U.S. patent number 3,918,445 [Application Number 05/462,582] was granted by the patent office on 1975-11-11 for inserter for intra-uterine device (iud).
This patent grant is currently assigned to Fuji Latex Co., Ltd.. Invention is credited to Atsumi Ishihama, Takeo Komamura, Tadao Okamoto.
United States Patent |
3,918,445 |
Okamoto , et al. |
November 11, 1975 |
Inserter for intra-uterine device (IUD)
Abstract
The inserter is designed to receive and hold an intra-uterine
device (IUD), as well as to insert the IUD in the uterus, and
comprises two opposed holding members, which are U-shape in
cross-section, which conjointly define an elongated tubular element
which preferably is slightly bowed. At a zone intermediate the ends
of the inserter, and substantially at its midpoint, the two holding
members are spread apart or opened to form an IUD receiving and
holding portion. In use, a cervix shield portion of the inserter is
inserted into the uterus, the cervix shield portion extending from
the receiving and holding portion to the inner end of the inserter,
and the inner end is tapered. A plunger is then inserted in the
outer end of the inserter to engage the IUD and move it through the
cervix shield portion out the inner end of the inserter and into
the uterus, after which the inserter is withdrawn. Elastic bands or
the like hold the U-shape members in engagement with each other, to
form the tubular inserter, while allowing the holding members, in
the cervix shield portion, to expand to facilitate movement of the
IUD therethrough. The spread apart portion of the inserter may be
provided with supporting surfaces for an IUD and may have the shape
of a flat trumpet.
Inventors: |
Okamoto; Tadao (Tokyo,
JA), Komamura; Takeo (Tokyo, JA), Ishihama;
Atsumi (Morioka, JA) |
Assignee: |
Fuji Latex Co., Ltd.
(JA)
|
Family
ID: |
12070277 |
Appl.
No.: |
05/462,582 |
Filed: |
April 19, 1974 |
Foreign Application Priority Data
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Feb 26, 1974 [JA] |
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49-21984 |
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Current U.S.
Class: |
128/840 |
Current CPC
Class: |
A61F
6/18 (20130101) |
Current International
Class: |
A61F
6/00 (20060101); A61F 6/18 (20060101); A61F
005/46 () |
Field of
Search: |
;128/127-131,263,264,270,271
;206/306,307,363,438,439,63.3,485,817 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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351,772 |
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May 1905 |
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FR |
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128,032 |
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Dec 1931 |
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OE |
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109,229 |
|
Nov 1927 |
|
OE |
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632,812 |
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Dec 1949 |
|
UK |
|
Primary Examiner: Trapp; Lawrence W.
Attorney, Agent or Firm: McGlew and Tuttle
Claims
What is claimed is:
1. An inserter for an intra-uterine device for contraceptive use
comprising, in combination, a pair of elongated continuous and
facing substantially U-shape cross-section members forming an
elongated intra-uterine device holding and guiding element, said
members being spaced apart only at a relatively short zone
intermediate their ends to form a widened receiving and holding
portion for an expanded IUD, said receiving and holding portion
being constituted by two opposed and laterally spaced coextensive
and uninterrupted intermediate portions of said continuous U-shape
cross-section members which latter are otherwise in contact with
each other throughout the length of said holding and guiding
element.
2. An inserter, as claimed in claim 1, including a cervix shield
portion extending from said receiving and holding portion and
communicating therewith; said cervix shield portion being
constituted by uninterrupted portions of said two U-shape
cross-section members forming a tube; and means retaining said
last-named portions of said members in engagement with each
other.
3. An inserter, as claimed in claim 2, in which said retaining
means comprises at least one resilient member embracing said cervix
shield portion forming portions of said members to provide for
elastic lateral spreading thereof to some extent.
4. An inserter, as claimed in claim 3, including a tubular plunger
guiding portion extending outwardly from said receiving and holding
portion to receive and guide a plunger into engagement with an
intra-uterine device received and held in said receiving and
holding portion to move the intra-uterine device into, through and
out of said cervix shield portion.
