Autoinjector with retracting needle

Abstract

An automatic drug delivery device is described, comprising: a housing (1); a skin sensor element (15) coupled to the housing and movable relative to the housing, wherein the skin sensor element is biased into a front position relative to the housing and is movable to a rear position relative to the housing when the skin sensor element is pressed against an injection site; a needle assembly comprising a hypodermic needle (11), the hypodermic needle extending outside of the housing when the device is in a needle insertion configuration; a drug delivery mechanism comprising a stored energy source (4), within the housing; wherein the drug delivery mechanism is released when the skin sensor element is moved from the front position towards the rear position and wherein the stored energy source is arranged to expand along an axis that is offset from an axis of travel of the needle assembly in use; a needle retraction mechanism configured to withdraw the hypodermic needle into the housing when the needle retraction mechanism is released; wherein the needle retraction mechanism is coupled to the skin sensor element such that when the skin sensor element is moved from the rear position towards the front position, and the needle is in the needle insertion position, the needle retraction mechanism is released.

Claims

1. An automatic drug delivery device comprising: a housing; a skin sensor element coupled to the housing and movable relative to the housing, wherein the skin sensor element is biased into a front position relative to the housing and is movable to a rear position relative to the housing when the skin sensor element is pressed against an injection site on a patient; a needle assembly comprising a hypodermic needle, the hypodermic needle extending outside of the housing when the hypodermic needle is in a needle insertion position; a drug delivery mechanism comprising a first stored energy source within the housing and a further stored energy source, wherein, in operation, the first stored energy source is configured to move the hypodermic needle from an initial position to the needle insertion position and the further stored energy source is releasable to deliver a drug through the hypodermic needle; and a needle retraction mechanism configured to withdraw the hypodermic needle into the housing when the needle retraction mechanism is released, wherein the needle retraction mechanism is coupled to the skin sensor element such that when the skin sensor element is moved from the rear position towards the front position, and the hypodermic needle is in the needle insertion position, the needle retraction mechanism is released.

2. An automatic drug delivery device according to claim 1, wherein when the hypodermic needle is in the needle insertion position and the skin sensor element is moved from the rear position towards the front position, the hypodermic needle or the needle assembly is uncoupled from the first stored energy source of the drug delivery mechanism.

3. An automatic drug delivery device according to claim 2, wherein the drug delivery mechanism comprises a drive member positioned between the first stored energy source and the needle assembly, and wherein the drive member comprises a resilient portion and engages the needle assembly to drive the hypodermic needle to the needle insertion position.

4. An automatic drug delivery device according to claim 3, wherein the resilient portion is moved out of engagement with the needle assembly when the hypodermic needle reaches the needle insertion position and the skin sensor element is moved from the rear position to the front position, so as to uncouple the first stored energy source from the needle assembly.

5. An automatic drug delivery device according to claim 1, wherein the needle retraction mechanism comprises a second stored energy source configured to withdraw the hypodermic needle into the housing.

6. An automatic drug delivery device according to claim 5, wherein the second stored energy source is restrained from retracting the hypodermic needle by the first stored energy source.

7. An automatic drug delivery device according to claim 5, wherein the first stored energy source transfers energy to the second stored energy source as the hypodermic needle is moved to the needle insertion position.

8. An automatic drug delivery device according to claim 5, wherein the second stored energy source is a spring which is compressed by the drug delivery mechanism as the needle assembly is moved to the needle insertion position.

9. An automatic drug delivery device according to claim 5, wherein the second stored energy source is a spring that is locked in a compressed state until the hypodermic needle is in the needle insertion position and the skin sensor is moved from the rear position towards the front position.

10. An automatic drug delivery device according to claim 5, wherein the second stored energy source is a spring held in a compressed condition by a retention feature prior to use of the device, and wherein the second stored energy source is uncoupled from the retention feature by travel of the skin sensor during use, or by a needle insertion mechanism during use, or by the drug delivery mechanism during use.

11. An automatic drug delivery device according to claim 5, wherein when the hypodermic needle is in the needle insertion position and the skin sensor element is moved from the rear position towards the front position, the hypodermic needle remains coupled to the first stored energy source and the second stored energy source is released to overcome any force provided by the first stored energy source and withdraw the hypodermic needle into the housing.

