Note : Les descriptions sont présentées dans la langue officielle dans laquelle elles ont été soumises.
U1/L5/UU r'H1 1N:40 r'A~ HUZ 484 ;1570 1S1LLAM LIBtLAIiY DUC: Uk~LY t~JUU4
FI~,1. ~~~
ThG invention pertains to the field of prosthefiic devices and, specifically,
to
an external liquid filled breast prosthesis that can be fabricated wish
readily
available mabarials and that includes a simple plug seal means for addition
and
s removal of filler substance by the wearer.
ExLemas breast prostheses, as in Canadian Patents CA 1327870, ~A
to 2269482 US Pat. No. 5,798,()62, arc most commonly comprised of a two part
plastic film outer shell simulatinga on oae side, the shape of a human breast
and
rnY the other side the surface of tix chest wall. The two parts of the shall
are fhsed
together at a eomt'~o~a p~'ipl'~eral edge so as to enclose a silicone gal
filler and the
assembly is oared at high temperature and pressure. 'fkte fabricating process
for
1 s these types of prostheses calls for specialized equipment and does not
lend itself
to "cottage industry" type pmducfiion. A low technology method for producing
silicone rubber shell membranes is described in 'CJS Pat. No. 5,527,359, but
even
this approach is considered more complicated than necessary for production of
generic liquid filled breast prostheses. Furt~ore, the above Patent's
20 prescription for embedded fabric to strengthen the breast form portion of
the shell
is considered an unaccepfiable compromise in texture and resiliency. There is
also
no simple means for addition or rednoval of filler substance by fha wearer, as
may
be desired to tailor the firmness or mass of the prosthesis to the wearer's
individual requirernmts. Seal means for a prosthesis shall that permits a
liquid
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or gel filler to be added end removed have been developed primarily for
internal
breast prostheses, as in US Pat. No. 4,253,201, 4,441,492, 4,775,379,
5,456,716
and 5,019,101 and for other prosthetic devioes, such as US Pat. No. 3,883,902
and 3,600,71$ but theso seal means are considered u~ocessarily complex for an
external breast prosthesis where seal failure does ~Qt pose ~. potential
health risk.
The present invention pertains to a simple, natural feeling, liquid fillod
breast
prosthesis that can be fabricated using corumonly available equipment and
materials and chat includes a discretely located, easy to fahricafie and
easily
operated, plug seal far addition and removal of filler substance as desired.
ThG prest~t invention pertains to a liquid filled external breast prosthesis
comprised of a resilient membrane shell which incorporates a. simplo plug
seal,
means for addition end removal of liquid or gel filler. in a preforrc.~
embodiment
the front tnembarane of the shell is fabricated of silicone rubber applied in
paste
form to the surface of a mandrel and to which an areola, with nipple,
fabricated
similarly in a cavity mold, is bonded. The remaining outer surface of the
front
membrane is covered with a protective layer of lightweight, skin towed fabric.
A
recess in the mandrel accommodates a short rubber tube which is incorporated
into the shell such that its outer end is #lush with the outer surface of the
shell.
The peripheral edge of the t'uat~'el is bevelled to provide, i~t co~ju~uotion
with a
removable under plate, a mold for a flanged mating surface extending inwardly
from the poriphet-al odgo of tho front membrane. The back membrane is
fabricated separately of silicone rubber. impregnated vith lightweight fabric
for
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added strength, and is bonded to part of the fr4nt membrane mating surface and
to the seal tube before the shell is removed from tha mandrel. Tlte rest of
the bond
is completed following removal from the mandrel. The removable plug consists
of a solid cylinder that is set in the tube with one end flush with the
exterior and
of the cube and the other end bearing an enlarged head portion that extends
beryond t$e ulterior end of the tube such as to prevent the plug from being
rejected
froial thG tube under the relatively Low internal prGSSUres generated in. the
wearing
of the prothesis. 'fhe flexibility of the shell permits the plug to be removed
by
applying forco 'd~rou~ fhe m'~brane to the head sufficient to push the head
into
the tube, thus allowing the exposed end of tho plug to be captured and
withdrawn.
io
The iavartion will now be described with reference to the following
drawings in which:
Figure 1 shows a perspective view of an external breast prosthesis of the
present irrveaiion;.
Figure 2 shows a side to side vertical section of the ex~nal breast
prosthesis in the preferred embodiment through the centre of the rapple and
plug
coal means.
24 Figura 3 shows a longitudinal section of an altemafie ambodimarrt of the
plug of tha plug seal means.
Figure 4 shows a vertical section of a mandrel that may be used to fashion
the prosthesis outer membrane.
Figure 5 shows a vertical section, of the prosthesis in the region of the plug
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seal means and illustrates how a fiuget raay be used to initiate removal of
the
plug.
