WO2009064509A1 - Implant annulaire - Google Patents

Implant annulaire Download PDF

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Publication number
WO2009064509A1
WO2009064509A1 PCT/US2008/053300 US2008053300W WO2009064509A1 WO 2009064509 A1 WO2009064509 A1 WO 2009064509A1 US 2008053300 W US2008053300 W US 2008053300W WO 2009064509 A1 WO2009064509 A1 WO 2009064509A1
Authority
WO
WIPO (PCT)
Prior art keywords
tissue
implant according
anchoring element
annular anchoring
substitute
Prior art date
Application number
PCT/US2008/053300
Other languages
English (en)
Inventor
James Huckle
Saad Ali
Original Assignee
Smith & Nephew, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from PCT/US2007/084905 external-priority patent/WO2008061216A2/fr
Application filed by Smith & Nephew, Inc. filed Critical Smith & Nephew, Inc.
Priority to PCT/US2008/053300 priority Critical patent/WO2009064509A1/fr
Priority to EP08729277A priority patent/EP2224883A1/fr
Priority to JP2010534065A priority patent/JP2011502703A/ja
Priority to AU2008321357A priority patent/AU2008321357A1/en
Publication of WO2009064509A1 publication Critical patent/WO2009064509A1/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
    • A61F2/30721—Accessories
    • A61F2/30749—Fixation appliances for connecting prostheses to the body
    • 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
    • A61F2/30756—Cartilage endoprostheses
    • 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
    • A61F2002/30032—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 absorbability or resorbability, i.e. in absorption or resorption time
    • 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
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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
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    • A61F2002/30108—Shapes
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    • A61F2002/302—Three-dimensional shapes toroidal, e.g. rings
    • 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
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    • 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
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30579—Special structural features of bone or joint prostheses not otherwise provided for with mechanically expandable devices, e.g. fixation devices
    • 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
    • A61F2002/30667—Features concerning an interaction with the environment or a particular use of the prosthesis
    • A61F2002/30677—Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
    • 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
    • A61F2/30721—Accessories
    • A61F2/30749—Fixation appliances for connecting prostheses to the body
    • A61F2002/30751—Fixation appliances for connecting prostheses to the body for attaching cartilage scaffolds to underlying bone
    • 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
    • A61F2/30756—Cartilage endoprostheses
    • A61F2002/30766—Scaffolds for cartilage ingrowth and regeneration
    • 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
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0004—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
    • A—HUMAN NECESSITIES
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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
    • 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
    • A61F2230/0065—Three-dimensional shapes toroidal, e.g. ring-shaped, doughnut-shaped
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    • 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
    • A61F2250/003—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 adsorbability or resorbability, i.e. in adsorption or resorption time
    • A—HUMAN NECESSITIES
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    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
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    • A61F2310/00011—Metals or alloys
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    • A61F2310/00365—Proteins; Polypeptides; Degradation products thereof

