WO2008061759A1 - Pièce constituée d'éléments de treillis - Google Patents

Pièce constituée d'éléments de treillis Download PDF

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Publication number
WO2008061759A1
WO2008061759A1 PCT/EP2007/010137 EP2007010137W WO2008061759A1 WO 2008061759 A1 WO2008061759 A1 WO 2008061759A1 EP 2007010137 W EP2007010137 W EP 2007010137W WO 2008061759 A1 WO2008061759 A1 WO 2008061759A1
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WO
WIPO (PCT)
Prior art keywords
braid
elements
mesh
component
component according
Prior art date
Application number
PCT/EP2007/010137
Other languages
German (de)
English (en)
Inventor
Gottfried Hans Buchhorn
Jörg WELLNITZ
Wolfgang Schultz
Original Assignee
Georg-August-Universität Göttingen Stiftung Öffentlichen Rechts
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 Georg-August-Universität Göttingen Stiftung Öffentlichen Rechts filed Critical Georg-August-Universität Göttingen Stiftung Öffentlichen Rechts
Publication of WO2008061759A1 publication Critical patent/WO2008061759A1/fr

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Classifications

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    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/80—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
    • A61B17/8085—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates with pliable or malleable elements or having a mesh-like structure, e.g. small strips
    • A—HUMAN NECESSITIES
    • A41—WEARING APPAREL
    • A41D—OUTERWEAR; PROTECTIVE GARMENTS; ACCESSORIES
    • A41D31/00—Materials specially adapted for outerwear
    • A41D31/04—Materials specially adapted for outerwear characterised by special function or use
    • A41D31/24—Resistant to mechanical stress, e.g. pierce-proof
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    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/80—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
    • A61B17/8061—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates specially adapted for particular bones
    • A61B17/8066—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates specially adapted for particular bones for pelvic reconstruction
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    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B21—MECHANICAL METAL-WORKING WITHOUT ESSENTIALLY REMOVING MATERIAL; PUNCHING METAL
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    • B—PERFORMING OPERATIONS; TRANSPORTING
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    • B21F—WORKING OR PROCESSING OF METAL WIRE
    • B21F33/00—Tools or devices specially designed for handling or processing wire fabrics or the like
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F41—WEAPONS
    • F41H—ARMOUR; ARMOURED TURRETS; ARMOURED OR ARMED VEHICLES; MEANS OF ATTACK OR DEFENCE, e.g. CAMOUFLAGE, IN GENERAL
    • F41H1/00—Personal protection gear
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    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F41—WEAPONS
    • F41H—ARMOUR; ARMOURED TURRETS; ARMOURED OR ARMED VEHICLES; MEANS OF ATTACK OR DEFENCE, e.g. CAMOUFLAGE, IN GENERAL
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    • F41H5/02—Plate construction
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    • A61B17/82—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin for bone cerclage
    • A61B17/826—Nets or webs
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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
    • A61F2/02—Prostheses implantable into the body
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    • A61F2210/0014—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol
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    • A61F2210/0019—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol operated at only one temperature whilst inside or touching the human body, e.g. constrained in a non-operative shape during surgery, another temperature only occurring before the operation
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    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
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    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
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Definitions

  • the invention relates to a component with a mesh of a plurality of interlocking, separately integral braid elements. According to a second aspect, the invention relates to a method for producing a component.
  • Braided components are known, for example, from JP 2004 347 294 A.
  • the braids serve in the components for absorbing tensile forces, in particular local tensile forces.
  • such braids are used in protective gloves and protective vests for cutting and puncture protection.
  • Another application for such braids are fishing nets, for example, in alpine winter sports, as they can absorb large tractive forces and at the same time are sufficiently flexible to avoid injuries in athletes who drive at high speed in such a safety net.
  • a disadvantage of such components is that they must always comprise a suspension or a support matrix for the braid. Such braids can namely only be charged to train and fall without suspension or support matrix together.
  • the invention has for its object to overcome said disadvantages in the prior art.
  • the invention solves the problem by a generic component in which individual integral braid elements, each as a separate, by integral
  • a method of fabricating a component comprising the steps of: a) providing one of a plurality of intermeshing mesh elements, each being separate, by integrally connecting portions of the individual Wicking element closed elements are executed, built-up, in any direction of space unstable braid b) aligning the braid elements of the braid in a predetermined shape and c) connecting braid elements so that the braid is shearing stable in at least one spatial direction.
