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WO2025045603A1 - Dispositif médical de liaison osseuse et méthode de liaison d'os ou de parties d'os - Google Patents

Dispositif médical de liaison osseuse et méthode de liaison d'os ou de parties d'os Download PDF

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Publication number
WO2025045603A1
WO2025045603A1 PCT/EP2024/073011 EP2024073011W WO2025045603A1 WO 2025045603 A1 WO2025045603 A1 WO 2025045603A1 EP 2024073011 W EP2024073011 W EP 2024073011W WO 2025045603 A1 WO2025045603 A1 WO 2025045603A1
Authority
WO
WIPO (PCT)
Prior art keywords
locking
connecting element
bone
connection device
elements
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.)
Pending
Application number
PCT/EP2024/073011
Other languages
German (de)
English (en)
Inventor
Ramon Jürgen HÜPPI
Emir DIZDAREVIC
Roger Heinrich STADLER
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.)
Icotec Ag
Original Assignee
Icotec Ag
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 Icotec Ag filed Critical Icotec Ag
Publication of WO2025045603A1 publication Critical patent/WO2025045603A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

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    • 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
    • A61B17/70—Spinal positioners or stabilisers, e.g. stabilisers comprising fluid filler in an implant
    • A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7032—Screws or hooks with U-shaped head or back through which longitudinal rods pass
    • A—HUMAN NECESSITIES
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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
    • A61B17/70—Spinal positioners or stabilisers, e.g. stabilisers comprising fluid filler in an implant
    • A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7002—Longitudinal elements, e.g. rods
    • A61B17/7004—Longitudinal elements, e.g. rods with a cross-section which varies along its length
    • A—HUMAN NECESSITIES
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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
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    • A61B17/70—Spinal positioners or stabilisers, e.g. stabilisers comprising fluid filler in an implant
    • A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7002—Longitudinal elements, e.g. rods
    • A61B17/7019—Longitudinal elements having flexible parts, or parts connected together, such that after implantation the elements can move relative to each other
    • A61B17/7025—Longitudinal elements having flexible parts, or parts connected together, such that after implantation the elements can move relative to each other with a sliding joint
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    • A61B17/70—Spinal positioners or stabilisers, e.g. stabilisers comprising fluid filler in an implant
    • A61B17/7049—Connectors, not bearing on the vertebrae, for linking longitudinal elements together
    • A61B17/705—Connectors, not bearing on the vertebrae, for linking longitudinal elements together for linking adjacent ends of longitudinal elements
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    • A61B17/80—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
    • A61B17/8052—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates immobilised relative to screws by interlocking form of the heads and plate holes, e.g. conical or threaded
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    • A61F2/446—Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages having a circular or elliptical cross-section substantially parallel to the axis of the spine, e.g. cylinders or frustocones
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    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86—Pins or screws or threaded wires; nuts therefor
    • A61B17/864—Pins or screws or threaded wires; nuts therefor hollow, e.g. with socket or cannulated
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
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    • A61F2002/30329—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/30818—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves castellated or crenellated

Definitions

  • the present invention relates to a medical bone connection device, such as in particular a pedicle system, an axial or parallel connector system, a cervical plate system or a vertebral body replacement. Furthermore, the present invention relates to a method for connecting two bones or bone parts by means of such a bone connection device.
  • Bone connection devices are frequently used in medicine to bring bones or bone parts into a desired position and to hold them in this position, for example after a break, such as a traumatic fracture, or in the event of a misalignment.
  • Bone connection devices are particularly known in the form of spinal implant systems, which serve to connect and stabilize several vertebrae of the spine. These include pedicle systems, in which several pedicle screws anchored in each vertebral body are usually fixed to a common connecting rod and thus connected to one another.
  • Several connecting rods of a pedicle system or connecting rods that serve to stabilize other bones or bone parts can be connected to one another via a connector.
  • a bone connection device is referred to as an axial connector or a parallel connector.
  • bone connection devices in the form of cervical and lumbar plate systems are known, in which a connecting plate is fixed to several vertebrae of the cervical spine by means of screws in order to stabilize them.
  • Another A frequently used bone connection device is the vertebral body replacement, which serves to replace one or more defective vertebral bodies.
  • the vertebral body replacement which is often used in combination with a pedicle system, is connected to the adjacent vertebral bodies, whereby an expandable vertebral body replacement is often used to adapt to the gap to be filled.
  • Bone connection devices are usually made of metal, for example titanium and/or a titanium alloy. Such bone connection devices are radiopaque and allow the precise position of the implant (for example the pedicle screw) to be determined when the patient is examined using an imaging procedure, for example computer tomography (CT).
  • CT computer tomography
  • metal implants hinder the view of the bone connected to the implant and the surrounding tissue during fluoroscopy because they are radiopaque and, in addition, scattering effects occur during fluoroscopy, which in turn create artifacts in the area of the implant when visualized.
  • Such metal bone connection devices also cause strong artifacts during magnetic resonance imaging (MRI). Due to their radioopacity, metal bone connection devices also impair the radiotherapy of cancer patients because the relatively large metal mass causes scattering phenomena that reduce the effectiveness of the radiation, thus requiring a higher radiation dose, which in turn can cause side effects in the surrounding tissue.
  • MRI magnetic resonance imaging
  • Bone connection devices made of non-metallic composite materials have been developed.
  • the production of three-dimensional complex shapes from composite materials is challenging, but it enables the production of radio-transparent components that do not have the above-mentioned disadvantages.
  • Bone connection devices made of non-metallic composite materials based on carbon fiber reinforced polyetheretherketone (PEEK) are preferred on the market.
  • Bone connection devices and in particular the types mentioned at the beginning, such as pedicle systems, connectors, plate systems and expandable artificial vertebrae, usually have several connecting elements which have to be attached to one another in order to fix the bones or bone parts.
  • the screws are fixed to the connecting rod or, in the case of a connector, the connecting rods are fixed to a connector housing.
  • screw connections are usually used in the prior art.
  • screw connections have disadvantages when it comes to components made from non-metallic composite materials. For example, producing threads that mesh precisely and are therefore easy to screw together and that are high-performance is considerably more difficult with composite materials than with metals.
  • the rigidity of non-metallic composite materials is also usually reduced compared to that of metals.
  • the document US 2004/0138660 A 1 discloses a fixation system for a pedicle system with a fixation cap that is screwed onto a tulip head and is thereby connected to a The pressure element attached to the underside presses the connecting rod against the screw head.
  • Claim 16 specifies a method for connecting two bones or bone parts, which is preferably carried out using such a bone connection device.
  • Advantageous embodiments of the invention are specified in the dependent claims.
  • the present invention therefore provides a medical bone connection device for connecting two bones or bone parts of a human or animal patient, comprising a first connecting element made of a fiber-reinforced plastic material, which has a first locking structure with a plurality of first locking elements, in particular locking teeth; and a second connecting element made of a fiber-reinforced plastic material, which has a second locking structure with a plurality of second locking elements, in particular locking teeth.
  • the first locking elements of the first locking structure can be locked with the second locking elements of the second locking structure in order to fix the first connecting element and the second connecting element to one another and thereby connect the two bones or bone parts to one another.
  • the fiber-reinforced plastic material enables the manufacture of connecting elements that are not only X-ray transparent, but also have high strength and rigidity and therefore allow a particularly high-performance connection of the bones or bone parts.
