Composite skull repair organism based on 3D frame structure

Abstract

The invention discloses a composite skull repair organism based on a 3D frame structure, the composite skull repair organism comprises a 3D frame and a biological patch unit, the 3D frame comprises an edge retention device and an internal main body frame, and the main body frame is provided with a support table; each supporting table is provided with the corresponding biological patch unit, and each biological patch unit comprises a porous layer, a bionic layer and a reinforcing layer which are sequentially arranged from outside to inside; the porous layer is of a porous structure with pores, the bionic layer is of a bionic structure of a bionic skull trabecula, and the reinforcing layer is of a full solid structure. According to the composite skull repair organism provided by the invention, the 3D frame part fully ensures the mechanical strength of the repair body; wherein the design of a single biological patch unit ensures integration of soft tissues and ingrowth of host bones while meeting certain mechanical strength, and provides guarantee for long-term stability of the prosthesis.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a composite skull repair organism based on a 3D frame structure. Background Art

[0002] A complete skull structure is of great significance to the human body, for example, it stabilizes intracranial pressure and effectively protects brain tissue. When a patient undergoes a decompressive craniectomy due to brain trauma or intracranial disease, a skull defect will be caused. Skull defects deprive the brain tissue of its protective barrier, which puts the brain tissue at risk of being easily injured. Patients will also experience varying degrees of clinical symptoms, which in turn produce physiological and psychological effects. Therefore, the repair of skull defects is very important, and the selection of restorations as a key part of success has become a research hotspot in the fields of medicine and materials science.

[0003] At present, the materials used for skull defect repair mainly include natural biological materials and artificial synthetic materials. Natural biological materials are divided into autologous bone and allogeneic bone. The source of autologous bone is limited and it is difficult to meet the needs of large-sized bone defects, while allogeneic bone has a high infection, absorption and rejection rate, so the use of both materials has been gradually eliminated. At present, the artificial synthetic materials commonly used for skull defect repair are mainly titanium alloy mesh and polyetheretherketone patch, but the above materials can only play a partial functional replacement role. Among them, the titanium alloy mesh with high biocompatibility has high mechanical properties, low infection rate and low cost, but there is a serious clinical complication that the soft tissue integration is unstable and leads to implant exposure. The polyetheretherketone patch has good biocompatibility, sufficient mechanical properties, light weight and non-conductive, and can be penetrated by X-rays, but the occurrence of subcutaneous effusion in soft tissue after surgery has always troubled many surgeons.

[0004] The clinical requirements and challenges for skull defect prostheses are, on the one hand, that the material needs to have good biocompatibility and sufficient mechanical properties; on the other hand, as a long-term implant for bone repair, it is necessary to consider whether it can be stably integrated with soft tissue in the long term and whether it is conducive to the growth of host bone.

[0005] The technologies proposed so far have not yet fully met the requirements of the above two aspects at the same time.

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

[0007] In view of this, the purpose of the present invention is to provide a composite skull repair organism based on a 3D frame structure. The composite skull repair organism provided by the present invention is composed of a combination of a 3D frame and a biological patch unit. The 3D frame fully guarantees the mechanical strength of the repair body. A single biological patch unit is designed as a solid plus porous structure. While meeting a certain mechanical strength, it also ensures the integration of soft tissue and the in-growth of host bones, providing a guarantee for the long-term stability of the repair body.

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

[0009] A composite skull repair organism based on a 3D frame structure, comprising a 3D frame and a biological patch unit.

[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 retaining device and an internal main frame, and a support platform is provided on the main frame; each support platform is installed with the biological patch unit; the edge retaining device is completely fitted around the defect on the skull to be repaired;

[0011] The biological patch unit is installed on each of the support platforms, and the biological patch unit includes a porous layer, a bionic layer and a reinforcement layer arranged in sequence from the outside to the inside; the porous layer is a porous structure with pores, the bionic layer is a bionic structure of bionic skull trabeculae, and the reinforcement layer is a fully solid structure.

[0012] Furthermore, the 3D frame and the biological patch are combined in a suturing manner and / or an inlay manner. The suturing manner refers to a plurality of first suture holes being opened on the support platform of the 3D frame, and a plurality of second suture holes corresponding to the first suture holes being opened on the biological patch unit. The first suture holes are connected to the corresponding second suture holes by sutures to achieve a suturing combination of the 3D frame and the biological patch. The inlay manner refers to a biological patch being directly placed on the support platform of the 3D frame, and the biological patch is covered and fixed by another 3D retention frame.

