U.S. patent number 3,703,896 [Application Number 05/102,363] was granted by the patent office on 1972-11-28 for intrauterine contraceptive device.
This patent grant is currently assigned to Abcor, Inc.. Invention is credited to Elie S. Nuwayser.
United States Patent |
3,703,896 |
Nuwayser |
November 28, 1972 |
INTRAUTERINE CONTRACEPTIVE DEVICE
Abstract
A three-dimensional intrauterine contraceptive device which
conforms in an infinite manner to the internal geometric shape of
the uterine cavity. The device is comprised of a plurality of
resilient interconnected rib-like members which define a generally
cylindrical-type shape. The device is inserted into the uterine
cavity in a compressed condition. Upon release from a holder the
device expands outwardly engaging the walls of the uterine cavity
to provide an effective contraceptive device.
Inventors: |
Nuwayser; Elie S. (Peabody,
MA) |
Assignee: |
Abcor, Inc. (Cambridge,
MA)
|
Family
ID: |
22289453 |
Appl.
No.: |
05/102,363 |
Filed: |
December 29, 1970 |
Current U.S.
Class: |
128/839 |
Current CPC
Class: |
A61F
6/142 (20130101) |
Current International
Class: |
A61F
6/00 (20060101); A61F 6/14 (20060101); A61f
005/46 () |
Field of
Search: |
;128/130,131,127,82.1 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
|
|
|
|
|
|
|
981,389 |
|
Jan 1965 |
|
GB |
|
150,127 |
|
Apr 1904 |
|
DD |
|
Primary Examiner: Trapp; Lawrence W.
Claims
Having described my invention, what I now claim is:
1. A three-dimensional intrauterine contraceptive device, which
device comprises:
a plurality of elongated members forming an elongated loop,
successive members joined at alternate ends to form said elongated
loop, the members adapted to engage and conform in a resiliant
manner to the wall of the uterine cavity, the members defining
therebetween a fluid-flow zone open at each end, and comprising an
upper and a lower zone, the zone facilitating the passage of
menstrual fluids during the monthly cycle, the members of the upper
fluid zone adapted to engage and contact directly the area of the
uterotubal junction, while the members of the lower fluid zone are
adapted to avoid contact with the cervical os.
2. The device of claim 1 wherein said members form a continuous
sinusoidal wall about the periphery of the three-dimensional
device.
3. The device of claim 1 wherein the loop members of the device
form a funnel-shaped fluid-flow zone.
4. The device of claim 1 wherein the loop members are arcuate in
form and define a globe-like fluid-flow zone.
5. The device of claim 1 which includes means to remove the device
from the uterine cavity.
6. The device of claim 1 which includes loop members comprising an
inert synthetic polymeric material.
7. The device of claim 1 wherein said loop members comprise a metal
known to reduce the incidence of pregnancy.
8. The device of claim 1 which includes a screen-like fabric
material secured to at least a portion of the device.
9. The device of claim 8 which includes a screen-like fabric
material secured across the upper or lower opening of the
fluid-flow zone.
10. The device of claim 8 wherein the screenlike fabric material is
secured to the loop members to form all or a portion of the
peripheral wall of the device.
11. A three-dimensional intrauterine device which comprises a
plurality of elongated loop members in generally sinusoidal form,
said members adapted to engage and conform in a resilient manner to
the walls of the uterine cavity, the loop members defining a
generally funnel-shaped fluid-flow zone open at each end and
comprising an upper and a lower zone, said members of the upper
zone adapted to engage and to contact directly the area of the
uterotubal junction, while the members of the lower fluid zone are
adapted to avoid contact with the cervical os.
12. The device of claim 11 which includes a screen-like inert
fabric material secured to at least a portion of the device.
13. The device of claim 11 which includes a screen-like fabric
secured across the upper or lower ends of the funnel-shaped
fluid-flow zone.
14. The device of claim 11 which includes a screen-like fabric
secured to the loop members in a continuous manner about the wall
of the device as defined by said members.
