INFUSION PUMP

• US 20110009814A1
• Filed: 07/08/2010
• Published: 01/13/2011
• Est. Priority Date: 07/08/2009
• Status: Active Grant

• Current Assignee: Micrel Medical Devices S.A.
• Original Assignee: Micrel Medical Devices S.A.
• Inventors: TSOUKALIS, ACHILLEAS
• Granted Patent: US 8,475,409 B2
• Time in Patent Office: Days
• US Class Current: 604/66
• CPC Class Codes: A61M 2005/14268 with a reusable and a disposable component
• CPC Class Codes: A61M 2205/3553 remote, e.g. between patient's home and doctor's office
• CPC Class Codes: A61M 2205/3561 local, e.g. within room or hospital
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 5/14224 Diaphragm type
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00

Abstract

Described is an infusion pump comprising electronic infusion regulating means with wired or wireless communication means and a power source, a medicament bag (7) and an infusion device, said infusion device being in fluid communication with said medicament bag (7) and comprising two valves (1, 2), a pressure cavity (4) provided between said two valves (1, 2) and a membrane (3) covering said cavity (4), wherein said infusion device comprises at least two active actuators, preferably either made of electroactive polymer so as to form a self actuating membrane (3) or made of shape memory alloy wire, one of said actuators being adapted to apply pressure to said membrane (3) for fluid displacement in said cavity (4), and the other of said actuators being adapted to operate one of said valves which is adapted to passively close in the flow direction of a fluid from said medicament bag (7) through the cavity (4), wherein the other of said valves is adapted to, in particular passively, close in a direction opposite to said flow direction.

Claims

1. An infusion pump, comprising electronic infusion regulating means (21) with wired or wireless communication means and a power source (20), a medicament bag (7) and an infusion device, said infusion device being in fluid communication with said medicament bag (7) and comprising two valves (1, 2), a pressure cavity (4) provided between said two valves (1, 2) and a membrane (3) covering said cavity (4), characterized in that said infusion device comprises at least two active actuators, preferably either made of electroactive polymer so as to form a self actuating membrane (3, 22) or made of shape memory alloy wire, one (24, 28, 29) of said actuators being adapted to apply pressure to said membrane (3) for fluid displacement in said cavity (4), and the other (25, 26, 27) of said actuators being adapted to operate one of said valves which is adapted to passively close in the flow direction of a fluid from said medicament bag (7) through the cavity (4), wherein the other of said valves is adapted to close in a direction opposite to said flow direction.

2. The infusion pump according to claim 1, wherein in case said other (2) of said valves operates as an active valve, said other of said valves is adapted to be actuated by the same actuator as said one (1) of said valves in a way that always said other (2) of said valves is closed when said one (1) of said valves is open.

3. The infusion pump according to claim 1, wherein said infusion regulating means (21) is adapted to monitor an actuation travel of said one (24, 28, 29) of said actuators being adapted to apply pressure to said membrane (3) for fluid displacement in said cavity (4) through electrical parameters of actuator changing with actuation stress/travel, as well as time of travel for safety and occlusion pressure alarm determination.

4. The infusion pump according to claim 1, wherein said infusion device with said medicament bag (7) define a disposable part (14), and the electronic infusion regulating means (21) and eventually the power source (20) are located in a non-disposable infusion regulator (11) which is attached to said disposable part (14) and communicates with it via contacts for driving, infusion error reading and optionally for pressure measurement.

5. The infusion pump according to claim 4, wherein said disposable part (14) is calibrated during production for infusion rate errors and comprises communication means for transmitting information about an error and for correcting this error by the infusion regulator (11).

6. The infusion pump according to claim 4, wherein said disposable part (14) is adapted to be prefilled with a drug.

7. The infusion pump according to claim 4, wherein said disposable part (14) comprises at least a hole covered by an hydrophobic, watertight but air-permeable material to facilitate sterilization with ethylene oxide, and by a rubber gasket for filling the medicament bag (7) through a drug introduction needle.

8. The infusion pump according to claim 4, wherein said disposable part (14) further comprises bags (16, 17, 18), a glucose sensor microflow calibration means (33,1&

2,4), an infusion needle (13) for insulin infusion, a measurement needle (15) for glucose measurement, a back side microdialysis circuit being an internal part of said measurement needle (15), and a glucose sensor provided on an external part of said measurement needle (15), wherein both said needles (13, 15) are spaced from each other by a predetermined distance, and wherein said infusion regulator for any case self-contained operation with built-in electronics (21) or non-disposable infusion regulator (11) includes a memory adapted to record dosing accuracy calibration data, said power source (20) and said wireless or wired communication means.

9. The infusion pump according to claim 8, wherein networks are provided which are used by said algorithm to predict the blood glucose concentration, and wherein said algorithm is provided to use a proportional integral derivative (PID) algorithm for infusion control.

10. The infusion pump according to claim 8, wherein a catheter is provided for intravenous administration which catheter comprises three integral lumens, one open at its end for infusion and the other two closed at their end, but communicating with a closed microflow and back side microdialysis circuit, for calibrating said glucose sensor, and wherein the parameters for closed-loop infusion are different from those of a subcutaneous infusion control.

11. The infusion pump according to claim 1, further comprising a handheld user communicator device including a user interface display, command input keys, communication means for data transmission from and to a central server computer via an Internet connection, such as GSM/GPRS, 3G/UMTS, WiFi, WiMax and any new wireless connection technique, means for local communication with said infusion regulator (11 or 21), sensors at a short distance from the user, and a memory for recording infusion events (event log) and optionally measurement events as communicated by said infusion regulator (11 or 21).

12. The infusion pump according to claim 11, wherein said handheld user communicator device is adapted to use said communication means for transmitting the infusion events and optionally the measurement events as communicated by said infusion regulator (11 or 21) to a remote database.

13. The infusion pump according to claim 11, wherein said handheld user communicator device includes a memory for storing a food library that may be updated by said long distance communication means to remote database with the corresponding glucose equivalent units and sensor or input of exercise also translated to negative glucose equivalent, either for calculating an insulin bolus or for communicating them to an infusion and measurement system for closed-loop infusion control.

14. The infusion pump according to claim 11, wherein reports and alarms of the pump and/or a glucose meter system are transmitted from said handheld user communicator device or a central computer via text messages (SMS) or other telecommunication means to persons capable to process the data.

15. The infusion pump according to claim 1, comprising a body having a lower skin contacting side (14) at which a self-adhesive is provided to support the weight of the pump.

16. The infusion pump according to claim 1, wherein said two valves are combined in a piston valve (1&

2) which is movable to at least a first working position and a second working position and adapted so that in said first working position said medicament bag (7) is linked with said cavity (4) while blocking an output, and in said second working position said cavity (4) is linked with said output while blocking the link with said medicament bag (7).

17. The infusion pump according to claim 16, wherein said piston valve (1&

2) is movable to a third working position in which both the links with said medicament bag (7) and said output are blocked.

18. An infusion pump consumable or consumable infusion pump according to claim 1, wherein the infusion pump is carrying individual infusion accuracy calibrating data, and the calibration is done during manufacturing/quality inspection of said infusion pump consumable or consumable infusion pump.

19. The infusion pump according to claim 8, wherein said infusion regulator (11 or 21) is adapted to operate in accordance with an algorithm for a closed-loop insulin infusion control in relation to the measured glucose, physiological parameters, carbohydrate ingestion and physical exercise information.

20. The infusion pump according to claim 10, wherein said glucose sensor comprises a diffusion reducing cover in both flow directions.