mm
from the base of the core. Accordingly, a tumor extending between
the 3 mm from the base to 10 mm from the base would be a tumor of 7
mm in length.
[0203] Returning to FIG. 72, for biopsy site "5" 1529, the first
tumor frame 1556 shows a Gleason value of 7, a Gleason start 1560
of 20%, and a Gleason end 1562 of 60%. Tumor "1" 1557 is shown as a
segment of the virtual image, and shown as a three-dimensional
tumor 1584 on the three-dimensional prostate image 1472. In some
embodiments, tumor "1" 1557 is represented as a red segment. The
biopsy length 1576 represents the length 1554 calculated above. The
left arrow button 1578 allows the user to move to the previously
numbered biopsy site, and the right arrow button 1580 allows the
user to move to the subsequently numbered biopsy site.
[0204] After the tumor information has been entered for a biopsy
site, the volume of the tumor 1584 can be adjusted using the
pathology control frame 1302. The volume of the tumor 1584 would be
adjusted by the pathologist to account for the location of
surrounding biopsy sites that do not indicate the presence of
tissue lesions thereby allowing the pathologist to set a maximum
volume of prostate tissue at risk of containing a tumor when
planning a treatment in the treatment phase. Referring to FIG. 73,
the pathology control frame 1302 appears below the biopsy control
frame 1280. The pathology control frame 1302 allows a user to
select whether to show negative biopsy sites 1304 to reflect the
portion of the biopsy specimen not designated as a tumor, adjust
the Gleason volume 1306 using a slider, and the Gleason volume size
1308 using a slider.
[0205] Treatment Phase
[0206] After the pathology phase is complete a treatment plan is
set up for the patient. Treatments can be administered to the
patient using the treatment module 1112 of the system 1102. To
begin the treatment phase, the patient 1002 is again positioned for
a procedure as shown and described above with the imaging system
1032, TRUS probe 1036, and template 1018 prepared for use.
[0207] Referring to FIG. 74, the three-dimensional reconstruction
1174 is shown in the image frame 1440 with virtual representations
of any lesions 1598, 1560 superimposed thereon. Any mismatching of
the margins of the gland are corrected with the contour tools. The
base and apex of the three-dimensional reconstruction 1174 of the
prostate and associated structures are aligned on the ultrasound
mage 1040 as described in the biopsy phase above (FIGS. 68-69). The
three-dimensional reconstruction 1174 now displays the tissue
structures and the extent of the lesions in the prostate. Thus, the
treating urologist is able to visualize the lesions on the
ultrasound image 1040 and insert ablative sources through a cannula
such as the outer component 152 above, or the ablative source can
be inserted into the lesions through the rectum. Alternatively, the
positive biopsy plan can be exported to DICOM, or other images,
which can be uploaded into another treatment planning system, for
example IMRT, or Proton Therapy, and any focal ablation can be
delivered in that manner.
[0208] In some embodiments, images acquired from other imaging
systems 1032 can be uploaded into the system 1102 allowing a user
to perform targeted biopsies and/or treatments. Such images include
radiographic images, including magnetic resonance imaging, nuclear
magnetic resonance imaging, and magnetic resonance tomography, and
X-ray computed tomography images, including positron emission
tomography, single-photon emission computed tomography, computed
axial tomography, and computer-assisted tomography. In such an
embodiment, lesions of interest are marked by the radiologist
allowing the urologist to perform the image acquisition and then
merge the images and three-dimensional reconstruction images at the
time of the procedure. The user then has the option of performing
biopsy or treatment on the marked lesions and additional biopsies
or treatment in different regions of the prostate as warranted.
[0209] The biopsy phase and the treatment phase can be performed
sequentially if the pathology phase and identification of tumors
can be made within a short time after removing the biopsy tissue,
thereby allowing the phases to be completed at one treatment visit
and under one anesthesia.
[0210] It will be appreciated that the components of the system
1102 can be used for various other applications. Moreover, the
system 1102 can be fabricated in various sizes and from a wide
range of suitable materials, using various manufacturing and
fabrication techniques.
[0211] It is to be understood that while certain aspects of the
disclosed subject matter have been shown and described, the
disclosed subject matter is not limited thereto and encompasses
various other embodiments and aspects.
