WO2018103640A1

WO2018103640A1 - Skull repair system and preparation method therefor

Info

Publication number: WO2018103640A1
Application number: PCT/CN2017/114640
Authority: WO
Inventors: 范小敏; 罗百顺; 刘曼; 文平; 袁玉宇
Original assignee: 广州迈普再生医学科技有限公司; 深圳迈普再生医学科技有限公司
Priority date: 2016-12-05
Filing date: 2017-12-05
Publication date: 2018-06-14

Abstract

A skull repair system and a preparation method therefor. The skull repair system comprises a repair main body (1) formed with a polyaryletherketone-based material. Tabs (3) are provided on the repair main body (1) and comprise extended parts (21) for connecting the repair main body (1) and an autogenous skull (4). The tabs (3) and the repair main body (1) are integrally formed. The shape, size and radian of the skull repair system match those of a defective skull. The tabs (3) facilitate fixation of the skull repair system during surgery, eliminating the need for an additional connecting part for connecting the repair main body (1) with the autologous skull (4), and can prevent collapse after repair. The skull repair system is formed with a polyaryletherketone-based material, and thus has good biocompatibility, avoiding rejection. The preparation process is simple and efficient. The skull repair system obtained after a three-dimensional design and an optimized treatment accurately matches the defected site, making it easier to use. The special design of the tab connecting part (22) facilitates formation of a smooth repaired surface after a surgery, making the repairing surface being visually pleasing.

Description

Skull repair system and preparation method thereof

Technical field

The invention relates to a human implant component, in particular to a skull repair system and a preparation method thereof.

Background technique

Cranioplasty is one of the most common operations in neurosurgery. Its main purpose is to prevent brain tissue from being damaged again, to restore cranial cavity tightness, and to treat skull defect syndrome. At present, the research on the skull repair prosthesis mainly focuses on the titanium metal material. Titanium is a metal element. After the skull repair prosthesis is made, the skull repair prosthesis of the titanium mesh is mostly a flat surface with high hardness. Metal plate. In order to completely cover the damaged part of the titanium mesh and reduce the stimulation of the damaged part by the sharp edge, a common method is to reserve about 1 cm at the edge of the titanium mesh to cover the edge of the bone window, but the titanium mesh is prone to curling after implantation. Problems such as exposed edges. In the invention patent CN103549990A, a PEEK skull repairing stencil is disclosed, which uses PEEK material instead of titanium metal to have better biocompatibility, and does not cause secondary damage to the injured skull, but needs to be additionally used during the operation. The connecting piece connects the repairing net and the skull, which is inconvenient to use.

Summary of the invention

The object of the present invention is to overcome the problem that the prior art skull repair prosthesis needs to additionally connect the skull repair prosthesis and the autogenous skull to fix the skull repair prosthesis during use, and the use of the inconvenient problem is provided. A cranial repair system that is easy to use and has good biocompatibility.

Another object of the present invention is to provide a method of preparing a skull repair system.

Another object of the present invention is to provide a method of using a skull repair system.

The object of the invention is achieved by the following technical solution:

A skull repair system comprising a repair body formed of a polyaryletherketone material, the repair body being provided with a lap, the lap comprising an extension for connecting the repair body and the self skull, the lap The sheet is integrally formed with the repairing body.

The structural relationship between the lap and the repairing body may be one of the following three ways.

The first way is that the extension is formed by directly extending the edge of the repairing body such that the upper surface of the extension is coplanar with the upper surface of the repairing body.

In the case of this structural solution, in the skull repair operation, the slab accommodating cavity is first ground at the corresponding position of the autogenous skull, and the depth of the accommodating cavity is substantially the same as the thickness of the lap. The extension of the tab is placed in the receiving chamber and then fixed using a fixing nail. Since the extension is formed by the edge extension of the repairing body, Therefore, after the skull repair system is fixed, the lap is embedded in the autologous skull, and the extension and the surrounding skull have a smooth transition and are more beautiful.

The second way is that the tab further comprises a connecting portion extending from an edge of the repairing body to form an upper surface slightly lower than the repairing body, the connecting portion being connected to the extending portion such that an upper surface of the extending portion Below the upper surface of the repaired body.

Preferably, the upper surface of the extended portion is lower than the upper surface of the repairing body by 0.5 to 1.5 mm, and more preferably 1.0 mm.

