WO2020178442A1

WO2020178442A1 - Needle insertion device for distributing a product in a site

Info

Publication number: WO2020178442A1
Application number: PCT/EP2020/056094
Authority: WO
Inventors: Gaëtan GRENOT; Loïck CASSAGNE; Marc TODESCO; Pierre ROMANET; Pierre PINTUS; Thierry Decock
Original assignee: Nemera La Verpilliere
Priority date: 2019-03-07
Filing date: 2020-03-06
Publication date: 2020-09-10
Also published as: FR3093437A1

Abstract

The device (1) for inserting a needle into a site (100) comprises: - a wall (19) for bearing on the site (100), - a base (22) having a guiding recess (23) defining a guiding axis (B) oriented toward the bearing wall (19) and intended to receive a needle support (24), - the needle support (24) on which a needle is mounted, the needle support (24) being mounted so as to be mobile in the guiding recess (23), between: * a pre-insertion position in which the needle is set back from the bearing wall (19), * an insertion position in which the needle protrudes from the bearing wall (19), and * a retracted position in which the needle is once again set back from the bearing wall (19), - a rotary element (6) having an axis of rotation (A) and comprising drive means (64) intended to cooperate with complementary drive means (26) borne by the needle support (24), so as to make the needle support (24) move in translation between the various positions of the needle support (24) when the rotary element (6) is driven in rotation about its axis of rotation (A), the insertion device (1) comprising axial holding means (9) for the rotary element (6) such that the axis of rotation (A) of the rotary element (6) is mounted fixed with respect to the base (22).

Description

Title of the invention: Device for inserting a needle for the distribution of a product in a site [0001] The invention relates to a device for inserting a needle into a site.

The invention relates more particularly to a device for inserting a needle making it possible to distribute a product in the site where the insertion of the needle has been carried out, in particular by means of a catheter (or cannula).

[0002] Document WO2015164645 discloses a device for inserting a needle with a view to inserting a catheter (or cannula) making it possible to convert a movement of a connection element driven by a torsion spring into a translation vertical needle holder causing the needle and catheter to be inserted into the skin of a patient. More precisely, the connection element comprises a first axis of rotation linked in translation to the needle support and around which the torsion spring is mounted, and a second axis allowing a drive pin to slide in a cam track integral with a base of the insertion device. The connection element must first be assembled with the needle support, then the assembly is attached to the base while taking care to compress the torsion spring against a stop provided on the base and to insert the drive pin in the cam track. This involves a number of assembly constraints.

[0003] One object of the invention is in particular to provide a needle insertion device that is easier to assemble.

[0004] To this end, the invention relates to an insertion device as defined in claim 1.

[0005] Thus, the axis of rotation (A) of the rotary element is fixed relative to the base, therefore mobile only in the plane of rotation. As a result, in order to assemble the insertion device, it is possible to assemble the rotary element on the one hand with the needle support and the return means, then in a second step to simply bring back the together in the base, by placing the rotating element in the axial holding means and finally by locking the insertion device with the locking means. For example, this step can consist in placing the assembly of the rotary element, of the needle support and of the return means in the base, without having to also introduce a drive pin in a cam track which would be carried by the base, as is the case in the state of the art.

[0006] In addition, the proposed insertion device makes it possible to offer better stability of the insertion device. Indeed, if we refer to the device for inserting the state In the art, when the inserter is activated for the purpose of inserting the needle, the connection member undergoes a combination of rotations and translations of different parts relative to each other, while in the device d 'proposed insertion, it implements a simple rotation of the rotary element to drive the needle support, without translation of the axis of rotation of this rotary element, so that there is better stability of the parts between they. As a result, the insertion device has a more reliable operation, since it requires less movement between the parts. This configuration further allows for less jerks to be generated during use of the inserter, thus providing less painful needle insertion and / or removal for the patient and improving the robustness of the device. insertion.

[0007] Furthermore, thanks to the axis of rotation (A) mounted fixed relative to the base, the proposed insertion device is particularly compact, which is very interesting in general, and more particularly for a device for insertion intended to be worn for a certain time by a user in the case of an injection taking place over a certain period, of the order of several hours.

