U.S. patent application number 16/838512 was filed with the patent office on 2020-07-23 for tissue matrices incorporating multiple tissue types.
The applicant listed for this patent is LifeCell Corporation. Invention is credited to Nathaniel Bachrach, Aaron Barere, Israel James Jessop, Sangwook Park, Mrinal Shah, Hui Xu.
Application Number | 20200230292 16/838512 |
Document ID | / |
Family ID | 59381691 |
Filed Date | 2020-07-23 |
![](/patent/app/20200230292/US20200230292A1-20200723-D00000.png)
![](/patent/app/20200230292/US20200230292A1-20200723-D00001.png)
![](/patent/app/20200230292/US20200230292A1-20200723-D00002.png)
![](/patent/app/20200230292/US20200230292A1-20200723-D00003.png)
![](/patent/app/20200230292/US20200230292A1-20200723-D00004.png)
![](/patent/app/20200230292/US20200230292A1-20200723-D00005.png)
![](/patent/app/20200230292/US20200230292A1-20200723-D00006.png)
![](/patent/app/20200230292/US20200230292A1-20200723-D00007.png)
![](/patent/app/20200230292/US20200230292A1-20200723-D00008.png)
![](/patent/app/20200230292/US20200230292A1-20200723-D00009.png)
![](/patent/app/20200230292/US20200230292A1-20200723-D00010.png)
United States Patent
Application |
20200230292 |
Kind Code |
A1 |
Park; Sangwook ; et
al. |
July 23, 2020 |
TISSUE MATRICES INCORPORATING MULTIPLE TISSUE TYPES
Abstract
The present disclosure provides tissue products produced from
extracellular tissue matrices. The tissue products can include
acellular extracellular matrices including combinations of
different tissue types. The combination can harness various
properties of the different tissues to provide improved composite
structures with desired mechanical and/or biologic properties.
Inventors: |
Park; Sangwook; (Virginia
Beach, VA) ; Xu; Hui; (Plainsboro, NJ) ;
Barere; Aaron; (Hoboken, NJ) ; Jessop; Israel
James; (Garden Ridge, TX) ; Shah; Mrinal;
(Parsippany, NJ) ; Bachrach; Nathaniel; (Clifton,
NJ) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
LifeCell Corporation |
Madison |
NJ |
US |
|
|
Family ID: |
59381691 |
Appl. No.: |
16/838512 |
Filed: |
April 2, 2020 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
15639592 |
Jun 30, 2017 |
10639398 |
|
|
16838512 |
|
|
|
|
62358347 |
Jul 5, 2016 |
|
|
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61L 27/3645 20130101;
A61L 27/3604 20130101; A61L 27/48 20130101; A61L 27/60 20130101;
A61F 2/12 20130101; A61L 27/56 20130101; A61L 27/3633 20130101;
A61L 27/362 20130101 |
International
Class: |
A61L 27/36 20060101
A61L027/36; A61L 27/48 20060101 A61L027/48; A61L 27/60 20060101
A61L027/60; A61L 27/56 20060101 A61L027/56; A61F 2/12 20060101
A61F002/12 |
Claims
1. A method of treatment comprising; selecting a tissue product,
wherein the tissue product comprises; a first component comprising
a sheet of acellular dermal tissue matrix; and a second component
comprising a porous acellular tissue matrix sponge covering at
least a portion of the intact acellular tissue matrix; and
implanting the tissue product into a patient.
2. The method of claim 1, wherein implanting the tissue product
comprises implanting the tissue product subcutaneously.
3. The method of claim 1, wherein implanting the tissue product
comprises implanting the tissue product subpectorally.
4. The method of claim 1, wherein implanting the tissue product
comprises placing the tissue product over a breast implant or
tissue expander.
5. The method of claim 1, further comprising shaping the second
component of the tissue product.
6. The method of claim 5, wherein shaping includes one of cutting,
slicing, grinding, or scraping.
7. The method of claim 1, wherein implanting the tissue product
comprises affixing the tissue product to the chest wall, muscle, or
skin of the patient.
8. The method of claim 1, further comprising: implanting an implant
or tissue expander into an anatomic site; and affixing the tissue
product to the breast implant or tissue expander.
9. A breast implant device comprising; a tissue product, wherein
the tissue product comprises: a first component comprising a sheet
of acellular dermal tissue matrix; and a second component
comprising a sheet of a second acellular tissue matrix derived from
a tissue type different than that of the first component; and a
breast implant, wherein the breast implant comprises; a flexible
outer wall; and an inner volume containing a liquid or gel.
