WO2024256828A1 - Système de stimulation électrique - Google Patents

Système de stimulation électrique Download PDF

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Publication number
WO2024256828A1
WO2024256828A1 PCT/GB2024/051519 GB2024051519W WO2024256828A1 WO 2024256828 A1 WO2024256828 A1 WO 2024256828A1 GB 2024051519 W GB2024051519 W GB 2024051519W WO 2024256828 A1 WO2024256828 A1 WO 2024256828A1
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WO
WIPO (PCT)
Prior art keywords
electrode
region
array
hydrogel
interface
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/GB2024/051519
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English (en)
Inventor
Timothy James Healey
Mark L. REEVES
Avril D. MCCARTHY
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Sheffield Teaching Hospitals NHS Foundation Trust
Original Assignee
Sheffield Teaching Hospitals NHS Foundation Trust
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from GB2308869.3A external-priority patent/GB2630953B/en
Priority claimed from GBGB2308868.5A external-priority patent/GB202308868D0/en
Priority claimed from GBGB2308867.7A external-priority patent/GB202308867D0/en
Application filed by Sheffield Teaching Hospitals NHS Foundation Trust filed Critical Sheffield Teaching Hospitals NHS Foundation Trust
Priority to EP24736053.0A priority Critical patent/EP4727633A1/fr
Publication of WO2024256828A1 publication Critical patent/WO2024256828A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/0404—Electrodes for external use
    • A61N1/0472—Structure-related aspects
    • A61N1/0476—Array electrodes (including any electrode arrangement with more than one electrode for at least one of the polarities)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/0404—Electrodes for external use
    • A61N1/0408—Use-related aspects
    • A61N1/0452—Specially adapted for transcutaneous muscle stimulation [TMS]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/0404—Electrodes for external use
    • A61N1/0408—Use-related aspects
    • A61N1/0456—Specially adapted for transcutaneous electrical nerve stimulation [TENS]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36003—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of motor muscles, e.g. for walking assistance
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36014—External stimulators, e.g. with patch electrodes
    • A61N1/36021—External stimulators, e.g. with patch electrodes for treatment of pain

Definitions

  • the present invention relates to electrical stimulation systems for therapeutic use, and in particular to a hydrogel interface for use with an electrode array of an array stimulation device; an electrode array for use with an electrical stimulation device; and a mounting sleeve for an array stimulation device.
  • UPN upper motor neurone
  • FES functional electrical stimulation
  • a FES device typically has one or two electrodes which are positioned appropriately to stimulate the correct nerve for the desired muscle contraction.
  • electrical stimulation systems that encompass an array of individually controllable electrodes arranged in a grid pattern (i.e. an array).
  • the location of electrical stimulation can thus be controlled by selecting which electrodes within the grid are activated.
  • the electrodes can be activated individually or in blocks depending on requirements.
  • TENS transcutaneous electrical nerve stimulation
  • array stimulation devices such as those described above for FES, but with smaller amplitude electrical pulses.
  • the spatial location of stimulation can be altered over time by activating only certain electrodes.
  • the current intensity of each electrode can also be varied within set limits to provide varied sensory stimulation.
  • Stimulation patterns can be developed to deliver electrical stimulation in a manner which varies to prevent nervous system habituation.
  • the stimulation pattern may mimic movement or stroking across the patient’s skin or electrodes may be grouped together to create a larger virtual electrode whose centre may be dynamically moved within the array.
  • the interesting or salient sensation resulting from a varied electrical stimulation pattern may also help to promote neuroplasticity, aiding long term recovery from neural injury (such as a stroke). This type of stimulation has been referred to as sensory barrage stimulation (SBS).
  • SBS sensory barrage stimulation
  • Electrodes used in FES, TENS and SBS typically have a hydrogel interface between the electrode and the patient’s skin.
  • the hydrogel interface ensures that the electrical current is conducted to the patient’s skin in a dispersed manner and also helps to adhere the electrode to the skin and improve contact. Poor contact between the electrode/hydrogel interface and skin can lead to discomfort. As a hydrogel ages and dries through use then there is an increased risk of poor skin contact and discomfort leading to discontinuation of the therapy.
  • the hydrogel interface is typically provided as a continuous sheet of material for ease of production and handling.
  • Electrodes and their hydrogel interfaces need regular replacement to ensure sanitary conditions are maintained and to ensure that the device continues to operate efficiently and with the required spatial resolution.
  • all electrodes have their own connection to the control unit and power supply. Removal and replacement of all electrodes is therefore not straightforward due to the number of individual electrical connections required.
  • Positioning, securing and removal of the electrode array in the correct position may be challenging for a device user to perform themselves, particularly if they have weakness, reduced manual dexterity and visual acuity as a result of a previous stroke, age or other underlying medical issues.
  • a device is positioned around a user’s upper arm then the user is required to position, secure and later remove the device one-handed.
  • the present invention seeks to reduce the magnitude of electrical current passing between adjacent electrodes to preserve the independence of the electrodes' stimulation and thus of the stimulation patterning programmes to be provided. Additionally, the present invention seeks to provide an electrode array and hydrogel interface that can easily be removed and replaced by a user of an array stimulation device or their carer; and an array stimulation device that can be easily positioned, secured and removed by a user of the device.
  • the present invention provides a hydrogel interface for an array stimulation device having an array of electrodes; comprising a discontinuous hydrogel sheet having multiple spaced apart electrode interface regions, each configured to align with an electrode in the array; wherein each electrode interface region is joined to at least one adjacent region through a bridge.
  • Each bridge extends between two or more adjacent electrode interface regions such that all the electrode interface regions are attached to each other in a single discontinuous sheet.
  • This advantageously allows the hydrogel interface to be manufactured and/or supplied as a single piece to allow the entire sheet to easily be applied to or removed from an electrode array of a multi-channel array stimulation device.
  • By providing a hydrogel sheet having a discontinuous structure possible pathways for stimulation current to dissipate from one electrode through its corresponding electrode interface region to adjacent electrode interface regions are significantly reduced. This enables the spatial resolution of electrode array stimulation devices to be maintained, increasing the effectiveness of array stimulation devices for FES and SBS.
  • the bridges may be composed of the same hydrogel material as the electrode interface regions or may be made of a different material. Where different, the material of the bridges preferably has a lower electrical conduct! vity/admittance than the hydrogel of the electrode interface regions.
  • the bridges may be composed of a hydrogel which has a higher resistance/impedance than the hydrogel of the electrode interface regions.
  • the bridges may be composed of a non-hydrogel material such as natural or synthetic rubber, silicone, or woven or non-woven fabric material.
