U.S. patent application number 16/329010 was filed with the patent office on 2019-07-04 for breast treatment device.
This patent application is currently assigned to LifeCell Corporation. The applicant listed for this patent is LifeCell Corporation. Invention is credited to Aaron Barere, Sangwook Park, Kai-Roy Wang.
Application Number | 20190201580 16/329010 |
Document ID | / |
Family ID | 59858791 |
Filed Date | 2019-07-04 |
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United States Patent
Application |
20190201580 |
Kind Code |
A1 |
Barere; Aaron ; et
al. |
July 4, 2019 |
BREAST TREATMENT DEVICE
Abstract
The present disclosure provides devices for treating breasts.
The devices (100) include a sheet of acellular tissue matrix having
a predefined shape that allows for complete or enhanced coverage of
an anterior portion of a breast implant or tissue expander or to
support an implant and/or surrounding tissues. The sheet includes
curved upper and lower borders or edges.
Inventors: |
Barere; Aaron; (Hoboken,
NJ) ; Park; Sangwook; (Dunellen, NJ) ; Wang;
Kai-Roy; (Jersey City, NJ) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
LifeCell Corporation |
Madison |
NJ |
US |
|
|
Assignee: |
LifeCell Corporation
Madison
NJ
|
Family ID: |
59858791 |
Appl. No.: |
16/329010 |
Filed: |
August 31, 2017 |
PCT Filed: |
August 31, 2017 |
PCT NO: |
PCT/US2017/049516 |
371 Date: |
February 27, 2019 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
62381865 |
Aug 31, 2016 |
|
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|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 2230/0013 20130101;
A61F 2220/0008 20130101; A61F 2210/0057 20130101; A61F 2/0063
20130101; A61L 2430/04 20130101; A61F 2230/0008 20130101; A61F 2/12
20130101; A61L 27/3666 20130101; A61L 27/3695 20130101; A61L
27/3641 20130101; A61L 27/362 20130101; A61L 27/56 20130101 |
International
Class: |
A61L 27/36 20060101
A61L027/36; A61F 2/12 20060101 A61F002/12; A61L 27/56 20060101
A61L027/56 |
Claims
1. A breast treatment device, comprising: a sheet of acellular
tissue matrix, wherein the sheet of acellular tissue matrix
comprises a flexible sheet with a top surface and a bottom surface,
wherein the sheet has a first section and a second section, and the
first and second sections have different shapes and are attached to
one another, and wherein the first section includes curved first
and second edges, and the second section includes curved first and
second edges.
2. The device of claim 1, wherein the first edge of the first
section has a degree of curvature that is greater than a degree of
curvature of the second edge of the first section.
3. The device of claim 1, wherein the first edge of the second
section has a degree of curvature that is greater than a degree of
curvature of the second edge of the second section.
4. The device of claim 1, wherein the first section and second
section are attached to one another along the second edge of each
of the first section and second section.
5. The device of claim 1, wherein the sheet of acellular tissue
matrix comprises a dermal tissue matrix.
6. The device of claim 1, wherein the acellular tissue matrix is a
porcine tissue matrix.
7. The device of claim 1, wherein the acellular tissue matrix is a
human tissue matrix.
8. The device of claim 1, wherein the device further comprises a
breast implant or tissue expander.
9. A method of treatment, comprising: selecting a breast treatment
device comprising a sheet of acellular tissue matrix, wherein the
sheet of acellular tissue matrix comprises a flexible sheet with a
top surface and a bottom surface, wherein the sheet has an upper
curved border having a first degree of curvature and a lower curved
border having a second degree of curvature, wherein the lower
curved border is shaped and sized to conform to a desired shape of
a lower margin of a breast, and wherein the upper curved border is
sized and shaped such that the flexible sheet of acellular tissue
matrix can cover substantially all of the anterior surface of a
breast implant or tissue expander when implanted in a breast; and
implanting the breast treatment device along with a breast implant
or a tissue expander within a breast.
10-27. (canceled)
28. The method of claim 9, wherein the method comprises implanting
the breast implant or tissue expander anterior to pectoralis
muscles.
29. The method of claim 9, wherein the sheet of acellular tissue
matrix is positioned adjacent to the breast implant or tissue
expander to cover substantially all of an anterior surface of the
breast implant or tissue expander.
30. The method of claim 9, further comprising securing a portion of
the sheet of acellular tissue matrix to tissue.
31. The method of claim 30, wherein the sheet of acellular tissue
matrix is secured to a portion of a chest wall.
