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WO2006053132A2 - Implants osseux prothetiques - Google Patents

Implants osseux prothetiques Download PDF

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Publication number
WO2006053132A2
WO2006053132A2 PCT/US2005/040751 US2005040751W WO2006053132A2 WO 2006053132 A2 WO2006053132 A2 WO 2006053132A2 US 2005040751 W US2005040751 W US 2005040751W WO 2006053132 A2 WO2006053132 A2 WO 2006053132A2
Authority
WO
WIPO (PCT)
Prior art keywords
bone
implant
foamable
precursor
prosthetic
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2005/040751
Other languages
English (en)
Other versions
WO2006053132A3 (fr
Inventor
Bhavin V. Mehta
Robert J. Setlock, Jr.
Betty Sindelar
John A. Bantle
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Ohio University
Original Assignee
Ohio University
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 Ohio University filed Critical Ohio University
Publication of WO2006053132A2 publication Critical patent/WO2006053132A2/fr
Publication of WO2006053132A3 publication Critical patent/WO2006053132A3/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B22—CASTING; POWDER METALLURGY
    • B22C—FOUNDRY MOULDING
    • B22C9/00—Moulds or cores; Moulding 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
    • A61F2/28—Bones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/3094—Designing or manufacturing processes
    • A61F2/30942—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/56—Porous materials, e.g. foams or sponges
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C44/00—Shaping by internal pressure generated in the material, e.g. swelling or foaming ; Producing porous or cellular expanded plastics articles
    • B29C44/02—Shaping by internal pressure generated in the material, e.g. swelling or foaming ; Producing porous or cellular expanded plastics articles for articles of definite length, i.e. discrete articles
    • B29C44/04—Shaping by internal pressure generated in the material, e.g. swelling or foaming ; Producing porous or cellular expanded plastics articles for articles of definite length, i.e. discrete articles consisting of at least two parts of chemically or physically different materials, e.g. having different densities
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C44/00—Shaping by internal pressure generated in the material, e.g. swelling or foaming ; Producing porous or cellular expanded plastics articles
    • B29C44/02—Shaping by internal pressure generated in the material, e.g. swelling or foaming ; Producing porous or cellular expanded plastics articles for articles of definite length, i.e. discrete articles
    • B29C44/04—Shaping by internal pressure generated in the material, e.g. swelling or foaming ; Producing porous or cellular expanded plastics articles for articles of definite length, i.e. discrete articles consisting of at least two parts of chemically or physically different materials, e.g. having different densities
    • B29C44/0461—Shaping by internal pressure generated in the material, e.g. swelling or foaming ; Producing porous or cellular expanded plastics articles for articles of definite length, i.e. discrete articles consisting of at least two parts of chemically or physically different materials, e.g. having different densities by having different chemical compositions in different places, e.g. having different concentrations of foaming agent, feeding one composition after the other
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C44/00—Shaping by internal pressure generated in the material, e.g. swelling or foaming ; Producing porous or cellular expanded plastics articles
    • B29C44/02—Shaping by internal pressure generated in the material, e.g. swelling or foaming ; Producing porous or cellular expanded plastics articles for articles of definite length, i.e. discrete articles
    • B29C44/12—Incorporating or moulding on preformed parts, e.g. inserts or reinforcements
    • B29C44/1204—Incorporating or moulding on preformed parts, e.g. inserts or reinforcements and giving the material during expanding the shape of a particular article to be supported, e.g. a human body-part
    • 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
    • A61F2/28—Bones
    • A61F2002/2835—Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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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
    • A61F2/28—Bones
    • A61F2002/2835—Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
    • A61F2002/2839—Bone plugs or bone graft dowels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/30004—Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis
    • A61F2002/30006—Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis differing in density or specific weight
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/30004—Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis
    • A61F2002/30011—Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis differing in porosity
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/3006—Properties of materials and coating materials
    • A61F2002/30062—(bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
    • 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
    • A61F2002/30224—Three-dimensional shapes cylindrical
    • A61F2002/30235—Three-dimensional shapes cylindrical tubular, e.g. sleeves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/3094—Designing or manufacturing processes
    • A61F2/30942—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
    • A61F2002/30948—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques using computerized tomography, i.e. CT scans
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
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    • 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
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    • A61F2210/0004—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof bioabsorbable
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    • B29L2031/753—Medical equipment; Accessories therefor
    • B29L2031/7532—Artificial members, protheses

Definitions

  • Bone is a natural composite material composed of hard, compact osseous tissue surrounding spongy cancellous tissue. Damage or loss of natural bone tissue can result from trauma, congenital deformities, pathologic conditions, and surgical procedures. In some instances, as a result of the bone damage or loss, and as an alternative to amputation, a person may undergo prosthetic operations to replace the missing bone tissue.