[0008] Among the advantages of the proposed configuration for the insertion device, it should also be noted that insertion devices having a different and / or adjustable insertion depth can be easily manufactured. Indeed, we know that it is interesting to be able to vary the depth of injection of a product into a patient to take account of his age (child or adult) or even his morphology (the fat mass then being different) . However, as the axis of rotation (A) is mounted fixed relative to the base, the movement of the needle support can easily be varied by simply increasing or reducing the diameter of the rotating element or by modifying the position. drive means with respect to the corresponding diameter of the rotating element, without the need to make any modifications which could be induced in the event that the axis of rotation (A) has to be moved.

[0009] The use of an axial retention element makes it possible to assemble the axis of rotation and the base without geometric constraints. This further facilitates the assembly of the parts. By choosing a suitable axial retaining element, it is possible to obtain better retention, which is more reliable.

It is understood that the axial holding element is a separate element from the base which blocks the axis of rotation (A) in translation once the latter is placed in the holding groove. The retaining groove can be continuous or discontinuous.

The term "axis of rotation" is understood to mean a theoretical straight line around which the rotary element rotates, generally defined by a rotation shaft. The term “axis of rotation mounted fixed relative to the base” is understood to mean the fact that the axis of rotation is linked in translation with the base, that is to say that the rotation shaft can turn on itself. same, but cannot be moved in translation relative to the base.

[00012] It will be noted that according to different possible alternatives, the locking means can act on:

- the return means, blocking it in a compressed state, or

- the rotating element by preventing its rotation, or

- the needle support by preventing its translation.

[00013] The invention may further include one or more of the following characteristics, taken alone or in combination.

- The rotary element comprises a first part having a discoid shape defining a drive disc carrying the drive means, and a second part having a generally cylindrical shape defining a rotation shaft and being coaxial with the first part along the axis of rotation (A) and integral with the first part.

The shape of the drive disc makes it easy to change the needle insertion depth by simply changing the radius of the drive disc or by changing the position of the drive means relative to the corresponding diameter of the disc drive of the rotary element. It is understood that a drive disc corresponds to a circular flat element which is a very thin cylinder of revolution. The drive disc can have a perfectly circular outline, or a serrated outline.

- The drive means comprise a drive finger offset from the axis of rotation (A) and carried by the rotary element or the needle support, and the additional drive means comprise a groove carried by the needle holder or the rotary member and extending in a direction other than the guide axis (B), the groove being intended to receive the driving finger in a sliding manner in order to drive the needle support in a translational movement relative to the bearing wall between its various positions.

The guide finger-groove connection makes it possible to make movements in the different positions of the needle support more reliable while avoiding jolts, the insertion thus being made less painful.

- The groove has a "T" -shaped section and the drive finger comprises an end having a suitable shape allowing its movement in the groove and its maintenance in the groove in a direction separate from the guide axis (B).

The groove thus ensures retention of the drive finger in a direction corresponding to that of the axis of rotation (A). When assembled, the drive finger can only move in the groove and cannot disengage of the rotating element. This facilitates the assembly and the reliability of the operation of the insertion device.

[00020] The rotary element has an outline comprising a series of teeth defining at least in part the drive means. According to a variant of the invention, the teeth are able to cooperate with a notched element external to the insertion device in order to energize the return element. This configuration makes it possible to facilitate assembly and easily pre-stress the return element, more particularly in the case where it is a spring.

- The additional drive means comprise at least one notched zone provided with notches and arranged on the needle support in a direction substantially parallel to the guide axis (B), so that when the rotary element is driven in rotation, the teeth mesh with the notches of the toothed zone and drive the needle support in a translational movement. This embodiment makes it possible to provide a gear drive, the assembly of which is simple.

[00022] The return means comprises a torsion spring provided with a first end fixed to the base and with a second end fixed to the rotating element, preferably to the rotating shaft of the rotating element.

[00023] When the return means is released, the compressive force of the torsion spring is transmitted to the rotary member which transforms it into a translational driving force of the needle holder in a particularly efficient manner. It is understood that, once assembled, the torsion spring is permanently linked at its two ends, which brings a certain reliability to the mechanism.

