Wireless Communication for On-Body Medical Devices

• US 20150025503A1
• Filed: 03/05/2013
• Published: 01/22/2015
• Est. Priority Date: 03/05/2012
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Searle, Gary, Burns, Deborah, Burns, Bruce, Mason, David, Hwang, Charles
• Granted Patent: US 9,623,173 B2
• Time in Patent Office: Days
• US Class Current: 604/506
• CPC Class Codes: A61M 2005/14252 with needle insertion means
• CPC Class Codes: A61M 2005/14268 with a reusable and a disposable component
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/3561 local, e.g. within room or hospital
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/3576 with non implanted data transmission devices, e.g. using external transmitter or receiver
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• 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 2205/581 by audible feedback
• CPC Class Codes: A61M 2205/582 by tactile feedback
• CPC Class Codes: A61M 2205/583 by visual feedback
• CPC Class Codes: A61M 2205/8212 with means or measures taken for minimising energy consumption
• CPC Class Codes: A61M 2209/01 Remote controllers for specific apparatus
• 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: A61M 5/1684 by detecting the amount of infusate remaining, e.g. signalling end of infusion
• CPC Class Codes: G16H 20/13 delivered from dispensers
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 40/67 : for remote operation

Abstract

Apparatuses, systems and methods for the wireless communication of medical devices in a subcutaneous fluid delivery system are disclosed. A system for subcutaneous fluid delivery includes a primary patch pump adapted to attach a first infusion cannula to a user and to perform a plurality of primary patch pump functions, and a secondary patch pump adapted to attach a second infusion cannula to a user. The secondary patch pump is further adapted to perform a plurality of secondary patch pump functions substantially similar to the plurality of primary patch pump functions if an error condition associated with the primary patch pump is determined.

Claims

1. A system for on-body fluid delivery comprising:

a primary patch pump adapted to attach a first infusion cannula to a user, the primary patch pump further adapted to perform a plurality of primary patch pump functions; and

a secondary patch pump adapted to attach a second infusion cannula to a user, the secondary patch pump further adapted to perform a plurality of secondary patch pump functions substantially similar to the plurality of primary patch pump functions if an error condition associated with the primary patch pump is determined.

2. The system for on-body fluid delivery of claim 1, wherein the plurality of primary patch pump functions comprises at least one of:

pairing with a primary user interface;

being filled with a medicament and primed;

deploying a cannula;

initiating a bolus dose or basal rate;

entering a primary patch pump SLEEP mode;

entering a primary patch pump WAKE mode at predetermined primary patch pump WAKE time intervals; and

entering a primary patch pump SNIFF mode for up to a predetermined primary patch pump SNIFF time.

3. The system for on-body fluid delivery of claim 2, wherein the primary user interface comprises a primary user interface real-time clock, and the primary patch pump comprises a primary patch pump real-time clock,

and wherein at least one of a SLEEP cycle, a WAKE cycle and a SNIFF cycle of the primary user interface is synchronized with at least one of a SLEEP cycle, a WAKE cycle and a SNIFF cycle of a primary patch pump to save energy, using the primary user interface real-time clock and the primary patch pump real-time clock.

4. The system for on-body fluid delivery of claim 2,

wherein a power level associated with the primary patch pump SLEEP mode is lower than a power level associated with a primary patch pump WAKE mode.

5. The system for on-body fluid delivery of claim 1, wherein the primary patch pump is communicatively couplable to the secondary patch pump.

6. The system for on-body fluid delivery of claim 1, wherein the primary patch pump comprises one of a completely disposable patch pump and a durable/disposable patch pump.

7. The system for on-body fluid delivery of claim 6, wherein the completely disposable patch pump comprises:

a reservoir to contain medicament;

at least one integral push-button to activate a bolus dose;

a cannula deployment assembly to deploy a cannula;

a pump engine to infuse medicament from the reservoir through the deployed cannula;

a printed circuit board assembly to control operations of at least one of the cannula deployment assembly and the pump engine; and

an adhesive to attach the system to skin.

8. The system for on-body fluid delivery of claim 6, wherein the at least one integral push-button comprises two push-buttons to activate a bolus dose if both push-buttons are depressed simultaneously.

9. The system for on-body fluid delivery of claim 6, wherein the durable/disposable patch pump comprises a durable assembly and a disposable assembly,

wherein the durable assembly comprises:

a pump engine to infuse medicament from the reservoir;

at least one integral push-button to activate a bolus dose; and

a coupler to couple the durable assembly to the disposable assembly; and

wherein the disposable assembly comprises;

a coupler to couple the disposable assembly to the durable assembly;

a connector to electrically connect the disposable assembly to the durable assembly;

a cannula deployment assembly to deploy a cannula;

a reservoir to contain medicament; and

an adhesive to attach the system to skin, and

wherein at least one of the durable assembly and the disposable assembly comprises a printed circuit board assembly to control operations of at least one of the pump engine and the cannula deployment assembly.

10. The system for on-body fluid delivery of claim 9, wherein the at least one integral push-button comprises two push-buttons to activate a bolus dose if both push-buttons are depressed simultaneously.

