U.S. patent application number 15/151026 was filed with the patent office on 2016-09-01 for method for utilizing an implant in a body of a patient.
The applicant listed for this patent is SenoRx, Inc.. Invention is credited to Lori Anthony, John Corbitt.
Application Number | 20160250018 15/151026 |
Document ID | / |
Family ID | 40790758 |
Filed Date | 2016-09-01 |
United States Patent
Application |
20160250018 |
Kind Code |
A1 |
Corbitt; John ; et
al. |
September 1, 2016 |
METHOD FOR UTILIZING AN IMPLANT IN A BODY OF A PATIENT
Abstract
A novel method for utilizing an implant in a body of a patient
includes placing within a cavity in the body of the patient an
implant constructed of biocompatible and biodegradable material
configured to support the tissue surrounding the cavity, the
implant having radio-opaque properties; and directing a radiation
beam to the implant.
Inventors: |
Corbitt; John; (Lake Worth,
FL) ; Anthony; Lori; (Lake Worth, FL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
SenoRx, Inc. |
Tempe |
AZ |
US |
|
|
Family ID: |
40790758 |
Appl. No.: |
15/151026 |
Filed: |
May 10, 2016 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14176252 |
Feb 10, 2014 |
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15151026 |
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14021271 |
Sep 9, 2013 |
8680498 |
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14176252 |
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13567303 |
Aug 6, 2012 |
8541764 |
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14021271 |
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12110748 |
Apr 28, 2008 |
8288745 |
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13567303 |
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11108785 |
Apr 19, 2005 |
7637948 |
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12110748 |
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10627718 |
Jul 28, 2003 |
6881226 |
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11108785 |
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09828806 |
Apr 10, 2001 |
6638308 |
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10627718 |
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09169351 |
Oct 9, 1998 |
6214045 |
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09828806 |
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60061588 |
Oct 10, 1997 |
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60077639 |
Mar 11, 1998 |
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60091306 |
Jun 30, 1998 |
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Current U.S.
Class: |
600/1 |
Current CPC
Class: |
A61B 90/39 20160201;
A61N 2005/1061 20130101; A61B 2090/3966 20160201; A61F 2/12
20130101; A61N 5/1049 20130101; A61B 2090/3908 20160201; A61F
2250/0098 20130101; A61N 5/10 20130101 |
International
Class: |
A61F 2/12 20060101
A61F002/12; A61N 5/10 20060101 A61N005/10; A61B 90/00 20060101
A61B090/00 |
Claims
1-30. (canceled)
31. A method for utilizing an implant in a body of a patient,
comprising: placing within a cavity in the body of the patient an
implant constructed of biocompatible and biodegradable material
configured to support the tissue surrounding the cavity, the
implant having radio-opaque properties; and directing a radiation
beam to the implant.
32. The method of claim 31, wherein the implant serves as a target
for delivery of radiation therapy to margins around the cavity.
33. The method of claim 32, wherein the act of directing comprises
initiating targeting of a radiation beam for delivery of radiation
therapy at least one day after placement of the implant in the
cavity.
34. The method of claim 32, wherein the act of directing occurs 90
to 120 days subsequent to placement of the implant in the
cavity.
35. The method of claim 31, further comprising aspirating air from
the cavity at any time after placement of the implant in the
cavity.
36. The method of claim 31, wherein the implant is constructed of a
porous material.
37. A method for utilizing an implant in a body of a patient,
comprising: providing an implant having a radio-opaque marker
contained within the implant; placing the implant within a cavity
in the body of the patient to support tissue surrounding the
cavity; and directing a radiation beam to the implant, the
radio-opaque marker within the implant serving as a target for
delivery of radiation therapy to margins around the cavity.
38. The method of claim 37, wherein the radio-opaque marker is
centrally located within the implant.
39. The method of claim 38, wherein the act of directing occurs 90
to 120 days subsequent to placement of the implant in the
cavity.
40. A method for utilizing an implant in a body of a patient,
comprising: forming a cavity within the body at a site where
potentially cancerous tissue has been removed, the cavity having
surrounding tissue; forming an implant of a biocompatible and
biodegradable material that is elastically compressible; sizing the
implant to occupy the cavity; and implanting within the cavity the
implant to support the tissue surrounding the cavity, the act of
implanting including initially compressing the implant.
41. The method of claim 40, further comprising directing a
radiation beam to the implant for delivery of radiation therapy to
margins around the cavity.
42. The method of claim 41, wherein the act of directing comprises
initiating targeting of a radiation beam for delivery of radiation
therapy at least one day after placement of the implant in the
cavity.
43. The method of claim 41, wherein the act of directing occurs 90
to 120 days subsequent to placement of the implant in the cavity.
