Monitoring device

Abstract

A monitoring device suitable for attachment to a surface of a subject, the device having a data collector and a processor. The data collector includes a flexible foil attached to a less flexible socket, where the foil forms a dermal side surface of the data collector for adhesion to a skin surface of a subject to be monitored. To enable communication of electrical signals between the data collector and the processor, the data collector includes a distribution structure formed as a pattern of an electrically conductive material on an outer surface of a foldable sheet. The foldable sheet forms a layer in the flexible foil and having an interface portion which is folded into an aperture in the socket to form a coupling inside the cavity for electrical communication with a matching coupling of the processor when the processor is received in the cavity.

Claims

1. A monitoring device comprising a data collector and a separate processor, wherein the data collector comprises a flexible foil attached to a less flexible socket, the foil forming a dermal side surface for adhesion of the data collector to a skin surface of a subject to be monitored and the socket forming a cavity for receiving the processor, wherein the data collector further comprises a foldable sheet with a first pattern of an electrically conductive material on an outer surface thereof, the first pattern extending between a sensing portion of the sheet which forms a layer in the flexible foil and an interface portion of the sheet which is folded into an aperture in the socket and forms an electrical coupling for electrically connecting the processor to the data collector, and wherein the processor is disposed within the cavity.

2. The device according to claim 1, wherein the data collector further comprises at least one electrode for communicating an electrical signal between the monitoring device and the subject, and where the first pattern provides individual conductivity between each electrode and the coupling.

3. The device according to claim 2, wherein the at least one electrode comprises a second pattern of electrically conductive material on the outer surface of the sensing portion of the foldable sheet.

4. The device according to claim 3, wherein the second pattern and the first pattern are of identical electrically conductive material.

5. The device according to claim 3, wherein the socket is between the interface portion and the sensing portion of the sheet.

6. The device according to claim 1, wherein the device comprising a spring structure forming part of the socket and located between the interface portion of the sheet and the dermal side surface of the data collector, the spring structure providing a spring force in an upwards direction being perpendicular to and directed away from the dermal side surface such that the force becomes towards the processor when the processor is received in the cavity.

7. The device according to claim 1, wherein the processor is received into the cavity in a downwards direction being perpendicular to and directed towards the dermal side surface.

8. The device according to claim 1, wherein the processor is received into the cavity in a sideways direction being parallel to and directed towards the dermal side surface.

9. The device according to claim 6, wherein the spring structure comprises a number of upwards protrusions separated from adjacent protrusions by recesses or openings in the socket.

10. The device according to claim 9, wherein the processor is received into the cavity in a sideways direction being parallel to and directed towards the dermal side surface, and wherein the recesses or openings between adjacent protrusions are oblong and extend in a direction being parallel to the sideways direction.

11. The device according to claim 1, wherein the socket forms a locking structure adapted to hold the processor in the cavity, the locking structure being adapted to apply a constant force on the processor in a downwards direction being perpendicular to and directed towards the dermal side surface thereby forcing the processor into the cavity.

12. The device according to claim 11, wherein the socket comprises a structurally weakened portion, and the locking structure is releasable by controlled destruction at the structurally weakened portion of the socket.

13. The monitoring device according to claim 1, wherein the processor comprises a connector for establishing a cabled connection to an external unit, the connector being covered by the socket, when the processor is received in the cavity.

14. The monitoring device according to claim 1, wherein the processor and the socket have matching non symmetric shapes facilitating the processor to be received in the cavity only in one singe orientation of the processor relative to the socket.

15. A method of making a device according to claim 1, wherein the method comprising the steps of: providing the first pattern of the electrically conductive material on the outer surface of the foldable sheet; providing the flexible foil which includes the foldable sheet and which forms the dermal side surface for adhesive contact with the skin surface; providing the socket which is less flexible than the foil; attaching the socket to an upper surface of the foil facing away from the dermal side surface; and folding the interface portion of the sheet through the aperture in the socket; providing, from the interface portion, the coupling for electrical communication with a matching coupling of the processor; and coupling the coupling of the processor to the coupling of the interface portion.

Description

LIST OF DRAWINGS

(1) In the following, embodiments of the invention will be described by way of example with reference to the figures in which:

(2) FIGS. 1 and 2 illustrate a monitoring device according to the invention;

(3) FIGS. 3 and 4 illustrate details of the socket and foil in a cross-sectional view;

(4) FIG. 5 illustrates the layers in a data collector adapted for EMG signal detection;

(5) FIG. 6 illustrates an embodiment of the data collector suitable for ECG signal detection;

(6) FIGS. 7-10 illustrate details of the locking structure adapted to hold the processor in the cavity;

(7) FIGS. 11 and 12 illustrate a socket and details of a spring structure forming part of the socket;

(8) FIG. 13 illustrates an exploded view of the processor; and

(9) FIGS. 14 and 15 illustrate an embodiment where the processor is inserted sideways in a track.

