WO2018172099A1

WO2018172099A1 - A modular casing system for a medical device

Info

Publication number: WO2018172099A1
Application number: PCT/EP2018/055850
Authority: WO
Inventors: Blake Matsuzaki; Kirk CORNELL; Thomas Dedenroth Miller
Original assignee: Novo Nordisk A/S
Priority date: 2017-03-22
Filing date: 2018-03-08
Publication date: 2018-09-27

Abstract

A handheld portable modular casing system for storing medical device(s) and comprising a plurality of separate casing modules, and where the module(s) are attachable to and detachable from each other. At least one module comprises a communication bridge module having data receiving means for wirelessly receiving data from a medical device via a first communication protocol, and data transferring means for wirelessly transferring said data to an external device/repository via a second communication protocol different from the first communication protocol.

Description

A MODULAR CASING SYSTEM FOR A MEDICAL DEVICE

The present invention relates to a handheld portable casing system for a medical device and that includes means enabling communication of data from the medical device to an external device.

Background of the invention

People with a chronic disease like diabetes are required to daily intake or inject medicine several times a day to keep them in control of the disease and for that they often need to bring a lot of medical device equipment with them. Most diabetes patients may often need to bring e.g. injection pen(s), blood glucose meters, test strips for blood glucose meters and some kind of storage for disposing used injection needles. However, users are different and these differences often are defined by things such as: what the user wants or needs to carry with them, how often a user needs to inject, how often a user takes a blood glucose reading, etc. With many different users it is preferable to have a flexible solution to balance the needs of all and not just have one static solution. Further, within diabetes performing the necessary insulin injections at the right time and in the right dose size is essential for managing the disease, i.e.

compliance with the specified insulin dosage regimen is important to control the blood sugar level and to minimise the risk of hypoglycaemia/hyperglycaemia episodes. In order to make it possible for the patient or the HCP to see, if the patient follows the recommended insulin dosage regimen, it is desirable that a log of the dose sizes and the time each dose was taken is kept and that these data can be transferred to an external source, like a smartphone. Thereby further analysis of the data, e.g. via an app on the smartphone, can be done in order to allow for some guidance to recommended doses and/or adjustments to a present dosage regimen, if needed. However, today a significant amount of different smartphones exist that uses different communication technologies for transmission and receiving of data, why it's a challenge to provide medical devices that are able to communicate via all these different protocols. As an example, if the patient uses a medical device that communicates data via NFC, which is a preferred method, the device can communicate with the NFC reader of an Android smartphone, as it can be accessed by a third party application, but a problem arises if the patient uses a smartphone that does not include an NFC reader but for example only Bluetooth. Numbers show that only 11% of smartphones sold include NFC readers. To solve this, casings have been provided allowing communication of data from the medical device via one kind of communication technology and transferring the data to another device via another communication technology. However such casings require that the medical device is placed in the casing to allow the communication to happen, which isn't a flexible solution, as the user needs to bring the whole casing with all the time. Different casings for carrying medical devices/materials have been described in patent publications, e.g . in WO2013/065055, US2010/0307649, JP2014050456, US2005182358, US 8,674,656, US 2013/0233741, EP 2 357 013,

WO2016/142726, WO2003/017860 and WO2005/110387. An example of a device allowing usage of different communication protocols to communicate data between a medical device and a consumer product is described in e.g . US

8,893,615.

Having regard to the above, it is an object of the present invention to provide a casing system for medical devices that in an easy way can be adapted to the patients' specific needs, i.e. can be modulated depending on what the patients want to bring with them, and that also include means for allowing communication of data from a medical device to an external device no matter what

communication protocol being used. A further object of the present invention is to provide a device adapted for storage in a casing system for medical device and which allow a user of a medical device to easily communicate data from the medical device to any of the majority of existing mobile smartphones wherever and whenever the user wants. Description of the invention

According to a first aspect of the invention a handheld portable modular casing system for storing medical device(s) is provided, the system comprising a plurality of separate casing modules, said module(s) being attachable to and detachable from each other, and wherein at least one module comprises a communication bridge module comprising; data receiving means for wirelessly receiving data from a medical device via a first communication protocol, and data transferring means for wirelessly transferring said data to an external

device/repository via a second communication protocol different from the first communication protocol.

In an exemplary embodiment the casing system comprises a module for storing an injection pen, and where the pen has means for wirelessly communicating dosage data from the pen to the communication bridge module. The injection pen may be a disposable or durable injection pen.

