WO2008057565A2 - Articulations artificielles élastiques et leurs procédés de fabrication - Google Patents

Articulations artificielles élastiques et leurs procédés de fabrication Download PDF

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Publication number
WO2008057565A2
WO2008057565A2 PCT/US2007/023460 US2007023460W WO2008057565A2 WO 2008057565 A2 WO2008057565 A2 WO 2008057565A2 US 2007023460 W US2007023460 W US 2007023460W WO 2008057565 A2 WO2008057565 A2 WO 2008057565A2
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WO
WIPO (PCT)
Prior art keywords
layer
magnetized
resistant layer
sphere
corrosion resistant
Prior art date
Application number
PCT/US2007/023460
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English (en)
Other versions
WO2008057565A3 (fr
Inventor
Zongtao Zhang
Daniel E. Lawrynowicz
Aiguo Wang
Original Assignee
Howmedica Osteonics Corp.
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 Howmedica Osteonics Corp. filed Critical Howmedica Osteonics Corp.
Publication of WO2008057565A2 publication Critical patent/WO2008057565A2/fr
Publication of WO2008057565A3 publication Critical patent/WO2008057565A3/fr

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    • 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
    • A61F2/32—Joints for the hip
    • 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
    • A61F2/38—Joints for elbows or knees
    • A—HUMAN NECESSITIES
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    • 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
    • A61F2/4425—Intervertebral or spinal discs, e.g. resilient made of articulated components
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    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/28—Materials for coating prostheses
    • A61L27/30—Inorganic materials
    • A61L27/306—Other specific inorganic materials not covered by A61L27/303 - A61L27/32
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    • C—CHEMISTRY; METALLURGY
    • C23—COATING METALLIC MATERIAL; COATING MATERIAL WITH METALLIC MATERIAL; CHEMICAL SURFACE TREATMENT; DIFFUSION TREATMENT OF METALLIC MATERIAL; COATING BY VACUUM EVAPORATION, BY SPUTTERING, BY ION IMPLANTATION OR BY CHEMICAL VAPOUR DEPOSITION, IN GENERAL; INHIBITING CORROSION OF METALLIC MATERIAL OR INCRUSTATION IN GENERAL
    • C23C—COATING METALLIC MATERIAL; COATING MATERIAL WITH METALLIC MATERIAL; SURFACE TREATMENT OF METALLIC MATERIAL BY DIFFUSION INTO THE SURFACE, BY CHEMICAL CONVERSION OR SUBSTITUTION; COATING BY VACUUM EVAPORATION, BY SPUTTERING, BY ION IMPLANTATION OR BY CHEMICAL VAPOUR DEPOSITION, IN GENERAL
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    • C—CHEMISTRY; METALLURGY
    • C23—COATING METALLIC MATERIAL; COATING MATERIAL WITH METALLIC MATERIAL; CHEMICAL SURFACE TREATMENT; DIFFUSION TREATMENT OF METALLIC MATERIAL; COATING BY VACUUM EVAPORATION, BY SPUTTERING, BY ION IMPLANTATION OR BY CHEMICAL VAPOUR DEPOSITION, IN GENERAL; INHIBITING CORROSION OF METALLIC MATERIAL OR INCRUSTATION IN GENERAL
    • C23C—COATING METALLIC MATERIAL; COATING MATERIAL WITH METALLIC MATERIAL; SURFACE TREATMENT OF METALLIC MATERIAL BY DIFFUSION INTO THE SURFACE, BY CHEMICAL CONVERSION OR SUBSTITUTION; COATING BY VACUUM EVAPORATION, BY SPUTTERING, BY ION IMPLANTATION OR BY CHEMICAL VAPOUR DEPOSITION, IN GENERAL
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    • C23—COATING METALLIC MATERIAL; COATING MATERIAL WITH METALLIC MATERIAL; CHEMICAL SURFACE TREATMENT; DIFFUSION TREATMENT OF METALLIC MATERIAL; COATING BY VACUUM EVAPORATION, BY SPUTTERING, BY ION IMPLANTATION OR BY CHEMICAL VAPOUR DEPOSITION, IN GENERAL; INHIBITING CORROSION OF METALLIC MATERIAL OR INCRUSTATION IN GENERAL
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    • H01F1/057—Alloys characterised by their composition containing rare earth metals and magnetic transition metals, e.g. SmCo5 and IIIa elements, e.g. Nd2Fe14B
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Definitions

  • the present invention is directed to an artificial joint for implantation into a living body and methods for constructing such an artificial joint.
