A craniofacial bone plate

Abstract

The utility model discloses a kind of craniofacial bone plates, the craniofacial bone plate includes: at least two fixed parts, the fixed part is provided with fixed hole, the fixed hole is spherical hole;At least one connecting part, every adjacent two The fixed part is connected as a whole by the connecting part;The craniofacial bone plate is made of including the polyether ether ketone material that meets medical implant requirement.In the utility model, by designing fixed hole with spherical hole structure on bone plate, the angle flexibility of screw fastening is significantly improved, the harsh requirement of traditional through hole / counterbore hole to screw vertical direction is solved, and medical PEEK material is used, which has the advantages of mechanical adaptability, no image artifact and biocompatibility.

Description

Technical Field

[0001] This utility model relates to the field of medical device technology, and further to a craniofacial bone plate. Background Technology

[0002] When patients suffer craniofacial fractures and bone defects due to various reasons, titanium and polyetheretherketone (PEEK) are commonly used artificial repair and fixation materials. PEEK craniofacial bone plates must meet the standards for implantable medical devices. Compared to titanium bone plates, which are more commonly used in clinical practice, PEEK bone plates offer several advantages in craniofacial procedures.

[0003] First, PEEK material's hardness and strength are closer to those of human bone, and its elastic modulus is much lower than that of titanium and titanium alloys, effectively reducing the risk of bone resorption caused by stress shielding. Additionally, PEEK material has low thermal conductivity, resulting in better patient comfort when using PEEK bone plates. Furthermore, PEEK material does not produce artifacts in imaging examinations, thus not affecting the doctor's assessment of surgical outcomes or subsequent disease examinations. Therefore, doctors currently prefer PEEK prostheses for surgery, especially suitable for young patients, those with metal allergies, and those requiring frequent imaging examinations.

[0004] In existing PEEK bone plate products, the holes used for fixation are usually through holes or countersunk holes. However, this requires that the screw axis direction, the vertical direction of the bone plate, and the vertical direction of the craniofacial bone tangent must be consistent during the tightening process of self-tapping screws and self-drilling screws in order to achieve a more ideal tightening effect. Otherwise, it may lead to screw loosening, loosening of bone repair plates and bone flaps, and surgical failure, which to some extent limits the application of PEEK bone plates.

[0005] Therefore, it is necessary to design a craniofacial bone plate to solve the above problems. Utility Model Content

[0006] To address the aforementioned technical problems, the purpose of this utility model is to provide a craniofacial bone plate. By designing a fixing hole with a spherical hole structure on the bone plate, the angular flexibility during screw tightening is significantly improved, solving the stringent requirements of traditional through-hole / counter-hole for the vertical direction of the screw. The use of medical-grade PEEK material combines the advantages of mechanical compatibility, absence of imaging artifacts, and biocompatibility.

[0007] To achieve the above objectives, this utility model provides a craniofacial bone plate, comprising:

[0008] At least two fixing parts are provided, and each fixing part is provided with a fixing hole, which is a spherical hole;

[0009] At least one connecting part, wherein every two adjacent fixing parts are connected as one unit through the connecting part;

[0010] The craniofacial bone plate is made of polyetheretherketone (PEEK) material that meets medical implant requirements.

[0011] In some embodiments, the spherical radius of the spherical hole is 1mm-5mm.

[0012] In some embodiments, the inner diameter of the upper side of the spherical hole is 1mm-5mm.

[0013] In some embodiments, the craniofacial bone plate is integrally formed, and the thickness of the craniofacial bone plate is 0.2mm-2mm.

[0014] In some embodiments, the width of the connecting portion is smaller than the width of the fixing portion.

[0015] In some embodiments, the connection between the connecting portion and the fixing portion is smooth.

[0016] In some embodiments, the length of the connecting portion is 3mm-50mm.

[0017] In some embodiments, the craniofacial bone plate is made of one of the following: pure polyetheretherketone, composite hydroxyapatite, composite calcium phosphate, or composite bone morphogenetic protein.

[0018] In some embodiments, the surface of the craniofacial bone plate is coated with a coating of hydroxyapatite or calcium phosphate.

