U.S. patent application number 10/856074 was filed with the patent office on 2004-11-04 for positioning needle guide for brachytherapy treatment of prostate disease and methods of use.
This patent application is currently assigned to NeoSeed Technology LLC.. Invention is credited to Boucher, Ryan P., Hogendijk, Michael.
Application Number | 20040220444 10/856074 |
Document ID | / |
Family ID | 28044232 |
Filed Date | 2004-11-04 |
United States Patent
Application |
20040220444 |
Kind Code |
A1 |
Hogendijk, Michael ; et
al. |
November 4, 2004 |
Positioning needle guide for brachytherapy treatment of prostate
disease and methods of use
Abstract
Methods and apparatus are provided for improved brachytherapy
treatment of prostate disease. The apparatus provides for angular
reorientation of a needle template with respect to an ultrasound
probe during brachytherapy administration. Angular reorientation is
expected to beneficially overcome anatomical constraints, such as
skeletal structures, that may limit a medical practitioner's
ability to deliver radioactive brachytherapy seeds into a prostate
in proper alignment.
Inventors: |
Hogendijk, Michael; (Palo
Alto, CA) ; Boucher, Ryan P.; (San Francisco,
CA) |
Correspondence
Address: |
FISH & NEAVE
1251 AVENUE OF THE AMERICAS
50TH FLOOR
NEW YORK
NY
10020-1105
US
|
Assignee: |
NeoSeed Technology LLC.
San Francisco
CA
|
Family ID: |
28044232 |
Appl. No.: |
10/856074 |
Filed: |
May 28, 2004 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10856074 |
May 28, 2004 |
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10273897 |
Oct 16, 2002 |
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10273897 |
Oct 16, 2002 |
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10128616 |
Apr 23, 2002 |
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10128616 |
Apr 23, 2002 |
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09648091 |
Aug 25, 2000 |
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6398711 |
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Current U.S.
Class: |
600/7 |
Current CPC
Class: |
A61B 2017/3411 20130101;
A61M 2210/166 20130101; A61M 25/01 20130101; A61N 5/1007 20130101;
A61M 5/427 20130101; A61N 5/1027 20130101; A61N 2005/1012
20130101 |
Class at
Publication: |
600/007 |
International
Class: |
A61N 005/00 |
Claims
What is claimed is:
1. Apparatus for improved positional control during administration
of brachytherapy, the apparatus comprising: a needle guide body
having a needle guide channel sized to slidably receive a standard
brachytherapy needle; a support for securing the needle guide body
to a brachytherapy apparatus; and means for disposing the needle
guide body at a selected angular and positional orientation
relative to the brachytherapy apparatus.
2. The apparatus of claim 1 wherein the needle guide body comprises
a socket configured to allow angular reorientation of the needle
guide channel.
3. The apparatus of claim 1, wherein the support further comprises
means for vertically repositioning the needle guide channel.
4. The apparatus of claim 1, wherein the support further comprises
means for horizontally repositioning the needle guide channel.
5. Apparatus for improved positional control during administration
of brachytherapy, the apparatus comprising: a needle guide body
having a plurality of needle guide channels, each one of the needle
guide channels sized to slidably receive a standard brachytherapy
needle; and a support for securing the needle guide body to a
brachytherapy apparatus, wherein the needle guide body is
configured for angular and positional orientation relative to the
brachytherapy apparatus having an ultrasound probe.
6. The apparatus of claim 5 wherein the plurality of needle guide
channels are oriented substantially normal to proximal and distal
surfaces of the needle guide body.
7. The apparatus of claim 6, wherein the apparatus is rotatable
about an axis perpendicular to a longitudinal axis of the needle
guide body.
8. The apparatus of claim 7, wherein the plurality of needle guide
channels are arranged in an orthogonal grid array.
9. The apparatus of claim 8, wherein the needle guide body is
composed of a malleable material.
10. The apparatus of claim 8, wherein the needle guide body further
comprises a plurality of sections coupled together with hinges.
11. The apparatus of claim 8, wherein the brachytherapy apparatus
further comprises slots adapted to slidably receive the needle
guide body.
