Fluid drug delivery device

• US 20030100863A1
• Filed: 11/26/2001
• Published: 05/29/2003
• Est. Priority Date: 11/26/2001
• Status: Active Grant

• Current Assignee: Nili-Med Limited
• Original Assignee: Nili-Med Limited
• Inventors: Shekalim, Avraham
• Granted Patent: US 6,736,796 B2
• Time in Patent Office: Days
• US Class Current: 604/141
• 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 fluid supply assembly having a chamber, a piston, and a spring element, said piston deployed within said chamber so as to define a fluid containment volume within said chamber, said spring element deployed so as to bias said piston toward said fluid containment volume so as to pressurize an amount of the fluid drug supplied within said fluid containment volume, said containment volume having a supply outlet;

(b) a pressure regulator having a fluid inlet in fluid communication with said fluid supply assembly, said pressure regulator also having a fluid outlet; and

(c) a flow control assembly in fluid communication with said pressure regulator fluid outlet.

2. The fluid drug delivery device of claim 1, wherein said flow control assembly includes:

(a) a flow control valve interconnected with said fluid outlet;

(b) a flow actuator deployed so as to regulate said flow control valve thereby varying amounts of fluid flowing through said flow control valve;

(c) a positioning component deployed so as to properly position said flow control valve actuator in relationship to said flow control valve; and

(d) a processing unit electronically interconnected with a pressure sensor and said flow actuator, said processing unit configured so as to use data from said pressure sensor to determine activation of said flow actuator.

3. The fluid drug delivery device of claim 2, wherein said pressure regulator includes an elongated pressure reduction passageway configured so as to reduce said pressure in the fluid thereby creating a pressure differential between said fluid inlet and said fluid outlet.

4. The fluid drug delivery device of claim 3, wherein at least one pressure sensor is interconnected with at least a first and a second pressure sensing points, said pressure sensing points being located at intervals along said flow reduction passage.

5. The fluid drug delivery device of claim 2, wherein said flow actuator includes a piezoelectric actuator.

6. The fluid drug delivery device of claim 2, wherein said positioning component includes a rotatable adjustment shaft manually rotated by a thumb-wheel, said shaft and said thumb-wheel being connected by way of an over-running clutch mechanism configured to allow said thumb-wheel to continue turning while discontinuing rotation of said shaft when said flow actuator is properly positioned in relationship to said flow control valve.

7. The fluid drug delivery device of claim 2, wherein said processing unit is further interconnected to an alarm unit, said processing unit using data from said pressure sensor to determine activation of said alarm unit.

8. The fluid drug delivery device of claim 2, wherein said flow actuator, said manual positioning component, said pressure sensor, and said processing unit are housed in a base unit further including a processing unit display, a processing unit input keypad, and a power supply.

9. The fluid drug delivery device of claim 8, wherein said fluid supply assembly, said flow reduction passage, and said flow control valve, are housed in a removable cartridge unit.

10. A fluid drug delivery device comprising:

(a) a fluid supply assembly;

(b) an elongated pressure reduction passageway having a fluid inlet in fluid communication with said fluid supply assembly, and a fluid outlet, said elongated passageway configured so as to reduce pressure in the fluid thereby creating a pressure differential between said fluid inlet and said fluid outlet;

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

(d) a flow control assembly responsive to said pressure sensor and controlled in response to said pressure differential.

11. The fluid drug delivery device of claim 10, wherein said flow control assembly includes:

(a) a flow control valve interconnected with said fluid outlet;

(b) a flow actuator deployed so as to regulate said flow control valve thereby varying amounts of fluid flowing through said flow control valve;

(c) a positioning component deployed so as to properly position said flow control valve actuator in relationship to said flow control valve; and

(d) a processing unit electronically interconnected with a pressure sensor and said flow control valve actuator, said processing unit configured so as to use data from said pressure sensor to determine activation of said flow control valve actuator.

12. The fluid drug delivery device of claim 11, wherein said flow actuator includes a piezoelectric actuator.

13. The fluid drug delivery device of claim 11, wherein said positioning component includes a rotatable adjustment shaft manually rotated by a thumb-wheel, said shaft and said thumb-wheel being connected by way of an over-running clutch mechanism configured to allow said thumb-wheel to continue turning while discontinuing rotation of said shaft when said flow control valve actuator is properly positioned in relationship to said flow control valve.