10. The tissue product of claim 9, wherein the second component
comprises a porous acellular tissue matrix sponge covering at least
a portion of the first component.
11. The tissue product of claim 9, further comprising a third
component contained between the first component and the second
component.
12. The tissue product of claim 11, wherein the first component and
second component completely enclose the third component.
13. The tissue product of claim 11, wherein the first component and
second component are sheets of tissue matrix and the third
component is a porous acellular tissue matrix sponge.
14. The tissue product of claim 9, wherein the porous acellular
tissue matrix sponge covers a top side and a bottom side of the
sheet of acellular dermal matrix.
15. The tissue product of claim 9, wherein at least a portion of a
surface of the sheet of acellular tissue matrix is textured,
roughened, or indented.
16. The tissue product of claim 9, further comprising at least one
additional acellular tissue matrix sheet, comprising a skeletal
muscle matrix.
17. The tissue product of claim 9, wherein the breast implant is
provided in volumes of about 100 cc to 2000 cc.
18. The tissue product of claim 9, wherein the breast implant
comprises a saline-filled implant.
19. The tissue product of claim 9, wherein the breast implant
comprises a silicone-filled implant.
20. The tissue product of claim 9, wherein the breast implant
comprises a tissue expander.
Description
[0001] This application a continuation application of U.S. patent
application Ser. No. 15/639,592, filed on Jun. 30, 2017, which
claims priority under 35 U.S.C. .sctn. 119 to U.S. Provisional
Application No. 62/358,347, filed on Jul. 5, 2016. The entire
contents of each of the above-referenced applications are
incorporated herein by reference in its entirety.
BACKGROUND
[0002] The present disclosure relates to tissue products, and more
particularly, to tissue matrices produced from a combination of two
or more different tissue types.
[0003] Various tissue matrix products (e.g., acellular tissue
matrices or similar tissue-derived or tissue regenerative
materials) are currently available. Such products can be used to
regenerate, reinforce, replace, and/or augment existing tissues, or
tissues damaged or lost due to disease, trauma, surgery, radiation,
or other events. Such materials can be very effective for treatment
of many conditions. For example, acellular tissue matrix products
such as ALLODERM.RTM., an acellular human dermal matrix, and
STRATTICE.TM., an acellular porcine dermal matrix (both from
LIFECELL.RTM. CORPORATION, BRANCHBURG, NEW JERSEY), are useful for
many surgical procedures, including abdominal wall defect repair
and breast reconstruction.
[0004] Although currently available acellular tissue matrix
products can be very effective at regenerating a range of tissue
types, there remains a need for tissue matrix products that harness
the beneficial regenerative and structural properties of tissue
products derived from multiple tissue types. Accordingly, the
present disclosure provides improved tissue matrix products that
include combinations of two or more tissue matrix materials (i.e.,
materials derived from two or more types of tissues). The tissue
matrix materials are arranged to provide improved methods of
treatment--in some case, taking advantage of the biologic and
mechanical properties of each of the component materials.
[0005] According to one embodiment, a tissue product is provided.
The product can include a first component comprising an intact
acellular tissue matrix and a second component comprising a porous
acellular tissue matrix sponge covering at least a portion of the
intact acellular tissue matrix. The porous acellular tissue matrix
sponge comprises a tissue matrix that has been mechanically
homogenized, resuspended, and stabilized, and wherein the intact
acellular tissue matrix and porous acellular tissue matrix sponge
are attached such that the intact acellular tissue matrix provides
mechanical support to the porous acellular tissue matrix
sponge.
[0006] According to one embodiment, a tissue product is provided.
The product can include a first component comprising a sheet of
acellular tissue matrix, and a second component comprising a porous
acellular tissue matrix sponge covering at least a portion of the
intact acellular tissue matrix. The second component may consist
essentially of adipose tissue matrix.
[0007] According to one embodiment, a tissue product is provided.
The tissue product can include a first component comprising a sheet
of acellular tissue matrix and a second component comprising a
sheet of a second acellular tissue matrix derived from a tissue
type different than that of the first component. The product can
further comprise a third component including a porous acellular
tissue matrix sponge, wherein the third component is contained
between the first component and the second component.
