DE102014219593A1 - Apparatus for hysteroscopic sterilization and a retrofit kit therefor - Google Patents

Abstract

The invention relates to a device (1) for hysteroscopic sterilization and a retrofit kit (30) for corresponding devices. The device (1) for hysteroscopic sterilization comprises an introducer catheter (3), a coaxially arranged release catheter (8) and a coaxially arranged inside flexible inner cable (10), wherein at one end of the inner cable (10) an end piece (4) and an at least partially elastic coil (12), wherein the coil (12) is tensioned at its ends by the tail (4) and the release catheter (8) at their ends such that their diameter is reduced from the relaxed state. Provided on the release catheter (8) is a retaining element (20) which is at least partially elastic and is held under tension by the overlying insertion catheter (3) in such a way that its radial extent is reduced compared to the relaxed state. The retrofit kit (30) for a hysteroscopic sterilization device includes a retention member (20) having a mounting portion adapted for attachment to the release catheter of a hysteroscopic sterilization device, wherein the retention member (20) is at least partially resilient and configured to detach from the overlying insertion catheter of the device for hysteroscopic sterilization can be kept under tension so that its radial extent is reduced compared to the relaxed state.

Description

The invention relates to a device for hysteroscopic sterilization and a retrofit kit for corresponding devices.

In the prior art sterilization methods are known in which a foreign body is inserted into the proximal part of a fallopian tube. The foreign body causes coalescence and ultimately closure of the fallopian tube.

From the international patent application WO 2011/049694 A1 is a device for hysteroscopic sterilization in which a foreign body is introduced into the fallopian tube as described. The foreign body in this case comprises a spiral made of an at least partially elastic material, which - possibly by additional components - stimulates tissue growth.

To introduce the coil into the fallopian tube, it is wound under tension around a flexible inner cable and an adjoining end piece so that its diameter is reduced compared to the relaxed state. The one end of the spiral is firmly connected to the tail. At the other end, the coil is gripped by a release catheter and held in tension as a whole. In the initial state, the spiral, the flexible inner cable and the release catheter are arranged in an insertion catheter which extends to the end piece.

At the side facing away from the tail end the concentrically arranged catheter and the inner cable in a handle that allows the insertion, placement and release of the spiral. The length of the catheter and the inner cable is sufficiently dimensioned so that the spiral can be guided through a hysteroscope into the fallopian tube.

To insert a coil into the fallopian tube, the insertion catheter is first inserted end-to-end into the fallopian tube, monitoring the positioning of the insertion catheter via a hysteroscope. For positioning, a marking is provided on the outside of the insertion catheter, which can serve, for example, the positioning relative to the ostium of the fallopian tube. In this case, the introducer catheter can be pushed into the fallopian tube until the marking is applied to the ostium of the fallopian tube.

The introducer catheter is then withdrawn, with the inner cable and the release catheter - and thus also the spiral under tension - remaining in the fallopian tube. By marking on the release catheter and / or the spiral, the physician can hysteroscopically recheck the position of the device. By analogy with the marking on the delivery catheter, it may be predetermined where the corresponding markings with respect to, for example, the ostium of the fallopian tube should be located.

When the live coil is properly positioned, the release catheter is withdrawn so far that the coil at the corresponding end is no longer encompassed by it. The coil then begins to relax and, by increasing its diameter, attaches itself to the inner wall of the fallopian tube.

Has the coil sufficiently relaxed, the inner cable from the tail - for example, by a rotary motion - separated and pulled out.

As a result, only the spiral resting against the inner wall of the fallopian tube and the end piece arranged therein remain in the fallopian tube. Since at least the spiral is made of material or has additional components that stimulate the tissue growth, it comes to a coalescence and closure of the fallopian tube and thus to a permanent sterilization.

A disadvantage of the prior art according to WO 2011/049694 A1 is that the positioning of the spiral throughout the insertion procedure is done solely by the handle. About this handle, however, not only the positioning but also the above-described operation of the catheter. This can lead to unintentional movements on the handle, which have a change in position and possibly a faulty placement of the spiral result.

The object of the present invention is to provide a device for hysteroscopic sterilization which no longer has the disadvantages known from the prior art or at least only to a lesser extent. A further object of the present invention is to provide a retrofit kit with which prior art devices can be further developed into a hysteroscopic sterilization device according to the invention.

These objects are achieved by the device according to the main claim, and the retrofit kit according to claim 6. Advantageous developments are the subject of the dependent claims.

Accordingly, the invention relates to a device for hysteroscopic sterilization comprising an insertion catheter, a coaxially arranged release catheter therein and in turn coaxially arranged flexible inner cable, wherein disposed at one end of the inner cable, an end piece and an at least partially elastic coil, wherein the coil in the initial state is held at its ends by the tail and the release catheter in tension so that its diameter is reduced from the relaxed state, and wherein on the release catheter, a retaining element is provided, which at least partially is elastic and is maintained under tension by the overlying introducer catheter such that its radial expansion is reduced from the relaxed state.

