U.S. patent number 3,665,520 [Application Number 05/078,863] was granted by the patent office on 1972-05-30 for surgically implantable breast prosthesis.
This patent grant is currently assigned to Medical Engineering Corporation. Invention is credited to Jacques Papillon, Colette Perras.
United States Patent |
3,665,520 |
Perras , et al. |
May 30, 1972 |
SURGICALLY IMPLANTABLE BREAST PROSTHESIS
Abstract
A surgically implantable breast prosthesis formed from a
flexible container having a front wall and a back wall; the front
wall having an outer shape approximately that of the human breast
and the back wall having a shape approximately that of the chest
wall. The container includes a prolongation extending angularly
outwardly toward the axilla region of the anatomy and overlying the
pectoral muscle. The container is filled with a silicone gel and a
fabric impregnated with the same material used to form the
container is secured to the back wall to increase the rigidity of
the back wall. A strip of Dacron felt is secured to the outer
periphery of the back wall around the axilla prolongation and a
small portion of the back wall of the container to support the
prosthesis by tissue ingrowth into the Dacron felt.
Inventors: |
Perras; Colette (Lacombe,
Montreal, CA), Papillon; Jacques (St. Lambert,
Montreal, CA) |
Assignee: |
Medical Engineering Corporation
(Racine, WI)
|
Family
ID: |
22146649 |
Appl.
No.: |
05/078,863 |
Filed: |
October 7, 1970 |
Current U.S.
Class: |
623/8; 450/38;
128/DIG.21 |
Current CPC
Class: |
A61F
2/12 (20130101); Y10S 128/21 (20130101) |
Current International
Class: |
A61F
2/12 (20060101); A61f 001/24 (); A41c 003/10 () |
Field of
Search: |
;3/36,1
;128/462,DIG.21 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
|
|
|
|
|
|
|
1,506,271 |
|
Nov 1967 |
|
FR |
|
1,506,272 |
|
Nov 1967 |
|
FR |
|
Primary Examiner: Gaudet; Richard A.
Assistant Examiner: Frinks; Ronald L.
Claims
We claim:
1. A surgically implantable breast prosthesis comprising,
a flexible container having a front wall and a back wall, said
front wall having an outer shape approximating that of the human
breast, and said back wall having an outer shape approximating that
of the chest wall,
said container including a prolongation formed by said back and
said front wall and extending angularly outwardly toward the
axillary region of the anatomy,
a silicone gel filling the inside of said container, and
means secured to the periphery of the back wall of said axillary
prolongation for permitting tissue ingrowth from the area of the
pectoral muscle.
2. The prosthesis according to claim 1 including means secured to
the inside of said back wall for maintaining the shape of the
prosthesis.
3. The prosthesis according to claim 1 including a polyester fabric
mesh impregnated with an organosiloxane copolymer secured to said
back wall of said container.
4. The prosthesis according to claim 1 including a polyester fabric
mesh impregnated with an organosiloxane copolymer secured to the
inside surface of the back wall of said container.
5. The prosthesis according to claim 1 wherein said back wall and
said front wall are formed as an integral unit having an arcuate
wall around the outer periphery of said container.
6. A surgically implantable breast prosthesis comprising,
a flexible container having a front wall and a back wall, said
front wall having a shape approximating that of the human breast,
said back wall having a shape approximating that of the chest
wall,
said container including an axillary prolongation,
a silicone gel filling the inside of said container, and
means for stiffening said back wall.
7. The prosthesis according to claim 6 wherein said stiffening
means comprises a polyester fabric.
8. The prosthesis according to claim 6 wherein said stiffening
means comprises a fabric mesh impregnated with an organosiloxane
copolymer prior to being attached to said container.
9. The prosthesis according to claim 6 including means secured to
the periphery of the back wall of said prolongation for promoting
tissue ingrowth to secure the prosthesis in position.
10. The prosthesis according to claim 6 wherein said container
includes a curved wall around the periphery of said container
formed integral with said front wall and said back wall.
11. A surgically implantable prosthesis comprising,
a flexible container molded from an organosiloxane copolymer and
having an axillary prolongation,
a silicone gel completely filling said container,
means attached to said container for stiffening the back portion of
said container, and
means secured to the periphery of said prolongation for promoting
tissue ingrowth.
