Craniomaxillofacial bone induction implant

Abstract

The utility model belongs to the technical field of bone implants, and discloses a cranio-maxillofacial bone induction implant, which comprises a plate-shaped PEEK (polyetheretherketone) support layer, a plurality of mounting holes formed in the edge of the PEEK support layer, and a plurality of connecting holes formed in the PEEK support layer, a bone induction layer covers the joint of the PEEK supporting layer and the part, needing to be attached, on the craniomaxillofacial surface; the inner layer of the bone induction layer is matched with a to-be-attached part on the craniomaxillofacial surface; the inner layer of the PEEK supporting layer is matched with the outer layer of the bone induction layer; and the bone induction layer is made of a material with biological activity. PEEK is adopted as a supporting structure and is connected with the bone induction layer, so that the good mechanical property of the PEEK material is ensured, and the bone inductivity of the bioactive material is also exerted. The PEEK material can ensure the required mechanical properties after the implant is implanted into a human body, and the bioactive material adopted by the bone induction layer can provide good bone ingrowth performance.

Description

Technical Field

[0001] The utility model belongs to the technical field of bone implants, and particularly relates to a craniofacial bone induction implant. Background Art

[0002] Traditional skull implant surgeries usually use high-hardness and light-weight titanium alloys, or implant-grade PEEK (Polyetheretherketone) processed and formed according to the shape of the bone defect site to repair injuries or fill gaps. However, after the titanium mesh is shaped and implanted, situations such as warping and edge protrusion are likely to occur, which may cause problems such as tissue infection, and there is an artifact phenomenon during postoperative CT examination, affecting the examination results; at the same time, it also has the disadvantages of good thermal conductivity and easy deformation under force; the craniofacial implant made of implant-grade PEEK (polyetheretherketone for surgical implants) basically completely matches the bone defect site, has good mechanical strength, and is not easily deformed by external forces; there is no artifact phenomenon in postoperative CT examinations; but because it is completely biocompatible and will not grow together with bone tissue, it will only be regarded as a foreign body by the human body and generate a fibrous membrane wrapping phenomenon.

[0003] The Chinese patent publication number is CN115212348A, and the patent application is named a PEEK-based composite implant and its preparation method and application. The PEEK matrix has a bone contact surface and a non-bone contact surface (the surface in contact with subcutaneous tissue and brain tissue), and a bone induction material is compounded on its bone contact surface. The bone induction material can be one of hydroxyapatite, tricalcium phosphate, biphasic calcium phosphate, and natural bone. Although this patent application also has PEEK material and bone induction material, this patent application sets the bone induction material on the outside of the PEEK material, and the mechanical properties of the PEEK material cannot be fully exerted on the craniofacial surface. Summary of the Utility Model

[0004] The purpose of the utility model is to provide a craniofacial bone induction implant. By covering a bone induction layer at the junction of the PEEK support layer and the part to be fitted on the craniofacial surface, the mechanical properties of the PEEK material can be fully exerted and the bone ingrowth performance can be ensured through the bone induction layer.

[0005] To achieve the above purpose, the technical solution adopted by the utility model is:

[0006] A craniofacial bone induction implant, comprising: a PEEK support layer, the PEEK support layer is plate-shaped, and a plurality of mounting holes are opened at the edge of the PEEK support layer; a bone induction layer is covered at the junction of the PEEK support layer and the part to be fitted on the craniofacial surface; the inner layer of the bone induction layer matches the part to be fitted on the craniofacial surface; the inner layer of the PEEK support layer matches the outer layer of the bone induction layer; the bone induction layer is made of a material with biological activity.

[0007] Optionally, the bone induction layer is made of a PEEK material uniformly distributed with hydroxyapatite powder, or a tricalcium phosphate composite PEEK material, or a degradable polylactic acid material.

[0008] Optionally, the bone induction layer has a porous structure or a solid non-porous structure.

[0009] Optionally, each pore in the porous structure of the bone induction layer communicates with the bone induction layer in a direction perpendicular to the bone induction layer.

[0010] Optionally, the wire diameter in the porous structure of the bone induction layer is 0.4 mm to 0.8 mm, and the spacing between each pore is 0.4 mm to 0.8 mm.

[0011] Optionally, the PEEK support layer and the bone induction layer are connected by fused deposition modeling with a dual nozzle.

[0012] Optionally, the thickness of the bone induction layer is greater than or equal to 0.8 mm.

[0013] Optionally, the PEEK support layer has a plurality of through holes.

