Drug Delivery Device

Abstract

The invention relates to a drug delivery device comprising: a syringe with a body from which a needle extends and an inner sheath; a piston rod comprising a piston and an actuation head, a support sheath for holding the body. It is envisaged that the support sheath and the actuation head comprise corresponding indicators.

Claims

1. Drug delivery device (1) comprising: a syringe (5) with a body (5.1) from which a needle (6) extends, an inner sheath (7) adapted to be movable between a retracted position in which the needle (6) projects beyond a distal end of the inner sheath (7) and an extended position in which the needle (6) is covered by the inner sheath (7); a support sheath (2) adapted to hold the body (5.1) and to hold the inner sheath (7) in the retracted position as well as in the extended position, a piston rod (3) comprising a piston, wherein the piston rod (3) is movable from a first position in which the piston rod is retracted to a second position wherein a drug delivery process is finished, and an actuation head (4), characterized in that the actuation head (4) is coupled on a proximal end of the piston rod (3), the support sheath (2) comprises a proximal section (2.2), wherein the proximal section (2.2) of the support sheath (2) and the actuation head (4) comprise corresponding indicators providing a visible feedback when the piston rod (3) is in the second position.

2. Drug delivery device (1) according to claim 1, characterized in that the corresponding indicators are designed as corresponding positive locking elements (9.1, 9.2), whereby a first positive locking element (9.1) is formed by a circumferential end portion (4.1) of the actuation head (4) extending in a distal direction (D), and a second positive locking element (9.2) formed by a proximal section (2.2) of the support sheath (2) extending in a proximal direction.

3. Drug delivery device (1) according to claim 2, characterized in that the first locking element (9.1) comprises an outer circumference smaller than an inner circumference of the second positive locking element (9.2), and a substantially annular portion (9.1.1) that extends perpendicular with respect to the longitudinal axis (A) of the drug delivery device (1) in such a manner that a circumference of the annular portion (9.1.1) is equal or larger than an outer circumference of the second positive locking element (9.2).

4. Drug delivery device (1) according to claim 3, characterized in that the piston rod (3) is movable between a retracted first position prior to drug delivery and a second position after complete drug delivery, wherein in the second position the annular portion (9.1.1) either abuts against the second locking element (9.2) or wherein the annular portion (9.1.1) remains axially spaced from the second locking element (9.2) by a maximal distance of 3 mm.

5. Drug delivery device (1) according to one of the claim 3 or 4, characterized in that the first locking element (9.1) is designed with a double wall, whereby an outer wall (9.1.3) comprises an inner circumference larger than the outer circumference of the second positive locking element (9.2), whereby an inner wall (9.1.4) comprises an outer circumference smaller than the inner circumference of the second positive locking element, (9.2) and whereby a recess (9.1.5) arranged between the outer wall (9.1.3) and the inner wall (9.1.4) is formed corresponding to the second positive locking element (9.2).

6. Drug delivery device (1) according to claim 5, characterized in that an inner surface of the outer wall (9.1.3) comprises at least one first latching element (9.1.3.1) that corresponds to a second latching element (9.2.1) arranged on an outer surface of the second positive locking element (9.2).

7. Drug delivery device (1) according to claim 6, characterized in that the first latching element (9.1.3.1) is designed as a latching nose (9.1.3.1.1) or a number of latching nose segments or a circumferential clip, whereby the second latching element (9.2.1) is designed as a corresponding latching recess (9.2.1.1), and whereby the latching recess (9.2.1.1) is adapted to receive the first latching element nose (9.1.3.1) at the end of a drug delivery process.

8. Drug delivery device (1) according to one of the claims 2 to 5, characterized in that the second positive locking element (9.2) comprises a number of spring elements (11) suitable for being deactivated to retain the inner sheath (7) in a retracted position inside the support sheath (2) and for being activated to allow the inner sheath (7) to move in the distal direction (D) towards an extended position.

9. Drug delivery device (1) according to claim 8, characterized in that the spring elements (11) are designed as first resilient tongues (11.1) that are integral with an inner surface of the second positive locking element (9.2).

10. Drug delivery device (1) according to claim 9, characterized in that the first resilient tongues (11.1) abut against a number of further spring elements (12) arranged on the inner sheath (7), whereby the further spring elements (12) are designed as second resilient tongues (12.1) that are held within the support sheath (2) in a snap-fastening manner.

