A composite cranial repair organism based on a 3D framework structure

Abstract

This invention discloses a composite cranial repair bioprobe based on a 3D frame structure, comprising a 3D frame and biological patch units. The 3D frame includes an edge retention device and an internal main frame, each with a support platform. Each support platform houses the biological patch unit, which comprises a porous layer, a biomimetic layer, and a reinforcing layer arranged sequentially from the outside in. The porous layer has a porous structure with pores, the biomimetic layer is a biomimetic structure mimicking the trabeculae of the skull, and the reinforcing layer is a solid structure. The 3D frame portion of the composite cranial repair bioprobe provided by this invention sufficiently ensures the mechanical strength of the repair. The design of individual biological patch units, while meeting certain mechanical strength requirements, also ensures the integration of soft tissue and the ingrowth of host bone, guaranteeing the long-term stability of the repair.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a composite cranial repair organism based on a 3D frame structure. Background Technology

[0002] The intact skull structure is of vital importance to the human body, serving purposes such as stabilizing intracranial pressure and effectively protecting brain tissue. However, when patients undergo decompressive craniectomy due to brain injury or intracranial disease, skull defects are created. Skull defects leave the brain tissue without its protective barrier, making it vulnerable to injury and causing varying degrees of clinical symptoms, resulting in both physiological and psychological impacts. Therefore, the repair of skull defects is crucial, and the selection of the appropriate prosthesis is a key factor in its success, making it a hot research topic in the fields of medicine and materials science.

[0003] Currently, materials used for skull defect repair mainly include natural biomaterials and synthetic materials. Natural biomaterials are divided into autologous bone and allogeneic bone. Autologous bone has limited availability and is difficult to use for large bone defects, while allogeneic bone has high rates of infection, absorption, and rejection; therefore, both materials have been gradually phased out. Currently, commonly used synthetic materials for skull defect repair are titanium alloy mesh and polyetheretherketone (PEEK) patches, but these materials can only provide partial functional replacement. Titanium alloy mesh, with its high biocompatibility, high mechanical properties, low infection rate, and low cost, has a serious clinical complication: soft tissue instability leading to implant exposure. PEEK patches have good biocompatibility, sufficient mechanical properties, are lightweight and non-conductive, and can be penetrated by X-rays; however, postoperative subcutaneous soft tissue effusion remains a concern for many surgeons.

[0004] The clinical requirements and challenges for cranial defect repair devices are twofold. On the one hand, the materials need to have good biocompatibility and sufficient mechanical properties. On the other hand, as long-term bone repair implants, it is necessary to consider whether they can be stably integrated with soft tissues in the long term and whether they are conducive to the ingrowth of host bone.

[0005] The technologies proposed so far have not yet fully met both of the above requirements simultaneously.

[0006] Therefore, it is necessary to provide a new cranial prosthesis. Summary of the Invention

[0007] In view of this, the purpose of this invention is to provide a composite cranial repair bio-organism based on a 3D framework structure. The composite cranial repair bio-organism provided by this invention is composed of a 3D framework and biological patch units. The 3D framework fully ensures the mechanical strength of the repair, and each biological patch unit is designed as a solid and porous structure, which not only meets certain mechanical strength requirements but also ensures the integration of soft tissue and the ingrowth of host bone, thus providing a guarantee for the long-term stability of the repair.

[0008] To achieve the above objectives, the technical solution of the present invention is as follows:

[0009] A composite cranial repair bio-organism based on a 3D framework structure includes a 3D framework and biological patch units.

[0010] The 3D frame is obtained by 3D printing and its material includes at least one of titanium, titanium alloy, tantalum, tantalum alloy, zinc, zinc alloy, and polyetheretherketone. The 3D frame includes an edge retention device and an internal main frame, and each main frame is provided with a support platform. Each support platform is equipped with the biological patch unit. The edge retention device fits perfectly around the perimeter of the defect on the skull to be repaired.

[0011] Each of the support platforms is equipped with a biological patch unit, which includes a porous layer, a biomimetic layer, and a reinforcing layer arranged sequentially from the outside to the inside; the porous layer is a porous structure with pores, the biomimetic layer is a biomimetic structure that mimics the trabeculae of the skull, and the reinforcing layer is a solid structure.

