Fluid delivery device needle retraction mechanisms, cartridges and expandable hydraulic fluid seals

• US 8,740,847 B2
• Filed: 06/09/2011
• Issued: 06/03/2014
• Est. Priority Date: 06/09/2010
• Status: Active Grant

• Current Assignee: Mannkind Corporation
• Original Assignee: Valeritas, Inc. (Zealand Pharma A/S)
• Inventors: Levesque, Steven F., Standley, Robert L., Jenkins, Geoffrey H., Johnson, Matthew P., Dube, Daniel A. Jr.
• Primary Examiner(s): FLICK, JASON E
• Application Number:
  US13/156,839
• Publication Number:
  US 20110306929A1
• Time in Patent Office: 1,090 Days
• Field of Search: 604/150
• US Class Current: 604/150
• CPC Class Codes: A61M 2005/14252 with needle insertion means
• CPC Class Codes: A61M 2005/14256 with means for preventing access to the needle after use
• CPC Class Codes: A61M 2005/1586 Holding accessories for holding infusion needles on the body holding devices for catheters A61M25/02
• CPC Class Codes: A61M 2005/3123 having air entrapping or venting means, e.g. purging channels in pistons
• CPC Class Codes: A61M 2005/3128 Incorporating one-way valves, e.g. pressure-relief or non-return valves
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/14526 the piston being actuated by fluid pressure
• CPC Class Codes: A61M 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
• CPC Class Codes: A61M 5/1684 by detecting the amount of infusate remaining, e.g. signalling end of infusion
• CPC Class Codes: A61M 5/322 Retractable needles, i.e. disconnected from and withdrawn into the syringe barrel by the piston devices for protecting guide needles in combination with catheters A61M25/0612
• CPC Class Codes: A61M 5/3232 Semi-automatic needle retraction, i.e. in which triggering of the needle retraction requires a deliberate action by the user, e.g. manual release of spring-biased retraction means
• CPC Class Codes: A61M 5/3234 Fully automatic needle retraction, i.e. in which triggering of the needle does not require a deliberate action by the user

Abstract

A fluid delivery device includes an automatic needle retraction mechanism configured to automatically retract a delivery end of a needle into a housing. In one embodiment, the needle assembly is configured to automatically withdraw the delivery end of the needle into the housing upon an actuator moving from the first position to the second position. In one embodiment, the needle assembly is configured to automatically withdraw the delivery end of the needle into the housing upon decoupling a bottom surface of the housing from a skin surface.

Claims

1. A fluid delivery device comprising:

a housing having a first hydraulic chamber and a second hydraulic chamber;

a flow restrictor fluidly coupling the first hydraulic chamber and the second hydraulic chamber;

a cartridge having a container forming a fluid reservoir sealed at a proximal end with a piston, the cartridge being insertable into the housing to couple the piston with the second hydraulic chamber, the fluid reservoir being substantially filled with a liquid and the second hydraulic chamber being filled with a hydraulic fluid prior to inserting the cartridge within the housing, the cartridge including a septum configured to be pierced by a delivery needle; and

an actuator coupled to the housing and configured to deliver a force to the piston through the first and second hydraulic chambers.

2. The fluid delivery device of claim 1, further comprising a cartridge seal coupled between the proximal end of the cartridge and the housing when the cartridge is inserted into the housing.

3. The fluid delivery device of claim 2, wherein the cartridge seal is compressible.

4. The fluid delivery device of claim 2 further comprising:

a hydraulic cap covering an end of the second hydraulic chamber, the hydraulic cap extending through the cartridge seal and coupling the piston and the second hydraulic chamber.

5. The fluid delivery device of claim 4, wherein the hydraulic cap is substantially rigid.

6. The fluid delivery device of claim 2, wherein the proximal end of the cartridge includes an overflow channel in fluid communication with the second hydraulic chamber when the cartridge is inserted into the housing.

7. The fluid delivery device of claim 6, wherein the overflow channel is formed between an outer peripheral edge of the proximal end of the cartridge and an inner peripheral edge of the proximal end of the cartridge, the outer peripheral edge extending axially further from the cartridge than the inner peripheral edge.

8. The fluid delivery device of claim 2, wherein the cartridge seal covers an end of the second hydraulic reservoir prior to inserting the cartridge into the housing and the cartridge seal is pierced upon insertion of the cartridge into the housing.