Description
STATEMENT OF PRIORITY
[0001] This application is a continuation in part of U.S. patent
application Ser. No. 11/168,785 filed on Apr. 19, 2005 which is a
continuation in part of U.S. patent application Ser. No. 10/627,718
filed Jul. 28, 2003, now U.S. Pat. No. 6,881,226, which is a
continuation of U.S. patent application Ser. No. 09/828,806 filed
Apr. 10, 2001, now U.S. Pat. No. 6,638,308, which is a division of
U.S. patent application Ser. No. 09/169,351, filed Oct. 9, 1998,
now U.S. Pat. No. 6,214,045, which claims the benefit of U.S.
Provisional Application Ser. No. 60/061,588, filed Oct. 10, 1997,
U.S. Provisional Application Ser. No. 60/077,639 filed Mar. 11,
1998, and U.S. Provisional Application Ser. No. 60/091,306, filed
Jun. 30, 1998, the disclosures of which are incorporated herein by
reference.
BACKGROUND OF THE INVENTION
[0002] Radiation for breast cancer currently mainly consists of
full breast radiation, which imparts radiotherapy to the full area
of the breast. It necessarily involves surrounding structures such
as, but not limited to the heart, lungs, esophagus, chest wall,
ribs and other structures that are in close proximity to the
breast. A new concept of partial breast radiation targeting the
area of the breast involved by cancer is currently gaining
popularity. Studies thus far indicate that it is as effective as
full breast radiation and eliminates damage to the surrounding
organs. Partial breast radiation is currently being delivered
through temporarily implanted balloon catheters such as but not
limited to the MAMMOSITE or the CONTURA. This process involves
placing a radioactive seed or target down the catheter for a brief
period of time, over three to five days.
[0003] Unfortunately, this method of utilizing a catheter and
radioactive seed has a number of drawbacks. Utilizing a
concentrated dose of radiation over a short period of time in the
form of a radioactive seed planted through means of the catheter or
other surgical means creates a multitude of side effects such as
fat necrosis, seromas, hematomas, infection and undesirable
cosmetic outcomes. When a lumpectomy is performed, a temporary
balloon catheter is put into place with the catheter extruding from
the breast. This allows an opening into the cavity which increase
the chance of infection. Furthermore, this method requires the
physician to wait for the pathology report to indicate margins of
the specimen to be free of cancer (as well as the absence of cancer
from the lymph nodes) before the temporary balloon can be removed
and a Mammosite, Contura or other external catheters can be
implanted in preparation for partial breast radiation therapy. This
sequence of procedures is preferred as soon as possible following
lumpectomy. An additional drawback to the catheter methodology is
the need to aspirate air from the lumpectomy cavity. Air in a
lumpectomy cavity creates "hot spots" or high heat conditions
within the cavity when subjected to radiation therapy, thereby
causing burns and other undesirable side effects. Accordingly, it
is desirable to aspirate or remove the air, most commonly with a
syringe and needle. Unfortunately, the current method catheter may
be punctured by the needle during aspiration, creating problems for
its subsequent use and effectiveness in treatment. These problems
are resolved by use of the proposed method. We propose the use of
external beam radiation delivered through a multi-directional
stereotactic radiation source such as but not limited to the
CYBERKNIFE, the BRAIN LAB, and other external beam sources.
However, external beam radiation requires a sufficiently
identifiable target. Currently, external beam radiation is used on
solid organs such as the liver that contains a tumor or the head of
the pancreas that contains a tumor whereby a gold seed is implanted
in these structures and acts as a guide for focusing the external
stereotactic beam. The solid tissue of these organs provides a
stable, non-shifting environment for placement of the seed which
acts as a target for the external beam source. The use of the
catheter in breast tissue has been previously necessary due to the
presence of primarily fatty tissue in the breast, precluding a
stable environment for placement of a small seed or target. In
fatty tissue, a small seed or target would move from the intended
target site, rendering the therapy ineffective. The breast is an
external structure, constructed primarily of fatty tissue, unlike
the other mentioned organs. Consequently, what is necessary then,
is a means of stabilizing a seed or other target source within the
fatty tissue of the breast, which seed or other target source may
then be utilized as a target in a new method of partial breast
radiation. The proposed invention addresses this problem. Being an
external structure also, the breast is also capable of being more
rigidly fixed for targeting in stereotactic radiation machines than
the internal organs and is therefore a good candidate for utilizing
partial irradiation through careful targeting of the internal
implant and/or marker.
