Bone fracture plate made of absorbable material

Abstract

The invention discloses a bone fracture plate made of an absorbable material, and belongs to the technical field of medical prostheses. The structure comprises a bending structure and two groups of Y-shaped branch structures; the bending structure and the Y-shaped branch structures are both in a plate shape, and the two Y-shaped branch structures are located at the two ends of the bending structure respectively and are parallel to each other. The bending structure and the Y-shaped branch structure are made of 62% of poly-L-lactic acid and 38% of polyglycolic acid. After being implanted into a body, the artificial bone is degraded in the body after fracture recovery, secondary operation is not needed, and physical and mental pain and economic burden of a patient are greatly reduced.

Description

Technical Field

[0001] The present invention relates to the technical field of medical prostheses, and particularly to an absorbable material bone plate. Background Art

[0002] In China, for the bone graft positioning and fixation of oral and maxillofacial fractures in clinical practice, miniplates or titanium plates are usually used. Although these materials have high strength and good biocompatibility, they may hinder the formation of initial bone callus. In addition, the bending modulus of metal materials is much higher than that of cortical bone, which is likely to cause the stress shielding effect, reducing the formation speed and quality of new bone, increasing the risk of osteopenia or osteoporosis, and even possibly leading to secondary fractures;

[0003] Current medical metal materials, such as stainless steel, cobalt-chromium alloy, nickel alloy, and titanium alloy, generally have some problems. Besides being expensive, their mechanical compatibility, biocompatibility, and biodegradability are not satisfactory. Taking titanium alloy as an example, although this material has been widely used in medicine, its main performance defects include: due to the mismatch of elastic modulus, there is an obstacle in the load transfer between the implant and adjacent bone tissues. This makes the risk as an implant unavoidable, which may inhibit bone healing, cause osteoporosis, bone resorption, or bone atrophy, and even lead to secondary fractures. In addition, the degradation of pure titanium in the body may cause allergic reactions and even death. Due to the poor biodegradability of these materials, after the reconstruction of the damaged tissue or organ function, patients often need a second operation to remove the implant, which not only hinders the rehabilitation process but also increases the physical and mental pain and economic burden of the patients;

[0004] PEEK is considered a promising fracture fixation material. However, PEEK itself is a bio-stable material and will not gradually degrade with the fracture healing process, which may cause the material to remain in the body, thus causing discomfort to the patient after fracture healing. In addition, the material conducts part of the stress, which will, to a certain extent, cause the stress shielding effect of the bone tissue in the fixed area, thus affecting the biomechanical strength of the bone tissue. When PEEK covers the surface of the bone tissue, its bio-inertia will hinder the material exchange between the bone tissue and the surrounding soft tissues, which is also the reason for osteoporosis after internal fixation and may even cause bone necrosis in severe cases. Summary of the Invention

[0005] In view of this, the present invention provides an absorbable material bone plate. After being implanted into the body, the bone plate degrades in the body after fracture recovery, eliminating the need for a second operation, greatly reducing the physical and mental pain and economic burden of the patients.

[0006] To achieve the above object, the technical solution adopted by the present invention is as follows:

[0007] An absorbable material bone plate, comprising a bending structure 1 and two groups of Y-shaped branch structures 2; both the bending structure and the Y-shaped branch structures are plate-shaped, the two groups of Y-shaped branch structures are respectively located at both ends of the bending structure, and the two groups of Y-shaped branch structures are parallel to each other;

[0008] The materials of the bending structure and the Y-shaped branch structures are 62% L-lactic acid and 38% glycolic acid.

[0009] Furthermore, the included angle between the bending structure and the Y-shaped branch structure is adjusted to enhance the matching between the bone plate and the jawbone.

[0010] Furthermore, working holes are provided at both the connection ends of the Y-shaped branch structure and the bending structure and the Y-shaped branch structure for installing screws to realize the connection with the jawbone.

[0011] Furthermore, the connection end of the bending structure and the Y-shaped branch structure is the end of the main branch node of the Y-shaped branch structure; there are large parts at the end of the branch node, the end of the main branch node, and the intersection position of the branch node and the main branch node of the Y-shaped branch structure; the working hole is located on the large part and has a step.

