U.S. patent application number 12/815374 was filed with the patent office on 2010-09-30 for brachytherapy apparatus and methods of using same.
This patent application is currently assigned to CIANNA MEDICAL, INC.. Invention is credited to Robert R. Bowes, Eduardo Chi Sing, George D. Hermann, Gail S. Lebovic, Doug S. Sutton.
Application Number | 20100249487 12/815374 |
Document ID | / |
Family ID | 37814128 |
Filed Date | 2010-09-30 |
United States Patent
Application |
20100249487 |
Kind Code |
A1 |
Hermann; George D. ; et
al. |
September 30, 2010 |
BRACHYTHERAPY APPARATUS AND METHODS OF USING SAME
Abstract
Apparatus, systems and methods for delivering brachytherapy to a
target tissue region of a human or other mammalian body. In some
embodiments, a flexible brachytherapy device is implanted that
includes a therapy delivery portion having one or more radioactive
sources securely retained thereto, and a tail portion extending
from the therapy delivery portion. Once implanted, the tail portion
may extend outside the body, where it may be folded and secured
flat against the skin. The device may be removed at therapy
completion. Other embodiments of the invention are directed to
systems and methods for delivering brachytherapy devices to the
body.
Inventors: |
Hermann; George D.; (Portola
Valley, CA) ; Sutton; Doug S.; (Pacifica, CA)
; Lebovic; Gail S.; (McKinney, TX) ; Chi Sing;
Eduardo; (Dana Point, CA) ; Bowes; Robert R.;
(Laguna Hills, CA) |
Correspondence
Address: |
Vista IP Law Group LLP
2040 MAIN STREET, Suite 710
IRVINE
CA
92614
US
|
Assignee: |
CIANNA MEDICAL, INC.
Aliso Viejo
CA
|
Family ID: |
37814128 |
Appl. No.: |
12/815374 |
Filed: |
June 14, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
11554731 |
Oct 31, 2006 |
7736292 |
|
|
12815374 |
|
|
|
|
60731879 |
Oct 31, 2005 |
|
|
|
Current U.S.
Class: |
600/3 |
Current CPC
Class: |
A61N 5/1007 20130101;
A61N 2005/1094 20130101; A61N 2005/1012 20130101; A61N 5/1014
20130101; A61N 2005/1011 20130101; A61N 2005/1023 20130101; A61N
2005/1005 20130101; A61N 5/1027 20130101 |
Class at
Publication: |
600/3 |
International
Class: |
A61M 36/04 20060101
A61M036/04 |
Claims
1. An apparatus for delivering a plurality of brachytherapy
treatment devices into a target tissue region of a body, the
apparatus comprising: a first compression member and a second
compression member to compress a portion of the body containing the
target tissue region; a needle guide securable relative to the
first compression member and defining an array of guide openings;
and a needle driver for advancing two or more needles
simultaneously through the needle guide and the first and second
compression members.
2. The apparatus of claim 1, wherein the needle driver and the
needle guide are coupled to an arm movably coupled to a base.
3. The apparatus of claim 1, wherein the first compression member
defines a proximal array of openings that correspond in location to
the array of guide openings.
4. The apparatus of claim 1, wherein the second compression member
defines a distal array of openings that correspond in location to
the array of guide openings.
5. The apparatus of claim 1, wherein the first compression member
defines a window to receive a membrane through which the two or
more needles may pass.
6. The apparatus of claim 1, wherein the first compression member
is operable to receive an anchoring tab through which the two or
more needles may pass.
7. The apparatus of claim 6, wherein the anchoring tab defines an
array of pre-formed openings through which the two or more needles
may pass.
8. The apparatus of claim 7, wherein a tail portion of one or more
of the plurality of brachytherapy devices extends through one of
the openings of the array of pre-formed openings.
9. The apparatus of claim 8, wherein the tail portion comprises two
or more anchoring ribs spaced along a length of the tail
portion.
10. The apparatus of claim 7, wherein each of the array of
pre-formed openings is defined by a clearance portion having a
diameter equal to or larger than an undeflected diameter of the
anchoring ribs, and an interference portion having a diameter
smaller than an undeflected diameter of the anchoring ribs.
11. The apparatus of claim 10, wherein the clearance portion and
the interference portion are connected via a slot.
12. The apparatus of claim 7, wherein the anchoring tab is operable
to conform to the shape of the body.
13. The apparatus of claim 1, wherein the first compression member
and the second compression member are attached to a base.
14. The apparatus of claim 1, further comprising a screw mechanism
to advance the needle driver.
15. A method of delivering a plurality of brachytherapy devices to
a target tissue region within a breast, the method comprising:
immobilizing the breast; locating a needle guide proximate the
breast, the needle guide defining an array of guide openings
corresponding to the target tissue region; advancing a plurality of
needles simultaneously through the needle guide and the target
tissue region, wherein each needle of the plurality of needles
includes one of the plurality of brachytherapy devices coupled
thereto; and withdrawing the plurality of needles simultaneously
while leaving the plurality of brachytherapy devices implanted in
the target tissue region of the breast.
16. The method of claim 15, wherein immobilizing the breast
comprises compressing the breast between a first compression member
and a second compression member.
17. The method of claim 15, wherein advancing the plurality of
needles comprises rotating a screw operatively attached to the
plurality of needles.
18. A method of delivering a plurality of brachytherapy devices to
a target tissue region within a breast, the method comprising:
immobilizing the breast between first and second compression
paddles; locating a needle guide proximate the first compression
paddle, the needle guide defining an array of guide openings
corresponding to the target tissue region; advancing a plurality of
needles simultaneously through the needle guide, the first
compression paddle, the breast, and the second compression paddle,
wherein each needle includes one of the plurality of brachytherapy
devices coupled thereto; and withdrawing the plurality of needles
while leaving the plurality of brachytherapy devices implanted in
the target tissue region of the breast.
19. The method of claim 18, further comprising: inserting each
needle of the plurality of needles and its associated brachytherapy
device through an opening in an anchoring tab positioned adjacent
the breast, wherein a tail portion of each brachytherapy device
extends outside the breast through the opening in the anchoring
tab; securing the tail portion relative to the anchoring tab.
20. The method of claim 18, wherein securing the tail portion
relative to the anchoring tab comprising moving the tail portion
from a clearance portion of the opening of the anchoring tab to an
interference portion.
Description
[0001] This application is a divisional of co-pending application
Ser. No. 11/554,731, filed Oct. 31, 2006, issuing as U.S. Pat. No.
7,736,292 on Jun. 15, 2010, which claims benefit of provisional
application Ser. No. 60/731,879, filed Oct. 31, 2005, the entire
disclosures of which are expressly incorporated by reference
herein.
TECHNICAL FIELD
[0002] The invention pertains generally to medical treatment and,
more specifically, to apparatus, methods, and systems for providing
brachytherapy to a human or other mammalian body.
BACKGROUND
[0003] Brachytherapy is a type of radiation therapy used to treat
malignant tumors such as cancer of the breast or prostate. In
general, brachytherapy involves the positioning of a radiation
source directly into target tissue, which may typically include the
tumor and/or surrounding tissue that may contain potentially
cancerous cells (such as a cavity or void created by removal of the
tumor).
[0004] Brachytherapy is often divided into two categories: high
dose rate (HDR); and low dose rate (LDR). In HDR brachytherapy, a
high activity radiation source is placed into the target tissue,
often via a previously implanted catheter, for a short period of
time, e.g., seconds to a few minutes. In contrast, LDR
brachytherapy places a low activity radiation source into the
target tissue for a longer--sometimes indefinite--period of
time.
[0005] Both forms of brachytherapy have advantages. For instance,
HDR brachytherapy provides higher radiation levels delivered over a
shorter dose delivery period. LDR brachytherapy, on the other hand,
utilizes lower activity radiation sources. The energy field of the
LDR radiation source results in a measured and localized dose of
radiation delivered to the target tissue, e.g., the tumor, gland,
or other surrounding tissue. However, the energy field thereafter
decays to avoid excessive exposure of nearby healthy tissue.
[0006] Due in part to the lower activity of LDR radiation sources,
LDR brachytherapy may provide various advantages. For example, for
healthcare workers, exposure precautions for LDR brachytherapy may
be less stringent than those for HDR brachytherapy. Also, there are
radiobiological advantages of LDR brachytherapy over HDR
brachytherapy (e.g., the dose rate effect), which can result in
less damage of normal tissue during treatment. Moreover, for
patients, the relatively longer implantation period associated with
LDR brachytherapy may result in fewer visits to a healthcare
facility over the course of radiation treatment, as compared to HDR
brachytherapy where patients return to the healthcare facility for
each fraction of radiation delivered (typically 8-10 fractions for
breast brachytherapy).
[0007] Common radiation sources used in LDR brachytherapy include
radioactive isotopes such as Palladium (Pd)-103, Iodine (I)-125,
Gold (Au)-198, and Iridium (Ir)-192. While the size and shape of
the isotopes may vary, they are, in common applications (e.g.,
prostate brachytherapy), provided in a standardized size of
cylindrically shaped capsules that are approximately the size of a
grain of rice, e.g., about 0.8 millimeters (mm) in diameter and
about 4.5 mm in length, and are often referred to as "seeds."
[0008] LDR seeds are often delivered through needles using a guide
template. The guide template may include a matrix of holes that
guide the longitudinal advancement of the needles to insure their
proper position relative to the target tissue. Once the needles are
properly located in the target tissue, the seeds may be deposited
along the longitudinal axis of each needle, after which the needles
may be withdrawn.
[0009] While effective, current brachytherapy implementations have
potential drawbacks. For example, the LDR seeds are typically left
indwelling and free floating within the target tissue and are,
therefore, susceptible to migration. Moreover, once implanted, LDR
seeds are generally not considered to be removable or
repositionable. LDR brachytherapy may also require careful dose
distribution calculations and seed mapping prior to, and often
during, seed implantation. Such calculation and mapping allows
effective radiation delivery to the target tissue volume, while
minimizing radiation to surrounding healthy tissue (the urethra and
rectum, for example, in prostate brachytherapy). Yet, while such
dose calculation and seed mapping techniques are effective,
problems--such as potentially significant variability in accuracy
of seed placement among different clinicians--may exist.
[0010] Yet another issue with conventional LDR brachytherapy
techniques is that many of these techniques often require the
radioactive seeds to be manipulated individually at the time of
implantation, an often time-consuming process. Moreover,
conventional LDR delivery needles are generally limited to
delivering the seeds linearly (along a relatively straight line).
Thus, to achieve the desired therapy profile, numerous implants
(e.g., about 50-100 seeds are common with prostate brachytherapy),
in conjunction with potentially complex dose distribution and
mapping techniques and equipment, are often required.
SUMMARY
[0011] The present invention is broadly directed to apparatus and
methods for delivering brachytherapy to a localized target tissue
region. While the invention is useful in treating most any area of
the body, it offers particular advantages in the treatment of
breast tissue, e.g., breast tumors or lumpectomy cavities. For
example, the apparatus, systems, and methods described herein may
be used to place and remove a localized radiation source for both
neoadjuvant and post-excisional treatment.
[0012] Exemplary embodiments are directed to brachytherapy devices
and apparatus. Such devices and apparatus are capable of delivering
brachytherapy treatment to a target region (e.g., breast tissue
region). Other embodiments are directed to delivering multiple
brachytherapy devices, either simultaneously or serially, to the
target region. Systems and methods for delivering brachytherapy to
the target region are also provided.
[0013] The above summary is not intended to describe each
embodiment or every implementation of the present invention.
Rather, a more complete understanding will become apparent and
appreciated by reference to the following detailed description and
claims in view of the accompanying drawings.
BRIEF DESCRIPTION OF THE VIEWS OF THE DRAWINGS
[0014] The present invention will be further described with
reference to the drawings, wherein:
[0015] FIG. 1A illustrates an exemplary brachytherapy apparatus or
kit in accordance with one embodiment;
[0016] FIG. 1B illustrates an exemplary brachytherapy apparatus or
kit in accordance with another embodiment;
[0017] FIG. 1C illustrates an alternative embodiment of a needle
for use with the apparatus or kits illustrated in FIGS. 1A and
1B;
[0018] FIGS. 2A-2E are diagrammatic illustrations of a method of
using the brachytherapy apparatus of FIG. 1A;
[0019] FIG. 2F is a diagrammatic illustration of another
brachytherapy apparatus;
[0020] FIGS. 2G-2L are diagrammatic illustrations of a method of
using the brachytherapy apparatus of FIG. 1B, or other exemplary
brachytherapy device;
[0021] FIGS. 3A-3B are enlarged partial views of a brachytherapy
device in accordance with another embodiment;
[0022] FIGS. 4A-4B are enlarged partial views of a brachytherapy
device in accordance with still another embodiment;
[0023] FIGS. 5A-5B are enlarged partial views of a brachytherapy
device in accordance with yet another embodiment;
[0024] FIG. 5C is a view of the brachytherapy device of FIGS. 5A-5B
illustrating an exemplary removal method;
[0025] FIG. 5D is an enlarged view of the brachytherapy device
illustrated in FIG. 1B;
[0026] FIG. 5E is an enlarged view of a brachytherapy device in
accordance with another embodiment;
[0027] FIGS. 5F-5G are enlarged views of a brachytherapy device in
accordance with still another embodiment, wherein FIG. 5G is a
section view taken along line 5G-5G of FIG. 5F;
[0028] FIGS. 5H-5J are enlarged views of a brachytherapy device in
accordance with yet another embodiment, wherein: FIG. 5H is a side
view of the device as assembled; FIG. 5I is a cross-sectional view
of the device; and FIG. 5J is a view of the device with an outer
portion removed;
[0029] FIGS. 6A-6D illustrate a brachytherapy device in accordance
with still yet another embodiment, wherein: FIG. 6A is a view of
the device as partially assembled; FIG. 6B is an exploded view;
FIG. 6C is an enlarged partially assembled view; and FIG. 6D is an
enlarged partial view;
[0030] FIGS. 6E-6H illustrate a brachytherapy apparatus or kit in
accordance with another embodiment, wherein: FIG. 6E is an exploded
view of components of the apparatus; FIG. 6F is an exploded view of
a brachytherapy device of the apparatus of FIG. 6E; and FIGS. 6G
and 6H are enlarged section views of portions of the apparatus;
[0031] FIGS. 6I and 6J illustrate a brachytherapy apparatus or kit
in accordance with yet another embodiment, wherein: FIG. 6I
illustrates a section view of the apparatus; and FIG. 6J is an
enlarged section view of a distal end of the apparatus;
[0032] FIG. 7A is an exploded view of a brachytherapy apparatus or
kit in accordance with yet another embodiment;
[0033] FIG. 7B illustrates the brachytherapy apparatus of FIG. 7A
as it may be partially assembled;
[0034] FIGS. 8A-8E are diagrammatic illustrations of a method of
using the brachytherapy apparatus of FIGS. 7A and 7B;
[0035] FIGS. 9A-9B are enlarged partial views of a brachytherapy
device in accordance with another embodiment;
[0036] FIGS. 10A-10B are enlarged partial views of a brachytherapy
device in accordance with yet another embodiment;
[0037] FIGS. 11A-11B are enlarged partial views of a brachytherapy
device in accordance with still yet another embodiment;
[0038] FIGS. 12A-12B are enlarged partial views of a brachytherapy
device in accordance with still another embodiment;
[0039] FIGS. 13A-13B are enlarged partial views of a brachytherapy
device in accordance with yet another embodiment;
[0040] FIGS. 14A-14B are enlarged partial views of a brachytherapy
device in accordance with still yet another embodiment;
[0041] FIG. 15 is a diagrammatic view of a brachytherapy apparatus
in accordance with another embodiment;
[0042] FIGS. 16A-16G are diagrammatic illustrations of non-linear
brachytherapy apparatus and methods in accordance with various
embodiments, wherein: FIGS. 16A-16E illustrate a dual, off-axis
catheter assembly; and FIGS. 16F-16G illustrate a spiral-shaped
catheter;
[0043] FIGS. 17A-17B illustrate a brachytherapy apparatus in
accordance with yet another embodiment;
[0044] FIG. 18 is a view of a radiation attenuating garment, e.g.,
brassiere, in accordance with one embodiment;
[0045] FIGS. 19A-19C are diagrammatic views of a balloon catheter
assembly, e.g., HDR catheter, in accordance with one
embodiment;
[0046] FIG. 20 is an exemplary embodiment of a delivery or
implantation system for use with brachytherapy methods and
apparatus described herein;
[0047] FIG. 21 is a diagrammatic view of the delivery system FIG.
