Drug infusion device with tissue identification using pressure sensing

• US 7,449,008 B2
• Filed: 04/20/2004
• Issued: 11/11/2008
• Est. Priority Date: 04/10/1998
• Status: Expired due to Term

• Current Assignee: Milestone Scientific Incorporated
• Original Assignee: Milestone Scientific Incorporated
• Inventors: Hochman, Mark N.
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): Koharski; Christopher D
• Application Number:
  US10/827,969
• Publication Number:
  US 20050004514A1
• Time in Patent Office: 1,666 Days
• Field of Search: 604/66, 604/67, 604/65, 604/123, 604/151, 604/118, 604/183, 604/218, 604/232, 604/152, 604/500, 604/154, 604/155, 600/561, 600/562
• US Class Current: 604/67
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61M 2205/3344 Measuring or controlling pressure at the body treatment site
• 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

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 to determine the exit pressure of the fluid expelled by the device. This exit pressure is then used to identify the kind of tissue in which the injection is being introduced.

Claims

1. An apparatus comprising:

a housing;

a pumping mechanism in said housing;

a fluid container coupled to said housing and activated by said pumping mechanism to pump a drug fluid, said drug fluid exiting at a dynamic exit fluid pressure, said fluid container including injection means for administering the drug fluid at an exit fluid pressure to a patient tissue type for receiving the drug fluid;

a sensor arranged for determining said exit fluid pressure based on a measured parameter of at least one of said pumping mechanism and said fluid container; and

a controller for receiving said dynamic exit fluid pressure and having at least one memory data bank and at least one microprocessor, said memory data bank storing a plurality of known interstitial fluid pressures corresponding to different patient tissue types, the memory data bank also storing the measured parameter, said microprocessor generating an output based on the measured parameter and the patient tissue type for receiving said drug fluid and for correlating said exit fluid pressure to one of said known interstitial fluid pressures.

2. The apparatus of claim 1 further comprising:

a pressure sensor for sensing a pressure within said pumping mechanism and a calculator for receiving said pressure within said pumping mechanism, and for deriving said exit fluid pressure.

3. The apparatus of claim 1 further comprising:

said memory data bank containing information correlating exit fluid pressures to tissue types, wherein said controller receives said exit fluid pressure, compares said exit fluid pressure to said information and generates said output in accordance with said information, the tissue types being selected from the group consisting of;

low density loosely organized connective tissue matrix interposed with adipose tissue, intercellular fluids and organized collagen fibers;

medium density packed collagen fiber bundles interposed with glandular tissues and/or adipose tissue;

muscular tissue;

high density tissue composed of predominately dense highly organized collagen fiber matrixes; and

mineralized tissue.

4. An apparatus comprising:

a pumping mechanism;

a fluid container coupled to said pumping mechanism to pump a drug fluid, said fluid exiting at a dynamic exit fluid pressure into a selected biological tissue type;

a sensor arranged to enable sensing and identification of specific biological tissue types based on the exit fluid pressures; and

a controller for receiving said dynamic exit fluid pressure and having at least one memory data bank and at least one microprocessor, said memory data bank storing a plurality of known interstitial fluid pressures corresponding to different biological tissue types, the memory data bank also storing measured parameters of at least one of said pumping mechanism and said fluid container, said microprocessor generating an output based on the measured parameter and the biological tissue type and for correlating said exit fluid pressure to one of said known interstitial fluid pressures.

5. The apparatus of claim 4;

wherein said pumping mechanism includes;

a container holding said drug fluid, a plunger reciprocating within said container and a motor responsive to signals from said controller and driving said plunger.

6. The apparatus of claim 5;

wherein said sensor is disposed between said motor and said plunger to sense a force applied to said plunger.

7. The apparatus of claim 5;

wherein said pumping mechanism includes;

a flexible tubing leading said drug fluid to the biological tissue, and wherein said sensor is coupled to said flexible tubing.

8. The apparatus of claim 7;

wherein said sensor includes;

a size sensor sensing a dimension of said tubing.

9. The apparatus of claim 8;

wherein said sensor includes;

a light source and a light sensor, said light sensor generating an output indicative of an internal pressure within the tubing.

10. The apparatus of claim 7;

wherein said tubing expands and contracts radially in response to the exit fluid pressure; and

wherein said sensor includes;

a tubing holder holding at least a portion of said tubing in a preselected position and a force sensor activated by said portion within said holder.

11. The apparatus of claim 10;

wherein said holder includes;

a base with a slot holding the tubing portion, a cover folded over said base and holding said tubing in said trough.

12. The apparatus of claim 11;

wherein said holder includes;

a base, a floating plate resting on said base, and a cover holding said tubing portion with said floating plate.

13. The apparatus of claim 12 further comprising:

a force sensor for sensing a force between the floating plate and said base.

14. The apparatus of claim 11 further comprising:

a hole passing to said slot with said force sensor being disposed in said hole.

15. The apparatus of claim 4 further comprising:

a power source providing power to said pumping mechanism, wherein said sensor determines the power provided to the pumping mechanism to determine said exit fluid pressure.

16. The apparatus of claim 4 further comprising:

a housing and said pumping mechanism includes a cartridge holding said fluid.

17. The apparatus of claim 16;

wherein said sensor includes;

a load sensor disposed between said housing and said cartridge holder.