5. An inserter, as claimed in claim 4, in which said receiving and
holding portion includes a supporting surface extending thereacross
between said spaced apart portions of said members.
6. An inserter, as claimed in claim 4, in which the junction
between said receiving and holding portion and said cervix shield
portion is shaped like a flattened trumpet.
7. An inserter, as claimed in claim 4, including an elongated
plunger inserted through said holding and guiding element to engage
an intra-uterine device to move the device from said receiving and
holding portion into, through and out of said cervix shielding
portion; said plunger having an outer manipulating end and an inner
end engageable with an intra-uterine device in said receiving and
holding portion; said plunger having, adjacent its outer end and at
a point spaced from its inner end by a distance equal to the length
of said holding and guiding element, a first reference mark, and
having, at a distance inwardly from said first reference mark equal
to the length of an intra-uterine device, a second reference mark;
said plunger being inserted through said holding and guiding
element up to said first reference mark.
8. An inserter, as claimed in claim 4, in which said cervix shield
portion has thereon at least one reference mark indicating the
depth of insertion.
Description
FIELD AND BACKGROUND OF THE INVENTION
This invention relates to contraceptive appliances for preventing
the fertilized ovum from being deposited on the bed of the uterus
by inserting an intra-uterine device (IUD) made of synthetic resin
into the uterus and, more particularly, to a novel and improved
inserter enabling a user to insert and set the IUD in the uterus by
setting the IUD in the inserter beforehand and using a plunger to
push the IUD through the inserter and out the inner end thereof
into the uterine cavity.
There are conventional devices of this kind, such as loop and
Dalkon types, in a ring form. For inserting such contraceptive
devices into the uterus, the cervix must be expanded and the cervix
tends to be harmed often by such expansion. As a consequence, many
users may suffer from such harmful effects as pain and
bleeding.
There are some other improved devices which are not in a ring form,
and which are still incapable of storing an IUD beforehand, due to
lack of full restoration of the original shape of the synthetic
resin IUD. Thus, an IUD must be set, just before insertion into the
uterus, into the tube of such a device by pulling threads attached
to the IUD. The IUD is then inserted and set in the uterine cavity
by means of a cylinder.
SUMMARY OF THE INVENTION
The invention is directed to an inserter for an intrauterine device
(IUD) for contraceptive use, in which the inconveniences of prior
art devices are eliminated. For the sake of brevity the term "IUD"
will be used, hereinafter, to designate an "intra-uterine
device."
An objective of the invention is to provide an IUD inserter by
means of which it is possible to insert an IUD into the uterus
instantly without mechanical harm to the cervix, merely by
introducing a plunger into the inserter in which the IUD has
already been set.
Another objective is to provide an inserter into which an IUD may
be set and kept in its original form, so as to be used without
undesired deformation even after a long period of storage.
In further accordance with the invention, the inserter has a cervix
shield portion at its leading end formed of two opposed members, of
U-shape cross-section arranged in facing engagement in such a
manner as to be freely spread apart to some extent for feeding an
IUD through the cervix shield portion, with the IUD being expanded
as it passes through the cervix shield portion without causing any
mechanical injury to the cervix.
For the purpose of receiving an IUD, the inserter has, intermediate
its ends, a spread apart or open IUD receiving and holding portion
shaped and adapted to hold various types of IUDs, different in
shape and size, firmly therein and permitting easy insertion of the
IUD into the cervix shield portion of the inserter.
A further object of the invention is to provide such an inserter
which enables a user to insert an IUD properly in the uterus
without the use of any probe, by making good use of an
interrelation in length between the inserter and a plunger for
inserting the IUD.