[0014] Optionally, the inner layer of the bone induction layer matches the surface of the skull.

[0015] Optionally, the inner layer of the bone induction layer matches the bone surface of the maxillofacial region.

[0016] Compared with the prior art, the present utility model has the following beneficial effects:

[0017] For a craniofacial bone induction implant of the present utility model, a PEEK material is used as a support structure and is connected with a bone induction layer, which not only ensures the good mechanical properties of the PEEK material but also exerts the bone induction property of the bioactive material. The PEEK material can ensure the mechanical properties required after implantation into the human body, and the bioactive material used in the bone induction layer can provide good bone ingrowth performance.

[0018] Furthermore, the bone induction layer of the present utility model has a porous structure, which can provide better bone ingrowth performance.

[0019] Furthermore, the PEEK support layer of the present utility model has a plurality of through holes, which can provide better bone ingrowth performance while providing support. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] The drawings described herein are for illustrative purposes only and are not intended to limit the scope of the disclosure of the present utility model in any way. Additionally, the shapes and proportional dimensions of the components in the drawings are only schematic and are used to assist in the understanding of the present utility model, rather than specifically defining the shapes and proportional dimensions of the components of the present utility model. In the drawings:

[0021] Figure 1 Schematic diagram of the outer layer of Embodiment 1 of the present utility model;

[0022] Figure 2 Schematic diagram of the inner layer of Embodiment 1 of the present utility model;

[0023] Figure 3 Schematic diagram of the side of Embodiment 1 of the present utility model;

[0024] Figure 4 Schematic diagram of the installation of Embodiment 1 of the present utility model;

[0025] Figure 5 Schematic diagram of the outer layer of Embodiment 2 of the present utility model;

[0026] Figure 6 Schematic diagram of the outer layer of Embodiment 2 of the present utility model;

[0027] Figure 7 Schematic diagram of the side of Embodiment 2 of the present utility model;

[0028] Figure 8 Schematic diagram of the installation of Embodiment 2 of the present utility model;

[0029] Figure 9 Schematic diagram of Embodiment 3 of the present utility model;

[0030] Figure 10 Schematic diagram of Embodiment 4 of the present utility model;

[0031] Figure 11 Schematic diagram of the outer layer of Embodiment 5 of the present utility model;

[0032] Figure 12 Schematic diagram of the inner layer of Embodiment 5 of the present utility model;

[0033] Figure 13 Schematic diagram of the installation of Embodiment 5 of the present utility model;

[0034] Figure 14 Schematic diagram of the outer layer of Embodiment 6 of the present utility model;

[0035] Figure 15 Schematic diagram of the inner layer of Embodiment 6 of the present utility model;

[0036] Figure 16 Schematic diagram of the installation of Embodiment 6 of the present utility model;

[0037] Wherein, 1, PEEK support layer; 2, osteoinductive layer; 3, through hole; 4, mounting hole. Detailed implementation manners

[0038] In order to enable those skilled in the art to better understand the technical solutions in the present utility model, the following will clearly and completely describe the technical solutions in the embodiments of the present utility model with reference to the accompanying drawings in the embodiments of the present utility model. Obviously, the described embodiments are only a part of the embodiments of the present utility model, rather than all of the embodiments. Based on the embodiments in the present utility model, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the protection scope of the present utility model.

[0039] It should be noted that when an element is referred to as being "disposed on" another element, it can be directly on the other element or there can also be an intermediate element. When an element is considered to be "connected" to another element, it can be directly connected to the other element or there may be an intermediate element at the same time. The terms "vertical", "horizontal", "left", "right" and similar expressions used herein are only for the purpose of illustration and do not represent the only embodiments.

[0040] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the technical field to which the present utility model belongs. The terms used in the specification of the present utility model herein are only for the purpose of describing specific embodiments and are not intended to limit the present utility model. The term "and / or" used herein includes any and all combinations of one or more of the related listed items.

[0041] The following will describe the present utility model in detail with reference to the accompanying drawings.

[0042] As Figures 1 to 16 shown, a cranio-maxillofacial bone induction implant of the present utility model includes: a PEEK support layer 1 and a bone induction layer 2. The PEEK support layer 1 is plate-shaped, and a plurality of mounting holes 4 are provided at the edge of the PEEK support layer 1. The PEEK support layer 1 is fixedly connected to the cranio-maxillofacial region through screws or bone plates passing through the mounting holes 4 to achieve stability after implantation.

