Note: Descriptions are shown in the official language in which they were submitted.
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MULTI-LUMEN BREAST PROTHESIS AND IMPROVED VALVE ASSEMBLY
THEREFORE
Cross-Reference to Related Applications
This application claims the benefit of the filing date of U.S. Provisional
Application
Ser. No. 61/111,440, filed November 5, 2008, entitled "Multi-Lumen Breast
Prosthesis and
Improved Valve Assembly Therefrom".
Field of the Invention
This invention relates to a multi-lumen breast prosthesis and improved valve
and seal
assembly for such prosthesis and more particularly to a multi-lumen breast
prosthesis of the
type having an outer lumen, a mass of gel disposed in the outer lumen and an
inner lumen
and a mass of saline disposed in the inner lumen. The invention also relates
to an improved
valve and seal assembly which includes means for preventing a plug valve from
being
dislodged and moving inwardly toward the interior of a lumen.
BACKGROUND FOR THE INVENTION
Dual lumen breast implants for insertion into a human body are well known and
have
been in use for a number of years. For example, one of my earlier Patents, No.
6,183,514
defines a self-positioning breast implant. As described, a dual lumen gravity
oriented breast
prosthesis or implant for surgical implantation includes inner and outer
lumens which are
defined by inner and outer closed envelopes of a medical grade elastamer. The
outer closed
envelope or lumen defines a generally oval or tear shape with upper and lower
portions. The
outer envelope also contains a quantity of fluid material as for example a
silicone gel having
a first density. The prosthesis also includes a second or inner lumen defined
by a second
closed envelope of medical grade elastamer which is disposed in and fixed in
the lower
portion of the outer closed envelope. The inner lumen may be of various shapes
such as
generally spherical or preferably crescent shape. The second lumen is filled
with a saline
solution which has a density which is greater than the density of the silicone
gel. The inner
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lumen with its greater density maintains or returns the prosthesis to its
predetermined
orientation on an individual in whom the prosthesis is implanted when the
individual is in a
standing or sitting position.
A more recent development in mammary prosthesis is disclosed in my more recent
Patent on An Adjustable Gel Filled Mammary Prosthesis, No. 7,081,136. As
disclosed
therein, an adjustable gel filled mammary implant includes inner and outer
envelopes with the
outer envelopment containing about 95% of its volume filled with a silicone
gel or the like.
The inner envelope is attached to a bottom portion of the outer envelope and
defines a
volume of about 5% to 10% of the volume of the outer envelope and is filled
with saline.
The implant also includes a self-sealing valve, filling tube and reservoir for
adjusting the size
of the implant.
For a more natural appearing beast, it is desirable to have the two lumens
move
independently of each other. This is particularly important in implants having
a predominant
amount of gel in an outer lumen with a relatively small lumen that can be
filled to 10 to 20%
(preferably) of the volume of the outer lumen with a saline solution. The
small saline inner
lumen which is free floating will move naturally within the breast. Further,
as the breast is
naturally pear shaped, the filled saline chamber will give the implant an
anatomical or pear
shape to simulate a natural breast.
Due to prior difficulties in manufacturing, the smaller inner lumen and outer
lumen
are adhered together with a single valve allowing saline to be added to the
inner lumen.
Although functional, the result in shape is not optimal. One and probably the
best approach
to overcome this problem was to use a filling tube and seal construction in
accordance with
my earlier patent No. 5,507,808. As described therein an inflatable implant
for use in human
breast reconstruction includes a chamber which is defined by a flexible
membrane. The
implant also includes a valve and a flexible filling tube which passes through
the valve and
into the chamber.
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The valve comprises a short semi-riged tube that surrounds an opening in the
membrane and extends inwardly of the membrane and into the chamber. The semi-
riged tube
defines a passageway extending therethrough and also defines a relatively
small reservoir
which opens into the passageway. A filling tube comprises a soft and flexible
length of
tubing and a solid portion that has an outer diameter which is slightly larger
than the inner
diameter of the semi-riged tube and is stretchable longitudinally to reduce
its outer diameter
to facilitate passage through the semi-riged tube and the solid portion is
adapted to sealingly
engage the semi-riged tube upon relaxation thereof. There are two problems
with this
approach when making a multi-lumen implant wherein the inner lumen is free
floating within
the outer lumen. The problems are that the filling tube and sealed
construction that includes a
small reservoir for a better seal are relatively large and expensive to
manufacture. Second,
the plug portion of the valve occasionally dislodges and moves backwardly into
the inner
lumen allowing a leak in the inner lumen.
Therefore it is presently believed that there is a need for and potential
commercial
market for an improved multi-lumen implant with an improved filling tube and
seal
construction in accordance with the present invention- There should be a
market for such
implants because the use of a smaller valve allows for a smaller inner lumen
as well as a
significant reduction in cost. Further, it is presently believed that the new
valve and seal will
reduce if not eliminate problems of the plug valve becoming dislodged.
