U.S. patent application number 17/717809 was filed with the patent office on 2022-09-29 for tissue matrices and methods of treatment.
The applicant listed for this patent is LifeCell Corporation. Invention is credited to Aaron Barere, Sangwook Park, Kai-Roy Wang.
Application Number | 20220304794 17/717809 |
Document ID | / |
Family ID | 1000006394970 |
Filed Date | 2022-09-29 |
United States Patent
Application |
20220304794 |
Kind Code |
A1 |
Wang; Kai-Roy ; et
al. |
September 29, 2022 |
TISSUE MATRICES AND METHODS OF TREATMENT
Abstract
Methods, systems, and compositions for treatment are provided.
The methods can be used to stretch and completely or nearly
completely wrap a composition around an implant or tissue expander.
The systems can be used to protect an implant or tissue expander by
completely or nearly completely wrapping a composition around the
implant or tissue expander. The compositions can be used to
completely or nearly completely wrap around an implant or tissue
expander to provide support and protection to the implant or tissue
expander.
Inventors: |
Wang; Kai-Roy; (Jersey City,
NJ) ; Park; Sangwook; (Dunellen, NJ) ; Barere;
Aaron; (Hoboken, NJ) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
LifeCell Corporation |
Madison |
NJ |
US |
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|
Family ID: |
1000006394970 |
Appl. No.: |
17/717809 |
Filed: |
April 11, 2022 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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16388966 |
Apr 19, 2019 |
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17717809 |
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15139458 |
Apr 27, 2016 |
10307237 |
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16388966 |
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62161971 |
May 15, 2015 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 90/02 20160201;
A61L 27/3666 20130101; A61F 2002/0068 20130101; A61F 2/12 20130101;
A61F 2220/0008 20130101; A61F 2220/0075 20130101; A61L 2430/04
20130101; A61F 2/0063 20130101 |
International
Class: |
A61F 2/00 20060101
A61F002/00; A61F 2/12 20060101 A61F002/12; A61B 90/00 20060101
A61B090/00; A61L 27/36 20060101 A61L027/36 |
Claims
1. A composition for treatment, comprising: a composition body; and
a mesh pattern formed in at least a portion of the composition
body; wherein the composition body comprises a tissue matrix or
synthetic material; and wherein the composition body is configured
to stretch and expand at the mesh pattern to completely or nearly
completely wrap the composition body around or position the
composition body onto an implant or a tissue expander.
2. The composition of claim 1, wherein the tissue matrix is an
acellular tissue matrix.
3. The composition of claim 1, wherein the composition body
comprises a central region and at least two extensions protruding
from opposing sides of the central region, the at least two
extensions having the mesh pattern formed therein.
4. The composition of claim 3, wherein the composition body is
configured to be positioned onto the implant or tissue expander
with the central region of the composition body disposed against an
anterior side of the implant or tissue expander.
5. The composition of claim 4, wherein the at least two extensions
are configured to be stretched and expanded at the mesh pattern to
wrap the composition body around the implant or tissue expander
such that one extension of the at least two extensions is wrapped
in a first direction around the implant or tissue expander and
another extension of the at least two extensions is wrapped in an
opposing direction to secure the composition body to the implant or
tissue expander.
6. The composition of claim 5, wherein the at least two extensions
are configured to be engaged with each other at a posterior side of
the implant or tissue expander, the posterior side opposing the
anterior side of the implant or tissue expander.
7. The composition of claim 3, wherein the composition body
comprises at least two additional extensions protruding form
opposing sides of the central region.
8. The composition of claim 4, wherein the at least two additional
extensions each comprise a mesh pattern formed therein.
9. The composition of claim 3, wherein the central region comprises
the mesh pattern formed therein.
10. The composition of claim 1, wherein the tissue matrix is a
tissue matrix sheet defining a planar and flexible
configuration.
11. The composition of claim 3, comprising a fastening element
configured to interlock the at least two extensions relative to
each other to secure the composition body to the implant or tissue
expander.
12. The composition of claim 1, wherein the composition body
comprises a top region, a central region, and a bottom region, at
least one strap being integrally formed adjacent to an edge of the
bottom region.
13. The composition of claim 3, wherein the at least two extensions
extend parallel to each other.
14. The composition of claim 11, wherein the fastening element
detachably interlocks the at least two extensions of the
composition body.
15. The composition of claim 11, wherein the fastening element
includes an elongated body with a proximal end and a distal end,
the proximal end including a rounded tip.
16. The composition of claim 15, wherein a diameter of the rounded
tip is dimensioned greater than a width of the elongated body.
17. The composition of claim 16, wherein the rounded tip includes a
slit configured to receive therethrough the distal end of the
fastening element to interlock the fastening element to the at
least two extensions.
18. The composition of claim 3, wherein the central region of the
composition body is mesh-free.
19. The composition of claim 3, wherein: the composition body
includes a horizontal axis passing through the central region, the
at least two extensions protruding from the opposing sides of the
central region and substantially parallel to the horizontal axis;
the composition body includes a vertical axis passing through the
central region; and the composition body includes two additional
extensions protruding from opposing sides of the central region and
substantially parallel to the vertical axis.
20. A system for treatment, comprising: a composition, the
composition including (i) a tissue matrix or synthetic material
defining a composition body, and (ii) a mesh pattern formed in at
least a portion of the composition body; and an implant or a tissue
expander; wherein the composition body is configured to stretch and
expand at the mesh pattern to completely or nearly completely wrap
the composition body around or position the composition body onto
the implant or the tissue expander.
Description
[0001] This application is a continuation of U.S. patent
application Ser. No. 15/139,458, filed Apr. 27, 2016, which claims
the benefit of priority to U.S. Prov. Patent App. No. 62/161,971,
filed on May 15, 2015, each of which is incorporated herein by
reference in its entirety.
[0002] The present disclosure relates to methods of treatment, and
more particularly, to methods of treatment and compositions and
systems for treatment in accordance with the methods.
[0003] Various methods are used for breast augmentation or
reconstruction. One method involves sub-glandular placement of
breast implants or tissue expanders, a procedure that is generally
considered less complicated compared to other techniques because
the pectoral muscles are left intact, resulting in shorter
operation times, lower pain levels, and shorter recovery times.
However, placing breast implants or tissue expanders in a
sub-glandular palpability of the implant, superficial ripples, and
a potential for capsular contracture.
[0004] Rippling can occur in patients with inadequate breast tissue
for covering the implant or tissue expander, resulting in folds or
wrinkles in the implant or tissue expander that are visible through
the skin. In particular, since the implant or tissue expander is
placed over the pectoral muscles, there may be inadequate breast
tissue to cover the implant or tissue expander. Rippling is
typically most noticeable on the bottom or sides of the implant or
tissue expander, but may also occur in the middle near the
cleavage.
[0005] Capsular contracture can occur as a response of the immune
system to foreign materials in the human body. In particular,
capsular contracture involves the formation of capsules of tightly
woven collagen fibers created by the immune response to the
presence of foreign objects, such as implants or tissue expanders,
in the body. The collagen-fiber capsule tightens and squeezes the
breast implant or tissue expander, resulting in pain and discomfort
to the patient, as well s a distortion of the breast implant or
tissue expander.
[0006] Various products are used as protective sleeves to
completely surround the breast implant or tissue expander prior to
sub-glandular implantation. For example, some products are formed
from completely solid sheets of acellular dermal matrix (ADM) that
are trimmed to conform to the size of and wrap around the breast
implant or tissue expander, and are sutured around the breast
implant or tissue expander. Berna, G. et al., "Evaluation of A
Novel Breast Reconstruction Technique Using the Braxon.RTM.
Acellular Dermal Matrix: A New Muscle-Sparing Breast
Reconstruction", ANZ J. Surg. (Sep. 29, 2014), doi:
10.1111/ans.12849. Such products, however, cover the entire surface
of the implant or tissue expander, and therefore require a
substantial amount of tissue, resulting in an expensive product.
Further, trimming the excess tissue to conform to the size of the
breast implant or tissue expander results in a waste of tissue.
[0007] To cover an implant or tissue expander, it may be desirable
to use a composition that has one or more mesh patterns that
facilitate stretching and expanding the composition to completely
or nearly completely wrap around the implant or tissue expander,
while providing the necessary coverage and support to the implant
or tissue expander. Accordingly, methods of treatment including
compositions, as well as compositions and systems used in the
methods, are provided.
[0008] According to certain embodiments, a method of treatment is
provided. The method can include providing a composition. The
composition can include a tissue matrix or synthetic material
defining a composition body. The composition can include at least
one mesh pattern formed in at least a portion of the composition
body. The method can include stretching and expanding the
composition body at the mesh pattern to completely or nearly
completely wrap the composition around or position the composition
onto an implant or a tissue expander. The mesh pattern allows less
material to be used to form the composition body, while providing
the necessary support and/or coverage to the implant or tissue
expander with the composition.
[0009] In certain embodiments, the tissue matrix can be a tissue
matrix sheet defining a planar and flexible configuration. In
certain embodiments, the tissue matrix can be an acellular tissue
matrix. In certain embodiments, the tissue matrix can be an
acellular dermal matrix.
[0010] In certain embodiments, the composition can include a
central region and four extensions extending from the central
region. The method can include forming the mesh pattern in at least
one of the four extensions. The method can include forming the mesh
pattern in the central region. The method can include interlocking
two of the four extensions of the composition with a fastening
element. The method can include feeding the fastening element
through the mesh pattern and interlocking the fastening element to
a strip of material associated with the mesh pattern. In certain
embodiments, the method can include interlocking the four
extensions of the composition with a fastening element, e.g., a
T-shaped fastening element.
[0011] In certain embodiments, the composition can include a top
region, a central region, and a bottom region. The composition can
include a first flap and a second flap extending from opposing
sides of the central region. The composition can include at least
one strap integrally formed adjacent to an edge of the bottom
region. The method can include stretching the at least one strap
around a portion of the implant or tissue expander to maintain the
composition in a wrapped configuration.