12. The apparatus of claim 11, wherein the needle guide body is
selectively positionable within the slots to angularly reorient the
needle guide body with respect to the ultrasound probe.
13. The apparatus of claim 8, wherein the needle guide body is
rotatably affixed to the brachytherapy apparatus.
14. The apparatus of claim 8, wherein proximal and distal surfaces
of the needle guide body are repositionable with respect to each
other while remaining substantially parallel.
15. The apparatus of claim 14, wherein the needle guide channels
further comprise means for rotating the proximal and distal
surfaces relative to the plurality of needle guide channels.
16. A method for administering brachytherapy, the method
comprising: providing an apparatus comprising an ultrasound probe,
a frame rigidly disposed in relation to the ultrasound probe, a
needle guide body comprising at least one needle guide channel, the
needle guide body affixed to the frame such that the needle guide
channel may be angularly orientated with respect to the probe;
longitudinally positioning the ultrasound probe through the
patient's rectum to facilitate imaging of the patient's prostrate
and reference plane; and angularly orienting the needle guide
channel at a desired angle in real-time with respect to the
ultrasound probe.
17. The method of claim 16 further comprising guiding the sharpened
distal tip of a needle containing brachytherapy seeds through the
needle template and into a target location within the patient's
prostate until it is aligned with the reference plane.
18. The method of claim 17 further comprising retracting the needle
in a manner that delivers the brachytherapy seeds into the
prostate.
Description
REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation-in-part of U.S. patent
application Ser. No. 10/128,616, filed on Apr. 23, 2002, which is a
continuation-in-part of U.S. patent application Ser. No.
09/648,091, filed on Aug. 25, 2000, now U.S. Pat. No.
6,398,711.
FIELD OF THE INVENTION
[0002] This invention relates to improved apparatus and methods for
the treatment of prostate cancer. More particularly, the present
invention provides an apparatus and method that provides for
multi-angle positioning for more effective administration of
brachytherapy.
BACKGROUND OF THE INVENTION
[0003] Excluding non-melanoma skin cancers, prostate cancer is the
most common cancer afflicting American men. The American Cancer
Society estimates that over 189,000 new cases will be diagnosed in
the U.S. in the year 2002 alone, and that nearly 30,200 people will
die from the disease. Prostate cancer is second only to lung cancer
as the leading cause of cancer death in men, accounting for roughly
11%.
[0004] Prostate cancer is defined as malignant tumor growth within
the prostate gland. Its cause is unknown, although high dietary fat
intake and increased testosterone levels are believed to be
contributory factors. A letter scale ("A" through "D"), which
accounts for aggressiveness and differentiation, is commonly used
to classify the stage of disease. In Stage A, the tumor is not
palpable but is detectable in microscopic biopsy. Stage B is
characterized by a palpable tumor confined to the prostate. By
Stage C, the tumor extends beyond the prostate with no distant
metastasis. By Stage D, cancer has spread to the regional lymph
nodes.
[0005] In the early stages, prostate cancer is most commonly
treated by prostate removal or by brachytherapy. More advanced
cases are treated by hormonal manipulation or orchiectomy to reduce
testosterone levels and curb spreading of the disease, by
chemotherapy, or by external beam radiation therapy.
[0006] With regard to treatment of early stage prostate cancer, the
state of the art has several drawbacks. Radical prostatectomy is
often recommended for treatment of localized stage A and B prostate
cancers. Under general or spinal anesthesia, an incision is made
through a patient's abdomen or perineal area, and the diseased
prostate is removed. The procedure is lengthy, especially if a
lymph node dissection is simultaneously performed, and requires a
hospital stay of 7-10 days. Possible complications include
impotence and urinary incontinence.
[0007] Internal radiation therapy or brachytherapy has recently
been developed and holds great promise for the treatment of early
stage prostate cancer. Radioactive pellets or seeds of, for
example, iodine-125, palladium-103, or iridium-192, are deposited
directly and permanently into the prostate through a small
incision. Imaging techniques, such as transrectal ultrasound, CT
scans, or MRI, are used to accurately guide placement of the
radioactive material. Advantageously, radiation from the
brachytherapy seeds is administered directly to the prostate with
less damage to surrounding tissues, delivering a substantially
higher radiation dosage to the prostate than to the surrounding
tissues, as compared to external beam radiation therapy. The
procedure need only be performed once, and impotence and urinary
incontinence complications are significantly reduced, as compared
to prostate removal procedures.
