U.S. patent application number 15/938810 was filed with the patent office on 2018-08-02 for surgical template and delivery device.
The applicant listed for this patent is LifeCell Corporation. Invention is credited to Heather Ansorge, Aaron Barere, Michael Diaz, Evan Friedman, Courtney Guyer, Sangwook Park.
Application Number | 20180214262 15/938810 |
Document ID | / |
Family ID | 48143349 |
Filed Date | 2018-08-02 |
United States Patent
Application |
20180214262 |
Kind Code |
A1 |
Diaz; Michael ; et
al. |
August 2, 2018 |
Surgical Template and Delivery Device
Abstract
The present disclosure provides devices and methods relating to
surgical breast procedures. The devices can include a holder and
backing to assist in positioning a biological material adjacent to
a tissue expander or implant.
Inventors: |
Diaz; Michael; (Satellite
Beach, FL) ; Barere; Aaron; (Hoboken, NJ) ;
Friedman; Evan; (Montvale, NJ) ; Park; Sangwook;
(Dunellen, NJ) ; Ansorge; Heather; (Philadelphia,
PA) ; Guyer; Courtney; (Hoboken, NJ) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
LifeCell Corporation |
Branchburg |
NJ |
US |
|
|
Family ID: |
48143349 |
Appl. No.: |
15/938810 |
Filed: |
March 28, 2018 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
13804741 |
Mar 14, 2013 |
9956072 |
|
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15938810 |
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61709692 |
Oct 4, 2012 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61L 2430/04 20130101;
F04C 2270/0421 20130101; A61F 2/12 20130101; A61B 90/02
20160201 |
International
Class: |
A61F 2/12 20060101
A61F002/12; A61B 90/00 20060101 A61B090/00 |
Claims
1. A method for preparing a site within a breast comprising:
creating a tissue pocket within or posterior to a breast;
positioning within the tissue pocket a template comprising a sample
of biocompatible material comprising a proximal edge and a distal
edge, a holding member comprising a proximal edge and a distal
edge, and a backing member, wherein the proximal edge of the
biocompatible material is detachably connected proximate to the
proximal edge of the holding member and the backing member is
detachably connected proximate to the distal edge of the holding
member; fastening the distal edge of the biocompatible material to
tissue within or surrounding the tissue pocket; and removing the
holding member and the backing member from the tissue pocket.
2. The method of claim 2, wherein the biocompatible material is
fastened to tissue at or proximate to an inframammary fold.
Description
[0001] This application is a divisional application of U.S. patent
application Ser. No. 13/804,741 filed on Mar. 14, 2013, which
claims priority under 35 U.S.C. .sctn. 119 to U.S. Provisional
Patent Application No. 61/709,692, filed on Oct. 4,2012. The entire
contents of each of the above-referenced applications are
incorporated herein by reference.
[0002] The present disclosure relates generally to devices for
positioning a sample of biocompatible material during breast
procedures, as well as methods for treating tissue sites with the
device.
[0003] Surgical breast procedures can use a tissue expander or a
breast implant and a sample of biocompatible material, which can
provide support to surrounding tissue. Proper placement of the
material can be difficult to achieve, but can be important to the
outcome of a breast procedure. Accordingly, there is a need for
devices to assist in the placement of such biocompatible materials
during surgical breast procedures.
[0004] According to various embodiments, a device for surgical
breast procedures is provided. The device can comprise a holding
member comprising a proximal edge and a distal edge and a first
side and a second side, wherein the proximal edge comprises a
convex portion curving away from the distal edge and the distal
edge further comprises a convex portion curving away from the
proximal edge. The device can further comprise a backing member
associated with the holding member and comprising a first dimension
and a second dimension, and at least one fastener configured to be
connected to the holding member proximate to the proximal edge and
configured to hold a sample of biocompatible material in apposition
to the first side of the holding member.
[0005] According to certain embodiments a system for facilitating
breast surgery is provided. The system can comprise a sample of
biocompatible material. The system can further comprise a holding
member comprising a proximal edge and a distal edge and a first
side and a second side, wherein the proximal edge comprises a
convex portion curving away from the distal edge, and the distal
edge further comprises a convex portion curving away from the
proximal edge and at least one indentation positioned along the
distal edge. The system can also comprise a backing member
comprising a first dimension and a second dimension, and at least
one fastener configured to hold the sample of biocompatible
material in apposition to the first side of the holding member.