Furthermore, the invention relates to a retrofit kit for a device for hysteroscopic sterilization, comprising a retaining element with a fastening portion designed for attachment to the release catheter of a device for hysteroscopic sterilization, wherein the retaining element is at least partially elastic and configured such that it from the overlying insertion catheter Hysteroscopic sterilization device can be kept under tension so that its radial expansion is reduced compared to the relaxed state.

By provided in a hysteroscopic sterilization device according to the invention or retrofittable retaining element release catheter and the inner cable arranged therein - and thus the spiral - after retraction of Einführkatheters in the fallopian tube against unintentional movement, in particular against unintentional further insertion, secured. The retention element relaxes when it is no longer held under tension by the insertion catheter, thereby increasing its extent in the radial direction, so that it can come to rest against the uterine wall at the entrance of the fallopian tube. Unintentional changes in the position of the spiral can be effectively prevented.

The retaining element of the device according to the invention can be formed in one piece with the release catheter. But it is also possible that the retaining element of the device - similar to the retrofit kit - has a mounting portion for attaching the retaining element to the release catheter. The attachment portion may be configured as a sleeve-shaped portion or as a snap clip. Snap clips have two elastically deformable legs and comprise an object disposed therein - in this case the release catheter - by a total of at least 180 °. The release catheter can be inserted laterally into the snap clip through the slot between the two legs.

The retaining element preferably has at least one latching tongue, which protrudes from the release catheter in the relaxed state. In the initial state, the latching tongue is pivoted by the insertion catheter in the direction of the release catheter, whereby the retaining element has a smaller radial extent than in the relaxed state. Preferably, two or more locking tongues are provided, which are distributed uniformly over the circumference of the release catheter or the retaining element.

The pivot axis of the at least one latching tongue preferably runs perpendicular to the axis of the release catheter and / or the attachment portion. The fastening element is preferably arranged on the release catheter such that the free end of the latching tongue points in the direction of the spiral.

The retaining element is preferably formed as connected to the release catheter or connectable sleeve or snap clip, wherein preferably the at least one latching tongue is formed by punching and plastic pre-bending to the outside.

"Plastic outward bending" in this context means that the punched out tongue is bent outwards in such a way that plastic deformation occurs. After this plastic Vorbiegung the at least one latching tongue is in the relaxed state to the outside of the sleeve or snap clip and can be pivoted according to the invention by the insertion catheter in the direction of the sleeve or snap clip.

The retaining element is preferably made of metal, preferably of resilient metal, more preferably of a shape memory alloy.

The retaining element can be secured solely by force against displacement along the release catheter. However, it is also possible for the retaining element and / or the release catheter to have elements for a form-locking connection. It is also alternatively or additionally possible that an adhesive connection is provided between the retaining element and the release catheter, for example by the use of an adhesive.

To explain the retrofit kit, reference is made to the above statements.

The invention will now be described by way of example with reference to preferred embodiments with reference to the accompanying drawings. Show it:

1 FIG. 2: the external view of a first exemplary embodiment of a device according to the invention for hysteroscopic sterilization; FIG.

2a -D: schematic sectional views of the device 1 ;

3a , b: schematic views of a first embodiment of a retrofit kit according to the invention; and

4 : A schematic view of a second embodiment of a retrofit kit according to the invention.

1 is an illustration of a device according to the invention for hysteroscopic sterilization 1 in the initial state, ie before starting a sterilization process.

The device 1 includes a handle 2 and a delivery catheter 3 , The introducer catheter 3 extends from the handle 2 up to a tail 4 which comes from the insertion catheter 3 protrudes and a guide ball 5 for easier insertion of the delivery catheter 3 in an oviduct. The introducer catheter 3 - And the elements arranged therein, later in connection with 2a -D are explained - are designed flexibly and can be guided, for example, through a hysteroscope.

The introducer catheter 3 has a mark 6 on, for positioning the delivery catheter 3 is provided opposite the ostium of the fallopian tube. In the illustrated embodiment, the Einführkatheter 3 so far with the tail 5 advance into the fallopian tube until the mark 6 abuts the ostium of the fallopian tube. The correct positioning can be checked via a hysteroscope.

At the handle 2 are actuators 7 provided with which the Einführkatether 3 and others, hereinafter related to 2a -D described components optionally in the handle 2 can be recovered.

In 2a is a section through the distal portion of the device 1 out 1 shown.