20 as it may be used with the brachytherapy methods and apparatus
described herein, e.g., the methods described in FIGS. 2A-2F,
2G-2L, and 8A-8E;
[0048] FIG. 22 is an enlarged view of an exemplary catheter, e.g.,
needle, guiding template for use with the delivery system of FIG.
21;
[0049] FIG. 23 is a diagrammatic view of another delivery or
implantation system for use with the brachytherapy methods and
apparatus described herein;
[0050] FIG. 24 is an exploded view of a portion, e.g., a cartridge,
of the delivery system of FIG. 23;
[0051] FIGS. 25A-25D are diagrammatic illustrations of a delivery
or implantation system and method in accordance with yet another
embodiment;
[0052] FIG. 26 is a view of a portion of a human body, e.g., a
female breast, after the brachytherapy devices as described herein
have been implanted and secured;
[0053] FIG. 27 is a cross-section of a portion of the delivery
system of FIGS. 25A-25D;
[0054] FIG. 28A is a perspective view of a delivery or implantation
system in accordance with yet another embodiment, the system for
use with brachytherapy apparatus and methods described herein,
e.g., the method of FIGS. 2G-2L;
[0055] FIG. 28B-28D illustrate a delivery or implantation system in
accordance with still yet another embodiment, the system for use
with brachytherapy apparatus and methods described herein, wherein:
FIG. 28B is a diagrammatic perspective view; FIG. 28C is a partial
perspective view illustrating a series of needles in place; and
FIG. 28D is a perspective view illustrating coupling of a needle
guide to the system; and
[0056] FIGS. 29-31 illustrate an anchoring tab in accordance with
one embodiment, the tab for use with a delivery system, e.g., the
delivery systems of FIGS. 28A and 28B, wherein: FIG. 29 is a plan
view of the tab; FIG. 30 is a view illustrating the tab in place;
and FIG. 31 is an enlarged view of a portion of the tab.
DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS
[0057] In the following detailed description of exemplary
embodiments, reference is made to the accompanying drawings, which
form a part hereof, and in which are shown by way of illustration
specific embodiments in which the invention may be practiced. It is
to be understood that other embodiments may be utilized and
structural changes may be made without departing from the scope of
the present invention. For example, additional information
regarding apparatus and methods that may be used in accordance with
the embodiments described herein may be found in co-pending
application Ser. No. 10/658,518, filed 9 Sep. 2003, the entire
disclosure of which is expressly incorporated by reference
herein.
[0058] Generally speaking, the present invention is directed to
brachytherapy apparatus and methods. More particularly, the present
invention provides a system for delivering one or more therapeutic
elements (e.g., radiation sources) relative to a target tissue
region. Once delivered, the radiation sources may be either
immediately withdrawn (e.g., in HDR applications), or left in
place, e.g., implanted, for a defined period (e.g., in LDR
applications). In either instance, the radiation sources may
deliver therapy to the target tissue region in accordance with a
predefined therapy profile.
[0059] In some embodiments, LDR radiation sources may be implanted
and secured to the body or target tissue in such a way as to
prevent or substantially limit movement of the sources relative to
the target tissue. Unlike conventional LDR brachytherapy, apparatus
and methods described herein provide not only indwelling therapy
using pre-arranged packages of radioactive sources, e.g., seeds,
but also allow easy removal of the radiation sources at the
completion of brachytherapy.
[0060] As used herein, "radiation source" and "radioactive source"
may include most any therapeutic element operable to deliver a dose
of radiation. For example, the radiation source may be a
radioactive seed or, alternatively, a LDR or HDR wire element
(e.g., Iridium wire).
[0061] The term "implantable," as used herein, indicates the
capability of a device to be inserted into the body and then
maintained in a fixed or static position, relative to the
immediately surrounding tissue, for an extended period of time,
e.g., an hour or more and, more optionally, several hours or more,
including several days or more.
[0062] Furthermore, "target tissue," "target tissue region,"
"target region," and "target tissue volume," as used herein, may
include most any portion of a human (or other mammalian) body that
has been identified to benefit from radiation therapy. For example,
the target tissue region may be a tumor or lesion itself, tissue
proximate or surrounding the tumor, or a cavity region created by
tumor excision (such as the surrounding tissue or cavity associated
with a lumpectomy cavity of the breast).
[0063] It should be noted that, while described herein primarily
with respect to LDR brachytherapy, the apparatus and methods
described herein may also have application to HDR brachytherapy
(e.g., HDR catheters) as further described below. Moreover, while
described herein with respect to brachytherapy, the apparatus and
methods described herein may also be used for other therapy
regimens that benefit from the removable implantation of
therapy-delivering elements.
[0064] For the sake of brevity, embodiments are described herein as
relating to the treatment of breast cancer. However, this
particular application is not limiting. That is, those of skill in
the art will readily appreciate that the systems, apparatus, and
methods described herein may find application to most any cancer
that may receive benefit from brachytherapy.
[0065] With this introduction, turning to the drawings, FIG. 1A
illustrates an exemplary kit or apparatus 100 for providing
brachytherapy to a target tissue region of a body. The apparatus
100 may include an elongate and flexible, removably implantable
brachytherapy treatment device 102 (also referred to hereinafter as
"brachytherapy device 102") having a therapy delivery portion 104,
and an elongate and flexible tail portion 106. The tail portion 106
may, as further described below, provide the ability to remove the
device 102 at therapy completion. Other components described below,
e.g., locking members, may also be included with the apparatus
100.
[0066] The term "flexible" is used herein to describe a component
that is highly pliant, e.g., a component that may be substantially
and easily bent, flexed, and/or twisted without experiencing
breakage or permanent deformation.
[0067] The therapy delivery portion 104 may form a carrier pod of
therapeutic elements, e.g., radiation sources such as radioactive
seeds 108, secured relative to one another and to the therapy
delivery portion 104. One or more spacers 110 may optionally be
located between each seed 108 to obtain the desired seed
separation.
[0068] The seeds 108 may be produced from most any acceptable
radioactive source now known (e.g., radioactive Palladium, Iodine,
Cesium, or Iridium) or later developed. Typically, numerous seeds
108 are provided and precisely placed along the length of the
therapy delivery portion 104 in order to correspond to the desired
therapy delivery regimen. While the radioactive sources are
described herein as seeds 108, they may take other forms such as a
continuous filament (or numerous discontinuous segments) of
radioactive wire (e.g., Iridium wire).
[0069] In some embodiments, the brachytherapy device 102 may
include a flexible casing or casing member, illustrated in the
figures as tube or tube member 112, in which the seeds 108 and
optional spacers 110 are securely retained. In some embodiments,
the casing is made from a non-dissolving and flexible,
heat-shrinkable tubing material. "Heat-shrinkable tubing," as used
herein, refers to tubing, such as various plastic tubing, in which
subsequent thermal exposure causes the tubing to shrink, thereby
allowing it to securely retain the seeds 108 in place. Exemplary
heat-shrinkable materials include polyester, fluorinated polymers,
and polyolefins.
[0070] While most any number of tubing sizes is contemplated, in
one embodiment, the tube 112 may have an initial inside diameter of
about one millimeter (1 mm) and a wall thickness of about 0.05 mm.
Once heated, the tube 112 may shrink (if unconstrained) to an outer
diameter ranging from about 0.3 mm to about 0.6 mm.
[0071] While the casing is described herein generally as
tube-shaped, the casing may, in other embodiments, be most any
shape that is capable of effectively securing the individual seeds
108 relative to the casing and to one another.
[0072] Once the seeds 108 and optional spacers 110 are located
within the tube 112, the tube may be shrunk by exposure to heat,
thus contracting the tube 112 around the seeds 108. The tail
portion 106 may be formed by an integral portion, e.g., extension,
of the casing (tube 112) that extends beyond the seeds 108. To
reduce the diameter of the tail portion 106, it may also be
thermally treated (shrunk). Other embodiments (described below) may
utilize a two-part brachytherapy device, e.g., a separate filament
tail portion attached to the therapy delivery portion.
[0073] Regardless of the specific configuration, the brachytherapy
devices 102 described herein provide not only proper spacing of the
seeds 108, but also facilitate subsequent seed identification and
removal. Moreover, because the seeds are contained within the pod
defined by the therapy delivery portion 104, seeds may not require
individual handling, thus simplifying inventory and handling prior
to, and at the time of, implantation.
[0074] The components of the device 102, including the casing (tube
112) and tail portion 106, may be constructed of non-dissolving
materials. The term "non-dissolving" is used herein to indicate
most any material that does not substantially deteriorate or
otherwise break down during the implantation period.
[0075] The brachytherapy apparatus 100 may also include a catheter,
e.g., needle 114. While illustrated as needle 114, any other type
of catheter, such as the cannulae described further below, may also
be used. The needle 114 defines a lumen 115 of sufficient size to
allow the therapy device 102 to pass through as indicated in FIG.
1A. The needle 114, in some embodiments, may further include a hub
116 at a proximal end to assist with manipulation of the needle and
insertion of the therapy device 102. A distal end of the needle 114
may form a sharpened tip 117 operable to pierce the body as further
described below. The needle 114 may be made from most any suitable
biocompatible material. For example, it may be made from metal,
e.g., stainless steel, titanium, or nickel titanium alloy. It may
also include a removable outer sheath (not shown) made of plastic,
e.g., fluorinated polymers.
[0076] FIGS. 2A-2E illustrate an exemplary method of using the
brachytherapy apparatus 100 of FIG. 1A. Once a target tissue region
202 (a tumor or tumor cavity) within body 200 is accurately
located, the needle 114 may be inserted into the body 200, as shown
by arrow 203 in FIG. 2A, to a predetermined depth. The relative
location(s) of the needle 114 and/or the target tissue region 202
may be determined by most any method, e.g., via ultrasound, CT
scan, stereotactic X-ray, etc. The needle 114 may further be
aligned with the use of a needle guiding template as further
described below, or by other techniques.
[0077] Next, the brachytherapy device 102 may be inserted into the
lumen 115 of the needle 114, as shown by arrow 205 in FIG. 2B,
until the therapy delivery portion 104 is located at the desired
depth relative to the target tissue region 202 as shown in FIG. 2C.
To assist in determining the approximate insertion depth of the
therapy device 102, the tail portion 106 may include measurement
demarcations 118. Other location verification techniques, e.g.,
X-ray, ultrasound, etc., may also be used.
[0078] Once the therapy device 102 is located at the desired depth,
the needle 114 may be withdrawn from the body in the direction 207
as shown in FIG. 2D, leaving the therapy delivery portion 104 of
the device 102 at the desired position within the body 200. The
tail portion 106 may have sufficient length such that it extends
outside of the body 200 as shown in FIG. 2E. That is, the tail
portion 106 may extend externally through a puncture made by the
needle 114.
[0079] In order to prevent migration of the therapy delivery
portion 104, a locking member 120 may be crimped or otherwise
attached to the tail portion 106 of the therapy delivery device 102
immediately adjacent the associated puncture in the body 200. The
locking member 120 may assist in maintaining the location of the
therapy delivery portion 104 relative to the target tissue region
202. While most any locking member may be used, one embodiment
utilizes a malleable, hat- or U-shaped lock that can be easily and
securely crimped to the tail portion with, for example, a surgical
clip applier or similar tool. An enlarged view of an exemplary
locking member is illustrated in FIG. 27.
[0080] For illustration purposes, only a single therapy delivery
device 102 is shown in FIGS. 2A-2E. However, in practice, multiple
devices would be utilized to provide adequate dosage to the target
tissue region 202. The actual number of devices 102 may vary
depending on various parameters such as lesion size, radiation
source activity levels, and proximity to other organs/vulnerable
tissue (e.g., skin, chest wall). However, quantities ranging from
about 5 to about 25 devices are contemplated.
[0081] FIG. 2F illustrates a variation of the therapy device 102 of
FIGS. 2A-2E that may offer additional benefits, especially to the
treatment of breast cancers. In this embodiment, a therapy device
152 similar in most respects to the device 102 is provided.
However, the device 152 may include both a first tail portion
extending from a first end of a therapy delivery portion 154 and a
second tail portion extending from a second end, i.e., it may
include a tail portion 156 at each end of the therapy delivery
portion 154. During implantation, the needle 114 may pass
completely through the body, e.g., breast 200, such that one tail
portion 156 extends out the opposite side of the breast 200. In
this way, locking members 120 may be secured at two locations
relative to the target tissue region 202, thus preventing or
substantially limiting movement of the therapy delivery portion 154
relative to the target tissue region 202.
[0082] Unlike conventional brachytherapy catheters, which may be
two millimeters (2 mm) or more in diameter, the devices described
herein, e.g., devices 102, may be about one millimeter (1 mm) or
less in diameter at the therapy delivery portion 104 and even
smaller at the tail portion 106. This construction permits the
devices 102 to be relatively small and flexible, and thus less
obtrusive to the patient. In fact, the size and flexibility of the
tail portions 106 may be similar to that of a conventional suture.
As a result, securing the tail portions 106 may be accomplished in
any number of ways including, for example, folding the tail
portions against the contour of the surrounding body and fixing
them such as by tying the ends and/or securing the ends with
adhesive, the latter represented by bandage 2600 in FIGS. 2E and
26.