The skull repair system in this manner is based on the position of the slab during the skull repair operation, and the bone corresponding to the lap on the autologous skull is honed, and the accommodating cavity formed by the ossicular bone has a depth greater than that of the extension. The thickness is about 1 mm, the length and width of the receiving cavity are larger than the size of the extension portion by about 1 to 2 mm, so that the position of the repairing body can be adjusted, and then the skull repairing system is placed in a corresponding position, and after adjusting the position to a suitable position, The prepared bone cement is filled into the accommodating cavity where the lap piece is placed to complete the fixation of the skull repair system.

The skull repair system of this structure, combined with the fixation method of the bone cement, can enable the skull repair system to be implanted in the body, and can truly achieve zero artifacts, and does not affect image examination such as CT and magnetic resonance. After being fixed by filling the bone cement, a smooth transition between the upper surface of the cured bone cement and the upper surface of the repairing body and the upper surface of the autologous skull can be achieved. After the lap and bone cement are fixed, it is enough to withstand the horizontal direction of the repairing body, and can meet the corresponding requirements in terms of mechanics. The combination of the lap and the bone cement can be fixed without additional drilling and fixing nails, reducing the risk of surgery and the cost of surgery.

The third type is that the tab further includes an upwardly protruding connecting portion of the edge of the repairing body such that the connecting portion protrudes from the upper surface of the repairing body, and the extending portion is connected to the repairing body through the connecting portion, so that The upper surface of the extended portion is higher than the upper surface of the repairing body.

Under such a design, when the skull repairing system is in use, the lower surface of the lap can be directly attached to the autologous skull, and the fixation can be directly performed by using the fixing nail without grinding the bone, which can simplify the operation.

Preferably, in this design, the lower surface of the extension is substantially coplanar with the upper surface of the repair body such that when the extension is in contact with the skull, the upper surface of the repair body is substantially coplanar with the upper surface of the native skull.

The structure design of the above-mentioned splicing piece and the repairing body can be selected by the doctor according to actual needs. However, those skilled in the art can also adopt other connection methods, and only need to achieve the connection purpose of the present invention.

The repaired body conforms to the size, shape, and curvature of the defect skull bone window.

The polyaryletherketone material (PAEK) is polyetheretherketone (PEEK), polyetherketoneketone (PEKK), polyetherketone, polyetherketoneetherketoneketone (PEKEKK) or polyetheretherketoneketone (PEEKK). Any one or a mixture of at least two, preferably polyetheretherketone (PEEK).

The polyaryletherketone-based material used in the present invention is preferably an implant grade polyaryletherketone-based material. The skull repairing system of the invention selects a polyaryletherketone material which is equivalent to the bone hardness, strength and weight of the human body, and has better biocompatibility compared with the titanium mesh, and avoids the stimulation of the skull tissue by the metal mesh plate. Allergic, rejection, and has good strength, toughness, and is not easily deformed by external forces. The repairing body is three-dimensionally reconstructed according to the data collected by the patient CT to complete the personalized design, and then is obtained by 3D printing and/or machining (such as CNC), which completely matches the shape, size and curvature of the missing skull. . Also integral with the prosthetic body is a tab for attachment to the autologous skull. The patch is used to connect the repairing body and the autologous skull, and it is no longer necessary to connect the repairing body and the autologous skull with another connecting member during the operation, which is more convenient to use and can prevent collapse after implantation.

In the present invention, the CT includes ordinary CT (Computed Tomography), and enhanced techniques of CT, such as CTA (CT angiography) and the like.

Preferably, the extension portion is preferably provided with a mounting hole, so that no additional opening is required during the operation, and the skull repair system can be directly fixed by screws.

Preferably, the extension has a thickness of 1.0 to 1.5 mm.

Preferably, the extension has a length of 8 to 10 mm, and the extension has a width of 4 to 9 mm.

Preferably, the edge of the extension is a rounded edge. The smooth edges are designed to avoid possible damage to the skull or other tissues caused by sharp parts.

Preferably, the tabs may be evenly or unevenly distributed around the repair body. The lap can be designed according to the actual needs, and can avoid the weak bones.

Preferably, the number of the tabs is 3-6. The number of laps is not limited, and can be set according to actual needs, and can be sufficiently stable to fix the skull repair system.

Preferably, the repair body has a thickness of 1 to 8 mm; and/or the thickness of the repair body is uneven.

Preferably, the repair body is provided with a through hole. The setting of the through hole can facilitate the discharge of the cerebral spinal fluid and effectively reduce the subcutaneous fluid.

Preferably, the through holes are distributed in a matrix.

