WO2006134343A2 - Methode et appareil de fixation de fractures osseuses - Google Patents

Methode et appareil de fixation de fractures osseuses Download PDF

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Publication number
WO2006134343A2
WO2006134343A2 PCT/GB2006/002158 GB2006002158W WO2006134343A2 WO 2006134343 A2 WO2006134343 A2 WO 2006134343A2 GB 2006002158 W GB2006002158 W GB 2006002158W WO 2006134343 A2 WO2006134343 A2 WO 2006134343A2
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WO
WIPO (PCT)
Prior art keywords
clip
bone
support member
fracture
clips
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/GB2006/002158
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English (en)
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WO2006134343A3 (fr
Inventor
Martin Elloy
Peter James Raffan
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.)
FIXATOR INNOVATIONS Ltd
Original Assignee
FIXATOR INNOVATIONS Ltd
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 GB0511964A external-priority patent/GB0511964D0/en
Priority claimed from GB0607302A external-priority patent/GB0607302D0/en
Priority claimed from GB0607441A external-priority patent/GB0607441D0/en
Application filed by FIXATOR INNOVATIONS Ltd filed Critical FIXATOR INNOVATIONS Ltd
Publication of WO2006134343A2 publication Critical patent/WO2006134343A2/fr
Publication of WO2006134343A3 publication Critical patent/WO2006134343A3/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08K—Use of inorganic or non-macromolecular organic substances as compounding ingredients
    • C08K3/00—Use of inorganic substances as compounding ingredients
    • C08K3/01—Use of inorganic substances as compounding ingredients characterized by their specific function
    • C08K3/013—Fillers, pigments or reinforcing additives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • 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 or setting implements
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/72—Intramedullary devices, e.g. pins or nails
    • A—HUMAN NECESSITIES
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    • A61B17/28—Surgical forceps
    • A61B17/2812—Surgical forceps with a single pivotal connection
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    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • 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
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    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • 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
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    • 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 or setting implements
    • 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
    • A61B17/8085—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates with pliable or malleable elements or having a mesh-like structure, e.g. small strips
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
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    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
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    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
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    • 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
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    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
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    • A61L27/42—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having an inorganic matrix
    • A61L27/422—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having an inorganic matrix of carbon
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    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
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    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/40—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
    • A61L27/44—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix
    • A61L27/48—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix with macromolecular fillers
    • 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
    • A61L31/126—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix containing carbon fillers
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08J—WORKING-UP; GENERAL PROCESSES OF COMPOUNDING; AFTER-TREATMENT NOT COVERED BY SUBCLASSES C08B, C08C, C08F, C08G or C08H
    • C08J5/00—Manufacture of articles or shaped materials containing macromolecular substances
    • C08J5/04—Reinforcing macromolecular compounds with loose or coherent fibrous material
    • C08J5/0405—Reinforcing macromolecular compounds with loose or coherent fibrous material with inorganic fibres
    • C08J5/042—Reinforcing macromolecular compounds with loose or coherent fibrous material with inorganic fibres with carbon fibres
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08K—Use of inorganic or non-macromolecular organic substances as compounding ingredients
    • C08K3/00—Use of inorganic substances as compounding ingredients
    • C08K3/02—Elements
    • C08K3/04—Carbon
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08K—Use of inorganic or non-macromolecular organic substances as compounding ingredients
    • C08K7/00—Use of ingredients characterised by shape
    • C08K7/02—Fibres or whiskers
    • C08K7/04—Fibres or whiskers inorganic
    • C08K7/06—Elements
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L67/00—Compositions of polyesters obtained by reactions forming a carboxylic ester link in the main chain; Compositions of derivatives of such polymers
    • C08L67/04—Polyesters derived from hydroxycarboxylic acids, e.g. lactones
    • D—TEXTILES; PAPER
    • D01—NATURAL OR MAN-MADE THREADS OR FIBRES; SPINNING
    • D01F—CHEMICAL FEATURES IN THE MANUFACTURE OF ARTIFICIAL FILAMENTS, THREADS, FIBRES, BRISTLES OR RIBBONS; APPARATUS SPECIALLY ADAPTED FOR THE MANUFACTURE OF CARBON FILAMENTS
    • D01F11/00—Chemical after-treatment of artificial filaments or the like during manufacture
    • D01F11/10—Chemical after-treatment of artificial filaments or the like during manufacture of carbon
    • D01F11/14—Chemical after-treatment of artificial filaments or the like during manufacture of carbon with organic compounds, e.g. macromolecular compounds
    • D—TEXTILES; PAPER
    • D06—TREATMENT OF TEXTILES OR THE LIKE; LAUNDERING; FLEXIBLE MATERIALS NOT OTHERWISE PROVIDED FOR
    • D06M—TREATMENT, NOT PROVIDED FOR ELSEWHERE IN CLASS D06, OF FIBRES, THREADS, YARNS, FABRICS, FEATHERS OR FIBROUS GOODS MADE FROM SUCH MATERIALS
    • D06M15/00—Treating fibres, threads, yarns, fabrics, or fibrous goods made from such materials, with macromolecular compounds; Such treatment combined with mechanical treatment
    • D—TEXTILES; PAPER
    • D06—TREATMENT OF TEXTILES OR THE LIKE; LAUNDERING; FLEXIBLE MATERIALS NOT OTHERWISE PROVIDED FOR
    • D06M—TREATMENT, NOT PROVIDED FOR ELSEWHERE IN CLASS D06, OF FIBRES, THREADS, YARNS, FABRICS, FEATHERS OR FIBROUS GOODS MADE FROM SUCH MATERIALS
    • D06M15/00—Treating fibres, threads, yarns, fabrics, or fibrous goods made from such materials, with macromolecular compounds; Such treatment combined with mechanical treatment
    • D06M15/19—Treating fibres, threads, yarns, fabrics, or fibrous goods made from such materials, with macromolecular compounds; Such treatment combined with mechanical treatment with synthetic macromolecular compounds
    • D06M15/37—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
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    • 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 or setting implements
    • 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
    • A61B17/842—Flexible wires, bands or straps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B2017/00831—Material properties
    • A61B2017/00867—Material properties shape memory effect

Definitions

  • the present invention relates to fixation of bone fractures in birds, animals and humans including apparatus and method for fixing fractured bones of small animals or birds so they can heal.