[0083] FIG. 1B illustrates another kit or apparatus 560 for
providing brachytherapy to a target tissue region of the body. The
apparatus 560 may include an elongate and flexible, removably
implantable, brachytherapy treatment device 562 ("brachytherapy
device 562") having a therapy delivery portion 564, and at least
one elongate and flexible tail portion 566. The tail portion(s) 566
may, as further described herein, provide for removal of the device
562 at therapy completion. Other components described below, e.g.,
locking members, may also be included with the apparatus 560.
[0084] As with the device 102, the therapy delivery portion 564 may
form a carrier pod of therapeutic elements, e.g., one or more
radioactive sources such as radioactive seeds 108, secured relative
to one another. Spacers 110 may optionally be located between each
seed 108 to obtain the desired seed separation. The brachytherapy
device 562 may also include a casing, e.g., heat-shrinkable tube or
tube member 112, in which the seeds 108 and optional spacers 110
are securely retained. In the embodiment illustrated in FIG. 1B,
the device 562 may optionally include alert markings (e.g.,
segments or markings 565) that indicate an outermost boundary of
the radioactive source, e.g., outermost seed 108, as further
described below. The device 562 may, in some embodiments, also
include positioning indicia, e.g., repeating linear markings 559,
along the tail portion 566 to indicate implantation depth. These
linear markings may be circumferential bands of ink or other
identifiable marks (e.g., foil, laser markings). The markings may
also be visible under X-ray (e.g., tantalum-impregnated paint, gold
bands, etc.). The markings may be placed directly on the surface of
the tail, or beneath the tail surface, such as on the surface of an
inner filament that resides within the tube 112 (see, e.g.,
filament 573 described below with respect to device 572 of FIG.
5E).
[0085] The brachytherapy apparatus 560 may also include a catheter,
e.g., needle 114' similar in many respects to the needle 114 of
FIG. 1A. The needle 114' defines a lumen 115' of sufficient size to
allow the device 562 to pass through as indicated in FIG. 1B. The
needle 114', in some embodiments, may further include a hub 116' at
a proximal end (although, as described below, such hubs may be
optional). Unlike the needle 114, the distal end of the needle 114'
may form a canoe-shaped ("huber") tip. This tip shape may reduce
tissue coring when the needle 114' pierces the body.
[0086] FIGS. 2G-2L illustrate an exemplary method of using the
brachytherapy apparatus 560 of FIG. 1B. While illustrated with only
one needle 114', it is to be understood that the described method
could be utilized to simultaneously or sequentially insert an array
of needles as will be further described below. Moreover, while
shown in conjunction with the brachytherapy device 562, other
devices as described and illustrated herein could certainly be
substituted for the device 562.
[0087] Prior to needle 114' insertion, the brachytherapy device 562
may be coupled to the needle 114', e.g., preloaded within the lumen
115'. Once the target region 202 (a tumor or lumpectomy cavity
region within the breast 200) is accurately located, the apparatus
560, e.g., the needle 114' with the brachytherapy device 562
contained therein, may be inserted into a proximal side of the
breast as shown by arrow 561 in FIG. 2G. The needle 114' may be
inserted to a predetermined depth (as the needle 114 of FIGS.
2A-2E), or may be inserted completely through the breast 200 as
shown in the Figures (see, e.g., arrow 563 in FIG. 2H). The
relative location(s) of the needle 114' and/or the target region
202 may be determined by any acceptable method, e.g., via
ultrasound, CT scan, stereotactic X-ray, etc. The needle 114' may
further be aligned with the use of a needle guiding template as
further described below, or by other guidance techniques.
[0088] Once the needle 114' passes through a distal side of the
breast 200 as shown in FIG. 2H, the distal tail portion 566 of the
brachytherapy device 562 may be extended through the distal end of
the lumen 115' of the needle by pushing a proximal tail portion 566
as represented by arrow 567 in FIG. 2I. The physician may then
grasp or otherwise immobilize the distal tail portion 566 and
withdraw the needle 114' in the direction 568 as shown in FIG. 2J,
leaving the therapy delivery device 562 implanted in the breast 200
as shown in FIG. 2K.
[0089] The physician may further manipulate the proximal and distal
tail portions 566 of the device 562, as represented by arrows 569
in FIG. 2K, to achieve the desired positioning of the therapy
delivery portion 564 relative to the target region 202. The alert
markings 565 may assist in visualizing and/or locating (e.g., via
X-ray or CT scan) the therapy delivery portion 564 during
positioning. The positioning indicia (e.g., the repeating linear
markings 559) may also be used to indicate the location of the
therapy delivery portion 564 relative to the skin surface.
[0090] In order to prevent migration of the therapy delivery
portion 564, a locking member 570 may be placed over each tail
portion 566 of the therapy delivery device 562 immediately adjacent
the associated puncture in the breast 200. The locking member 570
may assist in securing and maintaining the location of the therapy
delivery portion 564 relative to the target tissue region 202.
While most any locking member configuration may be used, one
embodiment utilizes a malleable, hat- or U-shaped grommet that can
engage the tail portion 566 via friction or crimping and hold the
device 562 in place. Similarly, a button (not shown) with a through
hole may also be used. A secondary clamp, e.g., a surgical clip
571, may be securely crimped to the tail portion immediately
adjacent and outboard of the locking member 570 (with, for example,
a surgical clip applier or similar tool) to more permanently secure
the device 562 in place.
[0091] Once again, only a single therapy delivery device 562 is
illustrated in FIGS. 2G-2L. However, in practice, multiple devices
could be utilized to provide the desired therapy dosage to the
target tissue region 202. Systems and methods utilizing such
multiple implants are described in more detail below.
[0092] FIG. 1C illustrates a needle 114'' that may be substituted
for either of the needles 114 or 114' described above. The needle
114'' is similar in most respects to the needles 114 and 114' with
the exception that its distal end includes a removable sharp tip
117''. The tip 117'' may include a stepped portion 119 (e.g., a
portion of reduced diameter) that is selectively received within
the lumen 115'' of the needle 114''. As shown, the stepped portion
119 of the tip 117'' may be received within the lumen 115'' with a
slight interference fit to ensure that the tip remains in place
during needle insertion. The outer diameter of the tip 117'' is
substantially the same as the outer diameter of the needle 114'' to
reduce any discontinuity in the needle profile. The needle 114''
provides a solid pyramidal tip that may substantially eliminate
tissue coring and minimizes wandering, but that is removable to
permit advancement of brachytherapy devices, e.g., device 562, from
the distal end of the needle.
[0093] During use, the tip 117'' may be coupled to the needle 114''
and the needle assembled and advanced through the tissue in a
manner similar to that illustrated in FIG. 2G. Once the needle
114'' emerges from the distal side of the breast as shown in FIG.
2H, the distal tip 117'' may be removed from the needle and the
distal tail portion 566 of the device 562 advanced through as shown
in FIG. 2I. Withdrawal of the needle and positioning/securing of
the device 562 may be accomplished in accordance with the methods
already described herein.
[0094] While illustrated as hubless in FIG. 1C, alternative
embodiments of the needle may include a hub similar to the hub 116
and 116' of FIGS. 1A and 1B, respectively.
[0095] FIG. 3A is an enlarged view of the therapy device 102 of
FIG. 1A. As clearly illustrated in this view, the therapy device
102 may include the therapy delivery portion 104 and the tail
portion 106. As described above, the therapy delivery portion 104
may include one or more radioactive seeds 108 separated by spacers
110 and encased within the casing, e.g., heat-shrinkable tube 112.
The tail portion 106 may be formed by the portion of the tube 112
that does not surround the seeds 108. In some embodiments, the
conformal properties of the tube 112 may be sufficient to ensure
proper seed spacing, thus negating the need for spacers 110. FIG.
3B illustrates a section view through a seed 108 and the tube 112
taken along line 3B-3B of FIG. 3A.
[0096] FIGS. 4A-4B illustrate a therapy device 402 in accordance
with another embodiment. The device 402 is similar in many respects
to the device 102 described above. For example, the device 402 may
include a therapy delivery portion 404 and a tail portion 406 as
illustrated in FIG. 4A. A casing, e.g., heat shrinkable tube 412,
may be used to encase the seeds 108 and optional spacers 110 as
well as to form the tail portion 406. However, unlike the
embodiment of FIGS. 3A-3B, the tube 412 may include a
radioabsorptive portion 414, e.g., a substance or liner, positioned
along a portion of the circumference of the therapy delivery
portion 404 (see FIG. 4B). The radioabsorptive portion 414 may
include a radiation attenuating material, and thus reduce radiation
exposure to tissue blocked by the radioabsorptive portion 414 as
opposed to tissue not blocked by the portion 414. While not limited
to any particular embodiment, the radioabsorptive portion may be
formed by a substance (e.g., Tungsten, Nickel-Titanium alloy,
stainless steel) applied to, or impregnated within, a portion of
the tube 412. Alternatively, the radioabsorptive portion(s) may be
formed by a liner within, or secured to a portion of, the tube 412.
FIG. 4B illustrates a section view through a seed 108 and the tube
412 taken along line 4B-4B of FIG. 4A.
[0097] The term "radiotransparent" is used herein to indicate only
that the identified portion of the apparatus or device is
relatively more transparent to radiation than the portion
identified as "radioabsorptive."
[0098] FIGS. 5A-5B illustrate a therapy device 502 in accordance
with yet another embodiment. The device 502 is similar in many
respects to the device 102 described above. For example, the device
502 may include a therapy delivery portion 504 and a tail portion
506 as shown in FIG. 5A. A casing, e.g., heat shrinkable tube 512,
may be used to encase the seeds 108 and optional spacers 110 as
well as to form the tail portion 506. However, unlike the previous
embodiments, the therapy device 502 may incorporate an anchor
member, e.g., a flat or round cross-section anchor wire 514, which
extends along at least a part of the therapy delivery portion 504.
The anchor wire 514 protrudes from one or both ends of the therapy
delivery portion and may be bent to form one or more hooks or
anchors 516.
[0099] When the therapy delivery portion 504 exits the needle 114
(see FIG. 1A) during implantation, the anchors 516 may extend and
engage surrounding tissue, thereby assisting in preventing
migration of the therapy device 502. While only a single anchor is
shown at each end of the therapy delivery portion 504, other
embodiments may include multiple anchors at one or both ends to
further resist movement, e.g., rotating or twisting. FIG. 5B
illustrates a section view through a seed 108 and the tube 512
taken along line 5B-5B of FIG. 5A.
[0100] After the desired dose of radiation has been delivered, the
therapy device 102 (or any of the other therapy devices described
herein, e.g., devices 402 or 502), may be removed in any number of
ways. For example, the device 102 may be removed by first removing
any dressing (e.g., bandage 2600 of FIG. 2E) and locking member(s)
120, and then simply applying a pulling force to one of the tail
portions 106 that extends outside of the body 200. Alternatively,
the devices 102 may be removed prior to or during excisional
surgery of the tumor 202 via known methods, e.g., via methods
similar to excision utilizing localization wires.
[0101] Where the therapy device 102 includes internal retaining
elements, e.g., anchors 516 of device 502 (FIG. 5A), a removal
catheter 550 as shown in FIG. 5C may be used. The removal catheter
550 is similar in most respects to the delivery cannulae and
needles described herein, e.g., needle 114. The catheter 550 may be
threaded over the tail portion 106 and advanced until it
encompasses the therapy delivery portion 104. For example, the
removal catheter 550 may be advanced until its distal end engages
the distal retaining element(s), e.g., distal anchor 516 of FIG.
5A. Further advancement of the removal catheter 550 may bend the
anchor sufficiently to permit the therapy delivery portion to slide
into the removal catheter as shown in the broken line
representation of FIG. 5C. The device 502 and the removal catheter
550 may then be withdrawn as a unit from the body.
[0102] FIG. 5D is an enlarged view of the therapy device 562 shown
in FIGS. 2G-2L. As clearly illustrated in this view, the therapy
device 562 may include the therapy delivery portion 564 and the
tail portions 566. As described above, the therapy delivery portion
564 may include one or more radioactive seeds 108 (e.g., low dose
rate seeds) separated by optional spacers 110 and encased within
the heat-shrinkable tubing 112. The tail portions 566 may be formed
by extensions of the casing, e.g., the tubing 112.
[0103] As with the other devices described herein, the device 562
may utilize tubing 112 that is heat-shrinkable. As a result, the
tubing 112 may frictionally engage the seeds 108 and spacers 110
and capture the same in place. In the illustrated embodiments, the
tubing 112 may have an internal diameter at its first and second
ends that is smaller than its internal diameter at an intermediate
location (e.g., smaller than the internal diameter at a location
between the first and second ends). Stated alternatively, the
internal diameter of the tubing 112 at the first end and the second
end may be less than the outer diameter of the seeds 108 and
spacers 110. Accordingly, the tubing may physically capture and
restrain the seeds and spacers.
[0104] As described above, the device 562 may further include
indicia, e.g., alert markings 565, at or near the ends of the
therapy delivery portion 564. The alert markings 565 may be located
on either the tail portions or on the therapy delivery portion. In
either case, the alert markings may be located immediately beyond
an outermost portion of the radioactive sources, e.g., the
outermost edge of the outermost seed 108. The markings 565 may
improve visibility of the therapy delivery portion 564 during
implantation (e.g., via CT or X-ray positioning methods). The alert
markings 565 may be brightly colored or otherwise distinguishable
from the remainder of the device 562. As a result, when the alert
markings 565 are visible after implantation, it serves as an
indication to the physician that the radioactive source is
potentially too close to the skin surface. To avoid skin
complications, the physician may then reposition the device 562 so
that the alert markings 565, and thus the radioactive sources,
thereby assuring a proper distance between the radioactive source
and the skin surface. An acceptable distance between the end of the
radioactive source and the skin surface may vary based on
radioactivity of the source. However, distances of about 7
millimeters to about 12 millimeters may be common for low dose rate
seeds.
[0105] The alert markings 565 may, in one embodiment, be formed by
a component portion of the therapy delivery portion 564 or the tail
portions 566. Alternatively, the markings 565 could be formed by
physical markings on the tubing 112. Similarly, the repeating
linear markings 559 may be physical markings placed directly on the
tubing 112, or, as with the device 572 described below, may be
formed on an elongate filament member 573 that extends through the
tail portion.
[0106] In one embodiment, each seed 108 may have substantially the
same radioactivity level as the other seeds within the device.
However, as with the other embodiments described herein,
brachytherapy may be modified by utilizing seeds that have
differing levels of radioactivity within the same brachytherapy
device. Stated another way, a first radioactive source (e.g., first
seed) of the device may have a first radioactivity level (e.g., 5
millicuries (mCi)), while a second radioactive source (e.g., second
seed) of the same device may have a second radioactivity level
(e.g., 1 mCi) that is less than the first radioactivity level.
