U.S. patent number 3,600,718 [Application Number 04/888,795] was granted by the patent office on 1971-08-24 for inflatable prosthesis.
This patent grant is currently assigned to Dow Corning Corporation. Invention is credited to Jack L. Boone.
United States Patent |
3,600,718 |
Boone |
August 24, 1971 |
INFLATABLE PROSTHESIS
Abstract
An improved surgically implantable mammary prosthesis comprising
an inflatable shell and a filling stem for said shell for
introduction of a filling fluid to inflate the shell. At the point
of introduction of the stem into the shell, there is provided a
capsule of sealing gel through which the stem passes. After
implantation and inflation, the stem is withdrawn either wholly or
partially and the gel in the capsule seals the stem outlet against
leakage of the inflating fluid. The inflation system is also
suitable for prostheses other than mammary prostheses.
Inventors: |
Boone; Jack L. (N/A, MI) |
Assignee: |
Corporation; Dow Corning
(MI)
|
Family
ID: |
25393911 |
Appl.
No.: |
04/888,795 |
Filed: |
December 29, 1969 |
Current U.S.
Class: |
623/8; 137/223;
141/313; 450/38; 128/DIG.21; 141/329 |
Current CPC
Class: |
A61F
2/12 (20130101); Y10T 137/3584 (20150401); Y10S
128/21 (20130101) |
Current International
Class: |
A61F
2/12 (20060101); A61F 001/00 (); A61F 001/24 ();
A41C 003/10 () |
Field of
Search: |
;3/1,36 ;128/462,DIG.21
;137/223 ;141/313,329,330 ;273/65C,65D ;46/87,90 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Gaudet; Richard A.
Assistant Examiner: Frinks; Ronald L.
Claims
That which is claimed is:
1. In an inflatable prosthetic device for replacing a body part or
supplementing a body contour comprising a collapsible closed shell
and a filling stem for introducing fluids into said shell, the
improvement which comprises:
said filling stem having at least one exit port therein and being
mounted in a manner such that it is freely slideable into and out
of the volume bounded by said shell to position said exit port in
communication with said shell volume and
a body of viscous jellylike material affixed to said shell and
surrounding said filling stem at the point where said stem passes
through the shell wall into the volume bounded by said shell
whereby said viscous material flows to seal at least the exit port
when the stem is withdrawn to the point where the exit port is
surrounded by said viscous material.
2. The invention as defined in claim 1 wherein said body of viscous
material is confined in a capsule having a thin flexible wall which
is adhered to the interior surface of said shell surrounding the
point of introduction of said stem into the volume bounded by said
shell, said stem protruding into said volume beyond the innermost
wall of said capsule and being freely slideable with respect
thereto.
3. The invention as defined in claim 2 wherein fibrous
reinforcement is provided on said capsule wall surrounding the
point of entry of said stem from said capsule into the volume
bounded by said shell.
4. The invention as defined in claim 2 wherein the inner
termination of said stem is sealed and is provided with a limiting
flange to prevent said stem from being pulled completely from said
shell;
said exit port in said stem being located in the sidewall of said
stem and said flange being designed to rest against the wall of
said capsule when said stem is withdrawn to its limiting
position.
5. The invention as defined in claim 1 wherein said inflatable
prosthetic device is a mammary prosthesis.
6. The invention as defined in claim 5 wherein said mammary
prosthesis is made from a suitable physiologically inert material
adapted for surgical implantation within the human breast.
Description
BACKGROUND OF THE INVENTION
The present invention relates to improvements in prostheses for
implanting within or replacement of parts of the human body and
more particularly is designed for use in mammary or breast
prostheses.
There are two known general types of breast prostheses. The first
type is worn externally in some type of brassiere arrangement and
is generally employed when breasts or portions thereof have been
removed by surgery. A second type involves a prosthesis for
insertion into the breasts in order to change the contour thereof.
This type is generally used for cosmetic purposes and it is to this
type prosthesis that the present invention primarily relates,
although it may also be used with the former type.
It is known, for example, from U.S. Pat. No. 2,842,775 issued to W.