11. Drug delivery device (1) according to claim 10, characterized in that the second resilient tongues (12.1) are resiliently moved inside the support sheath (2) when the first resilient tongues (11.1) are moved towards their inactive position, whereby the snap-fit connection of the inner sheath (7) and the support sheath (2) releases.

12. Drug delivery device (1) according to claim 1, characterized in that the corresponding indicators are designed as coloured or tactile markings (8).

13. Drug delivery device (1) according to claim 12, characterized in that the markings (8) are formed as fragmented markings and/or circumferential markings, whereby the actuation head (4) comprises a number of fragmented markings and at least one circumferential marking and the support sheath (2) comprises at least one circumferential marking, or whereby the actuation head (4) and the support sheath (2) respectively comprise at least one circumferential marking or respectively a number of fragmented markings.

14. Drug delivery device (1) according to claim 13, characterized in that the support sheath (2) is made from an optically transparent material and that the actuation head (4) is made from an optically intransparent coloured material, whereby the colour of the material of the actuation head (4) differs from the colour of the fragmented and/or circumferential markings.

15. Drug delivery device (1) according to claim 12, characterized in that the coloured and/or tactile markings (8) are formed respectively as a material colouration, whereby the material of the support sheath (2) is designed at least section-wise as a coloured translucent material or as an optically intransparent coloured material or as a transparent material, whereby the degree of transparency or colour of the translucent material and/or intransparent material of the support sheath (2) is substantially equal to the degree of transparency or colour of the material of the actuation head (4).

16. Drug delivery device (1) according to claim 12, characterized in that the tactile markings (8) are formed respectively as a surface modification, in particular a grain.

17. Drug delivery device (1) according to any preceding claim, characterized in at least two finger flanges (9.2.3) or a circular finger flange arranged on the support sheath (2) and extending perpendicular with respect to the longitudinal axis (A) of the drug delivery device (1), wherein in the second position of the piston rod (3) the finger flanges (9.2.3) either abut against the first locking element (9.1) or wherein the finger flanges (9.2.3) remain axially spaced from the first locking element (9.1) by a maximal distance of 3 mm.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0100] The present invention will become more fully understood from the detailed description given hereinbelow and the accompanying drawings which are given by way of illustration only, and thus, are not limitive of the present invention, and wherein:

[0101] FIG. 1 shows a perspective view of a part of a drug delivery device with a support sheath and an actuation head comprising corresponding coloured markings in a first embodiment,

[0102] FIG. 2 shows a perspective view of a part of a drug delivery device with a support sheath and an actuation head comprising corresponding coloured markings in a second embodiment,

[0103] FIG. 3 shows a perspective view of a part of a drug delivery device with a support sheath and an actuation head comprising corresponding coloured markings in a third embodiment,

[0104] FIG. 4 shows a perspective view of the drug delivery device with a support sheath and a piston rod coupled to an actuation head comprising corresponding positive locking elements in a first embodiment, whereby the piston rod is in a first position,

[0105] FIG. 5 shows a perspective view of the drug delivery device according to FIG. 4, whereby the piston rod is in a second position

[0106] FIG. 6 shows a part of a sectional view of the drug delivery device according to FIG. 5,

[0107] FIG. 7 shows a side view of a drug delivery device with corresponding positive locking elements in a second embodiment,

[0108] FIG. 8 shows a part of a sectional view of the drug delivery device according to FIG. 7,

[0109] FIG. 9 shows a perspective view of a drug delivery device with corresponding positive locking elements, whereby the piston rod is in a first position,

[0110] FIG. 10 shows a perspective view of the drug delivery device according to FIG. 9, whereby the piston rod is in a second position,

[0111] FIG. 11 shows a part of a sectional view of the drug delivery device according to FIG. 10,

[0112] FIG. 12 shows a part of a sectional view of a drug delivery device with corresponding positive elements in the third embodiment and with latching elements,

[0113] FIG. 13 shows a perspective view of a part of the drug delivery device according to the FIGS. 11 and 12 without actuation head and with an outer contour of a second positive locking element in a first embodiment,

[0114] FIG. 14 shows a perspective view of a part of the drug delivery device with a outer contour of the second positive locking element in a second embodiment, whereby the piston rod is in the second position,

[0115] FIG. 15 shows a part of a sectional view of a drug delivery device with corresponding positive locking elements in the third embodiment, latching elements, and second spring elements, and.