[0012] In certain embodiments, the composition can include two
flaps extending from one edge of the composition body. The method
can include passing the two flaps through slits of the mesh pattern
to maintain the composition completely or nearly completely wrapped
around the implant or tissue expander.
[0013] In certain embodiments, the composition can include a first
composition half and a second composition half. The first
composition half can include two flaps extending from a top edge
and two flaps extending from a bottom edge. The method can include
passing the two flaps extending from the top edge of the first
composition half into slits of the mesh pattern of one edge of the
second composition half. The method can include passing the two
flaps extending from the bottom edge of the first composition half
into slits of the mesh pattern of an opposing edge of the second
composition half. Interlocking the flaps with the slits of the mesh
pattern maintains the composition completely or nearly completely
wrapped around the implant or tissue expander.
[0014] According to certain embodiments, a composition for
treatment is provided. The composition can include a composition
body and a mesh pattern formed in at least a portion of the
composition body. The composition body can be formed from a tissue
matrix or synthetic material. The composition body can be
configured to stretch and expand at the mesh pattern to completely
or nearly completely wrap the composition body around or position
the composition body onto an implant or tissue expander.
[0015] In certain embodiments, the tissue matrix can be a tissue
matrix sheet defining a planar and flexible configuration. In
certain embodiments, the tissue matrix can be an acellular tissue
matrix. In certain embodiments, the tissue matrix can be an
acellular dermal matrix.
[0016] In certain embodiments, the composition body can include a
central region and four extensions extending from the central
region. At least one of the four extensions can include the mesh
pattern formed therein. The central region can include the mesh
pattern formed therein. The composition can include a fastening
element configured to interlock at least two of the four extensions
relative to each other (e.g., two opposing extensions). In certain
embodiments, the fastening element can include a linear elongated
body. In certain embodiments, the fastening element can define a
T-shape.
[0017] In certain embodiments, the composition body can include a
top region, a central region, and a bottom region. The composition
can include a first flap and a second flap extending from opposing
sides of the central region. The composition can include at least
one strap integrally formed adjacent to an edge of the bottom
region. The at least one strap can be configured to stretch around
a portion of the implant or tissue expander to maintain the
composition body in a wrapped configuration.
[0018] In certain embodiments, the composition body can include two
flaps extending from one edge of the composition body. The two
flaps can be configured to pass through slits of the mesh pattern
to maintain the composition body completely or nearly completely
wrapped around the implant or tissue expander.
[0019] In certain embodiments, the composition body can include a
first composition half and a second composition half. The first
composition half can include two flaps extending from a top edge
and two flaps extending from a bottom edge. In certain embodiments,
the first composition half can include two flaps extending from a
top edge and the second composition half can include two flaps
extending from a bottom edge. The two flaps extending from the top
edge of the first composition half can be configured to pass into
slits of the mesh pattern of one edge of the second composition
half. The two flaps extending from the bottom edge of the first
composition half can be configured to pass into slits of the mesh
pattern of an opposing edge of the second composition half.
Interlocking of the flaps with the mesh pattern maintains the
composition completely or nearly completely wrapped around the
implant or tissue expander.
[0020] According to certain embodiments, a system for treatment is
provided. The system can include a composition. The composition can
include a tissue matrix or synthetic material defining a
composition body. The composition can include a mesh pattern formed
in at least a portion of the composition body. The system includes
an implant or a tissue expander. The composition body can be
configured to stretch and expand at the mesh pattern to completely
or nearly completely wrap the composition body around or position
the composition body onto the implant or tissue expander.
[0021] In certain embodiments, the tissue matrix can be a tissue
matrix sheet defining a planar and flexible configuration. In
certain embodiments, the tissue matrix can be an acellular tissue
matrix. In certain embodiments, the tissue matrix can be an
acellular dermal matrix.
[0022] In certain embodiments, the composition body can include a
central region and four extensions extending from the central
region. At least one of the four extensions can include the mesh
pattern formed therein. The central region can include the mesh
pattern formed therein. The composition can include a fastening
element configured to interlock at least two of the four extensions
relative to each other (e.g., two opposing extensions). In certain
embodiments, the fastening element can include a linear elongated
body. In certain embodiments, the fastening element can define a
T-shape.
[0023] In certain embodiments, the composition body can include a
top region, a central region, and a bottom region. The composition
can include a first flap and a second flap extending from opposing
sides of the central region. The composition can include at least
one strap integrally formed adjacent to an edge of the bottom
region. The at least one strap can be configured to stretch around
a portion of the implant or tissue expander to maintain the
composition body in a wrapped configuration.
[0024] In certain embodiments, the composition body can include two
flaps extending from one edge of the composition body. The two
flaps can be configured to pass through slits of the mesh pattern
to maintain the composition body completely or nearly completely
wrapped around the implant or tissue expander.
[0025] In certain embodiments, the composition body can include a
first composition half and a second composition half. The first
composition half can include two flaps extending from a top edge
and two flaps extending from a bottom edge. In certain embodiments,
the first composition half can include two flaps extending from a
top edge and the second composition half can include two flaps
extending from a bottom edge. The two flaps extending from the top
edge of the first composition half can be configured to pass into
slits of the mesh pattern of one edge of the second composition
half. The two flaps extending from the bottom edge of the first
composition half can be configured to pass into slits of the mesh
pattern of an opposing edge of the second composition half.
Interlocking of the flaps with the mesh pattern maintains the
composition completely or nearly completely wrapped around the
implant or tissue expander.
DESCRIPTION OF THE DRAWINGS
[0026] FIG. 1 is front view of a breast implant or tissue expander,
according to certain embodiments.
[0027] FIG. 2 is a side view of a breast implant or tissue
expander, according to certain embodiments.
[0028] FIG. 3 is a front view of a composition, according to
certain embodiments.
[0029] FIG. 4 is a front view of a fastening element, according to
certain embodiments.
[0030] FIG. 5 is a perspective view of a fastening element,
according to certain embodiments.
[0031] FIG. 6 is a perspective view of a composition in a partially
wrapped configuration relative to a breast implant or tissue
expander, according to certain embodiments.
[0032] FIG. 7 is a perspective view of a composition in a partially
wrapped configuration relative to a breast implant or tissue
expander, according to certain embodiments.
[0033] FIG. 8 is a front view of a fastening element, according to
certain embodiments.
[0034] FIG. 9 is a perspective view of a fastening element,
according to certain embodiments.
[0035] FIG. 10 is a perspective view of a composition in a
partially wrapped configuration relative to a breast implant or
tissue expander, according to certain embodiments.
[0036] FIG. 11 is a front view of a composition, according to
certain embodiments.
[0037] FIG. 12 is a side view of a composition in a wrapped
configuration relative to a breast implant or tissue expander,
according to certain embodiments.
[0038] FIG. 13 is a rear view of a composition in a wrapped
configuration relative to a breast implant or tissue expander,
according to certain embodiments.
[0039] FIG. 14 is a front view of a composition, according to
certain embodiments.
[0040] FIG. 15 is a perspective view of a composition in a wrapped
configuration relative to a breast implant or tissue expander,
according to certain embodiments.
[0041] FIG. 16 is a front view of a first composition half,
according to certain embodiments.
[0042] FIG. 17 is a front view of a second composition half,
according to certain embodiments.
[0043] FIG. 18 is a perspective view of a first composition half
and a second composition half in a wrapped configuration relative
to a breast implant or tissue expander, according to certain
embodiments.
DESCRIPTION OF CERTAIN EXEMPLARY EMBODIMENTS
[0044] 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.
[0045] 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.
[0046] 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.
[0047] Various human and animal tissues can be used to produce
products or compositions 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).
[0048] In certain embodiments, these products or compositions can
be completely or partially decellularized to yield acellular tissue
matrices or extracellular tissue materials to be used for patients.
For example, various tissues, such as skin, intestine, bone,
cartilage, nerve tissue (e.g., nerve fibers or dura), tendons,
ligaments, or other tissues can be completely or partially
decellularized to produce tissue products useful for patients. In
some cases, these decellularized products can be used without
addition of exogenous cellular materials (e.g., stem cells). In
certain cases, these decellularized products can be seeded with
cells from autologous sources or other sources to facilitate
treatment. Suitable processes for producing acellular tissue
matrices are described below.
[0049] Tissue products can be selected to provide a variety of
different biological and mechanical properties. 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
fascia, may be selected to allow regeneration of the fascia without
excessive fibrosis or scar formation. In certain embodiments, the
tissue product can be formed from ALLODERM.RTM. or STRATTICE.TM.,
which are human and porcine acellular dermal matrices,
respectively. Alternatively, other suitable acellular tissue
matrices can be used, as described further below. The methods for
shaping tissues having an extracellular matrix can be used to
process any collagenous tissue type, and for any tissue matrix
product. For example, a number of biological scaffold materials as
described by Badylak et al., or any other similar materials, can be
used to produce tissues with a stable three-dimensional shape.
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 certain embodiments, the
compositions discussed herein can be formed from or can include a
tissue product, a synthetic material, or both.
[0050] The term "acellular tissue matrix," as used herein, refers
generally to any tissue matrix that is substantially free of cells
and/or cellular components. Skin, parts of skin (e.g., dermis), and
other tissues such as blood vessels, heart valves, fascia,
cartilage, bone, and nerve connective tissue may be used to create
acellular matrices within the scope of the present disclosure.
Acellular tissue matrices can be tested or evaluated to determine
if they are substantially free of cell and/or cellular components
in a number of ways. For example, processed tissues can be
inspected with light microscopy to determine if cells (live or
dead) and/or cellular components remain. In addition, certain
assays can be used to identify the presence of cells or cellular
components. For example, DNA or other nucleic acid assays can be
used to quantify remaining nuclear materials within the tissue
matrices. Generally, the absence of remaining DNA or other nucleic
acids will be indicative of complete decellularization (i.e.,
removal of cells and/or cellular components). Finally, other assays
that identify cell-specific components (e.g., surface antigens) can
be used to determine if the tissue matrices are acellular.
