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WO2010088766A1 - Implant pour remplacement total de disque, et procédé de formation - Google Patents

Implant pour remplacement total de disque, et procédé de formation Download PDF

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Publication number
WO2010088766A1
WO2010088766A1 PCT/CA2010/000148 CA2010000148W WO2010088766A1 WO 2010088766 A1 WO2010088766 A1 WO 2010088766A1 CA 2010000148 W CA2010000148 W CA 2010000148W WO 2010088766 A1 WO2010088766 A1 WO 2010088766A1
Authority
WO
WIPO (PCT)
Prior art keywords
implant
end plates
porous
flexible core
porous end
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.)
Ceased
Application number
PCT/CA2010/000148
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English (en)
Inventor
Louis-Philippe Lefebvre
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.)
National Research Council of Canada
Original Assignee
National Research Council of Canada
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Filing date
Publication date
Application filed by National Research Council of Canada filed Critical National Research Council of Canada
Publication of WO2010088766A1 publication Critical patent/WO2010088766A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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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
    • 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
    • A61L27/56—Porous materials, e.g. foams or sponges
    • 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
    • A61F2/442—Intervertebral or spinal discs, e.g. resilient
    • 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
    • A61F2002/30004—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
    • A61F2002/30014—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 elasticity, stiffness or compressibility
    • 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
    • A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30563—Special structural features of bone or joint prostheses not otherwise provided for having elastic means or damping means, different from springs, e.g. including an elastomeric core or shock absorbers
    • 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
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    • 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
    • A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30565—Special structural features of bone or joint prostheses not otherwise provided for having spring elements
    • 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
    • A61F2002/30841—Sharp anchoring protrusions for impaction into the bone, e.g. sharp pins, spikes
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0018—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in elasticity, stiffness or compressibility
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0023—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0023—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in porosity
    • A61F2250/0024—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in porosity made from both porous and non-porous parts, e.g. adjacent parts
    • 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
    • A61F2310/00011—Metals or alloys
    • A61F2310/00017—Iron- or Fe-based alloys, e.g. stainless steel
    • A—HUMAN NECESSITIES
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    • 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
    • A61F2310/00011—Metals or alloys
    • A61F2310/00023—Titanium or titanium-based alloys, e.g. Ti-Ni alloys
    • A—HUMAN NECESSITIES
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    • 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
    • A61F2310/00011—Metals or alloys
    • A61F2310/00029—Cobalt-based alloys, e.g. Co-Cr alloys or Vitallium
    • A—HUMAN NECESSITIES
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    • 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
    • A61F2310/00011—Metals or alloys
    • A61F2310/00035—Other metals or alloys
    • A61F2310/00131—Tantalum or Ta-based alloys
    • A—HUMAN NECESSITIES
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    • 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
    • A61F2310/00185—Ceramics or ceramic-like structures based on metal oxides
    • A61F2310/00227—Ceramics or ceramic-like structures based on metal oxides containing titania or titanium oxide
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    • A61F2310/00005—The prosthesis being constructed from a particular material
    • A61F2310/00179—Ceramics or ceramic-like structures
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    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00389—The prosthesis being coated or covered with a particular material
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    • A61F2310/00976—Coating or prosthesis-covering structure made of proteins or of polypeptides, e.g. of bone morphogenic proteins BMP or of transforming growth factors TGF
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    • A61L2430/00—Materials or treatment for tissue regeneration
    • A61L2430/38—Materials or treatment for tissue regeneration for reconstruction of the spine, vertebrae or intervertebral discs

Definitions

  • the invention relates in general to artificial intervertebral disc implants, and, in particular, to an implant having end plates made of a metal or ceramic foam and between the end plates a flexible material, the porosity of the end plates providing a mechanical interlock for both the flexible material and bone for oseointegration, to produce an artificial disc having flexibility, shock absorbing capability, better bonding and longevity, while having a small parts count and inexpensive production.
  • Implants have been used for many years for the treatment of musculoskeletic disorders, including arthritic disorders, joint replacements (hip, knee, shoulder, extremities), fractures, degenerative disc deseases, craniofacial reconstruction, teeth replacements, etc.