[0008] The radioactive seeds are placed inside thin needles, which
are inserted through the skin of the perineum (area between the
scrotum and anus) into the prostate. U.S. Pat. No. 5,928,130 to
Schmidt provides a slightly modified example of such a needle
device. Each needle is slowly retracted with a spinning motion by a
first practitioner while a plunger within the needle, and proximal
of the radioactive seeds, is held stationary by a second
practitioner. The plunger keeps the seeds in place during
retraction of the needle, while rotation of the needle during
retraction delivers the seeds in a line within the prostate.
[0009] The seeds, which are permanently implanted, give off
radiation for weeks or months. Their presence causes little
discomfort, and they remain in the prostate after decay of the
radioactivity. For several weeks following needle insertion,
patients may experience pain in the perineal area, and urine may
have a red-brown discoloration.
[0010] Although, when performed correctly, radioactive seed
implantation may provide several benefits as compared to prostate
removal and other techniques, current surgical apparatuses and
methods for delivering the seeds to target locations within the
prostate are somewhat crude and are subject to practitioner error.
U.S. Pat. No. 5,871,448 to Ellard, for example, describes apparatus
similar to that currently in widespread use. The apparatus includes
a needle template with a template holder. The template may be moved
longitudinally along a track to alter the distance between the
template and a patient's perineum. The template holder is then
rigidly affixed to the track, and brachytherapy needles are passed
through the needle template to stabilize the needles prior to
insertion through the patient's perineum. A drawback of the Ellard
device is that, apart from longitudinal adjustment, a medical
practitioner is not able to alter the orientation of the
template.
[0011] U.S. Pat. No. 5,957,935 to Brown et al. describes a
disposable needle template that need not be painstakingly
sterilized. It further discloses a mount for the template that may
be oriented in multiple planes. Specifically, the template may be
positioned longitudinally, horizontally, and vertically. Although
Brown's apparatus may provide improved needle template orientation
capabilities as compared to Ellard's apparatus, it permits
constrained movement, and does not allow simultaneous reorientation
in multiple planes, as is necessary to change the angle of attack
between the template and the patient.
[0012] A preferred angular orientation of the needle template may
vary from needle to needle during a procedure due to anatomical
constraints, including skeletal structures. Thus, a template that
allows only one angular orientation is not optimal and may lead to
incorrect placement of radioactive seeds within a patient's
prostate.
[0013] U.S. Pat. No. 5,626,829 to Koutrouvelis provides a
stereotactic assembly for orienting a template vertically,
horizontally, rotatably, and angularly. While the assembly may be
effective for the transgluteal brachytherapy procedure described by
Koutrouvelis, it is not tailored for the more commonly used
transperineal approach. For example, it does not provide for
longitudinal adjustment of the needle template. Furthermore, the
assembly is large and may prove cumbersome in the smaller surgical
field of transperineal procedures.
[0014] European Patent Application EP 0 995 406 A1 by Yanof et al.
provides a multi-apertured grid lattice positionable by a
stereotactic arm assembly. While the assembly may be effective for
a brachytherapy procedure after volumetric imaging of the patient
as described therein, it is not suitable when used in conjunction
with a transrectal ultrasound probe. Performing brachytherapy with
a transrectal probe requires exact positioning and orientation of
the needle and needle guide relative to the probe. The stereotactic
assembly described by Yanof et al. provides too many degrees of
freedom, and as a consequence requires "position resolvers" to
indicate its spatial position relative to a reference frame.
Furthermore, the device does not allow angular reorientation in
real-time in conjunction with a detection device.
[0015] In view of the drawbacks associated with orienting
previously-known needle templates, it would be desirable to provide
methods and apparatus that overcome such drawbacks.
[0016] It further would be desirable to provide methods and
apparatus with improved orientation capabilities, sized to permit
use in the surgical field of standard, transperineal brachytherapy
procedures in conjunction with a transrectal ultrasound probe.