Definitions

  • This invention relates generally to the field of orthopaedic surgery for the repair and replacement of damaged cartilage.
  • damaged tissue may be other types of tissue, for example, bone or skin, including damaged surfaces of or defects in the bone itself.
  • Articular cartilage is a highly organized avascular tissue composed of chondrocytes embedded within an extracellular matrix of collagens, proteoglycans and non-collagenous proteins. Its primary function is to enable the smooth articulation of joint surfaces, and to cushion compressive, tensile, and shearing forces.
  • Hyaline cartilage has one of the lowest coefficients of friction known for any surface to surface contact.
  • Cartilage is frequently injured, often as a result of sports related trauma, but due to its avascular nature, articular cartilage has very limited capacity for repair. It is well known that the capacity of articular cartilage for repair is limited. Partial-thickness defects in the articular cartilage do not heal spontaneously.
  • Injuries of the articular cartilage that do not penetrate the subchondral bone do not heal and usually progress to the degeneration of the articular surface. Injuries that penetrate the subchondral bone, and hence the vasculature, undergo repair through the formation of fibrocartilage. Although fibrocartilage fills and covers the defect, this is considered sub-optimal tissue from the biomechanical standpoint.
  • the fibrocartilage is made to resist tension forces, while the hyaline cartilage is made to resist compression forces, to enable smooth articulation, and to withstand long-term variable cyclic load and shearing forces.
  • the principal goals for surgical management of the symptomatic chondral and osteochondral defects are to reduce symptoms, improve joint congruence by restoring the joint surface with the best possible tissue, and to prevent additional cartilage deterioration.
  • debridement and lavage which is typically reserved for lower demand older patients with small lesions ( ⁇ 2 to 3 cm 2 ) and limited symptoms who would have difficulty with activity or weight-bearing restrictions post-operatively. It entails arthroscopic surgery where two to three small incisions are placed about the knee to place a small camera and instruments inside the joint to evaluate and treat the lesions. Loose chondral flaps that can cause mechanical symptoms are removed. Relief from this type of procedure may be incomplete or temporary because no attempt has been made to restore or repair the cartilage lesion. The recovery time from this type of procedure is relatively short, with immediate full weight-bearing and unrestricted activities.
  • Abrasion chondroplasty utilizes a high-speed endoscopic burr to resect a damaged area of cartilage to bleeding subchondral bone. This allows a blood clot to form over the defect which develops into a repair tissue of fibrocartilage that is relatively thin and tends to deteriorate overtime.
  • microfracture may be performed in an attempt to stimulate new cartilage growth.
  • the treatment involves a disruption of subchondral bone in an attempt to induce bleeding and to initiate primitive stem cell migration from the bone marrow into the cartilage defect site.
  • primitive stem cells which are capable of differentiating into bone and cartilage under the influence of various biologic and mechanical intra-articular factors.
  • the subchondral bone is penetrated in order to reach a zone of vascularisation, stimulating the formation of a fibrin clot containing pluripotential stem cells. This clot differentiates and remodels, resulting in a fibrocartilaginous repair tissue.
  • fibrocartilage Although fibrocartilage often appears to offer the patient significant pain relief, this tissue lacks several key structural components to perform the mechanical functions, as a wear-resistant and as a weight-bearing surface.
  • the fibrocartilage repair tissue does not produce a proper compressive stiffness against applied mechanical load and thus is subjected to an excessive deformation under physiological loading. This in turn causes a mechanical failure of the repaired tissue and eventually leads to a recurrence of degeneration of the repaired cartilage. Results for this technique are similar to abrasion chondroplasty.
  • Ostetoplasty is another surgical technique that can potentially restore the height and the shape of articulating surface in focal osteochondral defects, with composite autologous material that contains all necessary ingredients: hyaline articular cartilage, intact tidemark, and a firm bone carrier.
  • These osteochondral autograft plugs are most commonly transplanted to symptomatic lesions involving the femoral condyles.
  • the lesions should be small to medium-sized (0.5 to 3 cm 2 ) because the amount of donor tissue available is limited.
  • the main problem with this reconstructive technique is the limited availability of autografts, which significantly reduces the choice of treatable defects down to a small focal chondral defect, and a long term donor morbidity in multiple donor sites.
  • Deep and large, crater-like osteochondral defects are not suitable for osteochondral autograft transplantation, mainly because of the limited availability of autologous osteochondral grafts.
  • the procedure is also technically difficult, as all grafts must be taken with the axis of the harvesting coring drill being kept perpendicular to the reticular surface at the point of harvest.
  • it is difficult to reconstruct the subchondral bone and restore the contour of the defect area, and to cover the entire defect area with hyaline articular cartilage.