  • Orthopedics is a medical subspecialty that treats disorders of the human body related to bones, muscles, ligaments, tendons, and joints, with its current emphasis on the treatment of the bones and joints.
  • the treatment of bone and joint disorders can be generally subclassified into categories including the treatment of bone fractures, joint instability, early stage arthritis, and end stage arthritis.
  • the treatment of orthopedic conditions mainly relied on casting and bracing.
  • With the advent of new implantable materials, however, and development of better joint replacement prostheses, orthopedics shifted its focus to become increasingly more of a surgical subspecialty. With improved materials, better engineering, and a better understanding of the human body, the practice of orthopedic medicine and biomechanical experimentation have made remarkable progress.
  • the treatment of bone fractures and joint disorders has continually been refined to the present state of the art.
  • the component may include a first element having a first magnetized layer disposed thereon, wherein the first magnetized layer is configured with a pole facing in a generally proximal direction normal to the surface.
  • There may also be a second element having a second magnetized layer disposed thereon.
  • the second element may be configured to engage the first element, and the second magnetized layer may be configured with an equivalent pole facing in a generally distal direction normal to the surface.
  • the pole of the first magnetized layer may be thereby positioned opposite the equivalent pole of the second magnetized layer to create a repellant force therebetween.
  • the component may further include a corrosion resistant layer covering the surfaces of the first and second elements adjacent the first and second magnetized layers. Further preferably, the component may also include a wear resistant layer covering the surfaces of the first and second elements adjacent the corrosion resistant layer and forming a bearing surface of the prosthetic bearing component .
  • the magnetized layers of the prosthetic bearing component may be composed of a material selected from the group consisting of Nd-Fe-B, Sm- Co, SmCo 5 , and Sm 2 O 17 .
  • the corrosion resistant layer may be composed of a material selected from the group consisting of titanium, niobium, chromium, zirconium, tantalum, gold, silver, titanium nitride, titanium aluminum nitride, titanium carbonitride, chromium nitride, chromium carbonitride, zirconium nitride, and zirconium carbonitride.
  • the corrosion resistant layer may further be a film with a thickness of 0.1-50 microns.
  • the device of the present invention may also include a wear resistant layer composed of a material selected from the group consisting of chromium oxide, aluminum oxide, chromium carbide, zirconium oxide, polyurethane, artificial cartilage, and ultra high molecular weight polyethylene.
  • the wear resistant layer may also be a film with a thickness of 50-1000 microns.
  • a further embodiment of the present invention relates to a medical implant.
  • This implant may include a substrate, a magnetized layer attached to the substrate, a corrosion resistant layer disposed adjacent to the magnetized layer, and an outwardly facing wear resistant layer disposed adjacent to the corrosion resistant layer.
  • the magnetized layer may be composed of a material selected from the group consisting of Nd-Fe-B, Sm- Co, SmCo 5 , and Sm 2 O 17 .
  • the corrosion resistant layer may preferably be composed of a material selected from the group consisting of titanium, niobium, chromium, zirconium, tantalum, gold, silver, titanium nitride, titanium aluminum nitride, titanium carbonitride, chromium nitride, chromium carbonitride, zirconium nitride, and zirconium carbonitride. Further preferably, the corrosion resistant layer may be a film with a thickness of 0.1-5 microns .
  • the wear resistant layer of the implant may be composed of a material selected from the group consisting of chromium oxide, aluminum oxide, chromium carbide, zirconium oxide, polyurethane, artificial cartilage, and polyethylene.
  • the wear resistant layer may be a film with a thickness of 50-100 microns.
  • Another embodiment of the present invention relates to an artificial joint.
  • the joint includes a magnetized layer, a corrosion resistant layer disposed adjacent to the magnetized layer, and an outwardly facing wear resistant layer disposed adjacent to the corrosion resistant layer.
  • the magnitude of the magnetization of the magnetized layer preferably may not be constant across the surface of the magnetized layer.
  • a further embodiment of the present invention relates to a magnetizing fixture for magnetizing a layer of a prosthetic bearing component.
