WO2009145766A1 - Implants de disques intervertébraux élastomères à renforcement interne - Google Patents

Implants de disques intervertébraux élastomères à renforcement interne Download PDF

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Publication number
WO2009145766A1
WO2009145766A1 PCT/US2008/065013 US2008065013W WO2009145766A1 WO 2009145766 A1 WO2009145766 A1 WO 2009145766A1 US 2008065013 W US2008065013 W US 2008065013W WO 2009145766 A1 WO2009145766 A1 WO 2009145766A1
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WO
WIPO (PCT)
Prior art keywords
elastomer
elastomeric
polycarbonate
urethane
intervertebral disc
Prior art date
Application number
PCT/US2008/065013
Other languages
English (en)
Inventor
Michael J O'neil
Hassan Serhan
Seungkyu Daniel Kwak
Stephen Connolly
Original Assignee
Depuy Spine, Inc.
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 Depuy Spine, Inc. filed Critical Depuy Spine, Inc.
Priority to PCT/US2008/065013 priority Critical patent/WO2009145766A1/fr
Publication of WO2009145766A1 publication Critical patent/WO2009145766A1/fr

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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
    • A61F2/442—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
    • A61F2/30965—Reinforcing the prosthesis by embedding particles or fibres during moulding or dipping
    • 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
    • A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/3006—Properties of materials and coating materials
    • A61F2002/30065—Properties of materials and coating materials thermoplastic, i.e. softening or fusing when heated, and hardening and becoming rigid again when cooled
    • 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
    • A61F2002/30069—Properties of materials and coating materials elastomeric
    • 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
    • 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
    • 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
    • A61F2002/4495—Joints for the spine, e.g. vertebrae, spinal discs having a fabric structure, e.g. made from wires or fibres
    • 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
    • A61F2210/0071—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof thermoplastic
    • 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
    • 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
    • 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
    • A61F2310/00029—Cobalt-based alloys, e.g. Co-Cr alloys or Vitallium
    • 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
    • A61F2310/00185—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

