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
  • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
  • A61N1/0551—Spinal or peripheral nerve electrodes
  • A61N1/0556—Cuff electrodes
• • 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
  • A61B5/25—Bioelectric electrodes therefor
  • A61B5/279—Bioelectric electrodes therefor specially adapted for particular uses
  • A61B5/294—Bioelectric electrodes therefor specially adapted for particular uses for nerve conduction study [NCS]
• • 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
  • A61B5/6847—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 mounted on an invasive device
• • 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
  • 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
  • A61B5/6879—Means for maintaining contact with the body
  • A61B5/6884—Clamps or clips

Definitions

• the invention relates to an implantable electrical contact arrangement which has at least one electrode body arrangement which is otherwise completely integrated into a carrier substrate made of biocompatible, electrically insulating material and which includes at least one freely accessible, directly or indirectly from the biocompatible, electrically insulating carrier substrate
• intracorporeal tissue surfaces particularly on the surfaces of vessels, muscle or nerve cords.
• Intracorporeal obliteration of such implantable electrical contact arrangements consists in the contact arrangement being attached to an intracorporeal surface in a gentle and, as far as possible, location-invariable manner without permanently impairing or irritating it.
• this places high demands on the implant-side fixation of the electrical contact arrangement on the respective tissue surface concerned, especially as the tissue surface penetrates
• Electrode body with an unchangeable, defined Form surface contact pressure in order to ensure electrical transmission properties that are as constant as possible.
• extraneuronal, sleeve-like, so-called cuff electrodes which are placed circularly around a nerve cord, are able to carry out electroneuronal stimulation and also to tap electroneuronal signals locally along a nerve cord.
• the circular, open wrapping around the cuff electrode it can cling to the nerve fiber cord radially from the outside and at the same time follow radial changes in shape of the nerve cord.
• the electrode bodies, which come into contact with the nerve cord, of an implantable, electrical, contact arrangement designed as a cuff electrode are formed on a biocompatible, electrically insulating, film-like arrangement
• Carrier substrate applied, the shape of a straight from a planar shape state by surface winding and / or surface curvature
• Hollow cylinder is able to assume.
• the freely accessible electrode surfaces of the electrode bodies are located on the inside of the shell of the carrier substrate, which is shaped into a hollow cylinder, and when implanted they come to lie directly on the epineurium of the nerve cord.
• a known cuff electrode can be found in the document EP 0 843 574 B1, the carrier substrate of which is embodied in the manner of a film in the form of an interdigital
• the flexible finger sections shape through
• Foil curvature the shape of a straight hollow cylinder, its
• Cylinder diameter is flexibly variable by the freely ending and alternately interlocking finger sections.
• the film-like carrier substrate provides at least one layer of shape memory material or a mechanical layer
• the cuff electrode designed as a wound electrode consists of a film-like, flexible, biocompatible carrier substrate, preferably in the form of a polyimide film, on one carrier substrate top side of which an electrode arrangement composed of a plurality of individual electrode bodies is applied.
• the individual electrode bodies of the electrode arrangement get into
• the contact pressure with which the electrode surfaces rest against the epineurium of the nerve fiber bundle is essentially determined by the elastic material properties of the entire film-like carrier substrate.
• the publication DE 20 2010 015 346 U1 reveals electrode arrangements in which a one-piece nitinol tape protruding through the entire substrate is attached for shaping purposes under the electrodes within a strand-like substrate.
• the nitinol tape has an E-module that differs from the E-module of the carrier substrate and has a function that supports the shape of the electrode arrangement, in the manner of a back wheel.
• Electrode cuff in whose cuff material for shaping purposes, for example, shape memory material such as nitinol is incorporated. Presentation of the invention
• the invention is based on the object of an implantable electrical
• Contact arrangement which has at least one electrode body arrangement which is otherwise completely integrated into a carrier substrate made of biocompatible, electrically insulating material and has at least one freely accessible electrode surface, which is indirectly or directly encompassed by the biocompatible, electrically insulating carrier substrate, so that the
• Contact pressure with which the at least one electrode surface rests on an intracorporeal tissue surface can be individually adapted without changing or significantly changing the carrier substrate with regard to its spatial dimensions, in particular with regard to the carrier substrate thickness. It should be possible to individually design the contact pressure in the area along which the carrier substrate rests on an intracorporeal tissue surface, i.e. set depending on location along the contacting carrier substrate surface.
• the implantable electrical contact arrangement according to the solution is characterized in that within a half-space that does not contain the at least one electrode body arrangement, the carrier substrate has at least one central space. or immediately completely comprised, in which at least one substance is contained with an E module that differs from an E module assigned to the material of the carrier substrate.
• the measure according to the solution basically enables an individual one
• implantable electrical contact arrangements can be implemented in this way, the electrode surfaces of which are pressed onto an intracorporeal tissue surface with a higher contact pressure than the rest of the carrier substrate, which is configured in the manner of a film.
• the electrical contacting of the is permanent, stable and with constant electrical properties
• the film-like carrier substrate in the remaining area for the purpose of fixation rests on the nerve cord with a sufficiently lower pressing force, which is gentle on the tissue.
• at least one material with a higher modulus of elasticity is selected to fill the space compared to the modulus of elasticity of the material from which the carrier substrate is made.
• the surface rigidity can be locally reduced in areas of the carrier substrate by choosing at least one material with a lower modulus of elasticity to fill the at least one space compared to the modulus of elasticity of the material from which the
• Carrier substrate is made. Depending on the choice of material and the provision of spaces within the carrier substrate, which is configured in the manner of a film, any stiffness gradients can be implemented within the carrier substrate.
• the film-like design has
• Carrier substrate has a neutral fiber that is at least one
• Electrode body arrangement contained half space of the carrier substrate separates from the at least one space contained half space of the carrier substrate.
• the at least one space is completely encompassed by the biocompatible, electrically insulating material of the carrier substrate and, with regard to its dimensioning oriented in the longitudinal extent of the film, is dimensioned very much smaller than the carrier substrate itself, which is embodied in the manner of a film
