U.S. patent number 3,867,933 [Application Number 05/338,560] was granted by the patent office on 1975-02-25 for intrauterine device and process of making the same.
This patent grant is currently assigned to Tecna Corporation. Invention is credited to Sotiris Kitrilakis.
United States Patent |
3,867,933 |
Kitrilakis |
February 25, 1975 |
Intrauterine device and process of making the same
Abstract
An intrauterine device has a pair of initially flat,
registering, triangle-shaped sheets of soft, rubber-like,
substantially liquid-impervious, non-toxic flexible material of
about the same dimensions as the undistorted human uterine cavity.
The sheets are reinforced by a mat of flexible or pliable,
non-stretchable fibers to prevent stretching of the sheets. The
initially flat sheets are thermally preformed into a
three-dimensional final shape and size and are then secured
together in a marginal area forming a flat band all around the
edges except for a gap at one apex. The sheets are also secured
together along internal areas preferably bisecting the apices of
the triangle except at said gap and except at a central location.
This leaves unsecured or free zones in communication with each
other and with said gap and extending approximately parallel to the
sides of the triangle. In use, the unsecured zones are filled with
fluid, such as liquid, introduced through the gap. This stiffens
them so that, although they remain soft, they act somewhat like
beams and are not readily distorted. The liquid can contain hormone
crystals for slow release through a governing polymer coating.
Inventors: |
Kitrilakis; Sotiris (Berkeley,
CA) |
Assignee: |
Tecna Corporation (Emeryville,
CA)
|
Family
ID: |
23325255 |
Appl.
No.: |
05/338,560 |
Filed: |
March 6, 1973 |
Current U.S.
Class: |
128/836;
128/839 |
Current CPC
Class: |
A61F
6/16 (20130101) |
Current International
Class: |
A61F
6/00 (20060101); A61F 6/16 (20060101); A61f
005/46 () |
Field of
Search: |
;128/127,128,129,130,131,260 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Gaudet; Richard A.
Assistant Examiner: Dunne; G. F.
Attorney, Agent or Firm: Lothrop & West
Claims
What is claimed is:
1. An intrauterine device comprising a pair of sheets of soft,
rubber-like, substantially liquid-impervious, non-toxic material,
said sheets having the approximate shape in plan of a triangle and
being arranged in registry with each other, said sheets having
about the same dimensions as the undistorted human uterine cavity,
a non-stretchable mat of pliable fibers united with said sheets to
prevent stretching thereof, means securing said sheets together in
a planar band all around the edges of said sheets except for a gap
at one apex thereof, and means securing said sheets together along
areas bisecting the apices of said triangle except at said gap and
except at a region at the center of said triangle leaving three
unsecured zones communicating with each other and with said gap and
extending approximately parallel to the sides of said triangle.
2. A device as in claim 1 in which said fibers of said mat are
woven.
3. A device as in claim 1 in which said sheets are of silicone
rubber.
4. A device as in claim 1 in which said fibers are of Dacron.
5. A device as in claim 1 including a tube joined to said sheets
and communicating through said gap with said unsecured zones.
6. A device as in claim 1 in which said unsecured zones are
preformed to a predetermined three dimensional configuration.
7. A device as in claim 1 including a fluid filling said unsecured
zones and separating said sheets into said predetermined
configuration.
8. A device as in claim 1 in which said zones are preformed to
receive a predetermined maximum liquid volume when inflated.
Description
Most intrauterine devices are either solid, rigid objects or
hollow, soft objects expanded by inflation for use. It has been
learned that most rigid devices do not accommodate the normal,
continuous uterine muscular movements. Being stiff they produce
local pressure points and stimulate the uterine and cervical walls
to substantial contractions and thus to expel the intrauterine
device. The relatively soft, inflatable structures adapt to two
main procedures. One procedure is to inflate the stretchable device
like a balloon within the uterus, likewise stretching the uterus.
The theory is that if the uterus is substantially expanded it will
grip or hold the intrauterine device in position. Another procedure
is to make the inflated device very pliable and deformable to yield
to its surroundings. Clinical experience indicates that the normal
uterus by itself or as stimulated by localized pressure points or
expansive distortion of the uterine wall is subject to peristaltic
contractions. These tend to move the expanded, deformable device
into a generally spherical shape and to dislodge the spherical
device into the cervical canal and finally to expel it. Devices of
both main types may have substantial efficacy for their intended
purpose, as long as they are comfortably in place, but they cannot
work in the event they are easily or readily expelled or in the
event they produce discomfort and cramps. Clinical experience shows
that a large proportion of both types of such devices are in fact
expelled either within a very short time after introduction or
within a few months thereafter.
