U.S. patent application number 17/743213 was filed with the patent office on 2022-09-01 for inserter.
This patent application is currently assigned to Bayer Oy. The applicant listed for this patent is Bayer Oy. Invention is credited to Marjo Ali-Aijala, Ulla Calvo Alonso, Ilkka Jutila, Heikki Lyytikainen, Taina Tjader.
Application Number | 20220273487 17/743213 |
Document ID | / |
Family ID | 1000006337120 |
Filed Date | 2022-09-01 |
United States Patent
Application |
20220273487 |
Kind Code |
A1 |
Jutila; Ilkka ; et
al. |
September 1, 2022 |
INSERTER
Abstract
The invention relates to an inserter for an intrauterine system,
comprising a handle (3) having a longitudinal opening (8) at its
first end, said opening (8) having a longitudinal axis parallel to
the longitudinal axis of the inserter, a first end (8a) and a
second end (8b), a moveable slider (5) arranged in said
longitudinal opening (8) and having a first end (5a) and a second
end (5b), a plunger (2) attached to the handle (3), an insertion
tube (6) arranged around the plunder (2) having a first end and a
second end, with its second end attached to the slider (5), wherein
the inserter further comprises locking means for reversibly locking
the intrauterine system in relation to the plunder (2) via a
removal string of the intrauterine system, said locking means being
controllable by the slider (5) and/or the insertion tube (6).
Inventors: |
Jutila; Ilkka; (Littoinen,
FI) ; Lyytikainen; Heikki; (Nanntali, FI) ;
Alonso; Ulla Calvo; (Piispanristi, FI) ; Tjader;
Taina; (Littoinen, FI) ; Ali-Aijala; Marjo;
(Preitila, FI) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Bayer Oy |
Turku |
|
FI |
|
|
Assignee: |
Bayer Oy
Turku
FI
|
Family ID: |
1000006337120 |
Appl. No.: |
17/743213 |
Filed: |
May 12, 2022 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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17239417 |
Apr 23, 2021 |
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17743213 |
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15589789 |
May 8, 2017 |
10987244 |
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17239417 |
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13119397 |
Mar 16, 2011 |
9668912 |
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PCT/FI09/50735 |
Sep 14, 2009 |
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15589789 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 6/144 20130101;
A61F 6/18 20130101; A61F 6/142 20130101 |
International
Class: |
A61F 6/18 20060101
A61F006/18; A61F 6/14 20060101 A61F006/14 |
Foreign Application Data
Date |
Code |
Application Number |
Sep 17, 2008 |
FI |
20080523 |
Claims
1. A kit comprising: an intrauterine system comprising: a reservoir
containing a hormone, and a removal string attached to the
intrauterine system; and an inserter comprising: an insertion tube
configured to retain at least a portion of the intrauterine system;
a handle coupled to the insertion tube and configured to contain
the removal string wholly therein, the handle comprising: a
longitudinal opening; a lock arranged inside the handle and
configured to reversibly immobilize the removal string within the
handle prior to insertion into a uterus; and a slider coupled to
the insertion tube and configured to be moved within the opening of
the handle, wherein movement of the slider releases the removal
string and intrauterine system inside the uterus.
2. The kit of claim 1, wherein the handle further comprises a
plunger having a hollow configuration for allowing passage of the
removal string therethrough.
3. The kit of claim 1, wherein the handle further comprises a first
end having a channel configured to allow passage of the insertion
tube therethrough and a second end having a closed
configuration.
4. The kit of claim 1, wherein the inserter is configured for
positioning the intrauterine device within the uterus without
manual handling of the removal string.
5. The kit of claim 1, wherein the inserter is configured for
positioning the intrauterine device within the uterus with one
hand.
6. The kit of claim 5, wherein the slider is configured to be
movable within the longitudinal opening using a single digit of the
one hand.
7. The kit of claim 1, wherein the hormone is levonorgestrel.
8. The kit of claim 1, further contained within a sterilized
package.
9. The kit of claim 1, wherein the intrauterine system is a
T-shaped intrauterine system.
10. The kit of claim 9, wherein the T-shaped intrauterine system
comprises two wings, and wherein the wings remain partly uncovered
by the insertion tube, while the wings still remain together when
the intrauterine system is substantially covered by the insertion
tube.
11. The kit of claim 1, wherein the reservoir is covered by a
membrane or wherein the membrane comprises a siloxane based
elastomer.
12. The kit of claim 11, wherein the siloxane based elastomer is
polydimethylsiloxane.
13. The kit of claim 1, wherein the reservoir essentially consists
of an elastomer and levonorgestrel.
14. The kit of claim 13, wherein the elastomer is
polydimethylsiloxane.
