U.S. patent number 3,777,748 [Application Number 05/152,231] was granted by the patent office on 1973-12-11 for intrauterine contraceptive devices and inserters therefor.
This patent grant is currently assigned to G. D. Searle & Co.. Invention is credited to Harvey J. Abramson.
United States Patent |
3,777,748 |
Abramson |
December 11, 1973 |
INTRAUTERINE CONTRACEPTIVE DEVICES AND INSERTERS THEREFOR
Abstract
The present invention relates to intrauterine contraceptive
devices in the general shape of a "7" having a transverse arm and a
longitudinal arm dependent substantially from an end thereof;
method of contraception by insertion of such a device into the
uterus; instruments and methods for the insertion of intrauterine
contraceptive devices into the uterus without employment of forces
propelling said devices from the instruments in the direction of
the uterine fundus.
Inventors: |
Abramson; Harvey J. (New York,
NY) |
Assignee: |
G. D. Searle & Co.
(Chicago, IL)
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Family
ID: |
26652332 |
Appl.
No.: |
05/152,231 |
Filed: |
June 11, 1971 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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836371 |
Jun 25, 1969 |
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Foreign Application Priority Data
Current U.S.
Class: |
128/840 |
Current CPC
Class: |
A61F
6/142 (20130101) |
Current International
Class: |
A61F
6/00 (20060101); A61F 6/14 (20060101); A61f
005/46 () |
Field of
Search: |
;128/127,128,129,130,262,267 ;267/36 ;85/8.3,8.1 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Gaudet; Richard A.
Assistant Examiner: Dunne; G. F.
Parent Case Text
This application is a continuation-in-part of my copending U.S.
application Ser. No. 836,371 filed June 25, 1969, and now abandoned
and claims the priority of an application Ser. No. 11535 filed in
the Philippines on June 15, 1970.
Claims
What is claimed is:
1. An intrauterine device consisting essentially of two arms formed
of physiologically inert material and adapted to be placed in a
uterus, a first arcuate transverse arm and a second arcuate
substantially longitudinal arm coplanar with said first arm and
substantially dependent from one end thereof, said first transverse
arm bending concavely downwardly toward said second arm and said
second arm bending concavely downwardly from said first arm the
major portion of said second arm extending generally along a line
through the upper most point of said first arm.
2. An intrauterine device as in claim 1 wherein said first and
second arms are formed from a continuous length of spring wire
having a physiologically inert coating thereon.
3. An intrauterine device as in claim 2 wherein the physiologicaly
inert coating is polypropylene.
4. An intrauterine device as in claim 2 wherein the outside surface
further contains copper.
5. An intrauterine device as in claim 4, wherein a copper wire is
wound around at least one of the arms.
6. An intrauterine device as in claim 1 in which the transverse arm
has a downwardly concave flexure substantially in the midpoint
thereof.
7. An intrauterine device as in claim 1 in which said transverse
arm terminates in a generally rounded protuberance.
8. An intrauterine device as in claim 7 in which the outside
surface contains copper.
9. An intrauterine device as in claim 8 in which at least one of
said arms is wrapped with copper wire.
10. An intrauterine device as in claim 8 in which at least one of
said arms is plated with metallic copper.
11. An intrauterine device as in claim 1 in which said transverse
arm has a portion thereof in the shape of a substantially circular
arc and said longitudinal arm has an upper portion thereof in the
shape of a substantially circular arc and a lower portion thereof
which is substantially straight.
12. An intrauterine device as in claim 11 in which said transverse
arm is between about 20 and 38 millimeters in length and the
overall length of said device is between about 28 and 40
millimeters, said arms having a thickness of between about 1 and 3
millimeters at their thickest part.
13. An intrauterine device as in claim 12 in which said arc of said
transverse arm is between about 25-90.degree. and said arc of said
upper portion of said longitudinal arm is between about
45-120.degree..
14. An intrauterine device as in claim 1 in which the outside
surface contains copper.
