IP Library Granted Patent US 12667679
Granted Patent B2
US 12667679 · App. 17/431,304 · Granted Jun 30, 2026

Electronic system

Inventors: Benjamin Jung (Pulheim, DE); Kyle Wilson (Düsseldorf, DE); Richard Turner (Lancashire, GB); Julian Hemy (Cheshire, GB); Inga Meyer (Düsseldorf, DE); Nicholas G. Lesniewski-Laas (Somerville, MA)
Assignee: Presspart GmbH & Co. KG
A61M15/008A61M15/003A61M15/0045G16H20/10A61M2205/3375A61M2205/3553A61M2205/3584A61M2205/505A61M2205/583A61M2205/60
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Quick Facts
Patent No.
US 12667679
App. No.
17/431,304
Granted
Jun 30, 2026
Kind
B2
Abstract

An electronic system ( 1 ) comprises an electronic device ( 2 ) for gathering data from an inhaler ( 3 ) which is configured to dispense doses of a pharmaceutical formulation stored in a medicament reservoir. The system ( 1 ) further comprises an evaluation unit ( 9 ) being configured to receive and evaluate the gathered data in order to determine adherence to prescription data and/or to determine the number of doses having been dispensed or remaining in the inhaler ( 3 ) and a display ( 8 ) for visualizing the evaluated data. The electronic device ( 2 ) comprises a wireless interface ( 4 ) for receiving wireless data from the inhaler ( 3 ) via a wireless connection an input interface ( 5 ) for receiving manual input data and an acoustic or visual interface ( 6, 7 ) for receiving acoustic or visual data of the inhaler ( 3 ). The evaluation unit ( 9 ) is configured to identify the gathered data as wireless, acoustic, visual or manual input data, identify the inhaler model from which the data was gathered across different manufactures, process and evaluate the gathered data and visualize the processed data on the display ( 8 ).

Claims (65)

1 . Electronic system comprising,

an inhaler;

an electronic device for gathering data from an inhaler which is configured to dispense doses of a pharmaceutical formulation stored in a medicament reservoir, wherein the inhaler is a metered dose inhaler such as an electronic metered dose inhaler or a metered dose inhaler comprising a mechanical dose counter, a dry powder inhaler or a soft mist inhaler, an evaluation unit being configured to receive and evaluate the gathered data in order to determine adherence to prescription data and/or to determine the number of doses having been dispensed or remaining in the inhaler, and

a display for visualizing the evaluated data,

wherein the electronic device comprises,

a wireless interface for receiving wireless data from the inhaler via a wireless connection,

an input interface for receiving manual input data and an acoustic or visual interface for receiving acoustic or visual data of the inhaler,

wherein the evaluation unit is configured to:

identify the gathered data as wireless, acoustic, visual or manual input data;

process and evaluate the gathered data; and

visualize the processed data on the display;

wherein the evaluation unit is further configured to:

identify the inhaler model from which the data was gathered across different manufacturers;

wherein the identification of the inhaler model is accomplished depending on the type of the inhaler as follows:

(i) when the inhaler is an electronic metered dose inhaler the inhaler model is identified based on a serial number contained in the gathered data which is received wirelessly by the electronic device,

ii) when the inhaler is a metered dose inhaler comprising a mechanical dose counter the inhaler model is identified based on the gathered visual data, wherein the inhaler model is identified by its form, and

iii) when the inhaler is a dry powder inhaler the inhaler model is identified by a specific noise characteristic emitted during inhalation of the pharmaceutical formulation or the preparation or actuation of the device;

that the evaluation unit is further configured to process and evaluate the gathered data by:

generating a Type ID, which represents information regarding the type of the gathered data such as whether the gathered data is wireless, acoustic, visual or manual input data;

generating a Source ID which is unique for each inhaler model and by which each inhaler model is identifiable;

generating a timestamp representing information when a dose has been administered or the data has been received by the evaluation unit; and

generating an incremental dose count representing information regarding the number of doses dispensed since the previous timestamp,

that the system further comprises:

an identification database in which data allowing identification of the model of the inhaler of different manufacturers is stored and

a prescription database in which prescription data such as a prescribed number of administered doses over a given time interval is stored for each Source ID,

wherein when the inhaler is an electronic metered dose inhaler the Source ID is set to the serial number of the electronic metered dose inhaler,

wherein when the inhaler is a metered dose inhaler comprising a mechanical dose counter the evaluation unit is configured to assess the identification database and identify the model of the inhaler based on a comparison of the gathered data with the data stored in the identification database which provides the Source ID,

wherein when the inhaler is a dry powder inhaler the evaluation unit queries the user to select a model of an inhaler from the list stored in the identification database which provides the Source ID or determines the model based on the specific sound received,

that the system is configured to share the data via the display to be accessed remotely by a physician and,

that the system is configured such that the physician can access the prescription database in order to modify the exact number of doses to be dispensed for each patient individually, and that the system is configured to display the modified number of doses to the patient via the display and the inhaler is configured to dispense doses of pharmaceutical formulation to the patient in accordance with the modified number of doses; and

wherein the electronic system further comprises a storage database in which the processed data is stored as a data package, each data package comprising at least the Type ID, the Source ID, the timestamp and the incremental dose count;

wherein the evaluation unit is further configured to process and evaluate the gathered data by generating a quality ID which represents the accuracy of the gathered data, wherein the accuracy depends on whether the timestamp generated by the evaluation unit represents information when a dose has been administered or whether the generated timestamp represents information when the gathered data has been received by the evaluation unit; and

wherein the quality Id is stored for each data package in the storage database and is outputted to the patient.