  • Fractures of the long bones may be treated by means of internal fixation devices such as pins, plates and screws. These are applied to the broken bones after the fragments have been properly aligned and fixed to maintain that alignment.
  • pins or nails are sometimes driven along the intramedullary canal to provide good axial alignment.
  • Such devices do not however provide torsional control of the fragments.
  • Plates are usually made of metal and may be contoured to approximate to the bone surfaces. These are usually fixed in place by screws that pass through holes in the plate and through both the cortices of the bone. A variety of sizes and shapes are required to suit the different bones. They have to have a plurality of holes so that enough holes will occur at suitable sites on both sides of the fracture. Some may be supplied with a degree of contouring and others may be contoured to a limited degree with the use of bending equipment. Metal plates are also known with multiple protruding arms that can be hand-crimped into position around the bone. These can be adapted for use with a range of different sized and shaped bones.
  • external fixation devices can be used, such as splints, plaster casts and external fixators.
  • transfixion pins are screwed into the bone on either side of the fracture site and left protruding through the skin and are then clamped onto a rigid connecting bar outside the body that bears the load.
  • a general problem in the field is how to improve bone fixation for humans.
  • Another problem in this field is that there are no good bone fixation materials for small animals or birds.
  • External fixators are in general not suitable for small animals or birds, which tend not to tolerate such devices.
  • Using external fixators has the additional disadvantage that the pins tend to protrude at different angles and a complex series of clamps in combination with a fixator bar is needed to hold the fracture site secure. This applies to use on humans, too.
  • Biodegradable internal fixing plates are known for human use; but these are generally not used for bones that bear weight. Another problem is that it is impractical to manufacture contoured devices designed for internal use for the wide range of animals, from large dog to small bird, typically treated in a normal veterinary practice. Whilst metal plates can be used for several different sized bones, any crimping required e.g. for the known "Mermen plate” is subject to the insensitivity of the practitioner who may easily crimp the arms too tightly, or not tightly enough.
  • a further problem with plates is that a large inventory is required to ensure a suitable configuration is available in all cases. Holes where screws are not fitted constitute weaknesses in the device and screws usually prevent the simultaneous use of intramedullary nails. Lastly, bones may be too small or too fragile to accept bone screws, which may create a weakness in the uninjured regions.
  • An object of the invention is to solve or at least ameliorate the above-identified problems.
  • An object of specific embodiments of the invention is to provide improved fixation of bone fractures.
  • the present invention provides a method of fixing a bone having a fracture, comprising locating a support member along the bone and extending either side of the fracture; and attaching the support member to the bone using a plurality of clips, at least one clip either side of the fracture.
  • the clips can be separate from and not integral to the support member, which can be a plate or other fixation device that can run longitudinally along a bone, either side of a fracture site, supporting the fracture during healing.
  • Suitable clips are substantially C-shaped or substantially horseshoe-shaped and comprise one or more teeth to grip the bone. There are usually several teeth, say 2, 3, 4 or even more on each of two arms. The teeth can be designed to bite into the bone, and this gripping holds them in place and by action of the clip on the support member holds that in place. They extend around the bone, partly encircling it, but have to be placed around a bone in vivo so do not generally go fully around the bone as it would be harder to fit these during an operation and also harder to remove them in the future after the fracture has healed — preferred clips being separate from the support member and removable. In addition, few materials have the necessary resilience to allow deformation for location fully around a bone and also spring back with sufficient force to hold the plate or support member in situ. Clips are preferably one-piece, preferably without any screws or fasteners or moving parts.
  • the clips preferably comprise one or more teeth to grip the support member.
  • teeth are located on an inside or underside of the clip, lying in use against the support member which in turn lies along and preferably against the bone.
  • the teeth can be designed to bite into the support member, and this gripping holds them in place with respect to the support member.
  • Action of teeth positioned on arms of the clip in turn holds the unit in situ against and around the bone.
  • the teeth can also be designed to cooperate with the external shape of the support member - thus teeth can fit into grooves or ridges on a bone plate and can but do not need to bite into it.
  • Clips used in an embodiment of the invention comprise a body, a first arm extending from an upper portion of the body and a second arm extending from a lower portion of the body, the first arm, second arm and body forming a C-shaped or horseshoe- shaped opening wherein the clip can be resiliently deformed between a first position in which the opening is enlarged so that the clip fits around the bone and the support member and a second position in which the clip holds the support member onto the bone.