[0019] In some embodiments, the craniofacial bone plate is any one of the following: straight bone plate, C-type bone plate, Y-type bone plate, double Y-type bone plate, X-type bone plate, rectangular bone plate, square bone plate, H-type bone plate, L-type bone plate, T-type bone plate, U-type bone plate, Z-type bone plate, mesh bone plate, and irregular bone plate.

[0020] Compared with the prior art, the craniofacial bone plate provided by this utility model has at least one of the following beneficial effects:

[0021] This invention solves the problem of the craniofacial bone plate not fitting well with the craniofacial bone and bone repair plate during screw tightening, thus preventing weak connections between the bone plate and the PEEK bone repair plate, as well as between the bone plate and the craniofacial bones, which could affect the patient's health. By designing a fixing hole with a spherical hole structure on the bone plate, the angular flexibility during screw tightening is significantly improved, solving the stringent requirements of traditional through-hole / counter-hole holes on the vertical direction of the screw. The use of medical-grade PEEK material combines the advantages of mechanical compatibility, absence of imaging artifacts, and biocompatibility. Attached Figure Description

[0022] The preferred embodiments will be described below in a clear and easy-to-understand manner, in conjunction with the accompanying drawings, to further explain the above-mentioned characteristics, technical features, advantages and implementation methods of this utility model.

[0023] Figure 1 This is a schematic diagram of the structure of the craniofacial bone plate of the preferred embodiment of this utility model;

[0024] Figure 2 This is a schematic diagram of the structure of a preferred embodiment of the linear porous craniofacial bone plate of this utility model;

[0025] Figure 3 This is a schematic diagram of the structure of a linear porous craniofacial bone plate, another preferred embodiment of this utility model;

[0026] Figure 4 This is a schematic diagram of the structure of a linear porous craniofacial bone plate, another preferred embodiment of this utility model;

[0027] Figure 5 This is a schematic diagram of the structure of the preferred embodiment of the present invention, the C-type porous craniofacial bone plate;

[0028] Figure 6 This is a schematic diagram of the structure of the Y-shaped porous craniofacial bone plate, a preferred embodiment of this utility model;

[0029] Figure 7 This is a schematic diagram of the structure of the preferred embodiment of the double Y-shaped porous craniofacial bone plate of this utility model;

[0030] Figure 8 This is a schematic diagram of the structure of the preferred embodiment of the X-type porous craniofacial bone plate of this utility model;

[0031] Figure 9 This is a schematic diagram of the structure of the rectangular porous craniofacial bone plate, a preferred embodiment of this utility model;

[0032] Figure 10 This is a schematic diagram of the preferred embodiment of the square porous craniofacial bone plate of this utility model;

[0033] Figure 11 This is a schematic diagram of the structure of the preferred embodiment of the H-type porous craniofacial bone plate of this utility model;

[0034] Figure 12 This is a schematic diagram of the structure of the preferred embodiment of the L-shaped-left-type porous craniofacial bone plate of this utility model;

[0035] Figure 13 This is a schematic diagram of the structure of the preferred embodiment of the L-shaped-right porous craniofacial bone plate of this utility model;

[0036] Figure 14This is a schematic diagram of the structure of the T-shaped porous craniofacial bone plate, a preferred embodiment of this utility model;

[0037] Figure 15 This is a schematic diagram of the structure of the preferred embodiment of the U-shaped porous craniofacial bone plate of this utility model;

[0038] Figure 16 This is a schematic diagram of the structure of the preferred embodiment of the Z-type porous craniofacial bone plate before bending.

[0039] Figure 17 This is a schematic diagram of the structure of the Z-type porous craniofacial bone plate after bending, a preferred embodiment of this utility model.

[0040] Figure 18 This is a schematic diagram of the Z-type porous craniofacial bone plate, a preferred embodiment of the present invention, after bending, from another perspective.

[0041] Figure 19 This is a schematic diagram of the structure of the preferred embodiment of the mesh porous craniofacial bone plate of this utility model;

[0042] Figure 20 This is a schematic diagram of the structure of the preferred embodiment of the irregular porous craniofacial bone plate of this utility model.