  • the magnetizing fixture includes a shaft, a sphere attached to the shaft, a shaft coil wrapped around the shaft and attached to a current emitting device, a rod configured to articulate about an exterior surface of the sphere and to move in a direction perpendicular to the surface of the sphere toward and away from the sphere, and a rod coil wrapped around the rod and attached to a current emitting device.
  • the magnetizing fixture may be configured such that the sphere is positioned adjacent a substrate, and a magnetizable layer may deposited onto a surface of the substrate remote from the sphere. Similarly, the magnetizing fixture may be configured such that the magnetizable layer may be deposited onto a surface of the substrate between the substrate and the sphere.
  • the sphere may be rotated as a current is emitted through the shaft coil.
  • the rod may move perpendicularly toward and away from the magnetizable layer as a current is emitted through the rod coil, thereby applying a magnetic field across the magnetizable layer and causing the magnetizable layer to become magnetized.
  • the sphere and the shaft of the magnetizing fixture may be composed of a material selected from the group consisting of iron, cast iron, and wrought iron and have a coating composed of nickel or cobalt.
  • the shaft and the sphere may be rotated at a rate of 1-50 revolutions per minute.
  • the rod of the magnetizing fixture may be composed of iron.
  • the rod may move perpendicularly toward and away from the sphere at a rate of one minute per half cycle.
  • the magnetizing fixture of the present invention may be configured so that the magnitude of the current passing through the shaft and rod coils varies as the rod articulates relative to the sphere, whereby the magnitude of the magnetization of the magnetizable layer may be varied across the surface of the magnetizable layer.
  • a further embodiment of the present invention relates to a method of making a magnetized medical implant.
  • This method may include the steps of providing a substrate and depositing a magnetizable layer onto a surface of the substrate.
  • the method may further include magnetizing the magnetizable layer by exposing it to a magnetic field, as well as depositing a corrosion resistant layer onto the magnetizable layer.
  • the method may further include depositing a wear resistant layer onto the corrosion resistant layer.
  • the magnetic field may be generated by an electric current passing through a coil.
  • the magnetic field may be generated by a multi-pulse capacitor discharge magnetizer.
  • the corrosion and wear resistant layers may be deposited using a process selected from the group consisting of chemical vapor deposition, physical vapor deposition, sputtering, and plating.
  • proximal means close to the heart and the term “distal” means more distant from the heart .
  • FIG. 1 is a cross-sectional view of one embodiment of the present invention
  • FIG. 2 is a cross-sectional view of a portion of a femoral implant of FIG. 1 ;
  • FIG. 3 is a cross-sectional view of a portion of the femoral implant and an acetabular shell illustrated in
  • FIG. 4 is a cross-sectional view of an apparatus used to create an embodiment of the present invention
  • FIG. 4a is a cross-sectional view of an apparatus used to create an alternative embodiment of the present invention.
  • FIGS. 5 and 6 are cross-sectional views of alternate embodiments of the present invention,- and [0032]
  • FIG. 7 is a cross-sectional view of yet another alternate embodiment of the present invention.
  • FIG. 1 illustrates one embodiment of the present invention used in conjunction with a total hip system.
  • the hip system may include a femoral implant 10 having a stem 12, a neck 14 and a head 16.
  • the stem 12 and neck 14 may be constructed similar to conventional designs known in the art.
  • the stem 12 is adapted to be implanted into the medullary canal of the femur so as to anchor the femoral implant in place.
  • the stem 10 may include various anchoring mechanisms and features that can be found in conventional femoral stems.
  • the neck 14 extends outwardly from a proximal end of the femoral stem 12. A first end 15 of the neck 14 is coupled to the proximal end 13 of stem 12.
  • the neck 14 may be integrally formed with the stem 12 or may be a separate and distinct element. If the neck is a separate element, various coupling features may be included on the neck 14 and stem 12 to secure the neck to the stem. Such features may include a Morse taper, a key and key-way, as well as similar features.
  • a kit including a stem and a neck may include different sized stems and necks so that a customized procedure may be carried out for each patient.
  • a larger person may require a neck 14 having a length L, while a smaller person may only require a neck having a length L-I. Therefore, throughout this application the word "a” or “an” refers to a plurality of elements as well as a single element unless specified. Thus, a plurality of various features may be part of a kit, each having different dimensions and shapes.
  • a second end 17 of the neck 14 extends outwardly away from the stem 12.
  • the second end 17 is attachable or attached to the head 16.
  • the neck may be attached to the head 16 using various Morse tapers, ball and detent structures, and alternate coupling mechanisms known in the art.