32. The method of claim 9, wherein the sheet of acellular tissue
matrix comprises one of a dermal tissue matrix, a porcine tissue
matrix, or a human tissue matrix.
33. A method of treatment, comprising: selecting a breast treatment
device comprising a sheet of acellular tissue matrix according to
claim 1; and implanting the breast treatment device along with a
breast implant or tissue expander within a breast.
34. The method of claim 33, wherein the method comprises implanting
the breast implant or tissue expander anterior to pectoralis
muscles.
35. The method of claim 33, wherein the sheet of acellular tissue
matrix is positioned adjacent to the breast implant or tissue
expander to cover substantially all of an anterior surface of the
breast implant or tissue expander.
36. The method of claim 33, further comprising securing a portion
of the sheet of acellular tissue matrix to tissue.
37. The method of claim 33, wherein the sheet of acellular tissue
matrix is secured to a portion of a chest wall.
Description
[0001] This application claims priority under 35 USC .sctn. 119 to
U.S. Provisional Application No. 62/381,865, which was filed on
Aug. 31, 2016 and is hereby incorporated by reference in its
entirety.
[0002] The present disclosure relates generally to devices for
improving breast surgeries, including tissue matrices specially
shaped and sized for breast reconstruction or augmentation.
[0003] The use of acellular tissue matrices such as ALLODERM.RTM.,
a dermal acellular matrix produced by LIFECELL.RTM. CORPORATION
(Branchburg, N.J.), for use in breast procedures has become
increasingly popular with plastic surgeons. Such materials provide
a number of advantages and can be used to replace or augment
supportive structures after, for example, mastectomy. Such
materials can also be useful in reconstructive or aesthetic
procedures (e.g., breast augmentation) by providing additional
support for breast implants, allowing improved control of breast
shape, preventing skin rippling, and/or preventing or treating
other problems that may occur with breast augmentation (e.g.,
symmastia and bottoming out.)
[0004] For many surgical procedures, in order to achieve desired
results, surgeons must alter the shape of sheets of tissue
matrices. However, correctly forming the necessary shapes and
implanting the materials properly can be time consuming, especially
for less experienced surgeons. Furthermore, tissue matrices such as
acellular dermal matrices can be expensive. Accordingly, requiring
surgeons to reshape or resize relatively large pieces of such
materials is not cost effective. To improve both surgical results
and efficiency (in terms of both operative time and cost),
pre-sized or pre-shaped tissue matrices can be beneficial. In
addition, to provide coverage to select portions of implants or
tissue matrices (e.g., the anterior surface or skin-contacting
surface) improved, pre-formed shapes may be useful. Furthermore,
matrices that are sized and shaped to facilitate complete coverage
of the implant, complete coverage of selected parts (the anterior
portion and/or parts of the superior/inferior/lateral/posterior
implant), and/or attachment to surrounding structures can be
useful. In addition, matrices sized and shaped to provide support
to the breast and/or an implant, or to reinforce, augment, or
otherwise protect or improve the quality of the overlying dermal
tissue in prepectoral or other breast reconstructive procedures is
desired for some patients.
[0005] The present application provides improved breast treatment
devices including tissue matrix materials specially shaped and/or
sized to improve surgical breast procedures.
[0006] Accordingly, in some embodiments, a breast treatment device
is provided. The device can include a sheet of acellular tissue
matrix, wherein the sheet of acellular tissue matrix comprises a
flexible sheet with a top surface and a bottom surface, wherein the
sheet has a first section and a second section, and the first and
second sections have different shapes and are attached to one
another, and wherein the first section includes curved first and
second edges, and the second section includes curved first and
second edges.
[0007] In some embodiments, a breast treatment device is provided.
The device can include a sheet of acellular tissue matrix, wherein
the sheet of acellular tissue matrix comprises a flexible sheet
with a top surface and a bottom surface, wherein the sheet has an
upper curved border having a first degree of curvature and a lower
curved border having a second degree of curvature, wherein the
lower curved border is shaped and sized to conform to a desired
shape of a lower margin of a breast, and wherein the upper curved
border is sized and shaped such that the flexible sheet of
acellular tissue matrix can cover substantially all of the anterior
surface of a breast implant or tissue expander when implanted in a
breast.
[0008] In some embodiments, a breast treatment device is provided.
