System and method for detecting occlusions in an infusion pump

• US 9,962,486 B2
• Filed: 11/02/2015
• Issued: 05/08/2018
• Est. Priority Date: 03/14/2013
• Status: Active Grant

• Current Assignee: Tandem Diabetes Care Incorporated
• Original Assignee: Tandem Diabetes Care Incorporated
• Inventors: Rosinko, Michael J., Kruse, Geoffrey A., Harris, Paul
• Primary Examiner(s): Price, Nathan R
• Assistant Examiner(s): Snyder, Melissa A
• Application Number:
  US14/930,053
• Publication Number:
  US 20160051758A1
• Time in Patent Office: 918 Days
• CPC Class Codes: A61M 2005/14268 with a reusable and a disposable component
• CPC Class Codes: A61M 2005/16863 Occlusion detection
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2205/3368 Temperature
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• 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

Abstract

Occlusions in a delivery line of an infusion pump can be detected by measuring pressure differentials in the pump over short periods of time in order to minimize the effects of long term systematic sensor changes. In a delivery mode such as basal insulin delivery where a small portion of a volume of fluid is delivered, pressure readings can be obtained before and after the motor move to deliver each portion and compared. The differentials after one or more motor moves can be compared to determine whether an occlusion is present. In a delivery mode such as bolus insulin delivery in which an entire volume of fluid is delivered, pressure differentials can be obtained for consecutive deliveries at a common point in the delivery cycle of each delivery. Comparison of these pressure values can be used to determine whether an occlusion is present.

Claims

1. A method of detecting occlusions in an infusion pump comprising a disposable infusion cartridge and a pump device, 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, the infusion cartridge further including a delivery mechanism having a spool slidingly disposed in a bore, the spool including a main section and a distal section axially displaceable relative to the main section with a collapsible volume formed between a seal on the main section and a seal on the distal section, the pump device configured to selectively receive the infusion cartridge and cooperate with the infusion cartridge to deliver fluid from the reservoir into the collapsible volume and to a patient, the pump device including a drive mechanism powered by a motor and selectively engageable with the spool to impart controlled axial movements to the spool to deliver fluid to the patient, wherein the method comprises:

actuating an operation to deliver fluid stored in the collapsible volume to a patient;

determining whether the distal section of the spool moved axially at a time during the operation configured to deliver fluid from the collapsible volume to the patient when the distal section should have remained stationary; and

selectively generating an occlusion alarm if it is determined that the distal section of the spool moved at the time it should have remained stationary.

2. The method of claim 1, wherein the infusion pump further comprises a pressure sensor in communication with the interior volume of the infusion cartridge located in one of the infusion cartridge and the pump device, wherein the method further comprises:

obtaining a first pressure reading of the pressure in the interior volume of the infusion cartridge from the pressure sensor;

obtaining a second pressure reading of the pressure in the interior volume of the infusion cartridge from the pressure sensor following the operation configured to deliver fluid from the collapsible volume to the patient;

comparing the first pressure reading to the second pressure reading; and

determining whether the distal section of the spool moved axially at a time during the operation configured to deliver fluid from the collapsible volume to the patient when the distal section should have remained stationary based on the comparison.

3. The method of claim 2, wherein the operation delivers a portion of the fluid in the collapsible volume and determining whether the distal section of the spool moved axially at a time during the operation configured to deliver fluid from the collapsible volume to the patient when the distal section should have remained stationary includes determining that the distal section of the spool moved if the second pressure reading is not the same as the first pressure reading.

4. The method of claim 2, wherein the operation delivers all of the fluid in the collapsible volume and determining whether the distal section of the spool moved axially at a time during the operation configured to deliver fluid from the collapsible volume to the patient when the distal section should have remained stationary includes determining that the distal section of the spool moved if the second pressure reading is the same as the first pressure reading.

5. The method of claim 2, wherein the pressure sensor is disposed in the pump device.

6. The method of claim 1, wherein selectively generating the occlusion alarm includes ceasing all delivery of fluid from the reservoir.

