WO2020178444A1

WO2020178444A1 - Device for inserting a needle for dispensing a product into a site

Info

Publication number: WO2020178444A1
Application number: PCT/EP2020/056103
Authority: WO
Inventors: Loïck CASSAGNE; Nicolas PONTILLE; Pierre PINTUS; Thibaut PIERQUIN
Original assignee: Nemera La Verpilliere
Priority date: 2019-03-07
Filing date: 2020-03-06
Publication date: 2020-09-10
Also published as: FR3093436A1

Abstract

The invention relates to a device (1) for inserting a needle (21) into a site, comprising: - a support wall (19) on the site, - a needle (21) comprising an insertion end (21') which is movably mounted relative to the support wall (19) between at least one position before insertion, in which the needle (21) is recessed relative to the support wall (19), an insertion position, in which the needle (21) protrudes with respect to the support wall (19), and a retracted position, in which the needle (21) is again recessed with respect to the support wall (19), - a needle insertion unit (20) comprising actuation means (30) for the needle (21), capable of moving the needle (21) from its position before insertion into its insertion position, and from its insertion position to its retracted position, characterized in that it comprises means (11, 25, 12) for adjusting the position of the needle insertion unit (20) with respect to the support wall (19) for moving the needle insertion unit (20) relative to the support wall (19) and thus varying the distance between the insertion end (21') and the support wall (19) in the insertion position.

Description

Title of the invention: Device for inserting a needle for the distribution of a product in a site

[0001] The present 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 WO2018152073 discloses a cannula insertion device making it possible to insert a cannula to a predetermined depth in the skin of a patient. A drug product is then delivered through the cannula which remains partially under the skin. The device as described in this document does not allow the position of the cannula to be adjusted once it is inserted under the skin. In other words, the insertion depth is not adjustable. However, depending on the morphology, for example if there is a more or less substantial fat mass, the drug may be injected to an unwanted depth. In addition, such a cannula inserter should be able to be used for several different types of injection, such as subcutaneous injection or intramuscular injection. Thus, allowing an adjustment of the insertion depth would be a particularly interesting function to adapt the insertion depth according to the type of injection desired.

[0003] The aim of the invention is in particular to provide a needle insertion device which can be used in a more versatile manner.

[0004] To this end, the object of the invention is a device for inserting a needle into a site, comprising:

- a supporting wall on the site,

a needle comprising an insertion end mounted to move relative to the bearing wall between at least one position before insertion in which the needle is set back relative to the bearing wall, an insertion position in which the needle is prominent relative to the bearing wall and a retracted position in which the needle is again set back relative to the bearing wall,

- a needle insertion unit comprising means for actuating the needle capable of moving the needle from its position before insertion to its insertion position, and from its insertion position to its retracted position,

the insertion device comprising means for adjusting the position of the needle insertion unit relative to the bearing wall making it possible to move the unit needle insertion relative to the bearing wall and thus vary the distance between the insertion end and the bearing wall in the insertion position.

[0005] Thus, it is possible to vary the distance between the insertion end and the bearing wall in the insertion position so as to be able to adapt the insertion depth of the needle to the morphology of the subject. or again to the type of injection that it is desired to implement, which is particularly advantageous because the insertion device thus becomes particularly versatile. Preferably, the adjustment means are configured to be able, with the same insertion device, to insert the needle to a depth under the skin which varies according to the type of injection desired. Thus, it is possible to favor an insertion depth between 1 mm and 3mm for an intradermal injection, between 4mm and 8 mm for a subcutaneous injection and between 12mm and 18mm for an intramuscular injection, that is to say that the the insertion end can be arranged at a distance from the bearing wall and therefore from the skin surface of between 1 mm and 18mm

[0006] The term "support wall" is generally understood to mean a wall which is located in proximity to the skin of a subject, preferably a wall in direct contact with the skin. It is understood that the needle can be inserted into the site to directly inject a product into the site, or to introduce a flexible catheter, or cannula, subsequently allowing a product to be injected into the site.

[0007] The invention may further include one or more of the following features, taken alone or in combination.

