U.S. patent application number 15/094889 was filed with the patent office on 2016-08-04 for methods for nipple formation via collapsible devices.
This patent application is currently assigned to TauTona Group Research and Development Company, L.L.C.. The applicant listed for this patent is TauTona Group Research and Development Company, L.L.C.. Invention is credited to Geoffrey C. GURTNER, Kenneth N. HORNE, Christopher S. JONES, Joseph RIMSA, Michael H. ROSENTHAL, Sergio SALINAS.
Application Number | 20160220441 15/094889 |
Document ID | / |
Family ID | 47832587 |
Filed Date | 2016-08-04 |
United States Patent
Application |
20160220441 |
Kind Code |
A1 |
HORNE; Kenneth N. ; et
al. |
August 4, 2016 |
METHODS FOR NIPPLE FORMATION VIA COLLAPSIBLE DEVICES
Abstract
Apparatus and methods for nipple and breast formation are
described where devices precondition or expand a target nipple
tissue to reduce the pressure exerted by the skin on an eventual
implant. Generally, the apparatus comprises a mold having a contact
surface which is curved in conformance with a breast upon which the
mold is positionable, the contact surface having an adhesive for
securement upon the breast, and the mold defining a cavity along
the contact surface which conforms to a size of a nipple to be
formed upon the breast and where the cavity further comprises the
adhesive for securement to the nipple. A breast enlargement device
comprises a cup larger than the target breast and further defines
an inner surface which adheres to the breast when contacted.
Inventors: |
HORNE; Kenneth N.; (San
Francisco, CA) ; SALINAS; Sergio; (Redwood City,
CA) ; GURTNER; Geoffrey C.; (Palo Alto, CA) ;
ROSENTHAL; Michael H.; (Menlo Park, CA) ; JONES;
Christopher S.; (Menlo Park, CA) ; RIMSA; Joseph;
(Palo Alto, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
TauTona Group Research and Development Company, L.L.C. |
Menlo Park |
CA |
US |
|
|
Assignee: |
TauTona Group Research and
Development Company, L.L.C.
Menlo Park
CA
|
Family ID: |
47832587 |
Appl. No.: |
15/094889 |
Filed: |
April 8, 2016 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
13606517 |
Sep 7, 2012 |
9308081 |
|
|
15094889 |
|
|
|
|
61532734 |
Sep 9, 2011 |
|
|
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 90/02 20160201;
A61H 9/0057 20130101; A61F 2/12 20130101; A61H 2205/082
20130101 |
International
Class: |
A61H 9/00 20060101
A61H009/00; A61B 90/00 20060101 A61B090/00 |
Claims
1. A method of forming a nipple, comprising: reconfiguring a mold
into a first collapsed configuration and a mold skirt into a first
extended configuration, where the mold skirt is attached to a
portion of the mold; adhering the mold having a contact surface
which is curvable onto a region of a breast where a nipple is to be
formed; reconfiguring the mold into a second molding configuration
such that the mold defines a receiving cavity and draws the adhered
region of the breast into the mold and away from a remainder of the
breast; reconfiguring the mold skirt into a second supporting
configuration such that the mold skirt forms a smoothed surface
relative to the mold in its second molding configuration.
2. A method of forming a nipple, comprising: adhering a first mold
upon a breast such that the mold conforms to a surface of the
breast, wherein the first mold has to contact surface which is
curved and further has a first mold skirt attached to a portion of
the first mold, and wherein the first mold defines a first cavity
along the contact surface which conforms to a size of a nipple to
be formed upon the breast; adhering a portion of the breast where a
nipple is to be formed within the cavity maintaining the first mold
upon the breast for a first period of time of at least one day;
removing the first mold from the breast and adhering at least a
second mold having a contact surface upon the breast, if needed,
wherein the second mold has a second mold skirt attached, and
wherein the second mold defines a second cavity which is larger
than the first cavity; and maintaining the second mold upon the
breast for a second period of time of at least one day such that a
size of the nipple is maintained when the second mold is removed
from the breast.