7. A method of detecting occlusions in an infusion pump comprising a disposable infusion cartridge and a pump device, 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, the infusion cartridge further including a delivery mechanism having a spool slidingly disposed in a bore, the spool including a main section and a distal section axially displaceable relative to the main section with a collapsible volume formed between a seal on the main section and a seal on the distal section, the pump device configured to selectively receive the infusion cartridge and cooperate with the infusion cartridge to deliver fluid from the reservoir into the collapsible volume and to a patient, the pump device including a drive mechanism powered by a motor and selectively engageable with the spool to impart controlled axial movements to the spool to deliver fluid to the patient, the infusion pump further comprising a pressure sensor in communication with the interior volume of the infusion cartridge and located in one of the infusion cartridge and the pump device, wherein the method comprises:

actuating the motor to deliver a portion of fluid contained in the collapsible volume;

obtaining a first pressure reading of the pressure in the interior volume of the infusion cartridge from the pressure sensor prior to actuating the motor;

obtaining a second pressure reading of the pressure in the interior volume of the infusion cartridge from the pressure sensor after the motor is powered down following actuation;

comparing the first pressure reading to the second pressure reading; and

selectively generating an occlusion alarm based on the comparison of the first pressure reading to the second pressure reading if the second pressure reading is not the same as the first pressure reading.

8. The method of claim 7, wherein the first pressure reading is obtained immediately prior to actuating the motor and the second pressure reading is obtained immediately after the motor is powered down following actuation.

9. The method of claim 7, wherein selectively generating an occlusion alarm includes only generating the occlusion alarm if the second pressure reading is not the same as the first pressure reading and at least one previously obtained pressure reading.

10. The method of claim 7, wherein the second pressure reading is not the same as the first pressure reading if it is not within a predetermined threshold of the first pressure reading.

11. The method of claim 7, wherein the pressure sensor is disposed in the pump device.

12. The method of claim 7, wherein selectively generating an occlusion alarm includes ceasing all delivery of fluid from the reservoir.

13. A method of detecting occlusions in an infusion pump comprising a disposable infusion cartridge and a pump device, 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, the infusion cartridge further including a delivery mechanism having a spool slidingly disposed in a bore, the spool including a main section and a distal section axially displaceable relative to the main section with a collapsible volume formed between a seal on the main section and a seal on the distal section, the pump device configured to selectively receive the infusion cartridge and cooperate with the infusion cartridge to deliver fluid from the reservoir into the collapsible volume and to a patient, the pump device including a drive mechanism powered by a motor and selectively engageable with the spool to impart controlled axial movements to the spool to deliver fluid to the patient, the infusion pump further comprising a pressure sensor in communication with the interior volume of the infusion cartridge and located in one of the infusion cartridge and the pump device, wherein the method comprises:

actuating the motor to deliver all fluid contained in the collapsible volume to a patient;

obtaining a first pressure reading of the pressure in the interior volume of the infusion cartridge form the pressure sensor at a time prior to all of the fluid being delivered;

obtaining a second pressure sensor reading of the pressure in the interior volume of the infusion cartridge from the pressure sensor at a time after all of the fluid had been delivered;

comparing the first pressure reading to the second pressure reading; and

selectively generating an occlusion alarm based on the comparison of the first pressure reading to the second pressure reading if the second pressure reading is the same as the first pressure reading.

14. The method of claim 13, wherein the first pressure reading is obtained prior to delivering any of the fluid and the second pressure reading is obtained prior to a subsequent actuation of the motor to deliver a subsequent amount of fluid that has been drawn from the collapsible reservoir into the collapsible volume.

15. The method of claim 13, wherein the first pressure reading is obtained during a first fluid delivery cycle and the second pressure reading is made during a subsequent fluid delivery cycle, and each reading is taken at a common point in the respective delivery cycle.

16. The method of claim 13, wherein selectively generating an occlusion alarm includes only generating the occlusion alarm if the second pressure reading is the same as the first pressure reading and at least one previously obtained pressure reading.

17. The method of claim 13, wherein the second pressure reading is the same as the first pressure reading if it is within a predetermined threshold of the first pressure reading.

18. The method of claim 13, wherein the pressure sensor is disposed in the pump device.

19. The method of claim 13, wherein selectively generating an occlusion alarm includes ceasing all delivery of fluid from the reservoir.