Some of the inflatable soft devices are filled with contraceptive
material for slow release but experience shows that material
concentration and release rate vary over a period of time. Also,
the soft devices usually require related holding and insertion
devices some of which are awkward.
It is therefore an object of the invention to provide an
intrauterine device that is so constructed and arranged as not to
provide undue pressure or pressure points within the uterus and
thus not to traumatize or excite extraordinary muscular
contractions leading to expulsion.
Another object of the invention is to provide an inflatable
intrauterine device that is soft and of a limited or predetermined
size to accommodate the normal movements, contractions and
peristaltic motions of the uterus without triggering expulsion
contractions.
Another object of the invention is to provide an intrauterine
device that can be inserted in compact form and then inflated or
expanded to its normal fixed size after insertion but which cannot
be made any larger than its initial, predetermined size even by
excessive inflation.
Another object of the invention is to provide an inflated
intrauterine device that can move readily with the uterus to
accommodate various movements thereof and without giving rise to
pressure points or localized stresses.
Another object of the invention is to provide an intrauterine
device that, although soft, is retentive of its predetermined shape
and so cannot assume a shape favorable to expulsion.
A further object of the invention is to provide an intrauterine
device which, although soft and inflatable, is nevertheless able
substantially to maintain its designed or original shape.
A further object of the invention is to provide an inflatable
intrauterine device that is not subject to expulsion in most
cases.
A further object of the invention is in general to provide an
improved intrauterine device.
Another object of the invention is to provide a method of making an
improved intrauterine device.
Another object of the invention is to provide for closely
controlled release over a long time of a contraceptive material
carried in the contraceptive device.
A further object of the invention is to provide for an improved
holding and insertion device for the intrauterine device.
Other objects, together with the foregoing, are attained in the
embodiment of the invention described in the accompanying
description and illustrated in the accompanying drawings, in
which:
FIG. 1 is a plan view, to a somewhat enlarged scale, of an inflated
intrauterine device constructed pursuant to the invention, a
portion of the filling tube being broken away;
FIG. 2 is a cross-section to the same scale as FIG. 1 and is taken
along the line 2--2 of FIG. 1;
FIG. 3 is a cross-section to the same scale as FIG. 1 and is taken
along the line 3--3 of FIG. 1;
FIGS. 4, 5 and 6 are illustrations of an applicator for use with
the intrauterine device, each figure showing a separate one of the
normally linearly arranged parts of the applicator, the
intrauterine device being shown in position thereon for
insertion;
FIG. 7 is a side elevation of a syringe utilized in connection with
the applicator of FIGS. 4, 5 and 6 and carrying a material such as
liquid for the appropriate inflation of the intrauterine
device;
FIG. 8 is an end view of the applicator;
FIG. 9 is a diagram of a test arrangement; and
FIG. 10 is a plot of force against deformation developed by a test
of a device according to the invention and made according to FIG.
9.
A somewhat related disclosure is in the application of Bartosik et
al. entitled "Intrauterine Device" and filed Feb. 2, 1971 with Ser.
No. 111,943, now abandoned. Also of interest may be the reference
patent cited therein as follows:
3,464,409 Murphy September 2, 1969 3,401,689 Greenwood September
17, 1968 2,893,385 Millar July 7, 1959 3,490,456 Kortum January 20,
1970 3,633,574 Lerner November 14, 1968
To avoid previous difficulties there is now provided a soft,
inflatable device which is inflatable to and remains substantially
in its predetermined shape even when subjected to the normal
peristaltic or other muscular motions of the uterine wall. The
device is so constructed and configured that, though soft, it has
some characteristics of a beam and so does not readily deform under
external forces. To this end there is provided a pair of sheets 6
and 7 that are, when flat, substantially triangular in plan, albeit
the corners of the triangle are somewhat rounded. The shape is not
precisely that of a triangle but is relatively close thereto and
can be so denominated. The sheets 6 and 7 are conveniently
fabricated of a very flexible, soft, non-toxic material
substantially impervious to usual inflating liquids. Silicone
rubber sheeting is suitable since it retains liquid used for
inflation but can pass some germicidal or spermicidal
materials.
Such sheeting is subject to expansion or extension or stretching,
particularly in an envelope under internal pressure. To avoid that
unwanted characteristic of the elastomeric material, there is
either included within the rubber-like sheets themselves or firmly
attached thereto a non-extensible mat 8 of fibers of material such
as Dacron. These are not extensible under the forces encountered in
this environment. The fibers are preferably arranged by weaving in
closely arrayed form. Each of the sheets 6 and 7, although it can
fold, is thereby prevented from changing its surface extent and
from stretching by the closely allied or imbedded, non-stretchable
Dacron cloth fibers. The cloth is coextensive with the rubber
sheets and is either well imbedded in the rubber sheet or is
attached on one side thereof so as to leave an exposed rubber
surface. When the rubber faces of the sheets are in immediate touch
or in surface juxtaposition, the rubber portions can easily be
sealed together.