More preferably, the through hole has a hole diameter of 2 to 3 mm, and a distance between adjacent through holes is 10 to 15 mm. A method for preparing a skull repair system includes the following steps:

S1: acquiring CT scan data of the skull image, scanning layer thickness ≤ 2 mm, obtaining original data in DICOM format;

S2: reconstructing and obtaining a visual three-dimensional model of the missing skull by using the three-dimensional reconstruction software according to the original data in the DICOM format;

S3: The visualized three-dimensional model of the missing skull is designed by the design software to obtain the three-dimensional skull repairing body;

S4: designing a patch on the edge of the skull repairing body;

S5: designing a through hole in the body of the skull repair;

S6: 3D printing or machining to produce a three-dimensional structure of the skull repair system.

Skull scan data can be obtained from the hospital's imaging department to obtain CT or CTA scan data of the patient, and the data is saved in DICOM format. The original DICOM imaging format data is a two-dimensional black-and-white image. Through three-dimensional reconstruction software, such as mimics, 3Ddoctor, etc., the grayscale is extracted according to the bone and reconstructed to obtain a visual three-dimensional model of the missing skull. The skull design of the defect site is designed to obtain a three-dimensional skull restoration by introducing the defective skull model into design software, such as Solidworks, Freeform, 3-Matic, and the like. The edge of the skull prosthesis is designed to be lapped, and the position of the lap, that is, the position of the lap and the skull restoration should be avoided.

The specific design method of the lap is to draw a two-dimensional image of the slab on the plane, projecting to the surface where the splicing position is selected, such as the original skull surface, and the shape of the slab is on the original defect skull and the prosthesis. Displayed as a reference surface, using the increased thickness operation to obtain a slab of a certain thickness that fits perfectly with the edge of the original skull bone window.

Preferably, the scanning layer thickness in S1 is 0.625 to 2 mm.

More preferably, the scanning layer thickness in S1 is 0.625-1.25 mm.

Preferably, the design in S2 includes the design of the curvature, thickness, and edge contour of the skull restoration.

More preferably, the design in S2 also includes curvature adjustment, and/or sanding, and/or smoothing.

Preferably, the three-dimensional skull repair body described in S3 is introduced into an optimization software for optimization processing. Can be a skull Patch import optimization software, such as Wrap, rigin, matlab, etc. for optimization.

A method for using a skull repair system, which is placed in a skull defect site, adjusted to an appropriate position, and fixed.

A method of using a skull repair system includes the following steps:

Grinding bone: grinding the autologous skull of the repaired part, the bone depth is 1.5~2.5mm, and the length and width are larger than the extension 1~2mm;

And, the repairing system is placed in the skull defect site, adjusted to an appropriate position, and bone cement is implanted above the extension portion to complete the fixation of the repair system.

According to the second design mode of the lap, according to the position of the lap, the self-body skull of the corresponding part is ground, the depth after grinding is about 2 mm, and the length and width are about 1 to 2 mm larger than the size of the lap. More effective fixation is achieved by adjusting the position of the skull repair system and solidifying the bone cement.

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

According to the skull repairing system provided by the present invention, according to the patient's skull defect, a repairing body which is consistent with the shape, size and curvature of the missing skull is prepared, and the repairing body and the bone window are completely matched. The splicing facilitates the fixation of the skull repair system during surgery, eliminating the need for additional connecting components to connect the prosthetic body to the autologous skull. And the skull repairing system is formed by using polyaryletherketone material, which has good biocompatibility and avoids the phenomenon of rejection. The preparation process is simple and efficient. The three-dimensional design and optimized treatment of the skull repair system and the defect site are precisely matched, and the use is convenient and quick. The special design of the lap joint helps to form a smooth repair surface after surgery, so that the effect after repair is more beautiful. .

DRAWINGS

Figure 1 is a schematic view showing the structure of the skull repairing system;

2 and 3 are schematic views showing the first connection mode when the skull repair system is connected to the skull;

4 is a schematic view showing a second connection manner when the skull repair system is connected to a skull;

Figure 5 is a schematic view showing the third connection mode when the skull repair system is connected to the skull.

detailed description

The invention is further illustrated by the following specific examples, but the specific examples are not intended to limit the invention. The drawings are for illustrative purposes only, and are not intended to be a limitation of the embodiments of the invention. Shrinking does not represent the size of the actual item; for those skilled in the art, in the drawings It is to be understood that certain well-known structures and their description may be omitted.

