WO2019154926A1 - Gaine neurale - Google Patents

Gaine neurale Download PDF

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Publication number
WO2019154926A1
WO2019154926A1 PCT/EP2019/053037 EP2019053037W WO2019154926A1 WO 2019154926 A1 WO2019154926 A1 WO 2019154926A1 EP 2019053037 W EP2019053037 W EP 2019053037W WO 2019154926 A1 WO2019154926 A1 WO 2019154926A1
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WO
WIPO (PCT)
Prior art keywords
cladding tube
tube
neural
sheath according
shell elements
Prior art date
Application number
PCT/EP2019/053037
Other languages
German (de)
English (en)
Inventor
Peer Eysel
Original Assignee
Universität Zu Köln
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 Universität Zu Köln filed Critical Universität Zu Köln
Publication of WO2019154926A1 publication Critical patent/WO2019154926A1/fr

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/05Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0551Spinal or peripheral nerve electrodes
    • A61N1/0556Cuff electrodes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B17/1128Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis of nerves

Definitions

  • the invention relates to a neural sheath, in particular a spinal cord envelope.
  • a neural sheath is understood in the context of the invention that this is provided and set up a neural structure such as nerves, especially nerve cords particularly preferably the spinal cord of a human or other living being to envelop and protect against external influences.
  • neural sheaths for the protective covering of neural structures have hitherto been completely unknown. It is therefore an object of the invention to provide a neural sheath which opens up the possibility of a neural structure, such as the
  • a neural sheath in particular a spinal cord, which comprises a cladding tube which has at least one circumferential position over the entire axial length of the cladding tube extending separation point at which the cladding tube over the entire axial length can be opened and / or closed ,
  • a hermetic sealing understood, but at least a closure in the sense that the opposite at the separation point areas of the cladding tube are stabilized in position, so in particular the cladding can not open automatically and thus unintentionally.
  • a hermetic seal may be provided at the separation point.
  • the cladding tube according to the invention offers the possibility at a single existing separation point to spread the cladding tube at the separation point so far that the distance between the opposing regions at the separation point is so great that the cladding tube over the neural structure to be protected, such as
  • the spinal cord brought over and then the opening can be reduced again, if necessary, the separation point as mentioned above can be closed.
  • the cladding tube is in fact subdivided in the circumferential direction into a plurality of tube jacket pieces which can each be attached to the neural structure and then connected, or the separation points
  • separation points may preferably have the same angular distance to each other in the circumferential direction.
  • the invention thus offers the possibility without transection and other negative influence on the neural structure to be protected
  • the cladding tube can preferably be set such that growth of the cladding tube wall through tumor tissue is ruled out and / or the cladding tube can be set up, at least in the radial direction, to withstand the growth pressure of tumors so that the cladding tube is not pressed in by growing tumor tissue. but that yourself
  • a neural sheath according to the invention offers the possibility of treating patients affected by tumor growth the clinical picture of a
  • the invention may preferably provide that the sheath of a radial
  • the invention may provide that an envelope of bending stress that bends the sheath out of the rectilinear extent, in particular by 5 to 10 degrees, provides an (axial) restoring force that is less than 2 Newton, preferably less than 1.5 Newton, more preferably less than 1 Newton, even more preferably less than 0.5 Newton.
  • Particularly preferred is a resetting force of 0 Newton, so that the cladding follows any change in alignment of a surrounding structure, eg, any change in spinal alignment without backlash.
  • a method for applying such a neural sheath to the spinal cord may provide that in the
  • Vertebral body is exposed, the distant vertebral body area is bridged to the spine with a supporting structure and a cladding of the
  • Whirl body residues is threaded through and thereafter the cladding tube, which surrounds the spinal cord envelops closed at the at least one separation point, in particular so that it remains dimensionally stable as a cladding tube.
  • the two sides of a separating element lying cladding tube regions can be mechanically connected, e.g. through a surgical suture or wire.
  • the method may provide during the process of introducing the open cladding tube between spinal cord and spine a protective element, for example, first place a film on the dura mater of the spinal cord, to avoid injuries caused by the movement of the cladding tube on the spinal cord surface.
