PUMP, MOTOR AND ASSEMBLY FOR BENEFICIAL AGENT DELIVERY

• US 20150182697A1
• Filed: 12/30/2014
• Published: 07/02/2015
• Est. Priority Date: 12/31/2013
• Status: Active Application

• Current Assignee: Abbvie Incorporated
• Original Assignee: Abbvie Incorporated
• Inventors: Panzer, Mark
• Application Number:
  US14/586,927
• Publication Number:
  US 20150182697A1
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61M 2005/16863 Occlusion detection
• CPC Class Codes: A61M 2205/12 with interchangeable cassettes forming partially or totally the fluid circuit
• 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 2205/16 with back-up system in case of failure
• 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 2205/6054 Magnetic identification systems
• CPC Class Codes: A61M 5/142 Pressure infusion, e.g. using pumps
• CPC Class Codes: A61M 5/14228 with linear peristaltic action, i.e. comprising at least three pressurising members or a helical member
• 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: F04B 43/082 the tubular flexible member being pressed against a wall by a number of elements, each having an alternating movement in a direction perpendicular to the axes of the tubular member and each having its own driving mechanism
• CPC Class Codes: F04B 43/12 having peristaltic action
• CPC Class Codes: F04B 43/1223 the actuating elements, e.g. rollers, moving in a straight line during squeezing

Abstract

Device for delivering a beneficial agent to a user includes a cassette including a cassette housing with a fluid reservoir, the cassette housing having a cassette base region, and a delivery tube. The device also includes a pump having a pump housing containing a pump assembly and having a receiving region to receive the cassette base region. The pump assembly includes a fluid drive component, a display, a plurality of input buttons. The pump assembly also includes a first processor coupled to the fluid drive component and the display and configured to reduce power to the fluid drive component and the display when the pump is in an inactive state, and a second processor coupled to the first processor and the plurality of input buttons, the second processor configured to provide an activation signal to the first processor when one or more of the plurality of input buttons is deployed.

Claims

1. A device for delivering a beneficial agent to a user, comprising:

a cassette including a cassette housing with a fluid reservoir defined therein, the cassette housing having a cassette base region;

a delivery tube fluidly coupled with the fluid reservoir;

a pump including a pump housing containing a pump assembly and having a receiving region to receive the cassette base region, the pump assembly including;

a fluid drive component disposed proximate the receiving region,

a display to provide visual feedback to the user,

a plurality of input buttons disposed on the pump housing,

a first processor coupled to the fluid drive component and the display and configured to reduce power to the fluid drive component and the display when the pump is in an inactive state, and

a second processor coupled to the first processor and the plurality of input buttons, the second processor configured to provide an activation signal to the first processor when one or more of the plurality of input buttons is deployed.

2. The device of claim 1, wherein the pump assembly further comprises an RFID transceiver coupled to the first processor, the first processor configured to reduce power to the RFID transceiver when the pump is in the inactive state.

3. The device of claim 1, wherein the pump assembly further comprises an occlusion sensor coupled to the first processor, the first processor configured to reduce power to the occlusion sensor when the pump is in the inactive state.

4. The device of claim 1, wherein the pump assembly further comprises a serial bus coupled to the first processor, the first processor configured to reduce power to the serial bus when the pump is in the inactive state.

5. The device of claim 1, wherein the pump assembly further comprises a power supply voltage monitor coupled to the second processor, the second processor configured to maintain the power supply voltage monitor in an active state when the first processor is powered down.

6. The device of claim 1, wherein the pump assembly further comprises one or more memories, a primary power supply and a backup power supply coupled to the second processor, the second processor configured to utilize the backup power supply to save current data to the one or more memories when the second processor detects the primary power supply is removed or disabled.

7. The device of claim 1, wherein the pump assembly further comprises a battery coulomb counter coupled to the second processor, the second processor configured to maintain the battery coulomb counter in an active state when the first processor is powered down.

8. The device of claim 1, wherein the pump assembly further comprises a speaker, the first processor and the second processor each coupled to the speaker and configured to send an audio signal to the speaker when a fault is detected.

9. The device of claim 1, further comprising a beneficial agent contained in the fluid reservoir.

10. The device of claim 9, wherein the beneficial agent comprises one or more of levodopa and carbidopa.

11. A device for delivering a beneficial agent to a user, comprising:

a cassette including a cassette housing with a fluid reservoir defined therein, the cassette housing having a cassette base region;

a delivery tube fluidly coupled with the fluid reservoir;

a pump including a pump housing containing a pump assembly and having a receiving region to receive the cassette base region, the pump assembly including;

a primary power source,

a secondary power source coupled to the primary power source,

a fluid drive component disposed proximate the receiving region and coupled to the primary power source and isolated from the secondary power source,

a first processor coupled to the primary power source and the secondary power source,

a second processor coupled to the first processor, the primary power source and the secondary power source,

one or more memories coupled to the first processor, and

at least one of the first processor and second processor configured, when the primary power source is removed or disabled, to utilize the secondary power source and the first processor to complete writing operations to the one or more memories prior to depletion of the secondary power source.