  • Prosthetic operations can be used to replace missing or diseased portions of bone with solid artificial implants, such as metal rods. These implants, however, do not have the same material and structural properties as natural bone. The material and structural differences of these solid implants can cause unnatural secondary wear patterns on surrounding bone and joints. Summary
  • a prosthetic bone implant includes an interior region and a peripheral region, which has a relatively greater density than the interior region.
  • the prosthetic bone implant may be used to replace bone that has been damaged by trauma or disease.
  • the prosthetic bone implant maybe configured to match the characteristics of the bone to be replaced if that bone were healthy.
  • the peripheral region may approximate the morphologic traits of the cortical layer of a similar healthy bone.
  • the peripheral region and the interior region may be configured such that a density of the prosthetic bone implant and the size and shape of the peripheral region substantially matches a density, size, and shape that healthy bone in the area of bone to be replaced should have.
  • the implant comprises a biodegradable scaffold material.
  • An osteroinductive agent and/or osteointegration agent may be disposed in the implant, hi an exemplary embodiment, stem cells, such as for example bone marrow stem cells, are imbedded in a biodegradable scaffold material and eventually grow and replace the biodegradable scaffold material.
  • a foamable implant precursor comprising a scaffold material and a foaming agent
  • the foamable implant precursor is placed in a mold which is configured based on a region of bone to be replaced by the implant.
  • the foamable precursor is then activated to cause it to expand into engagement with the mold to form a prosthetic bone implant having a peripheral region and an interior region.
  • the resulting bone implant will have a peripheral region with a relatively greater density than the interior region.
  • the method includes creating a three dimensional model of human bone. A mold is fabricated based on the three dimensional model and the foamable implant precursor is formed based on the three dimensional model.
  • Figure 1 is a schematic cross-sectional view of an exemplary embodiment of a prosthetic bone implant
  • Figure 2 is a cross-sectional view taken along lines 2—2 of the prosthetic bone implant in Figure 1;
  • Figure 3 is a schematic cross-sectional view of the prosthetic bone implant of Figure 1, enriched with living bone tissue;
  • Figure 4 is a sectional view taken along lines 4—4 of the exemplary prosthetic bone implant in Figure 3;
  • Figure 5 is a graphical representation of an exemplary embodiment of a method of forming the prosthetic bone implant of Figure 1.
  • Figure 6 is an image of bone to be replaced by a prosthetic bone implant
  • Figure 7 is an illustration of a solid model of bone to be replaced by a prosthetic bone implant
  • Figure 8 is an illustration of a 3D rendering of a prototype of a bone to be replaced by a prosthetic bone implant
  • Figure 9 illustrates use of a prototype of a bone to create a prosthetic bone implant mold
  • Figure 10 is a schematic illustration of a foamable implant precursor placed in a mold
  • Figure 11 is a schematic illustration of a formed prosthetic bone implant in a mold
  • Figure 12 is a cross-sectional schematic illustration of the prosthetic bone implant of Figure 1, including living bone tissue plugs;
  • Figure 13 is a sectional view taken along lines 13—13 of the prosthetic bone implant of Figure 12. Detailed Description
  • the disclosed prosthetic bone implants more closely duplicate the morphology of biological bone to more closely mimic the overall material and structural properties of natural bone.
  • the size, shape, strength, density, density profile, weight, and/or weight distribution of the disclosed prosthetic bone implants more closely matches healthy natural bone than prior known prosthetic bone implants.
  • implants may operate as precision replacements, feeling and functioning like natural bone.
  • the new prosthetic bone implants may reduce the occurrence of unnatural secondary wear patterns caused by current prosthetic bone implants that function in unnatural fashions due to material and structural properties that do not match natural bone.
  • the disclosed prosthetic bone implants can be applied to bone conditions, such as complex fractures or malunions, related to trauma or disease processes and may reduce the number of amputation surgeries.
  • the disclosed prosthetic bone implant can be used in a wide variety of different applications.
  • the prosthetic bone implants can be used to replace bone that has been damaged by trauma, such as trauma that results from automobile accidents or gunfire and can be used to replace bone that has been degraded by disease, such as for example osteocarcinoma and osteoporosis.
  • FIGS 1 and 2 schematically illustrate an example of an prosthetic bone implant 10.