[0043] Explanation of icon numbers:

[0044] Fixing part 1, fixing hole 2, connecting part 3. Detailed Implementation

[0045] To more clearly illustrate the technical solutions in the embodiments of this utility model or the prior art, the specific implementation methods of this utility model will be described below with reference to the accompanying drawings. Obviously, the drawings described below are merely some embodiments of this utility model. For those skilled in the art, other drawings and other implementation methods can be obtained based on these drawings without any creative effort.

[0046] To keep the drawings concise, each figure only schematically shows the parts relevant to the utility model, and these do not represent the actual structure of the product. Furthermore, for ease of understanding, in some figures, only one of the components with the same structure or function is schematically depicted, or only one is labeled. In this document, "one" not only means "only one," but can also mean "more than one."

[0047] It should also be further understood that the term “and / or” as used in this application specification and the appended claims means any combination of one or more of the associated listed items and all possible combinations, and includes such combinations.

[0048] In this document, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to fixed connections, detachable connections, or integral connections; they can refer to mechanical connections or electrical connections; they can refer to direct connections or indirect connections through an intermediate medium; and they can refer to the internal connection between two components. Those skilled in the art can understand the specific meaning of the above terms in this utility model based on the specific circumstances.

[0049] Furthermore, in the description of this application, the terms "first," "second," etc., are used only to distinguish descriptions and should not be construed as indicating or implying relative importance.

[0050] In one embodiment, refer to the appendix to the specification. Figure 1 , Figure 2 The present invention provides a craniofacial bone plate, comprising: at least two fixing parts 1 and at least one connecting part 3, wherein the fixing parts 1 are provided with fixing holes 2, and the fixing holes 2 are spherical holes; each pair of adjacent fixing parts 1 are connected as one unit through the connecting part 3; the craniofacial bone plate is made of polyetheretherketone material that meets the requirements for medical implantation.

[0051] Furthermore, the spherical radius of the spherical hole is 1mm-5mm, and can be set to any value within this range according to actual needs. The fixing hole 2 is a spherical hole structure that works with screws for fastening, which allows for greater flexibility in the direction of fastening self-tapping screws and self-drilling screws, and the screw axis can be at a certain angle to the perpendicular direction of the bone plate.

[0052] Furthermore, the inner diameter of the upper side of the spherical hole is 1mm-5mm, and the spherical radius of the spherical hole can be set to any value within this range according to actual needs. The inner diameter of each fixation hole 2 is the same, and the outer diameter of the outermost and other fixation holes connected to autologous bone should be minimized according to the structural and material stress requirements to reduce autoimmune reactions caused by foreign body implantation as much as possible.

[0053] Furthermore, the craniofacial bone plate is integrally molded, with a thickness of 0.2mm-2mm and a length of 3mm-50mm for the connecting part 3. The width of the connecting part 3 is smaller than the width of the fixation part 1, and the connection between the connecting part 3 and the fixation part 3 is smooth. The specific dimensions of the craniofacial bone plate and the connecting part 3 can be set to any value within this range according to actual needs. By optimizing the structural dimensions of the craniofacial bone plate, the volume of foreign body implantation is reduced, the risk of immune rejection is lowered, while ensuring mechanical support strength.

[0054] Furthermore, the craniofacial bone plate is made of one of the following: pure polyetheretherketone (PEEK), composite hydroxyapatite, composite calcium phosphate, or composite bone morphogenetic protein. For example, the craniofacial bone plate may be made of PEEK material that meets medical implantability requirements, or a composite material of PEEK and other components (such as hydroxyapatite, carbon fiber, etc.), or a surface-modified material of the above materials.

[0055] Furthermore, the surface of the craniofacial bone plate is coated with a hydroxyapatite or calcium phosphate coating. By uniformly distributing hydroxyapatite or calcium phosphate on the surface of the craniofacial bone plate, new bone will form at the contact point between the defective craniofacial region and the bone plate, filling the entire gap between the defective craniofacial region and the bone plate, and growing on the hydroxyapatite. Callus is likely to form at the defective craniofacial region covered by the implant, ultimately integrating the craniofacial bone plate with the human tissue, significantly reducing the risk of postoperative infection.

