U.S. patent number 3,645,258 [Application Number 05/020,229] was granted by the patent office on 1972-02-29 for intrauterine device.
Invention is credited to Charis Aka Charilaos George Massouras.
United States Patent |
3,645,258 |
Massouras |
February 29, 1972 |
INTRAUTERINE DEVICE
Abstract
The invention concerns a gynaecologycal device for insertion in
a woman's womb, i.e., an intrauterine device. This device includes
a Y-shaped flexible support means, the branches of which are each
provided with a fanlike, inwardly extending membrane covering at
least part of the space between the two branches. This intrauterine
device has the advantage of enabling its part which penetrates into
the uterus to unfold after introduction therein so as to cover up
practically the whole internal wall of the uterus.
Inventors: |
Massouras; Charis Aka Charilaos
George (Athens, GR) |
Family
ID: |
26316337 |
Appl.
No.: |
05/020,229 |
Filed: |
March 17, 1970 |
Foreign Application Priority Data
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Apr 8, 1969 [GR] |
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37,193 |
Sep 18, 1969 [GR] |
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38,223 |
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Current U.S.
Class: |
128/839 |
Current CPC
Class: |
A61F
6/144 (20130101) |
Current International
Class: |
A61F
6/00 (20060101); A61F 6/14 (20060101); A61f
005/46 () |
Field of
Search: |
;128/128-131,270 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Charles; Lawrence
Claims
I claim:
1. An intrauterine device comprising a Y-shaped flexible support
having a pair of branches, each of said branches having an inwardly
extending membrane covering at least a part of the space between
the two branches, the membranes being separate from each other.
2. A device as claimed in claim 1, and a reinforcing flange along
the free edge of each membrane.
3. A device as claimed in claim 1, the support having a central leg
having at least one hole therethrough.
4. A device as claimed in claim 3, said hole being located in the
free end of said leg.
5. A device as claimed in claim 3, and a thread extending through
said hole for retrieving said device.
6. A device as claimed in claim 1, said support having a central
leg having at least one crossbar thereon.
7. A device as claimed in claim 6, said crossbar being disposed at
the free end of said leg.
8. A device as claimed in claim 1, said support having a central
leg and having a plate carried by said leg at a right angle to said
leg.
9. A device as claimed in claim 1, said branches extending beyond
the membranes in flexible filamentary extensions.
10. A device as claimed in claim 9, said extensions being
substantially thinner than said branches.
11. A device as claimed in claim 1, said support having a central
leg and a sliding block slidably mounted on said leg to fold
together the branches of the support.
12. A device as claimed in claim 3, and a tubular sliding block
slidably mounted on said leg to fold said branches toward each
other, and a plate secured to said tubular sliding block at a right
angle to said leg, said tubular sliding block having a crosswise
perforation that may be aligned with said hole to fix the position
of the sliding block and plate along said leg upon insertion of a
member through the holes of said leg and tubular sliding block.
13. A device as claimed in claim 12, there being a plurality of
said holes through said leg for selective positioning of said
tubular sliding block and plate along said leg.
14. A device as claimed in claim 8, said plate being oval.
15. A device as claimed in claim 12, said plate being oval.
16. A device as claimed in claim 1 made of soft plastic
material.
17. A device as claimed in claim 16, said material being
polyethylene.
18. A device as claimed in claim 16 in which said material includes
a filler of barium sulfate.
19. A device as claimed in claim 1 of molded construction.
20. A device as claimed in claim 1 of injection molded
construction.
Description
Gynaecologycal devices, so-called intrauterine devices are
increasingly used, following surgery, in cases of polypectomy,
curetting, therapeutic abortion, etc. They are also used as
feminine contraceptives provided to avoid the nesting of fecundated
ovules in the uterus.
The gynaecologycal device provided for introduction into a woman's
womb according to the invention, has the advantage of enabling its
part which penetrates into the uterus to unfold after introduction
therein so as to cover up practically the whole internal wall of
the uterus.
The device is characterized in that it includes a Y-shaped flexible
support, the branches of which are each provided with a fanlike,
inwardly extending membrane covering at least part of the space
between the two branches.
The attached drawing shows by way of example three embodiments of
the device according to the invention and variants thereof.
FIG. 1 is a front elevation of the first embodiment.
