U.S. patent application number 11/545865 was filed with the patent office on 2007-04-26 for breast implant injector.
Invention is credited to Joel R. Studin.
Application Number | 20070093893 11/545865 |
Document ID | / |
Family ID | 34887158 |
Filed Date | 2007-04-26 |
United States Patent
Application |
20070093893 |
Kind Code |
A1 |
Studin; Joel R. |
April 26, 2007 |
Breast implant injector
Abstract
A breast implant injector device comprising a hollow guide
cylinder having an open injection end and an opposed filling end,
the cylinder having an elongated slot extending from the injection
end toward the filling end, and an elongated plunger which can be
pushed through the interior of the hollow cylinder. An unfilled
breast implant can be inserted in the cylinder and a fill tube
extending from the implant can extend from the interior of the
cylinder through the elongated slot. Pushing the plunger through
the cylinder pushes the implant through the open injection end,
which can be directed into the open incision for injecting the
implant therein.
Inventors: |
Studin; Joel R.; (Great
Neck, NY) |
Correspondence
Address: |
FRENKEL & ASSOCIATES
3975 UNIVERSITY DR., STE. 330
FAIRFAX
VA
22030
US
|
Family ID: |
34887158 |
Appl. No.: |
11/545865 |
Filed: |
October 11, 2006 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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10789030 |
Mar 1, 2004 |
7137995 |
|
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11545865 |
Oct 11, 2006 |
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Current U.S.
Class: |
623/8 ;
623/7 |
Current CPC
Class: |
A61F 2/12 20130101 |
Class at
Publication: |
623/008 ;
623/007 |
International
Class: |
A61F 2/52 20060101
A61F002/52 |
Claims
1. A breast implant injector device capable of inserting a fixed or
changeable volume sac surgically into a breast, said device
comprising a hollow cylinder having opposed open ends, including a
filling end and an injection end, said injection end having a
narrower diameter than the opposed filling end, said cylinder
including an elongated slot extending through and beyond said
injection end toward the filling end and an elongated plunger
capable of passing through the interior of said guide cylinder.
2. The device of claim 1, wherein said elongated slot extends
through said injection end to said opposing filling end.
3. (canceled)
4. The device of claim 1, wherein said cylinder includes an outward
abutment surface adjacent said filling end to provide a surface
onto which increased finger pressure can be applied.
5. The device of claim 1, wherein said plunger has a flattened end
so as to provide sufficient surface area to push an implant through
said guide cylinder.
6. A combination of a breast implant injector device and an
unfilled breast implant comprising a fixed or changeable volume sac
and containing a fill tube extending therefrom, said combination
including a hollow cylinder having opposed open ends, including a
filling end and an injection end, said injection end having a
narrower diameter than said filling end, said cylinder including an
elongated slot extending through and beyond said injection end
toward said filling end, said breast implant lying within said
hollow cylinder and said fill tube extending from the interior of
said hollow cylinder through said elongated slot.
7. The combination of claim 6, wherein said elongated slot extends
from said injection end to said opposing filling end.
8. (canceled)
9. The combination of claim 6, wherein said cylinder includes an
outward abutment surface adjacent said filling end to provide a
surface onto which increased finger pressure can be applied.
10. The combination of claim 6, including an elongated plunger
capable of passing through the interior of said cylinder.
11. The device of claim 10, wherein said plunger has a flattened
end so as to provide sufficient surface area to push an implant
through said guide cylinder.
12. The combination of claim 6, wherein said cylinder containing
said breast implant is contained within a sanitary package
13. (canceled)
Description
FIELD OF THE INVENTION
[0001] The present invention relates to a device for injecting a
breast implant into a surgically created body cavity.
BACKGROUND OF THE INVENTION
[0002] Reconstruction of the human breast involves introducing a
fixed or changeable-volume sac-like silicone rubber structure into
a body cavity surgically created to receive such an implant. The
implants and coverings therefore are described, by way of
illustration and not by limitation, in: Braumann U.S. Pat. No.
4,648,880; Hamas U.S. Pat. No. 4,531,244; and Ledergerber U.S. Pat.
No. 4,955,907.
[0003] The usual skin incision is on the order of 3-8 centimeters
in length and is stretched open with retractors to facilitate the
introduction of the implant. In various surgical procedures, a
breast implant is placed within the surgically formed body cavity
for subsequent inflation and/or deflation with a fluid.
[0004] In plastic and reconstructive surgery, when a breast implant
or tissue expander is placed in the dissected pocket, it is
typically filled via a fill connector coupled to fill tubing which
is attached to a filling material (e.g. saline solution)
source.