12. The device of claim 11, wherein the secondary power source comprises a 1F capacitor.

13. The device of claim 11, wherein the secondary power source is coupled to the primary power source via a secondary power source charger configured to charge the secondary power source when the primary power source is active.

14. The device of claim 11, wherein the one or more memories comprises a nonvolatile memory storage.

15. The device of claim 11, wherein the pump assembly further comprises an RFID transceiver coupled to the secondary power source.

16. The device of claim 11, wherein the pump assembly further comprises a speaker coupled to the secondary power source, the first processor and the second processor each coupled to the speaker and configured to send an audio signal to the speaker when a fault is detected.

17. The device of claim 11, wherein the pump assembly further comprises a display to provide visual feedback to the user, the display coupled to the primary power source and isolated from the secondary power source.

18. The device of claim 11, wherein the pump assembly further comprises an occlusion sensor coupled to the primary power source and isolated from the secondary power source.

19. The device of claim 11, further comprising a beneficial agent contained in the fluid reservoir.

20. The device of claim 19, wherein the beneficial agent comprises one or more of levodopa and carbidopa.

21. A device for delivering a beneficial agent to a user, comprising:

a cassette including a cassette housing with a fluid reservoir defined therein, the cassette housing having a cassette base region;

a delivery tube fluidly coupled with the fluid reservoir;

a pump including a pump housing containing a pump assembly having a fluid drive component, the pump housing having a receiving region to receive the cassette base region, the fluid drive component disposed proximate the receiving region;

a contact force sensor in communication with the delivery tube and arranged to measure a force or pressure in the delivery tube; and

one or more processors in communication with the contact force sensor to receive data representing the measured force or pressure from the contact force sensor, the one or more processors configured to;

determine a maximum force value detected by the contact force sensor during an initial pumping cycle, the maximum force value corresponding to a baseline maximum force value,

obtain subsequent force values from the contact force sensor during each subsequent pumping cycle, and

determine an occlusion is present if one or more of the subsequent force values exceed the baseline maximum force value by a threshold amount.

22. The device of claim 21, wherein the one or more processors is further configured to:

determine a subsequent maximum force value during the subsequent pumping cycle, and

adjust the baseline maximum force value to the subsequent maximum force value if the subsequent maximum force value is less than the baseline maximum force value.

23. The device of claim 21, wherein the threshold amount is about 10% of the baseline maximum force value.

24. The device of claim 21, wherein the one or more processors is further configured to:

determine a local maximum force value during an initial pump revolution of each pump cycle, the local maximum force corresponding to a baseline local maximum force value,

obtain a subsequent local force maximum during each subsequent pump revolution of each pump cycle, and

determine an occlusion is present if one or more of the subsequent local force maxima exceeds the baseline local maximum force value by a local threshold amount.

25. The device of claim 24, wherein the local threshold amount is about 13% of the baseline local maximum force value.

26. The device of claim 24, wherein the one or more processors is further configured to determine the local maximum force value of each pump cycle when a flow rate of the fluid drive component is above a threshold flow rate.

27. The device of claim 26, wherein the threshold flow rate is 10 mL/hr.

28. The device of claim 24, wherein the one or more processors is further configured to:

determine a local minimum force value detected by the contact force sensor during each revolution of each pumping cycle, and

determine an error is present if the local minimum force value does not exceed the local maximum force value of a corresponding pump cycle by a local minimum threshold amount.

29. The device of claim 28, wherein the error comprises a mechanical failure of the fluid drive component.

30. The device of claim 28, wherein the error comprises an occlusion signal circuitry failure.

31. The device of claim 21, wherein a duration of each pumping cycle is determined at least in part by a flow rate of the fluid drive component.

32. The device of claim 21, further comprising:

a motor operatively coupled to the fluid drive component; and

a rotational position sensor operatively coupled to the motor to determine a rotational position of the motor;

wherein the one or more processors is further operatively coupled to the rotational position sensor and further configured to determine each pump revolution from the rotational position sensor

33. The device of claim 21, wherein the one or more processors is further configured to stop the fluid drive component when the occlusion is determined to be present.

34. The device of claim 21, further comprising a display operatively coupled to the one or more processors, wherein the one or more processors is further configured to display an error signal on the display when the occlusion is determined to be present.

35. The device of claim 21, wherein the contact force sensor consists of a single contact force sensor.

36. The device of claim 21, wherein the one or more processors is further configured to apply a four-sample moving average filter to the data representing the measured force or pressure from the contact force sensor.