15. The device of claim 11 wherein the members comprise an inert
synthetic polymeric material or stainless steel.
16. The device of claim 11 which includes a filament means to
remove the device, the filament means interwoven between the lower
loop members and adapted to reduce the diameter of the lower
portion of the device when tension is applied to said filament,
thereby permitting the removal of the device from the intrauterine
cavity.
17. The method of preventing pregnancy by the employment of an
intrauterine contraceptive device, which device includes a
plurality of resilient loop members, which method comprises:
a. inserting the device in a compressed condition into the uterine
cavity;
b. expanding the device in the uterine cavity to provide a
plurality of elongated members forming an elongated loop,
successive members joined at alternate ends to form said elongated
loop, the members forming a fluid-flow zone open at each end
comprising an upper zone and a lower zone, the upper zone having
the same or a greater flow size than the lower zone; and
c. contacting the area about the uterotubal junction with the loop
members defining the upper end of the fluid zone while avoiding
contact with the cervical os of the lower and of the loop members
defining the lower fluid-flow zone, thereby permitting the passage
of menstrual fluid through the fluid-flow zone between said
members, the members on expansion engaging and conforming in a
resiliant manner to the wall of the uterine cavity.
18. The method of claim 17 which includes the step of removing the
device from the uterine cavity by reducing the diameter of the
lower portion of the members in the lower fluid-flow zone by the
application of tension.
19. The method of claim 17 which includes inserting a screen-like
fabric material across at least a portion of the fluid-flow zone,
the fabric providing for the passage of menstrual fluid
therethrough by limiting the diameter of the loop members at the
lower end of the fluid-flow zone.
20. The method of claim 17 which includes securing a screen-like
fabric material about the wall of the device as defined by the loop
members.
21. The method of claim 17 which includes the step of providing a
funnel-shaped fluid-flow zone formed by the loop members.
22. The method of claim 17 which includes forming the loop members
into a globe-like structure wherein the upper and lower ends of the
fluid-flow zone are similar in flow diameter and the loop members
are arcuate in form.
Description
BACKGROUND OF THE INVENTION
One of the most effective methods of contraception is the use of
intrauterine devices (IUD). Although many theories have been
presented describing the mode of action of IUDs, the most popular
is that recently proposed by Sagiroglu. This theory states that a
foreign body in the uterus produces a foreign body reaction, with
subsequent accumulation of a high concentration of leukocytes in
the uterine cavity. The leukocytes in turn prevent fertilization of
the ovum by the spermatozoa. One of the essential elements of this
theory is that it requires maximum contact between the foreign
device and the uterine lining. Furthermore, in order to allow
maximum reaction time between the leukocytes, spermatozoa, and
blastocyst, in case of fertilization, the device should be as close
as possible to the uterotubal junction and make maximal contact
with the posterior and anterior walls of the uterine cavity.
Numerous intrauterine devices have been designed and are currently
in use. These are for the most part two dimensional in
configuration and do not conform to the size or shape of the
uterine cavity. They usually suffer either from a high expulsion
rate, a high pregnancy rate, or a high rejection rate due to pain
or bleeding. These three factors are the most important criteria
used today for evaluating the performance of all intrauterine
devices. In general, it has been found that if one device has a low
rate of pregnancy it may fail in one or both of the other
properties. Another important property which in this case will
facilitate the wide spread use of the intrauterine device, is the
need for dilatation of the cervical os. Some devices, although
quite efficacious, require chemical dilatation of the cervical os
for insertion. This highly specialized operation, however, must be
performed only by a physician who is trained in the procedure of
controlled administration of drugs having the desired local
dilatatory properties. A similar operation may also be required
when the device is withdrawn from the uterine cavity. The
dilatation procedure places a certain constraint on the ease of
application of the device and the time required for its insertion
and removal. It limits its widespread use, especially in places
where only paramedical personnel are available. Furthermore, it
adds to the total cost of inserting the device. From this, it is
obvious that an intrauterine device which does not require the
additional step of dilatation during insertion and withdrawal is
superior to another that requires it.