[0012] Furthermore, the combination of the 3D frame and the biological patch includes a suture-type and / or an inlay-type combination. The suture-type combination refers to the 3D frame having multiple first suture channels on its support platform, and the biological patch unit having multiple second suture channels corresponding to the first suture channels. The first suture channels are connected to the corresponding second suture channels by sutures to achieve the suture-type combination of the 3D frame and the biological patch. The inlay-type combination refers to the biological patch being placed directly on the support platform of the 3D frame, and then covered and fixed by another 3D fixation frame on top of the biological patch.

[0013] Furthermore, the 3D framework and biological patch unit may take the form of structures including but not limited to regular hexagons, equilateral triangles, regular quadrilaterals, and Thiessen polygons.

[0014] Furthermore, the outer porous structure of the biological patch unit is mainly to ensure long-term stable integration between soft tissue and implant. Its pore size is 200-800μm, and the structure includes, but is not limited to, porous structures with extremely small curved surfaces and honeycomb structures.

[0015] Furthermore, the biomimetic structure of the middle layer of the biological patch unit mainly ensures the adhesion and growth of bone cells, with a porosity of 60%-80% and a structure that mimics the trabecular structure of the skull.

[0016] Furthermore, the lower reinforcing layer structure of the biological patch unit is mainly to ensure that a single biological patch has sufficient mechanical strength, with a thickness of 2mm-4mm. In terms of structural design, reinforcing ribs can be set to further increase the mechanical strength.

[0017] Furthermore, the porous layer, the biomimetic layer, and the reinforcing layer are all made of at least one of hydroxyapatite, tricalcium phosphate, natural dentin, bioactive glass, or bioactive microcrystalline glass.

[0018] Furthermore, the fixing of the edge retaining device includes edge band retaining and / or handle retaining methods.

[0019] When the edge band fixation method is used, the edge fixation device includes an edge frame and a fixing pin. The edge frame has multiple edge band fixation channels that extend laterally through the edge frame. The fixing pin is connected and fixed to the skull to be repaired through the edge band fixation channels.

[0020] When the handle is fixed, the edge fixation device includes an edge frame and a fixing pin. Multiple handles are connected to the edge frame at intervals. Each handle is provided with a handle fixation channel. The fixing pin is connected and fixed to the skull to be repaired through the handle fixation channel.

[0021] The beneficial effects of this invention include at least the following:

[0022] (1) The overall structure of the prosthesis adopts a combination of 3D framework and biological patch unit; both the 3D framework and biological patch unit have good biocompatibility, which fully ensures the mechanical strength of the prosthesis while also taking into account the design of a porous structure that is conducive to soft tissue integration and host bone ingrowth.

[0023] (2) The design of a single biological patch unit is a solid plus porous structure, which ensures the integration of soft tissue and the ingrowth of host bone while meeting certain mechanical strength requirements, thus providing a guarantee for the long-term stability of the prosthesis; the porous structure of the porous layer ensures the ingrowth of soft tissue, while guiding tissue fluid through the pores to infiltrate the middle layer, i.e., the biomimetic layer, to avoid the occurrence of subcutaneous fluid accumulation; the biomimetic layer design is a biomimetic structure that mimics the trabecular bone of the skull, so as to better promote the ingrowth of host bone and ensure the long-term stability of the prosthesis; the reinforcing layer design adopts a completely solid structure design, i.e., solid structure design, to ensure the mechanical strength of a single biological patch unit during the use of the prosthesis;

[0024] (3) The edge frame can fit perfectly with the surrounding residual bone, so that the entire edge frame fits perfectly with the skull defect. The edge frame is provided with multiple holes for screw fixation, which can make it firmly connected to the skull defect. Attached Figure Description

[0025] Figure 1 This is a schematic diagram of the structure during installation of the present invention.

[0026] Figure 2 This is a structural breakdown diagram of the present invention.

[0027] Figure 3 This is a schematic diagram of the front view structure of the biological patch unit in this invention.