FIG. 2 is a view similar to FIG. 1 of the second embodiment.
FIGS. 4, 5, 6 and 8 are variants of the second embodiment.
FIGS. 3 and 7 are respectively views of the third embodiment and of
a variant thereof.
The device shown in FIG. 1 includes a Y-shaped flexible support 1
the branches 2 and 3 of which are each secured to one of the edges
of a fanlike membrane extending between the said branches 2 and 3.
The leg 5 of the Y is provided with spaced holes 6 which may
receive a thread and with a crossbar 7 extending, at its lower end,
in the same plane as the branches 2 and 3.
This device is preferably made by injection molding of polyethylene
or other soft plastic material including as an X-ray opacifier a
barium sulfate filler.
The use of the device is as follows:
After curetting, therapeutic abortion, intrauterine specimen
taking, excision of polyps etc., the part of the device provided
with membrane 4 may be introduced into the uterus by folding
together, by means of surgical pliers, the branches 2 and 3 thereof
so as to permit their introduction into the cervix and their
subsequent unfolding within the uterus itself. According to the
length of the uterine duct it may be possible either to insert the
whole device into the uterus, the crossbar 7 bearing then against
the edge of the cervix in order to avoid that the device penetrates
more deeply therein, or to shorten the leg 5 of the Y from the
bottom thereof in order to avoid that the lower end of the leg 5 of
the Y protrudes exaggeratedly into the vaginal cavity once the
device has been introduced into the uterus. In this case it is
preferable to provide the hole 6 most distant from the branches 2
and 3 of the Y with a thread permitting later on an easy extraction
of the device. Alternately the device may be produced in three
sizes: small, medium and large.
Provided the device is left at least 10 consecutive days inside the
uterus, following the above-mentioned types of surgery, one avoids
the occurrence of adhesions between the anterior and posterior
walls of the uterus in view of the insertion between them of
membrane 4.
Risks of sterility, oligomenorrhea, amenorrhea etc., following such
surgery are therefore prevented.
After Strassmann's operations or the excision of fibromyomas, the
device may be introduced from above, that is through the cut wall
of the uterus before it is restitched. In this case the crossbar 7
of the device must be taken off in order to permit the introduction
of leg 5 into the uterine duct from above and one usually provides
one of the holes 6 with a thread in order to permit the extraction
of the device from the womb through the cervix 10 or 60 days
later.
The device thus inserted into the womb avoids that, when stitching
the cut wall thereof, one stitches the anterior wall to the
posterior wall, since the needle is deflected by membrane 4 of the
inserted device. It further avoids adhesions which may occur during
the healing period and maintains the womb in shape during that
time. It further avoids that adhesions which were excised by
surgery are reformed.
The embodiment of FIG. 2 and its variants of FIGS. 4, 5 and 6 are
more advantageous when introducing the device into the womb through
the cervix. The membrane 4 is replaced therein by two half
membranes 8 and 9 respectively attached to branches 2 and 3 of the
Y by one of their edges and provided along their opposed free edges
with bulging stiffening ridges 10 defining between them a slit 11
coaxial with leg 5. This makes it possible to use a single device
for every size of uterus since the two half membranes 8 and 9
overlap when branches 2 and 3 are pressed together in the womb. It
makes also the introduction of the device into the uterus easier
and avoids an exaggerated crumpling or a deterioration of membranes
8, 9 as a result of this crumpling, which is frequently the case
for the membrane 4 of FIG. 1. The other parts of the device remain
unchanged and it may be provided at the bottom of leg 5 with a
crossbar and a hole 6. It may be provided with only one hole 6
(FIG. 5) or two holes 6 (FIG. 6) in locations of leg 5 showing a
bulge.
In the variant of FIG. 4 the crossbar is replaced by an oval plate
12, the diameters of which are at a right angle with leg 5, in
order to secure a better bearing on the edge of the cervix. A
tubular sliding block 13 may further be provided to help folding
the branches 2 and 3 together for their introduction into the
cervix. Thereafter the sliding block 13 may be slit longitudinally
and taken off by means of pliers.