  • the bridges may alternatively be provided by a continuous support sheet which extends across a face of or through each of the electrode interface regions and across the gaps between electrode interface regions to connect adjacent regions.
  • the continuous support sheet is preferably composed of a porous non-woven fabric material. Suitable materials for the continuous support sheet include polylactic acid (PLA), polyglycolic acid (PGA), polycaprolactone (PCL) or combinations thereof, or polyurethane (PU).
  • each bridge preferably has a minimum path length which is greater than a thickness of the hydrogel sheet (the distance between a first face of the hydrogel sheet configured to contact the electrodes and a second face of the hydrogel sheet configured to contact the skin of a patient, i.e. the distance an electrical current has to travel to pass from an electrode to the patient’s skin).
  • each bridge has a minimum path length which is at least twice the thickness of the hydrogel sheet.
  • each bridge is defined in the context of this invention as the distance across the bridge between any two adjacent electrode interface regions connected by the bridge, i.e. the length of the path electrical current must travel along to pass between two adjacent electrodes.
  • a bridge connects more than two adjacent electrodes (for example three or four electrodes) the bridge will have multiple path lengths between different pairs of connected electrodes.
  • the multiple path lengths may be the same for each electrode pair connected by a bridge or may be different.
  • the minimum path length is thus the shortest path length between two electrodes connected by a particular bridge.
  • the electrical resistance/impedance of the hydrogel between two adjacent electrodes is significantly higher than the electrical resistance/impedance of the hydrogel between the first and second faces. This reduces the amount of current able to dissipate through the hydrogel from one electrode to adjacent electrodes.
  • the electrode interface regions have a generally rectangular or square shape, corresponding to generally rectangular or square electrodes.
  • each bridge preferably connects two or more interface regions from the corners of the interface regions.
  • the dimensions and configuration of the electrode interface regions, bridges and the hydrogel sheet as a whole depend on the dimensions and configuration of the electrode array the hydrogel sheet is intended to be paired with.
  • Each electrode interface region preferably has a size sufficient to cover the entire surface of a corresponding electrode when the hydrogel sheet is positioned against an electrode array. This ensures good contact between the hydrogel interface and skin at each electrode, thus reducing the likelihood of discomfort or irritation. Preferably all of the electrode interface regions have substantially the same dimensions.
  • each electrode interface region is between 100% and 150% of the length of the electrode it is intended to cover.
  • a width of each electrode interface region is between 100% and 150% of the width of the electrode it is intended to cover.
  • each electrode interface region is substantially rectangular or square-shaped and has dimensions of between 8 mm x 8 mm and 12 mm x 12 mm.
  • each electrode interface region is between 110% and 130% of the length/width of the electrode it is intended to cover.
  • each electrode interface region is substantially rectangular or square-shaped and has dimensions of between 8.8 mm x 8.8 mm and 10.4 mm x 10.4 mm.
  • the electrode interface region By making the electrode interface region slightly larger than the electrode it covers, the electrodes are completely covered by the hydrogel in use. This improves skin contact and reduces the risk of discomfort and/or micro tissue damage. Slightly larger electrode interface regions also increase tolerance for misalignment of the hydrogel sheet on the electrode array.
  • Adjacent electrode interface regions may be spaced apart by a gap in the hydrogel (i.e. an air gap) to make the hydrogel sheet discontinuous or may be spaced apart by a solid or gel material having an electrical impedance/resistance higher than that of the electrode interface region.
  • a gap in the hydrogel i.e. an air gap
  • adjacent electrode interface regions are spaced apart by an air gap, as this simplifies the manufacturing process.
  • Adjacent electrode interface regions are preferably spaced apart by a distance of at least 20% of the length or width (whichever is smaller) of the electrode interface region. For example, where each electrode interface region has a length and width of 9.5 mm (i.e. is square-shaped), preferably adjacent electrode interface regions are spaced apart by at least 1.9 mm.
  • hydrogel sheet With repeated or prolonged use of the hydrogel sheet there may be some movement of the hydrogel border. For example, gaps between adjacent electrode interface regions may become narrower as a result of the hydrogel sheet being repeatedly sandwiched between the electrode array and patient’s skin. A separation distance of at least 20% helps to ensure that electrical separation between adjacent electrodes is maintained as the hydrogel sheet ages.
  • Particularly preferably adjacent electrode interface regions are spaced apart by a distance of between 25% and 40% of the length or width of each electrode interface region (whichever is smaller). For example, where each electrode interface region has a length and width of 9.5 mm, preferably adjacent electrode interface regions are spaced apart by between 2.375 mm and 3.8 mm. A separation distance of 40% or less helps to ensure that the structural integrity of the hydrogel sheet is maintained.
  • Each bridge may have a substantially constant width across an entirety of its length. Where a bridge connects more than two adjacent electrode interface regions, each bridge may comprise multiple arms extending from a meeting point to each of the connected electrode interface regions. The meeting point is preferably located substantially equidistant from each of the connected electrode interface regions. Each arm of the bridge may have a substantially equal width along an entirety of its length.
  • One or more bridge may comprise fillets around the meeting point where the diameter of the arms is greater.
  • the fillets preferably increase the width of the arms by less than 50% relative to the minimum width. This improves the structural integrity of the bridges.
  • one or more of the bridges or arms may have rounded or tapered edges such that the width of the bridge changes between a first end (located at a first electrode interface region) and a second end (located at a second electrode interface region where only two electrode interface regions are connected by the bridge, or at the meeting point where more than two electrode interface regions are connected by the bridge).
  • a minimum bridge or arm width may be located at or towards a central point on the bridge or arm (for example where the bridge has rounded edges) or may be positioned at or towards a first or second end (for example where the bridge has tapered edges).
  • Each bridge preferably has a minimum width of 40% or less of the smaller of the length/width of each electrode interface region.
  • each bridge between adjacent electrode interface regions has a minimum width of 3.8 mm or less.
  • a comparatively narrow bridge reduces dissipation pathways for electrical current, thus reducing the likelihood of current spreading between adjacent electrodes.
  • each bridge has a minimum width of between 15% and 35% (inclusive) of the smaller of the length/width of each electrode interface region.
  • each electrode interface region has a length and width of 9.5 mm
  • each bridge between adjacent electrode interface regions has a minimum width of between 1.425 mm and 3.325 mm inclusive. This offers an optimum balance between minimising electrical current dissipation pathways and maintaining the structural integrity of the hydrogel sheet.
  • the number and configuration of electrode interface regions and bridges depends on the number and configuration of electrodes in the array stimulation device.
