• 专利附录
  • 专利说明
  • 权利要求
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    • 专利摘要:
    CRANIAL IMPLANT, PARTS SET AND METHOD OF CONNECTING AN IMPLANT. The present invention relates to an implant, such as a cranial implant (3), for connection to a defect (2) in a bone structure (1) showing an edge (4). The implant comprises an extension direction and a shoulder (5) extending substantially perpendicular to the direction of the implant extension. The flange is configured to be connected to the edge of the bone structure and comprises at least one mounting portion (6) configured to accommodate a fastener (7) such that at least a fastener portion (7B) is extendable in a direction that it moves away from the ridge at an angle (a), which is mainly acute with respect to the direction of extension of the implant. The implant is configured in such a way that, with the placement of the implant in the defect, the fastener is controllably extensible at the edge of the bone defect.
    公开号:BR112012006526B1
    申请号:R112012006526-2
    申请日:2010-09-21
    公开日:2020-10-13
    发明作者:Maikel Michael Adrianus Beerens；Paul Frans Jozef Laeven；Jules Maria Nikolaas Poukens
    申请人:Academisch Ziekenhuis Maastricht；Universiteit Maastricht；
    IPC主号:
    专利说明:

    [001] The present description refers to an implant such as a cranial implant, for connection on an edge of a defect in a bone structure, the implant comprising a direction of extension at or near the ridge that extends substantially perpendicular to the ridge where the rim is configured to be connected to the edge of the bone structure.
    [002] Such implants, which are sometimes referred to as patient-specific implants (PSI), are used to repair defects in bone structures resulting, for example, from surgery or trauma and / or birth defects. An implant partially or totally closes a defect, such as an opening in a skull, protects the underlying tissue, for example, brain tissue, and / or corrects and / or restores the outline of the bone structure. Such implants are generally made to order, preferably adhering to the ISO 13485 quality control standard for medical devices.
    [003] Implants can have different origins. For example, autogenous grafts are taken from one part of the body of a person or animal and implanted in another part of the same body and allografts are bone grafts taken from a person of one species and inserted into the body of another person of the same species. Alloplastic implants are implants made of material foreign to the body.
    [004] All implants have in common the fact that they have to be firmly attached to the bone structure. The migration and micro movements of the implant can prevent osteointegration (sometimes also referred to as osseointegration) and even result in the rejection of the implant. Fixation of the implant is usually done by suturing or screwing the implant into the bone structure through holes, which are provided in or through the implant and / or bone structure.
    [005] U.S. Patent 6,618,623 describes a ferrule for retaining an implantable device within a patient's cranial opening. The ferrule is inserted into the cranial opening and attached to the skull. Then, an implantable device is inserted into the ferrule and attached to it. The ferrule can comprise an intraosseous extension and is attached to the patient's skull with bone screws (self-tapping).
    [006] EP 2 014 258 of the present inventors refers to an implant, such as a cranial implant, which comprises a ridge and one or more fasteners for connecting the ridge to an edge of a defect in a bone structure. One side of the flange is wider than the other side of the flange and / or comprises one or more protuberances that extend beyond the one preferred on the other side of the flange, such that, with the placement of the implant in the defect, the flange and / or the protuberances rest on the edge of the defect. The fastener (s) is / are mounted or mountable (s) within or at least on the rim and comprise at least one element that is extendable in a direction away from the rim to grasp under the frame bone. The EP 2 014 258 implant fasteners are accommodated on staple supports or guides configured in such a way that a portion of the fastener is extendable in a direction away from the ridge at an angle that is at most acute with respect to the extension direction of the implant, in order to be extensible under the bone structure.
    [007] US Patent 6,197,030 describes surgically loaded retractable ear pins having a hollow ear adapted to receive an elastically loaded retractable ear that can be inserted into a bone fold or the walls of a skull cavity from which the bone flap has been removed when the retractable spike is compressed against elastic loading, and the bone flap is placed in position in the skull cavity. The retractable spikes can expand outward to the corresponding holes positioned in the skull or bone flap, holding it in place without the need to project wires or other conventional location devices. The pins do not need to be positioned parallel to each other, and can be spaced around the bone flap, preferably constituting the only means of attaching the bone flap to the skull cavity. However, such pin-like devices are delicate, relatively complex and therefore costly devices, in particular with respect to a screw. Such pin-like devices also do not allow removal of the bone flap, once implanted, for example, in the case of complications. With elastic loading, the pins cause compressive forces on the skull and / or bone flap that cannot be precisely determined and / or controlled, with micro movements of the pin and / or bone flap with respect to the skull being inherent.
