EP1175191A1

EP1175191A1 - Method for retaining and actuating an inter-uterine device inserter and inserter enabling said method to be carried out

Info

Publication number: EP1175191A1
Application number: EP00918615A
Authority: EP
Inventors: Dirk Wildemeersch
Original assignee: Individual
Current assignee: Individual
Priority date: 1999-04-16
Filing date: 2000-04-13
Publication date: 2002-01-30
Also published as: US6588429B1; BE1012613A3; WO2000062725A1; CN1184937C; AU3950500A; CN1344141A

Abstract

The invention relates to a method for retaining and actuating an inter-uterine device inserter, in addition to an inserter enabling said method to be carried out.The inter-uterine device inserter comprises a sheath (4), a needle (1) which is accommodated inside said sheath and joined to a thumbpiece (3), and an inter-uterine device (15) which is also accommodated in the sheath and driven by the needle in addition to being provided with a draw-string (22). The inventive method consists in initially joining the needle (1) to the sheath (4) and keeping the draw-string in a tensed state, whereupon the needle is released (1) along with the draw-string (22). The invention is characterized in that the release of the needle (1) also results in the release of the draw-string (22).

Description

Method for retaining and actuating an IUD inserter, and inserter allowing the application of this method. Field of the invention

The present invention relates to a method for retaining and actuating an IUD insertor according to the introductory part of claim 1. It also relates to an IUD insertor for the application of this method, according to introductory part of claim 5. State of the art

Methods and devices for inserting IUDs, and in particular IUDs whose cooperation with an insertion needle is maintained by a pulling wire, are known, for example from EU patent 0 160 633, where in Figures 12 and 13 is illustrated such a device. The pull wire is simply retained therein by bending beyond the proximal edge of the inserter. Such an embodiment does not allow the constitution of single-use inserts, originally provided with an IUD securely retained on the needle and constituting a sterile assembly ready for use.

To this end, it has already been proposed in EU 0 191 747 to constitute a retaining element for the pulling wire in the form of a slot, as well as a device for releasably blocking the sheath on the needle. The method of actuating this inserter however requires that the blockage of the wire and the sheath be released separately, which on the one hand involves the risk that during handling the cooperation of the IUD with the needle is interrupted during actuation of the inserter, before the insertion of the IUD retaining member in the wall of the matrix is completed, and on the other hand makes it difficult to use with one hand the said device, and again, once the actuation of the inserter is completed, there is the risk that the pulling wire will be trapped between the needle and the sheath, with as a consequence a pulling on the IUD when withdrawing the extractor. Subject of the invention

The present invention aims to remedy these drawbacks, and in the first place to simplify the procedure for actuating the inserter to allow easy release of the pulling wire without risk of interrupting the cooperation of the needle and the IUD. This is achieved by the feature of claim 1.

Advantageous embodiments of the method of the invention, making it possible in particular to guarantee first an effective retention of the pulling wire, and then a total release of the latter, also after actuation of the inserter, are the subject of the claims. subsidiary 2 to 4.

The invention also aims to provide an inserter allowing the implementation of the method of the invention. The specific characteristics of the inserter allowing the implementation of this process are the subject of the characterizing part of claim 5.

Advantageous embodiments of the inserter are the subject of subsidiary claims 6 to 14. Description of the drawings

The invention will be better understood by referring to the description below at the same time as to the appended drawings which represent, by way of example only, various embodiments of the invention, and in which: FIGS. 1 to 7 give various views of a preferred embodiment of the invention, and more particularly, fig 1 is a partial plan view of this embodiment of the invention, the needle being in a first position in the sheath, fig 2 is a partial view, in profile and in section, corresponding to the Fig 1, Figs 3 to 5 are views similar to those of Figure 2, corresponding to successive stages of

1 actuation of one inserter, fig 6 is a section, only in the sheath, along AA in fig.3 fig 7 is a section, only in the pusher, along BB in fig.3 fig 8 to 10 show in partial view, in profile and in section, another embodiment of the invention, in its successive stages of actuation. Detailed description of the invention.

Referring to the preferred embodiment of the invention illustrated in Figs 1 to 7, the device of the invention consists of a needle 1, secured at its proximal end 2 to a thumb 3, and a sheath 4.

