CN111494061A - Personalized mandible substitute compounded with autologous bone - Google Patents

Abstract

The invention discloses a personalized mandible substitute compounded with autologous bone, wherein two ends of the substitute are respectively provided with a fixing wing plate to realize connection with the natural mandible, and the upper part of the substitute is provided with a fixing groove for fixing the autologous bone; the contact area of the two end parts of the substitute and the natural mandible, the contact area of the fixing wing plate and the natural mandible and the contact area of the substitute and the autogenous bone are provided with bone fusion areas, the contact area of the substitute and the surrounding soft tissue is provided with a soft tissue fusion area so as to promote the fusion of the substitute and the surrounding tissue, improve the biocompatibility of the substitute and enhance the biomechanical strength of the substitute, and the rest is a mandible main body supporting area. The invention can solve the problems of self-bone shortage, difficult shaping, poor fusion of the thermoplastic material serving as the mandibular bone implant with natural bone tissues and peripheral soft tissues and the like, thereby promoting the fusion of the mandibular bone substitute and the peripheral tissues, being beneficial to accelerating the healing of wounds after the substitute is implanted and further improving the life quality of patients.

Description

A Personalized Mandibular Replacement Composite with Autologous Bone

technical field

The invention belongs to the technical field of mandibular repair, and in particular relates to a personalized mandibular substitute compounded with autologous bone.

Background technique

The mandible is the largest bone in the human maxillofacial region and the main supporting structure for the facial shape. Mandibular defects are common in maxillofacial defects and can be caused by trauma, tumor resection and other reasons. The mandible and adjacent soft tissue defects caused by mandibular defects often lead to severe facial deformities and dysfunctions, which seriously affect the physical and mental health of patients and reduce their life satisfaction.

At this stage, bone grafting is often used to repair mandibular defects in clinic, including autologous bone, allogeneic bone or xenograft bone grafting and artificial bone substitute transplantation. Among them, autologous bone transplantation as the main treatment method is to take bone implants from different parts of the patient for transplantation and repair, such as sternorib, ilium, scapula or fibula. This technology has been used clinically for many years and is relatively mature. There are many types of mandibular defects, and the shape of the mandible between different individuals is also quite different. The complete use of autologous bone transplantation will face problems such as large-scale trauma, insufficient bone mass, and difficulty in shaping in the donor site.

In recent years, with the rapid development of 3D printing technology, personalized metal implants have been applied to a certain extent to repair partial mandibular defects. The most commonly used material in bone repair is titanium alloy, but because titanium alloy has a higher elastic modulus than natural bone, it is easy to cause the phenomenon of "stress shielding", resulting in the loosening or even falling off of the implant, and finally the mandible repair fails.

Thermoplastic polymer materials represented by polyetheretherketone PEEK have good biocompatibility and elastic modulus closer to human cortical bone, which can effectively reduce the phenomenon of stress shielding. Therefore, in 3D printing personalized bone implants The field has been widely researched and applied. Thermoplastic materials such as polyetheretherketone PEEK have good plasticity and radiolucency, and there are no artifacts in clinical examinations (such as X-ray, CT, MRI), which is convenient for tracking patients' postoperative recovery. However, thermoplastic materials have strong biological inertness as bone implants. It is difficult to integrate well with natural bone tissue and surrounding soft tissue, with poor osseointegration, slow postoperative recovery, and easy postoperative infection. Therefore, thermoplastic materials It is difficult to tightly fuse mandibular implants with natural bone tissue and surrounding soft tissue, which is an urgent problem to be solved in clinical application of thermoplastic materials.

SUMMARY OF THE INVENTION

The technical problem to be solved by the present invention is to provide a personalized mandibular substitute compounded with autologous bone in view of the above-mentioned deficiencies in the prior art, so as to solve the shortage of autologous bone, difficulty in shaping and the use of thermoplastic materials as a mandibular substitute and natural Poor fusion of bone tissue and surrounding soft tissue, thereby improving the fusion of mandibular substitutes with surrounding tissue and speeding up postoperative wound healing.

In order to achieve the above object, the present invention adopts the following technical solutions:

A personalized mandibular substitute compounded with autologous bone, the contour of the substitute is consistent with the contour of the normal mandible, the two ends of the substitute are respectively provided with fixed wing plates, and the upper part of the substitute is provided with a spacer for placing the autologous bone. Fixing groove, there are fluid drainage holes on the fixing groove to reduce postoperative fluid accumulation; the contact area between the two ends of the substitute and the natural mandible, the contact area between the fixed wing plate and the natural mandible, and the contact area between the substitute and the autologous Bone fusion area is set in the contact area of bone, soft tissue fusion area is set in the contact area between the substitute and surrounding soft tissue to promote fusion of the substitute and surrounding bone tissue and soft tissue, and the rest is the main support area of the mandible.