  • a protective element for example, first place a film on the dura mater of the spinal cord, to avoid injuries caused by the movement of the cladding tube on the spinal cord surface.
  • Such an additional film may optionally remain after the arrangement of the cladding tube in this or be removed from the cladding tube before closing the cladding tube at the at least one separation point.
  • guide elements for example guide wires, on the cladding tube or an enveloping element forming this, which will be described further below, on regions on both sides of a separation point
  • Such guide elements preferably extend away from the separation point and can thus be grasped manually by a surgeon carrying out the operation in order, for example, to exert a tensile force on the cladding tube or the cladding element with these guide elements and to align it in this way.
  • the invention can provide that a respectively provided
  • Guide element can also serve as a closure element at the same time to close the at least one separation point.
  • Guide element can also serve as a closure element at the same time to close the at least one separation point.
  • a knotting or twisting be made to opposite areas around a separation point around so as to achieve the shape and / or position stabilization of the cladding tube and to prevent the cladding tube opens automatically at a separation point.
  • the initially mentioned hermetic seal at the separation point can be provided, but is not necessary, for example, in such cases, when the T rennstelle of the cladding tube facing away from a tumor position, so that ingrowth of the tumor tissue in the cladding at the position of T rennstelle is not given ,
  • the cladding tube thus consists of a plurality of cladding tube elements or respectively
  • Pipe shell elements composed and this accordingly form a total of the invention according to the cladding tube after connection.
  • the provision of only a single separation point has the advantage that, therefore, after a performed operation, only a single T rennstelle is close, whereas the provision of multiple separation points can have the advantage that the cladding tube can be assembled at the application site in the patient of the plurality of cladding elements and thus, for example, with reference to the aforementioned operation of a spinal cord protection, the cladding tube only has to be passed over a comparatively shorter circumferential extension between the spinal cord and the spinal column.
  • the invention can provide it in particular, if only a single separation point is arranged in the cladding tube, that the cladding tube of an enveloping element, in particular a single enveloping element and particularly preferably a flat
  • Enveloping element is formed, which has a first stress-free, in particular relaxed state, in which the enveloping element is formed as a cladding tube with at the separation point in particular with a distance opposite or overlapping edges of the enveloping element.
  • the neural sheath according to the invention thus already exhibits the necessary or desired tubular shape in this tension-free, ie relaxed state, when no external forces are exerted on the neural sheath in order to surround the neural structure to be protected.
  • the invention then further provides that the enveloping element can be converted into a second tensioned state, in which the cladding tube is elastically spread at the separation point to form an axially extending opening against restoring internal forces and from which it is automatically moved by the action of the internal forces the first relaxed state returns.
  • the cladding tube can be brought over at the open separation point on the neural structure to be protected and then automatically the neural sheath passes back into the tubular state ,
  • said second stressed state is at least one such state in which the separation point allows a sufficiently large opening for passage of the neural structure.
  • the second tensioned state can also be one in which the enveloping element can be converted, for example, into a complete or at least almost complete planar shape.
  • the invention can also provide that the second stressed state is a stable state, from which the sheath element automatically returns to the first state only by an initiating action from the outside.
  • this can be done by a shape-memory function of
  • the sheath element may have at least one pocket extending in the circumferential direction of the cladding tube into which a stabilizing element extending in a straight line is inserted, which prevents the transition to the first state, until this stabilizing element has been pulled out of the pocket.
  • Enveloping element is formed for example of a tubular wound plastic film, either the tube shape is imprinted directly into the plastic material, which may be done for example by a thermal treatment, or the tube shape of the plastic film is produced by a shape-defining support structure, in or is arranged on the plastic film.
  • a support structure may be formed, for example, by circumferentially-arranged rings open at the point of separation, for example from a wire.
  • such a plastic film will always assume the shape of the tube, but can be deformed out of this tube shape in order to allow application around the neural structure to be protected.
  • the enveloping element is formed from a tubular metallic mesh, wherein a development can provide that on this network, for example, on the inside with respect to the formed cladding tube a sealing surface closing the mesh, preferably a film is arranged.
