WO2019123307A1

WO2019123307A1 - Wireless medical device and relative monitoring system

Info

Publication number: WO2019123307A1
Application number: PCT/IB2018/060327
Authority: WO
Inventors: Raffaele SMIMMO
Original assignee: Smimmo Raffaele
Priority date: 2017-12-19
Filing date: 2018-12-19
Publication date: 2019-06-27

Abstract

A portable, preferably modular and wearable, medical device (1) for monitoring at least one physiological parameter of a patient, which device (1) comprises: - a data detection module (20), in turn formed by: ■ one sensor (2), in particular an electrocardiogram electrode, configured to detect first data associated to at least a physiological parameter of the patient, and ■ support means (5) configured to implement a connection to a patient's body region; and - a data communication module (30), in turn including: ■ a control unit (3), comprising wireless communication means (6) connected to the sensor (2), which wireless communication means (6) is configured for transmitting the first data to one writing/reading device (11); ■ data storage means, wherein preferably the data detection module (20) and the data communication module (30) are coupled, in use, by reversible connection means (4).

Description

WIRELESS MEDICAL DEVICE AND RELATIVE MONITORING SYSTEM

DESCRIPTION Technical field of the invention

The present invention relates to a medical device apt to detect data associated to one or more physiological parameters of a patient, configured to transmit wirelessly the detected data to one or more remote processing systems or devices.

The invention further relates to a monitoring system based upon one or more of the above-mentioned devices.

Background

Nowadays, in the medical field several devices are known apt to detect indicative data of a physiological parameter of a patient by means of sensors of various type. Such devices usually are configured to be applied directly on a body region of the patient. By processing the data detected by hospital equipment configured to this purpose, it is possible to monitor in real time the course of the physiological parameter of the patient.

Generally, such medical devices of known type are connected to the hospital equipment for processing data by means of connection of cabled type.

Therefore, when the medical devices are applied to the patient, the latter has to tolerate not only the presence of the detection device, which often adheres directly to the his/her skin, but also the set of the cables connecting the device to the equipment. The more devices are applied to the patient at the same time, much more felt the problem is, for example in case of electrocardiographic detections or with the purpose of monitoring several physiological parameters simultaneously.

The presence of such connecting cables results to be strongly irritating as well as limiting for the patient, who during the time interval in which the monitoring is performed, cannot perform any activity involving even minimum motions, such as for example the simple reading of a book. In fact, such motions could involve artefacts in detection and correct connection of the cables respectively to the medical device and the hospital equipment for processing data.

Such problem is still more felt when the monitoring of the physiological parameter is required during execution of high-risk procedures for the patient involving his/her motion, such as for example his/her transfer from the operating room to the intensive care or, generally, emergency procedures wherein it is fundamental to perform a correct and constant monitoring of some physiological parameters In this case, the connecting cables represent a real obstacle to the patient’s motion and they make the procedures to be performed by medical personnel much more complex.

Still, the known medical devices are configured for transmitting in real time the data of the patient to the processing equipment, therefore their use implies necessarily that upon detecting data the patient is in hospital environment, where there is the equipment apt to process the data transmitted by the medical devices.

Summary of the invention

The technical problem placed and solved by the present invention is to provide a medical device apt to detect and transmit data associated to physiological parameters of a patient allowing to obviate the drawbacks mentioned above with reference to the known art.

Such problem is solved by a device according to claim 1 and by a system according to claim 20.

Preferred features of the present invention are set forth in the depending claims.

The present invention provides a medical device apt to detect data of a patient associated to one or more physiological parameters to be monitored. Such device allows the remote transmission of the detected data wirelessly, then without the help of connections of cabled type. Therefore, the present invention provides a medical device of portable type. To this purpose, the medical device of the invention has wireless (without wires) communication means, which in particular implements the standard Bluetooth®.

The possibility of transmitting data wirelessly allows to ease all procedures providing to move the patient, while maintaining unaltered the effectiveness of the concomitant monitoring of the physiological parameters of the same.