[0212] FIG. 75 depicts and exemplary embodiment of the process 1602
of planning a biopsy procedure according to some embodiments of the
disclosed subject matter. An image is acquired at step 1604. FIG.
76 depicts an exemplary embodiment of the image acquisition process
1604. The software grid and scale are aligned with the ultrasound
gird on an axial view of the image at step 1606. The ultrasound
probe sweep angle and height are aligned with the axial view of the
image at step 1608. The software grid and scale are aligned with a
sagittal view of the image at step 1610. The ultrasound probe
height is aligned with the sagittal view of the image at step 1612.
And the base and apex of the prostate are marked at step 1614. The
image acquisition process ends at step 1615.
[0213] The image is contoured at step 1616. FIG. 77 depicts an
exemplary embodiment of the image contouring process 1616. The
ultrasound probe is positioned at step 1618. The center of the
prostate is selected at step 1620. The margin of the prostate is
outlined at step 1622. The next step is determined at step 1624.
Step 1622 may be repeated to refine the margin of the prostate. The
margin of the urethra is outlined at step 1626. The next step is
determined at step 1628. Step 1626 may be repeated to refine the
margin of the urethra. The margin of the rectum is outlined at step
1630. The next step is determined at step 1632. Step 1630 may be
repeated to refine the margin of the rectum. The contour image is
captured at step 1634 creating an image slice. The next step is
determined at step 1636. Steps 1618-1634 may be repeated to contour
another image slice. Contouring is completed at step 1638. The
contouring process ends at step 1640.
[0214] A three-dimensional image of the prostate, urethra, and
rectum are generated from the image slices and aligned with the
image at step 1642.
[0215] The biopsy site plan process is created at step 1644. FIG.
78 depicts an exemplary embodiment of the biopsy site plan process
1644. The minimum section variable is selected at step 1646. The
needle lengths are calculated at step 1648. The capsule margin
variables are selected at step 1650. The multiple inline biopsy
variables are determined at step 1652. The biopsy site array is
generated at step 1654. The number of biopsy sites are calculated
at step 1656. The number of skipped biopsy sites is calculated at
step 1658. The number of biopsies that are outside the prostate are
calculated at step 1660. The next step is determined at step 1662.
Steps 1646-1660 may be repeated to modify the number of biopsy
sites and their associated characteristics. A three-dimensional
image of the prostate, urethra, and rectum with the biopsy needle
paths is generated from the image slices and the biopsy site plan
at step 1664. The next step is determined at step 1666. Steps
1646-1664 may be repeated to modify the number of biopsy sites and
their associated characteristics. The biopsy site plan process ends
at step 1668. The biopsy planning procedure ends at step 1670.
[0216] FIG. 79 depicts an exemplary embodiment of the biopsy
process 1672. A biopsy site is selected at step 1674. The virtual
biopsy specimen location and length is adjusted on the image at
step 1676. The biopsy specimen is taken at step 1678. The biopsy
specimen is deposited in a specimen cartridge at step 1680. The
next step is determined at step 1682. Steps 1674-1680 may be
repeated to take additional biopsy specimens. The biopsy process
ends at step 1684.
[0217] FIG. 80 depicts an exemplary embodiment of the pathology
process 1686. A biopsy specimen is selected and examined at step
1688. The biopsy site associated with the biopsy specimen is
selected at step 1690. Remarks of the pathological findings of the
examination, such as lesions, are entered into the system at step
1692. The next step is determined at step 1694. Steps 1688-1692 may
be repeated to examine additional biopsy specimens. A
three-dimensional image of the prostate, urethra, and rectum with
lesions is generated from the image slices and the pathological
findings at step 1696. The next step is determined at step 1698.
Step 1700 may be repeated to adjust the margins of the lesions. The
volume of the tissue lesions is calculated at step 1702. The
pathology process ends at step 1704.
[0218] FIG. 81 depicts an exemplary embodiment of the treatment
process 1706. The image is acquired at step 1708. The
three-dimensional image of the prostate, urethra, and rectum with
lesions is aligned with the image at step 1710. The lesions are
treated at step 1712. The treatment process ends at step 1714.
[0219] Exemplary Hardware Configuration
[0220] FIG. 82 is a block diagram of an exemplary hardware
configuration model for a device implementing the system 1102
described in reference to FIGS. 33-81.