Likewise, each seed within a given device could have the same
radioactivity level, but different devices could contain seeds of
different radioactive levels.
[0107] FIG. 5E illustrates a therapy delivery device 572 in
accordance with another embodiment. The device 572 is similar in
most respects to the device 562, e.g., it includes tail portions
576 and a therapy delivery portion 574 having seeds 108 and
optional spacer 110 surrounded by tubing 112. However, the tail
portions 576 may further include the elongate filaments 573. The
filaments 573 may extend from the therapy delivery portion 574
outwardly beyond the tubing 112. The filaments 573 may be used, for
example, when a less compliant tail portion is desired, or when the
tail portions 566 may be subject to pulling forces beyond the
capability of the tubing 112.
[0108] FIGS. 5F and 5G illustrate a therapy delivery device 582 in
accordance with yet another embodiment. As with the other
embodiments described herein, the therapy delivery device 582 may
include a therapy delivery portion 584 and tail portions 586. The
therapy delivery portion 584 may include radioactive seeds 108
separated by optional spacers 110 as already described herein.
[0109] However, unlike some of the other embodiments described
above, the device 582 may further include, in place of the single
segment of tubing 112, a first or inner layer 588 of material that
surrounds most or all of the therapy delivery portion 584, and a
second or outer layer 590 of material. The inner layer 588 may be
configured as a meltable tubing segment that may be melted once in
place. Exemplary materials for the inner layer 588 may include
polyolefin, polyvinyl chloride, and nylon. The inner layer 588 may
be melted either before or after the outer layer 590 (which could
be the heat-shrinkable tubing 112 as already described herein) is
placed over the therapy delivery portion 584. Exemplary materials
for the outer layer 590 may include heat-shrinkable fluorinated
ethylene propylene (FEP), polyethylene terephthalate (PET),
Polytetrafluoroethylene (PTFE), and other non-bioabsorbable
materials. In some embodiments, the outer layer 590 may be removed
after the inner layer 588 is melted. FIG. 5G illustrates a section
view taken along line 5G-5G of FIG. 5F. The tail portions 586 of
the device 582 may include a filament 583 as illustrated in FIG. 5F
and described above with respect to the device 572. In other
embodiments, the outer layer 590 may extend outwardly to form the
tail portions 586. In the case of the latter, the filaments 583 may
be optional.
[0110] FIGS. 5H-5G illustrate a brachytherapy device 592 in
accordance with yet another embodiment. As with other embodiments
described herein, the therapy delivery device 592 may include a
therapy delivery portion 594 and tail portions 596, wherein the
latter are defined by filaments 597, as shown in FIG. 5I. The
therapy delivery portion 594 may include the radioactive seeds 108
separated by optional spacers 110 as already described herein and
illustrated in FIG. 5I.
[0111] Like the device 582 of FIGS. 5F and 5G, the device 592 may
also include an inner layer 598 of material that surrounds most or
all of the therapy delivery portion 594 (see FIGS. 5I and 5J), and
an outer layer 599 that covers the inner layer (see FIG. 5H).
[0112] The inner layer 598 may be meltable to encapsulate the seeds
108, spacers 110, and ends of the filaments 597. In some
embodiments, the inner layer 598 may include thermoformed ends to
better capture the filament ends as shown in FIG. 5J. As with the
device 582, the inner layer 598 may be polyolefin, nylon or a
similar thermoplastic material. The outer layer 599, on the other
hand, may be FEP, PET or PTFE shrinkable tubing. The thickness of
the outer layer should be sufficient to provide adequate tensile
strength, and sufficient bending stiffness to minimize the amount
of bending within the tissue or cavity as the patient moves about
during the implantation period. The outer layer 599 may provide a
smooth outer surface that is advantageous during
implantation/removal. It may also assist in securing the filaments
597 to the therapy delivery portion 594.
[0113] The filaments 597 may be made from most any flexible
thermoplastic material including, for example polyolefin or nylon.
In the illustrated embodiment, the filaments 597 may include
spaced-apart anchoring ribs 595 that form knot-like protrusions
along the filaments (areas of enlarged cross section relative to
the remainder of the tail portion). The ribs 595 may be used in
conjunctions with an anchoring tab as further described below.
[0114] In addition to the noted attributes, the dual encapsulation
layer configurations described above (see e.g., FIGS. 5F-5J) may
offer additional benefits. For example, each of the two materials
(e.g., inner layer 598 and outer layer 599 in the device 592) may
be selected to provide different degrees of flexibility/rigidity,
as well as to maximize torsional (kinking) resistance of the
device. An additional layer of heat-shrinkable tubing over a
portion of the therapy delivery portion may also be provided to
further modify flexibility.
[0115] FIGS. 6A-6D illustrate a brachytherapy device 702 in
accordance with yet another embodiment. The device 702 may, like
the other embodiments described herein, include a therapy delivery
portion 704 containing seeds 108, and tail portions 706 (see FIG.
6A). As shown exploded in FIG. 6B, the therapy delivery portion 704
may further include: a support member (e.g., tray 708) that
supports the seeds 108; and tubing 710 that encases the seeds and
the tray and, in some embodiments, portions of the tail portion.
The tubing 710 may be heat-shrinkable tubing as already discussed
herein (e.g., similar to the tubing 112). The tray 708 may be made
of most any material including metal sheet (e.g., stainless steel,
titanium) and plastic (polyester, PET). The tail portions 706 may
again be formed by filaments 712 that attach to the therapy
delivery portion, e.g., to the tray 708, as further described
below. As with the filaments 597 described above, the filaments 712
may include anchoring ribs 718 that are best shown in FIG. 6C.
[0116] FIG. 6C is an enlarged view of the device 702 with the
tubing 710 removed for clarity. In this view, the tray 708 is
illustrated as having portions such as ears or tabs 714 capable of
mechanically engaging and securing the seeds 108 in place (e.g., by
crimping). In such a configuration, seed spacers (such as the
spacers 110 illustrated in previous embodiments) may be
unnecessary. The tray 708 may include other portions such as end
tabs 716. The end tabs 716 may be used to mechanically engage and
secure the tail portions, e.g., the filaments 712, to the tray 708.
In one embodiment, the tray 708 may be photo-chemically etched and
formed to yield the tabs 714 and 716.
[0117] The tray 708 may incorporate and retain most or all of the
"loose" components of the device 702. The tray may further augment
the overall structural integrity of the device 702, which may ease
physician manipulation, especially during implantation,
positioning, and removal from the body.
[0118] The device 702 may be implanted in accordance with methods
already described herein (e.g., with a needle 114' as described
with respect to FIGS. 2G-2L). Accordingly, one or both distal ends
of the tail portions 706, e.g., filaments 712, may be shaped as
plugs 719 (see FIG. 6A). The plugs 719 may have a diameter equal to
or greater than the other portions of the device 702. As a result,
the plugs 719 may act as a barrier to the entry of tissue into the
delivery needle, e.g., needle 114', during implantation.
[0119] FIG. 6D is an enlarged view of a portion of the device 702.
For clarity, the tubing 710 is illustrated in this view as
transparent. However, translucent or opaque tubing may also be
used. As clearly illustrated in this view, the filament 712 may
include a proximal end section 720 defining a groove 722 therein.
The groove 722 may be sized to fit within the end tabs 716 as
shown. In some embodiments, the end tabs 716 may be crimped to trap
the proximal end section 720 in place, e.g., at the groove 722. In
other embodiments, clearances between the proximal end section 720,
e.g., the groove 722, and the end tabs 716 may be selected to
ensure adequate fixation of the filament 712 (at least until the
tubing 710 is in place) without a crimping operation.
[0120] The length of the proximal end portion 720 of each filament
712 may be selected to position the adjacent seed 108 in the
desired location. As a result, the proximal end portion 720 may
also function as a marker, e.g., visual marker, indicating the
beginning/end of the therapy delivery portion 704 of the device
702.
[0121] The tubing 710 may encapsulate both the tray 708 and the
ends of the filaments 712 to provide a smooth transition
therebetween. The tubing 710 may further assist in retaining the
filaments relative to the tray 708. The tubing 710, as well as the
filaments 712, may also include additional markings, e.g.,
centimeter markings, to indicate position. In addition, the tubing
710 (rather than the proximal end section 720 of the filaments)
could incorporate markers to indicate the outermost edge of the
radioactive seeds 108.
[0122] FIGS. 6E-6H illustrate an brachytherapy apparatus 730 in
accordance with yet another embodiment. As shown in FIG. 6E, the
apparatus 730 may include a therapy delivery device 732 having both
a therapy delivery portion 734, and a tail portion 736 that extends
outside the body after implantation. The therapy delivery portion
734 may be surrounded by a sleeve, e.g., tubing 740, to secure the
various components of the therapy delivery portion relative to one
another. As further described below, the apparatus 730 may also
include a needle (e.g., trocar) 750 and a removal tool 760, both of
which may be passed through the therapy delivery device 732. By
utilizing a hollow device 732 with an internal needle 750, the
apparatus 730 may allow a reduction in puncture/insertion diameter
relative to those embodiments that utilize a hollow, external
needle.
[0123] FIG. 6F is an exploded view of the therapy delivery device
732 of the apparatus 730. As illustrated in this view, the device
732 may include hollow seeds 108' separated by hollow spacers 110'.
Unlike the seeds and spacers described previously, the seeds 108'
and spacers 110' have tubular bodies and thus form a hole or
opening extending between their respective first and second ends
(e.g., each seed and spacer has a ring-shaped cross-section). When
the seeds 108' and spacers 110' are aligned, the openings form a
lumen 738 (see FIG. 6E) extending entirely through the device 732.
The lumen 738 may be sized to receive the needle 750 and the
removal tool 760 as further described below.
[0124] While the seeds 108' may be of most any material and shape
that provide the desired lumen, they may, in one embodiment, be a
continuous filament such as that provided by the GENETRA brand
linear Pd-103 radiation source sold by Radiomed Inc., of Tyngsboro,
Mass., USA, or a conventional seed such as the model
INTERSOURCE-125 hollow seed produced by IBT, Inc. North America of
Norcross, Ga., USA.
[0125] Unlike most of the tail portions described herein, the tail
portion 736 may be formed from a generally rigid hub 737 (e.g.,
made from polycarbonate, nylon, or other plastic material) that is
rigidly attached to the therapy delivery portion 734. The hub 737
may include a tubular protrusion 735 as shown in FIG. 6F that is
captured by the casing, e.g., tubing 740. The protrusion 735 may be
formed of a different material (e.g., stainless steel) that is
co-molded with the hub material. Alternatively, the protrusion 735
could be formed from the same material as the remainder of the hub.
The protrusion 735 may include one or more barbs 733 that assist in
securing the hub 737 to the remainder of the device 732 via the
tubing 740. That is, the barb(s) 733 may provide increased
resistance to separation of the tubing 740 from the hub 737.
[0126] The tubing 740 may be similar in most respects to the tubing
already described herein (see, e.g., tubing 112). However, the
device 732 may further benefit from a shaped distal end 742 of the
tubing 740 such that a smooth transition in diameter exists from
the needle 750 to the therapy delivery portion 734 as perhaps best
illustrated in FIG. 6G. To achieve such shaping, the distal tip 742
of the tubing 740 may be thermoformed.
[0127] As further illustrated in FIG. 6G, the needle 750 and the
removal tool 760 may have an outer diameter that fits within the
lumen 738 formed by the seeds 110' and spacers 108'. A distal tip
of the needle 750 may include a sharp tip, e.g., tri-face knife
edge 753, to pierce the body, e.g., breast tissue, during
implantation.
[0128] In use, the seeds 108', spacers 110', and hub 737 may be
assembled and the tubing 740 heat-shrunk in place. This process may
be completed with the needle 750, or some other mandrel, in place
to hold all components in the proper orientation/position. With the
needle 750 positioned within the lumen 738, a hub lock 752 at a
proximal end 751 of the needle (see FIG. 6E) may be engaged (e.g.,
threadably engaged) with the hub 737. The device 732/needle 750 may
then be inserted into the body and positioned via acceptable
methods. Once in place, the hub lock 752 may be unthreaded from the
hub 737 and the needle 750 withdrawn from the device 732, leaving
the device implanted. During implantation, the tail portion, e.g.,
hub 737, is located outside the body.
[0129] To remove the device 732, the removal tool 760 may be
inserted into the lumen 738, which remains open during
implantation, via the exposed hub 737. Like the needle 750, the
removal tool 760 may include a hub lock 762 that threadably engages
the hub 737 of the device 732 as indicated in FIG. 6H. Once
engaged, the combined device 732/removal tool 760 may be withdrawn
from the body. The removal tool 760, like the needle 750, may
provide improved rigidity to the device while the latter is being
manipulated, e.g., removed.
[0130] While illustrated herein as utilizing a removal tool, other
embodiments may permit removal without the tool 760, e.g., by
application of a force directly to the hub 737.
[0131] FIGS. 6I and 6J illustrate a therapy delivery device 772 in
accordance with yet another embodiment. The device 772 is similar
to the therapy delivery devices already described herein in that it
may include seeds 108 and optional spacers 110 that form a therapy
delivery portion 774. Like other devices described herein, the
device 772 may also encase at least the therapy delivery portion
774 in tubing 112 (already described herein). Tail portions 776a
and 776b may also be provided and extend outwardly from each end of
the therapy delivery portion 774.
[0132] As illustrated in FIG. 6J, however, at least the distal tail
portion 776a may further include a filament 777. The filament 777
may extend from the therapy delivery portion 774 outwardly to or
near a sharp distal tip 778. The filament 777 may include an
enlarged end 779, e.g., the same diameter as the seed 108, to
permit adequate restraint of the filament with the shrink tubing
112.
[0133] The device 772 may fit within a hollow needle 780 that may
be relative rigid. The distal tip 778 may, in one embodiment, be
configured as a nosecone that fits, e.g., with interference, into
the distal end of the needle 780 as illustrated in FIG. 6J.
[0134] During use, the needle 780, with the device 772 contained
therein and the distal tip 778 attached, may penetrate the body.
The distal tip 778 may include sharp symmetrical edges (e.g., a
pyramidal trocar tip) to penetrate tissue without excessive
wandering. The needle 780 may be passed completely through the
body, e.g., through the breast 200, in a manner similar to that
described with respect to the needle 114' described above. Once the
distal tip 778 exits the distal side of the breast, the distal tip
may be removed from the needle 780. From the proximal end of the
needle 780, the distal tail portion 776a of the device 772 may be
advanced out of the distal end of the needle in a manner similar to
that illustrated in FIG. 2I. The physician may then grasp the
distal tail portion 776a and, while holding the tail portion 776a,
withdraw the needle 780 from the proximal incision point (see FIG.
2J). The device 772 may then be adjusted and secured as already
described herein (see, e.g., FIGS. 2K and 2L).