  • the metallic mesh may be formed, for example, by the material of a shape-memory alloy, such as nitinol.
  • the mesh has meshes that may be formed, for example, by producing a stretched mesh, but a more preferred embodiment of the invention may provide that the mesh is formed by a wire mesh with loops of loose wires routed over and under each other and slidable against each other , The mesh crossing points of the wires are thus not fixed and allow the wires to move toward one another, such that such an enveloping element adapts better to movements of the patient, such as the curvature of the neural structure, for example the spinal cord.
  • a metallic mesh in the sheath element By providing a metallic mesh in the sheath element, it can be ensured that a sufficiently great resistance to deformation is exerted against pressure exerted, for example, by a growing tumor.
  • the preferably inside, but also generally outside possible arrangement of the sealing surface on the network which may be formed for example by a film, for example a silicone film, it is ensured that the mesh of the network can not be crossed by the tumor tissue.
  • the invention may provide that the cladding tube, which may have one or more separation points, is formed from at least one cladding element, in particular formed from at least one planar cladding element, which is flexible and preferred
  • Such sheath elements can thus be brought into almost any shape due to their flexibility, for example, a substantially planar shape to facilitate the wrapping of a neural structure to be protected, especially in cramped conditions, as in the aforementioned application for the protection of the spinal cord in combination is found with the spine in front of it.
  • the invention then provides that such an envelope element to the
  • Cladding tube or a Hüllrohrteil Scheme is deformed and then stabilized in the form formed and is stabilized in the surgical application to achieve a lasting protection.
  • the enveloping element is connected to itself at the location of the separation point, d. H.
  • the enveloping element regions located on both sides of the separation point are connected. This can be done as mentioned above with wires, threads or other fasteners that can meet the other named leadership functions.
  • the cladding tube to be formed is thus composed of a plurality of cladding elements, so that these multiple cladding elements are connectable to each other at the separation points or are connected in the surgical application to achieve a permanent protection, such as again with the initially mentioned connecting elements, for example wires or threads.
  • the invention can also provide that at one or more separation points opposite each other
  • Connecting elements are provided, which are brought into operative contact by a togetherness. This knit can also be done automatically when the fasteners touch, e.g. by a then releasing bias. ,
  • the invention provides that this at least one enveloping element can be stabilized and stabilized on the patient in the specific application, which is preferably achieved, for example, by triggered polymerization of a material arranged in the enveloping element or a total of the enveloping material forming material can be made. Likewise, it can provide for the invention that stabilization takes place by at least one around the at least one enveloping element herumlegbare
  • Such a stabilizing element can be, for example, a wire or thread which is wrapped around the enveloping tube formed from at least one wrapping element in the circumferential direction and is twisted or knotted.
  • An embodiment in which the stabilization is effected by a polymerization of a Hüllelementmateriales, can provide that the at least one Hüllelement by a radiation-curing, in particular under
  • UV light polymerizable plastic film is formed.
  • a plastic film in the unpolymerized state, has sufficient flexibility to be wrapped around the neural structure to be protected while being formed into the tube shape
  • separation points may overlap opposite edges of the plastic film, or may be spaced apart from each other or disposed opposite each other in a contacting manner, and then, after formation of the cladding by illumination with polymerization-initiating light, e.g. Ultraviolet light to achieve a hardening of the formed cladding tube, so that the intrinsically stable retains the Hüllrohrform, but preferably still has such flexibility that the formed cladding travels movements of the neural structure, for example, the spinal cord, so in particular not hindered.
  • polymerization-initiating light e.g. Ultraviolet light
  • the invention can also provide that the at least one envelope element is formed from a textile, in particular flat, textile element.
  • such an enveloping element may be formed by a knit or mat product, a knitted fabric or a scrim of fibers.
  • any type of fibers can be used to form such a textile element, such as carbon fibers, whereby the invention then provides that such a textile covering element can be impregnated with a polymerizable material and used in the surgical field Application is soaked after the formation of the cladding tube, after which the material is polymerized and cured and thereby the Hüllrohrform is stabilized.
