Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
  • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
  • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
  • A61L31/148—Materials at least partially resorbable by the body
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
  • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
  • A61L27/02—Inorganic materials
  • A61L27/04—Metals or alloys
  • A61L27/047—Other specific metals or alloys not covered by A61L27/042 - A61L27/045 or A61L27/06
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
  • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
  • A61L27/40—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
  • A61L27/44—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix
  • A61L27/46—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix with phosphorus-containing inorganic fillers
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
  • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
  • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
  • A61L27/58—Materials at least partially resorbable by the body
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
  • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
  • A61L31/02—Inorganic materials
  • A61L31/022—Metals or alloys
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
  • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
  • A61L31/12—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
  • A61L31/125—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix
  • A61L31/127—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix containing fillers of phosphorus-containing inorganic materials
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P19/00—Drugs for skeletal disorders
  • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
  • A61L2430/00—Materials or treatment for tissue regeneration
  • A61L2430/02—Materials or treatment for tissue regeneration for reconstruction of bones; weight-bearing implants

Definitions

• the present invention relates, in a first aspect, to an element having a non-porous hollow body and a filling, wherein the non-porous hollow body is formed of bioresorbable magnesium and / or bioresorbable magnesium alloy, the filling having a biocomposite material, this
• Biocomposite material has at least one biocompatible polymer component and a ceramic component.
• the present invention is directed to a method of making this element, which is particularly suitable for bone surgery.
• Elements for use as implants find a wide field of application.
• elements of bioresorbable materials, elements of non-absorbable materials or combinations thereof are used depending on the field of application.
• bioresorbable implants or partial bioresorbable implants are increasingly used in bone surgery.
• These bioresorbable materials are characterized by the fact that they are corroded or otherwise degraded in the human body and dissolve almost residue-free.
• Medical implants of the type mentioned are known in various forms. These may be fasteners for a bone, such as plates, screws or nails, surgical sutures, surgical nets or films, or even prostheses.
• Disadvantages include a relatively large amount of gas produced per unit time, especially of hydrogen. This creates gas caverns in the body and the materials themselves are degraded unevenly.
• materials used as an implant must be inert insofar as no repellent or inflammatory reactions are caused in the living organisms or the materials have a negative effect on the recovery of the tissue or the entire organism.
• the materials of the implant must meet a variety of mechanical requirements, such as a high load capacity.
• the implant when used in the bone, z. B. as a bone nail or bone marrow nail, the implant must on the one hand have a high rigidity in order to strengthen the bone sufficiently.
• the implant must show sufficient flexibility, that is, it must not be too brittle to prevent breakage under load.
• resorbable implants are made of various resorbable materials.
• bioresorbable polymers are used in bioresorbable implants. These polymers have good biocompatibility, but have only a low mechanical strength and hardness, so that they are only partially suitable as a bone substitute material. They can not be implanted at heavily loaded mechanical sites.
• ceramic implants have been proposed. Ceramics generally have a high hardness. However, they are usually brittle and break easily. In particular, the easy breaking leads to problems because fragments can move uncontrollably in the tissue and thus can lead to complications. In addition, the dissolution of ceramic implants is rather slower. It can take years before a natural bone has formed again.
• EP 289 562 describes such biocomposite materials for bone surgery applications, which consists of a bioceramic portion and a polymer portion which is bioresorbable.
• such materials also do not meet the mechanical requirements for implants, especially in the field as bone replacement materials, such as a bone nail, especially a bone marrow nail.
• metallic implants made of bioresorbable materials have been proposed as further possibilities.
• bioresorbable metallic implants made of magnesium Another advantage of these magnesium-containing implants lies in the stimulation of bone growth by the magnesium.
• Such metallic implants are z.
• EP 1 338 293 or EP 1 395 297 The main disadvantage of these implants is the hydrogen produced by the corrosion within the body, in order to solve this problem, a reduction in the amount of magnesium has been considered.
• Another disadvantage of these sponges or other open-cell or porous structures is the increased hydrogen release. Accordingly, z.
• the invention has for its object to provide an element, in particular a medical implant, instrument or aid used in human or animal body, which avoids the aforementioned disadvantages and is degradable in the body with little or no side effects, this element, in particular this Implant resistant to mechanical stresses applied during use.
• the element according to the invention with a non-porous, in particular non-open-cell hollow body and a filling.
• the hollow body is formed of bioresorbable magnesium and / or a bioresorbable magnesium alloy
• the filling comprises a biocomposite material, said biocomposite material containing at least one biocompatible polymer component and a ceramic component.
• the present invention is directed to an element having a hollow body and a filling, wherein the hollow body is formed of bioresorbable magnesium and / or a bioabsorbable magnesium alloy and the filling comprises a biocomposite material, said biocomposite material at least one biocompatible polymer component and at least one having ceramic component.
• the element according to the invention is preferably one which consists of the non-porous hollow body and the biocomposite material.
• the element according to the invention is preferably an implant, instrument or auxiliary device, in particular an implant, such as a bone nail or bone marrow nail.
• the hollow body formed from magnesium and / or magnesium alloy is a biocompatible, coatable, degradable magnesium and / or magnesium alloy.
• the hollow body is formed from a magnesium alloy.
• the hollow body is a non-porous and in particular non-open-cell hollow body made of magnesium or a magnesium alloy. The fact that the magnesium or the magnesium alloy is non-porous, the release of hydrogen is reduced due to the low surface area. At the same time, the thickness of the hollow body can be reduced without affecting the stability too much.
