U.S. patent number 3,919,724 [Application Number 05/477,307] was granted by the patent office on 1975-11-18 for implantable prosthesis having a self-sealing valve.
This patent grant is currently assigned to Medical Engineering Corporation. Invention is credited to Henry W. Lynch, David H. Sanders, Sennen Uy.
United States Patent |
3,919,724 |
Sanders , et al. |
November 18, 1975 |
Implantable prosthesis having a self-sealing valve
Abstract
An implantable breast prosthesis including a flexible container
formed from a medical grade of silicone elastomer, a self-sealing
valve provided on the inside surface of the container, the valve
being formed of a self-sealing gel and including sufficient barium
sulfate, bismuth subcarbonate or tantalum powder so that the valve
is radiopaque for easy location after implanting in the body, and
an injection assembly for inflating the container with a fluid
after implantation in the body, said assembly including a catheter
for penetrating the valve and a syringe for injecting into or
removing fluid from the container through the catheter, the fluid
comprising either a saline solution or a gel. The self-sealing gel
can also be used as a valve for a catheter or in a fistula for
hemodialysis.
Inventors: |
Sanders; David H. (Deerfield,
IL), Lynch; Henry W. (Racine, WI), Uy; Sennen
(Racine, WI) |
Assignee: |
Medical Engineering Corporation
(Racine, WI)
|
Family
ID: |
23895383 |
Appl.
No.: |
05/477,307 |
Filed: |
June 7, 1974 |
Current U.S.
Class: |
623/8;
604/175 |
Current CPC
Class: |
A61F
2/12 (20130101); A61F 2250/0098 (20130101) |
Current International
Class: |
A61F
2/12 (20060101); A61F 2/00 (20060101); A61F
001/24 (); A41C 003/10 () |
Field of
Search: |
;3/1,36
;128/349B,349BV,214R,2R,DIG.25 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Frinks; Ronald L.
Attorney, Agent or Firm: Barry; Ronald E.
Claims
We claim:
1. An implantable prosthesis comprising a flexible container having
the shape of a breast, a self-sealing valve provided on the inside
surface of said container, a shell formed from a flexible medical
grade material, a self-sealing gel completely filling said shell, a
radiopaque material being combined with said gel, a fluid in said
container, and means for injecting and withdrawing said fluid
through said valve into or out of said container said radiopaque
material being selected from the group consisting of barium
sulfate, bismuth subcarbonate and tantalum.
2. The prosthesis according to claim 1 wherein said fluid is a
saline solution.
3. An implantable breast prosthesis comprising a flexible container
having the shape of a human breast, a self-sealing valve provided
on the edge of the inside surface of the container, said valve
including a shell of organosiloxane copolymer material, a
self-sealing gel completely filling said shell and a radiopaque
material wherein said valve can be located by X-ray after
implantation, and a saline solution completely filling said
container.
4. A self-sealing valve for admitting gaseous and fluid mediums
into an implantable breast prosthesis after implantation of the
prosthesis in the human body, said valve including a shell formed
from a flexible medical grade material, a self-sealing gel filling
said shell and a radiopaque material combined with said
self-sealing gel.
Description
BACKGROUND OF THE INVENTION
Implantable breast prostheses of the type disclosed in U.S. Pat.
No. 3,293,663, issued Dec. 27, 1966 to Thomas D. Cronin entitled
"Surgically Implantable Human Breast Prosthesis" and U.S. Pat. No.
3,665,520, issued May 30, 1972 to Colette Perras et al. for "Breast
Prosthesis", include flexible containers prefilled with a silicone
gel. These prostheses are then inserted into the body through an
opening which must be of sufficient size to accommodate the
prefilled prosthesis. The more recent type of prosthesis does not
include any tissue fixation material on the outer surface and after
implantation in the body is free to move within the fibrous capsule
that forms around the implant. This presents problems in an
inflated type implant because of the difficulty in trying to locate
the inflation plug or valve.
SUMMARY OF THE INVENTION
The breast prosthesis of the present invention is designed to be
filled after being implanted in the body. By inflating the
prosthesis after insertion into the body a smaller incision is
required. The prosthesis is provided with a valve or plug formed of
a self-sealing gel which can be radiopaque. The prosthesis is
filled by injecting a fluid, either saline solution or gel, through
a catheter which has been inserted through the self-sealing plug.
After filling the prosthesis, the incision is closed and allowed to
heal. After the incision has healed and the fibrous capsule has
formed around the implant, it may become necessary to either
increase or decrease the amount of fluid within the container. By
providing a radiopaque valve on the implant, the valve can be
quickly and easily located. The fluid within the container can be
increased or decreased without making any incision in the body.
The self-sealing valve can also be used in catheters for injecting
a gaseous medium into the secondary lumen for a cuff. In a further
application, the self-sealing plug or valve can be embedded in the
wall of a fistula used for hemodialysis work.