    [008] Bone screws, tacks and the like are proven techniques, but they require intrusion into the bone structure and, once applied, exert compressive (lateral) forces on the bone structure, Compressive forces, in turn, can cause resorption of the bone. bone and the detachment of the fixation means. Micromovements due to the gap between different parts of the implant or the fixation medium or between the fixation medium and the bone structure and / or implant can increase damage and detachment and should be prevented. A balance must therefore be found between the minimum compressive forces and optimum fixation. In addition, the implant and its fixation form an invasive volume within the patient's body. Such volume should be minimal, in particular, for a cranial implant to prevent damage to the brain.
    [009] An objective of the present description is to provide an improved implant.
    [0010] For this purpose, the implant, according to the present description, is characterized by the fact that it is configured in such a way that, with the placement of the implant in the defect, the fastener is controllably extensible at the edge of the bone defect.
    [0011] In one aspect, at least one mounting portion is configured in such a way that, with the placement of the implant in a defect in a curved bone structure presenting a curvature at or near the edge, for example, a convex shape, the the extensible portion of the fastener is extensible in a direction that is substantially tangential to the curvature of the bone structure at or near the edge at or near the mounting portion. In this way, the direction of the fastener conforms to the anatomical shape of the bone structure.
    [0012] In another aspect, the implant has a curved shape, such as a convex shape, with a curvature at or near the edge and at least one mounting portion is configured in such a way that at least the extensible portion of the fastener is extensible in a direction that is substantially tangential to the shape of the implant at or near the rim.
    [0013] Advantageously, the rim of the implant has a first thickness in the position of at least one assembly portion and at least one assembly portion is configured in such a way that the extensible portion of the fastener is extensible from the re-edge to approximately the middle of the first thickness.
    [0014] The implant can be configured to be connected to a bone structure having at least a portion of an edge with a second thickness, where at least one assembly portion is configured in such a way that the extensible portion of the fastener is extensible from from the rim to approximately the middle of the second thickness. In this way, the fastener is extensible to the middle of the (anatomical) shape of the edge of the bone structure, perfecting the achievement of a substantially symmetrical distribution of any forces in relation to the fastener.
    [0015] At least a mounting portion may comprise a closed channel.
    [0016] Advantageously, one side of the lip may be wider than the other side of the lip and / or may comprise one or more protuberances that extend beyond the periphery of the other side of the lip, such that, with the placement of the implant in the defect, the flange and / or protuberances rest on the edge of the defect.
    [0017] The mounting portion can be configured to receive at least a portion of a guide for a cutter to cut a recess at the edge of the bone defect.
    [0018] In an additional aspect, the implant has a thickness, and the fastener and at least a mounting portion are configured to define at least a relative position of the fastener and at least a mounting portion, such that a portion of the fastener extends from the implant and a remaining portion of the fastener is accommodated within the thickness of the implant.
    [0019] At least one fastener can be movably connected to at least one mounting portion.
    [0020] Yet another aspect of the present description is a set of parts comprising an implant, as described here, and one or more fasteners, one or more guides to guide a cutter, one or more cutters and / or tools for operating a fastener.
    [0021] At least a mounting portion may have a first shape with the guide having a shape complementary to the first shape.
    [0022] The present implant allows the fixation of the implant in the defect with greater precision and safety. The implant additionally allows the fixation in such a way that the implant remains in position and also fixed, when the holding force between the fastener and the implant is reduced, for example, by the fastener that is loose inside the edge of the bone structure. The implant can be made to order preoperatively and fixed in place with mounting portions in predetermined positions in a relatively faster and safer way than prior art implants.
    [0023] In some embodiments, the fixation of the implant is reversible in such a way that the implant can be removable, in the case of complications, for example, bleeding.
    [0024] In another aspect, a method of connecting an implant to a defect in a bone structure is provided. The method comprises the steps of providing an implant for connection to an edge (4) of the defect, such as the implant, according to any of claims 1-8. The implant comprises a ridge and an extension direction at and near the ridge extending substantially perpendicular to the ridge. The method additionally comprises connecting the ridge to the edge of the bone structure with the extension of a fastener in a direction away from the ridge at an angle that is at most acute with respect to the direction of extension of the implant and to the edge of the bone defect .