  • the stem 12, neck 14, and head 16 may be constructed as individual elements that are capable of being assembled together, or the three elements may be a substantially integral device.
  • the head 16 is positioned adjacent the second end 17 of the neck 14 and projects outwardly away from stem 10.
  • the head 16 is preferably substantially spherical and is designed to articulate within an acetabular shell as will be discussed below.
  • a portion 21 of head 16 is illustrated.
  • Portion 21 includes an exterior surface 20 of the head 16 that articulates within or adjacent an acetabular shell.
  • the portion 21 illustrated is remote from the neck 14 of the femoral implant 10 shown in FIG. 1.
  • the head 16 includes at least three separate layers including a wear resistant layer 22, a corrosion resistant layer 24 and a magnetized layer 26. In an alternative embodiment, the corrosion resistant layer and the wear resistant layer may be combined into one layer.
  • a substrate 28 may be included during construction of the head 16, but is not required.
  • the wear resistant layer 22 is preferably exterior the other two layers and comprises an outside face of the head 16. Therefore, an outer surface 23 of the wear resistant layer 22 is positioned adjacent an inner surface of an acetabular shell, as will be described, when the femoral implant is implanted into a body.
  • the outer surface 23 actually forms an articulation surface relative to an acetabular shell. Articulation surface refers to one surface moving relative to another surface. Contact between the two surfaces is not required.
  • the wear resistant layer 22 is specifically adapted for reducing surface wear of the head 16 during the life of the implant.
  • the wear resistant layer 22 is preferably a film in the order of about 50-100 microns thick.
  • Material that may be employed for the wear resistant layer includes chromium oxide, aluminum oxide, chromium carbide, zirconium oxide, and the like, as well as various combinations of such compounds.
  • the wear resistant material may be comprised of soft material such as polyurethane, artificial cartilage and polyethylene. The positioning of the corrosion resistant layer 24 may be altered such that it is exterior to the wear resistant layer 22.
  • the corrosion resistant layer 24 is positioned below or interior to the wear resistant layer 22 and abuts an interior surface of the wear resistant layer 22. Thus, the corrosion resistant layer 24 is remote from an exterior surface of an acetabular shell.
  • the corrosion layer 24 is specifically adapted to limit corrosion of the femoral implant 10 during its life expectancy and should also be biocompatible.
  • the corrosion resistant layer 24 is a film in the order of about 0.1-5 microns thick and may include corrosion resistant metals such as titanium, niobium, chromium, zirconium, tantalum, gold and silver as well as others, or metallic compounds such as titanium nitride, titanium aluminum nitride, titanium carbonitride, chromium (III) nitride, chromium carbonitride, zirconium nitride, zirconium carbonitride and the like.
  • the positioning of the corrosion resistant layer 24 may be altered such that it is exterior to the wear resistant layer 22.
  • the wear resistant layer 22 and corrosion resistant layer 24 extend the life expectancy of the femoral implant 10 in that they provide a protective barrier that reduces surface fractures and wear as well as reducing corrosive effects, which may inhibit the implant.
  • a magnetized layer 26 Directly positioned against the corrosion resistant layer 24, remote from the wear resistant layer 22, is a magnetized layer 26.
  • the magnetized layer 26 is preferably a film, approximately 100-3,000 microns thick, and is comprised of samarium cobalt compounds such as SmCo 5 or Sm 2 O 17 , although it may also comprise other rare earth magnets of an Nd-Fe-B system or Sm-Co system.
  • the magnetized layer 26 may be formed using either powder- sintered bulk magnetic inserts encapsulated by a corrosion resistant layer or a spray deposited magnetic coating.
  • the magnetized layer 26 provides a magnetic field that extends across the wear resistant layer 22 and corrosion resistant layer 24 and beyond the outer surface of the head 16.
  • the magnetic field provides a protective magnetic shell that extends beyond the exterior surface 23 of the wear resistant layer 22, shielding the head 16 from adjacent devices that are magnetized.
  • the north pole of the magnetized layer 26 projects outwardly from the magnetized layer 26 as shown by arrow A.
  • the south pole of the magnetized layer 26 extends inward as shown by arrow B.
  • the magnetic field denoted by arrow A preferably extends perpendicular (i.e., normal to the surface) to each point of the magnetized layer 26.
