Implant for fixing and repairing maxillofacial osteotomy

Abstract

The utility model relates to an implant for fixing and repairing in maxillofacial osteotomy, which is characterized by comprising a prosthesis (1) made of PEEK (polyetheretherketone) material, the prosthesis (1) is provided with an inner surface (1a) and an outer surface (1b), the inner surface (1a) is provided with a step part (11) matched with a step-shaped bone surface after maxillofacial osteotomy, the outer surface (1b) is a smooth surface matched with a soft tissue in shape, and the inner surface (1a) is provided with a step part (11) matched with the step-shaped bone surface after maxillofacial osteotomy. The prosthesis (1) is provided with a plurality of nail holes (2) penetrating through the inner surface (1a) and the outer surface (1b) in the thickness direction and a plurality of circulation holes (3) penetrating through the inner surface (1a) and the outer surface (1b) in the thickness direction. And the inner surface with the step part can also play a role in transition and shaping of the step surface after osteotomy, the appearance is beautified, personalized design is adopted, the bone surface of a patient is completely fitted, and shaping adjustment in an operation is reduced.

Description

TECHNICAL FIELD

[0001] The utility model relates to a kind of implants for maxillofacial Le-Fort Ⅰ osteotomy fixation and repair. BACKGROUND

[0002] Le-Fort Ⅰ osteotomy: maxillary Le-Fort Ⅰ advancement is a surgical method for correcting maxillary hypoplasia. The surgical procedure is as follows: the maxilla is cut along the Le-Fort Ⅰ fracture line, the cut bone block is moved forward or backward, and then a shaped titanium plate with steps is used to connect and fix. The following documents all describe the aforementioned osteotomy.

[0003] Zhou Nuo, Meng Min, Ouzi Min, et al. Application of Le Fort Ⅰ osteotomy in the treatment of maxillary deformity [J]. Journal of Guangxi Medical University, 1992, (04): 68-70. DOI: 10.16190 / j.cnki.45-1211 / r.1992.04.025.

[0004] Wang Yuqin, Chen Zhihong. Le Fort Ⅰ osteotomy for correction of midfacial 1 / 3 jaw deformity [J]. Chinese Journal of Plastic Surgery and Burns, 1992, 8(02): 105-107.

[0005] Lu Yuning, Li Weizhong, Wu Naiqiang. Common complications of maxillary Le Fort Ⅰ osteotomy and their possible causes [J]. Guangdong Dental Disease Prevention, 2000, (01): 74-75.

[0006] Le-Fort Ⅰ osteotomy uses titanium plates to fix the osteotomy site at the present stage. For example, the Chinese utility model patent with patent number CN201822120129.2 (publication number CN209404926U) discloses a straight mandibular condyle internal fixation titanium plate. However, the aforementioned osteotomy has the following problems:

[0007] 1. After osteotomy, there will be a clear step surface, and the transition will be unnatural. In the case of thin soft tissue in the middle of the face, the step may be visible in appearance.

[0008] 2. Due to insufficient contact area between bone segments or excessive distance between them without bone grafting, poor postoperative retention, or insufficient fixation time, etc., fibrous healing or partial fibrous healing may occur between bone segments. Common manifestations include varying degrees of maxillary loosening, unstable occlusion, and weak mastication, which affect mastication function.

[0009] 3. Titanium plates are standard products, which are bent and shaped according to the actual needs of patients, increasing the complexity of the operation. In addition, the titanium plates may not completely fit the patient's bone surface, resulting in poor fixation and forward movement effect.

[0010] 4. The use of titanium plates for connection and fixation can cause significant artifacts under CT.

[0011] Therefore, the existing titanium plate used to fix the osteotomy needs to be replaced by another structure. SUMMARY

[0012] The technical problem to be solved by the utility model is to provide a structure designed implant for replacing the titanium plate and used for maxillofacial osteotomy fixation and repair.