[0135] With any of the methods described herein, the time that the
brachytherapy devices remain implanted may vary according to the
desired therapy regimen. While not wishing to be bound to any fixed
period, implantations from about one hour up to about eight weeks
or more are contemplated for therapy. However, for breast
brachytherapy, implantation periods ranging from about one day to
several weeks, e.g., four to ten days, are more likely. Moreover,
because of the construction of the devices, e.g., devices 102, they
may be removed over a range of timeframes subsequent to
implantation. This is in contrast to the permanent placement
typically associated with conventional LDR brachytherapy and the
short exposure time associated with conventional HDR brachytherapy.
As a result, intermediate activity radiation sources may be
utilized with the methods and apparatus described herein, as well
as conventional low and, as further described below, high activity
sources.
[0136] FIG. 7A illustrates a brachytherapy kit or apparatus 600 in
accordance with another embodiment. Unlike the apparatus 100 of
FIG. 1A, the apparatus 600 may include, among other components, at
least a removably implantable brachytherapy treatment device
(brachytherapy device 602), a pusher or pusher member 620, a
catheter, e.g., cannula or cannula member 630, and a sharp
obturator 640.
[0137] The therapy device 602, once again, may include a therapy
delivery portion 604 and a removal or tail portion 606. The therapy
delivery portion 604 may include one or more seeds 108 and optional
spacers 110. The seeds 108 may be enclosed within a casing, e.g.,
heat-shrinkable tube or tube member 612, similar in most respects
to the tube 112 described above.
[0138] The tail portion 606 in this embodiment, however, is formed
by an elongate filament or wire, e.g., a non-dissolving surgical
suture 614, coupled or otherwise attached to the therapy delivery
portion 604. While most any method of attaching the suture 614 to
the therapy delivery portion 604 is possible, one embodiment forms
a knot 616 in the suture. The knot 616 may be captured when the
tube 612 is heat-shrunk to the therapy delivery portion 604. In
other embodiments, the suture 614 may be knotted around or
otherwise attached directly to the therapy delivery portion 604.
Such suture attachment methods are exemplary only, however, as most
any other method of attaching the suture 614 to the therapy
delivery portion 604 is possible. The suture 614, as with the tail
portion 106 described above, may be made from a non-dissolving
material, e.g., polypropylene, polyester, polyamide.
[0139] The pusher member 620 may include a lumen through which the
therapy device 602 may pass as indicated in FIGS. 6 and 7. The
pusher member may include a suture locking device 622, e.g., a luer
hub, at a proximal end to assist with loading and securing of the
therapy device 602. The locking device 622 may secure the suture
614 relative to the pusher 620 as further described below. While
illustrated as a luer hub, the locking device 622 may include most
any friction or clamping device known in the art. For example, the
locking device may be an O-ring that may be selectively compressed
to pinch the suture 614.
[0140] The cannula member 630 may also include a lumen through
which the pusher member 620 may pass as indicated in FIG. 7A. The
cannula member 630 may include a luer hub 632 at its proximal end
that is operable to secure the cannula member relative to the
either the sharp obturator 640 or the pusher member 620 when either
is slid into the lumen of the cannula member as further described
below.
[0141] The sharp obturator 640 may include a handle portion with a
hub 642 at a proximal end, and a sharp point 644 operable to pierce
body tissue at its distal end. The handle portion may permit
comfortable manipulation of the obturator 640. The external
diameter of the obturator 640 may be sized so that it fits within
the lumen of the cannula member 630 as indicated in FIG. 7A.
[0142] The components of the apparatus 600 may be made from most
any suitable biocompatible material. For example, the cannula
member 630, the pusher member 620, and the sharp obturator 640 may
be made from metal, e.g., stainless steel or Titanium, or
plastic.
[0143] FIG. 7B illustrates the apparatus 600 as it may be assembled
prior to use. The sharp obturator 640 may be placed into the
cannula 630 such that the sharp distal end 644 of the obturator
protrudes from the distal end of the cannula 630 as illustrated.
The therapy device 602, which includes the therapy delivery portion
604 and the suture 614 as described above, may be positioned within
the pusher member 620 such that the therapy delivery portion 604
extends from its distal end and the suture 614 extends from the hub
622 at its proximal end. The suture 614 may be pulled from the
proximal end of the pusher member 620 until the therapy delivery
portion 604 is at or near the distal end of the pusher member 620
as shown. The locking device 622 may then be engaged to hold the
suture 614, and thus the therapy delivery portion 604, in place
relative to the pusher member 620.
[0144] FIGS. 8A-8E illustrate an exemplary method of using the
system 600 for delivery of brachytherapy to a portion of a body,
e.g., breast 200. Once the target tissue region 202, e.g., tumor or
tumor cavity, is identified, the combined cannula 630 and sharp
obturator 640 (see FIG. 7B) may be advanced into the target tissue
region 202 as illustrated by arrow 802 in FIG. 8A. When the distal
end of the cannula 630 reaches the desired depth, the sharp
obturator 640 may be removed (moved in the direction 804) through
the proximal end of the cannula as shown in FIG. 8B, while leaving
the cannula 630 in place.
[0145] The combined pusher member 620 and therapy device 602 (see
FIG. 7B) may then be inserted into the proximal end of the cannula
630, in the direction 806, as shown in FIG. 8C. The pusher 620, and
therapy device 602, may be inserted until the therapy portion 604
is at its desired location, e.g., at or near the distal end of the
cannula 630. Location of the therapy portion 604 may be assisted by
image guidance, e.g., stereotactic X-ray, ultrasound, CT, etc.
[0146] Once the therapy portion 604 is positioned, the cannula 630
may be retracted (moved in the direction 808), exposing the therapy
portion 604 to the target tissue region 202 as shown in FIG. 8D.
The locking device 622 may then be unlocked such that the pusher
member 620 and cannula 630 may be fully withdrawn (moved in the
direction 810) from the body 200 as shown in FIG. 8E. The therapy
delivery portion 604 remains implanted at the target tissue region
202 while the suture 614 extends outside the body.
[0147] These steps may be repeated for placement of each
brachytherapy device 602, or multiple devices may be implanted as a
group as further described below.
[0148] Although not illustrated, a locking member, such as the
locking member 120 illustrated in FIGS. 2E and 27, may be used to
secure the therapy device 602, e.g., the tail portion(s) 606, at
one or both (see FIG. 2F) ends. Alternatively, the therapy device
602 may include securing elements such as the anchors 516 shown in
FIG. 5. Still further, the therapy device 602 may be secured simply
by folding and adhering the tail portions 606 to the breast 200
(see FIGS. 2E and 26).
[0149] After the desired dose of radiation has been delivered, the
therapy delivery device 102 may be removed in any number of ways as
already described herein, e.g., using a removal member, such as the
tail portion 606, or a removal cannula.
[0150] FIG. 9A is an enlarged view of the therapy device 602 of
FIGS. 6-7. As clearly illustrated in this view, the therapy device
602 may include the therapy delivery portion 604 and the tail
portion 606. The therapy delivery portion 604 may include one or
more radioactive seeds 108 securely retained within the casing,
e.g., heat-shrinkable tube 612. The tail portion 606 may be formed
by the suture 614. The knot 616 of the suture 614 may be secured to
the therapy delivery portion 604 by the heat shrinkable tube 612.
While shown as utilizing spacers 110, they may not be required in
some embodiments, e.g., the conformal properties of the casing,
e.g., tube 612, may be sufficient to ensure proper seed 108 spacing
and containment. FIG. 9B illustrates a section view of the seed 108
and tube 612 taken along line 9B-9B of FIG. 9A.
[0151] FIGS. 10A-10B illustrate a therapy device 1002 in accordance
with another embodiment. The device 1002 is similar in many
respects to the device 602 described above. For example, the device
1002 may include a therapy delivery portion 1004 and a tail portion
1006. A casing, e.g., heat shrinkable tube 1012, may be used to
encase the seeds 108 and optional spacers 110. Like the device 602,
the tail portion 1006 may be formed by a suture 614 having a knot
616 that may be heat shrinkable to the therapy delivery portion
1004. However, unlike the device 602 of FIGS. 9A-9B, the tube 1012
may include a radioabsorptive portion 1014 positioned along a part
of the circumference of at least the therapy delivery portion 1004
(see FIG. 10B). The radioabsorptive portion 1014, which may be
formed integrally or separately with the tube 1012, may limit
radiation exposure to tissue blocked by the radioabsorptive
portion. FIG. 10B illustrates a section view of the seed 108 and
tube 1012 taken along line 10B-10B of FIG. 10A.
[0152] FIGS. 11A-11B illustrate a therapy device 1102 in accordance
with yet another embodiment. The device 1102 is similar in many
respects to the device 602 described above. For example, the device
1102 may include a therapy delivery portion 1104 and a tail portion
1106. A casing, e.g., heat shrinkable tube 1112, may be used to
encase and constrain the seeds 108 and optional spacers 110. Like
the embodiment illustrated in FIGS. 5A and 5B, the therapy device
1102 may incorporate an anchor member, e.g., anchor wire 1114,
which extends along at least a part of the therapy delivery portion
1104 and protrudes from one or both ends. The anchor wire 1114 may
be bent at one or both ends to form anchors 1116. When the therapy
delivery portion 1104 exits the cannula 630 (see FIG. 8D), the
anchors 1116 may extend and capture surrounding tissue, thereby
assisting in preventing migration of the therapy device 1102. FIG.
11B illustrates a section view of the seed 108 and tube 1112 taken
along line 11B-11B of FIG. 11A.
[0153] It is to be understood that any of the various components of
the embodiments described herein may be used interchangeably with
any other of the described methods and systems. For example, any
one of the devices 102, 402, 502, 562, 572, 602, 582, 1002, and
1102 could be used with other methods described herein such as
those described in FIGS. 2A-2E, 2F, 2G-2L, and 8A-8E.
[0154] The embodiments described above utilize a therapy delivery
portion (e.g., portion 104 of FIG. 1A or portion 604 of FIG. 7A)
formed primarily by the shrink fit tube (e.g., tube 612 of FIG. 9A)
and seeds 108. However, other embodiments of the therapy delivery
portion may include an additional support member. The support
member may be any material that lends support to the therapy
delivery portion, e.g., a strip of material such as stainless steel
or superelastic nickel titanium alloy. In addition to partially
supporting the seeds 108, the material of the support member may
divide the therapy delivery portion into a radiotransparent portion
and a radioabsorptive portion. That is, it may partially surround
at least a portion of the seeds 108 to provide some degree of
attenuation or shielding of radiation to surrounding tissue. As a
result, tissue on a side of the support member opposite the seeds
108 may receive a lower dose of radiation than tissue on the seed
side. The support member may be enclosed within the casing, e.g.,
heat-shrinkable tube 112 or 612.
[0155] For example, FIGS. 12A and 12B illustrate a therapy device
1202 having a tail portion 1206 and a therapy delivery portion 1204
with a plurality of seeds 108 and a straight support member 1210
(see FIG. 12A). The support member 1210 may have a curved, e.g.,
arc-shaped, cross-section (see FIG. 12B). Alternatively, a
relatively flat cross-section (not shown) may be provided. Other
embodiments may utilize most any other cross-sectional shape, e.g.,
v-shaped. The support member 1210 may also have a variety of
leading edge shapes including the shovel-tip shape illustrated in
FIG. 12A. Some or all of the support member 1210 may be encased
within a casing, e.g., heat shrinkable tube 1212, as already
described above.
[0156] While the support member 1210 of FIG. 12A is generally
straight, other support members may be provided, which may be
curved, e.g., may have some degree of curvature. For example, FIG.
13A illustrates a therapy device 1302 having a therapy delivery
portion 1304 with a curved support member 1310 that imparts an arc-
or otherwise curved-shape to the delivery portion 1304. The support
member 1310 may be formed to have curvature in its relaxed state or
may simply be sufficiently flexible to permit curved implantation.
As with the support member 1210 of FIGS. 12A-12B, the support
member 1310 may have most any cross-sectional shape, e.g., flat,
curved (as shown in FIG. 13B), V-shaped, etc. Some or all of the
support member 1310 may be encased within a casing, e.g., heat
shrinkable tube 1312, generally identical to the casings already
described above. FIG. 13B illustrates a section view taken along
line 13B-13B of FIG. 13A.
[0157] While not illustrated herein, optionally, the support
members may include one or more slots, e.g., along a centerline, so
that seeds may be placed at least partially within the slot. As a
result, a therapy delivery portion that offers more rigidity than
the unsupported therapy delivery portions described herein may be
obtained while ensuring tissue on both sides of the support member
receives radiation treatment.
[0158] FIGS. 14A-14B illustrate another exemplary embodiment of a
therapy delivery portion 1404. In this embodiment, the therapy
delivery portion includes a catheter or casing, e.g., tube 1412,
having one or more lumens. A first or main lumen 1408 may receive
the seeds (not shown), while a second lumen 1414 may contain an
attenuating or shielding element 1416 extending over a longitudinal
length of the tube 1412. As a result, the tube 1412 may have a
radiotransparent portion (that portion not blocked by the element
1416), and a radioabsorptive portion (that portion shielded by the
element 1416). In one embodiment, the tube 1412 can be made by
co-extruding plastic (e.g., fluoropolymer) with an attenuating
material such as strands of fine metallic wire (e.g., stainless
steel, gold). In another embodiment, the attenuating material may
be a coextrusion of polymer loaded with an attenuating material
such as Tungsten powder. The tube 1412 may or may not be
heat-shrinkable. For versatility, the shielding element 1416 may be
straight or preformed in a curve. FIG. 14B illustrates a section
view taken along line 14B-14B of FIG. 14A.
[0159] FIG. 15 is a partial view of an exemplary brachytherapy
apparatus 1500 having a therapy device 1502 and catheter, e.g.,
cannula 1501, wherein the device 1502 includes a curved therapy
delivery portion 1504, and a tail portion 1506. Other components of
the system, e.g., pusher member and sharp obturator, are not
illustrated in this view. The curved therapy delivery portion 1504
may be formed by a curved support member such as support member
1310 of FIG. 13A. The cannula 1501 may have a lumen diameter
sufficiently large to accommodate the curved therapy delivery
portion 1504 when the latter is constrained in a straightened
configuration for delivery. Alternatively, the cannula 1501 may be
sized to receive the therapy delivery portion 1504 when the latter
is in its curved configuration. In still yet other embodiments, the
therapy delivery portion 1504 may be generally straight but
flexible and the cannula 1501 used to deliver the therapy delivery
portion may be curved.
[0160] Non-linear (e.g., curved) catheters may also be used for
delivery and placement of the brachytherapy devices described
herein to regions and positions inaccessible to straight catheters.