15. The kit of claim 1, wherein the reservoir is inside a first end
of the insertion tube, and the slider is attached to a second end
of the insertion tube.
16. The kit of claim 15, wherein the first end of the insertion
tube comprises a flexible material and is configured to conform to
the anatomy of the uterus.
17. The kit of claim 1, wherein the inserter further comprises an
adjustable flange arranged on the insertion tube, the adjustable
flange is used to mark a depth of a uterus.
18. The kit of claim 1, wherein the lock comprises an object
configured to prevent or allow movement of the removal string by at
least partly moving or pivoting from a first position to a second
position.
19. The kit of claim 18, wherein the lock further comprises a
counterpart against which the removal string is pressed by the
object and thus reversibly immobilized in a locked position.
20. The kit of claim 1, wherein the lock is rotatably mounted
inside the handle.
21. The kit of claim 18, wherein movement of the slider presses a
part or extension of the slider or of the insertion tube against
the object or an extension thereof thus changing its orientation
and releasing the removal string.
22. The kit of claim 1, wherein the lock comprises: a main part; an
extension of the main part having an abutment surface; and a
counterpart adapted to form a blocking together with the main part,
wherein the lock is rotatably mounted inside the handle.
23. The kit of claim 18, wherein the object comprises an opening or
a slot in a diagonal direction through essentially the whole
diameter of the object, adapted to receive the removal string.
24. The kit of claim 1, wherein the lock comprises: a main part; a
first extension of the main part having an abutment surface; a
second extension of the main part having a wedge-like shape; and a
counterpart, wherein the second extension is adapted to form a
blocking together with the counterpart and the lock is rotatably
mounted inside the handle.
25. The kit of claim 24, wherein the main part has essentially the
shape of a cylinder or is of a triangular shape.
26. The kit of claim 24, wherein the slider comprises an extension
adapted to abut the abutment surface.
27. The kit of claim 1, wherein the lock comprises: a main part; a
first extension of the main part; and a second extension of the
main part, wherein the first and section extension are arranged in
a first position of the slider to be essentially in contact with
each other to form a blocking, and wherein movement of the slider
to a second position separates the first and section extensions
from each other.
28. The kit of claim 1, wherein the lock comprises: a first locking
part and a second locking part movably mounted inside the handle
and arranged in a first position of the slider to be essentially in
contact with each other to form a blocking; and a first protrusion
and a second protrusion arranged inside the handle, wherein the
first and second protrusions are arranged to move the first and
second locking parts in response to movement of the slider to a
second position.
29. The kit of claim 1, wherein the lock comprises a knot in the
removal string or a mechanical hindrance attached to the removal
string.
30. The kit of claim 1, wherein the lock comprises welding, gluing,
or adhesion of the removal string to the inserter.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 17/239,417, filed Apr. 23, 2021, which is a
continuation of U.S. patent application Ser. No. 15/589,789, filed
May 8, 2017 (now U.S. Pat. No. 10,987,244), which is a continuation
of U.S. patent application Ser. No. 13/119,397, filed Mar. 16, 2011
(now U.S. Pat. No. 9,668,912), which claims priority to
International Patent Application No. PCT/FI2009/050735, filed Sep.
14, 2009, which claims priority to Finnish Patent Application No.
20080523, filed Sep. 17, 2008, the contents of all of which are
incorporated by reference herein.
SUMMARY
[0002] The present invention is related to an inserter for
positioning an intrauterine device or an intrauterine system in the
uterus.
BACKGROUND OF THE INVENTION
[0003] Various types of inserters have been developed for the
positioning of mechanical and copper wire-containing intrauterine
devices (IUDs) as well as of intrauterine systems having a drug
containing cylinder (IUSs). In the following, IUD and IUS can be
used interchangeably and when one is mentioned, it is to be
understood that either of them can be used. Simple rod-shaped
inserters have been suggested for inserting relatively small or
sufficiently flexible intrauterine devices in their original,
expanded shape by using simple push-in technique. However, most
common inserters are constructed for introducing the device into
the uterus in a contracted state. These inserters usually comprise
an insertion tube having a relatively narrow diameter and a
rounded, blunt end which will pass through the cervical canal
easily and will not damage or injure the fundus upon contact
therewith, and a plunger inside the insertion tube. Prior to
insertion the device, whether an IUD or an IUS, is usually
retracted into the insertion tube either by means of string(s)
attached to the device and intended for the removal of the device
from the uterus, or by pushing the device into the insertion tube
by a plunger with inserters having a special window to adapt the
device in the expanded shape (see for example GB 1 403 393). Then
the insertion tube with the device therein is introduced through
the cervical canal into the uterus. When the device is correctly
positioned, it is released either by pushing the plunger towards
the uterus or by holding the plunger steady and by retracting the
insertion tube outwards. Once expulsed from the insertion tube
within the uterine cavity, the device is supposed to resume its
original expanded shape. A typical example of an intrauterine
device has a T-shaped body fabricated of plastic material and
consisting of an elongated body part having at one end a transverse
member comprising two wings, the elongate member and the transverse
member forming a substantially T-shaped piece when the device is in
the expanded configuration, for example positioned in the uterus.