Example 1

2 and FIG. 3 show a first embodiment of the present invention, a skull repair system, which is reconstructed according to the data collected by the patient's CT or CTA, and is designed to match the shape, size, and curvature of the skull. The repairing body 1, and the tab 2 integrally formed with the repairing main body 1, and then obtaining the solid skull repairing system by a 3D printing technique using a preparation material containing a polyaryletherketone-based material. The thickness of the repair body 1 is 1 to 8 mm. The tab has an extension portion 21 for connecting the repairing body and the autologous skull, the extension portion 21 being formed by extending an edge of the repairing body such that an upper surface of the extending portion 21 and the upper surface of the repairing body The surface is coplanar. A mounting hole 5 is provided in the extended portion 21 of the tab. The extending portion has a rectangular shape as a whole, and the end portion has two rounded chamfers, the length is 8 to 10 mm, the width is 4 to 9 mm, and the thickness is 1.2 to 1.5 mm. The tab 2 is distributed around the repairing body 1. . A through hole 3 is provided in the repair main body 1. The through hole has a hole diameter of 2 to 3 mm and a through hole pitch of 10 to 15 mm.

In this case, in the skull repair operation, the same shape of the gap is made on the autologous skull at the edge of the defect skull window. Embelling the tab 2 into the notch, since the extension portion 21 is formed by directly extending from the edge of the repairing body, the extension portion does not protrude when the repairing body is connected to the skull in the manner shown in FIG. On the autologous skull 4, the transition between the lap and the surrounding autologous skull is smooth and more beautiful.

Example 2

As another solution for realizing the skull repair system of the present invention, it is also possible to design as shown in FIG. 4:

A skull repair system comprising a repair body 1 formed of a polyetheretherketone material, the repair body 1 being provided with a flap 2, the tab comprising an extension 21 for connecting the repair body and the autologous skull The patch is integrally formed with the repairing body;

The tab further includes a connecting portion 22 extending from an edge of the repairing body to be slightly lower than an upper surface of the repairing body, the connecting portion being connected to the extending portion 21 such that an upper surface of the extending portion 21 is lower than Repair the upper surface of the body 1. The thickness of the repaired body was 8 mm, the thickness of the extended portion was 1 mm, and the upper surface of the extended portion 21 was 1 mm away from the surface of the prosthesis main body. The extending portion has a rectangular shape as a whole, and the end portion has two rounded chamfers, the length is 8 to 10 mm, and the width is 4 to 9 mm. The tab 2 is distributed around the repairing body 1. A through hole 3 is provided in the repair main body 1. The through hole has a hole diameter of 2 to 3 mm, adjacent The distance between the through holes is 10 to 15 mm.

When adopting this scheme, in the skull repair operation, the splicing accommodating cavity is firstly grounded at the corresponding position of the autogenous skull, and the depth of the accommodating cavity is 2 mm, so that when the lap is placed in the accommodating cavity, the upper surface of the main body and the autologous skull are repaired. The upper surface is coplanar; the size of the receiving cavity is slightly larger than the size of the tab, so that the position of the repairing body can be adjusted for fixing, and then the bone cement is filled in the receiving cavity, so that the upper surface of the cured bone cement and the upper surface of the repairing body, A smooth transition between the upper surfaces of the autologous skull. After the lap and bone cement are fixed, they can withstand the horizontal force of the repairing body, and can meet the corresponding requirements in terms of mechanics. The combination of the lap and the bone cement can be fixed without additional drilling, eliminating the need for fixing nails.

Example 3

As another solution for realizing the skull repair system of the present invention, it is also possible to design as shown in FIG. 5:

A skull repairing system comprising a repairing body 1 formed of a polyetheretherketone-like material, the repairing body 1 being provided with a lap, the slat comprising an extension 21 for connecting the repairing body and the self-skull, The tab is integrally formed with the repairing body; the tab further includes an upwardly protruding connecting portion 22 by the edge of the repairing body such that the connecting portion protrudes relative to the upper surface of the repairing body, the extending portion 21 is connected to the repairing body 1 through the connecting portion 22 such that the upper surface of the extending portion is higher than the upper surface of the repairing body.

The remaining features are the same as in Embodiment 1.

When adopting this scheme, in the skull repair operation, the bone is not required to be ground, and the repaired body is adjusted to the corresponding position of the bone window, and the patch is directly placed on the surface of the autologous skull 4 to be fixed, which can simplify the operation.