  • the prosthetic bone implant 10 includes a interior region 12 disposed in a peripheral region 14.
  • the bone implant 10 can be configured to have the same morphology and characteristics of natural, healthy bone in the region of bone being replaced, hi the exemplary embodiment, the bone implant 10 can be configured to have substantially the same size, shape, strength, density, density profile, weight, and/or weight distribution of healthy bone in an area of bone to be replaced should have.
  • the bone implant includes a peripheral region having substantially a shape that healthy bone in an area of bone to be replaced should have.
  • the peripheral region has an peripheral region thickness that corresponds to a cortical bone thickness that healthy bone in the area of bone to be replaced should have.
  • the implant further includes a interior region disposed in the peripheral region, wherein the peripheral region and the interior region are configured such that a density of the prosthetic bone implant substantially matches a density that healthy cortical and trabecular bone in the area of bone to be replaced should have.
  • the bone implant 10 may be made from a variety of different materials.
  • acceptable implant materials include, but are not limited to, polymers, metals, composites, and biodegradable scaffold materials.
  • the bone implant 10 can be made from one or more non-biodegradable materials that are compatible with biomedical applications.
  • An example of an acceptable non-biodegradable material for use in the bone implant is short-glass-fiber-reinforced (SGFR) epoxy.
  • SGFR short-glass-fiber-reinforced
  • the implant in an exemplary embodiment of the prosthetic bone implant 10, can be configured to provide a platform for bone tissue regeneration, such as for example, the eventual, complete regeneration of living bone tissue.
  • a biodegradable scaffold material may allow eventual bone regeneration within and throughout the prosthesis.
  • the bone implant 10 can be made from a biodegradable scaffold material, such as one or more biodegradable materials that are compatible with biomedical applications and with regeneration of living bone tissue.
  • An example of an acceptable biodegradable material for use in the bone implant could be a biodegradable ceramic material, such as calcium hydroxyapatite. Other biodegradable materials that are compatible with biomedical applications, however, can be used.
  • some embodiments of the invention contain osteoinductive agents or osteointegration agents, which could be biological or non-biological.
  • the use is these agents are well known in the art.
  • living bone tissue 16 may be disposed in the interior region 12.
  • living bone tissue 16 comprising bone marrow stem cells can be disposed in the interior region 12. Any stem cells and suitable agents, however, which promote living bone tissue regenerations can be used.
  • the interior region 12 is a biodegradable scaffold material. As the stem cells grow, regenerated bone tissue will replace the biodegradable scaffold material. Methods that can be used to dispose living bone cells in the interior region 12 to promote bone tissue regeneration are disclosed in U.S. Patent Nos. 5,824,084 and 6,049,026 to Muschler, which are incorporated herein by reference in their entirety.
  • Figure 5 illustrates an example of a method for making the prosthetic bone implant 10.
  • the method includes the steps of creating a three dimensional model 18 ( Figure 7) of human bone; fabricating a mold 20 ( Figure 9) based on the three dimensional model 18; forming a foamable implant precursor 22 ( Figure 10) based on the three dimensional model 18; placing the implant precursor 22 in the mold 20; and activating the foamable implant precursor 22 to cause the precursor to expand into engagement with the mold 20 to form a prosthetic bone implant 10 having a peripheral region 14 and a porous interior region 12 ( Figure 1-2).
  • Figure 5 should not to read to imply a specific order to the steps of the example.
  • the step of forming the precursor does not necessarily follow the step of fabricating the mold.
  • foaming technologies that could be used for making the prosthetic bone implant disclosed in this application. While the method of using the foamable implant precursor 22, disclosed herein, is one possible approach, other methods can also be used. Some examples of alternative foaming technologies that could be used include, but are not limited to, those disclosed in U.S. Patent Nos. 6,905,516, 6,692,532, 6,607,302, and 6, 364,909, the disclosures of which are fully incorporated herein by reference.
  • the step of creating a three dimensional model 18 of human bone may include creating a digital three dimensional model ( Figure 7), which may be based on a variety of approaches and/or information sources.
  • the three dimensional model 18 can be based on, but not limited to, images 24 ( Figure 6) of the bone to be replaced; parametric modeling techniques; and/or images of a bone corresponding to the bone being replaced, such as for example, if a person's right tibia is being replaced, images of the person's left tibia might be used or images of another person's right tibia might be used if it is sufficiently similar to the bone being replaced.