BRIEF SUMMARY OF THE INVENTION
In essence, the present invention contemplates an improved filling tube and
seal
construction for a multi-lumen breast prosthesis of the type having an outer
lumen or
chamber and a mass of gel disposed within the outer lumen. The prosthesis also
includes an
inner lumen or chamber and a mass of saline disposed within the inner lumen.
The outer
lumen is defined by a flexible membrane with an inlet opening and a first semi-
riged tube
surrounded by the inlet opening and extending inwardly into the outer chamber.
The first
semi-riged tube defines a longitudinally extending passageway with a near end
adjacent to,
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abutting and sealed to the inlet opening to close the inlet opening except for
the
longitudinally extending passageway. The far end of the first semi-riged tube
extends into
the outer lumen or chamber.
A filling tube comprising a soft and flexible length of tubing with a solid
portion and
a T-shaped flange at its distal end. The solid portion of the filling tube is
slightly longer than
the length of semi-riged tube while the remaining portion of the filling tube
defines a second
hollow passageway with an opening for connecting the interior of the filling
tube with the
interior of the chamber for inflation of the chamber. The filling tube has an
outer dimension
that is slightly larger than the inner dimension of the semi-riged tube and is
stretchable
longitudinally to reduce the outer diameter to facilitate passage through the
passageway in the
semi-riged tube. The solid portion of the filling tube sealingly engages the
semi-riged tube
upon relaxation thereof but can be stretched longitudinally and moved
outwardly through the
semi-riged tube by pulling on the proximal portion until the T-shaped flange
engages the top
of the semi-riged tube. A key element in the present invention resides in
means such as a
plurality of reverse barbs for preventing a plug valve from being dislodged or
moved
inwardly into the interior of the inner lumen. These barbs are typically
disposed between the
solid portions of the filling tube and the semi-riged tube. For example, a
plurality of
rearwardly directed needle like elements or the like disposed in the solid
portion of the filling
tube allow the filling tube to move into a constricted area of the semi-riged
tube but once
pulled into place prevent the remaining plug valve from rearward movement. In
effect the
solid plug is blocked from movement by the barbs in one direction and by the T-
shaped
flange in the other direction.
In a preferred embodiment of the invention the improved filling tube and seal
construction are used for the inner chamber that is filled with saline while a
second
conventional flap valve is used to close the outer chamber that contains a
more viscose
silicone gel. This gel is less likely to leak in view of its higher viscosity.
Nevertheless, it is
contemplated that the improved sealing tube and seal construction may be used
for both the
interior and outer chambers.
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The invention will now be described in connection with the accompanying
drawings
wherein like reference numerals have been used to define like parts.
DESCRIPTION OF THE DRAWINGS
Figure 1 is a perspective view illustrating a single lumen inflatable
prosthesis
embodying a filling tube and seal construction as shown in Figures 2-6 and
shown with a
filling tube and an attached injection dome in place for inflating the
prosthesis;
Figure 2 is an enlarged view of a portion of figure 1 showing the filling tube
in
position for inflating the prosthesis;
Figure 3 is an enlarged view of a portion of figure 1 showing a closed filling
tube ;
Figure 4 is an enlarged view of the filling tube and sealing construction
according to
one embodiment of the invention;
Figure 5 is a perspective view of a plug seal in accordance with a preferred
embodiment of the present invention;
Figure 6 is a cross-section view of a plug seal in accordance with a further
embodiment of the invention;
Figure 7 is a schematic cross-sectional view of a breast with a dual lumen
mammory
prosthesis implanted therein with a dual valve in accordance with one
embodiment of the
invention;
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Figure 8 is a schematic illustration of the dual valve arrangement in an inner
and outer
lumen wherein the valve is shown as partially closed and a second plug is
shown near
closure;
Figure 9 is a schematic illustration of a dual lumen implant with inner and
outer plug
valves in accordance with the invention;
Figure 10 is a schematic illustration of a dual lumen implant with a plug
valve, a leaf
valve and a filling tube in accordance with the invention;
Figure 11 is schematic illustration of a dual lumen implant as shown in figure
10 but
with the filling tube removed;
Figure 12 is a schematic illustration of a dual lumen implant in accordance
with a
further embodiment of the invention wherein a thin tube connects the inner
lumen to the
exterior of the outer lumen and wherein a single plug valves acts as a seal
for the inner and
outer lumen;
Figure 13 is a schematic illustration of the dual lumen implant shown in
Figure 12 but
with the filling tube removed; and
Figure 14 is a schematic illustration of the further embodiment of the
invention shown
in Figures 12 and 13 within a human breast that illustrates the connection
between the inner
lumen and the outer lumen and that allows limited movement of the inner lumen
while
providing for a more natural shape.