  • the achieved curing is sufficient to stabilize the desired Hüllrohrform, in particular nevertheless the formed cladding tube movements of the enveloped neural structure with sufficient flexibility retraces.
  • the invention can also provide that instead of impregnation of the
  • Envelope element after application to the neural structure of the cladding tube element is already impregnated initially and is applied in the soaked state of the neural structure.
  • the impregnation material may be initiated by light for polymerization or is already initiated for polymerization prior to impregnation, e.g. by mixing 2-impregnating material components.
  • the cladding tube is closed in a simple manner at at least one of its separation points by overlaying the enveloping element regions on both sides of a separating point so that an overlap results and, as a result of the curing of the polymerizable material in the at least one impregnated enveloping element, a closure, preferably cohesive closure of the separation point, results automatically thereafter.
  • the embodiment with a plurality of such impregnable / impregnated enveloping elements also has the further advantage that the cladding tube by several in
  • An impregnation material may be for example a biocompatible silicone or a polymer having a neural structure (eg spinal cord) compatible curing temperature, in particular a curing temperature of less than 70 degrees Celsius, preferably less than 60 degrees Celsius, more preferably less than 50 degrees Celsius.
  • a neural structure eg spinal cord
  • the invention may provide that the neural sheath comprises a cladding tube, which at least in the circumferential direction at least two axially extending tube shell elements preferably a plurality of axially extending tube shell elements which are interconnected in the circumferential direction, more preferably articulated with each other in the Circumferential direction are connected.
  • each such pipe shell element extends over the entire axial extent of the cladding tube or at least over the majority of the Hüllrohrerstreckung thus in particular a pipe shell element is longer than
  • Another embodiment may also provide that the cladding tube both in the circumferential direction, as well as in the axial direction in each case at least two preferably a plurality of tube shell elements which are connected to each other, are particularly preferably hinged together.
  • the connection direction of the cladding tube between the tube openings is understood, even if the cladding tube itself does not extend exactly in a straight line, but optionally has a curvature.
  • the preferred articulated connection may be formed, for example, in that the cladding tube comprises a deformable cladding element, such as For example, a plastic film, on the outside of which, based on the cladding tube to be formed, the tube shell elements are arranged.
  • a deformable cladding element such as For example, a plastic film
  • the tube shell elements are arranged.
  • the pipe shell elements for example, have a greater modulus of elasticity than the material of said shell element.
  • the deformable envelope member such as the plastic film that tumor material can grow into the interior of the cladding tube, since the envelope itself provides a barrier against this growth.
  • the pipe shell elements due to their relative to the
  • Hüllelement stable design ensure that any pressure exerted by a tumor tissue from the outside on the cladding tube according to the invention pressure is not transmitted to the lying inside the cladding neural structure.
  • the invention can also provide that the articulated connection between the pipe shell elements mentioned as being preferred is realized by forming a thickness-reduced region of the jacket pipe material between adjacent pipe shell elements.
  • the invention provides, for example, that the cladding tube is substantially integrally formed from one and the same material, but the tube shell elements have a greater wall thickness than the intermediate thickness-reduced regions, which thus act as a kind of solid-state or living hinge between these tube shell elements.
  • the invention may provide that the cladding tube has at least two separating points extending over the entire axial length, possibly even more.
  • the cladding tube has at least two tube shell elements extending in the axial direction, which, when combined, add up to the cladding tube and can be separated and connected at the separation points. So can with this design For example, to the neural structure to be protected in the radial direction, the individual tube shell elements are introduced and then interconnected to form a total of the cladding tube.
  • Embodiment of the invention essentially provides that the number of separation points and the number of tube shell elements is the same.
  • the tube shell elements are preferably chosen so that they prevent a growth of tumor tissue, d. H. the
  • Pipe shell elements have in their surface no opening, mesh or other passages. Preferably, they also have such a stability that is selected that pressure exerted by a growing tumor on the tube shell elements is not forwarded to the interior of the cladding tube and that continue to be the tube shell elements are so flexible that
  • the invention can additionally provide that at least two tube shell elements lying opposite one another at a separation point at least partially overlap.