[0008] - The needle insertion unit comprises:

• a base with a housing intended to receive a needle support,

• the needle holder being movably mounted in the housing between the position before insertion, the insertion position, and the retracted position,

• the adjustment means being configured to adjust the position of the base relative to the supporting wall.

Thus, there is a base mounted to move relative to the support wall and in which the needle holder is itself movable to take its different positions. We therefore propose a particularly compact insertion unit.

[0009] - The insertion device comprises:

• a reusable part comprising at least part of the adjustment means, and

• a disposable part comprising at least the needle insertion unit and the needle, the disposable part being removably mounted on the reusable part.

It is thus proposed to reuse a part of the insertion device, and to throw away only another part of the insertion device after an injection, which is particularly ecological and economical. The arrangement of part of the adjustment means on the The reusable part has the further advantage of avoiding re-adjustment, or part of the adjustment, of the needle inserter unit before each use. In other words, the needle insertion unit and therefore the disposable part can be changed without having to fully adjust the insertion depth each time. The insertion depth can be preset through the reusable part regardless of which disposable part is used later.

[0010] The reusable part further comprises means for activating a pump connected to a reservoir of product to be dispensed to transfer the product from the reservoir to the needle insertion unit. The number of components used for the disposable part is minimized. The reusable part can include other high added value elements such as electronic means for interacting with the disposable part or with a telecommunications device, a display screen or visual or audible indication means for the device. user, sensors, etc.

[001 1] - The disposable part includes the pump to be connected to the reservoir, the support wall, or even the reservoir.

[0012] The adjustment means are configured to guide the needle insertion unit to a predetermined position and hold it in that position when the needle insertion unit is assembled in a housing. In other words, it is proposed that the assembly automatically allows the needle inserter unit to be held in a desired position. Thus, the insertion device is adjusted before use by the user or a member of the medical profession, without any intervention other than that of an assembly, for greater safety. The housing, in which the needle inserter unit is assembled, may be included in the reusable part of the needle inserter.

[0013] - The adjustment means include:

• a stop mounted to move relative to the housing,

• a guide ramp carried by the needle insertion unit,

• a complementary guide ramp carried by the housing and intended to cooperate with the guide ramp so as to guide the needle insertion unit towards the adjustable stop and thus assemble the needle insertion unit in the predetermined position defined by the adjustable stop.

This structure allows in particular an intuitive assembly of the insertion device. In the case where the adjustment means are at least partly in the reusable part, the user does not need to worry about a position adjustment of the needle insertion unit, which makes the particularly practical needle insertion device.

- The needle insertion unit is mounted movably relative to the bearing wall between at least two predetermined positions, the adjustment means being configured to move the needle inserter unit between the at least two predetermined positions after the needle inserter unit is assembled in a housing of the inserter. The user or a person from the medical profession therefore has the free choice of adjusting the insertion depth preferably before assembly of the insertion device.

- The adjustment means comprise a notched element and at least one locking finger carried one by the housing, the other by the needle insertion unit, one of the notched elements and at least one locking finger. blocking being movable between:

• a meshed configuration of the adjustment means in which the at least one locking finger (26) meshes with at least one of the notches of the notched element to prevent movement of the needle insertion unit, relative to the housing, and

• a free configuration of the adjustment means in which at least one locking finger (26) is disengaged from the notches of the notched element (13) allowing movement of the needle insertion unit relative to the housing to allow adjustment of the insertion depth,

one of the notched elements and locking finger being coupled to an activation means capable of passing the adjustment means from the meshed configuration to the free configuration, and one of the notched elements and at least one locking finger being biased by elastic return means to tend to maintain the adjustment means in the meshed configuration.

[0015] For example, at least the locking finger is connected to an activation means controlled manually or electronically, the activation means preferably being controlled from the housing or the reusable part of the insertion device.

[0016] The adjustment means comprise a threaded wheel and a thread carried one by a housing of the insertion device, the other by the needle insertion unit, the wheel being intended to cooperate with the thread to transform a rotation of the thumbwheel into a translation of the needle insertion unit relative to the housing.

