EP3021749A1

EP3021749A1 - Monitoring kit having a monitoring device in the form of a patch

Info

Publication number: EP3021749A1
Application number: EP14767113.5A
Authority: EP
Inventors: Thomas Gradel; Gérald Blanco-Gomez; Sylvain LEVY; Gérard Weil
Original assignee: Voice
Current assignee: Voice
Priority date: 2013-07-19
Filing date: 2014-07-18
Publication date: 2016-05-25
Also published as: FR3008602A1; WO2015008260A1

Abstract

A kit (34) for monitoring the physical activity of a human or an animal, comprising a monitoring device (1) and a prosthesis (32) intended to be implanted in the body of a patient. The monitoring device (1) comprises sensor means (2), processing means (3), storage means (4) and power supply means (5) included in a detection unit (6), and comprises flexible support means (7) suitable for being fastened to the skin of a patient. The flexible support means (7) comprise means (8) for receiving the detection unit (6), suitable for removably receiving the detection unit (6). The monitoring device (1) comprises means (33) for detecting and determining the orientation in space of said prosthesis (32).

Description

MONITORING KIT WITH SURVEILLANCE DEVICE

PATCH FORM

TECHNICAL FIELD OF THE INVENTION

The present invention relates to a kit for monitoring the bodily activity of a human, comprising a device for monitoring movements made by the body of a human and a prosthesis intended to be implanted in the body of said human (or patient).

In order to monitor the body activity of a patient, it has been possible to resort to a motion detection of a patient using a monitoring device as described in US 201 1/0295547 A1, WO 201 1/109716 A2 and WO 2009/127954 A2. Such a monitoring device comprises:

sensor means capable of detecting one or more movement parameters of the body of a patient and of generating signals,

processing means capable of processing the signals transmitted by the sensor means to convert them into data,

storage means, able to memorize the data,

- Power supply means.

This known monitoring device is placed and held on the body of the patient by means of an elastic band or straps, in particular in the form of a bracelet for gripping the patient's limb. Such placement and maintenance means, however, have certain disadvantages.

Firstly, the elastic bands and straps induce a consequent discomfort for the patient, who then has a tendency to unconsciously modify his physiological behavior during his movements. The measurements made by the sensor means are then not representative of the reality of the movements that are usually performed by the patient.

Next, the body parts to which the monitoring device is attached may vary in volume (as may be the volume of a ribcage, for example) during the patient's body activity, and the elastic band or straps may thus vary. become looser and allow movement of the monitoring device relative to the patient's body (in rotation and / or translation relative to the patient's limb), which affects the accuracy of the measurements made by the sensor means. Document US 2003/0153900 A1 describes a device for monitoring the determination of certain substances in the blood, such as glucose, in order to administer a drug to the patient if necessary.

Document US 2012/0022341 A1 describes a device for detecting the dissolution of a tablet by the gastric juices of a patient. This document comprises electrodes intended to be placed on the skin of the patient and adapted to detect an epidermal signal indicating the dissolution of the tablet by the gastric juices.

None of the aforementioned documents describes the monitoring of the proper functioning of a prosthesis after implantation in a patient.

SUMMARY OF THE INVENTION

A first problem proposed by the invention is to optimize the positioning, the maintenance and / or the orientation of a device for monitoring the bodily activity of a human, by limiting the discomfort experienced by the patient and making him more reliable. the measurements made.

Simultaneously, the invention aims to allow monitoring of the proper functioning of a prosthesis.

Simultaneously, the invention aims to allow the patient to maintain proper body hygiene in his daily life despite the presence of the monitoring device.

To achieve these and other objects, the invention provides a kit for monitoring the bodily activity of a human, comprising a monitoring device comprising:

sensor means, able to detect one or more movement parameters of the body of a patient, and able to generate signals representative of these parameters,

storage means, able to memorize the data,

- Power supply means;

flexible support means able to be fixed on the skin of the patient, in which:

said sensor, processing, storage and power supply means are included in a detection unit,

the flexible support means comprise means for receiving the detection unit, adapted to removably receive the detection unit, the monitoring kit comprises a prosthesis intended to be implanted in the body of the patient,

the monitoring device comprises means for detecting and determining the orientation in the space of said prosthesis.

