U.S. patent application number 17/698385 was filed with the patent office on 2022-09-22 for custom brachytherapy carriers.
The applicant listed for this patent is GT MEDICAL TECHNOLOGIES, INC.. Invention is credited to John Baker, David Brachman, Heidi Cole, Adam Turner.
Application Number | 20220296738 17/698385 |
Document ID | / |
Family ID | 1000006271219 |
Filed Date | 2022-09-22 |
United States Patent
Application |
20220296738 |
Kind Code |
A1 |
Brachman; David ; et
al. |
September 22, 2022 |
CUSTOM BRACHYTHERAPY CARRIERS
Abstract
A carrier having one or more non-planar surfaces may be embedded
with one or more radioactive seeds. A spherical carrier may be
substantially radially symmetrical around an axis or a spherical
carrier may include a non-spherical portion, such as a tapered
portion that extends from a spherical portion.
Inventors: |
Brachman; David; (Phoenix,
AZ) ; Baker; John; (Gilbert, AZ) ; Cole;
Heidi; (Phoenix, AZ) ; Turner; Adam; (Phoenix,
AZ) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
GT MEDICAL TECHNOLOGIES, INC. |
Tempe |
AZ |
US |
|
|
Family ID: |
1000006271219 |
Appl. No.: |
17/698385 |
Filed: |
March 18, 2022 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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63163583 |
Mar 19, 2021 |
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63163366 |
Mar 19, 2021 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61K 51/08 20130101;
A61N 5/1007 20130101; A61K 51/1262 20130101 |
International
Class: |
A61K 51/12 20060101
A61K051/12; A61N 5/10 20060101 A61N005/10; A61K 51/08 20060101
A61K051/08 |
Claims
1. A radioactive seed carrier comprising: a substantially radially
symmetrical body around an axis consisting essentially of a
bio-resorbable material, where a diameter of the body is in the
range of about one to seven centimeters; and one or more
radioactive seeds positioned within the body, the one or more
radioactive seeds comprising a radioactive emitting radiation
configured to kill living cells; wherein the seed carrier is
capable of compression.
2. The radioactive seed carrier of claim 1, wherein the body is
substantially spherical.
3. The radioactive seed carrier of claim 1, wherein the body
comprises a substantially spherical portion that tapers to a
substantially cylindrical portion.
4. The radioactive seed carrier of claim 1, wherein the body
comprises a substantially spherical portion and a tapered portion
extending from the spherical portion, wherein a diameter of the
tapered portion decreases with distance from the cylindrical
portion.
5. The radioactive seed carrier of claim 4, wherein one or more
radioactive seeds are embedded in the tapered portion.
6. The radioactive seed carrier of claim 1, further comprising: one
or more trim lines indicating locations where the radioactive seed
carrier is configured to be separated.
7. The radioactive seed carrier of claim 6, wherein the one or more
trim lines are separated by about five to twenty millimeters.
8. The radioactive seed carrier of claim 1, further comprising: a
drain channel extending through the body.
9. The radioactive seed carrier of claim 1, wherein an outer
surface of the body comprises one or more flutes.
10. The radioactive seed carrier of claim 1, wherein an outer
surface of the body comprises a sinusoidal surface.
11. The radioactive seed carrier of claim 1, wherein the
radioactive seed carrier is configured for implantation into
mammalian tissue via an endoscope.
12. The radioactive seed carrier of claim 1, wherein a diameter of
the body when compressed is less than about two-thirds of the
original diameter.
13. The radioactive seed carrier of claim 1, wherein the
bioresorbable material comprise human-derived collagen or
bovine-derived collagen.
14. A radioactive seed carrier comprising: a substantially radially
symmetrical body around an axis consisting essentially of a
bio-resorbable material; and one or more radioactive seeds
positioned within the body, the one or more radioactive seeds
comprising a radioactive material emitting radiation configured to
kill living cells.
Description
FIELD
[0001] The invention generally relates to improvements to
customization of radioactive seed carriers for use in
brachytherapy.
