Wearable drug delivery device

• US 10,661,015 B2
• Filed: 10/23/2017
• Issued: 05/26/2020
• Est. Priority Date: 10/31/2016
• Status: Active Grant

• Current Assignee: Falco Medical LLC
• Original Assignee: Summit Street Medical, LLC
• Inventors: Rioux, Robert F., Laplaca, Matthew, Grasso, Brian, Bomes, Matt
• Primary Examiner(s): Flick, Jason E
• Application Number:
  US15/790,263
• Publication Number:
  US 20180117251A1
• Time in Patent Office: 946 Days
• Field of Search: 604218
• CPC Class Codes: A61M 2005/2013 triggering of discharging means by contact of injector with patient body
• CPC Class Codes: A61M 2005/206 With automatic needle insertion
• CPC Class Codes: A61M 2005/247 with fixed or steady piercing means, e.g. piercing under movement of ampoule
• CPC Class Codes: A61M 2005/3022 Worn on the body, e.g. as patches pressure infusion of the skin patch type A61M5/14248
• CPC Class Codes: A61M 5/1782 Devices aiding filling of syringes in situ combination of a vial and a syringe for transferring or mixing their contents A61J1/2096, filling of medical containers in general B65B3/003
• CPC Class Codes: A61M 5/2033 Spring-loaded one-shot injectors with or without automatic needle insertion multishot dosing syringes A61M5/31525, needle insertion only A61M5/3287
• CPC Class Codes: A61M 5/204 connected to external reservoirs for multiple refilling
• CPC Class Codes: A61M 5/24 Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic ampoules or carpules A61J1/06
• CPC Class Codes: A61M 5/2466 by piercing without internal pressure increase A61M5/2429 takes precedence
• CPC Class Codes: A61M 5/3135 characterised by constructional features of the proximal end

Abstract

A wearable drug delivery device has a needle assembly and a drug vial arranged side-by-side. This arrangement makes the device compact so that it can be easily worn around a user'"'"'s wrist, for example. When the user triggers the device to inject a dose of medication like epinephrine, in an orchestrated sequence, a first spring drives the needle assembly downward and inserts a needle into the user while connecting the needle assembly to the drug vial. A second spring then delivers the dose from the drug vial through the needle and into the user. Advantageously, the small form factor encourages the user to wear the device and have lifesaving medication at the ready.

Claims

1. A wearable drug delivery device comprising:

a handheld portion, including a proximal end, a distal end, and a longitudinal axis extending between the proximal and distal ends;

a trigger portion in slidable engagement with the distal end of the handheld portion;

a needle assembly disposed within the handheld portion and aligned with the longitudinal axis, the needle assembly being movable towards the distal end of the handheld portion to an extended position by a penetration spring when the penetration spring is activated by the trigger portion sliding towards the proximal end of the handheld portion;

a drug vial disposed within the handheld portion alongside the needle assembly, the drug vial being moveable towards the distal end of the handheld portion to a seated position by a vial spring when the vial spring is activated by the trigger portion sliding towards the proximal end of the handheld portion;

an integral drug delivery port formed at the distal end of the handheld portion and transverse to the longitudinal axis of the handheld portion, wherein the needle assembly in the extended position and the drug vial in the seated position are in fluid communication with each other by way of the integral drug delivery port;

a rotator coupled to the drug vial, the rotator and the drug vial being urged towards the distal end of the handheld portion by the vial spring;

a yoke extending from the distal end of the handheld portion towards the proximal end, the rotator rests on the yoke thereby resisting movement toward the distal end of the handheld portion and moving the drug vial to the seated position; and

wherein the trigger portion includes a trigger blade extending from the trigger portion and through the distal end of the handheld portion, the trigger blade in slidable engagement with the rotator and configured to lift the rotator off the yolk and allow the rotator to move towards the distal end of the handheld portion and move the drug vial to the seated position when the trigger portion slides toward the proximal end of the handheld portion.

2. The wearable drug delivery device of claim 1 wherein the handheld portion includes a concave surface, the concavity of which is defined by a point offset from the longitudinal axis.

3. The wearable drug delivery device of claim 2 wherein the concave surface is configured to conform to a human wrist.

4. The wearable drug delivery device of claim 1 wherein the handheld portion includes a slot;

and

the device further comprising a band received in the slot for wearing the wearable drug delivery device around a part of a user'"'"'s body.