  • this can be realized by a
  • tongue and groove are in particular at the respectively facing each other edges of the shell elements
  • the invention can provide here that the pipe shell elements in
  • Circumferential direction are curved to form by their joining together the cladding tube with the desired diameter.
  • the pipe shell elements provide, which are optionally also arranged axially adjacent to each other and at least have a hinged connection with a large number of pipe shell elements in the circumferential direction, in particular with more than 10 pipe shell elements in the circumferential direction and the possibility the pipe shell elements even without Curvature form, as a total results on the articulated connection.
  • the cladding tube to be formed will correspond in cross section to a polygon.
  • the invention may further provide that in all embodiments, the opposing or overlapping axially extending edges of a Hüllettis, which are arranged at the respective separation points and / or provided at the openings of the cladding tube edges of the Hüllettis are provided with a protective element covering the edges , Such a provision of a protective element is particularly useful if an enveloping element is formed from a material which carries the risk at the edges that with these a violation of the neural structure to be protected can take place during the application of the enveloping element.
  • the enveloping element is designed as indicated at the beginning by a metallic net or else a thin foil whose edges can thus be made sharp.
  • a protective element may for example be realized by a coating applied to the edges.
  • Such a coating can be realized for example by silicone.
  • the invention in the case of the described neural sheath provides that the regions of the cladding tube located on either side of the cleavage site or the bilateral regions of cladding elements can be connected to a connecting element via the respective separation site and in the surgical application after the cladding to be protected Structure are connected, at least to stabilize the shape, if necessary, to seal the separation point.
  • This can be done for example by means of threads or wires, which are fixed in the cladding tube on both sides of the separation point or the cladding tube in total
  • a further function can also be exercised, such as, for example, a traction function in order to correctly place the cladding tube.
  • the invention may provide that the cladding tube at the axial ends compared to an end between the ends of greater flexibility
  • the envelope raw wall thickness at the ends is less than in an area lying between the ends.
  • the cladding tube is formed in the end region of a different material than in the intermediate region and this material in the end region, for example, has a lower modulus of elasticity than the material in the
  • All possible embodiments of the invention may further provide that the cladding tube, in particular the tube shell elements of the cladding tube, are adapted to the neural structure of the patient to be enveloped on the basis of data acquired radiographically by a patient. As a result, a particularly good fit of the cladding tube according to the invention is achieved.
  • a cladding tube 1 is formed by an enveloping element 2, which represents a planar structure that from a for example, planar shape shown here can be wound into a tube shape.
  • the sheath element 2 has a two-layer structure, namely, it has an outer layer 2a, which is formed by a metallic mesh or metallic fabric and an inner layer 2b, which is formed by a plastic film, which Mesh of the net closes. The layers may be interconnected or loose with each other.
  • the sheath element has an edge protection, which ensures that the metallic mesh 2a has no outwardly facing open wire ends, which can lead to injury.
  • the illustrated edge protector 2c thus surrounds the entire enveloping element on all edges.
  • the sheath element 2 shown here can be passed, for example, in the application of spinal cord protection between the spinal cord and spine, to then be placed on the left as shown in Figure 1 to form a tubular around the spinal cord around so as to form the cladding, here with a single point of separation 3, which can be sewn according to this embodiment with a thread along the entire axial extent. As a result, the tube is appropriately stabilized position.
  • the invention may provide in the embodiment of Figure 1 that the
  • Sheath element 2 shown occupies both the pipe shape automatically,
  • the metallic mesh is formed from a shape-memory alloy (e.g., Nitinol), or at least the desired tubular shape is initially imprinted in the cladding element, e.g. inelastic deformation.
  • a shape-memory alloy e.g., Nitinol
  • the invention can also provide that the enveloping element does not automatically adopt this required tube shape, but that only by the laying around and shaping the tube shape and by the connection of the opposite regions of the cladding tube at the T rennstelle 3, the tube shape is stabilized.
  • the meshes of the metallic mesh have no rigidly connected nodes, but are formed by overlying and underneath wires that are mutually displaceable in the mesh intersection points.
