WO2016209171A1 - Dispositif neuroprothétique et procédé de production d'un dispositif neuroprothétique - Google Patents

Dispositif neuroprothétique et procédé de production d'un dispositif neuroprothétique Download PDF

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Publication number
WO2016209171A1
WO2016209171A1 PCT/SG2016/050289 SG2016050289W WO2016209171A1 WO 2016209171 A1 WO2016209171 A1 WO 2016209171A1 SG 2016050289 W SG2016050289 W SG 2016050289W WO 2016209171 A1 WO2016209171 A1 WO 2016209171A1
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WO
WIPO (PCT)
Prior art keywords
sheet
neuroprosthetics
nerve
bendable
bendable probe
Prior art date
Application number
PCT/SG2016/050289
Other languages
English (en)
Inventor
Ning Xue
Tao Sun
Alex Yuandong GU
Original Assignee
Agency For Science, Technology And Research
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
Application filed by Agency For Science, Technology And Research filed Critical Agency For Science, Technology And Research
Publication of WO2016209171A1 publication Critical patent/WO2016209171A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/48—Other medical applications
    • A61B5/4851—Prosthesis assessment or monitoring
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/40—Detecting, measuring or recording for evaluating the nervous system
    • A61B5/4029—Detecting, measuring or recording for evaluating the nervous system for evaluating the peripheral nervous systems
    • A61B5/4041—Evaluating nerves condition
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6867—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive specially adapted to be attached or implanted in a specific body part
    • A61B5/6877—Nerve
    • 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
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0551—Spinal or peripheral nerve electrodes
    • A61N1/0556—Cuff electrodes

Definitions

  • the present invention relates to neuroprosthetics devices and methods for providing a neuroprosthetics device.
  • Peripheral neuroprosthetics research has been primarily focused on developing means to artificially restore the motor and sensory functions of patients with nervous system injuries.
  • the motor and sensory functions of a patient with nervous system injuries may be restored by placing appropriate electrodes, i.e. neural electrodes on the functionally amputated peripheral nerves of the patient.
  • Applications of peripheral neuroprosthetics include, for example, the use of upper and lower limb prostheses for pain relief, for the activation of lower extremity movement and for the control of hand movements.
  • Peripheral neuroprosthetics devices or systems can significantly improve the quality of life for those who suffer from neurological disabilities.
  • Neural electrodes are the key components of neural interface systems. These electrodes may be used for neural stimulation or neural signal recording.
  • Desired characteristics of the neural electrodes include low impedance, good contact to nerves and the ability to withstand erosion in the physiological environment.
  • Neural electrodes that may facilitate long term stable multi-channel neural signal inputs and outputs of the nervous system are in high demand.
  • various types of electrodes such as cuff electrodes, interfascicular electrodes, longitudinally implanted intrafascicular electrodes (LIFE), transverse intrafascicular multichannel electrodes (TIME), and regenerative sieve electrodes have been developed, according to the invasiveness to the nerve.
  • LIFE longitudinally implanted intrafascicular electrodes
  • TIME transverse intrafascicular multichannel electrodes
  • regenerative sieve electrodes have been developed, according to the invasiveness to the nerve.
  • less invasive electrodes may be highly preferred so that the electrodes do not damage the nerve structure.
  • cuff electrodes in general may encircle nerve surfaces without acutely damaging the nerve structure, cuff electrodes can still cause the nerve to be lessened over time where the nerve comes into contact with the cuff electrodes, due to micromotion of the electrodes.
  • the contact sites of the regular cuff electrodes may be commonly located on the spiral cuff structure.
  • a regular cuff electrode may be used in combination with an interfascicular nerve electrode to record the nerve signals of both the inside fascicular and the nerve surface. Nerve sizes, even in the same species, may vary to a certain degree. For instance, the diameter of the sciatic nerve in a rat ranges from 1.0 mm to 1.2 mm.
  • the nerve diameter may change chronically with the insertion of the neural electrodes from tissue inflammation, scarring, etc. Therefore, traditional cuff electrodes may need to be customized in size for each specific animal. Also, the diameters of the cuff electrodes may need to be about 1.3 to 1.5 times larger than that of the nerve to avoid spatial restriction to the nerve movement. As a result, there may not be good contact between the electrodes, i.e. the probes and the nerve. This in turn, may lead to poor quality of the nerve signal recording.