(10) Further scope of applicability of the present invention will become apparent from the following detailed description and specific examples. However, it should be understood that the detailed description and specific examples, while indicating preferred embodiments of the invention, are given by way of illustration only, since various changes and modifications within the scope of the invention will become apparent to those skilled in the art from this detailed description.

DETAILED DESCRIPTION OF DRAWINGS

(11) FIGS. 1 and 2 illustrate a monitoring device 1 comprising a data collector 2 and a separate processor 3 which is detachably attachable to the data collector. In FIG. 1, the processor is attached to the data collector, and in FIG. 2, the processor is detached from the data collector.

(12) The data collector comprises a flexible foil 4 made from an elastically or at least flexible material. On a dermal side surface 5, the foil comprises an adhesive, e.g. a hydrocolloid adhesive for adhesion of the data collector to a skin surface of a subject to be monitored. On an opposite, upper surface of the foil, the data collector comprises a socket 6 made from a rigid plastic material and being less flexible than the foil. The socket and the foil are adhesively, and preferably, non-detachably joined. The flexibility of the foil enables the foil to be adhesively attached to the skin surface and to follow the contour of the body. The foil may, additionally, be lengthwise elastically deformable such that it can be stretched. The foil has a laminated structure including numerous thin layers of different materials.

(13) The socket forms a cavity 7 for receiving the processor. The cavity has a depth of approximately half of the height of the processor, i.e. such that half of the processor may be depressed into the cavity. The processor includes a shoulder 8 which comes in contact with the upper edge 9 of the socket. At this point, the electrical coupling 10 of the processor and the electrical coupling 11 of the data collector are joined, and electrical communication between the data collector and the processor is established.

(14) To reduce impact of moisture, water, or dirt etc., the socket and/or the processor may include a resilient, elastically deformable, gasket located between the socket and the processor and which is compressed when the processor is inserted in the socket. The gasket could be located on or at the shoulder 8 or on/at the upper edge 9.

(15) The processor includes a pair of steps 12, 13 which are received in matching windows 14, 15 in the socket. The steps provide a free space under the electrical coupling of the processor, when the processor is placed on a table etc. and thereby protects the electrical terminals against contamination and wear.

(16) FIG. 3 illustrates a cross sectional view of the data collector and FIG. 4 illustrates details herein, particularly of the electrical coupling 11 of the data collector. The data collector comprises a sheet 16 with a pattern 17 of an electrically conductive material, herein referred to as “a first pattern”. The first pattern is printed on an outer surface of the sheet. A portion of the sheet, herein referred to as “a sensing portion” is integrated into the laminated structure of the foil, i.e. it forms one of the layers in the laminated structure. The sheet is foldable, and an interface portion of the sheet is folded through an aperture or window 18 into the cavity. By this folding of the sheet, the outer surface becomes upwards, i.e. it faces towards the processor when the processor is received in the cavity.

(17) Since the first pattern is applied to the outer surface of both the sensing portion and the interface portion, the folded sheet forms a very flat and thin electrical coupling for electrically connecting the processor to the data collector.

(18) FIG. 4 also illustrates an upward protrusion 19 forming a spring structure which provides a spring force in the upwards direction indicated by the arrow 20.

(19) FIG. 5 illustrates the data collector in an exploded view, in this case in an embodiment suitable for EMG signal detection. Herein, it is clearly seen that the foil has a laminated structure including a plurality of layers, 21-27, and that the foldable sheet 25 constitutes one of the layers. The more rigid socket has numeral 28.

(20) FIG. 5 illustrates the layers in a data collector adapted for EMG. In this data collector, table 1 below specifies detailed materials suitable for each layer.

(21) TABLE-US-00001 TABLE NO 1 Numeral Description Material 25 Foldable sheet with PET (polyester) foil with printed electrical silver/silver chloride conductors and conductive ink electrodes, i.e. printed with the first and second patterns of electrically conductive material. 26 Skin adhesive tape Acrylic adhesive with PET non-woven backing 24 Double sided adhesive Acrylate adhesive tape reinforced with polyester fibers 23 Skin adhesive tape Acrylic adhesive with PET non-woven backing 22 Conductive Sensing Polyacrylate based Hydrogel hydrogel 27 Double sided adhesive Acrylate adhesive tape located between reinforced with polyester the interface portion of fibers the sheet 25 and the socket 28. 29 Double sided adhesive Acrylate adhesive tape reinforced with polyester fibers 28 Injection molded ABS (Acrylonitrile socket butadiene styrene) 21 Release liner Silicone coated PET foil

(22) FIG. 6 illustrates an alternative embodiment of the data collector in an exploded view, in this case suitable for ECG signal detection. Again, it is clearly seen that the foil has a laminated structure including a plurality of layers, 30-37, and that the foldable sheet 34 constitutes one of the layers. The more rigid socket has numeral 38.

