HYBRID, ARTIFICIAL BONE TISSUE IMPLANT ABSORBING MECHANICAL VIBRATIONS, WHOSE ARCHITECTURAL STRUCTURE IMITATES TRABECULAR BONE, ALLOWING THE SATURATION OF BONE MARROW, BLOOD, AND NUTRIENTS, SUPPORTING AUTOLOGICAL REGENERATION, WHICH CAN BE USED WITH TITANIUM STRUCTURES

Abstract

A polymer scaffold structure is created as a result of the proportional combination of ?-Tricalcium Phosphate (?-TCP) that will increase the 3D and osteoconductive effect allowing/supporting cell infiltration by using extrusion deposition, in other words, added manufacturing process, and with physiological buffered HA solution with the Deep Coating Method and by increasing the transmission rate of growth factors as a result of coating and expanding their areas with the biological tissue implant, which allows its use with titanium mesh plates or contoured structures.

Claims

1. A method of obtaining a three-dimensional polymer and ?-tricalcium phosphate (?-TCP) scaffold structure (tissue scaffold) that allows/supports cell infiltration using an additive manufacturing process, coating with physiological buffered HA solution with deep coting method, and obtaining a biological tissue implant that allows an use of titanium mesh plate or contoured structures to increase a transmission rate of growth factors and expand the areas, wherein filament layers, which are connected to each other at angles that will support extracellular matrix (ECM) interaction and overlapped by connecting at 90 degrees with each other, overlapping the third filament layer as oblig, supporting vascularized tissue formation of the obtained structures together with osteoconductive effect in 50-70 micron pore structure, increasing a deep encapsulation of hyaluronic acid into the body by creating micro cracks on the body with the cryo-shock method or vacuum drying system of the three-dimensional tissue scaffold formed as a result of extrusion, and attachment and coating of the empass or hot polymer to a surface of the titanium mesh by extrusion.

2. The method according to claim 1, wherein the correct combination of the no-booster and hydrogel polymer the hyaluronic acid coating method performed to produce mechanically sound, electrically conductive, bioactive; with the correct combination of nano-enhancer and hydrogel polymer, mechanically sound, electrically conductive, hyaluronic acid coating method performed to produce bioactive; preparation of solutions with magnetic stirrer at room temperature with 10 mg/ml sodium hyaluronate (1 million Da, medical grade) in physiological buffer (PBS pH 7.4), covering the tissue scaffolds with the bottom-coating (immersion) method in the solution, and it is that it is left to dry for 3 days at 50? C. in a vacuum incubator.

3. The method according to claim 1, wherein cross-links in HA molecules are used to ensure that the hyaluronic acid molecule is permanent in the implant.

4. The method according to claim 1, wherein microcracks is formed on the body with the cryo-shock method in the 3D tissue scaffold forming as a result of the extrusion.

5. The method according to claim 1, wherein in the biological tissue implant, a cartilage repair patch is adapted to be placed on a first outer cell occlusive layer near a subchondral bone wound site.

6. The method according to claim 1, wherein in the biological tissue implant, a second outer cell is presented and has a permeable HA layer and a cartilagenic matrix (architecture) placed between the first and second layers.

7. The method according to claim 1, wherein in the biological tissue implant, a cartilagenic matrix and the formed permeate layer surface area are provided with the property of a receiving point for the diffusion of autologous stem cells, and components supporting the production of hyaline-like cartilage are contained in the presence of autologous stem cells.

8. The method according to claim 1, wherein in the biological tissue implant, as fully supporting bone augmentation, acting as a barrier with high-density polymer tissue, helping the regeneration, providing potential fibrovascular growth, covering the polymer structure on titanium mesh, giving form and volume to the tissue which has lost its volumetric integrity, growing the tissue inward and a hybrid structure.

9. The method according to claim 1, wherein the biological tissue implant has a cylindrical, square, free-form shape specially for the person.

10. The method according to claim 1, wherein the biological tissue implant, the therapeutic concentration, stem cell, growth factor is integrated into the scaffold structure, if desired.