The tips of these wings are preferably hemispherical in order to
facilitate the introduction of the device through the cervical
canal. The elongate member has a copper spiral or wire or a hormone
capsule arranged around the body. The end of the vertical body part
has a loop with a string or strings attached to it, with which the
device can be removed from the uterus after use or whenever
needed.
[0004] The diameter of the elongate member in intrauterine systems
having a drug containing cylinder is greater than in copper
wire-containing IUDs or mechanical devices, and thus the diameter
of the insertion tube also has to be larger. However, the frames of
these intrauterine systems, or in the commonly used T-shaped
systems the hemispherical ends of the transverse member, are small
in relation to the diameter of the insertion tube. Therefore the
correct positioning of the IUS within the insertion tube is
extremely important, and this will only be attained by properly
handling the removal string(s) during the preparatory steps and
insertion as well as when finally releasing the IUS after
insertion. Challenging steps, which will be exemplified with a
common T-shaped device, apply as well to intrauterine systems
having another type of frame, for example 7-shaped or closed,
continuous frames.
[0005] For the insertion of a T-shaped intrauterine system it is
extremely important that the hemispherical ends of the transverse
member are in the exactly correct position in relation to the edge
of the insertion tube at the moment of introducing the device in
the uterus. If the IUS is pulled into the insertion tube by means
of the removal string, which is usually the case with the existing
devices, it is understandable that it is difficult to make the IUS
stop in the correct position, especially if the relative movement
of the insertion tube and the plunger is not restricted by any stop
member. Pulling with too much force easily makes these ends enter
almost completely into the insertion tube. During the insertion of
the device, the sharp edges of the insertion tube may interfere
with the introduction of the device through the cervical canal. On
the other hand, if the device is not drawn deep enough into the
insertion tube, the frame ends project outwardly because of a
relatively wide insertion tube. The diameter at the level of the
wings remains too wide, which makes the introduction of the device
more difficult. It is easier to make the wings stop in the correct
position in the case of copper-wire devices, because then the
insertion tube is narrow in relation to the wings and therefore
there is no risk of the wings being drawn too deep into the tube
even by forceful pulling.
[0006] When the device is pulled into the insertion tube, it is
important that the device is directed onto the plunger in the
correct position, i.e. without damaging the loop, the rest of the
body or the string(s). If the device is pulled onto the plunger in
a wrong position, the edges of the insertion tube or the plunger
can damage the loop or the body. If pulling is continued and the
device does not turn into the correct position, the string(s) will
finally cut through the loop or the body, which can also cause the
device to get jammed within the insertion tube or plunger.
[0007] The European patent application EP 1 691 740 relates to an
inserter, with which the correct positioning and directional
stiffness of the device in the inserter prior to and during
insertion can be ensured, for instance, by shaping the forward end
of the plunger such that the IUS assumes a specified constant
configuration when drawn into the insertion tube. The IUS will thus
not be twisted during insertion.
[0008] European patent EP 798 999 relates to an inserter, which
allows the correct positioning of an IUS also in those cases in
which the elongate member of a T-shaped device contains active
material, which involves a diameter larger than that of an elongate
member of a copper-wire IUD. The inserter comprises a plunger, a
handle attached to the plunger, a string for the removal of the
IUS, a cleft on the end of the handle to lock the string(s) in such
a way that the IUS remains immobile in relation to the plunger, and
an insertion tube around the plunger. The IUS is drawn into the
insertion tube by pushing the tube over the device or by pulling on
the removal threads whereafter the threads are manually locked in
the cleft. The relative movement of the plunger and the protective
tube is restricted by a stop member or stop members to ascertain
that the correct configuration of the IUS is achieved. The stop
members ensure that the front edge of the insertion tube is stopped
in a configuration in which the hemispherical tips of the T-wings
remain partly uncovered by the insertion tube but the wings
nevertheless remain pressed against each other. This inserter
overcomes many of the problems encountered with the conventional
inserters, but the string(s) still need to be manually handled and
locked.
