Detection of infusion pump conditions

• US 9,180,243 B2
• Filed: 03/15/2013
• Issued: 11/10/2015
• Est. Priority Date: 03/15/2013
• Status: Active Grant

• Current Assignee: Tandem Diabetes Care Incorporated
• Original Assignee: Tandem Diabetes Care Incorporated
• Inventors: Michaud, Michael
• Primary Examiner(s): MEDWAY, SCOTT J
• Application Number:
  US13/842,990
• Publication Number:
  US 20140276538A1
• Time in Patent Office: 970 Days
• US Class Current: 1/1
• CPC Class Codes: A61M 2005/14264 with means for compensating influence from the environment
• CPC Class Codes: A61M 2005/14268 with a reusable and a disposable component
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2205/3351 Controlling upstream pump pressure
• CPC Class Codes: A61M 2205/3368 Temperature
• CPC Class Codes: A61M 2205/3372 Temperature compensation
• CPC Class Codes: A61M 2205/3389 Continuous level detection A61M2205/3393 takes precedence
• 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 2209/045 for filling, e.g. for filling reservoirs
• CPC Class Codes: A61M 5/14216 Reciprocating piston type
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• 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 5/1684 by detecting the amount of infusate remaining, e.g. signalling end of infusion

Abstract

An ambulatory infusion system and a method of operating including a disposable infusion cartridge having a collapsible reservoir and a substantially rigid shell disposed over the collapsible reservoir having an interior volume, a pump device, a pressure sensor in communication with the interior volume and a processor. The method includes actuating the pressure sensor to take pressure measurements at regular time intervals; periodically assessing a preselected number of the pressure measurements with statistical analysis to identify statistical measures associated with the pressure measurements; and using the statistical measures to assess the status of the flexible reservoir and the pump device.

Claims

1. An ambulatory infusion system, comprising:

an infusion cartridge, the infusion cartridge including a collapsible reservoir for containing a fluid and a substantially rigid shell disposed over the collapsible reservoir and forming an interior volume between an outside surface of the collapsible reservoir and an inside surface of the shell;

a pump device configured to selectively receive the infusion cartridge and cooperate with the infusion cartridge to deliver fluid from the reservoir to the patient;

a pressure sensor located in one of the infusion cartridge and the pump, the pressure sensor in communication with the interior volume of the infusion cartridge; and

a processor located in one of the infusion cartridge and the pump, wherein the processor is programmed with an algorithm to perform the following;

actuating the pressure sensor to take pressure measurements at regular time intervals;

periodically assessing a preselected number of the pressure measurements with statistical analysis to identify statistical measures associated with the pressure measurements including determining a standard deviation for the preselected number of the pressure measurements;

using the standard deviation to assess the status of the flexible reservoir and the pump device including identifying occasions wherein the standard deviation varies substantially from an expected standard deviation; and

associating the occasions wherein the standard deviation varies substantially from an expected standard deviation with the flexible reservoir being filled to or near its maximum level or capacity.

2. The ambulatory infusion system as claimed in claim 1, wherein the pump device further comprises a spool including a main section and a distal section;

and

wherein the processor is further programmed to;

command movement of the main section and the distal section to a ready to dispense position;

assess the statistical measures during a time following the movement of the main section and the distal section to a ready to dispense position including determining the standard deviation for a plurality of time periods following a plurality of movements of the main section and the distal section to a ready to dispense position.

3. The ambulatory infusion system as claimed in claim 1 wherein the processor is further programmed to:

present a message that the flexible reservoir is filled to or near its maximum level or capacity upon identifying an occasion wherein the standard deviation varies substantially from the expected standard deviation.

4. The ambulatory infusion system as claimed in claim 1, wherein the processor is further programmed to:

associate the flexible reservoir being filled to or near its maximum level or capacity with a risk that autodispensing may occur.

5. An ambulatory infusion system, comprising:

an infusion cartridge, the infusion cartridge including a collapsible reservoir for containing a fluid and a substantially rigid shell disposed over the collapsible reservoir and forming an interior volume between an outside surface of the collapsible reservoir and an inside surface of the shell;

a pump device configured to selectively receive the infusion cartridge and cooperate with the infusion cartridge to deliver fluid from the reservoir to the patient;

a pressure sensor located in one of the infusion cartridge and the pump, the pressure sensor in communication with the interior volume of the infusion cartridge; and

a processor located in one of the infusion cartridge and the pump, wherein the processor is programmed with an algorithm to perform the following;

actuating the pressure sensor to take pressure measurements at regular time intervals;

periodically assessing a preselected number of the pressure measurements with statistical analysis to identify statistical measures associated with the pressure measurements including determining a standard deviation for the preselected number of the pressure measurements;

using the standard deviation to assess the status of the flexible reservoir and the pump device including identifying occasions wherein the standard deviation varies substantially from an expected standard deviation; and

associating the occasions wherein the standard deviation varies substantially from the expected value as being indicative of external factors including transient temperature changes and mechanical pressure being applied to the disposable infusion cartridge.

6. The ambulatory infusion system as claimed in claim 5, wherein the processor is further programmed to:

reject the pressure measurements made on the occasions wherein the standard deviation varies substantially from the expected value when determining fluid volume in the cartridge from the pressure measurements.

7. The ambulatory infusion system as claimed in claim 5, wherein the processor is further programmed to:

assign the pressure measurements made on the occasions wherein the standard deviation varies substantially from the expected value a lesser weight than pressure measurements taken when the standard deviation is near the expected value when determining fluid volume in the cartridge from the pressure measurements.