  • the dead spaces between circular grafts, the lack of integration of donor and recipient hyaline cartilage, different orientation, thickness and mechanical properties of donor and recipient hyaline cartilage are further sources of clinical concern.
  • Autologous Chondrocyte Implantation is another advanced therapy which is used for intermediate to high-demand patients who have failed arthroscopic debridement or microfracture.
  • the technique is used for larger (2 to 10 cm 2 ) symptomatic lesions involving both the femoral condyles and trochlear and the patella. It allows chondrocytes to be harvested from the patients knee and cultured and multiplied. The fresh chondrocytes are then re- implanted into the patients knee and cause hyaline-like cartilage to repair the defect in articulating surface.
  • the ACI restores the articular surface with the patients own hyaline-like cartilage without compromising the integrity of healthy tissue or the subchondral bone.
  • TJR total joint replacements
  • Prosthetics available for the knee joint include either total knee replacements (TKR), whereby the entire knee joint is replaced or unicompartmental knee replacements (UKR) where a single compartment of the knee joint, typically the medial condyle, is replaced.
  • TKR total knee replacements
  • UBR unicompartmental knee replacements
  • the latter treatment is a common eventuality for the patient with a large focal defect.
  • These patients are managed with anti-inflammatory drugs, however, the remaining articular cartilage eventually erodes away resulting in pain, and loss of mobility.
  • total joint replacement the patient may face future problems associated with loosening of the implant, which may occur as a result of either wear, breakdown of the cement, osteolysis, or infection. Furthermore, healthy bone tissue has to be removed to accommodate the implant.
  • Total joint replacement is regarded as a last resort treatment option given that the patient has to face a long and difficult recovery and rehabilitation period, and the average life span is approximately 20 years.
  • Cartilage replacement devices are known in the art. These devices can usually be effected immediately by surgical procedures, resulting in the alleviation of a patient's accompanying pain and also in the rehabilitation of the patient in a relatively short time span.
  • the invention relates to an implant and method for resurfacing a large surface area of damaged or destroyed tissue.
  • an implant for installation into a site of damaged tissue, said implant comprising; a substitute tissue structure, and an annular anchoring element for anchoring the substitute tissue structure into an annular groove formed in an underlying tissue at or near the implantation site, wherein at least part of the annular anchoring element is bonded to the substitute tissue structure.
  • the damaged tissue is cartilage, synovium, tendon, ligament, meniscus, or bone.
  • the damaged tissue is cartilage and the annular anchoring element is secured into a groove formed within the subchondral bone.
  • the macro- and microstructure of the substitute tissue structure is designed to replicate structurally the tissue which it replaces.
  • the surface of the material is contoured to mimic the surface of the natural cartilage such that there is no impingement of the implant against the apposing joint surface.
  • the macro- and microstructure of the substitute tissue structure may also be optimized to regenerate and/or repair the desired anatomical features of the tissue that is being regenerated and/or repaired.
  • any material used within the substitute tissue structure is biocompatible. Such a material does not elicit an immune response upon implantation.
  • At least a part of the substitute tissue structure is formed of a bioresorbable material.
  • a bioresorbable material has the ability transiently resorb, preferably in a controllable manner, within the body environment.
  • various parts of the substitute tissue structure may be designed to resorb at different rates.
  • the rate of resorption is isotropic across the substitute tissue structure.
  • tissue substitute structure may be resorbable whilst another region may be non-resorbable.
  • the substitute tissue structure can be in the form of a solid non- deformable structure or a substantially deformable structure.
  • the substitute tissue structure is substantially porous.
  • suitable deformable, porous structures include, but are not limited to, felts, gauzes, gels, and sponges.
  • Suitable materials for the substitute tissue structure include, for example; a natural polymer, a synthetic polymer, a ceramic material, a meta,l or combinations thereof.
  • polymers can be used.
  • synthetic polymer refers to polymers that are not found in nature, even if the polymers are naturally occurring.
  • natural polymer refers to polymers that are naturally occurring.
  • suitable polymers include, but are not limited to; aliphatic polyesters, poly(amino acids), copoly(ether-esters), polyalkylenes oxalates, polyamides, tyrosine derived carbonates, poly(imniocarbonates), polyorthoesters, polyoxaesters, polyamidoesters, polyoxaesters containing amine groups, poly(anhydhdes), polyphosphazenes or blends thereof.
  • suitable synthetic polymers for use in the invention include biosynthetic polymers based on sequences found in collagen, elastin, thrombin, fibronectin, starches, poly(amino acid), polypropylene fumarate), gelatine, alginate, pectin, fibrin, silk oxidized cellulose, chitin, chitosan, tropelastin, hyaluronic acid, ribonucleic acids, deoxzyribonucleic acids, polypeptides, proteins, polysaccharides, polynucleotides or combinations thereof.
