ELECTRODE PATCH WITH MULTIPLE MEASUREMENT POINTS

Abstract

An electrode patch, in particular for performing electrocardiography. The electrode patch includes an elastic adhesive layer having an adhesive contact surface that is configured to adhere to the skin of a subject the electrode patch is applied to; an elastic conductive layer including a plurality of measurement points and conductive paths, the conductive paths being configured to conductively connect the plurality of measurement points to a connector; and a plurality of electrodes, wherein each of the plurality of electrodes is formed at least by one of the plurality of measurement points and a corresponding recess provided in the adhesive layer, which recess extends through the entire layer thickness of the adhesive layer and is provided or providable with a substance that is adhesive and conductive, such as hydrogel, so as to conductively connect the one of the plurality of measurement points to the skin of the subject. At least 90% of the area of the electrode patch is radiolucent by means of radiolucency of the adhesive layer and the conductive layer.

Claims

1. An electrode patch, in particular for performing electrocardiography, comprising: an elastic adhesive layer having an adhesive contact surface that is configured to adhere to the skin of a subject the electrode patch is applied to; an elastic conductive layer including a plurality of measurement points and conductive paths, the conductive paths being configured to conductively connect the plurality of measurement points to a connector; and a plurality of electrodes, wherein each of the plurality of electrodes is formed at least by one of the plurality of measurement points and a corresponding recess (28) provided in the adhesive layer, which recess extends through the entire layer thickness of the adhesive layer and is provided or providable with a substance that is adhesive and conductive, such as hydrogel, so as to conductively connect the one of the plurality of measurement points to the skin of the subject; wherein at least 90% of the area of the electrode patch is radiolucent by means of radiolucency of the adhesive layer and the conductive layer.

2. The electrode patch according to claim 1, wherein the adhesive layer has an elastic modulus from 1.0 to 600.0 N/mm.sup.2, preferably from 2.0 to 500.0 N/mm.sup.2, more preferably from 3.0 to 250.0 N/mm.sup.2, still more preferably from 3.0 to 20.0 N/mm.sup.2.

3. The electrode patch according to claim 1, wherein the adhesive layer is at least partially optically transparent.

4. The electrode patch according to claim 1, wherein the conductive layer comprises a conductive particle composition, in particular a silver-carbon paste, the silver-carbon paste preferably having 50 to 90 wt. % silver paste with 30 to 80% solid constituents.

5. The electrode patch according to claim 1, further comprising an elastic carrier layer, wherein the conductive layer is arranged between the carrier layer and the adhesive layer, and wherein the carrier layer is radiolucent.

6. The electrode patch according to claim 1, further comprising a description layer visualizing at least one of the plurality of measurement points and/or at least one instruction and/or at least one reference point for supporting the predetermined positioning of the electrode patch on the subject.

7. The electrode patch according to claim 1, further comprising a dielectric layer being arranged between the adhesive layer and the conductive layer, wherein the recess also extends through the entire layer thickness of the dielectric layer.

8. The electrode patch according to claim 1, wherein the adhesive layer is dielectric.

9. The electrode patch according to claim 1, wherein the electrode patch is partly perforated.

10. The electrode patch according to claim 1, wherein the electrode patch has a thickness between 10 and 1000 μm in the area of the at least one measurement point and a thickness between 10 and 1000 μm in the other areas, wherein preferably the thickness in the area of the at least one measurement point is larger than the thickness in the other areas.

11. The electrode patch according to claim 1, wherein the electrode patch comprises a hybrid adhesive layer comprising the adhesive layer, which is locally adhesively reinforced by a reinforcing adhesive layer.

12. The electrode patch according to claim 1, wherein the electrode patch has a single-piece form; and/or wherein the electrode patch comprises: a first portion which is designed to extend to the right side of the subject's sternal midline in an attached state of the electrode patch, a second portion which is designed to extend to the left side of the subject's sternal midline in an attached state of the electrode patch, and a third portion which is designed to being disposed posteriorly in an attached state of the electrode patch.

