U.S. patent application number 13/119399 was filed with the patent office on 2011-07-14 for an inserter.
Invention is credited to Calvo Alonson, Harri Jukarainen, Iikka Jutila, Heikki Lyyikainen, Andrew Macleod, Michael Noble, Taina Tjader, David Whitaker.
Application Number | 20110172593 13/119399 |
Document ID | / |
Family ID | 39852187 |
Filed Date | 2011-07-14 |
United States Patent
Application |
20110172593 |
Kind Code |
A1 |
Lyyikainen; Heikki ; et
al. |
July 14, 2011 |
AN INSERTER
Abstract
The present 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 movable 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) and having a
longitudinal axis, and an insertion tube (6) having a first end, a
second end and a longitudinal axis essentially parallel to the
longitudinal axis of the plunger (2), the insertion tube (6) being,
along said longitudinal axis, movably arranged around the plunger
(2). The invention is characterised in that it further comprises a
flange (4) arranged on the insertion tube (6) at its first end, and
means for locking the slider (5) into a position showing the
correct insertion depth for the intrauterine system, said means
being adjustable with respect to the opening (8) of the handle.
Inventors: |
Lyyikainen; Heikki;
(Naantaki, FI) ; Jutila; Iikka; (Raadelmaantie,
FI) ; Alonson; Calvo; (Piispanristi, FI) ;
Jukarainen; Harri; (Vadelmakatu, FI) ; Tjader;
Taina; (Littoinen, FI) ; Macleod; Andrew;
(Cambridgeshire, GB) ; Noble; Michael; (London
Greater, GB) ; Whitaker; David; (London Greater,
GB) |
Family ID: |
39852187 |
Appl. No.: |
13/119399 |
Filed: |
September 11, 2009 |
PCT Filed: |
September 11, 2009 |
PCT NO: |
PCT/FI2009/050733 |
371 Date: |
March 16, 2011 |
Current U.S.
Class: |
604/48 |
Current CPC
Class: |
A61F 6/142 20130101;
A61F 6/18 20130101 |
Class at
Publication: |
604/48 |
International
Class: |
A61M 31/00 20060101
A61M031/00 |
Foreign Application Data
Date |
Code |
Application Number |
Sep 17, 2008 |
FI |
20080524 |
Claims
1. 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 movable
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) and having a longitudinal axis, an insertion tube (6)
having a first end, a second end and a longitudinal axis
essentially parallel to the longitudinal axis of the plunger (2),
the insertion tube being, along said longitudinal axis, movably
arranged around the plunger (2), a flange (4) arranged on the
insertion tube (6) at its first end, characterized in that the
inserter further comprises means for locking the slider (5) into a
position showing the correct insertion depth for the intrauterine
system, said means being adjustable with respect to the opening (8)
of the handle.
2. An inserter according to claim 1, characterised in that the
flange (4) is arranged to at least partially protect the
intrauterine system before its insertion.
3. An inserter according to claim 1, characterised in that the
means for locking the slider (5) comprises a self-locking button
movable in a stepwise way.
4. An inserter according to claim 1, characterised in that it
further comprises means for holding and guiding the removal strings
of the intrauterine system during its insertion.
5. A kit comprising an intrauterine system and an inserter
according to claim 1.
Description
[0001] The present invention is related to an inserter for
positioning an intrauterine device or an intrauterine system in the
uterus.
BACKGROUND OF THE INVENTION
[0002] 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.
[0003] 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.
[0004] 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. With these inserters the correct positioning and a
secure attachment of an IUS or IUD on the inserter as well as a
proper handling of the removal strings may be difficult. Therefore
there is still need for an improved inserter.
[0005] European patent application EP1 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 thus will
not be twisted during insertion.
[0006] 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 where after 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. These stop members
are however fixed on the handle.
[0007] The inserters described in these documents overcome many of
the problems encountered with the conventional inserters, but the
string(s) still need to be handled and manually locked. Further,
the inserters are designed primarily for the insertion of the
conventional devices which are to be inserted in a compressed
configuration. Therefore there is still need for an improved
inserter, which can be used to insert in original expanded
configuration intrauterine devices and systems having frames of
various shapes.
OBJECT AND SUMMARY OF THE INVENTION
[0008] 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 securing the
simple and correct positioning of the intrauterine system in the
uterus.
[0009] A typical inserter for an intrauterine system according to
the present invention, comprises [0010] 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, [0011] a movable slider
arranged in said longitudinal opening and having a first end and a
second end, [0012] a plunger attached to the handle and having a
longitudinal axis, [0013] an insertion tube having a first end, a
second end and a longitudinal axis essentially parallel to the
longitudinal axis of the plunger, the insertion tube being, along
said longitudinal axis, movably arranged around the plunger, [0014]
a flange arranged on the insertion tube at its first end.