9. The fluid delivery device of claim 8, wherein the second hydraulic reservoir includes a piercing member configured to pierce the cartridge seal upon insertion of the cartridge into the housing.

10. The fluid delivery device of claim 9, wherein the piercing member includes a needle.

11. The fluid delivery device of claim 1, wherein the septum is slideably coupled with the container.

12. The fluid delivery device of claim 11, wherein the septum is configured to slide distally with respect to the container upon inserting the cartridge into the housing.

13. The cartridge of claim 11, wherein the septum includes a space for receiving an end of the delivery needle and a fluid passageway fluidly coupling the space and the fluid reservoir, the fluid passageway having a cross sectional area that is less than a cross sectional area of the space.

14. The cartridge of claim 11, wherein the septum seals a distal end of the container.

15. The cartridge of claim 11, wherein the septum is displaced with respect to the container when the septum is displaced upon inserting the cartridge into the housing.

16. The fluid delivery device of claim 1, wherein the second hydraulic chamber is configured to expel hydraulic fluid upon insertion of the cartridge into the housing.

17. The fluid delivery device of claim 1, wherein the cartridge further comprises a relief valve, the piston configured to expel air and/or fluid through the relief valve upon insertion of the cartridge into the housing.

18. The fluid delivery device of claim 1, wherein the cartridge further comprises a relief piston configured to slide distally upon insertion of the cartridge into the housing.

19. The fluid delivery device of claim 1 further comprising:

a cap coupling the piston and the second hydraulic reservoir when the cartridge is inserted into the housing, the cap having a side wall and at least one of a top surface or a bottom surface that extends axially outwardly from the side wall, at least one of the top surface or the bottom surface being configured to invert upon inserting the cartridge into the housing.

20. The fluid delivery device of claim 1, wherein the cartridge includes a volume and a pressure, the volume being reduceable to enable insertion of the cartridge into the housing prior to engagement with the delivery needle and without changing the pressure.

21. The fluid delivery device of claim 1, wherein the cartridge includes an pre-insertion pressure prior to inserting the cartridge into the housing and an assembled pressure after the cartridge has been inserted into the housing and prior to engagement with the delivery needle, the pre-insertion pressure being generally equal to the assembled pressure.

22. The fluid delivery device of claim 1, wherein there is substantially no air between the second hydraulic chamber and the septum after the cartridge has been inserted into the housing.

23. A fluid delivery device comprising:

a housing having a first hydraulic chamber and a second hydraulic chamber;

a flow restrictor fluidly coupling the first hydraulic chamber and a second hydraulic chamber;

a cartridge forming a fluid reservoir between a slideable piston and a septum configured to receive a delivery needle, the cartridge including a stopper configured to seal a distal end of the cartridge after the fluid reservoir is substantially filled with a liquid, the piston being coupled with the second hydraulic chamber; and

an actuator coupled to the housing and configured to deliver a force to the piston through the first and second hydraulic chambers.

24. The fluid delivery device of claim 23, wherein the delivery needle is configured to pierce the septum in a direction generally perpendicular to a direction the stopper is inserted in the distal end of the cartridge.

25. A fluid delivery device comprising:

a housing having a first hydraulic chamber and a second hydraulic chamber;

a flow restrictor fluidly coupling the first hydraulic chamber and a second hydraulic chamber;

a fluid reservoir having a piston;

a seal sealing an end of the second hydraulic chamber and configured to couple with the piston, the seal being expandable between a compressed position and an expanded position; and

an actuator coupled to the first hydraulic chamber and configured to expand the seal, move the piston and deliver a force to the fluid reservoir through the first and second hydraulic chambers.

26. The fluid delivery device of claim 25, wherein the cross sectional area of a distal end of the seal is smaller than the cross sectional area of a proximal end of the seal in the expanded position.

27. The fluid delivery device of claim 26, wherein the seal includes at least two telescoping members.

28. The fluid delivery device of claim 26, wherein the seal includes at least two cylindrical members having different diameters.

29. The fluid delivery device of claim 26, wherein the seal is generally conically shaped in the expanded position.

30. The fluid delivery device of claim 25, wherein the fluid reservoir is a prefilled cylindrical cartridge that is insertable into the housing.