WO2007000061A1 - Method for manufacturing a surgical implant - Google Patents

Method for manufacturing a surgical implant Download PDF

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Publication number
WO2007000061A1
WO2007000061A1 PCT/CH2005/000354 CH2005000354W WO2007000061A1 WO 2007000061 A1 WO2007000061 A1 WO 2007000061A1 CH 2005000354 W CH2005000354 W CH 2005000354W WO 2007000061 A1 WO2007000061 A1 WO 2007000061A1
Authority
WO
WIPO (PCT)
Prior art keywords
cavities
implant
spherical
coating
range
Prior art date
Application number
PCT/CH2005/000354
Other languages
French (fr)
Inventor
Armin Studer
Original Assignee
Synthes Gmbh
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 Synthes Gmbh filed Critical Synthes Gmbh
Priority to PCT/CH2005/000354 priority Critical patent/WO2007000061A1/en
Publication of WO2007000061A1 publication Critical patent/WO2007000061A1/en

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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
    • A61F2/30767—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
    • 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
    • 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
    • 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
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30108—Shapes
    • A61F2002/30199—Three-dimensional shapes
    • A61F2002/30205—Three-dimensional shapes conical
    • A61F2002/3021—Three-dimensional shapes conical frustoconical
    • 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
    • A61F2002/30317—The prosthesis having different structural features at different locations within the same prosthesis
    • A61F2002/30322—The prosthesis having different structural features at different locations within the same prosthesis differing in surface structures
    • 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
    • A61F2002/30317—The prosthesis having different structural features at different locations within the same prosthesis
    • A61F2002/30327—The prosthesis having different structural features at different locations within the same prosthesis differing in diameter
    • 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
    • A61F2002/30795—Blind bores, e.g. of circular cross-section
    • A61F2002/30807—Plurality of blind bores
    • A61F2002/30808—Plurality of blind bores parallel
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • 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
    • A61F2002/30795—Blind bores, e.g. of circular cross-section
    • A61F2002/30813—Stepped or enlarged blind bores, e.g. having discrete diameter changes
    • 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
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2002/3093—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth for promoting ingrowth of bone tissue
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0067—Three-dimensional shapes conical
    • 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
    • A61F2250/0026—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 surface structures
    • 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
    • A61F2250/0039—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 diameter
    • 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