15. An instrument for the insertion of an intrauterine device into
the uterus, said instrument comprising first barrel means for
accommodation of said intrauterine device, said first barrel means
having first stop means external to said barrel means in the
anterior portion thereof at a distance from the anterior end of
said first barrel means corresponding with a desired depth of
insertion of said first barrel means into the uterus; second barrel
means adjacent said first barrel means and extending to said first
stop means, said second barrel means having a keyway therein; and
bifurcate piston means in said first and second barrel means, said
piston means having second stop means at the anterior end thereof,
said second stop means being external to said second barrel means
and traveling in said keyway therein.
16. An instrument as in claim 15 wherein said first barrel means
are transversely slotted posterior to said first stop means for
accommodation of an intrauterine device partially within and
partially without said first barrel means.
17. An instrument as in claim 15 wherein said first barrel means
are axially slotted posterior to said first stop means for
accommodation of an intrauterine device partially within and
partially without said first barrel means.
18. An instrument as in claim 15 wherein at least that portion of
said first barrel means forward of said first stop means has an
elliptic cross-section.
19. In combination suitable for sterile packaging, an instrument as
defined in claim 15 and an intrauterine device in said first barrel
means thereof.
20. A combination as in claim 18 wherein said intrauterine device
comprises a first transverse arm having a downwardly concave
flexure substantially in the midpoint thereof and a second arcuate
arm, coplanar with said first arm and substantially dependent from
one end thereof.
21. A combination as in claim 20 wherein said device is folded
within said first barrel means.
22. In combination suitable for sterile packaging, an instrument as
defined in claim 16 and an intrauterine device in said first barrel
means thereof, said device comprising a transverse arm and a
longitudinal arm dependent therefrom, said dependent arm lying
axially within said first barrel mean and said transverse arm
extending outwardly from transversely slotted portions of said
first barrel means.
23. In combination suitable for sterile packaging, an instrument as
defined in claim 17 and an intrauterine device in said first barrel
means thereof, said device comprising a first transverse arm having
a downwardly concave flexure substantially in the midpoint thereof
and a second arcuate arm, coplanar with said first arm and
substantially dependent from one end thereof, said second arcuate
arm being positioned axially within said first barrel means and
said first transverse arm extending outwardly from axially slotted
portions of said first barrel means.
Description
The present invention relates to intrauterine contraceptive
devices; to methods of contraception employing said devices; to
instruments for the insertion of an intrauterine contraceptive
device into the uterus; to combinations, suitable for sterile
packaging, of an intrauterine contraceptive device and an
instrument for the insertion thereof into the uterus; and to
methods of inserting an intrauterine contraceptive device into the
uterus.
It is known in the prior art that the presence of a foreign object
in the uterus discourages conception. This phenomenon has been
medically exploited for the intentional prevention of conception by
insertion into the uterus of so-called intrauterine contraceptive
devices, such as the well-known Lippes loop, commonly comprising a
ring, spiral, or zigzag of a physiologically inert material,
commonly plastic.
The employment of these devices for the purposes of contraception
has heretobefore been subject to a number of disadvantages. First,
the devices of the prior art have generally been of such dimensions
as tend in situ to distort the uterus in the dorso-ventral and
lateral directions, thereby causing discomfort, bleeding, and
muscular spasms tending to eject the contraceptive device from the
uterus. Further, the structure of such devices has heretobefore not
always been such as to discourage involuntary ejection thereof from
the uterus. Also, the dimensions assumed by the prior art devices
when in a form suitable for insertion into the uterus either
prevent or make difficult their insertion into a nulliparous
cervical canal. Dilatation is often necessitated and requires
general anesthesia. Finally, the insertion of such intrauterine
devices has heretobefore been accompanied by a significant danger
of puncturing the uterine wall because insertion involves pushing a
device from suitable carrier instrument into the uterus in the
direction of the uterine fundus. By inadvertence or miscalculation,
the physician inserting the device may unknowingly push the device
into or through the uterine wall, thereby giving rise to serious
medical complications.