The pusher 3 has a front body 5, in which is fixed the proximal part 2 of the needle 1, connected by two arms 6, 6 'to a plate 7 of actuation, constituting the pusher itself. Said plate 7 is connected by an elastic tongue 8 to a pusher 9 extending, between the arms 6, 6 ', in a movable arm 10 provided with a projection 11. The fore-body 5 also includes a projection

12 intended to constitute a stop. A longitudinal groove

13 is formed in the fore-body 5, and, in the extension thereof, a groove 13 'is formed in the projection 11.

The sheath 4 comprises a tubular part 14 of small diameter, intended to receive the needle 1 and an IUD 15, and an enlarged base 16, intended to receive and guide the fore-body 5 of the pusher. In the enlarged base are formed two orifices 17, 17 ′, aligned to cooperate with the projection 11 of the pusher, a stop 18, a channel 19, forming a local enlargement of the base 16 intended to allow the passage of the projection 12 constituting an abutment on the fore-body 5. Are also formed in the base 16, in the extension of said channel 19: a groove 20 intended to allow the passage of the projection 12, and an elastic tongue 21, intended to rebound elastically beyond the projection 12 during the introduction of the pusher 3 into the sheath 4. For ease of reading the drawing, a pulling wire 22 of the IUD 15 is shown in dotted lines. The cooperation of the IUD and the needle is carried out by means of a fixing wire 23, fixed in a known manner to the distal end 24 of the needle by a loop and knot system 25.

During assembly, the device is constituted in the following manner. An IUD 15 is mounted on the needle 1 by engaging the loop and knot system 25 on the distal end 24 of said needle, the cooperation of the IUD 15 and the needle 1 being maintained by ensuring traction on the wire. traction 22. The traction wire is thus engaged in the grooves 13, 13 ′ of the pusher 3. The needle 1 is then introduced into the sheath 4 until the fore-body 5 of the pusher 3 enters the enlarged base 16 of the sheath, where the projection 22 crosses the channel 19 and enters the groove 20 until passing beyond the elastic tongue 21. In this position, the projection 11 of the pusher, in which is engaged the wire traction 22, engages in the hole 17 of the pusher up to the level of the bottom of the groove 13 ', thus blocking the traction wire 22 in the stretched state. The needle 1 is thus made integral with the sheath 4 and immobilized relative to the latter in a first position, in which the distal end 24 of the needle does not come out of the sheath 1. The assembly can then be stored sterile, the inserter provided with the IUD being ready for use. In use, when the inserter is actuated, it has normally been introduced into the die until the end of the sleeve 1, on the part tubular 14, is in contact with the bottom of the matrix. A pressure exerted on the pusher 9 in the direction of the arrow 26 (see fig. 3) causes the projection 11 to be released away from the orifice 17, and in this way jointly achieves the release of the needle 1 , which can be advanced in the sheath 4, and the release of the pulling wire 22, which is thus released from the tense state in which it was. Note that in this position, the cooperation of the projection 12 and the tongue 19 prevents, during the joint release of the needle 1 and the pulling wire 22, any recoil of the needle in the sheath, likely to cause disengagement of the loop and knot system 25 from the distal end 24 of the needle 1. The needle 1 is then advanced into the sheath 4, while its distal end 24, driving the IUD 15, projects from the tubular part 14 of the sheath. During this movement, the pressure on the pusher 9 is released and the pulling wire 22 is held in the grooves 13, 13 ′, excluding any blocking of said pulling wire 22 between the sheath 1 and the pusher 3.

The maximum stroke of the needle 1 in the sheath 4 corresponds to the distance a in fig.2. The needle 1, which in the first position, when released, was substantially, by the projection 12 of the thumb 3, in contact with the tongue 21 of the sheath 4, ends its progression in the sheath 4 when the fore-body 5 of the thumb comes substantially in contact with the stop 18 in the sheath. In this second position, the distal end 24 of the needle, driving the IUD, projects from the sheath by a predetermined distance, which in practice is the distance suitable for fixing the IUD in the matrix. Upon arrival in this second position, under the action of the elastic tongue 8 permanently recalling the movable arm 10 in its initial position, the top part of the projection 11 enters the orifice 17 ', while leaving free a part of the groove 13 'sufficient for the pulling wire 22 to move freely therein. Thus, the needle 1 is blocked in the sheath 4 in this second position, while the pulling wire 22 remains completely free. This blocking of the needle 1 in the sheath 4 therefore makes it possible to operate a movement of withdrawal of the inserter (assembly of the sheath 4 and the needle 1 secured to the pusher 3) by a simple traction exerted on the pusher, while the IUD 15, integral with the knot and loop system 25 introduced into the tissue of the matrix, and the traction wire 22, remains in place. The withdrawal of the inserter can thus take place without any risk of jamming the pulling wire 22 in the said inserter, and therefore without risk of pulling on the IUD 15. According to the preferred embodiment of the invention illustrated in FIGS. . 1 to 7, the projection 11, in which the groove 13 'is formed, has a stepped shape. The orifice 17 is of sufficient dimensions to receive all of the projection 11, while the orifice 17 ', of shorter length, receives only the top part of the step. The latter is spaced from the base of the groove 13 ′ by a distance substantially equal to or greater than the thickness of the traction wire 22.