  • a neuroprosthetics device including a sheet, a securing member configured to couple two opposing sides of the sheet to form a cuff, and a bendable probe formed in the sheet, wherein the bendable probe has a fixed end connected to the sheet and a free end opposing the fixed end, wherein the bendable probe includes a conducting surface extending from the fixed end to the free end.
  • a method for providing a neuroprosthetics device including providing a sheet, providing a securing member configured to couple two opposing sides of the sheet to form a cuff, forming a bendable probe in the sheet, wherein the bendable probe has a fixed end connected to the sheet and a free end opposing the fixed end, wherein the bendable probe includes a conducting surface extending from the fixed end to the free end.
  • FIG. 1A shows a conceptual diagram of a neuroprosthetics device according to various embodiments.
  • FIG. IB shows a conceptual diagram of a neuroprosthetics device according to various embodiments.
  • FIG. 2 shows a flow diagram illustrating a method for providing a neuroprosthetics device according to various embodiments.
  • FIG. 3 shows a neuroprosthetics device according to various embodiments.
  • FIG. 4 shows a perspective view of the neuroprosthetics device of FIG. 5.
  • FIG. 5 shows a partial cross-sectional view of a neuroprosthetics device according to various embodiments, before the bendable probe is bent.
  • FIG. 6 shows a cross-sectional view of the neuroprosthetics device when the cuff structure is encasing the nerve.
  • FIG. 7 shows a cross-sectional view of the neuroprosthetics device when the cuff structure is encasing a nerve, the nerve being smaller in diameter than the nerve shown in FIG. 6.
  • FIG. 8 shows a schematic diagram of a neuroprosthetics device according to various embodiments.
  • FIG. 9 shows a photo of a neuroprosthetics device prototype.
  • FIG. 10 shows a photo of a neuroprosthetics device according to various embodiments, wherein the bendable probes are pre-bent before the neuroprosthetics device prototype is implanted into an animal.
  • FIG. 11 shows a photo of the neuroprosthetics device of FIG. 10, wherein the bendable probes are released from the pre-bending.
  • FIG. 12 shows a photo of the neuroprosthetics device of FIG. 10, when the sheet is rolled and secured to form a cuff structure.
  • FIG. 13 shows a cross-sectional view of the neuroprosthetics device of FIG. 12.
  • FIG. 14 shows a photo showing the neuroprosthetics device of FIG. 10 implanted in vivo into a sciatic nerve of a rat.
  • Coupled may be understood as electrically coupled or as mechanically coupled, for example attached or fixed, or just in contact without any fixation, and it will be understood that both direct coupling or indirect coupling (in other words: coupling without direct contact) may be provided.
  • cuff structure may be but is not limited to being interchangeably referred to as a "cuff or a "cuff frame”.
  • Peripheral neuroprosthetics research has been primarily focused on developing means to artificially restore the motor and sensory functions of patients with nervous system injuries.
  • the motor and sensory functions of a patient with nervous system injuries may be restored by placing appropriate electrodes, i.e. neural electrodes on the functionally amputated peripheral nerves of the patient.
  • Applications of peripheral neuroprosthetics include, for example, the use of upper and lower limb prostheses for pain relief, for the activation of lower extremity movement and for the control of hand movements.
  • Peripheral neuroprosthetics devices or systems can significantly improve the quality of life for those who suffer from neurological disabilities.
  • Neural electrodes are the key components of neural interface systems. These electrodes may be used for neural stimulation or neural signal recording.
  • Desired characteristics of the neural electrodes include low impedance, good contact to nerves and the ability to withstand erosion in the physiological environment.
  • Neural electrodes that may facilitate long term stable multi-channel neural signal inputs and outputs of the nervous system are in high demand.
  • various types of electrodes such as cuff electrodes, interfascicular electrodes, longitudinally implanted intrafascicular electrodes (LIFE), transverse intrafascicular multichannel electrodes (TIME), and regenerative sieve electrodes have been developed, according to the invasiveness to the nerve.
  • LIFE longitudinally implanted intrafascicular electrodes
  • TIME transverse intrafascicular multichannel electrodes
  • regenerative sieve electrodes have been developed, according to the invasiveness to the nerve.
