WO2018124995A1

WO2018124995A1 - A wearable tens device for chronic pain management

Info

Publication number: WO2018124995A1
Application number: PCT/TR2016/050579
Authority: WO
Inventors: Gozde GONCU BERK
Original assignee: Inovent Fikri Mulkiyet Haklari Yonetim Ticaret Ve Yatirim Anonim Sirketi
Priority date: 2016-12-30
Filing date: 2016-12-30
Publication date: 2018-07-05

Abstract

This invention is related to a TENS (Transcutaneous electrical nerve stimulation) device (1) for chronic pain management. The aim of the invention is to provide a user friendly TENS device (1) comprising long life TENS electrodes (3) and transmission lines (4).

Description

A WEARABLE TENS DEVICE FOR CHRONIC PAIN MANAGEMENT Related Technical Field of the Invention

This invention is related to an electronic textile based, wearable transcutaneous electrical nerve stimulation (TENS) device for chronic pain management.

Prior Art

TENS is the electrical stimulation of nerves to block pain sensation for therapeutic purposes. The signals created by the TENS device disrupt the pain signals created by body parts affected from pain and thus decrease the pain sensation. Compared to pharmaceuticals used for pain management, use of TENS device does not cause any side effects and provide instant pain relief while in use.

Currently available TENS devices in the market are at least the size of a mobile phone and are composed of a control unit and electrodes hooked to this unit via cables. The low intensity current created by the TENS control unit is delivered to skin through conventional hydrogel Ag/AgCl electrodes that stick to skin. These disposable hydrogel Ag/AgCl electrodes usually require skin preparation such as shaving and cleansing with alcohol prior to application and can be irritating for long term use. They have limited life span. They need to be replaced after couple of uses to effectively deliver the TENS signal to the skin since they lose their moisture. The ability of hydrogel electrodes to reliably perform their functions depends on their ability to retain moisture, remain wet or hydrated. Since these electrodes lose their moisture after a few applications, they lack reusability.

The most common user problems related to conventional TENS devices are tangling of cables, blanking off electrodes from their sockets during movement and finally stigma of using TENS devices outside home because of its bulky structure. In the state of the art, the patent document of US2011077728 discloses a textile for providing Chinese therapy by using electronic stimulation.

Brief Description of the Invention

The aim of the invention is to provide a user friendly, electronic textile based, wearable TENS device. Another aim of the invention is providing a TENS device comprising long life TENS electrodes and transmission lines.

The disclosed invention is a user friendly, electronic textile based, wearable TENS device. It allows users to move freely while wearing the TENS device and eliminates problems of carrying a bulky device with tangling cables. Since it is textile based, it can come in different colors and patterns and improve the negative perception of using a TENS device with an aesthetically appealing look.

The disclosed wearable TENS device can be controlled with a mobile application wirelessly via Bluetooth or RFID. Description of the Figures

Figure 1-a: A pattern in which the conductive thread is embroidered with minimal thread overlap in the TENS device.

Figure 1-b: Another pattern in which the conductive thread is embroidered with minimal thread overlap in the TENS device.

Figure 2: A schematical view of a control unit of the TENS device.

Figure 3: A schematical view of the TENS device in one embodiment in a form of a patch. Figure 4: A schematical view of the TENS device in one embodiment in a form of an elbow sleeve.

Figure 5: A schematical view of the TENS device in another embodiment in a form of a knee sleeve.

Description of the References in the Figures

1. Device

2. Control unit

3. Electrode

4. Transmission line

5. Substrate

Detailed Description of the Invention

The disclosed invention is an electronic textile based TENS device(l). This device(l) comprises a substrate(5) for positioning the device(l) to the user's related body portion and housing at least one control unit(2) which has a cathode and an anode and delivers the TENS signal, at least two electrodes(3) to send signals to the user's body.

The device(l) preferably comprises at least two transmission lines(4) connecting the electrodes(3) to the control unit(2) and a textile substrate(5) for positioning the device(l) to the user's related body portion and housing all the components on its surface. One transmission line(4) connects the anode of the control unit(2) to at least one electrode(3) and the other transmission line(4) connects the cathode of the control unit(2) to at least one electrode(3). The electrodes(3) connected to the anode and cathode of the control unit(2) need to be different. That's why; there are at least two electrodes(3).

The amount of electrodes(3) that are connected to anode and cathode of the control unit(2) are equal.