Definitions

  • the invention relates to a method for manufacturing a surgical implant according to the concept of claim 1 and to a surgical implant according to the concept of claim 13.
  • the invention intends to provide remedial measures.
  • the invention is based on the objective of providing a method allowing to manufacture a plurality of cavities having an undercut on the surface of an implant, whereby location, shape and dimension of the cavities may be previously selected and determined. This allows to arbitrarily select the retention of the surface.
  • the invention solves the posed problem with a method including the features of claim 1 , as well as with an implant including the features of claim 13.
  • a clean surface structure for a surgical implant which may be previously manufactured and be provided with cavities in a second step.
  • the cavities are manufactured through turning on a lathe or through milling.
  • the cavities may have a spherical shape, preferably in the form of a spherical layer, truncated spherical sector or spherical segment.
  • the radius of the respective spherical zone or cap is preferably in the range of 1 ,0 to 2,0 mm.
  • at least 50% of said cavities have a periphery viewed in a cross-section perpendicular to the surface with a central angle ⁇ in the range of 181 ° to 350°.
  • at least 50% of said cavities have a spherical surface portion located within said implant, said spherical surface portions having arcs of great circles with central angles ⁇ in the range of 10° to 179°.
  • the cavities are arranged regularly with regard to their location on the surface.
  • the cavities are arranged irregularly with regard to their location and are preferably placed non-linearly. The advantage of the non-linear arrangement of the cavities is to be seen in the fact that a perforation of the end plates of the adjacent vertebral bodies through the implant may be prevented.
  • portions of the surface remain free of cavities.
  • the areas without cavities of such implants have a higher mechanical strength.
  • a further advantage is that the areas without cavities may be used for the acceptance of instruments, e.g. for manipulation of the implant.
  • the size of the cavities is different depending on the location of the cavity on the surface. This allows a better adaptation of the structured surface to different bone qualities.
  • an intervertebral implant may be provided with larger cavities in the peripheral area, particularly in the lateral and anterior portions of the apposition surface and the central area of the apposition surface may be provided with smaller and preferably more grippy cavities.
  • the shape of the individual cavities varies, therewith allowing a better matching to the bone structure.
  • the cavities may be mutually connected.
  • the implant manufactured according to the method according to the invention may consist of a plastic material, preferably of PEEK.
  • the implant is provided with a coating of titan, preferably manufactured by cathodic evaporation.
  • the implant may also be provided with a synthetic coating at locations where the cavities are positioned.
  • the implant is built as an intervertebral implant whereby at least the surfaces of the apposition surfaces of the implant that are determined for contacting the end plates of two intervertebral bodies are provided with a plurality of cavities.
  • Fig. 1 is a longitudinal section through the surface region of a surgical implant with cavities having spherical undercuts according to one embodiment of the invention
  • Fig. 2 is a top view on the surface region of the surgical implant shown in fig. 1 ;
  • Fig. 3 is a longitudinal section through the surface region of a surgical implant with cavities having frusto-conical undercuts according to another embodiment of the invention
  • Fig. 4 is a longitudinal section through the surface region of a surgical implant with cavities having undercuts that are shaped spherical/conical according to a further embodiment of the invention.
  • Fig. 5 is a longitudinal section through the surface region of a surgical implant with a plurality of cavities having undercuts according to one embodiment of the invention.
  • the structured surfaces 2 shown in figs. 1 and 2 are related to the surface region of a surgical implant 1 , the surface region here being part of the apposition surface of an intervertebral implant.
  • the smaller and larger cavities 3 are arranged in an irregular manner of the surface 2 and are provided with an undercut 5 as shown in fig. 1.
  • the cavities 3 have been produced by milling in the example presented here and have a spherical shape.
  • the manufacturing of the cavities 3 is effected in a first step via milling of cylindrical spaces and subsequently in a second step by means of a profiled or spherical cutter by means of which the size and the shape of the cavities 3 may be determined.
  • the cavities 3 have the shape of a spherical layer having a spherical surface portion located within said implant, said spherical surface portions having arcs of great circles with central angles ⁇ in the range of 20° to 50°. Furthermore, the cavities 3 have a periphery viewed in the cross-section perpendicular to the surface 2 with a central angle ⁇ in the range of 200° to 300°.
  • Fig. 3 depicts an embodiment of the structured surface 2 wherein the cavities 3 have a conical undercut 5. Therefore the form of the cavities 3 is frusto-conical.
  • Fig. 4 depicts another embodiment of the structured surface 2 wherein the cavities 3 having a spherical/conical undercut 5.
  • the general form of the cavities is frusto-conical whereby the edge adjacent the base of the conical frustrum is rounded.
  • Fig. 5 depicts a further embodiment of the structured surface wherein the cavities 3 have undercuts 5 in the form of a spherical layer, e.g. as shown in fig. 1. Furthermore, the fins 6 of material that are formed between the cavities 3 converge into edges at their free ends.

Abstract

A method is provided for manufacturing a surgical implant (1) having a structured surface (2) for improving the growing on of bone tissue. A plurality of cavities (3) are mechanically produced on said surface (2). Said cavities (3) are provided with an undercut (5).