DESCRIPTION OF THE DRAWINGS
[0008] FIG. 1A is a side cut away view of a tissue product
including tissue matrix from two or more tissue types, according to
various embodiments.
[0009] FIG. 1B is a side cut away view of a tissue product
including tissue matrix from two or more tissue types, according to
various embodiments.
[0010] FIG. 1C is a side cut away view of a tissue product
including tissue matrix from two or more tissue types, according to
various embodiments.
[0011] FIG. 1D is a side cut away view of a tissue product
including tissue matrix from two or more tissue types, according to
various embodiments.
[0012] FIG. 2A is a perspective view of the tissue product of FIG.
1B.
[0013] FIG. 2B is a perspective view of the tissue product of FIG.
1C.
[0014] FIG. 3 is a side cut away view of a tissue product including
tissue matrix from two or more tissue types, according to various
embodiments.
[0015] FIG. 4 is a perspective view of another tissue product
including a sheet of acellular tissue matrix and a porous tissue
matrix sponge covering opposing sides of the tissue matrix.
[0016] FIG. 5 is a perspective view of another tissue product
including a sheet of acellular tissue matrix and a porous tissue
matrix sponge covering a side of the tissue matrix.
[0017] FIG. 6 is a perspective view of another tissue product
including two sheets of acellular tissue matrix and a porous tissue
matrix sponge secured between the sheets.
[0018] FIG. 7 is a side cut away view of another tissue product
including two sheets of acellular tissue matrix and a porous tissue
matrix sponge secured between the sheets, the tissue product
forming a volume shaped for implantation within a breast.
[0019] FIG. 8 illustrates the tissue product of FIG. 7 implanted
within a breast to facilitate a breast augmentation,
reconstruction, or other breast procedure.
[0020] FIG. 9 is a perspective view of another tissue product
including two sheets of acellular tissue matrix and a porous tissue
matrix sponge secured between the sheets.
[0021] FIG. 10 illustrates a side cut away view of tissue products
within a breast to facilitate an improved breast procedure using
products and methods of the present disclosure.
[0022] FIG. 11 is a perspective view of another tissue product
including a sheet of acellular tissue matrix and a porous tissue
matrix sponge.
DESCRIPTION OF CERTAIN EXEMPLARY EMBODIMENTS
[0023] Reference will now be made in detail to certain exemplary
embodiments according to the present disclosure, certain 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.
[0024] In this disclosure, the use of the singular includes the
plural unless specifically stated otherwise. In this disclosure,
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.
[0025] 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 disclosure, including but not limited to patents, patent
applications, articles, books, and treatises, are hereby expressly
incorporated by reference in their entirety for any purpose.
[0026] Various human and animal tissues can be used to produce
products for treating patients. For example, various tissue
products for regeneration, repair, augmentation, reinforcement,
and/or treatment of human tissues that have been damaged or lost
due to various diseases and/or structural damage (e.g., from
trauma, surgery, atrophy, and/or long-term wear and degeneration)
have been produced. Such products can include, for example,
acellular tissue matrices, tissue allografts or xenografts, and/or
reconstituted tissues (i.e., at least partially decellularized
tissues that have been seeded with cells to produce viable
materials).
[0027] A variety of tissue products have been produced for treating
soft and hard tissues. For example, ALLODERM.RTM. and STRATTICE.TM.
(LIFECELL CORPORATION, Branchburg, N.J.) are two dermal acellular
tissue matrices made from human and porcine dermis, respectively.
Although such materials are very useful for treating certain types
of conditions, materials having different biological and/or
mechanical properties may be desirable for certain applications.
For example, ALLODERM.RTM. and STRATTICE.TM. have been used to
assist in treatment of structural defects and/or to provide support
to tissues (e.g., for abdominal walls or in breast reconstruction),
and their strength and biological properties make them well-suited
for such uses.
[0028] Such materials, however, may not be ideal for regeneration,
repair, replacement, and/or augmentation of certain soft-tissue
defects. For example, improved tissue fillers for replacing lost or
damaged tissues, including adipose or other soft tissues in the
form of porous sponges, may be beneficial for some patients. Such
porous sponges, however, may lack sufficient structural integrity
for certain uses.