  • the tube shape is initially embossed in the envelope 2 and thus this tube shape is automatically taken when no forces act on the cladding tube according to the invention, so this assumes its relaxed state ,
  • the superelasticity (or elasticity of transformation, caused by stress-induced phase transformation) of such a shape-memory alloy can be used to open the cladding tube at the separation point 3 sufficiently wide to allow it to be wrapped around the neural structure to be protected
  • the mesh sizes of the network shown here can be, for example, in the range of 1 to 3 mm.
  • the length and the diameter of the cladding tube are depending on the required
  • the length is preferably in In particular, it is preferably larger than the length of a vertebral body of the affected patient and also preferably smaller than the length of two vertebral bodies of an affected patient.
  • FIG. 2 shows an embodiment in which a cladding tube 1 is formed by an enveloping element 2, which is formed here from a foil, such as, for example, a foil made of polymethyl methacrylate, or silicone.
  • a foil such as, for example, a foil made of polymethyl methacrylate, or silicone.
  • the invention may provide that the film comprises a material which is polymerizable, for example by external action of light, such as ultraviolet light.
  • the invention provides here that the structure to be protected 4, as here, for example, the spinal cord, is enveloped by the flexible film, wherein the film according to this embodiment no
  • Preferred form, d. H. does not automatically form the required cladding tube.
  • impregnated mats such as textile mats from a mesh, knitted fabric, scrim or other arrangement of fibers, wherein then the impregnation material of such a mat is set to
  • FIG. 3 shows an embodiment in which the cladding tube 1 from a
  • Envelope 2 is formed, which assumes a stable relaxed state in a tubular form.
  • the embodiment of the invention is chosen so that after formation of the cladding tube 1 opposite edges of the envelope element 2 at the T rennstelle 3 overlap, so that tumor tissue can not grow through this.
  • the stability of the cladding tube is achieved here exclusively in that the shape of the cladding tube is permanently embossed in the material of the Hüllenses. This can be done for example in metallic formation of the Hülliatas for example from a metal sheet by a corresponding thermal impression due to the shape-memory properties of the material or by inelastic, plastic deformation. In the case of an embodiment of the enveloping element made of a plastic, for example a film, this can also be done by a thermal treatment, so that the film has its relaxed state in the tubular form.
  • the device of the invention shown here of Figure 3 can thus be opened at the separation point, whereby internal forces are generated in the material of the Hüllimplantations, which after laying around the
  • FIG. 3 further shows in the lower illustration that, based on the axial extension of the cladding tube 1, the invention can provide that axial upper and lower end regions 1a are softer or more flexible than an intermediate region 1b.
  • the region 1 a for example, have a lower modulus of elasticity or a smaller wall thickness than the intermediate region 1 b, in particular by this injury To avoid the neural structure to be protected at occurring curvatures of the structure within the cladding tube.
  • FIG. 4 shows an embodiment in which the cladding tube 1 has an enveloping element 2, such as a plastic film or even a fabric on its outer surface with respect to the cladding tube to be formed
  • FIG. 4 further shows that by means of connecting and / or guide elements 4, which are here designed as threads or wires, a tensile force can be exerted on the enveloping element 2, for example, this at the application to the spinal cord between spinal cord and spine to draw.
  • the guiding and connecting elements 4 are preferably further used after the deformation of the enveloping element 2 to the cladding tube 1 in order to close this at the separation point 3. Accordingly, after the connection of the elements 4, the Hüllrohrform stabilized and ensured that the pipe can not open automatically.
  • the pipe shell elements 2 ' may be formed for example by a plastic, as well as by a metal, for example by titanium.
  • Pipe shell elements 2 ' acts, furthermore, according to the invention, that Tumor tissue can not grow between the tube shell elements 2 ' in the interior of the cladding tube.
  • FIG. 5 shows an embodiment similar to FIG. 4, wherein, however, the tube shell elements of the cladding tube 1 preferably extend axially over the predominant length of the entire cladding tube or even along its entire length, even have a tube curvature and have a tube curvature on the outer surface of an envelope element 2, for example Foil are arranged so that between the curved pipe shell elements 2 ' results in a hinged connection, wherein the formed cladding tube 1 is closed at the here single separation point 3, which extends over the entire axial length, by a thread 4.