The device can include a sheet of acellular tissue matrix, wherein
the sheet of acellular tissue matrix comprises a flexible sheet
with a top surface and a bottom surface, wherein the sheet
comprises a lower curved border and an upper curved border, wherein
the upper curved border and lower curved border are joined at
apices at lateral ends of the device, and the sheet is
symmetrically shaped about an axis midway between the apices and
parallel to the top and bottom surfaces when lying on a flat
surface, wherein the lower border forms a single outward arc shape,
and wherein the upper border has three arc sections including first
and second sections each extending from one of the apices, and a
third section joining the first and second sections, the third
section having a degree of curvature that is different than the
degree of curvature of the first and section sections.
[0009] In some embodiments, a breast treatment device is provided.
The device can include a sheet of acellular tissue matrix, wherein
the sheet of acellular tissue matrix comprises a flexible sheet
with a top surface and a bottom surface, wherein the sheet has an
upper curved border having a first degree of curvature and a lower
curved border having a second degree of curvature, wherein the
lower curved border is shaped and sized to conform to a desired
shape of a lower margin of a breast, and wherein the sheet is sized
and shaped to provide an interface between subcutaneous tissue and
the entire anterior surface of a breast implant or tissue
expander.
[0010] Also provided are methods of treatment that include
implanting the disclosed devices within a breast along with a
breast implant or tissue expander.
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] Reference will now be made to exemplary embodiments,
examples of which are illustrated in the accompanying drawings.
Wherever possible, the same reference numbers will be used
throughout the drawings to refer to the same or like parts. The
drawings are not necessarily to scale.
[0012] FIG. 1 illustrates a breast treatment device for more
complete coverage of a breast implant or tissue expander in a
pre-pectoral position, according to certain embodiments.
[0013] FIG. 2 illustrates a breast treatment device for more
complete coverage of and/or support of a breast implant or tissue
expander, according to certain embodiments.
[0014] FIG. 3 illustrates another breast treatment device for more
complete coverage of and/or support of a breast implant or tissue
expander, according to certain embodiments.
[0015] FIG. 4 illustrates another breast treatment device for more
complete coverage of and/or support of a breast implant or tissue
expander, according to certain embodiments.
[0016] FIG. 5A is a frontal view of the breast treatment device
including an acellular tissue matrix positioned over a breast
implant to illustrate how the device provides coverage to the
implant or tissue expander or supports the implant or reinforces
surrounding tissue.
[0017] FIG. 5B is a side view of the breast treatment device of
FIG. 5A including an acellular tissue matrix positioned over a
breast implant to illustrate how the device provides coverage to
the implant or tissue expander or supports the implant or
reinforces surrounding tissue.
[0018] FIG. 5C is a top view of the breast treatment device of FIG.
5A including an acellular tissue matrix positioned over a breast
implant to illustrate how the device provides coverage to the
implant or tissue expander or supports the implant or reinforces
surrounding tissue.
[0019] FIG. 6A is a frontal view of a breast treatment device
including an acellular tissue matrix positioned over a breast
implant to illustrate how the device provides coverage to the
implant or tissue expander.
[0020] FIG. 6B is a side view of the breast treatment device of
FIG. 6A including an acellular tissue matrix positioned over a
breast implant to illustrate how the device provides coverage to
the implant or tissue expander.
[0021] FIG. 6C is a top view of the breast treatment device of FIG.
6A including an acellular tissue matrix positioned over a breast
implant to illustrate how the device provides coverage to the
implant or tissue expander.
[0022] FIG. 7A is a frontal view of a breast treatment device
including an acellular tissue matrix positioned over a breast
implant to illustrate how the device provides coverage to the
implant or tissue expander.
[0023] FIG. 7B is a side view of the breast treatment device of
FIG. 7A including an acellular tissue matrix positioned over a
breast implant to illustrate how the device provides coverage to
the implant or tissue expander.
[0024] FIG. 7C is a top view of the breast treatment device of FIG.
7A including an acellular tissue matrix positioned over a breast
implant to illustrate how the device provides coverage to the
implant or tissue expander.
[0025] FIG. 8A illustrates implantation of the breast treatment
device of FIG. 2 in a prepectoral position along with a breast
implant.
[0026] FIG. 8B illustrates implantation of the breast treatment
device of FIG. 3 in a prepectoral position along with a breast
implant.
[0027] FIG. 9 illustrates a breast treatment device for more
complete coverage of a breast implant or tissue expander and/or
support or reinforcement of surrounding tissues, wherein the device
further includes preformed tabs or extensions for attachment to
tissue, according to certain embodiments.
[0028] FIG. 10 illustrates a breast treatment device for more
complete coverage of a breast implant or tissue expander and/or
support or reinforcement of surrounding tissues, wherein the device
further includes preformed slits or openings, according to certain
embodiments.