  • less invasive electrodes may be highly preferred so that the electrodes do not damage the nerve structure.
  • cuff electrodes in general may encircle nerve surfaces without acutely damaging the nerve structure, cuff electrodes can still cause the nerve to be lessened over time where the nerve comes into contact with the cuff electrodes, due to micromotion of the electrodes.
  • the contact sites of the regular cuff electrodes may be commonly located on the spiral cuff structure.
  • a regular cuff electrode may be used in combination with an interfascicular nerve electrode to record the nerve signals of both the inside fascicular and the nerve surface. Nerve sizes, even in the same species, may vary to a certain degree. For instance, the diameter of the sciatic nerve in a rat ranges from 1.0 mm to 1.2 mm.
  • the nerve diameter may change chronically with the insertion of the neural electrodes from tissue inflammation, scarring, etc. Therefore, traditional cuff electrodes may need to be customized in size for each specific animal. Also, the diameters of the cuff electrodes may need to be about 1.3 to 1.5 times larger than that of the nerve to avoid spatial restriction to the nerve movement. As a result, there may not be good contact between the electrodes, i.e. the probes and the nerve. This in turn, may lead to poor quality of the nerve signal recording. Therefore, there is a need for a neuroprosthetics device that may achieve good contact between the nerve surface and the electrodes.
  • FIG. 1A shows a conceptual diagram of a neuroprosthetics device 100A according to various embodiments.
  • the neuroprosthetics device 100A may include a sheet 102 and a securing member 104.
  • the securing member 104 may be configured to couple two opposing sides of the sheet to form a cuff.
  • the neuroprosthetics device 100A may further include a bendable probe 106 formed in the sheet 102, wherein the bendable probe 106 has a fixed end connected to the sheet 102 and a free end opposing the fixed end.
  • the bendable probe 106 may include a conducting surface extending from the fixed end to the free end.
  • the neuroprosthetics device 100A may include a sheet 102 and a securing member 104.
  • the securing member 104 may be configured to couple two opposing sides of the sheet to form a cuff.
  • the sheet 102 may include a bendable probe 106 formed therein.
  • the bendable probe 106 may have a fixed end and a free end, wherein the free end is at an opposite of the fixed end.
  • the fixed end of the bendable probe 106 may be coupled to the sheet 102.
  • the bendable probe 106 may be bent to an adjustable angle.
  • the bendable probe 106 may be bent to an angle larger than a right angle, for example, at least 100°.
  • the bendable probe 106 may have a polygonal shape like rectangle or trapezoid, or other shapes such as ellipsoid.
  • the sheet 102 may include a metal layer sandwiched between a top polymer layer and a bottom polymer layer.
  • the polymer layer may include at least one of polyimide, polydimethylsiloxane (PDMS), polyethylene, parylene or other polymer materials.
  • the polymer may have a Young's Modulus of less than 3GPa.
  • the bendable probe 106 may include at least a portion of the metal layer. The bendable probe may be free from the top polymer layer so that the metal layer is exposed.
  • the bendable probe 106 may have a metallic surface extending from the fixed end to the free end.
  • the metallic surface may be the exposed metal layer.
  • the metallic surface may serve as an electrically conductive surface.
  • the metallic surface may include at least one of gold, platinum, platinum-iridium or iridium.
  • the securing member 104 may include a plurality of suturing holes along a length of the sheet. Alternatively, the securing member 104 may include other forms of fasteners, such as hooks, wires, threads or adhesive.
  • the sheet 102 may be rollable to surround a nerve.
  • the diameter of the cuff may be larger than a diameter of the nerve, for example, by a range of at least substantially equal to 0.1mm to 0.5mm.
  • the diameter of the cuff may depend on a width of the sheet 102.
  • the width of the sheet 102 may define the perimeter of the cross-section of the cuff.
  • the width of the sheet 102 may be perpendicular to a distance between the fixed end and the free end of the bendable probe 106.
  • FIG. IB shows a conceptual diagram of a neuroprosthetics device 100B according to various embodiments.
  • the neuroprosthetics device 100B may include a sheet 102 and a securing member 104.
