WO2004008991A1 - Medizinisches implantat - Google Patents

Medizinisches implantat Download PDF

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Publication number
WO2004008991A1
WO2004008991A1 PCT/EP2003/007926 EP0307926W WO2004008991A1 WO 2004008991 A1 WO2004008991 A1 WO 2004008991A1 EP 0307926 W EP0307926 W EP 0307926W WO 2004008991 A1 WO2004008991 A1 WO 2004008991A1
Authority
WO
WIPO (PCT)
Prior art keywords
implant
guide wire
microcatheter
filaments
implant according
Prior art date
Application number
PCT/EP2003/007926
Other languages
German (de)
English (en)
French (fr)
Inventor
Hans Henkes
Achim Flesser
Ronald Kontek
Jürgen SPEDER
Ralph Bodenburg
Original Assignee
Dendron Gmbh
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 Dendron Gmbh filed Critical Dendron Gmbh
Priority to EP03765067.8A priority Critical patent/EP1542617B1/de
Priority to JP2004522529A priority patent/JP4919217B2/ja
Priority to AU2003254553A priority patent/AU2003254553A1/en
Priority to CA002492978A priority patent/CA2492978A1/en
Publication of WO2004008991A1 publication Critical patent/WO2004008991A1/de
Priority to US11/039,066 priority patent/US7300458B2/en
Priority to US11/935,252 priority patent/US8632584B2/en
Priority to US14/136,281 priority patent/US10342683B2/en
Priority to US16/420,814 priority patent/US11426293B2/en

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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
    • 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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
    • A61B17/12113—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm
    • A61B17/12118—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm for positioning in conjunction with a stent
    • A—HUMAN NECESSITIES
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    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/221—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
    • A—HUMAN NECESSITIES
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    • 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
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    • 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
    • A61F2/91—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 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
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    • 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
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    • 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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A—HUMAN NECESSITIES
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    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B2017/1205—Introduction devices
    • A61B2017/12054—Details concerning the detachment of the occluding device from the introduction device
    • A61B2017/12063—Details concerning the detachment of the occluding device from the introduction device electrolytically detachable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
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    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/221—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
    • A61B2017/2215—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions having an open distal end
    • A—HUMAN NECESSITIES
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    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/3006—Properties of materials and coating materials
    • A61F2002/3008—Properties of materials and coating materials radio-opaque, e.g. radio-opaque markers
    • A—HUMAN NECESSITIES
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    • 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
    • A61F2/91—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 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915—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 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/91525—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 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other within the whole structure different bands showing different meander characteristics, e.g. frequency or amplitude
    • 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
    • A61F2/91—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 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915—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 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
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    • 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
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    • 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
    • A61F2/91—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 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
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    • A61F2002/9155—Adjacent bands being connected to each other
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    • A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
    • A61F2250/0098—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers radio-opaque, e.g. radio-opaque markers

Definitions

  • the invention relates to a medical implant which is preformed to take a superordinate structure at the implantation site, but is present in a reduced-volume form during insertion.
  • the invention further relates to the use of this implant as a neurostent, its combination with a guide wire and a system for using such implants in the treatment of aneurysms or other vascular malformations.
  • vascular constrictions stenoses
  • stents vascular endoprostheses, vascular supports
  • vascular lumen open there due to their inherent rigidity.
  • stents for closing vascular wall sacks (aneurysms) or fistulas.
  • balloon-dilatable stents are used. These are crimped onto an unexpanded balloon for insertion in a non-dilated state, guided to the site to be treated via a catheter system and dilated there by expanding the balloon and thus anchored in the vessel. Since no elaborate support and sheathing is necessary to insert balloon-dilatable stents, they can also be inserted into very fine vessels. It is problematic, however, that due to their plastic deformability, they can simply be compressed by external pressure. Another disadvantage is that they For anchoring by means of high pressure, it must first be expanded to the extent that they ultimately take up. This widening to the extent necessary entails the risk of vascular injury, which can lead to the formation of thrombi.