[0006] According to certain embodiments, a method for preparing a
site within a breast is provided. The method can comprise creating
a tissue pocket within or posterior to a breast; and positioning
within the tissue pocket a template comprising a sample of
biocompatible material comprising a proximal edge and a distal
edge, a holding member comprising a proximal edge and a distal
edge, and a backing member, wherein the proximal edge of the
biocompatible material is detachably connected proximate to the
proximal edge of the holding member and the backing member is
detachably connected proximate to the distal edge of the holding
member. The method can further comprise fastening the distal edge
of the biocompatible material to tissue within or surrounding the
tissue pocket; and removing the holding member and the backing
member from the tissue pocket.
[0007] According to certain embodiments, a device is provided. The
device can comprise a holding member comprising a proximal edge and
a distal edge and a first side and a second side, wherein the
proximal edge comprises a convex portion curving away from the
distal edge and the distal edge further comprises a convex portion
curving away from the proximal edge, wherein the distal edge of the
holding member comprises multiple indentations positioned along the
distal edge. The device can further comprise at least one fastener
configured to be connected to the holding member proximate to the
proximal edge and configured to hold a sample of biocompatible
material in apposition to the first side of the holding member.
[0008] According to certain embodiments, a system for treating
tissue is provided. The system can comprise a sample of
biocompatible material and a holding member. The holding member can
comprise a proximal edge and a distal edge and a first side and a
second side, wherein the proximal edge comprises a convex portion
curving away from the distal edge and the distal edge further
comprises a convex portion curving away from the proximal edge,
wherein the distal edge of the holding member comprises multiple
indentations positioned along the distal edge. The system can
further comprise at least one fastener configured to be connected
to the holding member proximate to the proximal edge and configured
to hold a sample of biocompatible material in apposition to the
first side of the holding member.
[0009] According to certain embodiments, a method for performing
breast surgery is provided. The method can comprise creating a
tissue pocket in a breast and inserting a holding member into the
tissue pocket, wherein the holding member includes a sample of
biocompatible material attached thereto. The method can further
comprise contacting a portion of the breast with a distal edge of
the holding member and fastening the sample of biocompatible
material to tissue within the breast, wherein the sample of
biocompatible material is attached to the holding member during
fastening. The sample of biocompatible material can also be
detached from the holding member, and the holding member can be
removed from the tissue pocket.
BRIEF DESCRIPTION OF THE DRAWINGS
[0010] Reference will now be made to exemplary embodiments,
examples of which are illustrated in the accompanying drawings.
Wherever possible, the same reference numbers will be used
throughout the drawings to refer to the same or like parts. The
drawings are not necessarily to scale.
[0011] FIG. 1 is a perspective view of a system comprising a sample
of biocompatible material and a device for surgical breast
procedures, according to certain embodiments.
[0012] FIGS. 2A, 2B, and 2C are front, back, and side views,
respectively, of a holding member for use in a device for surgical
breast procedures, according to certain embodiments.
[0013] FIG. 3 is a top view of a backing member for use in a device
for surgical breast procedures, according to certain
embodiments.
[0014] FIG. 4 is a perspective view of a system comprising a sample
of biocompatible material and a device for surgical breast
procedures, according to certain embodiments.
[0015] FIGS. 5A and 5B are front and rear views, respectively, of a
backing member for use in a device for surgical breast procedures,
according to certain embodiments.
[0016] FIG. 6 is a perspective view of a system comprising a sample
of biocompatible material and a device for surgical breast
procedures, according to certain embodiments.
[0017] FIG. 7 is a perspective view of a backing member for use in
a device for surgical breast procedures, according to certain
embodiments.
[0018] FIG. 8A is a rear view of a backing member for use in a
device for surgical breast procedures, according to certain
embodiments.
[0019] FIG. 8B is a side view of a backing member for use in a
device for surgical breast procedures, according to certain
embodiments.
[0020] FIG. 9A is a rear view of a device for use in surgical
breast procedures, according to certain embodiments.
[0021] FIG. 9B is a front view of a device for use in surgical
breast procedures, according to certain embodiments.
[0022] FIG. 10 illustrates use of a system for facilitating breast
surgery, according to certain embodiments.
[0023] FIG. 11 is a perspective view of a system comprising a
sample of biocompatible material and a device for surgical breast
procedures, according to certain embodiments.