Specifically, a first fixing hole is arranged on the fixing wing plate, and the substitute is fixed on the natural mandible through the first fixing hole; a second fixing hole is arranged on the fixing groove, and the autologous bone is fixed on the substitute through the second fixing hole the upper part.

Further, the thickness of the fixed wing plate is 1-10 mm, the number of the first fixing holes is 2-6; the depth of the fixing groove is 1-6 mm at the bottom of the coated autologous bone, and the number of the second fixing holes is 3-6 mm. 6.

Specifically, the effusion drainage holes are opened on the surface of the fixing groove, and the number is 2 to 5.

Specifically, the thickness of the bone fusion zone and the soft tissue fusion zone are both 0.1 to 15 mm, and both the bone fusion zone and the soft tissue fusion zone are provided with porous structures, and the porous structures are made of polymer materials, bone affinity materials and antibacterial materials. ; The main support area is made of polymer materials.

Further, the polymer material includes polyethylene, polypropylene, polyaryletherketone, aromatic polyester, polyurethane or their combination; the bone affinity material includes bioceramic, carbon fiber and glass fiber or their combination; the antibacterial material includes lipopeptide compounds, peptide compounds, or a combination thereof.

Further, the pore size of the porous structure is 0.1-3 mm, the porosity is 0%-90%, the content of the bone affinity material is 0%wt-50%wt, and the content of the antibacterial material is 0%wt-30%wt.

Specifically, the preparation method of the substitute includes 3D printing, injection molding, extrusion molding and/or machining.

Compared with the prior art, the present invention at least has the following beneficial effects:

The present invention is a personalized mandible substitute compounded with autologous bone. The contour of the substitute is consistent with the normal mandible, and the patient's appearance can be restored as much as possible; structurally, two ends of the substitute are respectively provided with fixed wings Plate to connect the substitute with the natural mandible. The upper part of the substitute is provided with a fixing groove for fixing the autologous bone to assist the positioning of the autologous bone. At the same time, the fixing groove is also provided with a drainage hole for fluid accumulation, which is convenient to reduce the postoperative area. In terms of function, the substitute has a bone fusion area, a soft tissue fusion area, and a main body support area according to the contact with the surrounding bone tissue and soft tissue. The combination of materials makes the substitute have good biocompatibility and meets the strength requirements of the normal work of the mandible, which is beneficial to promote the fusion of the contact area between the substitute and the surrounding tissue, thereby improving the long-term stability of the mandible substitute and improving the patient's Quality of Life.

Further, the thickness of the fixed wing plate is set to 1 to 10 mm, and the number of the first fixing holes opened on the fixed wing plate is set to 2 to 6, so as to meet the mechanical strength that the substitute is connected with the natural mandible; The number of second fixation holes on the surface of the groove is set to 3 to 6 to achieve stable fixation of the autologous bone and prevent the autologous bone from loosening; the depth of the fixation groove is 1 to 6 mm covering the bottom of the autologous bone to achieve accurate placement of the autologous bone , and at the same time play a certain role in the positioning of autologous bone.

Further, the number of effusion drainage holes is set to 2 to 5, which are arranged at a relatively low position on the surface of the fixing groove, so as to reduce the retention of postoperative effusion and achieve rapid wound healing.

Further, the thicknesses of the bone fusion area and the soft tissue fusion area are both set to 0.1-15 mm to meet the fusion requirements of the substitutes with different thicknesses; porous structures are provided in both the bone fusion area and the soft tissue fusion area to promote the surrounding bone tissue of the substitute. And the ingrowth of soft tissue to enhance the mechanical strength of the bone contact interface.

Further, the pore size of the porous structure is 0.1 to 3 mm, and the porosity is 0% to 90%. According to the contact conditions of different positions of the substitute, the pore size and porosity of the contact area between the substitute and the surrounding bone tissue and soft tissue are adjusted so that the substitute Good fusion with surrounding bone and soft tissue is achieved.

Further, the content of the bone affinity material is 0%wt to 50%wt, and the content of the antibacterial material is 0%wt to 30%wt. The bone affinity material can promote the fusion of the substitute and the surrounding bone tissue, and the antibacterial material can effectively prevent Oral bacteria can erode the substitute, so the content of bone-affinity materials and antibacterial materials can be adjusted according to the mechanical properties and functional requirements of the substitute, so that the mechanical properties and functional requirements can be adjusted.

