EP0227646A1 - Dispositif chirurgical d'immobilisation d'os fractures - Google Patents

Dispositif chirurgical d'immobilisation d'os fractures

Info

Publication number
EP0227646A1
EP0227646A1 EP85902992A EP85902992A EP0227646A1 EP 0227646 A1 EP0227646 A1 EP 0227646A1 EP 85902992 A EP85902992 A EP 85902992A EP 85902992 A EP85902992 A EP 85902992A EP 0227646 A1 EP0227646 A1 EP 0227646A1
Authority
EP
European Patent Office
Prior art keywords
bone
organ
resorbable
surgical device
fracture
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Withdrawn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
EP85902992A
Other languages
German (de)
English (en)
Inventor
Pertti Tormala
Pentti Rokkanen
Jyrki Kilpikari
Hannu Patiala
Seppo Vainionpaa
Kimmo Vihtonen
Matti Mero
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.)
Materials Consultants Oy
Original Assignee
Materials Consultants Oy
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 Materials Consultants Oy filed Critical Materials Consultants Oy
Publication of EP0227646A1 publication Critical patent/EP0227646A1/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Withdrawn legal-status Critical Current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
    • A61B17/80—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
    • 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
    • A61L31/12—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
    • A61L31/125—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix
    • A61L31/129—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix containing macromolecular fillers
    • 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
    • A61B17/82—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin for bone cerclage
    • 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
    • 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
    • A61L2430/00—Materials or treatment for tissue regeneration
    • A61L2430/02—Materials or treatment for tissue regeneration for reconstruction of bones; weight-bearing implants