[0013] Furthermore, the 3D framework and the biological patch unit may be in structures including but not limited to regular hexagons, regular triangles, regular quadrilateral structures, Thiessen polygons, and the like.

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

[0015] Furthermore, the bionic structure of the middle layer of the biological patch unit is mainly 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.

[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, and the thickness is 2mm-4mm. Reinforcing ribs can be provided in the structural design to further increase the mechanical strength.

[0017] Furthermore, the materials of the porous layer, the bionic layer and the reinforcement layer include at least one of hydroxyapatite, tricalcium phosphate, natural dentin material, bioactive glass or bioactive microcrystalline glass.

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

[0019] In the edge band retention mode, the edge retention device includes an edge frame and a fixing pin, the edge frame is provided with a plurality of edge band retention holes that transversely penetrate the edge frame, and the fixing pin is connected and fixed to the skull to be repaired through the edge band retention holes;

[0020] In the handle retention mode, the edge retention device includes an edge frame and a fixing pin, the edge frame is connected to a plurality of handles distributed at intervals, each handle is provided with a handle retention hole, and the fixing pin is connected and fixed to the skull to be repaired through the handle retention hole.

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

[0022] (1) The overall structure of the restoration is a combination of a 3D frame and a biological patch unit; both the 3D frame and the biological patch unit have good biocompatibility, fully ensuring the mechanical strength of the restoration 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 not only meets certain mechanical strength requirements but also ensures the integration of soft tissue and the growth of host bone, thus providing a guarantee for the long-term stability of the restoration. The porous structure of the porous layer ensures the growth of soft tissue and guides tissue fluid through the pores to infiltrate the middle layer, i.e., the bionic layer, to avoid the occurrence of subcutaneous effusion. The bionic layer is designed to mimic the bionic structure of skull trabeculae, so as to better promote the growth of host bone and ensure the long-term stability of the restoration. The reinforcing layer is designed to be a completely solid structure, thus ensuring the mechanical strength of a single biological patch unit during the use of the restoration.

[0024] (3) The edge frame can fit completely with the surrounding residual bones, so that the entire edge frame fits perfectly in the skull defect, and the edge frame is provided with multiple holes for screw fixation, which can make it firmly connected to the skull defect. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Figure 1 2 is a schematic diagram of the structure of the present invention when installed.

[0026] Figure 2 It is a schematic diagram of the structural decomposition of the present invention.

[0027] Figure 3 It is a schematic diagram of the main structure of the biological patch unit in the present invention.

[0028] Figure 4 It is a schematic diagram of the cross-sectional structure of the biological patch unit in the present invention.

[0029] Figure 5 It is a schematic diagram of the sutured combination of the 3D frame and the biological patch in the present invention.

[0030] Figure 6 It is a schematic diagram of the mosaic combination of the 3D framework and the biological patch in the present invention.

[0031] Figure 7 It is a schematic diagram of other regular hexagonal, regular triangle, and regular quadrilateral structures that can be presented by the 3D framework in the present invention.

[0032] Figure 8 It is a schematic diagram of the edge band retention method in the present invention.

[0033] Fig. 9 It is a schematic diagram of the handle retention method in the present invention.

[0034] In the figure,

[0035] 1. 3D frame; 11. Main frame; 12. Edge frame; 13. Support platform; 14. First suture line 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 line channel;

[0037] 3. Sutures; 4. Skull; 5. 3D retention frame. DETAILED DESCRIPTION

[0038] The technical solutions in the embodiments of the present invention are described clearly and completely below. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0039] In addition, the technical solutions between the various embodiments of the present invention can be combined with each other, but it must be based on the fact that ordinary technicians in the field can implement it. When the combination of technical solutions is contradictory or cannot be implemented, it should be deemed that such combination of technical solutions does not exist and is not within the scope of protection required by the present invention.

[0040] The solution proposed by the present invention is specifically described below through specific embodiments:

[0041] Example 1

[0042] refer to Figures 1 to 9 As shown, this embodiment provides a composite skull repair 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. A plurality of main frames 11 are sequentially connected to form a large mesh internal frame. A plurality of support platforms 13 for placing the biological patch unit 2 are formed on each of the main frames 11. The edge frame 12 can be selected to have edge retention channels 15 ( Figure 8 ) or setting a handle retention channel 16 ( Fig. 9 ) is connected and fixed to the skull 4 to be repaired, and the edge frame 12 is completely fitted around the defect on the skull 4 to be repaired;

[0044] The biological patch unit 2 is installed on each of the support platforms 13, and the biological patch unit 2 includes a porous layer 21, a bionic layer 22 and a reinforcing layer 23 arranged in sequence from the outside to the inside; the porous layer 21 is a porous structure with pores, the bionic layer 22 is a bionic structure of bionic skull trabeculae, and the reinforcing layer 23 is a fully solid structure.