  • a surgeon can flex the clip so that the mouth is large enough to fit over the bone and when the clip is in the right place, relax the flexing, allowing the clip to return towards an unflexed state, gripping onto the bone as it does so.
  • teeth of the bone clip it is preferable for teeth of the bone clip to embed into the bone to a significant degree but not to bury themselves completely.
  • the teeth therefore, have to be sharp enough to initiate this process but of an included angle that allows equilibrium conditions to be re-established before the elastic strain within the clip has relaxed completely.
  • the teeth are sufficiently sharp that local contact pressure induced in the bone by the elastic strain in the clip is sufficient to cause localised osteolysis and bone resorption.
  • the teeth have a geometry that, as bone resorption progresses, the contact area increases to reach a level that results in contact stress falling below that which causes resorption, leaving sufficient residual elastic strain in the clip to grip the plate.
  • the teeth are preferably able to be sufficiently embedded in the bone to provide sufficient resistance to shearing movement so as to secure the clip to the bone.
  • strain limits in the clips of the present invention When considering the strain limits in the clips of the present invention, it is important to consider that stress induced through bending. Stress is induced in a material by the application of a force and is defined as the force applied per unit of cross sectional area of material to which the force is applied. The material deforming elastically in the direction of the applied force causes stress. This deformation is strain, which is defined as the change in dimension as a proportion of the original dimension resulting from the application of a unit of stress. The ratio of the stress and strain is the Young's modulus of the material normally denoted by E. Metals such as Nitinol can be deformed elastically up to a limit (elastic limit) when further deformation is irreversible or plastic. When the load is removed the elastic part of the deformation is recovered but the plastic part is not.
  • the material in different areas of the structure are subjected to different degrees of strain.
  • the elastic limit of the structure is reached when the strain at any point reaches the elastic limit of the material from which the structure is composed.
  • clip dimensions can be designed which provide the maximum clamping force commensurate with sufficient opening of the clip.
  • the clips can be used at different positions along the support according to the location of the fracture and where there is good access to the bone for the clips to grip, thus there is flexibility for the user to position the clips in the best locations.
  • the support member does not need to be provided with existing holes (which would weaken it).
  • the clips can be rapidly located, reducing operating time.
  • Various support members can be used with the invention, provided they can support the fracture during healing.
  • An advantage of the clips that grip into the bone is that in combination with the support member they can provide torsional support to the fracture site.
  • suitable support members are selected from a bar, a plurality of bars, a plate and a reinforced plate.
  • a bar say of metal or alloy
  • torsional support is less, but the bar can be thin and take advantage of metal strength relative to bone.
  • Bars or rods can be useful in particular for fractures of very small bones, including bird bones and also bones where torsional resistance is not so required. Bars can be grouped together to form a raft, either loose prior to application of the clips or linked into a cohesive unit.
  • a bone plate is particularly suitable for operation of the invention.
  • a plate has a surface that can be gripped by teeth on the clips.
  • a plate can lie flatter against the bone fracture site - which is important for the necessary support during healing. Plates can be made of metal or plastics material or (as for all support members) any other material that is biocompatible.
  • the support member is mouldable.
  • a bone plate can be used which is mouldable at high temperatures but rigid at patient body temperature. Typically the plate will be mouldable above about 6O 0 C but set hard at 35-4O 0 C. This enables a user to heat the plate e.g. by immersion in hot water, mould the plate in situ onto and around the fracture and then cool the plate by application e.g. of water or saline, setting the plate in situ. Clips can then be applied, and can be applied to a cooling plate.
  • a mouldable bone plate can be used alone, i.e. without the application of clips or with fixing devices other than clips, e.g. using screws, cerclage ties and/or wires around the bone.
  • Support members can be reinforced, e.g. with bars or rods or with fibre, e.g. fibre- reinforced thermoplastic.
  • a particularly preferred support member comprises a reinforced, mouldable plate which is rigid at body temperature but which can be heated to a temperature at which it can be moulded.
  • the support member can be reinforced with one or more longitudinal bars.
  • the support member can be a reinforced, mouldable plastic.
  • the support member can be a mouldable plastic reinforced with carbon fibre.
  • Plates can also be prepared with one or more pre-existing holes. Plates can then be attached by a combination of clips and screws, or screws alone. Another option is that, in use, a hole is formed in the plate, e.g. whilst it is heated and soft enough to be moulded, hi this way a hole for a screw can be formed at the time of the operation and in the position required, without the plate having to have many pre-existing holes which are not all used. For certain bone fixations, including in humans, the dimensions of the damaged bones are sufficiently similar between different patients that plates are prepared in advance with holes in given positions.
  • Support members of the invention that contain carbon fibres are not biodegradable.
  • life span of a non-human animal is such that biodegradable polymers would outlive the animal anyway.
  • Polycaprolactone filled with glass fibre is biodegradable, and the speed of biodegrading can be varied by varying the polymer and fibre composition.
  • Biodegradable screws are also known and can be used with the invention.