[00024] The insertion device comprises an activation element configured to cooperate with at least one of the elements comprising the rotary element, the needle holder, the return means to hold the insertion device in position before insertion, the activation element having:

a) an activation button mounted to move relative to said at least one of the elements comprising the rotary element, the needle support, the return means between:

- a position before use in which the rotation of the rotary element is blocked, and

- an activated position, in which the rotation of the rotary element is released, b) a locking surface configured to abut against a complementary locking surface carried by the at least one of the elements comprising the rotary element, the support needle, the return means when the activation button is in the position before use.

c) the activation button being configured to separate the blocking surface and the complementary blocking surface in the activated position. [00025] According to an example of the invention, the locking means may itself constitute the activation element. Thus, a single part ensuring successively the locking of the rotary element and the release of its rotation, the unlocking can be particularly simple by only moving the activation element so that the locking surface is no longer in contact with the complementary blocking surface and thus free the rotation of the rotary element. With such an activation element, it is not necessary to remove a locking pin to activate the insertion device, as is the case in the state of the art. The blocking surface and / or the complementary blocking surface can incorporate a relief shape, for example the complementary blocking surface comprises a flat shape and the blocking surface a planar shape configured to fit into the flat shape, so as to ensure that they are held in position before insertion when they are facing each other. The activation element can also integrate a release surface releasing the complementary blocking surface when the activation button is in the activated position. The release surface may incorporate a recessed shape configured to allow rotation of the rotational shaft, for example the recessed shape has a radius substantially equal to the radius of the rotational shaft, the displacement of the rotating member. activation thus allowing the locking surfaces and complementary locking surface to no longer be in contact after activation of the insertion device and authorizes the release of at least one of the elements comprising the rotating element, the needle holder, means reminder.

However, it is understood that in the position before use, the rotation of the rotary element can also be blocked via a blocking of the needle support set back relative to the bearing wall, and / or a blocking of the power-on recall means. It is understood that in the activated position, the rotation of the rotary element can be released via a release of the translation of the needle holder towards the support wall, and / or a release allowing the return means to relax.

- The rotary element comprises a first part having a discoid shape defining a drive disc, comprising at least one protuberance intended to abut against the base once the needle holder is in the retracted position, the protuberance being advantageously configured so that the rotating element undergoes a total rotation of less than 358 °, preferably of less than 355 °, more preferably of about 353 °.

[00028] Thus, a rotation of less than 360 ° and not a full turn is proposed to avoid free movement of the needle support after retraction and possible disassembly of the parts relative to each other.

[00029] The insertion device comprises a catheter mounted to move relative to the needle and a catheter support capable of moving the catheter with the needle during the changing the needle holder from its position before insertion to its insertion position and disengaging it from the needle so that it remains in an insertion position when the needle holder moves from its insertion position to its retracted position.

[00030] - The needle support comprises guide means in the guide housing, the guide housing being arranged in a central part of the base.

[00031] This embodiment is particularly advantageous because this results in central guidance of the needle holder so that the force applied to the needle holder is balanced. In fact, when the guiding takes place at the level of the side walls of the housing of the guide, it is possible that the rotating element bears more on one side than the other, which corresponds to a phenomenon of arching during the guidance. With the solution as proposed by the invention, lateral guidance is dispensed with and the phenomenon of bracing is thus avoided. The guide means and the complementary guide means comprise, for example, a guide groove and a guide projection slidably mounted in this guide groove. Advantageously, the guide means and the guide housing have an axis of symmetry (E), this axis of symmetry (E) corresponding for the guide housing to the guide axis (B). Likewise, the needle support may have the same axis of symmetry (E).

- The guide housing and the guide means define an axis of symmetry (E) and have shapes substantially configured to cover the guide means over an angle greater than 181 °, preferably greater than 190 ° in a plane substantially perpendicular to the guide axis (B).

This configuration is particularly interesting because it allows to ensure retention of the guide means in the complementary guide means in a direction perpendicular to the guide axis (B). It is understood that the guide means have a longitudinal shape along the guide axis (B) and that the section through a plane perpendicular to the guide axis (B) can have various shapes, for example circular, square or else a "T" shape.

[00034] The insertion device comprises a means for detecting the needle holder in the insertion position, which can make it possible to trigger the dispensing of the product only when the needle has pierced the patient's skin.

Brief description of the figures

The invention will be better understood on reading the description which follows, given solely by way of example and made with reference to the accompanying drawings in which:

[00036] [Fig. 1] Figure 1 is a partial perspective view of a device for inserting a needle into a site according to a first embodiment of invention;

[00037] [Fig. 2] Figure 2 is a partial exploded view of the insertion device of Figure 1;

[00038] [Fig. 3] Figure 3 is a perspective view of the needle holder of the inserter of Figure 1;

[00039] [Fig. 4] Figure 4 is a partial sectional view of the inserter of Figure 1;

[00040] [Fig. 5] FIG. 5, consisting of FIGS. 5a-5f, is a series of partial sectional perspective views of an insertion device according to a second embodiment of the invention showing the steps of actuation of the support of. needle ;