In the sophisticated variant of FIG. 8, the oval plate 12 instead
of being fastened to the bottom of leg 5 as shown in FIG. 4, is
secured at a right angle to a tubular sliding block 13 traversing
the oval plate 12 concentrically. Sliding block 13 is further
provided with a crosswise perforation 15 which may be positioned in
line with any one of holes 6 of leg 5 to permit its fastening at
the corresponding height on leg 5 by means of a nylon thread 16
engaging the said perforation 15 and hole 6 and tied up around
sliding block 13. Any part of leg 5 protruding underneath sliding
block 13 may then be severed. That sliding block 13 may be used
initially to help folding up to the branches 2 and 3 of the device
for their introduction into the cervix and subsequently to adjust
the position of oval plate 12 at the desired height on leg 5
depending on the size of the cervix. The length of leg 5 in this
case is preferably of 5 to 10 cm., in order to facilitate the
introduction of the device into the cervix through the vagina, any
excess length of leg 5 being severed thereafter.
It is evident that in addition to their stiffening function the
bulging ridges 10 avoid any risk of cutting the walls of the cervix
when introducing the device or extracting it therethrough.
Preferably membranes 4, 8 and 9 have a thickness of 0.3 mm. The leg
5 is preferably cylindrical, 2 to 5 cm. long (except in the variant
of FIG. 8) and 2.7 mm. thick. The crossbar 7 is preferably 2 to 3
cm. long and 2.7 mm. thick. The branches 2 and 3 are preferably 2
to 2.5 cm. long and 2.7 mm. thick; they form preferably between
themselves an angle of 75.degree. to 120.degree..
In the embodiment of FIG. 3 and its variant of FIG. 7 each branch 2
and 3 of the device is provided at its free end with a filamentary
or flagellate extension 14 made of the same material and preferably
12 cm. long and 1 mm. thick. These extensions are to be introduced
into the Fallopian tubes when performing a Strassmann operation
with or without salpingostomy or implantation etc. so as to avoid
occlusion of the Fallopian tubes during the healing period.
Preferably in this case the variant of FIG. 7 is used and after
surgery the extensions 14 are inserted into the Fallopian tubes or
their equivalent obtained by salpingoplasty or salpingostomy to
avoid the formation of internal adhesion which may block or reblock
them. Thereafter leg 5 is inserted into the cervix from the inside
of the womb, while membranes 8 and 9 are unfolded between the front
and back walls of the womb to avoid, as with the device of FIGS. 1
or 5 the formation of the intrauterine adhesions.
Prior to introducing leg 5 into the cervix, one of its holes 6 is
provided with a nylon thread permitting subsequently the extraction
of the device through the vagina.
Since it is easy to cut off unwanted parts of the device, the
embodiment of FIG. 3 may be considered as a universal intrauterine
device which may be used in surgery for insertion after a
laparotomy of the womb (the two crossbars 7 are then cut off and
the leg 5 may further be shortened) or as a contraceptive to be
inserted from the vagina through the cervix (the extensions 14 and
one of the two crossbars 7 are then cut off).
Obviously one could provide the device of FIG. 3 with three
crossbars 7 to permit to adapt the length of leg 5 to three
dimensions of the uterus (and three holes 6 at the intersection of
the said crossbars 7 with leg 5) or else to substitute oval plates
such as 12 (see FIG. 4) for these cross-bars 7 and provide leg 5
with a sliding block 13 to facilitate the insertion of the device
into the womb from the vagina through the cervix.
Preferably the polyethylene chosen should have a sufficiently high
softening temperature to permit sterilization of the device in
boiling water before its use. However, a sterilization by means of
antiseptic surgical liquids or gamma rays for example is
preferred.
Preferably the insertion through the vagina is made under general
anesthesia after dilatation of the cervix by means of Hegar bougies
up to No. 7. The branches of the Y of the device are pressed
together by means of Knight's forceps for example and the device is
inserted into the womb through the cervix up to the first bulge or
crossbar of leg 5. The forceps is then withdrawn and branches 2 and
3 of the device unfold inside the womb by means of their own
elasticity in order to insert membrane 4 or membranes 8 and 9
between the front and back wall of the womb. Should a deeper
penetration be required the device may be pushed further forward up
to the second bulge, crossbar 7 or oval plate 12. Leg 5 is of
course curtailed in an appropriate manner for each particular
case.
The device may remain inside the womb without major harm up to 1
year since it is well tolerated by the organism.
* * * * *