Definitions

  • This invention relates to a reinforced, resorbable surgical device for immobilization of bone fracture as defined in the preamble of the claim 1.
  • the device comprises at least one organ, which is used to reinforce a fractured or weakened bone of a human or animal subject.
  • the said organ is formed of resorbable polymeric matrix containing resorbable reinforcing elements, such as fibers, threads, twines or structures constructed of them.
  • the osteosynthesis devices are plate-like perforated samples which are fixed to the bone by screws.
  • Such surgical devices have been manufactured of austenitic steel, titan or other metals or metal alloys, which fulfill the demands of the tissue environment.
  • Such conventional biostable surgical devices are removed at a separate subsequent operation, when the healing of the fracture has proceeded by means of the growth of the bone tissue far enough.
  • resorbable (soluble) osteosynthesis device where band-like or thread-like fixing element(s), which are fastened to the bone and/or tightened to their place to go over the fracture site and/or osteosynthesis plate, is applied.
  • resorbable material means a tissue compatible synthetic or modified polymeric material, which retains its tissue-supporting properties certain periods of time (typically weeks or months) and is gradually degraded biologically into tissue compatible components which are absorbed by living tissues and replaced by healing tissues (about during months or 1-2 years).
  • moulded PGA as bone plates and medullary rods is expressed in U.S. Pat. No. 3 739 773.
  • Surgical devices of poly-dioxanone are disclosed in U.S. Pat. No. 4 052 988-.
  • Surgical devices of poly- ⁇ -hydroxy butyric acid (PHB) or p ⁇ ly- ⁇ -hydroxy propionic acid are disclosed in G.B. Pat. No. 1 034 123.
  • U.S. Pat. No. 4 343 931 discloses surgical devices manufactured of polyesteramides (PEA) which contain long-chain molecular units, and which are copolymers of diamine, hydroxy acid and diacid: n o o o
  • U.S. Pat. No. 4 279 249 discloses the resorbable surgical device of polylactide (PLA) or polylactide copolymer very high in lactic acid units, which device is reinforced with resorbable polyglycolide fibers.
  • PLA polylactide
  • This structure has good mechanical properties but the resorption rate of polylactide is very slow (no appreciable resorption occurred for PLA 100 at 12 months; see P. Christel e_t al. Biomaterials , 1980,
  • the purpose of this invention is to present new combinations of materials for the resorbable surgical device especially for the organ immobilizing the bone fracture. By means of these combinations it is possible to avoid the drawbacks of the prior art combinations. According to this invention it has been unexpectedly found that very strong reinforced resorbable organs, which can be applied as osteosynthesis devices or as their components, with good resorption properties can be manufactured when polyglycolide fibers, threads, bands, fabrics or structures of the same kind are applied as reinforcing elements in the resorbable, polyester matrix which is constructed of (a) poly- ⁇ -hydroxybutyrate or of (b) glycolide/lactide copoly er, the said copolymer comprising at least 80 mole % of units derived from glycolic acid or of (c) of poly-dioxanone .
  • the organs of the invention have good mechanical properties (initial tensile strength 200-400 MPa) caused by the partially fibrous reinforced structure. Because the. resorption rates of the matrix polymers of the organs of the invention are clearly more rapid than that of PLA the organs of the invention are especially suitable in healing of fractures of cancellous bone where fixation of several weeks is needed whereafter the rapid absorption of organs is desired.
  • Fig. 1 shows the invention in connection with the conventional fixing technique
  • Fig. 2 and 3 show the invention in connection with the technique in accordance with the devices of FI-833351.
  • organs according to the invention can be applied as
  • the bone 1, which includes the fracture 2 is immobilized by means of the osteosynthesis plate 3 which goes beyond the fracture 2 and which is fixed to the bone by means of nails or screws 4.
  • the fixing element(s) 5 and 5' which are constructed about fibers, have been tightened to go over the fracture 2 of the bone 1 and/or over the osteosynthesis plate 3.
  • the osteosynthesis plate 3 has been located at least partially into a groove 6 in the bone and in the case of Fig. 3 the osteosynthesis plate or - beam 3 has been located totally inside the immobilized bone, into a channel 7 which has been drilled through the fracture plane.
  • the maximal reinforcing effect of the materials of the invention is achieved by means of reinforcing elements, when they are divided in fiber form into the reinforced matrix.
  • Fibers can be continuous or short fibers and they can be also weaved or collected to different kinds of reinforcing structures. Also other than fibrous reinforcing elements, such as bands or foils can give the desired effect.
  • One especially favourable solution of the device of the invention is such where the resorbable plate or beam 3 and/or fixing element 5, 5' have been coated with a thin inorganic material layer, which is hydrophobic and slackens therefore the diffusion of the water from tissue solutions into the osteosynthesis plate or beam. If the resorption needs enzymatic activity the inorganic surface layer delays also effectively the enzymatic resorption. As a consequence the decrease of the strength of the osteosynthesis device is in the beginning slow and is accelerated rapidly when the inorganic layer is decomposed.
  • Suitable inorganic coatings in this connection are many ceramics as oxides, carbides, nitrides, suicides and silicates, their mixtures and many metals, such as gold, silver and titan, metal alloys and alloys of metals and ceramics.
  • ceramics as oxides, carbides, nitrides, suicides and silicates, their mixtures and many metals, such as gold, silver and titan, metal alloys and alloys of metals and ceramics.
  • the bars had the initial bending strength of 230 MPa and after the hydrolysis in destilled water at 37°C for 8 weeks they had lost their mechanical strength. After 12 weeks the resorption had clearly begun and after the hydrolysis in the above conditions for 12 months the bars were absorbed appreciable as could be seen from the decrease of the dimensions of the bars, strong erosion on their surface and disintegration of the structure.
  • the ethylene oxide sterilized bars were successfully applied clinically to immobilize malleoral fractures of 20 adult patients.
  • the bars were placed within the cancellous bone in drill channels across the fracture surfaces.
  • the fixation was reinforced by means of the resorbable flexible fixing device (suture) according to the Finnish application for patent, FI-833351.
  • the fractures were healed with eventless union and no removal operation of the resorbable device was needed.
  • a mixture of 70 wt-% of poly-dioxanone and 30 wt-% of polyglycolic sutures was compression moulded in a pressure mould to cylindrical bars (length 40 mm and radius 2.0 mm) at 150°C 8 min with the pressure of 2000 bar.
  • the bars had the initial tensile strength of 270 MPa and after the hydrolysis in destilled water at 37°C for at least 16 weeks they had lost their mechanical strength. After 26 weeks the resorption had clearly proceeded as could be seen of the disintegration of the structure.
  • the bars were successfully applied to immobilize the osteothomies of the femurs of anesthetized rats using the bars as intermedullary rods.
  • the fractures were healed with eventless union and no removal operation of the resorbable device was needed.