  • suitable examples of natural polymers include, but are not limited to, fibrin-based materials, collagen-based materials, hyaluronic acid-based materials, glycoprotein-based materials, cellulose-based materials, silks, or combinations thereof.
  • suitable bioresorbable ceramic particles include, but are not limited to, calcium sulphate, calcium phosphate, calcium carbonate, and hydroxyapatite particles.
  • the tissue substitute structure comprises a non-bioresorbable material.
  • suitable non-bioresorbable metals include, but not limited to, stainless steel, cobalt chrome, or transition metals such as titanium and zirconium and their respective alloys.
  • suitable non-bioresorbable ceramic particles include alumina, and zirconia.
  • non-bioresorbable polymers include, but are not limited to, polyethylene, polyvinylacetate, polymethylmethacrylate, polypropylene, poly (ethyl terephthalate), silicone, polyethylene oxide, polyethylene glycol, polyurethanes and polyvinyl alcohol.
  • tissue substitute structure may further be associated with an agent that promotes healing and/or regeneration of a tissue.
  • Suitable agents include, but are not limited to, anti-inflammatory agents, analgesics, antibiotics, anti-viral agents, growth factors, hormones, cytokines, peptides, proteins, osteogenic agents, chondrogenic agents, anti-resprptive agents, glycosaminoglycans, immunosuppressants, nucleic acids, cells, tissue fragments and/or combinations thereof.
  • PRP platelet rich plasma
  • PRP platelet rich plasma
  • graft stabilization graft stabilization
  • wound sealing wound healing and haemostasis.
  • PRP concentrates a high number of autologous platelets in a small amount of plasma and mimics the last steps in the coagulation cascade, leading to the formation of a fibrin clot, which consolidates and adheres to the application site in a short period of time.
  • Platelet alpha granules contain potent growth factors necessary to begin and substantially accelerate tissue repair and regeneration at the wound site. Growth factors shown to enhance the body's natural healing process include:
  • PDGF Platelet Derived Growth Factors initiate connective tissue healing including bone regeneration and repair. PDGF also increases mitogenesis (healing cells), angiogenesis
  • TGF- ⁇ Transforming Growth Factor Beta
  • EGF Epidermal Growth Factors
  • VEGF Vascular Endothelial Growth Factors
  • PRP platelet alpha granules, and/ or growth factors derived from PRP are applied to the substitute tissue structure.
  • osteogenic proteins also referred to as bone morphogenetic, or morphogenic proteins (BMPs), which are a family of bone-matrix polypeptides which induce formation of new bone by causing the differentiation of mesenchymal ceils to chondroblasts and osteoblasts.
  • BMPs bone morphogenetic, or morphogenic proteins
  • the substitute tissue structure can also be associated with a cell.
  • Suitable cell types include a stem cell, pluripotent cell, chondrocyte progenitor, chondrocyte, osteocyte, fibroblast, osteoclast, osteoblast, chondroblast, endothelial cell, macrophage, adipocyte, monocyte, plasma cell, mast cell, umbilical cord cell, leukocyte, stromal cell, epithelial cell, myoblast, tenocyte, ligament fibroblast or bone marrow cell type, and/or combinations thereof.
  • the stem cell is a mesenchymal stem cell.
  • the substitute tissue structure is seeded with a cell population.
  • This cell population can be of a single cell type or at least two different cell types.
  • the cells can be seeded in a manner appropriate to the tissue that they are to form.
  • the layers of different cell types can be applied to the substitute tissue structure. Plasma treatment of the substitute tissue structure prior to or after sterilisation can be used to enhance cell adherence.
  • the substitute tissue structure can also be associated with at least one tissue fragment.
  • the fragment can be derived from, for example, cartilage, meniscus, tendon, ligament, periosteum or bone or bone marrow extract.
  • the cell ⁇ s) or tissue fragment(s) used in this invention may be autogenic, allogenic, xenogenic or combinations thereof.
  • the annular anchoring element is used to securely anchor the substitute tissue structure into a groove formed within the underlying tissue. This is of particular importance when there are moving parts adjacent to the implantation site which could dislodge the implant.
  • the implant is for use in repairing cartilage and the element is anchored into a groove formed in the underlying bone, specifically within the subchondral bone.
  • the annular anchoring element is preferably circular or oval, but may be of another shape known to one of skill in the art.
  • the annular anchoring element can be a continuous or non- continuous element.
  • any material used within the annular anchoring element is biocompatible, that is, it does not elicit an immune response upon implantation.
  • at least a part of the annular anchoring element is formed of a bioresorbable material. Such a material has the ability to transiently resorb, preferably in a controllable manner, within the body environment.
  • various parts of the annular anchoring element may be designed to resorb at different rates.
  • the rate of resorption is isotropic across the annular anchoring element.
  • a region of the annular anchoring element may be resorbable while another region may be non-resorbable.
  • this element comprises an agent that augments bone growth.