  • the magnitude and strength of the protective barrier to magnetized objects is a result of the magnitude of the magnetic field emanating from the magnetized layer 26.
  • the head 16, as shown in FIGS. 1 and 2 includes a protective magnetic shield extending 360° around the circumference of the head.
  • the magnetized layer 26 does not extend entirely around an inner circumference of the head 16.
  • the magnetic field may only extend partially around the circumference of the head 16 or the magnetic field may include different magnitudes of strength at different points around the circumference of the head.
  • the magnetized layer 26 may be built on or attached to a substrate 28.
  • the substrate 28 can be a non- magnetizable material or a magnetizable material that is sufficiently strong and tough so as to serve as a base for the magnetized layer 26.
  • the substrate 16 may be hollow so as to define a hollow cavity 29 positioned within head 16.
  • the femoral implant 10, and specifically head 16, of the femoral implant is illustrated positioned within a recess 32 of an acetabular shell 30.
  • the acetabular shell 30 may be shaped and positioned within an acetabulum during total hip replacement surgery by methods known to those in the art .
  • the acetabular shell 30 provides an articulation structure in which the head 16 of the femoral implant may articulate so as to mimic normal biomechanical motion of a hip.
  • the acetabular shell 30 is constructed similar to the femoral implant 10, and therefore includes a wear resistant layer 32, a corrosion resistant layer 34, a magnetized layer 36 and a substrate 38.
  • Wear resistant layer 32 of the acetabular shell is positioned remote from a bone such as an acetabular cup in which the acetabular shell 30 is implanted.
  • the wear resistant layer 32 helps define a recess 42 of acetabular shell 30, which is configured to receive the head 16 of the femoral implant 10.
  • the wear resistant layer 32 is preferably constructed similar to the wear resistant layer 22 of the femoral stem 10 and may include the same material or similar materials as discussed previously.
  • Adjacent an inner surface of the wear resistant layer 32 is corrosion resistant layer 34.
  • the corrosion resistant layer 34 is preferably similarly constructed as the corrosion resistant layer 24 of head 16 and may include the same material or similar material as discussed previously with regard to corrosion resistant layer 24.
  • the wear resistant layer 32 and corrosion resistant layer 34 of the acetabular shell 30 are adapted to protect the acetabular shell from corrosive and wearing effects. These features extend the shelf life of the acetabular shell 30, which preferably extends the time frame for which the implant may be positioned within the body.
  • magnetized layer 36 of acetabular shell 30 Positioned adjacent the corrosion resistant layer 34 and remote from the wear resistant layer 32 is magnetized layer 36 of acetabular shell 30.
  • the magnetized layer 36 may be constructed similar to the magnetized layer 26 as discussed previously. Specifically, the magnetized layer 36 may be constructed using ether powder-sintered bulk magnets or a spray deposited magnetic coating.
  • the acetabular shell 30 also includes a substrate 38 positioned adjacent the magnetized layer 36.
  • the substrate 38 is preferably adhered to the magnetized layer 36 so as to form a bond between the two elements and may be comprised of a non-magnetizable material.
  • the substrate 38 may include a porous surface 40 that promotes bone ingrowth.
  • the substrate 38 is positioned adjacent the bone, thereby enabling the porous surface 40 to promote and aid bone ingrowth, which in turn secures the acetabular shell 30 to the adjacent bone.
  • the porous surface 40 has been described as a surface, it may extend partially through the substrate 38 or even entirely through the substrate.
  • the magnetized layer 36 may be configured such that a magnetic field emulating from the magnetized layer 36 has its north pole extending outwardly toward the head 16 of the femoral implant 10.
  • the orientation of the north pole of the magnetized layer 36 is denoted by arrow A 1 and is shown in the FIG. 3 extending in the direction of the head 16 of the femoral implant 10.
  • the north pole of the magnetized layer 26 of femoral stem 10 extends in a direction toward the acetabular shell 30 and is denoted by the arrows with character reference A.
  • FIG. 3 when the femoral implant 10 and acetabular shell 30 are implanted during surgery, their respective north poles, emanating from magnetized layers 26 and 36, oppose each other, thereby resulting in a repulsive force between the acetabular shell 30 and head 16.
  • the resultant repulsive force tends to urge the two objects apart from each other. This is highly important because similar to normal hip biomechanics, the head 16 and acetabular shell 30 are actually urged toward each other during articulation of the head respective of the acetabular shell.
