Customized orbital bottom plate

Abstract

The utility model relates to a customized orbital bottom plate, which comprises a base plate with a top surface and a bottom surface, and is characterized in that the base plate is a plate body which is preformed according to the fracture condition and anatomical structure of a patient, is matched with the internal appearance of an orbital and is made of polyether-ether-ketone material; the base plate is provided with a plurality of body fluid communication holes penetrating through the top face and the bottom face and a plurality of connecting holes penetrating through the top face and the bottom face and allowing titanium nails to penetrate through, and the hole diameter of the body fluid communication holes is smaller than that of the connecting holes. The base plate is made of a polyether-ether-ketone material (also called PEEK material), so that the upper surface, close to an eyeball, of the orbital bottom plate is smooth, orbital soft tissue can be prevented from being adhered to an implant, and limitation on eyeball movement is reduced; as each product is customized for each patient, a personalized structure is realized, so that the surgical implantation is more accurate, the surgical time is shortened, and the surgical success rate is improved.

Description

Technical Field

[0001] The utility model belongs to the technical field of medical devices for repairing and reconstructing orbital floor bone defects, and in particular relates to a customized orbital floor plate. Background Art

[0002] In cases of orbital fractures or bone defects, orbital floor plates can be used to repair and reconstruct the orbital floor structure, restoring the normal position and function of the eyeball. Some orbital floor plate products, such as the Universal Orbital FloorSystem, are made of pure titanium TA2 material that meets specific standards and undergoes a color-anodized surface treatment for excellent biocompatibility and corrosion resistance. This design makes the product ideal for reconstruction and internal fixation following trauma or bone resection of the orbital floor and / or medial orbital wall. The orbital floor plate provides stable support for the eyeball, ensuring it remains in the correct position. It also protects the eyeball and surrounding nerves, blood vessels, and other tissues from external damage. During surgery, the surgeon will select the appropriate orbital floor plate based on the patient's specific condition and implant it into the orbital floor for fixation. Postoperatively, the orbital floor plate effectively supports the eyeball, restoring its normal position and function, while also reducing the risk of complications such as enophthalmos and diplopia.

[0003] The orbital floor is an important structure at the bottom of the orbit. In clinical applications, selecting appropriate orbital floor products and strictly adhering to surgical specifications are crucial to ensuring surgical effectiveness and patient safety.

[0004] For this purpose, a Chinese utility model patent with patent number ZL201320585550.5 (publication number CN203619658U) entitled "An orbital floor" discloses such an orbital floor, which provides an orbit, including an upper surface, a lower surface in contact with the bone, an isosceles trapezoidal area, two long strip areas, two attachment areas and four fixed areas; the lower base of the isosceles trapezoidal area is slightly longer than the upper base; one end of the two long strip areas is respectively connected to the inner side of the two waists of the isosceles trapezoidal area; one end of the two attachment areas is respectively connected to the two ends of the upper base of the isosceles trapezoidal area; multiple drainage holes are provided on each of the above areas; the fixed area is long strip-shaped, and a row of screw holes is provided on it, which are respectively connected to the lower ends of the two long strip areas and the lower base of the isosceles trapezoidal area.

[0005] The current orbital floor is a flat plate structure made of titanium and is a universal design. However, it has the following technical problems.

[0006] Problem 1: The universal design requires artificial bending and shaping before surgery, which cannot be personalized to different patients. The implant volume is difficult to accurately estimate, which affects eye movement or displacement.

[0007] Question 2: Titanium is the most widely used metal for human implants in modern medicine, accounting for over 80% of implants. Titanium is non-allergenic, carcinogenic, or teratogenic in contact with the human body and integrates well with bone, epithelium, and connective tissue, making it the most biocompatible metal material. The tissue compatibility of the lower surface of the titanium orbital floor enhances its secure fixation. However, the tissue compatibility of the upper surface can lead to postoperative orbital adhesions, compromising surgical outcomes and subsequent treatment.