[0051] In general, the steps involved in the production of an
acellular tissue matrix include harvesting the tissue from a donor
(e.g., a human cadaver or animal source) and cell removal under
conditions that preserve biological and structural function. In
certain embodiments, the process includes chemical treatment to
stabilize the tissue and avoid biochemical and structural
degradation together with or before cell removal. In various
embodiments, the stabilizing solution arrests and prevents osmotic,
hypoxic, autolytic, and proteolytic degradation, protects against
microbial contamination, and reduces mechanical damage that can
occur with tissues that contain, for example, smooth muscle
components (e.g., blood vessels). The stabilizing solution may
contain an appropriate buffer, one or more antioxidants, one or
more oncotic agents, one or more antibiotics, one or more protease
inhibitors, and/or one or more smooth muscle relaxants.
[0052] While an acellular tissue matrix may be made from one or
more individuals of the same species as the recipient of the
acellular tissue matrix graft, this is not necessarily the case.
Thus, for example, an acellular tissue matrix may be made from
porcine tissue and implanted in a human patient. Species that can
serve as recipients of acellular tissue matrix and donors of
tissues or organs for the production of the acellular tissue matrix
include, without limitation, mammals, such as humans, nonhuman
primates (e.g., monkeys, baboons, or chimpanzees), pigs, cows,
horses, goats, sheep, dogs, cats, rabbits, guinea pigs, gerbils,
hamsters, rats, or mice.
[0053] The compositions discussed herein can be implemented to
cover an implant or tissue expander prior to sub-glandular
implantation of the implant or tissue expander to reduce or prevent
palpability of ripples and/or capsular contracture. Although
discussed herein with respect to sub-glandular reconstruction and
augmentation procedures, it should be understood that the disclosed
compositions can be implemented for alternative medical procedures
involving a variety of implants. Covering the implant or tissue
expander with the composition allows for a smoother operation and
improved healing by reducing any reactions from implanting a
foreign element into the human body.
[0054] The compositions can include one or more mesh patterns
formed in the composition body that facilitate stretching and
expanding of the composition to wrap around the implant or tissue
expander, while providing the necessary coverage and support to the
implant or tissue expander. In particular, the mesh patterns reduce
the amount of tissue or material that must be used to form the
composition, thereby reducing the cost of preparing the
material.
[0055] In addition, the stretchable or expandable property of the
composition due to the mesh patterns allows the composition to
conform to the size of the implant or tissue expander without the
need to trim and discard excess tissue. Smaller amounts of tissue
can therefore be used to cover the implant or tissue expander
without the need for trimming the composition. As such, the
disclosed compositions reduce waste of expensive tissue materials
that form the compositions.
[0056] In the stretched and expanded configuration, the mesh
patterns form perforations through the body of the composition,
thereby exposing portions of the implant or tissue expander.
However, it is noted that the exposure of the implant or tissue
expander through the perforations or openings of the mesh pattern
still permits the compositions to provide the necessary coverage to
the implant or tissue expander to reduce or prevent undesired
reactions between the breast tissue and the implant or tissue
expander.
[0057] In certain embodiments, the composition can be formed from
an acellular dermal matrix (ADM) configured to provide full
coverage (e.g., substantially full coverage due to the mesh
patterns) to the implant or tissue expander. In certain
embodiments, the composition can be formed from a synthetic
material. In certain embodiments, the composition can be formed
from a combination of ADM and synthetic materials. The composition
can provide tissue to camouflage the implant or tissue expander to
decrease palpability of ripples, provide a natural tissue barrier
between the implant or tissue expander and the breast tissue flap,
and shield the implant or tissue expander from puncture during
adjust fat transfer or other medical techniques.
[0058] The mesh patterns can be designed to optimize coverage of
the composition relative to the implant or tissue expander,
minimize the total square area of the tissue composition, and
maintain beneficial regenerative properties of the tissue
composition post-implantation. Because the composition serves as
coverage over the implant or tissue expander and a barrier between
the host tissue and the implant or tissue expander, the mesh
patterns are configured to provide sufficient coverage to both mask
the implant or tissue expander, as well as prevent formation of a
continuous capsule.
[0059] The geometry of the composition can conform to the
three-dimensional shape of the breast pocket and tissue expander.
In particular, the mesh patterns allow the composition to stretch
and expand in the appropriate regions to conform to the geometry of
the implant or tissue expander to be positioned into the breast
pocket.
[0060] Adjunct fat injection techniques are generally used on an
upper pole of the breast. Therefore, in certain embodiments, rather
than a mesh pattern, a continuous matrix structure can be
maintained at the upper pole region of the composition to provide
protection from medical devices used during the adjunct fat
injection technique.
[0061] The compositions can include geometries with fastening
elements or features that allow for fixation of the composition to
the implant or tissue expander. In certain embodiments, the
composition can include one or more flaps that fit into and through
the perforations created by the mesh pattern in the composition. In
certain embodiments, a single continuous sheet or piece of ADM can
be wrapped around the implant or tissue expander and attached to
the implant or tissue expander by feeding the flaps into the
perforations and fixating the flaps with suture.
[0062] In certain embodiments, the composition can include two
separate pieces or sheets of ADM, e.g., a first composition half
and a second composition half. The first composition half can
include one or more mesh patterns, e.g., at the lower pole, and can
be configured to cover the posterior portion of the implant or
tissue expander. The second composition half can include flaps
located on and extending from both upper and lower poles that are
designed for passage through the mesh pattern and suture fixation
to the meshed areas of the posterior piece, e.g., the first
composition half. The second composition half can therefore cover
and provide the necessary support to the anterior portion of the
implant or tissue expander, while interlocking with the first
composition half to maintain the composition wrapped around the
implant or tissue expander.
[0063] In certain embodiments, the fastening elements in the form
of one or more individual tissue straps can be used to connect
portions of the composition to maintain the composition wrapped
around the implant or tissue expander. In certain embodiments, the
tissue straps can be used to connect the meshed portions of the
composition. The tissue straps can include a slit or opening on a
proximal end and suture holes on a distal end. The distal end of
the tissue strap can be snaked or passed through a perforation of
the mesh pattern and then through the slit at the proximal end for
fixation of one side of the composition. The distal end can further
be snaked or passed through a perforation of the mesh pattern on an
opposing side of the composition and sutured to the tissue strap
through a suture hole.
[0064] In certain embodiments, the composition can include one or
more continuous tissue straps formed directly in the composition
body that are designed to wrap around portions of the implant or
tissue expander and/or the composition body to hold the implant or
tissue expander in place within the three-dimensional geometry of
the composition during the implantation procedure. The tissues
traps can therefore maintain the composition wrapped around the
implant or tissue expander. The tissue straps can be cut directly
into the geometry of the composition and create a fixation
mechanism that is continuous with the composition and does not
require suturing.
[0065] The compositions discussed herein advantageously provide
full tissue coverage to an implant or tissue expander that can be
implanted, e.g., sub-glandularly, or the like. Fully covering the
implant or tissue expander lowers the risk of capsular contracture
and provides a soft tissue barrier to mask the implant or tissue
expander. The mesh patterns of the compositions decrease costs
associated with creating the compositions. The fastening elements
of the compositions can increase the ease of performing the
implantation procedure due to a reduction in suturing. The
compositions therefore improve the sub-glandular reconstruction or
augmentation procedure by creating a more predictable, aesthetic
and biologic outcome and simplifies the overall implantation
procedure.
[0066] With reference to FIGS. 1 and 2, one embodiment of an
implant 10 (e.g., a breast implant or tissue expander) is provided.
In certain embodiments, the implant 10 can be any type of breast
implant, such as a breast implant including a saline solution, a
silicone gel, or a composite filler material. In certain
embodiments, the implant 10 can be any type of tissue expander,
such as a tissue expander including an inflatable balloon device.
In certain embodiments, the implant 10 can be any type of implant
and should not be limited to breast implants.
[0067] The implant 10 can include a moldable body 12 that can be
shaped by a surgeon during the implantation procedure or can be
shaped prior to the implantation procedure. As diagrammatically
illustrated in FIGS. 1 and 2, the implant 10 can define an upper
pole 14 and a lower pole 16 separated by an axis 18. The implant 10
can also define a right side 20 and a left side 22 separated by an
axis 24. The implant can further define an anterior side 26 and a
posterior side 28 separated by an axis 30.
[0068] During sub-glandular breast reconstruction, the implant 10
can be implanted between the pectoral muscles and the breast tissue
of the patient. Although the compositions discussed herein cover or
substantially cover the entire surface area of the implant 10, the
lower pole 16 and/or the right and left sides 20, 22 may require
the most support post-implantation. As such, in certain
embodiments, the portions of the composition covering the lower
pole 16 and/or the right and left sides 20, 22 can define a
continuous structure (e.g., without mesh patterns), while the
remaining portions of the composition include mesh patterns formed
therein. In certain embodiments, the portions of the composition
covering the anterior side 26 can define a continuous structure,
while the remaining portions of the composition include mesh
patterns formed therein.
[0069] Similarly, adjunct fat injection techniques may be used on
the upper pole 14 of the breast. Therefore, in certain embodiments,
rather than a mesh pattern, a continuous structure can be
maintained at the upper pole 14 region of the composition to
provide protection from medical devices used during the adjunct fat
injection technique, while remaining portions of the composition
include mesh patterns formed therein. However, it should be
understood that a variety of configurations including continuous
structures and mesh patterns are contemplated to provide adequate
support to regions of the implant 10 during and
post-implantation.