  • Porous metallic coatings were developed in the late 1960's and early 70's to increase friction force between implants and surrounding bone to promote the initial and long term stability through bone ingrowth. These surfaces were initially proposed as a solution to problems encountered with methacrylate based bone cement used for orthopedic implant fixation.
  • Welsh, Pilliar, Cameron, Bobyn and Gallante worked on the initial development and validation of porous coating (titanium, stainless steel, CoCr) that laid the ground for their clinical acceptance in various applications such as hip, knee, and dental applications [ ⁇ 2 ].
  • Metallic foams have been used in the development of various treatments (i.e. bone augmentation, graft free vertebra fusion for the treatment of degenerative disk diseases for example). These materials have the advantage of being much more porous than the traditional porous coatings (i.e. sintered beads or mesh, plasma spray coating). The high porosity provides more space for bone in-growth and interlocking, provides more contact surface between bone and the implant and lowers the elastic modulus of the implant to values much closer to those of bone.
  • Levine recently reviewed some uses of metallic foams in joint replacement in Ref. [ 7 ] while Schiefer et al. presented the development of porous titanium for the production of dental implants in [ 8 ].
  • Porous ceramics and bioactive glasses have been proposed as alternatives to auto, allo and xenografts.
  • Porous metal and ceramics have been used in spine surgeries, as taught, for example, by German application DE19858579. They have been used for vertebra fusion as an alternative to bone graft thus avoiding the need to do a graft harvesting procedure.
  • Fusion type implants are different surgically, and conceptually from moving implants and moving implants are associated with different treatments than fusion devices.
  • Fused implants restore the normal space between vertebrae and eliminate pain coming from pinched nerves, but this solution does not, however, restore the motion or the absorption capability of the intervertebral disc.
  • Recently, different implants have been developed to restore the mobility of the vertebra. Some of the solutions proposed are based on the ball and bearing approach, similar to those used in joint replacement. These solutions usually limit the degree of motion by fixing a degree of rotation. In addition, this solution does not provide the absorption capability of a natural disc.
  • the disc consisted of a hexane-based polyolefin rubber core vulcanized to two titanium endplates.
  • the first example of these discs (Acroflex) disc consisted of a hexene-based polyolefin rubber core vulcanized to two titanium endplates.
  • the endplates were coated with sintered 250 micron titanium beads on each surface to provide an increased surface area for bone ingrowth and adhesion of the rubber [ 11 J.
  • the implant was not commercialized because a chemical used in the vulcanization process of the rubber (2- mercaptobenzothiazole) was reportedly potentially carcinogenic [ 12 ].
  • tear in the rubber at the junction of vulcanization was also reported due to poor bonding between the end plate and the rubber.
  • the implant body or its segments can be formed with throughgoing or blind bores forming part of the structuring described and as means to enable the groove of bone tissue into the implant body in situ.
  • the implant body or its segments can have a roughened surface to facilitate the growth of tissue into and onto the implant.
  • the implant body can be composed of a porous material, especially a porous metal foam.
  • the Bryan cervical disc is an artificial cervical disc made up of two small shell-shaped titanium end pieces, two titanium wires, a plastic nucleus, containing a plastic center disc that is surrounded by a protective plastic sheath and two titanium seal plugs.
  • the Bryan cervical disc has an elastomeric material bonded to one side of the disc and a lubricated surface between an opposing end plate and an opposite side of the elastomeric material.
  • the present invention solves the noted problems observed with previous implants.
  • a total disc replacement implant is provided that is flexible and restores the motion and the absorption capability of the natural disc.
  • the implant is composed of a flexible core between two porous endplates.
  • the end plates have an open pore structure with interconnected porosity that allows bone ingrowth, and implant stability.
  • the porous end plate permits integration of the flexible core into the porous material on the other side of the endplate, thus providing a good bonding and reducing the risk of failure at the interface between the core and the endplates.
  • Applicant proposes the use of porous metal/ceramic foam end plates to allow the infusion of the flexible core on one side and bone on the other.
  • the integration of the flexible core into the structure of the porous end plates assures a good adhesion bonding between the end plates and the flexible core (compared to solid plates) and bone integration allows a good cohesion between the implant and the adjacent vertebrae.
  • the dual use of the porosity permits better fixation of the core by gross mechanical interlocking of the flexible core and the end plate, while providing improved stress transfer across the interface.