BACKGROUND
[0002] Tumors in living organisms are highly variable in size,
location and their amount of infiltration into normal tissues, and
the variability of tumors in general make them very difficult to
treat with a one-size fits all approach. Furthermore, the extent of
tumors and/or void created upon debulking are typically not known
until presented in the operating room. Thus, the options necessary
to effectively treat a tumor or tumor bed need to be quite
diverse.
[0003] Brachytherapy involves placing a radiation source either
into or immediately adjacent to a tumor. It provides an effective
treatment of cancers of many body sites. Brachytherapy, as a
component of multimodality cancer care, provides cost-effective
treatment. Brachytherapy may be intracavitary, such as when
treating gynecologic malignancies; intraluminal, such as when
treating esophageal or lung cancers; external surface, such as when
treating cancers of the skin, or interstitial, such as when
treating various central nervous system tumors as well as
extracranial tumors of the head and neck, breast, lung, soft
tissue, gynecologic sites, liver, prostate, and skin.
SUMMARY
[0004] The systems, methods, and devices described herein each have
several aspects, no single one of which is solely responsible for
its desirable attributes. Without limiting the scope of this
disclosure, several non-limiting features will now be described
briefly.
[0005] Discussed herein are various custom shapes and
configurations of collagen seed carriers for providing improved
adjuvant radiation treatment. The custom shapes generally include a
spherical base loaded with one or more radioactive seeds, which may
be compressed for insertion into a surgical cavity and then
expanded to fill the cavity when hydrated (via an external source
or with bodily fluids). Other three dimensional shapes are also
disclosed herein.
BRIEF DESCRIPTION OF THE DRAWINGS
[0006] The principles of the present invention will be apparent
with reference to the following drawings, in which like reference
numerals denote like components:
[0007] FIG. 1A is a side view of a spherical carrier having
radioactive seeds embedded therein
[0008] FIG. 1B is a cross-sectional view of the carrier of FIG.
1A.
[0009] FIG. 2 illustrates an example spherical carrier held by
forceps.
[0010] FIGS. 3A, 3B, and 3C are cross-sectional views of a
spherical carriers loaded with different quantities, and
potentially radiation strengths or spacing of radioactive
seeds.
[0011] FIGS. 3D-3H are cross-sectional views of spherical carriers
loaded with different quantities and configurations of radioactive
seeds.
[0012] FIG. 4A is a perspective view of a spherical elongate
carrier.
[0013] FIG. 4B is a cross-sectional view of the carrier of FIG.
4A.
[0014] FIG. 4C illustrates a cross-sectional view of a carrier.
[0015] FIG. 5A is a perspective view of another custom carrier
having a spherical portion that tapers into a cylindrical
portion.
[0016] FIG. 5B is a cross-sectional view of the carrier of FIG.
5A.
[0017] FIG. 6A is a perspective view of a tapered carrier having
multiple sections each configured for embedding of a radioactive
seed therein.
[0018] FIG. 6B is cross-sectional view of the carrier of FIG.
6A.
[0019] FIG. 7A is a perspective view of a carrier having a channel,
or canal, extending through a longitudinal axis of the carrier.
[0020] FIG. 7B is a cross-sectional view of the carrier of FIG.
7A.
[0021] FIG. 8A is a perspective view of another carrier having
flutes extending along a length of the carrier.
[0022] FIG. 8B is a cross-sectional view of the carrier of FIG.
8A.
[0023] FIG. 9 illustrates a carrier that is configured for
placement in a tumor cavity of a patient via an introduction
tool.
DETAILED DESCRIPTION
[0024] Although certain preferred embodiments and examples are
disclosed below, inventive subject matter extends beyond the
specifically disclosed embodiments to other alternative embodiments
and/or uses and to modifications and equivalents thereof. Thus, the
scope of the claims appended hereto is not limited by any of the
particular embodiments described below. For example, in any method
or process disclosed herein, the acts or operations of the method
or process may be performed in any suitable sequence and are not
necessarily limited to any particular disclosed sequence. Various
operations may be described as multiple discrete operations in
turn, in a manner that may be helpful in understanding certain
embodiments; however, the order of description should not be
construed to imply that these operations are order dependent.