[0029] For example, tissue matrix sponges may have insufficient
tensile strength, burst strength, or suture retention strength to
provide needed support in various procedures such as breast
reconstruction, breast augmentation, abdominal wall defect
treatment, or treatment of soft tissues that are subjected to
repeated movements, or even occasionally experience relatively high
mechanical stresses. In addition, some materials may have less than
optimal compressive elasticity and strength, bending rigidity, kink
resistance, or abrasion resistance. Accordingly, improved devices
and methods are provided herein.
[0030] The improved devices incorporate combinations of tissue
matrix sponges (e.g., adipose tissue matrix sponges) along with
intact acellular tissue matrices, such as dermal, fascial, or
muscle tissue matrices. The improved devices are joined to harness
properties of the different tissue matrices, thereby providing
improved regenerative biologic and mechanic properties for certain
uses.
[0031] As used herein, the term "intact acellular tissue matrix"
refers to an extracellular tissue matrix having a shape and form
substantially similar to the tissue from which the matrix is
derived, although it will be understood that production of the
acellular matrix (e.g., by removing cells) will produce a matrix
that is modified from the original tissue matrix, by for example,
changing the microstructure of the matrix. For example, an "intact
acellular tissue matrix" produced from elongated, sheet-like tissue
such as dermis, bladder, intestinal layer(s), stomach layer(s),
dura, pericardium, or fascia may be in the form of a sheet formed
by the original protein structure. Such "intact acellular tissue
matrices", however, can include openings, meshes, or holes, as
discussed further below, and may be modified, e.g., by
cross-linking, enzymatic treatment, or chemical modification.
"Intact acellular tissue matrices" would not include tissues that
have been ground, cut, homogenized, or otherwise processed to form
small tissue fragments or particles, even if such fragments or
particles are resuspended or otherwise processed to produce a sheet
or other form.
[0032] Accordingly, in various embodiments, tissue products for
treatment or regeneration of tissue are provided. The tissue
products can include a first component comprising an intact
acellular tissue matrix and a second component comprising a porous
acellular tissue matrix sponge. The porous acellular tissue matrix
may cover at least a portion of the intact acellular tissue matrix,
or alternatively or additionally, the porous acellular tissue
matrix can be positioned near the intact acellular tissue matrix
during a surgical procedure. The porous acellular tissue matrix
sponge can be produced in a variety of ways, as discussed further
below.
[0033] FIGS. 1A-11 illustrate tissue products or methods of using
the tissue products of the present disclosure in different
embodiments and configurations. FIGS. 1A-1D illustrate side cut
away views of various tissue products, and FIGS. 2A-2B are
perspective views of the devices of FIGS. 1B and 1C,
respectively.
[0034] As shown, the products of FIGS. 1A-1D (10, 20, 30, 40) can
include multiple components. As discussed above, the products can
include a first component (12, 22, 32, 42) and a second component
(11, 21, 31, 41). The first component (12, 22, 32, 42) can include
an intact acellular tissue matrix, and the second component (11,
21, 31, 41) can include a porous tissue matrix sponge, both of
which will be described in more detail.
[0035] The first component (12, 22, 32, 42) can include a variety
of suitable acellular tissue matrices in the form of a sheet, or
other suitable three-dimensional structure, including for example,
folded shapes, boxes, cup-like shapes, tubes, irregular or
repeating patterned shapes, spheres or other rounded 3-D shapes.
The intact tissue matrix (first component) can be formed from a
variety of different tissue sources and can be processed and
configured to provide structure support or mechanical stability to
the devices (10, 20, 30, 40).
[0036] The tissue matrices used to produce the first component (12,
22, 32, 42) can include a variety of suitable tissue matrix
materials. Examples of the tissues that may be used to construct
the tissue matrices for the first component can include, but are
not limited to, skin, parts of skin (e.g., dermis), fascia, muscle
(striated, smooth, or cardiac), pericardial tissue, dura, umbilical
cord tissue, placental tissue, cardiac valve tissue, ligament
tissue, tendon tissue, blood vessel tissue, such as arterial and
venous tissue, cartilage, bone, neural connective tissue, urinary
bladder tissue, ureter tissue, and intestinal tissue. For example,
a number of biological scaffold materials that may be used for the
first component are described by Badylak et al., Badylak et al.,
"Extracellular Matrix as a Biological Scaffold Material: Structure
and Function," Acta Biomaterialia (2008),
doi:10.1016/j.actbio.2008.09.013. In some cases, the first
component includes a sheet of acellular tissue matrix derived from
human or porcine dermis. Suitable human and porcine dermal
materials include, for example, ALLODERM.RTM. and STRATTICE.TM.,
respectively.