In producing a device, two of the triangular sheets are arranged in
registry with the rubber sides together. They are then put into a
mold with vacuum on the exterior of the sheets to draw them apart
in many areas into mold cavities having the designed contour or
configuration of the ultimate, fully inflated device. This is a
carefully arranged, predetermined, three dimensional configuration
and leaves the sheet margins in abutment.
By heat sealing, applied adhesive or like technique, the two
mold-configured, three dimensional sheets 6 and 7, together with
their included restraining mats 8, are secured together all around
the periphery of the triangle. This results in a relatively planar
or flat, continuous, peripheral sealing band 9 of substantially
uniform width except for a gap 11 at one apex of the triangle
defined by the sheets. In this way there is afforded a three
dimensional pouch completely closed all around its edges by a
two-thickness circumferential band except at the gap 11.
While the wide band so afforded tends to establish and hold the
shape of the pouch, the technique is continued farther. At
convenient locations; for example, along each of the bisectors of
the triangle apices, is afforded an additional adhesively secured
or heat sealed area. Of these three areas the one near one apex is
denominated 12, another near the other apex is denominated 13 and
the one adjacent the gap 11 is denominated 14. There are thus
provided sealed areas 12, 13 and 14 corresponding to the bisectors
of the triangle apices and extending in the case of the areas 12
and 13 from the margin or band 9 toward and close to but not
exactly into a central zone 16 which is left unsealed and free.
Open to the central zone 16 and defined between the sealed areas
12, 13 and 14 are unsealed or free zones 17, 18 and 19 completely
intercommunicating. The zones are all open to the gap 11 and are
partly bounded along one side by walls 21, 22 and 23 substantially
parallel to the adjacent side walls of the triangle. The zones 17,
18 and 19 are so contoured or configured by the prior vacuum
molding and by the sealed portions adjacent to them that each zone
when fully inflated, as appears hereafter, has the shape and
approximate effect of a structural beam.
Preferably, the gap 11 in free communication with the interior
zones is supplied with sufficient fluid such as a gas or a liquid
so that the relaxed, unsecured, somewhat flaccid, molded sheet
portions are displaced from each other into their molded contour
but are not stretched because of the restraint imposed upon them by
the fibrous mat. When fully inflated the various zones 17, 18 and
19 bulge or round from the initial, somewhat wrinkled,
approximately planar contour of the uninflated device into the
maximum three dimensional, predetermined shape as preset by the
mold contour. The beam-like portions afford a structural stiffness
toward the maintenance of a flattish, certainly non-spherical,
relatively strong triangular configuration.
When in position and normally inflated the various zones 17, 18 and
19 can yield locally in small areas to externally imposed stresses
by some fluid displacement since the material of the device is
pliant. Thus pressure is not concentrated in any one localized area
to produce a pressure point or a local abrasion. The zones 17, 18
and 19, particularly when normally inflated, do not fold or wrinkle
easily and tend to act as beams with small deflection under load.
The usual muscular contractions and uterine movements are not
effective to displace one part of the structure toward or onto
another part to make the device assume the configuration of a ball.
The clinical experience has been that the normal uterine
contractions and muscular movements are readily accommodated
without any resulting cramping. The shape of the device is
maintained and there is no expulsion. Of a number of the present
devices installed, some under unfavorable physiological conditions,
the expulsion rate has to the date of filing this application been
zero.
It appears that the three elongated areas 12, 13 and 14 of contact
between the adjacent walls of the device, in effect forming a
sealed "Y," render the unsealed and inflated portions of the
structure substantially equivalent to three firm beams forming the
three sides of a stable triangle.
As an illustrative test, a tool as shown in FIG. 9 was made. This
includes two supports A and B spaced apart a distance D leaving a
gap about half the width of the intrauterine device. A bar C was
supported centrally of the distance D and above the supports A and
B and movable vertically downward. A Dalkon shield (a stiff or
rigid IUD) of a known size was placed on the supports spanning the
gap between them and the bar C was lowered with a force measured in
grams as shown in FIG. 10. The percentage of deformation of the
Dalkon shield with the imposed force was substantially linear up to
about 325 grams load and 70 percent deformation. Thereafter, with
greater load, the Dalkon shield yielded abruptly and broke at a
load of about 350 grams and 80 percent deformation as shown by the
curve E. The device described herein, of a size substituting for
the Dalkon shield, and inflated was similarly positioned on the
supports A and B as shown in FIG. 9. Load was imposed by lowering
the bar C. The increasing loads were accompanied by the percentage
deformation shown by the curve F. The device bent from the original
length L.sub.o to the deformed length L.sub.n, as shown in FIG. 9.