  • the tube shell elements of the cladding tube 1 preferably extend axially over the predominant length of the entire cladding tube or even along its entire length, even have a tube curvature and have a tube curvature on the outer surface of an envelope element 2, for example Foil are arranged so that between the curved pipe shell elements 2 ' results in a hinged connection, wherein the formed cladding tube 1 is closed at the here single separation point 3, which extends over the entire axial length, by
  • FIG. 6 shows a similar embodiment in which the formed cladding tube 1 is formed by an enveloping element which has tube shell elements 2 ' in the circumferential direction of the cladding tube, which are interconnected by regions 2c reduced in material thickness, which are accordingly solid bodies
  • the cladding tube 1 may be formed entirely of one and the same material and is open at the separation point 3, to put this around a structure to be protected around and also in turn to close with the connecting element 4, such as with a thread.
  • cladding tube 1 or the tube shell elements extend only over a surmounting axial length (> 50% of the cladding tube length), as shown in Figure 6 below.
  • upper and lower end portions 1 a of the cladding tube 1 also be reduced in wall thickness to achieve there higher flexibility / elasticity over the intermediate region 1 b.
  • FIG. 7 shows an embodiment in which the cladding tube 1 is composed of several individual tube shell elements 2 ' , which complement each other in the circumferential direction to the cladding tube 1.
  • the individual pipe shell elements 2 ' are separate components that have no initial connection with each other until they are assembled to the cladding tube 1 total.
  • the figure 7 illustrates here that between the individual pipe shell elements 2 ' a tongue and groove joint 5 is realized, which realizes an at least partial overlapping of the shells 2 ' at the respective separation points 3 and thus prevents tumor tissue at these separation points 3 in the interior of the formed cladding tube 1 can grow. According to the number of
  • Shell elements 2 ' results in an equal number of separation points.
  • Pipe shell elements 2 ' composite cladding tube 1 can be completely surrounded to stabilize the tubular shape with connecting elements 4.
  • Such connecting elements may be, for example, wires or threads, which are twisted or knotted after being wrapped around the pipe shell elements 2 ' and thus prevent the pipe shell elements 2 ' from being detached from one another.
  • the respective pipe shell elements 2 ' are preferably formed of an elastic material to allow for curvatures in the axial direction, as shown in Figure 7 top left.
  • the respective pipe shell elements 2 ' are preferably formed of an elastic material to allow for curvatures in the axial direction, as shown in Figure 7 top left.
  • Pipe shell elements 2 ' made of polyethylene formed with a preferred thickness of 0.3 to 1 mm. Depending on the field of application, however, it is also possible to form such pipe shell elements made of metal, such as
  • titanium which also provides sufficient flexibility at the aforementioned thickness of 0.3 to 1 mm.
  • connecting elements described in the various embodiments as well as in the general part, which are named, for example, as wires or as threads, can also be designed as such binding elements in an alternative embodiment, the ends of which can be connected to each other by a burglar function, so that the diameter of one with a such loop formed element can only be reduced.
  • Such an element may have the function as known from a so-called cable tie.
  • Such a connecting element 4 has at one end of the connector strand an eyelet through which the other free end can be passed.
  • the structural design is such that a pulling of the other end by the eyelet is possible only in a single direction, which only reduces the size of the loop formed.
  • a connecting element 4 may preferably be used in all possible embodiments.
  • the invention can also provide that the materials used in the cladding tube or the cladding tube forming the cladding element are selected so that these in radiological examinations no
  • markers it is also possible for markers to be arranged on the cladding tube or on the cladding element in order to be able to detect the cladding tube during radiological examinations, for example during image acquisition by means of X-rays or also in the field of radiation
  • Magnetic resonance tomographs can be detected using the markers.