Description

Method for manufacturing a surgical implant
The invention relates to a method for manufacturing a surgical implant according to the concept of claim 1 and to a surgical implant according to the concept of claim 13.
Methods by means of which the surface of a surgical implant is provided with a plurality of cavities, e.g. via chemistry through etching are already known. These known methods have the objective to increase growing on of bone tissue to a surface of the implant accordingly structured. This chemical method shows the disadvantage that location, shape and dimension of the cavities manufactured through etching may not be previously defined. A further disadvantage of this chemical method is that the surface of the implant is damaged through the strongly aggressive etchant.
Other methods use laser techniques in order to structure the surface, whereby no clearly defined cavities are achievable as well.
On this point, the invention intends to provide remedial measures. The invention is based on the objective of providing a method allowing to manufacture a plurality of cavities having an undercut on the surface of an implant, whereby location, shape and dimension of the cavities may be previously selected and determined. This allows to arbitrarily select the retention of the surface.
The invention solves the posed problem with a method including the features of claim 1 , as well as with an implant including the features of claim 13.
Additional advantageous embodiments of the invention are characterized in the subclaims.
The advantages achieved by the invention are essentially to be seen in the fact that thanks to the method according to the invention a clean surface structure for a surgical implant which may be previously manufactured and be provided with cavities in a second step. In a particular embodiment the cavities are manufactured through turning on a lathe or through milling.
The cavities may have a spherical shape, preferably in the form of a spherical layer, truncated spherical sector or spherical segment. The radius of the respective spherical zone or cap is preferably in the range of 1 ,0 to 2,0 mm. Preferably, at least 50% of said cavities have a periphery viewed in a cross-section perpendicular to the surface with a central angle β in the range of 181 ° to 350°. Typically, at least 50% of said cavities have a spherical surface portion located within said implant, said spherical surface portions having arcs of great circles with central angles α in the range of 10° to 179°.
In a further embodiment the cavities are arranged regularly with regard to their location on the surface. In another embodiment the cavities are arranged irregularly with regard to their location and are preferably placed non-linearly. The advantage of the non-linear arrangement of the cavities is to be seen in the fact that a perforation of the end plates of the adjacent vertebral bodies through the implant may be prevented.
Preferably, portions of the surface remain free of cavities. The areas without cavities of such implants have a higher mechanical strength. A further advantage is that the areas without cavities may be used for the acceptance of instruments, e.g. for manipulation of the implant.
In a particular embodiment the size of the cavities is different depending on the location of the cavity on the surface. This allows a better adaptation of the structured surface to different bone qualities. For example an intervertebral implant may be provided with larger cavities in the peripheral area, particularly in the lateral and anterior portions of the apposition surface and the central area of the apposition surface may be provided with smaller and preferably more grippy cavities.
In a further embodiment the shape of the individual cavities varies, therewith allowing a better matching to the bone structure.
The cavities may be mutually connected. The implant manufactured according to the method according to the invention may consist of a plastic material, preferably of PEEK. In one embodiment the implant is provided with a coating of titan, preferably manufactured by cathodic evaporation. The implant may also be provided with a synthetic coating at locations where the cavities are positioned.
In a preferred embodiment the implant is built as an intervertebral implant whereby at least the surfaces of the apposition surfaces of the implant that are determined for contacting the end plates of two intervertebral bodies are provided with a plurality of cavities.
The invention and additional configurations of the invention are explained in even more detail with reference to the partially schematic illustration of several embodiments. In the drawings:
Fig. 1 is a longitudinal section through the surface region of a surgical implant with cavities having spherical undercuts according to one embodiment of the invention;
Fig. 2 is a top view on the surface region of the surgical implant shown in fig. 1 ;
Fig. 3 is a longitudinal section through the surface region of a surgical implant with cavities having frusto-conical undercuts according to another embodiment of the invention;
Fig. 4 is a longitudinal section through the surface region of a surgical implant with cavities having undercuts that are shaped spherical/conical according to a further embodiment of the invention; and
Fig. 5 is a longitudinal section through the surface region of a surgical implant with a plurality of cavities having undercuts according to one embodiment of the invention.
The structured surfaces 2 shown in figs. 1 and 2 are related to the surface region of a surgical implant 1 , the surface region here being part of the apposition surface of an intervertebral implant. The smaller and larger cavities 3 are arranged in an irregular manner of the surface 2 and are provided with an undercut 5 as shown in fig. 1. The cavities 3 have been produced by milling in the example presented here and have a spherical shape. The manufacturing of the cavities 3 is effected in a first step via milling of cylindrical spaces and subsequently in a second step by means of a profiled or spherical cutter by means of which the size and the shape of the cavities 3 may be determined. The cavities 3 have the shape of a spherical layer having a spherical surface portion located within said implant, said spherical surface portions having arcs of great circles with central angles α in the range of 20° to 50°. Furthermore, the cavities 3 have a periphery viewed in the cross-section perpendicular to the surface 2 with a central angle β in the range of 200° to 300°.
Fig. 3 depicts an embodiment of the structured surface 2 wherein the cavities 3 have a conical undercut 5. Therefore the form of the cavities 3 is frusto-conical.
Fig. 4 depicts another embodiment of the structured surface 2 wherein the cavities 3 having a spherical/conical undercut 5. In the example here the general form of the cavities is frusto-conical whereby the edge adjacent the base of the conical frustrum is rounded.
Fig. 5 depicts a further embodiment of the structured surface wherein the cavities 3 have undercuts 5 in the form of a spherical layer, e.g. as shown in fig. 1. Furthermore, the fins 6 of material that are formed between the cavities 3 converge into edges at their free ends.