[0116] FIG. 16 shows an exploded illustration of a sectional view of a drug delivery device.

[0117] Corresponding parts are marked with the same reference symbols in all figures.

DETAILED DESCRIPTION

[0118] FIGS. 1 to 3 respectively show a part of a drug delivery device 1 defining a longitudinal axis A. In the following the drug delivery device 1 is considered generally as a device capable of delivering medicaments to a patient in a manual way. The drug delivery device 1 comprises a support sheath 2 and a piston rod 3 that is coupled with an actuation head 4 on a proximal end thereof.

[0119] The support sheath 2 is divided into two sections 2.1, 2.2, in particular in a distal section 2.1 designed as a substantially tubular body, and a proximal section 2.2 having a larger diameter than the distal section 2.1.

[0120] The proximal section 2.2 can be also described as a circumferential end section of the support sheath 2 that extends parallel to the axis A in a proximal direction P. In the exemplary embodiments of the invention, shown in the FIGS. 1 to 3, an inner periphery of the proximal section 2.2 is suitable to receive a circumferential end portion 4.1 of the actuation head 4 that extends parallel to the axis A in a distal direction D.

[0121] Further, the drug delivery device 1 comprises a syringe 5 with a body 5.1 designed as a cartridge respectively pre-filled with a liquid medicament component. The body 5.1 includes an open proximal end and a distal end from which a needle 6 extends. Furthermore, the body 5.1 is held within an inner sheath 7 and is conventionally formed as a substantially tubular body, being made of glass or of plastics material.

[0122] The inner sheath 7 is generally in a retracted position inside the support sheath 2 when the piston rod 3 is in a first position, wherein the piston rod 3 is retracted and the drug device 1 is ready for a drug delivery process. The body 5.1 is engaged within the inner sheath 7 and is held relative to the support sheath 2 in such a manner that the needle 6 projects beyond a distal end 2.1 of the support sheath 2 and a distal end 7.1 of the inner sheath 7.

[0123] When the piston rod 3 is in a second position, wherein the drug delivery process is finished, i.e. drug is completely delivered; the inner sheath 7 is in an extended position, in which the needle 6 is covered by the inner sheath 7. The body 5.1 is then held within the support sheath 2.

[0124] Moreover, the drug delivery device 1 comprises a first spring element 10, preferably designed as a helical spring that is compressed when the inner sheath 7 is retained in the retracted position and that urges the inner sheath 7 to move from the retracted position towards the extended position by relaxing of it. Therefore the first spring element 10 bears against the inner sheath 7 in the distal direction D and against the support sheath 2 in the proximal direction P.

[0125] The coupling of the body 5.1 and the inner sheath 7 respective with the support sheath 2 will be described in more detail in the description of FIG. 15.

[0126] To provide a user of the drug delivery device 1 with a visible and/or tactile feedback about the current state of the drug delivery process, in particular to inform the user that the dose of drug was fully delivered so the user can remove the drug delivery device 1 from a patient site, the actuation head 4 and the support sheath 2 comprise corresponding coloured and/or tactile markings 8 as indicators.

[0127] In a first embodiment shown in FIG. 1, the coloured and/or tactile markings 8 are designed as fragmented and circumferential markings. The actuation head 4 comprises a number of printed or moulded arrows as fragmented markings and one circumferential line as the circumferential marking. The support sheath 2 comprises one circumferential line as circumferential marking.

[0128] In a second embodiment shown in FIG. 2, the coloured and/or tactile markings 8 are designed respectively as printed or moulded circumferential lines. In a third embodiment illustrated in FIG. 3, the coloured and/or tactile markings 8 are designed respectively as fragmented lines in the form of a number of printed or moulded squares.

[0129] When the piston rod 3 is pressed down by application of a sufficient force on a bearing surface 4.2 of the actuation head 4 the coloured and/or tactile markings 8 of the support sheath 2 and the actuation head 4 come together. Pressing down the piston rod 3 means that it is moved from the first position towards the second position.