Landscapes

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

Abstract

Un dispositif chirurgical renforcé et résorbable utilisé pour immobiliser des os fracturés comprend au moins un organe (3) formé d'une matrice en polymère résorbable contenant des éléments résorbables de renforcement, tels que des fibres, des filaments, des fils retors ou des structures formées de ceux-ci. Les éléments de renforcement de l'organe sont formés de fibres de polyglycolide noyées dans la matrice en polymère résorbable. Cette matrice est composée de poly-beta-hydroxybutyrate ou d'un copolymère de glycolide/lactide comprenant au moins 80 moles % d'unités périodiques d'acide glycolique ou de poly-dioxanone.
EP85902992A 1985-06-14 1985-06-14 Dispositif chirurgical d'immobilisation d'os fractures Withdrawn EP0227646A1 (fr)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/FI1985/000052 WO1986007250A1 (fr) 1985-06-14 1985-06-14 Dispositif chirurgical d'immobilisation d'os fractures

Publications (1)

Publication Number Publication Date
EP0227646A1 true EP0227646A1 (fr) 1987-07-08

Family

ID=8556377

Family Applications (1)

Application Number Title Priority Date Filing Date
EP85902992A Withdrawn EP0227646A1 (fr) 1985-06-14 1985-06-14 Dispositif chirurgical d'immobilisation d'os fractures

Country Status (2)

Country Link
EP (1) EP0227646A1 (fr)
WO (1) WO1986007250A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU607964B2 (en) * 1987-01-22 1991-03-21 Ethicon Inc. Bone screw

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FI80605C (fi) * 1986-11-03 1990-07-10 Biocon Oy Benkirurgisk biokompositmaterial.
DE3644588C1 (de) * 1986-12-27 1988-03-10 Ethicon Gmbh Implantat und Verfahren zu seiner Herstellung
SE8802414D0 (sv) * 1988-06-27 1988-06-28 Astra Meditec Ab Nytt kirurgiskt material
CA2060635A1 (fr) * 1991-02-12 1992-08-13 Keith D'alessio Implants medicaux bioabsorbables
US8282674B2 (en) 2008-07-18 2012-10-09 Suspension Orthopaedic Solutions, Inc. Clavicle fixation
CN107050506A (zh) * 2017-05-03 2017-08-18 中国科学院长春应用化学研究所 一种纤维增强的可注射原位固化和成孔的骨组织工程支架材料及其制备方法

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3225766A (en) * 1962-03-26 1965-12-28 Grace W R & Co Method of making absorbable surgical sutures from poly beta hydroxy acids
US3626948A (en) * 1968-12-23 1971-12-14 American Cyanamid Co Absorbable polyglycolic acid suture of enhanced in-vivo strength retention
US3982543A (en) * 1973-04-24 1976-09-28 American Cyanamid Company Reducing capillarity of polyglycolic acid sutures
US3960152A (en) * 1974-01-21 1976-06-01 American Cyanamid Company Surgical sutures of unsymmetrically substituted 1,4-dioxane-2,5-diones
DE2546824C2 (de) * 1975-10-18 1986-05-07 Ernst Leitz Wetzlar Gmbh, 6330 Wetzlar Beschichtete Endoprothese und Verfahren zu ihrer Herstellung
FR2439003A1 (fr) * 1978-10-20 1980-05-16 Anvar Nouvelles pieces d'osteosynthese, leur preparation et leur application
AT364444B (de) * 1979-04-09 1981-10-27 Anderl Hans Dr Prothese
US4428376A (en) * 1980-05-02 1984-01-31 Ethicon Inc. Plastic surgical staple
FI69402C (fi) * 1983-09-20 1986-02-10 Materials Consultants Oy Osteosyntesanordning
US4655777A (en) * 1983-12-19 1987-04-07 Southern Research Institute Method of producing biodegradable prosthesis and products therefrom

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO8607250A1 *

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU607964B2 (en) * 1987-01-22 1991-03-21 Ethicon Inc. Bone screw

Also Published As

Publication number Publication date
WO1986007250A1 (fr) 1986-12-18

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Inventor name: PATIALA, HANNU

Inventor name: KILPIKARI, JYRKI

Inventor name: MERO, MATTI

Inventor name: VAINIONPAA, SEPPO

Inventor name: VIHTONEN, KIMMO

Inventor name: TORMALA, PERTTI

Inventor name: ROKKANEN, PENTTI