SUMMARY OF THE INVENTION
The ideal intrauterine device is one which satisfies all the above
criteria. It should produce a very low pregnancy rate, expulsion
rate, and rejection due to pain and/or bleeding. Furthermore, it
should not require pretreatment of the patient with other drugs.
The device I have developed is three dimensional and conforms to
the size and shape of the uterine cavity. It also does not require
dilatation of the cervical os for insertion or removal. Based on
results obtained with other intrauterine devices which have some of
the elements of this device, it is expected that the three
dimensional device will have a very low pregnancy rate, expulsion
rate and rejection rate due to either pain and/or bleeding.
Its three dimensional configuration conforms in an infinite manner
to the internal geometrical shape of the uterine cavity. Its low
resistance or elastic design permits continuous flexing and bending
with changes in the uterine size and shape during menstruation. It
is thus capable of compression under the lateral forces of the
uterus. This ability to conform in a three dimensional manner to
the uterine lining is especially important since the human uterus
also varies in size and shape from one individual to another.
The device may be inserted with the popular straw-type introducer
and is released in a uni-directional fashion. This eliminates the
need for dilatation of the cervical os before insertion, insures
its symmetrical location in the uterus and uniform distribution of
the pressure against the walls of the cavity. The upper open end of
the device produces direct contact between the device and the
uterotubal junction. This is important for producing minimal
pregnancy rates.
The lower end of the device is also open and does not have the
usual tail. Its broad, cervical base makes expulsion of the device
very difficult since it does not come in contact with the cervical
os, a zone which is known to be sensitive and which responds to
foreign objects by producing contractile motions, which in the past
have been the primary cause of expulsion of other intrauterine
devices. Both the open upper and lower ends of the device greatly
facilitate the passage of menstrual fluids during the monthly
cycle. The device is thin and has minimal volume. Its smooth,
contoured surface especially when coated with a medical grade soft
tissue substitute material such as medical grade silicone rubber,
will produce minimal pain and bleeding reactions. Further, the
device is easily removed by pulling a filament attached to its
lower end. This operation reduces the diameter of the lower opening
of the IUD to that of the cervical os, which allows the device to
pass through the cervix into the vaginal cavity.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a perspective view of the invention;
FIG. 2 is a front view of the device in the uterine cavity;
FIG. 3a is a side view of FIG. 2;
FIG. 3b is the device in view of FIG. 3a in the uterine cavity
during the menstrual cycle;
FIG. 4 is a schematic illustration of an alternative embodiment of
the invention;
FIG. 5 is a schematic illustration of a still further embodiment of
the invention;
FIGS. 6a and b are variations of a still further embodiment of the
invention.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
The device is shown generally in perspective view in FIG. 1 at 10
and is formed from a resilient material, such as spring stainless
steel wire. In order to minimize endometritis, the wire may be
coated with a synthetic, inert polymer, such as silicone rubber,
polyethylene, Teflon, a fluoronated hydrocarbon, polypropylene,
etc. Alternately, it can be constructed from a hydrocarbon
material, such as a parafin, for example polyethylene. Referring to
FIGS. 2 and 3, the device or daisy 10 as shown is inserted in the
uterine cavity 12. The device comprises a plurality of continuously
joined elongated loops 14. As previously stated, the device may be
inserted with the straw-type introducer as is well-known and is
released in a uni-directional fashion. The device or daisy when
inserted into the uterine cavity prior to its release from the
introducer is about 3 millimeters in diameter in its compressed
condition. When released, it will expand from about 25 to 55
millimeters depending upon the size of the uterine cavity. This
expansion allows the device to expand with varying diameters along
its axial length to intimately conform to the surface of the cavity
walls.