Additionally, the structures, systems, and/or devices described
herein may be embodied as integrated components or as separate
components. For purposes of comparing various embodiments, certain
aspects and advantages of these embodiments are described. Not
necessarily all such aspects or advantages are achieved by any
particular embodiment. Thus, for example, various embodiments may
be carried out in a manner that achieves or optimizes one advantage
or group of advantages as taught herein without necessarily
achieving other aspects or advantages as may also be taught or
suggested herein.
[0025] Illustrative embodiments are described below. In the
interest of clarity, not all features of an actual implementation
are described in this specification. It will of course be
appreciated that in the development of any such actual embodiment,
numerous implementation-specific decisions must be made to achieve
the developers' specific goals, such as compliance with
system-related and business-related constraints, which will vary
from one implementation to another.
Terms
[0026] To facilitate an understanding of the systems and methods
discussed herein, several terms are described below. These terms,
as well as other terms used herein, should be construed to include
the provided descriptions, the ordinary and customary meanings of
the terms, and/or any other implied meaning for the respective
terms, wherein such construction is consistent with context of the
term. Thus, the descriptions below do not limit the meaning of
these terms, but only provide example descriptions.
[0027] Tumor: an abnormal growth of tissue resulting from
uncontrolled, progressive multiplication of cells. Tumors can be
benign or malignant.
[0028] Tumor bed: an anatomical area of a patient (e.g., a human or
other mammal) where a tumor exists (pre-operative tumor bed) and/or
an area surrounding a surgically removed tumor (post-operative
tumor bed), such as a cranial cavity from which a tumor was
surgically removed. Even after surgical removal of a tumor, the
remaining tumor bed of the patient may include tumor cells.
[0029] Treatment area: an anatomical area that is targeted for
delivery of radiation, such as from one or more radiation delivery
devices (e.g., the carriers discussed below). A treatment area may
include tissue below and/or around a location where the radiation
deliver device is positioned, such as an anatomical area of a tumor
or a tumor bed.
[0030] Treatment surface: an anatomical surface of a patient (e.g.,
a human or other mammal) where a radiation delivery device is to be
placed to deliver radiation to a treatment area, such as the
treatment surface itself and/or tissue below the treatment surface.
A treatment surface may be a portion of a tumor bed or any other
anatomical surface. For example, if a tumor bed is surgically
created, the treatment surface may include an entire exposed
surface of the tumor bed, a portion of such exposed surface, or the
entire exposed surface of the tumor bed as well as a surrounding
area of tissue.
[0031] Brachytherapy: radiation treatment in which the radiation
delivery device is placed directly on and/or close to a treatment
surface of the body, such as directly on the surface of the body,
within the body, or in a tumor bed. For example, brachytherapy may
be intracavitary, such as in cranial or gynecologic malignancies;
intraluminal, such as in esophageal or lung cancers; external, such
as in cancers of the skin; and/or interstitial, such as in
treatment of various central nervous system tumors as well as
extracranial tumors of the head, neck, lung, soft tissue,
gynecologic sites, rectum, liver, prostate, and penis.
[0032] Seed: a radioactive material that is configured for delivery
of radiation to a tumor and/or tumor bed. A seed may be in various
shapes and sizes, such as cylinder, cone, sphere, pyramid, cube,
prism, rectangular prism, triangular prism, and/or any combination
of these or other shapes. While seeds are generally referred to
herein as cylindrical, any other shape or size of seed may
alternatively be used in the various systems and methods discussed
herein. Seeds may comprise any combination of one or more of
multiple radioactive components, such as Cs 131, Ir 192, I 125, Pd
103, for example. Seeds may include a protective outer shell that
partially or fully encases the radioactive material. Seeds are one
form of radiation source. The term "radiation source," as used
herein, generally refers to a radioactive seed (or other object
that emits radiation), either alone (e.g., a seed) or embedded, or
otherwise attached to, a carrier (e.g., a tile carrier with an
embedded radioactive seed).