For an understanding of the principles of the invention, reference
is made to the following description of typical embodiments thereof
as illustrated in the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
In the drawings:
FIG. 1 is a front elevational view, partly cut away, of an inserter
embodying the invention;
FIG. 2 is a side view, partly cut away, of the inserter shown in
FIG. 1;
FIG. 3 is an end elevation view taken along the line III--III of
FIG. 2, looking in the direction of the arrows;
FIG. 4 is an end elevation view, taken along the line IV--IV of
FIG. 3, looking in the direction of the arrows;
FIG. 5 is a front elevation view, partly broken away, of a plunger
for use with the inserter;
FIG. 6 is an end elevation view, taken along the line VI--VI of
FIG. 5, looking in the direction of the arrows;
FIG. 7 is a front elevation view, partly cut away, of a spread or
open portion of the inserter;
FIG. 8 is a front elevation view of an IUD;
FIG. 9 is an exploded perspective view of another inserter
embodying the invention, and its associated plunger;
FIG. 10 is a front elevation view, partly broken away, of the
spread or open portion of the inserter shown in FIG. 9;
FIG. 11 is a transverse sectional view taken on the line XI--XI of
FIG. 10 and looking in the direction of the arrows;
FIG. 12 is a front elevation view, partly broken away, of the
spread or open portion of still another inserter embodying the
invention;
FIG. 13 is a transverse sectional view, taken along the line
XIII--XIII of FIG. 12, looking in the direction of the arrows;
FIG. 14 is a front elevational view of another form of IUD;
FIG. 15 is a side elevation view of the IUD shown in FIG. 14;
FIG. 16 is an explanatory view illustrating the use of the inserter
and showing an IUD just before the setting thereof in the utuerus;
and
FIG. 17 is a view similar to FIG. 16 and illustrating the setting
of the IUD in the uterus.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
As previously mentioned, the present invention is directed to an
inserter for an IUD, such as a contraceptive ring. In conventional
inserters, such a ring device must be set therein at each time a
ring device is to be inserted, and in practice, this is very
troublesome. The invention is accordingly directed to an inserter
which provides for previous setting of an IUD in the inserter,
before use of the IUD, and immediate setting of the IUD into the
uterus simply by inserting a plunger through the inserter to move
the IUD out of the inner end of the inserter and into the
uterus.
In accordance with the invention, as shown in FIGS. 1 through 8, an
inserter 1 for an IUD, such as a contraceptive ring, has a spread
or open portion 2 provided at about its midportion, this spread or
open portion being formed by two holding members c and d arranged
in opposition to each other and U-shape in cross-section for
holding the IUD, such as a contraceptive ring. With the inserter of
the invention, an IUD 9, shown in FIG. 8, can be set beforehand or
stored in the spread portion 2 of the inserter 1. Inserter 1 has
the general form of a tube, being formed by two members a and b
arranged in facing opposition so as to form the tube, the members a
and b having a U-shape cross-section. These members are maintained
in firm but releasable engagement with each other by rubber rings
r, while, at the entrance for a plunger, the two members are
maintained in firm engagement with each other by means of a holding
ring 3. The setting exit portion 4 of the inserter is tapered so as
to be inserted easily into the vagina.
As best seen in FIG. 2, inserter 1 preferably is slightly arcuate,
so as to make a user's posture, during insertion of the IUD, easy
for the insertion. In order to insert the IUD into the uterus, the
inserter is put into the vagina up to the line 1--1 in FIG. 1,
whereby the exit or inner end of the inserter will contact the
fundus uteri. A plunger 5, shown more particularly in FIGS. 5 and
6, is introduced into the inserter through the holding ring 3 so as
to push the IUD 9 on the tip of the plunger into the uterus.
Plunger 5 has a support 6, for the IUD, on the leading end of a bar
7, the support 6 receiving a vertical shaft portion 10 of the IUD
9. The IUD 9 is inserted into the uterus with the assistance of a
grip 8 on the outer end of the plunger 5.
The IUD 9 used with the inserter shown in FIGS. 1 through 7 is
illustrated, in FIG. 8, as shaped like an inverted unfolded fan,
preferably including the vertical shaft 10 having branches 11
extending therefrom. However, the structure of the IUD is not
limited to the shape shown in FIG. 8, but the IUD may have any
other form so long as it can be held between the holding members c
and d of the spread portion 2 of the inserter 1, and can be pushed
out by means of plunger 5.