12. An automatic drug delivery device according to claim 2, wherein the needle retraction mechanism comprises a second stored energy source configured to withdraw the hypodermic needle into the housing, and the uncoupling of the hypodermic needle or the needle assembly from the first stored energy source of the drug delivery mechanism releases the second stored energy source to withdraw the hypodermic needle into the housing.

13. An automatic drug delivery device according to claim 1, wherein the drug delivery mechanism is restrained from release by a coupling between the drug delivery mechanism and the housing, and wherein the coupling is released when the skin sensor element is in the rear position.

14. An automatic drug delivery device according to claim 13, wherein a drive component of the drug delivery mechanism is restrained relative to a portion of the housing by a locking member engaging a portion of the drive component.

15. An automatic drug delivery device according to claim 3, wherein the drive member comprises a spring seat and an engagement portion configured to engage the needle assembly, wherein the spring seat and the engagement portion are connected by the resilient portion.

16. An automatic drug delivery device according to claim 15, wherein the resilient portion comprises one or more resilient arms.

17. An automatic drug delivery device according to claim 15, wherein the drive member comprises at least two resilient arms extending on opposite sides of the needle assembly and at least one spring seat connected to the resilient arms and engaging the first stored energy source of the drug delivery mechanism.

18. An automatic drug delivery device according to claim 1, wherein the first stored energy source is arranged within the housing so that the hypodermic needle travels through or past at least a portion of the first stored energy source as the hypodermic needle is withdrawn into the housing.

19. An automatic drug delivery device according to claim 18, wherein the first stored energy source comprises first and second drive springs arranged on opposite sides of the needle assembly when the hypodermic needle is in a retracted position.

20. An automatic drug delivery device according to claim 19, wherein the needle retraction mechanism comprises a second stored energy source which is a spring arranged to expand in a space between the first and second drive springs.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) Embodiments of the invention will now be described in detail, by way of example only, with reference to the accompanying drawings in which:

(2) FIG. 1 is a schematic cross-sectional illustration of a drug delivery device in accordance with a first embodiment of the invention, before use:

(3) FIG. 2 is an alternative cross-sectional view of the device of FIG. 1;

(4) FIG. 3 is an exploded view of the device of FIGS. 1 and 2;

(5) FIG. 4 is a further cross-sectional view of the device of FIG. 1, illustrating the locking mechanism restraining the main drive springs, with the cap removed:

(6) FIG. 5 is a still further cross-sectional view of the device of FIG. 1 illustrating the locking mechanism restraining the main drive springs;

(7) FIG. 6 shows the device of FIG. 1 with the cap removed;

(8) FIG. 7 is a cross-sectional view of the device of FIG. 6, with the skin sensor moved to the ‘activated’ position;

(9) FIG. 8 is an alternative cross-sectional view of the device of FIG. 7 showing the locking mechanism in the unlocked position;

(10) FIG. 8A is a detailed view of FIG. 8;

(11) FIG. 9 is a perspective view of the yoke component;

(12) FIG. 10 is a perspective view of the inner housing;

(13) FIG. 11 is a cross-sectional perspective view of the inner housing;

(14) FIG. 12 is a cross-sectional view of the device of FIG. 8 after the needle has moved to the ‘inserted’ position

(15) FIG. 13 is an alternative cross-sectional view of the device of FIG. 12 showing the drive spring retention mechanism in the unlocked position;

(16) FIG. 14 is a cross-sectional view of the device of FIG. 13 after the drug seal has ruptured, opening a fluid path between the drug and the needle;

(17) FIG. 15 is an alternative cross-sectional view of the device of FIG. 14;

(18) FIG. 16a is an alternative section view of the autoinjector of FIG. 14;

(19) FIG. 16b shows a detail of FIG. 16a, with the outer case hidden for clarity;

(20) FIG. 17 shows a similar detail section view of the autoinjector to FIG. 16b, with the outer case hidden for clarity, at a point after the skin sensor has been allowed to move forwards;

(21) FIG. 18 shows a section view of the autoinjector after the cartridge, needle and plunger rod have been pushed back by the needle safety spring:

(22) FIG. 19a is a section view of the autoinjector of FIG. 1 after use, with the needle retracted back inside the body;

(23) FIG. 19b is a detail view of FIG. 19a;

(24) FIG. 20a is a schematic illustration of an alternative embodiment in accordance with the invention, prior to use;

(25) FIG. 20b shows the embodiment of FIG. 20a with the skin sensor retracted;

(26) FIG. 20c shows the embodiment of FIG. 20b with the needle in an insertion position;

(27) FIG. 20d shows the embodiment of FIG. 20c after the drug has been delivered;

(28) FIG. 20e shows the embodiment of FIG. 20d after withdrawal of the skin sensor from the injection site; and

(29) FIG. 20f shows the embodiment of FIG. 20e with the needle retracted.