[0070] With reference to FIG. 3, a front view of one embodiment of
an exemplary composition 100 is shown. In certain embodiments, the
composition 100 can be made from processed tissue, e.g., an
acellular tissue matrix, an acellular dermal matrix, or the like.
In certain embodiments, the composition 100 can be made from a
synthetic material. In certain embodiments, the composition 100 can
be made from a combination of processed tissue and synthetic
materials.
[0071] The composition 100 includes a composition body 102. The
composition body 102 can be shaped or formed into a substantially
flat or sheet-like configuration. However, the composition body 102
can be flexible such that the composition body 102 can conform to
and wrap around the three-dimensional shape of the implant 10. The
composition body 102 includes a central region 104 from which
extensions 106-112 protrude or extend.
[0072] The central region 104 can define a substantially
rectangular configuration. The first extension 106 (e.g., a top
extension) and the second extension 108 (e.g., a bottom extension)
can extend from the central region 104 in a substantially parallel
manner relative to each other and a vertical axis 114. The third
extension 110 (e.g., a right extension) and the fourth extension
112 (e.g., a left extension) can extend from the central region 104
in a substantially parallel manner relative to each other and a
horizontal axis 116. The vertical axis 114 can be substantially
perpendicular to the horizontal axis 116. As such, the first and
second extensions 106, 108 can extend substantially perpendicularly
relative to the third and fourth extensions 110, 112.
[0073] Each of the extensions 106-112 can define a substantially
similar width 118, length 120, or both. In certain embodiments, one
or more of the extensions 106-112 can define a different width 118,
length 120, or both, as compared to the other extensions 106-112.
Although illustrated as defining a substantially rectangular
configuration, one or more of the extensions 106-112 can define,
e.g., a square shape, a rectangular shape, an oval shape, or the
like. In certain embodiments, the edges of the extensions 106-112
can be curved. In certain embodiments, the edges of the extensions
106-112 can be angled or pointed.
[0074] In certain embodiments, the composition 100 can include one
or more mesh patterns 122 formed therein. For example, the
composition 100 can include a mesh pattern 122 formed on a portion
or the entire surface area of, e.g., the central region 104, the
first extension 106, the second extension 108, the third extension
110, the fourth extension 112, combinations thereof, or the like.
In certain embodiments, the mesh pattern 122 can extend from one
area of the composition body 102 into another area of the
composition 102. For example, as shown in FIG. 3, the mesh pattern
122 can extend from the second extension 108 into a portion of the
central region 104.
[0075] The mesh pattern 122 can include a plurality of slits 124
(e.g., perforations, openings, or the like) formed in and passing
through the composition body 102. Portions of the composition body
102 including the mesh pattern 122 can be stretched and expanded
due to the pattern of slits 124 such that the length of the portion
of the composition body 102 can be increased or adjusted based on
the size of the implant 10.
[0076] In certain embodiments, each slit 124 can be dimensioned
equally. In certain embodiments, the slits 124 can have different
dimensions. In certain embodiments, the slits 124 can be
dimensioned between approximately 10 mm to approximately 15 mm in
length. In certain embodiments, the slits 124 can be dimensioned
between approximately 12 mm and approximately 15 mm in length. The
slits 124 of the mesh patterns 122 formed on the first and second
extensions 106, 108 can be substantially parallel to each other and
the horizontal axis 116. The slits 124 of the mesh patterns 122
formed on the third and fourth extensions 110, 112 can be
substantially parallel to each other and the vertical axis 114. In
certain embodiments, the slits 124 can be linear in form. In
certain embodiments, the slits 124 can be curved in form. In
certain embodiments, each row of slits 124 can be staggered or
offset relative to the adjacent row of slits 124. In certain
embodiments, each row of slits 124 can be staggered or offset
relative to the adjacent row of slits 124 by approximately 8 mm to
approximately 10 mm. In certain embodiments, each row of slits 124
can be spaced from the adjacent row of slits 124 by approximately
five mm or less. However, it should be understood that alternative
distance ranges can be used to optimize the size and/or stretching
of the composition 100.
[0077] Although illustrated as a plurality of slits, in certain
embodiments, the mesh patterns discussed herein can be formed from
any pattern of holes or openings. For example, in certain
embodiments, the mesh patterns can be formed from a pattern of
circular holes spaced relative to each other such that the
composition can be stretched and expanded at the mesh patterns. As
a further example, in certain embodiments, the mesh patterns can be
formed from a pattern of oval holes spaced relative to each other
such that the composition can be stretched and expanded at the mesh
patterns.
[0078] In certain embodiments, portions of the composition body 102
can define a continuous structure 126 (e.g., a structure without a
mesh pattern 122 formed therein). Areas with a continuous structure
126 can be aligned with portions of the implant 10 that require the
most amount of support or protection. The areas of the composition
body 102 including the mesh pattern 122 and the continuous
structure 126 can be customized depending on the type of implant 10
being used with the composition 100 and characteristics of the
patient receiving the implant 10. For example, if a patient is
known to have insufficient host tissue for supporting the implant
on certain sides, the composition 100 can be customized to define a
continuous structure 126 on those sides to provide added support to
the implant 10. As a further example, the continuous structure 126
can be located on the area of the composition 100 that will be used
to provide greater support to the lower pole 16 of the implant 10,
while the mesh patterns 122 are formed to allow the extensions
106-112 to wrap around the remaining areas of the implant 10.
[0079] With reference to FIGS. 4 and 5, front and perspective views
of one exemplary embodiment of a fastening element 130 are
provided. The fastening element 130 can be formed from a tissue
(e.g., an acellular tissue matrix, an acellular dermal matrix, or
the like) and/or a synthetic material. As will be discussed in
greater detail below, the fastening element 130 can be used to
secure the composition 100 to the implant 10 in the wrapped
configuration. The fastening element 130 can be in the form of an
elongated strap including an elongated body 132 with a proximal end
134 and a distal end 136. The width 138 of the elongated body 132
can be dimensioned to pass freely through the slits 124 of the mesh
patterns 122 formed in the composition 100. The fastening element
130 can be flexible to allow manipulation of the fastening element
130 when interlocking the fastening element 130 relative to
components of the composition 100.
[0080] The proximal end 134 of the fastening element 130 can
include a rounded tip 140. The diameter of the tip 140 can be
dimensioned greater than the width 138 of the elongated body 138 to
accommodate a slit 142 formed in the proximal end 134. The slit 142
can extend in a perpendicular direction relative to the elongated
body 138 extending from the tip 140. The slit 142 can pass through
the tip 140 and provides an aperture through which the distal end
136 and the elongated body 132 can pass. In particular, the slit
142 can be dimensioned to allow passage of the distal end 136 and
the elongated body 132 therethrough. In certain embodiments, the
slit 142 can be dimensioned slightly greater than the width 138 of
the elongated body 132.
[0081] The distal end 136 of the fastening element 130 can define a
rounded tip 144. The rounded tip 144 can provide an easier
configuration for passing into the slit 142 of the proximal end
134. Starting from a position spaced from the tip 144, the
elongated body 132 can include one or more suture holes or
apertures 146 formed in and passing through the elongated body 132.
In certain embodiments, the apertures 146 can be formed from the
distal end 136 up to the slit 142 of the proximal end 134. In
certain embodiments, the apertures 146 can be formed from the
distal end 136 a partial distance in the direction of the slit 142
of the proximal end 134. The apertures 146 can be configured and
dimensioned to allow suture to be passed therethrough for securing
the distal end 136 to the elongated body 102.
[0082] As shown in FIG. 5, during assembly, the distal end 136 of
the fastening element 130 can initially be snaked or passed through
a slit 124 in the mesh pattern 122 in the composition 100, and
further passed through the slit 142 in the proximal end 134 of the
fastening element 130. A first loop 148 can thereby be formed to
secure the fastening element 130 to a first portion of the
composition 100.
[0083] The distal end 136 is further snaked or passed through a
slit 124 in another mesh pattern 122 of the composition 100, and
folded over to align two of the apertures 146. A second loop 150
can thereby be formed to secure the fastening element 130 to a
second portion of the composition 100. The apertures 146 used for
alignment to create the second loop 150 can be selected based on
the desired tension between the first and second portions of the
composition 100, e.g., the desired tension to maintain the
composition 100 wrapped around the implant 10. In certain
embodiments, if insufficient tension is created by the fastening
element 130, the fastening element 130 can be passed through
alternative openings 152 in the mesh pattern 122 away from the edge
of the extension 106-112 such that certain extensions 106-112
overlap relative to each other to create the desired tension.
Suture can be passed through the aligned apertures 146 to secure
the distal end 136 to the elongated body 132, and to maintain the
fastening element 130 interlocked relative to the composition
100.
[0084] With respect to FIG. 6, a perspective view of the
composition 100 being wrapped around the implant 10 is shown.
Initially, the implant 10 can be positioned on and orientated
relative to the composition 100 such that the appropriate sections
of the implant 10 that require additional support are positioned
adjacent to continuous structure 126 portions of the composition
100. For example, the lower pole 16 and the anterior side 26 of the
implant 10 can be positioned against continuous structure 126
portions of the composition 100. With respect to the lower pole 16,
a greater amount of support may be desired due to most of the
weight of the implant 10 being relayed to the bottom breast tissue
post-implantation.
[0085] In the initial configuration, the composition 100 can be
dimensioned smaller than the surface area of the implant 10.
However, as shown in FIG. 6, one or more extensions 106-112 can
include mesh patterns 122 for expanding and stretching portions of
the composition 100 to wrap the composition 100 around the implant
10 (e.g., to completely or nearly completely surround the implant
10). As discussed herein, completely or nearly completely
surrounding, covering or wrapping the implant 10 indicates that the
composition 100 stretches or expands over a major portion of the
surface area of the implant 10. Thus, although the composition 100
includes mesh patterns 122 that stretch and expand to create
openings exposing portions of the implant 10 therethrough, it
should be understood that the composition 100 is still considered
as surrounding, covering or wrapping the implant 10.