  • n x m electrodes arranged in an n x m grid (where at least one of n and m >1; n and m may be the same or different)
  • n x m electrode interface regions arranged in a similar n x m grid.
  • the bridges connecting only 2 adjacent electrode interface regions are arranged around the outer edge of the grid.
  • both n and m are between 2 and 16 inclusive.
  • both n and m are between 4 and 12 inclusive.
  • the array stimulation device has 64 electrodes are arranged in an 8*8 configuration
  • the hydrogel sheet may further comprise a border surrounding all the electrode interface regions and bridges.
  • the border may be composed of the same hydrogel material as the interface regions and/or bridges. The border advantageously provides a region for a user to handle when positioning the hydrogel sheet, to prevent fouling or contamination of the electrode interface regions.
  • the border may include one or more indentations, cuts or protrusions configured to mate with a corresponding feature provided on an array stimulation device to facilitate correct positioning of the hydrogel sheet on the electrode array.
  • the hydrogel sheet may further comprise one or more counter electrode interface regions separated from the electrode interface regions and intended to cover a counter electrode.
  • the counter electrode interface region(s) are intended to cover the anode(s).
  • the counter electrode interface region(s) are preferably separated from the electrode interface regions by a distance greater than 100% of the smaller of the length/width of each electrode interface region. This helps to prevent electrical current short-circuiting through the hydrogel sheet between the cathode and the anode in use.
  • the hydrogel sheet may further comprise a discontinuous portion between the electrode interface regions and the (or each) counter electrode interface region(s).
  • the hydrogel sheet may be composed of any commercially available hydrogel suitable for use with electrical stimulation electrodes. Examples of suitable hydrogels are disclosed in EP2799507A1.
  • an electrode array for use with an electrical stimulation device, comprising a flexible printed circuit board (PCB) having an array region and a tail extending from the array region to a connection region at the distal end of the tail; an array of electrodes positioned on a face of the array region; wherein each electrode is independently connected by a conductive path along the tail to a corresponding contact pad in the connection region; wherein the connection region of the tail is configured to be insertable directly into a corresponding slot in an electrical stimulation device, wherein the corresponding slot is provided with contacts electrically connectable to each contact pad.
  • PCB flexible printed circuit board
  • the electrode array can easily be manipulated into the desired position, for example around the arm of a patient.
  • the conductive paths and the contact pads are intended to provide an electrical link between each electrode and an electrical stimulation device which provides the electrical power (pulses) to each electrode and controls the pattern, frequency and magnitude of pulses.
  • connection region is intended to be inserted into a corresponding slot in an electrical stimulation device.
  • a separate connector module or plug at the distal end of the tail. This simplifies the manufacturing process, as manufacturing and attaching a connector module with multiple independent channels required for the independently controllable electrodes is time consuming, and the relative bulkiness and rigidity of a separate connector module/plug makes the electrical connections between the plug and the PCB susceptible to failure during manipulation. This configuration also makes it easier for a user to connect and disconnect the electrode array to the electrical stimulation device.
  • the flexible PCB may comprise a support layer composed of an insulative material (z.e. a material having a volume resistivity of 10 9 Q-cm or greater) such as a flexible polymer (e.g. a polyimide or PET); and a conductive layer comprising a conductive metal such as gold or silver, or another conductive material such as graphite, wherein the electrodes, conductive paths and contact pads are each part of the conductive layer.
  • the flexible PCB preferably has a thickness of 1 mm or less, particularly preferably 0.5 mm or less (e.g. 0.2 mm).
  • the flexible PCB may have a substantially consistent thickness across the array region, the tail region and the connection region.
  • substantially consistent thickness should be interpreted as no location of the flexible PCB having a thickness which varies by > ⁇ 90% relative to the thickness of any other location of the flexible PCB.
  • the flexible PCB has a thickness no greater than 0.4 mm throughout.
  • the flexible PCB may comprise a first conductive layer positioned on a first side of the support layer; and a second conductive layer positioned on a second side of the support layer.
  • All the electrodes may be positioned in the first conductive layer. In this configuration, all the electrodes are positioned on one side of the flexible PCB but some of the conductive paths can be positioned on an opposite side of the flexible PCB to allow for increased separation between paths along the tail. Where a conductive path is positioned on an opposite side of the conductive layer to its corresponding electrode or contact pad, the conductive path includes a conductive link through the support layer.
  • a number (e.g. half) of the electrodes may be positioned in the first conductive layer, with the remaining electrodes positioned in the second conductive layer but exposed from the first side by one or more holes provided in the support layer, wherein the one or more holes are aligned with the electrodes in the second conductive layer, such that the electrodes in both the first conductive layer and the second conductive layer together define the array of electrodes on the face of the array region.
  • All the contact pads may be positioned in the same conductive layer (e.g. the first conductive layer). Alternatively a number (e.g. half) of the contact pads may be positioned in the second conductive layer. Where a number of the contact pads are positioned in both the first and second conductive layers, the contact pads positioned in either the first conductive layer or the second conductive layer may be exposed respectively from the second side or the first side by one or more holes provided in the support layer in the connection region.
  • the array of electrodes preferably comprises a grid of n x m electrodes, where at least one of n and m is greater than 1.
  • both n and m are between 2 and 16. Particularly preferably both n and m are between 4 and 12.
  • n m.
  • the electrodes in the grid preferably have a square-shaped contact face.
  • the electrodes in the grid are preferably spaced apart by a distance of at least 40% of the length/width of each electrode. Particularly preferably the separation distance is between 45% and 65%.
  • the contact pads are preferably arranged in a grid within the connection region (corresponding to the grid of electrodes).
  • the electrode array may further comprise a counter electrode provided on the same flexible PCB and electrically connected to a counter electrode contact pad positioned in the connection region by a counter electrode conductive path extending along the tail.
  • the counter electrode is preferably positioned adjacent the array region and spaced apart from the grid of n * m electrodes (z.e. the counter electrode is not part of the grid).
  • the counter electrode may be an anode, with each electrode in the grid being a cathode.
  • the counter electrode may have a larger size than the electrodes in the grid.
  • the electrode array may comprise two counter electrodes, with one positioned either side of the grid.
  • the flexible PCB may further comprise a stiffening layer extending across the connection region.
  • the stiffening layer may be composed of a material which is less flexible than the support layer of the flexible PCB, or may be composed of the same material as the support layer but have a greater thickness such that it is less flexible than the support layer.
  • the stiffening layer makes it easier to insert the connection region into a slot in an electrical stimulation device, and reduces the risk of tearing or damage to the flexible PCB at the connection region when inserting or removing it from the electrical stimulation device. Consequently the flexible PCB may have a greater thickness in the connection region.