[0043] The joint between the PEEK support layer 1 and the part of the cranio-maxillofacial region to be fitted is covered with the bone induction layer 2; the inner layer of the bone induction layer 2 matches the part of the cranio-maxillofacial region to be fitted; the inner layer of the PEEK support layer 1 matches the outer layer of the bone induction layer 2; the bone induction layer 2 is made of a biologically active material.

[0044] The PEEK (Polyetheretherketone) material of the PEEK support layer 1 can ensure the excellent mechanical properties of PEEK, provide good support, compression resistance, shear resistance and torsion resistance, and meet the mechanical requirements of the implant in clinical practice. The biologically active material of the bone induction layer 2 can exhibit good bone ingrowth induction performance.

[0045] Specifically, the thickness of the bone induction layer 2 is greater than or equal to 0.8 mm.

[0046] The PEEK support layer 1 and the bone induction layer 2 are integrally formed by 3D printing, can be adjusted according to clinical needs, and do not reduce the mechanical properties of the implant itself. Preferably, the PEEK support layer 1 and the bone induction layer 2 are connected by fused deposition modeling with a dual nozzle. This enables the PEEK support layer 1 and the bone induction layer 2 to have good bonding properties and ensures the structural safety and stability of the product.

[0047] Optionally, the bioactive material of the bone induction layer 2 is hydroxyapatite composite PEEK material or tricalcium phosphate composite PEEK material or degradable polylactic acid material.

[0048] Preferably, the bone induction layer 2 is made of PEEK material uniformly distributed with hydroxyapatite powder, providing good bone ingrowth performance. Further preferably, the mass ratio of the hydroxyapatite powder is 5% to 45%.

[0049] Optionally, the bone induction layer 2 is a solid non-porous structure. Optionally, the bone induction layer 2 is a porous structure. Specifically, each pore in the porous structure of the bone induction layer 2 communicates with the bone induction layer 2 in the direction perpendicular to the bone induction layer 2.

[0050] Specifically, the diameter of each pore in the porous structure of the bone induction layer 2 is 0.4 mm to 0.8 mm, and the distance between each pore is 0.4 mm to 0.8 mm.

[0051] Optionally, the PEEK support layer 1 has a plurality of through holes 3.

[0052] Example 1

[0053] As Figures 1 to 4 shown, in this embodiment, the inner layer of the bone induction layer 2 matches the surface of the zygomatic bone.

[0054] The PEEK support layer 1 includes an intermediate plate member, and the intermediate plate member extends branch plate members in four different directions, and the bone induction layer 2 is attached to the intermediate plate member and the branch plate members. Among them, two branch plate members are arranged around the outer side of the eye socket, and the other two branch plate members are arranged along the cheekbone.

[0055] The branch plate members have two to three mounting holes 4 for fixing the screw through the mounting holes 4 through the PEEK support layer 1 and the bone induction layer 2 on the surface of the zygomatic bone.

[0056] The bone induction layer 2 is made of a composite hydroxyapatite material, and the bone induction layer 2 is a non-porous structure.

[0057] Example 2

[0058] As Figures 5 to 8 shown, in this embodiment, the inner layer of the bone induction layer 2 matches the surface of the zygomatic bone; the bone induction layer 2 is a non-porous structure.

[0059] The PEEK support layer 1 includes a middle plate member, and branch plate members extend from one side of the middle plate member in two different directions in a Y shape. Among them, one side of the middle plate member and one of the branch plate members jointly surround the eye socket, and the other branch plate member is arranged along the cheek bone. Each branch plate member has two mounting holes 4. The bone induction layer 2 completely covers the edge of the joint between the inner layer of the PEEK support layer 1 and the surface of the zygomatic bone.

[0060] Example 3

[0061] As Figure 9 to, in this embodiment, the inner layer of the bone induction layer 2 matches the surface of the zygomatic bone.

[0062] The bone induction layer 2 is a porous structure, and the bone induction layer 2 is made of a PEEK material uniformly distributed with hydroxyapatite powder, wherein the mass ratio of the hydroxyapatite powder is 5%-45%.

[0063] The PEEK support layer 1 includes a middle plate member, and branch plate members extend from the middle plate member in four different directions, and the bone induction layer 2 is attached to the middle plate member and the branch plate members. Among them, two branch plate members are arranged around the outer side of the eye socket, and the other two branch plate members are arranged along the cheek bone.

[0064] Two to three mounting holes 4 are provided on the branch plate member.

[0065] Example 4

[0066] As Figure 10 shown, in this embodiment, the inner layer of the bone induction layer 2 matches the surface of the zygomatic bone.