[0015] The inserter is characterized in that it further comprises
[0016] means for locking the slider into a position showing the
correct insertion depth for the intrauterine system, said means
being adjustable with respect to the opening of the handle.
BRIEF DESCRIPTION OF THE DRAWING
[0017] FIG. 1 illustrates a general overview of an inserter
according to an embodiment of the invention.
[0018] FIGS. 2A, 2B, 2C and 2D illustrate an operating principle of
an inserter according to an embodiment of the invention.
[0019] FIGS. 3A and 3B illustrate a locking means according to an
embodiment of the invention.
[0020] FIGS. 4A and 4B illustrate a locking means according to
another embodiment of the invention.
[0021] FIGS. 5A and 5B illustrate a locking means according to yet
another embodiment of the invention.
[0022] FIGS. 6A and 6B illustrate a locking means according to a
further embodiment of the invention.
[0023] FIGS. 7A and 7B illustrate a locking means according to
still a further embodiment of the invention.
[0024] FIGS. 8A and 8B illustrate an intrauterine system and its
positioning on the inserter according to an embodiment of the
invention.
[0025] FIGS. 8C and 8D illustrate another intrauterine system and
its positioning on the inserter according to an embodiment of the
invention,
[0026] FIGS. 9A and 9B illustrate some details of FIG. 8B.
DETAILED DESCRIPTION OF THE INVENTION
[0027] A typical inserter for an intrauterine system according to
the present invention, comprises [0028] 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, [0029] a movable slider
arranged in said longitudinal opening and having a first end and a
second end, [0030] a plunger attached to the handle and having a
longitudinal axis, [0031] an insertion tube having a first end, a
second end and a longitudinal axis essentially parallel to the
longitudinal axis of the plunger, the insertion tube being, along
said longitudinal axis, movably arranged around the plunger, [0032]
a flange arranged on the insertion tube at its first end.
[0033] The inserter is characterized in that it further comprises
[0034] means for locking the slider into a position showing the
correct insertion depth for the intrauterine system, said means
being adjustable with respect to the opening of the handle.
[0035] 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.
[0036] 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
[0037] The inserter comprises a flange arranged on the insertion
tube at its first end. The aim of this flange is to keep the
intrauterine system in a correct position and to protect it prior
to insertion. The flange also functions as part of the means
regulating the movement of the insertion tube.
[0038] The inserter may further comprise means for holding and
guiding the strings during the insertion so that no manual handling
of said strings will be needed. The inserter may also comprise
locking means for reversibly locking the strings to immobilize the
intrauterine system in relation to the plunger, said locking means
being controllable by the slider and/or by the insertion tube.
[0039] The inserter according to the invention is suitable for the
positioning of intrauterine devices and intrauterine systems having
different sizes and shapes. The inserter is especially suitable for
installing intrauterine devices having a flexible frame with
continuous curved shape, for example annular, circular, oval,
spiral, toroidal, triangular, shield-like, almond-like,
diamond-like, elliptical or polygonal shape.
[0040] 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 and
removal strings are used when describing the preferred embodiment
of the present invention, but these are not to be construed as
limiting the claims.
[0041] A part of the handle comprises an opening having a first end
and a second end and running in the longitudinal direction of the
plunger. The handle also preferably has at its first end a channel
in which the insertion tube can slide in the longitudinal
direction.
[0042] The handle can have many shapes and is 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. To enable the optimal and
secure positioning of the intrauterine system in the inserter the
forward end of said plunger is shaped to the form of a a slot or an
extension to adapt the reservoir of the intrauterine system. Thus
the IUS will not drop or be twisted during insertion procedure and
assumes a specified constant configuration when released.
[0043] The forward part (part directed towards the uterus) of the
inserter is preferably made of a flexible material to avoid
perforation of the uterus, and can be straight or curved so as to
conform to the anatomy of the uterus. The first end of the
insertion tube comprises a flange and both are made of a relatively
flexible material, but are preferably stiffer than the plunger.
[0044] 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 insertion tube. According to an
embodiment of the invention the slider comprises a means to move
the slider, which preferably is a part of the slider. 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 adapt 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 may also comprise at least one structural element,
for example an extension, which is capable to generate the
necessary operation of the possible locking means to keep the
strings immobilized during storage or during preparatory steps
before insertion and/or to release the string(s) when the slider is
moved to the backward position.