[0029] FIG. 11 illustrates a breast treatment device for more
complete coverage of a breast implant or tissue expander and/or
support or reinforcement of surrounding tissues, wherein the device
further includes preformed holes or openings, according to certain
embodiments.
[0030] FIG. 12 illustrates a breast treatment device for more
complete coverage of a breast implant or tissue expander and/or
support or reinforcement of surrounding tissues, wherein the device
further includes preformed holes or pilot holes, according to
certain embodiments.
[0031] FIG. 13 illustrates a breast treatment device in accordance
with the embodiments of FIG. 3 for more complete coverage of a
breast implant or tissue expander and/or support or reinforcement
of surrounding tissues, wherein the device further includes
preformed holes or pilot holes, according to certain
embodiments.
[0032] FIG. 14 illustrates another breast treatment device in
accordance with the embodiments of FIG. 3 for more complete
coverage of a breast implant or tissue expander and/or support or
reinforcement of surrounding tissues, wherein the device further
includes preformed holes or pilot holes, according to certain
embodiments.
DESCRIPTION OF EXEMPLARY EMBODIMENTS
[0033] Reference will now be made in detail to various embodiments
of the disclosed devices and methods, examples of which are
illustrated in the accompanying drawings. Wherever possible, the
same reference numbers will be used throughout the drawings to
refer to the same or like parts.
[0034] In this application, the use of the singular includes the
plural unless specifically stated otherwise. In this application,
the use of "or" means "and/or" unless stated otherwise.
Furthermore, the use of the term "including", as well as other
forms, such as "includes" and "included", is not limiting. Any
range described herein will be understood to include the endpoints
and all values between the endpoints.
[0035] The section headings used herein are for organizational
purposes only and are not to be construed as limiting the subject
matter described. All documents, or portions of documents, cited in
this application, including but not limited to patents, patent
applications, articles, books, and treatises, are hereby expressly
incorporated by reference in their entirety for any purpose.
[0036] The present disclosure relates generally to devices for
surgical breast procedures and systems and methods relating to such
devices. The devices can be used for tissue augmentation, repair or
regeneration of damaged tissue, and/or correction of tissue
defects. As such, the devices, systems, and methods discussed
herein can be suitable for a wide range of surgical applications,
such as, for example, aesthetic surgery, breast reconstruction,
breast augmentation, breast enhancement, breast reduction, and
revisionary breast surgeries.
[0037] The tissue matrices used to produce the devices described
herein can include a variety of different materials. For example,
an acellular tissue matrix or other tissue product can be selected
to allow tissue ingrowth and remodeling to assist in regeneration
of tissue normally found at the site where the matrix is implanted.
For example, an acellular tissue matrix, when implanted on or into
subdermal tissue, fascia, mammary tissue, muscle, bone, adipose or
other tissue, may be selected to allow regeneration of the tissue
without excessive fibrosis or scar formation. In certain
embodiments, the devices can be formed from ALLODERM.RTM. or
STRATTICE.TM. (LIFECELL.RTM. CORPORATION, BRANCHBURG, N.J.) which
are human and porcine acellular dermal matrices, respectively.
Alternatively, other suitable acellular tissue matrices can be
used. For example, a number of suitable biological scaffold
materials are described by Badylak et al. "Extracellular Matrix as
a Biological Scaffold Material: Structure and Function," Acta
Biomaterialia (2008), doi:10.1016/j.actbio.2008.09.013. The devices
described herein can be produced from a variety of different human
or animal tissues including human, porcine, ovine, bovine, or other
animals tissues.
[0038] Tissue matrix products, such as acellular dermal tissue
matrices, are widely used in surgical breast procedures. For
example, sheets of acellular dermal matrix can be provided as a
square or rectangular sample, which can be cut to a desired shape
if needed. In addition, certain preformed tissue matrix shapes are
available. For example, crescent or other curved shapes are
available to reduce the amount of tissue matrix needed while
providing an appropriate shape for an aesthetically desirable
surgical result.
[0039] For some surgical applications, however, different shapes
and sizes for tissue matrices would be beneficial. For example,
when implanting a breast implant or tissue expander in a
pre-pectoral position, i.e., anterior to the pectoral muscles, it
would be beneficial in some cases to provide a tissue matrix shape
and size that allows one or more of (1) complete or near complete
anterior coverage of an implant or tissue expander, (2) minimized
need for resizing or shaping the tissue matrix, or (3) preshaped
borders that facilitate attachment to anatomical structures to
produce desired surgical results (e.g., aesthetic or reconstructive
result with low likelihood of complications).