• the hollow body may be a hollow body which is open at least on one side.
• the hollow body containing the biocomposite material is preferably closed.
• Suitable alloys are e.g. LANd442 (lithium, aluminum, neodymium 4, 4, 2 wt .-%) or ZM21 (zinc, manganese 2, 1 wt .-%)
• This coatable magnesium and / or magnesium alloy surrounding the filling and forming the non-porous hollow body fulfills a number of tasks. Due to the good mechanical properties, the element can be easily implanted in the form of an implant. Thus, these implants can also be used in places that are exposed to heavy mechanical loads. The presence of magnesium further promotes new bone formation on the implant. This leads to a rapid integration of the implant in the surrounding bone. The rapid growth of new bone on the implant is an important issue for the healing and rapid reloading of the bone.
• the hollow body is coated on its outside, which faces the tissue.
• This coating can in particular detect bone replacement and / or pharmacologically active substances. These include, for example, pluripotent cells, bone marrow cells or bone chips, which promote the ingrowth of bone into the degrading element.
• the hollow body is at least partially coated with growth factors that promote the ingrowth of bone.
• the hollow body is at least partially coated with active substances which improve tissue regeneration.
• the hollow body is provided with a rough surface, so that the ingrowth is further promoted.
• the filling of the element according to the invention comprises a biocomposite material.
• This biocomposite material is composed of at least one biocompatible polymer component and at least one ceramic component.
• This filling allows to increase the mechanical strength of the hollow body, in particular to improve the rigidity and strength, but also the ductility of the hollow body. At the same time, however, the danger of an excessive evolution of hydrogen in the case of corrosion of the magnesium or of the magnesium alloy is reduced. Due to the inventive structure of the element, the amount of magnesium in the element can be kept small without significantly deteriorating the mechanical properties of the element.
• materials In general, biocompatible, compact or porous composite materials, bone cement and functionalized materials can be used as a filling.
• the biocompatible polymer component is selected from polysaccharides, polyglycoid; Polylactide, glycolide / lactide Copolmyer, Glycolid ⁇ 'rimethylencarbonat copolymer, poly-.beta.
• the polymer component may be in the form of fibers, for example.
• the biocompatible polymer component is a polysaccharide selected from chitin or chitosan, e.g. B. formed as fibers.
• the filling has a ceramic biocompatible component.
• This biocompatible ceramic component is preferably selected from apatite, hydroxyapatite, fluorapatite, calcium phosphate, tricalcium phosphate, dicalcium phosphate, magnesium calcium phosphate, mixtures of hydroxyapatite and tricalcium phosphate, alumina ceramics, bioglass, glass-ceramic containing apatite or calcium carbonate.
• chitosan-hydroxyapatite composite materials as filler is advantageous.
• This filler is biocompatible and gives the hollow body the necessary mechanical strength.
• the strength of this filler is z. In the range of normal bone, so that these materials are excellently suited as bone implants, and especially as a bone marrow nail.
• the filler has bone formation-promoting factors, in particular growth factors. Other factors which assist in the regeneration of the bone or tissue may be present in the filler.
• the filling may possibly consist of porous material.
• the present invention is directed to a method of making the elements of the invention.
• This method comprises the steps of providing at least one page, such as 2 pages, open hollow body.
• This hollow body is formed from magnesium and / or magnesium alloys.
• this hollow body is filled with the above-described filling, which has a biocomposite material.
• This filling in the hollow body is optionally further compressed by suitable means.
• an insert is introduced into the opening (s) of the hollow body.
• This insert can for example be used to compress the filling, as mentioned above, in the hollow body.
• the insert which is likewise formed from magnesium and / or magnesium alloy, is designed in such a way that, after being introduced into the opening of the hollow body, it protrudes beyond the hollow body to the outside.
• the projecting beyond the hollow body insert is then in the section in which the insert is introduced into the cabbage body, having the hollow body.
• Joining is understood in particular to mean the joining designated in DIN 8593, for example soldering, gluing or welding. Preference is given to inductive welding or laser welding. Particularly preferred is a TIG welding process.
• the insert projects beyond the hollow body to the outside. This protruding allows the z. B. dissipate the heat generated by welding to the outside. Otherwise, the filling would be exposed to too much heat, so that the filling is destroyed or changed so that the biocompatibility is no longer present. So z. B. when using a chitosan-hydroxyapatite filling this temperature does not exceed 80 0 C, otherwise this is changed so that the biocompatibility is no longer present.
• the protruding of the inserts according to the invention allows the necessary dissipation of the heat and the excessive heating of the filling material is prevented. At the same time when using the insert is firmly bonded to the hollow body.
• the portions of the insert projecting beyond the hollow body may optionally be removed, e.g. B. by simply sawing.
• the protruding areas may be reworked to form the shape of a nail or a desired other shape.
• the resulting element can be further processed, for example, when used as Bone marrow nail or bone nail the element will be processed accordingly.
• the hollow body has two opposing openings and the filling is compressed or pressed by applying pressure to the two inserts.
• FIG. 1 shows the various embodiments of the element at different times of the method according to the present invention.
• FIG. 1a shows the element according to the invention with a hollow body 1 and the filling 2.
• the hollow body has two openings, in which the inserts 3 are introduced, sections 3b.
• the inserts 3 compress the filler 2 in the hollow body 1.
• the inserts 3 protrude beyond the filler body, section 3a.
• the inserts 3 in areas of the sections 3b with the molded body 1 has, for. B. by TIG welding process.
• the outstanding over the shaped body 1 sections 3a of the inserts 3 can be completely or partially separated, z. By sawing off the overhanging portions to obtain an element as shown in Figure 1b.
• This element according to the figure 1a or 1b can then be further processed, for. B. to a nail, as shown in the figure 1c.
• This filling consisting of a chitosan-hydroxylapatite mixture can then be cold-extruded and introduced into the hollow body or shaped body 1. Subsequently, the shaped body containing the chitosan hydroxylapatite filling is further treated, as described above under FIG.
• FIG. 2 shows the results of a determination of the bending stress of intramedullary nails.
• an intramedullary nail according to the invention is made of a
• the flexural strength of the nail according to the invention was also increased (273 N / mm 2 compared to 245 N / mm 2 ).