  • Examples of sizes for plates of the invention are 5mm x 20mm x 50 s- 500mm, 4mm x 12mm x 40 - 300mm, 3mm x 10mm x 30 - 150mm, 2mm x 8mm x 20 - 120mm, 1.4mm x 5mm x 6 - 15mm and lmm x 5mm x 6 - 15mm. Bigger plates are provided for use on bigger bones. Generally, the width of the plate will be approximately one third to two thirds the bone diameter. In use plates can be cut to desired size, and this is conveniently done when plates are of mouldable thermoplastic.
  • Clips of the invention preferably can flex between wide open positions so they can be put in place and closed, resting or relaxed positions. In holding a plate onto a bone the clips would not return fully to such a position - as they would not provide much grip in that case - but would return towards that position.
  • Metals and alloys are generally suitable. Particularly suitable are materials that are superelastic.
  • a preferred clip is made of superelastic metal or alloy.
  • Clips of the invention can also be designed such that they attach directly onto the bone, and the support member is attached to an external face of the clips. In this way the clips attach the support member to the bone but with the support member outside them.
  • a method of the invention comprises locating the support member along the bone and extending either side of the fracture; selecting a clip to hold the support member in place; flexing the clip so as enlarge the clip mouth and moving the clip into position around the bone and support member; allowing the clip to return towards an un-flexed state, the clip gripping the bone and holding the support member in place.
  • Support is needed either side of the fracture, though the support member need not be located so that equal portions lie either side — there should just be enough for support each side.
  • a surgeon carrying out the method may select different clips according to the size and shape of the bone at any given desired clip location. Generally several clips are used either side of the fracture, so generally at least 4 clips in total, and there can be more.
  • Another method of the invention comprises selecting a clip to hold the support member in place; flexing the clip so as enlarge the clip mouth and moving the clip into position around the bone; allowing the clip to return towards an un-flexed state, the clip gripping the bone and being held in place; repeating these steps with at least one further clip so that there are a plurality of clips in place; locating the support member along the bone, extending either side of the fracture and over the clips; attaching the support member to the clips, the clips thus holding the support member in place.
  • the plate plus clips are optionally left in situ thereafter. It is also optional for the clips or plate plus clips to be removed after healing. It is optional for just the clips to be removed.
  • the invention also provides a clip as described above for use in the invention.
  • the clip is for holding a support member along a bone having a fracture as described.
  • the clips are preferably substantially C-shaped or substantially horseshoe- shaped and comprise one or more teeth to grip the bone, with optionally one or more teeth to grip the support member.
  • Particular clips comprise a body, a first arm extending from an upper portion of the body and a second arm extending from a lower portion of the body, the first arm, second arm and body forming a C-shaped or horseshoe-shaped opening wherein the clip can be resiliency deformed between a first position in which the opening is enlarged so that the clip fits around the bone and the support member and a second position in which the clip holds the support member onto the bone.
  • Preferred clips are made of a superelastic material. Further features of preferred clips are as described elsewhere herein.
  • a clip tool adapted for location of a clip of the invention in situ to hold a support member onto a bone.
  • a particular clip tool is described in more detail below in use for locating a clip around a bone so as to hold a support member in place along the bone, the clip having a body, a first arm extending from an upper portion of the body and a second arm extending from a lower portion of the body, the body, first arm and second arm forming a substantially C-shaped or horseshoe-shaped clip with an opening or mouth, wherein the clip tool comprises upper and lower jaws that engage respective upper and lower arms of the clip and which jaws can be moved apart so as to move apart the respective upper and lower arms so as to enlarge the clip mouth.
  • the clip tool can have upper and lower jaws which each comprise at their distal ends first and second fingers joined at their tip by a joining bar, forming a hook which engages respective catches on upper and lower arms of the clip.
  • a surgeon can hold the tool in the first position and locate a clip in the jaws, moving it such that projections on the clip arms, which can be ends of the arms or separate projections, engage with the hooks, so that action to urge apart the jaws acts to urge apart the arms of the clip.
  • the hooks and projections may also be reversed - i.e. the hooks can be on the clip - but this can lead to the clip having portions which stick out and into flesh or tissue post operation.
  • the surgeon operates the tool, urging the jaws apart to open the clip, locates the clip and closes the jaws to attach the clip. The jaws are closed a little further and the tool can be removed, leaving the clip in place.
  • the surgeon pushes down on the clip, the hooks of the tool slide out of engagement with the projections on the clip and the tool jaws can be opened to withdraw the tool.
  • a disposable tool is provided loaded with a clip.
  • This tool does not have to include the specific features of other tools, though typically it will comprise jaws which engage respective ends of the clip and can hold the clip in a flexed, open position. In use the surgeon selects this from a rack of such tools, applies the clip and then disposes of the (now empty) tool. Tools of plastic are suitable for this.
  • a rack of many tools having a clip in each can be provided e.g. as part of surgery apparatus.
  • a surgical kit comprising a clip tool according to the invention and at least one clip according to the invention.
  • a kit comprises a tool plus a plurality of clips, especially at least 4. More preferably a kit comprises a plurality of tools of different sizes with a corresponding plurality of clips.
  • the kit can include one or more support members, optionally of different sizes and/or types, as described throughout herein.
  • a bone fracture support member of the invention and for use in the invention is provided, made of mouldable, thermoplastic which is rigid at body temperature and which can be moulded at a temperature above 60° C.
