U.S. patent number 3,681,787 [Application Number 05/128,500] was granted by the patent office on 1972-08-08 for implantable breast prosthesis filled with gels of different densities.
This patent grant is currently assigned to Moxness Products, Inc.. Invention is credited to Colette Perras.
United States Patent |
3,681,787 |
Perras |
August 8, 1972 |
IMPLANTABLE BREAST PROSTHESIS FILLED WITH GELS OF DIFFERENT
DENSITIES
Abstract
A breast prosthesis having a porous polyester fabric for
connecting the prosthesis to the chest wall and filled with layers
of silicon gel material of varying viscosity to provide a more
natural appearance of the breast.
Inventors: |
Perras; Colette (Montreal,
Quebec, CA) |
Assignee: |
Moxness Products, Inc. (Racine,
WI)
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Family
ID: |
22435642 |
Appl.
No.: |
05/128,500 |
Filed: |
March 26, 1971 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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782345 |
Dec 9, 1968 |
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Current U.S.
Class: |
623/8 |
Current CPC
Class: |
A61F
2/12 (20130101) |
Current International
Class: |
A61F
2/12 (20060101); A61f 001/24 () |
Field of
Search: |
;3/1,36
;128/462,463,464,478-481,DIG.21 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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1,085,676 |
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Jul 1954 |
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FR |
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1,506,272 |
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Nov 1967 |
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FR |
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Other References
"Mammaplasty Utilizing a Silastic Implant," The Bulletin of the Dow
Corning Center for Aid to Medical Research, Vol. 10, No. 2, April
1968, Midland, Mich., page 7..
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Primary Examiner: Gaudet; Richard A.
Assistant Examiner: Frinks; Ronald L.
Parent Case Text
This application is a continuation of application Ser. No. 782,345
filed Dec. 9, 1968, now abandoned.
Claims
I claim:
1. A surgically implantable breast prosthesis comprising,
a flexible container formed from a surgically implantable material
and having an outer shape approximating that of the human
breast,
a solid rim tapered outwardly to a fine edge provided around the
outer periphery of said container,
a silicone gel filling the inside of the container,
said gel being more viscous around the outer periphery than in the
center of said container,
and a tissue permeable strip attached to the back of the container
to provide for tissue ingrowth.
2. The prosthesis according to claim 1 wherein said container is
formed from an organopolysiloxane polycarbonate.
3. The prosthesis according to claim 1 wherein said strip is formed
from a polyester fabric.
4. The prosthesis according to claim 1 wherein said silicone gel
includes a liner of viscous gel around the outer section of said
container and a less viscous gel provided inwardly of said liner of
viscous gel.
5. The prosthesis according to claim 4 wherein said liner of said
viscous gel is vulcanized to said container and to said less
viscous gel.
6. A surgically implantable breast prosthesis comprising,
a container formed from an organopolysiloxane polycarbonate and
having an outer shape approximating that of the human breast,
a solid rim tapered outwardly to a fine edge provided around the
outer periphery of said container,
a silicone gel filling the inside of the container,
said gel being more viscous around the outer periphery than in the
center of said container,
and a fabric strip attached to the back of said rim to provide for
tissue ingrowth.
7. The breast prosthesis according to claim 6 wherein said silicone
gel includes a liner of viscous gel around the outer section of
said container and a less viscous gel provided inwardly of said
liner of viscous gel.
8. The breast prosthesis according to claim 7 wherein said liner of
said viscous gel is vulcanized to said container and to said less
viscous gel.
Description
This invention relates generally to a breast prosthesis suitable
for implanting within the human breast. More specifically this
invention relates to improved means for holding breast prosthesis
in place and retaining its configuration over longer periods of
time.
In recent years great strides have been made in the field of breast
prosthesis. U.S. Pat. No. 3,293,663 issued to T. D. Cronin, Dec.
27, 1966 teaches a gel filled silicone rubber breast prosthesis
that utilizes a polyester fabric to connect the prosthesis to the
chest wall. The polyester fabric is positioned against the chest
and retained there so that the body tissue actually grows through
and fabric to anchor the prosthesis to the body. In practice there
has been a tendency for this type of prosthesis to lose its
configuration after a few months use. Also, the edges of the
prosthesis tend to pull away from the chest wall and form a ridge
or bulge around the upper portion of the breast.
This invention overcomes the problems mentioned above by providing
an improved means of anchoring the prosthesis to the body. The
invention also incorporates a novel means of filling the prosthesis
with materials of varying viscosity to maintain the configuration
of the prosthesis over a longer period of time while also retaining
the desired consistency of the breast.
Therefore it is the object of this invention to provide a new and
improved breast prosthesis that more nearly resembles that of a
natural human breast.
Another object of this invention is to provide a new and improved
breast prosthesis that will retain its natural shape over longer
periods of time.
Another object of this invention is to provide a breast prosthesis
that more firmly adheres to the chest wall.