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• Health & Medical Sciences (AREA)
• Chemical & Material Sciences (AREA)
• Veterinary Medicine (AREA)
• Public Health (AREA)
• General Health & Medical Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• Life Sciences & Earth Sciences (AREA)
• Epidemiology (AREA)
• Inorganic Chemistry (AREA)
• Medicinal Chemistry (AREA)
• Transplantation (AREA)
• Oral & Maxillofacial Surgery (AREA)
• Dermatology (AREA)
• Heart & Thoracic Surgery (AREA)
• Surgery (AREA)
• Vascular Medicine (AREA)
• Engineering & Computer Science (AREA)
• Materials Engineering (AREA)
• Composite Materials (AREA)
• Physical Education & Sports Medicine (AREA)
• Orthopedic Medicine & Surgery (AREA)
• Rheumatology (AREA)
• Bioinformatics & Cheminformatics (AREA)
• Chemical Kinetics & Catalysis (AREA)
• General Chemical & Material Sciences (AREA)
• Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
• Organic Chemistry (AREA)
• Pharmacology & Pharmacy (AREA)
• Materials For Medical Uses (AREA)
• Surgical Instruments (AREA)

Applications Claiming Priority (2)

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• 2008
  • 2008-04-18 DE DE102008019748A patent/DE102008019748A1/de not_active Withdrawn
• 2009
  • 2009-04-17 WO PCT/EP2009/002829 patent/WO2009127423A2/de active Application Filing
  • 2009-04-17 JP JP2011504380A patent/JP2011519586A/ja active Pending
  • 2009-04-17 EP EP09732954A patent/EP2268325A2/de not_active Withdrawn
  • 2009-04-17 US US12/988,055 patent/US20110034926A1/en not_active Abandoned

Non-Patent Citations (1)

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