  • near boiling water is used to heat the thermoplastic which is mouldable at a temperature of about 80°C.
  • Reference to body temperature is to that generally of mammals and birds, the invention in all aspects being suitable for application to animals, including humans, and birds, including small animals and birds.
  • the support member can be made mouldable by use of heat and then moulded around a fracture site longitudinally the length of the bone and also partly or fully around the bone. Generally, the support member will wrap around the bone to a varying degree, depending upon the human, animal or bird being treated and the type of support member.
  • a rod or a plurality of rods or a raft of rods will typically lie alongside the bone, rather than wrap around the bone.
  • a plate will typically be wrapped around the bone, encircling at least say one third of the bone, preferably at least one half and conveniently more, even up to two-thirds. Whilst there is no technical difficulty in making plates which will entirely encircle a bone, these are harder to fit in an operation and that degree of encirclement goes beyond the support needed.
  • Preferred support members comprise a reinforced thermoplastic, more preferably reinforced with fibre, optionally carbon fibre.
  • Other support members are reinforced with one or more longitudinal bars made of metal or alloy. The bars are suitably titanium or stainless steel.
  • an internal fracture support member for location inside a fractured bone.
  • This is made of mouldable thermoplastic, rigid at body temperature and soft enough when heated to be moulded.
  • a bar of the polymer is heated to make it soft. It is then flexed so that, whilst still soft, one end can be pushed into the lumen of a bone one side of the fracture and again whilst still soft the other end can be pushed into the lumen of the bone on the other side of the fracture.
  • the bone is then set, e.g. straightened, which in turn straightens (at least partially) the support member in situ, inside the bone.
  • the bar cools and hardens, providing support to the fracture.
  • Screws can then be driven through the bone and into the now internal bar to fix the fracture.
  • a support member of the invention can then be attached externally with or without the use of clips, as described elsewhere herein.
  • the lumen Prior to pushing in the bar, the lumen can be enlarged or cleared e.g. using a tool to provide space for the bar.
  • a new material namely, a carbon fibre - filled mouldable thermoplastic.
  • This preferably comprises polycaprolactone, with suitably from 5-80% weight carbon fibres.
  • the invention provides carbon fibre — filled polycaprolactone.
  • Filled polycaprolactone containing carbon fibres can be prepared by known methods.
  • polycaprolactone from a commercial source is melted and poured over a mat of carbon fibres, suitably at from 5 to 80% more suitably to 50%, preferably 10 to 40% by weight, which are hence incorporated into the reinforced polymer matrix.
  • the carbon fibres can be a mixture of short and/or long fibres.
  • Fibres can be woven for increased strength e.g. to resist torsional, axial and/or bending forces, especially at +/- 45 degrees.
  • a specific polymer for use in the invention can be prepared in accordance with the methods disclosed in US-A-20040054372, the contents of which is incorporated herein, using carbon fibres instead of glass fibres.
  • the carbon fibre - filled mouldable thermoplastic is preferably built up from laminated layers of carbon fibre mat.
  • Each mat preferably has fibres running in two directions, further preferably at right angles to each other, for example, longitudinal and horizontal. Every second layer is preferably laid at about 45 degrees to the layer below.
  • fibres in the first layer preferably run longitudinal and horizontal
  • the fibres preferably run at about 45 degrees in both directions in relation to the first layer
  • in the third layer the fibres preferably run in substantially the same direction as the first layer
  • the fibres are again preferably at about 45 degrees, and so on.
  • This pattern has been shown to be particularly effective, however, it will be envisaged that other patterns may be suitable.
  • the carbon fibre - filled mouldable thermoplastic could be built up from carbon fibre mat having more horizontal and longitudinal layers, or more about 45 degree layers, or no about 45 degree fibres.
  • the polymer is preferably polycaprolactone.
  • suitable alternatives may be used, for example biocompatible polyethylene or nylon. Use of these polymers will result in a higher softening temperature and will be cheaper to manufacture.
  • the bone fracture support member comprises up to twelve layers or more of carbon fibre mat, preferably between 5 and 7 layers of carbon fibre mat.
  • the number of layers used depends upon the size of the support member required. In this connection, more layers will be used for larger, stronger support members and maybe fewer layers for smaller support members.
  • the strength of the carbon fibre - filled thermoplastic is tailored to the required strength of its application. For example, if the carbon fibre - filled thermoplastic is to be used in a bone plate for a fractured bone which would normally bear a high weight, the carbon fibre - filled thermoplastic will be provided with a greater strength than that required for a fractured bone which would normally bear a low weight.
  • the carbon fibre - filled thermoplastic preferably has a longitudinal strength of about 50 to 90 GPa, more preferably about 70 GPa.
  • the carbon fibre - filled thermoplastic has a minimum lateral strength of about 20 to 40 GPa, more preferably about 30 GPa.
  • the carbon fibre - filled thermoplastic has a shear strength of about 20 to 40 GPa, more preferably about 30 GPa.
  • the carbon fibre - filled thermoplastic has a minimum ultimate tensile strength (UTS) of about 130 to 170 MPa, more preferably about 150 MPa.
  • UTS ultimate tensile strength
  • the carbon fibre - filled thermoplastic has a minimum fatigue strength of about 120 to 160 MPa, more preferably about 140 MPa.