[0037] The first component (12, 22, 32, 42) can be selected based
on both biologic and mechanical properties. For example, suitable
tissue matrix materials used to produce the first component will
generally be capable of providing a regenerative tissue scaffold
suitable for supporting the ingrowth of native cells and formation
of tissue without excessive inflammation and with minimal scar
formation.
[0038] In addition, the first component (12, 22, 32, 42) can be
selected based on its ability to provide a desired amount of
structural support. For example, the first component (12, 22, 32,
42) may possess sufficient tensile strength, burst strength, and
suture retention strength to allow use of the device for treatment
of such conditions as complex or simple abdominal wall defects,
defects associated with surgical oncology for treatment of breast
cancer, treatment of structural defects in connective tissues
(e.g., fascia, tendons, or ligaments), and/or to provide structural
support around breast implants or tissue expanders used in
augmentation or reconstruction.
[0039] As noted above, however, the devices can include a second
component (11, 21, 31, 41), and the second component can be
selected to provide specific biologic and mechanical properties.
For example, in one embodiment, the second component includes a
tissue matrix derived from adipose tissue. The tissue matrix
derived from adipose tissue can be selected based on its ability to
support regeneration of certain tissue types, including
regeneration of adipose tissue, or predominantly adipose tissue;
and may be selected to produce a desired feel, compressibility,
size, shape, or other mechanical features. As such, the second
component can support a desired level of adipose regeneration,
which may be desirable for various anatomic sites, including, for
example, the breast (e.g., after surgical removal of tumors or for
augmentation), the buttocks, thighs, neck, face, or any other site
where adipose tissue may be desirable to produce a certain feel,
cosmetic appearance, biologic property, or other intended
result.
[0040] The first component (12, 22, 32, 42) and second component
(11, 21, 31, 41) can be arranged in a variety of ways to produce
desired mechanical and biologic properties when implanted in vivo.
For example, FIGS. 1A-1D illustrate various configurations of
devices (10, 20, 30, 40) consistent with the present invention.
[0041] As shown in FIG. 1A, the first component 12 can be formed as
a sheet of intact acellular tissue (e.g., acellular dermal matrix),
and the second component 11 can be formed on one side of the first
component 12 to produce a bilayer sheet or composite structure
(e.g., having a sheet of the first component 12 with a mass of the
second component 11 as a sheet or other configuration). In one
embodiment, the device 10 can optionally include a textured surface
15 on at least one side of the sheet of first component 12 to
assist in mechanical attachment of the first component 12 and
second component 11.
[0042] The textured surface 15 can facilitate joining between the
first component 12 and the tissue fibers in a slurry or suspension
used for form the second component 11 (discussed below). The
textures can be grooves or holes, or can include a roughened
surface such that it creates jagged edges or textures with some
loose collagen fibers that facilitate cross-linking. The textured
surface 15 can include a surface roughening (e.g., formed by
scraping or other mechanical process). In addition, the textured
surface 15 can include indentations 14 and/or protrusions 13 that
allow interdigitaion of the first and second components.
Alternatively, as shown in FIG. 1D, the textured surface 15' can
include small irregularities or changes in the surface shape for
the first component 42 and or second component 41.
[0043] Furthermore, although the embodiments described above with
respect to FIGS. 1A, 1B, and 1D illustrate a device having the
second component attached to or covering one side of a sheet of the
first component, it will be appreciated that the second component
may be applied to both sides (e.g., the top and bottom) of a sheet
of the first component, or may be applied only to a portion of one
or both of the top and bottom surfaces of the first component.
[0044] In other embodiments, the first component can be in the form
of a sheet having openings or a mesh structure in which the second
component can be positioned. For example, FIGS. 1B and 1C
illustrate devices 20, 30 having a first component 22, 32 in the
form of a sheet with openings 23, 33, and including a second
component 21, 31 covering one or both sides of the sheet of first
component 22, 32, while filing the openings 22, 32. Such
configurations are illustrated in more detail in FIGS. 2A and 2B,
which provide perspective views of the devices of FIGS. 1B and 1C,
respectively.