Definitions

  • This invention is concerned with devices used to repair intervertebral discs and more particularly with intervertebral disc replacement devices that are less susceptible to permanent disc height loss.
  • elastomeric disc replacement devices have been contemplated in the art for implantation in animal models and in humans.
  • the art discloses from solid rubber devices articulating on the vertebral bodies, solid elastomeric devices integrally attached to device endplates or elastomeric devices articulating on device endplates.
  • Several mechanical means to prevent excessive height loss are disclosed within the current art including positive stops, spring reinforcements, variable durometers materials, concentrically placed reinforcement fabrics (radial tires) and external containment methods like balloons, pistons, walls, for example.
  • the concept of internal laminate layers for elastomers has been utilized in other non-medical industries to prevent creep and permanent deformations; one notable example is skyscraper isolation mounts.
  • US20050171611 Al discloses the use of dehydrated polymers (hydrogels) to regain disc height. More specifically this publication focuses on the use of dehydrated polymers (hydrogels) with internal polyethylene teraphthalate layers to constrain hydrogel growth to a vertical direction for regaining disc height.
  • This publication also discloses a method of prosthesis production, which comprises: prefabricating soft and rigid layers; stacking at least two prefabricated soft and at least one prefabricated rigid layer in a parallel fashion into their final form; and, permitting the layers to firmly connect to one another by mutual interaction.
  • US 4,911,718 discloses a disc spacer having a central biocompatible elastomeric core circumferentially wrapped by several layers of laminae.
  • the laminate comprises strips of sheets of reinforcement fibers embedded in a biocompatible elastomer.
  • reinforcement members in a generally horizontal orientation to restrain the elastomer as hereinafter described.
  • This invention differs from the closest prior art as it employs specific internal reinforcement layers or tillers to reduce material deformations ol elastomeric polymers .
  • Figs. IA and IB represent an elastomeric intervertebral disc replacement device.
  • Figs. 1C and ID represents an elastomeric intervertebral disc replacement device containing a reinforcement member but no endplates .
  • Figs. 2A and 2B depict an elastomeric intervertebral disc replacement device containing reinforcement members.
  • Figs. 3A and 3B represent an elastomeric intervertebral disc replacement device containing reinforcement members of a concave design.
  • Figs. 4A and 4B depict an elastomeric intervertebral disc replacement device containing reinforcement members in the form of donut-shaped laminates.
  • Figs. 5A and 5B depict an elastomeric intervertebral disc replacement device containing reinforcement members in the form of crescent-shaped laminates.
  • Figs. 6A and 6B represent an elastomeric intervertebral disc replacement device containing a concave elastomer with a laminate reinforcement member contained therein.
  • Figs. 7A and 7B depict an elastomeric intervertebral disc replacement device containing a concave elastomer with two reinforcement members extending to the periphery of the elastomer.
  • Figs. 8A and 8B represent an elastomeric intervertebral disc replacement device containing reinforcement members designed to contact or nearly contact one another.
  • Figs. 9A and 9B depict an elastomeric intervertebral disc replacement device containing reinforcement members designed to contact or nearly contact one another.
  • Figs. 1OA and 1OB represent an elastomeric intervertebral disc replacement device containing reinforcement members designed to nest or nearly rest among one another.
  • Figs. HA and HB represent an elastomeric intervertebral disc replacement device containing reinforcement members designed to nest or nearly rest among one another.
  • Figs. 12A and 12B represent an elastomeric intervertebral disc replacement device containing reinforcement members of an interlocking platelet shape.
  • Figs. 13A and 13B depict an elastomeric intervertebral disc replacement device containing reinforcement members of a disc or flake design.
  • Figs. 14A-D depict various filler shapes capable of being used as reinforcement members.
  • This invention differs from the closest prior art as it employs specific internal reinforcement layers or fillers to reduce material deformations of elastomeric polymers in an intervertebral disc replacement device.
  • an intervertebral disc replacement device comprising:
  • an elastomeric core comprising at least one reinforcement member set in a substantially horizontal orientation
  • an intervertebral disc replacement device comprising:
  • a top endplate and a bottom endplate attached to the respective top and bottom ends of the elastomeric core.
  • Additional aspects of this invention relate to methods of manufacture of the intervertebral replacement discs comprising elastomeric cores with reinforcement members and/or fillers.
  • Elastomeric discs are subject to both short term and long term deformations upon anatomical loading.
  • the elastomers can be either theromset as is in the case of polyhexene (AcroFlex Bion rubber), silicones, polyol/issocyanate urethanes, for example; or can be a thermoplastic elastomers (TPE' s) as in the case of thermoplastic urethanes (aromatic and aliphatic) , as well as block co-polymers like polycarbonate urethanes