[0033] Carrier: a substrate that holds or contains a radioactive
seed. A carrier that contains one or more seeds is a radiation
delivery device. Carriers may comprise various materials, such as
one or more bioresorbable materials, such as collagen. Thus, these
bioresorbable materials are biodegradable, or naturally absorbing
into the mammalian tissue over time, such as over a period of weeks
or months. Carriers may be configured for permanent implantation
into a tumor bed, such as to provide radioactive energy to a
treatment surface surrounding an area where a tumor has been
removed in order to treat any remaining malignant tissue. Carriers
can be composed of various materials and take on various shapes and
sizes. Examples carriers, such as carriers having various sizes,
shapes, configurations, etc., as well as fabrication processes, are
included in the following patent and patent application, each of
which is hereby incorporated by reference in its entirety and for
all purposes: [0034] U.S. patent application Ser. No. 14/322,785,
filed Jul. 2, 2014, now U.S. Pat. No. 8,876,684, entitled
"Dosimetrically Customizable Brachytherapy Carriers and Methods
Thereof In The Treatment Of Tumors," and [0035] U.S. patent
application Ser. No. 14/216,723, filed Mar. 17, 2014, now U.S. Pat.
No. 9,492,683, entitled "Dosimetrically Customizable Brachytherapy
Carriers and Methods Thereof In The Treatment Of Tumors." [0036]
U.S. Patent Application No. 63/163,366, filed Mar. 19, 2021,
entitled "Systems And Methods For Creating Custom Brachytherapy
Carriers."
[0037] Tile Carrier (also referred to as "Tile"): type of carrier
that is substantially planar and generally maintains a
two-dimensional planar geometry when placed in a tumor bed. Tiles
are generally rectangular cuboids (or other parallelepipeds), e.g.,
wherein all 6 sides are rectangular and generally planar. Depending
on the material of the tile, though, the tile may be malleable such
that the tile can be deformed by bending in order to better conform
to a tumor bed. For example, for tiles comprising essentially
collagen (and/or other malleable materials), the tiles may be
substantially bent as placed in or on a treatment surface (and/or
when pressed against the treatment surface) to conform with the
shape of the treatment surface, such as a post-operative tumor
bed.
[0038] Custom Carrier: a carrier having one or more non-planar
surfaces, such as a spherical shape or having a spherical portion.
Examples of custom carriers include Spherical Carriers, Gore
Carriers, and Star Carriers, noted below, as well as other custom
carriers discussed herein.
[0039] Spherical Carrier (or "GammaSphere"): a substantially
radially symmetrical body around an axis. A spherical carrier may
also include a non-spherical portion, such as a tapered portion
that extends from a spherical portion. Examples of other variations
of spherical carriers are discussed herein.
[0040] Gore Carrier (also referred to as "Gore"): type of carrier
that is 3-dimensional and conforms to the tumor bed while
maintaining the geometry necessary for an effective implant. In
some embodiments, gores are initially planar and are reconfigured
to take on a 3-dimensional shape, such as to form a hemispherical
surface that may be placed into a similarly shaped tumor cavity.
Gore Carriers are further discussed in U.S. Pat. No. 8,876,684,
entitled "Dosimetrically customizable brachytherapy carriers and
methods thereof in the treatment of tumors," filed on Jul. 2, 2014
as application Ser. No. 14/322,785, which is hereby incorporated by
reference in its entirety and for all purposes.
[0041] Star Carrier (also referred to as "Star" or "arm-based
carrier"): type of carrier that assumes a conformable 3-dimensional
shape when arranged and placed into an operative cavity or similar
space and conforms to the treatment environment while maintaining
the geometry necessary for an effective implant. However, in some
embodiments, Star carriers may be used in their initial planar
state to cover a relatively flat tumor or tumor bed area. Star
carriers are further discussed in U.S. Pat. No. 9,492,683, entitled
"Dosimetrically customizable brachytherapy carriers and methods
thereof in the treatment of tumors," filed on Mar. 17, 2014 as
application Ser. No. 14/216,723, which is hereby incorporated by
reference in its entirety and for all purposes.