  • stents made of shape memory material which are initially in the form of an elongated filament and only when the catheter emerges through the change in temperature or the elimination of the constraint previously exerted from the catheter, the tubular structure of a stent accept.
  • DE 197 03 482 A1 it is known to use a stent made of two elongated filaments for the treatment of aneurysms and the like, which are kept in the elongated form due to the mechanical constraint of the strand and, after this constraint is removed, when pushed out the catheter, take the actual stent shape. This made it possible for the first time to use stents with shape memory properties, even in very small-lumen vessels, as a result of the intracranial and cerebral vascular branches.
  • these stents which are well suited for certain purposes, have a number of disadvantages, including their relatively difficult displaceability in the catheter and the fact that it cannot be returned to the catheter, the latter in the event of incorrect placement. Also, due to its very filigree structure, the stent is not very suitable for covering sacks and fistulas in the vessels in such a way that occlusion agents placed in them are retained.
  • the object of the invention is to provide implants which can also be introduced into small-lumen intracranial vessels through conventional microcatheters, are easy to position and reposition, can be returned to the microcatheter if necessary, and are suitable for bridging vascular sacs and fistulas so that they can be filled with occlusion agents.
  • implants that can adapt relatively freely to the vascular caliber, i. H. are not made to a special vessel caliber.
  • a medical implant of the type mentioned at the outset which has the shape of a longitudinally open tube with webs or filaments connected to one another to form a mesh structure, which converge on one side to form a tapering structure in a connection point.
  • the implant according to the invention consists of a flat object which, owing to the superordinate superimposed on it
  • Structure takes the form of a slit tube or hose, the free legs preferably overlap. In its reduced-volume form, it is further rolled up, ie the diameter of the implant in its reduced-volume form is significantly reduced compared to that of the superordinate structure. After the implant has been released, it tries to adopt the structure imprinted on it and expands as far as the vessel surrounding the implant allows. This expansion in the manner of an expanding spiral spring leads to an automatic adaptation of the implant to the vessel caliber or lumen in such a way that it can be used in vessels of different calibres. In the case of narrow vessels, this results in a relatively strong overlap of the two free legs, in the case of wide vessels a slight overlap or a gap which remains free, which may even be desired in the case of vascular branches.
  • the implant itself has a mesh structure made of interconnected webs or filaments. Bridges occur when the implant has cut structures, such as are often used for example in coronary stents, a mesh structure made of filaments when the implants are in the form of mats with a knitted or braided structure or made of individual filaments welded together.
  • the implant is a surface structure that is rolled into a longitudinally open tubular structure that can fit tightly against the wall of the vessel to be loaded with it.
  • the webs or filaments converging on one side into a tapering structure in a connection point allow the implant, which is still connected to a guide wire, to be pulled back into the catheter in the event of an incorrect placement or inadequate adaptation to the implantation location, in order to replace it with another implant or to replace it Reposition the catheter to implant again. Due to the tapered structure, the implant rolls closer together when it enters the microcatheter and takes on its reduced-volume shape again, whereby the tensile force of the guide wire and the forces exerted by the edge of the catheter interact. In the catheter itself, the implant is in its reduced-volume form, like rolled-up wire mesh.
  • connection point of the medical implant at the end of the tapered structure is also the connection point to the guide wire, either directly or via a connection element.
  • this is the point at which the webs of the implant converge.
  • a mesh structure composed of individual filaments at least two filaments converge there and are connected to one another by welding or crimping.
  • connection point is at the same time a connection element or a part thereof, which remains on the implant after the implant has been detached from the guide wire. It may be expedient to arrange this connection point in a platinum spiral or to connect it via a platinum spiral to a connecting element which can simultaneously serve as a radiopaque marker during positioning. Electrolytically corrodible connecting elements, as described for example in DE 100 10 840 A1, are particularly preferred. Such connecting elements make it possible to detach the implant from the guide wire after it has been correctly positioned by briefly acting on the current for, for example, 10 to 60 s.
  • the medical implant consists of a flat structure that rolls up into a tube due to the superordinate structure specified for it.
