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EP3946165A1 - Implant en un matériau de support entrecoupé de matériau donneur biologiquement actif et procédé de sa fabrication - Google Patents

Implant en un matériau de support entrecoupé de matériau donneur biologiquement actif et procédé de sa fabrication

Info

Publication number
EP3946165A1
EP3946165A1 EP20702771.5A EP20702771A EP3946165A1 EP 3946165 A1 EP3946165 A1 EP 3946165A1 EP 20702771 A EP20702771 A EP 20702771A EP 3946165 A1 EP3946165 A1 EP 3946165A1
Authority
EP
European Patent Office
Prior art keywords
implant
layers
ceramic
carrier material
donor material
Prior art date
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.)
Pending
Application number
EP20702771.5A
Other languages
German (de)
English (en)
Inventor
Adem Aksu
Frank Reinauer
Tobias Wolfram
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Karl Leibinger Asset Management & Co Kg GmbH
Original Assignee
Karl Leibinger Medizintechnik GmbH and Co KG
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 Karl Leibinger Medizintechnik GmbH and Co KG filed Critical Karl Leibinger Medizintechnik GmbH and Co KG
Publication of EP3946165A1 publication Critical patent/EP3946165A1/fr
Pending legal-status Critical Current

Links

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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/28—Bones
    • A61F2/2875—Skull or cranium
    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/3094—Designing or manufacturing processes
    • 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
    • A61F2/02—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
    • A61F2002/30004—Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis
    • A61F2002/30011—Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis differing in porosity
    • 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
    • A61F2/02—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
    • A61F2002/30062—(bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30108—Shapes
    • A61F2002/30199—Three-dimensional shapes
    • A61F2002/30242—Three-dimensional shapes spherical
    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30317—The prosthesis having different structural features at different locations within the same prosthesis
    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30667—Features concerning an interaction with the environment or a particular use of the prosthesis
    • A61F2002/30677—Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/30772—Apertures or holes, e.g. of circular cross section
    • A61F2002/30784—Plurality of holes
    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2002/3092—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth having an open-celled or open-pored 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/3094—Designing or manufacturing processes
    • A61F2002/30968—Sintering
    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/3094—Designing or manufacturing processes
    • A61F2002/3097—Designing or manufacturing processes using laser
    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/3094—Designing or manufacturing processes
    • A61F2002/30971—Laminates, i.e. layered products
    • 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
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005—The prosthesis being constructed from a particular material
    • A61F2310/00179—Ceramics or ceramic-like structures
    • A61F2310/00293—Ceramics or ceramic-like structures containing a phosphorus-containing compound, e.g. apatite