[0130] For an alternative or additional tactile feedback, the actuation head 4 and the support sheath 2 comprise corresponding circumferential latching elements (not shown). In an example, the support sheath 2 comprises a circumferential recess that is suitable to receive a circumferential bulging arranged on the actuation head 4.

[0131] In a further exemplary embodiment of the invention the support sheath 2 is made from an optically transparent material, whereby the actuation head 4 is made from an optically intransparent coloured material. Preferably, the colour of the material of the actuation head 4 differs from the colour of the coloured and/or tactile markings 8 so that they are clearly visible for the user. For example, the material of the actuation head 4 comprises is designed with a green colour and the circumferential and/or fragmented markings include a blue colour.

[0132] It goes without saying that the coloured and/or tactile markings 8 described in the above embodiments can be designed as any other geometric form suitable to give a user a clearly visible feedback.

[0133] In another embodiment of the invention (not shown in any of the FIGS. 1 to 15), the material of the support sheath 2 is designed at least section wise as a coloured translucent material or as an optically intransparent coloured material. Preferably, a colour of the translucent material and/or the intransparent material of the support sheath 2 is substantially equal to the colour of the material of the actuation head 4.

[0134] The FIGS. 4 to 15 show the drug delivery device 1 with corresponding positive locking elements 9.1, 9.2 in different embodiments as indicators. The FIGS. 4 to 6 show the drug delivery device 1 with the positive locking elements 9.1, 9.2 in a first embodiment.

[0135] A first locking element 9.1 is formed by the circumferential end portion 4.1 of the actuation head 4; a second positive locking element 9.2 is formed by the proximal section 2.2 of the support sheath 2.

[0136] According to the first embodiment, the first locking element 9.1 comprises an outer circumference smaller than an inner circumference of the second positive locking element 9.2, so that the first locking element 9.1 will join into the second positive locking element 9.2 if the piston rod 3 is moved from the first position, illustrated in FIG. 4, to the second position, illustrated in the FIGS. 5 to 7.

[0137] Further, the first locking element 9.1 comprises a substantially annular portion 9.1.1, e.g. a ring, which is arranged proximally and extends perpendicular with respect to the axis A.

[0138] A circumference of the annular portion 9.1.1 is equal or larger than an outer circumference of the second positive locking element 9.2. Likewise, the circumference of the annular portion 9.1.1 may be smaller than the outer circumference but greater than the inner circumference of the second positive locking element 9.2. The annular portion 9.1.1 is preferably integral with the actuation head 4 to enable effective costs and maintain regarding to a production process.

[0139] The annular portion 9.1.1 abuts against the second locking element 9.2 when the piston rod 3 is in the second position. This enables a visible and tactile feedback for the user when drug is fully delivered. Likewise, a distal edge of the first locking element 9.1 may abut against the second locking element 9.2 when the piston rod 3 is in the second position, while the annular portion 9.1.1 may remain axially spaced from the second locking element 9.2, e.g. by a distance between 0.1 mm and 3 mm. This may lead the user to fully depress the piston rod 3 thereby triggering the inner sheath 7.

[0140] The FIGS. 7 and 8 show the positive locking elements 9.1, 9.2 in a second embodiment, wherein the first positive locking element 9.1 comprises a proximal end portion 9.1.2 with a circumference equal to or larger than the inner circumference of the second positive locking element 9.2. The proximal end portion 9.1.2 abuts against the second locking element 9.2 when the piston rod 3 is in the second position equivalent as it is performed by the annular portion 9.1.1.

[0141] The FIGS. 9 to 15 show the drug delivery device 1 with positive locking elements 9.1, 9.2 in a third embodiment, whereby in FIG. 9 the piston rod 3 is retained in the first position and in the FIGS. 10 and 11 the piston rod 3 is retained in the second position.

[0142] The first positive locking element 9.1 is designed with a double wall. An outer wall 9.1.3 comprises an inner circumference larger than the outer circumference of the second positive locking element 9.2 and an inner wall 9.1.4 comprises an outer circumference smaller than the inner circumference of the second positive locking element 9.2.

[0143] The outer and inner wall 9.1.3, 9.1.4 are spaced apart from each other, hence defining a recess 9.1.5 between, which is formed corresponding to a contour of the second positive locking element 9.2.

