Fluid drug delivery device

• US 6,736,796 B2
• Filed: 11/26/2001
• Issued: 05/18/2004
• Est. Priority Date: 11/26/2001
• Status: Expired due to Fees

• Current Assignee: Nili-Med Limited
• Original Assignee: Nili-Med Limited
• Inventors: Shekalim, Avraham
• Primary Examiner(s): Casler, Brian L.
• Assistant Examiner(s): DeSanto, Matthew F
• Application Number:
  US09/991,708
• Publication Number:
  US 20030100863A1
• Time in Patent Office: 904 Days
• Field of Search: 604/30, 604/31, 604/131, 604/132, 604/133, 604/246, 604/247, 604/248, 604/249, 604/250, 604/256, 604/151, 604/134, 604/236, 251/129.06, 251/129.01
• US Class Current: 604/134
• CPC Class Codes: A61M 2205/0294 Piezoelectric materials
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/1454 spring-actuated, e.g. by a clockwork
• CPC Class Codes: A61M 5/1456 with a replaceable reservoir comprising a piston rod to be moved into the reservoir, e.g. the piston rod is part of the removable reservoir
• CPC Class Codes: A61M 5/16854 by monitoring line pressure
• CPC Class Codes: A61M 5/16881 Regulating valves on-off valves, e.g. clamps A61M39/28

Abstract

A portable insulin delivery device that supplies insulin in a pre-pressurized chamber, passes the insulin through a pressure-dropping labyrinth to a flow control valve. The valve is activated by a piezoelectric actuator. This allows for precise insulin delivery. An electronic package provides for programming of basal rates and bolus. A pressure sensor relays data concerning normal operation and pressure changes that indicate problems. The processor, keypad, display, power source, fluid pressure sensor and fluid flow control actuator are housed in a base unit. A removable cartridge unit houses the pre-pressurized fluid reservoir, flow path labyrinth, and flow control valve.

Claims

1. A fluid drug delivery device comprising:

(a) a portable base unit including a processing unit, and an actuator controlled by said processing unit;

(b) a cartridge removably interconnected to said base unit, said cartridge including a fluid supply assembly, a fluid outlet, and a flow control arrangement including a flow control valve, said flow control arrangement controlling flow from said fluid supply assembly to said fluid outlet, wherein said flow control arrangement further includes an elongated pressure reduction passageway; and

(c) at least one pressure sensor interconnected with a first and a second pressure sensing points, said pressure sensing points located at intervals alone said elongated passageway so as to discern a pressure differential between said first and second pressure sensing points,

wherein said flow control valve is operated by force applied to at least one actuation surface provided by said cartridge, said actuation surface being isolated from contact with the fluid, at least part of said actuator being deployable in contact with said actuation surface.

2. The device of claim 1, wherein said portable base unit further includes a retraction mechanism operative to displace said part of said actuator between a deployed position in which said part of said actuator is deployed in contact with said actuation surface and a retracted position in which said part of said actuator is removed from said actuation surface to facilitate interconnection of said cartridge with said base unit and removal of said cartridge from said base unit.

3. The device of claim 2, wherein said retraction mechanism is a manually operable retraction mechanism.

4. The device of claim 2, wherein said retraction mechanism is configured to generate a predefined initial contact pressure between said part of said actuator and said actuation surface.

5. The device of claim 2, wherein said retraction mechanism includes a clutch mechanism deployed to prevent said retraction mechanism from generating an initial contact pressure greater than a predefined maximum initial contact pressure between said part of said actuator and said actuation surface.

6. The device of claim 2, wherein said retraction mechanism includes a switch deployed to detect contact between said part of said actuator and said actuation surface.

7. The device of claim 1, wherein said actuator includes a piezoelectric actuator.

8. The device of claim 1, wherein said fluid supply assembly includes a pressurized chamber containing a quantity of the fluid drug.

9. The device of claim 1, wherein said at least one pressure sensor is electrically associated with said processing unit, said processing unit being responsive to data from said at least one pressure sensor to control said actuator so as to regulate fluid flow to said outlet.

10. The device of claim 1, further comprising an alarm unit associated with said processing unit, wherein said at least one pressure sensor is electrically associated with said processing unit, said processing unit being responsive to data from said at least one pressure sensor to activate said alarm unit on occurrence of at least one predetermined alarm condition.

11. The device of claim 1, wherein said base unit further includes a display and an input keypad both associated with said processing unit.

12. The device of claim 1, wherein said base unit further includes a power source, said processing unit being powered by said power source.