[0008] In summary, the existing titanium alloy orbital floor needs further improvement. Utility Model Content

[0009] The first technical problem to be solved by the present invention is to provide a customized orbital floor plate that is pre-formed to better fit the shape of the internal bone surface of the orbit in response to the above-mentioned defects of the prior art. The upper surface of the orbital floor plate close to the eyeball is smooth, which can inhibit adhesion of the orbital soft tissue and the implant and reduce restrictions on eyeball movement.

[0010] The second technical problem to be solved by the present invention is to provide a customized orbital floor plate that can further enhance the bonding ability between the implanted orbital floor plate and human tissue and improve the stability of the implant in response to the above-mentioned defects of the prior art.

[0011] The technical solution adopted by the present invention to solve the first technical problem mentioned above is: a customized orbital floor plate, including a base plate, having a top surface and a bottom surface, characterized in that: the base plate is a plate body made of polyetheretherketone material and pre-formed according to the patient's fracture condition and anatomical structure, matching the internal shape of the orbit, and the base plate has a plurality of body fluid exchange holes passing through the top surface and the bottom surface, and a plurality of connection holes passing through the top surface and the bottom surface for titanium nails to pass through, and the aperture of the body fluid exchange hole is smaller than the aperture of the connection hole.

[0012] The above-mentioned substrate has a first part that fits and matches the bone at the bottom of the orbit, and a second part that fits and matches the bone on the side of the orbit. The second part is located on the side of the first part and is tilted upward relative to the first part, and there is a smooth transition between the first and second parts. The outer edge of the second part is in the shape of an arc, and the front edge of the first part is a third part that protrudes forward relative to the front edge of the second part. The body fluid exchange hole is set on the first and second parts, and the connecting hole is set on the third part. The inner and outer surfaces of the substrate are curved, and the three-dimensional structure design makes the entire substrate basically match the internal shape of the orbit, achieving a close fit with the internal tissue of the orbit. It can better restore the original anatomical morphology and physiological function for the support and fixation of orbital comminuted fractures or bone defects. At the same time, the large contact area also avoids compression of bone tissue and prevents bone necrosis. The smooth transition design between the first and second parts avoids stress concentration, reducing the risk of fracture during bending during surgery and fracture during postoperative use.

[0013] In view of the characteristics of polyetheretherketone material, it is preferred that the above-mentioned substrate is manufactured by 3D printing or machining.

[0014] The present invention addresses the second technical problem by providing a bonding layer on the bottom surface of the substrate to enhance its ability to adhere to human tissue. The body fluid exchange holes and connection holes penetrate through the bonding layer, revealing it. This enhanced bonding layer allows the substrate's bottom surface to adhere to human tissue, ensuring the stability of the entire orbital floor implant, while also combining the advantages of traditional titanium substrates.

[0015] As a preferred bonding layer, the bonding layer is a rough tantalum coating. The tantalum coating is sprayed on the bottom surface of the base plate near the orbit. The tantalum coating enhances the bonding ability of the implant to human tissue and improves the stability of the implant. At the same time, the presence of metal allows for imaging with an X-ray machine, facilitating postoperative observation.

[0016] As an implementation method of bonding the tantalum spray coating to the bottom surface of the substrate, the tantalum spray coating is bonded to the bottom surface of the substrate through a plasma spraying process.

[0017] Another preferred bonding layer is a titanium mesh fixed to the bottom surface of the base plate. The titanium mesh is fixed to the bottom surface of the base plate near the orbit. Human tissue can bond with the titanium, providing a certain degree of stability to the implant. Furthermore, the presence of the metal allows for imaging with an X-ray machine, facilitating postoperative observation.

[0018] As a method of fixing the metal titanium mesh to the substrate, the metal titanium mesh is fixed to the bottom surface of the substrate by screws. Of course, the metal titanium mesh can also be fixed to the substrate made of polyetheretherketone in other ways.