[0024] FIG. 12 is a perspective view of a device for surgical
breast procedures, according to certain embodiments.
DESCRIPTION OF EXEMPLARY EMBODIMENTS
[0025] Reference will now be made in detail to various embodiments
of the disclosed devices and methods, examples of which are
illustrated in the accompanying drawings. Wherever possible, the
same reference numbers will be used throughout the drawings to
refer to the same or like parts.
[0026] 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.
[0027] 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.
[0028] The present disclosure relates generally to devices for
surgical breast procedures and systems and methods relating to such
devices. The devices can be used for tissue augmentation, repair or
regeneration of damaged tissue, and/or correction of tissue
defects. As such, the device, systems, and methods discussed herein
can be suitable for a wide range of surgical applications, such as,
for example, aesthetic surgery, breast reconstruction, breast
augmentation, breast enhancement, breast reduction, and revisionary
breast surgeries.
[0029] The devices discussed herein generally assist in surgical
procedures wherein a sample of biocompatible material can be
implanted within a tissue pocket in a breast. A variety of
synthetic or biologic materials can be used. In various
embodiments, the materials are capable of being attached to or
inserted into and/or fixed within the body for a prolonged period
of time without undesirable local or systemic effects. As
non-limiting examples, the materials can include medical-grade
polymeric materials; autologous, allogenic, or cadaveric tissue;
and/or biomatrices, such as acellular tissue matrices. As used
herein, acellular tissue matrices refer to tissue-derived biomatrix
structures that can be made from any of a wide range of
collagen-containing tissues by removing all, or substantially all,
viable cells and all detectable subcellular components and/or
debris generated by killing cells. Suitable exemplary acellular
tissue matrices include ALLODERM.RTM. and STRATTICE.TM., which are
acellular human and dermal tissue matrices, respectively, and are
produced by LIFECELL CORPORATION (Branchburg, N.J.).
[0030] The sample of biocompatible material can support a tissue
expander or breast implant within a tissue pocket, such as a
subcutaneous, subglandular, subfascial, or subpectoral tissue
pocket. Correct placement of the material can be important to the
success of the surgical procedure, and incorrect placement can
result in undesirable aesthetic results and/or medial, lateral, or
inferior displacement of a tissue expander or breast implant, which
may require additional surgeries to correct the location of the
inframammary, lateral, or medial folds. Correct placement of the
material can be hindered by difficulties in handling of the
biocompatible material, difficulties visualizing the placement of
the material, and difficulties manipulating the material within the
tissue pocket, as well as movement while fastening the material to
the underlying tissue. By addressing any or all of these problems,
the devices disclosed herein can make such surgical procedures more
consistent, faster, and more reproducible.
[0031] FIG. 1 is a perspective view of a system 100 comprising a
sample of biocompatible material 102 and a device 110 for surgical
breast procedures, according to certain embodiments. The system 100
can comprise a holding member 101 and a backing member 103. The
sample of biocompatible material 102 can be attached to the holding
member 101, and the holding member 101 can be attached to the
backing member 103. The holding member 101 and/or backing member
103 can provide stiffness to the sample of biocompatible material,
improving the ability of the surgeon to visualize and manipulate
the sample of biocompatible material 102. The holding member 101
and the backing member 103 can together mimic the dimensions of the
sample of biocompatible material 102 and a tissue expander or
breast implant when placed in the tissue pocket. When correctly
positioned and oriented within an implant site, the sample of
biocompatible material 102 can be fastened to the underlying
tissue. The device 110 can then be removed, leaving the sample of
biocompatible material 102 fastened to the underlying tissue.
[0032] As described further below, the device 110 and system 100
can be used to position the sample of biocompatible material 102 at
a desired location within a tissue expander and/or breast implant
site. For example, in various embodiments, a holding member 101 can
be shaped such that one edge (distal edge 203, shown in FIGS. 2A),
has a shape configured to produce a desired contour of a portion of
the breast. For example, the distal edge 203 can be shaped to be
positioned at or near a desired location for the inframammary fold
(IMF), a medial border of the breast, a lateral border of the
breast, or a location comprising parts of the IMF, medial border of
the breast, and/or lateral border of the breast.