  • the free legs of the implant preferably overlap at least slightly.
  • the implant itself can consist of a film which is provided with the corresponding web patterns, for example by laser technology.
  • the web width is, for example, 0.05 to 0.2 mm.
  • the manufacturing technique is the same as that used for tubular coronary stents.
  • expanded metal foils can also be used, the web widths being of the same order of magnitude. It is preferred here to smooth the film afterwards so that all of the webs are in one plane.
  • the film thickness is usually in the range of 0.02 to 0.2 mm.
  • the larger film thicknesses also permit use in other areas, for example as coronary stents or in other areas of the body, for example in the bile duct or in the ureter.
  • the mesh size is usually in the range of 0.5 to 4 mm and can vary within an implant. The same applies to the web width. It is generally preferred to use larger mesh sizes and lengths and / or larger web widths or thicker filaments in the area of the taper. In the area of the tapered structure, a particularly great support and covering of the vessel wall is generally not required, on the other hand increased tensile and shear strength.
  • filaments When using mesh structures based on filaments, knitted or knitted structures can be used, as can filaments connected by welding.
  • the filament thicknesses are generally in the range from 0.01 to 0.1 mm and preferably from 0.02 to 0.076 mm. What has already been said above applies to the mesh sizes.
  • the mesh structure consists of individual filaments welded together, a laser welding technique is preferably used.
  • a mesh of individual filaments braiding, knitting or knitting techniques known per se are used, as are known, for example, from wire mesh production or textile technology.
  • Meshes are particularly preferred which have an active structure which, due to the production process, leads to rolled-up edges, because in this way the required superordinate structure can be produced via the active method.
  • An active structure known to the textile specialist as "fluff" is particularly preferred.
  • a particular advantage of the medical implants according to the invention over conventional expandable stents is that there is no longer any contraction in length when adapting to the vessel to be loaded.
  • the longitudinally open structure with the specified "winding" has no influence on the length of the stent.
  • the film structures themselves have also proven to be extremely dimensionally stable during positioning under shear and pulling effects. The same applies to the active structure and the mesh structure made of welded individual filaments ,
  • Filaments can also be used which consist of a braid of individual strands, i.e. represent a rope. Braids made from 12 to 14 strands with a total thickness of 0.02 mm have proven to be useful.
  • Such alloys are, for example, titanium and nickel-containing alloys, which have become known under the name Nitinol, iron-based or copper-based alloys.
  • Shape memory properties can be based on a stress-induced martensitic transformation as well as on a temperature-induced martensitic transformation or combinations of the two.
  • Platinum, platinum alloys, gold and stainless steel are particularly suitable as materials for the filaments.
  • all permanent implant materials in medical technology that have the required properties can be used.
  • the implants according to the invention in particular also have radiopaque markers which allow monitoring of the positioning and implantation.
  • Spirals arranged proximally, in particular at the connection point of the webs or filaments, can serve as such markers.
  • Radiopaque markers are preferably also located at the distal end of the implant, in particular in the form of worked into the mesh structure or platinum or platinum / iridium elements attached to the mesh structure.
  • the meshes of the implant according to the invention can be provided distally with an eyelet or run out to an eyelet in which the marker element is arranged flush with the surface.
  • the invention further relates to the combination of the implant described above with a guide wire which has the implant releasably arranged at its distal end.
  • Solubility is brought about in particular by an element which can be corroded by the action of current, as is known from the prior art.
  • the guidewire is an otherwise customary guidewire that is suitable for both pushing the implant through a catheter for use and also pulling it back into the catheter in the event of incorrect positioning.
  • the corrosion site can also lie in the area of the guide wire itself or be based on a mechanical or thermal detaching technique known per se.
  • the invention also relates to a system for use in the treatment of aneurysms or other vascular malformations, which has a first microcatheter, a first guidewire for placement of the first microcatheter, a second guidewire which is intended to guide the implant through the first microcatheter to transport and place and the implant, which is detachably arranged at the distal end of the second guide wire.
