WO2011032720A1 - Appareil médical destiné à être introduit dans un organe creux du corps - Google Patents

Appareil médical destiné à être introduit dans un organe creux du corps Download PDF

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Publication number
WO2011032720A1
WO2011032720A1 PCT/EP2010/005732 EP2010005732W WO2011032720A1 WO 2011032720 A1 WO2011032720 A1 WO 2011032720A1 EP 2010005732 W EP2010005732 W EP 2010005732W WO 2011032720 A1 WO2011032720 A1 WO 2011032720A1
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WIPO (PCT)
Prior art keywords
wires
wire
wire strand
twisted
strand
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Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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PCT/EP2010/005732
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German (de)
English (en)
Inventor
Giorgio Cattaneo
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Acandis GmbH and Co KG
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Acandis GmbH and Co KG
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Publication of WO2011032720A1 publication Critical patent/WO2011032720A1/fr
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/01—Filters implantable into blood vessels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/88—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements formed as helical or spiral coils

Definitions

  • the invention relates to a medical device for insertion into a hollow body organ having the features of the preamble of claim 1.
  • a device of this kind is known, for example, from WO 99/25271.
  • stenoses and for the expansion or removal of thrombi implants are used with a fine mesh lattice structure.
  • the fine mesh of the lattice structures serves, for example, to influence the flow conditions in the aneurysm, i. E. To slow the flow so that the aneurysm coagulates and thus becomes deserted.
  • the fine-meshed lattice structure also promotes the rapid growth of cells (endothelialization). In the expansion of stenoses and thrombi particles are blocked by the fine mesh of the lattice structure.
  • the braiding angle can be increased.
  • an increase in the braid angle is limited by the compressibility of the vascular support in the longitudinal direction (harmonica effect), which occurs at very small diameter changes, so that the length of the vascular support with normal changes in vessel diameter or forces in the discharge and positioning the vascular support arise, significantly changes.
  • WO 99/25271 discloses a braided stent in which the wires are twisted together at the stent end. The twisted wire groups are parallel to each other and do not form meshes of the lattice structure. The twisted wires therefore exert no radially outward force.
  • braided stent is known from WO 99/55256, in which braid elements are formed from bundles consisting of at least three interwoven wires.
  • the strain to which a single wire is exposed in the bundle should be smaller than the elongation of a hypothetical wire with the dimension of the wire bundle.
  • wire bundles have relatively large dimensions. Especially with a few wires or with a low ratio between the bundle diameter and the individual wire diameters, there is a considerable deformation of the individual wire. This results in that the wires are not close to each other at the intersections of the braid. The increased dimensions of the overall system complicate the crimpability of the stent, so that introduction of the stent is impaired in small-lumen catheters.
  • the invention is based on the object to provide a medical device for insertion into a hollow body organ having a high relative to the respective vessel diameter radial force, as well as good Crimpeigenschaften in the expanded state. According to the invention this object is achieved by a medical device having the features of claim 1. In each case a sidelined aspect, this object is achieved by a medical device according to claim 16 or 17.
  • the invention is based on the idea to provide a medical device for insertion into a hollow body organ having a wall comprising a mesh-shaped mesh structure braided from wires.
  • the grid structure is convertible from a first compressed to a second expanded state.
  • the meshes of the grid structure are formed by crossings of the wires, the wires being arranged in different spiral directions.
  • At least in the area of a first section of the grid structure at least two wires are twisted into a respective wire strand, wherein at least two wire strands of twisted wires are intertwined to form the meshes of the grid structure.
  • Wire strands or elongated wire elements or strands are thus formed with the invention, each comprising at least two wires twisted together.
  • the wire strands with the twisted wires cross each other. Between at least two cross-overs associated with the wire mesh, the wires are twisted together.
  • the wire strands may also be intertwined to form the meshes of the grid structure.
  • a wire strand can alternate with another or several other strands of wire alternately.
  • a first crossover a first wire strand can be arranged above a second wire strand and the first wire strand can be arranged under the second or another wire strand in an adjacent crossover.
  • the wire strands are alternately guided over and under each other.
  • the interweaving of the strands of wire is not recognizable. Rather, at least two crossings in the wall of the lattice structure are to be considered for this purpose.