[0144] When the piston rod 3 is moved from the first position to the second position, the first positive locking element 9.1 moves over the second positive locking element 9.2 in such a manner that the outer wall 9.1.3 moves over the outer surface of the second positive locking element 9.2 and the inner wall 9.1.4 moves over an inside surface of the second positive locking element 9.2.

[0145] At the same time the recess 9.1.5 receives the contour of the second positive locking element 9.2. With this, the first positive locking element 9.1 hides the second positive locking element 9.2 when the piston rod 3 is in the second position. The end of drug delivery is then practically indicated when the circumferential end portion 4.1 is moved completely over the proximal section 2.2 of the support sheath 2. This corresponds to a visible feedback.

[0146] For an additional audible feedback, the FIGS. 12 and 13 show an exemplary embodiment of the invention, wherein an inner surface of the outer wall 9.1.3 comprises a first latching element 9.1.3.1, illustrated in the sectional view of FIG. 12. The first latching element 9.1.3.1 is arranged distally and comprises at least one latching nose 9.1.3.1.1 that is suitable to latch into a corresponding second latching element 9.2.1 arranged distally on an outer surface of the second positive locking element 9.2 and that comprises at least one latching recess 9.2.1.1.

[0147] In the terminology of the invention the inner surface of the outer wall 9.1.3 is a surface that is faced towards the inner wall 9.1.4, whereby an inner surface of the inner wall 9.1.4 is a surface faced towards the outer wall 9.1.3.

[0148] FIG. 13 illustrates the second positive locking element 9.2 in a perspective view so that two latching recesses 9.2.1.1, spaced apart from each other in a peripheral direction, are visible in more detail. Preferably, the second positive locking element 9.2 comprises two additional latching recesses 9.2.1.1 (not shown) arranged oppositely to the illustrated latching recesses 9.2.1.1. Hence, the outer wall 9.1.3 of the first positive locking element 9.1 comprises four latching noses 9.1.3.1.1.

[0149] It goes without saying that the illustrated embodiment in FIG. 13 only shows an exemplary embodiment of the invention. The corresponding latching elements 9.1.3.1, 9.2.1 can comprise a number of latching noses 9.1.3.1.1 respectively latching recesses 9.2.1.1 differing from that what is described above. Further, the first latching element 9.1.3.1 can be designed as a circumferential bulging that latches into the second latching element 9.2.1 designed as a corresponding circumferential recess.

[0150] When the piston rod 3 is moved from the first position to the second position and hence the outer wall 9.1.3 moves over the outer surface of the second positive locking element 9.2 the latching noses 9.1.3.1.1 latch into the corresponding latching recesses 9.2.1.1. This provides a feedback in the form of an audible click when drug delivery is finished and an indication of use as a lock in of the actuation head 4 in the support sheath 2 as to prevent reuse.

[0151] As can be seen further in FIG. 13 (and also in the FIGS. 4, 5 and 9), the second positive locking element 9.2 comprises a number of curvatures 9.2.2 that corresponds to the number of latching recesses 9.2.1.1, whereby the curvatures 9.2.2 are arranged in the area of the latching recesses 9.2.1.1. Preferably, the outer and inner wall 9.1.3, 9.1.4 of the first positive locking element 9.1, in particular the inner surface of the outer wall 9.1.3 and an inner surface of the inner wall 9.1.4, comprise corresponding forms to enable an optimal positive locking fit between the first and second positive locking elements 9.1, 9.2.

[0152] FIG. 14 shows an alternative embodiment of the invention, in which the first positive locking element 9.1 comprises a substantially round outer contour. Even it is not illustrated; the second positive locking element 9.2 comprises a corresponding form without the curvatures 9.2.2 shown in FIG. 13. This enables an easy performance of a production process of the drug delivery device 1.

[0153] For holding the drug delivery device 1 comfortably, the support sheath 2 comprises two finger flanges 9.2.3 that are illustrated best in FIG. 14. The finger flanges 9.2.3 are arranged distally on the second positive locking element 9.2 and extend perpendicular with respect to the axis A. Thereby, the user can handle the drug delivery device 1 between the index and middle fingers, placing these fingers against the finger flanges 9.2.3 and driving the piston rod 3 by pressing the thumb on the actuation head 4.