In the embodiments in which there are more than two electrodes(3); one transmission line(4) may connect more than one electrode(3) to the anode and another transmission line(4) may connect more than one electrode(3) to the cathode of the control unit(2). Therefore; the transmission lines(4) are provided to be shorter than the ones connected separately to each electrode(3) in order to create the shortest distance between the electrodes(3) and the control unit(2). So, this provides less thread to be used for the transmission lines(4), signal loss to be less and resistance of the transmission lines(4) to be less. For example in an embodiment having four electrodes(3); preferably one transmission line(4) connects two electrodes(3) to the anode and another transmission line(4) connects two electrodes(3) to the cathode.

The textile substrate(5) comprises a nonconductive flexible material providing the device(l) to dress the required body part for holding the device(l) on the body. The electrodes(3) are embedded in the textile substrate(5), so they cannot be separated from the device(l).

Electrode(3) and substrate(5) comprises textile based material. This electrode type will be called textile electrode(3) from now on.

Textile electrode(3) comprises a conductive thread. These electrodes(3) are constituted on the substrate(5) comprising non-conductive and flexible textile material, in such a way that each electrode(3) is embroidered with a conductive thread. It is embroidered on the non-conductive substrate(5). Due to embroidery, the electrode(3) becomes conjoint with the textile substrate(5) and therefore, cannot be taken off from this substrate(5).

Textile electrode(3) preferably has a diameter of 20-40 mm including limits, preferably 30 mm. The electrical resistance of the conductive thread is between 60 Ω/m - 2 kQ/m including limits. The conductive thread number is preferably between 350-650 DTEX including limits.

Specific stitch pattern and stitch density parameters of the electrode(3) are used based on the conductive thread number. The electrode(3) has the stitch density between 1.7 - 3.9 m for conductive thread numbers between 350-650 DTEX. The conductive thread is embroidered in a pattern in which a minimal or no thread overlap is provided via series of stitches filling the surface of the electrode(3). These specific configurations provide achieving a high Signal to Noise ratio (SNRdb) for the TENS signal and equal distribution of resistance values on the surface of textile electrode(3).

In one embodiment of the invention, each electrode(3) is in a form of circle or circular shape and comprises a circle or a circular shape at the center of it. Preferably, the ratio of the central circle diameter to the electrode(3) diameter is 1/6. Conductive thread is embroidered in such a way that each thread provides a line starting from a point on the circle (or a circular shape) which is at the center and ends at a point on perimeter of the electrode(3). (Fig 1-a) Thereby, each thread starts from a different point of the central circle and end at a different point of the perimeter of the electrode(3). Therefore, the distance between each subsequent two threads are shortest at the central circle. And the distance between each subsequent two threads are bigger at the perimeter than the center. Therefore, the surface of the electrode(3) is filled with conductive threads with minimal distances in between and minimal thread overlap in the electrode(3) and so TENS device(l) is provided. In another embodiment of the invention, conductive thread is embroidered on a circle or circular electrode(3) in such a way that each thread provides a line starting from a first point on perimeter of the electrode(3) and ending on a second point on the perimeter reciprocal to the first point, thereby constituting parallel lines on the electrode(3) (Fig 1-b). In this embodiment, the surface of the electrode(3) is filled like taking a cross-section with conductive threads with minimal distances in between and minimal thread overlap in the electrode(3) and so TENS device(l) is provided. In all embodiments, each electrode(3) may be formed directly on the substrate(5) via embroidery or electrodes(3) may be first formed apart from the substrate(5) and then stitched to the substrate(5). In preferred embodiment of the invention, each electrode(3) is formed directly on the substrate(5) via embroidery. To do this, the borders of electrodes(3) to be formed is first marked on the substrate(5) and then inside of the borders are embroidered with conductive threads to form the electrode(3).

The textile substrate(5) where conductive thread is embroidered is pretreated. The locations of the electrodes(3) to be constituted on the substrate(5) are first marked/identified and then inside of the marked/identified locations are embroidered with any thread preferably using a zig zag pattern to create a padded/raised effect for the electrode(3) in order to increase electrodes' contact with the skin. Then padded surfaces are embroidered with conductive thread to form the electrode(3).

The substrate(5) may comprise a knit or spacer knit or more preferably % 100 polyester spacer knit fabric. The electrode(3) is a dry TENS electrode(3). These dry textile electrodes(3) do not require moisture to function, so have longer life spans.