[0040] FIG. 1 illustrates a breast treatment device 100 for more
complete coverage of a breast implant or tissue expander in a
pre-pectoral position and/or to support a breast implant or tissue
expander, or help regenerate, reinforce, augment, or support
surrounding tissue such as overlying dermis and subdermal tissue,
according to certain embodiments. Although the devices and methods
discussed herein are made with respect to, primarily, prepectoral
procedures, the devices can be used by surgeons for other
procedures. The device 100 can include a flexible sheet of
acellular tissue matrix, as discussed above. As discussed in more
detail below, the device 100 can be affixed to a chest wall 30 or
other appropriate tissue to cover an implant or tissue expander
(not shown in FIG. 1). The device can be secured in place using
sutures 60 or other surgical fixation devices (e.g., staples,
clips, surgical adhesives).
[0041] FIGS. 2-4 are top views of various embodiments of devices,
according to the present disclosure. The devices illustrated in
FIGS. 2-4 can each include flexible sheets of acellular tissue
matrix, which can have one of the illustrated shapes when laid
flat. Each of the devices 100, 200, 300, can allow complete or
substantially complete coverage of the anterior portion of a breast
implant or tissue expander, including an implant or tissue expander
positioned anterior to the pectoralis muscles. In addition, or
alternatively, the devices can help support a breast implant or
tissue expander, or help regenerate, reinforce, augment, or support
surrounding tissue such as overlying dermis and subdermal tissue.
When placed in contact with overlying tissue, the tissue matrix
will support tissue regeneration, ultimately becoming infiltrated
by cells and becoming vascularized, thereby providing enhanced
tissue coverage to improve surgical outcomes, e.g., by preventing
various possible adverse events such as rippling, loss of tissue
integrity.
[0042] FIG. 2 illustrates a breast treatment device 100 for more
complete coverage of a breast implant or tissue expander and/or to
support a breast implant or tissue expander, or help regenerate,
reinforce, augment, or support surrounding tissue such as overlying
dermis and subdermal tissue, according to certain embodiments. As
shown, the device 100 includes a sheet of acellular tissue matrix.
The sheet can include a top surface and a bottom surface (the
surfaces correspond to the front and back of the two-dimensional
image of FIG. 2).
[0043] The sheet forming the device 100 has a first section 104 and
a second section 108, and the first 104 and second 108 sections
have different shapes and are attached to one another at a joining
section 110. The first section includes curved first 106 and second
edges 111, and the second section includes curved first 114 and
second edges 112.
[0044] The curvature of the edges 106, 111, 114, 112 of the first
104 and second 108 sections can be varied to produce a desired
shape. For example, in one embodiment the first edge 106 of the
first section 104 has a degree of curvature that is greater than a
degree of curvature of the second edge 111 of the first section
104. In addition, the first edge 114 of the second section 108 can
have a degree of curvature that is greater than a degree of
curvature of the second edge 112 of the second section 108. As
shown, the first edges 106, 114 of the sections 104, 108 are the
edges at opposite ends of the device 100.
[0045] The second edge 111 and second edge 112 will be understood
to refer to a curved edge extending from opposite apices 117/117',
119/119' of the sections 104, 108 (i.e., edges along dashed lines
113, 115). But, as shown in FIG. 2, the sections 104 and 108 are
joined at a joining section 110, such that the first section 104
and second section 108 are attached to one another along the second
edges 111,112 of each of the first section 104 and second section
108. The joining section 110 may simply be a continuation of a
single sheet of acellular tissue matrix forming the device 100. As
shown, the apices 117/117', 119/119' are pointed to form an acute
angle, but the apices may alternatively be curved or rounded.
[0046] The device 100 is illustrated as having two-dimensional
symmetry about a line or axis 120 passing midway through the tissue
matrix 100 when the device lies flat. Variations in the shape may
be made, or the device may be made nearly or perfectly symmetric.
Furthermore, the device 100, having first and second sections 104,
108 can more readily conform to an implant or expander shape,
provide improved support to an implant or expander, or provide
complete overlying tissue contact by virtue of spaces on the
lateral sides of the joining section 110, i.e., between the second
edges 111, 112, where a gap is formed.
[0047] FIG. 3 illustrates another breast treatment device 200 for
more complete coverage of a breast implant or tissue expander,
according to certain embodiments. As shown, the device 200 includes
a sheet of acellular tissue matrix, wherein the sheet of acellular
tissue matrix comprises a flexible sheet 200 with a top surface and
a bottom surface (the surfaces correspond to the front and back of
the two-dimensional image of FIG. 3).