  • the rolled-up structure of the implant and the combination with the guide wire make it possible to remove the first guide wire after placement of the first microcatheter and to insert and handle the second guide wire with the implant. Previous implants of this type were always placed using a so-called pusher technique, in which the retrieval of the implant was generally not possible.
  • the system additionally has a second microcatheter, which is designed and intended for the second
  • the first microcatheter is a microcatheter which is customary per se and is widely used in neuradiology, for example with a diameter / caliber of 0.51 mm (20 mil) to 0.36 mm (14 mil).
  • the system can also have conventional electrical devices for electrolytically detaching the implant from the guide wire at a detachment point provided for this purpose.
  • Fig. 1 An implant according to the invention with a
  • FIG. 3 shows a third embodiment of a stent according to the invention with a honeycomb structure
  • Fig. 5 a stent according to the invention together
  • the implant according to FIG. 1 consists of a mesh or honeycomb structure, which in the present case consists of a plurality of filaments which have been connected to one another with the aid of laser welding technology.
  • the implant is divided into an actual functional part A and the tapered proximal structure B, which u. a. differ by a different mesh size.
  • the meshes 3 are relatively narrow in the functional part A, so that they are suitable for retaining occlusion spirals arranged in an aneurysm.
  • the tapered proximal part B of the implant there is a wide mesh structure 4 which has been optimized for a minimal occlusion effect.
  • the filaments preferably have a greater thickness in order to be able to better transmit the thrust and tensile forces of the guidewire which are applied at the connection point 5 when the implant is placed on the functional part A.
  • Filament thicknesses in functional part A are generally on the order of 0.02 to 0.076 mm in part B 0.076 mm and above.
  • the proximal part B preferably forms an angle of 45 ° to 120 °, in particular approximately 90 °, in the connection point 5.
  • the filament thickness (or web width) as well as the mesh size and shape can vary widely depending on the requirements for stability, flexibility and the like. It goes without saying that the proximal part also leans against the vessel wall and does not hinder the blood flow in the vessel.
  • the filaments 2 run out into a series of “tails” 6 that are suitable for carrying platinum markers that facilitate the positioning of the implant.
  • the implant 1 is rolled up so that the edges 7 and 8 are at least close to one another, preferably even overlap in the edge area.
  • the implant 2 is rolled up in the form of a wire mesh roll to such an extent that the roll formed can be easily inserted into a microcatheter and moved therein.
  • the rolled-up structure After release from the microcatheter, the rolled-up structure jumps open and tries to take on the superimposed structure imprinted on it and thereby lies closely against the inner wall of the vessel to be acted upon, whereby a fistula, branching of the vessel or an aneurysm present there are covered superficially.
  • the degree of "rolling up” is determined by the volume of the vessel; in narrower vessels there is a greater overlap of the edges 7 and 8 of the implant 1, in wide vessels a slight overlap or even undercoverage, whereby care must be taken to ensure that the implant still has a residual voltage.
  • Alloys with shape memory properties are suitable as materials.
  • the finished product is annealed at the temperatures customary for the material, so that the embossed structure is fixed.
  • FIG. 2 shows a further embodiment of a stent 1 according to the invention with the honeycomb structure already described above, in which the tapering proximal part B is connected to the functional part A by additional filaments 9 in the peripheral region 10 and in the central region.
  • the additional filaments 9 and 10 effect a more uniform transmission of tensile and shear forces from the proximal structure B to the functional part A, so that the tensile forces can be better transmitted by retracting into the microcatheter, in particular if the stent has to be repositioned. This makes it easier to roll up the stent again. In the same way, the transfer of thrust forces when the stent is extended and deployed is facilitated and gently released. Otherwise, the same numbers designate the same positions.
  • FIG. 3 shows a further embodiment of a stent 1 according to the invention with a honeycomb structure in which the edges 7 and 8 are formed by filaments 9 which run essentially in a straight line.
  • the thrust or pressure exerted by the guide wire via point 5 is transmitted very directly to the edges 7 and 8 of the functional stent part A, which further reinforces the effect described with reference to FIG.
