OCCLUSION DETECTION TECHNIQUES FOR A FLUID INFUSION DEVICE HAVING A ROTARY PUMP MECHANISM AND SENSOR CONTACT ELEMENTS

• US 20160369789A1
• Filed: 06/22/2015
• Published: 12/22/2016
• Est. Priority Date: 06/22/2015
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Alderete, Juan M. Jr., Yavorsky, Matthew William, Pananen, Jacob E.
• Granted Patent: US 9,987,425 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61M 2005/16863 Occlusion detection
• CPC Class Codes: A61M 2205/33 Controlling, regulating or measuring
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 5/142 Pressure infusion, e.g. using pumps
• CPC Class Codes: A61M 5/14248 of the skin patch type
• 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: F04B 19/22 of reciprocating-piston type
• CPC Class Codes: F04B 9/042 the means being cams

Abstract

A fluid infusion device includes a pump mechanism having a rotor and a stator. The rotor includes a reference surface and a cam element rising from the reference surface. The stator includes a cam element with a stator cam surface. The cam elements cooperate to axially displace the rotor as it rotates. A drive motor is coupled to actuate the rotor to pump medication fluid from a fluid cartridge module to a body, via a subcutaneous conduit. A sensor contact element resides on the reference surface in an area unoccupied by the rotor cam element. A sensing element terminates at the stator cam surface, and cooperates with a detection circuit to detect when the stator cam surface contacts the sensor contact element. The circuit monitors a detection signal obtained from the sensing element to determine an operating condition of the pump mechanism.

Claims

1. A fluid pump mechanism comprising:

a stator comprising a fluid chamber defined therein, and further comprising a stator cam element having a stator cam surface;

a rotor comprising;

an endcap having a reference surface;

an axial extension section protruding from the endcap, wherein at least a portion of the axial extension section fits inside the fluid chamber;

a rotor cam element having a variable height rising from the reference surface, the rotor cam element cooperating with the stator cam element to axially displace the rotor, relative to the stator, as a function of angular position of the rotor;

a sensor contact element on the reference surface and located in an area that is unoccupied by the rotor cam element; and

a sensing element terminating at or near the stator cam surface, the sensing element cooperating with a detection circuit to detect whether or not the stator cam surface is in contact with the sensor contact element;

wherein the detection circuit monitors characteristics of a detection signal obtained from the sensing element in response to angular position of the rotor to determine an operating condition of the fluid pump mechanism.

2. The fluid pump mechanism of claim 1, wherein:

the sensor contact element comprises an electrically conductive trace; and

the sensing element comprises a first electrically conductive lead having a first end exposed at the stator cam surface, and having a second end coupled to the detection circuit, and a second electrically conductive lead having a first end exposed at the stator cam surface, and having a second end coupled to the detection circuit.

3. The fluid pump mechanism of claim 1, further comprising a biasing element that provides a biasing force to urge the rotor cam element toward the stator cam element and the reference surface.

4. The fluid pump mechanism of claim 3, wherein, under normal operating conditions:

a complete rotation of the rotor corresponds to one pumping cycle comprising a fluid intake period and a fluid expulsion period;

during the fluid intake period, the stator cam element is in contact with the rotor cam element;

during the fluid expulsion period, the rotor cam element disengages the stator cam element, and the biasing element axially displaces the rotor such that the rotor cam element moves toward the reference surface; and

after the fluid expulsion period and before a next fluid intake period, the stator cam element is in contact with the sensor contact element.

5. The fluid pump mechanism of claim 4, wherein, under downstream occlusion conditions:

fluid pressure caused by an occlusion downstream of the fluid pump mechanism prevents the stator cam element from contacting the sensor contact element after the fluid expulsion period; and

the detection circuit determines the presence of a downstream occlusion in response to the detection signal obtained under the downstream occlusion conditions.

6. The fluid pump mechanism of claim 1, wherein:

the detection signal obtained from the sensing element is a binary signal having a first logical state and a second logical state;

the first logical state corresponds to contact between the stator cam element and the sensor contact element;

the second state corresponds to non-contact between the stator cam element and the sensor contact element;

a first binary pattern of the detection signal obtained during one rotation of the rotor is indicative of normal and expected operation of the fluid pump mechanism; and

a second binary pattern of the detection signal during one rotation of the rotor is indicative of a fault condition of the fluid pump mechanism.

7. The fluid pump mechanism of claim 6, wherein:

the detection circuit initiates an alert, alarm, or warning message in response to detecting the second binary pattern.