[00041] [Fig. 6] FIG. 6 is a partial perspective view of a device for inserting a needle into a site according to a third embodiment of the invention;

[00042] [Fig. 7] Figure 7 is a partial perspective view of the insertion device according to a fourth embodiment of the invention;

[00043] [Fig. 8] Figure 8 is a partial perspective view of the insertion device of Figures 5a-5f;

[00044] [Fig. 9] Figure 9, consisting of Figures 9a-Fig.9e, is a series of perspective views showing the steps of partial assembly of the insertion device of Figure 1; and

[00045] [Fig. 10] Figure 10 is a perspective view of the insert device of Figure 1 cooperating with an outer notched member.

detailed description

A device for inserting a needle, as shown in Figures 1, 2, 9 and 10 according to a first embodiment of the invention and designated by the reference 1, comprises a housing having in this example a support wall 19 intended to be positioned in direct or indirect contact with the skin of a patient on the site 100. The insertion device 1 is an assembly forming part of a device for injecting product, generally a medicament, configured to ensure injection over a relatively long period, generally several hours, and which is for this purpose worn by the user during the injection, for example on the waist. The insertion device 1 further comprises a base 22 having a guide housing 23 defining a guide axis (B). The guide axis (B) can be provided substantially perpendicular to the bearing wall (19) or at any suitable inclination. The base 22 also comprises a retaining groove 27 and shoulders 29 (FIG. 2) which will be described later. A needle support 24 is movably mounted in the guide housing 23 between different positions as illustrated in Figures 5a-5f according to a second embodiment. The operation of the insertion device 1 will be described later.

The needle holder 24 comprises an insertion needle 21 mounted integral with the needle holder 24 and having an insertion end 21 ’(Fig.4). The needle holder 24 has an axis of symmetry (E) and further comprises a groove 26 extending in a direction other than the axis of symmetry (E) (Fig.3). According to the example illustrated, the groove 26 extends in a direction substantially orthogonal to the axis of symmetry (E). When the guide axis (B) is perpendicular to the bearing wall (19), the groove 26 therefore extends in a direction substantially orthogonal to the guide axis (B) in its assembly position which will be described later.

As shown in Figure 1, the needle support 24 comprises a central guide portion 25 forming guide means 25 and intended to cooperate with the guide housing 23 in the base 22. The guide housing 23 forms thus complementary guide means 23. The guide means 25 and the complementary guide means 23 are arranged in a central part of the base 22. The central guide portion 25 defines an axis of symmetry (E) and has a substantially circular shape. along this axis of symmetry (E). The section of the central guide portion 25 along a plane parallel to the support wall 19 is substantially circular according to this example. The guide housing 23 has a circular shape complementary to that of the central guide portion 25 and is configured to cover the central guide portion 25 at an angle greater than 181 °, preferably greater than 190 ° in a plane substantially perpendicular to it. the guide pin (B).

[00049] The insertion device 1 also comprises a catheter 30 (Fig.2) carried by a catheter support 31 which is linked in translation to the needle support 24 during the insertion of the needle 21. The needle 21 being housed inside the catheter 30, the insertion of the needle 21 into the site 100 allows the insertion of the catheter 30.

As shown in Figure 2, the insertion device 1 comprises a rotary member 6 rotatably mounted about an axis of rotation (A) on the base 22. The rotary member 6 comprises a first part 62 having a shape general discoidal defining a drive disc 62 and a second part 63 having a generally cylindrical shape defining a rotation shaft 63. The rotation shaft 63 is coaxial with the drive disc 62 along the axis of rotation (A) and integral with the drive disk 62. The rotation shaft 63 comprises a flat 65 forming a complementary locking surface 65 which will be described later. The drive disc 62 carries a drive finger 61 which is arranged off-center with respect to the axis of rotation (A). The drive finger 61 is configured to be slidably received in the groove 26 in order to drive the needle holder 24 in a translational movement relative to the bearing wall 19 when the rotary member 6 is driven. rotating around its axis of rotation (A). The drive disc 62 further comprises a series of teeth 64, the function of which will be described later, the teeth 64 being distributed over at least part of the contour of the drive disc 62.

[00051] The driving finger 61 and the series of teeth 64 defining at least in part the driving means 64 while the groove 26 forms complementary driving means 26 in this embodiment.