According to the present invention, intrauterine devices of such
dorso-ventral and transverse dimensions as minimize rejection
reactions have been devised. The novel structure of said devices,
further, discourages inadvertent or involuntary discharge of the
device from the uterus. Also, instruments for the insertion of
intrauterine contraceptive devices have been discovered, which
instruments do not require pushing forces in the direction of the
uterine fundus to deposit the devices in the uterus. The chances of
inadvertent puncturing of the uterine wall are thereby minimized.
Still further, combinations of these instruments with intrauterine
devices, including not only devices known in the prior art but also
the novel devices taught herein, have been discovered. These
combinations particularly lend themselves to sterile packaging as
an integral unit for immediate use by an attending physician and
disposal after use. Finally, methods of preventing conception
employing novel intrauterine contraceptive devices are disclosed
herein, as are novel methods of inserting intrauterine devices into
the uterus.
A better understanding of the present invention and of its many
advantages will be had by referring to the following drawings, in
which
FIG. 1 is a perspective view of an intrauterine device and an
instrument for the insertion of said device into the uterus;
FIG. 2 is a sectional view through the intrauterine device of FIG.
1 along the line 2--2 of FIG. 1;
FIG. 3 is an enlarged side view of the instrument of FIG. 1,
partially in section, showing the intrauterine device of FIG. 1
folded in anterior portions thereof;
FIG. 4 is an enlarged end view of the instrument of FIGS. 1 and 3,
showing an intrauterine device present folded therein;
FIG. 5 is a front view, partly in section, showing the instrument
of FIG. 1 inserted into the uterus and the contraceptive device of
FIG. 1 partially emergent therefrom;
FIG. 6 is the same view as FIG. 5 showing the further emergence of
the contraceptive device from the instrument for the insertion
thereof;
FIG. 7 is the same view as in FIGS. 5 and 6 showing the
intrauterine device in position in the uterus after withdrawal of
the instrument for insertion;
FIG. 8 is a side view of another embodiment of an instrument for
the insertion of an intrauterine device into the uterus, showing an
intrauterine device in combination therewith;
FIG. 9 is a plan view of the instrument and device of FIG. 8,
FIG. 10 is a sectional view of this same instrument taken along
line 10--10 of FIG. 8;
FIG. 11 is a further sectional view of this instrument and device
taken along line 11--11 of FIG. 8;
FIG. 12 is still another sectional view of this instrument taken
along line 12--12 of FIG. 8;
FIG. 13 is a side view of the instrument and device of FIGS. 8 - 12
showing the manner in which the instrument is readied for insertion
into the uterus for introduction of an intrauterine device
thereinto;
FIG. 14 is a side view of the same instrument, showing the
instrument in situ in the uterus;
FIG. 15 is a side view like that in FIG. 14, showing a later stage
in the insertion of an intrauterine device into the uterus;
FIG. 16 is the same view as in FIGS. 14 and 15 showing a still
later stage in the insertion process, and particularly showing an
intrauterine device present in the uterus and withdrawal of the
inserting instrument therefrom;
FIG. 17 is a front view, in section, taken along line 17--17 of
FIG. 16 showing an intrauterine device present within the uterus
after insertion thereof is complete;
FIG. 18 is a scale drawing of an embodiment of the intrauterine
device of the present invention;
FIG. 19 is an enlarged plan view, in section, of the device of FIG.