When the IUD is pushed by the plunger through the forward or inner
portion of the inserter 1, the branches 11 are folded inwardly as
shown by the dotted lines in FIG. 8. When the IUD is forced out of
the setting exit 4 and inserted into the uterus, the branches 11
spread apart and are set stably in the uterus to conform
substantially to the uterine shape as shown by solid lines in FIG.
8.
Upon completion of the insertion of the IUD into the uterus,
inserter 1 is withdrawn from the vagina and the IUD is left in the
uterus. For removing the IUD from the uterus, there are used
threads which have been previously attached to the IUD.
The IUD inserter embodying the invention has numerous advantages.
Thus, inserter 1, containing an IUD beforehand, may be sold as a
composite article, permitting simple insertion of the IUD into the
uterus by just inserting plunger 5 into the inserter. Furthermore,
the IUD is maintained safe against deformation before its sale due
to the shape of the spread portion 2, which is adapted to that of
the IUD. If an IUD formed of synthetic resin is stored in a
cylindrical case, not conforming to the shape of the IUD, the IUD
may be deformed, after the lapse of some time, due to permanent
deformation of the synthetic resin material, and may not resume its
original shape or form. This means a failure of the essential
function of the IUD.
In a prior art IUD inserter having a tubular inserting portion, an
IUD, when used, is set in the cervix shield portion of the inserter
by pulling or pushing the IUD thereinto while deforming the IUD.
Under these conditions, the inserter is placed into the uterus, and
the IUD is pushed into the uterus from the inserter with a bar,
from under the shield portion.
By contrast, with the present invention, an IUD can be previously
carried in a position outwardly of the cervix shield portion of the
inserter and without deformation, and the plunger may be easily
inserted into the inserter when it is desired to use the IUD. Thus,
an advantage of the invention arrangement is that it is very
convenient to use the inserter as it does not require troublesome
setting by pulling or pushing an IUD thereinto each time an IUD is
to be used.
A further advantage of the invention is that, when an IUD is being
inserted into the uterus, the cervix is protected from any
mechanical injury which otherwise might occur, as a result of the
passing of the IUD through the interior of the cervix shield
portion and into the uterus.
In accordance with a further feature of the invention, a supporting
surface 12, as shown in FIGS. 1 through 7, is provided at the
location where the holding members c and d, forming the spread
portion 2, engage each other, this supporting surface having a
proper area for supporting the IUD. Supporting surface 12 extends
in a plane from the inner side of either of the holding members
forming the spread portion 2, so as to hold an IUD more positively.
Portion 12 further serves to protect stored IUDs, which may be
different in shape and size, against accidentally falling out of
the inserter. The area of the supporting face 12 may be defined as
such as to span the space between holding members c and d, with the
supporting surface 12 extending from either of these holding
members.
Furthermore, in other embodiments of the invention as shown in
FIGS. 12 and 13, an IUD can be guided into the cervex shield
portion of the inserter more positively. In these figures, guide
plates 13 are provided in the form of a flat trumpet at the joining
positions of the holding members c and d. The guide plates 13 are
formed at the entrance into the shield portion 1', so as to hold an
IUD 9, set in spread portion 2, with the leading end engaged with
the cervix shield portion, and thereby protecting the IUD from
slipping as well as keeping it secured in position independent of
its size and shape. The guide plates 13 also serve as an effective
means for guiding and pushing an IUD 9, when used, into cervix
shield portion 1', smoothly and without fail by engaging the
leading end 6 of the plunger 5 with the stem portion of the
IUD.
As shown in the embodiments of the invention illustrated in FIGS.
1, 9 and 12, shield portion 1' is formed like a tube by engaging
the two opposed members a and b, and these members are elastically
retained into engagement so as to be expandable or spreadable to a
certain extent. In the embodiment of FIG. 2, the opposed members a
and b are retained in engagement by means of rubber rings r, so as
to permit some spreading thereof and smooth passage of an IUD, in
accordance with the form and size of the IUD.