13. The electrode patch according to claim 1, wherein the electrode patch comprises the connector, which is conductively connected to the conductive paths and is conductively connected or connectable to an internal or external device so that signals can be transferred from the conductive paths to the device via the connector; and wherein preferably the device is magnetically and/or mechanically, removably connectable to the connector.

14. A system, in particular for performing electrocardiography, comprising: an electrode patch according to claim 1; a connector which is conductively connected to the conductive paths; and an internal or external device which is conductively connected or connectable to the connector so that signals can be transferred from the conductive paths to an internal or external device via the connector.

15. A method of manufacturing an electrode patch, in particular an electrode patch according to claim 14, comprising the steps: providing an elastic adhesive layer having an adhesive contact surface that is configured to adhere to the skin of a subject the electrode patch is applied to; providing a flexible conductive layer including a plurality of measurement points and conductive paths, the conductive paths being configured to conductively connect the plurality of measurement points to a connector; and embedding a plurality of electrodes in the electrode patch, wherein each of the plurality of electrodes is formed at least by one of the plurality of measurement points and a corresponding recess provided in the adhesive layer, which recess extends through the entire layer thickness of the adhesive layer and is provided or providable with a substance that is adhesive and conductive, such as hydrogel, so as to conductively connect the one of the plurality of measurement points to the skin of the subject; wherein at least 90% of the area of the electrode patch is radiolucent by means of radiolucency of the adhesive layer and the conductive layer.

16. The electrode patch according to claim 2, wherein the adhesive layer is at least partially optically transparent.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0117] For a better understanding of embodiments of the invention and to show how the same may be carried into effect, reference will now be made, purely by way of example, to the accompanying drawings in which like numerals designate corresponding elements or sections throughout.

[0118] In the accompanying drawings:

[0119] FIG. 1 shows a schematic cross sectional view of a first embodiment of the electrode patch, displaying the electrode patch configuration in the region of a measurement point.

[0120] FIG. 2 shows a schematic cross sectional view of the first embodiment of the electrode patch, displaying the electrode patch configuration in the region of a conductive path.

[0121] FIG. 3 schematically shows an overall shape of an embodiment of the electrode patch in top view.

[0122] FIG. 4 shows a schematic cross sectional of the first embodiment of the electrode patch, displaying the electrode patch configuration during manufacturing.

[0123] FIG. 5 shows a schematic cross sectional view of a second embodiment of the electrode patch, displaying the electrode patch configuration in the region of a measurement point.

[0124] FIG. 6 shows a schematic cross sectional view of an embodiment of the adhesive layer.

[0125] FIG. 7 shows a schematic view of a further embodiment of the electrode patch comprising a hybrid adhesive layer.

DETAILED DESCRIPTION OF THE DRAWINGS

[0126] Various examples of embodiments of the present invention will be explained in more detail by virtue of the following embodiments illustrated in the figures and/or described below.

[0127] FIG. 1 shows the layers of a first embodiment of the electrode patch 10 according to the invention in the region of a measurement point. The electrode patch 10 comprises an adhesive layer 12 having an adhesive contact surface 14 which when the patch is used in the predetermined manner is oriented towards a subject surface 16. The adhesive contact surface 14 is configured to adhere to the subject surface 16, in particular to the skin of a subject such as a patient. The adhesive layer 12 can for example be an adhesive polymer film or coating or a double sided adhesive tape. The adhesive layer 12 is stretchable, which improves the positioning and wearing comfort of the electrode patch.

[0128] Further, opposite to the adhesive contact surface 14, the elastic adhesive layer 12 has an adhesive patch surface 18 that is configured to adhere to adjacent surfaces. As shown in the embodiment of FIG. 1, in the region of the measurement point, the adjacent surface is a surface of a dielectric layer 20. It will be understood that in other regions of the patch, the adhesive layer 12 can be in contact with other layers than the dielectric layer 20, e.g. with a description layer 22 and/or with a carrier layer 24, since the dielectric layer 20 can in some embodiments be provided only in the region of the measurement points 26A and conductive paths 26B, i.e. in the region of the conductive layer 26 so as to cover and insulate the conductive layer 26. In FIG. 1, a cross sectional view of a measurement point 26A of the conductive layer 26 is shown. As shown in FIG. 1, the dielectric layer 20 at least partially encompasses the subjacent conductive layer 26, i.e. the measurement point 26A. The dielectric layer is also stretchable.