[0019] Alternatively, the mesh holes of the titanium metal mesh are rectangular holes, which can make the human body tissue and the titanium metal mesh more firmly bonded.

[0020] Compared with the prior art, the advantages of the present invention are:

[0021] 1. The base plate is made of polyetheretherketone (also known as PEEK), which makes the upper surface of the orbital floor close to the eyeball smooth, inhibits the adhesion of orbital soft tissue and implants, and reduces restrictions on eye movement; the setting of body fluid exchange holes ensures the drainage of fluid on the upper and lower surfaces of the base plate, and the setting of connecting holes facilitates the passage of titanium nails to fix it in the eye socket. Because each product is customized for each patient, a personalized structure is achieved, making surgical implantation more precise, reducing operation time, and improving the success rate of surgery.

[0022] 2. The polyetheretherketone (PEEK) substrate is combined with a metal coating (tantalum coating), and the tantalum coating is located on the bottom surface of the substrate. The upper surface of the substrate close to the eyeball is still a smooth PEEK surface, which inhibits the adhesion of orbital soft tissue to the implant. The tantalum coating increases the bonding ability between the implant and human tissue, improving the stability of the implant. At the same time, due to the presence of metal material, it can be developed by X-ray machine, which is convenient for postoperative observation.

[0023] 3. The polyetheretherketone (PEEK) substrate is combined with a metal titanium mesh, and the metal titanium mesh is located on the bottom surface of the substrate. The upper surface of the substrate close to the eyeball is still a smooth PEEK surface, which inhibits the adhesion of orbital soft tissue to the implant. The metal titanium mesh increases the bonding ability between the implant and human tissue, improving the stability of the implant. At the same time, due to the presence of metal material, it can be developed by X-ray machine, which is convenient for postoperative observation. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Figure 1 This is a schematic diagram of the front three-dimensional structure of the first embodiment of the utility model;

[0025] Figure 2 This is a schematic diagram of the back three-dimensional structure of the first embodiment of the utility model;

[0026] Figure 3 This is a schematic diagram of the back three-dimensional structure of the second embodiment of the utility model;

[0027] Figure 4 This is a front perspective structural diagram of the third embodiment of the present utility model;

[0028] Figure 5 This is a schematic diagram of the back three-dimensional structure of the third embodiment of the present utility model. DETAILED DESCRIPTION

[0029] The present invention will be described in further detail below with reference to the accompanying drawings and embodiments.

[0030] like Figures 1-2 Shown is the first preferred embodiment of the present utility model.

[0031] A customized orbital floor plate includes a base plate 1 having a top surface 1a and a bottom surface 1b. The base plate 1 is pre-formed according to the patient's fracture condition and anatomical structure, matches the internal shape of the orbit, and is made of polyetheretherketone (also known as PEEK material). The base plate 1 has a plurality of body fluid communication holes 1c passing through the top surface 1a and the bottom surface 1b, and a plurality of connection holes 1d passing through the top surface 1a and the bottom surface 1b for titanium nails to pass through. The aperture of the body fluid communication hole 1c is smaller than the aperture of the connection hole 1d.

[0032] The base plate 1 is manufactured using 3D printing or machining. It comprises a first portion 11, which mates with the orbital floor bone, and a second portion 12, which mates with the orbital side bone. The second portion 12 is located to the side of the first portion 11 and tilts upward relative to the first portion 11, with a smooth transition between the first and second portions 11, and an arc-shaped outer edge 121. A third portion 13, with the front edge of the first portion 11 protruding forward relative to the front edge of the second portion 12, is provided. The body fluid exchange port 1c is provided on the first and second portions 11, 12, and the connection port 1d is provided on the third portion 13.

[0033] like Figure 3 FIG. 2 shows a second preferred embodiment of the present invention.

[0034] The difference between this embodiment and the first embodiment is that a bonding layer for enhancing the bonding ability with human tissue is provided on the bottom surface 1b of the polyetheretherketone substrate 1 of the first embodiment, and the body fluid exchange hole 1c and the connection hole 1d penetrate through the bonding layer.