  • a gap 42 between the head 16 and acetabular shell 30 results, as shown in FIG. 3.
  • the size of the gap 42 is directly proportional to the magnitude of the resultant repulsive force. For example, a relatively small repulsive force results in the head 16 and specifically the exterior surface of the wear resistant layer 22 being able to be positioned relatively close to the exterior surface of wear resistant layer 32 of acetabular shell 30. As the resultant repulsive force increases, the distance between the head 16 and acetabular shell 30 is also increased, thereby creating a larger gap between the two wear resistant layers 22, 32.
  • the resultant repulsive force of the two magnetized layers 26, 36 is computed so as to result in a gap size that reflects the normal gap size between a healthy hip and an acetabular cup, thus enabling the femoral head 16 to articulate within the acetabular shell similar to the normal biomechanics of a human hip.
  • a method of manufacture will now be described with reference to an acetabular shell. Although an acetabular shell is described, a similar method may be used to construct a femoral head or other portions of joint implants where a magnetized layer may be advantageously employed.
  • a magnetizing fixture 100 is illustrated. Magnetizing fixture 100 includes a sphere 102 attached to a shaft 104.
  • the sphere 102 and shaft 104 are preferably comprised of iron and may be attached to a device (not shown) that rotates the two at a rate of approximately 1-50 rpms .
  • the sphere 102 and shaft 104 may also be comprised of cast iron or wrought iron as well as have a coating that is made from nickel or cobalt.
  • a shaft coil 106 is wrapped around shaft 104 and attached to a current emitting device not shown in the figure. Once activated, the current emitting device may- disperse a current through the shaft coil 106 as the shaft 104 rotates within the interior space defined by the portion of the shaft coil wrapped around the shaft 104.
  • the size of sphere 102 is dependent on the desirable size of the acetabular shell as shown in FIG. 4 or on the size of the resultant feature such as a femoral head, as shown in FIG. 4a. In certain preferred embodiments, the sphere 102 has a diameter that is approximately between 28-60mm.
  • the magnetizing fixture 100 also preferably includes a rod 110, which is remote from sphere 102, but which may articulate about the exterior surface 103 of the sphere 102.
  • the rod 110 is also preferably comprised of iron and also includes a rod coil 112 wrapped around the rod. Similar to the shaft coil 106, the rod coil 112 is attached to a current emitting device (now shown in the figures) , which emits a current through the rod coil 112 during operation. A portion of the rod coil 112 is wrapped around the rod 110 such that the rod 110 remains bounded by the rod coil 112 but able to move within the coil.
  • the rod may move toward the sphere 102 and away from the sphere and preferably at a rate of one minute per half cycle.
  • a substrate 120 may be positioned near the exterior surface of sphere 102.
  • the substrate may be similar to the substrate 28 described in FIGS. 1-3 of the femoral implant 10.
  • the substrate 120 may be made from a nonmagnetizable metal or ceramic.
  • a magnetizable metal may be deposited onto a surface of the substrate 120 between the surface of sphere 102 and substrate 120. Once the substrate 120 has been coated with this magnetizable layer 122, the layer may be magnetized using magnetizing fixture 100.
  • rod 110 moves toward and away from magnetizable layer 122, thereby causing portions of the magnetizable layer 122 to become magnetized.
  • a current is also emitted through the rod coil 112 during this procedure.
  • an external magnetizing field must be applied across the magnetic layer.
  • the external magnetizing layer should be three to five times stronger than the resultant force desired.
  • the external magnetic field is generated by the electric current passing through the coil.
  • a multi-pulse capacitor discharge magnetizer may be used to create the magnetizing field for magnetizing the magnetic layer.
  • the rod may also articulate relative to the magnetizable layer as illustrated by arrows X and Y, in FIG. 4.
  • This process enables the rod to cause flash points at specific areas of the magnetizable layer 122 as the rod is brought proximate that particular area.
  • point M of the magnetizable layer 122 may be magnetized as the rod is brought proximate point M.
  • the rod may be articulated towards point P of the magnetizable layer 122 such that point P of the magnetizable layer becomes magnetized. This process is continued until all desirable portions of the magnetizable layer 122 are magnetized.
  • the magnitude of the result in magnetic force of the magnetizable layer 122 may be controlled. This process is carried out until the entire magnetizable layer 122 is magnetized such that a magnetic field emits outwardly from the layer.