[00052] Still illustrated in FIG. 2, the insertion device 1 comprises a return means 7 intended to drive the rotary element 6 in rotation when the return means 7 changes from a compressed state to a relaxed state. In the example illustrated, the return means 7 corresponds to a torsion spring 7, for example in a spiral, having one end 71 fixed to the base 22 and a second end 72 fixed to the rotation shaft 63. To do this, the torsion spring 7 comprises a first end 71 having a "V" shape oriented towards the outside of the torsion spring 7 and a second end 72 having a "V" shape oriented towards the inside of the torsion spring 7 and for example arranged in the direction of a radius of the circle inside the torsion spring 7. The base comprises a hooking means 221 arranged near the retaining groove 27, for example a shape substantially complementary to the first end 71 of the torsion spring 7 so that the first end 71 is held by the hooking means 221 when the torsion spring 7 goes from the compressed state to the relaxed state; Further, the rotation shaft 63 has a slot 631 for receiving the second end 72 of the torsion spring 7 so that the rotation shaft 63 is rotated by the second end 72 when the torsion spring 7 changes from the compressed state to the relaxed state. The torsion spring 7 is preferably spiral, which makes it possible to limit the size of the insertion device 1.

The insertion device 1 comprises a locking means (8) defined by an activation button 8 as shown in Figures 1 and 2 comprising an actuating part 83 intended to be actuated by the user according to the The illustrated example is a locking portion 84 having a locking surface 81 and a release surface 82. The locking surface 81 is a flat surface configured to abut against the complementary locking surface 65 carried by the rotating member 6. in the position before use. The release surface 82 is a hollow surface of a cylindrical shape and complementary to the rotation shaft 63 and is configured to release the complementary locking surface 65 when the activation button 8 is in the activated position.

Finally, as visible in Figure 2, the insertion device 1 comprises axial holding means 27, 9, 11 of the rotary element 6 forming a housing of retainer 11 configured to receive the rotation shaft 63. The retaining housing 11 is delimited by the retaining groove 27 provided in the base 22 and an axial retaining element 9 attached to the base 22 at the time of assembly. The retaining groove 27 has two retaining surfaces 271, 272 separated by a space 273. Each retaining surface 271, 272 represents a portion of a substantially cylindrical shape and complementary to the rotation shaft 63. The retaining groove 27 is discontinuous in the example illustrated but may well have a continuous shape. The axial retaining element 9 as visible in FIG. 2 comprises a closing element 91 of the retaining housing 11 also having a portion of a substantially cylindrical shape and complementary to the rotation shaft 63. The retaining element axial 9 further comprises a series of latching elements 92 (four according to the example illustrated) extending from the closure element 91 and each comprising a hook-shaped end intended to cooperate with the shoulders 29 of the base 22 in order to secure the retaining element 9 to the base 22 during assembly.

[00055] Figure 9 illustrates the different assembly steps. First, as seen in Fig. 9a, the torsion spring 7 is mounted on the rotating member 6, the second end 72 being inserted into the slot 631 of the rotating shaft 63. Then, the support for needle 24 which already carries needle 21 is assembled with the rotary element 6 carrying the torsion spring 7 as shown in FIG. 9b. To do this, the driving finger 61 of the rotary element 6 is inserted into the groove 26 by one of the ends of the groove 26. At the end of this assembly, the driving finger 61 is located substantially at the bottom. center of the groove 26 and the flat 65 carried by the rotation shaft 63 is at the end opposite the drive finger 61. In addition, the needle holder 24 is located opposite the wall of 'support 19 in the guide housing 23.

[00056] The catheter 30 is housed in the catheter support 31 in which it is held by elastic clamping. Then, the catheter holder 31 is placed with the needle holder 24 in the guide housing 23 by simple insertion. A stop provided for example between the catheter support 31 and the needle support 24 allows during insertion the displacement of the needle support 24 between the displacement of the catheter support 31 and that, after insertion, the raising of the support. needle 24 is done without causing the rise of the catheter support 31. As described below, this stop may be formed by an elastic arm 40. The catheter support 31 remains blocked in the insertion position, for example by means a snap-in provided by tabs provided on the base 22.

According to the example illustrated in Figures 1-3 and 9, the groove 26 of the needle support 24 has a "T" -shaped section and the drive finger 61 comprises a disc-shaped end having a diameter which substantially corresponds to the width of the bar of the "T" of the groove 26 so that the drive finger 61 slides in the groove 26 without separating therefrom at least in any direction distinct from the guide axis (B). Alternatively, the groove 26 may have a rectilinear shape as shown in Figures 5 to 7 and the drive finger 61 may simply have a regular cylindrical shape. The groove and the driving finger can have any other suitable shape.

