EP1981417A2 - Attaches chirurgicales et dispositifs de greffes associes a composants bioabsorbables - Google Patents

Attaches chirurgicales et dispositifs de greffes associes a composants bioabsorbables

Info

Publication number
EP1981417A2
EP1981417A2 EP06718192A EP06718192A EP1981417A2 EP 1981417 A2 EP1981417 A2 EP 1981417A2 EP 06718192 A EP06718192 A EP 06718192A EP 06718192 A EP06718192 A EP 06718192A EP 1981417 A2 EP1981417 A2 EP 1981417A2
Authority
EP
European Patent Office
Prior art keywords
base
diameter
shank
head
surgical
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.)
Withdrawn
Application number
EP06718192A
Other languages
German (de)
English (en)
Other versions
EP1981417A4 (fr
Inventor
James D. Ralph
Stephen L. Tatar
Thomas N. Troxell
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.)
Biodynamics LLC
Original Assignee
Biodynamics LLC
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 Biodynamics LLC filed Critical Biodynamics LLC
Publication of EP1981417A2 publication Critical patent/EP1981417A2/fr
Publication of EP1981417A4 publication Critical patent/EP1981417A4/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86—Pins or screws or threaded wires; nuts therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/064—Surgical staples, i.e. penetrating the tissue
    • A61B17/0642—Surgical staples, i.e. penetrating the tissue for bones, e.g. for osteosynthesis or connecting tendon to bone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86—Pins or screws or threaded wires; nuts therefor
    • A61B17/864—Pins or screws or threaded wires; nuts therefor hollow, e.g. with socket or cannulated
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00004—(bio)absorbable, (bio)resorbable or resorptive
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0412—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors having anchoring barbs or pins extending outwardly from suture anchor body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0414—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors having a suture-receiving opening, e.g. lateral opening
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0427—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors having anchoring barbs or pins extending outwardly from the anchor body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0438—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors slotted, i.e. having a longitudinal slot for enhancing their elasticity
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/044—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors with a threaded shaft, e.g. screws
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0445—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors cannulated, e.g. with a longitudinal through-hole for passage of an instrument
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0446—Means for attaching and blocking the suture in the suture anchor
    • A61B2017/0458—Longitudinal through hole, e.g. suture blocked by a distal suture knot
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/064—Surgical staples, i.e. penetrating the tissue
    • A61B2017/0647—Surgical staples, i.e. penetrating the tissue having one single leg, e.g. tacks
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/064—Surgical staples, i.e. penetrating the tissue
    • A61B2017/0647—Surgical staples, i.e. penetrating the tissue having one single leg, e.g. tacks
    • A61B2017/0648—Surgical staples, i.e. penetrating the tissue having one single leg, e.g. tacks threaded, e.g. tacks with a screw thread
    • 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
    • A61F2002/30064—Coating or prosthesis-covering structure made of biodegradable material