(23) Table 2 below specifies detailed materials suitable for each layer in the ECG data collector.

(24) TABLE-US-00002 TABLE NO. 2 Numeral Description Material 34 Foldable sheet with PET (polyester) foil with printed electrical silver/silver chloride conductors and conductive ink electrodes, i.e. printed with the first and second patterns of electrically conductive material 35 Skin adhesive tape Acrylic adhesive with PUR (Polyurethane) backing 37 Double sided adhesive Acrylate adhesive tape reinforced with polyester fibers 39 Double sided adhesive Acrylate adhesive tape reinforced with polyester fibers 32 Skin adhesive tape Acrylic adhesive with PET non-woven backing 31 Conductive Sensing Polyacrylate based Hydrogel hydrogel 30 Release liner Silicone coated PET foil 36 Carrier for patch Silicone coated paper 38 Injection molded ABS (Acrylonitrile socket butadiene styrene) 33 Double sided adhesive acrylate adhesive tape reinforced with polyester fibers

(25) FIGS. 7-10 illustrate details of the locking structure adapted to hold the processor in the cavity.

(26) The locking structure comprises a number of flexible protrusions 40 arranged sequentially around the upper edge 41 of the socket, i.e. mainly at the corners of the upper edge. Relative to the downwards direction for inserting the processor in the cavity, i.e. the direction indicated by the arrow 42, the protrusions has a beveled upper edge surface 43 and an opposite transverse edge surface 44. Due to the beveled upper edge surface, the depressed edge 45 of the processor 46 can be pressed down in level with the protrusions, whereby the protrusions engage the depressed edge and locks the processor to the socket. Due to the transverse edge surface 44, the processor is fixed and can only be removed by destruction of the socket.

(27) The socket, and particularly the protrusions are arranged and shaped relative to the processor and particularly relative to the depressed edge such that the locking structure applies a constant force on the processor in the downwards direction illustrated by the arrow 42, i.e. directed towards the dermal side surface thereby forcing the processor into the cavity and downwards onto the electrical coupling formed by the interface portion of the foldable sheet.

(28) The socket may form a sealing edge to the processor in the cavity. The sealing edge prevents fluid (e.g. water) from entering the cavity. The sealing characteristics may be obtained by use of the same rigid plastic materials by which the socket and the processor is made, e.g. by use of different angles of the edge surface ensuring sealing. Alternatively, or in combination, a softer material, e.g. rubber or thermoplastic elastomers, may be provided on the edge of the socket or on the processor. The locking structure may apply a constant force on the processor whereby the softer material becomes deformed and sealing is obtained.

(29) FIG. 9 illustrates an opposite end of the socket in a cross-sectional view. In this vies, it can be seen that the socket is designed for controlled destruction. By breaking an end portion 47 of the socket outwards, the locking protrusions 48 are pulled out of the depressed edge 49 and the processor is released from the socket. FIG. 10 illustrates that the processor can be lifted out of the socket.

(30) FIGS. 11 and 12 illustrate a socket 6 and details of a spring structure forming part of the socket. In FIGS. 11 and 12, the sheet and the foil in which the sheet forms an integrated layer is omitted to more clearly illustrate the spring structure. The spring structure 50 is located directly adjacent the through opening forming a window 51 through which the interface portion of the sheet is folded. The spring structure comprises a number of upwards protrusions best seen in FIG. 12 and being indicated with numeral 52. The upwards protrusions are separated from adjacent protrusions by through holes forming openings 53 (c.f. FIG. 12) in the socket. The openings are oblong and extend in a direction which herein is referred to as “a sideways direction”.

(31) Due to the upwards direction of the protrusions, indicated in FIG. 11 by the arrow 54, the spring structure provides a spring force in an upwards direction when the protrusions are deformed downwardly upon inserting the processor in the cavity. The spring structure forms part of the socket 6, i.e. it is formed in one part with the socket, e.g. by pressure molding or vacuum molding etc. e.g. from a plastic material being more rigid than the sheet and foil.