3. The method of claim 2 further comprising repeating additional
applications of molds with subsequently larger cavities until a
predetermined nipple size is achieved, if needed.
4. The method of claim 2 further comprising inserting an implant
into the formed nipple to maintain a shape and size of the
nipple.
5. The method of claim 4 further comprising reapplying a mold after
the implant is inserted to allow an implant-tissue interface time
to equilibrate.
6. The method of claim 2 wherein the first mold is invertible and a
portion of the first cavity is adhered to the target nipple tissue
while inverted, wherein reversion of the first mold back to its
first configuration recruits and stretches tissue at the surface of
the breast and secures the tissue in place within the cavity.
7. The method of claim 2 wherein adhering a first mold comprises
actuating a vacuum pump in fluid communication with the first
mold.
8. The method of claim 2 wherein adhering a first mold comprises
adhering the surface of the breast within the first cavity via an
adhesive.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a divisional of U.S. patent application
Ser. No. 13/606,517 filed Sep. 7, 2012 (now U.S. Pat. No.
9,308,081), which claims the benefit of priority to U.S.
Provisional Patent Application No. 61/532,734 filed Sep. 9, 2011,
the content of each of which is incorporated herein by reference in
its entirety.
FIELD OF THE INVENTION
[0002] The present invention relates generally to medical devices
and methods used for nipple reconstruction. More particularly, the
present invention relates to apparatus and methods for nipple
reconstruction utilizing devices which are mechanically simple to
utilize.
BACKGROUND OF THE INVENTION
[0003] In a majority of mastectomies, the nipple is not preserved.
While breast implants are an option for women who would like to
have their breasts reconstructed, nipple reconstruction is still a
challenging problem which lacks good options. Currently, surgeons
do their best to recreate a nipple, e.g., cinching skin together
and/or implanting the nipple area with some filler or material such
as a biomaterial or some allograft. The inherent challenge is that
the skin, which is taut, tends to push any additive material into
the body making the nipple appear flat.
[0004] Although techniques for nipple-saving mastectomies exist, in
most cases, the nipple and areola tissue are removed. There is no
established gold standard procedure for nipple reconstruction,
however, with all techniques permanence of nipple projection is
inconsistent or problematic, and therein is an unmet clinical
need.
[0005] An example of a commercially available product that helps
enlarge or precondition breasts prior to fat grafting is the
BRAVA.RTM. (Brava, LLC, Miami, Fla.) which is typically worn at
night by the user while sleeping.
[0006] However, the user is generally required to wear the device
for a minimum of 10 hours per day for 10 to 14 consecutive weeks.
This is usually very challenging given that a small pump must be
worn in addition to the molds and a sports bra-like garment.
Patient compliance is often a big challenge with BRAVA, and further
it is not intended for or capable of nipple expansion.
SUMMARY OF THE INVENTION
[0007] A nipple forming apparatus which may precondition, expand or
maintain target nipple tissue may be utilized to reduce the
pressure exerted by the skin on an implant. Generally, the
apparatus may comprise a mold having a contact surface which is
curved in conformance with a breast upon which the mold is
positionable, the contact surface comprising an adhesive for
securement upon the breast, and the mold defining a cavity along
the contact surface which conforms to a size of a nipple to be
formed or that has been formed by an implant upon the breast and
where the cavity further comprises the adhesive for securement to
the nipple.
[0008] In use, a first mold having a contact surface which is
curved may be adhered upon a breast such that the mold conforms to
a surface of the breast. The mold may further define a first cavity
along the contact surface which will precondition or expand the
skin on the breast that will eventually be formed into a nipple.
This mold is adhered to a portion of the breast and is maintained
upon the breast for a first period of time. The mold is then
removed from the breast and a second mold having a contact surface
is adhered upon the breast where the second mold defines a second
cavity which is equal to or larger than the first cavity. The
second mold is maintained upon the breast for a second period of
time such that a size of the nipple is maintained when the second
mold is removed from the breast. This process is repeated with
subsequent molds as necessary to achieve the desired preconditioned
or expansion.