[0129] A recess 28 is provided in the electrode patch 10 in the area of the measurement point 26A. The recess 28 extends through the entire thickness of both the adhesive layer 12 and the dielectric layer 20 and thus exposes the subjacent measurement point 26A. The recess 28 is aligned with the measurement point 26A. Further, the recess 28 and the measurement point 26A can be concentric as shown in FIG. 1. Both the recess 28 and the measurement point 26A can have circular, square, rectangular or any other suitable shape. The recess 28 and the measurement point 26A can have the same or a different shape.

[0130] The combination of layers and components in the region of the measurement point 26A forms one electrode of the electrode patch 10. Of course, the electrode patch can comprise multiple of such electrodes, e.g. 2 to 100 electrodes.

[0131] The recess 28 can receive or, as in FIG. 1, is provided with an adhesive and conductive substance 30, e.g. with hydrogel 30. Alternatively or additionally, the recess 28 can be provided with one or more cover layers such as AgCl. Alternatively, in a case in which biocompatible conductive substances for the measurement point, the recess does not need to be provided with any additional substance. The substance 30 is configured to conductively connect the corresponding measurement point 26A of the conductive layer 26 to the skin of the subject surface 16 when the electrode patch 10 is applied to the subject. As the dielectric layer 20 insulates all other portions of the conductive layer 26, apart from the portion/s in the area of the recess 28, conductive connections between the subject surface 16 and the conductive layer 26 can only be established via the substance 30, i.e. via the recesses 28. The signals received by the measurement point 26A are further transmitted to a conductive path 26B conductively connected with the corresponding measurement point 26A (see FIG. 3).

[0132] In the present embodiment, the conductive layer 26 is stretchable and is formed by a silver-carbon paste comprising 70 wt. % silver paste. This preferred composition ensures an optimal transmission of the obtained signals even when the electrode patch 10 is stretched during use.

[0133] Further, in the embodiment shown in FIG. 1, the description layer 22 is provided adjacent to the conductive layer 26 in a direction oriented away from the subject surface 16 when the electrode patch 10 is applied to the subject, i.e. used in the predetermined manner. The description layer 22 can visualize the corresponding measurement point 26A. Alternatively or in addition, the description layer 22 can visualize at least one instruction and/or at least one reference point for supporting the predetermined positioning of the electrode patch 10 on the subject. It will be understood that the description layer 22 does not have to be a continuous layer, but can be present e.g. only in predetermined positions of the patch. The description layer 22 can be stretchable.

[0134] The carrier layer 24 is disposed adjacent to the description layer 22 in a direction oriented away from the subject surface 16 when the electrode patch 10 is applied to the subject. In the present example, the carrier layer 24 is a TPU layer. It provides sufficient stability and elasticity, while providing sufficient comfortability for the subject applied with the electrode patch 10, even during long-term use.

[0135] FIG. 2 shows a cross sectional view of the same embodiment of the electrode patch shown in FIG. 1 in the region of a conductive path 26B. It is apparent from FIG. 2 that no recess is provided in the regions of conductive paths. Thus, the conductive paths of the electrode patch 10 are insulated towards the outside patch surfaces and are each only conductively connected to a corresponding measurement point and a connector 32 (see FIG. 3). With other words, each conductive path 26B is only indirectly conductively connected to the subject via a measurement point 26A and substance 30.

[0136] All of the layers of the electrode patch 10 shown in FIGS. 1 and 2 are radiolucent, i.e. are substantially or fully transparent to electromagnetic radiation employed in common (medical) imaging procedures, such as X-ray or MRI, in a manner and degree similar to human soft tissue, e.g. muscle tissue. Thus, these layers do not interferingly emerge in X-ray or MRI pictures so that the electrode patch according to the invention can be worn by a patient during X-ray and/or MRI treatment without negatively affecting the treatment.