  • the neuroprosthetics device 100B may further include at least one further bendable probe 108 formed in the sheet 102.
  • the further bendable probe 108 may be identical to, or at least substantially similar to the bendable probe 106.
  • One probe of the at least one further bendable probe 108 may serve as a reference electrode.
  • the neuroprosthetics device 100B may further include an electric wire 110.
  • the electric wire 110 may be provided in the sheet 102.
  • the neuroprosthetics device 100B may include a further sheet 112.
  • the further sheet 112 may be identical to, or at least substantially similar to the sheet 102.
  • the further sheet 112 may also include at least one of a bendable probe 106 or a further bendable probe 108.
  • the further sheet 112 may also include an electric wire 110.
  • the electric wire 110 may be a patterned conductive layer embedded in the sheet 102.
  • the electric wire 110 may be coupled to at least one of the fixed end of the bendable probe 106 or the fixed end of the further bendable probe 108 in any one of the sheet 102 or the further sheet 112.
  • the neuroprosthetics device 100B may further include a cable 114.
  • the cable 114 may have a first end coupled to the sheet 102 and the further sheet 112.
  • the cable 114 may have a second end coupled to a connector pad.
  • FIG. 2 shows a flow diagram 200 illustrating a method for providing a neuroprosthetics device according to various embodiments.
  • a sheet may be provided.
  • a securing member may be provided.
  • the securing member may be configured to couple two opposing sides of the sheet to form a cuff.
  • a bendable probe may be formed in the sheet.
  • the bendable probe may have a fixed end connected to the sheet and a free end opposing the fixed end.
  • the bendable probe may include a conducting surface extending from the fixed end to the free end.
  • the process of forming the bendable probe in the sheet may include making cuts in the sheet, such as by etching the sheet, using microelectromechanical systems (MEMS) technology.
  • MEMS microelectromechanical systems
  • the method may further include bending the bendable probe and coupling the two opposing sides of the sheet to form the cuff using the securing member.
  • the cuff may at least substantially surround a nerve.
  • the fixed end of the bendable probe may face away from the nerve.
  • the conducting surface of the free end of the bendable probe may contact the nerve.
  • a neuroprosthetics device may include an ultra- thin polymeric structure that may readily encircle a peripheral nerve.
  • the neuroprosthetics device may include multi-channel three-dimensional (3D) cuff electrodes.
  • the neuroprosthetics device may be used on the peripheral nerve interface.
  • the ultra-thin polymeric structure may be less than 20 ⁇ in thickness.
  • Each recording probe of the neuroprosthetics device may be able to bend out from the cuff frame plane up to 180° in angle, unlike other cuff electrodes which may have the recording sites, i.e. the probes contacting the nerves, located on the cuff frame.
  • the bending angle of each contact probe may be independent and self-adjustable so that each contact probe may firmly contact the nerve surface. Due to the firm contact between the probe and the nerve interface, the neuroprosthetics device may promote high signal-to-noise ratio in the nerve signal recordings. The neuroprosthetics device may also be gentle on the nerve interface, thereby avoid causing any nerve damage, especially in the event of chronic use.
  • a neuroprosthetics device may include an ultra- thin polymeric 3D cuff electrode with protruding bendable contact probes.
  • the diameter of the 3D cuff frame may be larger than the nerve so that the nerve movement is not restricted so that nerve damage is avoided even for long-term device implantation.
  • the diameter of the cuff frame may be larger than the nerve by about 0.1mm to 0.5mm.
  • the cuff frame may also be referred herein as the cuff structure.
  • a neuroprosthetics device may include protruding contact probes.
  • the contact probes may also be referred herein as the bendable probes.
  • the contact probes may be bent up to 100° in angle, before being rolled into a cuff frame over the nerve.
  • the contact probe may be able to touch the nerve surface firmly due to the high flexibility of the polymeric probe structure.
  • a neuroprosthetics device may include two or more cuff frames integrated into one device for multi-mode measurement, such as axisymmetrical and longitudinal nerve signal recording and nerve stimulation.
  • a first cuff frame may be configured to record nerve signals and a second cuff frame may be configured to provide nerve stimulation signals.
  • a neuroprosthetics device may be immobilized for the purpose of chronic measurement or long-term implantation.