  • a thickness of the flexible PCB in the connection region is no greater than four times (or more preferably no greater than two times) a thickness of the flexible PCB in the array region.
  • the thickness of the PCB in the connection region where a stiffening layer is present is 5 mm or less, more preferably 3 mm or less, or even more preferably 2 mm or less.
  • the flexible PCB may include one or more alignment tabs on the tail towards the connection region to provide a visual guide and physical stop to ensure correct insertion and alignment of the connection region within the slot on the electrical stimulation device.
  • the present invention provides a mounting sleeve for a medical device, such as an array stimulation device, comprising: an elongate flexible sheet having an interior face and an exterior face; and a tail region at a first longitudinal end, a head region at a second longitudinal end and a central region between the tail region and head region; a hinge composed of a flexible material and attached at the second longitudinal end of the flexible sheet and having a first surface on the same side of the sleeve as the interior face; a second surface on the same side of the sleeve as the exterior face; a sizing fastener on the first surface towards a distal end (the end furthest from the flexible sheet) and a securing fastener on the second surface towards a proximal end (the end closest to the flexible sheet), and a stiffener positioned between the sizing fastener and the proximal end; wherein the flexible sheet has a sizing attachment point provided on the exterior face in the tail region and
  • the terms “interior face” and “exterior face” are intended to describe the configuration of the faces when the mounting sleeve is in use (i.e. when positioned around the limb of a user, the interior face will face interiorly towards the patient’s skin, whilst the exterior face will face exteriorly).
  • the mounting sleeve may not have an interior or exterior (e.g. the sleeve may be substantially flat).
  • the flexible sheet may have one or more slots disposed in the head and/or central regions extending between the interior and exterior faces.
  • an electrode array as hereinbefore described (with a hydrogel interface as hereinbefore described) can be attached to the mounting sleeve, with the array region positioned against the interior face in the central region with the electrodes exposed (z.e. on the opposite side of the flexible PCB to the interior face).
  • the connection region and part of the tail of the electrode array can be passed through one of the slots to the exterior face, an electrical stimulation device can be fitted on the external face in the head region, and the connection region can be connected to the electrical stimulation device to form an array stimulation device.
  • the mounting sleeve can then be wrapped around a user’s limb in the required position such that the interior face (and electrodes) face towards the user’s skin and the mounting sleeve has a generally tubular shape.
  • the loose-fit size of the mounting sleeve i.e. internal circumference of the mounting sleeve when in a loose configuration to enable positioning and removal
  • the mounting sleeve In the loose configuration, the mounting sleeve has an internal circumference greater than the circumference of the limb at the position where the array stimulation device is to be mounted. Thus in the loose configuration, the mounting sleeve can be slid onto and off the limb without needing to detach the sizing fastener from the sizing attachment point. Thus the size of the mounting sleeve can be configured for a particular user and retained for as long as required.
  • the hinge is folded back against the flexible sheet such that the second face of the hinge at the proximal end abuts the exterior face of the flexible sheet; and the securing fastener mates with the securing attachment point.
  • the device In the tight fitted configuration, the device cannot be accidentally moved into an incorrect position.
  • This configuration advantageously makes it easier for a user to position and remove the array stimulation device one-handed, as (once the sizing fastener is attached at the correct position for the user), the mounting sleeve can be simply slid into position and tightened by pushing the head end of the flexible sheet, the hinge and the tail end of the flexible sheet together so that the hinge is sandwiched between the head and tail regions of the flexible sheet. The sleeve can be removed by pulling the head and tail regions apart to release the hinge and return the mounting sleeve to a loose configuration.
  • Any releasable two-part fastener may be used as the sizing fastener and respective sizing attachment point; and as the securing fastener and respective securing attachment point.
  • suitable two-part fasteners include hook and loop fasteners, magnetic fasteners, press studs or snap fasteners, buckles, buttons and button holes or zips.
  • the sizing attachment point provides a continuous attachment area (i.e. the sizing fastener can be attached to the attachment point over a continuous range rather than at one or more discrete points).
  • a hook and loop fastener is used as the sizing fastener and respective sizing attachment point, with a continuous area of loops (or hooks) provided in the tail region of the flexible sheet as the sizing attachment point; and complementary hooks (or loops) provided as the sizing fastener.
  • Providing a continuous attachment area advantageously allows the mounting sleeve to be more finely adjusted to the required size for a particular user. This provides an improved fit compared to two-part fasteners with discrete attachment points. Hook and loop fasteners are advantageously easier to secure and release, particularly one-handed, by simply pushing together or pulling apart.
  • the continuous attachment area provided by the sizing attachment point may extend over the entire exterior face of the flexible sheet in the tail region, and may thus also provide the securing attachment point where the securing fastener is the same type of fastener as the sizing fastener (e.g. a hook and loop type fastener).
  • the continuous attachment area may be an integral feature of the flexible sheet (i.e. the flexible sheet may comprise a material which is hook (or loop) receptive); or the continuous attachment area may be attached to the exterior face of the flexible sheet.
  • the flexible sheet is preferably composed of an elastic material. Having a flexible sheet composed of an elastic material enables the mounting sleeve to maintain adequate pressure to ensure good electrical contact between the electrode array and skin, including when the limb (e.g. arm or leg) where the sleeve is attached is moved. An elastic material can also conform more accurately to the particular shape of the user’s limb. Particularly preferably the flexible sheet is composed of neoprene.
  • the sizing attachment point and securing attachment point, or the continuous attachment area may be composed of a stretchable material to enable the attachment points to stretch as the flexible sheet is stretched.
  • the hinge is preferably composed of a flexible woven or non-woven fabric material such as polyester or nylon fabric, or a coated fabric such as polyurethane laminate.
  • the stiffener may be provided in an internal or external pocket of the flexible hinge material.
  • the hinge may comprise two sheets of flexible fabric material attached together around a perimeter with an internal cavity, and the stiffener may be provided in the internal cavity.
  • the stiffener helps to maintain the rigidity of the hinge, making it easier for a user to manipulate the hinge into the correct position to secure/release the mounting sleeve in/from the tight fitted configuration.
  • the stiffener also helps to prevent external forces from prematurely detaching the securing fastener and securing attachment point (for example if the device is tugged or pulled accidentally when in use).
  • the stiffener may be a plastic sheet (e g. a polypropylene, polystyrene, polycarbonate or acrylic sheet).
  • the stiffener may have a curved profile to improve positioning around the user’s limb.
  • the stiffener may have a straight profile but be configured to elastically deform to a curved profile as the sleeve is tightened around the user’s limb.
