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
  • A61F2/447—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 substantially parallelepipedal, e.g. having a rectangular or trapezoidal cross-section
• • 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
  • A61F2002/30316—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
  • A61F2002/30593—Special structural features of bone or joint prostheses not otherwise provided for hollow
• • 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
  • A61F2002/30604—Special structural features of bone or joint prostheses not otherwise provided for modular
• • 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
  • A61F2002/3082—Grooves
  • A61F2002/30827—Plurality of grooves
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
  • A61F2/02—Prostheses implantable into the body
  • A61F2/30—Joints
  • A61F2/30767—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
  • A61F2002/30838—Microstructures
• • 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
  • A61F2002/3084—Nanostructures
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
  • A61F2/02—Prostheses implantable into the body
  • A61F2/30—Joints
  • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
  • A61F2002/3092—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth having an open-celled or open-pored structure
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
  • A61F2/02—Prostheses implantable into the body
  • A61F2/30—Joints
  • A61F2/3094—Designing or manufacturing processes
  • A61F2002/30978—Designing or manufacturing processes using electrical discharge machining [EDM]
• • 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
  • A61F2002/448—Joints for the spine, e.g. vertebrae, spinal discs comprising multiple adjacent spinal implants within the same intervertebral space or within the same vertebra, e.g. comprising two adjacent spinal implants
  • A61F2002/4485—Joints for the spine, e.g. vertebrae, spinal discs comprising multiple adjacent spinal implants within the same intervertebral space or within the same vertebra, e.g. comprising two adjacent spinal implants comprising three or more adjacent spinal implants
• • 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
  • A61F2310/00035—Other metals or alloys
  • A61F2310/00131—Tantalum or Ta-based 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
  • A61F2310/00179—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
• • 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
  • A61F2310/00389—The prosthesis being coated or covered with a particular material
  • A61F2310/00395—Coating or prosthesis-covering structure made of metals or of alloys
  • A61F2310/00401—Coating made of iron, of stainless steel or of other Fe-based 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
  • A61F2310/00389—The prosthesis being coated or covered with a particular material
  • A61F2310/00395—Coating or prosthesis-covering structure made of metals or of alloys
  • A61F2310/00407—Coating made of titanium or of Ti-based 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
  • A61F2310/00389—The prosthesis being coated or covered with a particular material
  • A61F2310/00395—Coating or prosthesis-covering structure made of metals or of alloys
  • A61F2310/00419—Other metals
  • A61F2310/00431—Coating made of aluminium or of Al-based 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
  • A61F2310/00389—The prosthesis being coated or covered with a particular material
  • A61F2310/00395—Coating or prosthesis-covering structure made of metals or of alloys
  • A61F2310/00419—Other metals
  • A61F2310/00443—Coating made of vanadium or of V-based 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
  • A61F2310/00389—The prosthesis being coated or covered with a particular material
  • A61F2310/00395—Coating or prosthesis-covering structure made of metals or of alloys
  • A61F2310/00419—Other metals
  • A61F2310/00544—Coating made of tantalum or Ta-based alloys
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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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
  • A61F2310/00592—Coating or prosthesis-covering structure made of ceramics or of ceramic-like compounds
  • A61F2310/00796—Coating or prosthesis-covering structure made of a phosphorus-containing compound, e.g. hydroxy(l)apatite

Definitions

• the current invention relates to a spinal implant according to the preamble of the first claim, for example aiming to replace damaged spinal discs in between two vertebrae.
• the spinal implant comprises a top surface, a bottom surface, opposing lateral sides, opposing anterior and posterior portions, a substantially hollow center, and a single vertical aperture. At least one of the aforementioned surfaces forms a roughened surface topography having a regular repeating pattern.
• the implant comprises a substrate, more in particular a body of the implant, and, on top of the body, an integration layer, more in particular an integration plate, provided with the roughended surface topography.
• the integration plate is made of titanium as titanium is a metal that shows good cell adhesion properties which is a desired property for body implants as they allow an improved healing effect.
