• 专利附录
  • 专利说明
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    • 专利摘要:
    Device for intervertebral fusion comprising an intervertebral stabilization screw and a composition for bone remodeling. Intervertebral Stabilization Screw comprising a main body with an axial through hole and a distal bone fixation thread, located at a distal end of the main body, a hollow proximal secondary body with sliding capability along the main body and a stop to the travel of the proximal secondary body located on an outer surface of the main body, in which the proximal secondary body also externally has a thread for fixing to bone and in which between the distal thread and said stop the main body has at least one filling hole for connection of an intervertebral space with said axial hole. (Machine-translation by Google Translate, not legally binding)
    公开号:ES2672265A1
    申请号:ES201631413
    申请日:2016-11-07
    公开日:2018-06-13
    发明作者:Rudolf Morgenstern Lopez
    申请人:Inst Biomecanico De Barcelona S L；Instituto Biomecanico De Barcelona SL；
    IPC主号:
    专利说明:

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    Intervertebral fusion device comprising an intervertebral stabilization screw and a bone remodeling composition
    The present invention refers to an intervertebral fusion device comprising an intervertebral stabilization screw and a bone remodeling composition, said screw and said composition.
    It is known as vertebral fusion or arthrodesis to the process of creating bone between adjacent vertebrae, joining them with each other.
    Intervertebral fusions are currently performed by placing bone graft either from the patient himself (usually from the vertebra itself or from the iliac crest) or from another origin (external or artificial). The graft can be fixed to the affected vertebrae by screws. Additionally, it is necessary to place a fixation structure of the affected vertebrae comprising rods or plates that follow the shape of the spine and that are fixed to each vertebra by screws (posterior instrumentation). This structure is necessary to resolve intervertebral instability (spondylolisthesis) usually associated with these conditions and to protect the graft during the consolidation phase (bone creation). This operation usually requires open surgery. Intervertebral fusion or bone consolidation lasts for months or years, and in some cases it never occurs (pseudoarthrosis). 100% effective cures are not always common. The fixation structure of the affected vertebrae, despite being somewhat cumbersome, is not removed except in cases where it causes considerable discomfort and only after there has been a completely satisfactory bone mineral consolidation verifiable with radiological techniques.
    It is an objective of the present invention to disclose a device for immediate intervertebral fusion (vertebral fusion) that provides a solution to the problems posed. In particular, the spinal fusion allows immediate fusions by percutaneous techniques and outpatient surgery. The new melter eliminates the need for subsequent instrumentation to protect the area against movements during the bone consolidation phase and provides a solution to the problems that sometimes cause bone formation to fail. Local anesthesia can be used. The new melter also suppresses the need for other metal inserts that protrude from the spine and can be a source of problems. The new fusion device also allows some correction of intervertebral displacements. The new melter comprises, in combination, a new intervertebral stabilization screw and a new bone remodeling composition comprising a bone cement. Both the screw and the bone remodeling composition are novel and can usually be developed and manufactured by different technical teams.
    The present invention is of special application to spondylolisthesis at any level, single or multiple, although it can also be applied in the treatment of other spinal pathologies. In a general case, the device of the present invention can be installed by percutaneous techniques and even without the need for soft tissue dilation to facilitate surgical approach.
    For this, the present invention also discloses a composition for bone remodeling that generates a bed that promotes bone formation in the difficult growth conditions inside the ring.
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    intervertebral (disc) and an insert (typically formed by two screws per fused level) that allows the placement of said bed in the intervertebral disc space and cooperates with the bed in the stabilization of the intervertebral zone during the bone formation phase . During the bone formation phase, the stabilization and preservation of the intervertebral space is carried out jointly, both by the insert or inserts and by the bone cement contained in the bone remodeling composition.
    The bone remodeling composition object of the present invention is based on the use of what is called "bone cement". Different types of bone cements are known, in general biocompatible polymers that are polymerized during application thereof. The "in situ" polymerization allows its application in a liquid state and its subsequent and immediate hardening. Although the word “cement” is used in the sector, it should be noted that this does not imply a union of the cement to the bone, but that the cement simply fills the existing hole. That is, bone cements could in general also be called "mortar" or "filler" instead of "cement."
    Bone cements are used in orthopedic surgery as an implant or to reshape lost bone. They are also used to fill vertebral fractures. By hardening the cement, the continuous pain associated with the fracture is relieved.
