Pressure/force computer controlled drug delivery system and the like

• US 6,200,289 B1
• Filed: 11/30/1998
• Issued: 03/13/2001
• Est. Priority Date: 04/10/1998
• Status: Expired due to Term

• Current Assignee: Milestone Scientific Incorporated
• Original Assignee: Milestone Scientific Incorporated
• Inventors: Brown, Lawrence, Hochman, Mark, Hochman, Claudia, Lockwood, Michelle, Ascione, Angelo, Johnson, Hardie
• Primary Examiner(s): Seidel, Richard K.
• Assistant Examiner(s): Thanh, LoAn H.
• Application Number:
  US09/201,464
• Time in Patent Office: 834 Days
• Field of Search: 604/154-156, 604/67, 604/65, 604/93.01, 604/118, 604/181, 604/183, 604/187, 604/218, 604/232, 604/131, 604/151-152, 128/DIG.12, 128/13
• US Class Current: 604/67
• 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: Y10S 128/12 Pressure infusion

Abstract

An automatic injection device includes a drive mechanism and a sensor used to determine an internal characteristic such as a force or internal pressure generated during an injection process. This characteristic is then used as a control parameter by a microprocessor or controller which generates corresponding commands to the drive mechanism. In a particularly advantageous embodiment, the characteristic is used to calculate an exit pressure at which fluid ejected by the device through an elongated tube. The drive mechanism is then operated in such a manner that the exit pressure is maintained at a predetermined level to insure that a patient does not suffer pain and/or tissue damage.

Claims

1. An electronic device for selectively injecting or withdrawing fluid from a patient'"'"'s body comprising:

a reservoir for injecting or collecting said fluid;

a fluid delivery system having a first end coupled to said reservoir and a second end adapted to be inserted into the patient'"'"'s body;

an electrical drive mechanism arranged and constructed to apply a force within said reservoir in response to commands in one of a first direction in which fluid is injected from said reservoir through said fluid delivery system into the patient and a second direction in which fluid is withdrawn from the patient through said fluid delivery system;

a sensor coupled to one of said reservoir, fluid delivery system and electrical drive mechanism for sensing an internal parameter indicative of a force generated by said drive mechanism and internal resistances within said reservoir and said fluid delivery system to said force; and

a controller coupled to said sensor and said electrical drive mechanism, said controller including a calculator for calculating an entry/exit pressure at said second end as a function of said internal parameter, said controller generating said commands to insure said entry/exit pressure does not exceed a predetermined level.

2. The device of claim 1 wherein said controller includes a comparator that compares said entry/exit pressure to a predetermined threshold.

3. The device of claim 2 wherein said predetermined threshold is selected to correspond to a pressure level within a patient'"'"'s tissue which has been determined to minimize pain and/or tissue damage to said patient.

4. The device of claim 1 further comprising a memory storing physical characteristics of said fluid delivery system and said reservoir, and wherein said calculator is adapted to determine said exit/entry pressure based on said physical characteristics.

5. The device of claim 4 wherein said memory is further adapted to store fluid characteristics of said fluid, and wherein said calculator is adapted to generate said entry/exit pressure based on said fluid characteristics.

6. The device of claim 1 wherein said reservoir and said fluid delivery system are disposable.

7. An injection device for injection of fluids into body tissues comprising:

a fluid reservoir holding a fluid to be injected;

a fluid delivery section having a first end coupled to said fluid reservoir and a second end adapted to be inserted into the body tissues;

a drive mechanism adapted to generate an internal pressure within said fluid reservoir in response to commands to force said fluid to flow through said fluid delivery section and out through said second end, said fluid having an exit pressure at said second end;

an input element for inputting physical characteristics of at least one of said fluid, said fluid reservoir and said fluid delivery section;

a sensor that senses an internal parameter indicative of said internal pressure; and

a controller receiving said physical characteristics and said internal parameter, said controller including a calculator to determine said exit pressure based on said physical characteristics and said internal parameter, said controller generating said commands to insure that said exit pressure does not exceed a predetermined level.

8. The system of claim 7 wherein said controller includes a master microprocessor adapted to manipulate said physical characteristics and a slave microprocessor controlled by said master microprocessor for generating said commands.

9. The system of claim 8 wherein said drive system includes a motor controlled by said slave microprocessor and a coupling connecting said motor to said reservoir.

10. The system of claim 9 wherein said sensor is disposed within said coupling.

11. The system of claim 9 wherein said motor and said slave microprocessor are disposed within a housing.

12. The injection device system of claim 7 further comprising a housing, for the drive mechanism.

13. The system of claim 12 further comprising a mounting section that mounts said reservoir to said housing.

14. The system of claim 13 further comprising a reservoir sensor that senses when said reservoir is in position, said controller generating commands after said reservoir is sensed.

15. The system of claim 12 wherein said reservoir is a syringe having a barrel and a plunger reciprocating within said barrel, and wherein said drive mechanism is coupled to said plunger.

16. The system of claim 12 wherein said reservoir comprises a cartridge having a sidewall and a stopper and wherein said drive mechanism includes an adapter having a member coupled to said stopper.

17. A method injecting fluids into a body tissue comprising:

providing a reservoir filled with a fluid;

forcing said fluid from said reservoir through a fluid delivery system into the body tissue, said fluid having an exit pressure at an interface between said fluid delivery system and the body tissue;

automatically measuring said exit pressure;

monitoring said exit pressure; and

automatically reducing the flow of said fluid when said exit pressure becomes excessive.

18. The method of claim 17 further comprising determining an internal parameter indicative of forces/pressures within said reservoir, and calculating said exit pressure from said internal parameter.

19. The method of claim 17 wherein said fluid flow is restored to a predetermined level after said exit pressure has returned to normal.

20. The method of claim 17 further comprising filling said reservoir with said fluid prior to the injection.

21. An electronic injection device for selectively injecting a fluid comprising:

a fluid source adapted to hold said fluid;

a fluid ejection section having a first end coupled to said fluid source and a second end adapted to eject said fluid;

a drive mechanism coupled to said fluid ejection section and arranged and constructed to cause said fluid to be ejected in response to a command signal;

a sensor coupled to said fluid ejection section for sensing an internal pressure of said fluid within said fluid ejection section; and

a controller coupled to said sensor and said drive mechanism, said controller being adapted to generate said command signal dependent on said internal pressure.

22. The electronic injection device of claim 21 wherein said controller includes a calculator coupled to said sensor and adapted to calculate an exit pressure signal indicative of the exit pressure of said fluid at said second end, said command signal being related to said exit pressure.

23. The electronic injection device of claim 22 wherein said controller includes a comparator adapted to compare said exit pressure, to a predetermined threshold, said controller and said sensor cooperating to ,limit said exit pressure to a level below said predetermined threshold.

24. The electronic injection device of claim 23 wherein said fluid has a density and wherein said calculator is adapted to determine said exit pressure using said density.

25. The electronic injection device of claim 24 said further comprising a data entry section adapted to receive data from an operator indicative of said density.

26. The electronic ejection device of claim 23 wherein said fluid injection section includes a syringe having physical dimensions and wherein said calculator is adapted to determine said exit pressure using said physical dimensions.

27. The electronic ejection device of claim 23 wherein said fluid injection system includes a motor selectively actuated by said command signal, said motor generating a force in response to said command signal, and wherein said calculator is adapted to determine said exit pressure using said force.