  • the use of fibers, preferably carbon fibers, in the plastic material not only enables the respective component to be reinforced as a whole, but also allows the component to be specifically reinforced at certain points. Such a specifically reinforced point can be the locking structure in the first and/or second connecting element in particular. By aligning the fibers accordingly, the reinforcement can even be direction-dependent.
  • a locking connection allows considerably larger tolerances and a significantly higher surface roughness in the connection areas of the respective components compared to a threaded connection.
  • the provision of a locking connection is particularly well suited for connecting elements that are made of a fiber-reinforced plastic material.
  • the locking connection has the additional advantage that the two connecting elements can engage with each other more or less tightly as required.
  • the locking structures can be continuously brought into engagement with each other, similar to a threaded connection, in order to strengthen the fixation of the connecting elements to each other or, for example, to increase the clamping force on a component arranged between the two connecting elements.
  • the fixation of the two connecting elements to each other can be achieved particularly easily for the user, i.e. usually for the doctor.
  • a rotary movement which provides an additional This does not require a forceps, which can place a strain on the weakened spine.
  • the two connecting elements can usually simply be placed on top of each other, ie the joining, pressing and fixing of the connecting elements takes place in a single step, ie with a single, continuous movement. This also means that the doctor can connect the bones or bone parts much more quickly.
  • the locking elements of the first locking structure can in particular be locking teeth.
  • the locking elements of the second locking structure can also in particular be locking teeth.
  • embodiments are also possible in which only the locking elements of one of the two locking structures are designed as locking teeth, while the locking elements of the other locking structure are designed, for example, as depressions or openings in order to form an engagement structure for the locking teeth.
  • a locking tooth is generally a protruding, in particular serrated or toothed element.
  • the bone connection device usually has at least a first component, which is designed to be connected to a first bone or bone part, and a second component, which is designed to be connected to a second bone or bone part.
  • the two components are connected to one another by means of the first and second connecting elements.
  • the two components mentioned can be the first and second connecting elements themselves.
  • the two components to be connected directly to a bone or bone part each represent separate elements with respect to the two connecting elements.
  • the components to be connected directly to the bone or bone part can be attached, in particular fixed, to the first or second connecting part.
  • a connection to a bone or bone part means that a corresponding component is attached to the bone or bone part in such a way that it cannot change its position relative to it, even if the patient moves.
  • the component can be anchored in the bone or bone part, in particular screwed in. Alternatively, it can also just be attached to the outside of the bone, but then it is ensured, for example via other components and/or via the surrounding tissue, that the component cannot move relative to the bone. Gluing the component to the bone or bone part is also possible. e.g. using bone cement is conceivable.
  • Thermoplastics are preferably used as the plastic material, particularly preferably so-called high-temperature thermoplastics from the families of polyaryletherketones, polyimides and polysulfones. Carbon fibers are preferably used as the fibers.
  • the fiber-reinforced plastic material of the first and/or the second connecting element is particularly preferably carbon fiber-reinforced polyetheretherketone (PEEK).
  • PEEK polyetheretherketone
  • the first and the second connecting element are preferably made from the same materials.
  • the fiber length is preferably at least 1 mm.
  • the fibers advantageously have a length that corresponds at least to the complete length of the respective connecting element along its main extension direction.
  • the fiber volume content is preferably in a range from 20 to 80%, more preferably in a range from 35 to 70%, particularly preferably in a range from 45 to 60%.
  • the basic production of the connecting elements can be carried out using a process that is conventionally known in the composite sector. These include pressing processes, winding processes, tape laying processes, pultrusion processes and long-fiber injection molding processes such as "Injection Molding CMF" (Composite Flow Molding).
  • the pressing process described in document DE 44 45 305 C1 is preferred for producing the connecting elements and, if present, other components of the bone connection device.
  • the connecting elements can also be produced using so-called additive manufacturing processes, such as the 3D printing process (short, long or continuous fiber reinforced), or a combination of the above-mentioned processes.
  • the starting materials used in these processes are preferably so-called unidirectional pregregs, rods and fabric prepregs. Both are geometrically flat or round-shaped starting materials.
  • the prepregs are preformed into preforms and welded under pressure and temperature, for example in a press tool, and then cooled.
  • the above-mentioned processes for producing the connecting elements and possibly the other components are preferably near-net-shape manufacturing processes, which means that such manufactured connecting elements and/or components are Dimensions usually require only minor mechanical post-processing.
  • the locking elements, in particular locking teeth, of a respective locking structure are preferably arranged parallel to one another and advantageously have an identical shape in cross section.
  • the locking elements of a respective locking structure can, however, be arranged in groups, whereby the locking elements of different groups can, for example, have different orientations.
  • the locking elements of a first group can face in a first direction and the locking elements of a second group in an opposite direction, so that the two groups are directed towards one another.
  • a respective locking structure preferably has two or four locking elements or, even more preferably, one or two pairs of locking elements.
  • a pair of locking elements is formed by two individual locking elements, which are preferably arranged at the same height as the corresponding locking structure and are advantageously facing or facing away from each other, i.e. are arranged opposite each other.
  • the first locking structure preferably has one or two such pairs of locking elements and the second locking structure also has one or two pairs of locking elements. It has been found that a good locking of the two locking structures is possible and a particularly firm fixation is achieved if both the first locking structure and the second locking structure have two pairs of locking elements.
  • the two pairs are then preferably arranged one above the other, i.e. on different levels with respect to the locking direction. With two pairs of locking elements, two locking elements are preferably arranged parallel to each other on each side.
  • a respective locking structure has at least three, more preferably at least five and most preferably at least ten locking elements arranged parallel to one another, wherein these locking elements can each form part of three, at least five or at least ten pairs of locking elements each arranged at the same height. In this way, locking of the two connecting elements in several different positions is possible.
  • the first and/or the second Connecting element has a certain elasticity in the area of the locking structure. This elasticity can be given in particular due to the materialization and/or the geometric design of the connecting element.
  • the locking structure of the first connecting element is designed to be complementary to the locking structure of the second connecting element, so that a positive connection can be created between the two connecting elements when they are mutually locked.
  • the first locking elements and the second locking elements are each designed with an undercut in such a way that a release of the fixation between the first connecting element and the second connecting element is prevented when the first locking structure and the second locking structure are locked together.
  • the locking elements locked together engage with each other in such a way that a release of the connection by simply pulling the two connecting elements apart is impossible. An unintentional release of the connection between the two connecting elements can thus be effectively prevented even when a large amount of force is applied.
  • a release of the two connecting elements after locking is only possible with the aid of a tool, in particular a special tool. The bone connection is therefore particularly secure.
  • the first locking elements and/or the second locking elements each have an inclined surface inclined in a locking direction, which facilitates locking of the first locking structure with the second locking structure.
  • the locking structures can thus be easily brought into engagement with one another, but can only be separated from one another with difficulty due to the mentioned undercut.
  • the first locking structure is an inner locking structure, the first locking elements of which face outwards in at least two opposite directions
  • the second locking structure is an outer locking structure, the second locking elements of which face inwards in at least two opposite directions.
  • the first locking structure is thus preferably arranged within the second locking structure.
  • the bone connection device has a third connecting element, which can in particular be a connecting rod.
  • the connecting rod can, but does not have to, form part of a pedicle system.
  • the first and second connecting elements preferably serve to clamp the third connecting element between them.
  • the second connecting element can in particular be a locking clip, which is preferably designed to be placed on the first connecting element and to lock with it.
  • the locking clip is preferably designed as a whole in a C-shape, with two holding webs that are advantageously arranged more or less parallel to one another and a connecting web that connects the holding webs.