[0048] The sheet 200 can be sized and shaped to allow coverage of a
breast implant or tissue expander, provide improved support to an
implant or expander, or provide complete overlying tissue contact.
As shown, the sheet 200 has an upper curved border 210 having a
first degree of curvature and a lower curved border 220 having a
second degree of curvature. The upper border 210 and lower border
220 can be joined at lateral apices 224, 228, which can include a
sharp angle or rounder edges.
[0049] As with the device 100 of FIG. 2, the device 200 can be
sized and shaped to allow coverage of a breast implant or tissue
expander, particularly for coverage of an anterior portion of the
implant or expander when implanted in a prepectoral position. In
addition or alternatively, the device can provide improved support
to an implant or expander, or provide complete overlying tissue
contact. In one embodiment, the lower curved border 220 is shaped
and sized to conform to a desired shape of a lower margin of a
breast, and the upper curved border 210 is sized and shape such
that the flexible sheet of acellular tissue matrix can cover
substantially all of the anterior surface of a breast implant to
tissue expander
[0050] Many implants or expanders will have a shape and size such
that the implant volume at the lower pole is greater than that at
the upper pole. The device 200 (as well as other devices described
herein), allows coverage and support of such implants with little
or no additional manipulation by surgeons (e.g., no cutting to size
and shape). As such, the devices 200 (and 100, 300) prevent waste
of valuable tissue matrix material, save substantial operating room
time, and have preformed margins that produce a desired
configuration when implanted.
[0051] The size and shape of the devices 100, 200, 300 can be
selected based on typical implant or tissue expander (when fully
expanded) shapes and volumes. For example, for the device 200 of
FIG. 3, the device can include a lower section 230 and upper
section 240 and the height or length of the lower and upper
sections 230, 240 can be selected based on the desired implant or
expander size and shape as well as a the need for additional
material to cover tissue or affix the device to surrounding
structures. Exemplary, sizes can include, for example a height
(from the bottom or lower border 220 to top of upper border 210)
from 15-25 cm, and a width from apices 224, 228 of 15-30 cm. For
example, a small device may have a height of 15 cm and width of
17-18 cm; a medium device a height of 18-19 cm and width of 21-22
cm; and a large device a height of 20-21 cm and width of 23-24 cm;
and an extra-large device a height of 22-23 cm and width of 26-27
cm.
[0052] FIG. 4 illustrates another breast treatment device 300 for
more complete coverage of a breast implant or tissue expander. The
device 300 can include a sheet 300 of acellular tissue matrix,
wherein the sheet of acellular tissue matrix comprises a flexible
sheet with a top surface and a bottom surface (the surfaces
correspond to the front and back of the two-dimensional image of
FIG. 4).
[0053] The sheet 300 can include a lower curved border 314 and an
upper curved border 316, wherein the upper border 316 and lower
border 314 are joined at apices 308, 309 at lateral ends of the
device 300. As with the other devices 100, 200, the apices 308, 309
can be sharp angles or can be rounded.
[0054] The device 300 can have a configuration such that when lying
on a flat surface, the sheet 300 is symmetrically shaped about an
axis 320 midway between the apices 308, 309 and parallel to the top
and bottom surfaces.
[0055] The device 300 can also be shaped such that the lower border
314 forms a single outward arc shape (lower section 302), and the
upper border 316 has three arc sections 306, 306', 307, including
first and second sections 306, 306' each extending from one of the
apices 308, 309, and a third section 307 joining the first and
second sections 306, 306', the third section having a degree of
curvature that is different than the degree of curvature of the
first and section 306, 306' sections. The arc sections 306, 306',
307 can form the upper portion or section 304, while the lower
border 314 defines the lower section 302.
[0056] As discussed previously, the devices described herein can be
used to allow coverage of a tissue expander or implant, including
implants or expanders positioned in a prepectoral position. In
addition or alternatively, the device can provide improved support
to an implant or expander, or provide complete overlying tissue
contact. As such, FIG. 5A illustrates a frontal view of the breast
treatment device 100 including an acellular tissue matrix
positioned over a breast implant to illustrate how the device
provides coverage to the implant or tissue expander. It will be
understood that when implanted, and as discussed further below, the
tissue matrix will contact overlying dermal or subcutaneous tissue,
as well as possible contact and connection with muscle or other
tissues, and the matrix can support the implant, allow ingrowth of
tissue, and provide tissue regeneration, support, and
vascularization, in some cases for patients for whom insufficient
tissue or insufficient tissue strength or vascularity would have
been present in the absence of the tissue matrix. As such, the
tissue matrix allows prepectoral positioning while avoiding other,
often difficult procedures.