SUMMARY OF THE INVENTION
[0017] In view of the foregoing, it is an object of the present
invention to provide apparatus and methods for orientating a needle
guide that overcome drawbacks associated with previously-known
methods and apparatus.
[0018] It is also an object of the present invention to provide
methods and apparatus with improved orientation capabilities, sized
to permit use in the surgical field of standard, transperineal
brachytherapy procedures.
[0019] It is a further object of the present invention to provide
methods and apparatus for orienting a needle guide in a manner to
access the broadest range of available orientations, thereby
providing a more precise and accurate brachytherapy procedure.
[0020] It is a still further object of the present invention to
provide methods and apparatus for orienting a needle guide in
real-time in conjunction with a transrectal ultrasound probe.
[0021] These and other objects of the present invention are
accomplished by providing methods and apparatus for angular
repositioning of the needle guide with respect to an ultrasound
probe. When used in conjunction with previously-known apparatus for
longitudinal, horizontal, and vertical orientation of the template,
the present invention provides enhanced control over needle
template orientation, so that brachytherapy needles may be inserted
in a manner that avoids skeletal structures.
[0022] Methods of using the present invention also are
provided.
BRIEF DESCRIPTION OF THE DRAWINGS
[0023] The above and other objects and advantages of the present
invention will be apparent upon consideration of the following
detailed description taken in conjunction with the accompanying
drawings, in which like reference characters refer to like parts
throughout, and in which:
[0024] FIG. 1 is a schematic view of a prior art method of
performing brachytherapy;
[0025] FIGS. 2A-2G are schematic views detailing the prior art
method in greater detail;
[0026] FIGS. 3A and 3B are, respectively, a proximal view and a
side view of an apparatus constructed in accordance with an
embodiment of the present invention and installed on a
brachytherapy device;
[0027] FIGS. 4A and 4B are, respectively, an exploded isometric
view and an exploded cross-sectional view of the guide body and the
socket of the present invention, illustrating axes of rotation and
means for securing the guide body to the socket;
[0028] FIGS. 4C and 4D are isometric views of the guide body of the
present invention depicting means for rotation about, respectively,
the horizontal axis and the vertical axis;
[0029] FIGS. 5A and 5B are, respectively, a proximal view and an
isometric view of an embodiment of the present invention detailing
means for, respectively, vertical and horizontal repositioning;
[0030] FIGS. 6A-6D depict proximal and isometric views of
alternative methods for affixing the needle guide of the present
invention to a standard brachytherapy apparatus, detailing means
for horizontal and vertical repositioning;
[0031] FIG. 7 is an isometric view of a linear array embodiment of
the present invention;
[0032] FIGS. 8A and 8B are, respectively, an isometric view and a
side cross-sectional view of an alternative embodiment of the
present invention;
[0033] FIGS. 9A and 9B are, respectively, an isometric view and a
top view of another embodiment of the present invention, with FIG.
9B depicting angular reorientation of the apparatus;
[0034] FIGS. 10A and 10B are, respectively, an isometric view and a
top cross-sectional view of still another embodiment of the present
invention;
[0035] FIGS. 11A-11C are views of another embodiment of the present
invention, in which FIG. 11A depicts an isometric view and FIGS.
11B and 11C are top cross-sectional views of different angular
configurations; and
[0036] FIGS. 12A-12D are views of still another embodiment of the
present invention, in which FIG. 12A depicts an isometric view,
FIG. 12B details means for attachment of the guide channels to the
planes, and FIGS. 12C and 12D depict side views of different
angular orientations of the apparatus.
DETAILED DESCRIPTION OF THE INVENTION
[0037] The present invention provides methods and apparatus for
improved administration of brachytherapy. More particularly, the
present invention provides an apparatus comprising a needle guide
that allows angular repositioning of the guide to the ultrasound
device, thereby providing improved orientation capabilities for
implantation of radioactive seeds.