The device(l) also comprises a circuit board and a power supply snapped on substrate(5). The circuit board has power supply and other electronic components electrically connected to each other. The control unit(2) preferably housed in plastic casing comprises this circuit board. Said control unit(2) comprises at least two conductive snaps that are preferably metal and can be attached to and detached from the substrate(5) via these snaps which transmit TENS signal from the control unit(2) to the electrodes(3) directly or through the transmission lines(4). So, they can be transferred between different textile components (such as sleeves or patch) for treatment of different pain areas of the body. The disclosed device(l) is wireless because there is no need for wires to connect the electrode(3), control unit(2), circuit board and power supply to each other. Said control unit(2) can be charged once it is detached from the substrate(5); namely, the control unit(2) is rechargeable.

Preferably; the control unit(2) delivers a biphasic square wave signal with 1-250 Hz pulse rate, 0-80 mA amplitude, at 50-250 microsecond pulse width properties. The transmission lines(4) on the textile substrate(5) connects each electrode(3) to the control unit(2) electrically. The control unit(2) which delivers the TENS signal and holds the circuit board is encased in a plastic structure. Said control unit(2) can be attached to and detached from the electrodes(3) or the transmission lines(4) using metal snaps. The connection points for each snaps of the control unit(2) on the substrate(5) are embroidered with stitches of a conductive thread.

In the preferred embodiment; the electrodes(3) and/or the transmission lines(4) and/or the connection points of the snaps of the control unit(2) comprise silver coated polyamide thread embroidered on the substrate(5). The device(l) comprises transmission lines(4) embroidered as stitch lines by using conductive thread on the textile substrate(5) together with TENS electrodes(3) at once and without any interruption. Therefore; no connector is necessary between the electrodes(3) and the transmission line(4).

The electrodes(3) and transmission lines(4) comprise a predetermined insulation material laminated onto the textile substrate(5). This predetermined material is preferably thermoplastic polyurethane membrane. Said electrodes(3) have the material on the outer side of it while the transmission lines(4) have on both sides (inner and outer side) so they are fully insulated. Therefore; signal losses between the control unit(2) and electrodes(3) are eliminated. Here, the inner side is defined as the side contacting with skin and the outer side is defined as the side which does not contact with the skin.

The substrate(5) may be in the form of a wearable sleeve. The sleeve comprises at least two electrodes(3), one control unit(2) and two transmission lines(4). Preferably; the sleeve comprises at least one velcro to be closed.

The sleeve may be in different forms suitable for major pain areas such as knee, elbow, wrist, ankles and neck. Figure 4 and Figure 5 shows two different embodiments of the device(l) in the form of an elbow sleeve and knee sleeve respectively.

In one embodiment of the invention; the substrate(5) is in the form of a patch that has double sided adhesives, therefore can stick to body. Different types of sticking to the body may also be provided. In an alternative of this embodiment, the patch comprises two electrodes(3) and a control unit(2). In an embodiment of the invention; the substrate(5) is in the form of an elbow or knee sleeve. In an alternative of this embodiment, the substrate(5) comprises four electrodes(3) and a control unit(2) and preferably two transmission lines(4); however, there may be four transmission lines(4). In case that there is two transmission lines(4); two electrodes(3) are connected to control unit(2) separately and each of these two electrodes(3) is connected to a third and fourth electrode(3) individually. Therefore, each transmission line(4) connects a first/second electrode(3) connected to the control unit(2) to a third/fourth electrode(3). In this embodiment, the electrodes(3) are placed around the kneecap or the elbow end such that they are on the perimeter of a circle with equal distances between each other. Therefore, desired effects of the TENS signal are achieved such that they target specific nerve locations on these body parts.

The electrodes(3) are embedded in a wearable form and can be used repeatedly and do not require replacement. They demonstrate high SNRdb values compared to conventional electrodes and thus deliver the TENS signal effectively. The disclosed device(l) comprises a user interface wirelessly connected to the control unit(2) for users to monitor and control the settings of the device(l) such as the signal type, pulse rate and signal delivery time. The control unit(2) offers via user interface multiple predefined settings to the user based on the location and intensity of the pain.

In the preferred embodiment, the user interface is remotely connected to the control unit(2) preferably via Bluetooth or RFID.

In an embodiment, the disclosed invention comes in as a kit: an elbow sleeve, knee sleeve and a patch.

In an embodiment; the user interface can be a mobile application in mobile phones.

