# US 2017/0281864 A1 · Wireless Communication for On-Body Medical Devices

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 2017/0281864 A1
- Document ID: US20170281864A1
- Status: Published application
- Kind: A1
- Application number: 15/457,272
- Filed: 2017-03-13
- Published: 2017-10-05
- Earliest claimed: 2014-08-28
- Assignees: Becton, Dickinson and Company
- Applicants: Becton, Dickinson and Company
- Inventors: Gary Searle; Deborah Burns; Bruce Burns; David Mason; Charles Hwang
- Web page: https://patentgrep.com/patent/US20170281864A1

## CPC

- A61M 5/14248: {of the skin patch type}
- G16H 20/13: delivered from dispensers
- G16H 20/17: delivered via infusion or injection
- G16H 40/63: for local operation
- G16H 40/67: for remote operation
- 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)}
- A61M 5/1684: {by detecting the amount of infusate remaining, e.g. signalling end of infusion}
- A61M 2005/14252: {with needle insertion means}
- A61M 2005/14268: {with a reusable and a disposable component}
- A61M 2205/18: with alarm
- A61M 2205/3561: local, e.g. within room or hospital
- A61M 2205/3569: sublocal, e.g. between console and disposable
- A61M 2205/3576: with non implanted data transmission devices, e.g. using external transmitter or receiver
- A61M 2205/3592: using telemetric means, e.g. radio or optical transmission
- A61M 2205/50: with microprocessors or computers
- A61M 2205/502: User interfaces, e.g. screens or keyboards
- A61M 2205/581: by audible feedback
- A61M 2205/582: by tactile feedback
- A61M 2205/583: by visual feedback
- A61M 2205/8212: with means or measures taken for minimising energy consumption
- A61M 2209/01: Remote controllers for specific apparatus
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA

## Abstract

Apparatus, systems and methods for the wireless communication of medical devices in an on-body fluid delivery system are disclosed. A system for on-body 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

### Claim 1

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.

### Claim 2 (depends on 1)

The method of on-body fluid delivery of claim 1, 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.

### Claim 3 (depends on 2)

The method of on-body fluid delivery of claim 2, 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.

### Claim 4 (depends on 2)

The method of on-body fluid delivery of claim 2, 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.

### Claim 5 (depends on 1)

The method of on-body fluid delivery of claim 1, wherein the primary user interface re-synchronizes the primary user interface and the primary patch pump.

### Claim 6 (depends on 5)

The method of on-body fluid delivery of claim 5, wherein the primary user interface re-synchronizes the primary user interface and the primary patch pump using a real-time clock.

### Claim 7 (depends on 1)

The method of on-body fluid delivery of claim 1, 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.

### Claim 8 (depends on 1)

The method of on-body fluid delivery of claim 1, 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.

### Claim 9 (depends on 1)

The method of on-body fluid delivery of claim 1, wherein the primary patch pump is attachable to skin.

### Claim 10 (depends on 1)

The method of on-body fluid delivery of claim 1, wherein the first fluid comprises insulin.

### Claim 11 (depends on 1)

The method of on-body fluid delivery of claim 1, 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.

### Claim 12 (depends on 1)

The method of on-body fluid delivery of claim 1, 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.

### Claim 13 (depends on 11)

The method of on-body fluid delivery of claim 11, 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.

### Claim 14 (depends on 11)

The method of on-body fluid delivery of claim 11, 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.

### Claim 15 (depends on 1)

The method of on-body fluid delivery of claim 1, 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.

### Claim 16 (depends on 15)

The method of on-body fluid delivery of claim 15, 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.

### Claim 17 (depends on 16)

The method of on-body fluid delivery of claim 16, 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.

### Claim 18 (depends on 16)

The method of on-body fluid delivery of claim 16, 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.

### Claim 19 (depends on 15)

The method of on-body fluid delivery of claim 15, 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.

### Claim 20 (depends on 15)

The method of on-body fluid delivery of claim 15, further comprising continuing an infusion via the secondary patch pump if an error flag is detected.

### Claim 21 (depends on 15)

The method of on-body fluid delivery of claim 15, 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.

### Claim 22 (depends on 21)

The method of on-body fluid delivery of claim 21, further comprising setting a preemptive patch pump as the secondary patch pump.

### Claim 23 (depends on 15)

The method of on-body fluid delivery of claim 15, wherein the primary patch pump is attachable to skin.

### Claim 24 (depends on 15)

The method of on-body fluid delivery of claim 15, 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.

### Claim 25 (depends on 15)

The method of on-body fluid delivery of claim 15, wherein pairing the secondary patch pump to the primary user interface comprises assigning a third unique identifier to the secondary patch pump.

### Claim 26 (depends on 15)

The method of on-body fluid delivery of claim 15, wherein the second fluid comprises insulin.

### Claim 27 (depends on 15)

The method of on-body fluid delivery of claim 15, 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.

### Claim 28 (depends on 27)

The method of on-body fluid delivery of claim 27, 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.

### Claim 29 (depends on 27)

The method of on-body fluid delivery of claim 27, 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.