From zero up to a load of 100 grams, the present device had a
percentage deformation about twice that of the Dalkon shield and
between that load and about 250 grams the percentage deformations
of the two devices converged until both were about 50 percentage
deformation at above 250 grams. Thereafter, up to a load of about
600 grams the percentage deformation of the present device
increased only to about 60. Thus, the present device has a
non-linear relationship between load and percentage deformation
with a sharp decrease in percentage deformation between about 100
grams and 600 grams.
Since there is an increasing resistance to bending or distortion of
shape as load increases, the present, inflated intrauterine device
remains properly in the uterus and does not form a readily expelled
ball. Even though there is increasing resistance to deformation of
the device by the uterine muscles, they may still impinge upon
local areas of the relatively soft device without themselves being
traumatized or mechanically abraded.
Some of the prior art teaches that if the intrauterine device is
made bigger than or is inflated to a larger size than the cervical
canal or is inflated to expand against and dilate the uterine wall
the device cannot be expelled. This ignores the fact that the
uterus is an active muscle constantly in motion and that the os can
and does undergo manifold changes in diameter. In fact expulsion is
often triggered by pressure on the uterine wall due to the expanded
nature of even a pliant device. Other prior art indicates that if
the device is provided with sprags or projections or points, it
will interengage with the muscle wall of the uterus and thus be
anchored. The difficulty is that the anchoring force is the very
force which triggers contractions and causes the myometrium to
respond to the mechanical pressure by expulsive contractions.
In the present device there is no increase in local pressure, for
the device is substantially of the same dimensions as the normal
uterine cavity. The device avoids pressure points and abrasion
points. It abruptly resists deformation at higher pressures because
of the beam-like triangular sides. This precludes folding or
wadding of the device into a ball easily expelled through the
cervical canal.
Because of the compliant nature of this intrauterine device it
tends, as shown by clinical trials, to be well retained over
protracted times. It therefore is a suitable vessel for containing
contraceptive material for slow release over protracted times. A
difficulty is that many suitable liquid materials do not afford the
desired, substantially constant release rate. Consequently, in this
instance, the inflation liquid, usually isotonic saline solution,
preferably contains hormonal small crystals; for example,
progesterone. These afford a compact, long-term, supply diffusing
into the liquid and maintaining its concentration. In addition,
since there is sometimes a variation in the porosity of the
material of the intrauterine device itself, there is provided an
inner or outer coating of a material such as polyurethane having
known or closely controlled porosity or interstitial gaps for
release of the fluid hormonal contraceptive. In this way long-term
release is stabilized.
For application of the intrauterine device there is preferably
provided a relatively long, thin probe 26 having a handle 27 at one
end and having a slight, bulbous enlargement 28 at the other end.
The uninflated IUD is wrapped around the bulbous portion 28 and is
temporarily held in wrapped position by a removable, rounded cap
29. The cap can be of a material subject to disintegration in
uterine surroundings. There is attached to the intrauterine device
a tube 31 entering into the gap 11 and surrounded by a sleeve 32
which also encompasses and is fixed to an apex of the device in the
vicinity of the gap 11. There is free communication between the
tube 31 through the gap with the zones 17, 18 and 19. The tube 31
is provided with a loosely tied knot 33 and extends to a fitting
34. It is convenient to clip the fitting 34 into an appropriate
socket 36 on the handle 27. A syringe 38 with a movable plunger 39
is normally closed by a removable cap 41.
When the device is to be installed and inflated the cap can be left
in place or can be removed. The syringe is inserted into the
fitting 34, as indicated in FIG. 6. If the cap is not initially
removed, it shortly disintegrates or dissolves. The contents of the
syringe are expelled through the tube 31 and cause full inflation
of the device in situ. The tube 31 is then pulled, thus tightening
the knot 33 and preventing release of the injected fluid.
Thereafter the probe 26 is withdrawn and any excessive length of
the tube 31 is cut off. The installation has then been
accomplished. In some instances, although not generally, there may
be a preference for providing something other than the tube 31 as
an extracting means. In that instance, part of the band 9 near the
gap apex is provided with a perforation 51 and a fine cord 52 is
inserted therethrough and tied and is extended out alongside the
tube 31 to a more accessible location.
* * * * *