The communication bridge module may comprise a cavity adapted for storage of said injection pen, so that the communication bridge module can be used as a separate casing for the injection pen, if the user decides to only bring the bridge module and injection pen. In an embodiment, the communication bridge module is adapted to store only said injection pen and no other medical devices. Thus, the bridge module can be of a small size allowing it to be stored in a pocket of e.g. a shirt or a pair of trousers.

In another exemplary embodiment the communication bridge module may be in the form of a wearable adapted to be worn on the body of a user when not placed in the casing . It could e.g . be worn like a fitness tracker, medical ID bracelet or a discrete clip which can attach to any other existing wearable.

In yet another exemplary embodiment the communication bridge module may be in the form of a sticker adapted to be attached to a mobile phone when not placed in the casing, or it could be in the form of a fob adapted to be attached to a key ring, e.g. user's car keys.

The casing system may further comprise a module for storing injection needles and/or a module for storing a blood glucose meter and/or a module for storing blood test strips for the blood glucose meter.

Each of the modules are adapted for use either in combination with the casing system or separate from the casing system . By this it's possible to add and or remove modules of the system to fit a diverse user population . The casing system can be used as a discreet and small object or it can be a functional organizer to hold all supplies and medical devices. The on the move user, usually those patients that needs several injections per day (also called multi-daily- injections, MDI) can take a minimal approach and carry only the communication bridge module, including the injection pen, in a pocket to reduce the volume and number of objects, but still be able to capture and upload dosage data to an external device whenever the user wants. The stable once daily at home user can have all of their devices and supplies all in the device for easy management because they are not concerned with the size of the device. The in-between user can pick and choose what they want to include or leave out.

The communication bridge module allows for communication of data between the medical device and different kinds of smartphones, as the bridge can be modified to communicate via any appropriate protocol . The first communication protocol and second communication protocol can be selected from the group of Bluetooth, BLE, BLE Backscatter, NFC, NFMI, Wi-Fi, GSM, RFID, ZigBee, Infrared, ANT, Qwikradio, Lora, LPWan. In a specific embodiment, the communication between the injection pen and the bridge module is via NFC, whereas the communication between the bridge module and the external device, such as a smartphone, is via Bluetooth.

The external device may a mobile smartphone or server or PC or cloud. Alternatively, the communication could be wired, however it would require additional user steps.

According to a second aspect of the invention, a handheld portable

communication bridge module is provided comprising data receiving means for wirelessly receiving data from a medical device via a first communication protocol, data transferring means for wirelessly transferring said data to an external device/repository via a second communication protocol different from the first communication protocol, and wherein the module comprises a cavity for storing an injection pen having means for wirelessly communicating dosage data from the pen to the communication bridge module when positioned therein.

In an embodiment, the communication bridge module is adapted to store only said injection pen and no other medical devices and where the bridge module is of a size allowing it to be stored in a pocket of e.g . a shirt or a pair of trousers.

The bridge module according to any of the above aspects comprises a power source to power the communication parts, the power source could be a battery, e.g. in the form a coin cell, which may be rechargeable. Brief description of the drawings

Figures la-e show an embodiment of a modular casing system for medical devices, including an injection pen and a communication bridge module, according to the invention,

Figures 2a-d show another embodiment of a modular casing system for medical devices, according to the invention, including an injection pen, a communication bridge module and a module for injection needles, Figures 3a-c show a communication bridge module with an injection pen and a modular casing system with the communication bridge module, according to the invention, and Figures 4a-b and 5 show another embodiment of a modular casing system with a communication bridge module according to the invention.

Detailed description of the drawings An embodiment of a modular casing system according to the invention is shown in figs, la-e, where the casing system 1 comprises a base panel 2 having two opposite sides, each with various storage rooms 3 for equipment to be used by the user. A communication bridge module 4 has a cavity 5 for receiving and storing an injection pen 6. The bridge module can be attached to / detached from the base panel 2 at the surface 7, e.g . by Velcro. By this embodiment, the user is able to either bring the whole casing system 1, or just bring only the

communication bridge 4 with the injection pen 6 inserted therein, which then allows the user to capture and upload dosage data to an external device, e.g. a smartphone.