[0012] Furthermore, the included angle is 0° to 90°.

[0013] Furthermore, the ratio of the length of the bending structure to the sum of the lengths of the bending structure 1 and the two groups of Y-shaped branch structures 2 is 1:9 to 1:5.

[0014] Furthermore, both the end of the bending structure and the end of the main branch node of the Y-shaped branch structure have large ends, and the two relatively large ends are stacked and closely attached; the thickness of the two stacked and closely attached large ends is equal to the thickness of the branch node of the Y-shaped branch structure.

[0015] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0016] 1. By changing the ratio of PLLA and PGA in the copolymer, a synthetic polymer material with good biodegradability and biocompatibility is obtained, thus avoiding the pain of secondary surgery removal for patients; a high molecular copolymer synthesized from 62% L-lactic acid (PLLA) and 38% glycolic acid (PGA), the elastic modulus of this material is equivalent to that of human cortical bone; it avoids the stress shielding caused by using metal bone plates, reduces the risk borne by patients, and reduces the impact on the newly formed bone;

[0017] 2. The present invention uses 3D printing technology, combined with the reverse of the patient's CT scan data, and successfully realizes the personalized design and manufacturing of the bone plate through three-dimensional drawing, solves the matching problem between the bone plate and the jawbone, greatly improves the surgical accuracy, shortens the surgical time, and reduces the medical burden on patients;

[0018] 3. The absorbable maxillofacial osteosynthesis plate is customized and designed with a double-Y bending structure according to the bone surface conditions at the maxillofacial trauma site of the patient during the operation. The plate thickness is designed to be 0.8 - 1.2 mm, and the number of screw holes is designed to be 8 holes, which can significantly reduce the risks of plate fracture, loosening, etc., promote the efficient healing of bone fracture ends, and ensure that the patient can return to normal life faster;

[0019] 4. The absorbable osteosynthesis plate of the present invention is designed with screw countersinks (formed by steps) and bending structures, which can match the irregular mandibular angles, increase the fitting degree, and greatly reduce the discomfort after the plate is implanted into the face;

[0020] 5. The bending structure and Y-shaped structure of the absorbable maxillofacial osteosynthesis plate can adjust the angle through the rotating connection part to match different parts of different patients. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1 is a schematic structural diagram of an embodiment of the present invention.

[0022] Figure 2 is a schematic diagram of the degradation of a high molecular weight copolymer synthesized from 62% L-lactic acid (PLLA) and 38% glycolic acid (PGA) in an embodiment of the present invention.

[0023] Figure 3 is a schematic diagram of the degradation of a high molecular weight copolymer synthesized from 82% L-lactic acid (PLLA) and 18% glycolic acid (PGA) in an embodiment of the present invention. DETAILED DESCRIPTION OF THE EMBODIMENTS

[0024] Next, the technical solutions in the embodiments of the present invention will be described completely in conjunction with the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the protection scope of the present invention.

[0025] The present invention belongs to the field of bioabsorbable materials, and provides a maxillofacial osteosynthesis plate and screw system prepared from a bioabsorbable material poly(lactic-co-glycolic acid) (PLGA). This absorbable material is a high molecular weight copolymer synthesized from 62% L-lactic acid (PLLA) and 38% glycolic acid (PGA). By adjusting the proportion of glycolide units in PLGA, the degradation period of this material can be regulated to meet the requirements of the clinical degradation period of maxillofacial osteosynthesis plates. Different from metal materials, the present invention degrades in the body after fracture recovery after being implanted into the body, eliminating the need for a second operation, and greatly reducing the physical and mental pain and economic burden of patients.

[0026] Refer to Figure 1As shown, the absorbable maxillofacial plate is mainly composed of three parts: a bending structure 1 and a Y-shaped branch structure 2. These components are precisely made using modern advanced manufacturing technology and 3D printing technology to ensure the best match between their shape and function. The design and production of the absorbable maxillofacial plate is intended to provide a safe and effective solution for the repair of maxillofacial bones.