  • the invention may further provide for coating the outer obver vom Schemee, in particular the directed to a tumor outer surface areas of the cladding tube with a drug which inhibits tumor growth.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Neurology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Surgery (AREA)
  • Molecular Biology (AREA)
  • Medical Informatics (AREA)
  • Neurosurgery (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Cardiology (AREA)
  • Radiology & Medical Imaging (AREA)
  • Prostheses (AREA)

Abstract

L'invention concerne une gaine neurale, en particulier une gaine de moelle épinière, comprenant un tube de gaine (1) présentant à au moins un endroit périphérique un point de séparation (2) qui s'étire sur toute la longueur axiale du tube de gaine (1) et sur lequel le tube de gaine (1) peut être ouvert et/ou fermé sur toute la longueur axiale, est notamment fermé lorsqu'elle est utilisée conformément à sa destination. L'invention concerne en outre l'utilisation d'au moins un élément de gaine (2) pouvant être formé/étant formé en un tube de gaine (1) présentant à au moins un endroit périphérique un point de séparation (3) qui s'étire sur toute la longueur axiale du tube de gaine (1) et sur lequel le tube de gaine (1) peut être ouvert et/ou fermé sur toute la longueur axiale, en tant que gaine protectrice pour des structures neurales (6), en particulier pour la moelle épinière.
PCT/EP2019/053037 2018-02-07 2019-02-07 Gaine neurale WO2019154926A1 (fr)

Applications Claiming Priority (2)

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DE102018000966.2A DE102018000966A1 (de) 2018-02-07 2018-02-07 Neuralhülle
DE102018000966.2 2018-02-07

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WO2019154926A1 true WO2019154926A1 (fr) 2019-08-15

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US5919220A (en) * 1994-09-16 1999-07-06 Fraunhofer Gesellschaft Zur Foerderung Der Angewandten Forschung E.V. Cuff electrode
US7787959B1 (en) * 2006-12-22 2010-08-31 Pacesetter, Inc. Mechanism and method of attaching a stimulation and/or sensing electrode to a nerve
EP2374408A1 (fr) * 2006-07-10 2011-10-12 Christofer Toumazou Procédé et dispositif de mesure de l'activité dans le système nerveux périphérique
EP2861297A1 (fr) * 2012-06-15 2015-04-22 Case Western Reserve University Brassard implantable et procédé de surveillance et stimulation électrique fonctionnelle

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US5824054A (en) * 1997-03-18 1998-10-20 Endotex Interventional Systems, Inc. Coiled sheet graft stent and methods of making and use
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US6231597B1 (en) * 1999-02-16 2001-05-15 Mark E. Deem Apparatus and methods for selectively stenting a portion of a vessel wall
CN102245127B (zh) * 2008-10-10 2014-06-11 雷瓦医药公司 可扩展的滑动和锁定支架
WO2010048671A1 (fr) * 2008-10-30 2010-05-06 Macquarie University Support de vaisceau et sa méthode d’utilisation
WO2014055476A1 (fr) * 2012-10-02 2014-04-10 Icon Medical Corp. Dispositif expansible
US20170258611A1 (en) * 2014-05-09 2017-09-14 Mayo Foundation For Medical Education And Research Devices and methods for forming stents in vivo
WO2016118669A1 (fr) * 2015-01-20 2016-07-28 Nsvascular, Inc. Dispositif auto-expansible servant de squelette pour le traitement d'anévrismes

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Publication number Priority date Publication date Assignee Title
US5919220A (en) * 1994-09-16 1999-07-06 Fraunhofer Gesellschaft Zur Foerderung Der Angewandten Forschung E.V. Cuff electrode
WO1998022155A1 (fr) * 1996-11-20 1998-05-28 Tapic International Co., Ltd. Canal rachidien artificiel
EP2374408A1 (fr) * 2006-07-10 2011-10-12 Christofer Toumazou Procédé et dispositif de mesure de l'activité dans le système nerveux périphérique
US7787959B1 (en) * 2006-12-22 2010-08-31 Pacesetter, Inc. Mechanism and method of attaching a stimulation and/or sensing electrode to a nerve
EP2861297A1 (fr) * 2012-06-15 2015-04-22 Case Western Reserve University Brassard implantable et procédé de surveillance et stimulation électrique fonctionnelle

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