- The insertion device comprises means for controlling the adjustment of the predetermined position of the needle insertion unit relative to the bearing wall, configured to block the movement of the needle if the adjustment of the predetermined position of the needle insertion unit relative to the bearing wall does not correspond to a predetermined adjustment. Indeed, when the detection of an incorrect position of the insertion unit by the control means, the latter prevent the activation of the means for actuating the needle. This locking via the control means can be performed via at least one of the following locking elements: a retractable wire, a lever, an indexing finger, a pivoting or flexible ratchet, etc. The at least one locking element can exert a direct or indirect stress on the actuating means of the needle in order to obtain a non-displacement of the needle between its different positions. In one configuration of the invention, this constraint can be applied via at least one surface of the at least one locking element coming into engagement with at least one surface of the means for actuating the needle.

In another embodiment, it is possible to block the activation of the actuating means of the needle via the blocking of a button or any other type of actuator in connection with the movement of the needle. Likewise, in the case where the actuator is a motor, the blocking can be effected by simply deactivating the motor after receiving the information of the incorrect position of the needle insertion unit via the means of control.

[0019] In the configurations mentioned above, the blocking can be performed upon detection of an incorrect position of the needle insertion unit relative to a predetermined setting. Alternatively, blocking can also be performed before adjusting the predetermined position of the needle insertion unit. According to this alternative, the means for actuating the needle are blocked by the control means via the at least one blocking element until the control means detect that the position of the insertion unit d The needle corresponds to the setting of the predetermined position of the needle insertion unit. As soon as the position of the needle insertion unit corresponds to the predetermined position of the needle insertion unit, the control means interact with the at least one locking element so that the means of needle actuation are released.

[0020] Advantageously, the control means comprise at least one distance sensor and / or at least one displacement sensor. The at least one distance sensor and / or at least one displacement sensor can be inductive, capacitive or based on optics, ultrasound, microwave or optoelectronic type.

[0021] This helps to ensure safe and correct use of the inserter. Preferably, the control means are mounted on the reusable part of the insertion device, which makes it possible to ensure that a newly assembled single-use part has an insertion unit arranged in the desired position.

- The needle insertion unit comprises a catheter mounted movably relative to the needle and guide means of the catheter capable of moving it with the needle when the needle passes from its front position insertion to its insertion position and disengaging it from the needle so that it remains in an insertion position when the needle moves from its insertion position to its retracted position.

[0023] A catheter, or cannula, is generally a medical device in the form of a tube intended to be inserted into a site such as a blood vessel to distribute or withdraw liquid. [0024] The subject of the invention is also a reusable part for an insertion device as described above.

[0025] The subject of the invention is also a disposable part for an insertion device as described above.

Brief description of the figures

[0026] The invention will be better understood on reading the description which follows, given solely by way of example and made with reference to the drawings in which:

[0027] [Fig. 1a] Figure 1a is a partial side view of a needle inserter unit at the start of assembly on a housing of a needle inserter according to a first embodiment;

[0028] [Fig. 1b] Figure 1b is a partial side view of the needle insertion unit according to Figure 1a upon completion of assembly on the housing;

[0029] [Fig. 2] Figure 2:

- Figure 2a is a partial side view of the means for adjusting the needle insertion unit according to Figure 1a in a first position;

- Figure 2b is a partial side view of the means for adjusting the needle insertion unit according to Figure 1a in a second position;

[0030] [Fig. 3] Figure 3 is a partial perspective view of a needle inserter unit mounted on a housing of a needle inserter according to a second embodiment;

[0031] [Fig. 4] FIG. 4 is a partial side view of the means for adjusting the needle insertion unit according to FIG. 3;

[0032] [Fig. 5] Fig. 5 is a partial perspective view of a needle inserter unit mounted on a housing of a needle inserter according to a third embodiment;

[0033] [Fig. 6] Figure 6 is a perspective sectional view of the means for adjusting the needle insertion unit according to Figure 5.