For example, FIGS. 16A-16E illustrate an exemplary apparatus 1650
and method operable to implant a brachytherapy device, e.g., device
102 of FIG. 1A, along a non-linear axis. FIG. 16A illustrates the
apparatus 1650 including a first catheter member, e.g., needle
1652, a second catheter member, e.g., flexible catheter 1656, and a
brachytherapy device 102. The needle 1652 includes an off-axis
opening 1654 at or near a distal end of the needle. The needle 1652
may be inserted into the body 200, in the direction 1651, until the
distal end is positioned past the target tissue region 202 as shown
in FIG. 16A. The flexible catheter 1656 may then be inserted
through the needle 1652 (in the direction 1653) until a distal end
1667 of the catheter 1656 protrudes from the opening 1654 of the
needle 1652 at an angle 1661 as shown in FIG. 16B. That is, an axis
of the catheter 1656 may intersect, or be otherwise nonparallel to,
an axis of the needle 1652.
[0161] The angle 1661 between the axes may vary, but angles ranging
from greater than about zero to about ninety degrees
(0-90.degree.), or between about five to about thirty five degrees
(5-35.degree.), are contemplated.
[0162] The device 102 may then be threaded through the catheter
1656 (in the direction 1655), as shown in FIG. 16C, until the
therapy delivery portion of the device 102 is located at or near
the distal end 1667 of the catheter 1656.
[0163] At this point, the catheter 1656 may be withdrawn slightly
(in the direction 1669) as shown in FIG. 16D, exposing the therapy
delivery portion of the device 102. The needle 1652 and catheter
1656 may then be withdrawn (in the direction 1671) from the body
200 together as shown in FIG. 16E. The device 102 is then implanted
on a non-linear axis with its tail portion 106 extending outside
the body as generally described above with reference to other
embodiments (see e.g., FIGS. 2A-2E).
[0164] The ability to implant the device 102 along a non-linear
axis may be beneficial in many applications. For example, where the
target tissue region 202 is a breast lesion or a lumpectomy cavity
in the breast, the non-linear device 102 may provide the capability
to better focus radiation. Further, non-linear positioning may
permit implantation around obstructions in the body. For example,
in prostate brachytherapy, the region 202 could be a pubic arch
around which the clinician desires to place radiation sources.
While described above with respect to devices 102, the non-linear
placement of FIGS. 16A-16E could also be used to implant individual
radiation sources.
[0165] In yet other embodiments of non-linear placement apparatus
and techniques, the needle 1652 of FIGS. 16A-16E may be replaced
with a more spiral-shaped needle 1675 as shown in FIGS. 16F and
16G. While the actual needle size may vary depending on target
tissue volume, needles having a helix diameter of about 3
centimeters (cm) are contemplated. The needle 1675 may be advanced
into the body 200 in much the same way a corkscrew is inserted into
a cork. That is, the needle 1675 may be rotated in a direction 1678
such that a sharp end 1676 penetrates the body 200 as indicated in
FIG. 16F. FIG. 16G illustrates the needle 1675 once it is fully
inserted. A flexible catheter (not shown) and therapy device (also
not shown) may then be passed through the needle 1675 in much the
same way as the catheter 1656 and device 102 are described with
reference to FIGS. 16A-16E. The needle 1675 may then removed
("unscrewed"), leaving the therapy device in a spiral configuration
around the target tissue region 202 (not illustrated).
[0166] When non-linear, e.g., off-axis, curved, and spiral, therapy
delivery portions are used, the total number of therapy devices
required to treat a given target tissue region may potentially be
reduced as a result of the delivery portions' conformance to the
shape of the target tissue. For example, in the case of curved
delivery portions, several devices may be placed to curve around
the target tissue region, effectively focusing radiation on a
central area. This may result in lower dose exposure outside of the
target tissue area, and potentially improved dose coverage within
the target tissue. In the case of a spiral therapy delivery
portion, a single therapy device of sufficient length may deliver
adequate treatment by spiraling (e.g., forming a helix) around or
within the target tissue region.
[0167] FIGS. 17A-17B illustrate an apparatus 1600 similar in most
respects to apparatus 600 of FIG. 7A. For instance, it may include
a therapy device 1602 having a therapy delivery portion 1604 with
seeds 108, and tail portion formed by a suture 1614. The suture
1614 may pass through a pusher member 1620 and the combined pusher
member 1620 and delivery device 1602 may be placed within a cannula
1630. Unlike the cannula 630, however, the cannula 1630 may have a
cutout 1634, e.g., the cannula may have a C-shaped cross section,
as shown more clearly in FIG. 17B, over at least a portion of its
length. While shown as straight, the cannula 1630 may also be
curved. The cutout configuration may protect certain surrounding
tissues/organs, e.g., skin, chest wall, liver, heart, during
implantation. FIG. 17B is a cross-section taken along line 17B-17B
of FIG. 17A with the therapy delivery device 1602 also shown in
broken lines.
[0168] During implantation of any of the devices described herein,
the patient may optionally wear a protective garment, e.g., a chest
covering brassiere or binder 1900, such as that illustrated in FIG.
18. The brassiere/binder 1900 may be similar in many respects to
those garments described, for example, in U.S. Pat. No. 3,968,803
to Hyman; U.S. Pat. No. 5,152,741 to Farnio; and U.S. Pat. No.
5,538,502 to Johnstone. That is, it may include a partial body
covering that secures via fasteners, e.g., shoulder straps 1904, to
cover a portion of the chest (or other area surrounding the target
tissue region). However, in addition to a fabric portion 1906, the
binder 1900 may include a lining made from a radiation attenuating
material 1902, e.g., lead, stainless steel, Tungsten. Such a
garment may offer an added degree of shielding and permit greater
patient mobility, while the indwelling radioactive sources, e.g.,
seeds 108, are held in their proper position, in an out-patient
setting. The garment 1900 may be provided separately, or as part of
a brachytherapy kit, e.g., kit 100.
[0169] Although discussed above primarily with respect to LDR
brachytherapy, the apparatus and/or methods described herein may
also find use in HDR applications. For example, the tube 1412 of
FIGS. 14A-14B may be used as a shielded delivery catheter for HDR
treatment, e.g., the tube 1412 may be located in the body and a
conventional HDR source (e.g., afterload HDR cable) of smaller
diameter may be passed through the main lumen 1408. The attenuating
element 1416 in the wall of the catheter (along a circumferential
portion extending from about 10 o'clock to about 2 o'clock, for
example) may attenuate the radiation exposure of regions vulnerable
to radiation while the non-shielded section of the tube 1412 (along
a circumferential portion extending from about 2 o'clock to about
10 o'clock) would allow exposure to the target tissue.
[0170] Further, for example, HDR radiation sources may be passed
through a catheter, e.g., the cannula 1630 of FIGS. 17A and 17B,
whereby the HDR radiation sources may be partially shielded from
surrounding tissue by the geometry of the cannula 1630, e.g., the
cutout 1634.
[0171] FIGS. 19A-19C illustrate incorporation of a HDR shielded
catheter on a balloon-type brachytherapy treatment device 1800. The
device 1800 may be similar to the device disclosed in U.S. Pat. No.
5,913,813 to Williams et al. That is, it may include a
brachytherapy catheter assembly 1802 having a catheter shaft 1814
with a proximal end and a distal end. An inflatable balloon 1806
may be coupled to the catheter shaft 1814 between the proximal end
and the distal end. An inflation lumen 1830 may extend along the
catheter shaft 1814 between the inflatable balloon 1806 and the
proximal end to allow inflation of the balloon. A dose delivery
lumen 1804 (see FIG. 19B) may also be provided and extend along the
catheter shaft 1814 from the proximal end towards and the distal
end, e.g., extending between the inflatable balloon 1806 and the
proximal end.
[0172] In use, the distal end of the catheter shaft 1814 may be
placed into a cavity, e.g., a lumpectomy cavity 1808 of breast 200,
and the balloon 1806 inflated. A radiation source (not shown) may
then be passed through the dose delivery lumen 1804, where it
delivers radiation along a dose delivery portion of the catheter
shaft, e.g., along a portion surrounded by the inflatable balloon
1806. By incorporating a radioabsorptive portion (e.g., arc-shaped
member 1811 clearly illustrated in FIG. 19C) over the dose delivery
portion of the catheter shaft 1814, only a predetermined portion,
e.g., a window 1817, of the dose delivery portion may be relatively
radiotransparent. As a result, the device 1800 may attenuate the
radiation exposure of select areas, e.g., those close to the skin
or chest wall, while delivering higher radiation levels to target
tissue not blocked by the radioabsorptive portion 1811. While the
radioabsorptive portion is illustrated herein as a separate member
1811 extending along a portion of the catheter shaft 1814, other
embodiments may incorporate the radioabsorptive portion into the
catheter shaft 1814 itself (see. e.g., the catheters described
elsewhere herein such as the tube 1412 of FIGS. 14A-14B).
[0173] In some embodiments, the device 1800 may further include a
vent system having one or more vents 1810 positioned around at
least a portion of an outer surface of the balloon 1806. The vents
1810 may permit air and fluids within the cavity 1808 to escape as
the balloon 1806 expands. One or more vent lumens 1812 (shown in
FIG. 19B) associated with the catheter shaft 1814 may extend
between the proximal end of the catheter shaft 1814 and the one or
more vents 1810. The vents 1810 may fluidly communicate with one or
more vent lumens 1812, thereby allowing the air and fluids to exit
the body at the proximal end of the catheter shaft 1814 during and
after balloon expansion.
[0174] In some embodiments, the external vents 1810 and vent lumens
1812 are formed by individual pieces of tubing 1816 attached to the
balloon 1806 and catheter shaft 1814. In the vicinity of the
balloon 1806, the tubing 1816 may be perforated to form the
external vents 1810. The portion of the tubing 1816 located
proximate the catheter shaft 1814 may or may not include
perforations. The tubing 1816 may be formed of most any
biocompatible material that can be securely attached to, or formed
with, the balloon 1806 and catheter shaft 1814, e.g., silicone
tubing.
[0175] FIGS. 20-22 illustrate an exemplary system 1700 for
implanting the LDR brachytherapy devices and their associated
radiation sources described above to a target tissue region, e.g.,
the region surrounding a breast lumpectomy cavity. In the
illustrated embodiment, the system includes a catheter or needle
guiding template 1702 having a predetermined number and pattern
(array) of openings 1704 as shown in FIG. 20. The template 1702 may
form part of an adjustable catheter or needle guiding apparatus by
coupling to a stereotactic table 1720, which is diagrammatically
illustrated in the figures by base portion 1722, and translating
portion 1724 (portions 1722 and 1724 shown exploded in FIG. 20).
The stereotactic table 1720 may be coupled or attached to a patient
locating or treatment surface 1730, e.g., patient table.
[0176] The template 1702 may be coupled to, or otherwise associated
with, a first compression member 1726 located adjacent an opening
1732 in the treatment surface 1730. An opposing second compression
member 1728 may be located on an opposite side of the opening 1732.
The compression members 1726 and 1728 may be oriented about 90
degrees from a set of optional compression plates 1727 (only one
plate 1727 shown).
[0177] One or both compression members 1726, 1728 may include a
hole pattern similar to that of the template 1702, or may otherwise
at least permit the passage of the needles/cannulae (e.g., needles
114 of FIG. 1A) as illustrated in FIG. 21.
[0178] In use, a patient may lie on the treatment surface 1730,
e.g., with the patient's head located in the direction 1731, such
that the breast 200 passes through the opening 1732 of the
treatment surface 1730. The optional compression plates 1727 may
then be used to immobilize the breast 200.
[0179] Once the breast 200 is immobilized, the stereotactic table
1720, with the template 1702 attached, may be positioned, and the
translating portion 1724 moved, until the compression members 1726
and 1728 contact the breast 200. The position of the stereotactic
table 1720, and thus the needle guiding template 1702, may be
aligned with the location of the target tissue region 202 via the
use of various imaging techniques including, for example, X-ray,
ultrasound and CT scan. In some embodiments, the template 1702 may
be aligned relative to the target tissue region based upon input
provided by an imaging device, e.g., a side viewing ultrasound
apparatus 1739, located underneath the breast 200.
[0180] With the template 1702 aligned with the target tissue region
202 and positioned against the breast 200, one or more needles 114
may be inserted into the openings 1704. In the treatment of breast
lesions, the needles 114 may be inserted completely through the
breast 200 as illustrated in FIG. 21. Alternatively, and in the
treatment of other cancers, the length of each needle 114 may be
varied to ensure the correct depth penetration at each opening
1704, or the insertion depth of each needle 114 may simply be
varied.
[0181] Certain embodiments of the system 1700 may optionally
include an adhesive bandage member 1750 associated with the first
compression member 1726, and/or an adhesive bandage member 1752
associated with the second compression member 1728. As shown, the
bandage members 1750 and 1752 are located between the respective
compression members and the breast 200. The bandage members 1750
and 1752 may have adhesive on each side, e.g., a first side 1754
and a second side 1756, and include openings (not shown) that
correspond generally to the openings 1704 of the template 1702.
Alternatively, the bandage members 1750 and 1752 may be punctured
by the needles 114 during needle insertion. When the compression
members 1726 and 1728 are pressed against the breast 200, the
bandage members 1750 and 1752 may adhere to the breast 200 and
provide a dressing for the punctures created by the needles
114.
[0182] Once the needles 114 are inserted, the brachytherapy devices
described herein, e.g., devices 102 or 602, may be inserted, and
the needles 114 removed, in accordance with various methods as
described and illustrated herein. For example, the brachytherapy
devices 102 (or devices 602) may be inserted and the needles 114
(or the cannulae 630) removed in accordance with the methods
described herein and illustrated in FIGS. 2A-2E and 2F (or
8A-8E).
[0183] With the needles 114 removed, the template 1702 and contact
plates 1726 and 1728 may be withdrawn from the breast 200, leaving
the bandage members 1750 and 1752 adhered to the breast by their
respective first adhesive sides 1754. The tail portions 106 may
then be anchored, e.g., by using locking members such as members
120 illustrated in FIGS. 2E and 27.
[0184] A liner (not shown) may then be removed from the respective
second adhesive side 1756 of each bandage member 1750 and 1752.
Once the second adhesive side 1756 is exposed, the flexible tail
portions 106 may be folded against the second adhesive side, where
they adhere thereto. A second, single-sided adhesive member (not
shown) may be placed over each bandage member 1750 and 1752 to
secure the tail portions and cover any exposed adhesive on the
second adhesive side 1756. As a result, the flexible tail portions
may be folded against the contours of the breast and secured.
[0185] In some embodiments, the openings 1704 of the template 1702
may be grouped according to a particular target tissue volume,
e.g., lesion size, as shown in FIG. 22. For example, a small
square, five-opening pattern 1740 may be utilized for small target
tissue regions (e.g., those regions up to about 1 centimeter in
diameter), while a larger nine-opening pattern 1742 may be utilized
for larger target tissue regions (e.g., those regions up to about 2
cm in diameter). A still larger, thirteen-opening pattern may be
utilized for even larger target tissue regions (e.g., those regions
up to about 3 cm in diameter).