[0009] When desired result is achieved, the mold can be removed and
an implant placed in the newly formed nipple envelop. It may be
desirable to adhere an appropriately sized mold after placing the
implant within the nipple, which may hold the nipple in the desired
conformation while some degree of settling takes place.
BRIEF DESCRIPTION OF THE DRAWINGS
[0010] FIGS. 1, 2 and 3 are different views of the mold. FIG. 1 is
a near isometric view of the top. FIG. 2 is a side view and FIG. 3
is a near isometric view of the bottom.
[0011] FIG. 4 shows a variation of the mold having at least two
regions of differing stiffness, in an inverted position, with the
adhesive surface placed on breast tissue.
[0012] FIG. 5 shows a variation of the mold having at least two
regions of differing stiffness, in a partially inverted position,
with the all the adhesive surfaces placed on the breast and
deploying to recruit skin into the mold.
[0013] FIG. 6 shows a variation of the mold having at least two
regions of differing stiffness, in a deployed position, with breast
tissue recruited into the mold and the protective, low friction
skirt deployed.
[0014] FIG. 7 shows a vacuum source assisting to adhere the
variation of the mold having at least two regions of differing
stiffness in a partially inverted position, with all the adhesive
surfaces placed on the breast, deploying to recruit skin into the
mold.
[0015] FIG. 8 shows a vacuum source assisting to adhere and recruit
skin into the variation of the mold having at least two regions of
differing stiffness, in a deployed position, with breast tissue
recruited into the mold and the protective, low friction skirt
deployed.
[0016] FIG. 9 shows an implant placed under a formed nipple within
a mold.
[0017] FIG. 10 shows an implant placed under a formed nipple
without a mold.
DETAILED DESCRIPTION OF THE INVENTION
[0018] Generally, the cause of nipple flattening is multi-factorial
and includes inadequate subcutaneous fat, internal pressure,
external pressure, poor flap design, delayed healing, and tissue
memory. Poor flap design, inadequate subcutaneous flu and delayed
healing are more related to surgical technique. Permanent implants
like ARTECOLL.RTM. (Artes Medical, Inc., San Diego, Calif.) or
absorbable allografts like ALLODERM.RTM. (LifeCell Corp.,
Branchburg, N.J.) have been used to address the issues of internal
and external pressure as well as tissue memory however these
projections reduce over time. The devices and methods described
herein address the internal and external pressures and tissue
memory thereby making implants as described in U.S. Pat. No.
4,778,465, Surgically implantable areola and nipple prosthesis,
more likely to persist.
[0019] Generally, the devices described herein precondition, expand
or maintain the target nipple tissue (which is homogenous
post-mastectomy) which reduces the pressure exerted on an implant
by the skin. This can be done multiple ways where one variation may
utilize an external mold that is adhered to the nipple target skin
to create laxity in the skin prior to the implantation of a filler,
whether fat or a biomaterial. Once the nipple skin is expanded, an
implant such as ALLODERM.RTM. or a cylinder of hyaluronic acid
threads or a chitosan sponge, for example, is surgically implanted.
By creating a space, the forces acting on the nipple implant to
drive it into the body may be minimized or rendered non-existent.
In another variation designed to maintain nipple tissue, after
implanting a filler to create the nipple shape, an external mold is
adhered to the newly created nipple projection to reduce or
eliminate the external pressure exerted by the skin on the implant
while the skin remodels, allowing the nipple projection to be
maintained.