  • Laser cutting techniques for producing stents with a tubular structure are known and have been described many times.
  • the processing of a film to produce a pattern suitable for a stent proceeds accordingly.
  • the superimposed structure is stamped in the same way as for the filament.
  • Films processed with cutting technology are preferably electrochemically reworked to remove burrs and other irregularities, to smooth the surface and to round edges.
  • Such processing methods of an electrochemical nature are known to the person skilled in the art and are already being used to a large extent in medical technology.
  • the stents according to the invention which are based on two-dimensional geometries and to which a three-dimensional structure is only imprinted later, are fundamentally easier to manufacture and process than the classic “tube” stents, which are already produced in a three-dimensional one Structure in place and require correspondingly complex processing methods / devices.
  • the mesh structure of the implant according to the invention can consist of a mesh of individual filaments.
  • Such a knitting structure is shown in FIG. 4, in which the individual filaments 2 are knitted into individual stitches 3 of a stitch structure 11 in the manner of a right-hand knitted fabric.
  • Such right and left hand knitted fabrics are produced in a known manner from a row of needles.
  • the right-left fabric has two different-looking fabric sides, the right and the left stitch side.
  • a right and left knitted fabric is not very elastic in the transverse direction and is very light. It is particularly advantageous that the product edges of such a knitting structure roll up, as is the case, for example, with the "fluff", which is advantageous for the higher-level structure and the intended use required here. In this case, the higher-level structure can be impressed using the active method. Alternatively and additionally, the use of shape memory alloys is also possible and sensible.
  • the implants according to the invention are extremely small in size - for example with a size of 2 x 1 cm - it has proven to be advantageous to produce the implants from textile, non-metallic filaments, for example in the form of a conventional knitted fabric or knitted fabric an edge made of the respective metallic filaments, which is either worked on or from which the knitted or knitted fabric originates.
  • the arrangement of the metallic part of the knitted fabric or knitted fabric on the edge is important in order to achieve the curling effect.
  • the non-metallic textile parts of the active structure are then removed by ashing, chemical destruction or dissolution in a suitable solvent.
  • FIG. 5 shows a combination of a guide wire 21 with an implant 1 attached to it, which consists of individual filaments 2 welded together.
  • the distal ends 6 and the connection point 5, at which the filaments of the implant converge in the tapered structure and which simultaneously establishes the connection to the guide wire 21, can be clearly seen.
  • the guide wire 21 is guided into a microcatheter 22, which is a conventional product.
  • the implant 1 By moving the guide wire 21 in the catheter 22, the implant 1 is pushed out or drawn in.
  • the mesh structure seeks to take on the superordinate structure given to it, when it is pulled in, the mesh structure rolls or folds up again according to the spatial conditions in the microcatheter. Due to the stiffness of the mesh structure, the implant can be moved back and forth almost arbitrarily over the guide wire 21 until it has found its optimal arrangement in the vascular system.
  • FIG. 6 schematically shows an implant according to the invention in its superordinate form and in its reduced-volume form.
  • the implant 1 forms an annular structure with a slight overlap of the edges 7 and 8.
  • the illustration shows the implant 1 from its proximal end in a top view, with the connection point 5 approximately opposite to the edges 7 and 8.
  • the guide wire 21 follows at the connection point 5.
  • FIG. 6a shows the same implant in its reduced-volume form as it is arranged, for example, rolled up in a microcatheter.
  • the structure is maintained in the reduced volume form by the microcatheter 22; when the implant 1 is pushed out of the microcatheter 22, the latter jumps to the expanded form of FIG. 6a, comparable to a spiral spring.
  • FIG. 7a shows a marker element 12 suitable for the implants according to the invention, as can be used at the distal end of the implant 1.
  • the marker element 12 consists of an “eyelet” 13, which has a marker plate 15 made of a radiopaque material, for example platinum or platinum-iridium, in its interior (in the plane of the implant, without protruding elements).
  • the marker plate 15 is also a part of laser welding techniques the surrounding implant structure.