[0009] OBJECT AND SUMMARY OF THE INVENTION An object of the
invention is to provide a simple, easy to use inserter for the
positioning of an intrauterine system in the uterus by solving at
least partially at least some of the problems mentioned above. An
object of the invention is particularly to provide an inserter
having an improved system for locking and releasing the removal
strings of an IUS in the necessary steps during the insertion
process so that no manual handling of the strings as such is
needed.
[0010] A typical inserter for an intrauterine system according to
the present invention, comprises
[0011] a handle having a longitudinal opening at its first end,
said opening having a longitudinal axis parallel to the
longitudinal axis of the inserter, a first end and a second
end,
[0012] a movable slider arranged in said longitudinal opening and
having a first end and a second end,
[0013] a plunger attached to the handle,
[0014] an insertion tube arranged around the plunger having a first
end and a second end, with its second end attached to the
slider.
[0015] The inserter is characterized in that it further comprises
locking means for reversibly locking the intrauterine system in
relation to the plunger via a removal string of the intrauterine
system, said locking means being controllable by the slider and/or
the insertion tube.
BRIEF DESCRIPTION OF THE DRAWING
[0016] FIG. 1 illustrates a general overview of an inserter
according to an embodiment of the invention.
[0017] FIGS. 2A, 2B and 2C illustrate an operating principle of an
inserter according to an embodiment of the invention.
[0018] FIGS. 3A, 3B and 3C illustrate an operating principle of the
inserter shown in FIGS. 2A, 2B and 2C for insertion of another type
of intrauterine system.
[0019] FIGS. 4A, 4B, 4C and 4D illustrate a correct positioning of
an IUS in an insertion tube of an inserter according to the present
invention.
[0020] FIGS. 5A and 5B illustrate a locking means according to an
embodiment of the invention.
[0021] FIGS. 6A and 6B illustrate a locking means according to
another embodiment of the invention.
[0022] FIGS. 7A and 7B illustrate a locking means according to yet
another embodiment of the invention.
[0023] FIGS. 8A and 8B illustrate a locking means according to a
further embodiment of the invention.
[0024] FIGS. 9A and 9B illustrate a locking means according to yet
another embodiment of the invention.
DETAILED DESCRIPTION OF THE INVENTION
[0025] A typical inserter for an intrauterine system according to
the present invention, comprises
[0026] a handle having a longitudinal opening at its first end,
said opening having a longitudinal axis parallel to the
longitudinal axis of the inserter, a first end and a 10 second
end,
[0027] a movable slider arranged in said longitudinal opening and
having a first end and a second end,
[0028] a plunger attached to the handle,
[0029] an insertion tube arranged around the plunger having a first
end and a second end, with its second end attached to the slider
and/or the insertion tube.
[0030] The inserter is characterized in that it further comprises
locking means for reversibly locking the intrauterine system in
relation to the plunger via a removal string of the intrauterine
system, said locking means being controllable by the slider and/or
the insertion tube. This means that the locking means can also be
controlled by a part of the slider and/or of the insertion tube,
such as an extension of either or both of them.
[0031] The inserter according to the present invention thus
comprises means for reversibly locking the intrauterine system, for
example by locking the removal string or strings of the
intrauterine system, in such a way that the device remains immobile
in relation to the plunger during the necessary steps prior to
insertion and during insertion but can be released after the IUS
has correctly been positioned in the uterus. Moreover, with the
present invention, no manual handling of the strings as such is
needed, which increases security and hygiene.
[0032] The longitudinal opening on the handle can have be also
quite narrow and does not need to be symmetrically positioned on
the handle and with respect to the longitudinal axis.
[0033] The invention therefore provides an easy to use inserter, by
which only few simple steps are needed to prepare for the insertion
and to securely install and position an intrauterine system into
the uterus.
[0034] In the present description and claims, by first ends are
typically meant the ends that are closer to the uterus during the
insertion of the intrauterine system. Second ends are the ends
opposite to the first ends. Moreover, the terms IUS or IUD are used
when describing the preferred embodiment of the present invention,
but these are not to be construed as limiting the claims. The term
removal string means one or more strings used for removing the
system once it reaches the end of its use time. There may thus be
one or more such strings, and this term encompasses also strings
that are not used for removal but only for locking the device
during insertion.
[0035] According to one embodiment of the invention, the inserter
comprises stop members to control the movement of the slider.
[0036] According to a preferable embodiment of the invention, the
first end of the opening and the first end of the slider form a
first pair of stop members, and the second end of the opening and
the second end of the slider form a second pair of stop
members.