[0033] FIGS. 2A, 2B, and 2C are front, back, and side perspective
views, respectively, of a holding member 101 for use in a device
110 for surgical breast procedures, according to certain
embodiments. As shown in FIGS. 2A, 2B, and 2C, the holding member
101 can comprise a proximal edge 201 and a distal edge 203. A
portion of the proximal edge 201 can be convex, curving away from
the distal edge 203. Similarly, a portion of the distal edge 203
can be convex, curving away from the proximal edge 201. The
proximal edge 201 and the distal edge 203 of the holding member 101
can both be convex, thus making the holding member 101 generally
biconvex in shape. The holding member 101 can comprise a first side
205 and a second side 207. It will be appreciated that the proximal
edge 201 and distal edge 203 may have variations in their shapes
and may not be convex over their entire lengths. Furthermore, in
some embodiments, at least one of the edges 201 and 203 can be
substantially straight.
[0034] In some embodiments, the holding member 101 comprises at
least one indentation 209. The at least one indentation 209 can be
positioned along the distal edge 203 of the holding member 101 and
can assist in fastening of the sample of biocompatible material 102
to tissue underlying the distal edge 203 of the holding member 101.
The at least one indentation 209 can be sized to permit passage of
a suture, a staple, or an effective quantity of adhesive or similar
surgical fastener to fasten the biocompatible material 102 to the
underlying tissue. The at least one indentation 209 can be a curved
or polygonal recess or a slit in the distal edge 203. More than one
indentation 209 can be present, and the indentations 209 can be
regularly or irregularly sized, shaped, and/or spaced and can be
distributed along either the entire distal edge 203 or one or more
portions of the distal edge 203.
[0035] At least one fastener 211 can be configured to attach to
and/or hold a sample of biocompatible material in apposition to the
first side 205 of the holding member 101. In some embodiments, the
fastener 211 can be attached to the holding member 101 proximate to
the proximal edge 201, such that an edge of a sample of
biocompatible material held in apposition to the first side 205 of
the holding member 101 contacts the proximal edge 201 of the
holding member 101. In some embodiments, the at least one fastener
211 can comprise multiple regularly spaced clips attached to the
first side 205 of the holding member 101 and abutting the proximal
edge 201 of the holding member 101. In some embodiments, the
fastener 211 can be permanently attached to the first side 205 of
the holding member 101. In other embodiments, the fastener 211 is
removably attached to the holding member 101. Such fasteners can be
used with any of the variations of the holding members described
herein to hold a biocompatible material in apposition to the
devices described herein.
[0036] At least one fastener 213 can be configured to attach to the
backing member 103 and/or the holding member 101. The at least one
fastener 213 can be configured to hold the backing member 103 in
apposition to the second side 207 of the holding member 101. In
some embodiments, the at least one fastener 213 can comprise
multiple clips interspersed at regular or irregular intervals
between multiple indentations 209. In some embodiments, the
fasteners 213 can be permanently attached to the holding member 101
and/or backing member 103. In other embodiments, the fasteners 213
are removably attached to the holding member 101 and/or backing
member 103. Such fasteners can be used with any of the variations
of the holding members and backing members described.
[0037] Fasteners 211 and 213 can be chosen from a variety of
different fasteners, for example mechanical fasteners, such as
clips, pins, clasps, buttons, buckles, cleats, zippers,
VELCRO.RTM., hook and eye, toggle, screw, nail, suture, wire, ties,
permanent or temporary magnets; or chemical fasteners such as
adhesives, pastes, gums, cements, binders, and/or bonding
agents.
[0038] The holding member 101, backing member 103, fastener 211,
and fastener 213 can be associated with each other. As a
non-limiting example, the holding member 101, backing member 103,
fastener 211, and fastener 213 can be provided for use as part of a
kit or a collection. They can be provided temporarily or
permanently attached to one another and partially or completely
assembled into the device 110. In some embodiments, the holding
member 101 and backing member 103 are configured to be attachable
and detachable multiple times. In some embodiments, the holding
member 101 and backing member 103 are formed as a unitary
structure, i.e., are formed as a single material and/or are
permanently connected by an adhesive or other connection that does
not permit easy separation of the components from one another.
Further, any of the other devices and systems described herein can
be provided as a collection or kit, as described in this
paragraph.
[0039] Surgical breast procedures may require a variety of tissue
expander and/or breast implant sizes. A particular breast implant
or expander may require a certain tissue pocket size. Various
disclosed embodiments include backing members 300, 400, 500, and
600 that are capable of mimicking tissue expanders or breast
implants of various sizes and/or the base width of a tissue site,
increasing the flexibility and utility of these embodiments.