5. The wearable drug delivery device of claim 1 wherein the handheld portion and trigger portion are made from a metal, a plastic or a combination of metal and plastic.

6. The wearable drug delivery device of claim 1 wherein the trigger portion slides over the distal end of the handheld portion.

7. The wearable drug delivery device of claim 1 wherein the trigger portion includes a trigger arm extending from the trigger portion and through the distal end of the handheld portion, the trigger arm configured to release energy stored in the penetration spring when the trigger portion slides toward the proximal end of the handheld portion.

8. The wearable drug delivery device of claim 6 wherein the trigger portion includes two trigger arms.

9. The wearable drug delivery device of claim 1 wherein the trigger blade includes an angled surface to lift and turn the rotator off the yoke.

10. The wearable drug delivery device of claim 1 wherein the trigger portion includes three trigger blades.

11. The wearable drug delivery device of claim 1 wherein the needle assembly further includes a J-shaped needle.

12. The wearable drug delivery device of claim 1 wherein the integral drug delivery port includes a vial needle, an exit, and a channel connecting the vial needle to the exit, the vial needle punctures a vial membrane of the drug vial when the drug vial is in the seated position thereby allowing a drug dose to flow through the channel and out the exit.

13. The wearable drug delivery device of claim 12 wherein the exit is a septum seal that is pierced by the needle assembly when the needle assembly is in the extended position.

14. The wearable drug delivery device of claim 1 further comprising:

a return spring interposed between an exterior surface at the distal end of the handheld portion and an opposing surface on the trigger portion, the return spring providing a force separating the handheld portion from the trigger portion; and

a latch extending from the opposing surface of the trigger portion and releasable engaged with the handheld portion, the latch when engaged resists the force separating the handheld portion from the trigger portion.

15. The wearable drug delivery device of claim 14 wherein the latch is a leaf spring.

16. The wearable drug delivery device of claim 14 wherein the return spring is a torsion spring.

17. The wearable drug delivery device of claim 1 further comprising a safety guard covering the trigger portion and releaseably attached to the handheld portion by any one of an interference fit and a frangible weld joint.

18. The wearable drug delivery device of claim 1 further comprising:

a safety guard covering the trigger portion and releaseably attached to the handheld portion; and

a strip disposed circumferential between the handheld portion and the safety guard, the strip configured to be torn away from the handheld portion and the safety guard thereby allowing the safety guard to be removed from the handheld portion and expose the trigger portion.

19. The wearable drug delivery device of claim 1 wherein the handheld portion further includes an exterior surface parallel to the longitudinal axis, the device further comprising:

a one-way barb projecting from the exterior surface of the handheld portion; and

a snap feature joined to the trigger portion by a virtual hinge, the snap feature slides over the exterior surface of the handheld portion and flexes about the virtual hinge, away from the exterior surface, when the trigger portion slides toward the proximal end of the handheld portion and the snap feature slides over the one-way barb.

20. A wearable drug delivery device comprising:

a handheld portion, including a proximal end, a distal end, and a longitudinal axis extending between the proximal and distal ends;

a trigger portion in slidable engagement with the distal end of the handheld portion;

a needle assembly disposed within the handheld portion and aligned with the longitudinal axis, the needle assembly being movable towards the distal end of the handheld portion to an extended position by a penetration spring when the penetration spring is activated by the trigger portion sliding towards the proximal end of the handheld portion;

a drug vial disposed within the handheld portion alongside the needle assembly, the drug vial being moveable towards the distal end of the handheld portion to a seated position by a vial spring when the vial spring is activated by the trigger portion sliding towards the proximal end of the handheld portion;

an integral drug delivery port formed at the distal end of the handheld portion and transverse to the longitudinal axis of the handheld portion, wherein the needle assembly in the extended position and the drug vial in the seated position are in fluid communication with each other by way of the integral drug delivery port;

a return spring interposed between an exterior surface at the distal end of the handheld portion and an opposing surface on the trigger portion, the return spring providing a force separating the handheld portion from the trigger portion; and

a latch extending from the opposing surface of the trigger portion and releasable engaged with the handheld portion, the latch when engaged resists the force separating the handheld portion from the trigger portion.