[0037] A part of the handle thus comprises an opening having a
first end and a second end and running in the longitudinal
direction of the plunger. The handle also has at its first end a
channel in which the insertion tube can slide in the longitudinal
direction. At the second end, i.e. distal end (away from the
uterus) the insertion tube is attached to the slider or to a means
which can be used to move the slider and preferably forms at least
a part of the slider. With respect to the starting configuration,
the front surface of said means and the surface at the first end of
the opening (the end directed towards the IUS) together form the
first pair of stop members. By simply pushing the slider or the
means for moving the slider forwards in the opening the slider
arrangement and the insertion tube attached to it can be moved in
relation to the plunger to push the insertion tube past the plunger
at distance, which corresponds substantially to the length of the
IUS assembled for insertion. Because the string(s) and the IUS
remain immobile all the time, the IUS is retracted in the insertion
tube. To release the IUS after it has been positioned in the uterus
the slider and the insertion tube will be pulled backwards past the
plunger the distance determined by the second pair of stop members,
formed by the rear surface of the means to move the slider and the
surface at the second end of the opening.
[0038] The handle can have many shapes and is preferably designed
for easy handling of the inserter even by using only one hand. The
plunger attached to the handle is advantageously hollow or has a
groove or bore running in the axial direction thus allowing the
string(s) to slide freely in it, without any risk of them getting
jammed between the plunger and the insertion tube. The first end,
i.e. the forward end of the plunger is preferably suitably shaped
to have for example a notch, an indentation, an eyelet, a funnel or
a groove to adapt to the lower end of the intrauterine system and
to enable the optimal and secure positioning of the intrauterine
system on the plunger so that the probability of damage to the
intrauterine system is minimal. Thus the IUS will not be twisted
when it is drawn in the insertion tube or during insertion and
assumes a specified constant configuration when released.
[0039] The forward parts (parts directed towards the uterus) of the
plunger and the insertion tube can be straight or curved so as to
conform to the anatomy of the uterus. Preferably these parts are
made from a flexible material in order to avoid perforation of the
uterus.
[0040] The slider mechanism is preferably inside the handle and
comprises at least one elongated element, which can be moved in the
longitudinal direction of the plunger. According to an embodiment
of the invention the slider comprises means to move the slider,
which preferably is a part of the slider, and the insertion tube
attached to said means. According to another embodiment of the
invention the slider comprises at least two elements, preferably
parallel, which are combined on at least one point by a transversal
member. The transversal member may form means, for example a knob
or switch, by which the slider can be moved. The handle can
comprise one or more means to connect the slider elements and to
facilitate the movement of the slider, for example a support, a
shoulder, a holder, a saddle, a groove or a slot. The slider
preferably comprises at least one structural element, for example
an extension, which is capable to generate the necessary operation
of the locking means to keep the strings immobilized during storage
or during preparatory steps before insertion or during insertion
and/or to release the string(s) when the slider is moved to the
backward position.
[0041] The locking means is a lock which, induced by the movement
of the slider or of the means to move the slider and the insertion
tube, can immobilise the removal string(s) to hold the IUS in a
stable position and/or to release the string(s) after insertion to
release the IUS. Particularly, the invention relates to a locking
means which comprises an object capable of reversibly preventing
and/or allowing the movement of the string(s) by at least partly
moving or pivoting from the original position, for example rotating
around a shaft or an axle, and vertically or horizontally attached
to the handle. The object may have several shapes and may be for
example round or rod-shaped, wedge, polygonal or rectangular with
rounded or sharp corners. The surface of the object preferably
comprises one or more extensions having variable size and shape,
for example a knob, a rib or a switch. When the slider mechanism is
moving backwards, at a suitable point a part or an extension of the
slider or of the insertion tube is pressed against at least one
extension of the object thus changing its orientation enough
relative to the original position to cause release of the
string(s). Preferably the object has a slot or pinhole through
which the string(s) run. The locking means may also comprise at
least one counterpart against which the string(s) are pressed by
the object and thus reversibly immobilized in the locking position.
The counterpart has a suitable shape adapted to fit at least some
part of the surface of the object. An extension, or extensions of
the object can be used to keep the object and the counterpart in a
fixed configuration until the slider is moved backwards to release
the IUS. The counterpart preferably has a suitable design to keep
the string(s) in proper direction, for example a slot or pinhole
through which the string(s) run. Further, the object and said at
least one counterpart have preferably a suitable length and
diameter to fit inside the handle.
[0042] According to one embodiment of the invention, the locking
means thus comprises
[0043] a main part,
[0044] a first extension of the main part having an abutment
surface,
[0045] a counterpart adapted to form a blocking together with the
main part, wherein the locking means is rotatably mounted on the
inserter.