Furthermore, in certain embodiments, the backing members may be
adjustable in size and/or shape, thereby allowing flexibility of
use during a procedure.
[0040] FIG. 3 is a top view of the backing member 103 for use in a
device 110 for surgical breast procedures, according to certain
embodiments. The backing member 103 includes a first dimension 303
and a second dimension 305. In some embodiments, the first 303 and
second dimensions 305 of the backing member 300 can approximate
first and second dimensions of a tissue expander or breast implant.
For example, the first and second dimensions of a tissue expander
or breast implant can comprise a diameter of the tissue expander or
a distance measured along a portion of the circumference of the
tissue expander or implant, and the dimension 303 and 305 can
correspond to those dimensions of the tissue expander or implant.
As such, the backing member 103 can aid a surgeon in gauging the
position of a biocompatible material 102 relative to the size of a
desired expander or implant within a tissue pocket, as well as
assist in gauging the size of an implant site relative to a desired
expander or implant.
[0041] The backing member 103 can include a variety of different
shapes and sizes. In some embodiments, the backing member 103
includes a disk shape. The disk shape can include a detachable
outer ring member 309, along which at least one indentation 311 can
be positioned, as well as an inner disk member 313. In other
embodiments, the disk is formed of a unitary structure, i.e.,
without a detachable ring. The at least one indentation 311 can be
sized to permit use of a suture, staple, or other fixation device
to secure a biocompatible material to tissue. In some embodiments,
the disk 103 comprises at least one indentation 311 positioned
along the outer edge 312 of the detachable outer member (i.e., the
detachable outer ring member 309) and extending into the inner disk
member 313 (see inner extension 312). As such, a surgeon can modify
the size of the backing member 103 during a procedure by removing
or replacing the outer ring member 309. For example, the outer ring
can have a diameter of about 12 cm, and the inner disk member 313
can have a diameter of about 11 cm. This embodiment permits a
single backing member 103 to mimic more than one tissue expander.
In various embodiments, the indentations 311 can have a position
corresponding to the location of indentations 209 of the holding
member 101.
[0042] FIG. 4 is a perspective view of a system 400 comprising a
sample of biocompatible material 102 and a device 410 for surgical
breast procedures, according to certain embodiments. Similar to the
system 100 of FIG. 1, the system 400 can comprise a holding member
101 and a backing member 403. A sample of biocompatible material
102 can be attached to the holding member 101, and the holding
member 101 can be attached to the backing member 403. The holding
member 101 and/or backing member 403 can provide stiffness to the
sample of biocompatible material, improving the ability of the
surgeon to visualize and manipulate the sample of biocompatible
material 102. As noted above, however, the backing members
discussed herein, can have a variety of shapes and configurations,
and the structure of backing member 403 is described in more detail
below.
[0043] FIGS. 5A and 5B are front and rear views, respectively, of
the backing member 403, according to certain embodiments. The
backing member 403 comprises a central support member 401
adjustably connected to a plurality of vanes 405. The vanes 405 can
be flat, with a top surface and a bottom surface, or can have some
degree of curvature. The vanes 405 are distributed around the
central support member 401, for example in a circular arrangement.
These vanes 405 can circumferentially overlap to form a circular
shape comprising a diameter 407 and an outside edge 409. In some
embodiments, for example, each vane 405 in the circular formation
has two adjacent vanes. In such embodiments, each vane 405 in the
circular formation can be either above the two adjacent vanes,
below the two adjacent vanes, or above one adjacent vane and below
the other adjacent vane.
[0044] In some embodiments, the adjustable connection between the
central support member 401 and each vane 405 permits that vane 405
to move with respect to the central support member 401, the
movement having a circumferential component. For example, as shown
in FIG. 5B, at least one vane 406 can be moved circumferentially to
reduce the area of backing member 403. The circumferential
component of this movement causes the outside circumference of the
circular shape to increase or decrease and can affect the degree of
circumferential overlap between the vanes 405. Each of the vanes
405 can have at least two ends, tapering from a broader end distal
to the central support member to a narrower end proximal to the
central support member.