Example 4

The preparation of the skull repair system of Examples 1-3 includes the following steps:

S1: Obtain CT scan data of the patient from the imaging department of the hospital, scan the layer thickness 0.625mm, and save the data in DICOM format;

S2: Recognition by mimics of 3D reconstruction software, grayscale extraction and reconstruction of bone to obtain a visual 3D model of the defect skull, and introducing the defective skull model into the design software Solidworks to design the curvature, thickness and edge contour of the skull restoration. The three-dimensional skull prosthesis is further optimized by Wrap optimization software to optimize the curvature and edge contour of the skull prosthesis and smooth adjustment;

S3: Design the slab on the skull patch visualization model, draw a two-dimensional map of the slab on the plane, project to the surface where the splicing position is selected (such as the original skull surface), and the shape of the slab is in the original defect skull. And the patch is displayed on the prosthesis, which is displayed as a reference surface, and the thickness is increased to obtain a patch having a certain thickness and completely conforming to the edge of the original skull bone window;

S4: designing a through hole on a skull repair visualization model;

S5: 3D printing or machining to produce a three-dimensional structure of the skull repair system.

Claims

A skull repair system comprising a repair body formed by a polyaryletherketone material, wherein the repair body is provided with a lap, and the lap includes an extension for connecting the repair body and the self skull. The splicing piece is integrally formed with the repairing body.
The skull repair system according to claim 1, wherein said extension portion is formed by directly extending an edge of said repair body such that an upper surface of said extension portion is coplanar with an upper surface of said repair body.
A skull repair system according to claim 1, wherein said tab further comprises a connecting portion extending from an edge of said repairing body to form an upper surface slightly lower than said repairing body, said connecting portion being connected to said extending portion The upper surface of the extension is made lower than the upper surface of the repair body.
The skull repair system according to claim 3, wherein the distance from the upper surface of the extension to the upper surface of the repairing body is 0.5 to 1.5 mm.
A skull repair system according to claim 1, wherein said tab further includes an upwardly projecting connecting portion of said repairing body edge such that said connecting portion projects with respect to said upper surface of said repairing body, said extending The portion is connected to the repairing body through the connecting portion such that an upper surface of the extending portion is higher than an upper surface of the repairing body.
A skull repair system according to claim 1, wherein said extension portion is provided with a mounting hole.
The skull repair system according to claim 1, wherein said extension has a thickness of 1.0 to 1.5 mm.
The skull repair system according to claim 1, wherein said extension portion has a length of 8 to 10 mm, and said extension portion has a width of 4 to 9 mm.
The skull repair system of claim 1 wherein the edge of the extension is a rounded edge.
The skull repair system according to claim 1, wherein the number of the flaps is 3 to 6.
The skull repair system according to any one of claims 1 to 10, wherein the repairing body has a thickness of 1 to 8 mm; and/or the thickness of the repairing body is uneven.
The skull repair system according to any one of claims 1 to 10, wherein the repair body is provided with a through hole.
The skull repair system according to claim 12, wherein the through hole has a hole diameter of 2 to 3 mm and a through hole pitch of 10 to 15 mm.
A method for preparing a skull repair system according to any one of claims 1 to 13, characterized in that Including the following steps:

S1: acquiring CT scan data of the skull image, scanning layer thickness ≤ 2 mm, obtaining original data in DICOM format;

S2: reconstructing and obtaining a visual three-dimensional model of the missing skull by using the three-dimensional reconstruction software according to the original data in the DICOM format;

S3: The visualized three-dimensional model of the missing skull is designed by the design software to obtain the three-dimensional skull repairing body;

S4: designing a patch on the edge of the skull repairing body;

S5: designing a through hole in the body of the skull repair;

S6: A three-dimensional structure of the skull repair system is produced by 3D printing or machining.
The method of preparing a skull repair system according to claim 14, wherein the scanning layer thickness of S1 is 0.625 to 2 mm, preferably 0.625 to 1.25 mm.
The method for preparing a skull repair system according to claim 14, wherein the design of the skull portion of the defect portion in S2 comprises designing a curvature, a thickness, and an edge contour of the body of the skull repair.
The method of preparing a skull repair system according to claim 16, wherein the skull portion of the defect portion described in S2 further comprises a curvature adjustment, and/or a sanding, and/or a smoothing treatment.
The method for preparing a skull repair system according to claim 14, wherein the three-dimensional skull repair body of S3 is introduced into an optimization software for optimization.
A method of using the skull repair system according to claim 1, wherein the repairing system is placed in a skull defect site, adjusted to an appropriate position, and fixed.
A method of using a skull repair system according to claim 3 or 4, comprising the steps of:

Grinding bone: grinding the autologous skull of the repaired part, the bone depth is 1.5~2.5mm, and the length and/or width is larger than the extension 1~2mm;

And, the repairing system is placed in the skull defect site, adjusted to an appropriate position, and bone cement is implanted above the extension portion to complete the fixation of the repair system.