14. The fluid drug delivery device of claim 11, wherein said processing unit is further interconnected to an alarm unit, said processing unit using data from said pressure sensor to determine activation of said alarm unit.

15. The fluid drug delivery device of claim 11, wherein said, flow actuator, said manual positioning component, said pressure sensor, and said processing unit are housed in a base unit further including a processing unit display, processing unit input keypad, and a power supply.

16. The fluid drug delivery device of claim 15, wherein said fluid supply assembly, said flow reduction passage, and said flow control valve, are housed in a removable cartridge unit.

17. A fluid drug delivery device comprising:

(a) a fluid supply assembly;

(b) a pressure reduction passage having a fluid inlet in fluid communication with said fluid supply assembly, said flow passage also having a fluid outlet;

(c) a flow control valve interconnected to said fluid outlet; and

(d) a piezoelectric actuator deployed so as to regulated said flow control valve thereby varying the amount of fluid flowing through said flow control valve.

18. The fluid drug delivery device of claim 17, further comprising:

(a) a positioning component deployed so as to position said flow control valve actuator in a predefined spatial relationship to said flow control valve; and

(b) a processing unit electronically interconnected with a pressure sensor and said flow control valve actuator, said processing unit configured so as to use data from said pressure sensor to determine activation of said flow control valve actuator.

19. The fluid drug delivery device of claim 18, wherein said positioning component includes a rotatable adjustment shaft manually rotated by a thumb-wheel, said shaft and said thumb-wheel being connected by way of an over-running clutch mechanism configured to allow said thumb-wheel to continue turning while discontinuing rotation of said shaft when said flow control valve actuator is properly positioned in relationship to said flow control valve.

20. The fluid drug delivery device of claim 18, wherein said processing unit is further interconnected to an alarm unit, said processing unit using data from said pressure sensor to determine activation of said alarm unit.

21. The fluid drug delivery device of claim 18, wherein said, flow actuator, said manual positioning component, said pressure sensor, and said processing unit are housed in a base unit further including a processing unit display, processing unit input keypad, and a power supply.

22. The fluid drug delivery device of claim 21, wherein said fluid supply assembly, said flow reduction passage, and said flow control valve, are housed in a removable cartridge unit.

23. A fluid drug delivery device comprising:

(a) a portable base unit including, a flow actuator, a manual positioning component, at least one pressure sensor, a processing unit, a display, keypad and a power source for said processing unit are housed in a base unit; and

(b) a cartridge unit that is removably interconnected to said base unit, said cartridge including a fluid supply assembly, a pressure reduction passage, and a flow control valve, said fluid supply assembly providing a pre-pressurized chamber containing a quantity of fluid drug.

24. The fluid drug delivery device of claim 23, wherein said flow actuator includes a piezoelectric actuator deployed so as to regulate said flow control valve thereby varying the amount of fluid flowing through said flow control valve.

25. The fluid drug delivery device of claim 23, wherein said manual positioning component includes a rotatable adjustment shaft manually rotated by a thumb-wheel, said shaft and said thumb-wheel being connected by way of an over-running clutch mechanism configured to allow said thumb-wheel to continue turning while discontinuing rotation of said shaft when said flow control valve actuator is properly positioned in relationship to said flow control valve.

26. The fluid drug delivery device of claim 23, wherein said processing unit is electronically interconnected with said pressure sensor and said piezoelectric actuator, said processing unit configured so as to use data from said pressure sensor to determine activation of said piezoelectric actuator.

27. The fluid drug delivery device of claim 23, wherein said pre-pressurized chamber is accomplished by use of a piston deployed within said chamber so as to define a fluid containment volume within said chamber, a spring element deployed so as press said piston into said fluid containment volume so as to pressurize said quantity of fluid drug supplied within said fluid containment volume.

28. The fluid drug delivery device of claim 23, wherein said pressure reduction passage is an elongated passageway interconnected to said fluid supply assembly, said elongated passageway having a fluid inlet and a fluid outlet, said elongated passageway configured so as to reduce said pressure in the fluid thereby creating a pressure differential between said fluid inlet and said fluid outlet.