  • the known advantages of the metal/ceramic foam for oseointegration are achieved.
  • the high porosity of the metal/ceramic foam permits the end plates to act as fusion media between the vertebrae and the flexible core and help transferring the loads from the vertebra to the flexible core.
  • the porosity of the end plates may obviate the need for bone grafting, and the porous end plates may be impregnated with growth factor, or other medicinal compounds etc.
  • Another significant benefit of the present technique is the simplicity and reduced costs of manufacture.
  • an implant for total disc replacement includes two porous end plates formed of a metallic or ceramic foam or any other fully porous open pore material that is: biocompatible, has adequate corrosion resistance, and mechanical properties to sustain the stresses between adjacent vertebrae.
  • the end plates are stacked to sandwich a flexible core such that each end plate has a bone-facing surface facing away from the core, generally opposite a respective core-facing surface.
  • a resilient flexible core material is embedded into both of the end plates at the opposing core-facing surfaces, so that the porous end plates are partially impregnated with the flexible core to provide a good bonding between the porous end plates and the flexible core.
  • a maximum width and length is preferably similar to, or smaller than, that of a healthy natural disc or nuclei to be replaced.
  • a shape and volume of the implant may mimic that of the natural disc or nuclei.
  • a maximum thickness of the implant may be between 5 and 20 mm; or between 8 and 15 mm.
  • the porous end plates may be composed of a porous metal, alloy, ceramic and/or a mixture thereof.
  • a titanium foam, a tantalum foam, a nitinol foam (TiNi or NiTi), a stainless steel, or a CoCr foam may be used.
  • Ceramic or other inorganic foams such as bioglass, calcium phosphate, hydroxyapatite, titanium oxide or other ceramics used or considered in orthopedic applications may be used.
  • the porous end plates may be composed of a rigid polymer.
  • the porous end plates may have a pore size distribution with a substantial fraction of the pores between 25 and 2000 microns, or more preferably between 30 and 500 microns such that the end plates are permeable to bone and the flexible core material alike.
  • the porous end plates may be perforated or have fixtures or texture to promote stability, and may be coated, impregnated, or otherwise contain a pharmaceutical agent, biological composition, bone graft, or growth factor to help healing or promote cell growth into the structure.
  • the fixtures may be resorbable.
  • the flexible core material may be a polymer, an elastomer, a gel, or a composite structure composed of materials having different stiffnesses, and may be a biocompatible flexible material.
  • silicone, polyurethane, copolymer of silicone and polyurethane, polyolefins, polyisobutylene rubber, polyisoprene rubber, nitrile rubber, neoprene rubber, polyolefin rubber, vulcanized rubber or any other flexible polymer that is biocompatible and able to sustain the load and environment observed between vertebrae may be chosen.
  • the core material may be a composite structure, for example, composed of a central portion having properties that mimic the properties and/or functions of the nucleus and an annular portion that reproduces the function or properties on the annulus.
  • the core material may be a composite structure including at least one spring integrated in the flexible core to mimic the stiffness of natural disc A method for assembling an implant for total disc replacement is provided.
  • the method involves providing two porous end plates formed of a metallic or ceramic foam or any other fully porous open pore material that is biocompatible, has adequate corrosion resistance and mechanical properties to sustain the stresses between adjacent vertebrae, and infusing a resilient flexible core material into both of the end plates at opposing core-facing surfaces of the end plates, so that the porous end plates are partially impregnated with the flexible core to provide a good bonding between the porous end plates and the flexible core.
  • FIG. 1 is a schematic illustration of an implant in accordance with an embodiment of the invention
  • FIG. 2 is a schematic illustration of placement of the implant of FIG.1 ;
  • FIG. 3 is a schematic illustration of motion of an implant of FIG. 1 ;
  • FIG. 4 is a schematic illustration of alternative embodiments of the invention that incorporate features that may be used to improve bonding to the surrounding bone;
  • FIG. 5 is a schematic illustration of an alternative embodiment of the invention featuring a two-part composite core having materials of different stiffnesses
  • FIG. 6 is a schematic illustration of an alternative embodiment of the invention featuring a two-part composite core consisting of a matrix and fill;
  • FIG. 7 is a photograph of a model implant for total disc replacement, and shows three positions of the model between modeled vertebrae. Description of Preferred Embodiments
  • a flexible implant of simplified construction and improved durability is provided by infusing a flexible core material into two porous metal or ceramic end plates, providing a mobility zone between the end plates.
