Ambulatory infusion pump having programmable parameters

• US 4,529,401 A
• Filed: 01/11/1982
• Issued: 07/16/1985
• Est. Priority Date: 01/11/1982
• Status: Expired due to Term

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Leslie, James E., Anderson, Everett D.
• Primary Examiner(s): Howell, Kyle L.
• Assistant Examiner(s): Jaworski, Francis J.
• Application Number:
  US06/338,327
• Time in Patent Office: 1,282 Days
• Field of Search: 604/19, 604/27, 604/30, 604/31, 604/65, 604/66, 604/67, 604/131, 604/155, 128/DIG. 12, 128/DIG. 13, 128/DIG. 1
• US Class Current: 604/131
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• 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: Y10S 128/01 Motorized syringe
• CPC Class Codes: Y10S 128/12 Pressure infusion

Abstract

A portable infusion pump for controllably supplying a programmed volume of medicant to a patient. The apparatus generally comprises a small, portable container having a keyboard for programming the mode of operation and operating parameters, whereby a microprocessor controls the pump in the various BASAL, SUPPLEMENTAL OR MANUAL dose delivery modes. The apparatus also contains a photo-coupler controlled driven lead screw assembly for controlling the stroke of the syringe plunger, whereby metered doses of the medicant are injected into the patient; display means for confirming programmed inputs; means for audibly warning of error conditions; and means for recording the total cummulative dosage delivered.

Claims

1. A portable programmable infusion pump comprising in combination:

means for containing a medicant;

means for evacuating said containment means;

keyboard means for programming a medicant concentration, at least one medicant delivery mode of operation and dosage data for each programmed mode, said dosage data including a total dose to be delivered over a predetermined length of time for each programmed mode;

memory means for storing a microprogram, each programmed mode, said medicant concentration and said dosage data;

processing means responsively coupled to said memory means for determining the volume of an incremental dose and for controlling the rate at which said evacuation means delivers one or more of said incremental doses during each programmed delivery mode.

2. A portable programmable infusion pump as set forth in claim 1 wherein during a first programmed delivery mode said processing means in response to the programmed medicant concentration and the dosage data for said first delivery mode determines a first interval and controllably causes the delivery of one of said incremental doses of medicant once each of said first intervals over a predetermined first length of time.

3. A portable programmable infusion pump as set forth in claim 2 including a second programmed delivery mode and during which said processing means in response to the programmed medicant concentration and the dosage data for said second delivery mode, consecutively and continuously controls the delivery of a determined number of said incremental doses of medicant.

4. A portable programmable infusion pump as set forth in claim 3 including means for delaying the onset of the delivery of the incremental doses for said second delivery mode until a delay period of a predetermined length of time has elapsed.

5. A portable programmable infusion pump as set forth in claim 2 including a third programmed delivery mode and during which said processing means in response to the programmed medicant concentration and the dosage data for said third delivery mode determines a third interval and controllably causes the delivery of one of said incremental doses of medicant once each of said third intervals over a predetermined third length of time.

6. A portable programmable infusion pump as set forth in claim 5 wherein said processing means for one or the other of said programmed first and third modes, independent of the other programmed mode, causes the delivery of one of said incremental doses during one or more of the other mode'"'"'s first or third intervals.

7. A portable programmable infusion pump as set forth in claim 1 including means maintaining a selectively accessible record of the accumulated number of incremental doses delivered by said evacuation means for permitting a determination of the total dosage of medicant delivered relative to a known delivery start time.

8. A portable programmable infusion pump as set forth in claim 1 including means for selectively programming a lock out condition and thereby preventing the further programming or reprogramming of said infusion pump during said lock out condition.

9. A portable programmable infusion pump as set forth in claim 1 wherein said evacuation means includes a refillable syringe and means for controllably evacuating any air within said syringe in response to a programmed prime fuction.

10. A portable programmable infusion pump as set forth in claim 1 including selectively actuable display means for visibly confirming the entry of each delivery mode, said medicant concentration and said dose data into said memory means and for displaying error messages or predetermined status conditions during the operation of said infusion pump.

11. A portable programmable infusion pump as set forth in claim 1 including photo coupled detector means for monitoring the mechanical movement of said evacuation means during the delivery of each of said incremental doses and wherein said processing means compares said detected movement to said determined incremental volume to ensure the delivery of a constant volume of medicant with each incremental dose.