[0035] The bonding layer is a rough tantalum spray coating 2. The tantalum spray coating 2 is bonded to the bottom surface of the substrate 1 via a plasma spraying process. Plasma spraying is a method that uses a direct current-driven plasma arc as a heat source to heat materials such as ceramics, alloys, and metals to a molten or semi-molten state. The material is then sprayed at high speed onto the pre-treated workpiece surface, forming a firmly adhered surface layer.

[0036] like Figures 4-5 FIG. 2 shows a third preferred embodiment of the present utility model.

[0037] The difference between this embodiment and the second embodiment is that the bonding layer is a metal titanium mesh 3 fixed to the bottom surface of the substrate 1. The metal titanium mesh 3 is fixed to the bottom surface of the substrate 1 by screws 4. The mesh holes 31 of the metal titanium mesh 3 are rectangular holes.

[0038] It should be noted that in the description of this embodiment, the terms "front, back", "left, right", "up, down", etc. indicating directions or positional relationships are all based on the directions or positional relationships shown in the accompanying drawings. They are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific direction, be constructed and operated in a specific direction. Therefore, they cannot be understood as limitations on the present invention. The terms "install", "connect", and "connected" should be understood in a broad sense. For example, they can be fixed connections, detachable connections, or integral connections; they can be directly connected, or indirectly connected through an intermediate medium, or they can be internal connections between two elements. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

Claims

1. A customized orbital floor, comprising a base plate (1) having a top surface (1a) and a bottom surface (1b), characterized in that: The base plate (1) is a plate body made of polyetheretherketone material and pre-formed according to the patient's fracture condition and anatomical structure, matching the internal shape of the eye socket. The base plate (1) is provided with a plurality of body fluid communication holes (1c) penetrating the top surface (1a) and the bottom surface (1b), and a plurality of connection holes (1d) penetrating the top surface (1a) and the bottom surface (1b) for titanium nails to pass through. The aperture of the body fluid communication hole (1c) is smaller than the aperture of the connection hole (1d).

2. The customized orbital floor plate according to claim 1, characterized in that: The base plate (1) comprises a first portion (11) which fits with the bone at the bottom of the orbit and a second portion (12) which fits with the bone at the side of the orbit; the second portion (12) is located on the side of the first portion (11) and is tilted upward relative to the first portion (11); and there is a smooth transition between the first portion (11) and the second portion (12); the outer edge (121) of the second portion (12) is in an arc shape; the front edge of the first portion (11) is a third portion (13) which protrudes forward relative to the front edge of the second portion (12); the body fluid exchange hole (1c) is arranged on the first portion (11) and the second portion (12); and the connecting hole (1d) is arranged on the third portion (13).

3. The customized orbital floor plate according to claim 1, characterized in that: The substrate (1) is manufactured by 3D printing or machining.

4. The customized orbital floor plate according to any one of claims 1 to 3, characterized in that: The bottom surface (1b) of the substrate (1) is provided with a bonding layer for enhancing bonding ability with human tissue, and the body fluid communication holes (1c) and the connection holes (1d) penetrate through the bonding layer to expose the bonding layer.

5. The customized orbital floor plate according to claim 4, characterized in that: The bonding layer is a rough tantalum spray coating (2).

6. The customized orbital floor plate according to claim 5, characterized in that: The tantalum spray coating (2) is bonded to the bottom surface of the substrate (1) through a plasma spraying process.

7. The customized orbital floor plate according to claim 4, characterized in that: The bonding layer is a metal titanium mesh (3) fixed on the bottom surface of the substrate (1).

8. The customized orbital floor plate according to claim 7, characterized in that: The metal titanium mesh (3) is fixed to the bottom surface of the base plate (1) via screws (4).

9. The customized orbital floor plate according to claim 8, characterized in that: The mesh holes (31) of the metal titanium mesh (3) are rectangular holes.

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