[0046] According to another embodiment of the invention the main
part comprises an opening or a slot in a diagonal direction through
essentially the whole diameter of the main part, adapted to receive
at least one removal string of the intrauterine system.
[0047] According to yet another embodiment of the invention, the
locking means comprises
[0048] a main part,
[0049] a first extension of the main part having an abutment
surface,
[0050] a second extension of the main part having a wedge-like
shape,
[0051] a counterpart,
[0052] wherein the second extension is adapted to form a blocking
together with the counterpart and the locking means is rotatably
mounted on the inserter.
[0053] The locking means can be for example mounted on the handle
of the inserter. According to one embodiment of the invention, the
main part has essentially the shape of a cylinder, or it is of
triangular shape, or of any other suitable shape.
[0054] According to one embodiment of the invention the slider
comprises an extension adapted to abut on the abutment surface of
the first extension of the main part of the locking means.
[0055] According to one other embodiment of the invention the
locking means comprises a main part comprising a first extension
and a second extension arranged, in their initial position, to be
essentially in contact with each other to from a blocking, and
wherein the slider, a part of the slider, the insertion tube or a
part of the insertion tube is arranged to protrude into the main
part of the locking means so as to separate the first and second
extensions from each other.
[0056] According to yet one other embodiment of the invention the
locking means comprises [0057] a first locking part and a second
locking part movably mounted on the inserter and arranged, in their
initial position, to be essentially in contact with each other to
form a blocking, and [0058] a first protrusion and a second
protrusion arranged on a location selected from the group
consisting of the inner surface of the insertion tube, the outer
surface of the insertion tube, the inner surface of the slider and
the outer surface of the slider,
[0059] wherein the first and second protrusions are arranged so as
to move the first and second locking parts to a second position
when moving the insertion tube.
[0060] The locking means could also be welding, gluing, cutting,
knot or adhesion. The strings could thus be for example attached to
the body of the inserter by welding (for example by heating),
gluing with glue or attaching with an adhesive agent (such as
sticker). The slider would then release the attachment when moving
to release the device. Other options could be a knot or other
mechanical hindrance, when the slot provided for the strings is
larger in the releasing position. The slider could also comprise a
blade that cuts the strings loose from the inserter.
[0061] It is obvious to a person skilled in the art that, in
accordance with the above description, the locking means can be of
any other kind than those specifically listed above as well as a
combination of any of the embodiments and features described
above.
[0062] According to another embodiment of the invention, the
inserter further comprises a flange arranged on the insertion tube.
This flange can be adjusted to correspond to the depth of the
uterus in order to correctly position the device during its
insertion.
[0063] The inserter according to the invention is suitable for the
positioning of intrauterine devices and intrauterine systems having
different sizes and shapes as long as these can be managed to enter
the insertion tube by appropriate arrangements.
[0064] During the preparatory steps the string(s) are locked but
they are released automatically by the slider, when it is drawn
backwards in order to release the IUS. Compared to previous
inserters, there is no need to manually handle the removal strings
during the preparatory steps and during insertion, which eliminates
the possibility of user-made mistakes.
[0065] The invention further relates to a kit comprising an
intrauterine system and an inserter according to the present
invention. The intrauterine system can be any device known in the
art. Any details and embodiments listed above naturally apply
mutatis mutandis to the kit according to the invention.
[0066] The present invention also relates to a method for
positioning a intrauterine system in a uterus of a patient, wherein
the method uses an inserter according to the present invention. The
method comprises the steps of [0067] moving the slider towards the
first end of the opening until the first end of the opening is in
contact with the first end of the slider, and the intrauterine
system is substantially inside the insertion tube, [0068]
introducing the inserter into the uterus of the patient until the
intrauterine system is in its correct location, [0069] moving the
slider towards the second end of the opening until the second end
of the opening is in contact with the second end of the slider,
thus releasing the intrauterine system from the inserter, [0070]
removing the inserter from the uterus of the patient.
[0071] The method advantageously contains, at its beginning, the
further steps of sounding the uterus using a probe, and setting the
flange accordingly to show the correct insertion depth.
[0072] An example of the method for positioning the intrauterine
system is given hereafter. To insert the IUS only few steps are
needed. To prepare for the insertion the sterile package is
carefully opened. The IUS is in a correct configuration relative to
the inserter and there is no need to align the device or for
example to rearrange or correct the horizontal arms of a T or a
7-shaped device. The IUS is positioned at the forward end of the
plunger in the expanded configuration and with the lower end of the
device abutting the end of the plunger. In case of intrauterine
systems having for example the shape of T or 7, the elongate member
and the hormone cylinder are preferably protected by the insertion
tube and the wing(s) of the transverse member remain outside the
insertion tube in expanded configuration in order to prevent
fatigue. The removal string(s) attached to the device, running in
the groove of the plunger and ending at the end of the handle, are
immobilised by the locking means to keep the IUS at a steady and
correct position until it is released in the uterus.