    [0025] The implant can advantageously be prepared preoperatively, for example, based on computed tomography data (of the form) of at least a portion of the defect.
    [0026] For an accelerated treatment and / or reduction of the chances of complications, a first form of at least a portion of the defect can be determined, for example, through one or more X-ray images or computed tomography, and at least a portion of the implant can be formed with a second shape that is substantially complementary to the first shape.
    [0027] The implant and / or the bone structure can be curved, presenting a curvature at or near the edge or the rim, respectively, for example, a convex shape. Then, the fastener can be extended in a direction that is substantially tangential to said curvature of the bone structure and / or the implant, respectively.
    [0028] The implant can be provided with an assembly portion configured to accommodate a fastener, such that at least one fastener potion is extensible in a direction that moves away from the rim at an angle that is at most acute with respect to the direction of implant extension and to the edge of the bone defect. Then, a guide can be provided for a cutter to cut a recess at the edge of the defect, arranging at least a portion of the guide in at least one assembly portion, and cutting, guided by the guide, a recess to accommodate at least a portion of the fastener at the edge of the defect.
    [0029] The description will now be explained in greater detail with reference to the figures, which show an embodiment and details of the present implant by way of example.
    [0030] Figures 1-4 are seen in schematic partial cross section that indicate an embodiment of an implant in a portion of a skull and a method of connecting the implant to the skull.
    [0031] Figure 5 is a schematic side view of a skull that comprises an implant fixed in a skull defect.
    [0032] It is noted that the drawings are not necessarily represented in scale and that details that are not necessary for the understanding of the present description may have been omitted. The terms "up", "down", "below", "above", and the like refer to embodiments as directed in the drawings. In addition, elements that are at least substantially identical or that perform at least a substantially identical function are indicated by the same numeral.
    [0033] Figures 1-5 schematically show a portion of a bone structure, here, a human skull 1, presenting a defect 2 resulting from surgery or trauma, whose defect 2 is closed by means of a first embodiment of a cranial implant 3 according to the present description. The skull 1 and the implant 3 are generally convex, being curved along two substantially perpendicular directions of extension E. Preferably, the shape and the directions of extension E of the bone structure 1 and the implant 2 are such that a structure is formed substantially to be continued. Such an implant allows the reconstruction of the anatomical shape of the intact bone structure. Some other examples of curved bone structures that can be provided with a curved implant are a rib, a shoulder blade, a pelvis. Defect 2 has a border 4 that surrounds defect 2. In the cross-sectional view of figures 1-4, border 4 is rounded indicating that the outer and inner blades cover the diploe and, therefore, that the bone surface can be treated , typically for two to six months. The edge 4 has a thickness T in a direction substantially perpendicular to the extension E of the bone structure (see figure 2), as here in a direction substantially radial to the convex bone structure of the skull. The implant can be formed from a metal, for example, medical grade titanium. Alternative materials include, but are not limited to polymers, for example, polymethyl methacrylate (PMMA), polyetheretherketone (PEEK), or polyetherketonacetone (PEKK), and ceramic materials, for example, zirconium oxide or aluminum oxide. A non-metallic implant 3 tends to remain closer to the patient's local body temperature than a metallic implant 3, improving comfort and reducing complications. The implant 3 and the rim 5 of the implant 3 can be strictly matched in a desired shape and / or to the shape of the edge 4 of the defect 2 by means of CT scans and 3D models, in a way known per se, in such a way that a preoperatively manufactured implant can be employed.
    [0034] The implant 3 has a rim 5 that extends along the implant 3, the extension directions E of the implant 3 and can be defined substantially perpendicular to the rim 5 and following the common curvature of the implant in a convex shape 3. The rim 5 it has a thickness t in a direction substantially perpendicular to the E extension of the implant (see figure 2), for example, in a substantially radial direction in the case of a convex implant, such as for a skull. The implant 3 is generally tapered in cross-sectional view with a flared flange outward, i.e., side 5A of flange 5 of the implant 3 facing outward, i.e., the side that is at least substantially flush with the " the outer blade "of the skull 1, is wider than the side 5b of the inwardly facing edge, the edge of which 5B is at least substantially flush with the" inner blade ". With the placement of implant 3 in defect 2 in skull 1, the lateral portion facing out of ridge 5A rests on edge 4 of defect 2 and, in view of the narrow adjustment of ridge 5 and edge 4, only a degree of freedom it remains, that is, in a direction opposite to the direction of implant placement 3. In order to fix the implant 3 in this remaining direction, the shown embodiment of the present implant 3 comprises, along being edge 5, a plurality, for example, three portions mounting brackets 6 configured to accommodate a fastener 7. The implant in figure 5 comprises eight mounting portions 6, arranged along the edge 5 with various separations and mutual directions for optimal fixation of the implant 3 with minimal impact from the skull 1. The fastener 7 shown in figures 1-4 is a screw, but any suitable fastener, such as a pin, pin, etc., can be provided. The fastener may comprise or be of the same material as the implant or a different material.