8. The fluid pump mechanism of claim 6, wherein:

the detection circuit initiates an alert, alarm, or warning message in response to detecting the second binary pattern during a plurality of consecutive rotations of the rotor.

9. The fluid pump mechanism of claim 6, wherein the fault condition is a downstream occlusion condition.

10. The fluid pump mechanism of claim 1, further comprising:

an inlet valve that opens and closes as a function of angular and axial position of the rotor relative to the stator; and

an outlet valve that opens and closes as a function of angular and axial position of the rotor relative to the stator;

wherein the sensor contact element is located in an area on the reference surface corresponding to a valve state in which the inlet valve is closed and the outlet valve is open.

11. The fluid pump mechanism of claim 1, further comprising:

an inlet valve that opens and closes as a function of angular and axial position of the rotor relative to the stator; and

an outlet valve that opens and closes as a function of angular and axial position of the rotor relative to the stator;

wherein the sensor contact element is located in an area on the reference surface corresponding to a valve state in which the inlet valve is closed and the outlet valve is closed.

12. The fluid pump mechanism of claim 1, further comprising an inlet valve that opens and closes as a function of angular and axial position of the rotor relative to the stator, and an outlet valve that opens and closes as a function of angular and axial position of the rotor relative to the stator, the rotor cam element disengaging the stator cam element when both the inlet valve and the outlet valve are closed, and the sensor contact element is located on an area of the reference surface such that, under normal operating conditions, the sensing element makes no contact with the sensor contact element.

13. The fluid pump mechanism of claim 12, wherein the sensor contact element is located on the area of the reference surface such that, under upstream occlusion conditions, the sensing element contacts the sensor contact element after the rotor cam element disengages the stator cam element, when the inlet valve is closed, and when the outlet valve is closed.

14. The fluid pump mechanism of claim 13, wherein, under upstream occlusion conditions:

vacuum conditions created by an occlusion upstream of the fluid pump mechanism allow the rotor cam element to move toward the reference surface even though the outlet valve is closed; and

the detection circuit determines that an upstream occlusion has occurred in response to the sensing element contacting with the sensor contact element.

15. The fluid pump mechanism of claim 12, further comprising a trailing sensor contact element on the reference surface and located in a region that is unoccupied by the rotor cam element, wherein, under normal operating conditions, the sensing element contacts the trailing sensor contact element once per pumping cycle.

16. The fluid pump mechanism of claim 15, wherein, under upstream occlusion conditions, the sensing element contacts the sensor contact element and, thereafter, the trailing sensor contact element.

17. The fluid pump mechanism of claim 15, wherein, under downstream occlusion conditions, the sensing element makes no contact with the sensor contact element, and the sensing element makes no contact with the trailing sensor contact element.

18. A fluid infusion device for delivering a medication fluid to a body, the fluid infusion device comprising:

a fluid pump mechanism that cooperates with a fluid cartridge module, the fluid pump mechanism comprising a rotor and a stator, the rotor comprising a reference surface and a rotor cam element having a variable height rising from the reference surface, the stator comprising a stator cam element having a stator cam surface, the rotor cam element cooperating with the stator cam element to axially displace the rotor, relative to the stator, as a function of angular position of the rotor;

a subcutaneous conduit in fluid communication with an outlet valve of the fluid pump mechanism;

a drive motor coupled to actuate the rotor of the fluid pump mechanism to pump medication fluid from the fluid cartridge module to the body, via the subcutaneous conduit;

a sensor contact element on the reference surface of the rotor, the sensor contact element located in an area that is unoccupied by the rotor cam element; and

a sensing element terminating at or near the stator cam surface, the sensing element cooperating with a detection circuit to detect whether or not the stator cam surface is in contact with the sensor contact element;

wherein the detection circuit monitors characteristics of a detection signal obtained from the sensing element in response to angular position of the rotor to determine an operating condition of the fluid pump mechanism.

19. The fluid infusion device of claim 18, wherein:

the fluid infusion device is a disposable insulin pump device; and

the medication fluid comprises insulin.

20. The fluid infusion device of claim 18, wherein:

the detection signal obtained from the sensing element is a binary signal having a first logical state and a second logical state;

the first logical state corresponds to contact between the stator cam element and the sensor contact element;

the second state corresponds to non-contact between the stator cam element and the sensor contact element;

a first binary pattern of the detection signal obtained during one rotation of the rotor is indicative of normal and expected operation of the fluid pump mechanism; and

a second binary pattern of the detection signal during one rotation of the rotor is indicative of a fault condition of the fluid pump mechanism.