Definitions

  • Implant made of carrier material interspersed with biologically active donor material and
  • the invention relates to an implant, for example a cranial implant, for insertion into a (human) patient's body.
  • the invention also relates to a method for producing such an implant.
  • an implant is a non-body medical device that is introduced into a human or animal body and usually remains in the body for a defined period of time.
  • Cranial implants are cranial implants, i. H. Implants used in areas of a human or animal skull.
  • Resorbable / bioresorbable components / materials are materials / substances that a (patient) body can biologically absorb.
  • the cell metabolism or metabolism comprises all physical and chemical processes for the conversion of chemical starting materials into intermediate and end products in the body.
  • the ceramic or non-ceramic bone regeneration products currently available on the market or known as components of implants occur as granulates, hardenable cements or prefabricated molded bodies with simple, standard geometry. Thereby hardly any patient-specific implants with individually three-dimensionally adapted shape, structure and bioactive become
  • Materials with biological activity or bioactive substances are interactive substances that cause a positive cellular reaction and / or "repair" body tissue. It is known to coat implants with biological activation (coating), the coating being afflicted with stability problems for the implant and unsuitable for long-term activities.
  • ceramic materials are known which are introduced directly into the patient's body as granules or viscous paste. Such implants do not allow any structure-specific, geometric, pre-implantation shaping. Such changes can only be made through random changes in the implant composition
  • Implants with pores distributed like a gradient can be produced.
  • a medical device is known from EP 0 923 953 B1, for example, which has at least one portion that can be implanted in the body of a patient. At least a portion of the device portion is covered with a coating for the release of at least one biologically active material, the coating comprising a sub-layer having an outer surface and a polymer material having an amount of biologically active material therein for the timed Release from it contains.
  • the coating further comprises a discontinuous cover layer that covers less than the entire outer surface of the sub-layer, with covered and uncovered areas being formed through the entire outer surface of the sub-layers.
  • the cover layer comprises a polymer material that is free from pores and pore formers.
  • US Pat. No. 7,101,394 B2 discloses a medical device which supplies biologically active material to a patient's body.
  • a first cover layer comprises a biologically active material and optionally comprises a polymer material which is arranged on the surface of the medical device.
  • a second cover layer which has magnetic particles and a polymer material, is arranged on the first cover layer. The second cover layer, which has essentially no biologically active material, protects the biologically active material.
  • the implant has an at least partially resorbable and at least partially porous implant body made of a ceramic carrier material, e.g. a-TCP, ⁇ -TCP, hydroxyapatite, biphasic calcium phosphate, bioglass, ß-SiAION or
  • a donor material which, in the implanted state, releases ions to influence the patient's cell metabolism, and the donor material penetrates the carrier material.
  • the biologically active donor material which releases ions, is provided intrinsically structurally in the implant and not in the form of a
  • Implant coating is present.
  • the intrinsically provided biological activity means that the biological activity is a property of the implant itself and is not only applied externally to the implant. This means that the donor material is present over the entire implant volume.
  • Such an implant according to the invention enables optimal ingrowth of body soft tissue and new bone formation.
  • the implant according to the invention is biologically active longer than, for example, coated
  • Implants since the biological activity of the implant according to the invention comes from the inside (is intrinsic), not as in the case of coated implants in which only the surface is biologically active.
  • the donor material has ceramic and / or metallic particles. It is provided that the ceramic particles are bioresorbable. Such materials are particularly suitable for releasing ions and are therefore resorbable and bioactive.
  • the implant body it is expedient for the implant body to be divided into layers or subregions of different density and / or porosity. The biological activity is thus controlled by the layer geometry of the implant and by the ions released by the storage material.
  • such an implant is particularly well suited for the ingrowth of body tissue.
  • Connection channels are interconnected. Such connection channels connect pores with one another, so that they allow a substance exchange between the pores or across the pores and thus enable an improved and longer-lasting release of ions.
  • connection channels are arranged and concentrated so that when ions are released in the implanted state, the connection channels necessarily result (secondary connection channels), or that the connection channels are already present in the implant body before insertion into the patient (primary connection channels).
  • the implanted state is a state in which the implant is inserted into a patient's body or is present in the patient's body.
  • the implant body has a total porosity between 3% to 60%, in particular between 5% to 10%, preferably between 25% to 30%, more preferably between 50% to 60% and particularly preferably between 75% to 80%, having.
  • a total porosity in this area is particularly advantageous for the implant to grow in.
  • Implant body is in a range from 300 pm to 1,500 pm, in particular 350 pm to 450 pm, 800 pm to 900 pm, 1000 pm to 1200 pm.
  • the pore sizes are planned in advance and then implemented precisely in terms of construction. The pore sizes are therefore not generated randomly.
  • the largest possible choice of pore size for the respective application is possible Open-pore structure is possible with optimized mechanical conditions at the same time, and the optimal ingrowth of soft tissue and new bone formation in the patient's body are made possible.
  • pore gradients of 200 ⁇ m to 900 ⁇ m or up to 2500 ⁇ m are conceivable, the pore gradients each being stepped from one another by 100 ⁇ m.
  • the implant has a closed structure
  • the ceramic carrier material in the as yet unfinished implant is in the form of powdery or granular ceramic particles.
  • the granulate shape influences the geometric and biological properties in the implant.
  • the ceramic particles can be arranged partially crystalline or crystalline. This enables a more durable and long-lasting implant to be achieved.
  • a special embodiment is characterized in that the ceramic particles and the metal particles are spherical (spherical) with a respective particle size of the metal particles between 5-10 ⁇ m and the ceramic particles between 25-120 ⁇ m and / or the ceramic and metal particles are cubic (cube-shaped) with a Edge length of 5-25 pm for the metal particles and from 40-60 pm for the
  • Ceramic particles are.
  • a mixture of spherical and cubic particles ultimately achieves advantageous biomechanical strength.