  • a support member comprising the carbon fibre — filled thermoplastic has a minimum bending stiffness about 1 to 5Nm per degree of movement, more preferably about 2Nm per degree of movement.
  • a support member comprising the carbon fibre - filled thermoplastic has a fatigue strength of about 1 million cycles bending at a minimum of about 6Nm.
  • a support member comprising the carbon fibre — filled thermoplastic has a strength sufficient to allow about a 20 to 40 degree bend, more preferably a 30 degree bend, in the plane of the minimum section of the support member.
  • a support member comprising the carbon fibre - filled thermoplastic has a strength sufficient to allow about a 20 to 40 degree twist, more preferably a 30 degree twist, over a length of 10mm along the longitudinal axis of the support member.
  • the above discussed strength parameters are preferably achieved at below about 4O 0 C and about 100% humidity in physiological saline.
  • the carbon fibre - filled thermoplastic is manually bendable at below about 100 0 C.
  • the carbon fibre - filled thermoplastic is manually bendable at between about 50 0 C and about 100 0 C.
  • the support member preferably comprises a cross sectional profile to suit the bone on which it is to be used.
  • a cat femur support member preferably has a cross sectional profile to fit a 7mm diameter circle.
  • the support member comprises screw holes.
  • the support member is substantially straight.
  • the support member comprises a pre-determined shape for fitting the shape of a specific bone.
  • a support member for the canine humerus will be S —shaped.
  • Other bones that could have a shaped plate are the radius, the distal femur and the mandible. It is also envisaged that the support member can be moulded into the correct shape immediately prior to placement around a fracture site.
  • the thickness of the support member is tailored to the weight of the animal and the bone that is fractured.
  • a preferred thickness is between lmm and 5mm.
  • the support member may have a thickness of up to 10mm or more.
  • the width of the support member is preferably tailored to the size of the bone having a fracture.
  • a preferred width is between lmm and 12mm.
  • the support member may have a width of up to 40mm or more.
  • the length of the support member is preferably tailored to the length of the fractured bone and the fracture. In preferred embodiments, the support member is provided at a standard length and can then be cut to size by a surgeon.
  • bone plates comprising the support member of the present invention can be softened to a point where the plate can be manually shaped to the contours of the fractured bone. Then when it cools to body temperature (37-41 degrees C) the plate regains its strength and stiffness.
  • Methods of softening the plate preferably include by electricity conducted along the carbon fibres, e.g. with electrodes attached to each end of the plate and connected to a diathermy machine, by hot water, by hot air, or by other methods known in the art.
  • the fibres in the carbon mat are preferably prepared by burning off their proprietary coating in preparation of a wetting out process. This 'wetting out' of the fibres is a chemical process well known in the art.
  • the support member may be prepared using compression moulding.
  • Alternative methods of manufacture may also be used and may depend upon the amount of support member to be produced. For example, when it comes to bulk manufacture, the 'wetting out' process may be modified, or an alternative method used, and compression moulding may be replaced by another method such as pultrusion, which is cheaper than compression moulding.
  • pultrusion may preferably be used for straight plates, with another method such as compression moulding preferably used for shaped plates.
  • the plates of the present invention are preferably attached to a fractured bone by clips, screws, ties, wires, or a combination of two or more.
  • the bone plates of the present invention may be used alone, i.e. without the use of clips, screws, ties or wires, for supporting bone fractures.
  • a method of fixing a bone having a fracture comprising:-
  • thermoplastic wherein the thermoplastic is biocompatible and in a mouldable state, moulding the thermoplastic around the fracture, cooling the thermoplastic to render it rigid, and fixing the thermoplastic to and/or around the bone.
  • the bone is identified and a bone plate of suitable dimension, made of the thermoplastic, selected. If no suitably sized plate is available then a larger plate can be cut down to size. It is hence not necessary to provide to the surgeon a large inventory of differently sized plates. Instead, a larger section of the thermoplastic can be cut once the size of the plate needed for the particular fracture is known, and this can be done during the course of an operation.
  • the thermoplastic is applied to the bone, around the fracture, in a mouldable state. Typically, the thermoplastic is heated during the operation, or it can be heated prior to the operation and then maintained in a mouldable state. The thermoplastic may cool to some extent during handling and whilst it is being positioned and moulded in situ.
  • thermoplastics once heated to a temperature at which they can be moulded, will retain mouldability as their temperature decreases. If the temperature drops such that the thermoplastic can no longer be moulded then the thermoplastic can be removed from the fracture site, reheated to increase the mouldability, for example using hot water, and then re-applied to the fracture site so the surgeon can complete the process of locating the moulded plate around the fracture.
  • the thermoplastic plate once correctly positioned can be allowed to cool or can actively be cooled, for example using a cooling liquid such as water or saline solution or other solution suitable for use during surgery. The plate then becomes rigid and is rigid and sufficiently strong to support the bone at body temperature.
  • the plate can be fixed to the bone using screws and/or clips and/or other fixing devices.
  • the invention also provides a bone fixation plate comprising a plurality of screw holes, wherein the plate is made of mouldable, biocompatible thermoplastic, optionally reinforced.
  • the invention specifically provides a new material for veterinary and human use - e.g. polycaprolactone, reinforced with carbon fibres - and a new means of fixing bones using: -
  • the invention thus provides a new material for use in the veterinary field, exemplified as a carbon-fibre-reinforced mouldable, biocompatible polymer. It can be used in a bone plate held in place by bone clips, screws, ties and/or wires, or by the moulded shape of the plate alone.
