Feedback controlled drug delivery system

• US 5,697,899 A
• Filed: 02/07/1995
• Issued: 12/16/1997
• Est. Priority Date: 02/07/1995
• Status: Expired due to Fees

• Current Assignee: SICOR, Inc. (Teva Pharmaceutical Industries Limited)
• Original Assignee: SICOR, Inc. (Teva Pharmaceutical Industries Limited)
• Inventors: Valcke, Christian P., Gauthier, Robert T., Hillman, Robert S.
• Primary Examiner(s): HINDENBURG, MAX F
• Application Number:
  US08/386,916
• Time in Patent Office: 1,043 Days
• Field of Search: 604/28, 604/31, 604/53, 604/65, 604/67, 604/131, 604/183, 604/186, 604/257
• US Class Current: 604/28
• CPC Class Codes: A61M 2202/0007 introduced into the body
• CPC Class Codes: A61M 2202/0478 Heparin
• CPC Class Codes: A61M 2230/20 Blood composition characteristics
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: G01N 33/48707 by electrical means G01N33/49, G01N33/493 take precedence
• CPC Class Codes: G01N 33/4905 Determining clotting time of blood by chemical methods G01N33/86, C12Q1/54

Abstract

A feedback controlled drug delivery system includes automated blood sampling and analysis and dosing of the patient. Automated sampling is performed by direct analysis of patient blood, such as for measurement of its coagulation state. A novel manifold includes a fluid input port, a patient port adapted to output fluid and to receive a blood sample from the patient, and a fluid pathway connecting the fluid port and the patient port. A sample line is connected to the fluid pathway to provide the sample to an analyzer. In one aspect of this invention, the sample is forced through the sample line by isolating the patient port, such as by a valve, and non-drug fluid is forced into the manifold causing the blood to cross through the sample line. Alternately, a pump force may be utilized on the sample line. In another aspect of this invention, a positive interlock system is utilized between a drug source and the system. In yet another aspect of this invention, a improved multitest unit is provided, such as in a carousel or stacked manner.

Claims

1. A feedback controlled drug delivery system for delivering a fluid to a patient, the system comprising:

an input for receiving the fluid,

an infusion pump connected to the input for receiving the fluid to control delivery of the the fluid as regulated by the pump,

an analyzer adapted to receive a patient sample, and

an interconnection between the fluid pump, the patient and the analyzer, the interconnection comprising;

an interconnect input adapted for receiving the fluid and connected to the pump,

an interconnect output connected to the patient for outputting the fluid to the patient,

a fluid pathway formed between the interconnect input and the interconnect output, and

a connection between the fluid pathway and the analyzer.

2. The feedback controlled drug delivery system of claim 1 wherein the interconnect output is further adapted to receive the patient sample as input.

3. The feedback controlled drug delivery system of claim 1 wherein the patient sample is blood.

4. The feedback controlled drug delivery system of claim 1 further including a drug input operatively connected to the interconnect input and under control of the system.

5. The feedback controlled drug delivery system of claim 1 wherein the fluid is heparin.

6. The feedback controlled drug delivery system of claim 1 wherein the fluid is selected from the group consisting of:

Hirudin, Hirulog, and direct thrombin inhibitors.

7. The feedback controlled drug delivery system of claim 1 wherein the fluid is a IIb/IIIa antagonist.

8. The feedback controlled drug delivery system of claim 7 wherein the analyzer is a platelet aggregation assay or IIb/IIIa assay.

9. The feedback controlled drug delivery system of claim 1 further including an interlock adapted to positively interconnect between a predefined drug source and the remainder of the system.

10. A method for sampling blood in an automated sampling system having a non-drug fluid port connected to a non-drug fluid source, a patient port adapted for providing non-drug fluid to the patient and, alternatively, drawing blood from the patient, the non-drug fluid port and the patient port being connected by a fluid pathway, a first valve operatively connected to the fluid pathway to selectively isolate the patient from the fluid pathway, a sample pathway selectively connectable to the fluid pathway via a second valve, and an analyzer connected to the sample pathway, the steps comprising:

1. filling the fluid pathway to the patient with non-drug fluid,

2. drawing the non-drug fluid away from the patient so as to draw the patient'"'"'s blood into the fluid pathway;

to a point past the sample pathway,

3. isolating the patient from the sample pathway by closing the first valve,

4. opening the second valve to permit blood to pass into the sample pathway, and

5. moving the blood through the sample pathway to the analyzer.

11. The method of claim 10 wherein the blood is moved through the sample pathway to the analyzer by the step of flowing non-drug fluid through the non-drug fluid port into the fluid pathway.

12. The method of claim 10 wherein the blood is moved through the sample pathway to the analyzer by the step of pumping blood through the sample pathway to the analyzer.

13. The method of claim 10 wherein step 2 a detector generates a signal indicating that the blood has moved in the fluid pathway to a point past the sample pathway.

14. The method of claim 13 wherein the signal generated by the detector is utilized to cause termination of the drawing of the patient'"'"'s blood further through the fluid pathway.

15. A feedback controlled drug delivery device for adjusting the quantity of a fluid delivered to a patient in response to analysis of a sample taken from the patient, comprising:

a fluid pump receiving the fluid from a fluid source,

a fluid line creating a fluid path between the fluid pump and the patient;

an analyzer,

a sample line connecting the fluid line to the analyzer, creating a sample path between the patient and the analyzer,

a pressure means operatively associated with the analyzer for drawing the sample from the patient to the analyzer, and

a controller communicating with the analyzer and controlling the fluid pump and the pressure means.

16. A feedback controlled drug delivery device for regulating the quantity of a fluid delivered to a patient by adjusting the volumetric flow from a controllable fluid source in response to analysis of a sample taken from the patient, comprising:

a fluid tube creating a fluid path between the controllable fluid source and the patient,

an analyzer operatively connected to a sample drawing function,

a sample tube connecting the fluid tube to the analyzer,

a controller communicating with the analyzer and controlling the controllable fluid source and the sample drawing function.

17. A feedback controlled drug delivery device, comprising:

a controllable drug or non-drug fluid source for providing a fluid,

an analyzer for accepting a patient sample,

a fluid line invasively attached to a patient and connected to the controllable drug or non-drug fluid source and the analyzer,

a controller communicating to the controllable drug or non-drug fluid source and the analyzer wherein fluid flows into the fluid line and alternately the patient sample flows out the fluid line.