  • the second locking elements are then preferably arranged on the holding webs, with a first group of locking elements advantageously being arranged on the first holding web and a second group of locking elements on the second holding web, so that the two groups of locking elements face inwards towards one another.
  • the locking connection is arranged at the same height as the third connecting element in the locked state of the first and second connecting elements along the locking direction.
  • An arrangement at the same height means that the mutual locking engagement of the first and second locking structures along the locking direction takes place at the same height, i.e. partially or completely overlapping, with the third connecting element. In this way, the space required by the bone connection device along the locking direction can be minimized. This reduction in the height of the device along the locking direction is of great advantage, particularly in pediatric applications and in high thoracic and cervical applications.
  • the clamping surface of the clamping element and/or the third connecting element can have a friction-increasing coating.
  • the locking clip can have one or more local depressions in an area between the inward-facing second locking elements. Due to the one or more local depressions, the locking clip preferably has a material taper in the corresponding area, which increases the flexibility of the locking clip. Depending on how pronounced these depressions are, locking with the first connecting element is made easier or more difficult for the doctor and at the same time releasing the locking connection is made easier or more difficult. Preferably, one to three such depressions are provided.
  • the first connecting element and/or the second connecting element advantageously has an intervention structure which enables the locking connection to be released, for example with the aid of a suitable tool.
  • the intervention structure can in particular be arranged on the outside of the first or second locking structure.
  • the third connecting element is a connecting rod and the first connecting element is a tulip head, which serves to fix the connecting rod to a threaded shaft of a screw, in particular a pedicle screw.
  • the bone connection device then represents a pedicle system.
  • the tulip head can be formed in one piece with the screw or can represent a separate component in which the screw head of the screw is held. It is preferably a polyaxial fixation system in which the position of the threaded shaft of the screw or screws can be adjusted relative to the connecting rod.
  • the second connecting element which is advantageously designed as a locking clip is designed, then preferably serves to clamp the connecting rod to the tulip head.
  • the first locking structure is then preferably designed on the outside of the tulip head.
  • the second connecting element and/or a clamping element formed, for example, on the locking clamp can serve to clamp the screw to the tulip head by the connecting rod or the clamping element pressing the screw head against a stop surface provided on the tulip head.
  • a so-called washer can also be provided between the connecting rod and the tulip head or between the clamping element and the tulip head. The washer can be used in particular to improve the transmission of force from the connecting rod or clamping element to the screw head.
  • clamping with a locking clamp has the advantage that the space required on the side of the connecting rod opposite the screw is considerably reduced. In addition, no rotational movement is necessary for fixation.
  • the third connecting element is a connecting rod and the first connecting element is a connector, in particular an axial connector or a parallel connector, which serves to connect two connecting rods.
  • the second connecting element is advantageously designed as a locking clip and the first locking structure is preferably arranged on the outside of the connector.
  • the first locking structure can also be formed on the connecting rod, in particular on an end region of the connecting rod.
  • two preferably identically designed locking clips can be provided, one serving to clamp the first connecting rod and the other to clamp the second connecting rod.
  • a single locking clip with two clamping elements can be provided, the first clamping element serving to clamp the first connecting rod and the second clamping element serving to clamp the second connecting rod.
  • the connector then forms a connector system together with the second connecting element(s) and optionally the connecting rods.
  • the connector has at least one opening for receiving a connecting rod, which widens along the locking direction towards the second connecting element.
  • the connector can be used for connecting of connecting rods with different diameters.
  • the first connecting element is a screw and the second connecting element is a bone plate.
  • first connecting elements in the form of screws are present.
  • the screw or screws and bone plate can in particular together form a cervical plate system that serves to stabilize the cervical spine.
  • the screw or screws preferably each have an at least partially elastically deformable screw head on which the first locking structure is formed.
  • the second locking structure is preferably provided on the boundary surface of openings that are formed in the bone plate. The screw or screws can then be fixed in the openings of the bone plate with their first locking structure provided on the screw head.
  • the first locking elements of the screw(s) and/or the second locking elements of the bone plate form a thread.
  • the at least partially elastic design of the screw head with the first locking structure formed on it makes it possible to fix the respective screw to the bone plate in different angular positions. If a thread is present, the screw can be screwed with its screw head in the desired angular position into the corresponding opening in the bone plate. If the screw is screwed in at an angle, mutual engagement is impossible in certain areas of the locking structures. The elasticity of the screw head still allows screwing in in this case, as the locking structures cannot engage with each other in the areas mentioned, but can in other areas.
  • the screw or screws are preferably designed for direct screwing into a bone, in particular into a vertebral body of the cervical spine.
  • the bone connection device is designed as a vertebral body replacement.
  • the first connection element can then be an expansion slide and the second connection element an expansion body.
  • the expansion slide and expansion body can then be locked together with their respective locking structures along the longitudinal extension of the vertebral body replacement at different positions in order to adapt the longitudinal extension of the vertebral body to the patient.
  • the first and second locking structures can each be bent.
  • the expansion slide and expansion body are then locked into place along a correspondingly curved locking direction.
  • the first connecting element and the second connecting element preferably have guides that engage with one another, which can in particular together form a dovetail connection. In this way, correct fixing of the two connecting elements to one another can be guaranteed.
  • the second connecting element has a locking clip, which forms the second locking structure and is connected to the rest of the second connecting element via a flexible element.
  • the locking clip is preferably connected to the rest of the second connecting element exclusively via the flexible element.
  • the flexible element is preferably a web, which can in particular be formed in one piece with the locking clip and/or the rest of the second connecting element.
  • the flexibility preferably relates to the rest of the second connecting element, which generally has less flexibility than the flexible element.
  • the third connecting element is formed by a connecting rod, for example, and the second connecting element is used to attach the connecting rod to a pedicle screw
  • the provision of the flexible element can have the advantage that there is a certain amount of freedom of movement between the connecting rod and the pedicle screw despite the attachment. This can in particular reduce a tension discontinuity between the levels of the spine provided with the pedicle system and the sections of the spine adjacent to it. By creating a more gradual transition between the section of the spine stiffened by the pedicle system and the still mobile sections, the likelihood of proximal junctional kyphosis can be reduced and at the same time the adjacent intervertebral discs and vertebral bodies can be protected from further degeneration and unphysiological loading patterns.
  • the first connecting element and the second connecting element are displaceable relative to one another along the longitudinal direction of the first and second locking elements when locked together.
  • the second connecting element can in particular have a locking clip.
  • the second connecting element is also a Connecting rod.
  • the first connecting element can also be a connecting rod.
  • the first and second connecting elements can be moved relative to each other over at least a certain area despite being fastened to each other by means of the locking structures.
  • the moveability is only possible over a limited area, i.e. there is advantageously a stop on both sides so that the range of motion is restricted and the two connecting elements cannot come apart when moved.
  • such restricted mobility can bring advantages with regard to the therapy result.
  • the bone connection device can be, for example, a pedicle system, a connector system, such as in particular an axial or parallel connector system, a cervical plate system, a vertebral body replacement or an intervertebral disc cage. Similar to the vertebral body replacement, the intervertebral disc cage can also be expandable.
  • the invention also relates to a method for connecting two bones or bone parts of a human or animal patient, in particular by means of a bone connection device as specified above, wherein a first connecting element made of a fiber-reinforced plastic material and a second connecting element made of a fiber-reinforced plastic material are fixed to one another by locking a plurality of first locking elements of a first locking structure of the first connecting element with a plurality of second locking elements of a second locking structure of the second connecting element.