  • the plates may be combined with other methods of fixation to strengthen the fixation, for example, combined with an intramedullary pin or intramedullary biocompatible composite rod, or with an external fixator.
  • the plates have the potential to be used on any fracture and provide a more accurate plating system, particularly with plates shaped for specific bones, which is quicker to apply, lighter than metal plates and is radiolucent.
  • thermoplastic, mouldable, biocompatible polymer in manufacture of a bone fixation plate.
  • thermoplastic, mouldable, biocompatible polymer in the manufacture of an intramedullary support member.
  • a bone fracture support member adapted for insertion into the intramedullary canal of a fractured bone.
  • an intramedullary support member comprising the thermoplastic as detailed above.
  • Nitinol (more correctly, NiTiNOL or NiTinol), the name for the family of shape memory alloys (SMAs) which contain a nearly equal mixture of nickel (about 55 wt. %) and titanium.
  • SMAs shape memory alloys
  • Nitinol is an acronym for "Nickel Titanium Naval Ordnance Laboratory,” after where its shape-memory behaviour was discovered.
  • Nitinol displays two distinct crystal structures in the solid phase - martensite and austenite.
  • the martensite is the "soft" phase
  • the austenite is the rigid phase.
  • the particular crystal structure that Nitinol possesses at any given time depends on its temperature and the amount of force (stress) to which it is being subjected. Because the transformations between crystal structure occur over temperature ranges, scientists use the following naming conventions:
  • austenite start temperature (where Nitinol starts transforming to austenite during heating)
  • Af austenite finish temperature (where Nitinol has finished transforming to austenite during heating)
  • Ms martensite start temperature (where Nitinol starts transforming to martensite during cooling)
  • Mf martensite finish temperature (where Nitinol has finished transforming to martensite during cooling) Martensite exists at lower temperatures and is the phase in which Nitinol can be easily deformed into any shape. As long as the temperature does not change, Nitinol will remain deformed. When Nitinol is heated, it transforms into the austenite phase, where it "remembers" the shape it had before it was deformed. In the austenite phase, Nitinol is rigid and does not deform easily.
  • Nitinol' s ability to spring back after being deformed in the austenite phase - its superelastic property is about 10 times greater than that of stainless steel. Said differently, Nitinol can be bent more than stainless steel without permanent damage. This property exists within the superelastic limit which is generally for deformations producing a level of strain of up to about 8% within the material. Beyond this limit deformations become at least partially permanent.
  • metals and alloys having superelastic properties are preferred. These may also have shape memory metal properties, but these are not necessary for the invention.
  • the composition of the alloys or metals is preferably chosen such that the superelastic property is exhibited at body temperature, in some case this varying from the animal or bird to be treated.
  • Fig. 1 shows a side view of a clip
  • Fig. 2 shows a view from the front of a clip on its own and a similar clip inside a clip tool, the clip being in a flexed, open position;
  • Fig. 3 shows another clip on its own and a clip located in a clip tool in a non-flexed position
  • Fig. 4 shows a view from above and the front of a clip tool with a clip inside
  • Fig. 5 shows a view of a clip tool being used to locate a clip around a bone
  • Fig. 6 shows a view of clips and rods illustrating a use of the invention
  • Fig. 7 shows a schematic view of a plate of the invention and a cross-section thereof; and Fig. 8 shows schematic views of a support member held in place on a bone by clips.
  • a clip 1 made of Nitinol has a middle body 2 with upper portion 2a and lower portion 2b.
  • a first arm 3 extends from the lower body portion and a second arm 4 extends from the upper body portion forming clip mouth 5.
  • Located on an inside edge 6 of the body 2 are teeth 7.
  • Located on respective inside edges 8 and 10 of the first and second anus are teeth 9 and 11.
  • At the distal ends of the first and second arms 3 and 4 are respective first arm catch 12 and second arm catch 13.
  • An un-flexed clip 1 is shown at the bottom of fig. 2. Above it is a clip tool 20 which has been loaded with a clip Hn a flexed, open position.
  • the tool 20 has an upper jaw 21, a lower jaw 22 and a hinge 23, allowing pivoting of the upper and lower jaws so as to open and close the mouth of the clip.
  • An operator holds the tool using upper handle 24 and lower handle 25.
  • Each jaw is divided into respective fingers 29 and 30, joined at their distal ends by a joining bar 31 forming a hook portion 26 or 27.
  • the tool in fig. 2 is in a position which holds the clip open, as the hooks 27 of the tool engage the catches 12 and 13 of the clip, the upper and lower handles 24, 25 being held together.
  • the extent of opening of the mouth 5 is limited by the handles being brought together, this preventing over flexing of the clip beyond its superelastic limit.
  • the upper and lower handles 24, 25 are spaced apart, and the clip is in an un-flexed position, and can be released from the tool by pushing it towards the hinge, at which point catches 12 and 13 no longer engage on the hooks 26 and 27.
  • the upper and lower handles can then be closed whilst not engaging the clip and the clip can then be removed from the front of the jaws.
  • Fig. 4 shows in more detail how the fingers 29 and 30 surround the clip and enable it to be engaged with hooks on the jaws.