[0086] For example, the third and fourth extensions 110, 112 are
shown stretched in FIG. 6 to wrap around the right side 20, left
side 22 and posterior side 28 of the implant 10. The mesh patterns
122 can be expanded and stretched by applying a tensile force on
the respective extension 106-112 associated with the mesh pattern
122. The slits 124 that form the mesh pattern 122 can expand due to
the tensile force to create a plurality of openings 152 that are
dimensioned greater than the slits 124 in the non-expanded
configuration. The expanded and stretched mesh patterns 122 allow
the composition 100 to conform to the size and/or shape of the
implant 10. As such, less material is necessary to wrap the
composition 100 nearly completely or completely around the implant
10.
[0087] In order to secure portions of the composition 100 around
the implant 10 in a wrapped configuration, one or more fastening
elements 130 can be used. As discussed above, the distal end 136 of
the fastening element 130 can be passed through an opening 152
(e.g., the opening 152 in the fourth extension 112) and further
passed through the slit 142 formed in the proximal end 134 of the
fastening element 130. The first loop 148 formed at the proximal
end 134 of the fastening element 130 can thereby be passed around
and interlocked with a strip 154 of material surrounding the
opening 152 and, thereby, the fourth extension 112.
[0088] The distal end 136 can further be passed through the opening
152 in a different mesh pattern 122 (e.g., the opening 152 in the
third extension 110). In certain embodiments, the second loop 150
can be formed around a mesh pattern 122 in an extension 106-112
opposing the extension 106-112 around which the first loop 148 is
formed. After passing the distal end 136 through the opening 152,
the fastening element 130 can be used to tighten the first and
second extensions 110, 112 relative to each other until the desired
amount of wrapping of the composition 100 around the implant is
achieved. In certain embodiments, the third and fourth extensions
110, 112 can be stretched until the third and fourth extensions
110, 112 are in a touching relation, thereby wrapping around the
entire posterior side 28 of the implant 10. In certain embodiments,
the third and fourth extensions 110, 112 can be stretched and
remain in a spaced relation relative to each other, thereby leaving
a portion of the posterior side 28 of the implant 10 exposed.
However, in such embodiments, support to the implant 10 can
naturally be provided by the chest wall and/or the pectoral muscle
against which the implant 10 is positioned. Thus, the composition
100 completely or nearly completely surrounds the surface area of
the implant 10.
[0089] The distal end 136 can be folded over the strip 156 of
material surrounding the opening 152 and two apertures 146 in the
fastening element 130 can be aligned. Suture 158 can be passed
through the apertures 146 to secure the second loop 150 around the
strip 156, thereby interlocking the fastening element 130 to the
third extension 110. In certain embodiments, suture 158 can be
passed through the elongated body 132 without the use of the
apertures 146. The fastening element 130 therefore stretches
between the third and fourth extensions 110, 112 and around a
portion of the implant 10. The fastening element 130 can thereby
maintain the third and fourth extensions 110, 112 wrapped around
the implant 10. In certain embodiments, suture can be used to
secure the extensions 106-112 relative to each other.
[0090] With respect to FIG. 7, a perspective view of the
composition 100 being wrapped around the implant 10 is shown. The
composition 100 can be wrapped completely or nearly completely
around the implant 10 in a substantially similar manner to that
described with respect to FIG. 6. However, rather than using a
single fastening element 130, two or more fastening elements 130
can be used to secure the opposing extensions 106-112 relative to
each other. For example, a first fastening element 130 can be used
to secure the first and second extensions 106, 108 relative to each
other, and a second fastening element 130 can be used to secure the
third and fourth extensions 110, 112 relative to each other. It
should be understood that any number of fastening elements 130 can
be used to secure the composition 100 in a wrapped configuration
around the implant 10.
[0091] In certain embodiments, one fastening element 130 can be
used to secure three or more extensions 106-112 relative to each
other. For example, after the fastening element 130 has been
interlocked relative to one extension, e.g., the first extension
106, the distal end can be passed through the openings of the
third, second and fourth extensions 110, 106, 112 and interlocked
relative to the fourth extension 112. A single fastening element
130 can thereby be used to maintain each extension 106-112 wrapped
around the implant 10.
[0092] With reference to FIGS. 8 and 9, front and perspective views
of another exemplary embodiment of a fastening element 160 are
provided. The fastening element 160 can be formed from a tissue
(e.g., an acellular tissue matrix, an acellular dermal matrix, or
the like) and/or a synthetic material. As will be discussed in
greater detail below, the fastening element 160 can be used to
secure the composition 100 to the implant 10 in the wrapped
configuration.
[0093] The fastening element 160 can be in the form of a
substantially T-shaped strap including a vertical elongated body
162, a first horizontal elongated body 164, and a second horizontal
elongated body 166. The vertical elongated body 162 can define a
proximal end 168 and a distal end 170. The first and second
horizontal elongated bodies 164, 166 can extend in a substantially
parallel manner relative to each other from opposing sides of the
proximal end 168 of the vertical elongated body 162. In particular,
the first and second horizontal elongated bodies 164, 166 can
extend in a substantially perpendicular manner relative to the
vertical elongated body 162.
[0094] The first horizontal elongated body 164 can define a
proximal end 172 and a distal end 174. The proximal end 172 of the
first horizontal elongated body 164 can be formed integrally with
the proximal end 168 of the vertical elongated body 162. The first
horizontal elongated body 164 thereby connects to the vertical
elongated body 162 at the proximal end 172. The second horizontal
elongated body 166 can define a proximal end 176 and a distal end
178. The proximal end 178 of the second horizontal elongated body
166 can be formed integrally with the proximal end 168 of the
vertical elongated body 162. The second horizontal elongated body
166 thereby connects to the vertical elongated body 162 at the
proximal end 176.
[0095] The vertical elongated body 162 and the first and second
horizontal elongated bodies 164, 166 can define widths 180-184,
respectively, can be dimensioned to pass freely through the slits
124 of the mesh patterns 122 formed in the composition 100. The
fastening element 160 can be flexible to allow manipulation of the
fastening element 160 when interlocking the fastening element 160
relative to components of the composition 100.
[0096] In certain embodiments, the proximal end 168 of the vertical
elongated body 162 can include a rounded tip 186. The diameter of
the rounded tip 186 can be dimensioned greater than the width 180
of the vertical elongated body 162 to provide a stronger structure
for attachment of the first and second horizontal elongated bodies
164, 166. The rounded tip 186 can accommodate a slit 188 formed in
the proximal end 168. The slit 188 can extend in a perpendicular
direction relative to the vertical elongated body 162 extending
from the tip 186 and substantially parallel to the first and second
horizontal elongated bodies 164, 166. The slit 188 can pass through
the tip 186 and provides an aperture through which the distal end
170 and the vertical elongated body 162 can pass. In particular,
the slit 188 can be dimensioned to allow passage of the distal end
170 and the vertical elongated body 162 therethrough. In certain
embodiments, the slit 188 can be dimensioned slightly greater than
the width 180 of the vertical elongated body 162.
[0097] The distal end 170 of the vertical elongated body 162 can
define a rounded tip 190. The rounded tip 190 can provide an easier
configuration for passing into the slit 188 of the proximal end
168. Starting from a position spaced from the tip 190, the vertical
elongated body 162 can include one or more suture holes or
apertures 192 formed in and passing through the vertical elongated
body 162. In certain embodiments, the apertures 192 can be formed
from the distal end 170 up to the slit 188 of the proximal end 168.
In certain embodiments, the apertures 192 can be formed from the
distal end 170 a partial distance in the direction of the slit 188
of the proximal end 168. The apertures 192 can be configured and
dimensioned to allow suture therethrough for securing the distal
end 170 to the vertical elongated body 162.
[0098] In certain embodiments, the distal end 174 of the first
horizontal elongated body 164 can include a rounded tip 194. The
diameter of the rounded tip 194 can be dimensioned greater than the
width 182 of the first horizontal elongated body 164. The rounded
tip 194 can accommodate a slit 196 formed in the distal end 174.
The slit 196 can extend in a perpendicular direction relative to
the first horizontal elongated body 164 extending from the tip 194
and substantially parallel to the vertical elongated body 162. The
slit 196 can pass through the tip 194 and is dimensioned to provide
an aperture through which the vertical elongated body 162, the
second horizontal elongated body 166, and the first horizontal
elongated body 164 can pass. As will be discussed in greater detail
below, the flexibility of the fastening element 160 allows portions
of the fastening element 160 to be folded and passed through the
slit 196.
[0099] The proximal end 172 of the first horizontal elongated body
164 can be connected to the proximal end 168 of the vertical
elongated body 162. Other than the slit 196, the first horizontal
elongated body 164 can define a continuous and aperture-free
material.
[0100] The proximal end 176 of the second horizontal elongated body
166 can be connected to the proximal end 168 of the vertical
elongated body 162. The distal end 178 of the second horizontal
elongated body 166 can define a rounded tip 198. The rounded tip
198 can provide an easier configuration for passing into the slit
198 of the distal end 174 of the first horizontal elongated body
164. Starting from a position spaced from the tip 198, the second
horizontal elongated body 166 can include one or more suture holes
or apertures 200 formed in and passing through the second
horizontal elongated body 166. In certain embodiments, the
apertures 200 can be formed from the distal end 178 up to the slit
188 of the proximal end 168 of the vertical elongated body 162. In
certain embodiments, the apertures 200 can be formed from the
distal end 178 a partial distance in the direction of the slit 188
of the proximal end 168 of the vertical elongated body 162. The
apertures 200 can be configured and dimensioned to allow suture
therethrough for securing the distal end 178 to the second
horizontal elongated body 166.