  • the two connecting elements are preferably fixed to one another by means of a purely translational movement of the two connecting elements relative to one another, i.e. preferably no rotational movement is carried out.
  • Fig. 1a is a perspective view of a tulip head and a Pedicle screw of a pedicle system according to the invention fixed with a locking clamp on a connecting rod;
  • Fig. 1b is an exploded perspective view of the device of Fig. 1a;
  • Fig. 1c is a side view of the device of Fig. 1a from a first viewing direction;
  • Fig. 1d is a side view of the device of Fig. 1a from a second viewing direction;
  • Fig. 1e is a first central cross-sectional view of the device of Fig. 1a;
  • Fig. 1f is a second central cross-sectional view of the device of Fig. 1a;
  • Fig. 1g is an enlarged detailed view of the area outlined in dashed lines in Fig. 1d;
  • Fig. 2 is a perspective view of the locking clamp of another pedicle system according to the invention.
  • Fig. 3 is a perspective view of the locking clamp of yet another pedicle system according to the invention.
  • Fig. 4a is a perspective view of a pedicle screw of another pedicle system according to the invention, fixed to a connecting rod by means of a tulip head and a locking clip;
  • Fig. 4b is an exploded perspective view of the device of Fig. 4a;
  • Fig. 5 is a perspective view of the locking clamp of another pedicle system according to the invention.
  • Fig. 6a is a perspective view of a tulip head and a
  • Pedicle screw of yet another pedicle system according to the invention fixed with a locking clamp on a connecting rod;
  • Fig. 6b is an exploded perspective view of the device of Fig. 6a;
  • Fig. 7 is a perspective view of the locking clamp of another pedicle system according to the invention.
  • Fig. 8a is a perspective view of a tulip head and a
  • Pedicle screw of yet another pedicle system according to the invention fixed with a locking clamp on a connecting rod;
  • Fig. 8b is an exploded perspective view of the device of Fig. 8a;
  • Fig. 9a is a perspective view of two connecting rods connected to each other by means of an axial connector of an axial connector system according to the invention.
  • Fig. 9b is an exploded perspective view of the device of Fig. 9a;
  • Fig. 9c is a first central cross-sectional view of the device of Fig. 9a;
  • Fig. 9d is a second cross-sectional view of the device of Fig. 9a taken along the plane IX-IX shown in Fig. 9c;
  • Fig. 10a is a perspective view of two connecting rods connected to one another by means of an axial connector of an axial connector system according to the invention according to another embodiment;
  • Fig. 10c is an exploded perspective view of the device of Fig. 10a;
  • Fig. 11a is a perspective view of two connecting rods connected to each other by means of a parallel connector of a parallel connector system according to the invention
  • Fig. 11b is an exploded perspective view of the device of Fig. 11a;
  • Fig. 11c is a side view of the device of Fig. 11a;
  • Fig. 12a is a perspective view of a cervical plate system according to the invention with several screws fixed in a bone plate;
  • Fig. 12b is an exploded perspective view of the device of Fig. 12a;
  • Fig. 12c is a cross-sectional view of the device of Fig. 12a in a plane centrally located by three screws;
  • Fig. 13a is a perspective view of a vertebral body replacement according to the invention.
  • Fig. 13b is an exploded perspective view of the device of Fig. 13a;
  • Fig. 13c is a central cross-sectional view of the device of Fig. 13a, in an unexpanded state;
  • Fig. 13d is a central cross-sectional view of the device of Fig. 13a, in an expanded state
  • Fig. 14a is a perspective view of another vertebral body replacement according to the invention with curved locking structures
  • Fig. 14b is an exploded perspective view of the device of Fig. 14a;
  • Fig. 14c is a central cross-sectional view of the device of Fig. 14a, in an unexpanded state;
  • Fig. 14d is a central cross-sectional view of the device of Fig. 14a, in an expanded state
  • Fig. 15a is a perspective exploded view of a pedicle screw of a pedicle system according to the invention, fixed to a connecting rod by means of a tulip head and a locking clip, according to a further embodiment;
  • Fig. 15b is a central cross-sectional view of the device of Fig. 15a;
  • Fig. 16a is a perspective view of a pedicle screw of a pedicle system according to the invention, fixed to a connecting rod by means of a tulip head and a locking clip, according to yet another embodiment;
  • Fig. 16b is a perspective view of the device of Fig. 16a;
  • Fig. 17a is a side view of a bone connection device in the form of two ends of two connecting rods slidably connected to one another via a locking connection;
  • Fig. 17b is a perspective view of the device of Fig. 17a;
  • Fig. 18a is a central cross-sectional view of a fenestrated pedicle screw of a pedicle system according to the invention, fixed to a connecting rod by means of a tulip head and a locking clip, according to a further embodiment;
  • Fig. 18b is an exploded perspective view of the device of Fig. 18a;
  • Fig. 19a is a central cross-sectional view of a fenestrated pedicle screw of a pedicle system according to the invention, fixed to a connecting rod by means of a tulip head and a locking clamp, according to yet another embodiment;
  • Fig. 19b is an exploded perspective view of the device of Fig. 19a.
  • FIGS 1a to 19b show various embodiments of medical bone connection devices according to the invention and parts thereof. Elements of different or identical embodiments that have the same or similar effects are each provided with the same reference numeral.
  • FIGS 1a to 1g show, in different views, a first preferred embodiment of a bone connection device according to the invention in the form of a polyaxial fixation system 1.
  • the polyaxial fixation system 1 is designed as a pedicle system that has a plurality of screws 12, which can also be referred to as pedicle screws and can be screwed into a vertebral body of the spine of a human or animal patient.
  • Each of the screws 12 is attached to a connecting rod 11 by means of a tulip head 13.
  • the connecting rod 11 thus connects the screws 12 to one another and thereby blocks or stabilizes the corresponding vertebral bodies.
  • the connecting rod 11 is preferably made as a whole in one piece from a fiber-reinforced plastic material.
  • the screw 12 has a largely spherical screw head 121, in on which an engagement structure 122 is formed.
  • the engagement structure 122 is, for example, hexagonal or torx-shaped and serves to screw the screw 12 into a vertebral body with the aid of a corresponding tool.
  • the screw 12 has a threaded shaft 123 which extends from the screw head 12 to a screw tip 124.
  • the screw 12 is preferably made as a whole in one piece from a fiber-reinforced plastic material. In this way, the X-ray transparency of the polyaxial fixation system 1 can be ensured. In order to still be able to clearly recognize the position and orientation of the polyaxial fixation system 1 and in particular the screws 12 during X-ray imaging or other medical imaging, such as magnetic resonance imaging, the screw
  • Markers in particular radiopaque markers, can be provided. Such a marker can be inserted, for example, in a recess provided on the screw tip 124 (visible in Figures 1e and 1f).
  • the tulip head 13 which is also made of a fiber-reinforced plastic material and is preferably made in one piece, has a base body 131 from which two diametrically opposite lateral webs 132 and 132' extend upwards.
  • the two lateral webs 132, 132' laterally delimit two receiving openings 135, 135' arranged between them and open at the top, which serve to receive the connecting rod 11.
  • a locking structure 133 is formed, which is formed by locking elements in the form of locking teeth 134 and 134'.
  • a first group of locking teeth 134 each of identical design, arranged parallel to one another, is provided on the first lateral web 134 and a second group on the second lateral web 134.