Claims

Claims
1. Method for manufacturing a surgical implant (1) having a structured surface (2) for improving the growing on of bone tissue characterized in that a plurality of cavities (3) are mechanically produced on the surface (2), said cavities (3) being provided with an undercut (5).
2. Method according to claim T, wherein the cavities (3) are produced by means of turning on a lathe or milling.
3. Method according to claim 1 or 2, wherein the cavities (3) have a spherical shape.
4. Method according to claim 3, wherein the radii of the cavities (3) are in the range of 1 ,0 to 2,0 mm.
5. Method according to one of the claims 1 to 4, wherein at least 50% of said cavities (3) have a periphery viewed in a cross-section perpendicular to the surface (2) with a central angle β in the range of 181° to 350°.
6. Method according to one of the claims 1 to 5, wherein at least 50% of said cavities (3) have spherical surface portion located within said implant, said spherical surface portions having arcs of great circles with a central arc α in the range of 10° to 179°.
7. Method according to one of the claims 1 to 6, wherein the cavities (3) are regularly placed on the surface (2) regarding their position.
8. Method according to one of the/claims 1 to 6, wherein the cavities (3) are irregularly arranged on the surface (2) regarding their position and are preferably placed non- linearly.
9. Method according to one of the claims 1 to 8, wherein portions of the surface (2) are free of cavities (3).
10. Method according to one of the claims 1 to 9, wherein the size of the cavities (3) is different with regard to their position on the surface (2).
11. Method according to one of the claims 1 to 10, wherein the shape of the individual cavities (3) varies.
12. Method according to one of the claims 1 to 1 , wherein the cavities (3) are mutually connected.
13. Implant (1) with a structured surface (2) for improving the growing on of bone tissue, being provided with a plurality of cavities (3) in the surface (2), whereby said cavities (3) are provided with an undercut (5) characterized in that said undercuts (5) have been obtained by mechanical processes only.
14. Implant (1) produced according to the method according to one of the claims 1 to 12.
15. Implant (1) according to claim 13 or 14, wherein said implant comprises a plastic material, preferably PEEK and preferably has a coating of titan.
16. Implant (1) according to one of the claims 13 to 15, wherein said implant is provided with a plastic coating in which the cavities (3) are placed.
17. Implant (1) according to according to one of the claims 13 to 16, wherein said implant is provided with a coating of titan, said coating being preferably deposited by means of cathodic evaporation.
18. Implant (1) according to one of the claims 13 to 17, for use as an intervertebral implant and having two appositional surfaces apt to bear against the end plates of two juxtaposed vertebral bodies and wherein at least the surfaces (2) of said two appositional surfaces are provided with a plurality of cavities (3).
PCT/CH2005/000354 2005-06-27 2005-06-27 Method for manufacturing a surgical implant WO2007000061A1 (en)

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EP2286767A1 (en) * 2009-08-21 2011-02-23 Jossi Holding AG Method for producing a structured surface on a workpiece from a metallic material and implant with such a surface
US8140107B1 (en) 2008-01-04 2012-03-20 Sprint Spectrum L.P. Method and system for selective power control of wireless coverage areas

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Cited By (2)

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Publication number Priority date Publication date Assignee Title
US8140107B1 (en) 2008-01-04 2012-03-20 Sprint Spectrum L.P. Method and system for selective power control of wireless coverage areas
EP2286767A1 (en) * 2009-08-21 2011-02-23 Jossi Holding AG Method for producing a structured surface on a workpiece from a metallic material and implant with such a surface

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