J. Pangman, and from U.S. Pat. No. 3,416,160 issued to H. G. Arion,
that a prosthesis may be made utilizing a collapsible closed shell
and a filling stem for introducing fluids into the shell to inflate
the prosthesis. When used in a surgically implantable prosthesis,
the inflation technique allows the use of a relatively small
incision to introduce the prosthetic device. After insertion of the
device, the shell is inflated by means of a suitable fluid such as,
for example, a normal saline solution or a liquid silicone
material. The inflation may be accomplished to the extent desired
depending on the design of the device and the desired effect. The
inflatable type of device has advantages particularly in cases in
which the normal breasts are not of equal contour. It should be
understood, however, that this type of device is not limited to
such patients.
To the best of applicant's knowledge, in all prior art inflatable
prostheses of this type, it is necessary that the filling stem
provided on the inflatable shell be provided with some means of
sealing to prevent leakage of fluids from the shell after
inflation. A common practice has been to provide either a plug for
the filling stem as suggested in the aforementioned patent to Arion
or to simply tie off the filling stem with a ligature.
This type of sealing suffers from certain disadvantages. First of
all, it is difficult to insure against leakage in such situations
since the tube which acts as the filling stem is generally of
rather small diameter. Secondly, the closure must remain patent
throughout the life of the device; yet since it is in contact with
the human body, it must be of a material which does not introduce
tissue reaction and which is not attacked by the tissues. The
filling stem is presently available prostheses of this type is
palpable after implantation of the device. In many cases,
therefore, it is desirable to remove the filling stem after the
device is in place. With those prostheses presently available, this
can be accomplished only by cutting off the stem. Since sealing is
required, however, at least a short nipple, which may still be
palpable after implantation, must remain to provide adequate
sealing either by means of plugging or ligating. It is toward these
problems of the prior art to which the present invention is
directed.
It is also known that implants of silicone rubber or other
materials can be used, for example to fill depressions and for
performing other functions. In some of these applications,
inflatable devices can also be used and the present invention is
directed as well toward such use.
BRIEF DESCRIPTION OF THE INVENTION
It is a primary object of the present invention, therefore, to
provide an improved inflatable prosthesis usable either as a
surgical implant or as an external prosthesis which provides
sealing means not plagued by the problems inherent in prior art
devices. In accordance with this and other objects there is
provided by the present invention a mammary prosthesis comprising a
collapsible closed shell and a filling stem for introducing fluids
into the shell. The filling stem is mounted in a manner such that
the exit port of the filling stem is freely slideable into and out
of the volume bounded by the shell. A body of viscous jellylike
material is affixed in the shell and surrounds the filling stem at
the point where the stem passes through the shell wall into the
volume bounded by the shell. The viscous material flows to seal at
least the exit port of the filling stem when the stem is withdrawn
to the point where the exit port is surrounded by the viscous
material. If desired, the stem may be completely withdrawn from the
shell and the viscous material flows to close the hole through
which the stem passed into the shell interior. Similarly the same
filling system can be applied to other types of prostheses and
other implantable devices.
BRIEF DESCRIPTION OF THE DRAWINGS
Other objects and attendant advantages of the invention will become
understood by those skilled in the art from a consideration of the
following detailed description when read in conjunction with the
accompanying drawings wherein:
FIG. 1 is a view in cross section of a mammary prosthesis made in
accordance with the present invention;
FIG. 2 is a rear elevational view, with portions cut away, of the
prosthesis illustrated in FIG. 1;
FIG. 3 is a fragmentary, cross-sectional view of the sealing device
which constitutes the improvement of the present invention and
which is illustrated in less detail in FIGS. 1 and 2; and
FIG. 4 is a fragmentary view similar to FIG. 3 showing a
modification of the invention.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
Referring now to the drawings wherein like reference characters
designate like or corresponding parts throughout the figures
thereof, there is shown in FIG. 1 a surgically implantable
inflatable mammary prosthesis comprising a collapsible closed shell
11 and a filling stem 12 for introducing fluids into said shell.
The shell 11 desirably conforms substantially to the shape of the
human breast when inflated by a suitable fluid such as normal
saline solution or a silicone gel such as that described in U.S.
Pat. No. 3,293,663 issued Dec. 27, 1966, to Thomas D. Cronin. The
specific fluid used forms no part of the present invention as
such.
