MEDICAL PATCH

Abstract

A medical patch configured for being applied to a patient and for communicating with an in-vivo device located within the patient’s body; The medical patch comprises an adhesive surface configured for adhering the patch to the patient’s skin; and a communication arrangement configured for providing communication between the medical patch and the in-vivo device.

Claims

1. A medical patch configured for being applied to skin of a patient and for communicating with an in-vivo device located within the patient’s body, the medical patch comprising: an adhesive film configured for adhering the patch to the skin of the patient, the adhesive film including a first side having an adhesive surface configured to be adhered to the skin of the patient and a second side opposite the first side; at least one protective liner removably attached to the first side of the adhesive film and configured to cover the adhesive surface prior to application of the medical patch to the skin of the patient; at least one support liner removably attached to the second side of the adhesive film and configured to structurally support the adhesive film during application of the medical patch to the skin of the patient; and an antenna configured for providing communication between the medical patch and the in-vivo device.

2. The medical patch according to claim 1, wherein the antenna is configured to communicate with the in-vivo device during movement of the in-vivo device within the patient’s body.

3. The medical patch according to claim 1, wherein the in-vivo device is a swallowable in-vivo device configured for traveling along at least a portion of the patient’s GI tract.

4. The medical patch according to claim 1, wherein the adhesive film includes an inner surface and an outer surface, and the adhesive surface is disposed on at least a portion of the inner surface.

5. The medical patch according to claim 4, wherein the at least one protective liner is attached to the inner surface of the adhesive film and is configured for protecting the inner surface of the adhesive film prior to application of the medical patch to the skin of the patient.

6. The medical patch according to claim 1, wherein the at least one protective liner and the at least one support liner are configured for being removed from the adhesive film during application of the medical patch to the skin of the patient.

7-9. (canceled)

10. The medical patch according to claim 1, wherein the adhesive film has a thickness in the range of 0.05 mm to 0.5 mm.

11. The medical patch according to claim 1, wherein the at least one support liner comprises a plurality of support liners configured to be removed sequentially from the second side of the adhesive film after adherence of the adhesive surface to the skin of the patient.

12. The medical patch according to claim 1, wherein the at least one support liner comprises a plurality of support liners marked with indicia indicating a sequential order for removal of the plurality of support liners from the second side of the adhesive film after adherence of the adhesive surface to the skin of the patient.

13. (canceled)

14. The medical patch according to claim 1, wherein the at least one protective liner comprises a plurality of protective liners configured to be removed sequentially from the first side of the adhesive film during application of the medical patch to the skin of the patient.

15. The medical patch according to claim 1, wherein the at least one protective liner comprises a middle protective liner piece and two side protective liner pieces, one on either side of the central protective liner piece.

16. The medical patch according to claim 1, wherein the at least one protective liner comprises a plurality of protective liners marked with indicia indicating a sequential order for removal of the plurality of protective liners from the first side of the adhesive film during application of the medical patch to the skin of the patient.

17-25. (canceled)

26. A method for applying a medical patch to skin of a patient, the method comprising: removing a protective liner from a first side of an adhesive layer of the medical patch to expose at least a portion of the first side of the adhesive layer; adhering the exposed portion of the first side of the adhesive layer to the skin of the patient; removing, after removal of the protective liner, at least one additional protective liner from the first side of the adhesive layer while adhering the exposed portion of the first side of the adhesive layer to the skin of the patient; removing, after removal of the at least one additional protective liner, a support liner from a second side of the adhesive layer during application of the medical patch to the skin of the patient, the second side of the adhesive layer being opposite the first side of the adhesive layer; and removing, after removal of the support liner, at least one additional support liner from the second side of the adhesive layer during application of the medical patch to the skin of the patient.

27. The method according to claim 26, wherein the adhesive layer includes an inner area surrounded by an outer periphery area surrounding the inner area, and removing the protective liner from the first side of the adhesive layer includes removing the protective liner from the inner area of the adhesive layer.

28. The method according to claim 27, wherein removing the support liner from the second side of the adhesive layer includes removing the support liner from the outer periphery area of the adhesive layer.

29. The method according to claim 26, wherein removing the protective liner and removing the at least one additional protective liner includes removing a plurality of protective liners sequentially in accordance with indicia included on the plurality of protective liners, the indicia indicating a sequential order for removal of the plurality of protective liners.