The flexible support means readily conforms to the human body to attach to locations deemed appropriate by medical personnel. In this way, the flexible support means make it possible to place the monitoring device as close to the patient's body as possible in order to avoid annoying it, and as close as possible to the zones likely to promote a more precise detection of the movements of the patient's body and of the orientation in the space of the prosthesis.

The flexible support means attaches to the patient's skin, i.e. preventing any relative movement of translation and / or rotation between the patient's skin and the flexible support means. This promotes a more accurate detection of movements of the patient's body and orientation in the space of the prosthesis.

The support means being adapted to removably receive the detection unit, the latter can be reused with other support means that can be discarded after use.

The detection unit is thus kept for reuse, which provides an economic gain, and a regular change of the support means is allowed to allow the patient to maintain a suitable body hygiene.

Furthermore, the receiving means allow a temporary withdrawal of the detection unit for recharging thereof in electrical energy or for care of the patient (shower for example).

Finally, the detection and determination of the orientation in the space of the prosthesis, coupled with the simultaneous analysis of the movements of the patient, makes it possible to better know and qualify the behavior of the prosthesis after implantation.

For example, it is possible to monitor one or more movement parameters (amplitude, angle, etc.) of the patient in correlation with the orientation in the space of the prosthesis during said movements, and thus to check the dynamic operation of the prosthesis or to detect movement parameters of the patient's body that would be critical for the prosthesis. This can help medical staff verify the adequacy of the implanted prosthesis with the pathology that has been diagnosed.

It is also possible to quantify and verify the wear of the prosthesis during its operation. This can help medical staff to plan for a possible replacement of the prosthesis beyond a certain threshold of wear that is then specific to the patient and its specific body activity.

Finally, one can characterize the particular physical activity of the patient by detecting movements made to sit, get up, lie down, walk, run or climb a staircase.

According to a first embodiment of the invention, the flexible support means may comprise an adhesive layer adapted to be fixed on the skin of the patient. The adhesive layer allows uniform contact of the flexible support means on the patient's body, with satisfactory holding qualities.

In a variant of this first embodiment of the invention, the flexible support means may comprise a plurality of superimposed adhesive layers. This plurality of superimposed adhesive layers allows the same flexible support means to be glued, peeled off and then glued on the body of the patient satisfactorily several times. Each superimposed layer is painful and can thus be separated from the other adhesive layers of the flexible support means to be discarded. Its removal exposes an intact lower level adhesive layer that is ready to adhere effectively to the patient's body to secure the monitoring device.

According to a second embodiment of the present invention, the flexible support means may be able to be fixed on the skin of the patient by means of depression of the volume located between the skin of the patient and the flexible support means. Such depression means allow to plaster the flexible support means on the patient's skin by exerting a tensioning of the skin located under the flexible support means. This has the effect of limiting the "skin effects" (movements of the skin relative to the flesh and / or the bones of the patient) that could interfere with measurements.

In addition to the depressurizing means, the flexible support means may comprise a peripheral zone provided with an adhesive layer and surrounding a central zone devoid of adhesive material. The adhesive layer thus disposed at the periphery of the flexible support means makes it possible to ensure a satisfactory peripheral seal for an optimal depression of the volume situated between the skin of the patient and the flexible support means.

Advantageously, the depression means may be carried by the flexible support means, and the depression means may comprise: - a pumping unit,

measuring means adapted to measure the depression present in the volume located between the skin of the patient and the flexible support means,

- Control means of the pumping unit, adapted so that, when the depression present in the volume between the patient's skin and the flexible support means is below a predetermined value, the control means control the pumping unit for increasing the depression in the volume between the patient's skin and the flexible support means.

Maintaining the flexible support means against the body of the patient is thus optimized by servocontrol.

Preferably, it can be provided that:

the detection unit comprises a housing containing the sensor, processing, storage and power supply means,

- The receiving means comprise a housing of inner shape substantially complementary to the outer shape of the housing of the detection unit.

The flexible support means thus comprise receiving means that are simple to manufacture and to use by the patient and the medical personnel.

Advantageously, the inner shape of the housing and the outer shape of the housing of the detection unit can be shaped so that the receiving means receive the detection unit in a single predetermined orientation. This is particularly advantageous when the sensor means requires a precise position and / or orientation to make reliable measurements of certain patient movements.