  • a wire strand can be guided under two crossing wire strands and then over one or more further strands of wire.
  • a wire strand can be passed over two, then under two and then again over two wire strands.
  • Such a braid configuration is called l-over-2.
  • Other possible braid configurations are 2-over-2, 2-over-1, 1-over-2, 1-over-3, 2 over-3, 3-over-3 or the like.
  • the number of over or under braided wire strands is arbitrary, it being expedient if the braid configuration forms a substantially regular pattern. It is not excluded that pattern-like interwoven sections vary along the grid structure. That is, the grid structure may include a plurality of different sections each having a pattern-like braid configuration of the wire strands.
  • the invention has the advantage that the radial force is increased in comparison to wire strands which are braided from individual wires, or in general compared to braids which are made of individual wires. Compared to a single braid wire, which induces the same radial force, in a wire strand of a plurality of twisted wires, the crimp diameter of the medical device, particularly the stent, can be reduced.
  • the wire strands formed from a plurality of twisted wires can be arranged to save space in the region of the crossings of the wire mesh.
  • the single wire can be considered as a spring, the forces that occur in the wire, mainly torsional forces.
  • the single wire is stressed with a torque.
  • the torque depends on a certain deformation overlinear from the diameter of the wire, which is why the restoring force of the deformed wire decreases significantly with decreasing wire diameter.
  • the resistance that the twisted wires of a strand of wire can exert against twisting increases.
  • the wires of a wire strand are twisted in a direction corresponding to the spiral direction of the wires in the lattice structure.
  • the resistance increased by the twisted wires of a wire strand is further increased.
  • the wires are stretched and pressed against each other.
  • the entire restoring force is increased by the wire stretch beyond the effect of pure wire twist addition.
  • the wires of the wire strands are twisted together in the same direction as the winding direction of the respective wire strand, the wires are allowed to be twisted. te a wire strand in the spaces between the wires of the other wire strand are space-saving positionable.
  • a particularly space-saving arrangement of the wire elements in the wall is achieved in that the wires of a first wire strand are twisted together in opposite directions of winding than the wires of a second wire strand, which forms a crossover with the first wire strand.
  • the wires of at least one first and second wire strand which cross over, intertwined in the region of the crossover.
  • the interweaving of the individual wires or of wire subgroups of the respective intersecting wire strands in the region of the strand crossings fixes or anchors the wire strands in the area of the crossover.
  • the crossovers are stabilized and in turn are positionally stable.
  • the wire strands or wire elements can not be moved freely at the crossings relative to each other, but are blocked or at least movable against one another to an increased force or resistance to each other. This not only causes the torsion of the wire strands, the restoring force of the braid.
  • the crossovers are radially spaced from each other before the wires rest on the braid mandrel. The position of the crossovers is undefined in this intermediate phase and can shift unintentionally. The crossovers may shift in particular when changing the diameter of the dome or when setting a desired angle change of the braid.
  • the braid "pulls" under the tension of the wires, so that the cells are deformed, in particular lengthened
  • the braid is already defined prior to mounting on the braiding mandrel , in particular the length between two crossings, which determines the shape of the cell.
  • the braid angle of a wire strand may be different on either side of an interlaced crossover which the wire strand forms with at least one other wire strand.
  • At least one wire of the first wire strand may be arranged in the region of the crossing between two wires of the second wire strand. It is also possible to intertwine wire subgroups instead of individual wires in the region of the crossover, for example a group of two wires of the first wire strand with a single wire or another wire group, for example likewise a wire subgroup of two wires. Other combinations are possible depending on the number of twisted wires per wire strand.
  • the lattice structure can have at least one second section, in the region of which the interwoven wire strands each have a different, in particular a smaller number, of twisted wires than in the region of the first section. Additionally or alternatively, individual wires may be interlaced in the region of the second section. This makes it possible to fine-mesh and less fine-meshed wall areas of the medical device, in particular the stent set. In the area of the less fine-meshed lattice structure, in which the wire mesh is made of the wire strands, the radial force is increased. These force regions are preferably provided at the stent ends.