[0038] Referring now to FIGS. 1 and 2A-2G, the prior art method of
performing brachytherapy is described. The method and apparatus as
described here are taught by Peter Grimm, DO, in a pamphlet
entitled, "Ultrasound Guided Implantation of the Prostate: A
Practical Review Course." As seen in FIG. 1, brachytherapy
apparatus 50 comprises transrectal ultrasound probe 52, needle
template 54, needle 56, plunger 58, and radioactive seeds 60.
Ultrasound probe 52 is advanced through a patient's rectum R to
facilitate imaging of the patient's prostate P. Prostate P
surrounds the urethra U and is just proximal of the bladder B.
Needle 56, loaded with seeds 60 and plunger 58, is advanced through
needle template 54, through the patient's perineum Pe, and into
prostate P, where needle 56 is retracted and seeds 60 are delivered
to the patient.
[0039] Needle template 54 is attached to template mount 55, which
is slidably received on track 53 and may be longitudinally
repositioned with respect to ultrasound probe 52. Alternatively,
mount 55 may be rigidly attached to track 53, in which case the
track may be longitudinally repositioned with respect to ultrasound
probe 52.
[0040] With reference to FIG. 2, a previously known seed delivery
method is described in greater detail. Needle 56 has proximal end
62, sharpened distal end 64, and a lumen extending therebetween.
Proximal end 62 comprises hub 66 for easy grasping of the needle.
The opening at the distal tip of needle 56 is initially filled with
bone wax that melts when placed inside the body. The needle lumen
typically is filled in an alternating pattern of seeds 60 and
spacers 68.
[0041] Once a required number of seeds have been loaded, plunger 58
is inserted into proximal end 62 of needle 56 and is advanced
distally until it abuts the proximal-most seed. Plunger 58
comprises grip 70 at its proximal end. The distance from the distal
end of grip 70 to the distal end of the plunger is equal to the
length of needle 56. Thus, since seeds 60 and spacers 68 are of
known length, measurement of D1, the distance plunger 58 extends
proximally of needle 56 in the loaded configuration, provides
verification of the number of seeds 60 located within the needle
lumen, as seen in FIG. 2A.
[0042] Ultrasound probe 52 provides signals that are converted by a
previously known ultrasound system to display ultrasonic image 72
of base plane BP, which is located at a tangent to the distal
surface of prostate P. All positions within the prostate are
determined relative to base plane BP. With seeds 60 loaded into
needle 56 and the distance D1 verified; the needle, seeds, and
plunger 58 are inserted through needle template 54 and into the
patient until needle 56 appears as target T on ultrasonic image 72
and extends about a centimeter distal of base plane BP, as depicted
in FIG. 2B. The apparatus is then retracted until target T
disappears (FIG. 2C) and is once again advanced until target T just
reappears (FIG. 2D). All the while, distance D1 is maintained.
[0043] Once needle 56 is aligned with base plane BP, a distance D2
between the proximal face of needle template 54 and the proximal
face of hub 66 is established, as shown in FIG. 2E. D2 may be
altered via template mount 55 by longitudinally repositioning
template 54 relative to ultrasound probe 52. D2 serves as the
reference distance for determining insertion depth for all
subsequent needle insertions. A first medical practitioner then
holds needle 56 stationary while a second medical practitioner
advances the first seed 60 to the distal tip of the needle with
plunger 58, as depicted in FIG. 2F. The advancement distance equals
the length BW of the bone wax used to plug the tip.
[0044] Finally, the second medical practitioner holds plunger 58
stationary while the first practitioner rotates and proximally
retracts needle 56 to sew the seeds in a line within prostate P, as
shown in FIG. 2G. The needle and plunger are then removed from the
patient, and the procedure is repeated at other locations as
necessary.
[0045] While the previously known apparatus used to position
ultrasound probe 52 and needle template 54 may allow longitudinal,
vertical, and/or horizontal orientation of needle template 54, the
apparatus does not allow angular reorientation of the template
during a brachytherapy procedure. Angular reorientation is expected
to beneficially overcome anatomical constraints, such as skeletal
structures, that may limit the medical practitioner's ability to
deliver radioactive brachytherapy seeds into the prostate in proper
alignment.