[0137] At least one and preferably all of the adhesive layer 12, the dielectric layer 20, the description layer 22, the carrier layer 24 and the substance 30 have greater radiolucency than the conductive layer 26. However, in the present embodiment, even the conductive layer 26 is radiolucent, i.e. does not darken an image of a common hospital X-ray (RTG) more than 50% of image intensity, preferably not more than 40%, preferably not more than 30%.

[0138] As different layer combinations are present in different regions of the electrode patch, the radiolucency can vary in different regions of the electrode patch, depending on the number, thickness and type of layers present in the particular region.

[0139] Further, in the shown embodiment, all layers except of the description layer 22 and the conductive layer 26 are optically transparent, i.e. the human eye is able to see through these layers and to see structures, items, etc. underneath the electrode patch.

[0140] An overall shape of the electrode patch according to an exemplary embodiment of the present invention is shown in FIG. 3. The shape is not limited to a particular internal structure or layer combination of the electrode patch. FIG. 3 shows an example of the electrode patch 10 comprising a conductive layer 26 having 16 measurement points 26A, wherein each measurement point 26A is conductively connected to the connector 32 via a corresponding conductive path 26B.

[0141] The connector 32 is adhesively attached to the carrier layer 24 in the present case. The connector 32 is not only conductively connected to the conductive paths 26B, but is also conductively connectable to a device (not shown) so that signals can be transferred from the conductive paths 26B to the device via the connector 26A. Alternatively, the device and the connector can together form an integrated component. In the present example, the connector 32 is polymer based and is radiolucent and optically transparent.

[0142] The shown electrode patch 10 comprises a first portion 34 which is designed to extend to the right side of the subject's sternal midline in an attached state of the electrode patch 10. Further, the electrode patch 10 comprises a second portion 36 which is designed to extend to the left side of the subject's sternal midline in an attached state of the electrode patch 10, and a third portion 38 which is designed to being disposed posteriorly in an attached state of the electrode patch 10.

[0143] This electrode design is particularly advantageous regarding a quick and correct positioning. For applying the electrode patch 10, the user, e.g. a practitioner, can successively attach initially the first portion 34, subsequently the second portion 36 and afterwards a third portion 38 of the electrode patch 10. Thus, the shown electrode patch 10 can be placed fully and correctly in under 20 seconds (with right sided leads and posterior leads). Each of the above steps of attaching the first, second and third portions of the electrode patch 10 can include removing a corresponding first, second and third portion of an outer cover layer (see FIG. 4) of the electrode patch 10, which outer cover layer can be a backing foil protecting the adhesive layer 12.

[0144] The electrodes embedded in the third portion 38 of the electrode patch 10 are able to record posterior leads, which results in higher accuracy and an increase in the number of leads to visualize ST segment changes and to diagnose a heart attack in the posterior wall or occluded right sided arteries that currently are difficult to diagnose.

[0145] It will be understood that for patients with dextrocardia the afore-described configuration can be mirrored. Also, the shape and outline of the electrode patch can be adapted specifically for males and females as electrodes for females must go beneath the breast in contrast to electrodes for males.

[0146] As can be seen in the design of the electrode patch 10 shown in FIG. 3, all angles and radii of the outline of the electrode patch 10 are designed sufficiently obtuse and large. This further improves the wearing comfort for the subject the patch is applied to.

[0147] Each of the first portion 34 and the second portion 36 of the electrode patch comprises three aligned electrodes 40, 42 that are aligned along a straight line (shown by the dashed lines 44, 46). These straight lines are substantially parallel to the sternal midline of a patient in a state in which the electrode patch 10 is attached to the patient in a predetermined manner. These aligned electrodes 40, 42 are provided to obtain the limb leads during ECG. Thus, the aligned electrodes are spaced approx. 5 cm to 25 cm, preferably 10 cm to 20 cm, more preferably 12.5 cm to 17.5 cm, still more preferably about 15 cm, from a line where the first portion 34 and the second portion 36 of the electrode patch 10 are connected.