  • the feinmaschigere range in which the individual wires are intertwined or less twisted wire strands are intertwined may be arranged in the region of the stent center or spaced from the stent ends. Less heavily twisted wire strands can be designed, for example, by a smaller number of twists per length of the wire strand or a smaller total wire number.
  • the second section is arranged between the two first sections of the grid structure.
  • This embodiment is particularly suitable for stably fixing the stent or generally the medical device around the second section in the vessel.
  • the second portion may have a different function, for example, by its fine mesh an edema aneurysm.
  • the grid structure may include multiple sections comprising stronger or weaker twisted wire strands.
  • the grid structure may have sections in which the individual wires are present without being twisted. For example, a coarse-meshed section of twisted wire strands may be disposed in the center of the grid structure to allow for the expansion of a calcified stenosis.
  • the end portions of the grid structure may be less twisted or constructed of untwisted, individual wires, so that there is an increased Feinmaschmaschine and a smaller radial force, whereby the compliance is increased to a blood vessel.
  • wire strands whose individual wires are interlaced in the crossovers with other wire strands are referred to as "twisted".
  • the lattice structure it is also possible, for example, for the lattice structure to have a basket-like shape, which is particularly suitable for removing thrombi from blood vessels.
  • the opening of the basket-like lattice structure according to the invention with twisted wires twisted wires so have wire strands, so that the opening with a higher radial force expands than the remaining portions of the basket-like lattice structure.
  • These further sections can then be at least partially constructed of a mesh made of wire strands with fewer wires or of individual wires and therefore having an increased fine mesh, so that free particles in the bloodstream can be filtered.
  • proximal section of the lattice structure can comprise, for example, a mesh of a total of 48 individual wires, which can be individually interwoven with the lattice structure or be twisted in bundles into wire strands. Other transitions or a different number of individual wires per wire strand in the different sections are possible. Particularly preferred is the said progressive transition between different sections when the grid structure forms a stent.
  • the number of wires in each case of a wire strand 2, 3, 4, 6 or 8 wires can each comprise the same number of wires or a different number of wires, whereby the properties of the medical device can be varied in different areas.
  • the number of strands is 24, 32, 48, 64 or 72 wires.
  • the wire strands are arranged in a braided configuration 1 over 1, 1 over 2, 1 over 3, 2 over 2 or in another braiding configuration.
  • the individual wires or the wire strands may be arranged in the region of the second section in a braided configuration 1 over 1, 1 over 2, 1 over 3, 2 over 2 or in another braiding configuration.
  • first and second sections there may be arranged a transition region having a different braid configuration than the first and / or second section, whereby a continuous transition of the properties of the medical device from one section to another along the wall is possible.
  • the number of twists of the wires of a wire strand is different on both sides of an intertwined crossover formed by the wire strand and at least one other strand of wire.
  • the setting of a different number of twists and / or the directions of the twists on both sides of a crossover is only possible if this is fixed accordingly, for example by the individual wires or wire subgroups of the respective wire strands forming the crossover are intertwined. In this way, different areas with different forces can be generated precisely and finely.
  • the invention is based on the idea to provide a medical device for insertion into a hollow body organ having a wall comprising a wire-meshed grid-like structure braided with wires.
  • the grid structure is convertible from a first compressed state to a second expanded state.
  • At least in the region of a first section of the lattice structure at least two wires are twisted into a respective wire strand.
  • a first wire strand and a second wire strand form a crossover, in which the wires of the first wire strand and the second wire strand are intertwined with each other.
  • This aspect is based on the idea of connecting two wire strands in a crossover in such a way that the individual strands forming the respective strands of wire are intertwined in the region of the crossover.
  • the wire strands forming the mesh of the grid structure the same winding direction or a different Windungsraum exhibit. If the two wire strands are wound in the same direction about a longitudinal axis of the grid structure, the wire strands have different Windungsste Trenting or winding angles. The wire strands intersecting at different angles thus form an asymmetrical grid mesh.
  • the wire strands may also have the same winding angle or the same winding pitch.
  • twist number or number of wires per wire strand a variety of different configurations can be adjusted, which affect the expansion force, the flexibility and / or the stability of the grid structure.
  • At least one, in particular 2, 3, 4, 5 or more twists can be provided between two crossovers.