    Among the known cements, there can be mentioned polymethylmethacrylate (PMMA), bisphenol glycidyl methacrylate (bis-GMA) and poly (lactic-co-glycolic acid) (PLGA). The PMMA is the most widely used. Through a suitable selection of initiators and monomers, commercial versions are commercialized whose polymerization temperature is very close to the body temperature, which is convenient to avoid thermal necrosis of the surrounding tissue. Equipment is also provided to control the viscosity of the cement during the initial stages of polymerization, in order to control its injection. An example of polymerizable bone cement of commercial type that allows such control is that marketed under the name StabiliT®.
    Yamada et al. they reported in “Targeted therapy of low back pain associated with the novo degenerative lumbar scoliosis in the erderly: prospective observation cohort study (Eur Spine J (2014) 23 (Suppl 5): S496-S496) the transpedicular percutaneous injection of PMMA. Yamada applies the cement using a 11G needle to degenerate discs very painful but with the integrity of the preserved ring and with N2 formation inside it, which is not a common case. Yamada does not clean the core and simply fills the existing holes. This technique does not involve a vertebral fusion with bone formation, but the placement of cement as an insert that prevents an approach between vertebrae. As already mentioned, the union of the insert in space can be problematic. Also, the technique is only applicable if the intervertebral space has not been damaged or noticeably reduced.
    A problem associated with bone cements, and in particular with PMMA, and therefore with the Yamada technique, is that its Young's modulus is very different from that of human bone, so the efforts are concentrated on cement. Lacking the nearby bone of tension stimuli, it can cause resorption of the bone, which in turn can cause new fractures in the bone surrounding the bone cement. In short, the duration of bone cement prostheses may be limited.
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    The addition of hydroxyapatite to bone cement is known to bring the physical properties of bone cement closer to those of bone. For example, Arbmotlagh et al., In "PMMA-hydroxiapatite composite material increases Lifetime of augmented bone and facilitates bone apposition to PMMA: Biomechanical and histological investigation using a sheep mode" (European Cells and Materials Vol. 28 Suppl. 1, 2014 ( page 15), they found that the addition of 30% hydroxyapatite improved the cycles until the failure of the surrounding bone with respect to the use of PMMA only.The histological section at 6 months found weak areas of bone within the PMMA matrix when hydroxyapatite was used with PMMA.
    On the other hand, vertebral stabilization screws are also known, such as the commercially known Perpos®. This screw is intended to be installed through the facet of a vertebra and introduced into the pedicle of the lower vertebra (without affecting the vertebral ring). The vertebral stabilization screw comprises a distal thread intended to be threaded into the vertebra, in the area of the pedicle. It also comprises an axial through hole that is used for guiding the screw. The screw also comprises a proximal part capable of moving on the main body whose function is to adjust the operating length of the screw. The screw comprises a locking or trigger mechanism that fixes the proximal part at the desired travel point along the main body.
    According to another aspect, the present invention also discloses an intervertebral stabilization screw comprising a main body with an axial through hole (cannulated screw) and a distal bone fixation thread, located at a distal end of the main body, a body hollow proximal secondary with sliding capacity along the main body and a stop to the path of the proximal secondary body located on an outer surface of the main body, in which the proximal secondary body also externally has a bone fixation thread and because between The distal thread and said main body have, between the distal thread and said stop, at least one filling hole for connection of an intervertebral space with said axial hole.
    The screw object of the present invention comprises two threads, each intended to be threaded to two adjacent vertebrae. The area between the distal thread and the stop is intended to be within the space of the intervertebral ring. The filling hole allows filling the intervertebral space (intra-annular space) with a bone remodeling composition. The thread of the proximal secondary body (proximal thread) allows the screw to be fixed to a vertebra adjacent to the vertebra that receives the distal thread.
    In accordance with the present invention, the preferred screw installation can be carried out transpedicularly. The present invention provides for the insertion of two screws, one on each side, for each level to be fused. In this arrangement, the screws, thanks to the proximal thread, allow correcting the lordosis and lateral deviations of the spine before the injection of the bone remodeling composition.
    The present invention provides that, preferably, the outer diameter of the thread of the proximal secondary body (proximal thread) has a diameter greater than the diameter of the distal thread. In this way it is favored that the distal thread passes through the installation area of the proximal thread, without worsening the fixation of the thread proximal to the bone of the vertebra and also displacing the main body of the screw by pushing it when threading the secondary body into the vertebra lower.