    [0035] The mounting portion shown 6 comprises a first channel portion 8 and a second channel portion 9. The first channel portion 8 extends through the implant material 3 along an axis A and, in the embodiment shown, it is enclosed by the material of implant 3 perpendicular to axis A. The second portion of channel 9 also extends substantially along axis A, is substantially concentric with channel 8, as seen along axis A, and is partially closed by material of implant 3, here, in a direction perpendicular to axis A. A portion of fastener 7 is accessible from the outside of implant 3 (figures 4, 5). The A axis extends in a direction that intersects the edge 5, generally, but not necessarily, intersecting the edge 5 perpendicularly (for example, see figure 5), and being oriented with respect to the implant extension directions 3, in such a way that the A axis extends at an angle α that is at most acute with respect to the surface and the extension directions E of the implant 3 at or near the intersection of the A axis with the rim 5. The A axis extends at an angle that it is at most obtuse with respect to normal to implant 3 or at or near the intersection of axis A with the rim 5. The determination of angle α is shown in figure 3 for explanatory purposes only; in the embodiments shown, said direction of extension of axis A is substantially tangential to the curvatures of both the implant 3 and the skull 1 at the position of the interface between the rim 5 and the edge 4, such that the angle α for the embodiments shown is in fact substantially zero degrees.
    [0036] The mounting portion 6 is configured in such a way that a portion 7A of the fastener 7 is extendable through the channel 8 of the rim 5 of the implant 3 in a direction along the axis A. For example, the mounting portion 6 may have a shape complementary to the shape of the fastener 7, such as a screw thread, or have an internal diameter larger than an external diameter of the fastener 7.
    [0037] The mounting portion 6 shown in figures 1-4 is additionally configured such that the fastener 7 is movably disposed on the rim 5 and a portion 7A is extendable through the mounting portion 6 through the rim 5 in one direction out. The extendable portion 7A of the fastener 7 is extendable from the edge 5 to approximately the middle of the thickness t of the edge 5 and to approximately the middle of the thickness T of the edge 4, such that the portion 7A of the fastener 7 is substantially arranged symmetrically with respect to side 5A of the flange facing outward and to side 5B of the flange facing inward and similarly symmetrically with respect to the sides of the edge 4 facing outward and inward, respectively. In this way, the fastener 7, the (edge 5 of) the implant 3 and the (edge 4 of) the bone structure 1 are arranged in such a way that forces between them are exerted substantially in a symmetrical manner, preventing localized efforts that could lead to damage and / or complications.
    [0038] Figure 1 additionally shows a portion of a cutter 10, here, a drill 10, and an optional guide 11 to guide an operating direction for cutter 10.
    [0039] Figures 2-4 show the connection of implant 3 to skull 1. After optional enough regeneration of bone material at edge 4 of defect 2 in skull 1, an implant is manufactured to fit at least in a portion of the defect 2. The implant 3 can be provided preoperatively and can be manufactured with one or more mounting portions 6 in the predetermined positions on the implant 3. It is also possible, although uncomfortable, to provide the mounting portions 6 during the surgical procedure for implantation of the implant. implant 3, for example, using a dedicated drill.
    [0040] Then, implant 3 is placed in defect 2 (figure 2). In the case shown, implant 3 comprises a generally tapered shape in a cross-sectional view and the rim 5 of implant 3 can rest against edge 4 of skull 1. This provides a well-defined relative position between implant 3 and the skull 1.