[0005] There are currently three basic types of fill connectors
used to connect the fluid source to the implant, the choice of
which often depends on the implant and the particular surgical
approach used. The first is a permanent attachment of the fill
tubing to the implant. A common means for this attachment is to
make a small opening within the body or shell of the implant and
insert the tubing securing it by means of connecting materials such
as sleeves, patch assemblies, adhesives or vulcanizing
compounds.
[0006] The other two common connectors are for temporary attachment
of the fill tubing to the implant by means of a valve in the
implant which seals after the fill tubing is removed. One of these
two temporary attachment means is most commonly used with
saline-fill breast implant devices that include a diaphragm valve
within the shell. The valve has an opening that requires a rigid
male implement to be inserted in the opening thus opening the valve
and allowing fluid transfer. This male implement is the fill tip
end of the fill connector, which has on the opposite end one or
more barbs which accept the flexible (e.g. silicone or vinyl) fill
tubing. In use, the fill connector and fill tubing attach to the
implant normal to the implant surface.
[0007] Since breast implants are usually placed into the body
through incisions considerably smaller than the implant, it has
always been a challenge to introduce them. With greatly increased
friction at the interface between the surface of newer texturized
implants and the wound margins (body tissue), it has become
correspondingly more difficult to introduce these implants.
Increased manipulation of both implants and patient tissue often
results in trauma to both implants and patient tissue, thereby
increasing the risk associated with the procedure both in terms of
immediate consequences as well as delayed structural failure and
the implications deriving therefrom. Postoperative infection has
also been a troublesome consequence of the need to manipulate the
implant into place. It has become a matter of some urgency to be
able to introduce breast implants atraumatically.
SUMMARY OF THE INVENTION
[0008] A novel breast implant introducer is provided which has as
its object the alleviation of the difficulty of introducing breast
implants, and thus limiting greatly both the damage to implants and
trauma to patient tissues. The breast implant introducer greatly
reduces the need to manipulate the breast implant in to place in
the formed body cavity, and as a consequence greatly reduces
postoperative infection.
[0009] The breast implant introducer is a modified syringe
including a hollow guide cylinder open at opposite ends and having
an internal area capable of receiving an unfilled breast implant.
An elongated plunger sized to fit within the interior of the guide
cylinder through an opened end thereof is used to push the breast
implant into place in the surgically created body cavity. The
hollow cylinder includes along one side thereof an elongated slot
to allow the fill tube connected to the breast implant to extend
outside of the guide cylinder and move with the breast implant
without kinking and without inhibiting the movement of the breast
implant as it is injected from the guide cylinder into the body
cavity. In as much as the surgeon contacts only the outside surface
of the guide cylinder and the top of the plunger, risk of infection
by transfer from the surgeon to the breast implant is substantially
avoided.
BRIEF DESCRIPTION OF THE DRAWINGS
[0010] FIG. 1 is a perspective view of the breast implant injector
of this invention.
[0011] FIG. 2 is a perspective view of the breast implant injector
of this invention showing the initial placement of the breast
implant within the guide cylinder.
[0012] FIG. 3 is a perspective view of the breast implant injector
showing the displacement of the implant from within the guide
cylinder.
[0013] FIG. 4 is a schematic showing the use of the breast implant
injector of this invention.
[0014] FIG. 5 is a perspective view of the breast implant injector
of this invention packaged for sanitary use.
DETAILED DESCRIPTION OF THE INVENTION
[0015] FIG. 1 of the drawings illustrates the implant injector 10
as comprised of a guide cylinder 12 and a plunger 14, slideable
within and along the interior of the guide cylinder 12. The guide
cylinder 12 is open at the opposed ends thereof including filling
end 16 and opposed injection end 18 to allow the insertion of an
unfilled breast implant 20 within cylinder 12 and the injection
thereof out of cylinder 12, respectively, as shown in FIGS. 2 and
3. Along one side of guide cylinder 12 is an elongated slot 22
which is disposed from injection end 18, preferably, to filling end
16, to allow fill tube 24 of implant 20 to extend beyond the
interior of guide cylinder 12 and allow passage of the unfilled
breast implant 20 through the guide cylinder 12 in a smooth,
uninterrupted manner. It is preferred that the guide cylinder 12
narrow adjacent to the injection end 18 to improve the guidance of
the implant 20 into the body cavity or open incision during
injection of the implant 20 from the interior of guide cylinder 12.
Guide cylinder 12 can be formed of any material capable of forming
a relatively rigid cylinder having an interior surface which is
relatively smooth to not adversely impede the movement of the
breast implant through the interior of the guide cylinder 12. Thus,
glass, metal, ceramic, and plastic materials formed from synthetic
resins such as polyacrylates, polyesters, polyamides, polyacetals,
and the like are all acceptable to form the guide cylinder of this
invention. The guide cylinder 12 should be relatively rigid and not
easily bend once the unfilled breast implant 20 is inserted in the
interior of the guide cylinder 12 and is pushed out through the
open injection end 18 by means of plunger 14.