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    The stop can take different forms and its function is to prevent the proximal secondary body from filling the orifice or filling holes. Preferably, the main body has a step that performs said function. Said step can be obtained, preferably, by a variation of the outer diameter of the main body. In this way, the proximal body can slide around the area with the smallest outer diameter, but not through the area with the largest outer diameter.
    The filling holes preferably have a radial path, which minimizes their length. To ensure the filling function, the main body has at least two filling holes. Most preferably, the filling holes have a diametral path, with two outlets connecting opposite points of the main body wall. This arrangement allows the doctor to verify that the operation is being carried out, to verify that there is at least one hole in the intervertebral space. For this, the doctor must orient the screw in such a way that the diametral direction of the hole coincides with the direction of X-ray emission of the fluoroscope. In this way, the hole will be visible through the fluoroscope.
    The present invention also provides that the screw also has a cover for sealing access to the axial hole once the bone cement has been injected.
    To facilitate its placement by percutaneous surgery, the present invention provides that both the main body and the proximal body have at their proximal end a device for receiving a percutaneous tool, such as, for example, a hexagonal screwdriver or screwdriver or the like.
    The bone remodeling composition object of the present invention comprises a polymerizable bone cement, a calcium phosphate supplier and an O2 contribution compound. It preferably further comprises an osteogenic factor and / or a contrast agent.
    The O2-contributing compound in the composition object of the present invention has the dual function of increasing the porosity of bone cement, creating gaps in the polymer matrix of the cement and providing the O2 necessary to promote bone formation. This allows not only the formation of bone in an area such as the intervertebral without blood supply, but also leaves room for a coherent formation of it. The O2-contributing compound may preferably be hydrogen peroxide, ozone or an oxygen solution. More preferably, it is hydrogen peroxide. Oxygenated water has the advantage of being liquid, decomposing in water and oxygen under the right conditions, which allows its mixing with bone cement and its injection during the polymerization process of bone cement.
    The gaps generated by the release of O2 favor that the bed formed by the bone cement matrix has mechanical properties more similar to those of the bone.
    The polymerizable bone cement may be of any type, with those comprising at least one of polymethyl methacrylate (PMMA), bisphenol glycidyl methacrylate (bis-GMA) and poly (lactic-co-glycolic acid) (PLGA) being preferred. More preferably, the polymerizable bone cement comprises PMMA. PLGA may also be preferred due to its biocompatibility.
    The calcium phosphate contributing substance may preferably be hydroxyapatite, brushite, calcium phosphate or tricalcium phosphate. Hydroxyapatite is preferred because of its great biocompatibility and because it is the main form
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    in which calcium phosphate is found in the bone. The calcium phosphate supplier has as its preferred functions to favor the formation of bone and bring the properties of the bone cement bed closer to those of the bone, to minimize the possibility of fracture of the surrounding bone of the vertebral platforms.
    Osteogenic factors favor and mark the pathways of bone creation. Preferably, the osteogenic factor in the composition object of the present invention comprises at least one of: whole blood, blood growth factors and osteogenic stem cells. Blood growth factors are preferred for their effectiveness and ease of obtaining.
    The components of the composition object of the present invention can be present in any proportion.
    Preferably, the calcium phosphate supplier is present between 30% and 15% by weight.
    Preferably, the hydrogen peroxide is present in an amount equal to or less than 5% by weight. Also preferably, the osteogenic factor is present in an amount less than 5% by weight. Also preferably, the contrast is present in an amount less than 5% by weight, more preferably in an amount less than 1% by weight.
    The polymerizable bone cement will preferably be present in an amount of between 55% and 80% depending on the rest of the components present and the hardness desired for the bed to be formed.
    Particularly preferably, the presence of a contrast agent, preferably a non-ionic contrast agent, allows control of the placement of the composition in the disc space during a percutaneous installation operation of the device object of the present invention.
    Thus, the vertebral fusion device comprises the bone remodeling composition object of the present invention and at least one screw, preferably at least two.
    The installation of the device object of the present invention can be carried out by percutaneous techniques, preferably by guiding the vertebral stabilization screws. The installation preferably comprises the phases of cleaning the disc space, scratching, installation of the screws via transpedicular; where appropriate, correction of the relative position of the vertebrae by threading the proximal thread against the stop and injection of the bone remodeling composition into the intervertebral space through the axial hole and the filling hole. To facilitate bone formation from the vertebrae, the vertebral platforms must be scratched with a flexible or cozy osteotome, prior to the introduction of the bone remodeling composition.