[0020] FIGS. 1-3 show one variation of a first nipple forming mold
1 that may be adhered to a post-mastectomy breast which has had its
nipple surgically removed. The mold 1 may comprise an elastomeric
material which has a formed external shaped which is configured to
match the contour of the underlying breast. The contact surface of
the mold 1 which contacts the breast may have an adhesive layered
upon the surface to adhere the mold 1 directly to the skin of the
breast. The mold 1 may also define a pocket into which the nipple,
or soon-to-be nipple skin, is to be adhered directly via an
adhesive surface. The nipple skin may be undersized to the nipple
mold if the device is used to expand the nipple tissue. If the
device is used to maintain the nipple tissue, a nipple mold which
is equally sized to the nipple may be used
[0021] Pressing the mold 1 on the top of the dome will invert the
mold 1 to the configuration seen in FIG. 4. Inverting the mold 1
folds the mold skirt 2 into the center and out of the way and makes
positioning and adhering the adhesive surface 6 of the optionally
higher stiffness/durometer mold section 5 to the target area on the
breast tissue 7. The mold 1 may be made from an elastomeric
material having a first stiffness/durometer of Shore A 30-70, more
specifically Shore A 50. The receiving cavity may have a second
stiffness/durometer of Shore A 40-80, more specifically Shore A 58,
which is higher than the first stiffness/durometer.
[0022] Once adhered to the target area on the breast tissue 7, the
mold reversion process is initiated as shown in FIG. 5. As the
sides of the nipple mold 4 revert, the adhesive surface 6 adheres
to tissue adjacent to the target area on the breast tissue. When
reversion is complete and the nipple mold 4 has returned to the
relaxed state, the sides of the nipple mold 4 are shown to have
adhered to the breast tissue 7 and recruited the adhered breast
tissue 7 into the mold 1 as shown in FIG. 6. The mold skirt 2 fully
deploys to both protect and smooth the appearance of the mold 1.
The low friction material/covering/coating 8 on the mold skirt 2
ensures any local rubbing from clothes or other fabric minimizes
any transmitted stress or strain on the mold 1.
[0023] In yet another variation, another embodiment may comprise
stretching the breast tissue to form the nipple with the assistance
of a suction or vacuum force. As shown in the partial
cross-sectional side view of FIG. 7, the molding device may
comprise a contoured mold, as previously described, but also
including one or more openings 3 through the device in
communication with the nipple molding cavity.
[0024] When the device is released and allowed to revert back
towards its relaxed configuration as seen in FIG. 8, the adhered
breast tissue may be pulled to create skin laxity within the nipple
molding cavity. A vacuum or suction force 8 may be optionally
applied through the openings via a vacuum pump 9, 10 to further
draw the skin into the nipple molding cavity to ensure adherence of
the skin to the mold. Once the tissue has been adhered, the vacuum
may be desirably removed or left on until the next mold is
required.
[0025] Aside from the openings 3 for allowing fluid communication
with a vacuum source, the openings 3 may also serve to allow for
any sweat or fluid from the adhered skin to evaporate through the
openings 3. Additionally and/or alternatively, the material forming
the sides or walls of the nipple mold 4 may also define one or more
openings therethrough to allow for sweat or fluids to evaporate
from the underlying skin. Aside from the one or more openings, the
material and/or adhesive may be permeable to fluid.
[0026] Clinical experience has shown that forming the nipple must
be done gradually. Attempting to recruit skin too quickly creates
high stress/strain concentrations in the skin that can lead to
blisters, tears, infection and/or scarring. This can delay the
process and complicate further nipple formation efforts. To
minimize the risk, one or more molds may be utilized in progression
where each subsequent mold may define a nipple mold which is
progressively larger than the previous mold to subsequently stretch
the nipple into a progressively larger size.
[0027] Once the progression of one or more is completed and the
patient has reached the required nipple size, expansion may be
stopped and an implant material or filler such as fat or a
biomaterial may be inserted to permanently form the nipple as shown
in FIG. 10. Optionally, and after the implant, a mold may be
reapplied to the newly formed nipple with implant as shown in FIG.
9 to allow time for the tissue and implant to equilibrate.
[0028] The applications of the disclosed invention discussed above
are not limited to certain treatments or regions of the body, but
may include any number of other treatments and areas of the body.
Modification of the above-described methods and devices for
carrying out the invention, and variations of aspects of the
invention that are obvious to those of skill in the arts are
intended to be within the scope of this disclosure. Moreover,
various combinations of aspects between examples are also
contemplated and are considered to be within the scope of this
disclosure as well.
* * * * *