[0042] Loader: a device that aids in placement of radioactive seeds
in carriers, such as via injection of seeds into carriers. A
loader, also referred to herein as a "loading device," may include
multiple components, such as to hold a carrier in place and guide a
delivery device (e.g., a needle or injector) into the carrier in
order to place a seed at a precise location in the carrier. The
"Loader Patents" refers to U.S. patent application Ser. No.
13/460,809, filed Apr. 30, 2012, now U.S. Pat. No. 8,939,881,
entitled "Apparatus For Loading Dosimetrically Customizable
Brachytherapy Carriers," and U.S. patent application Ser. No.
14/696,293, filed Apr. 24, 2015, entitled "Apparatus and Method for
Loading Radioactive Seeds Into Carriers," which are each hereby
incorporated by reference in their entirety for all purposes,
describe several embodiments of loaders. As discussed further
herein, loaders may be operated manually, such as by human
operators, or may be fully automated, such that carriers can be
loaded with seeds using an automated process. Alternatively,
loaders may be configured to be automated in part and require
manual operation in part.
[0043] Shielding Material: any material that restricts movement of
radioactive particles, such as by absorbing, reflecting, and/or
scattering radioactive particles. The term "shielding," as used
herein, generally refers to any mechanism of preventing radiation
from moving through and exiting a corresponding shielding material,
such as by the shielding material absorbing, reflecting, or
otherwise blocking the radiation. Shielding materials in various
forms may be used in the various embodiments discussed herein. For
example, a shielding material may be in the form of a particle,
wire, rod, cylinder, bar, sheet, liquid, solution, foam, or any
other form in which a material having radiation absorbing and/or
reflecting properties is possible. A shielding material provides a
shielding rate, which is generally an amount of shielding of
radioactive energy (that is emitted from one or more radiation
sources), provided by the particular shielding materials.
Similarly, a shielding layer comprising multiple shielding
materials and an isolation sheet have associated shielding rates,
which are dependent on the combination of shielding (and possibly
non-shielding) materials therein. For some applications, such as
based on clinical need, an isolation sheet that provides a
shielding rate of 25%, 50%, 75%, 90%, 95%, 98% or some other
shielding percentage, may be desired. As discussed herein, material
composition, shape, size, dimensions, etc. may impact the shielding
abilities of a shielding material. For applications (e.g., based on
clinical need) where a higher shielding percentage is desired than
may be provided by a single shielding material, multiple shielding
materials may be used in combination, in one or more shielding
layers or isolation sheets.
[0044] High Z Materials: any element with an atomic number greater
than 20, or an alloy containing such materials.
[0045] Hot Carrier: a carrier that is loaded with a material that
is radioactive.
[0046] Cold Carrier: a carrier that is not loaded a material that
is radioactive, such as a carrier prior to loading of a radioactive
seed.
[0047] Dosimetry: a process of measurement and quantitative
description of the radiation absorbed dose (rad) in a tissue or
organ.
[0048] Treatment Specifications: any information that is useful in
selecting and/or manufacturing of custom radioactive seed carrier's
for a particular patient, such as based on a treatment plan
developed for the patient. Treatment specifications may include
information regarding a cavity into which the custom carriers will
be used, such as cavity size, cavity shape, etc. Treatment
specifications may also include a desired dose of radiation to be
realized with the custom carriers developed for the indicated
cavity. In some implementations, treatment specifications may
include further details, such as an indication of preferred sizes,
shapes, materials, etc. of carriers.
Example Custom Carriers
[0049] FIG. 1A is a side view of a spherical carrier 100 having
radioactive seeds embedded therein, and FIG. 1B is a
cross-sectional view of the carrier 100. As shown in the
cross-sectional view of FIG. 1B, radioactive seeds 110 (including
radioactive seeds 110A and radioactive seed 110 B) are embedded in
a central portion of the spherical carrier. Depending on the
embodiment, the spherical carrier 100 may comprise various
bioresorbable materials, such as synthetic collagen,
bovine--derived collagen, human-- derived collagen, and/or any
other suitable bioresorbable material. The spherical carrier 100,
as well as other custom carriers discussed herein, may be
manufactured in various manners, including those discussed in U.S.
