EP1490001A1 - Chirurgisches implantat - Google Patents

Chirurgisches implantat

Info

Publication number
EP1490001A1
EP1490001A1 EP03700041A EP03700041A EP1490001A1 EP 1490001 A1 EP1490001 A1 EP 1490001A1 EP 03700041 A EP03700041 A EP 03700041A EP 03700041 A EP03700041 A EP 03700041A EP 1490001 A1 EP1490001 A1 EP 1490001A1
Authority
EP
European Patent Office
Prior art keywords
implant
cavity
bone
bone substitute
substitute 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.)
Withdrawn
Application number
EP03700041A
Other languages
German (de)
English (en)
French (fr)
Inventor
Thierry Stoll
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.)
Synthes GmbH
Original Assignee
Mathys Medizinaltechnik AG
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 Mathys Medizinaltechnik AG filed Critical Mathys Medizinaltechnik AG
Publication of EP1490001A1 publication Critical patent/EP1490001A1/de
Withdrawn legal-status Critical Current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
    • A61F2/30—Joints
    • A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
    • A61F2/4455—Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages
    • A61F2/4465—Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages having a circular or kidney shaped cross-section substantially perpendicular to the axis of the spine
    • 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
    • A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
    • 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
    • A61L27/12—Phosphorus-containing materials, e.g. apatite
    • 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
    • A61L27/14—Macromolecular materials
    • A61L27/16—Macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
    • 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
    • A61F2002/2835—Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
    • 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
    • A61F2002/30316—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
    • A61F2002/30329—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2002/30331—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by longitudinally pushing a protrusion into a complementarily-shaped recess, e.g. held by friction fit
    • A61F2002/30332—Conically- or frustoconically-shaped protrusion and recess
    • 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
    • A61F2002/30329—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2002/30433—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements using additional screws, bolts, dowels, rivets or washers e.g. connecting screws
    • 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
    • A61F2002/30785—Plurality of holes parallel
    • 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
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0004—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof bioabsorbable
    • 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
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0033—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
    • 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
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0041—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements using additional screws, bolts, dowels or rivets, e.g. connecting screws
    • 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