The production method(lOO) of the device(l) comprises the steps of; - Immobilizing the substrate(5)(101),

Embroidering the electrodes(3) with a pattern creating a conductive surface on their locations of the substrate(5) and transmission lines(4) by creating a conductive line on the substrate using conductive thread(102),

Embroidering connection points for the snaps of the control unit(2) on the substrate(5) with stitches of a conductive thread(103), Insulating the transmission lines(4) from the inner and outer sides and the electrodes(3) on the outer side by laminating a predetermined material at predetermined conditions(104),

Inserting the snaps of the control unit(2) in the substrate(5)(105). In the 101. step, the substrate(5) is immobilized in an embroidery machine to eliminate stretching.

In the preferred embodiment, after the 101. step the locations of the electrodes(3) on the substrate(5) are embroidered to create padding for the electrodes(3) in order to increase electrodes' contact with the skin(102). This can be performed with any thread using a zig zag pattern. After that, the electrodes(3) are embroidered on these pretreated locations.

In the 102. step, the electrode(3) is embroidered such that it has the stitch density between 1.7 - 3.9 m for used conductive thread numbers between 350-650 DTEX.

In the 102. step, the transmission lines(4) are embroidered continuously.

In the 102. step, the transmission lines(4) are embroidered as stitch lines by using conductive thread and using lockstitch on the textile substrate(5) preferably together with the electrodes(3) at once and without any interruption. Therefore; no connector is necessary between the electrodes(3) and the transmission lines(4). The electrodes(3) are embroidered in a pattern in such a way that a minimal or no thread overlap is provided via series of stitches filling the surface of the electrode(3). In the 103. step, the electrodes(3) and transmission lines(4) are embroidered by using computer aided embroidery manufacturing.

In the 105. step, the electrodes(3) and transmission lines(4) are insulated with a predetermined insulation material laminated onto the textile substrate(5) at 100-200°C temperature and 25- 100 psi pressure for 10-30 seconds. The predetermined material is preferably thermoplastic polyurethane membrane. The invention is not limited with the disclosed embodiments above, a skilled person in the art can produce different embodiments of the invention easily. They should be evaluated within the scope of invention protection demanded with claims.

Claims

A TENS device(l) comprising a substrate(5) for positioning the device(l) to the user's related body portion and housing at least one control unit(2) which has a cathode and an anode and delivers the TENS signal, at least two electrodes(3) to send signals to the user's body, characterized in that, the electrodes(3) are constituted on the substrate(5) comprising non-conductive and flexible textile material, in such a way that each electrode(3) is embroidered with a conductive thread.

A TENS device(l) according to claim 1 wherein electrodes(3) have the conductive thread embroidered in a pattern in such a way that a minimal or no thread overlap is provided via series of stitches filling the surface of the electrode(3).

A TENS device(l) according to claim 1 or 2 whereby each electrode is formed via directly embroidery on the substrate.

A TENS device(l) according to claim 3 whereby the borders of electrodes(3) to be formed is first marked on the substrate(5) and then inside of the borders are embroidered with conductive threads to form the electrode(3).

A TENS device(l) according to any of claim above wherein each electrode(3) is in a form of circle or circular shape and comprises a circle or a circular shape at the center of it and whereby conductive thread is embroidered in such a way that each thread provides a line starting from a point on the circle or a circular shape which is at the center and ends at a different point on perimeter of the electrode(3), therefore the distance between each subsequent two threads are shortest at the central circle and the distance between each subsequent two threads are bigger at the perimeter than the center, so the surface of the electrode(3) is filled with conductive threads with minimal distances in between and minimal thread overlap in the electrode(3) and so TENS device(l) is provided.

A TENS device(l) according to claim 5 wherein the ratio of the central circle diameter to the electrode(3) diameter is 1/6.

A TENS device(l) according to any of claims 1-4 whereby conductive thread is embroidered on a circle or circular electrode(3) in such a way that each thread provides a line starting from a first point on perimeter of the electrode(3) and ending on a second point on the perimeter reciprocal to the first point, constituting parallel lines on the electrode(3) and therefore, the surface of the electrode(3) is filled with conductive thread with minimal distances in between and minimal thread overlap in the electrode(3) and so TENS device(l) is provided.

8. A TENS device(l) according to any of claims above comprising the electrodes(3) which are dry TENS electrodes(3).

9. A TENS device(l) according to any of claims above comprising the electrodes(3) which have a diameter of 20-40 mm including limits.

10. A TENS device(l) according to any of claims above comprising the electrodes(3) which have a diameter of 30 mm.

11. A TENS device(l) according to any of claims above comprising the electrodes(3) which have the stitch density between 1.7 - 3.9 m.