As seen in Figure 9c, the needle support 24, the catheter support 31 and the rotating element 6, once assembled, are attached to the base 22 by engaging the central guide portion 25 of the support needle 24 in the guide housing 23 of the base 22. Before housing the rotation shaft 63 in the retaining groove 27 of the base 22, the first end 71 of the torsion spring 7 engages with the means of hangs 221 of the base 22 integrally.

The axial holding element 9 is then attached to the base 22 as shown in Figure 9d. The closure element 91 covers the rotation shaft 63 and together with the retaining groove 27 forms the retaining housing 11. The latching elements 92 cooperate with the shoulders 29 on the base 22 in order to secure the retaining element. 9 to the base 22 by snap-fastening. Thus, the rotation shaft 63 is held in the retaining housing 11 and the axis of rotation (A) of the rotary element 6 is mounted fixed relative to the base (22).

Finally and as shown in Figure 9e, the activation button 8 is assembled to the base 22, the locking part 84 being inserted into the space 273 between the two retaining surfaces 271, 272 so that that the blocking surface 81 comes into contact with the flat 65 of the rotation shaft 63. The rotation of the latter is thus blocked after assembly. For assembly, an intermediate position of the activation button 8 can be provided in order to allow the tensioning of the torsion spring 7 without it being activated and then, once the torsion spring 7 under tension, to move the activation button 8 to its position before use.

According to the first embodiment as illustrated in Figures 1, 2 and 9, the drive disc 62 comprises a series of teeth 64 distributed over the contour of the drive disc 62. In this first embodiment , the insertion device 1 comprises a tensioning means 13 of the torsion spring 7 as illustrated in FIG. 10. The tensioning means 13 has the shape of a pinion having a series of complementary teeth intended to engage with the teeth 64 on the drive disk 62 of the rotary member 6 so that when the pinion 13 is rotated manually or automatically, the rotary member 6 is rotated to pre-stress the torsion spring 7. [00062] A second embodiment of the invention is illustrated in FIGS. 5a-5f. The insertion device 1 of this second embodiment is substantially similar to the previous one. It differs from it by its drive disc 62 which does not have a tooth on its circumference. It also differs from it by a different shape of the activation button 8. In addition, the insertion device 1 of the second embodiment comprises a means 4 for detecting the needle support 24 in the insertion position. The detection means 4 can comprise a position sensor making it possible to provide a visual or auditory signal when the needle support 24 is detected in the insertion position. The position sensor can also send a signal to means for automatically triggering the delivery of a dose to be injected into the site 100.

A third embodiment is illustrated in Figure 6, in which the needle support 24 comprises a notched zone 28 constituting the complementary drive means 28. The notched zone 28 is arranged laterally on the support d 'needle 24 in a direction substantially parallel to the guide axis (B) defined by the guide housing 23. When the rotary element 6 is driven in rotation, the teeth 64 engage in the notches of the notched zone 28 and drive the needle support 24 in a translational movement as described in the first embodiment to cause the insertion of the needle 21 and the catheter 30. The rise of the needle 21, in order to leave the catheter only in the site 100 the time of the injection, can be obtained by any suitable means, for example by a spring placed between the base 22 and the catheter 30.

[00064] According to an alternative embodiment not shown, the rotary element may comprise a zone of the drive disc devoid of teeth and, the needle support may comprise two notched zones, a first notched zone intended to ensure the descent of the needle and the catheter and a second notched zone intended to ensure, more or less in the continuity of the descent, the rise of the needle.

[00065] A fourth embodiment of the invention is illustrated in Figure 7. The insertion device 1 of this fourth embodiment is substantially similar to that of the first embodiment. It differs from it mainly by the section of the central guide portion 25 which, in a plane substantially parallel to the support wall 19, has a "T" shape. The guide housing 23 has a complementary cylindrical shape and is configured to cover the central guide portion 25. The latter is therefore covered by the guide housing 23 for approximately 75% of its periphery.

