Reservoir plunger position monitoring and medical device incorporating same

• US 9,517,303 B2
• Filed: 07/03/2014
• Issued: 12/13/2016
• Est. Priority Date: 08/21/2012
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Bazargan, Afshin, Vazquez, Pablo, Fonacier, EJMar, Weaver, Andrew E.
• Primary Examiner(s): Bosques, Edelmira
• Application Number:
  US14/323,931
• Publication Number:
  US 20140324018A1
• Time in Patent Office: 894 Days
• Field of Search: 604/151, 604/131
• US Class Current: 1/1
• CPC Class Codes: A61M 2005/16863 Occlusion detection
• CPC Class Codes: A61M 2205/14 Detection of the presence or absence of a tube, a connector or a container in an apparatus
• CPC Class Codes: A61M 2205/3306 Optical measuring means
• CPC Class Codes: A61M 2205/3317 Electromagnetic, inductive or dielectric measuring means
• CPC Class Codes: A61M 2205/332 Force measuring means
• CPC Class Codes: A61M 2205/3365 Rotational speed
• CPC Class Codes: A61M 2205/6054 Magnetic identification systems
• CPC Class Codes: A61M 2205/6063 Optical identification systems
• CPC Class Codes: A61M 2205/6081 Colour codes
• CPC Class Codes: A61M 5/14212 Pumping with an aspiration and an expulsion action
• CPC Class Codes: A61M 5/14248 of the skin patch type
• 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: 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
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00

Abstract

Apparatus are provided for infusion devices and related control systems and methods. In one embodiment, an infusion device includes a voided portion adapted to receive a shaft portion that includes a shaft coupled to a plunger of a reservoir. The shaft portion includes a detectable feature, and the infusion device includes a sensing arrangement proximate the voided portion to sense the detectable feature. In some embodiments, a control module is coupled to the sensing arrangement to determine a remaining amount of fluid in the reservoir based at least in part on the sensed position of the detectable feature. In other embodiments, the control module identifies an anomalous condition based at least in part on the sensed position of the detectable feature.

Claims

1. An infusion device, comprising:

a housing including a voided region to receive a reservoir, the voided region including a voided portion to receive a shaft portion including a shaft coupled to a plunger of the reservoir, the shaft portion comprising a detectable feature; and

a sensing arrangement proximate the voided portion to sense the detectable feature when the reservoir is inserted in the voided region, wherein resistance of the sensing arrangement is influenced by contact with the detectable feature, wherein;

the sensing arrangement comprises;

a bottom conductive layer comprising a substantially rigid material having a first conductive resistive carbon ink layer;

an upper conductive layer comprising a flexible material having a second conductive resistive carbon ink layer aligned with the first conductive resistive carbon ink layer on the bottom conductive layer; and

a spacer layer between the bottom conductive layer and the upper conductive layer, the bottom conductive layer and the upper conductive layer being spaced apart from one another by the spacer layer in the absence of a compressive force applied to the upper conductive layer; and

the resistance corresponds to a location where the upper conductive layer is compressed by the detectable feature.

2. The infusion device of claim 1, wherein the sensing arrangement comprises a resistive sensing arrangement having a variable resistance that is influenced by a location of the detectable feature with respect to the sensing arrangement.

3. The infusion device of claim 1, further comprising a flexible cover layer integrated with a wall of the voided portion, wherein:

the flexible cover layer overlies the upper conductive layer; and

the detectable feature contacts the flexible cover layer when the reservoir is provided within the voided region of the housing to compress the flexible cover layer and the upper conductive layer.

4. The infusion device of claim 3, wherein:

the detectable feature compresses the flexible cover layer and the upper conductive layer to cause the first conductive resistive carbon ink layer and the second conductive resistive carbon ink layer to contact one another.

5. The infusion device of claim 1, wherein the detectable feature comprises a protruding feature on the shaft.

6. The infusion device of claim 1, further comprising a control module coupled to the sensing arrangement to detect seating of the reservoir based on the electrical characteristic.

7. The infusion device of claim 1, further comprising a control module coupled to the sensing arrangement to obtain a measured position of the shaft using the sensing arrangement, estimate a remaining amount of fluid in the reservoir based on the measured position, and provide a low fluid notification when the remaining amount is less than a threshold value.

8. The infusion device of claim 1, further comprising a motor having a rotor coupled to the shaft, the shaft being displaced to deliver fluid from the reservoir in response to rotation of the rotor.

9. The infusion device of claim 8, further comprising:

a motor position sensor to measure an amount of rotation of the rotor; and

a control module coupled to the sensing arrangement and the motor position sensor to obtain a measured position of the shaft using the sensing arrangement, determine an expected position of the shaft based on the amount of rotation, and identify an anomalous condition based on a difference between the expected position and the measured position.