[0016] Plunger 14 is an elongated rod having a diameter which can
fit within the interior of guide cylinder 12. Typically, the
plunger 14 will have a flattened end 26 capable of providing
sufficient surface contact with the breast implant 20 so as to push
the implant 20 down the length of the guide cylinder 12 and out
through open injection end 18. Opposite flattened end 26, plunger
14 will include an end 28 which provides sufficient surface area to
allow the surgeon to push plunger 14 through guide cylinder 12 such
as by the thumb of the surgeon as the guide cylinder 12 is held
between two fingers. Thus, end 28 preferably provides a flat
surface, as shown in FIGS. 1-3. The plunger 14 can also be made of
glass, metal, ceramic, or any synthetic resin material which again
forms a rigid plunger which will not easily bend upon the
application of pressure at either or both ends of the plunger. If
the plunger is too flexible, pressure at either end would bend the
plunger and hinder the ejection of the breast implant 20 out of the
open injection end 18 of guide cylinder 12.
[0017] FIGS. 2 and 3 illustrate the placement and movement of the
breast implant 20 in and from the interior of guide cylinder 12.
With the plunger removed from filling end 16, the implant 20 can be
placed into the interior of guide cylinder 12 so that the fill tube
24 extends out through slot 22. Plunger 14 is then inserted into
the open filling end 16 of guide cylinder 12 and is pushed toward
open injection end 18. End 26 of plunger 14 pushes the breast
implant 20 toward end 18 until implant 20 is ejected from the guide
cylinder 12 through open injection end 18. The fill tube 24 of
breast implant 20 does not get entangled with or hinder the
movement of the breast implant 20 during passage through guide
cylinder 12 since the fill tube 24 extends outside the guide
cylinder 12 through elongated slot 22.
[0018] When mammoplasty is conducted using the present invention as
illustrated in FIG. 4, the unfilled implant 20 is placed within the
interior of guide cylinder 12, for example, through filling end 16.
The fill tube 24 attached to implant 20 extends outside of guide
cylinder 12 via slot 22. The injector 10 is inserted into the
incision 30 in the skin of the patient so that the tip, i.e.,
injection end 18, of guide cylinder 12 is placed inside the
incision 30. As illustrated in FIG. 4, the plunger 14 is placed
into the open filling end 16 of guide cylinder 12 for pushing
breast implant 20 through the cylinder 12 out through injection end
18 and positioned into the open body cavity through incision
30.
[0019] Referring to FIGS. 3 and 4, the surgeon can place the guide
cylinder 12 between two fingers which grasp opposite sides on the
outside of guide cylinder 12. Preferably, cylinder 12 has a widened
portion or abutment 32 adjacent open end 16 to provide a location
where the fingers of the surgeon can provide pressure and
sufficient leverage upon pushing the plunger 14 into cylinder 12.
The surgeon can then place the thumb of the same hand holding the
cylinder 12 on the outer end 28 of plunger 14 and push the thumb
and fingers holding the cylinder 12 toward each other to allow
passage of plunger 14 through guide cylinder 12 while the plunger
pushes the implant 20 through injection end 18 of cylinder 12 and
into the open incision 30. As the implant 20 is being pushed
through injection end 18, fill tube 24 is pushed along elongated
slot 22 until the fill tube passes out of elongated slot 22 at end
18. During passage of the implant through the guide cylinder 12,
the fill tube 24 does not impede the passage of the implant 20 such
as by folding under the implant as can happen if the elongated slot
22 were not present. The surgeon can manipulate the injection end
18 of guide cylinder 12 to ensure that the implant 20 is properly
in place without the need for manipulating the implant 20 with the
fingers, which can often transfer unwanted microbes into the open
body cavity and cause infection once the incision 30 is closed.
After the operation, the used injector, produced at cheap cost,
can, if desired, be disposed to completely stop infection caused by
insufficient disinfection and repeated use. Therefore, the present
invention is highly practical and safe. Once in place, the breast
implant 20 can be filled, for example, with the desired saline
composition at the desired level and the fill tube 24 removed. The
implant 20 self seals once the fill tube 24 is removed, as known in
the art.
[0020] With a novel configuration, the present invention allows a
faster and more smooth operation compared to the prior art in the
mammoplasty involving the insertion of the implant while there is
the major time saving; furthermore, for cheap production cost and
promoted production outputs, the injector of the present invention
can be disposable to completely rule out the infection problem due
to repeated use which requires the disinfection in the prior art.
It is contemplated that a kit 34 containing the unfilled breast
implant 20 placed within a guide cylinder 12 of this invention, and
optionally containing the plunger 14, can be packaged together in a
sanitary wrap 36 and opened when surgery is ready, again reducing
the handling of the implant by the surgeon.
* * * * *