More specifically, in a particular preferred embodiment thereof the device of the invention is configured to include two modules which can be selectively coupled, and in particular:

^■ a first module, or element, for detecting data, comprising at least one sensor apt to detect one or more physiological data from the patient, and

^■ a second module, or element, for communicating wirelessly, the latter apt to transmit such data to one or more systems, or devices, for the remote processing configured to receive and process the same data.

In an embodiment variant, the sensor(s) can be applied on the same wireless communication element. In this case, the above-mentioned first element, or module, can be absent or it can constitute a possibly disposable support for the application on the body of the patient. Advantageously, the first and the second element, when there are both of them, can be removably connected or connectable with one another.

It will be understood that in the present context under the term sensor any means for detecting physical, mechanical or electrical quantities, including the transducers, is meant.

The remote devices, advantageously, can include writing/reading means, as it will be appreciated hereinafter.

The above-mentioned preferred modular structure of the device allows, in case of need, to replace only one of the two above-mentioned modules. In particular, as detection module a disposable module can be used, for example constituted by an electrode. The non-reuse of the detection module can be due to reasons inherent to the hygiene of the device, above all in case the latter provides a direct contact with the skin or other body region of the patient. On the contrary, the wireless communication module is configured to be preferably re-used an undetermined number of times. Preferably, to this purpose, the detection module is advantageously made of washable and/or sterilizable material. Based upon a more preferred embodiment of the invention, the wireless communication element includes a memory unit configured to store personal data of the patient, in particular anamnestic data, anthropometric data, or others, and also, advantageously, the data detected by the sensor(s) of the device itself. Therefore, as said, the memory unit can be configured to store automatically the data detected by the sensor(s), to allow to process the collected data even in a moment subsequent to their detection. This results to be particularly advantageous since it allows to collect data from the patient even outside the hospital environment, their storage in memory and a subsequent communication and processing, for example performed periodically, in a centre having the equipment configured to receive the data from the device and to process them.

In the considered variant, the equipment is configured to access wirelessly to the memory of the device and in case to modify the data stored therein, for example by entering additional ones. Considering the sensitive nature of the treated data, it is possible to provide that the access to the memory of the device is allowed only to health care staff members having a determined authorization level.

In each case, an additional arrangement of the device can be provided to implement an accessory connection of cabled type, in addition to the wireless communication means.

According to preferred embodiments of the invention, the wireless communication element is further configured to receive data from other homologous devices, to store them and/or to send them to equipment for data processing.

In a preferred embodiment example, the device includes, as sensor, an electrocardiogram electrode, configured to detect data related to the cardiac electric activity of the patient.

Other advantages, features and use modes of the present invention will result evident from the following detailed description of some embodiments, shown by way of example and not for limitative purposes. Brief description of the figures

The figures of the enclosed drawings will be referred to, wherein:

■ Figure 1 shows an exemplifying block diagram of a first preferred embodiment of one device according to the present invention;

^■ Figure 2 shows a perspective view, in partially exploded configuration, of a preferred embodiment variant of the device of Figure 1 ; and

^■ Figure 3 shows an exemplifying block diagram of a preferred embodiment of a monitoring system according to the present invention, which can include the device of Figure 1 or 2.

Detailed description of preferred embodiments

By firstly referring to Figure 1 , a medical device according to a first preferred embodiment of the present invention is designated as a whole with 1.

The device 1 is modular and configured to implement the monitoring of at least a physiological parameter of a patient. To this purpose, the device 1 includes a first module, or element, for detecting data 20 and a second module, or element, for communicating data 30, the latter configured to allow the wireless transmission of the data detected by the first module 20 to a remote processing system.

The data detection module 20 comprises at least one sensor 2, configured to detect first data associated to at least a physiological parameter of the patient hereinafter, for convenience, one single sensor 2 will be referred to, but it is to be meant that the device 1 according to the present invention could include a plurality of such sensors, preferably each one assigned to the detection of a piece of data of different type, allowing ultimately to monitor a specific physiological parameter associated thereto, so that by means of one single device it is possible to monitor a plurality of physiological parameters of the patient.