  • an agent includes, but is not limited to, an osteogenic stimulant, osteoconductive stimulant and/or an osteoinductive stimulant.
  • Osteogenic stimulation of bone formation refers to the stimulation of bone forming or "osteogenic" cells to form new bone growth.
  • Osteoconductive stimulation of bone formation refers to the ability of some materials to serve as a scaffold on which bone cells can attach, migrate (meaning move or "crawl”), and grow and divide. In this way, the bone healing response is "conducted" through the graft site.
  • Osteoinductive stimulation of bone formation refers to the capacity of many normal chemicals in the body to stimulate primitive "stem cells" or immature bone cells to grow and mature, forming healthy bone tissue.
  • Suitable materials for the annular anchoring element include, but not limited to, a natural polymer, a synthetic polymer, a ceramic material, a metal and/or combinations thereof.
  • the annular anchoring element includes at least one synthetic polymer selected from the group consisting of aliphatic polyesters, poly(amino acids), copoly(ether-esters), polyalkylenes oxalates, polyamides, tyrosine derived carbonates, poly(imniocarbonates), polyorthoesters, polyoxaesters, polyamidoesters, polyoxaesters containing amine groups, poly(anhydrides), polyphosphazenes, and blends thereof.
  • synthetic polymer selected from the group consisting of aliphatic polyesters, poly(amino acids), copoly(ether-esters), polyalkylenes oxalates, polyamides, tyrosine derived carbonates, poly(imniocarbonates), polyorthoesters, polyoxaesters, polyamidoesters, polyoxaesters containing amine groups, poly(anhydrides), polyphosphazenes, and blends thereof.
  • Suitable synthetic polymers for use in the invention can also include biosynthetic polymers based on sequences found in collagen, elastin, thrombin, fibronectin, starches, poly(amino acid), poly(propylene fumarate), gelatine, alginate, pectin, fibrin, silk oxidized cellulose, chitin, chitosan, tropelastin, hyaluronic acid, ribonucleic acids, deoxzyribonucleic acids, polypeptides, proteins, polysaccharides, polynucleotides and combinations thereof.
  • suitable examples of natural polymers include, but are not limited to fibrin-based materials, collagen-based materials, hyaluronic acid-based materials, glycoprotein-based materials, cellulose-based materials, silks and combinations thereof.
  • the annular anchoring element is molded from polylactide carbonate (PLC), a bioresorbable polymer combined with calcium carbonate. After implantation the PLC gradually resorbs and the calcium carbonate promotes the growth of cancellous, or porous, bone within the bone.
  • the annular anchoring element comprises the bioresorbable polymer: poly (D,L-lactide-co-glycolide). After implantation the polymer gradually resorbs.
  • the annular anchoring element comprises a bioresorbable ceramic, for example, calcium phosphate, calcium carbonate or hydroxyapatite particles or combinations thereof.
  • the annular anchoring element comprises a non-bioresorbable material.
  • suitable non-bioresorbable metals include stainless steel, cobalt chrome, or transition metals such as titanium and zirconium and their respective alloys.
  • suitable non-bioresorbale ceramic particles include alumina, zirconia and calcium sulphate particles.
  • suitable non-bioresorbale polymers include polyethylene, polyvinylacetate, polymethylmethacrylate, polypropylene, poly (ethyl terephthalate), silicone, polyethylene oxide, polyethylene glycol, polyurethanes and polyvinyl alcohol,
  • annular anchoring element can be made of a non-porous material, a porous material, or combinations thereof.
  • the annular anchoring element may be rigid and therefore preformed to the shape of the groove.
  • the element may be deformable, advantageously resiliently deformable, thereby allowing any necessary deformation of the shape of the element to correspond with the shape of the groove.
  • the annular anchoring element may be expandable after implantation to fit securely into the groove, for example the annular ring may be formed of a shape memory polymer.
  • the osteoconductive properties of the annular anchoring element may be further enhanced by texturing of at least a part of the surface, for example, by etching or grit-blasting.
  • the annular anchoring element can be provided with an anti-rotational element, which may, for example, be a threaded ring or a barbed ring.
  • Additional elements may be applied to or incorporated within the annular anchoring element to increase its stability within the groove, for example, a tack, a screw, a barb, a pin, or a plug.
  • the tissue substitute structure may further be associated with an agent that promotes healing and/or regeneration of a tissue.
  • association is herein defined as the agent being incorporated within, attached to, adhered to, applied to, or seeded within, at least a part of the tissue substitute structure.
  • Suitable agents include, but are not limited to, anti-inflammatory agents, analgesics, antibiotics, anti-viral agents, growth factors, hormones, cytokines, peptides, proteins, osteogenic agents, chondrogenic agents, anti-resorptive agents, glycosaminoglycans, immunosuppressants, nucleic acids, cells, tissue fragments, and/or combinations thereof.
  • At least part of the annular anchoring element is bonded to the undersurface of the tissue substitute structure.
  • the undersurface of the tissue substitute structure is defined as that surface which is proximal to the underlying tissue when the implant is implanted at a site.
  • the bonding can be by a suitable chemical means and/or physical means.
