U.S. patent application number 14/679788 was filed with the patent office on 2015-10-08 for gravity sensitive silicone breast implants.
The applicant listed for this patent is Establishment Labs. Invention is credited to Juan Jose Chacon Quiros, Salvador Dada, Luis M. Gutierrez, Olivier Tourniaire.
Application Number | 20150282926 14/679788 |
Document ID | / |
Family ID | 54208722 |
Filed Date | 2015-10-08 |
United States Patent
Application |
20150282926 |
Kind Code |
A1 |
Chacon Quiros; Juan Jose ;
et al. |
October 8, 2015 |
GRAVITY SENSITIVE SILICONE BREAST IMPLANTS
Abstract
A gravity sensitive silicone breast implant is provided which,
in various embodiments, has a soft, natural feel and adapts shape
after implantation responsive to gravity, according to movements of
the patient.
Inventors: |
Chacon Quiros; Juan Jose;
(San Jose, CR) ; Dada; Salvador; (San Jose,
CR) ; Tourniaire; Olivier; (San Jose, CR) ;
Gutierrez; Luis M.; (San Jose, CR) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Establishment Labs |
Alajuela |
|
CR |
|
|
Family ID: |
54208722 |
Appl. No.: |
14/679788 |
Filed: |
April 6, 2015 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61975474 |
Apr 4, 2014 |
|
|
|
Current U.S.
Class: |
623/8 |
Current CPC
Class: |
A61F 2230/0076 20130101;
A61F 2210/0076 20130101; A61F 2230/008 20130101; A61L 27/18
20130101; A61L 27/18 20130101; A61F 2/12 20130101; A61L 2400/12
20130101; C08L 83/04 20130101 |
International
Class: |
A61F 2/12 20060101
A61F002/12; A61L 31/14 20060101 A61L031/14; A61L 31/06 20060101
A61L031/06 |
Claims
1. A gravity sensitive silicone breast implant, comprising a
flexible multilayer shell and a cohesive silicone gel filler with a
high elasticity and a low viscosity, and configured to shift its
maximum point of projection when subjected to gravity, wherein the
flexible multilayer shell reaches at least 25% elongation at forces
of about 1.4 N to about 1.9 N and at least 50% elongation at forces
of about 1.8 N to about 2.2 N when tested in accordance with ASTM
D412, and wherein the silicone gel filler reaches about 2 mm to
about 29 mm protrusion in a cone cohesion test and will not detach
from the cone when tested in accordance with ASTM F703.
2. The gravity sensitive silicone breast implant of claim 1,
wherein the flexible multilayer shell has a nano-textured outer
surface.
3. The gravity sensitive silicone breast implant of claim 1,
wherein the flexible multilayer shell has a micro-textured outer
surface.
4. The gravity sensitive silicone breast implant of claim 1,
wherein the flexible multilayer shell has a thickness of about
0.008 in to about 0.030 in.
5. The gravity sensitive silicone breast implant of claim 1,
wherein the flexible multilayer shell includes at least one low
diffusion barrier layer.
6. The gravity sensitive silicone breast implant of claim 5,
wherein the low diffusion barrier layer comprises a polysiloxane
backbone having at least 10 mole percent of a pendant chemical
group that retards permeation of silicone gel through the low
diffusion barrier layer.
7. The gravity sensitive silicone breast implant of claim 5,
wherein the low diffusion barrier layer comprises a
polydimethylsiloxane backbone having at least 10 mole percent of a
pendant chemical group comprising at least one of a phenyl group
and a fluorine group.
8. The gravity sensitive silicone breast implant of claim 5,
wherein the low diffusion barrier layer comprises a
polydimethylsiloxane backbone having at least 10 mole percent of a
pendant chemical group comprising at least one of a diphenyl group,
a methylphenyl group, a trifluoropropyl group, and mixtures
thereof.
9. The gravity sensitive silicone breast implant of claim 5,
wherein the low diffusion barrier layer has a color.
10. The gravity sensitive silicone breast implant of claim 1,
wherein the implant has a round base.
11. The gravity sensitive silicone breast implant of claim 1,
wherein the implant has an oval base.
Description
RELATED APPLICATIONS
[0001] This application claims the benefit of, and priority to,
U.S. Provisional Application No. 61/975,474, filed Apr. 4, 2014,
entitled "Gravity Sensitive Silicone Breast Implants," which is
incorporated herein by reference in its entirety.
