# US 2025/0144293 A1 · Medical infusion device with a leakage determining module

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- Number: US 2025/0144293 A1
- Document ID: US20250144293A1
- Status: Published application
- Kind: A1
- Application number: 19/016,151
- Filed: 2025-01-10
- Published: 2025-05-08
- Earliest claimed: 2022-07-13
- Applicants: Roche Diabetes Care, Inc.
- Inventors: Stefan Fernsner; Christian Janke; Aaron Smith
- Web page: https://patentgrep.com/patent/US20250144293A1

## CPC

- A61M 5/14244: {adapted to be carried by the patient, e.g. portable on the body}
- 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 5/14248: {of the skin patch type}
- A61M 2205/0227: Materials having sensing or indicating function, e.g. indicating a pressure increase
- A61M 2205/15: Detection of leaks
- A61M 2205/502: User interfaces, e.g. screens or keyboards
- 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)}

## Abstract

This disclosure relates to a medical infusion device having a reservoir for holding a liquid medicament, a cannula assembly, a fluid line, a drive mechanism, a dispensing member for dispensing medicament from reservoir through the fluid line and the cannula assembly, and a leakage determining module. For a more convenient determination of leakage of liquid medicament, the leakage determining module includes an electronic probe for receiving odor molecules and/or flavor molecules of the liquid medicament and the leakage determining module has evaluation electronics to determine presence of odor and/or flavor of the liquid medicament based on readings of the electronic probe.

## Claims

### Claim 1

A medical infusion device, comprising:
a reservoir configured to hold a liquid medicament;
a cannula assembly;
a fluid line in fluid communication with the reservoir and the cannula assembly;
a drive;
a dispenser that when actuated by the drive dispenses liquid medicament from the reservoir through the fluid line and the cannula assembly; and
a leakage determining module configured to determine leakage of the liquid medicament from at least one of the reservoir, the fluid line and the cannula assembly;
wherein, the leakage determining module comprises an electronic probe configured for receiving odor molecules and/or flavor molecules of the liquid medicament and the leakage determining module further comprises evaluation electronics configured to determine presence of odor and/or flavor of the liquid medicament based on readings of the electronic probe.

### Claim 2 (depends on 1)

The medical infusion device according to claim 1, wherein the electronic probe is located at one or more locations on or at the outside of the reservoir, and/or at one or more locations on or at the outside of the cannula assembly, and/or at one or more locations on or at the outside of the fluid line.

### Claim 3 (depends on 1)

The medical infusion device according to claim 1, wherein the medical infusion device comprises a drain channel configured for guiding liquid medicament that is leaking from at least one of the reservoir, the fluid line and the cannula assembly towards the electronic probe.

### Claim 4 (depends on 1)

The medical infusion device according to claim 1, wherein the medical infusion device comprises a drain chamber configured for collecting liquid medicament leaking out of at least one of the reservoir, fluid line and cannula assembly, wherein the drain chamber comprises the electronic probe.

### Claim 5 (depends on 1)

The medical infusion device according to claim 1, wherein the leakage determining module comprises an electronic reference probe configured and arranged for receiving odor molecules and/or flavor molecules of the liquid medicament outside of the medical infusion device and wherein the evaluation electronics is further configured to determine presence of odor and/or flavor of the liquid medicament based on readings of the electronic reference probe and the readings of the electronic probe.

### Claim 6 (depends on 1)

The medical infusion device according to claim 1, wherein the medical infusion device comprises a user interface configured to indicate to the user of the medical infusion device presence of a leakage of liquid medicament based on the determination of the leakage determining module.

### Claim 7 (depends on 1)

The medical infusion device according to claim 1, wherein the medical infusion device comprises a disposable portion and a reusable portion, wherein the disposable portion comprises at least the reservoir, the fluid line, the cannula assembly and the electronic probe of the leakage determining module and/or the electronic reference probe.

### Claim 8 (depends on 7)

The medical infusion device according to claim 7, wherein the reusable portion comprises the evaluation electronics.

### Claim 9 (depends on 7)

The medical infusion device according to claim 7, wherein the disposable portion comprises the evaluation electronics.

### Claim 10 (depends on 1)

The medical infusion device according to claim 1, wherein the leakage determining module is reversibly separable from the medical infusion device.

### Claim 11 (depends on 1)

The medical infusion device according to claim 1, wherein the evaluation electronics is configured to pause determining a leakage of liquid medicament out of at least one of the reservoir, the fluid line or the cannula assembly for a predetermined period of time subsequent to a determination of a leakage of liquid medicament out of at least one of the reservoir, the fluid line or the cannula assembly.

### Claim 12 (depends on 1)

The medical infusion device according to claim 1, wherein the electronic probe and/or the electronic reference probe comprises a gas-permeable membrane that is permeable for gaseous odor molecules and/or gaseous flavor molecules of the liquid medicament and impermeable for liquid components of the liquid medicament.

### Claim 13 (depends on 1)

The medical infusion device according to claim 1, wherein the medical infusion device is a body-wearable medical infusion pump, preferably a body-wearable medical patch pump.

### Claim 14

A medical infusion system comprising a medical infusion device and a remote control, wherein the medical infusion device comprises a reservoir configured for holding a liquid medicament, a cannula assembly, a fluid line that is in fluid communication with the reservoir and the cannula assembly, a drive, and a dispenser that when actuated by the drive dispenses liquid medicament from the reservoir through the fluid line and the cannula assembly, wherein the medical infusion device is operatively coupled to the remote control, wherein the remote control comprises a leakage determining module configured to determine leakage of the liquid medicament from at least one of the reservoir, the fluid line or the cannula assembly of the medical infusion device, wherein the leakage determining module comprises an electronic probe configured for receiving odor molecules and/or flavor molecules of the liquid medicament originating from outside the remote control, and an evaluation electronics configured to determine presence of odor and/or flavor of the liquid medicament based on readings of the at least one electronic probe.