  • images 24 Figure 6
  • parametric modeling techniques and/or images of a bone corresponding to the bone being replaced, such as for example, if a person's right tibia is being replaced, images of the person's left tibia might be used or images of another person's right tibia might be used if it is sufficiently similar to the bone being replaced.
  • the three dimensional model 18 of the bone to be replaced is created using computed tomography (CT) images, Magnetic Resonance Imaging (MRI) images and/or ultrasound images along with solid modeling software, as is known in the art.
  • CT computed tomography
  • MRI Magnetic Resonance Imaging
  • An example of a method for creating three dimensional models from these images is disclosed in Mehta B.V. and Hussain, T., Modeling of Human Vocal Tract Using MR Imaging and Acoustic Pharyngometer, Proceedings of IMECE 2004, IMECE2004-59662, ASME Winter Annual Meeting, Anaheim, November 2004, which are incorporated herein by reference in their entirety.
  • a model 18 representing bone in the area of bone to be replaced can be generated.
  • the model 18 of the bone to be replaced may need to be adjusted to represent healthy bone. It may be, that the reason underlying the need to replace bone is or causes an undesirable characteristic of the bone.
  • the model 18 of a bone having a degenerative condition such as for example, osteoporosis, may have to be adjusted to represent healthy bone.
  • a finite element analysis of the three dimensional solid model 18 may be performed to evaluate stresses that will be applied to the bone implant 10 under a variety of static and dynamic loads to study the effect of varying material properties of the implant 10 on these stresses.
  • the images and/or the finite element analysis can also be used to determine the density profile and/or the weight distribution of the bone to be replaced, as is known in the art.
  • An example of a method of utilizing finite element analysis to determine a density profile are disclosed in Fening, S. and Mehta, B. V., Finite Element Analysis of the Knee with the Menisci, Proceedings of the International Symposium on Computer Simulation in Biomechanics, Aug. 2005, Cleveland, OH, pp. 39-40, which are incorporated herein by reference in their entirety.
  • the model 18 can be adjusted to represent the density profile and/or weight distribution expected in healthy bone. Based on the results of the finite element analysis, an appropriate material for use in the prosthetic bone implant can be selected. Thus, the finite element analysis can be used to determine, for example, the appropriate implant material, the appropriate density profile of the implant including the relative density for the porous interior region 12, the appropriate thickness and thickness profile for the peripheral region 14, an appropriate foaming agent, and/or an appropriate binder.
  • parametric modeling techniques are used to determine the appropriate structural properties of the prosthetic bone implant.
  • An example of a method for utilizing parametric modeling techniques to develop a three dimensional model are disclosed in Fening, S., Gilders, N. and Mehta, B. V., Creating Fast Patient Specific Three Dimensional Models of Human Bones Using a Novel Parametric Approach, Proceedings of the World Congress on Medical Physics and Biomedical Engineering, Sydney, Aug. 2003, which are incorporated herein by reference in their entirety.
  • the step of fabricating a mold based on the three dimensional model 18 may include fabricating a full-scale physical model 26 of the prosthetic bone implant 10.
  • the physical model 26 may be produced in a variety of different ways. One acceptable way to produce the physical model 26 is by using rapid prototype technology, as is known in the art. One acceptable rapid prototyping machine is the model Dimension, available from Stratasys. Once fabricated, the physical model 26 may be used as a blank to produce the final casting mold 20 ( Figure 9) that is used to fabricate the prosthetic bone implant 10.
  • the mold 20 can be made by covering the physical model 26 with a mold forming material 28, such as for example, plaster or other suitable mold forming material. The mold forming material 28 is then allowed to harden.
  • the final casting mold 20 is composed of a material 28 that is compatible with temperatures associated with the molding process of the implant 10. For example, in the step of activating the foamable implant precursor 22 ( Figure 10) to cause the precursor to expand into engagement with the mold 20 to form a prosthetic bone implant 10, if the precursor is activated by elevated temperature, the mold material 28 used to fabricate the mold 20 would be selected to be able to withstand the elevated temperature.
  • the physical model 26 may need to be removed from the mold.
  • the mold 20 is bisected, allowing the physical model 26 to be removed by pulling each half of the physical model out of each half of the mold, hi alternative embodiments of the molding process, the physical model 26 may be dissolved, melted or burned out of the mold 20.
  • the step of forming a foamable implant precursor 22 may include combining the bone implant material with a suitable foaming agent.
  • the materials that make up the foamable precursor 22 are selected based on the results of the finite element analysis.
  • the density of healthy bone in an area of the bone to be replaced is determined and the foamable implant precursor materials are selected based on the density.