The upper open end 16 of the device 10 produces direct contact
between the device and the uterotubal junction 18. The broad
cervical base 20 defined by the lower loop ends 22 of the device
insures that the device does not come into contact with the
cervical os 24. The volumetric area defined by the device and its
upper and lower ends as shown in FIG. 2 provides a funnel-shaped
zone to facilitate the passage of menstrual fluids during the
monthly cycle. Because of the flexibility and resiliency of the
device 10, it is easily removed by pulling a filament 26 secured
thereto. The filament 26 is interwoven through the bottom loops
such that when the filament is pulled the lower loops are drawn
together diminishing the circumferential area. This reduces the
diameter of the lower opening 20 of the device 10 to that of the
cervical os 24 which allows the device to pass through the cervix
into the vaginal cavity 28. Referring to FIGS. 3a and b, the
efficiency and compatibility of the device are shown in that in the
lateral cross section as portrayed the device through its
three-dimensional aspect and resiliency conforms to the shape of
the uterine cavity during the menstrual cycle.
In FIG. 4, an alternative embodiment of the preferred embodiment is
shown wherein a fabric, either nonwoven or woven, for example, a
screen-like or lace fabric material, such as lace 30, covers the
lower end 20 and upper end 16 of the device 10. This provides for
the passage of menstrual fluids therethrough while limiting the
diameter of the device at this end which helps reduce the expulsion
and penetration of the device into the walls of the cervix. The
upper end of the device is shown as being covered with a fabric or
lace 30 to provide contact with the fundus thus helping enhance the
foreign body reaction and subsequent accumulation of leukocytes.
The combination of the device with the fabric provides maximum and
positive contact with the uterine cavity in all directions. For
example, to increase the foreign body (surface area of the device)
contact with the uterine walls the fabric may be disposed entirely
on the inner portion of the device, entirely on the outer portion
of the device, or threaded through the elongated loops 14 as shown
in FIG. 1. The fabric may also be secured between the rib-like
members to form a web-like surface. The fabric may cover all or a
portion of the device in any geometric arrangement thereon.
Further, the fabric used on the walls of the device may be more
sheer than that which covers the top and bottom opening, that is,
the interstices may be of a smaller dimension. Natural or synthetic
elastomers may be used in combination with the materials to form
the fabric or they may be used in lieu thereof.
A modification of the device of FIG. 4 would be to envelop the
whole device with a fabric such as a lace fabric. This would aid
significantly in nurturing the accumulations of leukocytes in the
interstices of the fabric structure. For the type of lace fabrics
which may be employed with the device, either at one end or the
other end or both ends of the device or completely enveloping the
device in the lace fabric or covering a portion thereof, the lace
fabric of course must be medically acceptable for incorporation
into the body cavity.
A further embodiment of the invention relating to its structure is
shown in FIG. 5 wherein a plurality of flexible members 34
intersect and are secured at 36 to define two cone-shaped zones 38
and 40.
Referring to FIGS. 6a and b, still further embodiment of the
invention is shown wherein a cage-type structure 42 having a
plurality of rib-like members 44 define a globe-like volume having
upper and lower open ends 46 and 48. A modification of this
embodiment is shown in FIG. 6b wherein the rib-like members extend
completely from one to the other end of the central axis about
which the member 42 is formed.
In addition to the components of construction mentioned above, if
the device is composed of metals, the metal may be composed of
copper or copper alloys or similar metals known to reduce
significantly the incidence of pregnancy. The fabric, whether woven
or nonwoven, should preferably be screen-like to allow for the
passage of fluids therethrough. The fabric, as the device, may be
formed from metallic materials, such as steel, copper and their
alloys, platinum, etc., nonmetallic materials, such as from a
variety of organic polymers and also from inorganic compounds which
offer the advantages of intertness, complete stability and a wide
range of surface properties. For example, organic materials, such
as polymeric materials which would include silicones, fluorinated
polymers, cellulose and its derivatives, polyesters, polyolefins,
vinyls, polyamides, etc., may be used.
Further, any of the devices shown may be constructed of these
materials or coated in whole or in part with a fabric such as a
lace-type fabric or a flock or nonwoven flock in order to increase
the surface area of the device which is exposed to the uterine
wall, thus increasing the formation of leukocytes.
* * * * *