Drug delivery device with needle actuation mechanism

• US 10,076,605 B2
• Filed: 07/24/2014
• Issued: 09/18/2018
• Est. Priority Date: 07/30/2013
• Status: Active Grant

• Current Assignee: Sensile Medical AG (Gerresheimer AG)
• Original Assignee: Sensile Medical AG (Gerresheimer AG)
• Inventors: Marbet, Regina, Fehlmann, Daniel
• Primary Examiner(s): Gilbert, Andrew
• Assistant Examiner(s): Ulsh, Dung
• Application Number:
  US14/908,572
• Publication Number:
  US 20160184512A1
• Time in Patent Office: 1,517 Days
• CPC Class Codes: A61M 2005/14252 with needle insertion means
• CPC Class Codes: A61M 2005/14268 with a reusable and a disposable component
• CPC Class Codes: A61M 2005/14533 cam actuated
• CPC Class Codes: A61M 2005/1585 Needle inserters
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body

Abstract

A delivery unit (2) of a drug delivery device (1), the delivery unit (2) comprising a subcutaneous delivery mechanism (9) having a subcutaneous delivery member (92), and a subcutaneous delivery member actuation mechanism (10) being operable to move the subcutaneous delivery member (92) between a retracted position and an extended position. The actuation mechanism (10) comprises a rotary member (102) having an engagement member (104) rotatable relative a support member (14), and an actuator (106) comprising a pivot portion (10A) and an engagement portion (10B) pivotally connected to the support member via the pivot portion. The engagement member (104) and engagement portion (10B) are configured to engage upon rotation of the rotary member to pivot the actuator between first and second positions and to thereby move the subcutaneous delivery member (92) between the corresponding retracted and extended positions. In an embodiment, the needle actuation mechanism may comprise a reuse protection.

Claims

1. A delivery unit of a drug delivery device, the delivery unit comprising a subcutaneous delivery mechanism having a subcutaneous delivery member and a subcutaneous delivery member actuation mechanism being operable to move the subcutaneous delivery member between a retracted position and an extended position, the actuation mechanism comprising a rotary member having an engagement member rotatable relative to a support member, and an actuator comprising a pivot portion and an engagement portion pivotally connected to the support member via the pivot portion, wherein the actuation mechanism is actuated by rotation of the rotary member and wherein the engagement member and engagement portion are configured to engage upon rotation of the rotary member to pivot an actuation portion of the actuator between first and second positions and to thereby move the subcutaneous delivery member between the corresponding retracted and extended positions, wherein the rotary member comprises a first track ad a second track around an outer circumference of the rotary member, the first track being configured to guide the actuator in the first direction of rotation (R+) of the rotary member and the second track being configured to guide the actuator in the second direction of rotation (R−

) of the rotary member, and wherein the engagement portion comprises a cam portion operable to axially displace the actuator from the first track to the second track.

2. The delivery unit according to claim 1, wherein the actuation mechanism further comprises a locking protrusion (380) secured to the support (14) and configured to restrict the actuator from moving back from the second track to the first track when in a retracted position after first use.

4. The delivery unit according to claim 1, wherein the engagement member of the rotary member and engagement portion of the actuator are configured such that rotation of the rotary member in a first direction (R+) causes the actuation of the actuator to move the subcutaneous delivery member from the retracted position to the extended position, and such that rotation of the rotary member in a second direction (R−

) causes the actuation portion of the actuator to move the subcutaneous delivery member from the extended position to the retracted position.

5. The delivery unit according to claim 1, wherein the actuation mechanism further comprises a subcutaneous delivery member support unit supporting the subcutaneous delivery member comprising an actuator engagement member and a first guide member, the actuator engagement member configured to be engaged with the actuation portion of the actuator, the first guide member slidably engaged with a second guide member of the support member.

6. The delivery unit according to claim 1, wherein the delivery unit further comprises a pump engine configured to pump a fluid to the subcutaneous delivery member by means of a rotary action, the pump engine being coupled to the rotary member.

7. The delivery unit according to claim 1, wherein the engagement portion of the actuator comprises an extension, the engagement member comprising a first engaging portion configured to engage the extension when the rotary member is rotated in a first direction (R+) and the extension is arranged on a first side of a line (P) between a rotational axis of the rotary member and a pivot axis of the pivot portion in the first position corresponding to the retracted position, and being further configured such that upon further rotation in the first direction, the extension is moved from the first position to the second position corresponding to the extended position, wherein in the second position, the extension is arranged on an opposed second side of said line (P).