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

[0046] It can be understood that, except for the different curvatures according to the specific positions of the skull, the design of the single biological patch unit 2 is completely the same, as shown in the following example. Figure 3 and 4 As shown, in this embodiment, a single biological patch unit 2 is designed as a solid plus porous structure, and its material, i.e., the material of the porous layer, the bionic layer and the reinforcement layer, includes any one or more of hydroxyapatite, tricalcium phosphate, natural dentin material, bioactive glass or bioactive microcrystalline glass; it has good biocompatibility and certain mechanical properties, and its composition can be a single material or a composite of multiple materials, which can be selected according to needs.

[0047] The design of the biological patch unit 2 meets certain mechanical strength requirements while also ensuring the integration of soft tissue and the in-growth of host bone, thus providing a guarantee for the long-term stability of the prosthesis; the porous structure of the porous layer 21 is conducive to the in-growth of soft tissue on the one hand, and can guide tissue fluid to infiltrate the middle layer, i.e., the bionic layer 22, through the pores to avoid the occurrence of subcutaneous effusion on the other hand, i.e., the structure of the outer porous layer 21 is mainly to ensure the long-term stable integration between the soft tissue and the implant, and its pore size is 200-800μm, and the structure includes but is not limited to extremely small curved surfaces, honeycomb structures, etc.; the bionic layer The design 22 is a porous structure that mimics the skull trabeculae, so as to better promote the growth of host bones and ensure the long-term stability of the restoration. That is, the structure of the middle layer bionic layer 22 of the biological patch unit is mainly to ensure the adhesion and growth of bone cells, and the porosity is 60%-80%; the reinforcing layer 23 is designed to adopt a completely solid structure design to ensure the mechanical strength of a single biological patch unit 2 during the use of the restoration, with a thickness of 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 Figure 5 and Figure 6 As shown, the 3D frame and the biological patch are combined in a suturing manner and / or an inlay manner;

[0049] When it is a suture type, a plurality of first suture holes 14 are provided on the support platform 13, and a plurality of second suture holes 24 corresponding to the first suture holes 14 are provided on the biological patch unit 2; the first suture holes 14 are connected with the corresponding second suture holes 24 through sutures 3 to realize the suture combination of the 3D frame and the biological patch. The setting of the first suture holes 14 and the second suture holes 24 can better fix the biological patch unit 2 on the main frame 11, and the second suture holes 24 also have the function of drainage holes, which is convenient for the flow of tissue fluid and the exchange of substances in the repair body.

[0050] exist Figure 5In the illustrated embodiment, 4-8 first suture holes 14 are provided on each of the support platforms 13, and 4-8 second suture holes 24 are provided on each of the biological patch units 2. It can be understood that the second suture holes 24 are arranged throughout 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 unit 2, and no specific limitation is made here.

[0051] exist Figure 6 In the illustrated embodiment, the 3D frame 1 and the biological patch unit 2 may also be combined in an inlay manner, in which case the biological patch unit 2 is directly placed on the 3D frame 1, and a 3D retaining frame 5 is placed thereon for retention.

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

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

[0054] When the edge band retention method is as described above, Figure 8 The edge retaining device includes an edge frame 12 and fixing pins (not shown). The edge frame 12 is provided with a plurality of edge band fixing holes 15 for connecting with the skull 4 to be repaired. The fixing pins can be connected and fixed to the skull 4 to be repaired through the edge band fixing holes, so that they can be firmly connected to the skull defect. In some other embodiments, they can also be fixed by bonding with biological adhesives.

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

[0056] In some preferred embodiments, the edge band retention channel 15 is arranged transversely through the edge frame 12, so that during installation, the fixing pins can be driven into the skull 4 from the side. This side driving method can prevent the retention pins from protruding and damaging the soft tissue, resulting in exposure of the restoration.

[0057] It should be noted that, in this article, the terms "include", "comprises" or any other variations thereof are intended to cover non-exclusive inclusion, so that a process, method, article or device including a series of elements includes not only those elements, but also other elements not explicitly listed, or also includes elements inherent to such process, method, article or device. In the absence of further restrictions, an element defined by the sentence "comprises a ..." does not exclude the existence of other identical elements in the process, method, article or device including the element.