[0004] U.S. Pat. No. 6,214,045, issued to the applicant, discloses
a breast implant of resorbable material sized to replace excised
tissue and allowing for in-growth of fibrous tissue to replace the
implant. The implant may be elastic, compressible, and expandable
and may further contain diagnostic substances. The specification of
U.S. Pat. No. 6,214,045 is incorporated by reference herein.
Certain diagnostic substances are identified in the '045 Patent as
"x-ray opaque or metallic material for identification of the area."
Many embodiments of the implants described in the '045 patent may
act as appropriate targets for stereotactic radiation sources as
radiopaque targets. Biodegradable materials such as, but not
limited to, collagen and other suitably dense biocompatible
materials, may be configured suitably radiopaque. The implants may
alternatively be constructed of two or more different materials or
contain large amounts of air, which will also aid in acquisition
and targeting by a suitable stereotactic radiation source. The
implant may be shaped spherical to keep the lumpectomy cavity open
in a more uniform manner however this is not always necessary as
the lumpectomy cavity created by a biopsy procedure can be allowed
to partially collapse and conform to the size or shape of the
implant. Consequently, the implant shape may guide the external
beam source in order to allow a more specific area of the cavity to
be radiated on one side or the other, or uniformly
circumferentially in the event of utilizing a spherical implant.
Particularly when compared with the previously disclosed catheter
methodology, the ability to utilize variously shaped implants is
superior to the catheter, which is spherically shaped, in the event
it is necessary to construct a non-spherical lumpectomy cavity to
obtain the desired margins upon removal of the cancer. The implant
itself may act as the radio-opaque target or may have added to,
more or less, the central portion of the implant, a tiny metallic
marker such as but not limited to a gold seed or a titanium seed to
further aid as a guide for the external beam. To conform with
desired diagnostic needs and procedures, more than one marker may
be utilized in a single implant or more than one implant, placed
within the lumpectomy cavity. Different marker materials may be
contained within a single implant or within more than one implant
placed within the lumpectomy cavity. Any metallic material,
suitably sterilized, or other relatively dense biocompatible
material, may be utilized as a marker within the implant. Where the
external beam radiation is utilized, it accomplishes local
brachytherapy with its benefits and the beam can be configured over
varying time periods so as to eliminate many of the complications
associated with the current method of partial breast radiation, the
balloon MammoSite or Contura. Use of the implants described in the
'045 patent, addresses a multitude of the current problems known to
the medical industry such as but not limited to cosmetic
deformities, seromas, hematomas, infection and the like while
simultaneously providing the stable target necessary for successful
targeted radiation therapy. The 045 implants are configured to keep
the cavity open and support the surrounding tissue. This is
particularly important in radiation therapy as new tissue growth
will be inhibited by the presence of radiation therapy.
Accordingly, this method and use of the implant will enable the
lumpectomy site to retain its configuration throughout radiation
therapy and thereafter provide time for regeneration and in-growth
of new tissue upon termination of radiation therapy. Once the
external beam radiation is accomplished, the implant may biodegrade
over a period of time allowing ingrowth of the patient's own
natural tissues and, therefore reduce the risk of undesirable
cosmetic changes to the overlying skin or the breast. It may also
have added to the implant hemostatic agents to minimize bleeding,
other metallic markers, oncologic agents, antibiotics and the
like.
[0005] Another advantage in the use of the implant for targeted
partial breast radiation therapy is that the biodegradable implant
can be inserted into the breast at the time of the lumpectomy but
radiation therapy my be delayed without presenting complications in
the maintenance of the targeting means, treatment or to the
patient. With the use of the catheter methodology, the externally
extruding catheter and its prior discussed issues necessitates
immediate radiation therapy treatment to minimize, to the extent
possible, potential complications such as infection and discomfort
to the patient. Immediate radiation therapy is not always preferred
because the surgical wound is fresh and has not healed. The use of
radiation further retards healing and promotes seroma formation,
infection, and cosmetic defects because of poor healing. The
proposed methodology, utilizing the implant, allows the implant to
be placed in the lumpectomy cavity and the wound surgically sealed.
The patient may maintain a normal lifestyle and radiation therapy
may be scheduled as appropriate in the particular case. The patient
may undergoe chemotherapy and can delay radiation therapy up to
about 120 days without decreasing the therapeutic effects of the
radiation. The implant may degrade somewhat over a period of time
while the breast is healing to allow the lumpectomy cavity to
compress down upon the implant or scar down around the implant
shrinking the cavity and stabilizing the target for future
radiation. Future radiation therapy may be initiated many days or
weeks after the lumpectomy. Radiation therapy may be discontinued,
if necessary, and re-instituted as necessary, within the life of
the biodegradable implant or, in the case of a marker, at any time
thereafter. This accomplishes the prevention of hematomas or
seromas, resulting in a better cosmetic outcome while maintaining a
stable target for future therapy or diagnosis.