BACKGROUND
[0002] Today, the augmentation and reconstruction of the human
breast, requiring the use of an implant, has become a fairly common
practice in the art of plastic and reconstructive surgery. Typical
long-term implantable devices, which are often selected for these
procedures, include round or preformed anatomically shaped silicone
gel-filled implants. However, such implants have a number of
drawbacks, including but not limited to a hard, unnatural feel and
behavior. Improved implantable devices for breast augmentation are
needed.
SUMMARY
[0003] The present invention provides, in various embodiments, a
gravity sensitive silicone breast implant that has a soft, natural
feel and is capable of adapting shape after implantation responsive
to gravity, according to movements of the patient.
[0004] In one aspect, the invention provides a gravity sensitive
silicone breast implant comprising a flexible multilayer shell and
a cohesive silicone gel filler with a high elasticity and a low
viscosity. The implant is configured to shift its maximum point of
projection when subjected to gravity. The flexible multilayer shell
of the implant reaches at least 25% elongation at forces of about
1.4 N to about 1.9 N and at least 50% elongation at forces of about
1.8 N to about 2.2 N when tested in accordance with ASTM D412. The
silicone gel filler reaches about 2 mm to about 29 mm protrusion in
a cone cohesion test and will not detach from the cone when tested
in accordance with ASTM F703.
[0005] In some embodiments, the flexible multilayer shell has a
nano-textured outer surface. In other embodiments, the flexible
multilayer shell has a micro-textured outer surface.
[0006] In some embodiments, the flexible multilayer shell has a
thickness of about 0.008 in to about 0.030 in.
[0007] In some embodiments, the flexible multilayer shell includes
at least one low diffusion barrier layer.
[0008] In some embodiments, the low diffusion barrier layer
comprises a polysiloxane backbone having at least 10 mole percent
of a pendant chemical group that retards permeation of silicone gel
through the low diffusion barrier layer.
[0009] In some embodiments, the low diffusion barrier layer
comprises a polydimethylsiloxane backbone having at least 10 mole
percent of a pendant chemical group comprising at least one of a
phenyl group and a fluorine group.
[0010] In some embodiments, the low diffusion barrier layer
comprises a polydimethylsiloxane backbone having at least 10 mole
percent of a pendant chemical group comprising at least one of a
diphenyl group, a methylphenyl group, a trifluoropropyl group, and
mixtures thereof
[0011] In some embodiments, the low diffusion barrier layer has a
color.
[0012] In some embodiments, the gravity sensitive silicone breast
implant has a round base.
[0013] In alternative embodiments, the gravity sensitive silicone
breast implant has an oval base.
[0014] Additional features and advantages of the present invention
are described further below. This summary section is meant merely
to illustrate certain features of the invention, and is not meant
to limit the scope of the invention in any way. The failure to
discuss a specific feature or embodiment of the invention, or the
inclusion of one or more features in this summary section, should
not be construed to limit the invention as claimed.
BRIEF DESCRIPTION OF THE DRAWINGS
[0015] The foregoing summary, as well as the following detailed
description of the preferred embodiments of the application, will
be better understood when read in conjunction with the appended
drawings. For the purposes of illustrating the implants of the
present application, there are shown in the drawings preferred
embodiments. It should be understood, however, that the application
is not limited to the precise arrangements and instrumentalities
shown. In the drawings:
[0016] FIG. 1 shows the variation in the shape and the shifting of
the maximum point of projection from the apex of a gravity
sensitive silicone breast implant of the present invention,
according to some embodiments.
[0017] FIG. 2 shows the variation in the shape and the shifting of
the maximum point of projection from the apex of the breast implant
before implantation and after implantation when the patient is
standing up, according to some embodiments.
[0018] FIG. 3 shows two possible base variations of the invention,
at left, where A and B are different measures (oval base) and, at
right, where A and B are equal measures (round base).
DETAILED DESCRIPTION
[0019] Typical silicone gel-filled breast implants are mammary
augmentation devices constructed of a shell comprising successive
cross-linked layers of silicone elastomer, which gives the implants
their elasticity and integrity. All silicone gel-filled implants
are composed, at least, of the above-mentioned shell, a silicone
patch, and silicone gel fill.