    [0041] Figure 2 additionally shows the guide 11 for the cutter 10 which is arranged in the mounting portion 6 to guide the cutter 10 in a desired direction, for example, along the direction of axis A, and to prevent damage to the material from implant 3 and / or the mounting portion 6. Contamination of the defect site 2 from dust and / or material debris from implant 3 can thus be prevented. To further reduce the chances of contamination of the defect 2 site, the guide 11 can be configured to remove debris, for example, comprising one or more channels and being at least connected or connectable to a debris removal device, such as a debris device. suction. The mounting portion 6 and the guide 11 may have complementary shapes, for example, one or more flat faces and / or ridges, such that the relative positions of the mounting portion 6 and the guide 11 and the direction of operation of the cutter 10 can be precisely defined.
    [0042] Figure 3 shows the cut of a recess 12, here, the drilling of a hole 12, at the edge 4 of the skull 1 with the cutter 10 through the guide 11. The extension direction of the hole 12 is substantially tangential to the curvature skull 1, defined by the patients' anatomy, in such a way that the hole extends into the bone. In this way, the predetermined position and direction of the mounting portion 6 are transferred to the bone structure 1. In some cases, an optimal position of the fastener 7 within the bone structure 1 can be achieved with the fastener 7 extending tangentially to a curvature of the bone structure that is at a distance, for example, approximately 1-5 cm, away from the defect. When planning surgery for implementation, such a direction can be precisely determined. The associated mounting portion 6 of the implant 1 can be formed accordingly, so that a fastener 7 inserted through that mounting portion 6 will be positioned in the desired manner and position, determined by the mounting portion 6.
    [0043] Then, as shown in figure 4, the cutter 10 and the guide 11 are removed from the skull 1 and the mounting portion 6, and the fastener 7 is disposed within the mounting portion 6 and in the hole 12 to fix the implant 3 in skull 1.
    [0044] The fastener 7 comprises a coupling portion 7B for coupling to a tool, for example, a transverse slot or a hexagonal feature, to temporarily couple the fastener with a driver, such as a surgical screwdriver. The fastener 7 is extended at the edge 4 of the skull 1 by a desired distance. The length of the fastener 7 can be predetermined by the fastener 7 comprising a portion that cooperates with a feature of the mounting portion 6. In the embodiment shown, the coupling portion 7A supports the interface between the first and second channel portions 8, 9. At least in this position, as shown in figure 4, a portion 7A of the fastener 7 extends from the implant to the edge 4 of the skull 1 to secure the implant to the bone structure, and the mounting portion of the fastener 7 is accommodated within the thickness of the implant 3, in such a way that it does not protrude from implant 3 and, therefore, from the common contour of the reconstructed bone part, here, the combination of skull 1 and implant 3. In this way, the chances of fastener 7 to damage the surrounding tissue they are minimized and a shallow implant 3, for example, an implant 3 substantially only covered by a thin layer of skin tissue, such as a skull, is relatively imperceptible.
    [0045] The mounting portion need not comprise a first channel portion 8 and a second channel portion 9, but may be substantially formed as an open channel, possibly having a jagged or constant size, such as an internal diameter. A closed channel 8, however, improves the strength and accuracy of the mounting portion 6 as well as the position and direction of the fastener 7 with respect to the mounting portion 6 and, therefore, the (edge 5 of) implant 3 and the edge 4 of bone structure 1.
    [0046] In a tangential orientation of the fastener 7 with respect to implant 3 and / or bone structure 1, there is little or no risk of fully penetrating through the bone and / or damaging the underlying tissue while cutting hole 12 or, for example , of the meninges or brain tissue, which is known to be happening when a fastener is screwed in or a hole substantially perpendicular to the bone is cut to secure a prior art implant with screw or suture techniques. In addition, hole 12 may have an extension within the material of bone structure 1 and / or implant 3, which is significantly longer than the thickness of bone structure 1 / implant 3, which is a limiting factor for the length of the fastener 7 in case of perpendicular fixation. This allows you to increase the retention of the fastener 7 and reduce the chances of the fastener 7 becoming loose. Implant 3 can therefore be used with bone structures with relatively little resistance to the torque of bone material at or near the location of the fastener, for example, relatively delicate bone structures or bone structures with relatively new defect edges that are not (yet) covered with cortical bone. In this way, the applicability of the implant is improved.
    [0047] Furthermore, since the extension direction of the fastener 7 is different from the direction of detachment of the implant 3 from the skull 1, such as a direction opposite to the implantation direction of the implant 3, the implant 3 remains fixed to skull 1 as well, when one or more fasteners 7 could inadvertently come loose or break from skull 1. This is, in particular, the case where the various mounting portions 6 and fasteners 7 are employed, extending in mutually directions different, for example, several fasteners extending in a substantially radial or star-shaped pattern with respect to the implant 3.