  • magnetizing fixture 100 has been shown in FIG. 4 with reference to a magnetizable layer on the surface of an acetabular shell, it is to be understood that this embodiment is merely illustrative. Magnetizing fixture 100 may also be used, for example, in conjunction with other joints or joint parts, such as with a femoral head, as shown in FIG. 4a.
  • the process of magnetizing a magnetizable layer on the surface of a femoral head is the same as that of an acetabular shell, except that magnetizable layer 122 may be deposited onto a surface of substrate 120 remote from the surface of sphere 102 while sphere 102 is positioned inside a hollowed out femoral head component. Because a solid femoral head component is desired, it may be necessary to fill the hollowed head with a solid material after magnetization has occurred and magnetizing fixture 100 has been removed from the head.
  • a corrosion resistant layer as discussed with regards to femoral implant 10 and acetabular shell 30 may be deposited onto the magnetizable layer 122 using a chemical vapor deposition process, physical vapor deposition process, sputtering, plating, or other similar method.
  • a wear resistant layer as discussed with regards to FIGS. 1-3 of the present application may be sprayed onto the corrosion resistant layer using similar processes, such as chemical vapor deposition, physical vapor deposition, sputtering, and the like.
  • the head 116 of the femoral implant is constructed using the methods as discussed above, the head 116 may be attached to a neck as well as a stem of a femoral implant .
  • the present invention may be adapted for other articulating joints, as, for instance, a knee joint, shown in FIG. 5, or a spinal joint, shown in FIG. 6.
  • a tibial base plate 210 is shown positioned adjacent distal femoral implant 220.
  • the tibial base plate 210 and distal femoral implant 220 are constructed similar to the acetabular shell 30 and head 16 of femoral implant 10.
  • tibial implant 210 includes a wear resistant layer 212, a corrosion resistant layer 214, a magnetized layer 216 and a substrate 218.
  • the substrate 218 may include various securing devices, such as pin 219, which may be implanted into a proximal surface of a tibia so as to help anchor the tibial base plate 210.
  • the substrate 218 may also include a porous surface 217 that promotes bone ingrowth, thereby further aiding in securing the tibial base plate to the tibia.
  • the distal femoral implant 220 includes a wear resistant layer 222, a corrosion resistant layer 224, a magnetized layer 226 and a base plate 228.
  • the magnetized layers 216, 226 work similarly.
  • the north pole of each magnetized layer projects outwardly toward the other magnetized layer, thereby creating a resultant repulsive force. This resultant repulsive force tends to urge the two implants away from one another, thereby forming a gap 230 between the two.
  • the gap 230 preferably has a dimension which is equivalent or similar to a gap between a normal articulating femur and a tibia.
  • the resultant repulsive force may also be increased, thereby causing the gap 230 to increase in size if so desired.
  • an intervertebral implant 300 may be constructed having a ball 302 and socket 304 configuration.
  • the ball 302 is attached to a first vertebral body and the socket 304 is attached to a second and adjacent vertebral body. Since the ball 302 and socket 304 are constructed similarly to the distal femoral implant 220 and tibial base plate 210, the resultant repulsive forces extending outwardly from the magnetized layers of the ball 302 and socket 304 tend to maintain separation between the two implants. This enables the two vertebral bodies to articulate relative to one another as the implants, ball 302 and socket 304, articulate relative to one another. Similar constructions may be used for various other joints throughout the body.
  • the magnitude of the magnetic field and the magnetized layer may be altered from one location to another location.
  • a head 416 of a femoral implant is illustrated positioned adjacent an acetabular shell 430, which is implanted into a hip socket.
  • the head 416 has a radius that is substantially smaller than the radius of the acetabular shell 430.
  • the radius of the acetabular shell's 430 inner surface 431 has an altering radius such that at the respective ends 441 and 442 of the implant 430, the radius is larger than in the middle of the implant.
  • the acetabular shell 430 and head 416 are similarly constructed to that described with reference to FIGS. 1 and 3 of the present application and include magnetized layers 436 and 426 as well as various other layers previously described.
  • magnetized layer 436 had an equal magnitude of strength throughout its entire surface area, only a portion of magnetized layer 436 would act on the magnetic field created by magnetized layer 426 because magnetized layer 426 is not equally positioned relative to all points of magnetized layer 436.