[0101] As shown in FIG. 9, during assembly, distal end 174 of the
first horizontal elongated body 164 can initially be snaked or
passed through a slit 124 in the mesh pattern 122 in the
composition 100. The vertical elongated body 162 and the second
horizontal elongated body 166 can then be snaked or passed through
the slit 196 of the distal end 174. For example, the vertical
elongated body 162 can be folded onto the second horizontal
elongated body 166 (e.g., to substantially align the distal ends
170, 178) and the distal ends 170, 178 can be snaked or passed
through the slit 196. A first loop 202 can thereby be formed to
secure the fastening element 160 to a first portion of the
composition 100 (e.g., a fourth extension 112).
[0102] Next, the distal end 170 of the vertical elongated body 162
can be snaked or passed through a slit 124 in another mesh pattern
122 in the composition (e.g., the second extension 108). The distal
end 170 of the vertical elongated body 162 can further be snaked or
passed through the slit 188 of the vertical elongated body 162. A
second loop 204 can thereby be formed to secure the fastening
element 160 to a second portion of the composition 100 (e.g., the
second extension 108).
[0103] Next, the distal end 170 of the vertical elongated body 162
can be snaked or passed through a slit 124 in another mesh pattern
122 of the composition 100 (e.g., the first extension 106), and
folded over to align two of the apertures 192. A third loop 206 can
thereby be formed to secure the fastening element 160 to a third
portion of the composition 100 (e.g., the first extension 106). The
apertures 192 used for alignment to create the third loop 206 can
be selected based on the desired tension between the second and
third portions of the composition 100, e.g., the desired tension to
maintain the second and third portions of the composition 100
wrapped around the implant 10. Suture can be passed through the
aligned apertures 192 to secure the distal end 170 to the vertical
elongated body 162, and to maintain the fastening element 160
interlocked relative to the third portion of the composition
100.
[0104] As a final step, the distal end 178 of the second horizontal
elongated body 166 can be snaked or passed through a slit 124 in
another mesh pattern 122 of the composition 100 (e.g., the third
extension 110), and folded over to align two of the apertures 200.
A fourth loop 208 can thereby be formed to secure the fastening
element 160 to a fourth portion of the composition 100 (e.g., the
third extension 110). The apertures 200 used for alignment to
create the fourth loop 208 can be selected based on the desired
tension between the first and fourth portions of the composition
100, e.g., the desired tension to maintain the first and fourth
portions of the composition 100 warped around the implant 10. In
certain embodiments, if insufficient tension is created by the
fastening element 160, the fastening element 160 can be passed
through alternative openings 152 in the mesh pattern 122 away from
the edge of the extension 106-112 such that certain extensions
106-112 overlap relative to each other to create the desired
tension. Suture can be passed through the aligned apertures 200 to
secure the distal end 178 to the second horizontal elongated body
166, and to maintain the fastening element 160 interlocked relative
to the fourth portion of the composition 100.
[0105] With respect to FIG. 10, a perspective view of the
composition 100 being wrapped around the implant 10 is shown.
Positioning and orientation of the implant 10 relative to the
composition 100 can be substantially similar to the process
described with respect to FIG. 6. However, rather than using one or
two fastening elements 130 to secure portions of the composition
100 around the implant 10 in a wrapped configuration, a single
fastening element 160 can be used to secure all four extensions
106-112 relative to each other.
[0106] As described above, the fastening element 160 can be used to
create loops 202-208 to interlock the fastening element 160
relative to respective extensions 106-112 of the composition 100.
For example, the first loop 202 can be formed relative to the
opening 152 and the strip 210 of material surrounding the opening
152 in the fourth extension 112. The second loop 204 can be formed
relative to the opening 152 and the strip 212 of material
surrounding the opening 152 in the second extension 108. The third
loop 206 can be formed relative to the opening 152 and the strip
214 of material surrounding the opening 152 in the first extension
106. The fourth loop 208 can be formed relative to the opening 152
and the strip 216 of material surrounding the opening 152 in the
third extension 110. However, it should be understood that the
fastening element 160 can be orientated differently relative to the
composition 100 such that loops 202-208 are used to secure the
fastening element 160 to alternative extensions 106-112. Suture 158
can be passed through the apertures 192, 200 to secure the loops
206, 208 around the strips 214, 216, respectively, thereby
interlocking the fastening element 160 to two of the extensions
106-112. In certain embodiments, suture 158 can be passed through
the elongated body 162, 166 without the use of the apertures 192,
200.
[0107] The vertical elongated body 162 can therefore be used to
secure two portions of the composition 100 (e.g., the first and
second extensions 106, 108) relative to each other and in the
wrapped configuration around the implant 10. In particular, the
passage of the distal end 170 of the vertical elongated body 162
through the opening 152 in the first extension 106 can be varied to
increase or decrease the tension and distance between the first and
second extensions 106, 108, thereby allowing adjustment of the
amount of surface area of the implant 10 wrapped by the composition
100.
[0108] The first and second horizontal elongated bodies 164, 166
can be used to secure two alternative portions of the composition
100 (e.g., the third and fourth extensions 110, 112) relative to
each other and in the wrapped configuration around the implant 10.
In particular, the passage of the distal end 178 of the second
horizontal elongated body 166 through the opening 152 in the fourth
extension 112 can be varied to increase or decrease the tension and
distance between the third and fourth extensions 110, 112, thereby
allowing adjustment of the amount of surface area of the implant 10
wrapped by the composition 100.
[0109] In certain embodiments, the extensions 106-112 can be
stretched until the two or more of the extensions 106-112 are in a
touching relation, thereby wrapping around the entire posterior
side 28 of the implant 10. In certain embodiments, the two or more
of the extensions 106-112 can be stretched and remain in a spaced
relation relative to each other, thereby leaving a portion of the
posterior side 28 of the implant 10 exposed. However, in such
embodiments, support to the implant 10 can naturally be provided by
the chest wall and/or the pectoral muscle against which the implant
10 is positioned. Thus, the composition 100 completely or nearly
completely surrounds the surface area of the implant 10.
[0110] With reference to FIG. 11, a front view of another
embodiment of an exemplary composition 300 is shown. In certain
embodiments, the composition 300 can be made from processed tissue,
e.g., an acellular tissue matrix, an acellular dermal matrix, or
the like. In certain embodiments, the composition 300 can be made
from a synthetic material. In certain embodiments, the composition
300 can be made from a combination of processed tissue and
synthetic materials.
[0111] The composition 300 includes a composition body 302. The
composition body 302 can be shaped or formed into a substantially
flat or sheet-like configuration. However, the composition body 302
can be flexible such that the composition body 302 can conform to
and wrap around the three-dimensional shape of the implant 10.
[0112] The composition body 302 includes a top region 304, a bottom
region 306, and a central region 308 disposed between the top and
bottom regions 304, 306. The top region 304 can define a
substantially semi-circular form 310 extending from the central
region 308. The bottom region 306 can define a substantially
semi-circular form 312 extending from an opposing side of the
central region 308 relative to the top region 304. The central
region 308 includes a first flap 314 and a second flat 316
extending therefrom on opposing sides of the central region 308. In
certain embodiments, the first and second flaps 314, 316 can define
pointed ends with curved sides. In certain embodiments, the first
and second flaps 314, 316 can define pointed ends with linear
sides.
[0113] In certain embodiments, the top region 304 can include two
groups 318, 320 of apertures formed therein. The groups 318, 320 of
apertures can be formed on opposing sides of the top region 304 in
a spaced manner. Each group 318, 320 can include a first pair of
apertures 322 and a second pair of apertures 324. The first and
second pair of apertures 322, 324 can be positioned on opposing
sides of a fold line 326. In certain embodiments, the fold line 326
can be formed in the composition body 302 to assist in folding the
top region 304 over the implant 10. In certain embodiments, the
composition body 302 does not include a fold line 326 and the fold
line 326 shown in FIG. 11 is provided for illustrative purposes
only.
[0114] The first pair of apertures 322 includes a first aperture
328 and a second aperture 330. The second pair of apertures 324
includes a first aperture 332 and a second aperture 334. The first
and second pair of apertures 322, 324 can be disposed on opposing
sides of the fold line 326 such that when the top region 304 is
folded along the fold line 326, the first apertures 328, 332 and
the second apertures 330, 334 align for suture passage
therethrough. Thus, in embodiments including a fold line 326 formed
in the composition body 302, the fold line 326 can assist with
aligning the first and second pair of apertures 322, 324 relative
to each other.
[0115] In certain embodiments, the bottom region 306 can include
one or more straps formed therein, e.g., a first strap 336 and a
second strap 338. In particular, the first and second straps 336,
338 can be formed directly in the composition body 302. For
example, the first strap 336 can be formed from material directly
adjacent to the semi-circular form 312 and the second strap 338 can
be formed from material directly adjacent to the first strap 336.
The straps 336, 338 can therefore extend from one edge to the
opposite edge of the bottom region 306 spanning the width of the
bottom region 306. In certain embodiments, the composition 300 can
include one or more straps formed adjacent to the top region
304.
[0116] Each strap 336, 338 can define an elongated body that can be
configured and dimensioned to be extended over portions of the
implant 10 to maintain the composition 300 in a wrapped
configuration relative to the implant 10. In particular, the straps
336, 338 can be stretched and fit over portions of the implant 10,
and the flexible material of the composition 300 allows the straps
336, 338 to stay in place and maintain a pressure on the implant 10
sufficient to prevent undesired unwrapping of the composition 300.
For example, the first strap 336 can be used to extend onto the
upper pole 14 of the implant 10. As a further example, the second
strap 338 can be used to extend onto the lower pole 16 of the
implant 10.
[0117] Although illustrated with two straps 336, 338, in certain
embodiments, the composition 300 can include a single strap (e.g.,
strap 336) that can sufficiently maintain the composition 300
wrapped around the implant 10. In certain embodiments, the
composition 300 can include two or more straps that provide an even
distribution of tension on the implant 10 to maintain the
composition 300 in a wrapped configuration . . . .