  • Another subsidiary aspect of the invention relates to a medical device for insertion into a hollow body member comprising at least one wire strand formed from at least two wires twisted together, the wire strand spiraling around a central axis of the medical device to form a substantially rotationally symmetric structure is winding.
  • the latter aspect thus relates to a medical device in which at least one wire strand is spirally wound around a common axis of the device and in this way forms a coil-like structure. It is possible that the wire strand spirally wound around a common axis of the medical device, deflected at one axial end of the medical device and is returned spirally in the same direction, so that there is essentially a double spiral winding. It is not excluded that the medical device comprises a plurality of wire strands which are spirally wound in parallel around the axis.
  • the medical device in this sibling aspect, wherein the wire strands form a rotationally symmetric structure in a spiral shape, also has the property of being able to be converted from a compressed state into an expanded state.
  • the expansion force or radial force is determined inter alia by the twisting of the individual wires, each of which has a wire Form strand.
  • the twisting of the individual wires is effective against the torosion of the medical device and thus requires different flexible or stable properties depending on the degree of twisting.
  • Fig. La is a schematic view of a section of two twisted together wires
  • Fig. Lb is a cross-section through the wires of Fig. La;
  • FIG. 2 shows a detail of a mesh of wire strands, which are each formed from a plurality of twisted together wires.
  • FIG. 3 shows a section of a braiding braided from a plurality of wire strands of twisted wires, the crossings of the wire strands being fixed by intertwining the individual wires of the respective wire strand;
  • FIG. 4 shows a section of a grid structure of a medical device in which a section of wire strands having respective twisted wires and a section of individual wires is braided;
  • Fig. 5 shows a section of a mesh in which crossovers are partially fixed by interlacing and partially unfixed.
  • the invention is generally applicable to medical devices intended for insertion into a hollow body organ, such as a vessel, having a braided wall 10. Braids can be achieved with the invention, which have advantages in terms of fine mesh and flexibility and also have an increased restoring force during expansion. The invention can therefore be realized in a particularly advantageous manner, without being limited thereto, in stents or stents.
  • Other devices which can be expanded in a hollow organ and have a braided wall are also usable within the scope of the invention, for example filters, flow dividers or medical devices.
  • niche devices that do not permanently remain in the body as opposed to implants, but temporarily take a support function, such as thrombus and the like.
  • the increased radial force which can be achieved with the invention results in better attachment of the system to the walls of the respective cavity, which reduces the risk of dislocation.
  • the dimensions of the delivery system can be reduced, in which the system is crimped or radially compressed, the radial forces are comparable with correspondingly larger-sized devices and corresponding delivery systems.
  • the invention is applicable to medical devices which are self-expandable or expandable by the application of external forces, for example, balloon expandable.
  • the materials required for the self-expandable properties such as nitinol, are known to those skilled in the art.
  • the wall 10 can form a rotationally symmetrical, in particular a cylindrical hollow body.
  • twist can be understood by braiding a mutual wrapping of two or more wires that wrap each other at an angle of 360 degrees.
  • Fig. La a half wrap of two wires is shown, which thus wrap around at an angle of 180 degrees. Accordingly, two successive or subsequent twists of two wires form an interlacing at an angle of 2x360 degrees. It is not excluded that the wires twisted together are partially spaced from each other. It is therefore not necessary that the twisted wires touch each other over the entire wire length. It is possible to twist more than two wires together, especially 3, 4, 5, 6, 7, 8 or more than 8 wires.
  • Fig. Lb is shown by the two arrows in the same direction that changes the cross-sectional position in the longitudinal extension of the wire element in the arrow direction and in particular runs on the circumference of the other wire in the longitudinal direction (twisting).
  • the twisted arrangement of the individual wires 11 in a wire strand 16 in a direction which corresponds to the spiral direction of the wire strand 16. speaks.
  • the individual wires 11 and the wire strand 16 formed therefrom thus run in the same direction of rotation, ie, the twisting direction corresponds to the spiral direction.
  • the arrangement in the same direction of rotation has the advantage that the entire restoring force is increased by the wire stretch beyond the effect of pure wire twist addition. Due to the opposite arrangement of the individual wires 11 to the spiral direction of the associated wire strand 16, the radial force or the restoring force can be reduced.