Definitions

  • the present invention has to do with surgical fasteners and related devices which are implanted in the body.
  • the invention has to do with improved surgical implants which are made with a base comprising metals and/or high strength plastic materials.
  • Bioabsorbable materials are molded or otherwise applied onto the base and attached thereto.
  • the base is made with elements which enhance the mechanical attachment of the bioabsorbable material to the base.
  • the products of the invention can accordingly withstand the torques and stresses encountered during surgery and following surgery, in the body, while providing the benefits of bioabsorbability to the patient.
  • Bioabsorbable surgical fastening devices such as screws, pins, tacks, bolts, nails, suture anchors, staples, etc.
  • bioabsorbable polymers have been made such as described in U.S. Patent No. 6,406,498.
  • bioabsorbable substances usually do not have sufficient strength to withstand the stresses encountered during surgery and, following surgery, in the body. When such materials fail during surgery, more extensive and prolonged surgery may be required. And when such materials fail in the body, re-surgery is usually required.
  • Coated implants have been described to a limited extent and for limited purposes such as in U.S. Patent No. 5,571 ,139 which describes a bidirectional suture anchor which can be constructed of a non-absorbable biocompatible material coated with a bioabsorbable coating having a low coefficient of friction. The low coefficient of friction is said to assist in the installation of the implant.
  • the present invention overcomes problems associated with the prior art by providing surgical fasteners and related devices with bioabsorbable components which are sufficiently attached to an underlying, non-bioabsorbable base that they will not separate from the base during surgery.
  • the present invention also provides implants having a base coated with bioabsorbable material which itself has functional mechanical features, such as bioabsorbable threads, which are not embodied in the base.
  • the invention has to do with improved surgical fasteners and related devices having as a base a tissue friendly metallic material or high strength plastic material which is not bioabsorbable.
  • the fasteners include any kind of surgical fastener which may be completely or partially implanted in the body. Examples of such fasteners include screws, cannulated screws, suture anchors, bone anchors, pins, tacks, bolts, nails, staples, etc.
  • Related devices include rods, plates, wires and the like.
  • the base is completely or partially coated with a bioabsorbable material and the bioabsorbable material is attached to the base.
  • the base is made with attachment elements which provide for the mechanical attachment of the bioabsorbable material thereto.
  • the base can be made from a mesh material or cable which provides for attachment of the bioabsorbable material by means of the structure of the mesh or cable.
  • the objective in selecting a material for the base is to find a material having sufficient strength for the particular application but also, in many cases, sufficient flexibility when implanted in the body. For example, a screw that is sufficiently flexible to allow micro-motion will be less likely to back out, will absorb shock and may generate or stimulate bone growth.
  • the bioabsorbable material optionally can have functional mechanical features which are not features of the base.
  • the bioabsorbable material can be threaded even though the base is not threaded.
  • Figs. 1-4 are views of various surgical screws according to the invention.
  • Fig. 5 is a section view of a base for a surgical screw of the invention.
  • Figs. 6-17 are views of various base designs for surgical fasteners of the invention.
  • Fig. 18 is a section view of a base for a surgical screw of the invention.
  • Fig. 19 illustrates a surgical screw of the invention.
  • Fig. 20 is a section view of a base for a surgical screw of the invention.
  • Fig. 21 is a section view of a base for a surgical screw of the invention.
  • Figs. 22 and 23 illustrate two pin designs according to the invention.
  • Fig. 24 illustrates a tack according to the invention.
  • Fig. 25 illustrates a bolt according to the invention.
  • Fig. 26 illustrates a nail according to the invention.
  • Fig. 27 illustrates a staple according to the invention.
  • Fig. 28 illustrates a rod according to the invention.
  • Fig. 29 illustrates a wire according to the invention.
  • Fig. 30 illustrates a plate according to the invention.
  • Figs. 31 and 32 illustrate a screw and washer combination according to the invention.
  • Fig. 33 illustrates six different head configurations for the screws of the invention and one head configuration for the pins of the invention.
  • Fig. 1 A illustrates a base 1 having a shank 2 and a head 3.
  • the shank 2 contains grooves 4 which serve as attachment elements.
  • bioabsorbable threads 5 have been attached to the base to make screw 6.
  • Fig. 1 C is a section view of screw 6 taken along section line a-a of Fig. 1 B. Slot 7 is illustrated in the head.
  • the base 1 can optionally be removed smoothly from the body.
  • the threads may stick to the surrounding tissue and in such cases removal of the screws can cause injury to the patient. This problem is avoided when the screws of the present invention are used.
  • Fig. 2A illustrates the same base as illustrated in Fig. 1A.
  • Fig. 2B a bioabsorbable coating 8 with bioabsorbable threads 9 have been coated over and attached to the shank of the base to make screw 6A.