[0118] In certain embodiments, one or more portions or areas of the
composition 300 can include a mesh pattern 340 formed therein. As
shown in FIG. 11, in certain embodiments, the bottom region 306 can
include a mesh pattern 340 formed on all or a portion of the
surface area thereof. In certain embodiments, the mesh pattern 340
can be formed on all or a portion of the surface area of, e.g., the
top region 304, the central region 308, the bottom region 306, the
first flap 314, the second flap 316, combinations thereof, or the
like. In certain embodiments, the mesh pattern 340 can extend from
one area into another area of the composition body 302. The
location or formation of the mesh pattern 340 can be selected based
on the areas of the implant 10 that require the most and least
support. For example, areas of the implant 10 requiring less
support can be covered by portions of the composition 300 including
the mesh pattern 340, while areas of the implant 10 requiring more
support can be covered by portions of the composition 300 including
the continuous structure (e.g., without a mesh pattern 340, such as
the central region 308 of FIG. 11).
[0119] The mesh pattern 340 can be substantially similar to the
mesh pattern 122 discussed above. In particular, the mesh pattern
340 can include a plurality of slits 342. In certain embodiments,
the slits 342 can be formed in a horizontal direction. In certain
embodiments, the slits 342 can be formed in a vertical direction.
In certain embodiments, each row of adjacent slits 342 can be
staggered relative to each other. Imparting a tensile force on any
portions of the composition 300 including the mesh pattern 340
allows the composition body 302 to stretch and expand to cover the
three-dimensional form of the implant 10.
[0120] With respect to FIGS. 12 and 13, side and rear views of the
composition 300 completely or nearly completely wrapped around the
implant 10 are shown. Initially, the implant 10 can be positioned
on and oriented relative to the composition 300 such that the
appropriate sections of the implant 10 that require additional
support are positioned adjacent to continuous structure portions of
the composition 300. For example, as shown in FIGS. 12 and 13, the
lower pole 16 of the implant 10 can be positioned at or near the
mesh pattern 340 of the bottom region 306 of the composition 300,
while the upper pole 14 of the implant 10 can be positioned at or
near the top and central regions 304, 308 of the composition 300
defining the continuous structure. However, it should be understood
that the implant 10 can be oriented in other ways relative to the
composition 300 and/or the composition 300 can include alternative
or additional areas including the mesh pattern 340.
[0121] In the initial configuration, the composition 300 can be
dimensioned smaller than the surface area of the implant 10.
However, as shown in FIGS. 12 and 13, one or more areas of the
composition body 302 including the mesh patterns 340 can be
expanded and stretched to at least partially wrap the composition
300 around the implant 10. For example, the bottom region 306 of
the composition 300 can be expanded and stretched to wrap around
the lower pole 16 of the implant 10. The mesh pattern 340 can be
expanded and stretched by applying a tensile force on the bottom
region 306. The slits 342 that form the mesh pattern 340 can expand
due to the tensile force to create a plurality of openings 344 that
are dimensioned greater than the slits 342 in the non-expanded
configuration. In particular, due to the flexibility of the mesh
pattern 340, the expansion and stretching of the mesh pattern 340
can be customized based on the particular implant 10 configuration
being used. Thus, less material can be used to completely or nearly
completely wrap the composition 300 around a variety of implants
10.
[0122] During the wrapping process, the top region 304 can be
folded along the fold line 326 to align the respective first pair
of apertures 322 with the second pair of apertures 324. In certain
embodiments, suture 346 can be passed through the apertures 322,
324 to maintain the top region 304 in the folded configuration. In
the folded configuration, the top region 304 can form a first flap
348 and a second flap 350. The first and second flaps 348, 350 can
extend outwardly from the surface of the implant 10.
[0123] The first and second flaps 314, 316 extending from the
central region 308 can be wrapped around portions of the respective
right and left sides 20, 22 of the implant 10. The bottom region
306 can be stretched over the lower pole 16 of the implant 10.
Thus, in the wrapped configuration, the top region 304, bottom
region 306, first flap 314 and second flap 316 can join in a
facing, spaced or overlapping manner at the posterior side 28 of
the implant 10.
[0124] In certain embodiments, to maintain the composition 300 in
the wrapped configuration, the first strap 336 can be pulled and
stretched upward and disposed around an edge of the top region 304
(e.g., FIG. 12). In certain embodiments, to maintain the
composition 300 in the wrapped configuration, the first strap 336
can be pulled and stretched upward and disposed around the first
and second flaps 348, 350 of the top region 304 (e.g., FIG. 13). In
particular, the first strap 336 can fit between the first and
second flaps 348, 350 and the implant 10 and/or the first and
second flaps 314, 316 to maintain the first strap 336 interlocked
relative to the top region 304. Specifically, the edges of the
first and second flaps 348, 350 prevent the first strap 336 from
returning to a position adjacent to the bottom region 306.
Stretching the first strap 336 from the bottom region 306 to the
top region 304 creates tension in the first strap 336, thereby
maintaining a tight grip on the first and second flaps 348, 350.
The tension in the first strap 336 also maintains the top region
304 wrapped around the implant 10.
[0125] Portions of the first strap 336 can pass over the first and
second flaps 314, 316, thereby also maintaining the first and
second flaps 314, 316 wrapped around the implant 10. The second
strap 338 can be stretched and wrapped around a portion of the
bottom region 306. The tension in the second strap 338 maintains
pressure on the bottom region 306, thereby ensuring that the bottom
region 306 remains wrapped around the implant 10. As such, the
first and second straps 336, 338 assist in maintaining the
composition 300 completely or nearly completely wrapped around the
implant 10.
[0126] With reference to FIG. 14, a front view of another
embodiment of an exemplary composition 400 is shown. In certain
embodiments, the composition 400 can be made from processed tissue,
e.g., an acellular tissue matrix, an acellular dermal matrix, or
the like. In certain embodiments, the composition 400 can be made
from a synthetic material. In certain embodiments, the composition
400 can be made from a combination of processed tissue and
synthetic materials.
[0127] The composition 400 includes a composition body 402 formed
as a single piece of material. The composition body 402 can be
shaped or formed into a substantially flat or sheet-like
configuration. However, the composition body 402 can be flexible
such that the composition body 402 can conform to or wrap around
the three-dimensional shape of the implant 10.
[0128] In certain embodiments, the composition body 402 can define,
e.g., a rectangular shape, a square shape, an oval shape, a
circular shape, or the like. The composition 400 can include two or
more tabs or flaps 404, 406 extending from one end of the
composition body 402. For example, the flaps 404, 406 can extend
from the bottom edge of the composition body 402. In certain
embodiments, the composition 400 can include flaps 404, 406
extending from the bottom and/or side edges of the composition body
402.
[0129] In certain embodiments, the composition 400 can include one
or more mesh patterns 408 formed therein. The mesh patterns 408 can
be formed from a plurality of slits 410 formed in and passing
through the composition body 402. In certain embodiments, the slits
410 can be formed in a horizontal direction. In certain
embodiments, the slits 410 can be formed in a vertical direction.
In certain embodiments, adjacent rows of slits 410 can be staggered
or offset relative to each other. In certain embodiments, the slits
410 can be linear, angled, a combination thereof, or the like. Each
slit 410 can be configured and dimensioned to allow passage of a
single flap 404, 406 therethrough. As described above, the mesh
patterns 408 allow portions of the composition body 402 to be
expanded and stretched to conform the composition body 402 to the
three-dimensional shape of the implant 10, thereby allowing the
implant 10 to be at least partially wrapped with the composition
400.
[0130] With reference to FIG. 15, a perspective view of the
composition 400 completely or nearly completely wrapped around the
implant 10 is provided. Initially, the implant 10 can be positioned
on or oriented relative to the composition 400 such that the
appropriate sections of the implant 10 that require additional
support are positioned adjacent to continuous structure portions of
the composition 400 (e.g., areas without the mesh pattern 408). In
the initial configuration, the composition 400 can be dimensioned
smaller than the surface area of the implant 10. However, as shown
in FIG. 15, one or more areas of the composition body 402 including
the mesh patterns 408 can be expanded and stretched to at least
partially wrap the composition 400 around the implant 10. For
example, the mesh patterns 408 shown in FIG. 15 can be expanded or
stretched to wrap around portions of the upper and lower poles 14,
16 of the implant 10. The mesh pattern 408 can be expanded or
stretched by applying a tensile force on the edges of the
composition body 402. The slits 410 that form the mesh pattern 408
can expand due to the tensile force to create a plurality of
openings that are dimensioned greater than the slits 410 in the
non-expanded configuration. In particular, due to the flexibility
of the mesh patterns 408, the expansion and stretching of the mesh
patterns 408 can be customized based on the particular implant 10
configuration being used. Thus, less material can be used to wrap
the composition 400 around a variety of implants 10.
[0131] During the wrapping process, the implant 10 can be
positioned on and oriented relative to the composition 400. The top
and bottom edges of the composition 400 can be wrapped around the
implant 10 such that the top and bottom edges meet in a facing
relation. As the composition 400 is wrapped around the implant 10,
the mesh patterns 408 can expand and stretch to conform the
composition 400 to the three-dimensional form of the implant 10.
The flaps 404, 406 can be passed through two slits 410 of the mesh
pattern 408 near the adjacent edge of the composition body 402.
[0132] In certain embodiments, suture 412 can be used to secure the
flaps 404, 406 to the composition body 402 such that the flaps 404,
406 cannot pass out of the slits 410. The flaps 404, 406 thereby
act as fastening elements and maintain the composition 400
stretched and wrapped around the implant 10. In certain
embodiments, the composition 400 can include tabs extending from
side edges of the composition 400 such that the sides of the
implant 10 can be fully covered by the composition 400 in the
wrapped configuration.