30. The method according to claim 26, wherein removing the support liner and removing the at least one additional support liner includes removing a plurality of support liners sequentially in accordance with indicia included on the plurality of support liners, the indicia indicating a sequential order for removal of the plurality of support liners subsequent to the removal of the at least one additional protective liner.

31. A medical patch configured for being applied to skin of a patient and for communicating with an in-vivo device located within the patient’s body, the medical patch comprising: a communication layer comprising an antenna configured for providing communication between at least one of the in-vivo device and the medical patch or the medical patch and an external device; an adhesive film layer configured for adhering the medical patch to the skin of the patient; a spacing layer interposed between the adhesive film layer and the communication layer and configured to separate the communication layer of the medical patch from the skin of the patient such that the communication layer is not in direct contact with the skin of the patient; a first constructive adhesive layer interposed between the adhesive layer and the spacing layer; and a second constructive adhesive layer interposed between the communication layer and the spacing layer.

32. The medical patch according to claim 31, wherein the antenna is configured to transmit data received from the in-vivo device to a mobile computing device.

33-34. (canceled)

35. The medical patch according to claim 31, wherein the first constructive adhesive layer is a double-sided adhesive layer configured to attach the adhesive film layer to the spacing layer and the second constructive adhesive layer is a double-side adhesive layer configured to attach the communication layer to the spacing layer.

36-43. (canceled)

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0093] In order to better understand the subject matter that is disclosed herein and to exemplify how it may be carried out in practice, embodiments will now be described, by way of non-limiting example only, with reference to the accompanying drawings, in which:

[0094] FIGS. 1A, 1B and 1C are a schematic front, side and rear views of a patch in accordance with the present invention;

[0095] FIG. 1D is a schematic enlarged view of a side portion of the patch shown in FIG. 1;

[0096] FIG. 2A is a schematic isometric exploded view of the patch shown in FIG. 1;

[0097] FIG. 2B is a schematic exploded isometric view of the communication layer shown in FIG. 2A;

[0098] FIGS. 3A and 3B are schematic top and side views of a tab arrangement of the patch under another example of the present application; and

[0099] FIGS. 4A and 4B are schematic isometric and side views of a casing configured for housing the medical patch and an in-vivo device.

[0100] It will be appreciated that for simplicity and clarity of illustration, elements shown in the figures have not necessarily been drawn accurately or to scale. For example, the dimensions of some of the elements may be exaggerated relative to other elements for clarity, or several physical components may be included in one functional block or element. Further, where considered appropriate, reference numerals may be repeated among the figures to indicate corresponding or analogous elements.

DETAILED DESCRIPTION OF EMBODIMENTS

[0101] Attention is first drawn to FIG. 1, in which a wearable medical patch (hereinafter: patch) is shown, generally designated 1, and configured for being adhered to a patient’s skin. The patch 1 has a contact side 3, also referred herein as an inner face, configured for coming in contact with the patient’s skin, when the patch 1 is applied, and an outer face 5 configured for facing away from the patient, when the patch 1 is applied.

[0102] The patch 1 further comprises a communication arrangement CA (shown in FIG. 2) configured for performing at least one of the following: [0103] receiving signals from an in-vivo device configured for being inserted into the patient’s body; [0104] sending signals to the in-vivo device; and [0105] transmitting data from the patch 1 to an external source (e.g. phone, tablet, cloud etc.).

[0106] The patch 1 comprises an adhesive film 10 configured for adhering to the patient’s skin when the patch 1 is applied. The adhesive film 10 is relatively thin and has a nominal thickness ranging between 0.05-0.3 mm. In order to protect the adhesive side 12 of the adhesive film 10, the adhesive film 10 is fitted with a protective liner arrangement 20, comprising a middle protective liner piece 22 (bearing the indicia 1) and two side protective liner pieces 24 (each bearing the indicia 2). The protective liner pieces 22, 24 are configured for protecting the adhesive surface 12 of the adhesive film 10 when in storage and prior to application of the patch 1.

[0107] Each of the protective liner pieces 22, 24, has a pulling tab, 23, 25 respectively, configured for allowing convenient removal of the protective liner pieces 22, 24. In addition, the indicia on the tabs 23, 25, dictates the order of removal of the protective liner pieces 22, 24, when applying the patch 1.

