U.S. patent number 3,883,902 [Application Number 05/428,396] was granted by the patent office on 1975-05-20 for variable volume prosthetic assembly.
This patent grant is currently assigned to Medical Engineering Corporation. Invention is credited to Henry W. Lynch.
United States Patent |
3,883,902 |
Lynch |
May 20, 1975 |
Variable volume prosthetic assembly
Abstract
A surgically implantable variable volume prosthetic assembly
including a first flexible implantable prosthesis having an outer
shape approximating that of the human breast, a second flexible
container or reservoir having a volume greater than the volume of
the first prosthesis with a silicone gel completely filling the
reservoir and means for sealingly connecting the reservoir to the
prosthesis, the reservoir being squeezed to force the gel into the
prosthesis after implantation, the connecting means can be severed
and sutured to the back of the prosthesis or a valve can be
provided in the connecting means to seal the reservoir and implant
during storage and after inflation.
Inventors: |
Lynch; Henry W. (Racine,
WI) |
Assignee: |
Medical Engineering Corporation
(Racine, WI)
|
Family
ID: |
26960738 |
Appl.
No.: |
05/428,396 |
Filed: |
December 26, 1973 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
|
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281150 |
Aug 16, 1972 |
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Current U.S.
Class: |
623/8;
128/DIG.21; 450/38 |
Current CPC
Class: |
A61F
2/12 (20130101); Y10S 128/21 (20130101) |
Current International
Class: |
A61F
2/12 (20060101); A61f 001/00 (); A61f 001/24 ();
A41c 003/10 () |
Field of
Search: |
;3/36,1,20
;128/462,DIG.20,349B,594,595,230,232,DIG.21 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Frinks; Ronald L.
Attorney, Agent or Firm: Barry; Ronald E.
Parent Case Text
RELATED APPLICATION
This application is a continuation-in-part of my copending
application entitled "Variable Volume Prosthetic Assembly", U.S.
Ser. No. 281,150, filed Aug. 16, 1972, and now abandoned.
Claims
I claim:
1. A closed system variable volume prosthetic assembly
comprising:
a first flexible container adapted to be implanted in the body,
a second flexible container having a volume greater than the volume
of said first container,
a silicone gel completely filling said second container,
a tube sealingly connecting said second container to said first
container whereby said gel can be squeezed from said second
container into said first container after implantation of said
first container and said assembly can be autoclaved prior to
implant without contaminating the gel,
and valve means within said tube for movement to a position closing
the tube after the gel has been forced into said container.
2. The assembly according to claim 1 wherein said valve means
comprises an enlarged section connected to one end of said tube and
a plug positioned in said enlarged section and being movable into
said tube for blocking the tube.
3. A closed variable volume prosthetic assembly comprising:
a shell having the shape of a part of the body to be replaced,
a reservoir having a volume at least equal to the volume of said
container,
a medical grade gel filling said reservoir,
tube means connecting said reservoir to said shell to form a closed
completely sealed container for transporting and storing said
gel,
and valve means in said tube means for closing said tube means
after the gel has been forced into said shell whereby said assembly
can be autoclaved prior to use and said reservoir can be squeezed
to force the gel from said reservoir into said shell after the
implantation.
4. The assembly according to claim 3 wherein said valve means
includes a plug in said tube means, said plug having a head for
closing said container after implant and an enlarged member for
closing said tube after removal from said container.
5. The assembly according to claim 4 wherein said plug includes a
reduced diameter section between said head and enlarged member to
indicate the cut off line for said tube.
6. A sealed variable volume prosthetic assembly comprising:
a flexible container adapted to be implanted in the body,
a flexible reservoir having a volume greater than the volume of
said container,
a medical grade gel filling said reservoir,
tube means for sealing said reservoir to said container whereby
said gel can be squeezed from said reservoir into said container
after implantation of said container in the body,
and plug means in said tube means for closing said container and
said reservoir after separating the reservoir from the
container.
7. The assembly according to claim 6 wherein said tube means
includes a first tube having one end sealed to said container and a
second tube having one end connected to said reservoir and the
other end to said first tube so that said plug means can be moved
through said first tube to close said container.
8. The assembly according to claim 7 wherein said closing means
comprises a plug having a head for sealing the container and a
second portion for sealing the tube.
9. The assembly according to claim 7 wherein said first tube
includes an open enlarged diameter section at said one end disposed
within said container and a closed enlarged diameter section at the
said other end, and said plug means is disposed in said tube for
movement into said closed section, said plug means being movable
through said tube into the open section in the container.
10. The assembly according to claim 9 wherein said plug means
includes a head for closing the open section and an enlarged
diameter member for closing said tube.
Description
BACKGROUND OF THE INVENTION
Implantable prostheses of the type shown in U.S. Pat. No.