  • Fig. 2C which is a section taken along section line a-a of Fig. 2B.
  • the bioabsorbable coating 8 and bioabsorbable threads 9 are easily identified in section.
  • Fig. 3A also illustrates the same base as illustrated in Fig. 1 A.
  • Fig. 3B illustrates screw 6B having bioabsorbable coating 10 and bioabsorbable threads 11 coated over and attached to the base 1 .
  • the section illustration of Fig. 3C is taken along section line a-a of Fig. 3B and illustrates base 1 entirely coated with bioabsorbable material including coated slot 12.
  • Fig. 4A illustrates a base 13 having a shank 14 with partial holes 15 therein. Partial holes 15 are the attachment elements.
  • Figure 4B illustrates a screw 6C made by adhering bioabsorbable threads 16 onto the base 13.
  • Fig. 4C illustrates screw 6C in section with the section being taken along section line a-a of Fig. 4B.
  • Fig. 5 illustrates in section a base 17 for a surgical screw. Through holes 18 are the attachment elements.
  • Fig. 6 illustrates base a 19 for a surgical screw having indentations or pockets
  • Fig. 7 illustrates base 21 for a surgical screw having protrusions, bumps or nubs 22 as the attachment elements.
  • Fig. 8 illustrates base 23 for a surgical screw having corrugations 24 as the attachment elements.
  • Fig. 9 illustrates a base 25 for a surgical screw having a through slit 26 as the attachment element.
  • Fig. 10 illustrates a base 27 for a surgical screw having splines 28 as the attachment elements.
  • Fig. 1 1 illustrates a base 29 for a surgical screw having threads 30 as the attachment elements.
  • Fig. 12 illustrates a base 31 for a surgical screw having knurls 32 as the attachment elements.
  • Fig. 13 illustrates a base 33 for a surgical screw having a roughened surface 34 as the attachment elements.
  • the roughened surface can be imparted to the base by, for example, sanding or sand blasting.
  • the attachment elements 34 are illustrated over the entire surface of base 33 and this design is suitable for screws, pins and other implant devices that will be completely coated with the bioabsorbable material.
  • Other attachment elements can be completely or partially applied to any base of the invention and combinations of two or more than two attachment elements can be used as will be apparent to those skilled in the art.
  • Fig. 14 illustrates a base 35 having an etched surface 36 as the attachment elements.
  • Fig. 15A illustrates a base 37 for a surgical screw having an adherency promoting surface coated or plated thereon.
  • the adherency promoting surface can also be seen in Fig. 15B which is a section view of Fig. 15A taken along section line a- a.
  • Fig. 16 illustrates a base 39 for a surgical screw having a shank 40 comprised of a cable.
  • Fig. 17 illustrates a base 41 for a surgical screw having a shank 42 comprised of or covered with a mesh material.
  • Fig. 18 illustrates in section a base 43 for a surgical screw having a bore 44 through the entire longitudinal length thereof.
  • This base can be used to make a cannulated screw or pin according to the invention.
  • Fig. 19A illustrates a surgical screw 45 having a shank coated with a bioabsorbable coating 46 and bioabsorbable threads 47.
  • the head 48 is illustrated in top view Fig. 19Aa.
  • Opening 49 is in open communication with a tapered slit 50 which is illustrated in Fig. 19B.
  • Fig. 19B illustrates the base for the screw 45 before it was coated with the bioabsorbable material.
  • Pin 52 illustrated in Fig. 19A can be inserted into opening 49 and driven into the slit 50.
  • the diameter of pin 52 is less than the diameter of the opening 49 and greater than the width of the slit at distal end 53.
  • Fig. 20 illustrates in section a base 55 for a surgical screw of the invention.
  • Transverse bore 56 is made across and through the entire diameter of the shank 57.
  • Fig. 21 illustrates in section base 58 for a surgical screw of the invention.
  • Transverse bore 59 passes across and through the entire diameter of head 60. It is noted that the bore 44 in Fig. 18, bore 56 in Fig. 20 and bore 59 in Fig. 21 can accommodate sutures and the screws made according to the invention with the bases illustrated in those drawings can be used as suture anchors or bone anchors.
  • Fig. 22 illustrates a pin 61 of the invention having bioabsorbable coating 62 thereon.
  • Fig. 23 illustrates a pin 63 of the invention having a tapered slit 64 which communicates with opening 65 in head 66. The pin is coated with bioabsorbable coating 67.
  • a pin 52 of the type illustrated in Fig. 19A can be driven into pin 63 to fix the pin 63 in position in the patient.
  • Fig. 24 illustrates a tack 68 having a partial bioabsorbable coating 69 thereon and attached thereto.
  • Fig. 25 illustrates a bolt 70 having bioabsorbable threads 71 attached thereto and a nut 72.
  • Fig. 26 illustrates a nail 73 having a bioabsorbable coating 74 thereon and attached thereto.
  • Fig. 27 illustrates a staple 75 having bioabsorbable coatings 76 thereon and attached thereto.
  • Fig. 28 illustrates a rod 77 having mounting holes 78 and a bioabsorbable coating 79 thereon and attached thereto.
  • Fig. 29 illustrates a wire 80 which has a bioabsorbable coating over the surface thereof and attached thereto.
  • Fig. 30 illustrates a plate 81 having mounting holes 82.
  • a bioabsorbable coating is provided over the surface thereof and attached thereto.
  • Fig. 31A illustrates screw 83 having bioabsorbable threads 84.
  • the screw 83 has a head 85 affixed to shank 86.
  • Annular ring 87 is affixed to shank 86.