DETAILED DESCRIPTION

(30) FIG. 1 shows a section view of an example of an autoinjector in accordance with the present invention. FIG. 2 is an alternative section view of the autoinjector of FIG. 1. FIG. 3 is an exploded view of the autoinjector of FIG. 1

(31) The autoinjector comprises a cartridge 8 that contains a drug 6. The cartridge is attached to a needle hub 9. A needle 11 is fixed to the hub 9. The cartridge 8 is sealed from the needle 11 by a drug seal 10. The other end of the cartridge 8 is closed by a plunger 5.

(32) The autoinjector has an external housing having an upper housing 1 and a lower housing 24. The external housing contains the cartridge 8. In use, the cartridge is moved relative to the external housing to insert the needle 11 into an injection site, as will be described. Two main drive springs 4 are provided to drive the cartridge forward to insert the needle into the injection site and subsequently to move the plunger 5 within the cartridge to eject the drug 6. The main drive springs 4 are positioned between the external housing 1 and a yoke 7. Before use of the autoinjector the main drive springs are in a compressed condition, as shown in FIG. 1. They are held in a compressed condition before use because the yoke is restrained from moving relative to the external housing. A back portion of the yoke 20 bears on a plunger rod 2. The plunger rod 2 bears on the plunger 5.

(33) An inner housing 3 is fixed to both the upper external housing 1 and the lower external housing 24.

(34) A skin sensor 15 is provided at a front end of the autoinjector and is slidable coupled to the inner housing 3, and extends within the external housing 1. The skin sensor 15 is urged forwards by two skin sensor springs 14 mounted between the skin sensor and the inner housing 3, but retained on the inner housing 3 by engagement of skin sensor bracing arms 26 with a recess on the inner housing.

(35) A needle safety spring 13 is provided between the needle hub 9 and a front end of the inner housing 3. The needle safety spring is much weaker than the main drive springs and is initially in an uncompressed condition.

(36) A cap 16 is coupled to the external housing 1 and covers the front of the autoinjector. The cap includes a needle shield portion 12 that is positioned within the needle safety spring.

(37) The autoinjector also includes a locking mechanism that prevents release of the drive springs 4. The components of this mechanism can be seen in FIG. 3. Four locking balls 17 are retained in corresponding recesses 18 in the yoke 7 and holes 28 in the inner housing 3, preventing relative movement between the yoke and the inner housing.

(38) FIG. 4 is a section view of the autoinjector of FIG. 1 with the cap 16 removed, showing the locking balls 17. The locking balls 17 prevent the yoke 7 from being moved forward by the main drive springs 4, by locking the yoke 7 to the inner housing 3. The locking balls 17 are retained in position by the skin sensor 15.

(39) FIG. 5 is an alternative section view of the autoinjector of FIG. 4, showing the cap in place.

(40) The various components shown in FIG. 3 may be moulded or otherwise formed from plastics materials and metals or other materials commonly used in drug delivery devices.

(41) The operation of the autoinjector shown in FIGS. 1 to 5 will now be described.

(42) FIG. 6 is a section view of the autoinjector of FIG. 1 with the cap removed, ready to use.

(43) To activate the autoinjector, the skin sensor 15 is pressed against an injection site on a patient. FIG. 7 is a section view of the autoinjector of FIG. 6 with the skin sensor 15 moved backwards, compressing the biasing springs 14.

(44) FIG. 8 is a section view of the autoinjector of FIG. 7, showing the locking balls 17 moving out of the locked position in the recesses 18 in the yoke 7, into an unlocked position that allows the yoke to move relative to the inner housing. This is possible because holes 19 in the skin sensor 15 have lined up with the locking balls 17 as the skin sensor 15 has been moved backwards. FIG. 8a is a detail view of FIG. 8 showing the holes 19 more clearly.