3,665,520, entitled "Surgically Implantable Breast Prosthesis" are
prefilled to the desired shape with a silicone gel. In order to
implant a prosthesis in the body, it is necessary to make an
incision of a length sufficient to insert the prefilled prosthesis
through the incision into the body. Once implanted, the volume of
this prosthesis could not be changed without removing the
prosthesis. Empty flexible containers have been implanted in the
body and subsequently filled by injecting liquids or a gel into the
container. However, difficulties have been encountered in inserting
silicone gels into the containers having the required viscosity.
The equipment required to fill this type of implant is also more
complicated, increasing the difficulty in maintaining operating
room standards.
SUMMARY OF THE INVENTION
The variable volume prosthetic assembly of the present invention
overcomes the above problems by using a closed system which
includes a reservoir for storing the gel attached to an empty
container. The silicone gel is thus sealed into the closed system
at the point of manufacture. The entire system can be shipped ready
for use and autoclaved at the point of manufacture. The flexible
container for the prosthesis can be implanted empty in a rolled up
or flattened condition and therefore can be inserted into a much
smaller incision. Once the empty prosthesis has been implanted, it
is a simple step to squeeze the reservoir to force the silicone gel
from the second container into the prosthesis. The second container
is connected to the first container by a tube which is secured and
sealed to the two flexible containers. Once the first or implanted
container has been filled to the desired fullness, the tube can be
tied and cut, folded over and tied, and then sutured to the back of
the flexible container. This closed system eliminates the necessity
of using additional equipment to insert the gel into the prosthesis
after implanting and as a consequence simplifies the entire
operation. The tube can also be provided with a valve or plug for
automatically sealing the container and reservoir during storage
and after implanting the container in the body.
DRAWINGS
FIG. 1 is a plan view of the back of the prosthetic assembly of
this invention;
FIG. 2 is a side view of the invention showing the tubular
connection between the prosthesis and the reservoir;
FIG. 3 is a view of the prosthesis and the reservoir after the gel
has been forced into the prosthesis;
FIG. 4 is a partial view of the prosthesis showing the prosthesis
after the tubular connection has been sealed and folded against the
back of the prosthesis;
FIG. 5 is a side view of the invention showing a one-way check
valve at the end of the connector tube;
FIG. 6 is an alternate embodiment of the invention wherein a plug
or valve is used to close both the container and reservoir;
FIG. 7 is a view similar to FIG. 6 showing the connecting tube cut
off and the valve cut off to seal both the container and the
reservoir; and
FIG. 8 is a view of the plug.
DESCRIPTION OF THE INVENTION
The implantable prosthetic assembly 10 of the present invention as
seen in FIG. 1 includes a first flexible container or shell 12 and
a second flexible container or reservoir 14. The containers 12 and
14 are connected by means of a tube 16 which is formed as an
integral part of the two containers 12 and 14. The second container
14 is filled with a silicone gel 18 and the entire assembly
autoclaved at the time of manufacture. The silicone gel 18 is
transferred to the implanted shell 12 by squeezing the reservoir 14
to force the silicone gel 18 into the shell 12.
The first container or shell 12 is formed from an implantable
material such as an organopolysiloxane compound as set forth in
U.S. Pat. No. 3,665,520 or from a silicone rubber such as General
Electric Elastomeric Resin 7000. The G. E. Elastomer resin contains
R.sub.2 SiO.sub.1/2 groups, and small amounts of vinyl R.sub.2 SiO,
where R represents methyl groups. This elastomer is known to have
characteristics such as softness and resiliency that can be
controlled to approximate that of the human body. The container 12
can be made to approximate any shape and as shown is formed with a
front surface 11 having the general shape of a natural breast and a
back surface 22 which is shaped to follow the general contour of
the chest wall.
The second container or reservoir 14 can be formed from the same
material as the first container 12 or from a medical grade material
such as silicone polycarbonate copolymer. The reservoir 14
preferably has a volume equal to or greater than the volume of the
first container 12. If desired, graduations 24 can be provided on
the surface of the reservoir 14 to indicate the amount of silicone
gel 18 available to be forced into the prosthesis 12.
The second container 14 is filled with the silicone gel 18 such as
set forth in U.S. Pat. No. 3,665,520. As an example, a gel
containing a major component of R.sub.2 SiO, a minor component of
vinyl R.sub.2 SiO.sub.1/2 and small amounts of R vinyl R.sub.2 SiO
and R.sub.3 SiO.sub.1/2 has been used successfully. Other gels
approved for medical use can be used if desired.
The reservoir 14 and shell 12 can be rotationally cast on a mold of
the required shape. The mold is dipped in the liquid elastomer and
rotated to form the reservoir or container on the outside of the
mold. The mold is repeatedly dipped and rotated to cure the
elastomer until the assembly has the desired wall thickness. The
wall of the containers 12 and 14 formed of this material has little
if any rigidity and is very soft and flexible in compression but is
known to have a tensile strength satisfactory for this use.