[0020] The objective of most of the surgical procedures performed
to increase breast size, including all reconstruction procedures,
is to recreate the feel, look and behavior of the natural breast
tissue. In the past, this objective has been addressed by means of
creating preformed anatomical implants to reproduce the natural
shape of the human breast. Nevertheless, this approach has created
problems of its own that in many aspects deter from the original
intention.
[0021] Preformed anatomical implants work on the basis of retaining
at all times after implantation a predefined form that is viewed as
anatomically correct for the breasts. This is achieved by means of
creating an implant that retains its form by utilizing a highly
cohesive filling gel with a high viscosity and a low elasticity,
together with a shell made to maintain its form at all times. The
aesthetic result is very good, as long as the patient is upright,
motionless, and as long as the breasts are not touched. Preformed
anatomical implants are hard and, once implanted, maintain their
form independently of the position or action taken by the patient.
These implants do not resemble the human tissue in movement or when
touched. There is no natural interaction between the breast tissue
and the silicone breast implant. Patients and their partners
typically complain about how unnatural those implants feel and
behave after implantation.
[0022] Additionally, traditional anatomical implants suffer from
complications endemic to their kind Since they are preformed to
have a teardrop-like form, they need to be implanted in a very
precise position, and no deviation, movement or rotation is
acceptable because it would show as a deformation of the breast.
Rotation and misplacement of anatomical breast implants is very
common and the only existing solution is re-operation.
[0023] In an effort to avoid rotation and movement of preformed
anatomical breast implants, manufacturing companies have opted to
give these implants very rough and aggressive surface textures,
with the purpose of making them adhere to the surrounding tissue,
or at least create sufficient friction to avoid slippage. This
approach has proven successful to some degree, but has created a
new set of problems.
[0024] Very aggressive surface textures on the outer shell of
breast implants have been identified as the cause of newer
complications originating in the shear forces causing irritation,
which can develop into late seromas and double capsules, leading to
the necessity of reoperation and additional procedures to attain a
healthy and acceptable aesthetic outcome.
[0025] The present invention provides, in various embodiments, an
alternative to anatomical preformed breast implants that eliminates
the above-described problems associated with their use, but
maintains their positive aesthetic features. In various
embodiments, the invention provides a silicone breast implant:
without an aggressively textured outer surface; with a consistency
similar to human tissue; which replicates and allows the natural
movements of the body; and/or which eliminates or greatly
diminishes the problem of implant rotation.
[0026] The present invention provides, in various embodiments, a
gel-filled implant consisting of an internal cohesive silicone gel
and a flexible silicone shell enclosing the gel. Once implanted,
the implant will shift its point of maximum projection according to
the movements of the patient, driven only by the force of gravity.
This shifting enables the implant resemble the movement of natural
breast tissue to obtain a real anatomical result. The implant has a
sensation to touch soft enough to resemble the sensation of breast
tissue. The implant of the present invention provides an improved,
closer reproduction of natural breast tissue according to standard
visual and tactile perceptions.
[0027] The implant of the present invention advantageously adapts
shape after implantation to give the natural look of traditional
preformed anatomical implants, without the complications associated
with rotation, implant hardness, and/or aggressive textures. As
shown, for example, in FIGS. 1 and 2, the implant of the present
invention, when subjected to gravity, will advantageously shift the
maximum point of projection to the lower pole of the implant when
the patient is in a standing position. When the patient lays flat
on her back, the implant will react as a natural breast and the
maximum point of projection will move closer to the middle point of
her breast.
[0028] As shown, for example, in FIG. 3, the implant can have a
round or oval base where all four quadrants are equivalent. When
employing a round base this condition allows the placement of the
implant using the same techniques employed for the placement of
non-anatomical breast implants, which makes for a simpler
procedure. Even though the result resembles an anatomically correct
breast, the breast implant of the present invention having a round
base can rotate in its vertical axis without impairing that
result.
[0029] When employing an oval base, the surgeon may choose whether
the physical characteristics of the patient call for the placement
of the implant in a vertical alignment of the longest or shortest
diameter of the implant with the patient's height. Due to the
adaptation of the implant according to the gravity pull, the
aesthetic result in case of a rotation would not be seriously
affected, or would not be noticeable to a large degree, minimizing
the possible complication. Since the gravity vector is equal in
rotated or non-rotated implants, the maximum point of projection
would tend to be localized in the same desired area.