  • the elastomer can be a solution cast material as in the case of the polyurethane elastomer sold under the trade name of Elasteon HF.
  • This invention contemplates internal reinforcement members to internally restrain the elastomer from radial deformations. This restraining force increases construct stiffness, reduces peripheral bulging and corresponding height loss.
  • the internal reinforcement members can be placed at a generally horizontal orientation to restrain the elastomer. Reinforcement members can be comprised of varying materials, geometries and locations to enhance resistance to deformation to the desired directional forces.
  • the internal reinforcement members may be produced from materials of various degrees of stiffness and range from relatively rigid metallics (CoCr, SS, for example) to more flexible metallics (Nitenol, for example) or elastomeric polymers (polyurethanes, silicones, for example, that recover following loading to minimize permanent deformation of the device) .
  • the internal laminate layers can be of varying shapes including strips, donut-shapes, discs, squares, ovals, for example, and various fabricated sheets, woven or non-woven fabrics, porous/non-porous foams, for example.
  • the layers can be produced from the following materials: metallics including SS, CoCr, CpTi, Ti6A14V, SS, TiN, for example, as well as polymeric and ceramic materials including Ti, Ta, SS, CoCr, Calcium, Barium, PEEK, PU,
  • the reinforcement layers can extend to the periphery of the device or may be contained within the elastomer.
  • the reinforcement layers can have protruding and receiving geometries that contact and even interlock to further reduce height deformation and loss.
  • Figs. IA and IB represent an intervertebral disc replacement device 10 comprising endplates 12 and elastomeric material 14. As force F is applied, elastomeric material 14 compresses and bulges as depicted in Fig. IB. Also identified in Fig. IB is the dimension C which represents the loss in disc height which results from elastomer 14 not able to return to its original orientation ("creep deformation") .
  • Figs. 1C and ID depict device 10 further comprising a reinforcement member 16 but with no endplates.
  • the benefits of reinforcement member 16 can be seen by comparing Fig. ID with Fig. IB. Specifically, one observes that creep deformation C of Fig. ID is less than creep deformation C of Fig. IB. This result is beneficial as the reinforcement member 16 has the effect of lessening intervertebral disc height loss.
  • a further benefit of the use of reinforcement member 16 is that the "bulging" of elastomeric material 14 is lessened as depicted in Fig. ID as compared to Fig. IB. In effect, the series of smaller bulges in Fig. ID has less of a pronounced bulge as compared to the large bulges of Fig. IB.
  • Figs. 2A and 2B depict device 10 further comprising several reinforcement members 16 and endplates 12.
  • the benefits of reinforcement members 16 can be seen by comparing Fig. 2B with Fig. IB. Specifically, one observes that creep deformation C of Fig. 2B is less than creep deformation C of Fig. IB. This result is beneficial as the reinforcement members 16 have the effect of lessening intervertebral disc height loss.
  • a further benefit of the use of reinforcement members 16 is that the "bulging" of elastomeric material 14 from endplates 12 is lessened as depicted in Figs. 2B as compared to Fig. IB. In effect, the series of smaller bulges in Fig. 2B has less of a pronounced bulge as compared to the large bulges of Fig. IB.
  • Figs. 3A and 3B depict additional shapes for endplates 12 and reinforcement members 16.
  • endplates 12 are shown as "domed” which would allow device 10 better conform with the anatomy of the adjacent intervertebral body endplates.
  • device 10 is also shown to contain reinforcement members 16 of varying shapes, including "dome” shaped members.
  • FIG. 4A and 4B Further reinforcement member embodiments are depicted in Figs. 4A and 4B and Figs. 5A and 5B.
  • the reinforcement members 16 of Figs. 4A and 4B are depicted as donut-shaped.
  • the reinforcement members 16 of Figs. 5A and 5B are shown as crescent- shaped.
  • elastomeric material 14 has a concave shape 22 and includes reinforcement members 16 either as a laminate layer fully contained within elastomer material 14 (Figs. 6A and 6B) or as laminate layers that extend to the peripheral edge of elastomeric material 14 (Figs. 7A and 7B) .
  • FIGs. 8A and 8B and Figs. 9A and 9B depict embodiments where reinforcement member 16 are shown as laminates that are arranged to have a point (s) of contact or near point (s) of contact among and between one another. These configurations aid in alleviating disc height loss by approximating "stops" when reinforcement members 16 contact or nearly contact each other.
  • Figs. 1OA and 1OB and Figs. HA and HB represent additional embodiments of the invention wherein device 10 comprises nesting or near nesting reinforcement members 16.
  • Figs. 1OB and HB show how reinforcement members 16 "nest" within one another and thus limit the potential amount of disc loss height and elastomeric material 14 deformation.
  • This invention further contemplates internal filler materials based on the internal restrain philosophy disclosed above, i.e., the principle of internal reinforcement with macro-laminate layers is applicable to the more micro-scale fillers.
  • Increasing surface area on the fillers that are well bonded to the elastomer increases the constraint upon the elastomer matrix, minimizing bulging and permanent deformations.
  • the fillers can be placed in random orientations, but preferably in a generally horizontal direction to minimize radial bulging and creep.
