Preparation method of 3D printing pelvic floor repairing mesh and pelvic floor repairing mesh

Abstract

The invention relates to a preparation method of a 3D printing pelvic floor repair mesh and the pelvic floor repair mesh, and the method comprises the steps: obtaining pelvic nuclear magnetic resonance data of a patient, and constructing a three-dimensional model of the pelvic floor as an operation planning model; based on the operation planning model and the individuation condition of the patient, marking an area needing to be repaired in the operation planning software, and drawing a net-shaped curved surface; the net-shaped curved surface is unfolded into a plane, thickness is applied to the plane, and an original net piece is formed; the original mesh is converted into a mesh model suitable for cell growth in 3D printing slicing software; the mesh model is imported into a 3D printer, and a mesh support is manufactured in a sterile environment; and carrying out cell culture on the mesh support, and carrying out cell detection and evaluation to obtain the clinical pelvic floor repair mesh. Compared with the prior art, the preparation method has the advantages that the biocompatibility and the mechanical property of the mesh are obviously improved, the production process is simplified, the surgical risk and complications are reduced, and the clinical requirements can be better met.

Description

Technical Field

[0001] The present invention relates to the field of pelvic floor repair meshes, and in particular to a preparation method of a 3D printed pelvic floor repair mesh and the pelvic floor repair mesh. Background Art

[0002] Currently, surgery to reconstruct the patient's pelvic floor using mesh is considered to be a treatment for pelvic organ prolapse. However, existing pelvic floor repair meshes are mainly made of traditional weaving technology or synthetic materials, which have problems such as uneven pore size, poor tissue embedding, poor biocompatibility and insufficient degradability, which affect the repair effect.

[0003] Although some research teams have tried to improve the material and structural design of meshes, such as using biodegradable polymers and adjusting the mesh pore size, shape and distribution, such as the utility model disclosed in the publication number CN217091026U, which discloses a pelvic floor repair mesh loaded with self-crosslinking hydrogel, these improvements still face problems such as mechanical property degradation, complex production process and high cost in clinical applications. Meshes made of biodegradable materials are prone to mechanical property degradation during the degradation process and cannot provide continuous and stable support, while meshes with optimized structural design have complex production processes and high costs, making them difficult to apply on a large scale. Summary of the invention

[0004] The purpose of the present invention is to provide a preparation method of a 3D printed pelvic floor repair mesh and a pelvic floor repair mesh in order to overcome the defects of the above-mentioned prior art that it is mainly made of traditional weaving technology or synthetic materials, has poor tissue embedding and poor biocompatibility.

[0005] The purpose of the present invention can be achieved by the following technical solutions:

[0006] A method for preparing a 3D printed pelvic floor repair mesh comprises the following steps:

[0007] Obtain the patient's pelvic MRI data and construct a 3D model of the pelvic floor using medical imaging 3D reconstruction software as a surgical planning model;

[0008] Based on the surgical planning model and the patient's individual situation, marking the area to be repaired in the surgical planning software, and drawing a mesh surface on the marked repair area;

[0009] Unfold the drawn mesh surface into a plane, and apply thickness on the unfolded plane to form the original mesh;

[0010] Convert the original mesh into a mesh model suitable for cell growth in the 3D printing slicing software and export it as a path planning file in a format recognizable by the 3D printer;

[0011] Importing the path planning file into the 3D printer, loading the printing material, adjusting the printing parameters, and manufacturing the mesh scaffold in a sterile environment;

[0012] Cell culture is performed on the manufactured mesh scaffold, and after the cell culture is completed, cell detection and evaluation are performed, and the mesh scaffold that passes the test is selected as the pelvic floor repair mesh for clinical use.

[0013] Furthermore, the drawn mesh curved surface fits the surface of the pelvic floor, and the surface is smooth and flat with continuous curvature.

[0014] Furthermore, the process of unfolding the drawn mesh curved surface into a plane is specifically as follows: while keeping the mesh shape and area unchanged, the three-dimensional mesh curved surface is unfolded into a two-dimensional mesh plane through geometric transformation.

[0015] Furthermore, the process of applying thickness on the unfolded plane is specifically: applying thickness to the mesh plane by stretching and thickening the curved surface of the unfolded plane, and the thickness selection process includes: simulating pelvic floor repair surgery in the simulation software through the mesh model obtained by the current thickness and the three-dimensional model of the pelvic floor, and obtaining the stress and strain release of each organ and the mesh, so as to determine the optimal thickness.

[0016] Furthermore, in the process of converting the original mesh into a mesh model suitable for cell growth, the porosity of the mesh model is controlled to be within a range suitable for cell growth by controlling the filling rate, layer thickness and line width.