[0030] Due to the described characteristics of the implants of the
present invention that eliminate or diminish the incidence of
rotation as a possible complication in breast augmentation
procedures, the need for aggressive textures on the outer side of
the implant shell is advantageously eliminated or diminished.
Accordingly, implants of the present invention can have a smooth
(e.g., nano-textured or micro-textured) outer surface throughout,
thus negating the additional range of complications that can
develop from the use of aggressive textures.
[0031] In some embodiments, the shell of the implant of the present
invention is a multilayer structure with at least one low diffusion
barrier layer included with (inside, outside, or nestled between) a
plurality of standard silicone elastomer layers. The barrier
layer(s) can be, for example, made of silicone elastomer comprising
a polysiloxane backbone and having a minimum mole percentage of 10%
of a substituted or pendant chemical group that retards permeation
of silicone gel through the layer. In some embodiments, the
silicone elastomer present in the barrier layer(s) is a
polydimethylsiloxane and the pendant chemical group is a phenyl
group (e.g., a diphenyl group or a methylphenyl group), a fluorine
group (e.g., a trifluoropropyl group), or a mixture thereof. In
some embodiments, the shell may comprise colored barrier layer(s)
as described, for example, in U.S. patent application Ser. No.
13/412,221, which is incorporated herein by reference in its
entirety.
[0032] Various systems and methods can be used for constructing a
silicone implant elastomeric shell and they are contemplated in
this invention. In some embodiments, the step of forming the shell
comprises coating a mold with a liquid elastomer; the shell may be
formed by dipping, spraying, pouring, blowing or rotational
molding, using a suitably shaped mold, coated with dispersion of a
silicone elastomer and a solvent, allowing the solvent to volatize,
and allowing the elastomer to cure.
[0033] In some embodiments, the implant of the present invention
achieves a pliable sensation resembling breast tissue and the
possibility of varying its shape from the use of an outer silicone
elastomer shell that is able to stretch with the application of
small forces which may come from the movement of the gel or the
application of force by hand. This flexibility can be measured and
demonstrated by calculating the stress of the shell at 25% and 50%
elongation on the apex section of the shell. Existing silicone
shelled breast implants have shells that require average forces
from 2 to 3 Newtons (N) or higher when tested for stress at 25%
elongation, and average forces from 2.7 to 3.5 N or higher when
tested for stress at 50% elongation, measured according to ASTM
D412 (Standard Test Methods for Vulcanized Rubber and Thermoplastic
Elastomers--Tension; see, e.g., www.astm.org/Standards/D412.htm).
In contrast, in various embodiments, implants of the present
invention comprise an outer shell having an average thickness
ranging from 0.008 to 0.030 inches, and requiring forces at the
apex from about 1.4 to about 1.9 N when tested for stress at 25%
elongation and from about 1.8 to about 2.2 N when tested for stress
at 50% elongation, measured according to ASTM D412.
[0034] In some embodiments of the present invention, movement or
conformation of the implant mass according to the gravity vector is
obtained by using a cohesive silicone gel filler with a high
elasticity and a low viscosity. The desired cohesiveness
characteristics are preferably achieved using a gel that will
attain a value in the range of 2 to 29 mm protrusion in the cone
cohesion test and that will not detach from the cone, according to
the test previewed in ISO 14607:2009 (Non-active surgical
implants--Mammary implants--Particular requirements; see, e.g.,
www.iso.org/iso/home/store/catalogue_tc/catalogue_detail.htm?csnumber=387-
60) and ASTM F703 (Standard Specification for Implantable Breast
Prostheses; see, e.g., http://www.astm.org/Standards/F703.htm).
[0035] While there have been shown and described fundamental novel
features of the invention as applied to the preferred and exemplary
embodiments thereof, it will be understood that omissions and
substitutions and changes in the form and details of the disclosed
invention may be made by those skilled in the art without departing
from the spirit of the invention. Moreover, as is readily apparent,
numerous modifications and changes may readily occur to those
skilled in the art. Hence, it is not desired to limit the invention
to the exact construction and operation shown and described and,
accordingly, all suitable modification equivalents may be resorted
to falling within the scope of the invention as claimed. It is the
intention, therefore, to be limited only as indicated by the scope
of the claims appended hereto.
* * * * *
References