The first module 20 and the second module 30 are operatively connected to allow to transfer data from the sensor 2 to the communication module 30. Moreover, the two modules 20 and 30 provide reversible connection means 4. The latter preferably includes a pressure locking system, for example of the clip button type or other interlocking mechanical coupling between a pin and a respective seat, as shown with reference to the embodiment variant of Figure 2. Alternatively, it is to be meant that additional means of known type could be used to connect reversibly the first module 20 and the second module 30, like for example mechanical closing systems which use threaded bodies, or bayonet fittings, or still the textile closing system of the hook and slot type (for example Velcro®).

According to preferred embodiments of the invention, the connection means 4 has a first connection portion 41 comprised in the first module 20 and a second connection portion 42 comprised in the second module 30, such first portion 41 and second portion 42 being apt to cooperate to implement the reversible connection between the modules 20 and 30 (Figure 2).

Advantageously, the modularity of the device 1 allows to be able to replace, for example in case of maintenance, failure or other needs, only one of the two modules. The data detection module 20 can even include support means 5, configured to implement a connection to a patient’s body region, for example to allow the sensor 2 to adhere directly to the skin of the patient or however to position at a distance suitable to detect the data required to determine the physiological parameter of interest.

In particular, the support means 5 can include a wearable element, for example an elastic bandage or bracelet. According to such implementation, the medical device 1 , indeed, is of wearable type.

Alternatively, or in combination, the support means 5 can be of adhesive type, that is apt to implement a direct adhesion or anchoring of the device 1 to the skin of the patient. For example, the support means 5 can include an adhesive film applied on a surface of the data detection module 20 which, in use, is assigned to adhere to the skin of the patient’s body region to be monitored. Before use, the adhesive layer can be protected by a removable film or layer.

Such embodiment of the support means is the one provided in Figure 2, wherein the data detection module 20 has a surface coated with adhesive film, not visible in Figure, which is opposite to the surface of the data detection module 20 faced on the data communication module 30.

As mentioned above, the data communication module 30 is configured to allow the wireless transmission of the data detected by the sensor 2 to one or more third systems, units or devices in turn equipped with wireless communication means (for example smartphone or electronic processors), in particular equipped with writing/reading means.

To this purpose, in the present example the data communication module 30 has a control unit 3 comprising wireless communication means 6.

The wireless communication means 6 is connected, directly or indirectly, to the sensor 2 so as to allow data communication and is configured for transmitting the data detected by the sensor 2 to the above-mentioned one or more systems, units or devices, preferably automatically and in real time. Preferably, the wireless communication means 6 implements the standard Bluetooth®. Advantageously, thanks to the modular structure of the device 1 , when required, it is possible to replace only one of the two modules 20 and 30. In particular, preferred embodiments of the device of the invention include a disposable detection module 20, for example comprising or constituted of an electrode for ECG, as in the example shown in Figure 2.

The non-reusability of the module 20 is provided particularly when the module 20 is configured to adhere directly on the skin of the patient, above all to avoid problems of hygienical nature.

The sensor 2, in embodiment variants, can be one pressure sensor or transducer, temperature or cardiac electric activity and it can be implemented cheaply.

Moreover, embodiment variants can provide that the sensor(s) is(are) associated to the communication module or element 30. In this case, the element 20 can be absent or constitute at least the support for the element 30.

The module, or element, for the wireless communication 30 preferably is configured to be re-used an undetermined number of times. In order to favour the re-use of the data communication module 30, this can be made of washable and/or sterilizable material, preferably of plastic material or rubber with high stiffness.

The data communication module 30 then can be advantageously used for new detections on the same patient or for detections on different patients

In particular, for each different detection, the data communication module 30 can be coupled to a different data detection module 20, in particular to a data detection module 20 having one sensor 2 apt to detect a different piece of data or parameter, for example with the purpose of monitoring a different physiological condition of the patient.

