WO1987000059A1 - Surgical resorbable devices with layered composite structure - Google Patents
Surgical resorbable devices with layered composite structure Download PDFInfo
- Publication number
- WO1987000059A1 WO1987000059A1 PCT/FI1986/000071 FI8600071W WO8700059A1 WO 1987000059 A1 WO1987000059 A1 WO 1987000059A1 FI 8600071 W FI8600071 W FI 8600071W WO 8700059 A1 WO8700059 A1 WO 8700059A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- resorbable
- component
- surgical
- surface layer
- manufactured
- Prior art date
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
-
- 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
-
- 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
- A61F2/30965—Reinforcing the prosthesis by embedding particles or fibres during moulding or dipping
-
- 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
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/04—Macromolecular materials
- A61L31/06—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
-
- 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
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L31/148—Materials at least partially resorbable by the body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—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
- A61B17/80—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
-
- 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
- A61B2017/00004—(bio)absorbable, (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
- A61F2002/30003—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
- 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
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/20—Applying electric currents by contact electrodes continuous direct currents
- A61N1/30—Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis
Definitions
- This invention describes new resorbable surgical osteosynthesis devices for operative treatment (internal fixation) of bone fractures, osteotomies and arthrodesis.
- this invention describes osteosynthesis devices or their parts, such as plates, screws, balks, nails or rods, which are manufactured of body resorbable (soluble) material combination in such a way that the osteosynthesis devices or their components have layered composite structure.
- Body absorbable materials and osteosynthesis devices have been described in several patents as in U.S. Pat. 3 463 158, U.S. Pat. 3 620 218 and U.S. Pat. 3 739 773, which comprise medullary nails, osteosynthesis plates, screws and hollow cylinders which are manufactured of polyglycolic acid.
- G.B. Pat. 1 034 123 shows osteosynthesis devices which are manufactured of poly- ⁇ -hydroxybutyric acid and poly- ⁇ -hydroxypropionic acid.
- U.S. Pat. 4 052 988 shows surgical devices manufactured of poly-p- dioxanone.
- 4 279 249 shows osteosynthesis parts which comprise composite parts constituted by a matrix of polylactic acid or a copolymer thereof; said copolymer comprising at least 90% of units derived from lactic acid, said matrix containing a reinforcement element in the shape of fibers, threads, films, fabrics, or strands embedded therein and present in an amount of 5 to 50% by weight based on the total weight of the osteosynthesis part, said element . being made of polyglycolic acid or a copolymer thereof.
- Polyglycolides, polylactides and poly- ⁇ - hydroxybutyric acid are fairly stiff materials and therefore also notch sensitive and they break under bending or shearing easily (bending strength and shear strength of bulk samples is typically 40-60 MPa).
- Poly-p-dioxanone and many of its derivatives are soft, flexible (elastic) and tough materials, which often do not break at all during normal bending experiments.
- Surgical osteosynthesis devices must be both stiff and tough.
- This invention describes surgical osteosynthesis devices, which are three-dimensional samples, such as plates, screws, balks, nails or rods and which have layered composite structure.
- This structure is constructed of at least partially resorbable material layers in such a way that the surface layer of the composite sample is constructed of a tough and flexible, resorbable polymeric material (polymer, copolymer or polymer alloy) and the layer below it is constructed of a at least partially resorbable material which is clearly stiffer and harder than the surface layer.
- the core of the layered resorbable composite material can be flexible of its character.
- the composite structures of this invention give possibilities to combine advantageously the desirable properties of the flexible resorbable polymers and stiff resorbable polymers and to eliminate the un- favourable mechanical properties of single materials when one manufactures macroscopical surgical samples, which are applied in the internal fixation of the bone fractures, osteotomies, arthrodesis, luxations or other tissue damages.
- the tough and flexible resorbable surface layer decreases the notch sensitivity of the sample and improves therefore the toughness (impact resistance) and the shear strength of the composite sample.
- the flexible and tough resorbable polymers are as a rule more hydrophobic of their nature than the stiff ones. Therefore the tough and flexible surface layer acts also as a hydrolysis barrier which favourably decreases the loss rate of the mechanical bending strength of the composite sample in hydrolytic conditions (like in tissue conditions).
- the stiff resorbable layer below the surface layer gives for the macroscopic sample the stiffness which is necessary in bone surgical internal fixation applications.
- a favourable embodiment of this invention from the point of view of bending stiffness and tensile strength is such a composite sample, where also the core of the stiff layer is flexible and elastic.
- the resorbable stiff material composes a tubular structure, which is favourable from the point of view of bending stiffness and on the other hand the flexible and elastic core increases the tensile strength of the sample.
- the different layers of the composite samples of the invention can be reinforced with resorbable fibers, threads, cords or corresponding structures.