DESCRIPTION OF THE PREFERRED EMBODIMENTS OF THE INVENTION
References will now be made in detail to the embodiments of the invention,
examples
of which are illustrated in the accompanying drawings. A preferred embodiment
i.e. best
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mode of the filling tube and seal construction is shown in Figures 1-3. In
accordance with the
invention a filling tube and seal construction is embodied in an inflatable
device such as an
inflatable implant 13 which includes at least one flexible membrane or lumen
15. The
flexible membrane or lumen 15 defines an inflation chamber 16 which is adapted
for filling
with a fluid to thereby inflate the implant 13, The lumen 15 also defines an
inlet opening 17
to which an inflating fluid is delivered (See figure 2).
In accordance with the invention, the filling tube and seal construction
includes a
semi-rigid tube 18 which has a relatively thick wall with respect to the
thickness of the
membrane and which surrounds the opening 17. The semi-riged tube 18 extends
inwardly of
the lumen 15, and has a passage 23 therethrough which opens inside of the
lumen 15.
The lumen 15 is constructed of a suitable material or membrane such as a
medical
grade silicone elastomer or similar material which does not react with human
tissue, as will
be understood by those skilled in the art. And, the short semi-rigid tube 18
may be formed of
the same or of a different material but is preferably fanned as an integral
part of the
membrane and derives its semi-rigid characteristic from the thickness of its
wall section. It
may also be desirable to form a thicker portion 19 of the lumen 15 as
illustrated to further
support the tube 18. This thickened portion 19 surrounds the opening 17 and
reduces the
likelihood of any breaking or tearing of the membrane. The semi-rigid tube 18
also defines
an inner passageway or passage 23
A filling tube 27 constructed of silicone tubing or the like is adapted to
pass through
the passage 23 which is defined by the relatively short, semi-rigid tube 18.
The filling tube 27
also includes a solid distal portion 28, which is preferably slightly longer
than the length of
the semi-rigid tube 18, and a proximal portion 29 which defines a hollow
passageway 30 and
an opening 32. The opening 32 connects the passageway 30 with the interior of
the chamber
16 and operatively connects the interior of the chamber 16 to an injection
dome or reservoir
34.
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The filling tube 27 is relatively soft so as not to puncture or damage the
tube 18 or the
lumen 15. This filling tube 27 has an outer diameter which is slightly larger
than the inside
diameter of the passageway 23 and is stretchable in the longitudinal direction
to reduce its
outside diameter. Reduction of the outside diameter facilitates the passage of
the filling tube
27 through the semirigid tube 18. And the solid portion 28 of the filling tube
is adapted to
sealingly engage the passageway 23 in the semi-rigid tube 18 upon relaxation
from a
stretched condition.
In practice, the filling tube may be forced through the passageway 23 by means
of a
rigid member (not shown) or could be molded into place by having the lumen and
semi-rigid
tube molded around the filling tube. In the latter case, the filling tube
would include an area
of reduced diameter so that the inside diameter of the tube 18 would be
smaller than the
outside diameter of at least the solid portion 28 of the filling tube 27.
The proximal end 27' of the tube 27 is adapted for connection to a fluid
source such as
the reservoir 34. Fluid such as a saline solution is then forced from the
reservoir 34 by means
of a hypodermic needle inserted therein (not shown) through the passageway 30
and opening
17 and into the chamber 16. When the chamber 16 is sufficiently filled, the
filling tube is
stretched longitudinally by pulling and passes through the passageway 23 until
the solid distal
portion 28 is encompassed by the semi-rigid tube 18. When the pressure or
longitudinal
extension is released, the solid distal portion returns to its original
outside diameter sealingly
engages the semi-rigid tube 18.
In a preferred embodiment of the invention, the solid distal portion 28
includes a
generally radially extending flange 35 having a generally T-shaped cross
section for engaging
a seat 36 on the semi-rigid tube 18. This radially extending flange acts as a
stop means and
prevents the filling tube 27 from being pulled through the semi-rigid tube 18
and contributes
to the reliability of the seal.
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Various factors must be considered in constructing the filling tube and seal
or valve,
such as the thickness of the semi-rigid tube, the stiffness of the materials,
the lengths of the
semi-rigid tube and the filling tube, their diameters including the nature
and/or viscosity of
the fluids contained within the implant, of the sealant in the reservoir, the
pressure of the
fluid, etc. Those skilled in the art will appreciate that the seal must not
leak and must not
cause discomfort to the patient.