According to preferred embodiments of the invention, the data communication module 30 - in particular its control unit 3 - comprises even a memory unit, or means 9, as shown in Figure 1. The memory unit 9 is programmed to store, preferably automatically, the data detected by the sensor 2. Such memory unit 9 is connected to the wireless communication means 6 to allow the transmission of the data stored therein. If the data communication module 30 is of reusable type and it is used in relation to different patients, the deletion of data of the patient previously stored in the memory unit 9 can be provided, to avoid confusion in attributing the detected data.

In particular, the wireless communication means 6 can be further configured for: transmitting the data detected by the sensor 2 to other homologous devices; receiving additional data, in particular associated to at least a physiological parameter of the patient, from other homologous devices; and/or transmitting even such additional data to a remote monitoring system and, in particular, to a writing/reading device. An example of communication between two medical devices 1 , T according to the present invention and one writing/reading device 11 , which implements a system 10 as a whole for monitoring at least one physiological parameter of a patient, is shown in Figure 3 by means of a block diagram.

The memory unit 9 preferably can be programmed to store, preferably automatically, even the additional data received by other devices T.

Preferably, the memory unit 9 can be accessed wirelessly by means of one writing/reading device 11 by a user, according to a predetermined authorization level of such user, who for example belongs to the medical personnel of the health facility which is treating the patient thereto the device 1 , T is applied According to such preferred variant, the memory unit 9 is further programmed to store, preferably automatically, data received from such writing/reading device 11. Such data can include data associated to at least a physiological parameter of the patient and/or historical clinical data of the patient. The latter advantageously can include also images and/or videos.

Preferably, based upon a preferred embodiment variant, the memory unit 9 is configured to store specific data of a patient such as for example anamnestic data, anthropometric data or other.

In such variant, the device 1 can even implement a real digital medical record, wherein data related to physiological parameters of the patient in different time ranges are included, detected by means of one or more devices 1 , T and/or inserted in the memory unit 9 for example by means of the writing/reading device 11 , and/or the results of clinical and instrumental tests, so that it is possible to know completely the history and the clinical picture of the patient by simply accessing wirelessly to the device 1.

Embodiment variants can further provide the possibility of re-writing the unit memory 9 or replacing the unit 9 itself, for example to use the device and/or the data communication module on a different patient.

One wishes to underline, together with the latter consideration, the customization of the device which could be owned, transported and used indifferently by the single patient or by the home consultation physician or in the health care facility. Preferably, the writing/reading device 11 includes a monitor or display, and it is programmed to process the data received by the device 1 to acquire or extrapolate the physiological parameter associated thereto, in case by representing graphically the time course thereof on the monitor.

In order to allow the energy supply of the device 1 , a battery 7, shown in Figure 1 , can be provided, preferably included in the data communication module 30. The battery 7 preferably is of rechargeable type, still more preferably rechargeable wirelessly.

According to preferred embodiments of the invention, the data communication module 30 comprises a first compartment, or seat, a wherein the control unit 3 (and in case the memory 9), is housed and a second compartment, or seat, b wherein such battery 7 is housed.

According to preferred embodiments of the invention, for example according to the preferred embodiment variant of Figure 2 wherein the sensor 2 is an electrode, the device 1 can have an overall substantially cylindrical shape or a disk, preferably comprising two circular base surfaces having an area comprised between about 5 and 10 cm² and a height (or overall thickness of the device 1 , meant as overall dimension in direction substantially orthogonal to the circular base surface) equal to about 1 cm. According to such embodiments, both modules 20, 30 have a substantially cylindrical, almost disk-like, shape thanks to the fact that the height of the cylindrical shape is much smaller than the area of the base circular surface.

Generally, even by considering other sensors commonly used for monitoring physiological parameters of patients, such as for example sensors for measuring blood pressure or temperature, the overall dimensions of the device 1 appear to be very limited and however comparable to those of a common electrode.

The present invention has been sofar described with reference to preferred embodiments. It is to be meant that other embodiments belonging to the same inventive core may exist, as defined by the protective scope of the herebelow reported claims.

