This application is a 371 U.S. National Stage of International Application No. PCT/GB2016/050033 filed on Jan. 7, 2016, which claims priority to United Kingdom Application No. 1500164.7 filed on Jan. 7, 2015.
The present invention relates to a tamper proof battery enclosure for incorporation into an electronic device. Aspects of the invention relate to an electronic device including such an enclosure. In particular, the enclosure is useful in disposable medical devices, for example an electronic neurostimulator device.
Low cost, disposable electronic devices are used in many fields, including the medical device field. The present applicants have previously described an electronic neurostimulator device, in international patent application WO2010/070332. The device described therein incorporates a control unit housing the necessary electronics to drive the device, and to allow a user to operate the device; these typically include a PCB and an electrical cell. A pair of electrodes driven by the control unit are printed onto a flexible electrically insulative substrate The substrate is mounted onto a more robust elongate tongue made from, for example, a flexible plastics material.
It is desirable for disposable single use or short term use electronic devices to be, firstly, tamper proof, to prevent unauthorised access or modification to the electronics, and, secondly, readily disabled prior to disposal, again to prevent unauthorised reuse. Indeed, such requirements may be imposed as part of the regulatory procedure for medical devices.
It is among the objects of embodiments of the present invention to provide such properties to a device.
According to a first aspect of the present invention, there is provided an electronic device comprising:
Thus, the device is so arranged such that the aperture is smaller than the clip, and the clip will be deformed when removed from the casing; this deformation will ensure that the clip and other components cannot be replaced back in the casing, such that the device cannot easily be reused. In addition, the cover is not replaceable, due to the broken portions of the casing.
Preferably the cover comprises a flange at a first location, to allow a user to apply force at said location in order to break said portions of relative weakness. The flange may act as a fulcrum for a lever, allowing the cover to be removed using a suitable tool (for example, a screwdriver or similar).
Preferably the cover is joined to the remainder of the casing along a first side by said portions of relative weakness, and along a second side by a further weaker portion which said further portion forms a hinge when the weaker portions along the first side are broken. When the cover comprises a flange, the flange may be located along said first side of the cover. Preferably the hinge portion is arranged to break on application of additional force to the cover; this serves to further place the device beyond use.
Preferably the clip is sized to extend across said aperture and includes a first portion extending beyond said aperture within the interior of the casing such that said first clip portion cannot be removed from the interior through the aperture without deformation of the first clip portion. Thus, the clip is essentially too large to pass through the aperture unless it is deformed so that it cannot be used again.
Preferably the clip is non-resilient, such that upon deformation the clip does not revert to the original shape.
Preferably the electrical cell is sized to extend across said aperture and beyond said aperture on a first side. Preferably said first side of the cell is adjacent said hinge side of the cover. This arrangement allows the cell to act as a pivot whereby the hinge may be caused to break when the cell (and optionally the PCB) are removed from the casing. In certain embodiments, the PCB may be located adjacent the cover, such that breakage of the portions of relative weakness and separation of the at least part of the cover also serves to displace the PCB with respect to the cell and clip to thereby damage at least one of the PCB and/or clip.
The device preferably further comprises a flexible electrically insulative substrate on which is carried a pair of electrodes connected to the PCB by an electrically conductive pathway.
Preferably the casing is substantially sealed against moisture ingress. Preferably the casing is injection moulded.
The device is preferably a medical device, more preferably an electrical neuromuscular stimulator.
The device may further comprise a flexible electrically insulative substrate on which is carried an electrically conductive pathway, the pathway being in electrical contact with the PCB; wherein the substrate is located adjacent the cover, such that breakage of the portions of relative weakness also serves to damage the substrate, such that the electrically conductive pathway is interrupted. This feature may also form a separate embodiment.
In an alternative embodiment, there is provided an electronic device comprising:
Shown in
On the tongue 14 are printed positive 18 and negative 20 electrodes. The positive is slightly larger than the negative. Each electrode includes a conductive track 22, 24 leading from the electrode to a respective contact point 26, 28 located in the recess 16.
Not shown in the figures are an insulative strip arranged between the positive track 22 and the negative electrode 20, and similar strips at the edges of the tongue, to prevent unwanted leakage of current.
Within the recess 16 are placed an electrical cell (not shown), and a PCB (not shown) including suitable circuitry to control the electrodes. Together with the conductive tracks 22, 24 and contact points 26, 28, this forms a complete circuit. A plastic cover is then sonically welded over the recess 16 to seal the components. A layer of gel is then placed over the whole device 10; this provides an electrical contact with a user's limb and helps keep the device adhered to a user. The gel may be protected in transit by a peelable backing layer.
The outer surface of the recess 16 is formed with an integral diaphragm button 30 and an aperture 32 for displaying an LED (visible in
An alternative device is shown in external view in
On the lower portion 44 of the casing 40 is formed a cover 52, which is defined by a thinner portion 54 extending around the cover 52, joining it to the rest of the casing. As can be seen in
The device incorporating the casing 40 is intended to be a disposable, single use (or few uses) device. After use, the cell 48 (and other electrical components) may be removed for recycling or disposal, and the device rendered inoperative.
In order to remove the cell 48, a user may insert a tool 58 (for example, a screwdriver) under the flange 56 and lever the cover 52 open. The thinner portion 54 of the casing will break, and the opposite side from the flange acts as a hinge 61 (
An alternative embodiment is shown in
This embodiment may be combined with the first embodiment, such that a tamper proof enclosure incorporates both means of rendering the device inoperative.
Number | Date | Country | Kind |
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1500164.7 | Jan 2015 | GB | national |
Filing Document | Filing Date | Country | Kind |
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PCT/BG2016/050033 | 1/7/2016 | WO | 00 |
Publishing Document | Publishing Date | Country | Kind |
---|---|---|---|
WO2016/110706 | 7/14/2016 | WO | A |
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Number | Date | Country | |
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20180026240 A1 | Jan 2018 | US |