[0221] Some embodiments of the above-described systems and methods
are implemented as software processes that are specified as a set
of instructions recorded on a computer readable medium. When the
instructions are executed by one or more computational element(s),
the instructions cause the computational element(s) to perform the
actions indicated by the instructions. The software processes
function with common operating systems, including systems provided
by Microsoft Corporation of Redmond, Wash., Apple Inc. of
Cupertino, Calif., and International Business Machines Corporation
of Armonk, N.Y.
[0222] The device can include one or more visual display(s) 1804
coupled with one or more visual display controller(s) 1806, one or
more auditory display(s) 1808 coupled with one or more auditory
display controller(s) 1810, and one or more tactile display(s) 1812
coupled with one or more tactile display controller(s) 1814. It can
include one or more input devices 1816 for the input of data,
information, and instructions into the system 1102 including,
alphanumeric and other keys, a cursor control such as a mouse,
trackball, or cursor direction keys, and any number of input
structures existing in various forms including sensors, buttons,
switches, control pad, stylus, wheel, camera, proximity sensor
and/or motion sensing technologies, each coupled to one or more
input interfaces 1818.
[0223] The device can include one or more computational elements,
including processor(s) 1820 and one or more computer readable
media, including memory bank(s) 1822 connected to one another and
connected to the various display controller(s) and input
interface(s) via one or more bus(ses) 1824. It can also be coupled
with one or more communication subsystem(s) 1826 that communicate
through one or more network(s) 1828 to one or more remote computing
device(s) 217.
[0224] The one or more communication subsystems(s) 1826 may provide
additional data channels for receiving and transmitting data,
information, or instructions. The communication subsystem(s) 1826
may include one or more network interface hardware elements and
associated communication protocols. The communication subsystem(s)
1826 provides two-way data communication to a network 1828. The
communication subsystem(s) 1826 may include several types of
systems, including a wireless carrier system, a wireless local area
network (WLAN) system, an unstructured supplementary service data
(USDD) system, a personal area network (PAN) system, a local area
network (LAN) system, and a wide area network (WAN) system. The
system 1102 may execute one or more sequences of one or more
instructions or user data contained in one or more computer
readable media connected to the network 1828. The network 1828
felicitates communication between the system 1102 and any other
local or remote computer devices 1830, including third party
computer devices, computer readable media, databases, servers, or
web servers. The network 1820 can be all or a portion of a
distributed or secure network, or a wireless or wired network.
[0225] The device may be powered by a suitable power source that
may include one or more batteries or an AC power source, such as
provided by an electrical outlet.
[0226] The term "computer" means a device or system with at least
one microprocessor. Examples of computers include laptop computers,
tablet computers, mobile phones, digital media players, game
consoles, digital wristwatches, head-mounted display systems,
digital televisions, set-top boxes and file servers. The term
"device" is meant to be interchangeable with the term computer
where it is clear from the context that the reference is to a
computer as defined herein (i.e. with at least one
microprocessor).
[0227] The terms "computer readable medium" and "computer readable
media" can be used interchangeably to mean storage that can be
accessed by a computer. These terms include non-volatile memory
such as a dynamic storage device, random-access memory (RAM),
read-only memory (ROM), flash memory, a hard drive, database, or
any other suitable non-transitory computer-readable media, such as
optical, magnetic, or solid-state computer readable media, as well
as a combination thereof, provided that neither term is intended to
include any propagated signal, any carrier wave or any other
non-statutory subject matter.
[0228] The noun "display" means an output device for conveying
information to a user, including visual display hardware (such as a
cathode ray tube (CRT), a liquid crystal display (LCD), a light
emitting diode (LED) display, an organic light emitting diode
(OLED) display, an image projector, or other suitable display),
auditory display hardware (such as speakers and headphones),
tactile display hardware (such as braille and textural haptics,
piezoelectric vibration motors and force-feedback systems) and
other sensory displays. The visual display hardware, such as the
visual display 1804, may include touch-sensitive functionality,
such as a touch screen. The visual display hardware displays the
graphical user interface 1104 that allows a user to interact with
the system 1102. The graphical user interface 1024 may include
various screens, layers, windows, images, elements, or
components.
* * * * *