[0057] FIGS. 5B and 5C are side and top views, respectively, of the
device of FIG. 5A. FIGS. 6A-6C provide comparable views of the
device 200 of FIG. 3 over an implant; and FIG. 7A. FIGS. 7A-7C
provide comparable views of the device 300 of FIG. 4 over an
implant. It should be noted that the frontal view is described in
reference to how the device and implant should be viewed with
respect to a patient if the implant covered by the devices 100,
200, 300 were located on the anterior chest wall. So, for example,
FIG. 5A is referred to as a frontal view as it is a view showing
the front of the device 100 when covering an implant (behind the
device) as it would be viewed from the front of a patient in whom
the device is implanted.
[0058] FIG. 8A illustrates implantation of the breast treatment
device 100 of FIG. 2 in a prepectoral position along with a breast
implant. And FIG. 8B illustrates implantation of the breast
treatment device 200 of FIG. 3 in a prepectoral position along with
a breast implant. A similar implantation process and configuration
would be applicable to the other devices 300 or variations thereof
described throughout. As shown, the devices 100, 200 are implanted
to cover an implant 20 or expander on an anterior portion of the
chest wall 30. One section 108 (or upper and lower section of
device 200) is positioned to cover a lower portion of the implant,
while the other section 104 covers an upper portion of the implant
20.
[0059] To secure the devices 100, 200 (or any other device
described herein) in place, parts of the device 100, 200, such as
the lower border 114, 220 and/or upper border 106, 210 can be
affixed to tissue using sutures, clips, staples, adhesives, or
other suitable surgical fixation systems. In some cases, the device
100, 200 (or device 300) can be sized to provide an amount of
tissue matrix that wraps around the posterior portion of the
implant or expander, e.g., at the lower margin/inframammary fold
and/or at the superior surface of the implant or expander. The
devices may be sized to wrap between, for example, 1-3 cm, 1-2 cm
around the posterior portion of the implant or expander at either
or both of the inferior or superior portions of the implant or
expander.
[0060] In some cases, the implant or tissue expander includes
suture tabs or other fixation components to allow the device 100,
200, or 300 to be secured to the implant or expander. In such
cases, the device can be joined to the expander or implant prior to
or during implantation before final positioning within an implant
site. In cases where the device 100, 200, 300 is sized to wrap
partially around a posterior portion of the implant or expander,
the tabs or fixation devices can be posteriorly located so that the
device can be secured to the posterior aspect of the implant or
expander, while the device is in contact with overlying subdermal
tissues when implanted.
[0061] The devices described herein can further be modified to
facilitate fixation to tissue for proper implantation. For example,
the devices can include features that provide additional material
for attachment to anchors such as sutures and/or can include
features that guide proper or easier placement of sutures or other
anchors. In addition, or alternatively, the devices can include
openings, slits, or holes that provide for one or more of improved
drainage or fluid flow, better coverage of the implant or expander,
or changes in mechanical properties (e.g., more flexibility due to
presence of slits, holes, or other mechanical modifications). FIGS.
9-14 illustrate various modified devices, and although shown with
respect to the device shape of FIGS. 2 and 3 (FIGS. 13 and 14
illustrate embodiments of the device of FIG. 3, it will be
understood that similar modifications can be used with the other
described devices of FIG. 4.
[0062] FIG. 9 illustrates a breast treatment device 900, wherein
the device further includes preformed tabs 910 or extensions for
attachment to tissue, according to certain embodiments. The tabs or
extensions 910 can provide additional area for passing sutures or
other anchors, or can be specifically shaped to engage with
fixations devices located on the surface of an implant or expander.
Although a finite and specific number of tabs 910 is illustrated,
additional or fewer tabs 910 may be used.
[0063] FIG. 10 illustrates a breast treatment device 1000, wherein
the device further includes preformed slits 1010 or openings,
according to certain embodiments. The slits 1010 or openings can
allow flow of fluid through the tissue matrix, thereby preventing
certain complications (e.g., seroma or inability to drain
infectious fluids). In addition, the slits 1010 can be shaped and
sized to allow expansion or more flexible coverage of an implant or
expander.
[0064] FIG. 11 illustrates a breast treatment device 1100, wherein
the device further includes preformed holes 1110 or openings,
according to certain embodiments. Similar to the openings 1010 of
FIG. 10, the holes 1110 can allow fluid to flow through the
material. The openings 1110 and slits 1010 can be arranged in
number, size, and location based on a variety of factors.