13 taken along line 199--19 of FIG. 13;
FIG. 20 is an enlarged plan view, in section, taken along line
20--20 of FIG. 15;
FIG. 21 is a perspective view of a preferred embodiment of the
intrauterine device of this invention comprising a transverse arm
and a longitudinal arm;
FIG. 22 is a sectional view through one section of the transverse
arm of the intrauterine devices of FIGS. 21 and 28 along the line
22--22 of FIGS. 21 and 28;
FIG. 23 is a sectional view through another section of the
transverse arm of the intrauterine device of FIG. 21 along the line
23--23;
FIG. 24 is a sectional view through the midsection of the
longitudinal arm of the intrauterine devices of FIGS. 21 and 28
along the line 24--24;
FIG. 25 is a sectional view through an end section of the
longitudinal arm of the intrauterine device of FIG. 21 along the
line 25--25;
FIG. 26 is an enlarged perspective view of the longitudinal arm of
a preferred alternate embodiment of FIG. 21 having a copper wire
wrapped around the arm;
FIG. 27 is a sectional view through a section of the intrauterine
device of FIG. 26 along the line 27--27;
FIG. 28 is a perspective view of an alternate embodiment of the
intrauterine device of this invention comprising a transverse arm
and a longitudinal arm with the transverse arm terminating in a
substantially hemispherical nub;
FIG. 29 is a sectional view through one section of the transverse
and longitudinal arms of the intrauterine device of FIG. 28 along
the line 29--29 of FIG. 28;
FIG. 30 is a perspective view of an alternate embodiment of the
intrauterine device of FIG. 28, as viewed from the line 30--30 of
FIG. 28, having a copper wire wrapped around the longitudinal
arm;
FIG. 31 is a sectional view of the aperture for attachment of
filament means to the device of FIG. 28 along the line 31--31 of
FIG. 28;
FIG. 32 is a partially sectional view of the intrauterine device of
FIG. 28 loaded in a folded configuration within an inserter
barrel;
FIG. 33 is a perspective view of the distal end of longitudinal arm
120 as viewed from the back side of FIG. 28;
FIG. 34 is a partially sectional view of the intrauterine device of
FIG. 28 loaded in an alternate configuration with the transverse
arm located outside of the inserter barrel.
Referring to FIGS. 1, 18, 21, 26 and 28 of the accompanying
drawings, it will be seen that the novel intrauterine contraceptive
devices of the present invention have the general shape of the
numeral "7," and comprise transverse arm 110 and longitudinal arm
120 dependent therefrom substantially at one end thereof.
The transverse and longitudinal arms of the device are proportioned
to be comfortably accommodated within the uterine cavity.
Transverse arm 110 suitably has an overall length of from 20 to 38
millimeters, whereas longitudinal arm 120 is of such dimensions
that the overall length of the device is from 28 to 40 millimeters.
The preferred dimensions depend on the size of the uterus which is
primarily dependent on the degree of parity. The multiparous,
primiparous and nulliparous uteri are generally decreasing in size
and may conveniently permit the use of correspondingly differently
sized intrauterine devices. The transverse and longitudinal arms of
the devices are coplanar and suitably have a thickness of from
about 1 millimeter to about 3 millimeters at the thickest part.
As shown in FIGS. 1 and 18, transverse arm 110 can optionally have
a flexure 130 substantially at the mid-point therein, flexed arm
110 being downwardly concave in the direction of longitudinal arm
120. If a line is drawn connecting the end points of transverse arm
110 and a perpendicular to this connecting line is dropped from the
mid-point thereof, the terminal portion of longitudinal arm 120
suitably lies on the perpendicular. Since longitudinal arm 120 is
dependent from an end of arm 110, longitudinal arm 120 is generally
arcuate.
In the devices of FIGS. 21 and 28, transverse arm 110 has the shape
of an arc and longitudinal arm 120 has an arched upper portion 132
and a generally straight lower portion 134. If the line of the
longitudinal arm 120 is extended upwardly, it will intersect the
transverse arm 110 at the uppermost portion of the arcuate
transverse arm 110. The arched portion of transverse arm 110 is
generally a substantially circular arc of between about
25.degree.-90.degree., preferably between about
40.degree.-60.degree., and the arched upper portion 132 of
longitudinal arm 120 is generally a substantially circular arc of
between about 45.degree.-120.degree., preferably between about
80.degree.-120.degree.. Such construction enables the arms to be
folded with minimum stress, i.e., the transverse arm and the
longitudinal arm can be folded in such a manner that the folded
transverse diameter will not be greater than the two transverse
arms and it will retain its shape.