  • Washer 88 illustrated in Figs. 31 B and C is provided with protuberances 89, center opening 90, radial openings 91 and fingers 92.
  • the fingers are somewhat flexible and permit the washer to snap over ring 87 so that the washer will stay rotatably disposed between the head 85 and ring 87 as illustrated in Fig. 32.
  • the distance d between the head 85 and the ring 87 is greater than the thickness t of washer 88 and the radius of center opening 90 is greater than the outer radius of the threads 84 but is less than the outer radius of ring 87.
  • protuberances 89 contact and enter the operating surface and prevent the washer from rotating as the screw is tightened down.
  • the combination of screw 83 and washer 88 is particularly suitable as a tissue anchor.
  • Fig. 33 illustrates top views of various head configurations for the screws and pins of the invention.
  • Fig. 17 A is a Philips head
  • B is a slotted head
  • C is a spannon
  • D is a torq
  • E is a hex
  • F is a new design.
  • Head G can be used for a pin.
  • Base designs of the invention have been illustrated for various types of screws and pins but, as will be apparent to those skilled in the art, the base can have various shapes and sizes depending on the design requirements of the end product.
  • One skilled in the art can design any implant according to the invention bearing in mind the limitations and advantages of the materials used.
  • a suitable base can be designed accordingly for any end product that will be completely or partially coated with a bioabsorbable material, bearing in mind that the bioabsorbable material itself can have mechanical features such as protrusions, indentations, threads and the like.
  • Suitable materials for the base of the invention include tissue friendly metals, alloys, synthetic metals, ceramics, plastics and reinforced plastics which are commonly used in surgical implants of all kinds. Such materials include materials that have sufficient strength to meet the objectives of the invention and that have been approved by the United States Food and Drug Administration (FDA) for surgical implant applications.
  • FDA United States Food and Drug Administration
  • alloys used in orthopedic metals today there are three main types of alloys used in orthopedic metals today, titanium alloys, cobalt alloys and iron alloys.
  • An exhaustive list is available on the FDA website which also provides the reference numbers and effective dates of the ASTM or ISO standards for the materials.
  • Some examples include unalloyed and alloyed titanium; molybdenum, chromium, cobalt, tungsten, aluminum, niobium, manganese or vanadium in various combinations as alloys or components of alloys, various stainless steels and other iron alloys; aluminum oxides, zirconium oxides, tantalum and calcium phosphates.
  • high strength plastic materials that are not considered to be bioabsorbable also are employed to make implants and many of these are identified not only on the FDA website mentioned above but also on the ASTM website.
  • suitable high strength plastic materials include polyetheretherketone (PEEK), epoxys, polyurethanes, polyesters, polyethylenes, vinyl chlorides, polysulfones, polytetrafluoro-ethylene (PTFE), polycarbonates, polyaryletherketone (PAEK), polyoxymethylene, nylon, carbon fiber polyester, polyetherketoneetherketoneketone (PEKEKK), silicones and the like.
  • high strength plastic material is defined as any tissue-friendly non-bioabsorbable polymer, copolymer, polymer mixture or polymer alloy having sufficient strength to withstand without failure the torques and stresses that a fastener or related implant device of the invention would normally be subjected to during surgery or in the body.
  • bioabsorbable material includes materials which are partially or completely bioabsorbable in the body. Suitable bioabsorbable materials include polyglycolide, poly(lactic acid), copolymers of lactic acid and glycolic acid, poly-L-lactide, poly-L-lactate; crystalline plastics such as those disclosed in U.S. Patent No. 6,632,503 which is incorporated herein by reference; bioabsorbable polymers, copolymers or polymer alloys that are self-reinforced and contain ceramic particles or reinforcement fibers such as those described in U.S. Patent No. 6,406,498 which is incorporated herein by reference; bioresorbable polymers and blends thereof such as described in U.S. patent No.
  • Bioactive materials can be admixed with the bioabsorbable materials, impregnated in the bioabsorbable materials and/or coated on the outer surface thereof and/or coated on the base or otherwise provided at the interface of the base with the bioabsorbable material.
  • These materials can include, for example, bioactive ceramic particles, capsules or reinforcement fibers and they can contain, for example, antimicrobial fatty acids and related coating materials such as those described in Published U.S. Patent Application No. 2004/0153125 A1 ; antibiotics and antibacterial compositions; immunostimulating agents; tissue or bone growth enhancers and other active ingredients and pharmaceutical materials known in the art.
  • the products of the invention can be made by molding, heat shrinking or coating the bioabsorbable material on a base which has been provided with attachment means.
  • the bioabsorbable material will have functional mechanical properties which are not made from the base material, the bioabsorbable material can be molded onto the base in the desired shape.
  • the bioabsorbable material also can be coated, shrink wrapped or molded onto the base and then machined to the desired shape and/or dimensions.