  • the screw 12 is inserted with the threaded shaft 123 first from above into the tulip head 13 until the screw head 121 strikes a contact surface 137 delimiting the interior space 136 (see Figures 1e and 1f). Due to the spherical design of the screw head 121, the screw 12 can be arranged and fixed in different angular positions relative to the tulip head 13.
  • the tulip head 13 thus forms a connecting element to connect and fix the screw 12 to the connecting rod 11.
  • a locking clip 15 is used to fix the screw 12 and the connecting rod 11 in a desired position on the tulip head 13.
  • the locking clip 15 which is made of a fiber-reinforced plastic material and preferably as a single piece, has a C-shaped configuration as a whole with two parallel, freely projecting holding webs 152, 152' and a connecting web 151 connecting the holding webs 152, 152'.
  • a locking structure 153 with a plurality of locking elements in the form of locking teeth 154 and 154' is formed on the radial inner sides of the holding webs 152, 152'.
  • a first group of locking teeth 154, each of identical design, arranged parallel to one another is provided on the first holding web 152 and a second group on the second holding web 152'. The locking teeth 154, 154' are thus directed inwards in the radial direction.
  • a clamping element 155 is attached centrally to the connecting web 151, which projects downwards from the latter parallel to the holding webs 152, 152' and forms a saddle-shaped contact surface, possibly coated (higher friction, locking), adapted to the outer surface of the connecting rod 11.
  • the connecting rod 11 is inserted into the receiving openings 135, 135' of the tulip head 13, with the screw head 121 already received in the interior 136 of the tulip head 13. Then, to fix it, the locking clip 15 is placed with its holding webs 152, 152' first onto the lateral webs 132, 132' of the tulip head 13, so that the locking structure 153 of the locking clip 15 locks with the locking structure 133 of the tulip head 13. By pressing the locking clip 15 onto the tulip head 13 along a locking direction R, the mutual engagement of the locking structures 153 and 133 can be increased and the clamping force acting on the connecting rod 11 can be increased.
  • the clamping element 155 presses the connecting rod 11 onto the screw head 121 arranged underneath, which in turn is pressed against the contact surface 137 of the tulip head 13 and is thereby clamped.
  • the clamping surface of the clamping element 155 and/or the connecting rod 11 can have a friction-increasing coating.
  • the inner locking teeth 134, 134' of the tulip head 13 each have a first surface facing away from the locking clip 15, which is perpendicular to the locking direction R, and a second surface facing towards the locking clip 15, which is inclined to the locking direction R.
  • the locking teeth 154, 154' of the locking clip 15, which are designed to complement each other each have a first surface facing the tulip head 13, which is perpendicular to the locking direction R, and a second surface facing away from the tulip head 13, which is inclined to the locking direction R.
  • the first and second surfaces of the locking teeth 134, 134' and 154, 154' are thus each at an acute angle to one another.
  • the first surfaces of the locking teeth 134, 134' and 154, 154' which are perpendicular to the locking direction R, thus together form an undercut, which prevents the locking clip 15 from being removed from the tulip head 13 after mutual locking.
  • the second surfaces of the locking teeth 134, 134' and 154, 154' allow easy attachment and locking of the locking clip 15 onto the tulip head 13 due to their inclination to the locking direction R.
  • a so-called washer 14 is preferably arranged between the connecting rod 11 and the screw head 121.
  • the washer 14 is ring-shaped, as can be seen in Figure 1b. It can be made of a metal or a plastic material, in particular a fiber-reinforced plastic material.
  • one or both of the adjacent surfaces of the washer 14 and the screw head 121 can have a friction-increasing coating and/or a surface structure.
  • the surface structure can be formed, for example, by grooves or notches.
  • the locking clip 15 and/or the tulip head 13 advantageously have a certain elasticity.
  • Such elasticity can be achieved, for example, by providing a slot 156 or 156' running in the longitudinal or axial direction on the holding webs 152, 152' of the locking clip 15, as is the case in the embodiment of Figures 1a to 1g.
  • a local recess 157 can be provided on the top of the connecting web 151 of the locking clip 15, as is shown in the locking clip 15 of the embodiment of Figure 2.
  • the recess 157 is arranged centrally between the two retaining webs 152, 152' and extends parallel to the retaining webs 152, 152' in the longitudinal direction of the connecting rod 11.
  • the elasticity of the locking clip 15 can be set very precisely. Due to the recess 157, the locking clip 15 thus forms a spring element.
  • the spring action of the locking clip 15 is achieved by two recesses 157 arranged laterally on the connecting web 151.
  • the recesses 157 each run parallel to the holding webs 152, 152' in the longitudinal direction of the connecting rod 11.
  • the central recess 157 of Figure 2 can also be combined with the two lateral recesses 157 of Figure 3.
  • no slot 156 or 156' is provided on the retaining webs 152, 152'.
  • a bow-shaped intervention structure 159 protruding outwards is attached to the radial outer side of the retaining webs 152, 152' in the area of their free ends.
  • the intervention structures 159 serve to release the mutual engagement of the locking structures 133 and 153 when necessary in order to remove the fastening of the connecting rod 11 on the tulip head 13.
  • the intervention structures 159 can be gripped behind with a suitable tool in order to move the retaining webs 152, 152' outwards in the radial direction.
  • the locking clip 15 has neither a slot 156, 156' nor a local recess 157.
  • the elasticity in the area of the locking structure 153 can be achieved here, for example, by an appropriate choice of material when producing the locking clip 15.
  • FIG 5 shows an embodiment of a locking clip 15 which has a slot 156 running in the axial direction on the holding webs 152, 152', similar to the locking clip 15 in Figure 1b.
  • Two bow-shaped intervention structures 159 are attached to the holding web 152 and 152' laterally to the slot 156.
  • Two parallel recesses 157 are formed on the connecting web 151 in order to give the locking clip 15 a certain flexibility with regard to locking.
  • the lateral webs 132, 132' of the tulip head 13 in the embodiments of Figures 1a to 4b each have rounded outer surfaces with locking teeth 134, 134' that are rounded in their longitudinal extension
  • the outer surfaces of the lateral webs 132, 132' in the embodiment of Figures 6a and 6b are each flat. Accordingly, the locking teeth 134, 134' also run in a straight line along their longitudinal extension. The same applies analogously to the inner surfaces of the holding webs 152, 152' and the locking teeth 154, 155 formed thereon. 154'.
  • Figure 7 shows a further embodiment of a locking clip 15 which, similar to that of Figures 3 and 5, has two parallel recesses 157 on the top of the connecting web 151 to create the locking clip elasticity.
  • the locking clip 15 is otherwise largely designed like that of Figures 6a and 6b, but it also has an intervention structure 159 on the outside of the holding webs 152 in order to be able to release the locking clip 15 from the tulip head 13 using a suitable tool if necessary.
  • intervention structures 159 which serve to release the mutual engagement of the locking structures, but can also be designed differently than in the present and previously described embodiments, is of course also conceivable for each of the locking clips 15 of the embodiments of Figures 1a to 2 and 4a, 4b and 6a, 6b.
  • the locking clips 15, 24 and 34 of the embodiments of Figures 8a to 11c described below can also have such intervention structures 159 for releasing the mutual engagement of the locking structures.
  • Figures 8a and 8b differs from that of Figures 6a and 6b in that guides are provided on the locking clip 15 and on the tulip head 13 in order to guide the locking clip 15 laterally onto the tulip head 13 and thereby ensure that the locking clip 15 is correctly attached.
  • a dovetail inner guide 158, 158' in the form of a downwardly projecting projection is provided on the holding webs 152.