(45) When the locking balls are moved out of the recesses 18 on the yoke, the yoke is driven forwards relative to the inner housing 3 by the main drive springs 4. It main drive springs 4 are positioned on opposite sides of the cartridge 8. It can be seen that the drive springs 4 expand along an axis offset from the axis of the needle. The back of the yoke 20 has thrust arms 22 that engage the plunger rod 2 and so moves the plunger rod 2 forwards, and with it the cartridge, needle and hub. The drug seal 10 prevents plunger moving within the cartridge and the drug 6 from being dispensed through the needle 11 at this stage.

(46) FIG. 9 is a perspective view of the yoke 7 component. It has two thrust faces 21 to take the load from the two main drive springs 4, and two further thrust arms 22 that apply this load to the plunger rod 2, and which form part of the back 20 of the yoke 7. Before and during drug delivery, these thrust arms 22 are held closed by bearing surfaces 27 bearing on corresponding bearing surfaces 23 on the inner housing 3, as shown in FIG. 8.

(47) FIG. 10 is a perspective view of the inner housing 3. The bearing surfaces 23 of the inner case 3 retain the yoke thrust arms 22, as described. The holes 28 work in combination with the locking balls 17 to lock the yoke 7 in position until the autoinjector is activated. Protrusions 29 are used to lock the inner housing to the upper external housing 1. Protrusions 30 are used to lock the inner housing to lower external housing 24. FIG. 11 is a section view of the inner case 3 of FIG. 10.

(48) FIG. 12 shows a section view of the autoinjector of FIG. 1 after the needle 11 has been inserted into the patient. The needle safety spring 13 has been compressed by the main drive springs 4 acting on the back 20 of the yoke 7, which in turn moves the plunger rod 2 forwards, and with it the cartridge, needle and hub. As described, the drug seal 10 prevents the drug 6 from being dispensed through the needle 11 at this stage.

(49) FIG. 13 is an alternative section view of the autoinjector of FIG. 12.

(50) Once the cartridge reaches the forward position shown in FIGS. 12 and 13, it cannot move any further forwards. The pressure exerted by the main drive springs 4 on the plunger 5 through the yoke and plunger rod then causes the drug seal 10 to deform and rupture on a back end of the needle 11. Once the drug seal 10 has been ruptured, the drug can be delivered to the injection site through the needle. The plunger rod moves relative to the cartridge to dispense the drug until a rear lip on the plunger rod abuts a rear end of the cartridge 8.

(51) FIG. 14 is a section view of the autoinjector of FIG. 1 after the drug 6 has been dispensed. The cartridge 8 has moved fully forwards and the pressure on the drug 6 due to the main drive springs 4 acting on the back 20 of the yoke 7 has caused the drug seal 10 to stretch and be pierced by the back end of the needle 11, allowing the drug 6 to be dispensed through the needle 11 into the patient.

(52) FIG. 15 is an alternative section view of the autoinjector of FIG. 14. It can be seen that with the cartridge in the fully forward position, the yoke bearing surfaces 27 are no longer supported by inner case bearing surfaces 23, but are supported by the skin sensor bearing surfaces 25.

(53) Following delivery of the drug, the autoinjector is removed from the injection site. The autoinjector is constructed so that when the skin sensor 15 is moved forwards again by the skin sensor springs 14 as the autoinjector is removed from the injection site, the needle 11 is retracted back into the inner housing 3

(54) FIG. 16a is an alternative section view of the autoinjector of FIG. 14. FIG. 16b shows a detail of FIG. 16a, with the outer case hidden for clarity. The skin sensor bracing arms 26 constrain the yoke thrust arms 22 so that they continue to bear on the plunger rod 2 even though they are no longer held in place by the inner body bearing surfaces 23. This is because the back of the yoke 20 is in contact with the skin sensor bearing surfaces 25. The outer case 1 (not shown) supports the skin sensor bracing arms 26.