[0065] FIG. 12 illustrates a breast treatment device 1200, wherein
the device further includes preformed holes or pilot holes (holes
and pilot holes represented by any of 1210, 1220, or 1230),
according to certain embodiments. The holes or pilot holes 1210 can
be provided to allow easier, more rapid, or better fixation. For
example, the holes or pilot holes can be positioned in a row or
locations that correspond to a desired spacing or positioning to
provide secure fixation, e.g., along the lower border corresponding
to the inframammary fold when implanted. The holes or pilot holes
can pass completely through the device to allow passage of sutures
or other anchors, or can include a countersink or divot formation
to provide an area of less density or strength to allow easy anchor
passage.
[0066] The holes or pilot holes can be positioned on the lower
section of the device (holes 1210, 1220) and/or upper section 1230
near edges. In addition, holes or pilot holes may be formed at
other regions if desired. Further, the holes or pilot holes can be
in two or more rows, as illustrated, to allow multiple points of
fixation and/or to give the surgeon some choice in selecting holes
location.
[0067] Similar to FIG. 12, FIGS. 13 and 14 illustrate embodiments
of the device 200 of FIG. 3, but further including holes, openings,
or pilot holes. As shown in FIG. 13, the holes, openings, or pilot
holes 2210 may be localizes to a portion of the device, e.g., the
lower section, thereby providing openings only around the lower
pole of the implant or tissue expander. Alternatively, the holes,
openings or pilot holes can be arranged in other patterns or
throughout the surface of the device, as shown in FIG. 14.
[0068] The holes, openings, and pilot holes will generally be
positioned and of a number such that they do not cause an
undesirable loss of strength or area for cellular ingrowth. In
addition, the holes, openings, or pilot holes may be a distance
from the edges of the devices such that they do not overlap with
areas where sutures may be placed, or alternatively, can be placed
to provide preformed opening/pilot openings to guide where sutures
may be placed.
[0069] In some cases, the tissue matrices can be produced from
materials that include a basement membrane on at least one surface.
For example, the devices can be produced from an acellular dermal
matrix, and either the top surface or bottom surface can include an
epithelial basement membrane across the surface. When implanted
next to a breast implant or tissue expander, the basement membrane
covered surface may face towards the implant or tissue expander
such that the surface not including a basement membrane faces
overlying vascularized tissue.
[0070] Methods of treatment using the devices discussed herein as
well as devices produced for use in such methods are further
contemplated as within the scope of the present inventions. The
methods are illustrated and discussed above with respect to FIGS.
8A and 8B, and aspects of the methods are elaborated upon herein.
The devices can be used for improving various procedures, such as
prepectoral implantation of an implant. In many cases, the method
will first include performing a procedure to remove tissue, e.g.,
for surgical oncology, and can therefore, include mastectomy,
lumpectomy, or variations on those procedures. The methods and
device may also be used for augmentation procedures without, or in
a separate procedure from mastectomy or other procedures (e.g., for
staged reconstruction). When used for implantation for
augmentation, or in a subsequent procedure, a surgeon may first
form a pocket or space in the subcutaneous region.
[0071] After performing a mastectomy or other procedure and
ensuring a proper space for the implant or expander, a surgeon may
then place the tissue matrix materials described herein within the
space, and affix portions of the tissue matrices to tissues such as
the chest wall or muscle, as illustrated in FIGS. 8A and 8B. As an
example, the tissue can be affixed to the superior medial and
lateral edges of the pectoralis major and to fascial at the level
of the inframammary fold. As such, the tissue matrix comes in
contact with overlying tissue (e.g., dermis) and is prepared to
provide support to the implant or expander and subsequently allow
tissue ingrowth and vascularization of overlying tissue.
[0072] Next, and implant or expander can be placed within the
pocket, and remaining edges of the tissue matrix are sutured or
otherwise attached to tissue to close the implant pocket, followed
by closure of the surgical site.
[0073] It will be appreciated that the tissue matrix may
alternatively be wrapped around the implant or expander outside the
body, and the entire device (e.g., implant/expander and tissue
matrix) can then be placed in the surgical site. Further, implants
or expanders may include a structure for securing to the tissue
matrix and/or chest wall or other tissue.
[0074] Other embodiments will be apparent to those skilled in the
art from consideration of the specification and practice of this
disclosure. It is intended that the specification and examples be
considered as exemplary only, with the true scope and spirit of the
disclosed devices and methods being indicated by the following
claims.
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