    The use of one or two transpedicular approach screws allows to preserve the integrity of the intervertebral disc and, in particular, the tightness of the disc ring during the surgical approach of the intradiscal space, thus allowing to be able to inject the composition for bone remodeling without causing leaks thereof. of its definitive solidification. Thanks to the preservation of the tightness and the immediate solidification (polymerization) it is possible to achieve an immediate fusion so far impossible to achieve with the traditional intervertebral arthrodesis surgical techniques.
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    For better understanding, some drawings of two embodiments of the object of the present invention are attached by way of explanatory but not limitative example.
    Figure 1 shows a side elevation view of a screw embodiment according to the present invention.
    Figure 2 shows a sectional view through the middle lateral plane of the screw of Figure 1;
    Figure 3 shows a sectional view through a middle plane perpendicular to the cutting plane of Figure 2.
    Figure 4 is a view from a sagittal plane of the vertebral level to be fused. The figure shows the lower vertebra and the disc space, the upper vertebra being omitted. The path of introduction of the screw object of the present invention has also been represented.
    Figure 5 corresponds to a view from an axial plane of the level to be fused from the previous figure, in which the screw placement path has also been marked.
    Figure 6 corresponds to the view from a coronal plane of the column shown in the previous figures, the path of placement of two screws according to the present invention having also been marked.
    Figure 7 shows a first phase of an example of the placement process of the device object of the present invention, in which the disc content (core) is removed.
    Figure 8 schematically shows a second phase of the device placement process.
    Figure 9 schematically shows a third phase of the device placement process.
    Figure 10 schematically shows a fourth phase of the device placement process.
    Figure 11 schematically shows a fifth phase of the device placement process.
    Figure 12 schematically shows a sixth phase of the device placement process.
    Figure 13 schematically shows a seventh phase of the device placement process.
    Figure 14 schematically shows an eighth phase of the device placement process.
    Figure 15 shows from a lateral point of view, a device object of the present invention already placed, prepared for the fusion of a vertebral level.
    Figures 1 to 3 show an exemplary embodiment of a screw object of the present invention.
    The example of the screw shown in the figures comprises two moving parts with each other: a main body -1- and a proximal secondary body, henceforth, proximal body -2-. The proximal body -2- slides along the body
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    Main, in axial direction. References to distal and proximal refer to the transcutaneous process of screw placement in a patient.
    The main body -1- has a distal thread -11- at its distal end for bone fixation. The rest of the main body is separated into two zones -12-, -13- separated by a stop -123- formed by a step generated by an abrupt change in its outer diameter. On the outside of the most proximal area -13- a proximal body -2- can be moved which also has a proximal thread -21- for bone fixation. Since the proximal thread -21- must be fixed to bone in an area through which the distal thread -11- has already passed, it may be advantageous if the outside diameter of the proximal thread -21 - is greater than that of the distal thread - 11-, in order to improve the fixation. The travel limit of the proximal part -2- is defined by the interference of its most distal face -213- with the stop -123-.
    Both the main body -1- and the proximal body -2- have at their proximal end two zones or devices -19-, -29- that allow their proper handling by percutaneous devices. Of course, these areas may be different from those shown.
    Both the main body -1- and the proximal body -2- are hollow, presenting an axial hole. In the case of the proximal body, this allows it to slide along the main body -1- it would also be possible, alternatively, for both bodies to be threaded together.
    The axial hole of the main body ends in a distal hole -14-. This allows guiding the main body in its path. Also, the example shows in the area -12- between the stop -123- and the distal thread -11- filling holes in diametral arrangement with opposite outlets -17-, -17'-, -18-, -18'- . These holes will allow the intervertebral space (inside the vertebral disc) to be filled with a bone remodeling composition through the axial hole and the filling holes.
    The core of filling holes is preferably two or more, and its arrangement can be symmetrical. The ideal core of filling holes and their composition depend on the anatomy and vertebral state of the patient.
    Figures 4 to 6 show the preferred placement path of two screws according to the present invention to fuse a vertebral level. Two screws are enough. Their introduction is transpedicular, crossing the disc space, so that the distal thread will be threaded in the upper vertebra and the proximal thread in the lower vertebra.