[0046] With reference now to FIGS. 3A and 3B, apparatus constructed
in accordance with a first embodiment of the present invention is
described. Needle guide apparatus 100 is installed upon frame 80 of
brachytherapy apparatus 50. Frame 80 provides a stable platform
that allows for longitudinal repositioning of ultrasound probe 52.
Accordingly, the proximity of frame 80 and apparatus 100 to
ultrasound probe 52 provides for a more accurate angular
reorientation relative to the longitudinal axis of the ultrasound
probe.
[0047] Needle guide apparatus 100 comprises needle guide body 110,
socket 120, support 130 and needle guide channel 150. Socket 120 is
configured to retain guide body 110, while allowing angular
reorientation of the guide body and guide channel 150 therein. The
apparatus is secured onto frame 80 by means of support 130.
[0048] Referring now to FIGS. 3B and 4A, guide channel 150 forms a
substantially linear passage through guide body 110 that
communicates with proximal aperture 160 and distal aperture 165.
The angular orientation of guide channel 150 is determined by the
angular orientation of guide body 110. Guide channel 150 and its
proximal and distal apertures are sized for slidably receiving a
standard brachytherapy needle. A needle slidably received within
guide channel 150 in the foregoing manner adopts an angular
orientation substantially the same as that of the guide channel.
The guide channels in the other embodiments described herein are
sized accordingly to provide substantially the same needle guidance
functions as that of guide channel 150.
[0049] Referring now to FIGS. 4A and 4B, socket 120 is configured
to retain guide body 110 while enabling angular reorientation of
guide body 110 and needle guide channel 150. For example, guide
body 110 may independently rotate about vertical axis 190 and
horizontal axis 195. Enabling rotation about these two axes allows
guide channel 150 to access a full range of angular orientations
with respect to the longitudinal axis of the brachytherapy
apparatus.
[0050] Referring again to FIGS. 4A and 4B, an embodiment to enable
rotation of guide body 110 within socket 120 is illustrated. Guide
body 110 further comprises recessed slot 175 that is disposed along
meridian 115, the meridian passing through both proximal and distal
apertures. Socket 120 comprises retaining knob 170 that is
centrally disposed on the interfacial surface of the socket.
Referring now to FIGS. 4C and 4D, knob 170 and slot 175 are
configured such that knob 170 is retained securely within slot 175,
thereby attaching guide body 110 to socket 120. Knob 170 and slot
175 are further configured to allow the knob to slidably translate
along the length of slot 175 while following meridian 115.
[0051] Referring again to FIG. 4C, a mechanism for rotating guide
body 110 about horizontal axis 195 is provided. Rotating the guide
body about horizontal axis 195 is accomodated by knob 170 following
meridian 115 while slidably moving within slot 175. In this manner,
the rotation may be accomplished while guide body 110 remains
secured by the socket. Referring again to FIG. 4D, knob 170 is
further configured so as not to impede rotation of guide body 110
about vertical axis 190 while the guide body is retained within the
socket. Rotation about both axes in the foregoing manner allows
guide body 110 to access substantially all angular orientations
bounded by the limits of each rotational means.
[0052] With reference to FIGS. 5A and 5B, means for horizontal and
vertical repositioning of apparatus 100 with respect to ultrasound
probe are illustrated. Support 130 may further comprise, for
example, telescoping member 136 that allows for vertical
repositioning of guide channel 150, thereby modifying height D3.
Referring now to FIG. 5B, frame 80 may further comprise slot 138
disposed thereon, which is configured to receive support 130 of
apparatus 100. Support 130 is slidably movable along the length of
slot 138, thereby allowing horizontal repositioning of apparatus
100 with respect to the brachytherapy apparatus and the ultrasound
probe.
[0053] With reference to FIGS. 6A-6D, alternative embodiments for
mounting the needle guide apparatus on frame 80 are depicted.
Referring now to FIGS. 6A and 6B, mount 132 comprises frame 134 to
which socket 120 and guide body 110 are affixed. In this
embodiment, mount 132 may further comprise mechanisms that allow
vertical or horizontal repositioning of the needle guide apparatus
relative to frame 80 and ultrasound probe 52. For example, frame
134 may comprise telescoping member 136 that allows repositioning
of height D3. Horizontal repositioning may be accomplished by, for
example, means of slot 138 disposed on frame 80 with frame 134
received therein. Slidable repositioning of frame 134 within slot
138 provides for horizontal repositioning of the needle guide
apparatus.