Other objects and advantages will be apparent from the following
description when read in connection with the accompanying drawings,
in which:
FIG. 1 is a sectional view of the breast prosthesis of this
invention attached to the chest wall and positioned beneath the
mammary gland;
FIG. 2 is a rear view of the prosthesis of FIG. 1;
FIG. 3 is a cross section view of the prosthesis of FIG. 1 taken
along the line III--III.
The prosthesis of this invention is made up of an envelope or
container 10 having a back section 11 which is generally flat and
adapted to fit against the chest wall and a front section 12 that
generally resembles the shape of a human breast. The prosthesis can
be positioned beneath the mammary gland as shown in FIG. 1 as well
as being used as a substitute for breasts that have been removed.
This changes the configuration of the breasts but allows the wearer
to nurse in a normal way and does not interfere in any way with the
normal functioning of the mammary gland. The container 10 is made
of a material that has characteristics that resemble that of the
normal human breast such as softness and resiliency. The material
also must be of a type that does not cause tissue reaction with the
wearer. A suitable material for the prosthesis container is
silicone rubber made in accordance with the teachings of U.S. Pat.
No. 3,189,662.
The container is filled with a suitable material to give the
prosthesis the proper shape and resiliency. Silicone gel made in
accordance with U.S. Pat. No. 3,020,260 is a good example of the
type of material suitable for use in the prosthesis of this
invention. In the preferred embodiment the container is filled with
silicone rubber gels of varying density with the stiffest most
viscous gel filling the outer portion of the container and the less
viscous gels forming the next layers and center portion being
filled with the softest material.
A preferred gel for use in this invention is a liquid methyl
silicone resin capable of being vulcanized to an elastomer blended
with a dimethyl silicone fluid. A suitable fluid is General
Electric's "Viscasil" and an appropriate resin recommended for this
use is General Electric's elastomeric resin TRV 615. The proportion
of resin to fluid may vary from 1:1 to 1:10 in order to obtain the
proper gel consistency. The resin contains RzSiOz groups, RzSiO
groups and Si0z groups where R represents methyl groups. The ratio
of the groups one to the other determines the consistency of the
gel. Cross linking of the resin may be done by means of an addition
type reaction or by exposure to radiation. After mixing the resin
and fluid the combination may be injected into the prosthetic
container 10 and heated to initiate cross- linking (vulcanization)
of the resin. Heating time and temperature may be varied over a
wide range from several days at room temperature to 10 minutes at
over 300.degree. F. The gel consistency may be adjusted by any or
all of the following steps:
1 by altering the proportion of the various chemical groups in the
resin;
2. by altering the resin/fluid ratio;
3. by varying the viscosity of the fluid used;
4. by varying the radiation dosage.
It is desirable to fill the container before placing the prosthesis
in the body. However this is not always convenient. In the
illustrated prosthesis, the outer two layers 15, 16 are formed in
the container prior to placing the prosthesis in the human body.
There are many suitable techniques for filling the container well
known in the synthetic material art. For example, the outer section
of the container 10 is lined with an outer or more viscous layer 15
of gel which is allowed to set before the inner or second less
viscous layer 16 is placed in the container. As the gels "cure"
they are vulcanized to the inside of the container and adjacent
layers of gel to form an integral unit. Any desired number of
layers of gel may be used to form the prosthesis. The final portion
of the container may be filled with a quantity of gel 18 after the
prosthesis has been planted in the body. This may be done in any
number of suitable ways such as through the use of a hypodermic
needle inserted through the layers of gel into the center section
of the container. The gel is then forced into the container in a
sufficient quantity to give the breast the desired size and
configuration. After the container has been filled the ends of the
stem are folded over and sealed by suitable means. The stem is then
positioned underneath the prosthesis and the flesh sewed over the
prosthesis.
To provide a smooth contour of the skin over the prosthesis, the
edge of the container where the front and back portions are joined
is provided with a narrow rim 22 around its entire periphery. This
rim is solid rubber but is tapered to a very fine edge at the outer
periphery so as to blend in with the body. When skin is drawn over
the prosthesis it forms a smooth continuous surface and the
juncture of the prosthesis and the body cannot be noticed except
upon close scrutiny.
A suitable porous material 24 is connected to the back 11 of the
container 10 and attached to the body to anchor the prosthesis in
place. The material is porous to allow human tissue to grow in and
around the material to securely anchor the prosthesis to the chest
wall. A suitable material for this purpose is a fabric of polyester
fibers commonly sold under the trademark Dacron. The fabric is
preferably corrugated and is affixed to the back section of the
prosthesis by suitable glue that will not be absorbed or destroyed
by the body cells.
As shown in the drawings, the fabric material 24 extends across the
top and more than half way around the periphery leaving only the
bottom edge unattached to the chest wall. In this way the fabric
provides a more uniform support for the prosthesis so that it does
not tend to become disfigured or pull away from the chest wall due
to constant weight of the gel in the unsupported prosthesis. The
porous material or fabric extends to the outer edge 25 of the rim
22 of the container 10 so as to anchor the tip of the container rim
to the chest wall without forming a fold or ridge at the junction
between the prosthesis and the body.
* * * * *