The devices of FIGS. 18, 21 and 28 are suitably made in whole or in
part of a rigid but flexible physiologically inert material,
commonly a plastic such as polyethylene, polypropylene, nylon, a
poly (organo siloxane) such as that sold under the trademark
Silastic, "Dacron" or the like. Polypropylene is particularly
preferred. Barium sulfate or other barium compounds may be used
with the above materials as an aid in detecting the presence of the
device in the uterus. The device can also be constructed in whole
or in part of a metal such as silver, gold, platinum or preferably
copper or zinc.
Because of the device's small size and high retentive properties,
the device is an excellent carrier for more active fertility
regulating materials, especially elemental copper or zinc or both.
For example, as shown in FIGS. 26 and 30, zinc wire, copper wire,
or copper tubing 136 can be wound around the arms. Other means of
applying the metals are vacuum metallizing, partial impregnation of
metallic granules, and the use of one or more shaped forms such as
a chain or wire dependent from an arm.
Although the intrauterine device of the present invention can have
cylindrical arms as shown in FIGS. 1 and 18, the arms of the device
can also be in the shape of semi-cylinders as shown in FIGS. 22, 24
and 29. These meet at a cylindrical apex 144, as shown in FIGS. 23,
or at a substantially hemispherical nub 151, as shown in FIG. 28,
the arms being designed in such a manner that when the device is
folded, the flat portions come in contact and the folded device
takes up a smaller amount of space, as shown in FIGS. 21-24. The
limited amount of space taken up by the device in its folded
configuration is particularly desirable since the device can then
be inserted easily into nulliparous or primiparous patients with no
dilation of the cervical canal being required.
In the device of FIG. 28, transverse arm 110 terminates in a
generally rounded protuberance 151, preferably a substantially
hemispherical nub, and longitudinal arm 120 is dependent therefrom.
This novel configuration provides a gently rounded surface at the
anterior end of the inserter barrel when the intrauterine device is
loaded in its folded configuration within the barrel of the
inserter as shown in FIG. 32. That rounded surface facilitates
insertion of the device into the cervical canal and minimizes any
irritation which might occur. Typically, nub 151 is of sufficient
diameter to cover the edges of the insertion tube when the device
is loaded in its folded configuration as shown in FIG. 32.
Furthermore, the rounded nub allows the loaded inserter instrument
to be used as a uterine sounding device.
Notch 152 on nub 151, as shown in FIGS. 29 and 30, and groove 154,
as shown in FIGS. 31 and 33, provide space for the placement of
filament means attached to the distal end of longitudinal arm 120
when the device of FIG. 28 is located in its folded configuration
within the barrel of an insertion instrument as shown in FIG. 32.
The device of FIG. 28 may be loaded in an alternate folded
configuration within the inserter as shown in FIG. 34 wherein
transverse arm 110 is located outside of the inserter barrel and
longitudinal arm 120 is singularly located within the inserter
barrel.
As shown in FIG. 30, notches 153 provide locations for embedment of
the ends of the copper wire 136 which is optionally wrapped on
longitudinal arm 120.
The device of FIG. 1, shown in section in FIG. 2, comprises
resilient core 150 made of material such as spring wire (e.g. piano
wire) having coating 160 thereover. Coating 160 is suitably of a
physiologically inert substance such as those mentioned just above.
Additional resilience and ease of flexion is achieved in the
alternate device of FIG. 1 by forming coils 170 at flexure 130 of
transverse arm 120 and at the point at which longitudinal arm 120
is attached thereto.
