Ambulatory infusion devices and associated methods

• US 10,300,195 B2
• Filed: 01/19/2017
• Issued: 05/28/2019
• Est. Priority Date: 01/20/2016
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medallion Therapeutics, Inc.
• Inventors: Merot, Christian M., Minaie, Pedrum
• Primary Examiner(s): Stiles, Amber R
• Assistant Examiner(s): Chidiac, Nicholas J
• Application Number:
  US15/410,736
• Publication Number:
  US 20170203031A1
• Time in Patent Office: 859 Days
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/14593 the diaphragm being actuated by fluid pressure
• CPC Class Codes: A61M 5/16813 by controlling the degree of opening of the flow line
• CPC Class Codes: A61M 5/16831 Monitoring, detecting, signalling or eliminating infusion flow anomalies low-level float-valves causing cut-off A61M5/40; indicating or recording presence, absence or direction of flow in general G01P13/0066
• CPC Class Codes: A61M 5/16859 Evaluation of pressure response, e.g. to an applied pulse

Abstract

A method of operating an infusion device that includes the steps of actuating a fluid transfer device, which is configured to deliver a predetermined volume during each actuation, in accordance with a delivery profile that includes a plurality of fluid transfer device actuations, determining, based on sensed pressure, whether an actual volume delivered during a fluid transfer device actuation is the predetermined volume, and adjusting the number of actuations in the delivery profile in response to the actual volume delivered differing from the predetermined volume.

Claims

1. A method of operating an infusion device, comprising the steps of:

actuating a fluid transfer device, which is configured to deliver a predetermined volume during each actuation, in accordance with a delivery profile that includes a plurality of fluid transfer device actuations;

determining whether an actual volume delivered during a fluid transfer device actuation is the predetermined volume by sensing pressure, at a single location with a single pressure sensor that is located upstream of a flow restrictor and that has a compliant diaphragm, a compliance value and a sensor apparatus located in spaced relation to the compliant diaphragm, and determining the magnitude of the of a pressure spike associated with the fluid transfer device actuation and multiplying the magnitude of the pressure spike by the compliance value; and

adjusting the number of actuations in the delivery profile in response to the actual volume delivered differing from the predetermined volume.

2. A method as claimed in claim 1, wherein

the fluid transfer device includes an electromagnet pump;

and

the actuation of the fluid transfer device includes a single pump stroke that creates a pressure spike.

3. A method as claimed in claim 1, wherein

determining the magnitude of the pressure spike comprises sampling pressure sensed by the pressure sensor before and during the single pump stroke.

4. A method as claimed in claim 3, wherein

determining the magnitude of the pressure spike comprises using a scaling factor to adjust for changes in head pressure.

5. A method as claimed in claim 1, wherein

adjusting the number of actuations in the delivery profile comprises adding an actuation equivalent of an over-delivery volume to a feedback accumulator in response to the actual volume delivered being greater than the predetermined volume.

6. A method as claimed in claim 5, wherein

adjusting the number of actuations in the delivery profile comprises subtracting an actuation equivalent of an under-delivery volume from the feedback accumulator in response to the actual volume delivered being less than the predetermined volume.

7. A method as claimed in claim 6, wherein

actuating the fluid transfer device in accordance with the delivery profile includes storing the number of actuations in a delivery accumulator;

and

adjusting the number of actuations in the delivery profile comprises adding the actuation equivalent in the feedback accumulator to the delivery accumulator.

8. A method as claimed in claim 7, wherein

adding the actuation equivalent in the feedback accumulator to the delivery accumulator comprises adding a whole number actuation equivalent to the delivery accumulator.

9. A method as claimed in claim 7, wherein

the fluid transfer device comprises a fixed displacement fluid transfer device.

10. A method as claimed in claim 1, wherein

the compliant diaphragm defines a first compliant diaphragm;

and

the sensor apparatus includes a second compliant diaphragm and a strain gauge.

11. A method as claimed in claim 10, wherein

the compliance value is a function of the compliance of the first and second compliant diaphragms.

12. An ambulatory infusion device, comprising:

an outlet port;

a fluid transfer device configured to deliver a predetermined volume during each actuation thereof;

a fluid path that operably connects the fluid transfer device to the outlet port;

a pressure sensor associated with the fluid path;

a flow restrictor between the pressure sensor and the outlet port; and

means for actuating the fluid transfer device in accordance with a delivery profile that includes a plurality of fluid transfer device actuations, determining based on pressure sensed only upstream of the flow restrictor whether an actual volume delivered during a fluid transfer device actuation is the predetermined volume, and adjusting the number of actuations in the delivery profile in response to the actual volume delivered differing from the predetermined volume.

13. An ambulatory infusion device as claimed in claim 12, wherein

the fluid transfer device includes an electromagnet pump that creates a pressure spike.

14. An ambulatory infusion device as claimed in claim 13, wherein

the electromagnet pump comprises a fixed displacement electromagnet pump.

15. An ambulatory infusion device as claimed in claim 12, wherein

the pressure sensor includes compliant diaphragm with a compliance value.

16. An ambulatory infusion device as claimed in claim 12, wherein

adjusting the number of actuations in the delivery profile comprises adding an actuation equivalent of an over-delivery volume to a feedback accumulator in response to the actual volume delivered being greater than the predetermined volume.

17. An ambulatory infusion device as claimed in claim 16, wherein

adjusting the number of actuations in the delivery profile comprises subtracting an actuation equivalent of an under-delivery volume from the feedback accumulator in response to the actual volume delivered being less than the predetermined volume.