  • the implant has first layers (for example the outermost 0 to 30 layers of the implant), last layers and middle layers
  • the implant is made hydrophobic or hydrophilic on different, in particular opposite, surfaces. This enables different possibilities of the implant for mechanical and physical interaction with the body tissue of a patient. These tissue interactions can be influenced (increased or decreased) via the partial resorbability of the defined structure or geometry of the implant.
  • the implant is manufactured using an additive / generative manufacturing process.
  • An implant manufactured using this method is particularly inexpensive to manufacture.
  • the object on which the invention is based is achieved by a method for securing the implant according to the invention.
  • the method has the following steps, which advantageously run one after the other and preferably in this order:
  • An implant produced according to these steps has the advantages defined above.
  • the invention relates to three-dimensional implants which are produced by additive manufacturing, the implants, for example, from ⁇ -tricalcium phosphate ( ⁇ -TCP), ⁇ -tricalcium phosphate ( ⁇ -TCP) and hydroxyapatite (HA) and mixtures of ⁇ -TCP and HA, so-called biphasic calcium phosphate (TCP), bioglass components, as well as mixtures of a-TCP, ß-TCP and HA, Zr02,
  • the ceramic particles or a composite of ceramic powder and the organic polymer matrix or an inorganic composite of a ceramic resorbable or non-resorbable material in combination with one or more are thereby energized
  • Implant with structurally defined macroscopic and microscopic porosity.
  • Generative manufacturing processes can be novel shape-related
  • Pore sizes of approx. 600 ⁇ m allow rapid ingrowth of
  • Blood vessels connective tissue and possibly bone tissue. Since the supply of nutrients to vital cells within the implant structure is only possible over a distance of 150-200 ⁇ m, primarily through diffusion, the formation of new blood vessels is a crucial process with regard to successful integration of the
  • the implant according to the invention is either completely or at least partially resorbable. This enables optimal soft tissue ingrowth and new bone formation. This extensive, vascular ingrowth helps transport important cells that fight infection deep into the implant. Large implants in terms of volume or smaller implants with a larger area due to the construction are particularly useful.
  • Implant and the biological activity of the implants will not be over
  • the implant according to the invention therefore does not receive any coating, but the biological activation of the implant according to the invention is intrinsically structurally present in it. This makes implants more robust during installation and biological activation of the implant is distributed over the time that the implant is in the patient's body.
  • the invention relates to a generatively manufactured, ceramic or partially ceramic, geometrically complex implant
  • the additively manufactured implant receives an increase in strength, the different energy inputs per layer and the pore strands connected by the connection channels are also exposed differently.
  • the ceramic implant is then given a heat treatment (in the temperature steps with the intervals 250 to 300 ° C, 380 to 400 ° C, 450 to 470 ° C and 600 to 650 ° C) without the pores being closed.
  • the heat treatment leads to an additional increase in strength, to a structural transformation as well as to changed surface properties of the
  • Temperature steps with the intervals 750 to 800 ° C, 870 to 890 ° C, 900 to 950 ° C, 950 to 1050 ° C, 1130 to 1170 ° C, 1200 to 1300 ° C and 1400 to 1450 ° C) can achieve smooth surface properties the implant is porous on the inside.
  • the implant can be made from at least one or two or three or four of the aforementioned material components.
  • the resorbable portion of the implant according to the invention can be between 0 and 100%, in particular between 20 to 30% or between 45 to 50% or between 65 to 80%. From the outside to the inside (from its outer to its inner layers), the implant can be constructed in such a way that the outer layers are resorbable to a large extent, the resorbability of the layers decreasing continuously or discontinuously from the outer to the inner layers.
  • the implant according to the invention can have specific structures for the fixation with the aid of screws or fixation devices made of titanium,
  • the fixation structure should have a wall thickness between 0.5 mm and 20.0 mm.
  • the three-dimensional implant according to the invention is provided with omissions or gaps in the case of an augmentation (method for rebuilding autologous bone using hererologic, xenogenic or synthetic bone replacement materials) with the implant according to the invention, in particular a dental implant.
  • the purpose of these omissions is to communicate with autologous bone tissue or bone fragments (the patient's own body
  • Bone tissue / bone fragments during implantation (during the
  • Holes can have a size of 1.0 to 1.5 mm, 1.5 to 2.0 mm, 2.0 to 2.5 mm or 2.5 to 2.8 mm. If larger bone fragments are to be introduced into the implant or if the implant is larger
  • the implant can accordingly provide bone fragments.
  • the materials used for the implant according to the invention are in
  • Powder form, granule form and as a liquid or viscous mixture the materials being mixed with one another in different amounts and compositions.
  • the granulate form is particularly important here, since the desired geometric and biological properties of the implant are regulated via the energy input and this depends on the powder and granulate form.
  • spherical particles with sizes of 5-18 ⁇ m and 25-120 ⁇ m can be used, the metallic components being smaller than the ceramic particles.
  • the ceramic particles can have completely or partially cubic shapes with edge lengths of 5-25 ⁇ m and 40-60 ⁇ m.
  • the first components of the ceramic particles can contain a mixture of geometrically non-uniform powder particles and the ceramic component can have a crystalline or partially crystalline arrangement.
  • the implant according to the invention structured in layers, with gradual or step-by-step degradation (degradability) enables cell-type-specific growth of the implant into the patient's body with regard to cell migration (active change of location of cells or cell associations in the patient's tissue).
  • an implant of this type advantageously has a defined
  • FIG. 1 shows a cross-sectional view of the implant according to the invention.
  • Fig. 2 is a flow chart showing the steps for producing an implant.
  • Fig. 1 shows the implant 1, which the carrier material 2 and a
  • the first layers 4 are arranged at the bottom, the middle layers 5 are above the first layers 4, and the last layers 6 in this view are arranged at the top (above the middle layers 5).
  • the first, middle and last layers 4, 5, 6 have different densities / porosities from one another.
  • FIG. 2 shows a flow diagram which shows the individual steps for obtaining the implant 1 according to the invention.
  • a first step S1 the ceramic carrier material 2 and the donor material 3, which is resorbable Contains components, mixed together to form a raw mixture RM.
  • the individual components of this raw mixture RM are in the following step S2
  • step S3 which follows step S2, these individual layers ES1, ES2,..