21. The wearable drug delivery device of claim 20 wherein the handheld portion includes a concave surface, the concavity of which is defined by a point offset from the longitudinal axis.

22. The wearable drug delivery device of claim 21 wherein the concave surface is configured to conform to a human wrist.

23. The wearable drug delivery device of claim 20 wherein the handheld portion includes a slot;

and

the device further comprising a band received in the slot for wearing the wearable drug delivery device around a part of a user'"'"'s body.

24. The wearable drug delivery device of claim 20 wherein the handheld portion and trigger portion are made from a metal, a plastic or a combination of metal and plastic.

25. The wearable drug delivery device of claim 20 wherein the trigger portion slides over the distal end of the handheld portion.

26. The wearable drug delivery device of claim 20 wherein the trigger portion includes a trigger arm extending from the trigger portion and through the distal end of the handheld portion, the trigger arm configured to release energy stored in the penetration spring when the trigger portion slides toward the proximal end of the handheld portion.

27. The wearable drug delivery device of claim 25 wherein the trigger portion includes two trigger arms.

28. The wearable drug delivery device of claim 20 further comprising:

a rotator coupled to the drug vial, the rotator and the drug vial being urged towards the distal end of the handheld portion by the vial spring;

a yoke extending from the distal end of the handheld portion towards the proximal end, the rotator rests on the yoke thereby resisting movement toward the distal end of the handheld portion and moving the drug vial to the seated position; and

wherein the trigger portion includes a trigger blade extending from the trigger portion and through the distal end of the handheld portion, the trigger blade in slidable engagement with the rotator and configured to lift the rotator off the yolk and allow the rotator to move towards the distal end of the handheld portion and move the drug vial to the seated position when the trigger portion slides toward the proximal end of the and held portion.

29. The wearable drug delivery device of claim 28 wherein the trigger blade includes an angled surface to lift and turn the rotator off the yoke.

30. The wearable drug delivery device of claim 28 wherein the trigger portion includes three trigger blades.

31. The wearable drug delivery device of claim 20 wherein the needle assembly further includes a J-shaped needle.

32. The wearable drug delivery device of claim 20 wherein the integral drug delivery port includes a vial needle, an exit, and a channel connecting the vial needle to the exit, the vial needle punctures a vial membrane of the drug vial when the drug vial is in the seated position thereby allowing a drug dose to flow through the channel and out the exit.

33. The wearable drug delivery device of claim 32 wherein the exit is a septum seal that is pierced by the needle assembly when the needle assembly is in the extended position.

34. The wearable drug delivery device of claim 20 wherein the latch is a leaf spring.

35. The wearable drug delivery device of claim 20 wherein the return spring is a torsion spring.

36. The wearable drug delivery device of claim 20 further comprising a safety guard covering the trigger portion and releaseably attached to the handheld portion by any one of an interference fit and a frangible weld joint.

37. The wearable drug delivery device of claim 20 further comprising:

a safety guard covering the trigger portion and releaseably attached to the handheld portion; and

a strip disposed circumferential between the handheld portion and the safety guard, the strip configured to be torn away from the handheld portion and the safety guard thereby allowing the safety guard to be removed from the handheld portion and expose the trigger portion.

38. The wearable drug delivery device of claim 20 wherein the handheld portion further includes an exterior surface parallel to the longitudinal axis, the claim further comprising:

a one-way barb projecting from the exterior surface of the handheld portion; and

a snap feature joined to the trigger portion by a virtual hinge, the snap feature slides over the exterior surface of the handheld portion and flexes about the virtual hinge, away from the exterior surface, when the trigger portion slides toward the proximal end of the handheld portion and the snap feature slides over the one-way barb.

39. A wearable drug delivery device comprising:

a handheld portion, including a proximal end, a distal end, and a longitudinal axis extending between the proximal and distal ends;

a trigger portion in slidable engagement with the distal end of the handheld portion;

a needle assembly disposed within the handheld portion and aligned with the longitudinal axis, the needle assembly being movable towards the distal end of the handheld portion to an extended position by a penetration spring when the penetration spring is activated by the trigger portion sliding towards the proximal end of the handheld portion;

a drug vial disposed within the handheld portion alongside the needle assembly, the drug vial being moveable towards the distal end of the handheld portion to a seated position by a vial spring when the vial spring is activated by the trigger portion sliding towards the proximal end of the handheld portion; and