[0017] Further, the printing material is polycaprolactone, polylactic acid, polypropylene or polylactic acid-glycolic acid copolymer;

[0018] The technical principle of the 3D printer is photocuring bioprinting, inkjet bioprinting or jet bioprinting;

[0019] The printing parameters to be adjusted include nozzle diameter, heating temperature and printing speed.

[0020] Furthermore, the construction process of the three-dimensional model of the pelvic floor is specifically as follows:

[0021] Through grayscale measurement, threshold segmentation, region growing, multi-layer extraction and Boolean operations, the bladder, urethra, uterus, vagina, rectum, perineal body, pubic bone, sacrum, fascia, ligament and muscle data are extracted from the pelvic MRI data according to the human anatomical structure, thus obtaining a relatively complete pelvic floor three-dimensional model.

[0022] Furthermore, the medical image three-dimensional reconstruction software includes mimics, 3D slicer, Simpleware or Amira;

[0023] The surgical planning software includes 3-matic, RODIN 4D, FREEFORM or Brainlab;

[0024] The 3D printing slicing software includes Cura, PrusaSlicer, Meshmixer or ideaMaker;

[0025] The cell detection and evaluation methods include Cell Counting Kit-8 technology, fict / DAPI staining experiment or ATP bioluminescence method.

[0026] Furthermore, the cell culture process is specifically as follows: extracting primary cells, performing cell passaging, selecting appropriate generations after the passaging is completed and inoculating them on the mesh support to complete the cell culture;

[0027] The cells include fibroblasts, smooth muscle cells or adult stem cells.

[0028] The present invention also provides a pelvic floor repair mesh, which is obtained by using the preparation method of the 3D printed pelvic floor repair mesh as described above.

[0029] Compared with the prior art, the present invention has the following advantages:

[0030] (1) The present invention proposes to use 3D printing technology to prepare pelvic floor repair mesh, design a personalized mesh structure through surgical planning, select materials with excellent biocompatibility for 3D printing, and add cells, thereby significantly improving the biocompatibility and mechanical properties of the mesh, simplifying the production process, saving production costs, reducing surgical risks and complications, and better meeting clinical needs.

[0031] (2) The present invention designs the mesh model in a personalized way according to the patient's pelvic MRI data and the patient's own conditions, and performs preoperative planning, which can ensure that the mesh structure that best suits the patient is designed to better meet the patient's specific needs. From the physician's perspective, planning the mesh structure in advance can save surgical time and reduce surgical risks.

[0032] (3) The present invention uses 3D printing technology to print the mesh into a grid-like cell scaffold. Compared with the traditional thermoplastic process, the pore size is more uniform and the mechanical properties are better, especially in terms of the balance of strength, rigidity and flexibility.

[0033] (4) Traditional processes are not suitable for cell culture due to manufacturing precision issues. Adding cells of the present invention to the 3D printed mesh can improve the host's response to the biomaterial, promote local tissue growth, control inflammatory responses, and reduce the occurrence of complications. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] Figure 1 The present invention provides a schematic flow chart of a method for preparing a 3D printed pelvic floor repair mesh in an embodiment of the present invention. DETAILED DESCRIPTION

[0035] In order to make the purpose, 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 in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Generally, the components of the embodiments of the present invention described and shown in the drawings here can be arranged and designed in various different configurations.

[0036] Therefore, the following detailed description of the embodiments of the present invention provided in the accompanying drawings is not intended to limit the scope of the invention claimed for protection, but merely represents selected embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0037] It should be noted that similar reference numerals and letters denote similar items in the following drawings, and therefore, once an item is defined in one drawing, further definition and explanation thereof is not required in subsequent drawings.

[0038] Example 1

[0039] like Figure 1 As shown, this embodiment provides a method for preparing a 3D printed pelvic floor repair mesh, comprising the following steps:

[0040] S1: Obtain the patient's pelvic MRI data and construct a 3D model of the pelvic floor using medical imaging 3D reconstruction software as a surgical planning model;

[0041] S2: Based on the surgical planning model and the patient's individual situation, the area that needs to be repaired is marked in the surgical planning software, and a mesh surface is drawn on the marked repair area;

[0042] S3: unfolding the drawn mesh surface into a plane, and applying thickness on the unfolded plane to form an original mesh; saving the three-dimensional model of the original mesh into a file format recognizable by 3D printing slicing software;

[0043] S4: Convert the original mesh into a mesh model suitable for cell growth in the 3D printing slicing software and export it as a path planning file in a format recognizable by the 3D printer;

[0044] S5: import the path planning file into the 3D printer, load the printing material, adjust the printing parameters, and manufacture the mesh scaffold in a sterile environment;

[0045] S6: Perform cell culture on the manufactured mesh scaffold, and after the cell culture is completed, perform cell detection and evaluation, and select the mesh scaffold that passes the test as the pelvic floor repair mesh for clinical use.