    [0048] An implant, according to the present description, can strictly match the shape (the edge) of the defect and the force directions exerted on or by the implant with respect to the bone structure may be close to an intact bone structure or be substantially identical to an intact bone structure.
    [0049] The implant 3 can comprise one or more markings 13 (see figure 5) associated with one or more portions of the implant 3, for example, mounting portions 6, etc., which can serve as a reference point and / or to provide information regarding implant 3, bone structure 1, etc. The markings can correspond to the pre-operatively identified positions and / or restrictions to be considered during the implantation operation. For example, a marking 13 may indicate an orientation of the implant in defect 2. A marking 13 associated with a mounting portion 6 may indicate one or more dimensions of a fastener 7 to be used with the mounting portion 6, such as the type , the length, size and / or diameter of fastener 7, and / or a force or torque with which fastener 7 is to be attached. Other information may refer to the use of glue or cement, etc. A mark 13 may comprise one or more alphanumeric characters or other symbols and may differ or be the same for each mark 13. A mark 13 may comprise the information itself and / or refer to a remote source of information, such as a look-up table which may have been prepared in conjunction with the implant surgery design and / or planning. One or more markings 13 can be substantially permanent, for example, marked with permanent ink, inlaid, stamped and / or embossed on the implant, and / or be transitory, for example, marked with removable or resorbable ink or with detachable objects, such as adhesives. A closed channel of a mounting portion 6 can be blocked with an object to be removed during surgery to prevent dirt, damage and / or obstruction of the channel. Such an object can carry a mark, for example, being color coded.
    [0050] The time to fix a preoperatively prepared implant according to the present description with one or more fasteners, including cutting one or more recesses, can be significantly less than the prior art fixation methods, in particular compared to methods including casting or shaping an implant during surgery. The time and costs invested in the pre-operative determination of desired fixing positions and, therefore, the position and direction of one or more mounting portions are recovered for the reduced operating time. The patient's recovery time and changes in complications can also be reduced.
    [0051] The implant can be provided in a set together with one or more fasteners, guides to guide a cutter and / or tool, such as cutters, drills and tools to operate a fastener. A manual and / or consultation table corresponding to any markings can also be provided
    [0052] The description is not restricted to the above described embodiments, which can be varied in various ways within the scope of the claims, for example, the mounting portion 6 does not need to be rotationally symmetrical, the recess 12 does not need to be a drilled hole and the fastener does not have to be an object similar to an elongated rounded pin, such as a pin or screw. It is conceivable that the mounting portion and / or the recess is in the form of a slit, having a relatively larger size in one direction and a relatively smaller size in another direction perpendicular to an extension direction, for example, the direction of penetration into the structure bone of the recess. Such a mounting portion and / or recess can be configured to accommodate a blade fastener.
    [0053] It should be noted that (use of) the guide 11 is optional and that a recess 12 can be cut through (the mounting portion 6 of) implant 3, taking care not to damage implant 3. A recess 12 can even be cut directly at the edge 4 of the bone structure 1 with or without any additional guide object. Alternatively, implant 3 can be fixed with self-tapping bone screws, preventing the cut of a recess 12, with or without the use of a guide 11, before fixing the implant 3.
    [0054] An implant 3 can be provided as an integrated assembly with one or more fasteners 7 movably connected to the mounting portions 6, such that the fasteners 7 are extensible. In particular, when the fasteners are self-tapping bone screws or similar devices, such an integrated assembly may facilitate a surgical procedure, for example, in preventing the fall or loss of a fastener.
    [0055] Elements and aspects discussed for or in relation to a specific embodiment can be appropriately combined with elements and aspects of other embodiments, unless explicitly stated otherwise.
    权利要求:
    Claims (12)
    [0001]
    1. Implant, such as a cranial implant (3), for connection to an edge (4) of a defect (2) in a bone structure (1), the implant comprising a central portion and a peripheral ridge (5) and the implant extending in an extension direction at or near the ridge (5) perpendicular to the ridge, where the ridge (5) is configured to be connected to the edge of the bone structure and comprises at least a mounting portion (6), where the mounting portion (6) comprises a channel (8) that extends along an axis (A) that intersects the rim and is configured to accommodate a fastener (7) such that at least a portion (7A) of the fastener be extensible along the axis (A) through the channel (8) through the ridge in a direction that departs from the ridge at an angle (a) that is at most acute with respect to the direction of extension of the central portion of the implant, characterized by the fact that the implant is configured in such a way that, with the implant placed in the defect, the implant covers the defect and the fastener are arranged in the channel movably in relation to the channel and extendable along the channel to the edge of the bone defect in a controllable manner.