  • the stiffener has rounded edges to reduce the risk of the stiffener pressuring the patient’s skin or of damaging or tearing the fabric of the hinge.
  • the mounting sleeve may include a control attachment provided in the head region on the exterior face to enable an electrical stimulation device to be releasably attached to the mounting sleeve.
  • the control attachment may be one half of a two-part fastener as described above, with the other half provided on the electrical stimulation device.
  • straps or a pocket may be provided on the exterior face in the head region to releasably secure an electrical stimulation device in place.
  • the length of the tail region is preferably longer than required to wrap around and secure the mounting sleeve in place on the relevant limb of a typical user using the hinge and securing fastener.
  • Typical user in this context means a user having a limb segment circumference (depending on which the mounting sleeve is intended for) within two standard deviations of the mean limb segment circumference for a given representative sample of the population.
  • one size of mounting sleeve can fit >95% of users.
  • the tail region can be cut to the required size.
  • the interior surface may include a gradated scale or a markable area within the central region. This allows a user or clinician to note (by reading the gradated scale) or mark (by marking in the markable area) the position of the electrode array. This ensures that when the electrode array requires replacement, the new electrode array can be secured in the correct position.
  • the markable area or gradated scale may be printed onto the interior surface.
  • the exterior surface may also include a markable area within the central region to allow a clinician to mark the centre of the muscle or other notation to aid a user in positioning the device on the limb correctly.
  • an electrical stimulation device comprising: a housing; a power supply at least partially enclosed by the housing; a control system at least partially enclosed by the housing; and a slot within the housing configured to receive a connection region of an electrode array as hereinbefore defined; wherein the control system is operable to selectively and independently supply electrical current from the power supply to a plurality of electrical contacts positioned on an interior of the slot; wherein the plurality of electrical contacts are configured to contact and thus provide an electrical connection with contact pads on the connection region of the electrode array to supply power independently to each electrode in the electrode array.
  • the plurality of electrical contacts may be positioned on a moveable circuit board mounted within the slot.
  • the moveable circuit board may be moveable between a locked position where the electrical contacts contact the contact pads of the connection region to hold or grip the connection region of the tail and prevent or limit its movement or removal from the slot; and an open position where the electrical contacts are separated from the contact pads and insertion or removal of the connection region from the slot is possible.
  • the electrical stimulation device may be provided with a handle or slider on an external face of the housing, wherein the handle or slider is operable to move the moveable circuit board between the locked and open positions.
  • the electrical stimulation device may be provided with one or more cams connected to the handle or slider which are configured to rotate upon actuation of the handle or slider to push the moveable circuit board into a locking position and apply a clamping force to the moveable circuit board and the connection region.
  • the electrical stimulation device may include a biasing mechanism (e.g. a spring) to bias the moveable circuit board towards an open position when no clamping force is provided by the one or more cams.
  • the present invention provides an electrical stimulation system; comprising an electrode array as hereinbefore described; a hydrogel interface as hereinbefore defined, wherein each electrode interface region covers the surface of an electrode in the electrode array; a mounting sleeve as hereinbefore described; and an electrical stimulation device as hereinbefore described, wherein the electrical stimulation device is electrically connectable to each electrode on the electrode array to supply power to each electrode individually.
  • the electrode array preferably comprises a grid of n x m electrodes, where at least one of n and m is greater than 1. Preferably both n and m are between 2 and 16.
  • the hydrogel interface preferably comprises an array of n x m electrode interface regions corresponding to the electrode array.
  • the present invention provides a kit of parts, comprising an electrode array as hereinbefore described; and a hydrogel interface as hereinbefore defined.
  • the kit of parts may further comprise a mounting sleeve as hereinbefore described.
  • the kit of parts may further comprise an electrical stimulation device electrically connectable to each electrode on the electrode array to supply power to each electrode individually.
  • Figure 1 is a perspective view of an electrical stimulation system having an electrode array with an array of electrodes, and a mounting sleeve.
  • Figure 2 shows the electrode array of the electrical stimulation system of Figure 1.
  • Figure 3 shows a first example of a hydrogel interface according to the present invention, intended to be paired with the electrode array of Figure 2.
  • Figure 4 shows the hydrogel interface of Figure 3 superimposed on part of an electrode array.
  • Figure 5 is a partial view of the hydrogel interface of Figure 3 showing 4 adjacent electrode interface regions and their connecting bridge.
  • Figure 6 is a partial view of an alternative hydrogel interface showing 4 adjacent electrode interface regions and their connecting bridge.
  • Figure 7 is a partial view of another alternative hydrogel interface showing 4 adjacent electrode interface regions and their connecting bridge.
  • Figure 8 is a partial view of yet another alternative hydrogel interface showing 4 adjacent electrode interface regions and their connecting bridge.
  • Figure 9 is a circuit diagram of a test circuit for testing inter-electrode resistance.
  • Figure 10 shows the connection region of the electrode array of Figure 2 within a slot on an electrical stimulation device.
  • Figure 11 is a simplified diagram showing how the connection region is secured within the slot on an electrical stimulation device.
  • Figure 12 shows a circuit board located within the electrical stimulation device for interaction with the connection region.
  • Figure 13 shows the mounting sleeve of the electrical stimulation system of Figure 1 laid flat with the interior face of the flexible sheet visible.
  • Figure 14 shows the mounting sleeve of the electrical stimulation system of Figure 1 laid flat with the exterior face of the flexible sheet visible.
  • Figure 15 is a side perspective view of the electrical stimulation system of Figure 1.
  • an electrical stimulation system 1 is shown.
  • the electrical stimulation system 1 is intended to be releasably securable around a patient’s upper arm and has a generally tubular-shaped flexible mounting sleeve 4 which includes a flexible sheet 40 with an interior face 41 pointing inwardly and an exterior face 42 pointing outwardly.
  • the mounting sleeve 4 is shown in a secured tight-fit configuration as it would appear when in position on a patient’ s upper arm.
  • Figure 15 shows the mounting sleeve 4 in an intermediate position between the secured tight-fit configuration of Figure 1 and a loose-fit configuration.
  • the mounting sleeve 4 is shown in a laid-flat (disassembled) configuration. This configuration facilitates transport and storage of the mounting sleeve 4 when not required.
  • Figure 13 the interior face 41 of the flexible sheet 40 is visible; whereas Figure 14 shows the exterior face 42 of the flexible sheet 40.
  • the flexible sheet 40 has an elongate shape with a longitudinal axis X extending between a tail end 46 and a head end 47.