    The preferred access point in the case of percutaneous placement is located in the pedicle, in the center of the upper joint process and approximately 1 mm below the lower edge of the transverse process of the vertebra, varying according to the specific anatomy and other factors.
    The angle of introduction (defined by the value of the angles -A-, -B- and -C-) also varies depending on the specific anatomy of the vertebra. An optimal value in the case of a L4-L5 fusion would be 35 ± 5 ° for each of the three values (-A-, -B-, -C-), more preferably 35 °
    Figures 7 to 14 show an example of the installation process of an example of an intervertebral fusion device object of the present invention.
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    In said figures, elements equal or equivalent to those shown in the previous figures have been identified with identical numerals and, therefore, will not be explained in detail.
    Initially, the guides can be installed in the direction shown in Figures 4 to 6. For reasons of clarity, the guides have not been shown in any figure. For the application shown, for example, trocar 11G of the Jamshidi type can be used for the approach and penetration of the pedicle and Kissner needle as a guide for screw placement. The placement is transcutaneous, bilateral and pedicular. Through fluoroscopic techniques, its passage through the disc space and its penetration 5-10 mm into the body of the upper vertebra and through the lower platform of the upper vertebra can be controlled.
    During some time of the process (not shown in the figures) it may be interesting to check the sealing status of the ring by radiological discography, in order to verify that the technique is viable and / or adjust the viscosity of the bone cement.
    The process begins with an ablation or nucleolysis, for example by radiofrequency, of the material inside the disk -1000-. This can be done through a Jamshidi-like cannula, as shown in Figure 7. This technique seems viable since it has already been applied for the ablation of posterior metastatic tumors in the vertebral bone body using a bipolar device for radiofrequency ablation. Alternatively, the material could also be removed mechanically. The cannula -901- may have been introduced by guidance, according to sufficiently known percutaneous techniques. A single cannula has been shown in the figure, but two can be introduced, one on each side. This technique has the advantage that it can ensure the preservation of the disc ring.
    Subsequently, the waste of disc material generated by the nucleolysis is emptied. To do this, a cleaning liquid is introduced on one side and extracted on the other side, which will drag the waste. For this, two transpedicular cannulas can be used, such as cannula -901- shown in Figure 7, one on each side. In Figures 8 and 9 an alternative technique has been shown in which two screws are introduced, threading them by means of the appropriate tool -900-, until the distal hole -14- of both is located in the distal space and subsequently circulated the cleaning liquid through the axial holes of both screws.
    Once the disc space has been cleaned, scratching (or stippling) of the vertebral platforms of the adjacent vertebrae -1001-, -1002- is carried out (see figure 10). This can be done in several ways and with different tools. For example, alternatively to the tool shown in Figure 10, an osteotome, for example the osteotome marketed under the name DFINE Midline®, or another, can be used to perform multiple perforations in the platforms. Thanks to this technique, the new bone will grow from the platforms and will be attached to them.
    Once the core of the ring has been cleaned and the vertebral platforms have been damaged, the screw object of the present invention can be introduced until the end of its path (see figures 11 to 13).
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    Initially, the main body -1- enters until the distal thread -11- is threaded into the upper vertebra -1001- and the holes -17-, -18- remain in the inner space of the disc -1000-. The bilateral placement process, with two screws, allows some correction of possible distractions of the vertebrae.
    Subsequently, we proceed to thread the proximal body -2- inside the pedicle and the body of the lower vertebra -1002- until it reaches the top. Once reached the stop, you can continue to thread the proximal thread -21- against the stop. This creates a distraction that generates a slight intervertebral lordosis. This effect is recommended, while most patients who require a fusion have lost lordosis. This overdrive can also correct vertebral distractions.
    Once the screws are placed, the Kissner type guide wire (not shown in the figures) can be removed and the vacuum generated in the disc space filled with a bone remodeling composition.
    Any type of polymerizable bone cement can be used for the generation of the bone regeneration composition object of the present invention. The polymerization allows the introduction of the cured bone cement in a liquid or semi-liquid state and the immediate hardening of the bone cement inside the intervertebral disc.
    There are different grades of commercial polymers that are biocompatible and that, thanks to the selection of components and / or additives, have polymerization temperatures close to body temperature. In general, its commercialized in the form of a powder that has to be mixed with a liquid polymerization activator. Once mixed activator and powder, some commercial bone cements allow to modify its viscosity, for example by heating. An example of such bone cement is called StabilitT®, whose main component is PMMA. The hardening time is less than 30 minutes, which allows the relative position of the vertebrae to be consolidated at the end of the operation, allowing splints and exoskeletons to be dispensed during the period of bone formation.
