Hydraulically actuated pump for long duration medicament administration

• US 9,072,828 B2
• Filed: 12/16/2008
• Issued: 07/07/2015
• Est. Priority Date: 04/23/2003
• Status: Active Grant

• Current Assignee: Mannkind Corporation
• Original Assignee: Valeritas, Inc. (Zealand Pharma A/S)
• Inventors: Gonnelli, Robert R., McAllister, Devin V., Levesque, Steven F.
• Primary Examiner(s): GILBERT, ANDREW M
• Application Number:
  US12/336,395
• Publication Number:
  US 20090157005A1
• Time in Patent Office: 2,394 Days
• Field of Search: 604/131, 604/151, 604/891.1, 604/133, 604/132, 417/385, 417/390
• US Class Current: 1/1
• CPC Class Codes: A61M 2005/14264 with means for compensating influence from the environment
• CPC Class Codes: A61M 2005/14506 mechanically driven, e.g. spring or clockwork
• CPC Class Codes: A61M 2005/14513 with secondary fluid driving or regulating the infusion
• CPC Class Codes: A61M 2037/0023 Drug applicators using microneedles
• CPC Class Codes: A61M 2037/0038 having a channel at the side surface
• CPC Class Codes: A61M 2037/0046 Solid microneedles
• CPC Class Codes: A61M 2250/00 Specially adapted for animals
• CPC Class Codes: A61M 37/0015 by using microneedles
• CPC Class Codes: A61M 5/1452 pressurised by means of pistons
• CPC Class Codes: A61M 5/14526 the piston being actuated by fluid pressure
• CPC Class Codes: A61M 5/14593 the diaphragm being actuated by fluid pressure
• CPC Class Codes: A61M 5/155 pressurised by gas introduced into the reservoir
• CPC Class Codes: A61M 5/16877 Adjusting flow; Devices for setting a flow rate
• CPC Class Codes: A61M 60/405 the force acting on the blood contacting member being hydraulic or pneumatic
• CPC Class Codes: F04B 15/02 the fluids being viscous or non-homogeneous
• CPC Class Codes: F04B 53/14 Pistons, piston-rods or piston-rod connections
• CPC Class Codes: F04B 53/16 Casings; Cylinders; Cylinder liners or heads; Fluid connections
• CPC Class Codes: F04B 9/103 having only one pumping chamber
• CPC Class Codes: F04B 9/1095 having two or more pumping chambers in series

Abstract

Presently disclosed is a hydraulic pump device and its use thereof, especially in a fluid delivery system. In one embodiment, the fluid delivery system is an inexpensive, single-use device for slow dosing medicament applications. The fluid delivery system may employ a spring-compressed bellows crank or other combination of simple mechanisms operating according to the well-known peristaltic principle to force a volume of ultrapure bio-inert hydraulic fluid through an aperture, thereby expanding one chamber of a two chamber hydraulic cylinder. The second, fluid storage chamber, containing the medicament, is emptied through a conventional orifice in response to the expansion of the pump chamber. The medicament may then flow through any suitable infusion set into a patient removeably attached thereto.

Claims

1. A fluid delivery device comprising:

a hydraulic housing having a piston configured to sealingly slide along an inner wall of the hydraulic housing and separate the hydraulic housing into a hydraulic pump chamber and a fluid reservoir, the hydraulic pump chamber having a viscous hydraulic fluid and configured to urge the piston along the inner wall to deliver a fluid in the fluid reservoir to a patient, a viscosity of the hydraulic fluid being at least about ISO VG 1000 or more;

a first actuator;

a first hydraulic reservoir chamber having the hydraulic fluid and coupled between the first actuator and the hydraulic pump chamber, the first actuator being configured to urge the hydraulic fluid in the first hydraulic reservoir chamber into the hydraulic pump chamber;

a flow restrictor fluidly coupling the first hydraulic reservoir chamber and the hydraulic pump chamber;

a second hydraulic reservoir chamber having the hydraulic fluid and fluidly coupled with the hydraulic pump chamber; and

a second actuator configured to urge the hydraulic fluid from the second hydraulic reservoir chamber into the hydraulic pump chamber, independent of the first actuator.