[0028] Figure 4 This is a schematic cross-sectional view of the biological patch unit in this invention.

[0029] Figure 5 This is a schematic diagram of the 3D framework and biological patch stitching combination in this invention.

[0030] Figure 6 This is a schematic diagram of the 3D framework and biological patch inlay combination in this invention.

[0031] Figure 7 These are schematic diagrams of other regular hexagonal, equilateral triangle, and regular quadrilateral structures that can be presented by the 3D frame in this invention.

[0032] Figure 8 This is a schematic diagram of the edge band fixation method in this invention.

[0033] Figure 9 This is a schematic diagram of the handle fixing method in this invention.

[0034] In the picture,

[0035] 1. 3D frame; 11. Main frame; 12. Edge frame; 13. Support platform; 14. First suture channel; 15. Edge band retention channel; 16. Handle retention channel; 17. Handle;

[0036] 2. Biological patch unit; 21. Porous layer; 22. Bionic layer; 23. Reinforcing layer; 24. Second suture channel;

[0037] 3. Sutures; 4. Skull; 5. 3D fixation frame. Detailed Implementation

[0038] The technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of the present invention.

[0039] Furthermore, the technical solutions of the various embodiments of the present invention can be combined with each other, but only if they are based on the ability of those skilled in the art to implement them. When the combination of technical solutions is contradictory or cannot be implemented, it should be considered that such combination of technical solutions does not exist and is not within the scope of protection claimed by the present invention.

[0040] The following specific embodiments illustrate the solution proposed in this invention:

[0041] Example 1

[0042] refer to Figures 1 to 9 As shown, this embodiment provides a composite cranial repair bio-organism based on a 3D frame structure, including a 3D frame 1 and a biological patch unit 2.

[0043] The 3D frame 1 is obtained by 3D printing, and its material includes any one of titanium and titanium alloy, tantalum and tantalum alloy, zinc and zinc alloy, and polyetheretherketone. The 3D frame 1 includes an edge retention device and an internal main frame 11. Multiple main frames 11 are connected in sequence to form a large mesh-like internal frame. Each main frame 11 has multiple support platforms 13 for placing the biological patch unit 2. The edge frame 12 can be selected to have edge retention channels 15 depending on the retention method. Figure 8 Alternatively, a handle retaining channel 16 can be provided. Figure 9 The structure of the edge frame 12 is connected and fixed to the skull 4 to be repaired, and the edge frame 12 is completely fitted to the periphery of the defect on the skull 4 to be repaired.

[0044] Each of the support platforms 13 is equipped with a biological patch unit 2. The biological patch unit 2 includes a porous layer 21, a biomimetic layer 22, and a reinforcing layer 23 arranged sequentially from the outside to the inside. The porous layer 21 is a porous structure with pores, the biomimetic layer 22 is a biomimetic structure that mimics the trabeculae of the skull, and the reinforcing layer 23 is a solid structure.

[0045] In this embodiment, the 3D frame 1 is printed using materials such as titanium and titanium alloy, tantalum and tantalum alloy, zinc and zinc alloy, or polyetheretherketone, which has good biocompatibility and sufficient mechanical properties; the edge frame 12 can fit completely with the surrounding residual bone, so that the entire edge frame 12 fits perfectly with the skull defect.

[0046] Understandably, aside from varying curvatures depending on the specific location of the skull, the design of each individual biological patch unit 2 is completely identical, specifically as follows: Figure 3 and 4 As shown in this embodiment, a single biological patch unit 2 is designed as a solid plus porous structure. The materials of the porous layer, the biomimetic layer and the reinforcing layer include any one or more of hydroxyapatite, tricalcium phosphate, natural dentin, bioactive glass or bioactive microcrystalline glass. It has good biocompatibility and certain mechanical properties. Its composition can be a single material or a composite of multiple materials, which can be selected according to the needs.