A needle insertion device, as shown in Figures 1a to 6 and designated by the reference 1, comprises a housing 10 having in this example a bearing wall 19 intended to be positioned near of the skin of a subject, even in direct contact with the skin. The insertion device 1 further comprises a needle insertion unit 20 intended to actuate a needle 21, the needle insertion unit 20 being mounted movably with respect to the bearing wall 19 so that the needle 21 moves from a position before insertion to an insertion position and from its insertion position to its retracted position. When the needle 21 is in the position before insertion, the needle 21 is set back relative to the bearing wall 19. In the insertion position, the needle 21 is prominent with respect to the bearing wall 19, and in the retracted position the needle 21 is again set back relative to the bearing wall 19.

According to the illustrated examples, and as seen in Figures 1a, 1b, 4 and 6, the needle insertion unit 20 comprises the needle 21, which includes an insertion end 21 '. As illustrated in Figures 3, 5 and 6, the needle 21 is fixedly mounted in a needle holder 24. The needle insertion unit 20 further comprises a base 22 having a housing 23 for receiving. the needle holder 24. The needle insertion unit 20 further comprises means 30 for actuating the needle 21 which will be described later.

In order to adjust the position of the base 22 of the needle insertion unit 20 relative to the bearing wall 19 of the housing 10, the insertion device 1 comprises means for adjusting the position of the needle insertion unit 20 relative to the housing 10, allowing the needle insertion unit 20 to be moved relative to the bearing wall 19 and thus to vary the distance between the end insert 2 T and the support wall 19 in the insertion position.

A first embodiment of these adjustment means is illustrated in Figures 1a, 1b, 2a and 2b.

In this embodiment, the adjustment means are configured to guide the needle insertion unit 20 to a predetermined position and maintain it in this position when the needle insertion unit 20 is assembled. in the housing 10. To do this, the base 22 comprises a guide ramp 25 located at the front of the base 22 in an assembly direction A. Furthermore, the housing 10 comprises a stop 1 1 and a guide ramp complementary 12, the stop 11 being adjustable relative to the housing 10. More specifically, the stop 11 defines an upper stop for the guide ramp 25 and allows to define a predetermined position of the needle insertion unit 20 and immobilize it by cooperation with the upper end of the complementary guide ramp 12 which then forms a lower stop for the guide ramp 25. The stop 1 1 and the complementary guide ramp 12 are here molded. When the needle insertion unit 20 is moved in the assembly direction A to be mounted in the housing 10, the guide ramp 25 cooperates with the complementary guide ramp 12 so as to guide the unit from. insertion of needle 20 in a guidance direction B substantially orthogonal to the assembly direction A and towards the stop 11. The guide ramps 25 and the complementary guide 12 are oriented so that the guide direction B is substantially perpendicular to the bearing surface 19. The guide ramp 25 and the complementary guide ramp 12 each preferably form a angle close to 45 ° relative to the bearing wall 19. However, it may be a different angle which varies between 30 ° and 75 °. The needle insertion unit 20 comprises a base 50 carrying the base 22. The base 50 comprises first guide bars 16, the housing 10 comprises first guide holes (not shown) adapted to receive the first guide bars 16. The first guide bars 16 and first guide holes are oriented so that the movement between the housing 10 and the needle insertion unit 20 when it is assembled to the housing 10 is substantially parallel to the bearing surface 19. According to an alternative embodiment, the first guide bars 16 are carried by the housing and the first guide holes provided in the base.

The base 50 comprises second guide bars 16 ", the base 22 comprises second guide holes (not shown) adapted to receive the second guide bars 16". The second guide bars 16 'and second guide holes are oriented so that the needle insertion unit 20 moves substantially perpendicular to the bearing surface 19 during its assembly to the housing 10 and the adjustment of the needle. position of the needle support 24 relative to the housing 10. According to an alternative embodiment, the second guide bars 16 'are carried by the needle support and the second guide orifices provided in the base.