(32) FIG. 13 illustrates an exploded view of the processor. The processor comprises a top-shell 55, two PCB (printed circuit boards) 56, 57, a battery 58 and a bottom shell 59 on which the top-shell is received to form a closed capsule. Internally, the processor comprises a memory block 60, an antenna 61 enabling wireless communication with an external data recipient, a CPU (computer processing unit) 62 programmed to perform processing of data received from or transmitted to the data collector. Additionally, the processor comprises a micro USB connector for connecting the processor to an external data receiver or for charging the battery. Additionally, the processor comprises a coupling 64 facing downwards and adapted for electrical connection to the coupling in the socket of the data collector.

(33) Where the embodiment described above is adapted for insertion of the processor in a downwards direction from above into the socket, FIGS. 14 and 15 illustrate an embodiment where the processor is inserted sideways in a track formed by cooperating ledges 65 of the socket and processor. In this embodiment, the spring structure formed in the socket comprises protrusions separated by recesses or openings which are oblong and extend in a direction being parallel to the sideways direction indicated by arrow 66, and the first pattern 67 printed on the interface portion of the foldable sheet forms conductors which, correspondingly, extend in parallel with the sideways direction.

LISTED EMBODIMENTS

(34) 1. A monitoring device comprising a data collector and a separate processor, the data collector comprising a flexible foil attached to a less flexible socket, the foil forming a dermal side surface for adhesion of the data collector to a skin surface of a subject to be monitored and the socket forming a cavity for receiving the processor, wherein the data collector further comprises a foldable sheet with a first pattern of an electrically conductive material on an outer surface thereof, the first pattern extending between a sensing portion of the sheet which forms a layer in the flexible foil and an interface portion of the sheet which is folded into an aperture in the socket and forms an electrical coupling for electrically connecting the processor to the data collector. 2. A device according to embodiment 1, where the data collector further comprises at least one electrode for communicating an electrical signal between the monitoring device and the subject, and where the first pattern provides individual conductivity between each electrode and the coupling. 3. A device according to embodiment 2 or 3, where the at least one electrode comprises a second pattern of electrically conductive material on the outer surface of a sensing portion of the foldable sheet. 4. A device according to embodiment 3, where the second pattern and the first pattern are of identical electrically conductive material. 5. A device according to any of embodiments 3-4, where the socket is between the interface portion and the sensing portion of the sheet. 6. A device according to any of the preceding embodiments, comprising a spring structure forming part of the socket and located between the interface portion of the sheet and the dermal side surface of the data collector, the spring structure providing a spring force in an upwards direction being perpendicular to and directed away from the dermal side surface such that the force becomes towards the processor when the processor is received in the cavity. 7. A device according to any of the preceding embodiments, where the processor is receivable into the cavity in a downwards direction being perpendicularly to and directed towards the dermal side surface. 8. A device according to any of the preceding embodiments, where the processor is receivable into the cavity in a sideways direction being parallel to and directed towards the dermal side surface. 9. A device according to any of embodiment 6-9, where the spring structure comprises a number of upwards protrusions separated from adjacent protrusions by a recess or opening in the socket. 10. A device according to embodiments 8 and 9, where the recesses or openings between adjacent protrusions are oblong and extend in a direction being parallel to the sideways direction. 11. A device according to any of the preceding embodiments, where the socket forms a locking structure adapted to hold the processor in the cavity, the locking structure being adapted to apply a constant force on the processor in a downwards direction being perpendicularly to and directed towards the dermal side surface thereby forcing the processor into the cavity. 12. A device according to embodiment 11, where the locking structure is releasable by controlled destruction at a structurally weakened portion of the socket. 13. A monitoring device comprising a data collector and a separate processor, the data collector comprising a flexible foil attached to a less flexible socket, the foil forming a dermal side surface for adhesion of the data collector to a skin surface of a subject to be monitored and the socket forming a cavity for receiving the processor, wherein the processor comprises a connector for establishing a cabled connection to an external unit, the connector being covered by the socket, when the processor is received in the cavity. 14. A monitoring device comprising a data collector and a separate processor, the data collector comprising a flexible foil attached to a less flexible socket, the foil forming a dermal side surface for adhesion of the data collector to a skin surface of a subject to be monitored and the socket forming a cavity for receiving the processor, wherein the processor and the socket have matching non symmetric shapes facilitating the processor to be received in the cavity only in one singe orientation of the processor relative to the socket. 15. A method of making a device according to any of embodiments 1-14, the method comprising the steps of: providing an interface pattern of an electrically conductive material on an outer surface of a foldable sheet; providing a flexible foil which includes the foldable sheet and which forms a dermal side surface for adhesive contact with a skin surface; providing a socket which is less flexible than the foil; attaching the socket to an upper surface of the foil facing away from the dermal side surface; and folding an interface portion of the sheet through an aperture in the socket; and providing from the interface portion, a coupling for electrical communication with a matching coupling of the processor.