10. The infusion device of claim 9, wherein the control module identifies the anomalous condition based on the difference when an axial force aligned with the shaft is less than a threshold value and identifies an occlusion condition based on the difference when the axial force is greater than the threshold value.

11. An infusion device, comprising:

a housing including a voided region to receive a reservoir, the voided region including a voided portion to receive a shaft portion including a shaft coupled to a plunger of the reservoir, the shaft portion comprising a detectable feature; and

a sensing arrangement proximate the voided portion to sense the detectable feature when the reservoir is inserted in the voided region, wherein;

a resistance of the sensing arrangement is influenced by contact with the detectable feature; and

the sensing arrangement comprises;

a flexible cover layer integrated with a wall of the voided portion;

a bottom conductive layer;

an upper conductive layer; and

a spacer layer between the bottom conductive layer and the upper conductive layer, the bottom conductive layer and the upper conductive layer being spaced apart from one another by the spacer layer in the absence of a compressive force applied to the upper conductive layer;

the flexible cover layer overlies the upper conductive layer; and

the detectable feature contacts the flexible cover layer when the reservoir is provided within the voided region of the housing to compress the flexible cover layer and the upper conductive layer to provide the resistance corresponding to a location where the flexible cover layer and the upper conductive layer are compressed by the detectable feature.

12. The infusion device of claim 11, wherein:

the bottom conductive layer comprises a substantially rigid material having a first conductive resistive carbon ink layer;

the upper conductive layer comprises a flexible material having a second conductive resistive carbon ink layer aligned with the first conductive resistive carbon ink layer on the bottom conductive layer; and

the detectable feature compresses the flexible cover layer and the upper conductive layer to cause the first conductive resistive carbon ink layer and the second conductive resistive carbon ink layer to contact one another.

13. The infusion device of claim 11, wherein the detectable feature comprises a protruding feature on the shaft.

14. The infusion device of claim 11, further comprising a control module coupled to the sensing arrangement to detect seating of the reservoir based on the electrical characteristic.

15. The infusion device of claim 11, further comprising a control module coupled to the sensing arrangement to obtain a measured position of the shaft using the sensing arrangement, estimate a remaining amount of fluid in the reservoir based on the measured position, and provide a low fluid notification when the remaining amount is less than a threshold value.

16. The infusion device of claim 11, further comprising a motor having a rotor coupled to the shaft, the shaft being displaced to deliver fluid from the reservoir in response to rotation of the rotor.

17. The infusion device of claim 16, further comprising:

a motor position sensor to measure an amount of rotation of the rotor; and

a control module coupled to the sensing arrangement and the motor position sensor to obtain a measured position of the shaft using the sensing arrangement, determine an expected position of the shaft based on the amount of rotation, and identify an anomalous condition based on a difference between the expected position and the measured position.

18. The infusion device of claim 17, wherein the control module identifies the anomalous condition based on the difference when an axial force aligned with the shaft is less than a threshold value and identifies an occlusion condition based on the difference when the axial force is greater than the threshold value.

19. A method of operating an infusion device to deliver fluid from a reservoir including a plunger coupled to a shaft such that displacement of the shaft results in displacement of the plunger, the infusion device including a sensing arrangement to sense a detectable feature on the shaft, the method comprising:

operating a motor having a rotor coupled to the shaft to displace the shaft in response to rotation of the rotor and deliver the fluid from the reservoir;

obtaining a measured shaft position based at least in part on an electrical output signal provided by the sensing arrangement that is indicative of the detectable feature contacting the sensing arrangement, wherein the electrical output signal corresponds to a location of the detectable feature contacting the sensing arrangement;

determining a remaining amount of fluid in the reservoir based on the measured shaft position; and

providing a low fluid notification when the remaining amount is less than a threshold value, wherein;

a resistance of the sensing arrangement is influenced by contact with the detectable feature; and

the sensing arrangement comprises;

a flexible cover layer integrated with a wall of the voided portion;

a bottom conductive layer;

an upper conductive layer; and

a spacer layer between the bottom conductive layer and the upper conductive layer, the bottom conductive layer and the upper conductive layer being spaced apart from one another by the spacer layer in the absence of a compressive force applied to the upper conductive layer;

the flexible cover layer overlies the upper conductive layer; and

the detectable feature contacts the flexible cover layer when the reservoir is provided within the voided region of the housing to compress the flexible cover layer and the upper conductive layer to provide the resistance corresponding to a location where the flexible cover layer and the upper conductive layer are compressed by the detectable feature.

20. The method of claim 19, wherein the sensing arrangement comprises a resistive sensing arrangement having a variable resistance that is influenced by the position of the detectable feature with respect to the sensing arrangement.