- the different resorbable layers can be also self- reinforced as is described in EPO-appl. 86105465.8.
- Figure la shows typical embodiments of this invention.
- Figure la shows the cross-sections of a cylindrical and a rectangular resorbable osteosynthesis device or its component like plate, medullary nail or osteosynthesis balk (BE Pat. 900 513), which is composed of the surface layer 1, which is constructed of flexible, (elastic) and tough resorbable polymer, copolymer or polymer alloy and of the inner part 2 which is constructed of stiffer and harder resorbable polymeric material.
- the surface layer 1 and/or the inner part 2 can additionally contain resorbable reinforcing elements (such as fibers, threads, cords etc.) or the surface layer 1 and/or the inner part can be self-reinforced (e.g.
- Figure lb shows the cross-sections of a cylindrical and of a rectangular osteosynthesis device or its component, which is composed of flexible and tough resorbable surface layer 1, of stiff resorbable inner part 2 and of flexible and elastic core 3. Also in this case at least one of the layers can be reinforced with resorbable reinforcing elements.
- Flexible, tough resorbable polymers which are suitable for surgical applications and which can be applied as surface layers 1 or cores 3 of the osteosynthesis devices of the invention, are e.g. poly-p-dioxanone and its derivatives and as a rule polymers, which are synthetized of the following monomer:
- R and R' can be hydrogen-, methyl- or ethyl group.
- the surface layer 1 or core 3 can be manufactured also of polyesteramides, which contain long hydrocarbon chains in their structure.
- polyesteramides which are copolymers of diamine, hydroxy acid and diacid (U.S. Pat. 4 343 931) can be applied in surface layer 1 or core 3 of the osteosynthesis devices of the invention:
- x is e.g. 11-14, giving flexible polymers with melting points between 80 - 100°C.
- the stiff inner part 2 of the osteosynthesis devices of the invention can be manufactured of e.g. polyglycolides, polylactides, glycolide/lactide copolymers and of poly- ⁇ -hydroxybutyric acid.
- Surgical polyglycolic acid sutures (trade name Dexon, size 2 USP) were sintered at 220°C temperature and 2000 bar pressure to cylindrical self-reinforced bars (length 70 mm, 0 4 mm).
- the bars were coated by injection moulding with 0.25 mm thick layer of poly-p-dioxanone (
- the shear load carrying capacity of layered (PDS coated) bars was 2100 N.
- the shear load carrying capacity of the corresponding non-coated self-reinforced polyglycolide bars was 1800 N.
- the bending strength of layered (PDS coated) composite bars after three weeks immersion at 37°C in destilled water was 230 N/mm 2 .
- the bending strength of corresponding non-coated self-reinforced poly ⁇ glycolide bars after three weeks immersion at 37°C in destilled water was 80 N/mm 2 .
- Polyglycolic acid melt (
- the inner cores of tubes were filled and outer surfaces were coated with PDS by means of injection moulding giving layered composite rods with 0 4.5 mm (chf. fig. lb).
- Glycolide/lactide copolymer sutures were sintered at 180°C temperature and 2000 bar pressure to tubular, - self-reinforced samples (length 70 mm, outer diameter 4 mm, inner diameter 1.5 mm).
- the inner cores of tubes were filled and outer surfaces were coated with PDS by means of injection moulding giving layered composite rods with 0 4.5 mm( chf. fig. lb).
- Glycolide/lactide copolymer sutures polyglactin 910 (trade name Vicryl) were sintered at 180°C temperature and 2000 bar pressure to tubular, self-reinforced samples (length 70 mm, outer diameter 4 mm, inner diameter 1.5 mm).