  • the force acting on the vessel forces can be fine adjusted in areas by an appropriate arrangement of the wires 11.
  • FIG. 2 shows a first wire strand 16a and a second wire strand 16b, wherein the wire strands 16a, 16b form a crossover 14.
  • the first wire strand 16a comprises two wires 11, which are twisted together in a clockwise direction and thus in the same direction of rotation as the first wire strand 16a is wound around a longitudinal axis of the lattice structure.
  • the second wire strand 16b has two wires 11, which are also twisted together in a clockwise direction, but the second wire strand 16b is wound in a counterclockwise direction about the longitudinal axis of the lattice structure 12.
  • both wire strands 16a, 16b comprise the same or opposite twisted wires 11.
  • the wire strands 16 resulting from the twisted individual wires 11 are intertwined to form the mesh structure 12.
  • a mesh 13 of the grating structure 12 is shown in FIG.
  • the arrangement of the meshes 13 in the lattice structure 12 is also shown in FIG. 4.
  • the wire strands 16 form crossings 14, wherein the shape of the mesh 13 depends on the arrangement of the crossings 14 of the individual strands of wire 16 and, for example, diamond-shaped, as in Fig. 3, or with other geometries (see Fig. 4) may be formed.
  • braid counter-rotating strands of wire can cross, for example, in the following way: down, up, down, up, etc.
  • This type of braid is called 2 about 2 twisted.
  • this type of braid 2 is called twisted over 4.
  • a 1 over 1 braided wire 16 of the braiding type 2 corresponds to 2 wires when each wire strand is composed of two wires 11.
  • braiding configurations such as 1 over 2 or 1 over 3 or 2 over 2 are twisted respectively, or all other arbitrary braiding configurations are possible.
  • the wire strands 16 or a first wire strand 16a and a second strand 16b can be arranged in the region of the crossover 14 without the wire strands 16a, 16b being connected to one another in the region of the crossover.
  • the two wire strands 16a, 16b are freely movable in the region of the crossover 14.
  • the crossings 14 it is also possible to stabilize the crossings 14 by the wire strands 16 and the cross-over 14 forming first and second strands of wire 16a, 16b are interlocked with each other.
  • the stabilization of the crossovers 14 is achieved in the embodiment according to FIG. 3 in that the two wire strands 16a, 16b are intertwined in the region of the crossover.
  • at least one wire 11 of the first wire strand 16a is arranged between two wires 11 of the second wire strand 16b.
  • at least one wire 11 of the second wire strand 16b is arranged between two wires 11 of the first wire strand 16a. This has the advantage that higher forces are required to deform the mesh 13 or the cell associated with the respective stabilized crossover region 14.
  • the anchoring of the wire strands 16a, 16b at the crossings 14 also has the advantage that the direction of the twist on both sides of the crossover 14 can be changed. This is not possible without anchoring.
  • By changing the twisting direction for example, an area in front of the crossover 14 with high radial force can be adjusted by making the twist in this area corresponding to the spiral direction of the wire strand 16.
  • a region with lower force can be set by the twisting in the opposite direction. tion to the spiral direction of the wire strand runs. In this way, a fine adjustment of the radial force is partially, in particular between two subordinate crossovers 14 possible.
  • Another advantage of anchoring the wire strands 16a, 16b in the region of a crossover 14 is that very precise braiding angle changes can be achieved before and after the respective crossover 14 or before and after different crossovers 14. Without a firm anchorage, the crossovers 14 tend to shift as the braiding angle is varied.
  • the braiding angle can be varied in very small areas on both sides of the respective crossover 14, whereby a very fine adjustment of the flexibility and the radial force or expansion force of the medical device or the stent can be achieved.
  • the change in the braiding angle can be achieved, for example, by changing the number of twists between two successive crossings 14 along a wire strand 16.
  • the number of twists between two crossovers 14 may also be constant, with the twist density, i.
  • the braiding angle is the acute angle which a wire strand 16 encloses with a longitudinal axis projected into the wall of the device.