  • the neuroprosthetics device may include suturing holes along an entire edge of the device, so that any portion of the device can be secured in position with respect to tissues such as muscles and nerve surface membrane.
  • the neuroprosthetics device may further include a ribbon cable that is long enough to enable connecting pads or connectors to be sutured beside the skin surface for the ease of external wire connection.
  • FIG. 3 shows a neuroprosthetics device 300 according to various embodiments.
  • the neuroprosthetics device 300 may be a 3D cuff electrode device.
  • the neuroprosthetics device 300 may be able to adapt to the chronic changes in the nerve and thereby be suitable for use in long-term animal testing.
  • the neuroprosthetics device 300 may be suitable for both nerve signal recording and nerve stimulation applications.
  • the neuroprosthetics device 300 may be one of the neuroprosthetics devices 100A or 100B.
  • FIG. 4 shows a perspective view 400 of the neuroprosthetics device 300 of FIG. 5.
  • the neuroprosthetics device 300 may include a sheet.
  • the sheet may be ultra-thin so that the sheet may be rolled around the trunk of the nerve 332.
  • the thickness of the sheet may be 20 ⁇ or less, for example in a range of 0 ⁇ to 15 ⁇ , or in a range of 5 to 10 ⁇ .
  • the sheet may have a polymer-metal-polymer sandwich structure.
  • the substrate material, i.e. the polymer of the polymer-metal-polymer sandwich may be a biocompatible polymeric material.
  • the top polymer layer may be formed from the same polymer as the bottom polymer layer.
  • the top polymer layer may also be formed from a different polymer from the bottom polymer layer.
  • the substrate material may have a low Young's Modulus, for example less than 3GPa. Suitable substrate material may include polyimide, polydimethylsiloxane, polyethylene and other flexible polymers.
  • the metal layer 440 may include at least one of gold, platinum, platinum-iridium, or iridium depending on the usage of the neuroprosthetics device 300, for example whether the neuroprosthetics device 300 is used for nerve signal recording or nerve stimulation.
  • the metal layer 440 may be patterned to form electric wires, such that the electric wires are a patterned conductive layer embedded in the sheet between two polymer layers.
  • the sheet may be patterned, or in other words, have a pattern cut into the sheet, before the sheet is rolled into the cuff structure 330.
  • the sheet may have patterns of strips cut therein, such that there are cantilevers formed in the sheet.
  • the strips may be polygonal in shape, for example, rectangular or trapezoidal.
  • the strips may be cut into the sheet such that one side of the polygon is still attached to the sheet while the rest of the strip is bendable out of the plane of the sheet.
  • a plurality of such strips may be formed in the sheet.
  • Each strip may form the basis for a bendable probe 306.
  • Portions of the top polymer layer of the sheet may be removed to expose the metal layer 440 on portions of the sheet where the nerve contact sites and connector pads are positioned.
  • the sheet may be fabricated from a polymer and the metal layer 440 may be patterned on the polymer only where required.
  • the exposed metal layer 440 allows the bendable probe 306 to conduct electrical signals.
  • the sheet may be rolled around a nerve 332 and then have two opposing ends of the sheet secured with a securing member, so that the sheet at least substantially encloses or encircles part of the nerve 332.
  • the rolled sheet may be referred herein a cuff structure 330.
  • the cuff structure 330 may preferably be cylindrical in shape, but may also have other cross-sectional shapes such as elliptical or polygonal.
  • the diameter or width of the cuff structure 330 may be about 0.1mm to 0.5 mm larger than the nerve 332.
  • the bendable probe 306 may protrude out of the cuff structure 330, and may even bend through an obtuse angle to contact the nerve 332.
  • the bendable probe 306 may contact the nerve 332 at a surface where the metal layer 440 is exposed.
  • FIG. 5 shows a partial cross-sectional view 500 of a neuroprosthetics device according to various embodiments, before the bendable probe 306 is bent.
  • the bendable probe 306 may be formed out of a sheet comprising a polymer layer 550 and a metal layer 440.
  • the bendable probe 306 may be partially detached from the cuff structure 330 such that the bendable probe 306 may deflect out of the plane of the cuff structure 330.
  • the bendable probe 306 may include the metal layer 440 arranged over a polymer layer 550.
