Device for monitoring the operation of a delivery system and the method of use thereof

• US 5,190,522 A
• Filed: 04/11/1991
• Issued: 03/02/1993
• Est. Priority Date: 01/20/1989
• Status: Expired due to Term

• Current Assignee: Institute of Biocybernetics and Biomedical Engineering PAS, Novo Nordisk A/S
• Original Assignee: Institute of Biocybernetics and Biomedical Engineering PAS, Novo Nordisk A/S
• Inventors: Wojcicki, Jan, Bielawski, Stanislaw, Lilpop, Boguslaw, Ziembicki, Marek
• Primary Examiner(s): YASKO JR, JOHN D
• Application Number:
  US07/745,988
• Time in Patent Office: 691 Days
• Field of Search: 604/118, 604/245, 604/65, 604/66, 604/67, 604/30, 604/31, 604/151, 604/152, 604/153, 604/154, 604/6, 128/DIG. 12, 128/DIG. 13
• US Class Current: 604/65
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/16859 Evaluation of pressure response, e.g. to an applied pulse
• CPC Class Codes: Y10S 128/12 Pressure infusion

Abstract

A device for monitoring a delivery system comprising a volumetric micropump, a measuring element or sensor located in the infusion line, a matching system and an analyzing system. The devices are preferably for use in insulin administration when treating type-I diabetes and in analytical laboratories, the chemical and pharmaceutical industries and other technologies.

Claims

1. A device for monitoring the operation of a drug delivery system comprising:

(a) a volumetric micropump which delivers in the form of a single stroke a preset amount of a drug from a drug reservoir through a catheter to a patient body;

(b) a measuring element or sensor located in the infusion line which generates an analog signal based on the actual pressure or the single stroke volume of the micropump;

(c) a matching system which conditions the signal produced by the measuring element or sensor and transmits the signal to a measuring system which measures the peak value and zero level of the signal and transmits the measured parameters to an analog-to-digital converter; and

(d) an analyzing and control system which compares the measured parameters and the calculated amplitude with preset values recorded in the memory of the analyzing and control system and which (i) signals an alarm state or automatically corrects the operation of the micropump if a quantitative deviation in the volume of a single stroke of the pump is detected and (ii) signals an alarm state if another alarm state of the drug delivery system is detected.

2. The device according to claim 1, wherein the device differentiates between alarm states by recording the measured parameters, comparing the measured parameters with subsequently measured values and analyzing the character of change in the measured parameters.

3. The device according to claim 1, wherein the device operates during each cycle of the micropump.

4. The device according to claim 1, wherein the drug is insulin.

7. A drug delivery system comprising the device of claim 1.

8. A method for monitoring the operation of a drug delivery system comprising using the device of claim 1.

5. A device for monitoring the operation of a drug delivery system which comprises:

(a) a volumetric micropump which delivers in the form of a single stroke a preset amount of a drug from a drug reservoir through a catheter to a patient body;

(b) a measuring element or sensor located in the infusion line which generates an analog signal based on the actual pressure or the single stroke volume of the micropump;

(c) a matching system which conditions the signal produced by the measuring element or sensor and transmits the signal to a measuring system which measures the peak value and zero level of the signal and transmits the measured parameters to an analog-to-digital converter; and

(d) an analyzing and control system which compares the calculated amplitude with a preset value recorded in the memory of the analyzing and control system and which signals an alarm state or automatically corrects the operation of the micropump if a quantitative deviation in the volume of a single stroke of the pump is detected.

6. A device for monitoring the operation of a drug delivery system which comprises:

(a) a volumetric micropump which delivers in the form of a single stroke a preset amount of a drug from a drug reservoir through a catheter to a patient body;

(b) a measuring element or sensor located in the infusion line which generates an analog signal based on the actual pressure or the single stroke volume of the micropump;

(c) a matching system which conditions the signal produced by the measuring element or sensor and transmits the signal to a measuring system which measures the peak value and zero level of the signal and transmits the measured parameters to an analog-to-digital converter; and

(d) an analyzing and control system which compares the measured parameters and the calculated amplitude with preset values recorded in the memory of the analyzing and control system and which signals an alarm state if one of many alarm states of the drug delivery system is detected.