  • Filler shapes include flakes, platelets, spheroids, spherlites, microspheres, micro-tubes, small disc, or other random external geometries.
  • the fillers can be porous to allow for elastomer intrusion and increase surface for containment or can have interlocking features to providing filler based positive stop to deformations.
  • the filler can be either organic or inorganic and fabricated from the following materials: metallics including SS, CoCr, CpTi, Ti6A14V, SS, TiN, for example, as well as polymeric and ceramic materials including Ti, Ta, SS, CoCr, calcium, barium, PEEK, PU, PMMA, clays, talc, mica, TiO2, for example.
  • Figs. 12A and 12B and Figs. 13A and 13B illustrate how filler materials 24 acting as reinforcement members provide the necessary constraint to lessen disc height loss and elastomeric material deformation.
  • filler materials 24 are interlocking flake shaped, more clearly depicted in Fig. 14C.
  • filler materials 24 are small porous micropheres (Fig. 14B) or microspheres (Fig. 14E) .
  • Filler materials 24 are not limited to any particular shapes and for illustrative purposes, in addition to the shapes described above, include but are not limited to, spherlites and platelets (Fig. 14A) and tubes (Fig. 14D) .
  • the devices of this invention may be produced by a number of methods.
  • the methods of laminate molding or pre-impregnation lamination may be utilized.
  • Laminate molding relates to a process that utilizes a two-part mold with a cavity having a shape that corresponds to the external geometry of the device.
  • an end plate is placed in both halves of the mold.
  • the endplate or reinforcing layers may contain surfaced modifications to enhanced polymer attachment including surface finish, primers, coatings, ion bombardment, plasma treatments, for example.
  • Preformed elastomeric materials and reinforcing layers are cut to fit within the cavity. Alternating levels of the preformed elastomeric material and reinforcement materials are placed within the cavity. Once each half of the mold is filled with the required levels of preformed elastomeric material and reinforcement material, the mold is then closed and compression applied to consolidate the preformed elastomeric material and reinforcing layers. If a thermoplastic or thermoset polymer is utilized for the elastomeric material, the mold is heated and cooled to ensure laminate incorporation and/or material cure. Conversely, a thermoset cast polymer can also be utilized for the elastomeric material by pouring/dispensing into the cavity and then applying alternating layers of the reinforcement material.
  • thermoset polymers known to the industry can be employed, including radiation, UV, steam, and ultrasonics, for example.
  • the pre-impregnation lamination technique refers to a method wherein the reinforcement members are pre- attached and/or impregnated with the elastomer before placement into the mold. This can be accomplished by several means including co-extrusion or vacuum forming.
  • the co-extrusion method relates to formation of co- extruded sheets of reinforcing layer and elastomeric material that are extruded into a multilayer sheet which is then cut and placed into the mold cavity for attachment to the endplates .
  • Vacuum forming is used to attach the reinforcement layers to the polymer by layering several sheets and applying a vacuum to pull the sheets and elastomer together in a cavity.
  • the laminate sheet can then be cut and placed into the cavity for compression molding.
  • the sheets are subsequently cut to fit and layer into the mold as described above, or the sheets can be processed to have multiple layers of elastomeric material and reinforcing members and then cut to fit for placement into the mold.
  • the mold is closed and then cured by techniques described above or by other known in the art curing techniques.
  • the device of this invention can be produced by the same methods described above with a few refinements.
  • the domed reinforcement layers are radiused or domed prior to placement into the pre-impregnation lamination mold or laminate mold.
  • the final over molding is performed to encapsulate the subassembly.
  • One method may be referred to as the orientated reinforcement filler method in which the relatively small particulate type fillers are oriented by methods typical in the polymer processing industry. These include controlled injection/flow by injection location at one edge of the part and gas vent at the opposite edge of the part. Flow of the polymer/filler encourages orientation of the filler in parallel to the direction of flow.
  • Another manufacturing technique for incorporating fillers in to the elastomeric core of the device of this invention may be described as a compression method technique.
  • this technique thin sheets of uncured elastomer are covered with generally flat fillers by manual or spray application of the filler. The sheet is then gently exposed to compression flattening of the filler material unto the polymer surface. Several layers of the filler coated sheet are then combined together .
  • Yet another manufacturing method for incorporating fillers in to the elastomeric core of the device of this invention relates to use of cast polymers.
  • the generally flat fillers are added to the cast polymer solution with solvents.
  • the solvent evaporates from the mixture allowing the fillers to lay flat as the cast polymer solution forms sheets. Sheets of the cast polymer containing the fillers are then cut and placed into the cavity for final cure such as by compression molding.