[0046] Specifically, in step S1, the medical image three-dimensional reconstruction software used includes but is not limited to mimics, 3Dslicer, Simpleware or Amira, etc., which can convert a series of two-dimensional image data into a three-dimensional model.

[0047] The specific process of constructing the pelvic floor three-dimensional model is as follows: through grayscale measurement, threshold segmentation, region growing, multi-layer extraction and Boolean operations, according to the human anatomical structure, the bladder, urethra, uterus, vagina, rectum, perineal body, pubic bone, sacrum, fascia, ligaments and muscles are extracted from the MRI data to obtain a relatively complete pelvic floor three-dimensional model.

[0048] The surgical planning software in step S2 includes, but is not limited to, 3-matic, RODIN 4D, FREEFORM or Brainlab, etc., which have the ability to read, measure and design three-dimensional models.

[0049] The personalized design process of the mesh surface is as follows: based on the ordinary pelvic floor repair mesh, according to medical images and the doctor's opinions, the specific area that needs to be repaired is marked in the software, and the shape of the mesh surface is drawn on the marked repair area through drawing tools.

[0050] The mesh surface should be drawn to fit the pelvic floor surface as closely as possible to ensure that the surface boundary does not cause additional pressure on the surrounding tissue. The surface must be smooth and flat, and the curvature must be continuous.

[0051] In step S3, the specific implementation process of the surface unfolding is: while keeping the shape and area of ​​the mesh unchanged, the three-dimensional mesh surface is unfolded into a two-dimensional mesh plane through geometric transformation.

[0052] The specific implementation process of applying a certain thickness to the mesh plane is to convert the mesh plane into a solid original mesh with a thickness of 0.5-2mm through operations such as stretching and thickening the curved surface. The thickness selection needs to be determined after simulation with the simulation software to ensure that the mesh provides sufficient support while maintaining good flexibility and adaptability.

[0053] The simulation software includes but is not limited to ANSYS, ABAQUS, COMSOL and PROE, etc., which can simulate pelvic floor repair surgery through mesh models and pelvic floor models, and can reflect the stress and strain release of organs and meshes during the operation.

[0054] In step S4, the 3D printing slicing software includes but is not limited to Cura, PrusaSlicer, Meshmixer, and ideaMaker, which can convert the sliced ​​model into a software containing the movement path and instruction G code of the 3D printer according to the geometric features of the model and printing requirements.

[0055] In the process of converting the original mesh into a mesh model suitable for cell growth, the porosity of the mesh model is kept within a range suitable for cell growth by controlling the filling rate, layer thickness and line width.

[0056] The porosity of the mesh model is an important factor affecting cell growth, which is controlled by parameters such as filling rate, layer thickness and line width. Pores that are too large will reduce the mechanical properties, while pores that are too small are not suitable for cell growth.

[0057] In step S5, the technical principles of the 3D printer include but are not limited to light-curing bioprinting, inkjet bioprinting, and jet bioprinting, which are machines that can stack printing materials in various forms layer by layer to form a mesh scaffold.

[0058] Printing materials include but are not limited to polycaprolactone, polylactic acid, polypropylene and polylactic acid-glycolic acid copolymer, which have good biocompatibility and are suitable for 3D printing.

[0059] Printing parameters include but are not limited to nozzle diameter, heating temperature, printing speed and other parameters that can affect the quality of mesh scaffold formation.

[0060] After printing, the mesh bracket needs to be cleaned and disinfected.

[0061] In step S6,

[0062] The specific process of cell culture is: extracting primary cells, performing cell subculture, selecting appropriate generations after subculture and inoculating them on the mesh scaffold to complete cell culture;

[0063] In this embodiment, the specific implementation process of cell culture is: extracting primary cells, then performing cell subculture, selecting appropriate generations after subculture and inoculating them on the cell scaffold, and completing cell culture after 7 days. On the 1st, 3rd, and 7th days of cell culture, the cell activity, survival rate, and function are evaluated.

[0064] Methods for evaluating cell activity, survival rate and function include but are not limited to Cell Counting Kit-8, fic / DAPI staining experiment, ATP bioluminescence method, etc.

[0065] The standard for qualified cell detection is that the cell survival rate reaches more than 80% and the cell metabolism and proliferation ability are normal.

[0066] Cells include but are not limited to fibroblasts, smooth muscle cells, and adult stem cells, which can improve scaffold performance, recruit neighboring cells for tissue repair, and promote angiogenesis.