Physiologically inert filament 180 is suitably attached to terminal
portions 140 of the devices of FIGS. 1 and 18 to facilitate their
removal from the uterus and, as will be seen, in some cases to aid
in their insertion into the uterine cavity. As shown in FIGS. 21,
25 and 28, the filament can be emplaced in aperture 148.
FIG. 1 further shown tubular instrument 190 comprising barrel 200
for accommodation of an intrauterine device. Stop means 21 are
located on the exterior portions of instrument 190 at a distance
from anterior end 22 thereof corresponding with a depth to which it
is desired to insert barrel 20 into the uterine cavity. Means 23
are provided at the posterior end of instrument 190 to facilitate
grasping and manipulation of the instrument.
FIGS. 3 and 4 show the intrauterine device of FIG. 1 and FIG. 21
mounted within barrel 200 of instrument 190 of FIG. 1. As is best
seen from FIG. 3, transverse arm 110 of the device is bent downward
from the point of attachment to longitudinal arm 120 to lie along
an axis substantially parallel to that of the longitudinal arm,
which position also requires some straightening of arm 110 at
flexure 130 in the case of the intrauterine device of FIG. 1.
Distortion of the device in this manner is possible because of the
inherent resiliency of the material of core 150 as well as
structural features such as coils 170. The device is loaded within
instrument 190 such that terminal portion 140 of longitudinal arm
120 is farthest from anterior orifice 22. Filament 180 extends from
terminal portion 140 out of orifice 22.
As is best seen from FIG. 4, barrel 200 is suitably elliptic in
shape, whereby the folded device is constrained within a plane
fixed with respect to inserting instrument 190.
FIGS. 5 - 7 show the insertion of a contraceptive intrauterine
device according to the present invention into the uterus employing
instrument 190 of FIG. 1. In particular, FIG. 5 shows instrument
190 in situ with barrel 200 inserted into uterus 24 until stop
means 21 abut exterior cervical os 25. By pulling on filament 180
downwards in the direction of the arrow, said filament extending
from anterior orifice 22 backwards along barrel 200 into the vagina
26, the contraceptive device lodged in barrel 200 is pulled
therefrom until emergence from anterior orifice 22 of coil 170 at
the junction of transverse arm 110 and longitudinal arm 120. The
arcuate shape of longitudinal arm 120 and the resilience of folded
transverse arm 110 tend to embed the juncture (coil 170) firmly
into the uterine wall at point 27. Because of this embedment at
point 27, further pulling on filament 180 exerts a downward force
on the rim of barrel 200 at anterior orifice 22 tending to retract
barrel 200 from the uterus.
This stage is shown in FIG. 6 of the accompanying drawings in which
barrel 200 is shown sufficiently retracted from uterus 24, and from
the intrauterine device therein, to permit escape of entire
transverse arm 110. Lateral pressure exerted by the resilient
material of the device around flexure 130 tends to embed the free
end of transverse arm 110 into the uterine wall at point 28.
Finally, FIG. 7 shows the intrauterine device in situ in the uterus
after complete withdrawal of the inserting instrument. It will be
evident from FIG. 7 that the device is firmly anchored in the
uterine cavity at points 27 and 28 already discussed, as well as at
point 29 at which terminal portion 140 of longitudinal arm 120
makes contact with the uterine wall. This three point contact is
highly effective in preventing inadvertent dislodgement or
expulsion of the device from the uterus.
As will further be seen from FIGS. 5 - 7, it is evident that
deposition of the intrauterine device within uterine cavity 24' has
been accomplished without pushing forces tending to move the device
in the direction of uterine fundus 30. Once the device has been
sufficiently expelled from barrel 200 for one end of transverse arm
110 to make contact with the uterine wall (cf. point 27 of FIG. 5),
further tension on filament 180 repels barrel 200 from uterus 24,
rather than propelling the intrauterine device from the barrel. In
this manner, the danger of puncturing uterine fundus 30 due to the
propulsion of an intrauterine device into the uterus by pushing
forces is greatly reduced.