• the body of the implant is made of polyetheretherketone (PEEK), a plastic material which is frequently used in body implants.
• PEEK is a highly inert material leading to weaker cell adhesion.
• the polymer material is covered with the titanium integration plate provided with the roughened surface topography. The roughened topography of the integration layer is obtained by using a subtractive or additive process directly on the titanium integration plate.
• Titanium is a very hard material with a greater stiffness (modulus of elasticity) than bone: this can result in the implants becoming embedded in the endplates of the vertebrae, which may cause considerable pain for the patient.
• the combination of the PEEK body with the titanium integration plate offsets a bit the dissatis of titanium's stiffness but still has a relatively large risk of damaging adjacent vertebrae.
• the integration layer of the spinal implant is in the form of a coating applied onto the substrate.
• such a coating layer on the substrate can greatly have a greatly decreased thickness.
• the implant will show more the better elasticity and/or stiffness properties of the polymer substrate decreasing the risk that vertebrae become damaged, especially when a metal containing coating is used.
• the presence of the coating can provide improved cell adhesion properties such that an improved healing effect is obtained.
• such a configuration allows conferring the more adapted mechanical properties of, for example, PEEK, thus for example reducing the risk of embedment in the endplates of the vertebrae, together with the improved cell-growth promotion characteristics of the coating. This combination allows, for example, an acceleration of the development of a stable bone bridge and a faster healing of the patient.
• the thickness of the integration layer can be reduced down to the nanometer range.
• This step of coating can be for example performed by using a sputtering deposition technique.
• a high-energy ionic beam for example an argon beam
• the beam releases titanium atoms which are then deposited on the object to be coated.
• the texture in which the distance, preferably depth, between adjacent local extrema is less than 1 mm, for example in micrometer range, into and/or onto the biocompatible polymer material, for example directly into the biocompatible polymer material, and to subsequently cover the texture in the polymer material with the coating without substantially altering the texture.
• the texture of the implant is substantially defined by the texture of the substrate.
• the coating is a metal containing coating. It has been found that such coating can be relatively easily applied by sputtering techniques and can offer improved cell adhesion properties.
• the metal of the metal containing coating is one of the list consisting of titanium, aluminium, vanadium, tantalum, stainless steel, and alloys of these materials. It has been found that these metals, especially titanium, have very good cell-growth promoting characteristics, and improve healing. More preferably, the metal containing coating is a metal coating.
• the metal containing coating comprises a metal coating.
• the metal of the metal coating is one of titanium and a titanium alloy.
• the metal coating is a titanium coating. It has been found that titanium has good cell adhesion properties and therefore offers good healing properties.
• the metal containing coating comprises a metal oxide, the metal of the metal oxide being one of the list consisting of titanium, aluminium, vanadium, tantalum, stainless steel, and alloys of these materials, for example titanium oxide.
• the coating comprises any one or more of calcium phosphate, hydroxyapatite. It has been found that such materials also offer good cell adhesion properties. According to preferred embodiments of the current invention, the coating is in the form of any one of amorphous, crystalline, polycrystalline, nanocrystalline, etc.
• coatings especially titanium comprising coatings, for example a titanium coating
• coatings especially coatings having a thickness of between 0.3 nm - 5 ⁇ , preferably between 100 nm - 2.5 ⁇ , more preferably 250 nm, follow the deformation of the substrate, also adding to the improved elasticity and/or stiffness properties.
• Such properties for example avoid that the coating flakes off the substrate.
• a coating of 250 nm offers a visual check that a coating is present in the implant, for example for the practitioner, for example a surgeon, having to perform the operation.
• the reduced thickness of the coating layer for example the thicknesses mentioned above, on the substrate also improves the transparency of the spinal implant, especially when the coating comprises a metal containing coating, for example for X-rays, for example in classic X-ray photography and/or X-ray computed tomography (CT), magnetic resonance imaging (MRI) and/or single-photon emission computed tomography (SPECT), so that the implant is less visible on X-ray images so that the surrounding body tissue, for example bone tissue, is better visible. Therefore, for example when monitoring the course of healing, for example the formation of bone bridges as well as for example the specific position of the implant can be more clearly and more distinctly observed and recognized.