On the other hand, in the embodiment of the invention shown in
FIGS. 9 and 12, shield portion 1' is inserted slidably through a
slot 14 on a frame 15 which has a fixed bearing piece 16 extending
therefrom and cooperable with an opposed movable bearing piece 17.
Bearing pieces 16 and 17 are elastically retained in engagement
with each other by a rubber band r' so that movable bearing piece
17 is elastically displaceable relative to fixed bearing piece 16.
Bearing pieces 16 and 17 are engaged and supported in such a manner
as to embrace the two opposed members a and b. An IUD may pass
through the tubular cervix shield portion thus formed by the
members a and b.
In conventional inserters, which are of a simple tubular form, use
of different IUD's is limited by the diameter of the shield
portion. In accordance with the present invention, the shield
portion is spreadable or expandable laterally, so that limitation
due to the difference in size between IUD's is eliminated. It is
thus possible to set an IUD in the uterus without mechanical harm
to the cervix uteri by inserting the shield portion of the inserter
through the cervix, with the shield portion compressed, feeding the
IUD from the rear or outer end of the shield portion, and passing
the IUD through the shield portion while the latter is expanded or
spread. Thus, the inserter embodying this invention has a wider and
more useful application.
In the embodiment of the invention shown in FIG. 9, the opposed
members a and b are provided, at their respective leading ends,
with a recess 18 and a protrusion 19, each protrusion on one member
being engageable into a recess on the other member. This reinforces
the shield portion, as well as prevents the shield portion from
undesired distortion or axial misengagement as a result of the
spreading of the shield portion at the time of insertion of the IUD
into the uterus.
In this embodiment of the invention, marks 20 are provided for
measuring the length of the insertion. In the embodiment of FIG. 1,
on the other hand, the mark to indicate the insertion depth is the
position of the rubber ring r furthest from the spread portion 2.
In the embodiment of FIG. 9, an indication plate 21 is wound around
the inserter.
As illustrated in FIGS. 14 and 15, an IUD of synthetic resin has
holes 22 for the pulling threads, and these are positioned in a
recessed portion 23 of the inserter shown in FIG. 10, for drawing
the pulling threads outside.
A further object of the present invention is to provide an inserter
which permits proper spreading of an IUD in the uterine cavity
without the use of any probe. FIGS. 9, 16 and 17 illustrate how
this is accomplished in practice. In FIG. 9, a point P, close to
grip 8 on plunger 5, is used as a reference point, plunger 5 having
the same length as inserter 1, and a point Q is marked, at a
position spaced from point P, by the length L of an IUD and in the
forward axial direction.
In practical use, the shield portion of inserter 1 is inserted
toward the uterus until its inner or leading end strikes against
the fundus uteri R, illustrated in FIGS. 16 and 17, and plunger 5
is introduced into the inserter 1 until point Q is aligned with the
outer end of inserter 1. At this time, the leading or inner end of
plunger 5 has pushed an IUD 9 to the inner end of shield portion
1', where the leading end of the IUD is brought into contact with
the fundus uteri R. Inserter 1 is now drawn back to the point or
marking P on plunger 5, so that shield portion 1' is retracted from
the fundus uteri R by the length L with plunger 5 being maintained
stationary. As a result, the IUD is released from the setting exit
4 of the inserter 1 and remains in the uterus.
By contrast with the present invention, for setting an IUD properly
in the uterus, that is, right against the fundus uteri, in
conventional inserters, the distance must be measured by the use of
a probe before insertion of the IUD, after which the IUD is
inserted so as to engage against the fundus uteri. Such an
operation cannot be carried out with external direct
perception.
On the other hand, with the arrangement of the present invention
and its operation as described above, it is possible to operate the
inserter quite in the same way and with visual perception of the
actual state inside the shield portion, and to set the IUD in
proper position in the uterine cavity.
While specific embodiments of the invention have been described in
detail to illustrate the application of the principles of the
invention, the invention may be embodied otherwise without
departing from such principles .
* * * * *