[0073] Then, the handle is held tightly and the insertion tube is
moved towards the IUS by pushing the slider forwards until the
first pair of stop members gets together, thereby stopping the
movement of the insertion tube. At this moment the IUS is
substantially inside the insertion tube, and ready for insertion.
The distance the slider can be moved forwards from the preliminary
position substantially corresponds to the length of the IUS
assembled for insertion. This ensures that the front edge of the
insertion tube, the edge toward the uterus, is stopped in a
configuration in which upper ends of the intrauterine system or the
hemispherical tips of the wings remain partly uncovered by the
insertion tube, but nevertheless remain pressed against each
other.
[0074] The inserter is introduced into the uterus until the IUS is
in the correct location, which is determined beforehand by using a
probe. To release the IUS the insertion tube is drawn backwards by
retracting the slider towards the handle all the way until the
second pair of stop members gets together. The movement of the
slider also releases the locking means thus releasing the removal
string(s). The distance the slider or the insertion tube moves has
been selected so that at this point the IUS has completely been
released from the insertion tube.
[0075] The inserter thus allows easy and secure positioning of an
IUS. The use of the slider mechanism is straightforward and the
locking means to hold the string(s) and the IUS immobile long
enough as well as the predetermined distance the insertion tube can
be moved in each step guarantee an accurate positioning of the IUS
during insertion and its accurate release. The stop members and the
designed frontal end of the plunger control the correct positioning
of the IUS in the insertion tube. Hence it is not necessary to
provide so much clearing between the plunger and the insertion tube
as in conventional inserters in which the IUS is positioned by
retraction without any stop member. This results in an extremely
stable construction, which involves no risk of irremediable bending
of the tube.
DETAILED DESCRIPTION OF THE DRAWING
[0076] In the following description, the term slider and the
corresponding reference number are used to designate both the
slider itself and the means to move the slider attached to the
slider. The term slider is thus used for convenience of
reading.
[0077] FIG. 1 illustrates a general overview of an inserter
according to the invention. The inserter comprises a handle 3, a
plunger 2 attached to the handle, a slider 5, an insertion tube 6
around the plunger, the second end of the insertion tube being
attached to the slider or to the means to move the slider. The
inserter also comprises means for reversibly locking the string(s)
(not shown) in such a way that the IUS remains immobile in relation
to the plunger during the necessary steps prior to and during
insertion, and again for releasing the string(s) and the IUS after
it has been inserted. The inserter further comprises an opening 8
in a part of the handle, a channel 9 in which the insertion tube
slides in the longitudinal direction, and a flange 4, which can be
adjusted so that its distance from the first end of the insertion
tube corresponds to the depth of the uterus.
[0078] The part of the handle 3 that is closer to its first end has
an opening 8 having a first end 8a and a second end 8b, which
opening runs in the direction of the plunger 2. The surface of the
first end 5a of the slider 5 and the surface at the first end 8a of
the opening 8 together form a first pair of stop members, and the
surface of the second end 5b of the slider 5 and the surface at the
second end 8b of the opening 8 together form a second pair of stop
members. When inserting the IUS, the slider and the insertion tube
can be moved forward until the surfaces 8a and 5a contact each
other, and backwards until the surfaces 5b and 8b contact each
other. The locking means are arranged inside the handle 3 and are
thus not visible.
[0079] FIGS. 2A, 2B and 2C illustrate an operating principle of an
inserter according to an embodiment of the invention.
[0080] FIG. 2A shows an inserter and a T-shaped IUS 1 in a
configuration as they are in a sterilized package. The IUS is
placed in the first end (i.e. the front end, i.e. the end of entry
into the uterus) of the inserter so that the elongate member of the
device with a drug containing reservoir is inside the insertion
tube 6 with the tip of the elongate member abutting the end of the
plunger (shown with reference number 2a). The means to move the
slider 5 is on the starting or initial position, and the removal
string(s) inside the inserter are tightened and locked by the
locking means (not shown in the Figure).
[0081] FIG. 2B illustrates the first step of insertion procedure.
While holding the handle 3, the insertion tube is moved towards the
IUS by pushing the slider forward until surface 5a abuts the
surface 8a of the opening 8 of the handle 3, thereby stopping the
movement of the insertion tube. At this moment the IUS is
substantially inside the insertion tube, and ready for insertion.