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

Abstract

La présente invention concerne deux techniques permettant de réduire au minimum la perte de hauteur de disque intervertébral due au fluage de polymère, suite à l’implantation d’un disque élastomère, avec l’utilisation d’un renforcement interne. Les dispositifs et les procédés spécifiques concernent l’utilisation des éléments suivants : (i) des éléments de renforcement interne seuls ou multiples, visant à accroître la rigidité du produit de combinaison et à réduire le gonflement périphérique et la perte de hauteur correspondante; et (ii) des charges élastomères internes de formes diverses qui sont mélangées dans l’élastomère pour partager la charge et empêcher les déformations excessives du matériau élastomère.
PCT/US2008/065013 2008-05-28 2008-05-28 Implants de disques intervertébraux élastomères à renforcement interne WO2009145766A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/US2008/065013 WO2009145766A1 (fr) 2008-05-28 2008-05-28 Implants de disques intervertébraux élastomères à renforcement interne

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/US2008/065013 WO2009145766A1 (fr) 2008-05-28 2008-05-28 Implants de disques intervertébraux élastomères à renforcement interne

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WO2009145766A1 true WO2009145766A1 (fr) 2009-12-03

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013055723A1 (fr) * 2011-10-10 2013-04-18 Synthes Gmbh Implant à couche souple

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6562466B2 (en) * 2001-07-02 2003-05-13 Essilor International Compagnie Generale D'optique Process for transferring a coating onto a surface of a lens blank
US20040220669A1 (en) * 2001-06-27 2004-11-04 Armin Studer Intervertebral disk prosthesis
US20050113923A1 (en) * 2003-10-03 2005-05-26 David Acker Prosthetic spinal disc nucleus
US7182783B2 (en) * 2005-04-25 2007-02-27 Sdgi Holdings, Inc. Selectively expandable composite structures for spinal arthroplasty
US20070173936A1 (en) * 2006-01-23 2007-07-26 Depuy Spine, Inc. Intervertebral disc prosthesis

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040220669A1 (en) * 2001-06-27 2004-11-04 Armin Studer Intervertebral disk prosthesis
US6562466B2 (en) * 2001-07-02 2003-05-13 Essilor International Compagnie Generale D'optique Process for transferring a coating onto a surface of a lens blank
US20050113923A1 (en) * 2003-10-03 2005-05-26 David Acker Prosthetic spinal disc nucleus
US7182783B2 (en) * 2005-04-25 2007-02-27 Sdgi Holdings, Inc. Selectively expandable composite structures for spinal arthroplasty
US20070173936A1 (en) * 2006-01-23 2007-07-26 Depuy Spine, Inc. Intervertebral disc prosthesis

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013055723A1 (fr) * 2011-10-10 2013-04-18 Synthes Gmbh Implant à couche souple
US8685101B2 (en) 2011-10-10 2014-04-01 DePuy Synthes Products, LLC Implant with compliant layer

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