Moving basal engine for a fluid delivery device

• US 9,814,831 B2
• Filed: 01/28/2015
• Issued: 11/14/2017
• Est. Priority Date: 01/31/2014
• Status: Active Grant

• Current Assignee: Mannkind Corporation
• Original Assignee: Valeritas, Inc. (Zealand Pharma A/S)
• Inventors: Gonnelli, Robert R.
• Primary Examiner(s): Hayman, Imani
• Assistant Examiner(s): Ponton, James D
• Application Number:
  US15/106,853
• Publication Number:
  US 20170000942A1
• Time in Patent Office: 1,021 Days
• CPC Class Codes: A61M 2005/1405 Patient controlled analgesia [PCA]
• CPC Class Codes: A61M 2005/14204 with gas-producing electrochemical cell
• 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 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/14248 of the skin patch type
• 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 5/1454 spring-actuated, e.g. by a clockwork
• CPC Class Codes: A61M 5/31526 by means of stepwise axial movements, e.g. ratchet mechanisms or detents
• CPC Class Codes: A61M 5/31533 Dosing mechanisms, i.e. setting a dose administrating mechanisms A61M5/31565
• CPC Class Codes: A61M 5/31578 based on axial translation, i.e. components directly operatively associated and axially moved with plunger rod
• CPC Class Codes: A61M 5/3159 Dose expelling manners

Abstract

A fluid delivery device comprises a fluid reservoir for containing medicament. The fluid reservoir is sealed proximate one end with a sliding seal piston. A delivery path is configured to fluidly couple the fluid reservoir and a patient wearing the fluid delivery device. A basal engine mechanism is configured to directly or indirectly move the sliding seal piston in the fluid reservoir at a controlled basal rate. A bolus mechanism configured to move the basal engine relative to the fluid reservoir and directly or indirectly move the sliding seal piston in the fluid reservoir a discrete bolus amount at a time.

Claims

1. A fluid delivery device comprising:

a housing including a fluid reservoir for containing medicament, the fluid reservoir being sealed proximate one end with a sliding seal piston;

a delivery path configured to fluidly couple the fluid reservoir and a patient wearing the fluid delivery device;

a basal actuator slidingly coupled to an inside surface of the fluid reservoir and configured to directly or indirectly move the sliding seal piston in the fluid reservoir at a controlled basal rate; and

a bolus actuator coupled to a proximal end of the basal actuator and configured to move the basal actuator relative to the fluid reservoir and move the sliding seal piston in the fluid reservoir a discrete bolus amount at a time,

wherein the basal actuator is contained within the bolus actuator, and

wherein the basal actuator includes a reservoir containing a hydraulic fluid under pressure from a stored energy source, the reservoir of the basal actuator including an aperture configured to release the hydraulic fluid at a rate determined by the force of the stored energy source, the viscosity of the hydraulic fluid and the geometry of the aperture.

2. The fluid delivery device of claim 1, wherein the hydraulic fluid that is released by the reservoir of the basal actuator presses on the sliding seal piston.

3. The fluid delivery device of claim 1, wherein the stored energy source includes one or more springs.

4. The fluid delivery device of claim 1, wherein the stored energy source includes a compressed gas or a combustible material to create a compressed gas.

5. The fluid delivery device of claim 1, wherein the basal actuator includes an electrochemical device that expands in at least one dimension while being charged or discharged.

6. The fluid delivery device of claim 5, wherein the electrochemical device is connected to a circuit to control the charge or discharge rate.

7. The fluid delivery device of claim 5, wherein the electrochemical device is connected to a circuit for user interface and device function,

wherein the circuit is powered by the discharge of the electrochemical device.

8. The fluid delivery device of claim 1, wherein the sliding seal piston is in contact with the basal actuator and the medicament.

9. The fluid delivery device of claim 1, wherein the basal actuator includes the sliding seal piston.

10. The fluid delivery device of claim 1, wherein the basal actuator includes a sliding seal, the sliding seal being in contact with the hydraulic fluid that is in contact with the sliding seal piston.

11. The fluid delivery device of claim 1, wherein the housing includes an adhesive patch configured to be adhered to a skin surface of a patient.

12. The fluid delivery device of claim 1, wherein the delivery path includes a needle.

13. The fluid delivery device of claim 1, wherein the bolus actuator includes a plunger.

14. The fluid delivery device of claim 13, wherein the plunger includes a rack coupled to a pawl.

15. A method of using a fluid delivery device having a housing including a fluid reservoir configured to contain medicament, the fluid reservoir being sealed proximate one end with a sliding seal piston, a delivery path configured to fluidly couple the fluid reservoir and a patient wearing the fluid delivery device, a basal actuator within the housing and including an electrochemical device, and a bolus actuator coupled to a proximal end of the basal actuator, the method comprising the steps of:

expanding the electrochemical device by charging or discharging the electrochemical device to move the sliding seal piston in the fluid reservoir at a controlled basal rate; and

selectively sliding the basal actuator relative to the fluid reservoir and the housing to move the sliding seal piston in the fluid reservoir a discrete bolus amount at a time.