• CT X-ray computed tomography
• MRI magnetic resonance imaging
• SPECT single-photon emission computed tomography
• the texture is engineered in the form of grooves and/or holes. It has been found that such a texture offers good cell adhesion properties.
• the grooves and/or holes follow a periodic pattern.
• a periodic pattern of grooves preferably a periodic pattern of parallel grooves, wherein the grooves have a depth of between 200 nm and 1 ⁇ and a width of between 1 ⁇ and 10 ⁇ , preferably a depth of about 500 nm and a width of about 4 ⁇ .
• surface roughness and/or waviness can improve the cell adhesion properties of the surface of the implant. It has for example been found that grooves allow to increase the cell adhesion properties as they induce cell contact guidance.
• the integration layer is located on the outer surface of the substrate, allowing a more direct contact between the integration layer and the human body cells and thus optimizing the integration of the implant in the human body and therefore, the healing.
• the distance between the adjacent local extrema is between 0.3 ⁇ and 150 ⁇ , preferably 0.5 ⁇ and 130 ⁇ . It has been found that such distances confer a roughened texture to the integration layer and further improve the cell adhesion properties, and increases the surface of contact between the human body and the spinal implant.
• the integration layer has a thickness in the nanometer range. It has been found that such thicknesses confer to the implant better elasticity properties and decreases the risk that vertebrae become damaged.
• the thickness of the integration layer is between 0.3 nm and 5 ⁇ , preferably between 100 nm and 2.5 ⁇ , more preferably about 250nm, or even 250 nm.
• the metal containing coating has a thickness in the nanometer range.
• the metal coating has a thickness in the nanometer range.
• the biocompatible polymer is one of the list comprising polyether ketone ketone (PEKK), polyether ether ketone (PEEK), ultra high molecular weight polyethylene, preferably polyetheretherketone (PEEK). It has been found that such material have mechanical properties that are adapted to a clinical use, for example as spinal implants.
• the thickness of the integration layer remains substantially constant. It has been established that a substantial constant thickness, preferably a constant thickness, of the integration layer allows the texture of the spinal implant not to be altered.
• the spinal implant is an intersomatic cage.
• intersomatic cages can for example be found in WO201 1/054958.
• the metal containing coating is located on the vertebrae contacting surfaces, allowing a more direct and/or intimate contact between the integration layer and the human body cells and thus optimizing the tolerance of the human body towards the implant and therefore, the healing.
• the implant comprises cavities extending between the vertebrae contacting surfaces and at least part of the metal containing coating is located on the outer surface of the cavities. It has been found that such cavities make a more intimate interconnection between the vertebrae contacting the vertebrae contacting surfaces possible.
• the invention also relates to a method for making the spinal implant according to the invention.
• the method comprises coating a substrate having a texture at the outer surface of said substrate with the coating. It has been found that this method of coating is easily applicable.
• the coating is done by physical vapour deposition, preferably a cold vapour deposition technique, preferably a sputtering deposition technique, for example by any one of or combinations of direct current (DC) sputtering, alternating current (AC) sputtering, radio frequency (RF) sputtering, reactive sputtering, for example to make a metal oxide coating.
• DC direct current
• AC alternating current
• RF radio frequency
• this technique allows the production of controlled coating thicknesses, thus generating homogeneous titanium coating onto the polymer material, for example PEEK.
• the use of such sputter deposition technique allows the thickness of the integration layer to be controlled with a precision in the nanometer range, thus allowing a precise monitoring of the process.
• Other physical vapour deposition techniques such as plasma deposition although less preferred are also possible.