  • the bonding can be achieved by the application of various adhesives.
  • the tissue substitute structure is extended radially beyond the annular anchoring element as illustrated in Figures 4 and 5.
  • an implant according to the invention for repair of damaged tissue present at or on the surface of a bone in an animal.
  • a method for the repair of damaged tissue present in an animal comprising the steps of; i) forming a groove around at least part of the damaged tissue, the groove extending into the underlying tissue below the damaged tissue, ii) removing the tissue about which the groove extends, iii) providing an implant comprising a substitute tissue structure having an annular anchoring element bonded thereto; and iv) inserting the annular anchoring element into the groove.
  • the animal is a human or non- human animal.
  • the method is used for the repair of damaged cartilage.
  • Figure 1 A schematic of an implant according to a first embodiment of the invention.
  • Figure 2 A schematic of the implant in Figure 1 seated within subchondral bone.
  • Figure 3 A photograph of the implant.
  • Figure 4 A schematic of an implant according to a second embodiment of the invention.
  • Figure 5 A schematic of the implantation of the implant in Figure 4 into a bone site.
  • Felt & ring anchored implants of a resorbable non- woven felt of PLGA (10:90) attached directly to a ring of poly lactide carbonate (PLC) were made according to the method described below:
  • Non-woven (un-bonded) poly(L-lactic-co-glycolic) acid (PLGA 10:90) scaffolds were produced with the following specification:
  • Powdered polycaprolactone, PCL (CAPA 686, Solway) is dissolved in Chloroform (GPC Grade) to form a 6% w/v solution.
  • the PCL solution is then introduced onto at least part of one side of the PLC ring using a small spatula.
  • the PLGA non-woven felt is then applied to the side of the PLC ring provided with the PCL solution to bond them together.
  • the felt & ring implants are then placed on a release paper and air-dried in a fume cupboard overnight and subsequently dried in a vacuum oven at 40°C for 24 hours.
  • FIG 1 shows an implant 1 of a first embodiment.
  • the implant 1 includes a substantially circular scaffold, or substitute tissue structure 2, and an annular anchoring element 3, each having the same diameter.
  • the scaffold 2 includes a first end 2a and a second end 2b.
  • the annular anchoring element 3 includes a first end 3a having an opening 3b and a second end 3c having an opening 3d.
  • Figure 2 shows a cross-sectional view of the implant 1 anchored into subchondral bone 5.
  • the annular anchoring element 3 is retained within an annular groove 6 formed within the subchondral bone 5 and which surrounds a cartilage defect 8.
  • the implant 1 is anchored into subchondral bone 5 by first forming the groove 6 around at least part of damaged cartilage and/or bone tissue (not shown).
  • the groove 6 is formed by a reaming device or other instrument known to one of ordinary skill in the art.
  • the damaged tissue is then removed, via a scraping device, wire brush, or other instrument known to one of ordinary skill in the art, and the implant 1 is inserted into the groove 6.
  • the scaffold 2 is of an appropriate thickness such that when the anchoring element 3 is seated in the subchondral bone 5, the first end 2a of the scaffold 2 lies flush with the surrounding cartilage 7.
  • Figures 3A and 3B show a plan view and a cross-sectional view, respectively, of the implant 1.
  • FIG 4 shows an implant 11 according to a second embodiment of the present disclosure.
  • This implant 11 is designed for implantation into a site of a cartilage defect, as will be further described below.
  • the annular anchoring element 13 is retained within an annular groove 14 formed within the subchondral bone 15 and which surrounds a cartilage defect 18, as will be further described in Figure 5.
  • the substitute tissue structure 12 is of an appropriate thickness such that when the anchoring element is seated in the subchondral bone 15, the first end 12a of the structure 12, lies flush with the surrounding cartilage 17.
  • the substitute tissue structure 12 has a larger diameter than the annular anchoring element 13, such that the periphery 19 of the substitute tissue structure 12 extends radially of the annular anchoring element 13.
  • the upper surface of the subchondral bone 15 forms a ledge 20 onto which this radially extended region 19 is supported.
  • An advantage of this region 19 is that the scaffold, or substitute tissue structure 12, is restricted from being pulled down into the groove 14.
  • Figures 5A-5F show the implantation of the implant 11.
  • Figure 5A shows the cartilage defect 18.
  • Figure 5B shows the preparation of an annular groove 30 using a saw trephine 40 and a guide 50.
  • Figure 5C shows the defect site 70 after preparation of the annular groove 30.
  • Figure 5D shows preparation of the ledge 20 of subchondral bone 15, as described above, using a cutter 60.
  • Figure 5E shows the defect site 70 after preparation of the ledge 20.
  • Figure 5F shows the implant 11 implanted into the prepared defect site 70.
  • Other tools known to one of ordinary skill in the art may be used to prepare the annular groove 30 and the ledge 20.
  • the implants 1 ,11 of the present disclosure are used, as described above, in the repair of tissue, such as cartilage tissue, in human or non-human animals. Formation of the grooves and removal of the damaged tissue induces bleeding of the subchondral bone and stimulates formation of a blood clot within/around the scaffold.