11. The system for on-body fluid delivery of claim 1, further comprising at least one of a primary user interface and a secondary user interface communicatively couplable to at least one of the primary patch pump and the secondary patch pump.

12. The system for on-body fluid delivery of claim 11, wherein the at least one of a primary user interface and a secondary user interface comprises a timer function enabling bolus infusions at predetermined intervals.

13. The system for on-body fluid delivery of claim 11, wherein the at least one of a primary user interface and a secondary user interface comprises one of a fully-functioning graphical user interface and a minimally-functioning key fob.

14. The system for on-body fluid delivery of claim 11, wherein the at least one of a primary user interface and a secondary user interface is communicatively couplable to a network link.

15. The system for on-body fluid delivery of claim 13, wherein the minimally-functioning key fob comprises:

a dose setting device adapted to set a bolus dose; and

at least one depressible button adapted to initiate a bolus dose.

16. The system for on-body fluid delivery of claim 15, wherein the dose setting device is a turnable dial.

17. The system for on-body fluid delivery of claim 1, further comprising a primary user interface communicatively couplable to at least one of the primary patch pump and the secondary patch pump.

18. A method of on-body fluid delivery using a primary user interface communicatively couplable to a primary patch pump,

wherein the primary patch pump comprises a first reservoir adapted to contain a first fluid, a first cannula, a first pump adapted to infuse the first fluid from the first reservoir through the first cannula, and a first microcontroller adapted to control operations of the first pump,

the method comprising the steps of:

pairing the primary patch pump to the primary user interface;

the primary patch pump communicating with the primary user interface to determine whether user instructions have been received at the primary user interface; and

if it is determined that user instructions have been received at the primary user interface;

sending machine instructions from the primary user interface to the primary patch pump according to the user instructions; and

initiating a bolus dose or basal rate using the first microcontroller according to the machine instructions.

19. The method of on-body fluid delivery of claim 18, further comprising the steps of:

checking by the primary patch pump for an error condition;

if an error condition is detected by the primary patch pump, alerting a user via an alert mechanism and transferring relevant data from the primary patch pump to the primary user interface; and

if no error condition is detected by the primary patch pump, transferring relevant data from the primary patch pump to the primary user interface, and returning to the step of the primary patch pump communicating with the primary user interface.

20. The method of on-body fluid delivery of claim 19, wherein an error condition comprises a condition indicative of at least one of a cannula occlusion, a low reservoir, an end of reservoir, a depleted battery, a battery failure, a cannula deployment, entrapped air and a leakage.

21. The method of on-body fluid delivery of claim 19, wherein relevant data comprise data indicative of at least one an infusion profile update, an infusion command, a bolus dose, a bolus dose requirement, a basal rate, a basal rate adjustment, a confirmation of delivery, an error state or condition, and a confirmation of adjustment.

22. The method of on-body fluid delivery of claim 18, wherein the primary user interface re-synchronizes the primary user interface and the primary patch pump.

23. The method of on-body fluid delivery of claim 22, wherein the primary user interface re-synchronizes the primary user interface and the primary patch pump using a real-time clock.

24. The method of on-body fluid delivery of claim 18, wherein pairing the primary patch pump to the primary user interface comprises assigning a first unique identifier to the primary user interface and a second unique identifier to the primary patch pump.

25. The method of on-body fluid delivery of claim 18, further comprising the step of:

entering a primary patch pump SNIFF mode for up to a predetermined primary patch pump SNIFF time to check for an error condition.

26. The method of on-body fluid delivery of claim 18, wherein the primary patch pump is attachable to skin.

27. The method of on-body fluid delivery of claim 18, wherein the first fluid comprises insulin.

28. The method of on-body fluid delivery of claim 18, further comprising the steps of:

entering a primary user interface SLEEP mode by the primary user interface;

entering a primary patch pump SLEEP mode by the primary patch pump;

entering a primary user interface WAKE mode by the primary user interface at predetermined primary user interface WAKE time intervals; and

entering a primary patch pump WAKE mode by the primary patch pump at predetermined primary patch pump WAKE time intervals,

wherein a power level associated with the primary user interface SLEEP mode is lower than a power level associated with a primary user interface WAKE mode, and

wherein a power level associated with the primary patch pump SLEEP mode is lower than a power level associated with a primary patch pump WAKE mode.

29. The method of on-body fluid delivery of claim 18, wherein if the primary patch pump detects the primary user interface, entering a primary patch pump IMPROVED-RESPONSE-TIME mode by the primary patch pump to communicate with the primary user interface to determine whether user instructions have been received at the primary user interface.

30. The method of on-body fluid delivery of claim 28, wherein at least one of a SLEEP cycle, a WAKE cycle and a SNIFF cycle of the primary user interface is synchronized with at least one of a SLEEP cycle, a WAKE cycle and a SNIFF cycle of the primary patch pump.

31. The method of on-body fluid delivery of claim 28, wherein if the primary user interface is engaged for an adjustment of basal rate or a setting of bolus delivery, after the adjustment or setting at least one of a SLEEP cycle, a WAKE cycle and a SNIFF cycle of the primary user interface is synchronized with at least one of a SLEEP cycle, a WAKE cycle and a SNIFF cycle of the primary patch pump.