[0056] Furthermore, craniofacial bone plates can be manufactured using traditional subtractive processing methods such as machining, or additive manufacturing methods such as 3D printing.

[0057] Furthermore, the craniofacial bone plate can be any one of the following: straight bone plate, C-type bone plate, Y-type bone plate, double Y-type bone plate, X-type bone plate, rectangular bone plate, square bone plate, H-type bone plate, L-type bone plate, T-type bone plate, U-type bone plate, Z-type bone plate, mesh bone plate, or irregular bone plate.

[0058] In this embodiment, the craniofacial bone plate is made of polyetheretherketone (PEEK) material or its composite material that meets the requirements for medical implantability. It can be used to connect with PEEK material bone repair plates after craniofacial bone defects, and can also be used for internal fixation and orthodontics after craniofacial fractures. Fixation hole 2 is a spherical hole structure for screw fastening, which allows for more flexible direction of the self-tapping screw and self-drilling screw fastening process. The screw axis can be at a certain angle to the perpendicular direction of the bone plate. The inner diameter of each fixation hole is the same, and the outer diameter of the outermost and other fixation holes connected to autologous bone should be minimized according to the structural and material stress requirements to reduce the autoimmune reaction caused by foreign body implantation as much as possible.

[0059] This invention solves the problem of poor adhesion between the craniofacial bone plate and the craniofacial bone and bone repair plate during screw tightening, preventing weak connections between the bone plate and the PEEK bone repair plate, as well as between the bone plate and the craniofacial bones, which could affect the patient's health. By designing fixation holes with a spherical hole structure on the bone plate, the angular flexibility during screw tightening is significantly improved, solving the stringent requirements of traditional through-hole / counter-hole screws on the vertical direction. The use of medical-grade PEEK material combines the advantages of mechanical compatibility, absence of imaging artifacts, and biocompatibility.

[0060] In one embodiment, refer to the appendix to the specification. Figure 1 , Figure 2 The craniofacial bone plate has a straight-chain structure with a thickness of 0.2–2 mm. It features six identical spherical holes (more holes can be added), with an upper inner diameter and radius of 1–5 mm. The fixation parts 1 at both ends are used for connection to the bone; therefore, their outer diameter is smaller, while the middle fixation part 1 is larger. The distance between the connecting parts 3 is 2–60 mm. Screws are used for fixing bone flaps and for fixing bone flaps to the bone repair plate. The screws can be tightened even when inserted at an angle. The craniofacial bone plate can be used on the skull and maxillofacial region. The plate specifications vary depending on the application; smaller plates are used for the nose, orbit, and zygomatic region, while larger plates are used for the mandible and skull.

[0061] In practical applications, craniofacial bone plates can be designed with different structures according to actual needs. The following are some examples of these structures:

[0062] For example, refer to the appendix to the instruction manual. Figure 3 This is a schematic diagram of a linear porous craniofacial bone plate. The craniofacial bone plate has six identical fixing parts 1, six identical fixing holes 2, and five identical connecting parts 3. ； The size of the fixing hole 2 can also be set to be different, and the shape and size of the connecting part 3 can also be set to be different. Of course, the fixing part 1 and the connecting part 3 can also be set to other quantities, such as the number of connecting parts 3 being n and the number of fixing parts 1 being n+1, where n is a positive integer greater than 1.

[0063] For example, refer to the appendix to the instruction manual. Figure 4 This is a schematic diagram of another type of straight-chain porous craniofacial bone plate. The craniofacial bone plate has six fixing parts 1. The two fixing parts 1 at both ends are used for direct connection to the bone and are smaller in size than the fixing parts 1 at other locations. The six fixing holes 2 are the same in shape and size, and the five connecting parts 3 are the same in shape and size. Of course, the number of fixing parts 1 and connecting parts 3 can also be set to other numbers, such as n connecting parts 3 and n+1 fixing parts 1, where n is a positive integer greater than 1.