  • two complementary dovetail outer guides 138, 138' are provided in the form of a short guide groove each extending parallel to the locking direction R.
  • a central recess 157 is formed on the upper side of the connecting web 151 of the locking clip 15.
  • Figures 9a to 9d, 10a to 10c and 11a to 11c show further embodiments of bone connection devices according to the invention, which are designed here as connectors for connecting and fixing two connecting rods 21 and 22 or 31 and 32.
  • the connecting rods 21 and 22 or 31 and 32 are connected to one or more bones or bone parts via further components not shown in the figures, such as screws in particular. While the embodiment of the Figures 9a to 9d and 10a to 10c each refer to an axial connector system 2, the embodiment of Figures 11a to 11c relates to a parallel connector system 3.
  • the axial connector system 2 of Figures 9a to 9d has an axial connector 23, which forms a housing that is designed to receive a first connecting rod 21 and a second connecting rod 22 from opposite sides.
  • the connecting rods 21 and 22 are each inserted into a receiving opening 232 or 232', which are formed by a base body 231 of the axial connector 23.
  • the connecting rods 21, 22 each protrude with their free ends into an interior space 235 or 235' (see Figures 9c and 9d), where they can be clamped by means of a respective locking clip 24.
  • the two almost identical locking clips 24 have a similar design to the locking clip of the embodiment of Figures 6a and 6b. They have an overall C-shaped configuration with two parallel holding webs 242, 242' and a connecting web 241 connecting them. Between the holding webs 242, 242', a clamping element 245 with a bottom side that is complementary to the connecting rod 21 or 22 is provided on the underside of the connecting web 241. While the clamping element 245 of the first locking clip 24 that rests on the first, thicker connecting rod 21 is somewhat wider, that of the second locking clip 24 that rests on the second, thinner connecting rod 22 is correspondingly narrower. In this way, a tight fit of the respective locking clip 24 on both connecting rods 21, 22 is ensured.
  • the base body 231 and the locking clips 24 thus each form a connecting element. They are preferably each made as a single piece and from a fiber-reinforced plastic material.
  • the locking clips 24 are attached to the base body 231.
  • corresponding locking structures 233 and 233' with a plurality of locking teeth 234 and 234' are provided for this purpose.
  • a correspondingly complementary locking structure 243 with locking teeth 244 and 244' is formed on the inside of the two locking clips 24.
  • the receiving openings 232, 232' are each surrounded by a contact surface 236 and 236', respectively, which widens along the locking direction R towards the locking clamp 24, as can be seen in particular in Figure 9d.
  • the connecting rods 21, 22 After the two connecting rods 21, 22 have been connected and fixed by means of the axial connector 23, the connecting rods are arranged one behind the other along their longitudinal extension. As can be seen in Figure 9c, the axial connector 23 can cause the connecting rods 21, 22 to be inclined to a certain extent relative to one another, i.e. the first connecting rod 21 extends at a certain angle along its longitudinal extension relative to the second connecting rod 22.
  • Figures 10a to 10c show another embodiment of an axial connector system 2, which has two locking clips 24, which are connected to one another by means of a connecting section 247 and are therefore preferably formed together in one piece.
  • the connecting section 247 can connect the two locking clips 24, as here, at a certain angle, so that a corresponding inclination of the interconnected connecting rods 21, 22 towards one another is brought about (see Fig. 10b).
  • the two identically designed locking clips 24 each have a connecting web 241 with a clamping element 245 attached thereto, as well as two holding webs 242, 242' extending parallel from the connecting web 241 with locking teeth 244 and 244' attached thereto.
  • the locking teeth 244, 244' each form a locking structure 243 which is designed to engage in a locking structure 212 or 222 provided on the connecting rod 21 or 22.
  • the respective free ends of the connecting rods 21, 22 are each formed by a cuboid locking block 211 or 221 on which the locking structure 212 or 222 is formed with corresponding locking teeth 213, 213' or 223, 223'.
  • the locking block 211 or 221 is advantageously formed in one piece with the rest of the connecting rod 21 or 22.
  • the connecting rods 21 and 22 each form a connecting element of the axial connector system 1.
  • the embodiment of Figures 10a to 10c has fewer components, but requires a specific design of the connecting rods 21, 22 in their respective end regions.
  • the parallel connector 33 of the parallel connector system 3 shown in Figures 11 a to 11 c also serves to connect two connecting rods 31 and 33 to one another and to fix them to one another.
  • the connecting rods 31, 33 are arranged and fixed with their free ends parallel to one another in the base body 331 of the connector. Instead of two locking clips 24, the clamping is achieved here with a single common locking clip 34.
  • the locking clip 34 has two clamping elements 345, 345', which are designed to clamp one of the connecting rods 31, 33 in each case and are adapted in terms of their shape to the diameter of the respective connecting rod 31, 33.
  • the receiving openings 332, 332' for inserting the connecting rods 31 and 33 are also delimited here by a contact surface 336 or 336' that widens along the locking direction R towards the locking clip 34, which enables the fixing of connecting rods 31, 33 with different diameters.
  • the locking clip 34 has a locking structure 343 with locking teeth 344 and 344' arranged opposite one another on its holding webs 342 and 342' that are connected to one another via the connecting web 341.
  • a further locking structure 333 with locking teeth 334 and 334' projecting outwards is formed on the outside of the base body 331.
  • FIG. 12a to 12c Another embodiment of a bone connection device, which is also in accordance with the invention, is shown in Figures 12a to 12c.
  • This is a cervical plate system 4 with a bone plate 41, which has a base body 411 with several openings 412, into which a screw 42 can be inserted to connect bones or bone parts.
  • the screws 42 each have a screw head 421 and a threaded shaft 426 extending from this along a longitudinal central axis 428 to a screw tip 427.
  • the screws 42 are designed to be anchored in a bone or bone part, in particular in a vertebral body of the cervical spine.
  • an engagement structure 425 for example in the form of a hexagon or torx, is provided, which can be accessed with an appropriate tool through the screw head 421, which is designed as a semi-hollow sphere.
  • Both the bone plate 41 and each of the screws 42 thus form a connecting element of the bone connection device and are preferably each designed as Whole in one piece and made of a fiber-reinforced plastic material.
  • the screw heads 421 each have a locking structure 423 with a plurality of outwardly projecting locking teeth 424 on their outside.
  • a correspondingly complementary locking structure 413 with a plurality of inwardly projecting locking teeth 414 is formed on the surfaces of the bone plate 41 that border the openings 412.
  • the locking teeth 424 of the screws 42 and/or the circumferentially extending locking teeth 414 of the bone plate form a thread.
  • the screw head 421 of the screws 42 each has a certain elasticity, which is achieved by means of slots 422, due to which the screw head 421 is divided into several segments that can be elastically pressed inwards.
  • a screw 42 is screwed into an opening 412 in such a way that its longitudinal center axis 428 extends exactly along the longitudinal center axis 415 which is defined by the locking structure 413 provided in the opening 412, the locking teeth 424 of all segments of the screw head 421 engage in the locking structure 413. This is the case with the screw 42 shown on the far right in Figure 12c.
  • the longitudinal center axis 428 of the screw 42 deviates from the longitudinal center axis 415 predetermined by the locking structure 413. Due to the angular deviations, the locking teeth 424 of certain segments of the screw head 421 can no longer engage in the locking structure 413 of the bone plate 41, but are pressed slightly radially inwards, which is made possible by the elasticity of the screw head 421 caused by the slots 422.