[0148] FIG. 4 shows the first embodiment of the electrode patch 10 described above referring to FIGS. 1 and 2 during a manufacturing process. The electrode patch 10 is shown in the region of a measurement point 26A. As most of the layers shown in FIG. 4 correspond to the layers shown in FIG. 1, it is primarily referred to the differences between FIG. 4 and FIG. 1.

[0149] In addition to the layers seen in FIG. 1, there is further provided an outer cover layer 48. The outer cover layer 48 is applied onto the adhesive contact surface 14 of the adhesive layer 12 so as to protect the adhesive contact surface 14, e.g. during transportation and storage. The outer cover layer 48 can be a PET liner, a backing foil, etc. The outer cover layer 48 has to be removed from the electrode patch 10 before the patch is applied to the subject. In an embodiment, the outer cover layer 48 can be separated into three outer cover layer portions (not shown) for covering each of the three electrode patch portions described above.

[0150] Further, FIG. 4 shows a support layer 50 that is arranged on the electrode patch adjacent to the carrier layer 24 on a surface of the carrier layer 24 opposing the surface that faces the conductive 26 and adhesive layer 12. The support layer 50 provides support and stability to the electrode patch 10 during manufacturing is removed after manufacturing. Thus, the support layer 50 is only an auxiliary layer supporting the manufacturing of the electrode patch. The support layer 50 can be a siliconized PET layer and can be stretchable, which improves the handling during manufacturing.

[0151] FIG. 5 shows a second embodiment of the electrode patch in the region of a measurement point. In contrast to the first embodiment of FIGS. 1 and 2, the electrode patch 10′ of FIG. 5 comprises an adhesive layer 12′ that is dielectric. Thus, a separate dielectric layer can be omitted in this embodiment. Consequently, the electrode patch 10′ has a thinner configuration than the electrode patch 10 described above. Besides this difference, the electrode patch 10′ according to the second embodiment and the electrode patch 10 according to the first embodiment can be alike in its structure, configuration and function. Exemplarily, the adhesive layer 12′ being dielectric can be a double sided adhesive tape.

[0152] The structure of such a double sided adhesive tape is exemplarily shown in FIG. 6. As can be seen, the double sided adhesive tape comprises an adhesive contact surface 14′, a structure layer 15′ and an adhesive patch surface 18′. The structure layer 15′ is arranged between the adhesive contact surface 14′ and the adhesive patch surface 18′. The structure layer 15′ can for example be a non-woven layer.

[0153] FIG. 7 shows a further embodiment of the electrode patch 10, in which the electrode patch 10 comprises a hybrid adhesive layer 52 comprising the adhesive layer 12 and a reinforcing adhesive layer 54. Apart from the adhesive layers, FIG. 7 only shows a simplified representation of the electrode patch 10, more precisely only shows carrier layer 24. However, the electrode patch 10 shown in FIG. 7 can comprise further features discussed in the context of the other embodiments (conductive layer, measurement points, etc.).

[0154] As can be seen in FIG. 7, the reinforcing adhesive layer 54 is only arranged in predetermined positions and areas of the patch 10 so as to locally reinforce the adhesiveness of the electrode patch 10 in the area of the patch edges, in the form of rings in the area of the measurement points and in the area in which a connector or device is attachable to the patch 10. The adhesive layer 12 is made of a silicone adhesive, which is highly biocompatible and gentle to the skin of a subject, wherein the reinforcing adhesive layer 54 is made of an acrylic adhesive, which has a stronger adhesiveness compared to the silicone adhesive layer.

[0155] It is to be mentioned that in other embodiments of the electrode patch according to the invention other (not shown in the Figures), some of the layers shown in the embodiments can be omitted. In particular, there can be provided an electrode patch only comprising an elastic adhesive layer and an elastic conductive layer. In this case, the adhesive layer should be dielectric. The adhesive layer can be used to apply the conductive layer to the subject. Such an electrode patch is very thin and comfortable to wear for the subject, e.g. a patient.

[0156] While the invention has been described with respect to a limited number of embodiments, it will be appreciated that many variations, modifications and other applications of the invention may be made, and that various combinations and subcombinations of embodiments are also possible and encompassed within the scope of this application.