Advantageously, the housing may be defined by an elastic contour and may have an inner shape of dimensions slightly smaller than the dimensions of the outer shape of the housing of the detection unit. The detection unit can thus be inserted into the housing in order to be satisfactorily retained. Conversely, the detection unit can, thanks to the elastic nature of the housing contour, be extracted if necessary.

Preferably, the monitoring device may comprise means for wireless transmission of the stored data to a remote central unit. The medical staff can thus collect the data contained in the monitoring device as a result of measurements without having to remove the latter from the patient. This also allows data collection in the remote CPU as time goes by when the storage means of the storage device monitoring are insufficient to contain all the data to be stored, especially when the monitoring period to ensure is very long.

Advantageously, the sensor means may comprise a gyrometer, and / or an inclinometer, preferably of the magnetometer type, and / or an accelerometer. Such sensor means allow satisfactory detection and analysis of most movements of the human body.

SUMMARY DESCRIPTION OF THE DRAWINGS

Other objects, features and advantages of the present invention will become apparent from the following description of particular embodiments, with reference to the accompanying figures, in which:

FIG. 1 is a front view of a body activity monitoring kit of a human, comprising a prosthesis intended to be implanted in the body of a patient and a monitoring device according to a first embodiment. of the invention;

FIG. 2 is a perspective view of a first variant of the first embodiment of a monitoring device illustrated in FIG. 1;

- Figure 3 is a side view of a second variant of the monitoring device of Figures 1 and 2;

- Figures 4 and 5 are side views and in section of a first and a second variant of a second embodiment of the monitoring device of the invention;

FIG. 6 is a view from below of the monitoring device of FIG. 4 or 5; and

FIG. 7 is a perspective view of a third variant of the second embodiment of a monitoring device of the invention.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

In Figures 1 to 7 are illustrated two particular embodiments of a monitoring device 1 according to the invention. This monitoring device 1 comprises:

sensor means 2, able to detect one or more movement parameters of the body of a patient, and able to generate signals representative of these parameters,

processing means 3, able to process the signals emitted by the sensor means 2 to convert them into data,

storage means 4, capable of storing the data,

- Supply means 5 in electrical energy. The sensor 2, processing 3, storage 4 and supply 5 means are included in a detection unit 6.

The monitoring device 1 also comprises flexible support means 7 capable of being fixed on the skin P of the patient, which flexible support means 7 comprise receiving means 8 of the detection unit 6, adapted to receive removably the detection unit 6.

FIGS. 2 and 3 show two variants of a first embodiment of surveillance device 1.

The first variant is distinguished in that the flexible support means 7 comprise, on their lower face 7a intended to be in contact with the skin P of the patient, an adhesive layer 9 adapted to be fixed on the skin P. In this illustrated variant in FIG. 2, the flexible support means 7 comprise a single adhesive layer 9 and are therefore discarded after being used.

In the second variant illustrated in FIG. 3, the flexible support means 7 comprise a plurality of superimposed adhesive layers 9a to 9e. The layers 9a to 9d are peelable, that is to say they can be removed from the flexible support means 7 after use to reveal the adhesive layer 9b, 9c, 9d or 9e placed underneath and intended to ensure new fixing flexible support means 7.

In the second embodiment illustrated in FIGS. 4 and 5, the flexible support means 7 are able to be fixed on the patient's skin P by means of depression of the volume V situated between the patient's skin P and the flexible support means 7.

To do this, the vacuuming means 10 comprise a suction channel 1 1 opening on the lower face 7a of the flexible support means 7 and comprise non-return valve means 12. The non-return valve means 12 comprise a closure ball 13 permanently urged against a seat 14 by elastic return means 15.

In the first variant illustrated in FIG. 4, the depression of the volume V situated between the skin P of the patient and the flexible support means 7 requires the use of suction means (by means of a syringe for example). intended to suck the air present in the volume V by the suction channel 1 1 to extract it as illustrated by the arrow 16. The vacuum means 10 can be carried by the flexible support means 7, as illustrated in FIG. 4, or can be carried by the detection unit 6. In the second variant illustrated in FIG. 5, the depression means 10 are carried by the flexible support means 7 and the depression means 10 comprise:

a pumping unit 17,

measuring means 18 adapted to measure the depression present in the volume V situated between the skin P of the patient and the flexible support means 7,

control means 19 of the pumping unit 17 adapted so that, when the depression present in the volume V situated between the skin P of the patient and the flexible support means 7 is below a predetermined value, the control means 19 control the pumping unit 17 to increase the depression in the volume V located between the skin P of the patient and the flexible support means 7.