12. A TENS device(l) according to any of claims above wherein the amount of electrodes(3) that are connected to anode and cathode of the control unit(2) are equal.

13. A TENS device(l) according to any of claims above comprising at least two transmission lines(4) which connect the electrodes(3) to the control unit(2) electrically.

14. A TENS device(l) according to claim 13 wherein one transmission line(4) connects the anode of the control unit(2) to at least one electrode(3) and the other transmission line(4) connects the cathode of the control unit(2) to at least one other electrode(3).

15. A TENS device(l) according to claim 13 or 14 whereby the transmission lines(4) are embroidered continuously as stitch lines by using conductive thread on the substrate(5).

16. A TENS device(l) according to any of claims 13-15 whereby the transmission lines(4) are embroidered together with the electrodes(3) at once and without any interruption.

17. A TENS device(l) according to any of claims 13-16 wherein one transmission line(4) connects more than one electrode(3) to the control unit(2).

18. A TENS device(l) according to any of claims above comprising a circuit board and a power supply.

19. A TENS device(l) according to claim 18 whereby the circuit board and power supply are snapped on the substrate(5).

20. A TENS device(l) according to claim 18 comprising the control unit(2) which has the power supply and circuit board.

21. A TENS device(l) according to any of claims above comprising the control unit(2) which has at least two conductive snaps providing that the control unit(2) can be attached to and detached from the electrodes(3) or the transmission lines(4) via these snaps which transmit TENS signal from the control unit(2) to the electrodes(3) directly or through the transmission lines(4).

22. A TENS device(l) according to claim 21 wherein the snaps are metal.

23. A TENS device(l) according to any of claims above comprising the control unit(2) which delivers a biphasic square wave signal.

24. A TENS device(l) according to claim 23 whereby the signal is delivered with 1-250 Hz pulse rate.

25. A TENS device(l) according to claim 23 or 24 whereby the signal is delivered with 0- 80 mA amplitude.

26. A TENS device(l) according to any of claims 23-25 whereby the signal is delivered with 50-250 microsecond pulse width.

27. A TENS device(l) according to any of claims 21-26 comprising a connection point for each snap of the control unit(2) on the substrate(5) embroidered with stitches of a conductive thread.

28. A TENS device(l) according to any of claims above comprising the substrate(5) which comprises a knit fabric.

29. A TENS device(l) according to any of claims above comprising the substrate(5) which comprises a spacer knit fabric.

30. A TENS device(l) according to any of claims above comprising the substrate(5) which comprises %100 polyester spacer knit fabric.

31. A TENS device(l) according to any of claims above comprising the electrodes(3) having a predetermined insulation material at the outer side of it.

32. A TENS device(l) according to claim 31 wherein the predetermined material is thermoplastic polyurethane membrane.

33. A TENS device(l) according to any of claims above wherein the substrate(5) is in the form of a wearable sleeve.

34. A TENS device(l) according to claim 33 wherein the sleeve comprises at least one velcro to be closed.

35. A TENS device(l) according to claim 33 or 34 wherein the sleeve may be in different forms suitable for major pain areas such as knee, elbow, wrist, ankles and neck.

36. A TENS device(l) according to any of claims 33-35 wherein the substrate(5) in the form of an elbow or knee sleeve comprises four electrodes(3) and a control unit(2) and two or four transmission lines(4).

37. A TENS device(l) according to claim 36 whereby the electrodes(3) are placed around the kneecap or the elbow end, such that they are on the perimeter of a circle with equal distances between each other.

38. A TENS device(l) according to any of claims above wherein the substrate(5) is in the form of a patch that has double sided adhesives, therefore can stick to body.

39. A TENS device(l) according to any of claims above comprising the electrodes(3) which have silver coated polyamide thread as conductive thread.

40. A TENS device(l) according to any of claims 13-39 comprising the transmission lines(4) which have silver coated polyamide thread as conductive thread.

41. A TENS device(l) according to any of claims 27-40 comprising the connection points of the snaps of the control unit(2) comprise silver coated polyamide thread as conductive thread.

42. A TENS device(l) according to any of claims above comprising a user interface wirelessly connected to the control unit(2) for users to monitor and control the settings of the device(l) such as the signal type, pulse rate and signal delivery time.

43. A TENS device(l) according to claim 42 whereby the control unit(2) offers multiple predefined settings to the user based on the location and intensity of the pain via the user interface.