[0067] The bone induction layer 2 is a porous structure, and the bone induction layer 2 is made of a PEEK material uniformly distributed with hydroxyapatite powder, wherein the mass ratio of the hydroxyapatite powder is 5%-45%.

[0068] The PEEK support layer 1 includes a middle plate member, and branch plate members extend from one side of the middle plate member in two different directions in a Y shape. Among them, one side of the middle plate member and one of the branch plate members jointly surround the eye socket, and the other branch plate member is arranged along the cheek bone. Each branch plate member has two mounting holes 4. The bone induction layer 2 completely covers the edge of the joint between the inner layer of the PEEK support layer 1 and the surface of the zygomatic bone.

[0069] Example 5

[0070] As Figures 11 to 13 shown, in this embodiment, the inner layer of the bone induction layer 2 matches the surface of the skull.

[0071] The PEEK support layer 1 has a plurality of through holes 3 passing through the bone induction layer 2. Mounting holes 4 are provided at the four corners of the PEEK support layer 1 for fixing the bone plate to the surface of the skull by passing the bone plate through the PEEK support layer 1 and the bone induction layer 2 via the mounting holes 4.

[0072] The bone induction layer 2 completely covers the inner layer edge of the PEEK support layer 1. The bone induction layer 2 is a porous structure.

[0073] Embodiment 6

[0074] As Figures 14 to 16 shown, in this embodiment, the inner layer of the bone induction layer 2 matches the surface of the skull; the bone induction layer 2 is a non-porous structure.

[0075] The PEEK support layer 1 has a plurality of through holes 3 passing through the bone induction layer 2; mounting holes 4 are provided at the four corners of the PEEK support layer 1; the bone induction layer 2 completely covers the inner layer edge of the PEEK support layer 1.

[0076] In the above embodiments, the device elements involved are all conventional device elements unless otherwise specified. The structural setting methods, working methods or control methods involved are all conventional setting methods, working methods or control methods in this field unless otherwise specified.

[0077] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention and are not intended to limit them. Other modifications or equivalent replacements made by those of ordinary skill in the art to the technical solutions of the present invention should be covered within the scope of the claims of the present invention as long as they do not depart from the spirit and scope of the technical solutions of the present invention.

Claims

1. A cranio-maxillofacial bone induction implant, characterized in that, Including: A PEEK support layer (1), the PEEK support layer (1) is plate-shaped, and a plurality of mounting holes (4) are provided at the edge of the PEEK support layer (1); a bone induction layer (2) is covered at the joint of the PEEK support layer (1) and the part to be fitted on the cranio-maxillofacial surface; the inner layer of the bone induction layer (2) matches the part to be fitted on the cranio-maxillofacial surface; the inner layer of the PEEK support layer (1) matches the outer layer of the bone induction layer (2); the bone induction layer (2) is made of a material with biological activity.

2. The cranio-maxillofacial bone induction implant according to claim 1, characterized in that, The bone induction layer (2) is made of a PEEK material uniformly distributed with hydroxyapatite powder, or a tricalcium phosphate composite PEEK material or a biodegradable polylactic acid material.

3. The cranio-maxillofacial bone induction implant according to claim 1, wherein The bone induction layer (2) is a porous structure or a solid non-porous structure.

4. The craniofacial bone induction implant according to claim 3, wherein, Each hole in the porous structure of the bone induction layer (2) communicates with the bone induction layer (2) in the direction perpendicular to the bone induction layer (2).

5. The cranio-maxillofacial bone induction implant according to claim 3, characterized in that, In the porous structure of the bone induction layer (2), the wire diameter is 0.4 mm to 0.8 mm, and the distance between each hole is 0.4 mm to 0.8 mm.

6. The cranio-maxillofacial bone induction implant according to claim 1, wherein, The PEEK support layer (1) and the bone induction layer (2) are connected by double-nozzle fused deposition modeling.

7. The cranio-maxillofacial bone induction implant according to claim 1, characterized in that, The thickness of the bone induction layer (2) is greater than or equal to 0.8 mm.

8. A cranio-maxillofacial bone induction implant according to claim 1, characterized in that, The PEEK support layer (1) has a plurality of through holes (3).

9. A craniofacial bone induction implant according to claim 1, wherein The inner layer of the bone induction layer (2) matches the surface of the skull.

10. The craniofacial bone induction implant according to claim 1, characterized in that, The inner layer of the bone induction layer (2) matches the bone surface of the maxillofacial region.

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