(55) FIG. 17 shows a similar detail section view of the autoinjector to FIG. 16b, with the outer case hidden for clarity, at a point after the skin sensor 15 has been allowed to move forwards by the skin sensor springs 14 due to the autoinjector being pulled away from the injection surface of the patient following drug deliver. It can be seen that the skin sensor bracing arms 26 have moved forwards with the rest of the skin sensor, allowing the yoke thrust arms 22 to move apart, releasing the plunger rod 2 from engagement with the yoke and main drive springs 4. With the cartridge no longer engaged with the main drive springs, the needle safety spring urges the needle hub 9, and with it the needle 11, cartridge 8 and plunger rod 2, rearwards within the inner housing 3.

(56) FIG. 18 shows a section view of the autoinjector after the cartridge 8, needle 11 and plunger rod 2 have been pushed back by the needle safety spring 13, having been released from the main drive springs due to the movement of the yoke thrust arms 22. The needle is moved back past the main drive springs 4 until the plunger rod 2 abuts the external housing 1. In this position the needle 11 is retracted inside the external housing.

(57) FIG. 19a is a section view of the autoinjector of FIG. 1 after use, with the needle retracted back inside the body. The yoke arms 22 have sprung back to their original position due to the resilience of the yoke material, causing the back of the yoke 20 to block forward movement of the cartridge 8 and needle 11. This prevents the risk of a needle stick injury due to the needle moving forwards against the needle safety spring 13, for instance due to inertia during handling of a used autoinjector. FIG. 19b is a detail view of FIG. 19a.

(58) The embodiment described above has main drive springs that expand along axes offset from but parallel to the axis of movement of the needle assembly during operation. However it is possible for the drive spring or springs, or other stored energy source, to expand along an axis non-parallel to the direction of travel of the needle. FIGS. 20a-20e are a schematic illustration of such a device.

(59) FIG. 20a is an illustration of an alternative embodiment in accordance with the invention, prior to use. The device shown in FIG. 20 is an autoinjector comprising a housing 40 containing a cartridge 42 containing a drug to be delivered. A hypodermic needle 44 is fixed to the cartridge. A rear end of the cartridge is closed by a plunger 46. A drive spring 48 is positioned to drive the plunger 46 through the cartridge 42 to eject the drug through the needle 44. Prior to use, the drive spring is restrained from acting on the plunger 46 by the engagement of a protrusion 50 on the housing with a drive element 49 positioned between the drive spring and the plunger. A skin sensor element 52 is pivotally connected to the housing 40. The skin sensor element 52 has an aperture 53, which aligns with an aperture 43 on the housing, through which the needle can pass in use, as will be described.

(60) FIG. 20b shows the device of FIG. 20a with the skin sensor element 52 pushed back against the housing 40 when it has been placed on an injection site. FIG. 20c shows the device of FIG. 20b with the needle subsequently moved to a needle insertion position. The cartridge and drive mechanism are pivoted within the housing so that the needle extends through apertures 43 and 53 and into the injection site. A needle insertion mechanism (not shown) may be used to drive the needle to the needle insertion position shown in FIG. 20c. The needle insertion mechanism may be released by the movement of the skin sensor or by other means, such as a user actuated button. Alternatively the needle insertion may be effected manually.

(61) Movement of the cartridge to the needle insertion position releases the protrusion 50 from the drive element 49. This releases the drive spring 48 to push the plunger 46 through the housing to eject the drug through the needle and into the injection site. FIG. 20d shows the device of FIG. 20c after the drug has been ejected.

(62) Following drug ejection, the device is lifted from the injection site. The skin sensor element 52 is then pushed away from the injection site by a biasing spring (not shown). FIG. 20e shows the device of FIG. 20d after withdrawal of the device from the injection site, with the skin sensor element extending from the housing. Extension of the skin sensor releases a needle retraction mechanism (not shown) that pulls the cartridge back to its initial position within the housing, which withdraws the needle back inside the housing. FIG. 20f shows the device of FIG. 20e with the needle retracted inside the housing.

(63) It should be clear that the embodiments described are just examples of devices in accordance with the invention. Modifications can be made and alternative specific mechanisms used for locking and releasing the components of the device during use. For example, the locking balls 17 could be replaced by locking latches on the inner housing. The needle safety spring may be retained in a compressed condition before use and released by movement of a locking latch when the cartridge is moved forwards through the inner housing. Different arrangements for the relative direction of travel of the needle and the expansion of the stored energy source can be foreseen. These and other modifications could easily be foreseen by a skilled person.