• the at least one space preferably overlaps at least partially, preferably completely, in an orthogonal projection onto the electrode surface
• Electrode surface In this way, it is ensured that at least the carrier substrate area containing the electrode surface with an increased or individually adjusted contact force locally against an intracorporeal
• Tissue surface is pressed.
• the film-like carrier substrate consists of a polymer such as polymide, liquid crystal polymer (LCP), parylene or PDMS. Such materials typically have a modulus of elasticity between 1 and 2 GPa.
• LCP liquid crystal polymer
• PDMS parylene
• a material filling at least one space is used
• Converter material used for the purpose of its shape and / or
• Suitable transducer materials are materials such as bimetals, shape memory alloys, piezo ceramics,
• electrostrictive ceramics magnetostrictive alloys, electro or
• the implantable electrical contact arrangement typically has a flat carrier substrate which is designed with dimensions suitable for application to an intracorporeal tissue or nerve cord region in terms of shape and size.
• Typical area sizes for the carrier substrate which depending on the application can be folded and / or wound with one or more overlapping layers, are between a few mm 2 and a few cm 2 , for example between 4 mm 2 and 20 cm 2 , preferably from 10 mm 2 to 6 cm 2 .
• the carrier substrate which is mostly formed like a film, has a substrate thickness of a few ⁇ m to a few hundred ⁇ m, for example from 2 ⁇ m to 650 ⁇ m, preferably 10 ⁇ m to 100 ⁇ m.
• the at least one of the carrier substrate material completely, i. Hermetically enclosed space, which is preferably cubic or parallelepiped
• the shape of the room is much smaller than the dimension of the
• the at least one space has a maximum volume of 17 mm 3 .
• the space filled with a substance, the modulus of elasticity of which differs from the modulus of elasticity of the carrier substrate, is only able to locally increase the mechanical properties of the carrier substrate in the area around the room influence. Due to the small dimensions of the at least one space in relation to the size of the carrier substrate, the substance contained in the space does not exert any supporting forces that influence the entire spatial shape of the carrier substrate.
• the spatial areas with the E-modules different from the E-module of the carrier substrate have a stiffening or softening effect in areas, but not the Shape-defining the shape of the carrier substrate, since the spaces are unable to develop a coherent supporting effect.
• one embodiment provides a first multiplicity of spaces, each filled with at least one substance, distributed along a first straight line or along a first plane, spaced apart from one another in the form of an array within the carrier substrate.
• the first and second straight lines or the first and second planes are preferably each oriented parallel to one another.
• a further exemplary embodiment provides a further plurality of spaces each filled with at least one substance spaced apart from one another along a further straight line or along a further plane distributed within the carrier substrate.
• carrier substrate regions which are designed in the manner of a film and have individually impressed strengths and / or stiffnesses can be specified.
• the one that is directly adjacent to the nerve cord can be used
• Carrier substrate material is selected. In the radially adjoining one
• Carrier substrate material In this way, increased contact pressure acting radially from the outside can be exerted on the inner carrier substrate layers.
• Fig. 1 a, b, c shows a longitudinal section through a respective carrier substrate
• Electrode arrangement and at least space are Electrode arrangement and at least space
• Fig. 1 a shows a longitudinal section through a film-like formed carrier substrate 1, preferably in the form of a polyimide film, with a carrier substrate upper side 2 and a carrier substrate underside 3 opposite this
• an electrode arrangement is embedded which has at least one electrode body 4, which is contacted via electrical supply and discharge lines 5 running within the carrier substrate 1.
• the electrode body 4 has a freely accessible electrode surface 6. Not necessarily, but advantageously, the electrode body 4 protrudes beyond the
• Carrier substrate top 2 which in the implanted state a no further
• the carrier substrate 1 embodied in the manner of a film has a neutral fiber 7 which divides the carrier substrate 1 into an upper half space 8 and a lower half space 9.
• the upper half space 8 comprises the electrode arrangement, whereas the lower one
• Half-space of the carrier substrate 1 comprises at least one space 10 which is completely enclosed by the material of the carrier substrate 1 and in which
• At least one substance 11 is contained, which has a modulus of elasticity E1 that differs from the modulus of elasticity E t of the carrier substrate 1.
• the space 10 is arranged locally in an orthogonal projection onto the carrier substrate upper side 2, completely overlapping, below the electrode body 4.
• a preferred choice of material relates to the use of a metallic substance 11 within the space 10, preferably in the form of a one-piece metallic layer made of the biocompatible, electrically insulating material of the
• Carrier substrate 1 is completely enclosed.
• the metallic substance 11 is able to stiffen the carrier substrate 1 locally, which results in the formation of the
• Carrier substrate as a cuff electrode arrangement a local increase in the
• Tissue surface preferably in the form of a nerve cord surface, is achieved.
• the additional implementation or integration of a substance 11 within the space 10 is not associated with an increase in the carrier substrate thickness d.
• the arrangement, dimensioning and spatial configuration of the space 10 within a carrier substrate can be chosen in many ways.
• Figure 1b illustrates an alternative embodiment, which provides a plurality of individual spaces 10 'within the carrier substrate 1, all of which are uniformly with one substance 1 1 or with different substances, depending on the desired setting of the rigidity of the carrier substrate 1 in the area of at least one
• Electrode body 4 are filled.
• the plurality of spaces 10 ′ is arranged along a plane e1 running parallel to the neutral fiber 7.
• e1 running parallel to the neutral fiber 7.
• alternative arrangement patterns of the large number of individual rooms 10 ' for example within two or more planes e1, e2 etc. arranged parallel to one another.
• 1 c illustrates a further exemplary embodiment with at least two spaces 10 ′′, which are each attached laterally next to the electrode body 4 in an orthogonal projection to the carrier substrate top 2.
• the spaces 10 ' are appropriately filled with a substance that has a higher modulus of elasticity than the modulus of elasticity of the carrier substrate 1, in the area of
• Electrode arrangement has a lower rigidity than in the laterally adjoining carrier substrate areas.
• any customizable rigidity gradients can be introduced within the carrier substrate 1.
• the surface stiffness behavior of the entire carrier substrate can be tailored individually and finely.
• fabric-like or fiber-like materials are also conceivable, which can be integrated individually or in layers within the carrier substrate in a locally limited manner.
• this can be a matrix of the
• biocompatible, electrically non-conductive material of the carrier substrate may be included.
• Carrier substrate which is filled with a substance whose modulus of elasticity differs from the modulus of elasticity of the material of the carrier substrate, is also used for