The two containers 12 and 14 are interconnected by means of a tube
16. In this regard, the tube 16 is provided at one end with a
flange 17 which is connected to the inside of the container 12. The
other end of the tube 16 is bonded to an opening 15 provided in the
reservoir 14. The tube 16 can be reinforced with a fabric 19 such
as Dacron or nylon if desired.
The shell 12 is implanted by inserting the shell 12 through a small
incision in the patient. The shell can be rolled up and inserted as
a tube and the unrolled after implanted or inserted flat, whichever
is preferred. The second container or reservoir 14 as seen in FIG.
3 is then squeezed or rolled to force the gel 18 from the reservoir
14 through the tube 16 into the shell 12 to fill the prosthesis.
The amount of silicone gel 18 forced into the prosthesis can be
determined by observing the graduations 24 provided on the wall of
the reservoir 14 and also observing the extent of expansion of the
body. After the prosthesis 12 has been filled to the desired size,
the tube 16 is tied off with a surgical thread 26. The tube is then
cut at 28 to remove the reservoir. The remaining portion of the
tube is then folded at the tie thread 26 and sutured or tied by
means of a thread 27 to hold the tube in place on the back 22 of
the prosthesis 12 as seen in FIG. 4. It should be noted that during
this entire procedure, the silicone gel 18 is sealed in the
reservoir and is never exposed to the atmosphere and will remain
sterile during the entire operation.
Referring to FIG. 5, means are shown for preventing back flow of
gel from the first container 12 to the second container or
reservoir 14. Such means is in the form of a one-way valve 30
provided at the end of the tube 16 and within the first container
12. The one-way valve shown is a duck bill type valve having upper
and lower resilient flaps 32 and 34 extending into the container
12. The valve 30 allows for the admission of gel into the container
12 but will prevent back flow of gel from the container 12.
Referring to FIGS. 6 and 7, an alternate embodiment of the
invention is shown which includes means for sealing the container
12 from the reservoir 14 and for closing both the container and
reservoir after implant. In this embodiment, a resilient tube 40
made of medical grade material is shown having one end 42 sealed to
the reservoir 14 by means of a transverse tube 45 and the other end
44 sealed directly to the opening 47 in the container 12. In this
regard, the end 44 is provided with a flange 46 which extends
radially outwardly from the tube 40 and is sealed by means of a
suitable adhesive to the wall of the conainer 12. An enlarged
diameter section 48 is provided within the container 12 at the end
44 of the tube 40. The enlarged diameter section 48 includes an
opening 50 at the inner end to allow for the flow of gel through
the section 48 into the container. The other end of the tube 40 is
closed by means of enlarged section 54.
The tube 40 is closed or blocked by means of a plug 32 which is
normally located in tube 40 to prevent gel from flowing in the
container 12 during storage. The plug 56 is moved into the closed
enlarged section 54 formed on the end 42 of the tube 40 after the
container 12 has been implanted to allow for the flow of gel from
the reservoir into the container.
The plug 52 includes a head 56 having an outer diameter
substantially equal to the inner diameter of the section 48, body
58 having a diameter substantially equal to the diameter of the
tube 40 and an enlarged member 57 having a diameter substantially
equal to the diameter of the head 56. A slot or groove 60 is
provided in the body 58 to form a reduced diameter cut-off section
59 between the body 58 and member 57. The body 58 should have a
length long enough to extend beyond flange 46 when the head 56 is
seated in the section 48. The slot 60 is used as a guide to
determine the location of the point-of cut-off of the tube 40 and
to simplify cutting the plug by providing the reduced diameter
cut-off section 59.
In regard to this last, after the implant 12 has been filled with
the gel, the plug 52 is moved from the section 54 through the tube
40 by squeezing the section 54 and tube 40 behind the plug 12. The
gel acts as a lubricant and allows the plug 52 to slide freely into
the section 48. The head 56 of the plug 52 will fit snugly within
section 48 blocking the flow of gel from the reservoir. The tube 40
and reduced section 59 are then cut at the slot 60. The section 57
remaining in the tube 40 will act as a plug preventing any gel in
the tube 40 from flowing out of the tube 40 after the reservoir 14
has been removed.
Resume
The variable volume prosthetic assembly of this invention provides
a simple sterile method for implanting a prosthesis. Once filled,
the reservoir and container can be stored and shipped without any
fear of contamination. The incorporation of a self-sealing valve or
plug into the tube eliminates the possibility of any gel escaping
from the implant. After the container or shell has been implanted,
the shell can be filled to the extent required to fill out the
portion of the anatomy to be augmented. Although prostheses of the
type disclosed herein are more commonly used as a breast
prosthesis, the prosthesis or container can also be used in other
parts of the body either as a replacement or augmentation
prosthesis.
* * * * *