Claims

1. A medical device (1 ) for monitoring at least one physiological parameter of a patient, comprising:

- a data detection element (20), having at least one sensor (2) configured to detect data associated to the above-mentioned physiological parameter of the patient;

- a data communication element (30), in turn comprising wireless communication means (6) operatively connected to said at least one sensor (2) and configured to transmit the data detected by the latter to a remote monitoring system (10);

- storage means (9), configured to store additional data of the patient; and

- support means (5), configured to connect the device (1 ) to a patient’s body region.

2. The device according to claim 1 , which is of a modular type and comprises:

- a first module, including said support means (5) and preferably said data detection element (20);

- a second module (30), including said data communication element (30) and said storage means (9),

wherein said first and/or second module have reversible connection means (4) configured for mutual connection

and wherein said first module is preferably of a disposable type.

3. The device (1 ) according to claim 1 or 2, wherein said storage means (9) is connected to said wireless communication means (6).

4. The device (1 ) according to anyone of the preceding claims, wherein said storage means (9) is programmed to store, preferably automatically, data received from other homologous devices (T).

5. The device (1 ) according to anyone of the preceding claims, wherein said storage means comprises a memory unit (9) programmed to store, preferably automatically, the data detected by at least one sensor (2).

6. The device (1 ) according to anyone of the preceding claims, wherein said storage means (9) is accessible, through said wireless communication means (6), to a remote writing/reading device (11 ), preferably performed by a user according to a predetermined authorization level.

7. The device (1 ) according to anyone of the preceding claims, wherein said storage means (9) is programmed to store, preferably automatically, additional data comprising: data associated to at least a physiological parameter of the patient, historical patient clinical data and/or anamnestic data, preferably even in form of images and/or videos.

8. The device (1 ) according to anyone of the preceding claims, wherein said wireless communication means (6) is configured for: transmitting the data detected by the sensor (2) to other homologous devices (T); receiving additional data, in particular associated to at least a physiological parameter of the patient, from other homologous devices (T); and/or transmitting also such additional data to a remote monitoring system (10) and, in particular, to a writing/reading device (1 1 ).

9. The device (1 ) according to anyone of the preceding claims, wherein said support means (5) comprises a wearable device.

10. The device (1 ) according to anyone of the preceding claims, wherein said support means (5) comprises an adhesive film, suitable, in use, to adhere to a patient’s body region.

11. The device (1 ) according to anyone of the preceding claims, wherein said data communication element (30) is reusable.

12. The device (1 ) according to anyone of the preceding claims, wherein said data communication element (30) is made of washable and/or sterilizable material, preferably of plastic material.

13. The device (1 ) according to anyone of the preceding claims, comprising a battery (7), preferably rechargeable and even more preferably rechargeable wirelessly.

14. The device (1 ) according to the preceding claim, comprising a first compartment (a) wherein said storage means (9) is housed and a second compartment (b) wherein said battery (7) is housed.

15. The device (1 ) according to anyone of the preceding claims, wherein said sensor (2) is selected in a group comprising: an electrocardiogram electrode; a pressure sensor, in particular of blood pressure; a thermometer.

16. The device (1 ) according to claim 2, wherein said reversible connection means (4) comprises a pressure locking system, preferably of the clip button type.

17. The device (1 ) according to anyone of the preceding claims, wherein said wireless communication means (6) implements the Bluetooth® standard.

18. The device (1 ) according to anyone of the preceding claims, which is a portable device.

19. The device (1 ) according to anyone of the preceding claims, having an overall substantially cylindrical shape, preferably comprising two circular base surfaces having an area comprised between about 5 and 10 cm² and a height equal to about 1 cm.

20. A system (10) for monitoring at least one physiological parameter of a patient, comprising at least one medical device (1 ) according to anyone of the preceding claims and at least one writing/reading device (11 ), preferably configured for a wireless communication with said medical device (1 ).

21. The system (10) according to claim 20, wherein said at least one writing/reading device (11 ) comprises a monitor, said writing/reading device (11 ) being programmed to process data received from said at least one device (1 ) to calculate the respective physiological parameter associated thereto and to graphically represent the course over time of this physiological parameter on said monitor.