  • An advantage of the invention is that components are provided which can be made entirely of braid and yet manage without suspension or support matrix. Such components can be brought into almost any shape due to the deformability of a braid whose braid elements are not connected to each other. This bringing into shape preferably takes place according to a predetermined shape, as further explained below.
  • the shaping can be done before the connection of the mesh elements with each other.
  • By a suitable connection so components can be produced in almost any geometric shape.
  • free-form surfaces can be produced which have very small curve radii on their surface. This allows body edges whose included angle is smaller than the minimum bending radius of the base material of the mesh elements.
  • Another advantage of a component according to the invention is that an open porosity is adjustable. This is particularly favorable in those cases in which the component is used, for example, as a human or veterinary implant in which the body's own cells are to be sprouted.
  • the porosity of the component can be varied in a simple manner by the choice of the geometric shape and spatial arrangement of the mesh elements.
  • components according to the invention can be produced very quickly. Braids, which serve as a base material for components according to the invention, are also obtained mechanically quickly and inexpensively and therefore can be easily kept in stock, which further shortens the production time of components according to the invention.
  • a further advantage of the invention is that components according to the invention can be produced in such a way that they have a predetermined modulus of elasticity. This makes them particularly suitable for use as medical implants. If, for example, a conventional implant is implanted in a bone, for example, by an operation, mechanical loading of the bone and implant results in a relative displacement between the two. This may loosen the implant, requiring reoperation.
  • a component according to the invention used as an implant can be manufactured in such a way that its modulus of elasticity comes very close to that of the bone, so that it deforms similarly under load as the bone surrounding it.
  • the disadvantages of known implants described above are thus reduced.
  • the braid elements can also be connected in such a way that the component has a (space-dependent) (anisotropic) electricity modulus.
  • Another advantage of the invention is that components according to the invention are easily subsequently deformable. So it is easily possible to correct any manufacturing errors later. In the obtained flat or complex three-dimensional body, compression without deformation can only take place by displacement of the mesh elements and into one another.
  • the component according to the invention overcomes the risk that in the
  • a braiding is understood to mean, in particular, a two-dimensional or macroscopic structure which is stable in every direction of its surface extent against tension. However, it is not necessary that the mesh be flat. It is possible to fabricate the mesh three-dimensionally and then to connect individual mesh elements so that the three-dimensional shape is obtained and strengthened.
  • integral connection is understood to mean a connection in which two sections are connected in such a way that they form a whole.
  • the sections may have an end-to-end connection, e.g. when forming a ring, or the sections may go beyond the closed structure.
  • This bonding can be accomplished by providing, in part, the braid elements can also be made as a whole.
  • the integral connection does not mean simply abutting the two sections or twisting the sections.
  • An integral braid element is one that, eventually, has an entire element.
  • the component may, but not necessarily, include other components besides the braid, such as fasteners for securing the component to a bone.
  • other components besides the braid such as fasteners for securing the component to a bone.
  • the feature that individual intrinsically connected mesh elements are connected to one another is to be understood in particular as meaning that the mesh elements are rigidly coupled to one another in pairs or are fastened to a common, rigid or rigid body ,
  • the braid is shear stable in two spatial directions, in particular it is dimensionally stable.
  • the braid is dimensionally stable, in particular, if it initially deforms elastically only by applying an external force at any point and then, when the external force is no longer applied, assumes the previous form again.
  • the mesh elements are joined together by joining.
  • Joining is understood in particular to mean the joining designated in DIN 8593, for example soldering, gluing or welding. Preference is given to laser welding or inductive welding.
  • the braid elements may also be connected by separate fasteners such as brackets, clips, or clamps.
  • Braided elements are preferably connected to one another via at least one connecting element, which is not a braid element.
  • Such connecting elements are preferably rods, wires, plates and / or three-dimensional rigid bodies.
  • the connecting elements can form a mesh arranged on the mesh.
  • the braid elements are connected to the connecting elements, for example by welding, plugging or mechanical fastening means.
  • individual mesh elements are joined exclusively to one another, that individual mesh elements are connected to other mesh elements exclusively via connecting elements, and that individual mesh elements are connected both by joining and by connecting elements.
  • the braid elements are formed so that the braid or the material from which the braid is created has osteoconductive properties. By this is meant that the mesh, when joined to a living human or animal bone, stimulates bone cells to sprout into the mesh.