12. A portable programmable infusion pump as set forth in claim 11 including a syringe and axially operable plunger, a driven lead screw coupled to said plunger for axially moving said plunger with the rotational movement of said lead screw and a multi-apertured member mounted relative to said lead screw and wherein said photo coupled detector means monitors the mechanical movement of said lead screw relative to said apertures, the space between each aperture corresponding to the delivery of a predetermined volume of medicant.

13. A portable programmable infusion pump as set forth in claim 1 including emergency power supply means separate from a primary power supply and responsive to a low primary power supply condition for maintaining power to said infusion pump for a finite period, and during which period said infusion pump suspends the delivery of medicant and produces an alarm condition.

14. A portable programmable infusion pump as set forth in claim 1 wherein each incremental dose is one microliter and said medicant concentration is programmed in standard units of medicant per millimeter.

15. A portable programmable infusion pump comprising:

means for containing a medicant;

means for evacuating said containment means;

keyboard means for programming a plurality of medicant delivery modes of operation, one of a plurality of medicant concentrations and dosage data for each programmed delivery mode, said dosage data including a total dose to be delivered over a predetermined length of time;

memory means for storing an operating microprogram, said programmed medicant concentration, said programmed medicant delivery modes and said dosage data; and

processing means responsively coupled to said memory means for determining the volume of an incremental dose and a delivery rate for each programmed mode and for correspondingly controlling the rate at which said evacuation means delivers one or more of said incremental doses during each of said programmed modes.

16. A portable programmable infusion pump as set forth in claim 15 wherein said processor, depending upon the dosage data for each of said programmed modes and the programmed medicant concentration, determines an incremental dose-to-dose interval for each programmed delivery mode and causes said evacuation means to deliver an incremental dose of said medicant once each determined dose-to-dose interval during each mode until each mode'"'"'s programmed total dose is delivered.

17. A portable programmable infusion pump as set forth in claim 16 wherein each delivered incremental dose is one microliter.

18. Apparatus as set forth in claim 15 wherein said processing means for each of said programmed modes, independent of the other programmed mode or modes, causes the delivery of one of said incremental doses during each of a determined dose-to-dose interval for one or more modes.

19. A portable programmable infusion pump comprising:

a tubular syringe mounted in a patient transportable container for containing a medicant and having a plunger axially coupled thereto;

driven lead screw means mounted in coaxial relation to said plunger for axially moving said plunger to and fro;

keyboard means for programming a plurality of medicant delivery modes of operation, one of a plurality of medicant concentrations and dosage data for each programmed delivery mode, said dosage data including a total dose to be delivered over a predetermined length of time;

memory means for storing an operating microprogram, said medicant concentration, said programmed delivery modes and said dosage data; and

processing means responsively coupled to said memory means for determining an incremental dose-to-dose delivery interval for each programmed delivery mode and for correspondingly controlling said driven lead screw means so as to deliver a predetermined volume of said medicant during each dose-to-dose interval for each of said programmed modes, thereby delivering a desired dosage profile to said patient over time.

20. An improved patient transportable, programmable infusion pump having a medicant storage chamber and means for controllably evacuating the storage chamber and delivering the medicant to a patient in response to one or more programmed medicant delivery modes, the improvement comprising:

means for programming at least one of a plurality of medicant concentrations that may be dispensed by said infusion pump; and

means responsive to said programmed medicant concentration and each of said programmed delivery modes for determining the volume of an incremental dose and a dose-to-dose interval between the delivery of each incremental dose for each of said delivery modes, and whereby said infusion pump delivers said medicant in a predetermined delivery profile over time.

21. An improved infusion pump as set forth in claim 20 wherein the volume of the determined incremental dose for each mode is predetermined to be a constant and the same for each mode and whereby said infusion pump delivers said medicant in a predetermined delivery profile over time.

22. In an infusion pump having medicant containing means and means for producing volume controlled incremental doses of medicant, the improvement comprising:

means responsive to a plurality of initially programmed medicant delivery modes for determining a rate of delivery over time for each mode, independent of the other modes, for a plurality of incremental doses and for delivering the incremental doses of said medicant at each mode'"'"'s determined rate, whereby over time the incremental doses are delivered as a desired delivery profile.