The orientation of components is presenbcd herein with referoncc to att
installed prosthesis of the prcsent invention. With reference to Figures 1 and
2
the irrventi4n consists of a brcast prosthesis 1 comprised of a thin, flexible
shell
sealably enclosing a lumetl 25 and a removable plug scal means 30 for addition
and removal of a fillar substanoe.
l0
In the preferred embodiment the shell 10 is comprised of a front membrane
11, formed in the shape of a human breast, and consisting of a. thin $lm of
flexible, resilient material, such as silicone rubber, and a generally planar
book
membrane 20 of a similarly characterized material. 'The front membrane 11 is
characterized in having a peripheral edge 12 that generally corresponds to the
region where the hraast and chcst wall mcct. The front membrane 11 extends
outward angularly from the chest wall from the edgy 12 aad terminates in a
gern~e, compound curved surface. With reference to Figure 2 file edge 12
includes
an inwardly dir'ect'ed flange 13 bearitrg a flat surface 14 ilaat is generally
coplanar
2o with the bank mombrana 20. A thin, pliable areola disc 15, catxesponding in
dimension and bone to a breast stools is appropriately located and bonded to
the
exterior surface of the front membrane l I . 'I'he ce~ral region of the areola
disc
I S projects outwardly in the form of a nipple I b. The remaining exterior
surface
of the fiont membrane 11 is preferably enclosed in a closely complying Iayer
of
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elastic, skin tonal fabric 17 bonded directly to the front mombrano in a nanaw
strip 1$ bordering, the edge 12 and at least in a second nan~ow strip 19
bordering
the areola disc 15. The thickness of the fabric 17 closely CQlTeSpOndS to the
thickness of the areola disc 15 such as to provide a smooth transition between
the
areola disc 15 and the fabric 17.
The back membrane 20 of the shell 10 is preferably comprised of a layer
of light fabric 21 sandwiched between two tlrin layers of flexible, resilient
material, such as silicone rubber, and is sealably bonded on its front surface
to the
flat sur,~ace X 4 of th$ flange 13 .
The plug seal means 34 is comprised of a short tube 31, fabricated of
flexible, resilient material, such as silicone rubber, and is cut generally
normal to
its major axis at ~eriar end 32 and ax interior end 33 and is set in the front
membrane 11 with its maj or axis generally normal to the exG~rior surface of
the
front membrane 11 in the region of the edge 12 such that the tube 31 passes
through the front membrane 11 with the outer surface of the tube 31 proximal
to
the i~rtenior surface of mombrane 20 such that the channel 34 com~.utxicates
between the lumen 25 and the exterior enviraaarlen~t of the prosthesis 1. The
tube
31 is bonded to the font membrane 11 and back mambrano 20 at all contact
2U surfaces so as to soalably ineorporat a the tube 31 into the structure of
the
prosthesis atMl limit its ~oadom of movement to that of the back membrane 20.
The tube 31 contains a plug 35 comprised of a cylindrical solid shaft 36, of
equal
or slightly larger diameter and length to the channel 34. The plug 35 is
generally
squat'ed at ono end and includes a head 37 of larger diameter than the shaft
36 at
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the opposite end. The plug 35 is set in the tube 31 with the head 37 adjacent
to
the interior end 33 of the tuba 31 and the squarcd end gencrally coincident
with
the exterior end 32 of the tube 31 so as not to project appreciably beyond the
exterior surface of ~e lx ant mombrar~e 11. The edges of the ),~e~d 37 are
bevelled
such that it may be forced tl~caugh tire tube froth either direction. The
diameter
3 of the head 37 is sufl'xcient to prevent it from being forced out of the
tube under
the relatively low internal pressures generated in riotxnal usage of the
gtosthosis.
In an alternate embodiment, p'igure 3, the exposed end of the shaft 36 may
bear
a barrow ridge 38 to facilitate anal removal.
~tNAND. OPERATION OF THE INVENTION
The prosthesis of the present ixxvo~tiol~, can be fabricated by convcntional
industrial means. p'or Gxarnple, the front membrane 11, with incorporated
areola
and tipple, can bt inflection molded and bonded a$erward to the back membrane
20. ~at'e simply, a9 in Figure 4, the front membrane 11 may be fabricated
scparatoly by applying rubber paste onto the surface of a breast shaped
mandrel
40 having a bevelled edge 41 and a recess 42 to closely accomraodate the Vibe
31.
A. removable flat molding surface 50 is applied against the undersurface of
the
mandrel 40 so as to define the flat surface 14 of the flange X3 wherx the
nubbcr
Zo paste is forced into the area of the bevelled edge 41. The areola disc 15
can be
similarly fabricated on a cavity mould a~ bonded oato the front rncmbrano 11
afterward, followed by the f~bx'io 17, while the rubber is still on the
mandrel 40.
The areola disc 15 may be fabricated of appropriately toned rubber or of clear
rubber bonded to a lightweight, appropriately toned fabric. Ths back membrane
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20 can be fabricated separately a as sheet then bolded to a portion of the
$ange
13 before removal ofthe front membrano 11 from the mandrel. The rema~der of
the fxatxt to back membrane bond earl be completed afterward and excess back
melnbrarra triulmGd off In tho preferrai embodiment the liquid filler consists
of
a mixfu~ of hypaallergenio mineral oil, white petroleum jelly and com starch
in
s ratios that closely simulate tile density of breast tissue while providing a
white
base tone for $le overlying skin toned fabric 17, hut any biocompatable liquid
dr
gel mixture that is also compatible with the tnat~erial of the prosthesis
shell 10 may
be used. With the shell 10 charged as desiorod and all air purged the plug 35
is
inserted into the tube 31, head 37 end first, until tho head 3? passes the
interior
end 33 of the channel 34. With rofororlce to Figure 5, the glug 35 can be
removed
by applying force with a finger or blunt tool to the back membrane 20 adjacent
the
head 37 to force the shaft 3fr out of the tube 31 sufficiently to permit the
shaft 36
to be captured attd withdraw with finger tips or as instrument such as a small
pair
of pliers.
While the overate invention has been described in conjunction wi$1 the
embodiments thereof it is evident plat many atte.tives, modifications aad
variations will be appareirt to those skilled in the art in light of the
foregoing
description. Accordingly, it is intendod to embrace all such alternafi'rvcs,
nnodifications and variations as f~l within tllo spirit and broad scope of the
appended claims.
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