  • the braid for human bone cells is osteoconductive.
  • the component can be used particularly well as a permanent implant for replacing lost bone material. It can then be used particularly well as an individual implant as a bone substitute for expansive destruction, which, for example, by tumors, infections, aseptic loosening of joint implants, etc. arise.
  • Such components serving as an implant are particularly suitable for the skull, for the shoulder blade, for the pelvis, the lower jaw, the zygomatic bone and the kneecap.
  • the braid elements are rings. Such braids are particularly easy and therefore inexpensive to manufacture and process.
  • the mesh elements are oval or angular.
  • the braid elements are produced, for example, by forming and disposing, such as welding, bar elements, such as wires. In this case, the connection can be made by having an end-to-end connection on the end sides of the end sections. Alternatively, the joining of two sections of the bar elements can take place, with the sections overlapping each other.
  • a mesh element is connected to four other mesh elements.
  • Such braids are referred to as 1: 4 braids.
  • a mesh element is connected to six or eight mesh elements, respectively, or two mesh elements each are connected to six or eight other mesh elements.
  • Such braids are also referred to as 1: 6, 1: 8, 2: 6 or 2: 8 braids.
  • the mesh elements are at least partially absorbable. By this is meant that, when a component has been implanted in a human or animal body, the mesh elements are at least partially degraded by the body.
  • Corresponding braid elements include, for example, magnesium or resorbable polymers or consist thereof.
  • the mesh elements are at least partially non-absorbable.
  • the parts of the mesh members which are to be non-absorbable are preferably made of a material selected from the group consisting of: titanium, cobalt, iron, alloys of the above metals, tantalum, shape memory alloys, and biocompatible polymers.
  • individual parts of the braid are preferably absorbable, whereas other parts of the braid are not absorbable.
  • At least a part of the mesh elements is at least partially coated with titanium, tantalum and / or hydroxyapatite.
  • the component is designed to be implanted in an animal or human body.
  • it is provided or coated in particular with bone substitutes and / or pharmacologically active substances.
  • bone substitutes and / or pharmacologically active substances include, for example, pluripotent cells, bone marrow cells or bone chips, which promote the sprouting of bone into the component.
  • the braid is at least partially coated with growth factors that promote bone ingrowth.
  • the braid is at least partially coated with active substances which reduce and suppress bone ingrowth.
  • a method according to the invention is preferably carried out such that, prior to joining braid elements, the braid is arranged in such a way that it assumes a three-dimensional shape.
  • the mesh may be aligned on a three-dimensional model made by rapid prototyping. Possibilities of arranging or aligning are laying on or clamping.
  • the mesh is stretched in a frame so that it takes on the desired shape.
  • the braid arranged in this way can then be processed, for example by laser welding, so that it permanently assumes a predetermined three-dimensional shape. According to the invention, therefore, a three-dimensional body is formed from the two-dimensional braid.
  • FIG. 1 shows a mesh of rings (ring mesh) for producing a component according to the invention
  • FIG. 2 shows the ring mesh according to FIG. 1, which has been locally compressed
  • Figure 3 shows the ring mesh of Figure 1, in the braid elements on
  • FIG. 4 shows the ring mesh according to FIG. 1, which has been placed on a model of a hip joint near section of a thigh in order to carry out a method according to the invention
  • FIG. 5 shows a sketch of a human pelvis into which a component according to the invention is to be implanted as part of a method according to the invention
  • FIG. 6 a an exploded view of a component according to the invention in the form of an implant
  • FIG. 6b shows the component according to FIG. 6a in an assembled arrangement
  • FIG. 6c the component according to Figures 6a and 6b in the state in which it is connected to the remaining basin.
  • FIG. 1 shows a braid 10 which is constructed from a plurality of interlocking, closed braid elements 12a, 12b,....
  • a mesh element is connected to four other mesh elements.
  • the braid member 12a is connected to the four braid members 12b, 12c, 12d and 12e.
  • the individual braid elements which are designed as separate elements which are closed by integral connection of sections of the individual braid element, 12a, 12b,..., are connected to one another only by their meshing, so that two braid elements can be displaced relative to one another to some extent.
  • the braid member 12a may be moved towards the braid member 12b without the braid member 12b having to deform or move.
  • the braid 10 is therefore unstable in any spatial direction x or y.
  • the braid 10 shown in Figure 1 is formed flat or macroscopically two-dimensional. By macroscopic two-dimensional, it is to be understood that although the braid 10 has a three-dimensional structure in the strict mathematical sense, the relevant properties relate only to two dimensions.