[0045] To ensure the correct positioning of the intrauterine system
in the uterus, the slider is adjusted to correspond to the depth at
which intrauterine system will be inserted, said depth being
beforehand determined by using a sound or a probe. The slider
comprising said means for locking it, which means are adjustable
with respect to the opening of the handle can be for example a
self-locking button slider and movable in a stepwise way controlled
for example by an indentation, a cogwheel or a rack and pinion
mechanism positioned inside the handle. The outer side of the
handle has clear depth markings to facilitate the adjustment of the
slider.
[0046] The slider and/or the insertion tube may additionally
comprise 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 to release the string(s) when
the slider is moved to the backward position.
[0047] According to an embodiment of the invention relating to the
kit comprising also an intrauterine system, a therapeutic component
of the intrauterine system is connected to the frame in at least
one point. Moreover, the intrauterine system can be connected to
the inserter for example via at least one connection part. The
connection part is preferably designed such that it enhances the
retention of the device on the inserter prior and during the
insertion of the device.
[0048] The connection part can be for example a hollow knob,
adapted to receive a pin, one of these parts being arranged on the
intrauterine system and the other on the inserter. Another option
is to use a traditional ball joint. A person skilled in the art is
readily able to find a suitable solution for this connection
part.
[0049] Also in view of this, and according to an embodiment of the
invention, the first end of the plunger comprises at least one
connection slot for receiving the connection part of the
intrauterine system. The first end of the plunger may also comprise
two diagonally symmetrical connection slots for receiving the
connection part of the intrauterine system. It is naturally
possible that there are more than two connection slots, such as
three, four, five or six slots. The connection part then preferably
comprises suitable parts fitting to these connections slots.
[0050] According to another embodiment of the invention, the first
end of the plunger comprises at least one frame slot for receiving
the frame of the intrauterine system. The first end of the plunger
may also comprise two diagonally symmetrical frame slots for
receiving the frame of the intrauterine system. The number of frame
slots can also be higher, such as three, four, five or six. The
frame slots can be parallel to the longitudinal axis of the plunger
or non-parallel to it. The frame slots can for example be straight
or slightly curved with respect to the outer surface of the
plunger, in order for allowing the frame to be released. The frame
slots are preferably narrow enough to prevent the therapeutic
component from slipping out and long enough to allow the movement
of the therapeutic component and the stretching/compression of the
frame during the insertion step. The plunger or at least the first
end of the plunger is large enough for containing the therapeutic
component. The frame slot(s) together with connection parts and the
flange assure that the intrauterine system will be securely fitted
and in the correct configuration during the insertion.
[0051] According to a further embodiment of the invention, the
first end of the insertion tube comprises at least one frame slot
for receiving the frame of the intrauterine system. The first end
of the insertion tube may also comprise two diagonally symmetrical
frame slots for receiving the frame of the intrauterine system. The
number of frame slots can also be higher, such as three, four, five
or six. The frame slots can be parallel to the longitudinal axis of
the insertion tube or non-parallel to it. The frame slots can for
example be straight or slightly curved with respect to the outer
surface of the insertion tube, in order for allowing the frame to
be released. The frame slots are preferably narrow enough to
prevent the therapeutic component from slipping out and long enough
to allow the movement of the therapeutic component and the
stretching/compression of the frame.
[0052] The inserter according to the present invention may also
comprise locking means for reversibly locking the intrauterine
system in relation to the plunger, 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. The locking means is any arrangement which,
induced by the movement of the slider, of the means to move the
slider or of the insertion tube, can immobilize the removal
string(s) to held IUS in stable position and again unlock 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 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.
[0053] When the slider mechanism is pressed down and moved to
adjust the correct insertion depth a part or an extension of the
slider 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). As soon as the slider is
released, the strings will lock again.
[0054] 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 IUS is released. 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.
[0055] As an alternative or in addition to the locking means, the
outer surface of the insertion tube or the handle can have means to
hold the strings until the intrauterine system has been
inserted.
[0056] According to one embodiment of the invention, the locking
means thus comprises [0057] a main part, [0058] a first extension
of the main part having an abutment surface, [0059] a counterpart
adapted to form a blocking together with the main part, wherein the
locking means is rotatably mounted on the inserter.
[0060] 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.
[0061] According to yet another embodiment of the invention, the
locking means comprises [0062] a main part, [0063] a first
extension of the main part having an abutment surface, [0064] a
second extension of the main part having a wedge-like shape, [0065]
a counterpart adapted to form a blocking together with the main
part, wherein the second extension is adapted to form a blocking
together with the counterpart and the locking means is rotatably
mounted on the handle of the inserter.
[0066] 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.