12. The prosthesis according to claim 1 wherein said container is
formed with a curved wall around the periphery.
Description
BACKGROUND OF THE INVENTION
Gel-filled silicone rubber breast prostheses have been employed for
a number of years to maintain the natural appearance of the breast.
The most common breast prostheses of the gel filled type is shown
in U. S. Pat. No. 3,293,663 issued to T. D. Cronin on Dec. 27,
1966. This prosthesis included a flexible container having an outer
peripheral ridge and a fabric material secured to the back wall of
a flexible container to secure the container to the chest wall.
This prosthesis is implanted solely within the breast area of the
patient. It has been found, however, that due to the natural
tendency of the body to reject foreign objects, the prosthesis
tends to lose its shape often becoming distorted or out of place.
This tendency is due to the force exerted by the growth of scar
tissue around the implant. This scar tissue growth forces the edges
of the prosthesis to roll up or to be pushed away from the chest
wall, forming a ridge or bulge around the upper portion of the
breast.
SUMMARY OF THE INVENTION
The breast prosthesis of the present invention retains the natural
appearance of the breast by the inclusion of a prolongation on the
prosthesis which extends outwardly from the breast area towards the
axilla region of the anatomy. This prolongation when implanted in
the patent will overlie the pectoral muscle. This prosthesis is
held in position by a strip of felt material provided around the
periphery of the back wall of the prolongation and around a portion
of the back wall of the container. Tissue ingrowth is promoted only
in the region of the strip of material leaving the major portion of
the back wall free. Since the major portion of the back wall of the
prosthesis is now physiologically inert, the prosthesis has greater
freedom to follow the natural movements of the breast.
Distortion of the prosthesis by the force of the scar tissue is
minimized by a fabric material which has been pre-impregnated with
the polycarbonate material used to form the container and is
secured to the inside surface of the back wall of the container.
This fabric mesh increases the rigidity of the back wall with
sufficient force to counteract the forces of tissue ingrowth. The
fabric mesh extends across the entire back wall of the container
and also across the back wall of the prolongation.
Other objects and advantages will be apparent from the following
description when read in connection with the accompanying
drawings.
THE DRAWINGS
FIG. 1 is a front view of a portion of the anatomy showing the
approximate location of the prosthesis of this invention;
FIG. 2 is a front view of a prosthesis according to this invention
for implanting on the right side of the patient;
FIG. 3 is a back view of the prosthesis of FIG. 2; and
FIG. 4 is a section view taken on line 4-4 of the prosthesis of
FIG. 2 showing the position of the fabric mesh.
DESCRIPTION OF THE INVENTION
Referring to FIG. 1 of the drawing, the location of the prosthesis
10 is shown in position in the right upper torso of the anatomy 12.
The prosthesis 10 is so located that it follows generally the same
contour for the right side of the anatomy as shown for the normal
breast line 14 on the left side of the anatomy. The prosthesis 10
can be located behind the mammary gland of the patient to augment
the appearance of the breast but will not interfere with the
ability of the patient to nurse in the normal way, and does not
interfere in any way with the functioning of the mammary gland.
In accordance with the invention, the breast prosthesis 10 is
formed from a container 20 which is filled with a soft gel 22. The
container 20 is made of a material that has characteristics that
resemble that of the normal human breast, such as softness and
resiliency. The material must also be of a type which does not
cause tissue reaction after implantation. A suitable material for
the container 20 is an organopolysiloxane polycarbonate block
copolymer.
The container 20 is formed with a front wall 24 having the general
shape of a natural breast and a back wall 26 which follows the
contour of the chest. In this respect, the back wall 26 has a
generally concave appearance to fit comfortably against the chest
wall. The container 20 can be formed on a mold having the general
shape of the prosthesis. The mold is dipped in a liquid copolymer
and rotated to form the container on the outside of the mold. The
mold is repeatedly dipped and rotated to cure the copolymer until
the container has the desired wall thickness. The wall of the
container formed of this material has the same thickness and has
little, if any, rigidity, being very soft and very flexible in
compression but has great tensile strength. It should be noted that
the edge or peripheral wall 25 of the container is round or curved
as seen in FIG. 4.