[0064] For example, refer to the appendix to the instruction manual. Figure 5This is a schematic diagram of another type of C-shaped porous craniofacial bone plate. The craniofacial bone plate has twelve fixation parts 1. The two fixation parts 1 at both ends are used for direct connection to the bone and are smaller than the size of the fixation parts 1 in other locations. The twelve fixation holes 2 are of the same shape and size, and the eleven connecting parts 3 are of the same shape and size. The size of the fixation holes 2 and the shape and size of the connecting parts 3 can also be set differently. More small-sized fixation parts 1 can also be set, and their specific locations are not limited. Of course, the number of fixation parts 1 and connecting parts 3 can also be set to other quantities, such as n for the number of connecting parts 3 and n+1 for the number of fixation parts 1, where n is a positive integer greater than 1.

[0065] For example, refer to the appendix to the instruction manual. Figure 6 This is a schematic diagram of a Y-shaped craniofacial bone plate. The connecting part 3 at one end is different from other parts. The connecting part 3 is Y-shaped. The three fixing parts 1 at the end of the craniofacial bone plate are used to directly connect with the bone and are smaller in size than the fixing parts 1 at other positions.

[0066] For example, refer to the appendix to the instruction manual. Figure 7 This is a schematic diagram of a double Y-shaped craniofacial bone plate, wherein the four fixing parts 1 located at the ends of the craniofacial bone plate are used to directly connect with the bone and are smaller in size than the fixing parts 1 in other positions.

[0067] For example, refer to the appendix to the instruction manual. Figure 8 This is a schematic diagram of an X-shaped craniofacial bone plate. The craniofacial bone plate has four fixation parts 1 with the same shape and size, four fixation holes 2 with the same shape and size, and one connecting part 3. The connecting part 3 is cross-shaped and can be used with screws to fix bone flaps or bone flaps and bone repair plates.

[0068] For example, refer to the appendix to the instruction manual. Figure 9 This is a schematic diagram of a rectangular craniofacial bone plate. The craniofacial bone plate is provided with four fixing parts 1 that are exactly the same in shape and size, four fixing holes 2 that are the same in shape and size, and four connecting parts 3, of which two connecting parts 3 that are arranged opposite each other are the same.

[0069] For example, refer to the appendix to the instruction manual. Figure 10 This is a schematic diagram of a square craniofacial bone plate. The craniofacial bone plate has four fixing parts 1 with the same shape and size, four fixing holes 2 with the same shape and size, and four connecting parts 3 with the same shape and size.

[0070] For example, refer to the appendix to the instruction manual. Figure 11This is a schematic diagram of an H-shaped porous craniofacial bone plate. The craniofacial bone plate is provided with eleven fixing parts 1. The four fixing parts 1 at both ends are used to directly connect with the bone and are smaller in size than the fixing parts 1 at other positions. The eleven fixing holes 2 are the same in shape and size, and the ten connecting parts 3 are the same in shape and size, or the size of the vertical connecting parts 3 is set to be different from the size of the horizontal connecting parts 3.

[0071] For example, refer to the appendix to the instruction manual. Figure 12 This is a schematic diagram of an L-shaped-left PEEK craniofacial bone plate. The craniofacial bone plate has ten fixation parts 1. The two outermost fixation parts 1 and the fixation part 1 at the turning point are used to directly connect with the bone. The size of the fixation parts 1 is smaller than that of the fixation parts 1 at other positions. The ten fixation holes 2 are the same in shape and size. There are nine connecting parts 3. The size of the connecting part 3 located at the corner is different from that at other positions.

[0072] For example, refer to the appendix to the instruction manual. Figure 13 This is a schematic diagram of an L-shaped-right PEEK craniofacial bone plate. The craniofacial bone plate is provided with ten fixation parts 1. The two outermost fixation parts 1 and the fixation part 1 at the turning point are used to directly connect with the bone. The size is smaller than the size of the fixation parts 1 at other positions. The ten fixation holes 2 are the same in shape and size. There are nine connecting parts 3. The size of the connecting part 3 located at the corner is different from that at other positions.

[0073] For example, refer to the appendix to the instruction manual. Figure 14 This is a schematic diagram of a T-shaped craniofacial bone plate. The craniofacial bone plate is provided with seven fixing parts 1. The three outermost fixing parts 1 are used to directly connect with the bone and are smaller in size than the fixing parts 1 in other positions. The seven fixing holes 2 are the same in shape and size. There are six connecting parts 3. The connecting part 3 located at the connection between the horizontal and vertical segments is different in size from the other positions.