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Transplantation (AREA)
  • Cardiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Manufacturing & Machinery (AREA)
  • Neurosurgery (AREA)
  • Prostheses (AREA)

Abstract

L'invention concerne un implant (1) pour la mise en œuvre chez un patient, comportant un corps d'implant au moins en partie résorbable et au moins poreux dans des zones partielles en un matériau de support (2) en céramique, qui est doté d'un matériau donneur (3) cédant des ions pour influencer le métabolisme cellulaire du patient à l'état implanté, le matériau donneur (3) étant intercalé dans le matériau de support (2). L'invention concerne en outre un procédé de fabrication d'un tel implant (1).
EP20702771.5A 2019-03-29 2020-01-29 Implant en un matériau de support entrecoupé de matériau donneur biologiquement actif et procédé de sa fabrication Pending EP3946165A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102019108190.4A DE102019108190A1 (de) 2019-03-29 2019-03-29 Implantat aus mit biologisch aktivem Spendermaterial durchsetzten Trägermaterial und Verfahren zu dessen Herstellung
PCT/EP2020/052114 WO2020200539A1 (fr) 2019-03-29 2020-01-29 Implant en un matériau de support entrecoupé de matériau donneur biologiquement actif et procédé de sa fabrication

Publications (1)

Publication Number Publication Date
EP3946165A1 true EP3946165A1 (fr) 2022-02-09

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Country Status (5)

Country Link
US (1) US20220168104A1 (fr)
EP (1) EP3946165A1 (fr)
CN (1) CN113631121B (fr)
DE (1) DE102019108190A1 (fr)
WO (1) WO2020200539A1 (fr)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2022398612A1 (en) * 2021-11-26 2024-05-23 Poriferous, LLC Implant

Citations (1)

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US20030114936A1 (en) * 1998-10-12 2003-06-19 Therics, Inc. Complex three-dimensional composite scaffold resistant to delimination

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US5947893A (en) * 1994-04-27 1999-09-07 Board Of Regents, The University Of Texas System Method of making a porous prothesis with biodegradable coatings
US6099562A (en) 1996-06-13 2000-08-08 Schneider (Usa) Inc. Drug coating with topcoat
AU2759397A (en) * 1996-05-28 1998-01-05 1218122 Ontario Inc. Resorbable implant biomaterial made of condensed calcium phosphate particles
US7468075B2 (en) * 2001-05-25 2008-12-23 Conformis, Inc. Methods and compositions for articular repair
EP1457214A4 (fr) * 2001-11-27 2010-04-14 Takiron Co Materiau d'implant et procede de realisation associe
WO2003092791A2 (fr) 2002-05-02 2003-11-13 Scimed Life Systems, Inc. Administration commandee energetiquement d'une matiere biologiquement active a partir d'un dispositif medical implante
EP2104472A1 (fr) * 2007-01-19 2009-09-30 Cinvention Ag Implant poreux dégradable réalisé à l'aide d'un moulage de poudre
US20100145469A1 (en) * 2007-02-07 2010-06-10 Jake Edward Barralet Bioceramic implants having bioactive substance
US20110085968A1 (en) * 2009-10-13 2011-04-14 The Regents Of The University Of California Articles comprising nano-materials for geometry-guided stem cell differentiation and enhanced bone growth
EP3115025A1 (fr) * 2015-07-08 2017-01-11 Skulle Implants OY Implant
CN108420573A (zh) * 2018-03-27 2018-08-21 深圳德智达科技有限公司 一种生物医用陶瓷人工椎骨植入物

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US20030114936A1 (en) * 1998-10-12 2003-06-19 Therics, Inc. Complex three-dimensional composite scaffold resistant to delimination

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WO2020200539A1 (fr) 2020-10-08
DE102019108190A1 (de) 2020-10-01
US20220168104A1 (en) 2022-06-02
CN113631121B (zh) 2025-06-13
CN113631121A (zh) 2021-11-09

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