[0045] It should be noted, that the pattern of openings or meshwork
in the devices of FIGS. 1A and 1B can be varied based on a number
of factors. For example, FIGS. 4 and 5 are perspective views of
tissue products including a sheet acellular tissue matrix and a
porous tissue matrix sponge covering one side or both opposing
sides of the tissue matrix. As shown, FIG. 4 illustrates a device
60 including a sheet of the first component (an intact acellular
tissue matrix) 62 with openings 63 formed as circular holes. In
addition, the device 60 includes a second component 61 covering an
opposing side of the sheet of the first component 62 and filling
the openings 63. Similarly, the device 60' of FIG. 5 includes a
sheet of the first component (an intact acellular tissue matrix)
62' with openings 63' formed as circular holes. In addition, the
device 60' includes a second component 61' covering one side of the
sheet of the first component 62' and filling the openings 63'.
[0046] The devices illustrated in FIGS. 4-5 (as well as those in
FIGS. 1A-2B) can be used for breast reconstruction applications or
other treatments. The size of the openings 63 can be selected based
on the desired strength, wherein the size of the openings 63 and
spacing of openings can be varied to produce desired properties.
The size and number of the openings can be selected to modulate the
rate of cellular ingrowth into the openings 63 (or corresponding
parts of FIGS. 1A-2B. In addition, the second component 61 can be
formed of a material that is more suitable for cellular ingrowth,
and may provide a better biological response while harnessing the
mechanical properties of the first component 62.
[0047] The devices illustrated in FIGS. 4-5 (as well as those in
FIGS. 1A-2B) can be designed for specific applications. The designs
may depend on the specifics of the application. For example, the
design in an application where strength needs to be maintained,
shear is low, and fluid flow across the intact matrix is not
important (e.g., facial reconstruction or minimally invasive
facelifts) can include smaller openings 63. Conversely, when more
compressibility is important, larger and more openings 63 might be
better.
[0048] In some embodiments, the second component may cover or be
applied to only a portion of a surface of the first component,
and/or may be applied as a bulk material having a desired shape.
For example, FIG. 3 is a side cut away view of another tissue
product, according to various embodiments. As shown the device 50
of FIG. 3 includes a sheet of the first component 52, with the
second component 51 covering a limited section 53 of the first
component, but it should be understood that the second component
may cover more or different sections. The section 53 may have a
modified surface (e.g., by roughening or texturing) that
facilitates stronger bonding between the second component 51. As
such, the second component can be in the form of a bulky or larger
mass, and the device 50 may be used, for example, in breast
surgery, wherein the first component 52 provides structural
support, e.g., to attach to the chest wall or muscle, and the
second component 51 provides an improved biological response to
allow rapid ingrowth to produce tissue with a desired composition,
texture, feel, and biological properties.
[0049] Similar to the device of FIG. 3, FIG. 11 is a perspective
view of another tissue product 130 including a sheet 132 of intact
acellular tissue matrix and a porous tissue matrix sponge 134. FIG.
11 is intended to illustrate that the sponge 134 (corresponding to
the second component 51 of FIG. 3) can include a variety of
configurations (e.g., covering differing amounts of the sheet 132).
The product 130 can, like the product of FIG. 3, be implanted to
treat a breast, but as with FIG. 3's embodiment, could also be used
to treat other sites (e.g., a facial defect, buttock, abdominal
wall, or other structure). Furthermore, the components of the
product 130 can be provided as a single device or as separate
components to facilitate methods of treatment discussed further
below.
[0050] The devices and methods described herein can also include
more than two types of tissue matrices. Specifically, in some
cases, the devices include a first component comprising a sheet of
acellular tissue matrix and a second component comprising a sheet
of a second acellular tissue matrix derived from a tissue type
different than that of the first component. In addition, the
devices can include a third component comprising a porous acellular
tissue matrix sponge, wherein the third component is contained
between the first component and the second component. Embodiments
including such structures as well as their uses and methods of use
are discussed further below.
[0051] FIG. 6 is a perspective view of another tissue product 70
including two sheets 72, 73 of acellular tissue matrix and a porous
tissue matrix sponge 71 secured between the sheets 72, 73. As
shown, the device 70 is provided in the form of flat or flexible
sheet of material, but may include a variety of different shapes,
including a box-like shape. Alternatively, the device 70 can
include any suitable three-dimensional form such as a spherical,
ovoid, or irregular three-dimensional form.