8. The delivery unit according to claim 1, wherein the delivery unit further comprises a coupling system having a coupling extension that comprises a bearing surface pivotally supporting a ring of the pivot portion, and an interior reservoir head mounting portion for coupling a reservoir to the delivery unit.

9. The delivery unit according to claim 1, wherein a needle support member and the support member comprise a releasable connection formed by a protrusion engaging in a recess, at least one of the protrusion or recess being elastically deformable or elastically supported, configured for releasably holding the needle support member in the second position.

10. The delivery unit according to claim 1, wherein the actuator comprises spring arms configured to elastically bias against a portion of the support member in the first and second positions.

11. A drug delivery device comprising a re-usable base unit including a pump drive, and a delivery unit according to claim 1, the delivery unit forming a non-reusable or single use disposable part separable from the base unit.

3. A delivery unit of a drug delivery device, the delivery unit comprising a subcutaneous delivery mechanism having a subcutaneous delivery member and a subcutaneous delivery member actuation mechanism being operable to move the subcutaneous delivery member between a retracted position and an extended position, the actuation mechanism comprising a rotary member having an engagement member rotatable relative to a support member, and an actuator comprising a pivot portion and an engagement portion pivotally connected to the support member via the pivot portion, wherein the actuation mechanism is actuated by rotation of the rotary member and wherein the engagement member and engagement portion are configured to engage upon rotation of the rotary member to pivot an actuation portion of the actuator between first and second positions and to thereby move the subcutaneous delivery member between the corresponding retracted and extended positions, wherein the actuation mechanism comprises an elastically deformable member allowing relative elastic movement between the engagement portion of the actuator and the engagement member of the rotary member, and wherein the deformable member is a deformable portion arranged on the actuator and is positioned between the engagement portion and the pivot portion of the actuator.

12. The delivery unit according to claim 3, wherein the engagement member of the rotary member and engagement portion of the actuator are configured such that rotation of the rotary member in a first direction (R+) causes the actuation of the actuator to move the subcutaneous delivery member from the retracted position to the extended position, and such that rotation of the rotary member in a second direction (R−

) causes the actuation portion of the actuator to move the subcutaneous delivery member from the extended position to the retracted position.

13. The delivery unit according to claim 3, wherein the actuation mechanism further comprises a subcutaneous delivery member support unit supporting the subcutaneous delivery member comprising an actuator engagement member and a first guide member, the actuator engagement member configured to be engaged with the actuation portion of the actuator, the first guide member slidably engaged with a second guide member of the support member.

14. The delivery unit according to claim 3, wherein the delivery unit further comprises a pump engine configured to pump a fluid to the subcutaneous delivery member by means of a rotary action, the pump engine being coupled to the rotary member.

15. The delivery unit according to claim 3, wherein the engagement portion of the actuator comprises an extension, the engagement member comprising a first engaging portion configured to engage the extension when the rotary member is rotated in a first direction (R+) and the extension is arranged on a first side of a line (P) between a rotational axis of the rotary member and a pivot axis of the pivot portion in the first position corresponding to the retracted position, and being further configured such that upon further rotation in the first direction, the extension is moved from the first position to the second position corresponding to the extended position, wherein in the second position, the extension is arranged on an opposed second side of said line (P).

16. The delivery unit according to claim 3, wherein the delivery unit further comprises a coupling system having a coupling extension that comprises a bearing surface pivotally supporting a ring of the pivot portion, and an interior reservoir head mounting portion for coupling a reservoir to the delivery unit.

17. The delivery unit according to claim 3, wherein a needle support member and the support comprise a releasable connection formed by a protrusion engaging in a recess, at least one of the protrusion or recess being elastically deformable or elastically supported, configured for releasably holding the needle support member in the second position.

18. The delivery unit according to claim 3, wherein the actuator comprises spring arms configured to elastically bias against a portion of the support member in the first and second positions.

19. A drug delivery device comprising a re-usable base unit including a pump drive, and a delivery unit according to claim 3, the delivery unit forming a non-reusable or single use disposable part separable from the base unit.