[0154] In an alternative embodiment a circular finger flange can be arranged.

[0155] In FIG. 15, a safety mechanism of the drug delivery device 1 is shown in more detail. The safety mechanism enables that the inner sheath 7 is movable from the retracted position to the extended position, in which a distal tip 6.1 of the needle 6 is covered completely by the inner sheath 7.

[0156] Therefore, the second positive locking element 9.2 comprises a number of second spring elements 11 designed as resilient tongues, following named as first resilient tongues 11.1, which are integral with an inner surface of the second positive locking element 9.2.

[0157] The first resilient tongues 11.1 are directed inwards and build a ramp surface for the first positive locking element 9.1 directed outwards, when the piston rod 3 is moved towards the second position.

[0158] A free end 11.1.1 of the first resilient tongues 11.1 abut against third spring elements 12 arranged on the inner sheath 7. The third spring elements 12 are designed as resilient tongues, following named as second resilient tongues 12.1 that tend naturally to spread apart slightly, going away from the axis A. In the example shown, the second resilient tongues 12.1 are integral with the inner sheath 7 and hook onto the support sheath 2, in particular the proximal section 2.2 that comprises therefore corresponding nuts 2.3.

[0159] The first resilient tongues 11.1 are suitable for being moved resiliently from an inactive position, in which they abut against the second resilient tongues 12.1 without prestressing the second resilient tongues 12.1, to an active position, in which they release the inner sheath 7 from the support sheath 2.

[0160] For releasing the inner sheath 7 the second resilient tongues 12.1 are urged by the first resilient tongues 11.1 to move resiliently inside the support sheath 2 by a distal movement of the piston rod 3. In particular, when the inner wall 9.1.4 of the first positive locking element 9.1 has moved over the ramp surface of the first resilient tongues 11.1 it abuts against an end 11.1.2 of the first resilient tongues 11.1 that is arranged on the inner surface of the second positive locking element 9.2.

[0161] This abutting causes a resilient movement of the first resilient tongues 11.1 inside the support sheath 2 which in turn causes that the second resilient tongues 12.1 are resiliently moved inside the support sheath 2 releasing the inner sheath 7 from the support sheath 2.

[0162] Therefore, the end 11.1.2 of the first resilient tongues 11.1 comprises a material weakness compared to the free end 11.1.1. According to a distal direction D, behind the material weakness a projection 13 is arranged on the second positive locking element 9.2 that projects in the proximal direction P. When the inner wall 9.1.4 abuts against the material weakness and thus the first resilient tongues 11.1 moved resiliently inside the support sheath 2 the material weakness of the first resilient tongues 11.1 abuts against the projection 13. This enables a good rolling up of the first resilient tongues 11.1 on the projection 13 so that a risk for damages of the first resilient tongues 11.1 is reduced.

[0163] Thus, the actuation head 4 actuated the first resilient tongues 11.1 to release the inner sheath 7. The first spring element 10 thrust the inner sheath 7 forward into the distal direction D so that it projects well beyond the distal section 2.1 of the support sheath 2 over a length suitable for forming a protective shield around the distal tip 6.1 of the needle 6. Thus, a risk for a user to come in contact with the needle 6 after drug delivery is reduced.

[0164] The inner sheath 7 is retained in the extended position by coming into abutment against a shoulder 2.1.1 formed into the support sheath 2. Therefore, FIG. 16 shows a drug delivery device 1 in an exploded view. As can be seen a proximal end of the second resilient tongues 12.1 abuts against the shoulder 2.1.1 in the proximal direction P when the inner sheath 7 is retained in the extended position. Thus a proximal movement of the inner sheath 7 is limited when the second resilient tongues 12.1 passes the shoulder 2.1.1. With this the inner sheath 7 is prevented for being retracted into the support sheath 2 and to expose the needle 6. The resilient tongues 12.1 flex outwards against the support sheath 2 so that they always interfere with the shoulder 2.1.1 thus providing reliable safety.

[0165] The body 5.1 is held relative to the support sheath 2 in a not shown way by holding elements belonging to the support sheath 2, co-operating with a proximal end of the body 5.1.