  • FIG. 1 is a schematic illustration of an embodiment of the invention, from a materials perspective.
  • the implant has two opposing end plates 2 between a flexible core 1.
  • Each end plate 2 is composed of a porous metal/ceramic foam.
  • a substantial number of the pores of the foam have minimum dimensions of about 25 microns to 2 milimeters, more preferably 25 microns to 1 mm more preferably 30 to 500 microns, to facilitate ingrowth of bone, to form a fused interlock when implanted, and to permit a mechanical interlock for the flexible core.
  • the porous end plates are infused with the flexible core material. This provides for stress distribution throughout the volume of the end plates 2 that would otherwise be focused on the surface between the core 1 and end plate 2.
  • An enlarged section of the image shows the flexible material of the core 1 infused in the open porosity network 4 of the end plates 2, that is not visible in the whole view.
  • a shape and thickness of the end plates, and porosity can be chosen to provide a desired mechanical properties of the end plates. Also an alloy of the metal can provide for independent variation of the mechanical properties without varying the porosity.
  • the end plates may be thick enough to permit a desired thickness for integration with the flexible material while providing a desired space for oseointegration. Typically, the thickness of the implant should range between 5 and 20 mm, but is preferably between 8 and 15 mm. The maximum width and length should generally be smaller than those of a natural disc or nuclei.
  • the end plates can also be modular (i.e. made out of smaller plates or segments) to better adapt the surface of the vertebrae.
  • the porous end plates are preferably made of a ceramic, or more preferably a metallic foam such as a titanium foam, a tantalum foam, a nitinol foam (TiNi or NiTi), a CoCr foam, a stainless steel foam, or any other fully porous metal that is biocompatible, has good corrosion resistance, and the mechanical properties to sustain the stresses observed between adjacent vertebrae.
  • Nitinols are known as shape memory metals, and may be preferable along with other materials that have superelastic properties.
  • the end plates 2 can be composed of ceramic or other inorganic foam such as bioglass, calcium phosphate, hydroxyapatite, titanium oxide or other ceramics used or considered in orthopedic applications.
  • the endplates can be textured or have additional perforations or protruberences to increase the adhesion with the flexible core and bone, and to provide higher shearing friction against bone.
  • a mobility zone provided between the opposing end plates contains the flexible core material 1.
  • the end plates can partially or fully cover the surface of the flexible core.
  • the material of the flexible core should be biocompatible and have sufficient mechanical properties to support the load between the vertebrae, even in the most extreme cases.
  • the flexible core materials selected should also withstand the intervertebra environment without deterioration or corrosion.
  • the flexible core can be produced with biocompatible flexible materials.
  • the flexible material can be selected from silicone, polyurethane, copolymer of silicone and polyurethane, polyolefins, polyisobutylene rubber, polyisoprene rubber, nitrile rubber, neoprene rubber, polyolefin rubber, vulcanized rubber or any other flexible polymer that is biocompatible and able to sustain the load and environment observed between vertebrae.
  • the flexible material can also be a gel.
  • the properties of the flexible core must be stable after many cycles of loading and the material must not denature, crumble, or leak harmful fluids or absorb fluids in undesired amounts.
  • the implant geometry in FIG. 1 is schematic, as in fact the implant may have a variety of shapes.
  • the shape may be selected to occupy a space previously occupied by an undamaged natural disc or nuclei.
  • the geometry of the implant can mimic the geometry of the natural disc or nuclei, in static support over a wide range of positions, and also the dynamic support provided during motion, by selection of the core material.
  • the ability to bond a wide variety of materials to the end plates is instrumental in making this possible.
  • the geometry may not be designed to resemble or occupy the space of an undamaged natural disc, but may have a different form if it provides better performance, eases manufacturing and/or the surgeries.
  • FIG. 2 schematically illustrates bone growth within an implant, and a location for the implant.
  • Surgical operations for implanting artificial disks are well known in the art.