To sum up, the present invention not only makes the design of substitutes more personalized, but also can satisfy different types of mandibular defects in different patients, relieve the shortage of autologous bone source and the difficulty of autologous bone shaping, etc. Problems such as poor fusion of mandibular bone implants with natural bone tissue and surrounding soft tissue can promote the fusion of mandibular bone substitutes and surrounding tissues, which is conducive to accelerating the healing of wounds after implantation of the substitutes, thereby improving the quality of life of patients.

Description of drawings

1 is a schematic diagram of a complete repair model of a mandibular defect site of the present invention;

FIG. 2 is a schematic diagram of a personalized mandibular substitute model compounded with autologous bone according to the present invention;

Fig. 3 is the A-A (fluid drainage hole) cross-sectional schematic diagram of Fig. 2;

Fig. 4 is the B-B (second fixing hole) cross-sectional schematic diagram of Fig. 2;

Fig. 5 is the top view structure schematic diagram of Fig. 2;

FIG. 6 is a schematic view of the bottom view of FIG. 2 .

Among them: 1. Mandibular substitute; 2. Autologous bone; 3. Natural mandible; 4. Fixed wing plate; 5. First fixing hole; 6. Fixing groove; 7. Second fixing hole; 8. Effusion Drainage hole; 9. Bone fusion area; 10. Soft tissue fusion area.

Detailed ways

In the description of the present invention, it should be understood that the terms "center", "portrait", "horizontal", "top", "bottom", "front", "rear", "left", "right", " The orientation or positional relationship indicated by "vertical", "horizontal", "top", "bottom", "inside", "outside", "one side", "one end", "one side", etc. The orientation or positional relationship is only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the indicated device or element must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of the present invention. In addition, the terms "first" and "second" are only used for descriptive purposes, and should not be construed as indicating or implying relative importance or implying the number of indicated technical features. Thus, a feature defined as "first" or "second" may expressly or implicitly include one or more of that feature. In the description of the present invention, unless otherwise specified, "plurality" means two or more.

1 and 2, the present invention discloses a personalized mandibular substitute compounded with autologous bone, including a substitute 1, a fixed wing plate 4, a fixed groove 6, a bone fusion area 9 and a soft tissue fusion area 10. .

The contour of the substitute 1 is consistent with the normal mandible, the fixed wing plates 4 are arranged on both ends of the substitute 1, the fixation groove 6 is arranged on the upper part of the substitute 1, and is used for placing the autologous bone 2. There are effusion drainage holes 8 for reducing postoperative effusion; bone fusion areas 9 are respectively arranged in the contact area between the two ends of the substitute 1 and the natural mandible 3, the contact area between the fixed wing plate 4 and the natural mandible 3 and In the contact area between the substitute 1 and the autologous bone 2, the soft tissue fusion area 10 is set in the contact area between the substitute 1 and the surrounding soft tissue, so as to achieve good fusion between the substitute 1 and the surrounding bone tissue and soft tissue, and the rest area is the main support area of the mandible.

Please refer to FIG. 5 and FIG. 6 , the fixing wing plate 4 is provided with a first fixing hole 5 , and the substitute 1 is fixed on the natural mandible 3 through the first fixing hole 5 ; the fixing groove 6 is provided with a second fixing hole 7 , the autologous bone 2 is fixed on the upper part of the substitute 1 through the second fixing hole 7 .

Preferably, the thickness of the fixing wing plate 4 is 1-10 mm, the number of the first fixing holes 5 is 2-6; the depth of the fixing groove 6 is 1-6 mm covering the bottom of the autologous bone 2, and the second fixing holes 7 The number is 3 to 6.

Referring to FIG. 3 , 2 to 5 drainage holes 8 are opened at a relatively low position on the surface of the fixing groove 6 .

Please refer to Fig. 3, Fig. 4, Fig. 5 and Fig. 6. The thickness of the bone fusion zone 9 and the soft tissue fusion zone 10 are both 0.1-15mm, and there are porous structures with a pore diameter of 0.1-3mm and a porosity of 0%-90%. , made of polymer material, bone affinity material and antibacterial material composite material, the content of bone affinity material is 0%wt ~ 50%wt, the content of antibacterial material is 0%wt ~ 30%wt; Made of polymer materials.

Polymer materials include polyethylene, polypropylene, polyaryl ether ketone, aromatic polyester, polyurethane or their combinations; bone-affinity materials include bioceramics, carbon fibers and glass fibers or their combinations; antibacterial materials include lipopeptides, peptides compounds or their combinations.