2. The fluid delivery device of claim 1, wherein any insoluble impurity particles in the hydraulic fluid have a maximum diameter of 1 mm or less.

3. The fluid delivery device of claim 1, wherein any insoluble impurity particles in the hydraulic fluid have a maximum diameter of 500 nm or less.

4. The fluid delivery device of claim 1, wherein any insoluble impurity particles in the hydraulic fluid have a maximum diameter of 100 nm or less.

5. The fluid delivery device of claim 1, wherein any insoluble impurity particles in the hydraulic fluid comprise less than 0.1% of a total volume of the hydraulic fluid.

6. The fluid delivery device of claim 1, wherein any insoluble impurity particles in the hydraulic fluid comprise less than 0.01% of a total volume of the hydraulic fluid.

7. The fluid delivery device of claim 1, wherein any insoluble impurity particles in the hydraulic fluid comprise less than 0.001% of a total volume of the hydraulic fluid.

8. The fluid delivery device of claim 1, wherein the flow restrictor and the first actuator are configured to transfer the hydraulic fluid from the first hydraulic reservoir chamber to the hydraulic pump chamber to deliver the fluid from the fluid reservoir at a sustained basal rate.

9. The fluid delivery device of claim 1, wherein the first actuator includes one or more springs.

10. The fluid delivery device of claim 1 further comprising the fluid in the fluid reservoir, wherein the fluid comprises insulin.

11. The fluid delivery device of claim 8, wherein the sustained basal rate is constant.

12. The fluid delivery device of claim 8, wherein the sustained basal rate is over a period of more than 5 hours.

13. The fluid delivery device of claim 8, wherein the sustained basal rate is over a period of approximately 24 hours.

14. The fluid delivery device of claim 1, wherein the hydraulic fluid has a viscosity of approximately ISO VG 1500 or more when in use.

15. The fluid delivery device of claim 1, further comprising a moveable piston separating the hydraulic pump chamber and the second actuator.

16. The fluid delivery device of claim 1, wherein the hydraulic pump chamber and the fluid reservoir are comprised of a polymer.

17. The fluid delivery device of claim 1, wherein any insoluble impurity particles in the hydraulic fluid each have a maximum diameter that is smaller than a diameter of the flow restrictor.

18. The fluid delivery device of claim 1, wherein the first actuator is purely mechanical.

19. The fluid delivery device of claim 18, wherein the first actuator includes two springs.

20. The fluid delivery device of claim 1, wherein the second hydraulic reservoir is positioned between the second actuator and the hydraulic pump chamber.

21. The fluid delivery device of claim 1, wherein the flow restrictor is a fixed aperture.

22. The fluid delivery device of claim 1, wherein the piston is a single piston that contacts the fluid in the fluid reservoir on one side and the hydraulic fluid on another side.

23. A fluid delivery device comprising:

a hydraulic housing having a piston configured to sealingly slide along an inner wall of the hydraulic housing and separate the hydraulic housing into a hydraulic pump chamber and a fluid reservoir, the hydraulic pump chamber having a hydraulic fluid, a viscosity of the hydraulic fluid being at least about ISO VG 1000 or more, the hydraulic pump chamber being configured to urge the piston along the inner wall to deliver a fluid in the fluid reservoir to a patient;

a first hydraulic reservoir chamber having the hydraulic fluid;

a fixed aperture flow restrictor fluidly coupling the first hydraulic reservoir chamber and the hydraulic pump chamber, the fixed aperture flow restrictor configured to control the rate the hydraulic fluid flows between the first hydraulic reservoir chamber and the hydraulic pump chamber;

a first actuator coupled to the first hydraulic reservoir chamber and configured to continuously deliver the hydraulic fluid from the first hydraulic reservoir chamber to the hydraulic pump chamber for a period of time;

a second hydraulic reservoir chamber fluidly coupled to the hydraulic pump chamber, independent of the first hydraulic reservoir chamber; and

a second actuator coupled to the second hydraulic reservoir chamber and operable independent of the first actuator and at discrete intervals during the period of time to periodically deliver the hydraulic fluid from the second hydraulic reservoir chamber to the hydraulic pump chamber independent of and in addition to the continuous delivery of the hydraulic fluid from the first hydraulic reservoir chamber.