  • the difference between the braid angles on both sides of an interlaced crossover 14 may comprise at least 5 degrees, in particular at least 10 degrees, 20 degrees, 30 degrees, 40 degrees, 50 degrees, 60 degrees, 70 degrees, 80 degrees, the above values respectively Describe the lower limit of the possible range. It is also possible that the number of twists on both sides of an interlaced crossover 14 are different. This makes it possible to change the braiding angle on both sides of the crossover 14.
  • the difference in the number of twists on both sides of the respective crossover 14 can be at least 0.5, 1, 1.5, 2, 2.5, 3 are twists, the above values mean lower limits.
  • a medical device or a stent is disclosed that has the structures described above with their properties.
  • a further variation of the properties of the medical device can be achieved in that the individual wire strands 16 each comprise a different number of wires. It is also possible that the wire strands 16 each have the same number of wires that are twisted together.
  • FIG. 4 shows that the lattice structure 12 has different first and second sections 15a, 15b.
  • the mesh of individual wires 11 is formed, which are intertwined with each other in a conventional manner.
  • the first section 15a is formed from interwoven wire strands 16, each having a plurality, in particular two wires 11 twisted together. It is also possible to form the second section 15b of interwoven wire strands 16 having a different, in particular a smaller number of twisted wires 11 than the first section 15a.
  • the wire strands 16 or at least a part of the strands of wire 16 of the first section 15a each with four twisted wires, which are split in pairs in the second section 15b, so that a wire strand in the second section 15b has two individual wires twisted together.
  • Another combination of the wire number of wire strands 16 in the first and second sections 15a, 15b is possible.
  • the number of individual wires 11 can be 24, 32, 48, 64 or 72.
  • the number of individual wires each of a wire strand 16 may be 2, 3, 4, 6 or 8 wires. This applies to both the first and the second section 15a, 15b, provided that the wire strands 16 of the second section 15b each comprise a plurality of individual wires 11.
  • the first portion 15a with the relatively coarse mesh extends in Fig. 4 to the right in the direction of the stent end.
  • the stent end may, for example, be in the form of loops or in the form of free stent ends.
  • An example of looped stent ends is disclosed in the applicant's DE 10 2009 006 180, which is not prepublished.
  • the second section 15b with the finer mesh may extend in the direction of the stent center.
  • a coarse-meshed section may be arranged corresponding to the first section 15a.
  • the lattice structure 12 is then symmetrical with respect to a central stent plane perpendicular to the longitudinal axis of the stent.
  • the restoring force is increased compared to the more fine-meshed braid of the second section 15b.
  • the first section 15a serves primarily to fix the stent in the vessel.
  • the fine-meshed second section can take on a different function, such as the coverage of an aneurysm, with less radial force and higher fine mesh.
  • the mesh or lattice structure 12 asymmetrically with respect to the various sections 15a, 15b.
  • the first portion 15a with increased radial force may be present on only one side.
  • the fine-meshed area that performs the main function of the mesh increases.
  • the first section 15a only at the proximal end of the stent, since the dimensions of a vessel generally increase in the proximal direction. There, the mesh is less compressed, causing the radial force drops accordingly. Therefore, the first increased radial force portion 15a is particularly effective in this range.
  • the first portion 15a with increased radial force can also be arranged only at the distal end of the stent.
  • the distal stent end is first pushed out of the catheter.
  • the good fixation of the first portion 15a with increased radial force in the vessel, the further positioning of the stent can be done safely without the grid structure 12 shifts when the stent is discharged.
  • the first portion 15a with increased radial force may assume different lengths or configurations at the two ends. As a result, a fine adjustment of the radial force along the braid is possible. It is also possible to change the radial force within the first section 15a. This is possible by changing the parameters number of twisted wires 11 per wire strand 16 or number of twists between two crossings 14.
  • crossings 14 at the twists or by crossovers 14, which only overlap, without being fixed to change the radial force in areas in the first section 15a.
  • FER ner the type of fixation, in particular the course of the wires in the crossing region 14 can be changed. Medical devices, or stents with these features are explicitly disclosed.
  • the mesh In the area of the fine-meshed second section 15b, the mesh consists of more than 24, 32, 48, 64, 72 wires braided, for example, in a 1-over-1 (diamond) or 2-over-1 or other braiding fashion, resulting in a correspondingly fine mesh Structure leads.