[0054] In still another embodiment as illustrated in FIGS. 6C and
6D, support 140 comprises vertical segment 142 and cantilevered
horizontal arm 144, to which is affixed socket 120 and guide body
110. Segment 142 may comprise telescoping mechanism 146 that allows
vertical repositioning of the guide apparatus, thereby adjusting
height D4. To adjust distance D5, cantilevered arm 144 is slidably
movable with respect to vertical segment 142, thereby providing a
means for horizontal repositioning of guide channel 150.
Horizontal, vertical and angular repositioning of the needle guide
in foregoing manners may be controlled by automated means, such as
are known in the art.
[0055] With respect to FIG. 7, an alternative embodiment of the
present invention is described. In this embodiment, guide apparatus
200 comprises a plurality of guide bodies 210 conjoined linearly
following common axis 250, each guide body 210 comprising a guide
channel 220. Guide channels 220 are arranged substantially
perpendicular to common axis 250. Guide apparatus 200 is installed
on frame 80 of the brachytherapy device via shaft 230 that allows
rotation about axis 250, thereby enabling angular reorientation of
guide channels 220 with respect to the longitudinal axis of the
ultrasound probe. Apparatus 200 allows independent rotation of each
guide body 210 with respect to the other guide bodies.
[0056] In another embodiment of the present invention, guide
apparatus 300 comprises guide body 310 as depicted in FIGS. 8A and
8B. Guide body 310 comprises proximal plane 360 and distal plane
365 directed towards the practitioner and the patient,
respectively. Guide body 310 further comprises orthogonal arrays of
distal apertures 370 and proximal apertures 375 disposed on the
distal and proximal planes, respectively. Each proximal aperture
370 communicates with its corresponding distal aperture 375 by
guide channel 320, the guide channels substantially the same as
those described hereinabove. Guide apparatus 300 may be installed
on a standard brachytherapy device by shaft 330, which provides
vertical axis 360 about which the guide apparatus may rotate for
angular reorientation. Handle 390 may be disposed on guide body 310
to provide a mechanical advantage for guide body rotation.
[0057] Referring now to FIGS. 9A and 9B, guide apparatus 300
further comprises guide posts 340 instead of aforementioned shaft
330. Guide posts 340 are received within curved guide tracks 390
disposed on the surface of frame 80. When installed in this manner,
guide apparatus 300 may be angularly reoriented by slidably moving
guide posts 340 within their respective guide tracks, as depicted
in FIG. 9B.
[0058] In still another embodiment as depicted in FIGS. 10A and
10B, curved guide body 410 of needle guide apparatus 400 comprises
proximal convex surface 460 and distal concave surface 465.
Proximal apertures 470 and distal apertures 475 are disposed on,
respectively, the proximal and distal surfaces. Needle guide
channels 420 communicate between corresponding apertures such that
the longitudinal axis of each guide channel 420 is substantially
normal to both surfaces. Therefore, the guide channels disposed
within curved guide body 410 in the foregoing manner provide a
spectrum of angular orientations relative to the longitudinal axis
of ultrasound probe 52. Guide body 410 may be composed of a
malleable material, such as plastic, metal, synthetic polymer,
natural polymer or a metal frame embedded within or supporting a
plastic or polymer body, thereby allowing the medical practitioner
to modify its curvature, hence adjusting the angular orientations
of the guide channels therein.
[0059] With reference to FIGS. 11A-11C, another embodiment of the
guide apparatus is illustrated. Guide apparatus 500 comprises two
or more guide body sections 570 that are joined by hinges 540,
thereby forming a single articulated guide body 510. These hinges
are configured to allow the guide body sections to be oriented at
different angles with respect to each other as illustrated in FIGS.
11B and 11C. Guide channels 520 are disposed in orthogonal arrays
on each section 570, the guide channels being substantially the
same as those described hereinabove. Guide channels 520 communicate
through each section 570, each guide channel having a longitudinal
axis substantially normal to its respective section.