As known to those skilled in the art, the shell 11 may, if desired,
have affixed to the back thereof a plurality of patches 13 of
polyester fabric material, or the like, for ingrowth of tissue to
anchor the device to the chest walls. Alternatively, an open cell
foam type material or other fixation devices may be substituted for
this purpose. The patches are affixed to the back by means of
suitable adhesive materials, which of course must be
physiologically inert. It should be understood that the device need
not have tissue anchoring means at all if desired.
In accordance with the present invention, the filling stem 12
enters the volume defined by the shell 11 through a hole in the
shell. The stem 12 is made freely slideable into and out of the
shell for reasons which will become more fully understood after the
reader considers the operation of the device. Affixed to the
interior of the shell 11 at the point of entry of the filling stem
12 into the shell 11, there is provided a body of viscous jellylike
sealant material 14 through which the stem 12 passes. The sealing
material 14 is preferably enclosed in a capsule 16 of a thin
flexible material such as silicone rubber. The capsule is adhered
to the interior of the shell 11 by means of a suitable adhesive
material. Preferably, there is provided at the points of entrance
and exit of the filler tube 12 through the capsule 16 a layer of
fabric reinforcing material 17 and 18, respectively which will be
seen more clearly from FIG. 3.
FIG. 3 shows an enlarged fragmentary portion of the device of FIGS.
1 and 2 and illustrates particularly details of the sealing
capsule. The reinforcing material 17 and 18 is provided to prevent
tearing of the capsule 16 as the filler stem 12 slides through the
capsule. In a preferred embodiment, the viscous jellylike material
14 contained in the capsule is a silicone gel of the type defined
in the aforementioned patent to Cronin. More specifically,
exemplary gels are described in U.S. Pat. No. 3,020,260 or can be
made in other ways such as, for example, by injecting a mixture of
hydroxylated siloxane and ethyl silicate into the capsule along
with a suitable catalyst such as stannous octoate. The fluid will
then set in place forming a soft flowable gel.
In operation, the device is inflated by the introduction of the
filling fluid through the filling stem 12 and out of the exit ports
19, 21 and 22 at the terminal portion thereof. When the device has
been inflated sufficiently to produce the desired contours and
breast firmness, the filling stem 12 is simply pulled back through
the shell wall 16 until at least the exit ports 19, 21, and 22 are
within the body of viscous jellylike material 14 which flows to act
as a seal against leakage to the outside of the fluid contained
within the shell 11. If desired, the filling stem 12 can be
completely withdrawn and the sealing gel 14 prevents leakage of the
liquid filler material of the prosthesis through the hole in the
shell 11 which was formerly occupied by the filling stem 12.
Thus, there is no need for plugging or attempting to ligate the
filling stem 12. The fluid is simply retained within the device by
a withdrawal motion. In some instances, it may be desired to leave
the filling stem patent for introduction of additional fluid at a
later time. In such circumstances, a modification such as that
shown in FIG. 4 is desirable. In the embodiment of FIG. 4, the
terminal end 22 of the filling stem 12 is sealed and a flange 23 is
mounted thereon. The flange 23 acts as a limit stop to prevent
total withdrawal of the filler stem 12 from the device. The stem 12
is withdrawn until the flange 23 abuts the surface of the capsule
16 or the reinforcement material 18 affixed thereto. At this point,
the exit ports 19 and 21 which are spaced from the termination of
the stem and the flange 23, are completely engulfed by the viscous
material 14 which acts to seal them. Should additional fluid need
to be injected at a later time, the stem 12 is again pushed into
the device to the point that the exit ports 19 and 21 are in
communication with the liquid confined by the shell 11. Additional
liquid can then be injected into the device or removed from the
device and the stem 12 again withdrawn.
While the invention has been specifically described in relation
with an inflatable mammary prosthesis, it will be understood by
those skilled in the art that the same principles can be applied to
other types of inflatable devices. For example, other types of
surgical implants can be made in a similar manner by shaping the
shell to provide the desired contours.
Obviously, many other modifications and variations of the invention
will become obvious to those skilled in the art from a
consideration of the foregoing. Therefore, it is to be understood
that the invention may be practiced otherwise than as specifically
described.
* * * * *