  • the wires In the second section 15b, the wires are not twisted in pairs or together with other wires, but extend one at a time, with all the wires equidistant from the adjacent wires.
  • the second section 15b has, for example, a length of at most 60, 50, 40, 30, 25, 18, 15, 12, 10, 8, 5 mm, the above-mentioned values forming upper limits.
  • the first section 15a or the two first sections 15a arranged laterally from the second section 15b have a length of between 1 and 11 mm, in particular between 2 and 8 mm, in particular between 3 and 6 mm, in order to ensure a good fixation of the stent in the vessel guarantee.
  • the length of the first section 15a may be more than 5, 8, 10, 12, 15, 20, 25, 30 mm , wherein the above values represent lower limits. It is possible to arrange the first section 15a only distally or only proximally.
  • the transition between the first portion 15a and the second portion 15b may be formed by other types of braids.
  • the second portion 15b may be in braid 1 over 2 (based on the individual wires) in the transition region between first and second portions 15a, 15b in braid 2 over 2 (with respect to the individual wires) and in first portion 15a 2 twisted over 2 (based on the single wire) or 1 over 1 (based on the wire strands) may be formed.
  • the number of twists between two crossovers 14 the radial force of the braid can be changed. A high number of twists increases the radial force. Between two crossovers 14 at least 1, 2, 3, 4, 5 or more twists are provided.
  • FIGS. 4 and 5 Another variation possibility of the lattice structure of the first section 15a may consist in that, as shown in FIGS. 4 and 5, some crossings 14 are fixed by interlacing and other crossings 14 are designed by overlapping without mechanical fixation.
  • the purely overlapping crossings 14 are also denoted by the reference numeral 14a and the intertwined crossovers.
  • gene 14 with the reference numeral 14b in Figs. 4, 5 denotes. In this way, it is possible to finely adjust the radial force and the flexibility of the stent in the region of the first portion 15a.
  • the braid is covered with a plastic layer, for example with a polyurethane layer.
  • the plastic layer anchors particularly well on the twisted wires due to the cavities between the two individual wires 11.
  • the interwoven wire strands 16 in the region of the crossovers 14 improve the anchoring of the plastic layer.
  • the application of the lattice structure 12 according to the above-mentioned embodiments is also possible with a basket, for example in a suction basket or in a filter whose wall consists of a grid mesh. The increased radial force achieves improved adhesion of the filter to the vessel wall and reduces the risk of a distal embolism.
  • a stent with a high vascular compliance by reinforcing the mesh according to the first section 15a in the middle stent region.
  • the edge regions or side regions of the stent are produced in a conventional manner with the associated reduced radial force.
  • the radial force gradually decreases at the braid ends.
  • This can also be achieved by changing the twisting parameters, for example by reducing the number of twists between two crossovers 14 or the number of intertwined crossovers 14 with respect to the stent center. This achieves a continuous radial force reduction to the stent ends and reduces pulsatile wave disturbance. The risk of re-stenosis is reduced.
  • the braid is released in the vessel according to the above-mentioned embodiments, this expands to the vessel wall.
  • the vessel lumen is smaller than the diameter of the braid or the lattice structure 12 in the idle state, so that the lattice structure 12 exerts the remaining restoring force radially on the vessel wall.
  • the lattice structure 12 remains in a radially partially compressed state. In this condition, the spirals forming the wire strands 16 are stretched in length.