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• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• General Health & Medical Sciences (AREA)
• Veterinary Medicine (AREA)
• Animal Behavior & Ethology (AREA)
• Heart & Thoracic Surgery (AREA)
• Engineering & Computer Science (AREA)
• Biomedical Technology (AREA)
• Public Health (AREA)
• Surgery (AREA)
• Molecular Biology (AREA)
• Biophysics (AREA)
• Medical Informatics (AREA)
• Physics & Mathematics (AREA)
• Pathology (AREA)
• Neurology (AREA)
• Neurosurgery (AREA)
• Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
• Radiology & Medical Imaging (AREA)
• Orthopedic Medicine & Surgery (AREA)
• Cardiology (AREA)
• Physiology (AREA)
• Electrotherapy Devices (AREA)
• Prostheses (AREA)
• Materials For Medical Uses (AREA)
• Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

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Publications (1)

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• 2019
  • 2019-05-03 DE DE102019206388.8A patent/DE102019206388A1/de not_active Ceased
• 2020
  • 2020-04-30 ES ES20724762T patent/ES2962991T3/es active Active
  • 2020-04-30 JP JP2021564933A patent/JP7548940B2/ja active Active
  • 2020-04-30 EP EP20724762.8A patent/EP3962582B1/de active Active
  • 2020-04-30 CN CN202080033422.2A patent/CN113766946B/zh active Active
  • 2020-04-30 US US17/608,673 patent/US12324911B2/en active Active
  • 2020-04-30 WO PCT/EP2020/062018 patent/WO2020225090A1/de not_active Ceased

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