  • Other suitable methods may be used for selecting the appropriate materials.
  • An appropriate quantity of the material for the prosthetic bone implant 10 is mixed in powdered form with a powdered foaming agent.
  • foaming agents may be used.
  • An example of an acceptable foaming agent for use with SGFR epoxy and calcium hydroxypatite might be a low temperature sulfonylhydrazine foaming agent that is compatibility for use with thermoset materials including epoxies.
  • Celogen TSH-C ® available form Crompton Corporation, is an example of such a foaming agent.
  • Other foaming agents which are compatible with the material selected for the prosthetic bone implant 10 may be used.
  • the mixture is homogenously blended and heated to a temperature that is lower than the melting temperature of the mixture.
  • the powdered foaming agent decomposes near the melting temperature of the implant material.
  • a powdered binder with an appropriate melting temperature may be included in the mixture.
  • the biodegradable ceramic material calcium hydroxypatite can be used with a biodegradable thermoplastic such as polycaprolactone which would act as a binder.
  • Other suitable binders that are compatible with the selected implant material may be used.
  • one or more additional components can be added to strengthen the prosthetic bone implant.
  • carbon fibers may be added to the mixture to add strength.
  • the composition of the foamable precursor mixture may vary, depending on the exact application.
  • an example of a mixture used to make the foamable precursor can include 0.5% to 5.0% of a foaming agent and 99.5% to 95.0% of SGFR epoxy (by weight).
  • an example of a mixture used to make the foamable precursor can include 0.5% to 45.0% of a foaming agent and 80.0% to 20.0% of calcium hydroxyapatite, and 90.0% to 10.0% polycaprolactone (by weight).
  • the mixture is pressed to form the foamable precursor 22 of predetermined size and shape for use in molding the prosthetic bone implant.
  • the predetermined size, shape, and composition of the precursor 22 are selected to ultimately result in a bone implant with the desired characteristics, as will be discussed in more detail herein.
  • the step of placing the implant a precursor in the mold 20 may include bisecting the mold or creating an opening in the mold to allow the insertion of the foamable precursor 22. Once properly positioned inside the mold 20, the precursor 22 can be activated
  • the step of activating the foamable implant precursor 22 may include applying heat 30.
  • the mold 20 is heated in a furnace to bring the foamable precursor 22 to a temperature that activates the foaming agent and melts the implant material and/or the binder.
  • the mold is heated to about 140 degrees Celsius, the activation temperature for the foaming agent, Celogen TSH-C ® .
  • the foaming agent decomposes as the powdered material and/or binder melts together.
  • the foaming agent causes small bubbles to form throughout the foamable precursor 22, which causes the foamable precursor 22 to expand into engagement with a mold wall 32.
  • the foamable precursor 22 expands, more material of the foamable precursor will be pressed against the walls 32 of the mold 20 than will remain in the inner core 12.
  • peripheral region 14 of the implant 10 will be denser than the interior region 12 resulting in the peripheral region 14 surrounding the interior region 12.
  • the predetermined size, shape, and composition of the precursor 22 impacts the resulting characteristics of the bone implant 10.
  • the foam core porosity and peripheral region thickness, density, and distribution of thickness and density can be controlled by the proper sizing, shaping, and material selection of the pre-foamed precursor 22.
  • peripheral region thickness of the prosthetic bone implant 10 is dependent on the ratio of an amount of implant material to an amount of foaming agent in the precursor 22. More foaming agent will result in thicker walls, since more of the prosthetic bone implant material is displaced to walls 32 of the mold 20 by the foaming agent.
  • the overall density of the prosthetic bone implant is dependent on the total amount of implant material used, and the magnitude of the distribution of that material from the porous core to the outer surface is dependent on a ratio of an amount of implant material to an amount of foaming agent.
  • different portions of the foamable precursor 22 can be configured to have different implant material to foaming agent ratios. This could be achieved, for example, by forming the precursor material in batches, in which one portion of the precursor is formed from a first batch and a second portion of the precursor is formed from the second batch.
  • the prosthetic bone implant can have regions with varying densities and varying peripheral region thickness to provide a density profile that substantially matches the density profile of the healthy bone in the area of bone replacement.
  • Multiple foamable precursor could also be used with the same mold to provide a prosthetic bone implant with regions having varying densities and/or varying peripheral region thickness.
  • the foamable precursor 22 is formed such that a first portion of the prosthetic bone implant 10 approximates the density of the first bone region and a second portion of the prosthetic bone implant approximates the density of the second bone region.