[0067] According to one embodiment of the invention the insertion
tube comprises an extension adapted to abut on the abutment surface
of the first extension of the main part of the locking means.
[0068] 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, wherein
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.
[0069] According to yet one other embodiment of the invention the
locking means comprises [0070] 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 [0071] a first protrusion and a second
protrusion arranged on the inner surface of the outer insertion
tube, wherein the first and second protrusions are arranged to move
the first and second locking parts when moving the outer insertion
tube.
[0072] 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 insertion tube would then release the attachment when
contacting the slider. Other options could be a knot or other
mechanical hindrance, when the slot provided for the strings is
larger in the releasing position. The insertion tube could also
comprise a blade that cuts the strings away from the inserter.
[0073] 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 thereof.
[0074] During the preparatory steps the string(s) are hold tightly
or locked but they are released automatically, when the slider is
moved for example to adjust the insertion depth or when the second
end of the insertion tube meets the slider or when the inserter is
drawn out after insertion in order to release the IUS. As compared
to previous inserters there is no need to manually handle the
removal strings during the preparatory steps and during insertion,
which increases security and hygiene and eliminates the possibility
of user-made mistakes. Moreover, during the insertion the plunger
and the medical device are protected by the insertion tube up to
the cervix, which also increases hygiene. 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 intrauterine system known in the art. Any details and
embodiments listed above naturally apply mutatis mutandis to the
kit according to the invention.
[0075] The present invention also relates to a method for
positioning an 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 [0076] sounding the
depth of the uterus to obtain the correct positioning depth, [0077]
moving the slider mechanism towards the second end of the opening
until its position corresponds to said positioning depth, as shown
by the depth markings of the handle, [0078] introducing the
inserter into the uterus of the patient until the flange on the
insertion tube abuts the cervical opening, [0079] introducing the
plunger with the intrauterine system further into the uterus until
the insertion tube meets the slider while moving backwards away
from the uterus, which shows that the intrauterine system is in its
correct location, [0080] removing the inserter from the uterus of
the patient.
[0081] 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 intrauterine system
or for example to rearrange or correct the frame. The IUS is
positioned at the forward end of the plunger with the reservoir of
the intrauterine system protected by the extension of the plunger
and the frame locating outside the plunger in the expanded
configuration, secured and protected by the flange. The removal
string(s) attached to the intrauterine system are preferably
immobilized by the locking means, by the means on the surface of
the insertion tube, or by both, to keep the IUS at a steady and
correct position until it is released in the uterus. The removal
strings do however not necessarily need to be immobilized.
[0082] Prior to the insertion procedure the depth of the uterus is
measured by sounding. The slider mechanism or the means to move the
slider is moved to correspond to the correct sounding depth. In the
simplest form the slider is equipped with a self-locking press down
and slide back button to adjust the correct sounding depth.
[0083] Then, the handle is hold tightly and the inserter is
introduced into the uterus until the flange touches the cervical
opening. At this point the insertion tube starts moving backwards
and the flexible plunger with the intrauterine system will go
forwards into the uterus. The insertion is continued until the
insertion tube meets the slider, when also the removal string(s),
if locked, are released by the locking means or by the means on the
insertion tube. At this point IUS is in the correct location, as
determined beforehand by using a sound as described above.
[0084] 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 distances the insertion tubes
can be moved in each step guarantee an accurate positioning of the
IUS during insertion and its accurate release.
DETAILED DESCRIPTION OF THE DRAWING
[0085] 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 used for convenience of reading.
[0086] 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 having means to move the
slider 5, an insertion tube 6 around the plunger, an IUS and the
string or strings (not shown here) for the removal of the IUS,
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, an
opening 8, a channel 9 in which the insertion tube slides in the
longitudinal direction, and depth markings 19 on the handle which
are used to adjust the slider to correspond the depth of the
uterus.
[0087] In this case the forward part of the handle 3 forms an
opening 8, having the first end 8a and the second end 8b, which
opening runs in the direction of the plunger 2 and has at the first
end a channel 9 in which the insertion tube 6 slides in the
longitudinal direction. The front surface of the means to move the
slider 5a is set on the depth marking corresponding the depth of
the uterus, i.e. the insertion depth, as determined before hand by
using a sound or a probe.
[0088] FIGS. 2A, 2B, 2C and 2D illustrate an operating principle of
the inserter.