  • the flexible sheet 40 is formed of a continuous sheet of material, it may be considered to have three regions: a tail region 43 towards the tail end 46; a head region 45 towards the head end 47; and a central region 44 positioned longitudinally between the head and tail regions 45, 43.
  • the flexible sheet 40 has a width of 170 mm and a total length of 500 mm, with the tail region 43 having a length of 225 mm, the central region 44 having a length of 175 mm and the head region 45 having a length of 100 mm (i.e. a 9:7:4 ratio of lengths for tail, central and head regions).
  • the tail region 43 has a generally longer length than the each of the central and head regions 44, 45 to allow the size (internal circumference) of the mounting sleeve 4 to be adjusted to fit most patients.
  • a mounting sleeve 4 having a flexible sheet 40 of these dimensions has advantageously been found to fit on the upper arm of 95% of patients.
  • each region can be adapted as required for the size and shape of limb (arm or leg) and intended position of the cuff (i.e. the muscle to be stimulated).
  • limb arm or leg
  • the cuff i.e. the muscle to be stimulated
  • patients having larger limbs may require a mounting sleeve 4 having a longer flexible sheet 40; and a longer flexible sheet 40 may be required for an electrical stimulation system 1 intended to be mounted to a leg rather than an arm.
  • excess material in the tail region 43 for example when the mounting sleeve 4 is used on a patient with smaller arms
  • excess material can be removed by cutting the flexible sheet 40 from the tail end 46.
  • the flexible sheet 40 is composed of neoprene, and has a stretchable fabric material provided on the exterior face 42 which is hook-receptive, in that it comprises loops or loose stitches to which a hooked portion of a hook and loop fastener can attach.
  • a hinge 48 is attached to the flexible sheet 40 at the head end 47.
  • the hinge 48 has substantially the same width as the flexible sheet 40 and is composed of a woven fabric material coated with a polyurethane coating for improved strength and water resistance.
  • the hinge 48 has two sheets of fabric material stitched together around a perimeter; and stitched to the head end 47 of the flexible sheet 40 to define a proximal end 49 of the hinge 48.
  • the hinge 48 extends from the proximal end 49 to a distal end 410.
  • a sizing fastener 412 Towards the distal end 410 on a first surface 414 of the hinge 48 is a sizing fastener 412.
  • the sizing fastener 412 is a hook portion of a hook and loop fastener and is intended to be releasably mateable with the hook-receptive fabric material provided on the exterior face 42 of the flexible sheet 40.
  • the sizing fastener 412 extends across a majority of the width of the hinge 48.
  • the hinge 48 has a stiffener 411 positioned longitudinally between the proximal end 49 and the sizing fastener 412.
  • the stiffener 411 comprises a polypropylene plate which is positioned internally, i.e. in an internal cavity between the two fabric sheets of the hinge 48 and held in place by stitching (not shown).
  • the stiffener 411 and the sizing fastener 412 together restrict the positions where the hinge 48 can be folded along a transverse line (i.e. folded perpendicularly to the longitudinal axis) to an area between the proximal end 49 and the stiffener 411; and an area between the stiffener 411 and the sizing fastener 412.
  • the hinge 48 has a pair of securing fasteners 413 positioned on a second surface 415 towards the proximal end 49 within the stiffener 411.
  • These securing fasteners 413 are each hook portions of a hook and loop fastener and (like the sizing fastener 412) are intended to be releasably mateable with the hook-receptive fabric material provided on the exterior face 42 of the flexible sheet 40.
  • the mounting sleeve 4 can be assembled into a useable state by folding the hinge 48 along a transverse line between the stiffener 411 and the sizing fastener 412 such that the second surface 415 is folded in on itself.
  • the sizing fastener 412 is then attached to the hook-receptive fabric on the exterior face 42 of the flexible sheet 40 in the tail region 43.
  • the position where the sizing fastener 412 is attached can be set according to the required inner circumference of the mounting sleeve 4, based on the size of the intended user’s upper arm.
  • the mounting sleeve 4 can then be secured in place around the arm of the user by folding the hinge 48 along a transverse line between the stiffener 411 and the proximal end 49 in an opposite direction to the first fold (i.e. such that the first surface 414 is folded in on itself).
  • the securing fasteners 413 can then be brought into contact with and attached to the hook-receptive fabric in the tail region 43.
  • the sizing fastener 412 is larger than the securing fasteners 413.
  • the sizing fastener 412 When attached to the hook-receptive fabric on the exterior face 42, the sizing fastener 412 will thus have a stronger attachment than the securing fasteners 413 (i.e. separating the sizing fastener 412 from the hook-receptive fabric will require more force than separating the securing fasteners 413 from the hook-receptive fabric). This reduces the chance of the sizing fastener 412 becoming detached as the mounting sleeve 4 is secured/removed by the user.
  • the sizing fastener 412 remains in place on the exterior face 42 once the mounting sleeve 4 has been assembled into a useable state (as shown in Figures 1 and 15).
  • the mounting sleeve 4 will remain the correct size for repeated use in the same position (in this embodiment the upper arm of a particular user) even with repeated removal/replacement.
  • the mounting sleeve 4 includes two slots 418 in the flexible sheet 40.
  • the slots 418 are positioned centrally widthwise and have a greater transverse extent than longitudinal extent.
  • one slot is provided in the head region 45 and a second slot is provided in the central region 44.
  • the slots 418 are intended for a tail 23 of an electrode array 2 to pass through to provide an electrical connection to an electrical stimulation device 5.
  • the most appropriate slot can be chosen depending on the internal circumference of the mounting sleeve 4 to improve user comfort.
  • the interior face 41 includes two markable areas 419 in the central region 44. These markable areas 419 are painted onto the interior face 41 and provide an area which can be marked with a pen, to note the position where an electrode array 2 is mounted. When an electrode array 2 requires replacement then this ensures that the replacement array can be fitted in the same position.
  • the printed markable areas 419 are discontinuous. This helps to maintain the elasticity / stretchability of the flexible sheet 40 in these areas so the mounting sleeve 4 can better conform to the shape of the arm.
  • the exterior face 42 also has a markable area 421 in the central region 44.
  • This markable area 421 is also discontinuous, and is intended for a clinician to mark the centre of the muscle to ensure the mounting sleeve 4 is secured on the arm in the correct orientation.
  • the exterior face 42 also has a printed outline in the head region 45 marking the correct mounting area 420 for an electrical stimulation device 5.
  • the exterior face 42 in this area is provided with a hook-receptive material, to releasably mate with corresponding hooks provided on the electrical stimulation device 5.
  • an electrode array 2 is provided on the interior face 41 of the flexible sheet 40.