[0108] Since the adhesive film 10 is extremely thin, and since the protective liner pieces 22, 24, are to be removed before application of the patch 1, the adhesive film 10 requires and additional reinforcing layer allowing it to maintain structural integrity during application of the patch 1. For this purpose, the adhesive film 10 is also provided with a supportive liner arrangement 30 comprising four support liner pieces 32L, 32R, 34L and 34R.

[0109] In operation, when the patch 1 is applied to the patient, the middle protective liner piece 22 is first removed by pulling on the tab 23, and the patch 1 is then applied to the patient such that the adhesive portion of the adhesive film 10 revealed by the removal of the middle protective liner piece 22.

[0110] With additional reference being made to FIGS. 3A and 3B, the tabs 35 are configured for being angled to the plane of the patch 1 and have a greater area, making it more convenient for the person applying the patch to remove the support liner piece from the patch 1, once it has been adhered to the body.

[0111] In order to increase the accuracy of placement, the patch 1 is provided with a placement indent 7, configured for being aligned with the area under the naval. This further allows preventing the patch from being applied at an angle or even upside down.

[0112] Once the middle portion of the adhesive film 10 is adhered to the patient, the two side protective liner pieces 24 are removed by pulling on the tabs 25, in and outwards direction, while applying pressure to the supportive liner arrangement 30 in order to assure proper adhesion to the patient’s skin.

[0113] Once the entire adhesive surface 12 of the adhesive film 10 is adhered to the patient’s skin, the protective liner pieces 32L, 32R, 34L and 34R are to be removed, sequentially, leaving only the thin adhesive film 10 around the periphery of the patch 1.

[0114] It is noted that each of the protective liner pieces 32L, 32R, 34L and 34R also has a pulling tab 33L, 33R, 35L and 35R respectively, and are also marked with indicia (4, 5, 6 and 7), dictating the order of removal of the protective liner pieces.

[0115] The support liner pieces 32L, 32R, 34L and 34R are peeled away from the external side 14 of the adhesive film from the center outwards. Each of the support liner pieces is designed as a generally straight segment, thereby reducing the tugging forces on the adhesive film 10 during removal of the support pieces. In addition, the shape and size of the support liner pieces 32L, 32R, 34L and 34R are designed such that the areas covered by each of these pieces are substantially similar so as not to create an imbalance in the tuggiqng forces applied to the adhesive film 10.

[0116] With additional reference being made to FIG. 1D, each of the support liner pieces 32L, 32R, 34L and 34R extends along a centerline C.L. The shape and size of the support liner pieces is such that they do not extend over a certain angle θ along their trajectory. The angle θ is defined as the angle between two tangent lines T1 and T2, at lead and end points of the centerline C.L. Thus, the pulling back of the adhesive film 10 is prevented during removal of the support liner pieces. In other words, during removal of a support liner piece it is always pulled in essentially the same direction - outwards, without returning inwards (as would be the case if liner pieces 32R and 34R were a single piece). This design prevents unnecessary tugging forces on the adhesive film 10 which may otherwise have resulted in poorer adhesion, decreased functionality and lower placement accuracy.

[0117] After the support liner pieces 32L, 32R, 34L and 34R have been successfully peeled away, the patient or a health care practitioner (HCP) may further apply pressure with their fingers all along the periphery of the adhesive film 10 in order to secure the patch 1 to the patient’s skin.

[0118] As noted before, the indicia on the protective liner pieces 22, 24 (1, 2 and 3), and on the support liner pieces 32L, 32R, 34L and 34R (4, 5, 6 and 7) help indicate to the HCP the order of removal/peeling of the pieces from the adhesive film 10.

[0119] Attention is now drawn to FIG. 2, in which an exploded view of the patch 1 is shown, displaying the layer stack-up thereof. In particular, the patch 1 comprises: [0120] an adhesive film 10; [0121] a protective liner arrangement 20; [0122] a support liner arrangement 30; [0123] a first constructive adhesive layer 40A; [0124] a spacing layer 50; [0125] a second constructive adhesive layer 40B; [0126] a communication layer 60; [0127] a power unit 70; [0128] a processor unit 80; [0129] a cage 90; and [0130] a third constructive adhesive layer 40C and an external cover 100.

[0131] The spacing layer 50 is made of a material and having a thickness chosen to be such that minimally interferes with transmission and reception of signals between the communication layer and the in-vivo device. In addition, the material of the spacing layer is chosen to be such that returns to its original shape following deformation, thereby maintaining a fairly constant distance between the communication layer and the patient’s skin (when the patch is applied). This distance insures proper communication between the communication layer and the in-vivo device. In accordance with a specific example, the spacing layer 50 is made of a closed-cell foam material.