[0186] By aligning the center opening of the template 1702 with the
center of the target tissue region, the template may indicate a
standard number of seeds, e.g., a particular number of therapy
devices 102, based upon the predetermined target volume. This could
simplify, or possibly eliminate, the need for complex dose mapping
calculations commonly associated with conventional brachytherapy
methods.
[0187] It is noted that the patterns 1740, 1742, and 1744 are
exemplary only. In other embodiments, the patterns may include most
any number of openings 1704 in most any shaped pattern, e.g., a
circular array of 5 to 50 catheters. Moreover, the templates could
accommodate more that one diameter catheter or needle (e.g., 10,
15, and 20 mm diameters). Moreover, while shown with three
patterns, templates having most any number are possible.
[0188] FIGS. 23 and 24 illustrate another embodiment of a system
for implanting brachytherapy devices. FIG. 23 illustrates a system
2300 similar in many respects to the system 1700 described above.
For instance, the system 2300 may include a stereotactic table 2320
secured to treatment surface, e.g., patient table (not shown). The
table 2320 may include a base portion 2322 and a translational
portion 2324. The system 2300 may also include a first or proximal
compression member 2326 and a second or distal compression member
2328. One or both compression members 2326 and 2328 may be movable
relative to the other and/or the base portion 2322, e.g., along a
slide rail 2329.
[0189] Unlike the system 1700, however, the system 2300 may also
include a catheter or needle cartridge receiver 2340 operable to
receive a pre-assembled needle cartridge 2342 having multiple
needles 114 positioned in a predetermined array. The needle
cartridge 2342 is shown in an exploded view in FIG. 24. The
cartridge 2342 may include a first holder 2344 and a second holder
2346 (second holder 2346 not shown in FIG. 24). The holders 2344
and 2346 may include holes 2348 to hold and guide the multiple
needles 114 in the desired predetermined array during insertion.
Where needles 114 include a hub 116, the holes 2348 in the holder
2346 may be larger than the corresponding holes 2348 in the holder
2344 to permit the passage of the hub 116 (see FIG. 23).
[0190] During operation of the system 2300, the stereotactic table
2320 may be aligned as described above with respect to the system
1700. Once aligned, the breast 200 may be immobilized with the
compression members 2326 and 2328. Based upon the particular volume
of the target tissue region 202, a specific cartridge 2342 may be
selected and pre-assembled with a corresponding number of
catheters, e.g., needles 114. For instance, the cartridge in FIG.
24 is a 5 catheter configuration. However, other cartridges may
utilize more or less catheters (e.g., 9 catheter and 13 catheter
cartridges). The cartridge 2342, including the holders 2344 and
2346 and the catheters 114, may then be loaded into the cartridge
receiver 2340. Portions of the holders 2344 and 2346 may be
designed to contact one or more internal surfaces of the cartridge
receiver 2340 so that the cartridge 2342 aligns with the cartridge
receiver upon insertion.
[0191] Once the cartridge 2342 is loaded, each needle 114 may be
independently and manually advanced through the proximal
compression plate 2326 (which may include a hole pattern identical
to the holder 2344), the breast 200, and the distal compression
member 2328. The central needle 114 may be advanced first and its
position within the target tissue region 202 confirmed (or
repositioned) before the remaining needles are advanced.
Brachytherapy devices, e.g., devices 102 of FIG. 1A, may then be
placed into the needles 114 as described in FIGS. 2A-2E.
Alternatively, the devices 102 could be pre-installed in the
cartridge 2342.
[0192] With the devices 102 inserted completely, the distal tips of
the tail portions, see e.g., tail portion 106 of FIG. 1A, may be
temporarily secured relative to the distal compression member 2328.
At this point, the needles 114 may be retracted and removed from
the breast 200, and ultimately, withdrawn from the cartridge loader
2340. The proximal compression member 2326 may then be withdrawn
and the proximal tail portions secured to the breast using, for
example, the locking devices 120 described above and illustrated in
FIGS. 2E and 27. The distal compression member 2328 may then be
withdrawn and the distal tail portions secured relative to the
breast 200 in a similar manner.
[0193] FIGS. 25A-25D illustrate yet another system and method for
inserting brachytherapy devices, such as those described elsewhere
herein into a target tissue region. FIG. 25A illustrates a system
2500 similar in many respects to the systems 1700 and 2300
described above. For example, the system 2500 includes a
stereotactic table (not shown) having a catheter or needle
cartridge receiver 2540 coupled thereto. The stereotactic table may
be coupled to the treatment table (also not shown). The system 2500
may also include a catheter or needle cartridge 2542. The needle
cartridge 2542 may include a series of needles 2514, e.g., 5, 9, or
13 needle array, which are generally rigidly and orthogonally
mounted to a first plunger member 2550. In this embodiment, the
needles 2514 may be hubless as the proximal ends of the needles
2514 are secured (e.g., press fit, staked, adhered, etc.) to the
first plunger member 2550.
[0194] The cartridge 2542 may also include a first or proximal
compression member 2526 (which may form the needle guiding
template) as well as a second plunger member 2552 and an optional
backing plate 2554. In other embodiments, the backing plate 2554
may be part of the cartridge receiver 2540. As with the systems
previously described herein, the system 2500 may also include a
second or distal compression member 2528 to assist in immobilizing
the breast 200.
[0195] During operation, the stereotactic table may be aligned such
that the center of the needle cartridge receiver 2540 is centered
relative to the target tissue region 202. The cartridge 2542 may
then be loaded into the cartridge receiver 2540, and the breast
immobilized by the first and second compression members 2526 and
2528. The brachytherapy devices, e.g., devices 102 of FIG. 1A, may
have been previously loaded into the needles 2514 of the cartridge
2542. The first plunger member 2550 may then be advanced toward the
breast 200. Because the needles 2514 are rigidly coupled to the
first plunger member 2550, the needles 2514 advance simultaneously
into the target tissue region of the breast 200 in the
pre-determined parallel array. The first plunger member 2550 may
include a tab 2560 that rides along a slot or surface 2561 of the
cartridge receiver 2540 so that the first plunger member 2550 may
be manually or automatically advanced from outside the
cartridge.
[0196] After the first plunger member 2550 has been fully advanced
as shown in FIG. 25B, the second plunger member 2552 may be
advanced toward the breast 200. The second plunger member 2552 has
the proximal tail portions 106 of the brachytherapy devices 102
releasably secured thereto. Thus, advancing the second plunger
member 2552 may advance one or more of the brachytherapy devices
102 into place such that the distal tail portions 106 emerge from
the distal ends of the needles 2514 as shown in FIG. 25C.
[0197] The distal tail portions 106 may temporarily be secured to
the distal compression member 2528 to hold the brachytherapy
devices 102 in place. Once the distal tail portions 106 are
secured, the proximal tail portions 106 may be released from the
second plunger member 2552 and the first and second plunger members
2550 and 2552 may be retracted as shown in FIG. 25D. The cartridge
receiver 2540 may also be retracted so that the proximal tail
portions 106 may be secured in accordance with methods already
described herein (e.g., locking members 120). The distal tail
portions 106 may then be disconnected from the distal compression
member 2528 and the latter withdrawn. The distal tail portions 106
may then be secured relative to the breast 200.
[0198] Thus, the system 2500 provide an apparatus for
simultaneously implanting, in a two dimensional array, multiple
brachytherapy devices into the body. Moreover, the systems
described herein allow simultaneously advancing a two-dimensional
array of catheters into a target tissue region, and then delivering
or implanting one or more radiation sources through at least one of
the catheters of the array. Once the radiation sources are
implanted, sequential or simultaneous removal of the catheters of
the array of catheters from the target tissue region may be
accomplished.
[0199] As already described above, some embodiments may permit the
tail portions 106 to be secured to the breast using an adhesive pad
or bandage 2600 as illustrated in FIG. 26. Here, the bandage may be
used in conjunction with, or as an alternative to, the locking
members 120.
[0200] To assist the health-care provider in securing the distal
and/or proximal tail portions 106, the compression members 2526,
2528 may be configured as generally illustrated in FIG. 27. That
is, openings 2570 in the plate (e.g., plate 2528) through which the
tail portions 106 pass may include a recess 2572 that holds the
locking member 120 against the skin. As a result, when the
compression plate 2528 is withdrawn, the locking member 120 may
already be threaded over the tail portion 106. The health care
provider may then quickly crimp the locking member 120, e.g., along
a deformable portion 2576.
[0201] FIG. 28A illustrates a system and method for inserting
brachytherapy devices into the body in accordance with yet another
embodiment. The system 2800 is similar in many respects to the
systems 1700, 2300, and 2500 already described above. For example,
the system 2800 may include a stereotactic positioning apparatus
2802 having a fixed base 2803 and a movable arm 2804 slidably
attached thereto. The movable arm 2804 may move along one or more
rails 2805 formed in the fixed base 2803. A needle driver or driver
plate 2806 may be coupled to the movable arm 2804 via slots 2808
provided along an upper surface 2810. A screw mechanism, driven by
a rotating wheel 2812 or the like, may be provided to displace the
driver plate 2806 along the slots 2808. The rotating wheel 2812
provides a method for moving the needle driver in a uniform manner
while providing adequate tactile feedback to the physician.
Alternate methods of driving and retracting the array of needles
may be employed. For example, a lever-operated rack and pinion
apparatus (not shown) could offer the desired characteristics,
i.e., controlled movement of the needles to and from the target
tissue, while maintaining an acceptable degree of tactile
feedback.
[0202] An array of needles 114' may be displaced by the driver
plate 2806 under control of the wheel 2812. As with the needle
cartridge 2542, the needle cartridge used herein may include the
array of needles 114' (see also FIG. 1B), which are generally
orthogonally positioned relative to the driver plate 2806. The
number and position of the array of needles 114' may be
predetermined based upon particular dose mapping calculations. The
needles 114' may be hubless (i.e., exclude the hub 116 shown in
FIG. 1B) as the proximal ends may be secured (e.g., press fit,
staked, adhered, abutted, etc.) to the driver plate 2806. In other
embodiments, the needles 114' may include a hub such that they
resemble the needles 114 of FIG. 1A.
[0203] The stereotactic positioning apparatus 2802 may be located
proximate a table 2814 upon which a patient may be accommodated in
a face-down position. For treatment of the breast, the stereotactic
table 2814 may include an opening through which the breast 200 may
protrude. The stereotactic positioning apparatus 2802 may be
positioned such that the breast 200 is located between a first or
proximal compression member 2818 and a second or distal compression
member 2820. The compression members 2818 and 2820 may clamp
against the breast to immobilize it prior to implantation. The
distal compression member 2818 may also include an array of
openings that corresponds to the array of needles.
[0204] The apparatus 2802 may further include a needle guide 2816
positioned between the driver plate 2806 and the proximal
compression member 2818. The needle guide may include an array of
guide openings 2817 that correspond in position to the array of
needles 114' (i.e., there is an opening 2817 aligned with each
needle 114'). The needle guide 2816 may support and guide the
needles 114' during the implantation process.
[0205] In some embodiments, the needle guide 2816 comprises two
spaced-apart templates having the series of aligned openings 2817.
The array of needles 114' may be assembled into the openings 2817
prior to or after the needle guide is secured to the arm 2804. The
driver plate 2806 may then be used to push against the free
proximal end of the needles 114' to drive the same through the
breast.
[0206] The proximal and distal compression members 2818 and 2820
may also include an array of openings that correspond in location
to the array of needles 114'. Such a configuration may assist with
confirming that the needles did not wander or excessively deflect
within the body. Alternatively, the proximal and distal compression
members 2818 and 2820 may simply include a large opening in place
of the array of openings. Such a larger opening could be covered
with, for example, a membrane (not shown) that may be penetrated by
the needles 114'. Such a membrane could be configured to remain in
place during implantation, e.g., could function as a dressing or
bandage. The apparatus 2802 may further include imaging equipment,
e.g., image receptor 2822, to allow imaging of the breast before,
during, or after implantation.
[0207] During operation of the system 2800, the stereotactic table
2814 may be aligned relative to the positioning apparatus 2802 such
that the compression members 2818, 2820 and the needle guide 2816
(and thus the array of needles 114') are accurately positioned
relative to the target tissue region of the breast 200. The breast
may then be immobilized between the proximal and distal compression
members 2818 and 2820 by moving the movable arm 2804 relative to
the fixed base 2803. Each needle 114' (which may be preloaded with
a brachytherapy device, e.g., the device 562 of FIG. 1B), may then
be secured to the driver plate 2806 or, alternatively, to the
needle guide 2816.
[0208] The driver plate 2806 may be advanced towards the needle
guide 2816 whereby the needles 114' pass through the guide openings
2817 in the guide and towards the proximal compression member 2818.
The needles 114' may advance simultaneously through the array of
openings in the needle guide 2816, through the proximal compression
member 2818, and through the target tissue region of the breast 200
in the pre-determined array formation. Further advancement results
in the needles 114' passing completely through the breast and,
finally, the distal compression member 2820.
[0209] The face of the driver plate 2806 that contacts the proximal
ends of the needles 114' is illustrated in FIG. 28A as a generally
flat surface. However, this surface could also be staggered (e.g.,
stepped) from row to row. For example, each row may be recessed by
about 5 mm from the row below it. When the face of the driver plate
2806 is so staggered, the needles 114' will be simultaneously
advanced through the tissue in a correspondingly staggered fashion
as well. This stair-step advancement enables the peak force
necessary during implantation (typically during skin penetration)
to be reduced, as the various rows of needles will penetrate the
region of high resistance (e.g., the skin) at slightly different
times during needle advancement.
[0210] Although described as a row-by-row variation, any one of a
variety of offset patterns could be utilized (e.g., row-to-row
variation, column-to-column variation, concentric ring (of a
circular array) variation, etc.). In any case, the total load to
the patient, and to the apparatus, may be reduced by staggering the
leading ends of the needles as they advance. The staggered shape of
the driver plate face 2806 could be integrated into the driver
plate, or could be a separate piece or pieces that are placed
relative to the driver plate face to create the desired staggered
configuration.
[0211] Once the needles 114' have passed through the breast 200,
the brachytherapy devices, e.g., devices 562, may be advanced out
of the distal ends of the needles in a manner similar to that
illustrated in FIG. 2I (e.g., the devices may be simultaneously
advanced from their respective proximal ends). The devices may then
be immobilized at their distal tails and the needles withdrawn as
indicated in FIGS. 2J and 2K. Fine adjustment of the brachytherapy
devices may then be made utilizing most any acceptable method,
e.g., X-ray, CT scan.
[0212] FIGS. 28B-28D illustrates a system 2850 and method for
inserting brachytherapy devices into the body in accordance with
still yet another embodiment. The system 2850 is similar in many
respects to the system 2800 already described above. For example,
the system 2850 may include a driver and positioning apparatus
2852. In one embodiment, the components of the apparatus 2852 could
be attached to a stereotactic breast biopsy table (e.g., such as
those available from Fischer Imaging Corp. of Denver, Colo., USA).