It is clear from the above description that the actuation of the inserter and its removal, due to the simplicity of the operations to be carried out, can easily be carried out with one hand.

Another embodiment of the invention is illustrated by way of example in FIGS. 8 to 10. In this other embodiment, a protrusion 5 ′ of a pusher 3 ′ moves in an enlarged base 16 ′ d 'a sheath 4'. The fore-body 5 'extends below a stop 12' intended to come into cooperation with an elastic tongue 21 'of the sleeve, and has in this extension two notches 17 ", 17"', also intended to cooperate with the elastic tongue 21 '. The sash 5 'further has two grooves 13 ", 13"', in the extension of each other, separated by a solid boss 27. The traction wire (not shown) of the IUD is intended to be received in the grooves 13 ", 13"'while crossing the boss 27. The face 28 of the boss 27 forming the wall of the notch 17 "constitutes at the same time, by its cooperation with the elastic tongue 21 ', as illustrated in FIG. 8, means for wedging the pulling wire and, under the action of a thrust exerted on the thumb 3 ', means for releasing the needle and this thread, the said face then acting as a ramp to spread the tongue from the notch 17 ".

At the end of the travel, when the tongue 21 'comes in cooperation with the second notch 17 "', the depth of the groove 13" 'is sufficient to guarantee free movement of the pulling wire, while the cooperation of the tongue 21' and the notch 17 '"allows simultaneous withdrawal of the inserter, by a simple pull exerted on the thumb.

Claims

claims

1. Method for retaining and actuating an IUD insertor which comprises a sheath (4; 4 ') - a needle (1; l') secured to a thumb (3; 3 ') at its proximal end, housed in the sheath (4; 4 ') and capable of moving relative thereto, an IUD (15), also housed in the sheath (4; 4'), fixed to drive at the distal end (24 ) of the needle (1; l ') and provided with a pulling wire (22), the said method comprising the steps consisting in rendering the needle (1; l'), the distal end of which (24) is in training relation with the IUD

(15), integral with the sheath (4; 4 '), to immobilize it relative to the latter in a first position in which the distal end

(24) of the needle (1; l ') does not come out of the sheath (4; 4'), to maintain the pulling wire (22) in the stretched state, to guarantee the drive relationship between the needle (1; l ') and the IUD (15) and, in the actuation phase, - to release the traction wire (22), and to release the needle (1; l') from said first position for bring it into a second position in which the distal end (24) of the needle projects from the sheath (4; 4 ') by a predetermined distance, driving the IUD (15), characterized in that in phase actuation, releasing the needle

(1; l ') of said first position jointly ensures the release of the pulling wire (22).

2. Method according to 1, characterized in that, after its release, the maintenance of the pulling wire (22) in the free state is guaranteed throughout the actuation phase remaining of the inserter, and in that, at the end of its travel between the first and the second position, the needle (1; l ') is maintained in said second position.

3. Method according to 1 and 2 characterized in that, during the actuator activation phase, the stroke

(a) the needle (1; l ') in the sheath (4; 4') is blocked from and below the first position and from and beyond the second position.

4. Method according to 1 to 3, characterized in that maintaining the tension wire (22) of the IUD in the tensioned state

(15) and the immobilization of the needle (1; l ') in the sheath (4; 4') in said first position are carried out jointly.