[0074] For example, refer to the appendix to the instruction manual. Figure 15 This is a schematic diagram of a U-shaped craniofacial bone plate. The craniofacial bone plate has a bottom section and two side sections. The fixing part 1 located at the bottom section is used to directly connect with the bone and its size is smaller than that of the fixing part 1 located at the side sections. The size of the connecting part 3 located at the bottom section is also different from that of the connecting part 3 located at the side sections.

[0075] For example, refer to the appendix to the instruction manual. Figures 16 to 18 This is a schematic diagram of a Z-shaped craniofacial bone plate, in which... Figure 16 This is a schematic diagram of the Z-shaped porous craniofacial bone plate before bending. Figure 17 This is a top view of the Z-shaped porous craniofacial bone plate after bending. Figure 18This is a side view of the Z-shaped porous craniofacial bone plate after bending. The craniofacial bone plate has four fixing parts 1 with the same shape and size, four fixing holes 2 with the same shape and size, and four connecting parts 3. The two connecting parts 3 that are arranged opposite each other are the same, and two of the connecting parts 3 are Z-shaped.

[0076] For example, refer to the appendix to the instruction manual. Figure 19 This is a schematic diagram of a mesh craniofacial bone plate. The craniofacial bone plate has six fixing parts 1 with the same shape and size, six fixing holes 2 with the same shape and size, and one connecting part 3, which is a mesh structure.

[0077] For example, refer to the appendix to the instruction manual. Figure 20 This is a schematic diagram of a heteromorphic craniofacial bone plate. Its specific shape and size can be set according to actual needs.

[0078] It should be noted that the specific structure of the craniofacial bone plate is described in accordance with the accompanying drawings in the specification. In actual use, it can be configured with other structures according to different actual needs, as long as the above functions can be achieved. This is only for better illustrating the present invention and should not constitute a limitation on the present invention.

[0079] In the above embodiments, the descriptions of each embodiment have different focuses. For parts that are not described in detail or recorded in a certain embodiment, please refer to the relevant descriptions of other embodiments.

[0080] It should be noted that the above embodiments can be freely combined as needed. The above are merely preferred embodiments of this utility model. It should be pointed out that for those skilled in the art, several improvements and modifications can be made without departing from the principle of this utility model, and these improvements and modifications should also be considered within the protection scope of this utility model.

Claims

1. A craniofacial bone plate, characterized in that, include: At least two fixing parts are provided, and each fixing part is provided with a fixing hole, which is a spherical hole; At least one connecting part, wherein every two adjacent fixing parts are connected as one unit through the connecting part; The craniofacial bone plate is made of polyetheretherketone (PEEK).

2. The craniofacial bone plate according to claim 1, characterized in that, The spherical radius of the spherical hole is 1mm-5mm.

3. The craniofacial bone plate according to claim 1, characterized in that, The inner diameter of the upper side of the spherical hole is 1mm-5mm.

4. The craniofacial bone plate according to claim 1, characterized in that, The craniofacial bone plate is integrally formed, and the thickness of the craniofacial bone plate is 0.2mm-2mm.

5. The craniofacial bone plate according to claim 1, characterized in that, The width of the connecting part is smaller than the width of the fixing part.

6. The craniofacial bone plate according to claim 4, characterized in that, The connection between the connecting part and the fixing part is smooth.

7. The craniofacial bone plate according to claim 1, characterized in that, The length of the connecting part is 3mm-50mm.

8. The craniofacial bone plate according to claim 1, characterized in that, The surface of the craniofacial bone plate is coated with a hydroxyapatite or calcium phosphate.

9. The craniofacial bone plate according to any one of claims 1-8, characterized in that, The craniofacial bone plate is any one of the following: straight bone plate, C-type bone plate, Y-type bone plate, double Y-type bone plate, X-type bone plate, rectangular bone plate, square bone plate, H-type bone plate, L-type bone plate, T-type bone plate, U-type bone plate, Z-type bone plate, mesh bone plate, or irregular bone plate.

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