[0132] In particular, the spacing layer 50 has a combination of three or more of the following features: [0133] low water retention (or low water absorption) - reducing the amount of water retained in the foam layer; [0134] puncture resistance - reducing the risk of accidental puncture of the medical patch by the user; [0135] differential stretchability - reducing the risk of tear of the medical patch; [0136] low breathability - reducing the chances of vapor reaching the functional components of the medical patch; [0137] good bond strength - increasing proper adhesion to the rest of the layers of the medical patch; [0138] low electric loss constant - reducing interference with communication; and [0139] high elastic recovery - increasing the chances of the medical patch properly withstanding stretching caused by movement and position of the patient.

[0140] One example of such a spacing layer 50, which may be used in the present invention is an EVA foam by 3M (3M EVA MSX-7373A).

[0141] It should also be noted here that most medical patches required breathability in order to better deal with sweating issues by the patient by allowing sweat to vaporize through the patch. However, in the present invention, such breathability proves disadvantageous, since such vapor may reach the communication layer and disrupt communication between the medical patch and the in-vivo device.

[0142] With additional reference being made to FIG. 2B, the communication layer 60 may be in the form of a flexible antenna, configured for both transmitting and receiving signals to and from the in-vivo device respectively. In particular, the communication layer 60 comprises a downlink antenna (not shown) configured for transmitting signals to the in-vivo device, and an uplink antenna (not shown) configured for receiving signals from the in-vivo device.

[0143] In addition, the communication layer may also be integrated with an adhesion detection arrangement 64 (not shown), configured for monitoring the adhesion state of the patch 1 to the patient’s skin and provide an alert in case of detachment of the patch 1 from the skin. In accordance with a specific example, the adhesion detection arrangement may be constituted by a capacitance detection arrangement configured for measuring the electrical capacitance between the patch 1 and the patient’s skin.

[0144] The processing unit 80 constitutes part of the communication layer 60, and is configured for transmitting signals to the downlink antenna and for receiving signals from the uplink antenna, processing signals and communicating with external devices (e.g. tablet, phone, PC, cloud etc.). The power unit 70 is connected to both the processing unit 80 and the communication layer 60 and is configured for providing power thereto.

[0145] In order to protect the communication layer, and specifically the power unit 70 and processing unit 80, there is provided an external cover layer 100, made of a flexible material. The cover layer 100 has two cavities 102, 103, configured for accommodating the power unit 70 and processing unit 80, protruding from the patch and received within these cavities. However, in order to further protect the processing unit 80 itself, there is provided a rigid cage 90 encapsulating the processing unit 80.

[0146] The processing unit 80 comprises an indication light 82 configured for alerting the patient on various actions and operation of the patch. In order for this indication light to be visible, the cage 90 comprises a transparent window 94 through which the indication light 82 is visible, and the cover layer 100 is formed with a cut out 104, through which the window 94 is visible.

[0147] In addition, the cage 90 further comprise an opening 96 configured for providing access to a USB port (not shown) of the processing unit 80. In accordance with a specific example, the opening may be provided with a flap that is naturally closed and may be torn open if access to the USB is required. Following tearing open, the flap may be closed again to cover the USB port.

[0148] The constructive adhesive layer 40A, 40B and 40C are used in order to adhere the various layers of the patch 1 to each other.

[0149] Attention is now drawn to FIGS. 4A and 4B, in which a casing 120 is shown, configured for accommodating therein the medical patch 1 and a swallowable in-vivo device (not shown). The casing 120 comprises a compartment 130 configured for accommodating the in-vivo device. The casing 120 also comprises a first magnetic safety arrangement (not shown) configured for preventing spontaneous operation of the medical patch 1, and the compartment 130 comprises a second magnetic safety arrangement (not shown) configured for preventing spontaneous operation of the in-vivo device.

[0150] When the casing is opened, and the medical patch 1 is removed therefrom, the first magnetic safety arrangement is no longer in proximity to the medical patch 1, thereby allowing turning it on. Similarly, when the in-vivo device is removed from the compartment 130, the second magnetic safety device is no longer in proximity to the in-vivo device, allowing it to function properly.

[0151] Those skilled in the art to which this invention pertains will readily appreciate that numerous changes, variations, and modifications can be made without departing from the scope of the invention, mutatis mutandis.