The flexible support means 7 are thus held against the skin P of the patient by means of a servocontrol of the depression.

In FIG. 6, showing the lower face 7a of the flexible support means 7, there is a peripheral zone 20 provided with an adhesive layer 21.

The peripheral zone 20 surrounds a central zone 23 devoid of adhesive material. The adhesive layer 21 thus provides a seal between the support means 7 and the skin P of the patient along the entire periphery of the lower face 7a of the flexible support means 7. This limits the risk of rupture of the seal between the lower face 7a and the skin P of the patient, to maintain a vacuum in the volume V able to ensure satisfactory contact between the flexible support means 7 and the skin P of the patient.

In Figures 1 to 6, the receiving means 8 comprise a boss 24 provided with a through-light 25, while the detection unit 6 has a recess 26 for receiving the boss 24. The recess 26 is provided with lights lateral 27.

To removably attach the detection unit 6 to the support means 7, the boss 24 is engaged in the recess 26 so that the side lights 27 and the through-light 25 are in correspondence. A locking rod 22 is then inserted which locks the detection unit 6 on the support means 7 by simultaneously engaging in the side lights 27 and the through-light 25.

To remove the detection unit 6 from the support means 7, the locking rod 22 is extracted from the side openings 27 and the through-light 25. The detection unit 6 is then freely separable. support means 7. In the monitoring device 1 illustrated in FIG. 7, the detection unit 6 comprises a housing 6a containing the sensor means 2, the processing means 3, the storage means 4, and the supply means 5. The receiving means 8 comprise a housing 8a of inner shape 8b substantially complementary to the outer shape 6b of the housing 6a of the detection unit 6.

The housing 8a is defined by an elastic contour 28 which has an inner shape 8b of dimensions slightly smaller than the dimensions of the outer shape 6b of the housing 6a of the detection unit 6. The detection unit 6 can thus be inserted slightly in force, and removably, in the housing 8a by a translational movement illustrated by the arrow 29.

Note also that the inner shape 8b of the housing 8a and the outer shape 6b of the housing 6a of the detection unit 6 are shaped so that the flexible support means 7 receive the detection unit 6 in a single and unique predetermined orientation.

This ensures an introduction of the detection unit 6 into the housing 8a in a single orientation when the sensor means 2 present in the detection unit 6 require precise positioning with respect to the patient's body, precise positioning which has been determined and applied to flexible support means 7 when attached to the skin P of the patient.

In FIG. 1, it can be seen that the monitoring device 1 comprises wireless transmission means 30 of the data stored at a remote central unit 31. The sensor means 2 comprise a gyrometer, and / or an inclinometer, preferably of the type magnetometer, and / or an accelerometer.

In Figure 1, there is also shown a prosthesis 32 (prosthetic femoral stem in this case) intended to be implanted in the body of a patient. The monitoring device 1 comprises means 33 for detecting and determining the orientation of said prosthesis 32. The assembly comprising the monitoring device 1 and the prosthesis 32 thus forms a monitoring kit 34 of the activity body of a human, to monitor the proper functioning of the prosthesis 32 and / or to quantify and check the wear of the prosthesis 32 during its operation, and / or to check several parameters of movements (amplitude, angle, etc. .) of the patient in correlation with the orientation in the space of the prosthesis during said movements. The invention is not limited to a prosthesis of the femoral stem type.

It will be understood that the arrangement characteristics of the sensor 2, processing 3, storage 4 and supply 5 means in a control unit. detection 6, and the ability characteristics of the receiving means 8 to removably receive the detection unit 6, improve patient hygiene and reuse of the detection unit 6 with support means 7 new. These characteristics can nevertheless be omitted without compromising the knowledge and qualification of the behavior of the implanted prosthesis 32 obtained by the detection and the determination of the orientation in the space of the prosthesis 42, coupled with the simultaneous analysis of the movements of the prosthesis. patient.