For example, the apparatus 2852 may include an upwardly extending
arm 2854 having flange portions 2853 that permit attachment
directly to the stereotactic table. Alternatively, the components
of the apparatus 2852 may be secured to a fixed base member (e.g.,
for other imaging modalities such as CT). While shown as rigidly
attached, the arm may, in other embodiments, be slidably attached
to such a fixed base member.
[0213] The arm 2854 may support a platform 2855 having a needle
driver or driver plate 2856 that may move along an upper surface
2860 of the platform. A mechanism, e.g., rotating wheel 2862 or the
like, may be provided to displace the needle driver plate 2856 via
a lead screw that is connected to a portion of the driver plate
extending through one or more slots 2858 formed in the surface
2860. The rotating wheel 2862 provides a method for moving the
needle driver in a uniform manner while providing adequate tactile
feedback to the physician, as well as providing desirable
mechanical advantage for driving simultaneously multiple needles
through tissue. The platform 2855 itself may be movable (e.g.,
slidable within one or more channels 2857), relative to the arm
2854, with the use of a clamp, e.g., screw clamp 2863, or
cam-operated clamp.
[0214] The stereotactic positioning apparatus 2852 may be located
proximate the table 2814 in a manner similar to that illustrated in
FIG. 28A. The driver and positioning apparatus 2852 may be
positioned such that the breast 200 is located between a first or
proximal compression member 2868 and a second or distal compression
member 2870 (which is illustrated attached to an image receptor
2872). The compression members 2868 and 2870 may clamp against the
breast to immobilize it prior to implantation. The proximal and
distal compression members 2868 and 2870 may also contain large
openings 2869a and 2869b, respectively, or smaller openings that
approach the size of the thru-holes in the compression member 2870
of FIG. 28B. The openings may be covered with a thin membrane of
polyester film, paper, spun-bound polyolefin, or the like. The
membrane may have an adhesive on at least one side to allow
adherence to the compression members. The membrane may include a
foam backing on the non-adherent side as well, such as a Mammopad
brand breast cushion available from Biolucent, Inc., of Aliso
Viejo, Calif., USA. The foam backing may provide comfort to the
patient as the breast is compressed, and also aid in securing the
brachytherapy devices by providing residual axial tension to the
devices as they reside within the breast.
[0215] Like the apparatus 2802, the apparatus 2852 may further
include a needle guide 2866 positioned between the driver 2856 and
the proximal compression member 2868. The needle guide may include
two spaced-apart plates that each incorporate an array of aligned
guide openings 2867 that correspond in position to the array of
needles that are to be implanted (i.e., there is an opening 2867
aligned with each needle). The needle guide 2866 may support and
guide the needles 114' during the implantation process. The array
of needles may be assembled into the openings 2867 prior to or
after the needle guide is secured to the arm 2854. In some
embodiments, the needles, e.g., with brachytherapy devices (e.g.,
devices 562 of FIG. 1B) contained therein, may be inserted into the
openings 2867 of the needle guide 2866 prior to attachment of the
needle guide to the arm 2854. The needle guide 2866 may be
attachable to the arm 2854 in most any manner. For example, it may
rest or fasten against posts 2874 attached to the platform 2855 as
shown in FIGS. 28C and 28D.
[0216] During operation of the system 2850, the patient table 2814
may be aligned relative to the driver and positioning apparatus
2852 such that the compression members 2868, 2870 are accurately
positioned relative to the target tissue region of the breast 200.
The breast may then be immobilized between the proximal and distal
compression members 2868 and 2870 by moving the proximal
compression member towards the distal compression member. As
described above, the openings 2869a and 2869b of the compression
members may have a thin, penetrable membrane operable to adhere to
compression members on one surface and to the breast on the
other.
[0217] Needles, such as needles 114' (which may be preloaded with a
brachytherapy device, e.g., the device 562 of FIG. 1B), may be
inserted into the needle guide 2866 and the needle guide attached
to the platform 2855 as shown in FIGS. 28C and 28D.
[0218] The platform 2855 may be advanced along the channel 2857
relative to the arm 2854 until the needle guide 2866 is proximate
the breast tissue constrained by the proximal compression paddle
2868. Tightening of the screw clamp 2863 may secure the platform in
the desired position relative to the arm 2854.
[0219] The driver plate 2856 may then be advanced towards the
needle guide 2866 via the wheel 2862 until a face of the driver
plate contacts the proximal end of the needles (e.g., contacts the
hub 116' of FIG. 1B) as shown in FIG. 28C. As this occurs, the
proximal tail portions (see tail portion 566 in FIG. 2G) of the
brachytherapy devices 562 may pass through openings 2875 formed in
the driver plate 2856. The openings 2875 may be funnel-shaped to
aid in passage of proximal tail portions of the brachytherapy
devices through the driver plate 2856. Continued movement of the
wheel 2862 causes the needles 114' to pass completely through the
breast 200 and the membranes attached to each compression member
2868 and 2870. Once the needles 114' have passed through the breast
200, the brachytherapy devices, e.g., devices 562, may be advanced
out of the distal ends of the needles in a manner similar to that
illustrated in FIG. 2I (e.g., the devices may be simultaneously
advanced from their respective proximal ends). The devices may then
be immobilized at their distal tails and the needles withdrawn as
indicated in FIGS. 2J and 2K.
[0220] As with the driver plate 2806 described above, the driver
plate 2856 may be stepped, e.g., form a stair step profile when
viewed from one side. As a result, the tips of the needles may be
staggered such that a first subset of needles may puncture the
breast, then a second subset, followed by a third subset, etc.
[0221] Needle withdrawal may also be accomplished by retracting the
needle guide from the breast. To release the needle guide, the
screw clamp 2863 may be loosened and the platform 2855 retracted
along the channel 2857. As the platform is retracted, the needle
guide 2866 may move away from the first compression member 2868. If
desired, the entire driver assembly may be removed to permit full
retraction of the needle guide. Eventually, the needle guide 2866
will abut the hubs (see hubs 116' in FIG. 1B) such that further
movement of the needle guide causes withdrawal of the needles. Fine
adjustment of the brachytherapy devices may then be made by
applying traction on the brachytherapy device in the proper
direction, as guided by most any acceptable visualization method,
e.g., X-ray, CT scan.
[0222] In an alternative embodiment, the needle guide 2866 could be
detached from the platform 2855 where it is then held stationary
while the platform is retracted. The physician could then withdraw
the needle guide and, simultaneously, the accompanying needles, by
hand. In this embodiment, the needle guide 2866 could be attached
to the platform such that it may load axially (e.g., from the
direction of the compression members) with the platform. For
example, the needle guide 2866 could attach to a face 2877 (see
FIG. 28D) of the post 2874 (e.g., via a dowel pin or fastener).
Detachment of the needle guide could then occur mainly via axial
separation of the platform from the needle guide.
[0223] To assist the physician in securing the distal and/or
proximal tail portions 156 (see FIG. 2L) the distal compression
member 2870 may contain an array of buttons or grommets that are
pre-loaded into the holes of a distal compression template, as
shown and described with reference to FIG. 27.
[0224] FIGS. 29-31 illustrate an exemplary anchoring tab that may
be used to secure brachytherapy devices in accordance with the
embodiments described herein. For example, an anchoring tab 2840
shown in FIG. 29 may be used to secure the tail portions of
brachytherapy devices described herein without the need for locking
members 120 or the like. Alternatively, the anchoring tab could be
used in place of the penetrable membranes described above. The
anchoring tab also serves to preserve the spacing of the puncture
sites thereby preserving the spacing of the brachytherapy elements
as they exit the skin.
[0225] The anchoring tab 2840 may include an array of pre-formed
openings 2842 that correspond in location to the array of needles
114' (see FIGS. 28A, 28C) and through which the needles may pass.
This array can be a radial pattern as shown in FIG. 29, or can also
be a rectilinear array of holes (rows and columns, not shown) with,
for example, 1 cm spacing between adjacent rows and columns. One
side of the tab 2840 may incorporate an adhesive to permit it to
adhere to one or both of the first compression member 2818 or the
second compression member 2820 such that it is positioned between a
respective compression member and the breast during implantation.
Alternatively, the tab 2840 may have no pre-formed openings, but
could be made to be penetrated by the needle tips. Such a tab could
be made of an elastomer such as silicone, or a thermoplastic
elastomer (e.g., Kraton.RTM.). Accordingly, the tab could be
penetrable by the needles, while also providing some residual
retentive force on the tails of the brachytherapy device once
implanted. The tabs could thus aid in preserving the axial position
of the brachytherapy devices.
[0226] FIG. 30 illustrates an enlarged view of brachytherapy
treatment devices implanted within the body, e.g., breast 200, and
secured, on one side, with the anchoring tab 2840. As clearly
evident in this view, the openings 2842 of the anchoring tab 2840
may be configured to secure tail portions of brachytherapy devices
incorporating anchoring ribs on their tail portions. For example,
the anchoring tab 2840 may be used with the devices 592 of FIGS.
5H-5J, which, as described above, incorporate tail portions 596
having anchoring ribs 595 thereon.
[0227] FIG. 31 illustrates an exemplary opening 2842 in the tab
2840 with the tail portion 596 of the device 592 secured therein.
Each opening 2842 may include a clearance portion or opening 2843,
and an interference portion or opening 2844. Each clearance opening
2843 may have a diameter equal to or larger than an undeflected
diameter of the anchoring rib to permit the passage of the
anchoring rib 595 with clearance, while the interference openings
2844 may have a diameter smaller than an undeflected diameter of
the anchoring rib. Multiple interference openings 2844 may be
provided to allow various positions of the tail portion 596
relative to the clearance opening 2843. A slot 2846 may connect the
clearance portion or opening 2842 to each of its interference
portions or openings 2844. The slot may be sized to accommodate
with clearance, or a slight interference, the section of the tail
portion 596 between the anchoring ribs 595.
[0228] In use, the brachytherapy devices, e.g., devices 592, may be
inserted into the breast 200 in accordance with any of the
embodiments already described herein. Once each device 592 is
correctly positioned, the tail portion 596 may be manipulated to
displace the device from the clearance opening 2843, through the
appropriate slot 2846, and into the interference opening 2844. Once
the tail portions 596 are secured in this manner, they may be
folded against the template as shown in FIG. 30 and secured, e.g.,
taped.
[0229] The choice of which of the multiple ribs are engaged in the
slot 2846 would be dependent on many variables, including the
thickness of the breast, the degree of post-procedural swelling of
the breast, and also the desired amount of residual tension to
impart on the brachytherapy source. As with the penetrable membrane
on the compression paddle described earlier, the anchoring tab 2840
may contain a compressible foam layer to provide residual tension
on the brachytherapy device. This layer would help keep the
brachytherapy device in its proper position during positional
changes of the breast in the normal course of daily activity of the
patient. The change in position of the breast during normal
movement can be minimized with the use of an external support
device as well (described earlier herein). such a support device
could include radiation attenuating material in it, as well as
provide structure to minimize breast movement. By minimizing
positional changes of the breast, the brachytherapy devices are
less likely to deviate from their intended location during the
course of implantation.
[0230] In some embodiments, the tab 2840 may be made from an
adhesive backed polyester or polyolefin film. For example, the tab
2840 may be constructed to have sufficient structural integrity
around the openings 2842 to prevent tear-out of the device during
the implantation period. However, the template may also benefit
from being somewhat flexible so that it may conform to the contours
of the body, e.g., breast, during implantation to reduce
discomfort.
[0231] The brachytherapy devices described herein may be implanted
into (and/or around) the tumor prior to surgical excision
(neoadjuvantly), and then subsequently removed before or at the
time of surgery. For example, such treatments may shrink or even
destroy the tumor. In other embodiments, the apparatus and methods
described herein may be used to deliver brachytherapy after
surgical removal of the tumor tissue to treat surrounding tissue
post-operatively (post-lumpectomy in breast). In some instances, it
is contemplated that brachytherapy apparatus and methods described
and illustrated herein may supplement or reduce the need for
conventional treatment options, e.g., tumor excision, full field
external beam radiation therapy (EBRT), and chemotherapy.
Alternatively, the methods described herein may be performed
adjuvantly with these and other treatments, e.g., with chemo,
EBRT.
[0232] It is also contemplated that the brachytherapy devices
described herein could be utilized in conjunction with conventional
HDR catheters. For example, HDR catheters may be implanted in
accordance with conventional methods. Thereafter, in place of the
HDR source, the devices described herein, e.g., brachytherapy
devices 102, 402, 502, 562, etc., may be inserted into the HDR
catheters and secured in place for a predetermined period of
time.
[0233] Treatment in accordance with the apparatus and methods
described herein may also avoid some of the disadvantages of HDR
treatment, e.g., high activity, exposure of unintended tissue,
potentially bulky and protruding catheters, and the need for
numerous patient visits to receive treatment.
[0234] The brachytherapy devices described herein are also
substantially flexible, in comparison to conventional HDR
catheters, such that they may be placed in either a straight or
curvilinear (e.g., curved or spiral) fashion. Such flexibility may
permit implantation of radiation sources (e.g., seeds) in
configurations and locations that otherwise may be considered
inaccessible.
[0235] The apparatus and methods described herein may also
potentially achieve desired dosage with relatively few catheters.
For example, the apparatus and methods described herein may
potentially obtain desired dose delivery levels with fewer
catheters per target than is typically utilized with conventional
HDR methods. Yet, the devices described herein may still be
implanted with the use of conventional imaging methods (e.g.
stereotactic X-ray, ultrasound, CT).
[0236] The apparatus and methods described herein may also provide
other benefits to the patient. For example, potentially less skin
damage and discomfort may result from smaller and more flexible
catheter insertions. Further, the small flexible tail portions,
once in their proper position, may be trimmed short, or may also be
folded and taped against the skin, unlike rigid HDR catheters.
Thus, the patient may have less discomfort over the course of
treatment and potentially improved post-procedural cosmesis.
Further, for example, apparatus and techniques described herein may
potentially result in reduced side effects as compared to other
treatments, e.g., EBRT and chemo, and may require fewer hospital
visits over the course of the treatment regimen as compared to, for
example, current HDR brachytherapy.
[0237] Still further, the brachytherapy delivery systems described
herein may provide a standardized dose of radiation based upon
lesion size. As a result, the need for extensive dose calculating
and mapping systems could potentially be reduced or eliminated with
certain cancers (e.g., breast).
[0238] Exemplary embodiments of the present invention are described
above. Those skilled in the art will recognize that many
embodiments are possible within the scope of the invention. Other
variations, modifications, and combinations of the various
components and methods described herein can certainly be made and
still fall within the scope of the invention. For example, any of
the treatment devices described herein may be combined with any of
the delivery systems and methods also described herein.
* * * * *