Inside the delivery catheter 3 coaxially is a release catheter 8th arranged. The release catheter 8th extends like the introducer catheter 3 until the in 2a not shown handle 2 (please refer 1 ) and can be separated from the delivery catheter 3 about the actuators 7 in the handle 2 move in. The release catheter 8th has a marking ring 9 on the in 2a illustrated embodiment in a plane with the mark 6 of the delivery catheter 3 lies.

Inside the release catheter 8th Coaxial is a flexible inner cable 10 arranged, which is also up to in 2a not shown handle 2 (please refer 1 ). At its free end is a connecting element 11 provided with the inner cable 10 with the tail 4 is detachably connected. The connecting element 11 can be - depending on the design - for example, by a relative rotation of the inner cable 10 opposite the tail 4 or by an actuator, not shown, (for example, a wire train) in the interior of the inner cable 10 to solve.

With the tail 4 firmly connected is a spiral 12 , The spiral 12 is in the 2a illustrated initial state under tension so that its diameter is less than in the relaxed state. To maintain this state of tension is the spiral 12 at its one end with the tail 4 At the other end, she is taken off the release catheter 8th includes. The spiral 12 is in the initial state almost completely within the delivery catheter 3 arranged.

Firm with the release catheter 8th connected is a retaining element 20 , The retaining element 20 is through a sleeve 21 formed by punching two over the circumference of the sleeve 21 evenly distributed retaining tongues 22 are created, the respective pivot axis 23 perpendicular to the plane of representation and thus perpendicular to the axis of the release catheter 8th or the sleeve 21 are arranged. The free end 24 the retaining tongues 22 points in the direction of the spiral 12 , The retaining element 20 is not with the retention tabs 22 forming sleeve-shaped mounting portion frictionally on the release catheter 8th at.

The retaining tongues 22 are plastically bent outward. In relaxed state are the retaining tongues 22 in the radial direction so to the outside of the sleeve 21 from. In the initial state of the device 1 as well as in 2a is shown, the retaining tongues 22 however, from the introducer catheter 3 but kept under tension so that the radial extent of the retaining element 20 is reduced compared to the relaxed state. The retaining element 20 is inside the delivery catheter 3 arranged.

Starting from the 2a will now be based on the 2 B -D the use of the device 1 explained in more detail.

Im in 2a illustrated initial state is the Einführkatheter 3 with the tail 4 advanced into the fallopian tube. This can be the positioning of the delivery catheter 3 be monitored by a hysteroscope. Using the marker 6 can the correct insertion depth of the delivery catheter 3 be checked.

Is the correct positioning of the delivery catheter 3 reached, the introducer catheter becomes 3 using the controls 7 on the handle 2 so far pulled back that spiral 12 and the retaining element 20 be exposed. This is in 2 B shown.

By the retaining tongues 22 of the retaining element 20 no longer in this state of the delivery catheter 3 kept under tension, they swing outward and lie down with their free ends 24 on the uterine wall at the entrance of the fallopian tube (indicated by the dashed line). The position of the spiral 12 against the fallopian tube is thereby against unintentional change -bspw. by small unintentional movements of the handle 2 when operating the actuators 7 - protected. In particular, an unintentional further insertion of the spiral 12 in the fallopian tube by the described arrangement of the locking tongues 22 effectively prevented. The correct positioning of the spiral 21 can by the marker ring 9 be checked via a hysteroscope.

The next step is the release catheter 8th by operation of the actuators 7 on the handle 2 so far opposite the inner cable 10 withdrawn that release catheter 8th the spiral 12 no longer included. The spiral 12 relaxes on it, so enlarges its diameter, and attaches to the inner wall of the fallopian tube. The corresponding is in 2c shown.

It may be provided that when retracting the release catheter 8th the retaining element 20 is also moved and the retaining tongues 22 thus no longer rest against the uterine wall. But it is also possible that instead of actually retracting the release catheter 8th the retaining element 20 remains stationary and rather the inner cable 20 a piece from the release catheter 8th is pushed out. It may just need the markers 6 and 9 easily adapted.

Finally, the inner cable 10 from the tail 4 separated, wherein the connecting element 11 is pressed. Depending on the design of the connecting element 11 It may be sufficient for this, the handle 2 around the axis of the delivery catheter 3 to turn or one inside the inner cable 2 arranged further wire train (not shown) to operate. In 2d is the inner train 10 already from the tail 4 separated.

delivery catheter 3 , Release catheter 8th and inner cable 10 can then be completely pulled out, due to the selected arrangement of the locking tongues 22 no hooking is to be expected. This also applies to the case when the device 1 pulled out through a hysteroscope. At the end of the procedure, only the spiral remains 12 and the tail 4 in the fallopian tube and stimulate tissue growth there. As a result, the fallopian tube grows and closes.

In 3a , b is an inventive retrofit kit 30 provided, which is a retaining element 20 includes. The retaining element 20 is identical to the retaining element 20 the device according to 1 and 2a -D designed, which is why reference is made to the above statements. Conversely, can 3a , b also as a detailed representation of the retaining element 20 the device 1 out 1 and 2a -D be understood.