As visible in Figures 2a and 2b, the stop 1 1 as well as the complementary guide ramp 12 are movable in opposite adjustment directions C and D via an adjustment system 15, which is in this example an adjustment system by screw, wheel or rack and pinion. The adjustment system 15 may be manual or assisted by an electric motor and may for example include an adjustment screw or any other suitable means. This mobility makes it possible to define various predetermined positions for the needle insertion unit 20 once assembled, these positions being able to be separated by a predetermined pitch, for example 1 mm. Thus, when the base 22 is in contact with the stop 11 at a preset position, the movement of the needle insertion unit 20 is stopped at its desired position corresponding to a chosen insertion depth.

When the insertion device 1 is implemented according to the first embodiment, the adjustment of the insertion depth of the needle 21 and the assembly of the insertion device 1 can advantageously be carried out by a medical staff. When a patient is led to use such an insertion device 1, it is already preset and will not be able to change the setting.

A second embodiment of the adjustment means is illustrated in Figures 3 and 4.

[0044] In this embodiment, the needle insertion unit 20 is mounted movably relative to the bearing wall 19 between several predetermined positions, the adjustment means being configured to move the needle insertion unit 20 between these predetermined positions once the needle insertion unit 20 is assembled in the housing 10. To do this, the housing 10 comprises a return means, for example a compression spring 17 (visible in figure 4) under the base 22, the compression spring 17 being intended to exert a force on the base 22 to move the needle insertion unit 20 in an E direction away from the bearing surface 19 and tend to maintain the needle insertion unit 20 in a predetermined locking position. The housing 10 comprises a notched element 13 and an auxiliary notched element 13 'which are opposite one another and substantially perpendicular to the bearing wall 19. The notched element 13 and the auxiliary notched element 13 'define between them a housing receiving elastic return means 40 forming part of the base 22, the elastic return means 40 being in the form of an elastically movable arm 40 in the example illustrated. A multitude of locking fingers 26 are distributed on each side of the arm 40 opposite the notches of the notched element 13 and of the auxiliary notched element 13 '. The arm 40 can be deformed by means of an actuator 18, for example a retractable wire 18 which is connected to it. The notched element 13 is oriented so that its notches are each at distances from the support wall 19, the notched element 13 being preferably rectilinear and preferably substantially perpendicular to the support wall 19.

The notched element 13, the auxiliary notched element 13 ’and the locking fingers 26 form the adjustment means. According to an alternative embodiment, the adjustment means comprise a notched element without an auxiliary notched element. In this case, the adjustment step of the insertion depth is doubled.

As shown in Figure 4, before adjustment, the needle insertion unit 20 is locked in an initial position by the gear of the locking fingers 26 in the notched member 13. When the thread retractable 18 actuates the arm 40, the latter deforms to release the locking fingers 26 from the notched element 13 and bring other locking fingers 26 into the auxiliary notched element 13 '. When the action of the retractable wire 18 on the arm 40 ceases, the arm 40 returns to its initial state and the locking fingers 26 return to the notched element 13. During this movement of the arm 40, the insertion unit d The needle 20 is subjected to the action of the compression spring 17 and moves one notch, thereby reducing the height of the needle insertion unit 20 relative to the housing 10, and hence the depth of the needle. needle 21, the interval between two notches. The action can be repeated to reach the depth of the needle 21, desired. The same first and second guide bars 16, 16 'described in the first embodiment can be used in this second embodiment to guide the movement of the needle insertion unit 20 relative to the housing 10 and of the base 22 relative to the base 50. The activation of the retractable wire 18 is preferably carried out in the housing 10, the activation may be manual or electronic. The retractable wire can be replaced by a button or an actuator operating with a motor. However, the retractable wire remains a simple solution.

The notched element 13 and the auxiliary notched element 13 ’are arranged so that an actuation of the arm 40 takes place in a step-by-step fashion. The locking fingers 26 of the actuated arm 40 cannot move more than one notch of toothed element 13 and auxiliary toothed element 13 ’to each other, so that the adjustment is fine.

Finally, a third embodiment of the adjustment means is illustrated in Figures 5 and 6.