[0013] The utility model adopts the technical scheme that a kind of implant for maxillofacial osteotomy fixation and repair, characterized by: including the prosthesis made of PEEK material, the prosthesis has inner surface and outer surface, the inner surface has the step part matched with the step-shaped bone surface after maxillofacial osteotomy, the outer surface is the smooth surface matched with the soft tissue form, the prosthesis is equipped with multiple nail holes along the thickness direction and penetrates the inner surface and outer surface, and multiple through-flow holes along the thickness direction and penetrates the inner surface and outer surface.

[0014] As preferred, the nail hole has a small hole part and a large hole part, the small hole part penetrates the inner surface and communicates with the large hole part, and the large hole part penetrates the outer surface. The large hole part can hide the head of the titanium nail and better constrain the head.

[0015] As preferred, the large hole part is a conical hole with a large outer diameter and a small inner diameter. The conical hole can increase the contact area of the head of the titanium nail and the large hole part.

[0016] To further increase the bonding effect of soft tissue and implant surface, the number of through-flow holes is more than the number of nail holes, and each nail hole has at least one through-flow hole on both sides.

[0017] To fix the prosthesis and the jaw bone more firmly, as preferred, the nail hole is divided into upper and lower rows, each row has multiple nail holes, the nail holes in the upper row are all located above the step part, and the nail holes in the lower row are all located below the step part.

[0018] To make the soft tissue on both sides of the osteotomy line well combined with the implant surface, at least multiple through-flow holes are located above the step part, and multiple through-flow holes are located below the step part.

[0019] Compared with the prior art, the implant for maxillofacial osteotomy fixation and repair has the advantages that: the personalized peek implant prosthesis is designed according to CT data of a patient, which plays a role in rigid connection of bone segments, avoids possible fibrous healing or partial fibrous healing between the bone segments, and the inner surface of the stepped portion can play a role in transition and shaping of the stepped surface after osteotomy, beautify the appearance, and the personalized design is completely fitted to the bone surface of the patient, so that the shaping adjustment in surgery is reduced; the nail holes are used for fixing the implant by titanium nails, the through holes are used for increasing the combination effect of soft tissue and the surface of the implant, and animal experiments are conducted, so that the combination effect of the surface of the implant and tissue is significantly improved, the titanium nail has a small volume, and almost no artifact appears under CT imaging, so that the artifact problem of CT imaging existing in titanium plate connection and fixation is avoided. BRIEF DESCRIPTION OF DRAWINGS

[0020] Figure 1 It is a front perspective view of an embodiment of the utility model.

[0021] Figure 2 It is a back perspective view of an embodiment of the utility model.

[0022] Figure 3 It is a side perspective view of an embodiment of the utility model.

[0023] Figure 4 It is a use state diagram of an embodiment of the utility model. DETAILED DESCRIPTION

[0024] The utility model will be further described in detail in combination with the drawings.

[0025] As shown in the figure, it is an embodiment of the utility model. Figures 1 to 4

[0026] An implant for maxillofacial osteotomy fixation and repair, comprising a prosthesis 1 made of PEEK material, the prosthesis 1 has an inner surface 1a and an outer surface 1b, the inner surface 1a has a stepped portion 11 matched with the stepped bone surface after maxillofacial osteotomy, the outer surface 1b is a smooth surface matched with the shape of soft tissue, a plurality of nail holes 2 and a plurality of through holes 3 are arranged on the prosthesis 1 and penetrate the inner surface 1a and the outer surface 1b in the thickness direction.

[0027] The nail hole 2 has a small hole part 2a and a large hole part 2b, the small hole part 2a penetrates the inner surface 1a and communicates with the large hole part 2b, and the large hole part 2b penetrates the outer surface 1b. The large hole part 2b is a tapered hole with an outer large and inner small structure. The nail hole 2 is divided into two rows, each row has a plurality of nail holes 2, the nail holes 2 in the upper row are all located above the stepped portion 11, and the nail holes 2 in the lower row are all located below the stepped portion 11.​

[0028] The number of flow-through holes 3 is more than the number of nail holes 2, and at least one flow-through hole 3 is arranged on each side of each nail hole 2. Among the flow-through holes 3, at least a plurality of flow-through holes 3 are arranged above the stepped portion 11, and a plurality of flow-through holes 3 are arranged below the stepped portion 11.