  • the magnetic field of magnetized layer 436 of the acetabular shell 430 may be varied from location to location. For instance, point P of magnetized layer 436 may have a magnitude that is equivalent to X, while points Q and Q 1 have a magnitude of X plus Y.
  • This increased magnitude of the magnetic field emanating from points Q and Q 1 relative to point P has an additional advantage of pushing or urging head 416 toward the middle of acetabular shell 430, thereby balancing head 416 within the acetabular shell.
  • the articulation of head 416 within a recess 439 of acetabular shell 430 may be controlled by adjusting the magnetic strength at different points in magnetized layer 436.
  • relative ends 441, 442 of acetabular shell 430 may have magnetized field where the south pole of magnetized layer 436 points towards head 416, as denoted by arrows S. The remaining arrows in the figure all denote the direction of the north pole of the respective magnetized layer.

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  • Oral & Maxillofacial Surgery (AREA)
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  • Prostheses (AREA)

Abstract

L'invention concerne un composant d'appui prothétique pour le remplacement d'articulations comportant un premier élément sur lequel est disposée une première couche magnétisée (26), où la première couche magnétisée (26) comporte un pôle (N) orienté dans une direction proximale, normale à la surface (20) du premier élément et un second élément sur lequel est disposée une seconde couche magnétisée (36). Le second élément est conçu pour venir au contact du premier élément, et la seconde couche magnétisée (36) comporte un pôle équivalent (N) orienté dans une direction distale, normale à la surface du second élément, moyennant quoi le pôle (N) de la première couche magnétisée (36) est opposé au pôle équivalent (N) de la seconde couche magnétisée (36), de sorte qu'une force de répulsion se crée entre les deux. Le composant d'appui prothétique comporte en outre une couche résistant à la corrosion (24, 34) couvrant les surfaces des premier et second éléments adjacents aux première et seconde couches magnétisées (26, 36) et une couche résistant à l'usure (22, 32) couvrant les surfaces des premier et second éléments adjacents à la couche résistant à la corrosion (24, 34) et formant une surface portante du composant d'appui prothétique.
PCT/US2007/023460 2006-11-06 2007-11-06 Articulations artificielles élastiques et leurs procédés de fabrication WO2008057565A2 (fr)

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FR2993578A1 (fr) * 2012-07-18 2014-01-24 Auris Placage protecteur pour aimant en alliage neodyme-fer-bore et son procede de fabrication
WO2014052152A1 (fr) * 2012-09-27 2014-04-03 Elwha Llc Composants d'articulation artificielle incluant des champs magnétiques intégraux configurés pour dévier des particules de débris d'usure
US8795378B2 (en) 2012-09-27 2014-08-05 Elwha Llc Artificial joint components including synovial fluid deflecting structures and particle retaining structures
US8845740B2 (en) 2012-09-27 2014-09-30 Elwha Llc Artificial joint components including mechanized synovial fluid deflecting structures and particle retaining structures
US9129535B2 (en) 2010-07-23 2015-09-08 Shuhei Takasu Anatomical model for training aid for learning reduction techniques and a method for learning the reduction techniques using the anatomical model for training aid
CN105266930A (zh) * 2015-11-05 2016-01-27 同济大学 一种易组装磁悬浮人工椎间盘复合体及安装方法
US9387080B2 (en) 2012-09-27 2016-07-12 Elwha Llc Artificial joint components including synovial fluid deflecting structures
JPWO2015133231A1 (ja) * 2014-03-06 2017-04-06 越智　光夫 創内関節腔拡大器
US10507111B2 (en) 2018-03-09 2019-12-17 Stephen Bramblett Johnson Magnetic prosthetic
KR20210012976A (ko) * 2019-07-26 2021-02-03 인하대학교 산학협력단 상완관절 보조장치
CN114005665A (zh) * 2021-11-04 2022-02-01 无锡普天铁心股份有限公司 一种能够快速包装多台铁心的工艺及包装结构
EP3977964A1 (fr) * 2020-10-01 2022-04-06 Fellowship of Orthopaedic Researcher, Inc. Prothèse de hanche totale magnétiquement stabilisée
KR20220065318A (ko) 2020-11-13 2022-05-20 인하대학교 산학협력단 상완관절 보조장치
US20240008991A1 (en) * 2022-07-11 2024-01-11 James Stuart Melvin Prosthetic hip replacement assembly with new and improved prosthetic ball

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