• an ion-beam preferably an Argon-beam, preferably a high energy ion-beam
• a surface preferably a metal containing surface, for example a metal surface, for example a titanium surface, for example a metal containing wafer, for example a metal wafer, for releasing atoms, for example metal atoms, from the surface, and wherein the released atoms are then deposited onto the texture of the substrate.
• Figure 1 a shows a view in perspective of a spinal implant, more in particular an intersomatic cage, more in particular a median intersomatic cage, according to the invention.
• Figure 1 b shows a view of a kit of spinal implants according to the invention.
• the median intersomatic cage 1 shown on figure 1 a has a first lateral wall 2 and a second lateral wall 3 positioned on both sides of the bone tissue cavities 4. Both lateral walls 2, 3 preferably, as shown in the figures, are significantly planar. Furthermore, as a result of the conception of the lateral walls 2, 3, this median intersomatic cage 1 can be positioned in the two possible ways between two vertebrae. As shown in figure 1 , each lateral wall 2, 3 preferably comprises openings 7 allowing for blood-circulation for osteo- integration, once the median intersomatic cage 1 has been implanted between the two vertebrae. Such openings 7 are however not critical for the invention and can be omitted.
• the implant 1 shown in figure 1 is substantially beam-shaped, this is however not critical for the invention and other shapes deemed appropriate by the person skilled in the art can be used.
• the median intersomatic cage 1 as shown in figure 1 a and 1 b comprises two metal indicators, for example made from tantalum although any other material is possible, 8 (one of which is not visible on figure 1 a), in order to check with for exmaple X-ray imaging techniques that the median intersomatic cage has not migrated once that it has been implanted into the patient.
• the median intersomatic cage 1 as shown in figure 1 a and 1 b preferably comprises a mechanical engraving 9 allowing its identification with respect to other intersomatic cages.
• This mechanical engraving 9 is not critical for the invention.
• the median intersomatic cage 1 for example is implanted in the space between two vertebrae in a posterior unilateral way, using for example a cage-holder (not represented on figure 1 a).
• the median intersomatic cage 1 has been sterilized using gamma-rays.
• the intersomatic cage can be used alone or coupled to other intersomatic cages, according to, for example, the morphology of the patient.
• Figure 1 b is a perspective view of a kit 10 kit of three spinal implants according to the invention. Although several spinal implants may be necessary to obtain the desired result, this is not critical for the invention as also a single spinal implant may be sufficient or, for example, two, four, five, six seven, eight, or even more spinal implants 1 .
• the kit 10 specifically shown in figure 1 b comprises two intersomatic cages 5, 6 and one median intersomatic cage 1 .
• the exact configuration of the kit 10 is however not critical for the invention.
• the intersomatic cages 5, 6 and the median intersomatic cage 1 of kit 10 comprise two cavities 4 each, for bone tissue, as well as openings 7 allowing blood circulation for osteo-integration once said intersomatic cages 5,6 and median intersomatic cage 1 are implanted in an intervertrebrae space, preferably of lumbar vertrebrae.
• the number, dimensions, shape and presence of the cavities 4 are however not critical for the invention and can be determined by the person skilled in the art depending on the desired configuration.
• the intersomatic cages 5, 6 and the median intersomatic cage 1 of kit 10 moreover comprise fixation means 15, allowing the fixation of a cage- holder.
• the fixation means can be any means that are deemed appropriate by the person skilled in the art and can for example be in the form of holes, for example screw holes for receiving screws. This is however not critical for the invention and other configurations deemed appropriate by the person skilled in the art are possible.
• the median intersomatic cage 1 has lateral walls 2, 3 that are significantly planar, and that are conceived to form a contact surface adapted respectively to the intern surface 1 1 of the intersomatic cage 6 and to the intern surface 12 of the intersomatic cage 5.
• the intern surfaces 1 1 , 12 are significantly planar aswell.
• the outer surface 13 of the intersomatic cage 6 and the outer surface 14 of the intersomatic cage 5 preferably are significantly curved from the side, as shown in the figures, in order to facilitate the shift of said cages 5, 6 after their introduction between the vertebrae.