[0027] During the operation, the bending structure 1 and the Y-shaped branch structure 2 of the absorbable maxillofacial plate are assembled and implanted into the patient's body to help promote the healing of the maxillofacial region. As the patient's body gradually recovers, the bending structure 1 and the Y-shaped branch structure 2 will be completely absorbed by the human body after a certain period of time. This process can not only effectively reduce the long-term impact of the implant material on the body, but also avoid the pain and financial burden of secondary surgery that the patient may face during the recovery period, greatly improving the patient's comfort and quality of life after surgery.

[0028] The Y-shaped branch structure 2 is designed at both ends of the plate. Compared with traditional straight plates, this Y-shaped branch structure not only provides better support, but also effectively reduces the risk of loosening after implantation in the patient, thereby improving the stability and adaptability of the plate. This innovative design enables it to better meet the needs of patients in clinical applications and ensure the durability and reliability of the repair effect.

[0029] like Figure 1 As shown, in the design of the absorbable maxillofacial plate, an innovative bending structure 1 is specially added. This design allows the fit between the plate and the implant site to be optimized by adjusting the angle and length of the bending structure 1, which not only improves the applicability of the absorbable maxillofacial plate, but also enhances its flexibility in clinical applications. Specifically, the angle of the bending structure 1 can be adjusted within the range of 0° to 90°. When the angle of the bending knot 13 is set to 0°, the plate presents a straight double Y-shaped structure, which is very suitable for bone surfaces with flat surfaces. Correspondingly, when the angle of the bending structure 1 is adjusted between 0° and 90°, the plate can present other corresponding shapes, such as an oblique "Z" shape. In addition, the bending structure 1 and the Y-shaped branch structure 2 can be rotated to the desired angle through the connecting part 3. This flexible design allows doctors to select the most suitable bending angle and rotation angle according to specific surgical needs and the patient's bone structure characteristics, thereby further improving the adaptability and functionality of the absorbable maxillofacial plate, so that it can perform optimally in different clinical scenarios.

[0030] like Figure 2 , Figure 3 As shown, Figure 2The relationship between the in vivo fixation strength and time of an absorbable maxillofacial osteosynthesis plate produced from a high molecular weight copolymer synthesized from 62% L-lactic acid (PLLA) and 38% glycolic acid (PGA) used in the present invention; Figure 3 The relationship between the in vivo fixation strength and time of an absorbable maxillofacial osteosynthesis plate produced from a high molecular weight copolymer synthesized from 82% L-lactic acid (PLLA) and 18% glycolic acid (PGA); The specific comparison is shown in Table 1.

[0031] Table 1

[0032]

Claims

1. An absorbable material bone plate, characterized in that, It includes a bending structure (1) and two groups of Y-shaped branch structures (2); both the bending structure and the Y-shaped branch structures are plate-shaped, the two groups of Y-shaped branch structures are respectively located at both ends of the bending structure, and the two groups of Y-shaped branch structures are parallel to each other; The materials of the bending structure and the Y-shaped branch structures are 62% left-handed polylactic acid and 38% polyglycolic acid.

2. The absorbable material bone plate according to claim 1, characterized in that, Adjust the angle between the bending structure and the Y-shaped branch structures to enhance the matching of the bone plate with the jawbone.

3. The absorbable material bone plate according to claim 1, wherein, Working holes are provided at the connection ends of the Y-shaped branch structures and the bending structure and the Y-shaped branch structures for installing screws to achieve connection with the jawbone.

4. The absorbable material bone plate according to claim 3, characterized in that, The connection end of the bending structure and the Y-shaped branch structure is the end of the main branch of the Y-shaped branch structure; huge parts are provided at the end of the branch of the Y-shaped branch structure, the end of the main branch, and the cross position of the branch and the main branch; the working holes are located on the huge parts and have steps.

5. The absorbable material bone plate according to claim 2, characterized in that, The angle is 0° to 90°.

6. The absorbable material bone plate according to claim 2, wherein, The ratio of the length of the bending structure to the sum of the lengths of the bending structure (1) and the two groups of Y-shaped branch structures (2) is 1:9 to 1:

5.

7. The absorbable material bone plate according to claim 1, characterized in that, Huge ends are provided at the end of the bending structure and the end of the main branch of the Y-shaped branch structure, and the two opposite huge ends are stacked and closely attached; the thickness of the two stacked and closely attached huge ends is equal to the thickness of the branch of the Y-shaped branch structure.

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