[0045] As with the embodiment of FIG. 1, the device 410 can include
one or more fasteners 213 that can be attached to the holding
member 101 proximate to the distal edge 203 of the holding member
101 and/or to the backing member 403 to hold the holding member 101
and backing member 403 in apposition. In such embodiments, when the
backing member 403 is held in apposition to the second side 207 of
the holding member 101, the outside edge 409 can be held in contact
with the distal edge 203 of the holding member 101.
[0046] The backing member 403 can further include one or more
indentations 411. The indentations 411 can be positioned along at
least one edge of the backing member 403 at a position
corresponding to the position of indentations 209 on the holding
member 101. The indentations can be spaced and oriented to align
with indentations of a backing member.
[0047] FIG. 6 is a perspective view of a system 600 comprising a
sample of biocompatible material 102 and a device 610 for surgical
breast procedures, according to certain embodiments. The system 600
is similar to the systems 100 and 400 described above, except that
the backing member 603 of the device 610 has a different
structure.
[0048] FIG. 7 is a perspective view of the backing member 603 for
use in a device for surgical breast procedures, according to
certain embodiments. The backing member 603 comprises a curved
segment 601 having a maximum length and a connecting segment 607.
In some embodiments, portions of the curved segment 601 can be a
circular arc having a first end 604 connected to a first end 611 of
the connecting segment 607 and having a second end 605 connected to
a second end 609 of the connecting segment 607. The width,
thickness, and cross-sectional area of the curved segment 601 can
vary, and the material dimensions and mechanical properties can be
selected to produce a desired rigidity.
[0049] In some embodiments, the curved segment 601 can include a
first interlocking section 613, a second interlocking section 615,
and an adjustable connector 617 for adjusting the length of the
curved segment by securing the first interlocking segment 613 to
the second interlocking segment 615. In some embodiments, the first
interlocking section 613 and the second interlocking section 615
can overlap to a varying degree determinable by the adjustable
connector 617 for adjusting the length of the curved segment. By
way of non-limiting example, the first interlocking section 613 can
be hollow, and the second interlocking section 615 can fit at least
partially within the first interlocking section 613. Similarly, the
second interlocking section 615 can have a top face, the first
interlocking section 613 can have a bottom face, and the first
interlocking section 613 can contact the second interlocking
section 615 face-to-face.
[0050] The adjustable connector 617 for adjusting the length of the
curved segment can prevent unintentional changes in the overlap
between the first interlocking section 613 and the second
interlocking section 615, thus preventing unintentional alteration
of the length of the curved segment 601. As shown in FIG. 7, for
example, the adjustable connector 617 for adjusting the length of
the curved segment can comprise a button projecting from the second
interlocking section 615 through a slot in the first interlocking
section 613. By projecting through the slot, the button restricts
the relative movement of the first 613 and second 615 interlocking
sections. Alternatively, other mechanisms can be used instead of a
button.
[0051] In some embodiments, at least one fastener 213 (as depicted
with respect to the backing member and holding members described
above) can be attached to the holding member 101 proximate to the
distal edge 203 of the holding member 101. In such embodiments,
when the backing member 603 is held in apposition to the second
side 207 of the holding member 101, a portion of the curved segment
601 can be held in contact with the distal edge of the holding
member 101. Similarly, the at least one fastener 213 can hold a
portion of the connecting segment 607 in contact with the distal
edge of the holding member 101.
[0052] FIG. 8A is a rear view of a backing member 800 for use in a
device for surgical breast procedures, according to certain
embodiments; and FIG. 8B is a side view of the device of FIG. 8A.
The backing member 800 comprises a first overlapping member 801
having a first end 807 and a second end 809 and a second
overlapping member 803 having a first end 804 and a second end 805.
Each overlapping member can be thin, substantially flat, and
substantially longer than it is wide. The first overlapping member
801 can overlap the first end 804 of the second overlapping member
803. An adjustable connector 808 can be provided to control the
relative position and orientation of the two overlapping members
801, 803 and to connect the first overlapping member 801 and the
second overlapping member 803. As shown in FIG. 8B, the device can
include fasteners 818 for attachment to a holding member.