The retaining element 20 includes a sleeve 21 in which by punching two over the circumference of the sleeve 21 evenly distributed retaining tongues 22 are formed. The pivot axes 23 are each perpendicular to the axis of the sleeve 21 arranged.

The retaining tongues 22 are plastically bent outward. In relaxed state are the retaining tongues 22 in the radial direction so to the outside of the sleeve 21 from (see 3a ). However, the retaining tongues can be 22 For example, by an insertion catheter 3 (see. 2a ) under tension so that the radial extent of the retaining element 20 is reduced compared to the relaxed state (see 3b ).

The retrofit kit 30 according to 3a , b is suitable for further developing devices known from the prior art for hysteroscopic sterilization in such a way that it becomes a device according to the invention 1 according to 1 and 2a -D arrived.

In 4 is an alternative embodiment of a retrofit kit according to the invention 30 shown. The retrofit kit 30 is almost identical to the one from 3a , b, why reference is made to the statements there.

In contrast to the embodiment according to 3a , b is the retaining element 20 of the retrofit kit 30 in 4 but not from a sleeve 21 (see. 3a , b) shaped, but as a snap clip 21 ' designed. In the illustrated embodiment, the snap clip 21 ' formed by a longitudinally slotted sleeve. Because the retaining element 20 made of elastic material, can be the snap clip 21 ' along the longitudinal slot 25 bend and so laterally on a release catheter 8th a device for hysteroscopic sterilization attach.

The retaining elements 20 Nitinol, a shape memory alloy, is mainly made of nickel and titanium in the figures. Alternatively, the retaining element 20 from other materials, such as medical grade stainless steel.

QUOTES INCLUDE IN THE DESCRIPTION

This list of the documents listed by the applicant has been generated automatically and is included solely for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions.

Cited patent literature

• WO 2011/049694 A1 [0003, 0011]

Claims (10)

Contraption ( 1 ) for hysteroscopic sterilization comprising an introducer catheter ( 3 ), a coaxially arranged release catheter ( 8th ) and in turn coaxially arranged flexible inner cable ( 10 ), wherein at one end of the inner cable ( 10 ) an end piece ( 4 ) is arranged, and an at least partially elastic spiral ( 12 ), whereby the spiral ( 12 ) in the initial state at their ends of the tail ( 4 ) and the release catheter ( 8th ) is kept under tension so that its diameter is reduced compared to the relaxed state, characterized in that the release catheter ( 8th ) a retaining element ( 20 ) is provided, which is at least partially elastic and by the overlying Einführkatheter ( 3 ) is kept under tension so that its radial extent is reduced compared to the relaxed state. Device according to claim 1, characterized in that the retaining element ( 20 ) at least one latching tongue ( 22 ) in the relaxed state of the release catheter ( 8th ) protrudes. Apparatus according to claim 2, characterized in that the pivot axis ( 23 ) the at least one latching tongue ( 22 ) perpendicular to the axis of the release catheter ( 8th ) and / or the free end ( 24 ) the at least one latching tongue ( 22 ) in the direction of the spiral ( 12 ) is arranged pointing. Device according to one of the preceding claims, characterized in that the retaining element ( 20 ) as a sleeve connected to the release catheter ( 21 ) or snap clip ( 21 ' ), wherein preferably the at least one latching tongue ( 22 ) is formed by punching and plastic pre-bending to the outside. Device according to one of the preceding claims, characterized in that the retaining element ( 20 ) of metal, preferably of resilient metal, more preferably of a shape memory alloy. Retrofit kit ( 30 ) for a device for hysteroscopic sterilization, comprising a retaining element ( 20 ) having a mounting portion adapted for attachment to the release catheter of a hysteroscopic sterilization device, the retention member (10) 20 ) is at least partially resilient and configured to be tensioned by the overlying introducer catheter of the hysteroscopic sterilization device so as to reduce its radial expansion from the relaxed state. Retrofit kit according to claim 6, characterized in that the retaining element ( 20 ) at least one latching tongue ( 22 ), which projects in the relaxed state relative to the attachment portion to the outside. Retrofit kit according to claim 7, characterized in that the pivot axis ( 23 ) of the latching tongue ( 22 ) runs perpendicular to the axis of the attachment portion. Retrofit kit according to one of claims 6 to 8, characterized in that the retaining element ( 20 ) is formed as connectable with the release catheter sleeve or snap clip, wherein preferably at least one latching tongue ( 22 ) is formed by punching and plastic pre-bending to the outside. Retrofit kit according to one of claims 6 to 9, characterized in that the retaining element ( 20 ) of metal, preferably of resilient metal, more preferably of a shape memory alloy.

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