37. The device of claim 21, further comprising a beneficial agent contained in the fluid reservoir.

38. The device of claim 37, wherein the beneficial agent comprises one or more of levodopa and carbidopa.

39. A device for delivering a beneficial agent to a user, comprising:

a cassette including a cassette housing with a fluid reservoir defined therein, the cassette housing having a cassette base region;

a delivery tube fluidly coupled with the fluid reservoir;

a pump including a pump housing containing a pump assembly having a fluid drive component, the pump housing having a receiving region to receive the cassette base region, the fluid drive component and a proximity sensor disposed proximate the receiving region;

a lock member coupled to the pump housing and movable between an open position and a closed position, the cassette capable of being inserted into and removed from the receiving region when the lock member is in the open position, and the cassette being secured to the pump with the cassette base region within the receiving region and a length of the delivery tube in operative engagement with the fluid drive component when the lock member is in the closed position, the lock member comprising a proximity tag configured to be disposed proximate the proximity sensor when the lock member is in the closed position;

a contact force sensor in communication with the delivery tube and arranged to measure a force or pressure in the delivery tube; and

one or more processors in communication with the proximity sensor and the contact force sensor to receive a proximity signal and contact force data, respectively, therefrom, the one or more processors configured to;

determine whether the lock member is in the closed position using the proximity signal,

determine whether the delivery tube is in operative engagement with the fluid drive component using the contact force data, and

enable operation of the fluid drive component if the lock member is determined to be in the closed position and the delivery tube is determined to be in operative engagement with the fluid drive component.

40. The device of claim 39, wherein the proximity sensor comprises a reed switch.

41. The device of claim 39, wherein the proximity tag comprises a magnet.

42. The device of claim 39, wherein the one or more processors is further configured to:

compare the contact force data to a threshold value, and

determine the delivery tube is in operative engagement with the fluid drive component if the contact force data exceeds the threshold value.

43. The device of claim 39, wherein the one or more processors is further configured to:

determine a local minimum force value detected by the contact force sensor during each revolution of each pumping cycle, and

determine the delivery tube is in operative engagement with the fluid drive component if the local minimum force value exceeds the local maximum force value of a corresponding pump cycle by a local minimum threshold amount.

44. The device of claim 39, wherein a cassette base region comprises a radio frequency identification (RFID) tag, and the pump comprises an RFID reader configured to read the RFID tag when the cassette is secured to the pump.

45. The device of claim 44, wherein the one or more processors is further configured to:

receive identification information for the cassette encoded on the RFID tag from the RFID reader,

determine whether the identification information is valid, and

enable operation of the fluid drive component if the identification information is valid.

46. The device of claim 45, wherein the RFID tag further comprises an expiration date of the beneficial agent, and the one or more processors is further configured to:

receive the expiration date of the beneficial agent from the RFID reader, determine whether the expiration date is exceeded, and

enable operation of the fluid drive component if the expiration date is not exceeded.

47. The device of claim 45, wherein the RFID tag comprises high or ultra-high radio frequency ID.

48. The device of claim 39, further comprising a beneficial agent contained in the fluid reservoir.

49. The device of claim 48, wherein the beneficial agent comprises one or more of levodopa and carbidopa.

50. A device for delivering a beneficial agent to a user, comprising:

a cassette including a cassette housing with a fluid reservoir defined therein, the cassette housing having a cassette base region including a RFID tag;

a delivery tube fluidly coupled with the fluid reservoir;

a pump including a pump housing containing a pump assembly including a fluid drive component, a proximity sensor and a RFID reader, the pump housing having a receiving region to receive the cassette base region, wherein the fluid drive component, the proximity sensor and the RFID reader are disposed proximate the receiving region, and the RFID reader is configured to read the RFID tag when the cassette is secured to the pump;

a lock member coupled to the pump housing and movable between an open position and a closed position, the cassette capable of being inserted into and removed from the receiving region when the lock member is in the open position, and the cassette being secured to the pump with the cassette base region within the receiving region and a length of the delivery tube in operative engagement with the fluid drive component when the lock member is in the closed position, the lock member comprising a proximity tag configured to be disposed proximate the proximity sensor when the lock member is in the closed position;

a contact force sensor in communication with the delivery tube and arranged to measure a force or pressure in the delivery tube; and

one or more processors in communication with the proximity sensor, the contact force sensor and the RFID reader to receive a proximity signal, contact force data and identification information for the cassette encoded on the RFID tag, respectively, therefrom, the one or more processors configured to;

determine whether the lock member is in the closed position using the proximity signal,

determine whether the delivery tube is in operative engagement with the fluid drive component using the contact force data,

determine whether the identification information is valid, and

enable operation of the fluid drive component if the lock member is determined to be in the closed position, the delivery tube is determined to be in operative engagement with the fluid drive component and the identification information is determined to be valid.

51. The device of claim 50, wherein the RFID tag further comprises an expiration date of the beneficial agent, and the one or more processors is further configured to:

receive the expiration date of the beneficial agent from the RFID reader,

determine whether the expiration date is exceeded, and

enable operation of the fluid drive component if the expiration date is not exceeded.

52. The device of claim 50, wherein the RFID tag comprises high or ultra-high radio frequency ID.

53. The device of claim 50, further comprising a beneficial agent contained in the fluid reservoir.

54. The device of claim 53, wherein the beneficial agent comprises one or more of levodopa and carbidopa.