11. The method according to claim 1, wherein the biological tissue implant, ?-tricalcium phosphate (?-TCP), a biocompatible, radiopaque and resorbable osteoconductive material is included in the prepared PCL granule at a rate of 3-15%, supporting new bone formation in the defect area.

12. The method according to claim 2, wherein cross-links in HA molecules are used to ensure that the hyaluronic acid molecule is permanent in the implant.

13. The method according to claim 2, wherein microcracks is formed on the body with the cryo-shock method in the 3D tissue scaffold forming as a result of the extrusion.

14. The method according to claim 3, wherein microcracks is formed on the body with the cryo-shock method in the 3D tissue scaffold forming as a result of the extrusion.

15. The method according to claim 2, wherein in the biological tissue implant, a cartilage repair patch is adapted to be placed on a first outer cell occlusive layer near a subchondral bone wound site.

16. The method according to claim 3, wherein in the biological tissue implant, a cartilage repair patch is adapted to be placed on a first outer cell occlusive layer near a subchondral bone wound site.

17. The method according to claim 4, wherein in the biological tissue implant, a cartilage repair patch is adapted to be placed on a first outer cell occlusive layer near a subchondral bone wound site.

18. The method according to claim 2, wherein in the biological tissue implant, a second outer cell is presented and has a permeable HA layer and a cartilagenic matrix (architecture) placed between the first and second layers.

19. The method according to claim 3, wherein in the biological tissue implant, a second outer cell is presented and has a permeable HA layer and a cartilagenic matrix (architecture) placed between the first and second layers.

20. The method according to claim 4, wherein in the biological tissue implant, a second outer cell is presented and has a permeable HA layer and a cartilagenic matrix (architecture) placed between the first and second layers.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0016] In the drawings on the biological tissue implant, which is the subject of the invention;

[0017] FIG. 1: The schematic view of the cylindrical tissue scaffold.

[0018] FIG. 2: Detail view of the cylindrical tissue scaffold.

[0019] FIG. 3: The schematic view of the front face of the cylindrical scaffold.

[0020] FIG. 4: The schematic view of the cartilage repair patch.

[0021] FIG. 5: The schematic and detailed view of the filament structure.

[0022] FIG. 6: The schematic view of the filament array (cross).

[0023] FIG. 7: The schematic-perspective view of the hybrid system.

[0024] The parts in the figures are numbered one by one and are given below: [0025] 1. Tissue scaffold [0026] 1.1. Filaments [0027] 1.2. Chamber [0028] 2. Hybrid implant [0029] 2.1. Polymer layer [0030] 2.2. Titanium mesh

DETAILED DESCRIPTION OF THE EMBODIMENTS

[0031] Our invention is basically the creation of a 3D polymer and ?-Tricalcium Phosphate (?-TCP) scaffold structure (tissue scaffold) and a biological tissue implant allowing/supporting cell infiltration by using the added manufacturing process, coating it with physiological-buffered HA solution with the deep coting method to increase the delivery rate of growth factors and enlarge their areas allowing the use of titanium mesh plate or contoured structures.

[0032] Since a normal hyaluronic acid molecule is metabolized and excreted 12 hours after it is injected into the human skin, cross-links are used in HA molecules to make it permanent. The cross-linking of hyaluronic acid makes the solution more viscous increasing its effect by prolonging the residence time in the implant.

[0033] The layers are connected at angles to support extracellular matrix (ECM) interaction in our invention, and the overlapping structures are overlapped obliquely. The resulting structures have an hfa 50-70-micron porous structure and support the formation of vascularized tissue with osteoconductive effect.

[0034] The 3D tissue scaffold formed as a result of extrusion crates micro-cracks on the body with the cryo-shocking method, and the deep encapsulation of hyaluronic acid into the body is increased. The HA solution is 20-70 ?m-1 mL per square centimeter of scaffold body.