It is also understood that the fixation feature on the skin using flexible support means 7 greatly improves the accuracy of the detection of one or more movement parameters of the body of a patient and the detection and determination the spatial orientation of said prosthesis 32. Such a fixation feature may nevertheless be omitted without totally compromising the knowledge and qualification of the behavior of the prosthesis 32 after implantation provided by the detection and determination of the orientation in the space of the prosthesis 42, coupled with the simultaneous analysis of the movements of the patient.

In the foregoing description and in the claims, the term "patient" should be understood to mean a human or an animal.

The present invention is not limited to the embodiments which have been explicitly described, but it includes the various variants and generalizations thereof within the scope of the claims below.

Claims

1 - Kit for monitoring (34) the body activity of a human or an animal, comprising a monitoring device (1) comprising:

sensor means (2) capable of detecting one or more movement parameters of the body of a patient and able to generate signals representative of these parameters,

processing means (3), able to process the signals emitted by the sensor means (2) to convert them into data,

storage means (4) capable of storing the data,

- Power supply means (5),

flexible support means (7) able to be fixed on the skin (P) of the patient, in which:

said sensor (2), processing (3), storage (4) and supply (5) means are included in a detection unit (6),

the flexible support means (7) comprise receiving means (8) of the detection unit (6) adapted to removably receive the detection unit (6),

characterized in that

the monitoring kit (34) comprises a prosthesis (32) intended to be implanted in the body of the patient,

- The monitoring device (1) comprises means (33) for detecting and determining the orientation in the space of said prosthesis (32).

2 - Surveillance kit (34) according to claim 1, characterized in that the flexible support means (7) comprise an adhesive layer (9) adapted to be fixed on the skin (P) of the patient.

3 - monitoring kit (34) according to one of claims 1 or 2, characterized in that the flexible support means (7) comprise a plurality of adhesive layers (9a - 9e) superimposed.

4 - Surveillance kit (34) according to claim 1, characterized in that the flexible support means (7) are adapted to be fixed on the skin (P) of the patient by means of depression (10) of the volume (V) located between the skin (P) of the patient and the flexible support means (7).

5 - Surveillance kit (34) according to claim 4, characterized in that the flexible support means (7) comprise a peripheral zone (20) provided with an adhesive layer (21) and surrounding a central zone (23) devoid of adhesive material. 6 - Surveillance kit (34) according to one of claims 4 or 5, characterized in that the vacuum means (10) are carried by the support means (7) flexible, and in that the means of depression (10) comprise:

a pumping unit (17),

measuring means (18) adapted to measure the depression present in the volume (V) located between the skin (P) of the patient and the flexible support means (7),

- control means (19) of the pumping unit (17) adapted so that, when the depression in the volume (V) between the skin (P) of the patient and the support means (7) flexible is below a predetermined value, the control means (19) controls the pumping unit (17) to increase the depression in the volume (V) between the skin (P) of the patient and the support means ( 7) flexible.

7 - Surveillance kit (34) according to any one of claims 1 to 6, characterized in that:

the detection unit (6) comprises a housing (6a) containing the sensor (2), processing (3), storage (4) and power supply (5) means,

- The receiving means (8) comprise a housing (8a) of inner shape (8b) substantially complementary to the outer shape (6b) of the housing (6a) of the detection unit (6).

8 - Surveillance kit (34) according to claim 7, characterized in that the inner shape (8b) of the housing (8a) and the outer shape (6b) of the housing (6a) of the detection unit (6) are shaped so that the receiving means (8) receives the detection unit (6) in a single predetermined orientation.

9 - Surveillance kit (34) according to one of claims 7 or 8, characterized in that the housing (8a) is defined by an elastic contour (28) and has an inner shape (8b) of dimensions slightly smaller than the dimensions the outer shape (6b) of the housing (6a) of the detection unit (6).

10 - Surveillance kit (34) according to any one of the claims

1 to 9, characterized in that it comprises means for wireless transmission (30) of the stored data to a remote central unit (31).

1 1 - Surveillance kit (34) according to any one of the claims

1 to 10, characterized in that the sensor means (2) comprise a gyrometer, and / or an inclinometer, preferably a magnetometer type, and / or an accelerometer.