  • FIG. 6 shows a cross-sectional view 600 of the neuroprosthetics device of FIG. 5 when the cuff structure 330 is encasing the nerve 332.
  • the bendable probes 306 may be connected to the cuff structure 330 only at one side, in other words, each bendable probe 306 may be attached to the cuff structure 330 at a respective fixed end 660.
  • the fixed end 660 of each bendable probe 306 is encircled in the cross- sectional view 600 for illustration purpose.
  • the bendable probes 306 may be bent over an obtuse angle, to have the metal layer 440 exposed inwards so that the metal layer 440 may contact the nerve 332.
  • the obtuse angle may be in a range between 90° to 180°, such as in a range between 90° to 150° or 95° to 120° or may be about 100°.
  • the sheet may be rolled around the nerve 332 and then secured by having sutures threaded through holes on opposing sides of the sheet.
  • the bent bendable probes 306 with exposed metal layer 440 may readily contact the nerve surface firmly.
  • FIG. 7 shows a cross-sectional view 700 of the neuroprosthetics device when the cuff structure 330 is encasing a nerve, the nerve being smaller in diameter than the nerve 332 shown in FIG. 6.
  • the bent bendable probe 330 may still contact the nerve firmly, even though the nerve is of a smaller diameter.
  • the neuroprosthetics device may be adaptable to a range of nerve diameters, such that the bendable probes 306 may be able to contact the nerve firmly across a range of nerve diameters.
  • FIG. 8 shows a schematic diagram of a neuroprosthetics device 800 according to various embodiments.
  • the neuroprosthetics device 800 may include two or more cuff structures.
  • the cuff structures are shown in their flat form, i.e. as sheets prior to being rolled.
  • the sheets may be the sheet 102 and the further sheet 112 of FIG. IB.
  • the neuroprosthetics device 800 may be identical to, or similar to the neuroprosthetics device 100B.
  • FIG. 8 includes a magnified view 880 of the sheets. It can be seen from the magnified view 880, that each of the sheet 802 and the further sheet 812 may have more than one protruding bendable probe 306.
  • the schematic diagram shows that there are four bendable probes 306 in each sheet.
  • the four bendable probes 306 may include the bendable probe 106 and the further bendable probe 108 of the neuroprosthetics device 100B.
  • the neuroprosthetics device 800 may have a plurality of bendable probes 306, not limited to four bendable probes 306.
  • the neuroprosthetics device 800 may be configured to record nerve signal axisymmetrically across the nerve or longitudinally towards the nerve.
  • the neuroprosthetics device 800 may also be configured to provide nerve stimulation in the same manner.
  • the neuroprosthetics device 800 may further include a reference electrode 824 coupled to at least one of the sheet 802 or the further sheet 812. When the sheet 802 or the further sheet 812 is rolled into a cuff structure, the reference electrode 824 may be located at the neck of the cuff structure.
  • any one of the bendable probes 306 may be used as the reference electrode 824, based on different measurement modes.
  • Each sheet may include a plurality of holes 890 along the edges of the sheet.
  • the holes 890 may be suturing holes for the purpose of securing two opposing sides of the sheet together using sutures.
  • the neuroprosthetics device 800 may be fixed onto animal tissues such as muscles or the outer membrane of nerves by having sutures threaded through the holes 890.
  • the neuroprosthetics device 800 may further include connector pads 892.
  • the connector pads 892 may be designed for electrical coupling to a commercial connector such as an Omnetics connector, for external connection.
  • the connector pads 892 may be arranged above the skin surface of the animal or patient, so that the connector pads 892 may be connected to external connections for signal recording or nerve stimulation.
  • a cable 814 such as a ribbon cable, may be provided between at least one of the sheet 802 or the further sheet 812 and the connector pads 892.
  • the cable 814 may be sufficiently long so that the cable 814 may be fixed underneath the skin surface of the animal or the patient.
  • the cable 814 may also be arranged underneath inner tissues, such as muscles.
  • the abovementioned features of the layout design may be especially beneficial for ensuring that the neuroprosthetics device 800 is immobile during a chronic animal test.
  • FIG. 9 shows a photo 900 of a neuroprosthetics device prototype.
  • the prototype may be similar or identical to the neuroprosthetics device 800.
  • the prototype has two cuff structures in a single device.