The container 20 is formed with a prolongation 28 which is arranged
to extend outwardly from the breast area toward the axilla region
30 of the anatomy. The prolongation 28 should overlie the area 32
of the pectoral muscle 32 and should be tapered outwardly toward
the outer end. The axillary prolongation 28 follows the anatomical
contour of the anatomy, thus providing a more natural appearance
when implanted in the breast.
The container 20 is filled with the silicone gel 22 to give the
prosthesis the proper shape and resiliency. Silicone gel made in
accordance with U.S. Pat. No. 3,020,260 which issued on Feb. 6,
1962 and entitled, "Organosiloxane Potting Compound" is a good
example of a gel suitable for use in the prosthesis of this
invention. The 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
Electic'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 RzSiO-1/2 groups, RzSiO
groups, and SiOz groups, where R represents methyl groups. The
ratio of the groups one to the other determines the consistency of
the gel.
Means are provided in the backwall 26 of the container 20 for
stiffening or increasing the rigidity of the back wall in
compression and thereby resist the tendency of the container to be
deformed due to the force of the scar tissue. In this respect, it
has been found that the scar tissue ingrowth in the entire back
wall of a prosthesis as described in Cronin U.S. Pat. No. 3,293,663
tends to deform the prosthesis forcing the rigid edges of the
prosthesis outward. A bulge will eventually appear around the
periphery of the breast of the patient. This is prevented by means
of a bio-compatible fabric material 40 such as a polyester,
polypropylene or polyamide fabric in the form of a mesh which is
secured to the back wall 26 of the container 20. The fabric
material can be secured to the inside of the back wall or embedded
therein. Any suitable means can be used for securing the fabric to
the back wall, such as a silicone adhesive, or by heat sealing, or
by laminating with the copolymer.
The fabric material 40 can be initially impregnated with the
organosiloxane copolymer and cured to reduce the probability of
tissue ingrowth and to increase the rigidity of the mesh. The
impregnated mesh 40 can be secured to either the inside or outside
surface of the back wall of the container. Impregnating the mesh
with the copolymer will prevent tissue ingrowth if secured to the
outside of the container. The fabric mesh 40 thereby increases the
strength of the back wall in compression without increasing the
thickness of the container nor the strength of the front wall
24.
The prosthesis 10 is secured to the chest wall of the patient by
means of a strip 50 of felt-like material formed from a polyester
material such as Dacron which is provided around the periphery of
the axillary prolongation 28, and across the top portion of the
back wall 26 of the container. The strip of felt 50 limits the
amount of tissue ingrowth and at the same time provides sufficient
support to maintain the prosthesis 10 in position. The felt strip
50 is secured to the container by a silicone adhesive and is
provided only along the upper edges of the prosthesis. The
felt-like material limits the penetration of the adhesive to one
side of the strip leaving the other side free for tissue ingrowth.
The prosthesis is secured to the area of the pectoral musclealong
the upper portion of the container only since the normal forces
acting on the prosthesis are downward, thus leaving the major
portion of the back wall 26 free or unattached to the chest wall.
This arrangement for supporting the prosthesis in the breast allows
for a more natural amount of movement of the breast.
Another important feature of the present invention is the
elimination of any ridge or bulge around the prosthesis 10 which
can be seen or felt after the prosthesis has been implanted in the
patient. This has been achieved by forming the container as an
integral unit having a curved wall or edge 25 between the front and
back walls. Since the container material has no compressive
strength and is very thin, the edge 25 will collapse when touched
and cannot be felt through the skin of the patient.
RESUME
The prosthesis of this invention includes a number of important
features which have not previously been available in a breast
prosthesis. The most important of these features is the axillary
prolongation which tapers outwardly toward the axilla region of the
patient. This prolongation provides a more natural appearance to
the prosthesis after implant. The felt strip which is used to
support and maintain the implant in position allows for greater
freedom of movement of the prosthesis again providing a more
natural appearance. The curved edge provided between the front wall
and back wall of the container has eliminated the bulge or ridge
which generally occurs around the prosthesis. The fabric material
secured to the back wall of the container has increased the
strength or rigidity of the back wall of the container 20 so that
the prosthesis does not become distorted after implant.
* * * * *