44. A TENS device(l) according to claim 42 or 43 whereby the user interface is remotely connected to the control unit(2) via Bluetooth or RFID.

45. A TENS device(l) according to any of claims 42-44 wherein the user interface can be a mobile application in mobile phones.

46. A production method(lOO) of the TENS device(l) comprising the steps of;

Immobilizing the substrate(5)(101),

Embroidering the electrodes(3) with a pattern creating a conductive surface on the their locations of the substrate(5) and transmission lines(4) by creating a conductive line on the substrate using conductive thread(102),

Embroidering connection points for the snaps of the control unit(2) on the substrate(5) with stitches of a conductive thread(103),

Insulating the transmission lines(4) from the inner and outer sides and the electrodes(3) on the outer side by laminating a predetermined material at predetermined conditions(104),

Inserting the snaps of the control unit(2) in the substrate(5)(105).

47. A production method(lOO) of the TENS device(l) according to claim 46 wherein after the 101. step the locations of the electrodes(3) on the substrate(5) are embroidered to create padding for the electrodes(3) in order to increase electrodes' contact with the skin.

48. A production method(lOO) of the TENS device(l) according to claim 47 wherein the locations of the electrodes(3) on the substrate(5) are embroidered with any thread using a zig zag pattern.

49. A production method(lOO) of the TENS device(l) according to any of claims 46-48 wherein the electrode(3) is embroidered such that it has the stitch density between 1.7 - 3.9 m in the step of "Embroidering the electrodes(3) with a pattern creating a conductive surface on the their locations of the substrate(5) and transmission lines(4) by creating a conductive line on the substrate using conductive thread(102)".

50. A production method(lOO) of the TENS device(l) according to any of claims 46-49 wherein the transmission lines(4) are embroidered as stitch lines by using lockstitch on the textile substrate(5) together with the electrodes(3) at once and without any interruption in the step of "Embroidering the electrodes(3) with a pattern creating a conductive surface on the their locations of the substrate(5) and transmission lines(4) by creating a conductive line on the substrate using conductive thread(102)".

51. A production method(lOO) of the TENS device(l) according to any of claims 46-50 wherein the electrodes(3) are embroidered in a pattern in such a way that a minimal or no thread overlap is provided via series of stitches filling the surface of the electrode(3) in the step of "Embroidering the electrodes(3) with a pattern creating a conductive surface on the their locations of the substrate(5) and transmission lines(4) by creating a conductive line on the substrate using conductive thread(102)".

52. A production method(lOO) of the TENS device(l) according to any of claims 46-51 wherein the electrodes(3) and transmission lines(4) are embroidered by using computer aided embroidery manufacturing in the step of "Embroidering the electrodes(3) with a pattern creating a conductive surface on the their locations of the substrate(5) and transmission lines(4) by creating a conductive line on the substrate using conductive thread(102)".

53. A production method(lOO) of the TENS device(l) according to any of claims 46-52 wherein the electrodes(3) and transmission lines(4) are insulated with a predetermined insulation material laminated onto the textile substrate(5) in the step of "Insulating the transmission lines(4) from the inner and outer sides and the electrodes(3) on the outer side by laminating a predetermined material at predetermined conditions(104)".

54. A production method(lOO) of the TENS device(l) according to any of claims 46-53 wherein the predetermined material is laminated at 100-200°C in the step of "Insulating the transmission lines(4) from the inner and outer sides and the electrodes(3) on the outer side by laminating a predetermined material at predetermined conditions(104)".

55. A production method(lOO) of the TENS device(l) according to any of claims 46-54 wherein the predetermined material is laminated at 25-100 psi pressure in the step of "Insulating the transmission lines(4) from the inner and outer sides and the electrodes(3) on the outer side by laminating a predetermined material at predetermined conditions(104)".

56. A production method(lOO) of the TENS device(l) according to any of claims 46-55 wherein the predetermined material is laminated for 10-30 seconds in the step of "Insulating the transmission lines(4) from the inner and outer sides and the electrodes(3) on the outer side by laminating a predetermined material at predetermined conditions(104)".

57. A production method(lOO) of the TENS device(l) according to any of claims 46-56 wherein the predetermined material is thermoplastic polyurethane membrane in the step of "Insulating the transmission lines(4) from the inner and outer sides and the electrodes(3) on the outer side by laminating a predetermined material at predetermined conditions(104)".

58. A TENS device(l) characterized by being produced by the production method(lOO) according to any of claims 46-57.