[0089] FIG. 2A shows an inserter and in this case an almond-shaped
IUS 1 in a configuration as they are in the sterilized package. The
IUS is placed in the front end (entry into the uterus) of the
inserter so that the elongate member of the intrauterine system or
the elongated member with a drug containing reservoir is inside the
head of the plunger and the frame of the intrauterine system is in
the expanded configuration and partly covered by the flange 4. The
means to move the slider 5 is on the basic position. The removal
string(s) are inside the inserter, tightened and locked by the
locking means (not shown in the Figure) or outside under the
insertion tube hold by suitable means or extensions.
[0090] FIG. 2B illustrates the first step of insertion procedure.
After the insertion depth has been determined by sounding, the
slider is moved backwards until surface 5a is on a correct depth
marking of the handle 3.
[0091] FIG. 2C illustrates the procedure to insert the IUS. The
intrauterine system in the configuration according to FIG. 2B is
gently introduced into the uterus until the flange abuts the
cervical opening. The frame of the IUS will compress against the
head of the plunger.
[0092] FIG. 2D illustrates the final step of insertion procedure.
Insertion is continued from the step of FIG. 2C. The flange pressed
against the cervical opening will cause the insertion tube to move
backwards, and only the plunger with the intrauterine system will
move towards the uterus. The insertion tube will move until the
rear end of the tube meets the slider and at this point the
intrauterine system is correctly positioned in the uterus. The
inserter is retracted out of the uterus. The strings and the
intrauterine system are automatically released when the insertion
tube meets the slider or when the inserter is drawn out. The
distance the insertion tube can move has been selected to indicate
clearly the moment at which the IUS has completely been
positioned.
[0093] FIGS. 3A and 3B illustrate a locking means according to an
embodiment of the invention. The locking means are arranged
preferably at the 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.
[0094] FIG. 3A illustrates a locking means according to an
embodiment of the invention comprising a main part 10 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 10 is rotatably mounted
on the handle, on a shaft or an axle (not shown). The locking means
also comprises a counterpart 11, 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 10a of the main part 10 thus
turning it enough to release the string(s), as shown in FIG.
3B.
[0095] FIGS. 4A and 4B illustrate a locking means according to
another embodiment of the invention. FIG. 4A illustrates an object
similar to the one presented in FIG. 3A, but having a different
construction of the extension 10a.
[0096] FIGS. 5A and 5B illustrate a locking means according to yet
another embodiment of the invention. This is a side view of a
cylindrically shaped locking means, having a main part 13 which
comprises two extensions 13a and 13b. The locking means can rotate
around a shaft or an axle 14 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) 7 are
immobilised between the counterpart 15 and the extension 13b. The
counterpart 15 has a suitable shape adapted to fit to a part of the
surface of the extension 13b. When the slider is moving backwards,
at a suitable point a part or an extension of the slider is pressed
against the extension 13a thus turning it enough to release the
string(s), as shown in FIG. 5B. In this case the handle can also
comprise a groove in which the string(s) run (not shown).
[0097] FIGS. 6A and 6B illustrate a locking means according to an
embodiment of the invention. The locking means 16 comprises two
extensions 16a and 16b to immobilize the strings as shown in FIG.
6A. When the slider 5 and the insertion tube 6 move backwards the
slider and/or the insertion tube protrudes into the locking means
at least partly to expand the means enough to separate the
extensions and to release the strings, as shown in FIG. 6B.
[0098] FIGS. 7A and 7B illustrate a locking means according to a
further embodiment of the invention. The locking means comprises
two parts 17a and 17b to immobilize the strings as shown in FIG.
7A, said parts being able to move or turn from the original
position. The slider 5 has two extensions 18a and 18b. When the
slider 5 and the insertion tube 6 move backwards the slider
extensions turn the locking parts 17a and 17b apart from each other
enough to release the strings, as shown in FIG. 7B.
[0099] FIGS. 8A and 8B illustrate an intrauterine system and its
positioning on the inserter according to an embodiment of the
invention. The intrauterine system has a frame 1a and a therapeutic
component 1b and it is positioned in the plunger or in an extension
of the plunger 2. The intrauterine system is connected to the
inserter via one connection part 19. The first end of the plunger 2
comprises one connection slot 20 for receiving the connection part
19. The therapeutic component is essentially completely and the
frame essentially only partly positioned in a frame slot 21.
[0100] FIGS. 8C and 8D illustrate another intrauterine system and
its positioning on the inserter according to an embodiment of the
invention, which has the same parts 1a, 1b, 2, 19 and 20 as in
FIGS. 8A and 8B. In this embodiment, the therapeutic component is
essentially completely positioned inside the plunger and the frame
is essentially completely outside the plunger.
[0101] FIGS. 9A and 9B illustrate some details of FIG. 8B, namely
the first end of the plunger 2 and the connection of the
intrauterine system on the plunger.
* * * * *