an integral drug delivery port formed at the distal end of the handheld portion and transverse to the longitudinal axis of the handheld portion, wherein the needle assembly in the extended position and the drug vial in the seated position are in fluid communication with each other by way of the integral drug delivery port;

wherein the handheld portion further includes an exterior surface parallel to the longitudinal axis, the device further comprising;

a one-way barb projecting from the exterior surface of the handheld portion; and

a snap feature joined to the trigger portion by a virtual hinge, the snap feature slides over the exterior surface of the handheld portion and flexes about the virtual hinge, away from the exterior surface, when the trigger portion slides toward the proximal end of the handheld portion and the snap feature slides over the one-way barb.

40. The wearable drug delivery device of claim 39 wherein the handheld portion includes a concave surface, the concavity of which is defined by a point offset from the longitudinal axis.

41. The wearable drug delivery device of claim 40 wherein the concave surface is configured to conform to a human wrist.

42. The wearable drug delivery device of claim 39 wherein the handheld portion includes a slot;

and

the device further comprising a band received in the slot for wearing the wearable drug delivery device around a part of a user'"'"'s body.

43. The wearable drug delivery device of claim 39 wherein the handheld portion and trigger portion are made from a metal, a plastic or a combination of metal and plastic.

44. The wearable drug delivery device of claim 39 wherein the trigger portion slides over the distal end of the handheld portion.

45. The wearable drug delivery device of claim 39 wherein the trigger portion includes a trigger arm extending from the trigger portion and through the distal end of the handheld portion, the trigger arm configured to release energy stored in the penetration spring when the trigger portion slides toward the proximal end of the handheld portion.

46. The wearable drug delivery device of claim 44 wherein the trigger portion includes two trigger arms.

47. The wearable drug delivery device of claim 39 further comprising:

a rotator coupled to the drug vial, the rotator and the drug vial being urged towards the distal end of the handheld portion by the vial spring;

a yoke extending from the distal end of the handheld portion towards the proximal end, the rotator rests on the yoke thereby resisting movement toward the distal end of the handheld portion and moving the drug vial to the seated position; and

wherein the trigger portion includes a trigger blade extending from the trigger portion and through the distal end of the handheld portion, the trigger blade in slidable engagement with the rotator and configured to lift the rotator off the yolk and allow the rotator to move towards the distal end of the handheld portion and move the drug vial to the seated position when the trigger portion slides toward the proximal end of the and held portion.

48. The wearable drug delivery device of claim 47 wherein the trigger blade includes an angled surface to lift and turn the rotator off the yoke.

49. The wearable drug delivery device of claim 47 wherein the trigger portion includes three trigger blades.

50. The wearable drug delivery device of claim 39 wherein the needle assembly further includes a J-shaped needle.

51. The wearable drug delivery device of claim 39 wherein the integral drug delivery port includes a vial needle, an exit, and a channel connecting the vial needle to the exit, the vial needle punctures a vial membrane of the drug vial when the drug vial is in the seated position thereby allowing a drug dose to flow through the channel and out the exit.

52. The wearable drug delivery device of claim 51 wherein the exit is a septum seal that is pierced by the needle assembly when the needle assembly is in the extended position.

53. The wearable drug delivery device of claim 39 further comprising:

a return spring interposed between an exterior surface at the distal end of the handheld portion and an opposing surface on the trigger portion, the return spring providing a force separating the handheld portion from the trigger portion; and

a latch extending from the opposing surface of the trigger portion and releasable engaged with the handheld portion, the latch when engaged resists the force separating the handheld portion from the trigger portion.

54. The wearable drug delivery device of claim 53 wherein the latch is a leaf spring.

55. The wearable drug delivery device of claim 53 wherein the return spring is a torsion spring.

56. The wearable drug delivery device of claim 39 further comprising a safety guard covering the trigger portion and releaseably attached to the handheld portion by any one of an interference fit and a frangible weld joint.

57. The wearable drug delivery device of claim 39 further comprising:

a safety guard covering the trigger portion and releaseably attached to the handheld portion; and

a strip disposed circumferential between the handheld portion and the safety guard, the strip configured to be torn away from the handheld portion and the safety guard thereby allowing the safety guard to be removed from the handheld portion and expose the trigger portion.