Patent Application No. 63/163,366, filed Mar. 19, 2021, entitled
"Systems And Methods For Creating Custom Brachytherapy Carriers,"
which is incorporated by reference in its entirety and for all
purposes.
[0050] FIG. 2 illustrates the example spherical carrier 100 held by
forceps 210, such as may be used in a surgical process of
implanting the carrier 100 into a tumor cavity. Depending on the
application, as well as characteristics of the particular carrier,
other tools and procedures may be used to place a carrier into its
proper location within a tumor cavity. For example, in some
embodiments an endoscope may be used to insert one or more carriers
into a tumor cavity.
[0051] FIGS. 3A, 3B, and 3C are cross-sectional views of a
spherical carrier 300A, 300B, and 300C, respectively, loaded with
different quantities, and potentially radiation strengths, of
radioactive seeds. The spherical carrier 300A includes two
radioactive seeds 310A and 3108, while the spherical carrier 300B
includes only a single radioactive seed 310C and the spherical
carrier 300C includes three radioactive seeds 310D, 311E, and 310F.
In some implementations, the radioactive seed 310C is a higher
radiation strength then radioactive seeds in carriers 300A or 300C
because the carrier 300B includes only a single radioactive seed.
In other implementations, the radioactive seed 310C is a similar
strength as those in higher seed count carriers, as prescribed by a
radiation treatment plan. Depending on the embodiment, seeds may be
positioned in various arrangements within a seed carrier.
[0052] FIGS. 3D-3H are cross-sectional views of spherical carriers
loaded with different quantities and configurations of radioactive
seeds. The cross-sections of FIGS. 3D-3H include a cross-section of
radioactive seeds, such as seeds that are generally cylindrical.
FIGS. 3D, 3E, and 3F each illustrate, for example, a custom carrier
with a radioactive seed in the center of a spherical carrier, with
additional radioactive seeds positioned equidistant around the
periphery of the spherical carrier. In some embodiments, the
strength of the center and the periphery seeds may vary, such as a
higher strength seed in the center and lower strength seeds on the
periphery. Similarly, the strength of the seeds around the
periphery may vary, such as to achieve a desired treatment plan.
For example, a side of the spherical carrier that is distal to the
treatment service may not include a radioactive seed, while the
opposite side that is proximal to the treatment service includes a
radioactive seed. In other embodiments, any other quantity of
radioactive seeds may be positioned around the periphery and/or in
a central portion of the spherical carriers.
[0053] The example embodiments of the year 3G and 3H illustrate
radioactive seeds positioned near a periphery of the spherical
carrier, without a radioactive seed in the center.
[0054] While the seeds in FIGS. 3D-3H are each indicated in a
similar orientation, in other embodiments seeds may be implanted at
different orientations within a custom carrier. For example, a seed
in the center of the custom carrier may be orthogonal in one
dimension to a plurality of seeds near the outer edges of the
custom carrier. Additionally, any other quantity and positioning of
radioactive seeds within a custom carrier is contemplated.
[0055] FIG. 4A is a perspective view of a spherical elongate
carrier 400 and FIG. 4B is a cross-sectional view of the carrier
400. The spherical elongate carrier 400 may advantageously be
placed into a tumor cavity that is larger than a channel through
tissue leading to the tumor cavity. Thus, the specialized shape of
carrier 400 may advantageously fill a tumor cavity as well as they
narrower channel to the cavity. Spherical elongate carriers, such
as carrier 400, may be manufactured using custom molds or bio
printing, such as is discussed in U.S. Patent Application No.
63/163,366, filed Mar. 19, 2021, entitled "Systems And Methods For
Creating Custom Brachytherapy Carriers."