  • the prosthetic bone implant 10 can have a density profile that varies along a length of the implant.
  • the three dimensional model 18 can be configured to provide a representation of a density of a first bone region and a representation of a density of a second bone region.
  • the three dimensional model 18 can include a representation of bone density and bone thickness and the foamable precursor is formed such that the peripheral region of the prosthetic bone implant approximates the model's representation of bone density or and thickness.
  • the formed prosthetic bone implant 10 is cooled and removed from the mold.
  • plugs 50 of living bone cells 16 are placed in the interior region 12.
  • the plugs 50 of living bone cells can be taken from healthy bone and implanted into the biodegradable scaffold material.
  • the inclusion of living bone plugs 50 in the prosthetic bone implant may reduce the number of occurrences of rejection of the bone implant by the patient's body .
  • the living bone plugs 50 grow and eventually replace the biodegradable scaffold material, resulting in a fully living regenerated bone capable of remodeling to loading. This ability could help ensure the longevity of the bone replacement in the system.
  • the inclusion of stem cells in the bone plugs 50 stimulates the regeneration of living bone tissue.

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Abstract

La présente invention concerne des implants osseux prothétiques qui possèdent une région interne et une région périphérique qui a une densité relativement supérieure à celle de la région interne. Ledit implant prothétique osseux peut être utilisé pour remplacer un os qui a été endommagé par un traumatisme ou une maladie. Cet implant osseux prothétique peut être conçu pour correspondre aux caractéristiques qu'auraient eu l'os à remplacer, s'il était sain.
PCT/US2005/040751 2004-11-10 2005-11-10 Implants osseux prothetiques Ceased WO2006053132A2 (fr)

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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2015052710A1 (fr) * 2013-10-09 2015-04-16 Yosibash Zohar Procédé automatisé spécifique à un patient d'analyse biomécanique d'os
CN112075989A (zh) * 2020-09-29 2020-12-15 华侨大学 一种正多面体多孔填充结构跟骨假体及其优化设计方法
IT201900019310A1 (it) * 2019-10-18 2021-04-18 Materias S R L Procedimento per realizzare prodotti in materiale polimerico espanso multi-gradiente
US20210114266A1 (en) * 2018-04-19 2021-04-22 Materias S.R.L. Process for preparing layered foamed polymeric materials

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US5147904A (en) * 1989-08-24 1992-09-15 Thera Patent Gmbh & Co. Kg Open-pored moldings, a process for their production and use thereof
US5152791A (en) * 1989-12-07 1992-10-06 Olympus Optical Co., Ltd. Prosthetic artificial bone having ceramic layers of different porosity
US5686091A (en) * 1994-03-28 1997-11-11 The Johns Hopkins University School Of Medicine Biodegradable foams for cell transplantation
US6116911A (en) * 1997-03-27 2000-09-12 The Johns Hopkins University Bone substitute for training and testing
US6333029B1 (en) * 1999-06-30 2001-12-25 Ethicon, Inc. Porous tissue scaffoldings for the repair of regeneration of tissue
US6458162B1 (en) * 1999-08-13 2002-10-01 Vita Special Purpose Corporation Composite shaped bodies and methods for their production and use

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2015052710A1 (fr) * 2013-10-09 2015-04-16 Yosibash Zohar Procédé automatisé spécifique à un patient d'analyse biomécanique d'os
US20210114266A1 (en) * 2018-04-19 2021-04-22 Materias S.R.L. Process for preparing layered foamed polymeric materials
IT201900019310A1 (it) * 2019-10-18 2021-04-18 Materias S R L Procedimento per realizzare prodotti in materiale polimerico espanso multi-gradiente
WO2021074729A1 (fr) * 2019-10-18 2021-04-22 Materias S.R.L. Procédé de fabrication de produits de matériau polymère expansé à gradients multiples
CN114555316A (zh) * 2019-10-18 2022-05-27 马特利艾斯有限责任公司 用于制造多梯度发泡聚合物材料的产品的方法
CN114555316B (zh) * 2019-10-18 2024-09-10 马特利艾斯有限责任公司 用于制造由多梯度的发泡聚合物材料制成的产品的方法及产品
US12447655B2 (en) 2019-10-18 2025-10-21 Materias S.R.L. Process for making products of multi-gradient foamed polymeric material
CN112075989A (zh) * 2020-09-29 2020-12-15 华侨大学 一种正多面体多孔填充结构跟骨假体及其优化设计方法

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