32. The method of on-body fluid delivery of claim 18, further using a secondary patch pump communicatively couplable to at least one of the primary patch pump and the primary user interface,

wherein the secondary patch pump comprises a second reservoir adapted to contain a second fluid, a second cannula, a second pump adapted to infuse the second fluid from the second reservoir through the second cannula, and a second microcontroller adapted to control operations of the second pump,

the method further comprising the steps of:

pairing the secondary patch pump to the primary user interface;

checking for an error flag;

if no error flag is detected, the primary patch pump communicating with the primary user interface to determine whether user instructions have been received at the primary user interface; and

if it is determined that user instructions have been received at the primary user interface;

sending machine instructions from the primary user interface to the primary patch pump according to the user instructions; and

initiating a bolus dose or basal rate using the first microcontroller according to the machine instructions.

33. The method of on-body fluid delivery of claim 32, further comprising the steps of:

checking for an error condition;

if an error condition is detected, setting an error flag;

if no error condition is detected, transferring relevant data from the primary patch pump to the primary user interface and the secondary patch pump; and

returning to the step of checking for an error flag.

34. The method of on-body fluid delivery of claim 33, wherein an error condition comprises a condition indicative of at least one of a cannula occlusion, a low reservoir, an end of reservoir, a depleted battery, a battery failure, a cannula deployment, entrapped air and a leakage.

35. The method of on-body fluid delivery of claim 33, wherein relevant data comprise data indicative of at least one an infusion profile update, an infusion command, a bolus dose, a bolus dose requirement, a basal rate, a basal rate adjustment, a confirmation of delivery, an error state or condition, and a confirmation of adjustment.

36. The method of on-body fluid delivery of claim 32, further comprising the step of:

entering a primary patch pump SNIFF mode for up to a predetermined primary patch pump SNIFF time to check for an error flag.

37. The method of on-body fluid delivery of claim 32, further comprising continuing an infusion via the secondary patch pump if an error flag is detected.

38. The method of on-body fluid delivery of claim 32, further comprising the steps of:

if an error flag is detected, determining whether the primary user interface is communicatively coupled to the primary patch pump;

if it is determined that no primary user interface is communicatively coupled to the primary patch pump, transferring relevant data from the primary patch pump to the secondary patch pump, and continuing an infusion via the secondary patch pump; and

if it is determined that the primary user interface is communicatively coupled to the primary patch pump;

transferring relevant data from the primary patch pump to the secondary patch pump and to the primary user interface, and setting the secondary pump as the primary pump; and

returning to the step of the primary patch pump communicating with the primary user interface.

39. The method of on-body fluid delivery of claim 38, further comprising setting a preemptive patch pump as the secondary patch pump.

40. The method of on-body fluid delivery of claim 32, wherein the primary patch pump is attachable to skin.

41. The method of on-body fluid delivery of claim 32, wherein the primary user interface re-synchronizes the primary user interface and at least one of the primary patch pump and the secondary patch pump.

42. The method of on-body fluid delivery of claim 32, wherein pairing the secondary patch pump to the primary user interface comprises assigning a third unique identifier to the secondary patch pump.

43. The method of on-body fluid delivery of claim 32, wherein the second fluid comprises insulin.

44. The method of on-body fluid delivery of claim 32, further comprising the steps of:

entering a primary user interface SLEEP mode by the primary user interface;

entering a primary patch pump SLEEP mode by the primary patch pump;

entering a secondary patch pump SLEEP mode by the secondary patch pump;

entering a primary user interface WAKE mode by the primary user interface at predetermined primary user interface WAKE time intervals;

entering a primary patch pump WAKE mode by the primary patch pump at predetermined primary patch pump WAKE time intervals; and

entering a secondary patch pump WAKE mode by the secondary patch pump at predetermined secondary patch pump WAKE time intervals;

wherein a power level associated with the primary user interface SLEEP mode is lower than a power level associated with a primary user interface WAKE mode,

wherein a power level associated with the primary patch pump SLEEP mode is lower than a power level associated with a primary patch pump WAKE mode, and

wherein a power level associated with the secondary patch pump SLEEP mode is lower than a power level associated with a secondary patch pump WAKE mode.

45. The method of on-body fluid delivery of claim 44, wherein if the primary user interface is engaged for an adjustment of basal rate or a setting of bolus delivery, after the adjustment or setting at least one of a SLEEP cycle, a WAKE cycle and a SNIFF cycle of the primary user interface is synchronized with at least one of a SLEEP cycle, a WAKE cycle and a SNIFF cycle of the primary patch pump and with at least one of a SLEEP cycle, a WAKE cycle and a SNIFF cycle of the secondary patch pump.

46. The method of on-body fluid delivery of claim 44, wherein at least one of a SLEEP cycle, a WAKE cycle and a SNIFF cycle of the primary user interface is synchronized with at least one of a SLEEP cycle, a WAKE cycle and a SNIFF cycle of the primary patch pump and with at least one of a SLEEP cycle, a WAKE cycle and a SNIFF cycle of the secondary patch pump.

47-72. -72. (canceled)