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Surgery (AREA)
- Heart & Thoracic Surgery (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Vascular Medicine (AREA)
- Epidemiology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Medical Informatics (AREA)
- Molecular Biology (AREA)
- Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Neurology (AREA)
- Manufacturing & Machinery (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Materials For Medical Uses (AREA)
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
FI852706A FI78238C (fi) | 1985-07-09 | 1985-07-09 | Kirurgisk osteosyntesanordning. |
FI852706 | 1985-07-09 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO1987000059A1 true WO1987000059A1 (en) | 1987-01-15 |
Family
ID=8521104
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/FI1986/000071 WO1987000059A1 (en) | 1985-07-09 | 1986-07-02 | Surgical resorbable devices with layered composite structure |
Country Status (5)
Country | Link |
---|---|
EP (1) | EP0239577A1 (fi) |
AU (1) | AU6135686A (fi) |
CA (1) | CA1277602C (fi) |
FI (1) | FI78238C (fi) |
WO (1) | WO1987000059A1 (fi) |
Cited By (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO1989000431A1 (en) * | 1987-07-10 | 1989-01-26 | Biocon Oy | Absorbable material for fixation of tissues |
AU590270B2 (en) * | 1985-05-08 | 1989-11-02 | Biocon Oy | Material for osteosynthesis devices |
WO1993015694A1 (en) * | 1992-02-14 | 1993-08-19 | Board Of Regents, The University Of Texas System | Multi-phase bioerodible implant/carrier and method of manufacturing and using same |
US5876452A (en) * | 1992-02-14 | 1999-03-02 | Board Of Regents, University Of Texas System | Biodegradable implant |
US6013853A (en) * | 1992-02-14 | 2000-01-11 | The University Of Texas System | Continuous release polymeric implant carrier |
Families Citing this family (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
FI80605C (fi) * | 1986-11-03 | 1990-07-10 | Biocon Oy | Benkirurgisk biokompositmaterial. |
Citations (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3867190A (en) * | 1971-10-18 | 1975-02-18 | American Cyanamid Co | Reducing capillarity of polyglycolic acid sutures |
US4052988A (en) * | 1976-01-12 | 1977-10-11 | Ethicon, Inc. | Synthetic absorbable surgical devices of poly-dioxanone |
EP0013862A1 (de) * | 1979-01-26 | 1980-08-06 | Osteo Ag | Knochenplatte für die Osteosynthese |
US4345339A (en) * | 1980-06-03 | 1982-08-24 | Sulzer Brothers Limited | Biologically implantable member for a tendon and/or ligament |
US4512038A (en) * | 1979-04-27 | 1985-04-23 | University Of Medicine And Dentistry Of New Jersey | Bio-absorbable composite tissue scaffold |
EP0146398A2 (en) * | 1983-12-19 | 1985-06-26 | Southern Research Institute | Method of producing biodegradable prothesis and products therefrom |
-
1985
- 1985-07-09 FI FI852706A patent/FI78238C/fi not_active IP Right Cessation
-
1986
- 1986-07-02 AU AU61356/86A patent/AU6135686A/en not_active Abandoned
- 1986-07-02 WO PCT/FI1986/000071 patent/WO1987000059A1/en not_active Application Discontinuation
- 1986-07-02 EP EP86904187A patent/EP0239577A1/en not_active Withdrawn
- 1986-07-03 CA CA000512961A patent/CA1277602C/en not_active Expired - Fee Related
Patent Citations (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3867190A (en) * | 1971-10-18 | 1975-02-18 | American Cyanamid Co | Reducing capillarity of polyglycolic acid sutures |
US4052988A (en) * | 1976-01-12 | 1977-10-11 | Ethicon, Inc. | Synthetic absorbable surgical devices of poly-dioxanone |
EP0013862A1 (de) * | 1979-01-26 | 1980-08-06 | Osteo Ag | Knochenplatte für die Osteosynthese |
US4512038A (en) * | 1979-04-27 | 1985-04-23 | University Of Medicine And Dentistry Of New Jersey | Bio-absorbable composite tissue scaffold |
US4345339A (en) * | 1980-06-03 | 1982-08-24 | Sulzer Brothers Limited | Biologically implantable member for a tendon and/or ligament |
EP0146398A2 (en) * | 1983-12-19 | 1985-06-26 | Southern Research Institute | Method of producing biodegradable prothesis and products therefrom |
Cited By (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
AU590270B2 (en) * | 1985-05-08 | 1989-11-02 | Biocon Oy | Material for osteosynthesis devices |
WO1989000431A1 (en) * | 1987-07-10 | 1989-01-26 | Biocon Oy | Absorbable material for fixation of tissues |
GR880100451A (en) * | 1987-07-10 | 1989-02-12 | Materials Consultants Oy | Absorbable material for fixating masts |
WO1993015694A1 (en) * | 1992-02-14 | 1993-08-19 | Board Of Regents, The University Of Texas System | Multi-phase bioerodible implant/carrier and method of manufacturing and using same |
AU667877B2 (en) * | 1992-02-14 | 1996-04-18 | Board Of Regents, The University Of Texas System | Multi-phase bioerodible implant/carrier and method of manufacturing and using same |
US5876452A (en) * | 1992-02-14 | 1999-03-02 | Board Of Regents, University Of Texas System | Biodegradable implant |
US6013853A (en) * | 1992-02-14 | 2000-01-11 | The University Of Texas System | Continuous release polymeric implant carrier |
Also Published As
Publication number | Publication date |
---|---|
FI852706L (fi) | 1987-01-10 |
FI78238B (fi) | 1989-03-31 |
FI78238C (fi) | 1989-07-10 |
CA1277602C (en) | 1990-12-11 |
AU6135686A (en) | 1987-01-30 |
FI852706A0 (fi) | 1985-07-09 |
EP0239577A1 (en) | 1987-10-07 |
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