Other objects and advantages of the present invention will become
more readily apparent from the following description when read in
conjunction with the drawings, in which:
FIG. 1 is a top view of the breast prosthesis of this invention
showing the location of the radiopaque self-sealing valve;
FIG. 2 is a view of the breast prosthesis in the uninflated and
rolled up condition ready for insertion into the body;
FIG. 3 is a view of the portion of the breast prosthesis which
protrudes from the body after being partially inserted showing the
penetration of the valve by a catheter and needle;
FIG. 4 is a view similar to FIG. 3 showing the catheter with the
needle removed and a syringe connected to the catheter for
inflating the implant;
FIG. 5 is a partial view in section of the prosthesis showing the
self-sealing valve;
FIG. 6 is a cross sectional view of a catheter showing the
self-sealing plug in the lumen for the cuff; and
FIG. 7 is a schematic view of a fistula for hemodialysis showing
the self-sealing plug embedded in the wall of the fistula.
DESCRIPTION OF THE INVENTION
Referring to the drawing, the breast prosthesis 10 of this
invention as shown in FIG. 1 includes a flexible container 12 and a
self-sealing valve or plug 14. The container 12 is formed from a
medical grade of silicone elastomer such as MEC 127 although an
organo siloxane copolymer of the type as set forth in U.S. Pat. No.
3,665,520 can also be used. The container material should have low
modulus, but high ultimate tensile and tear strengths.
In accordance with the invention, the valve or plug 14 is located
on the inside wall of the container 12 and preferably on the lower
end of the container or on the center of the front of the
container. As seen in FIG. 1, the valve 14 is located at the lower
end of the container 12. A prosthesis having the valve 14 located
in this position would normally be inserted into the breast through
a small incision made at the perimeter of the breast. If the
prosthesis is implanted through the periareola of the breast, the
valve 14 should be located in the center of the prosthesis.
The valve 14 includes a shell 16 made of the same material as used
for making the container 12. The shell 16 is filled with a silicone
gel 18 of the type set forth in U.S. patent application Ser. No.
428,396, filed on Dec. 26, 1973 and entitled "Variable Volume
Prosthetic Assembly". The gel has a slightly higher penetrometer
reading so that it will be self-sealing on penetration by a needle.
The valve 14 is bonded to the inside wall of the container.
Means can be provided for locating the valve after implanting in
the body. Such means is in the form of a radiopaque material which
is added to the gel. In the preferred embodiment, barium sulfate is
added to the gel prior to filling the shell 16. The addition of up
to 5% by weight of barium sulfate, bismuth subcarbonate or powdered
tantalum, to the gel is sufficient for this purpose.
In use, the breast prosthesis 10 is rolled up as shown in FIG. 2,
with the self-sealing valve 14 located at one end of the implant
10. The valve 14 should be at approximately a right angle to the
axis of the rolled up container 12. The prosthesis 10 is left in
the rolled up form for implantation.
The prosthesis 10 in the rolled up condition is partially inserted
under the breast leaving the valve 14 protruding or exposed, as
seen in FIG. 3. A catheter 20 having a needle 22 extending through
the center of the catheter is used to pierce the valve 14. The
valve 14 should be pulled slightly away from the body to elongate
the container and assure that a cavity 24 is formed within the
container behind the valve 14. The valve 14 is penetrated by the
needle 22 to allow the catheter 20 to penetrate the valve 14. By
pushing the valve 14 away from the body, the tip of the needle 22
will not pierce the wall of the container 12.
The prosthesis 10 is filled by removing the needle 22 from the
catheter 20 and connecting an extension tube 26 for a syringe 30 to
the catheter. The valve 14 for the prosthesis 10 is then pushed
completely into the body. After the valve 14 has been inserted
completely into the body, the prosthesis is filled with a saline
solution or a silicone gel to the desired volume. The flow of the
solution into the prosthesis can be controlled by a hand valve 28
provided in the extension tube 26.
After implantation the prosthesis may roll within the cavity in the
body. If it is desired to either enlarge or deflate the prosthesis,
the valve can be located by X-ray. After the valve has been located
the saline solution or gel can be either added to or withdrawn from
the implant in the same manner as originally filled except that an
incision is not required in this procedure.
In FIG. 6, the self-sealing valve 14 is shown bonded in the
entrance 35 to the secondary lumen 32 for a catheter 34. In this
regard, the catheter 34 includes a main lumen 36 and a cuff 38
connected to the secondary lumen 32 through a port 40. Gas is
forced into the secondary lumen 32 to inflate the cuff 38.
In accordance with this form of the invention, the self-sealing
plug or valve 14 is bonded in the open end 35 of the lumen 32. Air
is injected into the lumen by inserting a needle through the plug
14. After the cuff 38 has been inflated, the needle is withdrawn
and the cuff remains inflated.
In the embodiment of the invention shown in FIG. 7, the
self-sealing plug 14 is used to provide for the connection of a
dialysis machine to a fistula 42. The fistula 42 is in the form of
a hollow tube 50 which is connected through the skin 44 to an
artery 40 and a vein 48. The fistula forms a shunt for bypassing
blood to the dialysis machine.
The plug 14 is embedded in the wall of the tube 50. The dialysis
machine is connected to the tube 50 by inserting a catheter 52 into
the tube 50 through the plug 14. The catheter is withdrawn after
dialysis has been completed and the tube 50 is automatically
sealed.
* * * * *