Alternative 1 preparation methods include 3D printing, injection molding, extrusion molding, and machining, such as fused deposition modeling (FDM), selective laser sintering (SLS), and CNC machining.

In order to make the purposes, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments These are some embodiments of the present invention, but not all embodiments. The components of the embodiments of the invention generally described and illustrated in the drawings herein may be arranged and designed in a variety of different configurations. Thus, the following detailed description of the embodiments of the invention provided in the accompanying drawings is not intended to limit the scope of the invention as claimed, but is merely representative of selected embodiments of the invention. 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.

Take, for example, a personalized mandibular replacement compounded with an autologous fibula.

1. The personalized mandibular substitute compounded with the autologous fibula is provided with fixed wings 4 at both ends of the substitute, the upper part of the substitute 1 is provided with an autologous bone fixation groove 6, and the fixation groove 6 is provided with a reduction surgery. The effusion drainage hole 8 for effusion; the bone fusion area 9 and the soft tissue fusion area 10 are provided according to the contact between the substitute 1 and the surrounding tissue, and the rest are the mandibular main body support area. The fixed wing plate 4 is provided with a certain number of first fixing holes 5, which are used for connecting the mandibular substitute 1 and the natural mandibular fixing groove 6, and are also provided with second fixing holes 7 and 6 for connecting the autologous bone 2. The effusion drainage hole 8 for reducing postoperative effusion, the shape of the fixation groove 6 is kept similar to that of the autologous bone 2; And the contact area between the upper part of the substitute 1 and the autologous bone 2 is provided with a bone fusion area 9, and the contact area between the substitute 1 and the surrounding soft tissue is provided with a soft tissue fusion area 10, wherein, the bone fusion area 9 is made of polyetheretherketone and other polymer materials, The soft tissue fusion zone 10 is made of polyether ether ketone PEEK and other polymer materials, peptides and other antibacterial materials. It also has a porous structure with variable porosity and pore size within a certain range.

2. The design and preparation of the personalized mandibular substitute matched with the autologous fibula includes the following procedures:

(1) First, use CT, MRI and other imaging detection methods to obtain the imaging data of the mandibular disease part, and use Mimics, Geomagics, SolidWorks and other three-dimensional software to reconstruct the three-dimensional model of the mandible;

(2) Based on the three-dimensional reconstruction model of the mandible, determine the resection position and size of the mandibular lesion, and remove the lesion at a distance of 5-7 mm from the edge of the lesion area;

(3) According to the resection position and size of the lesion, determine the cutting and arrangement of the autogenous bone, the angle of each segment is set to 125°～135°, and the distance between the top of the autogenous bone and the upper tooth crown is set to 10～12mm;

(4) According to the normal shape of the patient's mandible or the contour of the normal mandible, determine the overall shape of the substitute; according to the arrangement of the autogenous bone, determine the shape of the autologous fibula fixation groove, and the depth of the groove is set to cover the bottom of the autologous bone 1~ 6mm; according to the surface position of the fixing groove, there are 3 effusion drainage holes on the groove, and according to the size of the autologous bone, there are 3 second fixing holes for connection on the groove;

(5) According to the contact relationship between the mandibular substitute and the natural mandible, establish a substitute fixed wing plate that can fit the surface of the natural bone. The number of the first fixing holes is 4;

(6) Test the force of the mandibular substitute in different load environments through finite element analysis, and the adjustment parameters include the thickness of the mandibular substitute fixing wing, the number and arrangement of the first fixing holes on the fixed wing, and the replacement. The number and arrangement of the second fixation holes on the upper part of the object to ensure the mechanical strength of the mandibular substitute;

(7) According to the fusion requirements of the mandibular substitute and the natural bone, a 0.1-10 mm thick bone fusion area is set in the contact area between the mandibular substitute and the natural bone, and a three-dimensional software is used to establish the porous structure of the bone fusion area. The porous structure is The square hole with a diameter of 0.6mm is used to ensure good fusion between the bone fusion area and the natural bone tissue. The bone fusion area uses polyetheretherketone, hydroxyapatite, carbon fiber and other multi-component composite materials to meet the mechanical properties of the mandible. Requirements and improve the mechanical strength, in which the content of hydroxyapatite is 25%wt, and the content of carbon fiber is 7%wt;