21. The fluid infusion device of claim 18, wherein:

the fluid pump mechanism further comprises an inlet valve that opens and closes as a function of angular and axial position of the rotor relative to the stator, and an outlet valve that opens and closes as a function of angular and axial position of the rotor relative to the stator; and

the sensor contact element is located in an area on the reference surface corresponding to a valve state in which the inlet valve is closed and the outlet valve is open.

22. The fluid infusion device of claim 18, further comprising an inlet valve that opens and closes as a function of angular and axial position of the rotor relative to the stator, and an outlet valve that opens and closes as a function of angular and axial position of the rotor relative to the stator, the rotor cam element disengaging the stator cam element when both the inlet valve and the outlet valve are closed, and the sensor contact element located on an area of the reference surface such that, under normal operating conditions, the sensing element makes no contact with the sensor contact element.

23. The fluid infusion device of claim 22, wherein the sensor contact element is located on the area of the reference surface such that, under upstream occlusion conditions, the sensing element contacts the sensor contact element after the rotor cam element disengages the stator cam element, when the inlet valve is closed, and when the outlet valve is closed.

24. The fluid infusion device of claim 23, further comprising a trailing sensor contact element on the reference surface and located in a region that is unoccupied by the rotor cam element, wherein, under normal operating conditions, the sensing element contacts the trailing sensor contact element once per pumping cycle.

25. The fluid infusion device of claim 24, wherein, under upstream occlusion conditions, the sensing element contacts the sensor contact element and, thereafter, the trailing sensor contact element.

26. The fluid infusion device of claim 24, wherein, under downstream occlusion conditions, the sensing element makes no contact with the sensor contact element, and the sensing element makes no contact with the trailing sensor contact element.

27. A fluid pump mechanism comprising:

a stator comprising a stator cam element having a stator cam surface;

a rotor comprising a reference surface and a rotor cam element having a variable height rising from the reference surface, the rotor cam element cooperating with the stator cam element to axially displace the rotor, relative to the stator, as a function of angular position of the rotor;

an inlet valve that opens and closes as a function of angular and axial position of the rotor;

an outlet valve that opens and closes as a function of angular and axial position of the rotor;

a sensor contact element on the reference surface and located in an area corresponding to a valve state in which the inlet valve is closed and the outlet valve is open; and

a sensing element terminating at or near the stator cam surface, the sensing element cooperating with a detection circuit to detect whether or not the stator cam surface is in contact with the sensor contact element;

wherein the detection circuit monitors characteristics of a detection signal obtained from the sensing element in response to angular position of the rotor to determine an operating condition of the fluid pump mechanism.

28. The fluid pump mechanism of claim 27, wherein:

the sensor contact element comprises an electrically conductive trace; and

the sensing element comprises a first electrically conductive lead having a first end exposed at the stator cam surface, and having a second end coupled to the detection circuit, and a second electrically conductive lead having a first end exposed at the stator cam surface, and having a second end coupled to the detection circuit.

29. The fluid pump mechanism of claim 27, further comprising a biasing element that provides a biasing force to urge the rotor cam element toward the stator cam element and the reference surface, wherein:

under normal operating conditions, a complete rotation of the rotor corresponds to one pumping cycle comprising a fluid intake period and a fluid expulsion period;

during the fluid intake period, the inlet valve is open, the outlet valve is closed, and the stator cam element is in contact with the rotor cam element; and

during the fluid expulsion period, the inlet valve is closed, the outlet valve is open, the rotor cam element is disengaged from the stator cam element, and the biasing element axially displaces the rotor such that the rotor cam element moves toward the reference surface.

30. The fluid pump mechanism of claim 27, wherein:

the detection signal obtained from the sensing element is a binary signal having a first logical state and a second logical state;

the first logical state corresponds to contact between the stator cam element and the sensor contact element;

the second state corresponds to non-contact between the stator cam element and the sensor contact element;

a first binary pattern of the detection signal obtained during one rotation of the rotor is indicative of normal and expected operation of the fluid pump mechanism; and

a second binary pattern of the detection signal during one rotation of the rotor is indicative of a fault condition of the fluid pump mechanism.

31. The fluid pump mechanism of claim 30, wherein:

the detection circuit initiates an alert, alarm, or warning message in response to detecting the second binary pattern.