Figures 2a-d show another embodiment of a modular casing system 10 for medical devices, a communication bridge module 4 including an injection pen 6, and a module for injection needles 11. The casing system 10 has three

independent parts 10a, 10b and 10c, which can be attached to each other, e.g. by Velcro, or used separately. Each of the parts 10b and 10c further comprises compartments 12 adapted for storage of other equipment, e.g . test strips for a BG meter. In fig. 2c and 2d, only the two parts 10a and 10b are attached to each other, and where fig. 2c shows the casing in a folded position and fig . 2d show an unfolded position. Again, by this embodiment, the user is able to either bring the whole casing system 10, or just bring one or some of the parts 10a, 10b or 10c together with the communication bridge 4 with the injection pen 6 inserted therein and/or the module 11 for the injection needles.

Figures 3a-c shows a communication bridge module with an injection pen 6 and a modular casing system 20 with and without the communication bridge module 21 attached, respectively. The communication bridge module 21 comprises a cavity for storing the injection pen 6 meaning that the bridge module 21 can be used as an independent casing for the pen, if the user decides to only bring these. In the casing system cavities are provided for new or used cartridges 22 for a durable injection pen, a bottle 23 for storage for test strips and for a BG meter 24. Fig. 3c shows the casing system including the communication bridge module with an injection pen inserted therein.

Figures 4a-b and 5 show another embodiment of a modular casing system 30 for medical devices, including a communication bridge module 31, a module 32 for storing e.g . a BG meter, test strips etc. and a module 33 for storing injection needles, each having a hinged lid allowing access the interior of each module. In figure 4a all three modules 31, 32 and 33 are attached to each other by means of magnets 34. In figure 4b the three modules are detached from each other, i.e. the modules can be carried individually or they can be attached to each other in any combination, i.e. module 31 and 32 together or module 31 and 33 together or module 32 and 33 together. Each of the modules 31, 32 and 33 are of pocket- size meaning they can each be carried in a small pocket. As shown in figure 5, the injection pen 6 fits into the interior of the communication bridge module 31.

For all of the examples shown in all the figures, the communication bridge module 4, 21, 31 has data receiving means for wirelessly receiving data from the injection pen 6 via a first communication protocol 8, e.g . NFC, when the injection pen 6 placed in the module, and data transferring means 9 for wirelessly transferring said data to an external device/repository (as shown in figs, lc and 3a) via a second communication protocol, e.g . Bluetooth.

In the above description of exemplary embodiments, the different structures and means providing the described functionality for the different components have been described to a degree to which the concept of the present invention will be apparent to the skilled reader. The detailed construction and specification for the different components are considered the object of normal design procedure performed by the skilled person along the lines set out in the present

specification.

Claims

1. A handheld portable modular casing system for storing medical device(s), the system comprising a plurality of separate casing modules, said module(s) being attachable to and detachable from each other, and wherein at least one module comprises a communication bridge module comprising;

- data receiving means for wirelessly receiving data from a medical device via a first communication protocol, and

- data transferring means for wirelessly transferring said data to an external device/repository via a second communication protocol different from the first communication protocol.

2. A casing system according to claim 1, wherein each of the modules is adapted for use either in combination with the casing system or separate from the casing system.

3. A casing system according to claim 1 or 2, wherein the communication bridge module comprises a cavity adapted for storage of an injection pen having means for wirelessly communicating dosage data from the pen to the communication bridge module.

4. A casing system according to claim 3, wherein the communication bridge

module is adapted to store only said injection pen and no other medical devices.

5. A casing system according to claims 1-4, wherein the first communication protocol and second communication protocol is one selected from the group of Bluetooth, BLE, BLE Backscatter, NFC, NFMI, Wi-Fi, GSM, RFID, ZigBee, Infrared, and wherein the external device is a mobile phone or server or PC or cloud.

6. A casing system according to any of the preceding claims, further comprising a module for storing injection needles, a module for storing a blood glucose meter and/or a module for storing blood test strips for the blood glucose meter.

7. A casing system according to any of the preceding claims, wherein the

communication bridge module is in the form of a wearable adapted to be worn on the body of a user when not placed in the casing .

8. A casing system according to any of claims 1-6, wherein the communication bridge module is in the form of a sticker adapted to be attached to a mobile phone when not placed in the casing.

9. A casing system according to any of claims 1-6, wherein the communication bridge module is in the form of a fob adapted to be attached to a key ring when not being placed in the casing .

10. A handheld portable communication bridge module comprising; - data receiving means for wirelessly receiving data from a medical device via a first communication protocol

- data transferring means for wirelessly transferring said data to an external device/repository via a second communication protocol different from the first communication protocol, and wherein the module comprises a cavity for storing an injection pen having means for wirelessly communicating dosage data from the pen to the

communication bridge module when positioned therein.

11. A module according to claim 10, wherein the module is adapted to store only said injection pen and no other medical devices.