[0029] In use, as shown in the figure, the prosthesis 1 is fixed in the corresponding position by titanium nails. Figure 4

[0030] The specific design process of the implant is as follows.

[0031] 1. Reverse reconstruction: according to the CT data of the patient, the patient's skeleton with complete, accurate and clear boundary contour is reversely extracted by threshold segmentation, manual selection segmentation and other methods.

[0032] 2. Bone cutting design: according to the patient's bite type, the amount of forward movement required after cutting the patient's jaw bone is determined, and the Le-Fort Ⅰ fracture line is cut off and moved forward.

[0033] 3. Prosthesis design: according to the stepped bone surface after cutting, the implant with a stepped portion is designed to completely fit the patient's bone surface, and the outer surface is designed according to the patient's bone and soft tissue morphology, so as to achieve smooth transition. After the surface design is completed, the nail hole and the flow-through hole are designed. The function of the nail hole is to fix the implant with titanium nails (the volume of the titanium nail is small, and there is almost no artifact under the CT image), and the function of the flow-through hole is to increase the combination effect of the soft tissue and the surface of the implant.

[0034] 4. Flow-through hole optimization: the diameter, angle and hole distance combination of the flow-through hole are optimized, and animal experiments are conducted, which can significantly improve the combination effect of the implant surface and the tissue.

[0035] It should be noted that in the description of the embodiments, the terms "front, back, left, right, up and down" indicate the orientation or positional relationship shown in the drawings, and are only used to facilitate the description of the present application and simplify the description, and do not indicate or imply that the devices or elements referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as a limitation on the present application. The terms "mounting", "connection", "connection" should be understood broadly, for example, it can be fixed connection, or detachable connection, or integral connection; it can be directly connected, or indirectly connected through an intermediate medium, or the communication between two elements. For those skilled in the art, the specific meaning of the above terms in the present application can be understood according to the specific circumstances.​

Claims

1. An implant for fixation and repair in maxillofacial osteotomy, characterized in that: The prosthesis (1) is made of PEEK material. The prosthesis (1) has an inner surface (1a) and an outer surface (1b). The inner surface (1a) has a step portion (11) that matches the step-shaped bone surface after maxillofacial osteotomy. The outer surface (1b) is a smooth surface that matches the soft tissue morphology. The prosthesis (1) is provided with a plurality of pin holes (2) that penetrate the inner surface (1a) and the outer surface (1b) along the thickness direction, and a plurality of flow holes (3) that penetrate the inner surface (1a) and the outer surface (1b) along the thickness direction.

2. The implant for fixation and repair of maxillofacial osteotomy according to claim 1, characterized in that: The nail hole (2) has a small hole (2a) and a large hole (2b). The small hole (2a) penetrates the inner surface (1a) and communicates with the large hole (2b), while the large hole (2b) penetrates the outer surface (1b).

3. The implant for fixation and repair of maxillofacial osteotomy according to claim 2, characterized in that: The large hole (2b) is a tapered hole for the outer large inner pin.

4. The implant for fixation and repair of maxillofacial osteotomy according to claim 1, characterized in that: The number of flow holes (3) is greater than the number of nail holes (2), and each nail hole (2) has at least one flow hole (3) on both sides.

5. The implant for fixation and repair of maxillofacial osteotomy according to claim 1, characterized in that: The nail holes (2) are divided into two rows, with multiple nail holes (2) in each row. All the nail holes (2) in the upper row are located above the step (11), and all the nail holes (2) in the lower row are located below the step (11).

6. The implant for fixation and repair of maxillofacial osteotomy according to claim 1, characterized in that: In the flow holes (3), at least a plurality of flow holes (3) are located above the stepped portion (11), and a plurality of flow holes (3) are located below the stepped portion (11).

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