As in the second embodiment, the needle insertion unit 20 is mounted movably relative to the bearing wall 19 between several predetermined positions, the adjustment means being configured to move the unit. needle insertion 20 between these predetermined positions once the needle insertion unit 20 is assembled in the housing 10. According to this third embodiment, the housing 10 comprises a thumbwheel 14 having numbers distributed over its periphery. The needle insertion unit 20 includes a thread 27 intended to cooperate with the thumbwheel 14 to transform a rotation of the thumbwheel 14 into a translation of the needle insertion unit 20 relative to the wall of the needle. 'support 19.

When the insertion device 1 is implemented according to the second or the third embodiment, the user receiving the insertion device 1 already assembled can adjust the needle insertion depth 21 before each use by himself. In order to ensure safe and correct use of the insertion device 1, the latter comprises means (not shown) for controlling the adjustment of the predetermined position of the needle insertion unit 20 relative to the wall d. support 19, configured to block movement of needle 21 if the adjustment of the predetermined position of the needle insertion unit 20 relative to the support wall 19 does not correspond to a predetermined adjustment. This locking of the needle insertion unit 20 can be achieved by an indexing finger (not shown) connected to the control means to interact with the actuating means 30 when an incorrect adjustment of its position. predetermined is detected by the control means. Thus, through the constraint of the index finger, the actuating means 30 are locked by constraint and cannot allow the movement of the needle 21 between its different positions.

Figure 6 succinctly illustrates the structure of the needle insertion unit 20 according to the third embodiment of the invention. In particular, FIG. 6 shows actuating means 30 comprising a spiral spring 31, one of which one end is fixed on the base 22 and the other end is connected to a driving wheel 32. The driving wheel 32 cooperates with the needle support 24 to transform the rotation of the driving wheel 32 into a translation. of the needle support 24. The actuating means 30 may nevertheless take other forms. In particular, the spiral spring 31 can be replaced by one or more compression springs.

In addition, the reusable part of the insertion device 1 comprises a reservoir of product to be dispensed and means for activating a pump connected to the reservoir to transfer the product to be dispensed from the reservoir to the insertion unit needle 20.

It is understood that the needle 21 can be inserted into the site to inject a product into the site, or to introduce a flexible catheter, subsequently allowing a product to be injected into the site after retraction of the needle 21. For example, and as illustrated in FIG. 6, the insertion device 1 comprises a catheter 28 carried by a guide means 29 which is linked in translation with the needle holder 24 during the insertion of the needle. 21. The needle 21 being housed inside the catheter 28, the insertion of the needle 21 into the site allows the insertion of the catheter 28.

[0055] According to a particularly advantageous aspect of the proposed insertion device 1, the insertion device 1 comprises a reusable part carrying the housing 10 and elements with high added value, in particular at least part of the adjustment means. The insertion device 1 also comprises a disposable part removably mounted on the reusable part and comprising parts in contact with the product to be dispensed, in particular the needle insertion unit 20, the pump to be connected to the reservoir, the reservoir and the support wall 19. According to another embodiment, the support wall may be provided on the part to be reused.

Claims

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

- a supporting wall (19) on the site,

- a needle (21) comprising an insertion end (21 ') movably mounted relative to the bearing wall (19) between at least one 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 protruding relative to the bearing wall (19) and a retracted position in which the needle (21) is again set back from the support wall (19),

- a needle insertion unit (20) comprising means (30) for actuating the needle (21) capable of moving the needle (21) from its position before insertion to its insertion position, and from its insertion position to its retracted position,

characterized in that it comprises means (11, 25, 12; 13, 26; 14, 27) for adjusting the position of the needle insertion unit (20) relative to the bearing wall (19), allowing the needle insertion unit (20) to be moved relative to the bearing wall (19) and thus to vary the distance between the insertion end (21 ') and the support wall (19) in the insertion position.

2. Insertion device (1) according to the preceding claim, wherein the needle insertion unit (20) comprises:

- a base (22) having a housing (23) intended to receive a needle support (24),

- the needle holder (24) being movably mounted in the housing (23) between the position before insertion, the insertion position, and the retracted position,

- the adjustment means (11, 25, 12; 13, 26; 14, 27) being configured to adjust the position of the base (22) relative to the support wall (19).