[0047] The design of the biological patch unit 2 satisfies certain mechanical strength requirements while ensuring soft tissue integration and host bone ingrowth, thus guaranteeing the long-term stability of the prosthesis. The porous structure of the porous layer 21 facilitates soft tissue ingrowth and guides tissue fluid through the pores to infiltrate the intermediate layer, i.e., the biomimetic layer 22, preventing subcutaneous fluid accumulation. The outer porous layer 21 primarily ensures long-term stable integration between the soft tissue and the implant; its pore size is 200-800 μm, and its structure includes, but is not limited to, extremely curved surfaces and honeycomb structures. The biomimetic layer... The design 22 is a porous structure that mimics the trabeculae of the skull to better promote the ingrowth of host bone and ensure the long-term stability of the prosthesis. The middle biomimetic layer 22 of the biological patch unit mainly ensures the adhesion and growth of bone cells, with a porosity of 60%-80%. The reinforcing layer 23 adopts a completely solid structure to ensure the mechanical strength of a single biological patch unit 2 during the use of the prosthesis. The thickness is 2mm-4mm. Preferably, reinforcing ribs can also be set on the reinforcing layer 23 to further increase the mechanical strength of the entire biological patch unit 2.

[0048] Continue to refer to Figure 5 and Figure 6 As shown, the 3D framework and the biological patch are combined in a suture-like and / or inlay-like manner;

[0049] In the suture type, the support platform 13 has multiple first suture channels 14, and the biological patch unit 2 has multiple second suture channels 24 corresponding to the first suture channels 14. The first suture channels 14 and the corresponding second suture channels 24 are connected by sutures 3 to realize the suture type combination of the 3D frame and the biological patch. The setting of the first suture channels 14 and the second suture channels 24 can better fix the biological patch unit 2 to the main frame 11. The second suture channels 24 also have the function of drainage holes, which facilitates the flow of tissue fluid and the exchange of substances in the repair body.

[0050] exist Figure 5In the illustrated embodiment, each support platform 13 has 4-8 first suture channels 14, and each biological patch unit 2 has 4-8 corresponding second suture channels 24. It can be understood that the second suture channels 24 are arranged through the biological patch unit 2 and are evenly distributed at the edge of the biological patch unit 2. The number can be adjusted according to the different shapes and sizes of the biological patch units 2, and no specific limitation is made here.

[0051] exist Figure 6 In the embodiment shown, the combination of the 3D frame 1 and the biological patch unit 2 can also be in an embedded manner. In this case, the biological patch unit 2 is placed directly on the 3D frame 1, and then a 3D fixation frame 5 is placed on top for fixation.

[0052] Continue to refer to Figure 7 As shown, in this embodiment, the main frame 11 can be in the form of a regular hexagon, equilateral triangle, regular quadrilateral, or Thiessen polygon structure, and the corresponding biological patch unit 2 is also in the form of a regular hexagon, equilateral triangle, regular quadrilateral, or Thiessen polygon structure.

[0053] Continue to refer to Figure 8 and Figure 9 The fixing of the edge retaining device includes edge band retaining and / or handle retaining methods;

[0054] When the edge band is fixed, such as Figure 8 The edge retention device includes an edge frame 12 and a fixing pin (not shown in the figure). The edge frame 12 is provided with a plurality of edge band retention channels 15 for connecting with the skull 4 to be repaired. The fixing pin can be connected and fixed to the skull 4 to be repaired through the edge band retention channels, so that it can be firmly connected to the skull defect. In some other embodiments, it can also be fixed by bonding with a biological adhesive.

[0055] Or it could be a handle-locking method, such as... Figure 9 The edge fixation device includes an edge frame 12 and a fixing pin. The edge frame 12 is circumferentially connected with a plurality of evenly spaced handles 17. Each handle 17 is provided with a handle fixation channel 16. The fixing pin is connected and fixed to the skull to be repaired through the handle fixation channel 16.

[0056] In some preferred embodiments, the edge retaining channel 15 is provided laterally through the edge frame 12, so that during installation, the fixation pin can be driven into the skull 4 from the side. This side-entry method can avoid the fixation pin protruding and damaging the soft tissue, thus preventing the prosthesis from being exposed.

[0057] It should be noted that, in this document, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Unless otherwise specified, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes that element.