• the surgeon can decide to implant the intersomatic cages 5, 6 with or without the median intersomatic cage 1 in between two vertebrae, according to the patient's morphology. Also, the space between the intersomatic cages are adapted to the morphology of the patient therefore allowing to fit a very broad panel of morphologies, with one single size of implants.
• the intersomatic cages 5, 6 and the median intersomatic cage 1 comprise a mechanical engraving 9 allowing their identification.
• the indication "II” is engraved on cage 1
• the indications ⁇ " and “IN” are engraved respectively on cages 5 and 6.
• These mechanical engravings 9 are not critical for the invention.
• intersomatic cages 5, 6 and the median intersomatic cage 1 of kit 10 according to the invention have been sterilized using gamma-rays.
• the intersomatic cages 5, 6 and the median intersomatic cage 1 preferably comprise, as shown in figure 1 b, two tantalum indicators 8 (one of which is not visible on figure 1 b), in order to check with X- ray imaging techniques that the median intersomatic cage has not migrated once that it has been implanted into the patient.
• the implant 1 , 5, 6 comprise a substrate 16.
• the substrate 16 preferably forms a substantial part of the implant, as can be seen in the figures.
• the implant further comprises at least one integration layer 17 at an outer surface of the spinal implant.
• the integration 17 has only been shown on top of the substrate 16. This is however not critical for the invention and the integration layer 17 can also be provided on other surfaces such as, for example, the later walls 2, 3, the bottom of the substrate, etc.
• the integration layer 17 is located on the outer surface of the substrate 16 and/or the integration layer 17 is located on vertebrae contacting surfaces 18 and/or the outer surface of the cavities 4.
• the substrate 16 of the implant according to the invention for example the intersomatic cages 5, 6 and of the median intersomatic cage 1 shown in figure 1 a and is made of a biocompatible polymer, for example any one ore more of polyether ether ketone (PEEK), polyether ketone ketone (PEKK), ultra-high molecular weight polyethylene (UMHPWE).
• PEEK polyether ether ketone
• PEKK polyether ketone ketone
• UMHPWE ultra-high molecular weight polyethylene
• the substrate is substantially made of a single biocompatible polymer, for example PEEK.
• a texture is engineered on the PEEK surface in which the distance between adjacent local extrema is less than 1 mm, for example in micrometer range. Then, after coating the integration onto the texture the texture can remain substantially unaffected due to the relatively small thickness of the integration layer.
• the integration layer 17 for example is in the form of a metal containing coating applied onto the substrate.
• the metal containing coating can be in the form of a metal-only coating.
• the metal containing coating can be a metal-only layer, for example titanium, covered with a layer of metal oxide, for example titanium oxide, which can be a result of the natural oxidation of the metal due to air exposure, or deposited with a sputtering technique, for example the same sputtering technique and/or reactive sputtering.
• Another embodiment of this invention is a metal-containing coating on a substrate, the metal containing coating being for example exclusively a metal oxide, for example a layer of titanium oxide deposited with a sputtering technique.
• the integration layer 17 for example can also be in the form of a calcium phosphate coating, which can for example be sputtered on top of the substrate 16, or can be applied in combination with the metal containing coating.
• the integration layer 17 can be in the form of a calcium phosphate coating, which is sputtered on top of the previously applied metal containing coating, preferably metal coating, more preferably titanium coating.

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• 2013
  • 2013-10-02 WO PCT/EP2013/070589 patent/WO2015048997A1/en not_active Application Discontinuation
• 2014
  • 2014-09-30 WO PCT/EP2014/070902 patent/WO2015049222A1/en active Application Filing
  • 2014-09-30 BR BR112016007334-7A patent/BR112016007334B1/pt active IP Right Grant
  • 2014-09-30 CN CN201480059302.4A patent/CN105939691B/zh active Active
  • 2014-09-30 ES ES14789533T patent/ES2770416T3/es active Active
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