  • the mobility zone unlike ball joints or other mechanical joints, permit limited motion with 6 degrees of freedom. By controlling a shape, and dimensions of the mobility zone, different degrees of motion in the respective dimensions can be favored or limited. By providing more core material in two dimensions and less in the third, as shown, a high resistance to shearing motions across the end plates is provided to limit motion in these directions.
  • FIG. 3 schematically illustrates the typical motions of the implant.
  • the structure provided with the porous end plates with the flexible core is known to better mimic the natural motion of discs.
  • Unfortunately other structures of this kind are known to be more expensive to produce, and/or have problems at the interface between the end plates and core. Such problems include partial slippage or complete delamination.
  • expensive machining procedures for patterning surfaces to provide a desired mechanical interlock can be made.
  • the porous end plates being made of a foam or foam-like high porosity material naturally possess the desired surfaces for mating with bone or with a variety of elastomeric or rubbery materials.
  • FIG. 4 schematically illustrates a variety of embodiments that incorporate features that may be used to improve bonding to the surrounding bone.
  • the end plates can have gross surface features such as textures, or additional perforations (second figure), or protuberances (first figure) to increase the adhesion with the flexible core and bone.
  • the third figure shows additional fixtures for the implant. Naturally other additional features could be used.
  • the protuberances or fixtures may be resorbable and therefore temporary.
  • the mobility zone does not necessarily have to be monolithic. There can be differentiated regions. For example a core can be wrapped in a sheath material. The material does not have to be isotropic, in particular cylindrical, radial or helical arrangements may be preferred for certain embodiments. The medium could have graduated density or other properties as a function of distance from the end plates, or a central axis of the core material.
  • FIG. 5 schematically illustrates a two-part flexible core consisting of first and second materials, the first material effectively radially surrounding the second. This provides an option for controlling certain motions to certain degrees.
  • This embodiment provides a closer model of a natural disc, which includes an annulus surrounding a nucleus.
  • FIG. 6 schematically illustrates a two-part flexible core consisting of a matrix and fill. Structuring of the matrix can permit control and limit of the motion between the end plates. This may be an effective means for modifying the properties of the flexible material.
  • springs or other structural elements may be included in the flexible core, as will be appreciated by those of skill in the art.
  • FIG. 7 An exemplary implant illustrating the concept is photographed in FIG. 7 (top).
  • the implant was produced with two titanium foam end plates produced with the process described in the patent [ 14 ].
  • Industrial silicone was the material used for the flexible core.
  • the porous end plates were partially impregnated into the porous structure of the titanium foam. The impregnation was done by placing a first titanium foam disc in a mold of the same diameter as the disc, applying a thick layer of the silicone, covering the silicone with the second end plate in the same manner, and applying a pressure in such a way that the silicon was partially impregnated with the silicon. The pressure was applied by hand for a few seconds.
  • Both the top and bottom surface of the implant present porous titanium surface not filled with the flexible core in such a way that space is available for bone ingrowth.
  • the resulting implant is flexible.
  • two artificial vertebrae coupled with the model implant is subject to stresses and deforms according to various states of flexure in a manner that is realistic.

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Abstract

L'invention porte sur un implant destiné à remplacer des disques endommagés tout en préservant le mouvement entre les vertèbres adjacentes, lequel implant est composé d'un noyau souple et de deux plaques poreuses d'extrémité au niveau de la partie supérieure et de la partie inférieure de l'implant. Les plaques poreuses d'extrémité permettent à la fois une ostéo-intégration et une liaison du noyau souple par un verrouillage mécanique grossier. Les propriétés d'intégration osseuse et l'intégration du noyau souple sont apportées par des pores ayant une répartition de dimension centrée entre 25 microns et 2 mm. La fonction principale des plaques poreuses d'extrémité est de lier le noyau souple aux vertèbres. Les plaques poreuses d'extrémité sont en contact étroit avec les vertèbres afin de permettre une croissance osseuse interne. Ceci permet une intégration de l'implant et un mouvement moins limité de l'articulation par comparaison avec des articulations par fusion ou à rotule sphérique. Cet implant est simple à fabriquer et à assembler du fait qu'il est uniquement composé d'un noyau souple recouvert de plaques poreuses d'extrémité.
PCT/CA2010/000148 2009-02-03 2010-02-02 Implant pour remplacement total de disque, et procédé de formation Ceased WO2010088766A1 (fr)

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