  • the locking teeth 424 of other segments of the screw head 421 can still engage in the locking structure 413 of the bone plate even when the screw 42 is in an oblique position.
  • the screw 42 can be fixed to the bone plate 41 via the locking structures 413 and 423 even when the screw 42 is in an oblique position relative to the bone plate 41, as shown on the far left in Figure 12c.
  • the screws 42 can thus be fixed to the bone plate 41 in different polyaxial positions.
  • FIGS 13a to 13d show an embodiment of a bone connection device according to the invention in the form of a vertebral body replacement 5.
  • the vertebral body replacement 5 has an expansion slide 51, a cover plate 52, a Expansion body 53 and a base plate 54, which are each made of a fiber-reinforced plastic material and preferably formed as a single piece.
  • the expansion slide 51 has an overall cube-like shape, with a base body 511, which forms the centrally arranged component of the vertebral body replacement 5.
  • a connecting structure 512 is formed on the top of the base body 511, which enables the attachment and fastening of the cover plate 52 to the expansion slide 51 via, for example, a bayonet connection.
  • the expansion slide 51 has a locking structure 513, which is formed by a plurality of locking teeth 514 and 514', which are arranged on two opposite sides of the base body 511. The locking teeth 514 and 514' are thus directed outwards in opposite directions and form an inner locking structure.
  • the cover plate 52 is formed by a substantially flat base body 521, on the underside of which a connecting structure 522 is formed, which serves to attach and fasten the cover plate 52 to the connecting structure 512 of the expansion slide 51.
  • the expansion slide 51 and the cover plate 52 could in principle also be formed integrally with one another.
  • an upper bone contact surface 523 is formed, which is designed to rest on a bone, in particular on an upper vertebral body of the patient, and has a corresponding surface structure that promotes a close connection and in particular bone growth.
  • the base body 521 has a notch 524, which serves to attach an instrument with which the doctor can expand the vertebral body replacement 5.
  • the expansion body 53 has a substantially cube-shaped base body 531, which is hollow on the inside and open at the top, thus allowing the expansion slide 51 to be accommodated.
  • a connecting structure 532 is formed on the underside of the base body 531, which enables the base plate 54 to be attached and secured via, for example, a bayonet connection.
  • a locking structure 533 with a plurality of locking teeth 534 and 534' is formed on two opposite inner sides of the base body 531.
  • the locking structure 533 which thus forms an external locking structure, is designed to be complementary to the locking structure 513 of the expansion slide 51, thus enabling a mutual locking connection between the expansion slide 51 and the expansion body 53.
  • the expansion slide can 51 protrude from the expansion body 53 to different distances depending on the position at which the locking structures 513 and 533 are locked together.
  • slots 535 are provided on the sides of the locking structure 533.
  • the base plate 54 has a base body 541, which has a connecting structure 542 on its upper side for attaching the base plate 54 to the connecting structure 532 of the expansion body 53.
  • the expansion body 53 and the base plate 54 could also be formed together in one piece.
  • the base body 541 On its underside, the base body 541 has a lower bone contact surface 543, which is designed to rest on a bone, in particular on a lower vertebral body of the patient, and has a corresponding surface structure that promotes a close connection and in particular bone growth.
  • the base body 541 has a notch 544, which is used to attach an instrument with which the doctor can expand the vertebral body replacement 5.
  • the vertebral body replacement 5 is inserted in a non-expanded state, as in Figure 13c, into the free space between two vertebral bodies of a patient and is then expanded by the doctor in order to fill the space between the two vertebral bodies and to fit snugly against the vertebral bodies with the bone contact surfaces 523 and 543.
  • the expanded state is shown in Figure 13d.
  • the doctor carries out the expansion using a tool or instrument not shown in the figures, which engages in the notches 524 and 544. Due to the surfaces of the locking teeth 514, 514' and 534, 534' inclined to the locking direction R in combination with the elasticity provided by the slots 535, the expansion slide 51 can be easily moved out of the expansion body along the locking direction R. In the opposite direction, however, the locking teeth 514, 514' and 534, 534' each have a surface perpendicular to the locking direction R and thus together form an undercut which effectively prevents subsequent compression of the vertebral body replacement 5.
  • Figures 14a to 14d show another embodiment of a vertebral body replacement 5, which is also according to the invention and differs from that of Figures 13a to 13d in particular in that the locking structures 513 and 533 of the expansion slide 51 and the expansion body 53 are designed to be slightly curved. to enable locking along a correspondingly curved locking direction R (see in particular Figures 14c and 14d).
  • the vertebral body replacement 5 is thus better adapted to the anatomical conditions of a patient.
  • the expansion body 53 of this embodiment has a bow-shaped, outwardly protruding intervention structure 536, which makes it possible to pull the locking teeth 534 away from the locking teeth 514 using a suitable tool in order to thereby cancel the mutual engagement of the locking structures 533 and 513 if necessary.
  • the vertebral body replacement 5 can thus be shortened along the locking direction R in order, for example, to remove the vertebral body 5 from the spine.
  • Figures 15a and 15b show an embodiment of a bone connection device according to the invention in the form of a polyaxial fixation system 1, which essentially corresponds to that of Figures 1a to 1f, but with the difference that the locking structures 133 and 153 here each have only two pairs of locking teeth 134, 134' and 154, 154' respectively.
  • a pair of locking teeth 134, 134' of the locking structure 133 formed on the tulip head 13 is formed by the two locking teeth 134 and 134', which are arranged at the same height of the lateral webs 132 and 132'.
  • a pair of locking teeth 154, 154' of the locking structure 153 formed on the locking clip 15 is formed by the two locking teeth 154 and 154', which are arranged opposite one another at the same height of the holding webs 152 and 152'.
  • the embodiment with only two pairs of locking teeth 134, 134' or 154, 154' has proven to be particularly advantageous in terms of the strength of the connection when the locking clip 15 is locked onto the tulip head 13. This can be explained by the fact that the mutual undercuts formed by the locking teeth 134, 134' or 154, 154' are larger due to the smaller number of locking teeth. Nevertheless, it is still possible to lock the locking clip 13 onto the tulip head 15.
  • a number of just one or two locking teeth or one or two pairs of locking teeth has proven to be particularly advantageous in terms of the strength of the connection.
  • Figures 16a and 16b show an embodiment of a polyaxial fixation system 1, i.e. a pedicle system, in which a connecting rod 11 is attached to a pedicle screw 12 by means of a locking clamp 15.
  • the connecting rod 11 is not clamped between the locking clamp 15 and the tulip head 13, as in the embodiment of Figures 1a to 1f, but is held by a connecting clamp 16, which is preferably connected in one piece to the rest of the locking clamp 15 via a web 161.
  • the connecting clamp 16 itself forms a locking clamp.
  • the locking clamp 15 has an enlarged clamping element 155.
  • the connecting clamp 16 has an internal locking structure 163 which is arranged on two retaining webs 162, 162' of the connecting clamp 16 which extend parallel to one another and has locking teeth 164, 164' arranged opposite one another.
  • the locking teeth 164, 164' are designed to engage in locking teeth 113 which are formed by a locking structure 112 of the connecting rod 11.
  • the locking structure 112 is in turn formed by a locking block 111 which is arranged on a free end of the connecting rod 11 and is integrally formed thereon.
  • the connection between the connecting rod 11 and the pedicle screw 12 is thus made in particular via the web 161 which, due to its shape, has a certain flexibility and thus allows certain movements between the connecting rod 11 and the screw 12. In this way, a gradual transition can be achieved between the section of the spine stiffened by the pedicle system and the adjacent, still mobile sections.