2 . Electronic system according to claim 1 , wherein the evaluation unit is further configured to evaluate the gathered data by summing up all of the incremented dose counts stored in combination with one or more Source IDs and stored in combination with timestamps which fall within a given time interval in order to generate usage data.

3 . Electronic system according to claim 1 , wherein the electronic device comprises the evaluation unit or is connectable thereto.

4 . Electronic system according to claim 1 , wherein the electronic system comprises a server on which the evaluation unit is stored.

5 . Electronic system according to claim 1 , wherein the medicament reservoir is a canister, a blister or a capsule.

6 . Electronic system according to claim 1 , wherein the evaluation unit comprises system specific data management units which are each configured to pre-process data of the inhaler of the corresponding manufacturer wherein the evaluation unit is configured to generate the Type ID, the Source ID, the timestamp and the incremental dose count based on the pre-processed data of the system specific data management units.

7 . Electronic system according to claim 6 , wherein the system specific data management units are configured to store the pre-processed data in a system specific database, wherein the evaluation unit is configured to access the system specific database and retrieve the pre-processed data therefrom.

8 . Method for processing and evaluating data gathered from an inhaler which is configured to dispense doses of a pharmaceutical formulation stored in a medicament reservoir, the method comprising the following steps:

Providing an electronic system according to claim 1 ;

Gathering the data of the inhaler via the wireless interface,

the input interface and the acoustic or visual interface;

Identifying the gathered data as wireless, acoustic, visual or manual input data;

Identifying the inhaler model from which the data was gathered across different manufacturers;

wherein the identification of the inhaler model is accomplished depending on the type of the inhaler as follows:

i) when the inhaler is an electronic metered dose inhaler the inhaler model is identified based on a serial number contained in the gathered data which is received wirelessly by the electronic device,

ii) when the inhaler is a metered dose inhaler comprising a mechanical dose counter the inhaler model is identified based on the gathered visual data, wherein the inhaler model is identified by its form, and

iii) when the inhaler is a dry powder inhaler the inhaler model is identified by a specific noise characteristic emitted during inhalation of the pharmaceutical formulation or the preparation or actuation of the device;

Processing and evaluating the gathered data; and

iv) Visualizing the processed data on the display; and

wherein the system is configured to share the data via the display to be accessed remotely by a physician,

wherein the gathered data is processed and evaluated by:

generating a Type ID, which represents information regarding the type of the gathered data such as whether the gathered data is wireless, acoustic, visual or manual input data;

generating a Source ID which is unique for each inhaler model and by which each inhaler model is identifiable;

generating a timestamp representing information when a dose has been administered or the data has been received by the evaluation unit; and

generating an incremental dose count representing information regarding the number of doses dispensed since the previous timestamp,

wherein when the inhaler is an electronic metered dose inhaler the Source ID is set to the serial number of the electronic metered dose inhaler,

wherein when the inhaler is a metered dose inhaler comprising a mechanical dose counter the evaluation unit is configured to assess the identification database and identify the model of the inhaler based on a comparison of the gathered data with the data stored in the identification database which provides the Source ID,

wherein when the inhaler is a dry powder inhaler the evaluation unit queries the user to select a model of an inhaler from the list stored in the identification database which provides the Source ID or determines the model based on the specific sound received and,

wherein the system is configured such that the physician can access the prescription database in order to modify the exact number of doses to be dispensed for each patient individually, and the system is configured to display the modified number of doses to the patient via the display, and the inhaler is configured to dispense doses of pharmaceutical formulation to the patient in accordance with the modified number of doses, the description database storing prescription data such as a prescribed number of administered doses over a given time interval for each Source ID; and

wherein the electronic system further comprises a storage database in which the processed data is stored as a data package, each data package comprising at least the Type ID, the Source ID, the timestamp and the incremental dose count;

wherein the evaluation unit is further configured to process and evaluate the gathered data by generating a quality ID which represents the accuracy of the gathered data, wherein the accuracy depends on whether the timestamp generated by the evaluation unit represents information when a dose has been administered or whether the generated timestamp represents information when the gathered data has been received by the evaluation unit; and

wherein the quality Id is stored for each data package in the storage database and is outputted to the patient.

9 . Electronic system according to claim 1 , wherein the evaluation unit is further configured to evaluate the gathered data by compiling compliance metrics by comparing the usage data with prescription data stored in the prescription database, wherein a usage data and the prescription data to be compared are related to the same one or more source IDs.