[0056] In some embodiments, carriers are compressed for insertion
into a tumor cavity. For example, the spherical portion 405 of
carrier 400 may be compressed to fit through a channel leading to a
tumor cavity. Once properly positioned within the tumor cavity, the
carrier 400 may be hydrated, either with added saline and/or
through bodily fluids in the tumor cavity, causing the spherical
portion 410 to expand and fill the tumor cavity.
[0057] FIG. 4B shows carrier 400 with three radioactive seeds 410,
with one seed 410A in a central portion of the spherical portion
405, another seed 410B positioned in a portion where the spherical
portion 405 begins to taper into a cylindrical portion 407, and a
third seed 410C in the cylindrical portion 407.
[0058] In some embodiments, the carriers are configured for size
customization, such as at the time of surgery, e.g., either prior
to insertion or after insertion into a tumor cavity. With reference
to carrier 400, cut lines 402 (including 402A and 402B) indicate
locations on the carrier where the carrier may be safely cut
without impacting one of the embedded radioactive seeds 410. FIG.
4C illustrates, for example, a cross-sectional view of a carrier
400C, which is the carrier 400 after trimming the distal end of the
carrier 400 (FIGS. 4A and 4B) at the trim line 402B (FIG. 4A).
Thus, the carrier 400 is reconfigured to reduce a length of the
carrier, such as to better fit into a tumor cavity. In some
implementations, if the surgeon suspects that trimming of the
portion of the carrier will be performed, such as to remove the
portion that extends outside of the cavity, the radioactive seed
410C may not be loaded into the carrier 400.
[0059] FIG. 5A is a perspective view of another custom carrier 500
having a spherical portion 510 that tapers into a cylindrical
portion 520. In the cross-sectional view of carrier 500 in FIG. 5B,
four radioactive seeds 510 are shown within the carrier 500. In
this example, the radioactive seeds are evenly spaced, and cut
lines are shown on the outer surface of the carrier (FIG. 5A) to
indicate areas between the seeds where the carrier 500 may be cut
to shorten its size. In other embodiments, the radioactive seeds
may be spaced differently and/or different quantities of
radioactive seeds may be included.
[0060] FIG. 6A illustrates a tapered carrier 600 having multiple
sections each configured for embedding of a radioactive seed
therein. Depending on the implementation, the orientation of the
carrier 600 (as well as other carriers discussed herein), may be
reversible. For example, one application of the carrier 600 may
call for insertion with the proximal and 602 entering the cavity
first, with the distal end 604 extending closer to (or extending
out of) the cavity. However, depending on parameters such as the
shape, size, depth, etc. of the tumor cavity, in some
implementations the distal end 604 may be inserted first into the
cavity, with the proximal end 602 extending closer to (or extending
out of) the cavity. Additionally, the quantity and spacing of
radioactive seeds within carrier 600 may vary from one application
to the next. For example, in one implementation (e.g., a particular
surgical implantation) the carrier 600 may be embedded with six
radioactive seeds, in each of the six indicated sections. In
another implementation, the carrier 600 may be embedded with three
radioactive seeds, alternating sections from the first section at
the proximal and 600 towards the distal end 604. Any other
combination of radioactive seed placements is contemplated.
Advantageously, the carrier 600 includes cut lines 605 indicating
locations where the carrier length may be safely trimmed (either
pre- or post-implant) without impacting a radioactive seed.
[0061] FIG. 6B is cross-sectional view of carrier 600 with
radioactive seeds embedded in each of the six sections.
[0062] FIG. 7A illustrates a perspective view and FIG. 7B
illustrates a cross-sectional view of a carrier 700 having a
channel 702, or canal, extending through a longitudinal axis of the
carrier. As shown in cross-sectional view of FIG. 7B, the channel
702 is positioned parallel to the multiple seeds 710 embedded in
the carrier 700. In other embodiments, a channel may be positioned
in other locations. The channel 702 may be used for drainage, such
as to remove excess fluid around the carrier and/or as a path to
adding hydration to the carrier, such as to cause the proximal end
of the carrier to hydrate and expand into a cavity. In other
implementations, the channel may be used for gas exchange with the
treatment surface, such as to allow a fluid (e.g., a gas or a
liquid) to escape from a tumor cavity as the carrier is
inserted.