It will also be appreciated that inflatable prosthesis of this type often have
the filling
tube inserted in place at the time the prosthesis is manufactured and prior to
packaging. Thus,
the filling tube remains in place during the entire shelf life of the
prosthesis which can be for
a considerable length of time. A number of previous valves acquired a "set"
during this time
so that when the prosthesis was implanted, expanded, and the filling tube
removed, leakage
occurred at the valve. This problem was remedied by incorporating a kink or
curled valve
into the system. However, the complexity of manufacture adds to the cost of
the device.
Furthermore, the curled valve can often be felt by the patient. It is
presently thought that
because of the small size of the valve and seal according to the present
invention will
overcome this tendency and as such constitutes an improvement on the valves
disclosed in
my earlier patent.
Figure 5 is an enlarged view of a plug valve 34 in accordance with a preferred
embodiment of the invention. As shown, the plug valve 34 is formed from the
distal end of
the solid portion 28 of the filling tube 27 and thus has a generally circular
cross-section with
the outwardly extending valve 35 at the top of the plug valve 34 to provide a
T-shaped cross-
section. The plug portion of the plug valve 34 also includes a plurality of
rearwardly directed
barbs 36. In other words, the barbs 36 in a preferred embodiment of the
invention are pointed
rearwardly i.e. toward the interior of a chamber and form an acute angle with
a longitudinal
axis of a semi-riged tube. With the longitudinal axis of the plug valve with
this design, the
barbs are pressed down into the soft filling tube as the plug is pulled into
the semi-riged tube,
but spring upwardly and penetrate into the semi-riged tube if the plug is
moved backwards.
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An alternative plug valve 38 includes a flap-like closure 39 on its end that
opens up to
prevent the plug valve from being forced out of the semi-riged tube.
A dual lumen mammary prosthesis in accordance with a preferred embodiment of
the
invention is shown in figure 7. As shown, in figure 7, a mammary prosthesis or
breast
implant 40 is implanted in the breast tissue 12 of a patient. The implant 40
includes an outer
envelope 44 of a medical elastomer such as silicone and a silicone gel is
contained within the
outer envelope 44. The silicone gel 16 may be replaced by other suitable
material such as
polyvinyl pyrralidone, hyaluronic acid, polyacrlimids and polysacckarides.
The walls of the lumen i.e. the outer envelope 44 and inner envelope 48 may be
made
of various soft flexible biocompatible materials such as silicone elastomer.
Preferred
materials include silicone elastomers such as polydimethylsiloxane or
polymethylvinyl
siloxane or copolymers thereof with other substances. Other polymers may be
substituted as
will be apparent to persons of ordinary skill in the art.
As illustrated in figure 7, the outer envelope 44 has an oval or generally
tear-shape
with a relatively flat rear portion 45 and rounded dome or forward surface 47.
The outer
envelope 44 defines an outer lumen which may be of a generally tear-drop shape
or other
non-symmetrical shape in order to conform to the contours of a human breast.
It should be
recognized that in certain cases a round shape may be needed.
The implant 40 also includes an inner lumen which is defined by an inner
envelope
48. This inner envelope 48 is preferably of the same medical grade elastomer
as the outer
envelope 44. The inner envelope 48 may be of a substantially spherical shape
and upon
filling is preferably free floating within the outer envelope. The inner lumen
or inner
envelope 48 also contains a fluid 50 such as silicone solution which has a
density greater than
the density of the gel in the outer lumen, As illustrated, the implant 40
includes a pair of
valves 51 and 52, one valve 51 for the inner envelope 48 and the other valve
52 for the outer
envelope 44. As shown, the valves 51 and 52 are each plug valves with the
valve 51 closing
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the inner envelope and the plug valve 52 attached to a nylon filament that
extends from and
positions the valve 52 to be drawn into a semi-riged tube 53.
Figures 8 and 9 show the positioning of the two valves 51 and 52 as positioned
for
adjusting the amount of saline 50 in the inner chamber 48 and before the inner
envelope 48 is
allowed to float or move freely within the outer chamber and with the fill
tube removed
through the valve 52.
A further embodiment of the invention is illustrated in figures 10 and 11
wherein a
dual lumen implant includes an inner plug valve 51 in accordance with the
present invention
for sealing the inner lumen and a leaf valve 53 in the outer lumen. Figure 10
illustrates the
valves and filling tube in place while figure 11 illustrates the valves 51 and
53 in a closed
position with the filling tube removed.
Figures 12 and 13 illustrate a still further embodiment of the invention
wherein an
outer envelope and an inner envelope are sealed by a single inner valve 51 and
cooperates
with a connecting member 68 to thereby maintain the fluid 50 within the inner
lumen and at
the same time close the chamber 16.
While the invention has been disclosed in connection with its preferred
embodiments
it should be recognized that changes and modifications may be made therein
without
departing from the scope of the claims.
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