FIGS. 8 - 12, in which the reference numbers respectively refer to
the same structural features, show a preferred embodiment of an
instrument for the insertion of an intrauterine contraceptive
device into the uterus.
The device shown in these Figures comprises first barrel 31 having
exterior stop means 32 positioned therealong at a distance from
anterior orifice 33 of barrel 31 corresponding to a desired depth
to which barrel 31 is to be inserted into the uterus.
The device shown in these figures similarly has second barrel 34
adjacent said first barrel and having a slot or keyway 35 (best
seen in FIGS. 11 and 12) therein. Bifurcate piston 36 slides within
barrels 31 and 34, and has first fork 37 in barrel 31 and second
fork 38 in barrel 34. Second fork 38 of piston 36 is provided with
stop means 39 external to barrel 34 movable within keyway 35
therein, as is best seen from FIG. 10.
First and second barrels 31 and 34 suitably have common grip means
40, advantageously fashioned to engage with the index and middle
finger of the hand. Similarly, piston 36 is provided with handle
means 41 which, when actuated (for example by thumb pressure),
cause simultaneous movement of piston forks 37 and 38 within
barrels 31 and 34 respectively.
The instrument of FIGS. 8 - 12 is there shown in combination with
an intrauterine device like that of FIG. 18 comprising transverse
arm 110, longitudinal arm 120, and filament 180 attached thereto.
The intrauterine device is suitably loaded into the instrument of
FIGS. 8 - 12 by insertion into transverse slot 42 in barrel 31
posterior to stop means 32. Longitudinal arm 120 lies axially
within barrel 31, which is advantageously further slotted in an
axial direction. Suitably, one or two axial slots are provided to
accommodate a transverse arm or arms of an intrauterine device.
These axial slots and their function can best be seen and
understood by referring to FIGS. 13, 14, and 19, and to FIGS. 15
and 20.
In particular, FIGS. 13, 14, and 19 show an intrauterine
contraceptive device positioned within barrel 31 of the instrument
shown in FIGS. 8 - 12. Transverse arm 110 of the device extends
from barrel 31 in one direction through axial slot 43 and, in the
other direction, through somewhat longer axial slot 44.
Longitudinal arm 120 of the device is within barrel 31 and extends
axially therealong. This "start" or "rest" position of the
intrauterine device is shown in FIG. 19 in dashed lines and
represents the preferred position of the intrauterine device in the
inserting instrument at the time of sterile packaging. In this
position, no forces are exerted on the flexible intrauterine device
which might tend to distort of malform it.
When the physician intends to insert an intrauterine device using
the combination shown in FIG. 13, he opens the sterile package in
which the device and inserting instrument are packed. As shown in
FIGS. 13 and 14, barrels 31 and 34 are conveniently grasped with
one hand and movable piston 36 with the other. The device is then
inserted into uterus 24, as in FIG. 14, until stop 32 on barrel 31
makes contact with exterior cervical os 25. Then, as shown in FIG.
15, pressure is applied to handle means 41 against counterpressure
applied to grip 40 to advance piston 36 forwards in barrels 34 and
31 until stop means 39, external to barrel 34 and traveling in the
keyway therein, also make contact with external cervical os 25.
As is best seen from FIG. 19, advancement of piston fork 37 within
barrel 31 causes the intrauterine device therein to fold itself
within barrel 31 into the position shown in solid lines in FIG. 19.
To distinguish the rest position and the folded position in FIG.
19, the reference numerals referring to the folded position have
been primed.
Thus, upward pressure on piston 37 of FIG. 19 causes arm 110 of the
intrauterine device to pivot counter-clockwise around a pivot point
at the upper end 45 of shorter axial slot 43. As further upward
pressure is exerted on the device by piston 37, transverse arm 110
ascends, enters longer axial slot 44 in barrel 31, and folds back
on longitudinal arm 120 until the arms assume the positions 110'
and 120' shown in solid lines in FIG. 19. The folding of the device
within barrel 31 also causes some advancement of the device within
the barrel, e.g. such that terminal portion 140 moves to a new
position 140'.