[00066] FIG. 5 illustrates the operation of the insertion device 1, which operation is similar for the various embodiments described. When the inserter 1 is ready for use by a patient or caregiver medical profession, the needle support 24 is in a position before insertion in which the needle 21 is set back relative to the bearing wall 19. The torsion spring 7 is compressed, the activation button 8 is in position. position before use and the rotation of the rotary element 6 is blocked. This position is illustrated in Figure 5a. When the user positions the insertion device 1 on a site 100 to be injected, the support wall 19 is for example in direct contact with the site 100. The user presses the actuating part 83 of the button. activation 8 as illustrated in FIG. 5b to make it move in the direction of the support force. The locking part 84 moves in the space 273 so that the release surface 82 which is a hollow surface is opposite the flat 65 of the rotation shaft 63. The activation button 8 is in position. activated and the rotation of the rotation shaft 63 is released by the activation button 8.

The decompression of the torsion spring 7 drives the second end 72 and therefore the rotation shaft 63 in a rotational movement in the retaining housing 11. The drive disc 62 is also rotated and the finger d 'drive 61 slides in the groove 26 of the needle support 24 in a first direction (C) in order to transform the rotation of the rotary element 6 into a translational movement of the needle support 24 towards the support wall 19 along the guide axis (B). The needle 21 as well as the catheter 30 carried by the catheter holder 31 move simultaneously with the needle holder 24 in the same direction towards the support wall 19, as seen in FIG. 5c. When the needle 21 is protruding from the supporting wall 19, the needle pierces the skin and continues to insert with the catheter 30 into the site 100.

When the needle support 24 arrives at the end in the guide housing 23 towards the support wall 19, the needle 21 and the catheter 30 are in the insertion position and protrude from the insertion device 1 of a length allowing the desired insertion depth to be respected. This insertion position is illustrated in Figure 5d. Just before reaching this position, an elastic arm 40 forming part of the guide housing 23 is deformed by the movement of the catheter holder 31. The elastic arm 40 has a hooked end making it possible to retain the catheter holder 31 in position d. insertion when the elastic arm 40 returns to its initial position. This position is also visible in partial sectional view in Figure 4.

Under the return force of the torsion spring 7, the rotary element 6 continues to rotate and the drive finger 61 continues to move in the groove 26 in a second direction (D) opposite to the first direction ( VS). As illustrated in FIG. 5e, the needle support 24 is then driven in translation to move away from the support wall 19. According to the example illustrated, the rotary element 6 comprises on the drive disc 62 a protuberance 66 configured so that the rotary element 6 undergoes a total rotation of less than 353 °. To do this, this protuberance 66 abuts against the base 22 once the rotation of 353 ° of the rotary element 6 is achieved. The rotary element 6 is thus locked in this position and the needle support 24 is in the retracted position relative to the bearing wall 19. This retracted position is illustrated in FIG. 5f.

The invention is not limited to the embodiments presented and other embodiments will be apparent to those skilled in the art. It is in particular possible that the activation button is mounted movable relative to an element other than the rotary element. For example, the activation button can be configured to cooperate with the needle holder or with the return means to hold the inserter 1 in position before insertion. Likewise, a release surface may be provided on the rotating member, needle holder or biasing means to release the locking surface in the activated position of the inserter. It is also possible that the activation of the insertion device is obtained by any other means such as a shape memory wire which retracts under the effect of the electric current heating it when the insertion device is energized. . The retraction of the retractable wire can be prevented before activation by any other locking means known to those skilled in the art.

Claims

1. Device for inserting (1) a needle (21) into a site (100), comprising:

- a supporting wall (19) on the site (100),

- a base (22) having a guide housing (23), defining a guide axis (B) and intended to receive a needle support (24),

- the needle support (24) on which a needle (21) is mounted, the needle support (24) being movably mounted in the guide housing (23) between:

^* a position before insertion in which the needle (21) is set back relative to the bearing wall (19),

* an insertion position in which the needle (21) is prominent with respect to the supporting wall (19), and

^* a retracted position in which the needle (21) is again set back relative to the bearing wall (19),

- a rotary element (6) having an axis of rotation (A) and comprising drive means (61, 64) intended to cooperate with complementary drive means (26, 28) carried by the needle support ( 24), so as to drive the needle support (24) in a translational movement between the different positions of the needle support (24) when the rotating element (6) is rotated about its axis of rotation (AT),

- a return means (7) intended to drive the rotary element (6) in rotation when the return means (7) changes from a compressed state to a relaxed state,

- a locking means (8) configured to hold the insertion device (1) in its position before insertion,

the insertion device (1) comprising axial holding means (27, 9, 1 1) of the rotating element (6) so that the axis of rotation (A) of the rotating element (6) is mounted fixed in relation to the base (22),

the axial holding means (27, 9, 1 1) comprising a holding housing (1 1) configured to receive the axis of rotation (A) of the rotating element (6) and delimited at least partially by:

- a retaining groove (27) provided in the base (22) and

- an axial retention element (9) attached to the base (22).