[0067] The preferred specific embodiments of the present invention are described in detail above. It should be understood that a person skilled in the art can make many modifications and changes based on the concept of the present invention without creative work. Therefore, any technical solution that can be obtained by a person skilled in the art through logical analysis, reasoning or limited experiments based on the concept of the present invention on the basis of the prior art should be within the scope of protection determined by the claims.

Claims

1. A method for preparing a 3D printed pelvic floor repair mesh, characterized in that: The following steps are involved: Obtain the patient's pelvic MRI data and construct a 3D model of the pelvic floor using medical imaging 3D reconstruction software as a surgical planning model; Based on the surgical planning model and the patient's individual situation, marking the area to be repaired in the surgical planning software, and drawing a mesh surface on the marked repair area; Unfold the drawn mesh surface into a plane, and apply thickness on the unfolded plane to form the original mesh; Convert the original mesh into a mesh model suitable for cell growth in the 3D printing slicing software and export it as a path planning file in a format recognizable by the 3D printer; Importing the path planning file into the 3D printer, loading the printing material, adjusting the printing parameters, and manufacturing the mesh scaffold in a sterile environment; Cell culture is performed on the manufactured mesh scaffold, and after the cell culture is completed, cell detection and evaluation are performed, and the mesh scaffold that passes the test is selected as the pelvic floor repair mesh for clinical use.

2. The method for preparing a 3D printed pelvic floor repair mesh according to claim 1, characterized in that: The drawn mesh curved surface fits the surface of the pelvic floor, and the surface is smooth and flat with continuous curvature.

3. The method for preparing a 3D printed pelvic floor repair mesh according to claim 1, characterized in that: The process of unfolding the drawn mesh curved surface into a plane is specifically as follows: while keeping the mesh shape and area unchanged, the three-dimensional mesh curved surface is unfolded into a two-dimensional mesh plane through geometric transformation.

4. The method for preparing a 3D printed pelvic floor repair mesh according to claim 1, characterized in that: The process of applying thickness on the unfolded plane is specifically as follows: applying thickness to the mesh plane by stretching and thickening the curved surface of the unfolded plane, and the thickness selection process includes: simulating pelvic floor repair surgery in the simulation software through the mesh model obtained by the current thickness and the three-dimensional model of the pelvic floor, and obtaining the stress and strain release of each organ and the mesh, thereby determining the optimal thickness.

5. The method for preparing a 3D printed pelvic floor repair mesh according to claim 1, characterized in that: In the process of converting the original mesh into a mesh model suitable for cell growth, the porosity of the mesh model is controlled to be within a range suitable for cell growth by controlling the filling rate, layer thickness and line width.

6. The method for preparing a 3D printed pelvic floor repair mesh according to claim 1, characterized in that: The printing material is polycaprolactone, polylactic acid, polypropylene or polylactic acid-glycolic acid copolymer; The technical principle of the 3D printer is photocuring bioprinting, inkjet bioprinting or jet bioprinting; The printing parameters to be adjusted include nozzle diameter, heating temperature and printing speed.

7. The method for preparing a 3D printed pelvic floor repair mesh according to claim 1, characterized in that: The construction process of the three-dimensional model of the pelvic floor is specifically as follows: Through grayscale measurement, threshold segmentation, region growing, multi-layer extraction and Boolean operations, the bladder, urethra, uterus, vagina, rectum, perineal body, pubic bone, sacrum, fascia, ligament and muscle data are extracted from the pelvic MRI data according to the human anatomical structure, thus obtaining a relatively complete pelvic floor three-dimensional model.

8. The method for preparing a 3D printed pelvic floor repair mesh according to claim 1, characterized in that: The medical image three-dimensional reconstruction software includes mimics, 3D slicer, Simpleware or Amira; The surgical planning software includes 3-matic, RODIN 4D, FREEFORM or Brainlab; The 3D printing slicing software includes Cura, PrusaSlicer, Meshmixer or ideaMaker; The cell detection and evaluation methods include Cell Counting Kit-8 technology, fict / DAPI staining experiment or ATP bioluminescence method.

9. The method for preparing a 3D printed pelvic floor repair mesh according to claim 1, characterized in that: The cell culture process is specifically as follows: extracting primary cells, performing cell subculture, selecting appropriate generations after subculture and inoculating them on the mesh support to complete cell culture; The cells include fibroblasts, smooth muscle cells or adult stem cells.

10. A pelvic floor repair mesh, characterized in that: The pelvic floor repair mesh is obtained by using a preparation method of a 3D printed pelvic floor repair mesh as described in any one of claims 1-9.

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