Landscapes

  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Neurology (AREA)
  • Rheumatology (AREA)
  • Surgical Instruments (AREA)
  • Prostheses (AREA)
  • Materials For Medical Uses (AREA)

Abstract

La présente invention concerne des greffes chirurgicales comprenant des attaches et des dispositifs associés qui sont partiellement bioabsorbables. Les greffes sont construites sur une base non bioabsorbable comprenant des métaux et ou des matériaux plastiques d’une grande robustesse. La base est partiellement ou complètement enduite d’une matière bioabsorbable qui peut avoir ses propres caractéristiques mécaniques, telles que le filetage d’une vis. Des pièces sont jointes sur la base pour améliorer la jonction mécanique de la matière bioabsorbable à la base. Les greffes peuvent supporter les torsions et les pressions exercées lors de l’opération chirurgicale et, suite à l’implantation, dans le corps.
EP06718192A 2006-01-13 2006-01-13 Attaches chirurgicales et dispositifs de greffes associes a composants bioabsorbables Withdrawn EP1981417A4 (fr)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/US2006/001092 WO2007086832A2 (fr) 2006-01-13 2006-01-13 Attaches chirurgicales et dispositifs de greffes associes a composants bioabsorbables

Publications (2)

Publication Number Publication Date
EP1981417A2 true EP1981417A2 (fr) 2008-10-22
EP1981417A4 EP1981417A4 (fr) 2009-11-18

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EP06718192A Withdrawn EP1981417A4 (fr) 2006-01-13 2006-01-13 Attaches chirurgicales et dispositifs de greffes associes a composants bioabsorbables

Country Status (5)

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EP (1) EP1981417A4 (fr)
JP (1) JP2009527261A (fr)
AU (1) AU2006336475A1 (fr)
CA (1) CA2635486A1 (fr)
WO (1) WO2007086832A2 (fr)

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KR101711417B1 (ko) * 2015-10-14 2017-03-14 인하대학교 산학협력단 의료용 미소스테이플 삽입장치
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Also Published As

Publication number Publication date
JP2009527261A (ja) 2009-07-30
AU2006336475A1 (en) 2007-08-02
WO2007086832A3 (fr) 2009-04-09
CA2635486A1 (fr) 2007-08-02
EP1981417A4 (fr) 2009-11-18
WO2007086832A2 (fr) 2007-08-02

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