[0058] The serial numbers of the above embodiments of the present invention are only for description and do not represent the advantages or disadvantages of the embodiments.

[0059] In the present invention, unless otherwise clearly specified and limited, the terms "installed", "connected", "connected", "fixed" and the like should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements, unless otherwise clearly defined. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0060] In the description of this specification, the description with reference to the terms "this embodiment", "one embodiment", "some embodiments", "example", "specific example", or "some examples" means that the specific features, structures, materials or characteristics described in conjunction with the embodiment or example are included in at least one embodiment or example of the present invention. In this specification, the schematic representations of the above terms do not necessarily refer to the same embodiment or example. Moreover, the specific features, structures, materials or characteristics described may be combined in a suitable manner in any at least one embodiment or example. In addition, those skilled in the art may combine and combine different embodiments or examples described in this specification and the features of different embodiments or examples, unless they are contradictory.

[0061] In addition, the terms "first" and "second" are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of the indicated technical features. Therefore, the features defined as "first" and "second" may explicitly or implicitly include at least one of the features. In the description of the present invention, the meaning of "plurality" is at least two, such as two, three, etc., unless otherwise clearly and specifically defined.

[0062] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions and simple improvements made to the essential contents of the present invention should be included in the protection scope of the present invention.

Claims

1. A composite skull repair organism based on a 3D frame structure, characterized in that: Including 3D frame 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 retaining device and an internal main frame, and a support platform is provided on the main frame; each support platform is installed with the biological patch unit; the edge retaining device is completely fitted around the defect on the skull to be repaired; The biological patch unit is installed on each of the support platforms, and the biological patch unit includes a porous layer, a bionic layer and a reinforcement layer arranged in sequence from the outside to the inside; the porous layer is a porous structure with pores, the bionic layer is a bionic structure of bionic skull trabeculae, and the reinforcement layer is a fully solid structure.

2. The composite skull repair organism based on a 3D frame structure according to claim 1 is characterized in that: The 3D frame and the biological patch are combined in a sutured manner and / or inlaid manner. The suture type refers to that a plurality of first suture holes are provided on the support platform of the 3D frame, a plurality of second suture holes corresponding to the first suture holes are provided on the biological patch unit, and the first suture holes are connected with the corresponding second suture holes by sutures to realize the suture type combination of the 3D frame and the biological patch; The inlaid type refers to that the biological patch is directly placed on the support platform of the 3D frame, and another 3D retention frame is used to cover and retain the biological patch.

3. The composite skull repair organism based on a 3D frame structure according to claim 1 is characterized in that: The support platform and biological patch unit of the 3D frame are in the shape of a regular hexagon, a regular triangle, a regular quadrilateral, or a Thiessen polygon.

4. The composite skull repair organism based on a 3D frame structure according to claim 1, characterized in that: The porous layer of the biological patch unit is used to ensure long-term stable integration between soft tissue and implant, and its pore size is 200-800 μm, and the structure includes a minimal curved surface and a honeycomb porous structure.

5. The composite skull repair organism based on a 3D frame structure according to claim 1, characterized in that: The bionic layer of the biological patch unit is used to ensure the adhesion and growth of bone cells, has a porosity of 60%-80%, and has a structure that mimics the trabecular structure of a bionic skull.

6. The composite skull repair organism based on a 3D frame structure according to claim 1, characterized in that: The reinforcing layer of the biological patch unit is used to ensure the mechanical strength of a single biological patch, and has a thickness of 2 mm to 4 mm. Preferably, reinforcing ribs are provided thereon.

7. The composite skull repair organism based on a 3D frame structure according to claim 1, characterized in that: The materials of the porous layer, the bionic layer and the reinforcement layer include at least one of hydroxyapatite, tricalcium phosphate, natural dentin material, bioactive glass or bioactive microcrystalline glass.

8. The composite skull repair organism based on a 3D frame structure according to claim 1, characterized in that: The fixing of the edge retaining device includes edge band retaining and / or handle retaining. In the edge band retention mode, the edge retention device includes an edge frame and a fixing pin, the edge frame is provided with a plurality of edge band retention holes that transversely penetrate the edge frame, and the fixing pin is connected and fixed to the skull to be repaired through the edge band retention holes; In the handle retention mode, the edge retention device includes an edge frame and a fixing pin, the edge frame is connected to a plurality of handles distributed at intervals, each handle is provided with a handle retention hole, and the fixing pin is connected and fixed to the skull to be repaired through the handle retention hole.

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