[0053] The adjustable connector 808 can prevent translation of
either the first overlapping member 801 or the second overlapping
member 803 perpendicular to a plane formed by the first overlapping
member 801 and second overlapping member 803. The adjustable
connector 808 can also permit limited translation of the first
overlapping member 801 and the second overlapping member 803 with
respect to each other and limited rotation around the point of
intersection of the first overlapping member 801 and second
overlapping member 803 in a plane formed by the first overlapping
member 801 and second overlapping member 803. Each of the first
overlapping member 801 and second overlapping member 803 can have a
slot, indentation, or similar cut-out. Such slot, indentation, or
similar cut-out can overlap, and the adjustable connector 808 can
include a pin, dowel, threaded or unthreaded rod, screw, or similar
connector inserted through the cut-outs in the first overlapping
member 801 and second overlapping member 803. Such a connector can
be secured at one or both ends with a cotter pin, nut, bolt, or
similar locking mechanism such that the first overlapping member
801 and second overlapping member 803 are held in contact with
variable force. The degree of force can be decreased to permit an
intentional change in the respective position and orientation of
the first overlapping member 801 and second overlapping member 803
and then increased to prevent unintentional changes in the
respective position and orientation of the first overlapping member
801 and second overlapping member 803. In this manner, the position
and the orientation of the first overlapping member 801 and second
overlapping member 803 can be adjusted, enabling the backing member
800 to mimic the dimensions of the tissue expander.
[0054] In some embodiments, the first overlapping member 801 can
further comprise a first interlocking member 811 and/or a second
interlocking member 813. The interlocking members 811, 813 can
allow adjustment of the length of the overlapping member 801. Each
of the first interlocking member 811 and second interlocking member
813 can have a slot, indentation, or similar cut-out. Such cut-outs
can overlap and a pin, dowel, threaded or unthreaded rod, screw, or
similar connector can be inserted through said cut-outs. Such
connector can be secured at one or both ends with a cotter pin,
nut, bolt, or similar locking mechanism such that the first
interlocking member 811 and second interlocking member 813 are held
in contact with variable force. The length of the first overlapping
member can be adjusted so that the backing member will mimic tissue
expanders or implants of various sizes.
[0055] FIG. 9A is a rear view of a device 900 for use in surgical
breast procedures, according to certain embodiments. The device 900
comprises a holding member 101 and a backing member 800'. Backing
member 800' can have a variety of configurations. In one
embodiment, backing member 800' has a T-shape and can incorporate
features, as described with respect to FIG. 8, but the backing
member 800' can have a variety of different shapes.
[0056] In certain embodiments, the backing member 800' can be
integrally formed as a part of or permanently connected to the
holding member. For example, as shown in FIG. 9A, the backing
member 800' can be permanently attached to the holding member 101
to provide desired rigidity to the holding member. The backing
member 800 can be attached to the holding member using an adhesive
and/or by embedding the backing member 800 within the holding
member 101, e.g., by embedding within a polymeric material forming
the backing member.
[0057] FIG. 9B is a front view of the device 900' for use in
surgical breast procedures, according to certain embodiments,
before final assembly. As shown, the backing member 800' can be
formed of the same material as the holding member 101', or can be
formed of another material attached to and extending from the
holding member 101'. The backing member 800' can then be bent or
folded and connected to the surface of the holding member. As with
each of the devices described herein, the devices 900 and 900' can
include fasteners 211 for removably attaching a biologic material
to the device for implantation of the biologic material.
[0058] FIG. 10 illustrates use of a system for facilitating breast
surgery, according to certain embodiments. In particular, FIG. 10
illustrates use of the system 900' of FIG. 9B. Any system described
herein, however, may be similarly used as part of a method for
facilitating breast surgery. The method for facilitating breast
surgery may first include creating a tissue pocket in a breast. In
one embodiment, for example, an incision can be made in the
inframammary fold or other desired location near the breast 1000;
the pectorialis muscle can then be released and raised; and a
tissue pocket 1010 created partially or completely under the
pectorialis muscle. Alternatively, the tissue pocket 1010 can be
formed for placement of an implant anterior to the pectoralis
muscle in a subcutaneous or subglandular pocket.
[0059] The method for facilitating breast surgery may further
include selecting a system for facilitating the placement of
biocompatible material 102 including a holding member and/or a
backing member. As described herein, the holding member and the
backing member may be fastened to one another. The holding member
and the backing member may be selected so that when the holding
member and the backing member are placed in the tissue pocket, they
mimic the dimensions of a biological sample 102 and/or a tissue
expander or implant. In addition, or alternatively, the holding
member may be selected so that its distal edge 203 has a shape
configured to produce a desired contour of a portion of the breast.