  • a clip is shown being located around bone 32. This figure is for illustration only. In use, a support or reinforcing member would be located along the length of the bone so that it can be held in place by the clips.
  • Fig. 6 illustrates an embodiment of the invention in which support for a fracture is provided by four longitudinal bars 31 held to a length of wood 33 (used to represent a bone) by a plurality of clips, the clips being spaced either side of a break 34 in the wood.
  • a plate 35 is shown schematically in fig. 7. The cross-section on x-x shows reinforcing metal rods 35 longitudinally arranged inside the plate.
  • the plate is separate from the clips for fixation of a fracture, avoiding e.g. the hand crimping of known devices.
  • Superelastic clips are used to retain the plate in situ, and are designed to fit over the contours of the bone plate (if reinforced with rods). Clips are contoured to fit the bone plate (when fibre-reinforced). Teeth on the body of the clips mean the clips don't slide along the plate. Clips have teeth on their arms to grip the bone and hold the plate in situ.
  • FIG 8 which uses the same number scheme as previous figures, there is a shown a support member 31 held in place along a bone 32 having fracture 34 by four clips 1 of the invention to illustrate the invention in use. Whilst only four clips are shown more can be used in practice. Teeth 9, 11 grip the bone to lesser and greater degress according to the respective positions of the clip and the particular geometry of the bone at that point. Views a - d show cross-sections on the four clips along the bone. Views e - I are, respectively, anterior, antero-later, posterior and two straight plate views.
  • Example I Protocol for bone fixation (using bone plate and clips)
  • bone clips may be placed onto the bone, before the plate is applied, to tie in bone fragments at the fracture site to give extra support
  • the plate and clips may be removed at the surgeon's discretion.
  • the plate may be removed at the surgeon's discretion.

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Abstract

Selon cette invention, un thermoplastique biocompatible rempli de fibres de carbone peut être moulé à 60 °C et il est rigide à la température du corps. Un système de fixation de fracture osseuse comprend une plaque du thermoplastique de manière à contourner un site de fracture. La plaque moulable peut être retenue en place par des agrafes amovibles de matière superélastique.
PCT/GB2006/002158 2005-06-13 2006-06-13 Methode et appareil de fixation de fractures osseuses Ceased WO2006134343A2 (fr)

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
GB0511964A GB0511964D0 (en) 2005-06-13 2005-06-13 Method and apparatus for fixing bone fractures
GB0511964.9 2005-06-13
GB0607302A GB0607302D0 (en) 2006-04-11 2006-04-11 Method and apparatus for fixing bone fractures
GB0607302.7 2006-04-11
GB0607441A GB0607441D0 (en) 2006-04-12 2006-04-12 Method and apparatus for fixing bone fractures
GB0607441.3 2006-04-12

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WO2006134343A2 true WO2006134343A2 (fr) 2006-12-21
WO2006134343A3 WO2006134343A3 (fr) 2007-05-03

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Cited By (2)

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Publication number Priority date Publication date Assignee Title
DE102012108709A1 (de) * 2012-09-17 2014-03-20 Alumedica Aluminiumbearbeitung und Medizintechnik GmbH Instrument zur Positionierung wenigstens eines Knochens während einer Osteosynthese, Implantat sowie System zum Durchführen einer Osteosynthese
CN109730747A (zh) * 2019-01-08 2019-05-10 王峰 一种定位准确的创伤骨科用复位固定钳

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US20090263458A1 (en) * 2008-04-21 2009-10-22 Lasse Daniel Efskind Material for surgical use in traumatology

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FR2515955B1 (fr) * 1981-11-11 1987-11-20 South African Inventions Implant chirurgical
US4643734A (en) * 1983-05-05 1987-02-17 Hexcel Corporation Lactide/caprolactone polymer, method of making the same, composites thereof, and prostheses produced therefrom
US4595713A (en) * 1985-01-22 1986-06-17 Hexcel Corporation Medical putty for tissue augmentation
DE3734108A1 (de) * 1987-10-06 1989-04-20 Mecron Med Prod Gmbh Marknagel fuer die behandlung von knochenbruechen
JPH068385B2 (ja) * 1988-01-19 1994-02-02 帝人化成株式会社 ポリカーボネート樹脂組成物
US5053035A (en) * 1990-05-24 1991-10-01 Mclaren Alexander C Flexible intramedullary fixation rod
JP3285990B2 (ja) * 1993-02-19 2002-05-27 帝人化成株式会社 電磁波遮蔽用樹脂組成物
JP3355742B2 (ja) * 1993-12-28 2002-12-09 東レ株式会社 強化樹脂組成物およびその成形品
US20050240187A1 (en) * 2004-04-22 2005-10-27 Huebner Randall J Expanded fixation of bones

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102012108709A1 (de) * 2012-09-17 2014-03-20 Alumedica Aluminiumbearbeitung und Medizintechnik GmbH Instrument zur Positionierung wenigstens eines Knochens während einer Osteosynthese, Implantat sowie System zum Durchführen einer Osteosynthese
CN109730747A (zh) * 2019-01-08 2019-05-10 王峰 一种定位准确的创伤骨科用复位固定钳
CN109730747B (zh) * 2019-01-08 2020-08-25 王峰 一种定位准确的创伤骨科用复位固定钳

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