[0133] With reference to FIGS. 16 and 17, front views of another
embodiment of an exemplary composition (e.g., first and second
composition halves 500, 550) are shown. As will be discussed in
greater below, the first and second composition halves 500, 550 can
mate relative to each other to at wrap around and at least
partially cover the implant 10. In certain embodiments, the
composition halves 500, 550 can be made from processed tissue,
e.g., an acellular tissue matrix, an acellular dermal matrix, or
the like. In certain embodiments, the composition halves 500, 550
can be made from a synthetic material. In certain embodiments, the
composition halves 500, 550 can be made from a combination of
processed tissue and synthetic materials.
[0134] The first composition half 500 includes a composition body
502. The composition body 502 can be shaped or formed into a
substantially flat or sheet-like configuration. However, the
composition body 502 can be flexible such that the composition body
502 can conform to or wrap around a portion of the
three-dimensional shape of the implant 10.
[0135] In certain embodiments, the composition body 502 can define,
e.g., a rectangular shape, a square shape, an oval shape, a
circular shape, or the like. The first composition half 500 can
include two or more tabs or flaps 504, 506 extending from a top
edge 508 of the composition body 502. The first composition half
500 can include two or more tabs or flaps 510, 512 extending from a
bottom edge 514 of the composition body 502. In particular, the
flaps 504, 506 can extend in a parallel manner relative to the
flaps 510, 512. In certain embodiments, the flaps 504, 506 and the
flaps 510, 512, respectively, can extend in line or be aligned
relative to each other. In certain embodiments, the flaps 504, 506,
510, 512 can be formed integrally and from the same material as the
composition body 502. In certain embodiments, the first composition
half 500 can include flaps extending from the side edges of the
composition body 502.
[0136] In certain embodiments, the first composition half 500 can
include one or more mesh patterns 516 formed therein. The mesh
patterns 516 can be formed from a plurality of slits 518 formed in
and passing through the composition body 502. In certain
embodiments, the slits 518 can be formed in a horizontal direction.
In certain embodiments, the slits 518 can be formed in a vertical
direction. In certain embodiments, adjacent rows of slits 518 can
be staggered or offset relative to each other. In certain
embodiments, the slits 518 can be linear, angled, a combination
thereof, or the like. In certain embodiments, the mesh patterns 516
can be formed in a substantial portion of the composition body 502
(e.g., areas excluding the flaps 504, 506, 510, 512). In certain
embodiments, the mesh patterns 516 can be formed in a central
portion of the composition body 502 (e.g., leaving portions of the
composition body 502 as continuous structures). In certain
embodiments, the As described above, the mesh patterns 516 allow
portions of the composition body 502 to be expanded and stretched
to conform the composition body 502 to the three-dimensional shape
of the implant 10, thereby allowing the implant 10 to be at least
partially wrapped with the first composition half 500.
[0137] The second composition half 550 includes a composition body
552. The composition body 552 can be shaped or formed into a
substantially flat or sheet-like configuration. However, the
composition body 552 can be flexible such that the composition body
552 can conform to or wrap around a portion of the
three-dimensional shape of the implant 10.
[0138] In certain embodiments, the composition body 552 can define,
e.g., a rectangular shape, a square shape, an oval shape, a
circular shape, or the like. In certain embodiments, the
composition body 552 can define a shape substantially complementary
to the shape of the composition body 502 of the first composition
half 500. In certain embodiments, the second composition half 550
can include one or more mesh patterns 554 formed therein. The mesh
patterns 554 can be formed from a plurality of slits 556 formed in
and passing through the composition body 552. In certain
embodiments, the slits 556 can be formed in a horizontal direction.
In certain embodiments, the slits 556 can be formed in a vertical
direction. In certain embodiments, adjacent rows of slits 556 can
be staggered or offset relative to each other. In certain
embodiments, the slits 556 can be linear, angled, a combination
thereof, or the like. Each slit 556 can be configured and
dimensioned to allow passage of a single flap 504, 506, 510, 512 of
the first composition half 500 therethrough.
[0139] In certain embodiments, the mesh patterns 554 can be formed
in a substantial portion of the composition body 552 (e.g.,
covering the surface area within the edges of the composition body
552). In certain embodiments, the mesh patterns 554 can be formed
in a central portion of the composition body 552 (e.g., leaving
portions of the composition body 552 as continuous structures). In
certain embodiments, the mesh patterns 554 can be formed at the
edges of the composition body 552 (e.g., leaving the central area
of the composition body 552 as a continuous structure). As
described above, the mesh patterns 554 allow portions of the
composition body 552 to be expanded and stretched to conform the
composition body 552 to the three-dimensional shape of the implant
10, thereby allowing the implant 10 to be at least partially
wrapped with the second composition half 550.
[0140] With reference to FIG. 18, a perspective view of the first
and second composition halves 500, 550 completely or nearly
completely wrapped around the implant 10 is provided. For example,
the first composition half 500 can wrap around and cover the
anterior side 26 of the implant 10, while the second composition
half 550 can wrap around and cover the posterior side 28 of the
implant 10. Initially, the implant 10 can be positioned on or
oriented relative to the first and/or second composition half 500,
550 such that the appropriate sections of the implant 10 that
require additional support are positioned adjacent to continuous
structure portions of the first and/or second composition half 500,
550 (e.g., areas without the mesh pattern 516, 554).
[0141] In the initial configuration, the first and second
composition halves 500, 550 can be dimensioned smaller than half of
the surface area of the implant 10. However, as shown in FIG. 18,
one or more areas of the composition bodies 502, 552 including the
mesh patterns 516, 554 can be expanded and stretched to at least
partially wrap the first and second composition halves 500, 550
around the implant 10. For example, the mesh pattern 516 of the
first composition half 500 can be expanded or stretched to wrap
around portions of the posterior side 28 of the implant 10.
Similarly, the mesh patterns 554 of the second composition half 550
can be expanded or stretched to wrap around portions of the
anterior side 26 of the implant 10.
[0142] The mesh patterns 516, 554 can be expanded or stretched by
applying a tensile force on the edges of the composition body 502,
552. The slits 518, 556 that form the mesh pattern 516, 554 can
expand due to the tensile force to create a plurality of openings
that are dimensioned greater than the slits 518, 556 in the
non-expanded configuration. In particular, due to the flexibility
of the mesh patterns 516, 554, the expansion and stretching of the
mesh patterns 516, 554 can be customized based on the particular
implant 10 configuration being used. Thus, less material can be
used to wrap the first and second composition halves 500, 550
around a variety of implants 10.
[0143] During the wrapping process, the implant 10 can be
positioned on and orientated relative to the first composition half
500. The top and bottom edges 508, 514 of the first composition
half 500 can be wrapped around a portion of the implant 10 (e.g.,
the posterior side 28) such that the flaps 504, 506 extend over the
top side of the implant 10 and the flaps 510, 512 extend over the
bottom side of the implant 10. As the first composition half 500 is
wrapped around the implant 10, the mesh pattern 516 can expand and
stretch to conform the first composition half 500 to the
three-dimensional form of one half of the implant 10.
[0144] The second composition half 550 can be positioned on and
oriented relative to the implant 10. The second composition half
550 can be wrapped around a portion of the implant 10 (e.g., the
anterior side 26) such that the top edge of the second composition
half 550 is positioned adjacent to the flaps 504, 506 of the first
composition half 500, and such that the bottom edge of the second
composition half 550 is positioned adjacent to the flaps 510, 512
of the first composition half 500. As the second composition half
550 is wrapped around the implant 10, the mesh patterns 554 can
expand and stretch to conform the second composition half 550 to
the three-dimensional form of the opposing half of the implant 10.
The flaps 504, 506 can be passed through two slits 556 of the mesh
pattern 554 near the top edge of the second composition half 550.
Similarly, the flaps 510, 512 can be passed through two slits 556
of the mesh pattern 554 near the bottom edge of the second
composition half 550.
[0145] In certain embodiments, suture 558 can be used to secure the
flaps 504, 506, 510, 512 to the composition body 552 such that the
flaps 504, 506, 510, 512 cannot pass out of the slits 556. The
flaps 504, 506, 510, 512 thereby act as fastening elements and
maintain the first and second composition halves 500, 552 stretched
and wrapped around the implant 10. In particular, the flaps 504,
506, 510, 512 maintain the first and second halves 500, 550
interlocked relative to each other. In certain embodiments, the
first and second composition halves 500, 550 can include flaps
extending from side edges such that the sides of the implant 10 can
be fully covered by the first and second composition halves 500,
550 in the wrapped configuration.
[0146] The compositions described herein can therefore be
implemented to cover an implant or tissue expander in an adjustable
manner. In particular, the compositions include one or more mesh
patterns formed therein that allow for expansion and stretching of
the composition body to conform to the three-dimensional shape and
size of the implant or tissue expander. Thus, a smaller amount of
material can be used to form the compositions, while ensuring that
sufficient coverage and support is provided to the implant or
tissue expander.
[0147] Although the compositions, systems and methods of the
present disclosure have been described with reference to exemplary
embodiments thereof, the present disclosure is not limited to such
exemplary embodiments and or implementations. Rather, the
compositions and methods of the present disclosure are susceptible
to many implementations and applications, as will be readily
apparent to persons skilled in the art from the disclosure hereof.
The present disclosure expressly encompasses such modifications,
enhancements and or variations of the disclosed embodiments. Since
many changes could be made in the above exemplary embodiments and
many widely different embodiments of this disclosure could be made
without departing from the scope thereof, it is intended that all
matter contained in the drawings and specification shall be
interpreted as illustrative and not in a limiting sense. Additional
modifications, changes, and substitutions are intended in the
foregoing disclosure. Accordingly, it is appropriate that the
appended claims be construed broadly and in a manner consistent
with the scope of the disclosure.
* * * * *