    [0002]
    2. Implant (3), according to claim 1, characterized by the fact that the implant has a curved shape, such as a convex shape, with a curvature at or near the edge (5) and at least a portion of The assembly (6) is configured in such a way that at least the extensible portion (7A) of the fastener (7) is extensible in a direction that is tangential to the curvature of the implant at or near the rim.
    [0003]
    3. Implant (3) according to any of the preceding claims, characterized by the fact that the rim (5) of the implant has a first thickness (t) in the position of at least one mounting portion (6) and in which the at least one mounting portion is configured such that the extendable portion (7A) of the fastener (7) is extendable from the flange in the middle of the first thickness.
    [0004]
    4. Implant (3) according to any one of the preceding claims, characterized in that the at least one mounting portion (6) comprises a closed channel (8).
    [0005]
    5. Implant (3) according to claim 4, characterized by the fact that at least one closed channel (8) of an assembly portion (6) is obstructed with an object to be removed during the surgery to prevent dirt, damage and / or obstruction of the channel.
    [0006]
    6. Implant (3), according to any of the preceding claims, characterized by the fact that it comprises one or more markings (13) associated with one or more portions of the implant (3).
    [0007]
    7. Implant (3) according to any one of the preceding claims, characterized in that one side (5A) of the rim (5) is wider than the other side (5B) of the rim, and / or comprises a or more protuberances extending beyond the periphery on the other side (5B) of the ridge in such a way that, with the placement of the implant in the defect (2), the ridge and / or the protuberances rest on the edge (4) of the defect.
    [0008]
    8. Implant (3) according to any one of the preceding claims, characterized by the fact that it comprises at least one fastener (7) movably connected to at least one mounting portion (6).
    [0009]
    9. Set of parts characterized by the fact that it comprises an implant (3), as defined in any one of claims 1 to 8, and at least one or more fasteners (7), guides (11) to guide a cutter (10) , cutters (10) and tools for operating a fastener.
    [0010]
    10. Set of parts according to claim 9, characterized in that it comprises at least one implant (3), as defined in any one of claims 1 to 8 and a guide (11) to guide a cutter (10) , wherein at least a mounting portion (6) is configured to receive at least a portion of a guide (11) for a cutter (10) to cut a recess (12) at the edge (4) of the defect (2).
    [0011]
    11. Set of parts according to claim 10, characterized in that the at least one assembly portion (6) has a first shape and the guide (11) has a shape complementary to the first shape.
    [0012]
    12. Set of parts according to any one of claims 9 to 11, characterized in that it comprises an implant (3), as defined in any one of claims 1 to 8, and at least one fastener (7), in that the implant has a thickness and in which the fastener (7) and at least a mounting portion (6) are configured to define at least a relative position of the fastener and at least a mounting portion in such a way that a portion ( 7A) of the fastener extends from the implant to extend the edge (4) of the defect (2) and the remaining portion (7B) of the fastener is accommodated within the thickness of the implant.
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    法律状态:
    2019-01-08| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|
    2019-07-09| B06T| Formal requirements before examination [chapter 6.20 patent gazette]|
    2019-12-31| B07A| Technical examination (opinion): publication of technical examination (opinion) [chapter 7.1 patent gazette]|
    2020-05-19| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
    2020-10-13| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 10 (DEZ) ANOS CONTADOS A PARTIR DE 13/10/2020, OBSERVADAS AS CONDICOES LEGAIS. |
    2021-06-22| B16C| Correction of notification of the grant|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 21/09/2010, OBSERVADAS AS CONDICOES LEGAIS. PATENTE CONCEDIDA CONFORME ADI 5.529/DF, QUE DETERMINA A ALTERACAO DO PRAZO DE CONCESSAO |
    优先权:
    申请号 | 申请日 | 专利标题
    EP09171189|2009-09-24|
    EP09171189.5|2009-09-24|
    PCT/EP2010/063887|WO2011036148A1|2009-09-24|2010-09-21|Cranial implant|
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