  • the mesh 10 extends both in the two spatial directions x and y, which are predetermined in Figure 1 by the paper plane, as well as in the protruding from the paper plane third spatial direction z.
  • exclusively braids 10 are described, which in this sense are flat or macroscopic two-dimensional. In alternative embodiments of the invention, however, the use of three-dimensional braids is possible. In this case, individual regions of the braid 10 are connected to other, spatially-spaced or remote regions of the braid via additional braid elements.
  • FIG. 2 shows the braid 10 according to FIG. 1 in the state in which it has been locally compressed in two spatial directions.
  • the upsetting creates two overlapping regions of increased braid density 14a and 14b, in which the braid is one-dimensionally compressed.
  • the mesh elements lie closer together than in the arrangement shown in FIG. In the area shown in the middle in Figure 3, the mesh is compressed two-dimensionally.
  • FIG. 3 shows a braid 10 in which individual braid elements are interconnected by connecting elements 16a, 16b,... And 18a, 18b,.
  • the connecting elements 16a, 16b, ... are perpendicular to the connecting elements 18a, 18b,.
  • these connecting elements may consist of welded-on additive and then also follow the points of contact of the braid elements of a deliberately deformed braid.
  • the arrangement of the connecting elements can be made according to the mechanical requirements.
  • the mesh element 12a is connected to both the connecting element 16b and the connecting element 18b by joints in the form of laser welding points.
  • the mesh member 12c is exclusively connected to the connection member 18b
  • the mesh member 12d is connected exclusively to the connection member 16b
  • the two mesh members 12b and 12e are both connected to the connection members 16b and 18b, respectively. Because the braid elements 12a to 12e are connected via the connecting elements 16b and 18b, they can only be displaced relative to one another within the framework of the mechanical strength of the connecting elements 16b and 18b.
  • a braid member 12f is connected to none of the connecting members 16, 18, but only to the adjacent braid members, for example, 12c and 12d.
  • each mesh element is connected to at least one other mesh element.
  • braid elements are provided which are not connected to any of the other braid elements, for example a braid element 12g.
  • the mesh element 12g is rotatable about its axis of rotation and entwined with the surrounding mesh elements.
  • the braid member 12f may be unconnected in this embodiment, while being further entwined with its neighbors.
  • the braid elements 12 are rings made of rod members, such as wire, of a given wire diameter by welding the two free ends (end-to-end connection).
  • FIG. 4 shows a component 20 according to the invention, which consists of a braid 10.
  • the braid 10 is constructed of braid elements 12a, 12b,..., Which are connected to one another by joining in such a way that the braid 10 is dimensionally stable in the form shown in FIG.
  • the component shown in FIG. 4 is produced by a method according to the invention as described below.
  • a braid 10 is provided as shown in FIG.
  • a three-dimensional model 22 is produced by means of a rapid prototyping method, which is smaller by a predetermined amount than the component to be manufactured. The predetermined amount is selected so that the component 20 produced from the mesh 10 has exactly the desired geometric dimensions.
  • the model 22 is shown schematically in FIG. 4 below the braid 10.
  • the braid 10 is placed on the model 22 so that it rests on the model 22 completely and without wrinkles, at least in part.
  • individual braid elements 12a, 12b,... are joined by laser beam welding by means of a computer-controlled laser welding robot in such a way that the contours of the model 22 are recorded. In this way, all the braid elements lying in the area where the braid 10 rests completely on the model 22 are joined together with their respective neighbors.
  • the model 22 is then rotated so that further mesh elements come into direct contact with the model 22. Subsequently, these braid elements are connected to their respective neighbors. This results in a dimensionally stable component 20, which rests completely on the model 22. Subsequently, the model 22 is removed. If possible, the model 22 is simply removed. If, as shown in FIG. 4, it is not possible to remove the model 22 from the component 20 without destroying the component 20, the model 22 is melted out, burnt out or released. In this case, the model 22 is constructed, for example, of a plastic or a wax.
  • the braid 10 is first braced in a framework so that it assumes the desired geometric shape.
  • the individual braid elements are then joined together.
  • This workbook of bracing can also be combined with the above described operations of laying on a model.
  • Basin may be necessary, for example, due to tumors, infections or bone resorption due to foreign body reactions.