  • FIG. 7b gives an example of the arrangement of the marker elements 12 at the distal end of the implant 1 (see position 6 in FIG. 1).
  • FIG. 8 shows schematically two variants of a detachment point 8a and 8b, via which the implant according to the invention is detachably connected to a guide wire.
  • the separation point 23 consists of a dumbbell-shaped element that dissolves under the influence of current when it comes into contact with an electrolyte.
  • the dumbbell-shaped element 23 according to FIG. 8a has a spiral structure 25 on its proximal (guide wire side) end, which cooperates with a reinforcement spiral 26 of the guide wire.
  • a spherical element 27 which is connected by laser welding technology to a platinum spiral 28, which in turn is connected to the connection point 5 at the proximal end of the implant.
  • the platinum spiral 28 also serves as a proximal radiopaque marker of the implant 1.
  • a reinforcing wire 29 can be useful for strengthening the connection between the spherical element 27 and the connection point 5.
  • the platinum spiral 28 can also be designed so that it can withstand the tensile and thrust forces exerted on it.
  • the detachment element 23 which is susceptible to corrosion under the influence of current in an electrolyte. Structural or chemical weakening of the barbell makes sense, for example by grinding or thermal treatment, to accelerate corrosion and reduce the peeling time.
  • the area of the dumbbell 23 accessible to the electrolyte has a length of 0.1 to 0.5 mm, in particular 0.3 mm.
  • the spiral structure 25 is connected to the dumbbell-shaped element 23 as well as to the reinforcement spiral 26 of the guide wire 21 via welding points.
  • the guide wire 21 itself is slidably mounted in the microcatheter 22.
  • Fig. 8b shows a second embodiment, which differs from that of Fig. 8a in that the hand-shaped element 23 has at both ends a spherical element 27, which in turn distally with the connection point 5 of the implant and proximally with the guide wire 21 via spirals 28 and 26 are connected.
  • release principles can be used, such as those based on mechanical principles or based on the melting of plastic compounds.

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EP03765067.8A EP1542617B1 (de) 2002-07-19 2003-07-21 Kombination eines medizinischen Implantats und eines Führungsdrahts
JP2004522529A JP4919217B2 (ja) 2002-07-19 2003-07-21 医用移植物
AU2003254553A AU2003254553A1 (en) 2002-07-19 2003-07-21 Medical implant
CA002492978A CA2492978A1 (en) 2002-07-19 2003-07-21 Medical implant
US11/039,066 US7300458B2 (en) 2002-07-19 2005-01-19 Medical implant having a curlable matrix structure
US11/935,252 US8632584B2 (en) 2002-07-19 2007-11-05 Medical implant having a curlable matrix structure and method of use
US14/136,281 US10342683B2 (en) 2002-07-19 2013-12-20 Medical implant having a curlable matrix structure and method of use
US16/420,814 US11426293B2 (en) 2002-07-19 2019-05-23 Medical implant

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DE10233085.9A DE10233085B4 (de) 2002-07-19 2002-07-19 Stent mit Führungsdraht
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ES2552907T3 (es) 2015-12-03
JP5091985B2 (ja) 2012-12-05
US20080125855A1 (en) 2008-05-29
EP2415424B1 (de) 2014-11-26
CA2492978A1 (en) 2004-01-29
EP1542617B1 (de) 2016-09-14
EP1542617A1 (de) 2005-06-22
JP2005532887A (ja) 2005-11-04
AU2003254553A1 (en) 2004-02-09
US7300458B2 (en) 2007-11-27
US20140371839A1 (en) 2014-12-18
EP2781196A3 (de) 2014-11-12
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JP4919217B2 (ja) 2012-04-18
US11426293B2 (en) 2022-08-30
EP2415424A2 (de) 2012-02-08
US10342683B2 (en) 2019-07-09
US20190307585A1 (en) 2019-10-10
ES2527836T3 (es) 2015-01-30
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US20050209678A1 (en) 2005-09-22
US8632584B2 (en) 2014-01-21
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EP2781196A2 (de) 2014-09-24
DE10233085B4 (de) 2014-02-20

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