When stop 39 external to barrel 34 contacts exterior cervical os
25, as shown in FIG. 15, because of upward pressure on piston fork
38, piston fork 37 will have accomplished the folding of the
intrauterine device within barrel 31 anc caused advancement of the
device substantially to anterior orifice 33 of barrel 31, as shown
in FIG. 15 and, particularly, in FIG. 20. At this time, the device
is in position in the uterus, but is still sheathed within barrel
31. In the region of orifice 33, interior 31' of barrel 31 is
preferably elliptic to maintain the device in a fixed plane with
respect to the instrument (cf. FIG. 12).
As shown in FIG. 16, further pressure on handle means 41 cannot
cause further forward movement of piston 36 because of the
impedance of the forward movement of piston fork 38 by contact of
stop means 39 thereon with exterior cervical os 25. Rather, the
instrument, comprising barrels 34 and 31, will tends to retract
from the uterus in the direction of the arrow shown in FIG. 16,
permitting the escape of the folded intrauterine device from
anterior orifice 33. Piston fork 37 within barrel 31 retains a
fixed position relative to the uterus during this stage. It is the
retrograde movement of barrel 31 downwards along piston fork 37
which causes unsheathing of the device within the uterus. The
instrument is withdrawn from around the intrauterine device when
the device is in situ in the uterus. There is no propulsion of the
device from the instrument by any pushing forces in the direction
of uterine fundus 30. Proper planarity of the device with respect
to the uterus is assured by elliptic interior 31' of barrel 31 and
by the proper orientation of barrel 31 (and the instrument) to the
uterine cavity.
FIG. 17 shows the device in situ in uterus 24 after insertion. As
in FIG. 7, lateral and longitudinal arms 110 and 120 of the device
make a three-point contact with the uterine wall at points 27, 28,
29, imparting particular stability to the device against accidental
dislodgement from the uterus.
It is to be understood that the instrument shown in FIGS. 8 - 12
need not be used in conjunction with novel "7"-shaped intrauterine
contraceptive devices particularly shown in the drawings and
described in this specification. Rather, a device of a shape known
in the prior art, such as a zig-zag or vermiform device, may be
loaded within barrel 31 of the instrument prior to sterilization
and packaging. Pre-packaging of a device of such a shape, however,
entails the risk that the device will become distorted while
constrained within the barrel 31 of the instrument, especially on
long storage.
The instrument shown in these Figures can, however, also be
employed with other intrauterine devices which are packed in
combination with the instrument in an unstrained state. For
example, thus, the "7"-shaped device of the present invention can
be replaced with a "T"-shaped device, in which case it is suitable
to make axial slots 43 and 44 in barrel 31 of the instrument (cf.
FIG. 19) of substantially equal length. Pressure on piston 36
causes fork 37 thereof to fold such a "T"-shaped device into barrel
31 in the shape of an arrow, with the arms of the "T" folded back
along the longitudinal arm.
Still further, a contraceptive device in the shape of an inverted
"L" can be combined in an unstrained condition with the instrument
of FIGS. 8 - 12. For folding such a device, the transverse arm of
the "L" may extend from a single axial slot in barrel 31, or an
axial slot may be dispensed with altogether, in which case the
transverse arm merely extends from transverse slit 42 in barrel
31.
The material from which the instruments contemplated according to
the present invention can be fashioned is not critical. However,
the use of plastics is particularly convenient because the devices
can be cheaply manufactured and then disposed of after use. The
manufacture of the barrel from transparent or semi-transparent
plastic materials permits the physician to observe the proper
functioning of the device.
Although illustrative embodiments of the present invention have
been described herein with reference to the accompanying drawings,
it is to be understood that the invention is not limited to those
precise embodiments and that various changes and modifications may
be effected therein by one skilled in the art without departing
from the scope or spirit of this invention.
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