[0060] Referring now to FIG. 12A, guide apparatus 600 comprises
proximal plane 660 and distal plane 665 positioned in parallel with
respect to each other. Disposed therebetween are a plurality of
rigid guide channels 620 that connect distal plane 660 to proximal
plane 665. As in the other embodiments described herein, the guide
channels are in communication with their respective proximal
apertures 670 and distal apertures 675. Disposed at the ends of the
guide channels are flexible junctions 680. Flexible junctions 680,
which may be ball joints 690 as illustrated in FIG. 12B, allow
guide channels 620 to rotate with respect to the distal and
proximal planes while remaining in communication with their
respective proximal and distal apertures. In this manner, proximal
plane 660 may be repositioned horizontally, vertically, or a
combination thereof with respect to distal plane 665 while
remaining parallel and connected thereto.
[0061] In the configuration depicted in FIG. 12C, distal plane 665
and proximal plane 660 are positioned such that the longitudinal
axis of each guide channel 620 is substantially normal to the
planes. Hence, a needle slidably received by a guide channel in
this configuration is oriented also substantially perpendicular to
the planes. Angular reorientation of the guide channels is
accomplished by repositioning proximal plane 660 vertically,
horizontally, or a combination thereof with respect to distal plane
665. As in the example depicted in FIG. 12D, vertical repositioning
of the planes in the foregoing manner causes the guide channels
connected therebetween to rotate with respect to both planes in
order to remain in communication with their respective apertures.
Rotation in this manner results in angular reorientation of the
guide channels.
[0062] With reference to FIGS. 3-12, it is understood that the
features described in the embodiments depicted therein may be
combined, thereby providing their respective advantages to a single
apparatus.
[0063] Referring now to FIGS. 3A-5B, as well as FIGS. 1-2G, a
method of using apparatus 100 is described.
[0064] With seeds 60 loaded into needle 56 and distance D1
verified; the needle, seeds, and plunger 58 are inserted through
needle guide channel 120 of needle guide apparatus 100 and into the
patient. The longitudinal axis of the guide channel may initially
be aligned with the longitudinal axis of ultrasound probe 52, or it
may be oriented at an angle. The distance D2 is established and may
be altered by longitudinally repositioning frame 80 relative to
ultrasound probe 52. As will of course be understood, longitudinal
repositioning of needle guide apparatus 100 may also require
angular repositioning to ensure proper alignment with prostate
P.
[0065] The first medical practitioner holds needle 56 stationary
while the second medical practitioner advances the first seed 60 to
the distal tip of the needle with plunger 58. The second medical
practitioner then holds plunger 58 stationary while the first
practitioner rotates and proximally retracts needle 56 to sow the
seeds in a line within prostate P. The needle and plunger are
removed from the patient.
[0066] The seed delivery procedure is repeated at other locations
as necessary. In accordance with the present invention, needle
guide body 110 and needle guide channel 120 may be angularly
reoriented with respect to ultrasound probe 52 between seed
delivery procedures, in the manner illustrated in FIGS. 4C and 4D.
Angular reorientation may, for example, be used when anatomical
constraints, such as skeletal structures, for example, the pelvis
and pubic bone, are expected to limit the medical practitioner's
ability to deliver radioactive brachytherapy seeds into the
prostate in proper alignment. The procedure outlined hereinabove is
then repeated as necessary.
[0067] With respect to the embodiments depicted in FIGS. 7-12 and
described herein, the needle guide apparatus of those embodiments
are used in conjunction with the foregoing method for performing
brachytherapy in substantially the same manner. The needle guide
apparatus depicted in FIGS. 7-12 may be angularly reoriented with
respect to ultrasound probe 52 in preparation for and during
brachytherapy. Reorientation of these embodiments are accomplished
in the manners provided in their respective descriptions
hereinabove.
[0068] Although preferred illustrative embodiments of the present
invention are described hereinabove, it will be evident to one
skilled in the art that various changes and modifications may be
made without departing from the invention. It is intended in the
appended claims to cover all such changes and modifications that
fall within the true spirit and scope of the invention.
* * * * *