    The control of viscosity can allow the generation inside the disc of a bed promoting bone growth that serves as a support even in the event that the ring is damaged. In particular, higher viscosities allow controlled delivery and solidification before the composition leaves the disc space.
    The process of generating the composition object of the present invention comprises the addition of a calcium phosphate input, an O2 feed and, optionally, an osteogenic factor and a contrast agent, more preferably non-ionic.
    For example, to generate a composition according to the present invention, StabiliT® bone cement (PMMA) was used using a commercial activator mixture with 5% by weight of hydrogen peroxide, which was mixed with a mixture of StabiliT powders and 20% hydroxyapatite by weight. It was observed that the polymerization was not stopped by the presence of hydrogen peroxide. Once hardened, it was observed that, at a glance, a superior porosity of the hardened bone cement could be seen.
    The same test was performed by adding to the activator fluid bone growth factors obtained from blood and a contrast agent (Iopamir or similar) in amounts less than 5%. The polymerization was equally successful.
    5 Before the completion of the polymerization, the composition is introduced into the generated disc vacuum (see figure 14), checking that it does not leave the limited disc space and contained by the disc ring and wait a few minutes for its complete polymerization. The composition exits through the filling holes -17-, -18-, -17’-, -18’-.
    10 Likewise, it is convenient to proceed with the installation of a cover -920- that will grant access to the disc space by foreign elements.
    Once hardened, the composition introduced inside the disc -1000- generates a bed -30- with numerous pores -31- in which bone will grow from the damaged areas of the platforms of the 15 upper vertebrae -1001- e lower -1002-. The growth is enhanced by the presence inside the oxygen disc space, osteogenic growth factors and favored by the availability of calcium phosphate, preferably hydroxyapatite.
    The installation process may be different from that shown, and different percutaneous techniques and even non-percutaneous techniques may also be used. The order of operations is also subject to change.
    While the invention has been described with respect to examples of preferred embodiments, these should not be construed as limiting the invention, which will be defined by the broader interpretation of the following claims.
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    权利要求:
    Claims (28)
    [1]
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    1. Intervertebral stabilization screw comprising a main body with an axial through hole and a distal bone fixation thread, located at a distal end of the main body, a hollow proximal secondary body with sliding ability along the main body and a stop to the path of the proximal secondary body located on an outer surface of the main body, characterized in that the proximal secondary body also externally has a bone fixing thread and because between the distal thread and said stopper the main body has at least one hole filling for connection of an intervertebral space with the aforementioned axial hole.
    [2]
    2. Screw according to the preceding claim, characterized in that the outer diameter of the thread of the proximal secondary body is larger than the diameter of the distal thread.
    [3]
    3. Screw, according to any of the preceding claims, characterized in that said stop consists of a step that prevents the passage of the proximal secondary body to said filling.
    [4]
    4. Screw according to the preceding claim, characterized in that the step is formed by a variation of the outer diameter of the main body.
    [5]
    5. Screw according to any of the preceding claims, characterized in that it comprises at least two filling holes.
    [6]
    6. Screw, according to any of the preceding claims, characterized in that said orifice or filling holes have or present a radial path.
    [7]
    7. Screw, according to the preceding claim, characterized in that said orifice or filling holes have or have a diametral path, with two outlets connecting opposite points of the main body wall.
    [8]
    8. Screw, according to any of the preceding claims, characterized in that both the main body and the proximal secondary body have devices for receiving a percutaneous tool at its proximal end.
    [9]
    9. Screw, according to any of the preceding claims, characterized in that it comprises a proximal cover to close access to the axial hole once the screw is installed.
    [10]
    10. Composition for bone remodeling comprising a polymerizable bone cement and a calcium phosphate supplier, characterized in that it also comprises an O2 contributing compound.
    [11]
    11. Composition according to the preceding claim, characterized in that it further comprises an osteogenic factor.
    [12]
    12. Composition according to claim 10 or 11, characterized in that it further comprises a contrast agent.
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    [13]
    13. Composition according to any of claims 10 to 12, characterized in that the O2-contributing compound is one selected from the group consisting of: hydrogen peroxide, ozone and an oxygen solution.