[0052] Furthermore, the configuration of FIG. 6 can be modified to
include openings in the sheets 72, 73. For example, FIG. 9
illustrates an embodiment of a device 90, including sheets 92, 93,
similar to those of FIG. 6, as well as a sponge 91, but further
includes openings or perforations. The openings or perforations may
include a variety of sizes, shapes, spacings, or configurations, as
discussed above with respect to FIGS. 4 and 5.
[0053] In some cases, the device 70 of FIG. 6 can be modified to
produce a material shaped for a specific use, e.g., as a breast
implant. Suitable breast implants may be used, for example, for
augmentation or reconstruction after procedures such as mastectomy,
skin-sparing mastectomy, lumpectomy, or any other procedure such as
revision breast augmentation, breast augmentation, or
mastopexy.
[0054] FIG. 7 is a side view of another tissue product 80, for use
as a breast implant, and FIG. 8 illustrates implantation of the
device 80 within a breast 85. As shown, the device 80 includes
including two sheets 82, 83 of acellular tissue matrix and a porous
tissue matrix sponge 81 secured between the sheets to form a volume
shaped for implantation within a breast.
[0055] The device 80 is illustrated having the shape of a typical
breast implant, such as a rounded or teardrop implant. The devices
80, however, of the present disclosure need not have typical breast
implant (teardrop or rounded) shapes. For example, the devices can
have other shapes including, for example, irregular shapes,
spherical shapes, ovoid shapes, or custom-made shapes based on
patient anatomy or treatment site. For example, a surgeon may
select a spherical or custom-made shape for implantation in a
lumpectomy site or based on patient-specific factors. In addition,
the surgeon may select two-or more implants to be implanted next to
one another or in different locations. In addition, although
described in particular with respect to breast implants the
presenting disclosed implants, systems, and methods can be used at
other sites where synthetic implants may be used (e.g., gluteal
implants).
[0056] As discussed above, the two sheets 82, 83 can include intact
acellular tissue matrix, but can be formed from tissue matrix
derived from different tissue types. For example, in one
embodiment, the first sheet 82, which may form an anterior or
frontal portion of the implant 80 can be formed from a tissue
matrix selected to allow cellular ingrowth and tissue regeneration,
while also providing sufficient mechanical properties (e.g.,
tensile strength, burst strength, suture retention strength) to
allow the sheet 82 to provide structural support and load-bearing
capacity, as may be needed to support a mass of the tissue matrix
sponge 81 and surrounding breast structures. In some embodiments,
the sheet 82 is a dermal acellular tissue matrix such as
ALLODERM.RTM. or STRATTICE.TM.. The sheet can include other tissue
such as bladder, intestinal layer(s), stomach layer(s), dura,
pericardium, skeletal muscle, nerve, peritoneum, or fascia.
[0057] The second sheet 83 can be produced from a different tissue.
For example, one suitable tissue can include a muscle tissue
matrix. Suitable muscle matrix materials are described in U.S.
Patent Publication Number 2015/0282925A1 (application Ser. No.
14/410,204), which was filed on Jul. 1, 2013 to Xu et al.
[0058] As shown in FIG. 8, the device 80 can be implanted within
the breast 85 with the first sheet 82 facing substantially
anteriorly, and the second sheet 83 facing posteriorly and near or
in contact with chest wall muscles (e.g., the pectoralis muscles).
As such, the first sheet 82 can be configured to allow cellular
ingrowth and tissue revascularization from cutaneous or immediately
subcutenous tissues, or from anteriorly located tissue within a
pocket formed in a breast 85. In addition, the second sheet 83 can
allow cellular ingrowth from posteriorly located (relative to the
implant 80) tissues such as muscle, and may support desired muscle
generation.
[0059] As discussed above, the devices described herein in each of
the figures can include acellular tissue matrix sponge (11, 21, 31,
41, 51, 61, 71, 81). As used herein, tissue matrix sponge will be
understood to refer to a tissue matrix material that has been
processed to produce a sponge-like matrix. The sponge-like matrix
can be formed of an extracellular tissue matrix (ECM) that retains
ECM components including extracellular collagen, glycoproteins, and
other molecules important for supporting cellular ingrowth and
tissue regeneration.
[0060] As used herein, the term "tissue matrix sponge" will be
understood to refer to a tissue matrix material that includes
extracellular tissue matrix (ECM) (including collagen and important
non-collagenous proteins), wherein the ECM has been mechanically
processed to form fragments or particles, and has been resuspended
or reformed (e.g., by casting and drying) to form a porous
sponge-like material. The sponge properties can be tailored by
selecting an appropriate tissue type (e.g., using adipose, dermis,
muscle, fascia, nerve, vascular tissue, intestinal components,
skeletal muscle, peritoneum, tendon, ligament, or other appropriate
tissue).