  • the method according to the invention fulfills these requirements
  • FIG. 5 shows a sketch of a human pelvis 24 with a left pelvic half 26a and a right pelvic half 26b.
  • a computed tomography or magnetic resonance tomography image of the pelvis 24 is first made. This gives a spatial representation of the right half of the pelvis 26b.
  • a mathematical model for the left pelvic half 26a is calculated by mirroring. This mathematical model then becomes mathematical sub-models disassembled, the individual sub-components 28, 30, 32, 34, 36 describe. These partial components are shown in FIG. 6a.
  • Part components 30 to 36 arise.
  • the component 28 is made by milling from a solid block of titanium using a prior art method. Alternatively, the component 28 is prefabricated as semi-finished and is brought by deformation in the correct shape.
  • the component parts 30 to 36 are then coated with hydroxyapatite. Subsequently, bone growth and bone-cell-promoting substances are applied to these mesh elements 12a, 12b,.... Alternatively, the entire mesh is coated. If necessary, interstices between individual mesh elements are filled up with bone chips or pluripotent cells, so that a bone chips sprouting is further promoted.
  • both short-term and long-term implants can be designed.
  • Short-term implants in the area of the bones are equipped so that the predominantly connective tissue are sown. Subsequent surgical removal is then not hindered by bone ingrowth.
  • Used as a long-term implant components of the invention are equipped to promote bone ingrowth.
  • a component according to the invention is constructed, for example, from biocompatible polymers in such a way that a connective tissue deposition takes place. In this way, implants for use in the abdominal cavity are realized.
  • individual braid elements are first connected so that the braid is dimensionally stable. Subsequently, the dimensionally stable braid thus obtained is brought by forming into the desired shape. The resulting braid can also be purposefully braced or relieved.
  • first temperature which is preferably body temperature (36 ° C.)
  • second temperature for example, lower temperature
  • the component resumes the desired first shape.
  • the following variations can be made: At one edge of the braid, it is possible to provide specially shaped wire elements which serve for fastening the component to, for example, bones.
  • the mesh can be constructed of varying numbers, sizes and different shapes of the mesh elements.
  • the mesh elements have the same geometric shape with each other. Rather, it is possible that the individual mesh elements are made with varying diameters.
  • the braid elements can also be constructed of rod elements, such as wires, of varying thickness.
  • components according to the invention are stabilized, reinforced, shaped or functionalized by braided or inserted objects made of metal, polymers or other materials. In particular, passages or motorized elements can be provided. It is also possible that two or more braids are connected by cross-connector to three-dimensional objects.
  • Individual mesh elements may also be provided with substances that cause a rejection reaction to prevent sprouting of unwanted tissue. It is also possible that the mesh is surface-activated by mechanical and / or chemical treatment, for example by coatings with organic and / or inorganic substances.
  • the component may comprise a mesh that is partially closed, for example, by coating, potting or gluing, one or two-sided or completely closed.
  • Components according to the invention may be in the form of multiple-sleeve collars
  • Another application is temporary implants for the formation of an artificial body cavity or implants with surfaces for connective tissue demarcation. Also possible is the replacement of plate bones, for example in the area of the skull, the scapula and the pelvis by one or two-sided closed ring mesh structures.
  • Another application is a joint endoprosthesis or a total thigh bone replacement with additionally attached ring mesh for refixation and biological ingrowth of bone fragments, tendon plates and musculature.
  • an inventive component z As drug dosing, telemetry facilities and measurement and control units are integrated.

Abstract

L'invention concerne une pièce avec un treillis (10) constitué de plusieurs éléments fermés de treillis (12) s'engageant les uns dans les autres. Selon un second aspect, L'invention concerne un procédé de fabrication d'une pièce (16). Pour cette pièce, les éléments individuels de treillis sont assemblés (16, 18) de telle sorte que le treillis est stable en poussée dans au moins une direction spatiale.
PCT/EP2007/010137 2006-11-22 2007-11-22 Pièce constituée d'éléments de treillis WO2008061759A1 (fr)

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DE102015226063A1 (de) * 2015-12-18 2017-06-22 Aesculap Ag Medizinisches Produkt sowie medizinisches Kit zur Anwendung bei der Behandlung, insbesondere zur Anwendung beim Auffüllen und/oder Verschluss, einer Knochenkavität
US11628517B2 (en) 2017-06-15 2023-04-18 Howmedica Osteonics Corp. Porous structures produced by additive layer manufacturing
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