3. Insertion device (1) according to any one of the preceding claims, comprising:

- a reusable part comprising at least part of the adjustment means (11, 12; 13, 14), and

- a disposable part comprising at least the needle insertion unit (20) and the needle (21), the disposable part being removably mounted on the reusable part.

4. Insertion device (1) according to the preceding claim, wherein the reusable part further comprises means for activating a pump connected to a reservoir of product to be dispensed in order to transfer the product from the reservoir to the unit. needle insertion (20).

An insertion device (1) according to any preceding claim, wherein the adjustment means (11, 25, 12) are configured to guide the needle insertion unit (20) to a position. predetermined and keep it in this position when the needle insertion unit (20) is assembled in a housing (10).

6. Insertion device (1) according to the preceding claim, wherein the adjustment means (11, 25, 12) comprise:

- a stop (11) movably mounted relative to the housing (10),

- a guide ramp (25) carried by the needle insertion unit (20),

- a complementary guide ramp (12) carried by the housing (10) and intended to cooperate with the guide ramp (25) so as to guide the needle insertion unit (20) towards the stop (11) and thereby assembling the needle insertion unit (20) in the predetermined position defined by the adjustable stopper (11).

7. An insertion device (1) according to any one of claims 1 to 4, wherein the needle insertion unit (20) is movably mounted relative to the bearing wall (19) between the. at least two predetermined positions, the adjusting means (13, 26; 14, 27) being configured to move the needle insertion unit (20) between the at least two predetermined positions after the insertion unit needle (20) is assembled in a housing (10) of the inserter (1).

8. Insertion device (1) according to the preceding claim, wherein the adjustment means (13, 26) comprise a notched element (13) and at least one locking finger (26) carried one by the housing ( 10), the other by the needle insertion unit (20), one of the notched elements (13) and at least one locking finger (26) being movable between:

- a meshed configuration of the adjustment means (13, 26) in which the at least one locking finger (26) meshes with at least one of the notches of the notched element (13) to prevent the displacement of the needle insertion unit (20), relative to the housing (10), and

- a free configuration of the adjustment means (13, 26) in which the at least one locking finger (26) is disengaged from the notches of the notched element (13) allowing the displacement of the insertion unit of needle (20) in relation to the housing (10) to allow adjustment of the insertion depth,

one of the notched elements (13) and at least one locking finger (26) being coupled to an actuator capable of passing the adjustment means (13, 26) from the meshed configuration to the free configuration, and one notched elements (13) and at least one locking finger (26) being biased by elastic return means (40) to tend to maintain the adjustment means (13, 26) in the meshed configuration.

9. Insertion device (1) according to any one of the preceding claims, wherein the adjusting means (14, 27) comprise a threaded wheel (14) and a thread (27) carried one by a housing (10) of the insertion device (1), the other by the needle insertion unit (20), the wheel (14) being intended to cooperate with the thread (27) to transform a rotation of the thumbwheel (14) into a translation of the needle insertion unit (20) relative to the housing (10) to allow adjustment of the insertion depth.

10. An insertion device (1) according to any one of the preceding claims, comprising means for controlling the adjustment of the predetermined position of the needle insertion unit (20) relative to the bearing wall. (19), configured to block movement of the needle (21) if the setting of the predetermined position of the needle inserter unit (20) relative to the bearing wall (10) does not match at a predetermined setting.

1 1. An insertion device (1) according to any preceding claim, wherein the needle insertion unit (20) comprises a catheter (28) mounted movably relative to the needle (21) and means guide (29) of the catheter (28) able to move it with the needle (21) during the passage of the needle (21) from its position before insertion to its insertion position and to detach it from the needle (21) so that it remains in an insertion position when the needle (21) moves from its insertion position to its retracted position.

12. Reusable part for an insertion device (1) according to any one of claims 3 to 11.

13. Single-use part for an insertion device (1) according to any one of claims 3 to 11.