5. IUD inserter, for the application of the method 1 to 4, comprising a sheath (4; 4 '), a needle (1; l'), secured to a thumb (3, 3 ') at its end proximal (2; 2 '), housed in the sheath (4; 4') and capable of moving relative thereto, an IUD (15) also housed in the sheath (4; 4 '), fixed to drive at the distal end (24) of the needle (1; l '), and provided with a pulling wire (22), characterized in that the sheath (4; 4') and the thumb (3; 3 ') include first cooperating locking members (17, 11; 17 ", 21'), provided with means for locking the needle (1; l ') in the sheath (4; 4'), in a first position in which the distal end (24) of the needle (1; l ') does not come out of the sheath (4; 4'), and of clamping means (17, 13 ', 11; 28, 21') of the pulling wire (22) of the IUD, ensuring that it is held in the stretched state, - a release member (9, 10; 28), to release an unfolding relative acement between the needle (1; l ') and the scabbard (4; 4'), under the action of the pusher (3; 3 '), in the direction of insertion of the needle (1; l ') into the sheath (4; 4'), as well as to release the traction wire (22) from the IUD.

6. Insertor according to 5, characterized in that at least one groove (13, 13 '; 13 ", 13"'), at least substantially parallel to the direction of the needle (1; l '), is provided in at least one of the members (5; 5 ') of the inserter to guarantee the freedom of the pulling wire (22) on the actuation path of the inserter outside the position of the first cooperating blocking members , and in that second cooperating blocking members (17 ', 11; 17 "', 21 '), intended to block any relative movement between the needle (1; l') and the sheath (4, 4 ') without restricting the freedom of the pulling wire (22), are provided in said second position of the needle.

7. Insertor according to claims 5 and 6, characterized in that it comprises cooperating stop members (12, 21, 18, 5; 12 ', 21', 18 ', 5'), active in positions of l 'needle (1; l') in the sheath (4; 4 ') corresponding substantially to said first and second positions, in order to limit the stroke of the needle (1; l') in the sheath (4; 4 ') between these two positions.

8. Insertor according to claim 7, characterized in that the cooperating stop members, active when the needle occupies the first position in the sheath, consist of a tongue (21; 21 ') formed on the sheath (4; 4 '), elastically deformable to allow the passage of a stop (12; 12') formed on the pusher (3; 3 ') and bounce behind it to then prevent any movement of the needle (1; l') below this position.

9. An insertor according to claims 5 to 8, characterized in that the first locking members comprise a projection (11) on the pusher (3), crossed by the groove (13 ') for the passage of the pulling wire (22) , and a first orifice (17) in the sheath (4), said projection (11) being provided to come by effect elastic to be housed, substantially up to the level of the bottom of the groove (13 ') which passes through it, in said first orifice (17), to ensure the blocking of the pusher (3) and therefore the needle (1) relative to the sheath (4), and the jamming of the traction wire (22) of the IUD at the bottom of the groove (13 ').

10. Insertor according to claim 9, characterized in that the release member comprises a pusher (9) connected to said projection (11), intended to be moved elastically so as to dislodge the projection (11) from the first orifice (17 ), to release the relative movement between the needle (1) and the sheath (4) as well as the jamming of the pulling wire (22).

11. An insertor according to claim 10, characterized in that the second locking members comprise a narrowed top part of the projection (11) and a second orifice (17 ') in the sheath, aligned longitudinally with the first orifice (17), and of dimensions corresponding to the narrowed top part of the projection (11), in which said top part can be accommodated by elastic effect, while keeping a part of the groove (13 ') free to guarantee unconstrained movement of the pull wire (22).

12. An insertor according to claim 11 characterized in that the projection (11) has, in a plane parallel to the plane of the groove, a stepped shape, the step being spaced from the base of the groove (13 ') by distance substantially equal to or greater than the thickness of the pull wire (22).

13. Insertor according to claims 5 to 8, characterized in that the first locking members consist of a first notch (17 ") on the thumb (3 '), arranged immediately following the stop (12') , and of the tongue (21 '), the face (28) of the notch (17 ") not adjacent to the stop having the form of an inclined ramp constituting on the one hand, by cooperation with the tongue (21' ), wire clamping member (22) and on the other hand, under the effect of a longitudinal thrust on the pusher (3 '), member for spreading the tongue (21') ensuring the release of the pusher (3 ') and therefore of the needle (1 '). .

14. Insertor according to claim 13, characterized in that the second cooperating blocking means consist of the tongue (21 ') and a second notch (17 "') on the pusher (3 '), to which a groove ( 13 "'), notch (17"') cooperating with the tongue (21 ') to secure the needle (1') relative to the sheath (4 ') without blocking the IUD traction wire.