(8) According to the fusion requirements of the mandibular substitute and the surrounding soft tissue, a soft tissue fusion area with a thickness of 0.1-10 mm is set in the contact area between the mandibular substitute and the surrounding soft tissue. This area is also provided with a porous structure, and the porous structure is 0.5 mm. The porosity increases from the inside to the outside. The soft tissue fusion area is composed of antibacterial substances such as polyetheretherketone and 15%wt peptides to promote the fusion of the mandibular substitute and the surrounding soft tissue, enhance the antibacterial ability of the mandibular substitute, and adapt to the complex microenvironment of the oral cavity , prolong the service life of mandibular substitutes;

3. The mandibular substitute is prepared by fused deposition 3D printing. After the printing is completed, the doctor will implant the mandibular substitute into the mandibular defect;

4. According to the shape of the actual defect of the patient, the doctor will insert the cut autologous fibula into the autologous fibula fixation groove to complete the full repair process of the mandibular defect;

Autologous bone can also be selected from autologous ilium, rib, etc., and the rest are similar to those described in the examples.

To sum up, the present invention is a personalized mandibular substitute compounded with autologous bone, which can solve the problems such as shortage of bone source and difficulty in plasticity caused by clinical use of autologous bone transplantation. The main mandibular substitute has good biocompatibility and mechanical strength, and can meet the strength requirements of the normal working of the mandible. In addition, by adding antibacterial materials such as bioceramics, fibrous bone-affinity materials and peptides, it can be To achieve the fusion of mandibular substitute with natural bone tissue and surrounding soft tissue, to achieve a satisfactory repair effect, thereby improving the quality of life and comfort of patients.

The above content is only to illustrate the technical idea of the present invention, and cannot limit the protection scope of the present invention. Any changes made on the basis of the technical solution according to the technical idea proposed by the present invention all fall within the scope of the claims of the present invention. within the scope of protection.

Claims (8)

1. The personalized mandibular bone substitute compounded with the autogenous bone is characterized in that the outline of the substitute (1) is consistent with the outline of the normal mandibular bone, two ends of the substitute (1) are respectively provided with a fixing wing plate (4), the upper part of the substitute (1) is provided with a fixing groove (6) for placing the autogenous bone (2), and the fixing groove (6) is provided with a effusion drainage hole (8) for reducing postoperative effusion; the contact area of both ends and the nature mandible (3) of substitute (1), the contact area of fixed pterygoid lamina (4) and nature mandible (3) and the contact area of substitute (1) and autologous bone (2) all are provided with bone fusion district (9), and substitute (1) and surrounding soft tissue contact area are provided with soft tissue fusion district (10), promote the fusion of substitute and surrounding bone tissue and soft tissue, and the rest is the mandible main part support area.

2. The substitute according to claim 1, characterized in that the fixing wing (4) is provided with a first fixing hole (5), and the substitute (1) is fixed on the natural mandible (3) through the first fixing hole (5); the fixing groove (6) is provided with a second fixing hole (7), and the autogenous bone (2) is fixed on the upper part of the substitute (1) through the second fixing hole (7).

3. The substitute according to claim 1 or 2, characterized in that the thickness of the fixing wing plate (4) is 1 to 10mm, the number of first fixing holes (5) is 2 to 6; the depth of the fixing groove (6) is 1-6 mm for covering the bottom of the autogenous bone (2), and the number of the second fixing holes (7) is 3-6.

4. The substitute according to claim 1, characterized in that the effusion drainage holes (8) are opened on the surface of the fixing groove (6) in a number of 2-5.

5. The substitute according to claim 1, characterized in that the thickness of the bone fusion area (9) and the soft tissue fusion area (10) is 0.1-15 mm, porous structures are arranged inside the bone fusion area (9) and the soft tissue fusion area (10), and the porous structures are made of high polymer materials, bone affinity materials and antibacterial material composite materials; the main body supporting area is made of high polymer materials.

6. The surrogate of claim 5, wherein the polymeric material comprises polyethylene, polypropylene, polyaryletherketones, aromatic polyesters, polyurethanes, or combinations thereof; the bone affinity material comprises bioceramic, carbon fiber and glass fiber or combination thereof; the antimicrobial material comprises lipopeptides, peptidic compounds, or combinations thereof.

7. The substitute according to claim 5, wherein the porous structure has a pore diameter of 0.1 to 3mm, a porosity of 0 to 90%, and a content of the bone-compatible material of 0 to 50% by weight; the content of the antibacterial material is 0-30 wt%.

8. The surrogate according to any of claims 1-7, characterized in that the surrogate (1) is prepared by means comprising 3D printing, injection moulding, extrusion and/or machining.

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