2. Insertion device (1) according to the preceding claim, wherein the rotary element (6) comprises a first part (62) having a discoid shape defining a drive disc, carrying the drive means (61, 64), and a second part (63) having a generally cylindrical shape defining a rotation shaft and being coaxial with the first part (62) along the axis of rotation (A) and integral with the first part (62).

3. Insertion device (1) according to the preceding claim, wherein the drive means (61) comprise a drive finger (61) offset with respect to the axis of rotation (A) and carried by the rotary element (6) or the needle holder (24), and the complementary drive means (26) comprise a groove (26) carried by the needle holder (24) or the rotary element (6) and extending in a direction other than the guide axis (B), the groove (26) being intended to receive the driving finger (61) in a sliding manner in order to drive the needle holder (24) in a translational movement relative to the bearing wall (19) between its different positions.

4. Insertion device (1) according to the preceding claim, wherein the groove (26) has a "T" -shaped section and the drive finger (61) comprises one end having a suitable shape allowing its movement in the groove (26) and its retention in the groove (26) in a direction distinct from the guide axis (B).

5. Insertion device (1) according to any one of the preceding claims, in which the rotary element (6) has an outline comprising a series of teeth (64) defining at least in part the drive means (64 ).

6. Insertion device (1) according to any one of claims 1 to 2 and claim 5, wherein the additional drive means comprise at least one notched zone (28) provided with notches and arranged on the support d. 'needle (24) in a direction substantially parallel to the guide axis (B), so that when the rotary element (6) is driven in rotation, the teeth (64) mesh with the notches of the notched zone ( 28) and drive the needle holder (24) in a translational movement.

7. An insertion device (1) according to any one of the preceding claims, wherein the return means (7) comprises a torsion spring (7) provided with a first end (71) fixed to the base (22). and a second end (72) fixed to the rotating element (6), preferably to a rotating shaft (63) of the rotating element (6).

8. Insertion device (1) according to any one of the preceding claims comprising an activation element (8) configured to cooperate with at least one of the elements comprising the rotary element (6), the support of needle (24), the return means (7) for maintaining the insertion device (1) in position before insertion, the activation element (8) having: - an activation button (8) mounted to move relative to said at least one of the elements comprising the rotary element (6), the needle support (24), the return means (7) between:

^* a position before use in which the rotation of the rotary element (6) is blocked, and

^* an activated position, in which the rotation of the rotary element (6) is released,

- a locking surface (81) configured to come into abutment against a complementary locking surface (65) carried by the at least one of the elements comprising the rotary element (6), the needle support (24), the means reminder (7), when the activation button (8) is in the position before use;

- the activation button being configured to separate the blocking surface (81) and the complementary blocking surface (65) when the activation button (8) is in the activated position.

9. An insertion device (1) according to any one of the preceding claims, wherein the rotary member (6) comprises a first part (62) having a discoid shape defining a drive disc 62, comprising at least one. protuberance (66) intended to come into abutment against the base (22) once the needle support (24) is in the retracted position, the protuberance (66) being advantageously configured so that the rotating element (6 ) undergo a total rotation of less than 358 °, preferably less than 355 °, more preferably about 353 °.

10. An insertion device (1) according to any one of the preceding claims comprising a catheter (30) mounted movably relative to the needle (21) and a catheter support (31) adapted to move the catheter (30). with the needle (21) during the passage of the needle holder (24) from its position before insertion to its insertion position and to separate it from the needle (21) so that it remains in a position of insertion when the needle holder (24) moves from its insertion position to its retracted position.

1 1. An insertion device (1) according to any one of the preceding claims, in which the needle holder (24) comprises guide means (25) in the guide housing (23), the guide housing (23) , being arranged in a central part of the base (22).

12. Insertion device (1) according to the preceding claim, wherein the guide housing (23) and the guide means (25) have substantially complementary shapes configured so that the guide housing (23) covers the means of guide (25) over an angle greater than 181 °, preferably greater than 190 ° in a plane substantially perpendicular to the guide axis (B).

13. Insertion device (1) according to any one of the preceding claims comprising a detection means (4) of the needle holder (24) in the insertion position.