[0035] It is a biological tissue implant and its features are; [0036] Overlapping filament layers (1.1) connected at angles to support Extracellular Matrix (ECM) interaction with each other connected by angling at 90? to each other, [0037] Oblige overlapping structures of the third filament layer, [0038] Supporting the formation of vascularized tissue with the osteoconductive effects of 50-70-micron pore structure of the obtained structures, [0039] Increasing the encapsulation of the hyaluronic acid deep into the body by creating micro cracks with the cryo-shock method or vacuum drying system of the 3D tissue scaffold (1) formed as a result of extrusion, [0040] Attachment and coating of empass or hot polymer (2.1) onto the surface of the titanium mesh (2.2) by extrusion,

[0041] Bone augmentation (to patients with a bone deficiency) to repair severely traumatic and degraded tissues is not suitable for reshaping especially in the jaw region if the discomfort has gained aesthetic concern. It will be an important solution for bone tissue that cannot be reshaped or volumized.

[0042] Another feature of the system is the polymer implant technology that has a hybrid structure.

[0043] Bionic titanium, which is the raw material of the scaffold obtained, is coated on the mesh plate with the extrusion or drying method. The vascularized tissue is re-grown and formed inward by reshaping the volumetric defect. The tissue is protected against environmental loads while shaped with a titanium mesh scaffold thanks to this technology. The reinforced titanium plates provide a barrier by minimizing softness. The titanium mesh also provides radiographic visibility. It is of vital importance especially for the defects in the head region with its high ability to imitate bone.

[0044] A device and method for providing surgical therapy for the in situ treatment and repair of intra-articular cartilage lesions and/or defects are described with this invention.

[0045] The device is an implantable, biocompatible, and physiologically absorbable laminate cartilage repair patch. The cartilage repair patch is adapted to be placed near a first outer cell occlusive layer, a subchondral bone wound site.

[0046] The hybrid structure (2) fully supports bone augmentation, acts as a barrier, has high-density polymer tissue, helps in the regeneration, provides potential fibrovascular growth, covers the polymer structure (2.1) on titanium mesh (2.2), and provides form and volume to the tissue, which has lost its volumetric integrity, and has the feature allowing the tissue to grow inward. The thin polymer layer (2.1) on the implants minimizes the upper surface tissue adhesion supporting vascular tissue growth by increasing the lower surface porous structure.

[0047] A second outer cell has a permeable HA layer and a cartilagenic matrix (architecture) between the first and second layers. The cartilagenic matrix and the permeate layer surface area have the characteristics of a receiving point for the diffusion of autologous stem cells and has components supporting the production of hyaline-like cartilage in the presence of autologous stem cells.

[0048] The accurate combination of nano-enhancer and hydrogel polymer, hyaluronic acid coating method to produce mechanically firm, electrically conductive, bioactive;

[0049] It contains the following process steps; [0050] The preparation of solutions with a magnetic stirrer at room temperature with 10 mg/ml sodium hyaluronate (1 million Da, medical-grade) in physiological buffer (PBS pH 7.4), [0051] Completing the work by coating the scaffolds with dip-coating method into the solution and drying at vacuum oven at 50? C. for 3 days,

[0052] The biological tissue implant can be manufactured in cylindrical, square, and free forms anatomical shapes allowing rapid implantation requiring minimal manipulation. The tissue implant, which is suitable for specific shapes, can be produced in multiple thicknesses and models that are specific to anatomical regions to meet clinical needs, and the reinforced layer increases strength and contours. The fixation hole/position allows optimum screw placement, anatomical shape, and the radial titanium mesh design minimize the cutting option offering many fixation options and promoting cell preinflation by gaining micro-mobility.

[0053] If desired, therapeutic concentration, stem cell, or growth factor can be integrated into the scaffold structure.

[0054] ?-Tricalcium Phosphate (?-TCP) is included in the prepared PCL granule by 3-15%. In this way, the toughness values of the scaffold body formed by reducing the viscosity of the polymer are increased.

[0055] ?-Tricalcium Phosphate (?-TCP) is a biocompatible, radiopaque, and resorbable osteoconductive material as an important factor supporting the formation of new bone in the defect area.