[0063] FIG. 8A illustrates a perspective view of another carrier
800 having flutes 810 extending along a length of the carrier. FIG.
8B is a cross-section of the carrier 800, illustrating the fluting.
The fluting may be used in a similar manner as the channel 702 of
FIG. 7, e.g., for drainage and/or for providing fluid to (or
allowing fluid removal from) a proximal end of the carrier.
Additionally, the fluting may adhere better to certain tissue than
a smooth outer surface. In some embodiments, a channel (e.g., as in
FIGS. 7A-7B) and/or fluting (e.g., as in FIGS. 8A-8B) may also be
used to allow delivery of antibiotics and/or other therapeutic
agents. For example, in some embodiments, one or more channels or
fluting may allow delivery of a fluidic therapeutic agent, such as
a chemotherapy drug, to the treatment surface.
[0064] In any of the embodiments discussed herein, at least a
proximal portion of a carrier (or the entire carrier) may comprise
a biopolymer material that delivers a therapeutic agent to a
treatment area and/or may be coated with a therapeutic agent.
[0065] In any of the embodiments discussed herein, markings may be
included during a custom carrier fabrication process (e.g., prior
to shipment to the surgical site) and/or as part of an
intra-operative implantation process. For example, markings (which
may be visual and/or tactile) may indicate a proximal portion of
the custom carrier that should contact (or be closest to) the
treatment surface. Alternatively, markings may indicate a distal
portion of the custom carrier that should be furthest away from the
treatment surface. In some implementations, markings may indicate
location of each radioactive seed embedded in a custom carrier
and/or a strength of each of the radioactive seeds, such as using a
color coding scheme or printing the numerical radiation strength
(e.g., in Gy) on the surface of the custom carrier. Similarly,
markings may indicate location of shielding, such as to indicate a
distal portion of the carrier.
[0066] FIG. 9 illustrates a carrier 900 that is configured for
placement in a tumor cavity of a patient via an introduction tool
930, such as endoscope 930A or tubing 930B or 930C. In this
example, the carrier may be compressed to form carrier 900B, which
is then sized for insertion into one of the introduction tools 930,
which may be selected based on the resection cavity size and access
cavity, for example. For example, insertion via a nasal passage may
be best performed using an endoscope while direct insertion into a
shallow resection cavity may be easier with one of the insertion
tools 930B or 930C. The introduction tool may then be used to find
the appropriate location for insertion of the carrier and embed the
carrier at that location. As noted above, in some embodiments the
compressed carrier 9106 expands to fill the tumor cavity upon
hydration within the tumor cavity.
Other Embodiments
[0067] Conditional language, such as, among others, "can," "could,"
"might," or "may," unless specifically stated otherwise, or
otherwise understood within the context as used, is generally
intended to convey that certain embodiments include, while other
embodiments do not include, certain features, elements and/or
steps. Thus, such conditional language is not generally intended to
imply that features, elements and/or steps are in any way required
for one or more embodiments or that one or more embodiments
necessarily include logic for deciding, with or without user input
or prompting, whether these features, elements and/or steps are
included or are to be performed in any particular embodiment.
[0068] It should be emphasized that many variations and
modifications may be made to the above-described embodiments, the
elements of which are to be understood as being among other
acceptable examples. All such modifications and variations are
intended to be included herein within the scope of this disclosure.
The foregoing description details certain embodiments of the
invention. It will be appreciated, however, that no matter how
detailed the foregoing appears in text, the invention can be
practiced In many ways. As is also stated above, the use of
particular terminology when describing certain features or aspects
of the invention should not be taken to imply that the terminology
is being re-defined herein to be restricted to including any
specific characteristics of the features or aspects of the
invention with which that terminology is associated. The scope of
the invention should therefore be construed in accordance with the
appended claims and any equivalents thereof.
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