  • the elastic deformation of the individual wires 11 forming the wire strands 16 The twisting of the individual wires 11 in the same direction as the wire strands 16 and thus also the wire strands 16 forming individual wires 11 in the braid (spiral direction) leads to a, which is in the form of a torsion high restoring force in the diameter compression or in the longitudinal stretching of the lattice structure 12 in the partially compressed state in the vessel. Due to the torque, the individual wires 11, which are twisted in each case into a wire strand 16, are further twisted, which leads to an elongation of all the wires 11 in the twisted wire strand 16. The force exerted on the individual wire is to a great extent an axial stretching force. This results in an increased restoring force, which in turn leads to an increased radial force in the vessel.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

L'invention concerne un appareil médical destiné à être introduit dans un organe creux du corps, ledit appareil présentant une paroi qui comprend une structure de grille sous forme de mailles, tressée de fils métalliques, pouvant passer d'un premier état comprimé à un second état étendu, les mailles de la structure de grille étant formées par les entrecroisements des fils métalliques agencés dans différentes des directions de spirale. L'invention est caractérisée en ce que, au moins dans la zone d'une première partie de la structure de grille, au moins deux fils métalliques sont torsadés chacun en un brin de fils métalliques, au moins deux brins de fils métalliques présentant chacun des fils métalliques torsadés étant entrelacés l'un avec l'autre pour la formation des mailles de la structure de grille.
PCT/EP2010/005732 2009-09-18 2010-09-17 Appareil médical destiné à être introduit dans un organe creux du corps Ceased WO2011032720A1 (fr)

Applications Claiming Priority (2)

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DE102009042121A DE102009042121B3 (de) 2009-09-18 2009-09-18 Medizinisches Gerät zum Einführen in ein Körperhohlorgan
DE102009042121.1 2009-09-18

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WO (1) WO2011032720A1 (fr)

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WO2014071837A1 (fr) * 2012-11-08 2014-05-15 先健科技(深圳)有限公司 Endoprothèse endoluminale autoexpansible tressée
CN105250058A (zh) * 2015-10-26 2016-01-20 先健科技(深圳)有限公司 管腔编织支架
WO2018078452A1 (fr) * 2016-10-27 2018-05-03 Rapid Medical Ltd. Dispositif intraluminal à fils tissés
CN115153953A (zh) * 2022-09-08 2022-10-11 深圳市华和创微医疗科技有限公司 三维编织支架、制作方法
CN116250962A (zh) * 2021-12-10 2023-06-13 深圳市先健呼吸科技有限公司 一种气道支架
CN116327461A (zh) * 2023-03-23 2023-06-27 上海励楷科技有限公司 双层编织支架
US11980380B2 (en) * 2016-12-18 2024-05-14 Rapid Medical Ltd. Controllable retriever with distal clot anchor

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DE102014107113A1 (de) * 2014-05-20 2015-11-26 Acandis Gmbh & Co. Kg Medizinische Vorrichtung und System
DK3370641T3 (da) * 2015-11-04 2020-11-23 Rapid Medical Ltd Intraluminal anordning

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Cited By (14)

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WO2014071837A1 (fr) * 2012-11-08 2014-05-15 先健科技(深圳)有限公司 Endoprothèse endoluminale autoexpansible tressée
US10743980B2 (en) 2015-10-26 2020-08-18 Lifetech Scientific (Shenzhen) Co. Ltd. Lumen woven support
CN105250058A (zh) * 2015-10-26 2016-01-20 先健科技(深圳)有限公司 管腔编织支架
AU2017349575B2 (en) * 2016-10-27 2022-11-17 Rapid Medical Ltd. Woven wire intraluminal device
CN109890323A (zh) * 2016-10-27 2019-06-14 急速医疗有限公司 编织丝线管腔内装置
WO2018078452A1 (fr) * 2016-10-27 2018-05-03 Rapid Medical Ltd. Dispositif intraluminal à fils tissés
CN109890323B (zh) * 2016-10-27 2023-09-12 急速医疗有限公司 编织丝线管腔内装置
US12016581B2 (en) 2016-10-27 2024-06-25 Rapid Medical Ltd. Woven wire intraluminal device
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US11980380B2 (en) * 2016-12-18 2024-05-14 Rapid Medical Ltd. Controllable retriever with distal clot anchor
CN116250962A (zh) * 2021-12-10 2023-06-13 深圳市先健呼吸科技有限公司 一种气道支架
CN115153953A (zh) * 2022-09-08 2022-10-11 深圳市华和创微医疗科技有限公司 三维编织支架、制作方法
CN115153953B (zh) * 2022-09-08 2023-01-03 深圳市华和创微医疗科技有限公司 三维编织支架、制作方法
CN116327461A (zh) * 2023-03-23 2023-06-27 上海励楷科技有限公司 双层编织支架

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