  • the electrode array 2 When the electrical stimulation system 1 is secured on a user’s upper arm, the electrode array 2 will be positioned against the skin of the user.
  • a hydrogel interface 3 (not shown in Figure 1) is provided on the electrode array 2 and is positioned between the electrode array 2 and the user’s skin when the system 1 is in use.
  • the electrode array 2 is composed of a polyimide support layer; a first conductive layer positioned on a first side of the support layer (the side visible in Figure 2); and a second conductive layer positioned on a second side of the support layer (the underside, not visible in Figure 2).
  • the electrode array 2 has a connection region 21, an array region 22 and a tail 23 extending in a longitudinal direction between the array region 22 and the connection region 21.
  • Electrodes 20 On an upper face of the array region 22, there is a grid of equally spaced apart squareshaped electrodes 20. In this particular embodiment there are a total of sixty -four electrodes 20 arranged in an 8 * 8 grid.
  • the electrodes 20 are square-shaped copper plates, each having dimensions of 8 mm x 8 mm. Adjacent electrodes 20 are spaced apart by a distance of 4 mm.
  • Each electrode 20 within the grid is individually electrically connected by a conductive path 26 to a corresponding contact pad 25 provided at the connection region 21 at the distal end of the tail 23.
  • the contact pads 25 are configured in an 8 x 8 grid to match the grid of electrodes 20.
  • the conductive paths 26 and contact pads 25 are composed of copper.
  • conductive paths 26 are shown in Figure 2 for illustrative purposes, only half (i.e. thirty -two) of the conductive paths are provided in the first conductive layer.
  • the electrodes 20 in the four rows of the grid closer to the tail 23 i.e. the bottom four rows in Figure 2) are connected to conductive paths 26 provided in the first conductive layer.
  • the remaining electrodes i.e. the top four rows in Figure 2) are connected to conductive paths 26 provided in the second conductive layer, on an underside of the electrode array 2 in the view of Figure 2. This is to ensure adequate electrical separation between adjacent conductive paths 26.
  • Two larger counter electrodes 210 are positioned to the sides of the grid of electrodes 20. Where the electrodes 20 within the grid are cathodes, the counter electrodes 210 are anodes and act to complete the electrical circuit through the user’s skin when in use. Each counter electrode 210 is connected by a counter electrode conductive pathway 28 to a respective counter electrode contact pad 27 provided in the connection region 21.
  • the electrode array 2 is positioned on the interior face 41 of the flexible sheet 40 so that the array region 22 and the counter electrode regions 24 are positioned with the electrodes exposed (i.e. facing towards the space within the tubular shaped mounting sleeve 4). As illustrated in Figure 15, the tail 23 extends through a slot 418 in the mounting sleeve 4 and is connected at the connection region 21 to an electrical stimulation device 5 mounted on an exterior face 42.
  • connection region 21 of the electrode array 2 is inserted into an opening 50 on the side of the electrical stimulation device 5.
  • the electrode array 2 has a pair of alignment tabs 29 positioned on either side of the tail 23 adjacent to the connection region 21. These alignment tabs 29 are configured to abut the housing of the electrical stimulation device 5 when the connection region 21 is fully inserted into the opening 50. This ensures that the connection region 21 is properly aligned within the opening 50.
  • connection region 21 is shown in simplified form (with conductive paths 26, 28 not shown for clarity) within the opening 50 of an electrical stimulation device 5.
  • the module housing is opened and simplified for illustration.
  • the alignment tabs 29 abut the exterior of the housing, and internal guides 54 within the housing ensure correct positioning and alignment of the connection region 21 and the contact pads 25, 27.
  • connection region 21 within the opening 50 is shown.
  • a circuit board 55 (shown in Figure 12) having an array of electrical contacts 56 and two counter electrode contacts 57 which correspond in spacing and relative position to the array of contact pads 25 and the counter electrode contact pads 27 on the electrode array 2 is provided above the opening 50.
  • the circuit board 55 and the connection region 21 are brought together into a locked position so that each contact pad 25, 27 in the connection region 21 contacts an electrical contact 56, 57 on the circuit board 55.
  • Friction between the electrical contacts 56, 57 and the contact pads 25, 27 secures the connection region 21 within the opening 50.
  • the circuit board 55 is configured to be biased in an open position (as shown in Figure 11) where the electrical contacts 56, 57 are not in contact with the contact pads 25, 27 and the connection region 21 can be removed from the opening 50.
  • a user turns a handle 51 provided outside the housing. This turns a rod 52 to which a cam 53 is attached. The cam 53 pushes the circuit board 55 into the locked position.
  • the hydrogel interface 3 is intended to be positioned over the electrode array 2 such that, in use, it is positioned between the electrodes 20 and the system user’s skin.
  • the hydrogel interface 3 in this particular embodiment is composed of SCBZAB-05 hydrogel provided by Sekisui Plastics, and has a thickness of 0.5 mm.
  • the hydrogel interface 3 in this particular embodiment is formed as a single hydrogel sheet 30. Within the sheet 30 are a plurality of gaps 32 arranged in lines extending along a longitudinal or transverse axis of the sheet 30.
  • the gaps 32 are arranged in a grid pattern within a central array area of the hydrogel sheet 30 and define an array of electrode interface regions 31 and interconnecting bridges 33, 34.
  • Each electrode interface region 31 has a height (in a longitudinal direction) of 9.5 mm and a width (in a transverse direction) of 9.5 mm.
  • each electrode interface region 31 is slightly larger than its corresponding electrode 20, with 0.75 mm tolerance around the electrode 20 (assuming the electrode 20 is positioned centrally). This tolerance ensures that each electrode 20 is fully covered by an electrode interface region 31 to reduce the likelihood of damage, fouling or degradation of the electrodes 20 and to reduce the risk of discomfort leading to discontinuation of the treatment, for example if the hydrogel interface 3 is not positioned entirely correctly or if there is shifting in the shape of the hydrogel interface 3 as it ages.
  • the gaps 32 also define a series of interconnecting bridges 33, 34 between adjacent electrode interface regions 31.
  • four-way interconnecting bridges 33 connect four adjacent electrode interface regions 31.
  • two-way interconnecting bridges 34 connect two adjacent electrode interface regions 31.
  • the bridges 33, 34 aid in maintaining the structural integrity of the hydrogel interface 3, whilst the gaps 32 improve electrical separation between adjacent electrode interface regions 31 to reduce the likelihood of electrical current dissipating between electrodes 20 through the hydrogel sheet 30.
  • the border 35 is provided to facilitate handling and positioning of the hydrogel interface 3.
  • the hydrogel interface 3 also includes a counter electrode interface region 36 towards each longitudinal end of the hydrogel sheet 30.