[0061] Further, the tissue properties can be modified by
controlling solid content of the sponge (i.e., the about of tissue
matrix present in suspension). Higher solid content will generally
form higher modulus and stronger materials. Additional
modifications to the material to adjust mechanical properties can
include chemical cross linking, particle or fiber sizes, increasing
solid content per volume through compression, and pattern molding
with fiber alignment for directional properties.
[0062] The tissue matrix sponge can be formed from a number of
tissue matrix types and with a number of processes. For example, in
some embodiments, the tissue matrix sponge is formed from adipose
tissue. Suitable adipose tissues are described generally is number
U.S. Patent Publication Number 2012/0310367A1 (application U.S.
Ser. No. 13/483,674, filed May 30, 2012, to Connor). Such adipose
materials can be formed generally by mechanical homogenization,
washing, resuspension, and stabilization of the material. The
material may be dried (e.g. by freeze drying before or after
stabilization), and stabilization can be by dehydrothermal
treatment (DHT), cross-linking (UV, radiation, or chemical
cross-linking). The stabilization can further be used to bond or
attach the sponge to the other material. For example, DHT treatment
can cause some degree of cross-linking, which can be improved by
surface roughening to texturing (see e.g., FIG. 3, item 53). In
addition, the sponge may be sterilized before or after joining to
the intact tissue matrix. Sterilization may be performed after the
components of the devices described herein are joined. Further, the
sponge may be formed while in contact with the intact acellular
tissue matrix components, or may be formed separately prior to
joining.
[0063] In addition, although the devices shown above have a number
of layers or components, it will be appreciate that the structures
can include additional layers. For example, devices including
multiple layers of the components shown in the figures may be used.
And multiple layers of the tissue matrix components can be added,
for example, to improve device strength.
[0064] As noted above, the products discussed herein can be used
for treatment of breast. And, in varying embodiments, the intact
acellular tissue matrix component and porous tissue matrix sponge
can be provided either as a single premanufactured article, or as
separate components to be implanted by a surgeon, or as
combinations of single articles and separate components (e.g., for
different section of a treatment site).
[0065] For example, FIG. 10 illustrates a side cut away view of a
prospective use of the tissue product of FIG. 7 implanted, together
with additional tissue products, within a breast to facilitate an
improved breast procedure using products and methods of the present
disclosure.
[0066] As shown, the products of the present disclosure can be
implanted at a breast 85 treatment site, e.g., for augmentation or
reconstructive procedures. As such, the products can be used in
conjunction with various implants 102 or similar devices (e.g.,
tissue expanders) and can be used for a variety of implant
procedures and location (e.g., subcutaneous or subpectoral). And
the products of the present disclosure, including an intact
acellular tissue matrix sheet 104 can be implanted to support the
implant or tissue expander and/or to facilitate other goals (e.g.,
provide tissue coverage, restore blood flow, etc.
[0067] In some breast treatment procedures, however, in addition to
the benefits provided by the intact tissue matrix sheets, it is
desirable to implant other tissue, such as adipose tissue matrix
sponge, to provide additional implant coverage. For example, in
some cases, e.g., with thin patients, the implant may cause
undesirable effects such as skin rippling or less than desirable
shapes (e.g., due to the bulk of the implant at the superior
portion or other areas with insufficient breast tissue
coverage).
[0068] Accordingly, in various embodiments, a surgeon may use a
sheet of tissue matrix 104 and a tissue matrix sponge such as
adipose matrix 110. The adipose matrix can be provided as a
separate component and implanted where needed, or can be provided
preassembled and attached to the sheet of tissue matrix (as shown
in FIG. 11). In the latter case, the sponge 134 can be provided
with sufficient bulk so that the surgeon can shape or contour
(e.g., remove portions) of the sponge to produce a desired
implant.
[0069] The sponge 110 or 134 can be implanted at a variety of sites
around the breast to prevent rippling, reduce undesired shapes
(e.g., reduce appearance of the superior portion of the implant as
illustrated in FIG. 10), and/or to improve overall aesthetic
results.
[0070] The above description and embodiments are exemplary only and
should not be construed as limiting the intent and scope of the
invention.
* * * * *