[0058] The sequence numbers of the above embodiments of the present invention are for descriptive purposes only and do not represent the superiority or inferiority of the embodiments.

[0059] In this invention, unless otherwise explicitly specified and limited, the terms "installation," "connection," "linking," and "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components, unless otherwise explicitly limited. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0060] In the description of this specification, the references to terms such as "this embodiment," "an embodiment," "some embodiments," "example," "specific example," or "some examples," etc., refer to specific features, structures, materials, or characteristics described in connection with that embodiment or example, which are included in at least one embodiment or example of the present invention. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in a suitable manner in any at least one embodiment or example. Moreover, without contradiction, those skilled in the art can combine and integrate the different embodiments or examples described in this specification, as well as the features of different embodiments or examples.

[0061] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this invention, "a plurality of" means at least two, such as two, three, etc., unless otherwise explicitly specified.

[0062] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, and simple improvements made on the substantive content of the present invention should be included within the protection scope of the present invention.

Claims

1. A composite cranial repair organism based on a 3D framework structure, characterized in that, Includes 3D framework and biological patch unit, The 3D frame is obtained by 3D printing and its material includes at least one of titanium, titanium alloy, tantalum, tantalum alloy, zinc, zinc alloy, and polyetheretherketone. The 3D frame includes an edge retention device and an internal main frame, and each main frame is provided with a support platform. Each support platform is equipped with the biological patch unit. The edge retention device fits perfectly around the perimeter of the defect on the skull to be repaired. Each of the aforementioned support platforms is equipped with a biological patch unit, which includes a porous layer, a biomimetic layer, and a reinforcing layer arranged sequentially from the outside to the inside; the porous layer is a porous structure with pores, the biomimetic layer is a biomimetic structure that mimics the trabeculae of the skull, and the reinforcing layer is a completely solid structure. The 3D framework and biological patch are combined in ways including suture and / or inlay. The suture-type structure refers to the fact that the support platform of the 3D frame has multiple first suture channels, and the biological patch unit has multiple second suture channels corresponding to the first suture channels. The first suture channels are connected to the corresponding second suture channels by sutures, thereby realizing the suture-type combination of the 3D frame and the biological patch. The embedded biological patch is placed directly on the support platform of the 3D frame, and another 3D fixation frame is used to cover and fix the biological patch. The porous layer of the biological patch unit is used to ensure long-term stable integration between soft tissue and implant. Its pore size is 200-800μm and its structure includes a porous structure with extremely small curved surfaces and a honeycomb shape. The biomimetic layer of the biological patch unit is used to ensure the adhesion and growth of bone cells, with a porosity of 60%-80% and a structure that mimics the trabecular structure of the skull. The reinforcing layer of the bio-patch unit is used to ensure the mechanical strength of a single bio-patch, and has a thickness of 2mm-4mm.

2. The composite cranial repair organism based on a 3D framework structure according to claim 1, characterized in that, The support platform and biological patch unit of the 3D frame are in the form of regular hexagons, equilateral triangles, regular quadrilaterals, or Thiessen polygons.

3. The composite cranial repair organism based on a 3D framework structure according to claim 1, characterized in that, The reinforcing layer of the biological patch unit is provided with reinforcing ribs.

4. The composite cranial repair organism based on a 3D framework structure according to claim 1, characterized in that, The porous layer, biomimetic layer, and reinforcing layer are all made of at least one of hydroxyapatite, tricalcium phosphate, natural dentin, bioactive glass, or bioactive microcrystalline glass.

5. The composite cranial repair organism based on a 3D framework structure according to claim 1, characterized in that, The edge retention device is fixed by edge band retention and / or handle retention. When the edge band fixation method is used, the edge fixation device includes an edge frame and a fixing pin. The edge frame has multiple edge band fixation channels that extend laterally through the edge frame. The fixing pin is connected and fixed to the skull to be repaired through the edge band fixation channels. When the handle is fixed, the edge fixation device includes an edge frame and a fixing pin. Multiple handles are connected to the edge frame at intervals. Each handle is provided with a handle fixation channel. The fixing pin is connected and fixed to the skull to be repaired through the handle fixation channel.

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