The distance the slider and the insertion tube will move between
the surfaces 5a and 8a has been designed substantially to
correspond to the length of the IUS assembled for insertion. The
first end of the insertion tube is stopped at a level at which the
hemispherical tips (10a, 10b as shown in FIGS. 4A and 4B) of the
wings of the IUS partly remain uncovered by the insertion tube,
while the wings still remain together.
[0082] FIG. 2C illustrates the procedure to release the IUS. The
device in the configuration according to FIG. 2B is introduced into
the uterus until the IUS is in the correct location, where after
the device is released from the insertion tube. While retaining the
inserter stationary, the insertion tube is retracted towards the
handle by moving the slider 5 backwards until the surface 5b of the
slider abuts the surface 8b of the opening 8 of the handle 3. The
distance the slider and the insertion tube can be moved has been
selected to indicate clearly the moment at which the IUS has
completely been released from the insertion tube moving towards the
handle.
[0083] FIGS. 3A, 3B and 3C illustrate an operating principle of the
inserter shown in FIGS. 2A, 2B and 2C for insertion of another type
of intrauterine system. For this intrauterine system, the
triangular frame of the IUS can be bent such that the frame is
two-fold on its whole length when ready for insertion, or such that
it is four-fold on the top half of its length.
[0084] FIGS. 4A, 4B, 4C and 4D illustrate a correct positioning of
an IUS in an insertion tube of an inserter according to the present
invention. FIG. 4A shows one type of IUS 1 and FIG. 4B its position
in an insertion tube: the first end of the insertion tube 6 is
stopped at a level at which the hemispherical tips 10a, 10b of the
wings of a T-shaped IUS partly remain uncovered by the protective
tube 6. FIG. 4C presents another type of IUS 1, having a frame with
triangular shape. In FIG. 4D is shown how the outer end 10c of the
retracted and compressed closed frame partly remain uncovered by
the protective tube 6.
[0085] FIGS. 5A and 5B illustrate a locking means according to an
embodiment of the invention. The locking means are arranged
preferably inside of the handle 3, on any of the inside surfaces of
the handle. The locking means are used to immobilise and release
the string(s) of the IUS.
[0086] FIG. 5A illustrates a locking means according to an
embodiment of the invention comprising a main part 11 having
essentially the shape of a cylinder and comprising an opening 12
there through in a diagonal direction. The string(s) 7 of the IUS
pass through the opening 12. The main part 11 is rotatably mounted
on the handle, on a shaft or an axle (not shown). The locking means
also comprises a counterpart 13, such that in the locking position
the string(s) are immobilized between the counterpart and the main
part. The counterpart thus has a suitable shape adapted to fit to a
part of the surface of the main part. When the slider is moving
backwards, at a suitable point a part or an extension of the slider
is pressed against the extension 11a of the main part 11 thus
turning it enough to release the string(s), as shown in FIG.
5B.
[0087] FIGS. 6A and 6B illustrate a locking means according to
another embodiment of the invention. FIG. 6A illustrates an object
similar to the one presented in FIG. 5A, but having a different
construction of the extension 11a.
[0088] FIGS. 7A and 7B illustrate a locking means according to yet
another embodiment of the invention. This is a side view of a
locking means having a cylindrically shaped main part 14 which
comprises two extensions 14a and 14b. The main part 14 can rotate
around a shaft or an axle 16 and is preferably attached to a
shorter side of the inner surface of the handle. The locking means
also comprises a counterpart 15 such that the string(s) 4 are
immobilised between the counterpart 15 and the extension 14b. The
counterpart 15 has a suitable shape adapted to fit to a part of the
surface of the extension 14b. When the slider is moving backwards,
at a suitable point a part or an extension of the slider is pressed
against the extension 14a thus turning it enough to release the
string(s), as shown in FIG. 7B. In this case the handle can also
comprise a groove in which the string(s) run (not shown).
[0089] FIGS. 8A and 8B illustrate a locking means according to a
further embodiment of the invention. The locking means 17 comprises
two extensions 17a and 17b to immobilize the strings as shown in
FIG. 8A. When the slider 5 and the insertion tube 6 move backwards
the slider protrudes into the locking means at least partly to
expand the means enough to separate the extensions 17a and 17b and
to release the strings, as shown in FIG. 8B.
[0090] FIGS. 9A and 9B illustrate a locking means according to a
yet another embodiment of the invention. The locking means
comprises two parts 18a and 18b to immobilize the strings as shown
in FIG. 9A, said parts being able to move or turn from their
original position. The slider 5 has two extensions 19a and 19b.
When the slider 5 and the insertion tube 6 move backwards the
slider extensions turn the locking parts 18a and 18b apart from
each other, enough to release the strings, as shown in FIG. 9B.
* * * * *