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

Abstract

L'invention propose un implant destiné à être placé sur le site d'un tissu endommagé ou détruit, l'implant comprenant une structure (2) de tissu de remplacement et un élément annulaire d'ancrage (3) qui ancre la structure de tissu de remplacement dans une rainure formée dans l'os sur ou à proximité du site d'implantation, et dans lequel au moins une partie de l'élément annulaire d'ancrage est liée à une surface de la structure de tissu de remplacement.
PCT/US2008/053300 2007-11-16 2008-02-07 Implant annulaire WO2009064509A1 (fr)

Priority Applications (4)

Application Number Priority Date Filing Date Title
PCT/US2008/053300 WO2009064509A1 (fr) 2007-11-16 2008-02-07 Implant annulaire
EP08729277A EP2224883A1 (fr) 2007-11-16 2008-02-07 Implant annulaire
JP2010534065A JP2011502703A (ja) 2007-11-16 2008-02-07 環状リング移植片
AU2008321357A AU2008321357A1 (en) 2007-11-16 2008-02-07 Annular ring implant

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
PCT/US2007/084905 WO2008061216A2 (fr) 2006-11-18 2007-11-16 Implant de bague annulaire
USPCT/US2007/084905 2007-11-16
PCT/US2008/053300 WO2009064509A1 (fr) 2007-11-16 2008-02-07 Implant annulaire

Publications (1)

Publication Number Publication Date
WO2009064509A1 true WO2009064509A1 (fr) 2009-05-22

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PCT/US2008/053300 WO2009064509A1 (fr) 2007-11-16 2008-02-07 Implant annulaire

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WO (1) WO2009064509A1 (fr)

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030036801A1 (en) * 2001-07-16 2003-02-20 Schwartz Herbert E. Cartilage repair apparatus and method
WO2003028535A2 (fr) * 2001-10-01 2003-04-10 Scandius Biomedical, Inc. Appareil et procede permettant la reparation de lesions ou de la perte du cartilage articulaire
US20030220700A1 (en) * 2002-05-22 2003-11-27 Hammer Joseph J. Attachment of absorbable tissue scaffolds ot fixation devices
WO2005051242A1 (fr) * 2003-10-28 2005-06-09 Xiros Plc Reparation de tissu altere sur un site osseux

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030036801A1 (en) * 2001-07-16 2003-02-20 Schwartz Herbert E. Cartilage repair apparatus and method
WO2003028535A2 (fr) * 2001-10-01 2003-04-10 Scandius Biomedical, Inc. Appareil et procede permettant la reparation de lesions ou de la perte du cartilage articulaire
US20030220700A1 (en) * 2002-05-22 2003-11-27 Hammer Joseph J. Attachment of absorbable tissue scaffolds ot fixation devices
WO2005051242A1 (fr) * 2003-10-28 2005-06-09 Xiros Plc Reparation de tissu altere sur un site osseux

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