  • the cuff structures are shown pre-rolled, as flat sheets, i.e. sheet 802 and further sheet 812.
  • the prototype is fabricated to demonstrate the concept of the neuroprosthetics device.
  • the sheets are fabricated with a polymer-metal-polymer structure, similar to the neuroprosthetics device 800.
  • the sheets may include at least one of the sheet 802 and the further sheet 812.
  • the polymer layer is fabricated from polyimide.
  • the metal layer includes gold.
  • a connector may be coupled to the connector pad 892 by inserting the connector into the polyimide-metal connector pads 892 and then sealing the connecting portion with silver conductive glue. After that, the connector pads 892 are covered by biocompatible UV epoxy.
  • FIG. 9 also shows a magnified view 990 of part of the further sheet 812.
  • the further sheet 812 may be identical to the sheet 802 and hence, the magnified view 990 may also be representative of the sheet 802. As can be seen in the magnified view 990, each bendable probe 306 is connected to a respective electrical wire.
  • the holes 890 are also clearly visible in the magnified view 990.
  • FIG. 10 shows a photo 1000 of a neuroprosthetics device according to various embodiments, wherein the bendable probes 306 are pre-bent before the neuroprosthetics device prototype is implanted into an animal.
  • the neuroprosthetics device may be pre- operated or pre-adjusted before it is passed to a surgeon for inserting into an animal or a patient.
  • a flat-end needle may be used to preset the bending angle of the bendable probes 306 to approximately 100° by poking the bendable probes 306 from a back of the neuroprosthetics device. This would facilitate contact between the bendable probes 306 and the nerve surface when the sheet 802 is rolled into a cuff structure.
  • the sheet 802 may be rolled around the nerve and its circular cross-sectional shape may be fixed by threading sutures through the holes 890 on the cuff structure.
  • the bendable probes 306 may tend to recover to their preset angle of 100° by applying restoring force towards the nerve surface, so that the bendable probes 306 may closely contact the nerve surface.
  • FIG. 11 shows a photo 1100 of the neuroprosthetics device of FIG. 10, wherein the bendable probes 306 are released from the pre-bending.
  • FIG. 12 shows a photo 1200 of the neuroprosthetics device of FIG. 10, when the sheet 802 is rolled and secured to form a cuff structure 330.
  • the cuff structure 330 encircles a wire having a diameter of about 1.2mm.
  • Forming the cuff structure 330 from the sheet 802 may include securing opposing ends of the sheet 802 together.
  • FIG. 13 shows a cross-sectional view 1300 of the neuroprosthetics device of FIG. 12.
  • the cross-sectional view 1300 shows the cuff structure 330 encircling the wire and the bendable probes 306 bent and touching the wire surface.
  • FIG. 14 shows a photo 1400 showing the neuroprosthetics device of FIG. 10 implanted in vivo onto a sciatic nerve of a rat. While the cuff structure 330 is loose enough to avoid damage to the nerve, the bendable probes still firmly contact the surface of the nerve 332.

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Abstract

La présente invention concerne un dispositif neuroprothétique, qui comprend une feuille, un élément de fixation configuré pour coupler deux côtés opposés de la feuille pour former un manchon ; et une sonde flexible formée dans la feuille, la sonde flexible ayant une extrémité fixe connectée à la feuille et une extrémité libre opposée à l'extrémité fixe, et la sonde flexible comprenant une surface conductrice s'étendant de l'extrémité fixe à l'extrémité libre.
PCT/SG2016/050289 2015-06-25 2016-06-23 Dispositif neuroprothétique et procédé de production d'un dispositif neuroprothétique WO2016209171A1 (fr)

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JP2020501639A (ja) * 2016-11-18 2020-01-23 ニューロループ ゲーエムベーハー 植込み可能な電気的多極結合構造

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JP2014008244A (ja) * 2012-06-29 2014-01-20 Olympus Corp 神経刺激装置

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2020501639A (ja) * 2016-11-18 2020-01-23 ニューロループ ゲーエムベーハー 植込み可能な電気的多極結合構造
JP7027421B2 (ja) 2016-11-18 2022-03-01 ニューロループ ゲーエムベーハー 植込み可能な電気的多極結合構造

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