In one embodiment, for example, a device operator may select a
holding member and a backing member that each include a desired
size and shape. Alternatively, or in addition, a device operator
may adjust the size and shape of the holding member and/or backing
member so that a desired size and shape may be achieved.
[0060] Prior to insertion of the holding member and backing member
into the tissue pocket 1010, the method for facilitating breast
surgery may include attaching a sample of biocompatible material
102 to the holding member. Attachment may include any suitable
means described herein or known to those skilled in the art so long
as the sample of biocompatible material 102 can be detached from
the holding member upon placement in the created tissue pocket
1010.
[0061] The sample of biocompatible material 102 may be attached at
any suitable location on the holding member, such that the sample
of biocompatible material 102 can be placed in a desired position
within the tissue pocket 1010. In one embodiment, as illustrated in
FIGS. 1 and 2A-C, for example, the method may include attaching the
sample of biocompatible material 102 with at least one fastener 211
proximate to the proximal edge 201 of the holding member 101, such
that the sample of biocompatible material 102 is held in opposition
to the first side 205 of holding member 101. The at least one
fastener 211 may be any suitable fastener described herein or known
to those skilled in the art, including, but not limited to a clip,
suture, wire, tie, adhesive, paste, or gum.
[0062] Once the sample of biocompatible material 102 is attached to
the holding member, the method for facilitating breast surgery can
further include inserting the holding member, backing member and
sample of biocompatible material 102 at any suitable location
within the created tissue pocket 1010. For example, suitable
locations within the created tissue pocket may include, but are not
limited to a location at or near a desired location for the
inframammary fold, medial border of the breast, and/or lateral
border of the breast.
[0063] Upon placement of the holding member, backing member, and
sample of biocompatible material 102 in a desired location within
the created pocket, the sample of biocompatible material 102 may be
fastened to underlying tissue in the breast. Fastening may be
accomplished via any fastening means known to those skilled in the
art including, but not limited to, a suture, a staple, and/or an
effective quantity of adhesive. Fastening of the sample of
biocompatible material 102 to the underlying tissue in the breast
may occur while the sample of biocompatible material 102 is
attached to the holding member. In one embodiment, for example, the
fasteners may pass through at least one indentation 209 in the
distal edge 203 of the holding member 101.
[0064] Once the sample of biocompatible material 102 is fastened to
the underlying tissue in the breast at the desired location, the
sample of biocompatible material 102 may be detached from the
holding member, and the holding member and the backing member may
be removed from the created tissue pocket 1010.
[0065] FIG. 11 is a perspective view of a system comprising a
sample of biocompatible material 102 and a device 120 for surgical
breast procedures, according to certain embodiments. As shown, the
device 120 is a unitary structure. That is to say, the device
includes a holding member 121, which has a shape similar to those
described above (see element 101). In the embodiment of FIG. 11,
however, the device does not include a separate backing member.
Rather, the device 120 is formed of a material having desired
flexibility/rigidity such that a separate backing member is not
needed. The device 120 has indentations 209, which function like
those described with reference to holding member 101.
[0066] In each of the embodiments described above, the backing
member and/or holding member are depicted as substantially flat
objects. The devices can, however, have a number of suitable
three-dimensional shapes. For example, FIG. 12 is a perspective
view of a device for surgical breast procedures, according to
certain embodiments. As shown, the device comprises a backing
member 130 having a curved or cup-like configuration. The
configuration may be selected to mimic an implant site and/or a
tissue expander or implant. Further, a holding member may be
configured to have a similar shape. In addition, the backing member
may be formed of a flexible material, and the holding member can be
provided in a range of suitable shapes to produce a desired shape
for the backing member 130 at the time of use.
[0067] In addition, the holding members described herein, as well
as the biocompatible materials for use therewith, can have any
desired shape. For example, the holding member (with or without a
backing member of similar or different shape) and/or biocompatible
material can be rectangular, square, ovoid, triangular,
trapezoidal, or any other shape. Such holding members can include a
plurality of indentations along at least one edge to assist in
fastening the biocompatible material to tissue.
[0068] Other embodiments will be apparent to those skilled in the
art from consideration of the specification and practice of this
disclosure. It is intended that the specification and examples be
considered as exemplary only, with the true scope and spirit of the
disclosed devices and methods being indicated by the following
claims.
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