  • the invention relates to a surgical implant according to the preamble of patent claim 1, in particular an intervertebral implant, an intramedullary nail or an endograft prosthesis.
  • Intervertebral implants or other surgical implants with cavities, which are to be built with bone, are filled intraoperatively in most cases with bone or bone-like materials in order to optimally facilitate the intergrowth (in intervertebral implants, it is the so-called fusion of two vertebral bodies).
  • a bone-like material This may be natural or fully synthetic origin. In the case of natural origin, there is a residual risk of infection transmission in both allogeneic and xenogeneic materials. Furthermore, the physical properties of a bone substitute material are subject to strong fluctuations, starting from the various origins individuals, as well as their donor sites on the body.
  • the above discussion of the prior art is merely illustrative of the scope of the invention and does not imply that the cited prior art was actually public published or publicly known at the time of this application or priority.
  • the invention aims to remedy this situation.
  • the invention is based on the problem of providing an implant which already contains in its dosage form the bone substitute material on a fully synthetic basis in the implant itself in the form of a combination product.
  • the invention solves the problem with an implant having the features of claim 1.
  • the invention makes it possible by means of using a fully synthetic bone replacement material to prevent all the above-mentioned disadvantages.
  • the advantage is achieved that against bone replacement products of natural origin - because of the absence of possible pathogenic proteins, germs, viruses or bacteria - the risk of disease transmission does not exist.
  • the fully synthetic bone replacement material preferably consists of a calcium phosphate, typically a beta tricalcium phosphate.
  • a ceramic is used which corresponds in its stoichiometric composition largely to that of human bone.
  • the degradation time of beta-tricalcium phosphate is neither too fast nor too slow, as cavities, or implant residues may arise in the course of degradation.
  • the invention brings further advantages for the patient. These are to be seen in particular in that thanks to the simplified surgical technique:
  • the bone substitute material can be present either in the form of a rigid body corresponding to the geometry of the cavity or alternatively in the form of a plastically deformable mass which can be filled into the cavity.
  • the cavity of the implant widens conically or wedge-shaped toward the surface or the lower surface of the implant.
  • the introduced into the cavity body of fully synthetic bone replacement material receives a tight press-fit in the cavity.
  • the body can also be fastened in the cavity with a suitable fixation means, preferably a screw or a pin or a lock.
  • the implant may comprise a single cavity or a plurality of it, typically 2 to 8 separate cavities.
  • the implant is preferably designed as an intervertebral implant, but it can also be realized as an intramedullary nail or in the form of another osteosynthetic implant or an endogenous prosthesis.
  • this is preferably designed as a cage, which has a surface and a lower surface, which are suitable for bearing against the end plates of two adjacent vertebral bodies.
  • the cavity in this case connects the surface with the lower surface of the cage.
  • the surface and / or bottom surface of the cage has a three-dimensional patterning, e.g. in the form of grooves, grooves, nubs or other elevations or indentations.
  • the implant consists of a radiolucent material, in particular a polymer, e.g. PEEK.
  • a radiolucent material in particular a polymer, e.g. PEEK.
  • the bone substitute material consists of a resorbable material, preferably of hydroxyapatite or tricalcium phosphate. This has the advantage that due to the absorption of the Material can regrow new bone tissue and does not have to squeeze through the pores of the permanent material.
  • the body of bone replacement material advantageously has a porosity of at least 25%, typically at least 35%, wherein at least 50% of the pores should have a diameter in the range of 200 to 500 microns.
  • the bone substitute material has interconnections between individual pores having a diameter in the range of 10 to 500 microns, preferably 200 to 400 microns.
  • the implant can be produced, for example, by forcing a rigid body of fully synthetic bone substitute material corresponding to the geometry of the cavity into the cavity of the implant or fixing it with fixation means therein.
  • a moldable, preferably kneadable mass of fully synthetic, preferably present in granular form bone substitute material is introduced into the cavity and left there in uncured or cured state.
  • the latter method is also suitable for intraoperative filling of the cavities with bone substitute material.
  • FIG. 1 shows a perspective view of the implant in the unfilled state
  • FIG. 2 is a perspective view of the implant in the filled state
  • FIG. and FIG. 3 shows a longitudinal section along the line III-III through the implant according to FIG. 2.
  • the implant shown in FIGS. 1 to 3 is a cage-shaped intervertebral implant with four separate cavities 2, which connects the surface 4 with the lower surface 5 of the cage.
  • the surface 4 and lower surface 5 are for abutment with the end plates of two adjacent vertebral bodies determined and partially have a three-dimensional structure 6 in the form of
  • the cavities 2 widen, as shown in Fig. 3, to the surface 4 of the
  • Fig. 2 geometrically correspondingly shaped body 3 made of a fully synthetic bone substitute material.
  • the bodies 3 are fixed by means of a
  • the cage is made of PEEK while the bodies 3 are made of porous hydroxyapatite.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • General Health & Medical Sciences (AREA)
  • Neurology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Vascular Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Dermatology (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Inorganic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Prostheses (AREA)
  • Materials For Medical Uses (AREA)
EP03700041A 2002-03-30 2003-01-16 Chirurgisches implantat Withdrawn EP1490001A1 (de)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE20205016U 2002-03-30
DE20205016U DE20205016U1 (de) 2002-03-30 2002-03-30 Chirurgisches Implantat
PCT/CH2003/000020 WO2003082160A1 (de) 2002-03-30 2003-01-16 Chirurgisches implantat

Publications (1)

Publication Number Publication Date
EP1490001A1 true EP1490001A1 (de) 2004-12-29

Family

ID=27763035

Family Applications (1)

Application Number Title Priority Date Filing Date
EP03700041A Withdrawn EP1490001A1 (de) 2002-03-30 2003-01-16 Chirurgisches implantat

Country Status (18)

Country Link
US (1) US7135042B2 (pt)
EP (1) EP1490001A1 (pt)
JP (1) JP2005529634A (pt)
KR (1) KR20040105797A (pt)
CN (1) CN100428920C (pt)
AU (1) AU2003258526B2 (pt)
BR (1) BR0308852A (pt)
CA (1) CA2480884C (pt)
CO (1) CO5611081A2 (pt)
DE (1) DE20205016U1 (pt)
IL (1) IL164149A0 (pt)
MX (1) MXPA04009547A (pt)
NO (1) NO20044685L (pt)
NZ (1) NZ535475A (pt)
RU (1) RU2004131849A (pt)
TW (1) TW200304368A (pt)
WO (1) WO2003082160A1 (pt)
ZA (1) ZA200407708B (pt)

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US7135042B2 (en) 2006-11-14
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JP2005529634A (ja) 2005-10-06
CA2480884C (en) 2010-08-03
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CO5611081A2 (es) 2006-02-28
IL164149A0 (en) 2005-12-18
KR20040105797A (ko) 2004-12-16
BR0308852A (pt) 2005-01-25
WO2003082160A1 (de) 2003-10-09
RU2004131849A (ru) 2005-08-10
NZ535475A (en) 2005-12-23
CN1642497A (zh) 2005-07-20
CN100428920C (zh) 2008-10-29
DE20205016U1 (de) 2003-08-14
US20050065604A1 (en) 2005-03-24

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