    [14]
    14. Composition according to the preceding claim, characterized in that the O2 contributor is hydrogen peroxide.
    [15]
    15. Composition according to any one of claims 10 to 14, characterized in that the polymerizable bone cement comprises a polymer selected from the group consisting of polymethylmethacrylate (PMMA), bisphenol glycidyl methacrylate (bis-GMA) and poly (lactic acid-co -glycolic) (PLGA).
    [16]
    16. Composition according to the preceding claim, characterized in that the polymerizable bone cement comprises PMMA.
    [17]
    17. Composition according to any of claims 10 to 16, characterized in that the calcium phosphate supplier is hydroxyapatite, brushite or tricalcium phosphate.
    [18]
    18. Composition according to the preceding claim, characterized in that the calcium phosphate contributor is hydroxyapatite.
    [19]
    19. Composition according to any one of claims 10 to 18, characterized in that the osteogenic factor is one to be selected from: blood growth factors, whole blood or osteogenic stem cells.
    [20]
    20. Composition according to the preceding claim, characterized in that the osteogenic factor is a blood growth factor.
    [21]
    21. Composition according to any of claims 10 to 20, characterized in that the contrast factor is a non-ionic contrast factor.
    [22]
    22. Composition according to any of claims 10 to 21, characterized in that the polymerizable bone cement is present in an amount between 55% and 80% by weight of the composition.
    [23]
    23. Composition according to any of claims 10 to 22, characterized in that the calcium phosphate supplier is present between 15% and 30% by weight of the composition.
    [24]
    24. Composition according to any of claims 10 to 23, characterized in that the O2-contributing compound is present in an amount equal to or less than 5% by weight.
    [25]
    25. Composition according to any of claims 11 to 24, characterized in that the osteogenic factor is present in an amount less than 5% by weight.
    [26]
    26. Composition according to any of claims 12 to 25, characterized in that the contrast agent is present in an amount less than 1% by weight.
    [27]
    27. Intervertebral fusion device, characterized in that it comprises at least one vertebral stabilization screw according to any one of claims 1 to 9 and a composition according to any one of claims 10 to 26.
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    [28]
    28. Device according to the preceding claim, characterized in that it comprises at least two of said vertebral stabilization screws.
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    同族专利:
    公开号 | 公开日
    EP3508151A4|2020-08-05|
    WO2018083359A1|2018-05-11|
    MX2019004226A|2019-06-10|
    US20200008944A1|2020-01-09|
    CN109715094A|2019-05-03|
    ES2672265B1|2019-04-10|
    EP3508151A1|2019-07-10|
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    法律状态:
    2017-11-20| PC2A| Transfer of patent|Owner name: INSTITUTO BIOMECANICO DE BARCELONA, S.L. Effective date: 20171114 |
    2018-06-13| BA2A| Patent application published|Ref document number: 2672265 Country of ref document: ES Kind code of ref document: A1 Effective date: 20180613 |
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    优先权:
    申请号 | 申请日 | 专利标题
    ES201631413A|ES2672265B1|2016-11-07|2016-11-07|DEVICE FOR INTERVERTEBRAL FUSION COMPRISING AN INTERVERTEBRAL STABILIZATION SCREW AND A COMPOSITION FOR BONE REMODELING|ES201631413A| ES2672265B1|2016-11-07|2016-11-07|DEVICE FOR INTERVERTEBRAL FUSION COMPRISING AN INTERVERTEBRAL STABILIZATION SCREW AND A COMPOSITION FOR BONE REMODELING|
    US16/331,793| US20200008944A1|2016-11-07|2017-10-24|Intervertebral fusion device comprising an intervertebral stabilising screw and a composition for bone remodelling|
    MX2019004226A| MX2019004226A|2016-11-07|2017-10-24|Intervertebral fusion device comprising an intervertebral stabilising screw and a composition for bone remodelling.|
    CN201780057558.5A| CN109715094A|2016-11-07|2017-10-24|The inter vertebral fusing device of composition including interbody stabilizer screw and for bone remodeling|
    EP17866442.1A| EP3508151A4|2016-11-07|2017-10-24|Intervertebral fusion device comprising an intervertebral stabilising screw and a composition for bone remodelling|
    PCT/ES2017/070712| WO2018083359A1|2016-11-07|2017-10-24|Intervertebral fusion device comprising an intervertebral stabilising screw and a composition for bone remodelling|
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