  • FIGs 17a and 17b show a bone connection device according to the invention, designed as an axial connector system, according to yet another embodiment.
  • the locking structures 212 and 163 are each integrally connected to the first connecting rod 21 and the second connecting rod 22, respectively. molded onto it.
  • the first connecting rod 21 forms a locking block 211 at one of its free ends, which, similar to the first connecting rod 21 shown in Figure 10c, forms a locking structure 212 with locking teeth 213, 213' on the outside.
  • the locking structure 212 extends further along the longitudinal direction of the connecting rod 21.
  • a connecting clamp 16 is molded onto the free end of the second connecting rod 22, which forms a locking clamp and is connected to the rest of the connecting rod 22 exclusively via a web 161.
  • the connecting clamp 16 has a locking structure 163 with locking teeth 164 and 164' on the inside, which are designed to lock into the locking teeth 213, 213' of the locking structure 211 formed on the first connecting rod 21. Since the locking structure 211 extends further along the longitudinal direction of the connecting rods 21 and 22 than the locking structure 163, the connecting rods 21 and 22 can be displaced relative to one another in the longitudinal direction over a limited area when locked together. Such mutual displaceability of the interconnected connecting rods 21, 22, limited by corresponding stops, can bring advantages depending on the application and have a positive effect on the therapy.
  • the connecting rods 21 and 22 of this and other embodiments can be straight or bent with any desired curvature.
  • Figures 18a and 18b and figures 19a and 19b show further embodiments of bone connection devices according to the invention in the form of a pedicle system.
  • the pedicle screws 12 are each fenestrated here. This means that bone cement, for example, can be fed through the screw 12 in order to strengthen the bone in the corresponding area and/or to improve the anchoring of the screw 12 in the vertebra.
  • the screw 12 therefore has several openings in the area of the screw tip 124, which communicate with an inner channel extending along the screw's longitudinal axis and open outwards from this.
  • the locking elements of the locking structure 133 formed on the tulip head 13 are not formed as locking teeth, as in the previously described embodiments, but as openings 139, 139'.
  • the openings 139, 139' serve to engage the locking teeth 154, 154' of the locking clip 15, as shown in Figures 18a and 19a.
  • the openings 139, 139' can have the shape of slots, while the locking teeth 154, 154' of the locking clip can be designed to engage in the slots.
  • the locking clip 15 has a locking structure 153 with only two locking teeth 154, 154', which are arranged as a pair at the same height and are directed outwards away from each other.
  • the locking teeth 154, 154' can each be provided on a pair of flexible hooks or fingers of the clip 15.
  • the locking structure 133 of the tulip head 13 also has a locking structure 133 which has only two locking elements designed as openings 139, 139'.
  • the openings 139, 139' can be designed in one embodiment as slots for receiving the locking teeth 154, 154'.
  • the clip 15 can be pressed onto the tulip head 13 so that the flexible hooks which comprise the locking teeth 154, 154' are slightly deformed to allow the locking teeth 154, 154' to slide along the shaped inner guides of the tulip head 13 until they engage the apertures 139, 139'.
  • the locking clip 15 has a locking structure 153 with a total of four locking teeth 154, 154', which are provided in the form of two pairs.
  • a pair of locking teeth 154, 154' can be provided on each pair of flexible hooks or fingers of the clip 15.
  • the locking teeth 154 and 154' of each pair are arranged at the same height and face outwards away from each other.
  • the locking structure 133 of the tulip head 13 also has a locking structure 133 which has a total of four locking elements designed as openings 139, 139'. Analogous to the locking teeth 154, 154', the openings 139, 139' are also provided in the form of two pairs.
  • the apertures 139, 139' may be formed as slots for receiving the locking tooth pairs 154, 154'.
  • the clip 15 may be pressed onto the tulip head 13 so that the flexible hooks which comprise the pairs of locking teeth 154, 154' are slightly deformed to allow the pairs of locking teeth 154, 154' to slide along the shaped inner guides of the tulip head 13 until they engage the pairs of apertures 139, 139'.
  • the screw 12 could also be designed as one piece with the tulip head 13.
  • the locking clips 24 of the axial connector 23 could also be designed as one piece and the locking clip 34 of the parallel connector 33 could just as well be designed as two parts, i.e. with one for each connecting rod 31, 32.
  • the Bone plate 41 could have any other number of openings 412 for inserting one screw 42 each and/or be shaped in any other way. Different and/or additional elements from different embodiments can also be transferred or exchanged without any problem.
  • the locking clips 24 and 34 can have one or more local depressions 157 for adjusting the flexibility and/or have an inner guide that interacts with an outer guide provided on the base body 231 or 331.
  • the outer guide to be provided on the locking clip 15, 24, 34 and the inner guide to be provided on the tulip head 13 or on the base body 231 or 331.
  • the mutual displaceability of the first connecting element and the second connecting element along the longitudinal direction of the locking teeth according to the embodiment shown in Figures 17a and 17b is basically conceivable in all embodiments.
  • the locking structure 112 of the embodiment of Figures 16a and 16b could also be made longer in order to enable a corresponding, preferably limited, longitudinal displacement. A large number of other modifications are conceivable.

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Abstract

L'invention concerne un dispositif médical de liaison osseuse (1; 2; 3; 4; 5) destiné à relier deux os ou parties d'os d'un patient humain ou animal, comportant un premier élément de liaison (13; 21, 22; 23; 33; 42; 51) et un second élément de liaison (15; 24; 34; 41; 53), qui sont tous deux constitués d'une matière plastique renforcée par des fibres et qui peuvent être fixés l'un à l'autre. Le premier élément de liaison (13; 21, 22; 23; 33; 42; 51) présente une première structure d'accrochage (133; 212, 222; 233, 233'; 333; 423; 513) avec une pluralité de premiers éléments d'accrochage (134, 134'; 139, 139'; 213, 213', 223, 223'; 234, 234', 334, 334'; 424; 514, 514'), et le second élément de liaison (15; 24; 34; 41; 53) présente une seconde structure d'accrochage (153; 243; 343; 413; 533) avec une pluralité de seconds éléments d'accrochage (154, 154'; 244, 244'; 344, 344'; 414; 534, 534'). Pour fixer le premier et le second élément de liaison l'un à l'autre, les premiers éléments d'accrochage (134, 134'; 139, 139'; 213, 213', 223, 223'; 234, 234', 334, 334'; 424; 514, 514') peuvent être accrochés aux seconds éléments d'accrochage (154, 154'; 244, 244'; 344, 344'; 414; 534, 534').
PCT/EP2024/073011 2023-08-25 2024-08-15 Dispositif médical de liaison osseuse et méthode de liaison d'os ou de parties d'os Pending WO2025045603A1 (fr)

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EP23193575.0 2023-08-25
EP23193575 2023-08-25

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US6251112B1 (en) 2000-04-18 2001-06-26 Roger P. Jackson Thin profile closure cap for open ended medical implant
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US20100292739A1 (en) * 2009-05-15 2010-11-18 Warsaw Orthopedic, Inc. Bone Screws With Improved Locking Mechanisms
US20100292736A1 (en) * 2009-05-15 2010-11-18 Warsaw Orthopedic, Inc. Linkage for Connection of Fusion and Non-Fusion Systems
US20120253400A1 (en) * 2011-03-31 2012-10-04 Corporation Spinelab AG Vertebral column implant
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