  • the counter electrode interface regions 36 are spaced apart from the central array area by discontinuous portions 37, to improve electrical separation of the central array area and counter electrode interface regions 36.
  • each of the counter electrode interface regions 36 are intended to cover a counter electrode 210.
  • the hydrogel sheet 30 is provided with indentations 38 around its perimeter.
  • the indentations 38 aid in accurately positioning the hydrogel interface 3 on the electrode array 2.
  • FIG 5 a partial view of the hydrogel interface 3 is shown, with a particular focus on a four-way bridge 33 between four adjacent electrode interface regions 31.
  • each electrode interface region 31 is slightly larger than its corresponding electrode 20, with each electrode 20 (shown as dashed lines) completely covered by the interface region 31.
  • the gap 32 between adjacent electrode interface regions have a width of 2.5 mm.
  • the bridge 33 extends from a comer of each electrode interface region 31 and has four arms 39, each of which extends from an electrode interface region 31 towards a central point 311 which is equidistant from the four connected interface regions 31.
  • Each arm 39 has rounded edges 310 (with a radius of 1.25 mm) such that the width of each arm 39 varies between the corner of the electrode interface region 31 and the central point 311.
  • FIG. 6 a partial view of a second hydrogel interface 350 having an alternative bridge configuration is shown.
  • the four-way bridge 353 in the embodiment of Figure 6 is similar to the bridge 33 with four arms 359 with curved edges 360 extending from corners of the electrode interface regions 351.
  • the gap 352 between adjacent electrode interface regions 351 is 3 mm, (i.e. 0.5 mm larger than the gap 32 in the embodiment of Figures 3-5).
  • FIG 7 a partial view of a third hydrogel interface 370 having another alternative bridge configuration is shown.
  • the arms 379 of the four-way bridge 373 in the embodiment of Figure 7 have straight edges 380 and have substantially the same width (1.4 mm) along their entire length between the comer of an electrode interface region 371 and a central point 381.
  • the gap 372 between adjacent electrode interface regions 371 is 3 mm, (i.e. 0.5 mm larger than the gap 32 in the embodiment of Figures 3-5).
  • FIG 8 a partial view of a fourth hydrogel interface 390 having yet another alternative bridge configuration is shown.
  • the four-way bridge 393 is similar to the four-way bridge 373 of the embodiment shown in Figure 7 with the arms 399 having substantially straight edges 3910.
  • the bridge 393 is provided with fillets 3912 arranged around the central point 3911.
  • the fillets 3912 provide additional structural rigidity to the bridge 393.
  • the inter-electrode impedance of the hydrogel interfaces 3, 350, 370, 390 was tested and compared to the inter-electrode impedance of existing continuous hydrogel interfaces to determine the effectiveness of each bridge configuration.
  • a test hydrogel interface having a thickness of 0.5 mm and comprising a 2 x 2 grid of electrode interface regions was prepared, similar to the partial views of Figures 5 to 8.
  • the test hydrogel interface was composed of ST-gel (NR grade) from Sekisui Plastics. The hydrogel interface region was then placed over a 2 * 2 electrode array.
  • Each electrode pair in the array was then connected to a measuring circuit 60 as shown in Figure 9, and the inter-electrode resistance was measured between the first electrode 61 and the second electrode 62 by applying a pulse of a known current from a ODFS Pace stimulator 63 and measuring the voltage drop using voltmeters 64, 65.
  • the average resistance values from all electrode pairs measured for a particular hydrogel interface 66 were then calculated and the results are shown in Table 1.
  • each of the discontinuous hydrogel interfaces tested exhibits significantly higher inter-electrode impedance than a continuous hydrogel sheet.
  • each hydrogel interface offers improved performance compared to existing continuous hydrogel sheets, enabling spatial resolution to be maintained in electrode array stimulation devices.
  • the bridge configuration of the hydrogel interface 370 offers the highest inter-electrode resistance. However the relatively thin arms 379 in this hydrogel interface 370 make this configuration more challenging to manufacture, and more prone to damage. Thus the bridge configuration of the hydrogel interface 3 offers a good balance between ease of manufacture/structural integrity and high impedance.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
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  • Electrotherapy Devices (AREA)

Abstract

L'invention concerne un système de stimulation électrique et des composants d'un système de stimulation électrique comprenant un réseau d'électrodes sur une carte de circuit imprimé flexible, une interface d'hydrogel comprenant une feuille d'hydrogel discontinue ayant de multiples zones d'interface d'électrode conçues pour s'aligner avec des électrodes dans le réseau d'électrodes, un dispositif de stimulation électrique pouvant être connecté au réseau d'électrodes par l'intermédiaire d'une zone de connexion au niveau de l'extrémité de la carte de circuit imprimé flexible, et un manchon de montage pour monter un dispositif médical tel qu'un dispositif de stimulation de réseau sur le membre d'un patient.
PCT/GB2024/051519 2023-06-14 2024-06-13 Système de stimulation électrique Ceased WO2024256828A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP24736053.0A EP4727633A1 (fr) 2023-06-14 2024-06-13 Système de stimulation électrique

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
GB2308868.5 2023-06-14
GB2308869.3 2023-06-14
GB2308869.3A GB2630953B (en) 2023-06-14 2023-06-14 Electrical stimulation system
GB2308867.7 2023-06-14
GBGB2308868.5A GB202308868D0 (en) 2023-06-14 2023-06-14 Electrical stimulation system
GBGB2308867.7A GB202308867D0 (en) 2023-06-14 2023-06-14 Electrical stimulation system

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WO2024256828A1 true WO2024256828A1 (fr) 2024-12-19

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2799507A1 (fr) 2011-12-28 2014-11-05 Sekisui Plastics Co., Ltd. Hydrogel adhésif et son utilisation
US9358384B2 (en) * 2014-09-05 2016-06-07 Advanced Neuromodulation Systems, Inc. Implantable lead with flexible paddle electrode array
CN115736936A (zh) * 2022-11-21 2023-03-07 中国科学院空天信息创新研究院 一种双脑区神经元长期检测微电极阵列及多向驱动系统

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2799507A1 (fr) 2011-12-28 2014-11-05 Sekisui Plastics Co., Ltd. Hydrogel adhésif et son utilisation
US9358384B2 (en) * 2014-09-05 2016-06-07 Advanced Neuromodulation Systems, Inc. Implantable lead with flexible paddle electrode array
CN115736936A (zh) * 2022-11-21 2023-03-07 中国科学院空天信息创新研究院 一种双脑区神经元长期检测微电极阵列及多向驱动系统

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