DESCRIPTION OF THE DRAWINGS
[0006] FIG. 1 depicts one embodiment of an implant placed within a
breast lumpectomy cavity to act as a target for radiation therapy
emissions.
[0007] FIG. 2 depicts an alternative embodiment of an implant
placed within a breast lumpectomy cavity and containing an internal
marker to act as a target for radiation therapy emissions.
[0008] FIG. 3 depicts one example of an implant placed within a
breast lumpectomy cavity and subjected to radiation therapy
emissions.
[0009] FIG. 4 depicts an alternative embodiment of an implant
containing an internal marker to act as a target for radiation
therapy emissions.
[0010] FIGS. 5A and 5B depict implants of various shapes and
configurations placed within breast lumpectomy cavities.
[0011] FIG. 6 depicts a partially re-absorbed implant within a
shrinking breast lumpectomy cavity.
[0012] FIG. 7 depicts a partially re-absorbed implant containing a
metallic marker within a shrinking breast lumpectomy cavity.
DETAILED DESCRIPTION OF THE DRAWINGS
[0013] In FIG. 1, a substantially spherical implant (100) is
composed of biodegradable material and is placed within a breast
lumpectomy cavity (110) following a biopsy or other surgical
procedure. The implant may be constructed of materials such as
biodegradable foams, sponges, gels, liquids, or other biocompatible
substances. The material is formed in such a way that it can
support surrounding breast tissue, assisting in breast cosmesis by
keeping the breast lumpectomy cavity from collapsing. The implant
further functions as a radio-opaque target for external beam
stereotactic partial breast radiotherapy. The implant can be
constructed with varying pore sizes thus allowing for example, more
air to be incorporated into the implant, rendering the implant more
radio-opaque while preventing the collection of air pockets within
the breast cavity which create unsuitable conditions for radiation
therapy. The implant does not need to be the exact size of the
lumpectomy cavity, however. Breast tissue will collapse around the
implant, keeping the cavity open and relatively equal distance from
the center of the implant. The implant is of a sufficient size and
solid consistency to allow a stereotactic radiation source to be
directed to the implant as a target for delivery of radiation
therapy to the surrounding margins of the lumpectomy cavity in a
precise configuration as determined by the radiotherapist.
[0014] In FIG. 2, the implant (100) of FIG. 1 further contains a
gold seed, metallic seed, titanium clip or other suitably dense
implant material (120) to aid in successful targeting of the
implant area for a stereotactic radiation source. Since margins can
vary from patient to patient, the use of an implant material can
serve as a guide for programming the stereotactic radiation unit.
The target material may be centrally located within the implant or
located about the periphery of the implant. One or more implant
materials may be concurrently used as necessary to conform the
intended radiation therapy to the patient's breast cancer
treatment. As the target material may or may not be biodegradable,
the implant material may remain available for extended radiation
therapy as necessary. Biodegradable material may have variable
absorption rates.
[0015] In FIG. 3, an example of multi-directional (stereotactic)
radiation therapy (160) targets a breast implant (100) in the
breast lumpectomy cavity (110), partially irradiating the breast
within targeted margins (170) around the lumpectomy cavity
(110).
[0016] In FIG. 4, an example of multi-directional (stereotactic)
radiation therapy (160) targets a breast implant (100) containing
an internal marker (120), in the breast lumpectomy cavity (110),
partially irradiating the breast within targeted margins (170)
around the lumpectomy cavity (110).
[0017] In FIG. 5A and FIG. 5B, an implant (100) in the breast
lumpectomy cavity (110) may be configured to conform to the
lumpectomy cavity excised to create sufficient margins for excision
of cancer or in accordance with good medical practice for the
surgical procedure. The ability to conform the implant to the
cavity allows appropriate margins to be maintained for following
radiation treatment and supports the surrounding breast tissue
without deformation.
[0018] In FIG. 6, the implant (100) has partially reabsorbed as a
consequence of the passage of time. Unlike the prior art catheter,
the implant can act as a target to the biopsy site for weeks or
months after implantation, to allow for healing, chemotherapy or
other issues necessitating a delay in radiation treatment. The
surrounding breast tissue comprising the lumpectomy cavity
collapses or generates growth as the implant resorbs, holding the
implant in place and the geometry of the breast tissue in static
relation.
[0019] In FIG. 7, the resorbing implant (100) also contains one or
more markers (120) to aid in targeting. Again, the implant and
marker allow the treating physician to delay radiation treatment
pending healing, chemotherapy or other favorable reasons for
delay.
* * * * *