3D printing nose prosthesis based on preset folding line sheet paper folding structure and preparation method

Abstract

The present application relates to the field of biological medical materials and preparation technology, and specifically provides a 3D printing nose prosthesis based on a preset folding line sheet origami structure, the nose prosthesis is made of a biocompatible material, is integrally formed in a foldable sheet form through a 3D printing technology, and is provided with a plurality of preset folding line origami structures on the nose prosthesis, the nose prosthesis can be implanted into the body after being folded along the preset folding lines, and is unfolded along the preset folding lines after being implanted, so as to form a three-dimensional nose support structure; a preparation method of the 3D printing nose prosthesis based on the preset folding line sheet origami structure specifically includes five steps. Through the sheet structure and the preset folding line design, the present application significantly reduces the manufacturing and operation difficulty; the implantation can be completed through a small incision, so that the surgical incision and the infection probability are reduced; the folding and unfolding paths are controllable, and the unfolded form is stable; the material and the printing process selection range are wide, and the adaptability is strong; and the present application is beneficial to the realization of personalized customization and clinical popularization and application.

Description

Technical Field

[0001] This invention relates to the field of biomedical materials and preparation technology, and in particular to a 3D-printed nasal prosthesis based on a pre-set folded sheet origami structure and its preparation method. Background Technology

[0002] Nasal implants are medical implant materials used in cosmetic rhinoplasty to improve the shape of the nose. They help patients achieve a more ideal nasal contour by raising the bridge of the nose and reshaping the tip. Currently, commonly used nasal implant materials in clinical practice mainly include... Silicone implants, expanded polytetrafluoroethylene (ePTFE), etc. Silicone implants advantage It is one of the most widely used rhinoplasty materials due to its long application history, soft and easy-to-sculpt texture, relatively low price, and convenient removal. Disadvantages include potential issues such as translucency, displacement, or capsular contracture (leading to an upturned nasal tip), especially noticeable in individuals with thinner skin. Expanded polytetrafluoroethylene (ePTFE) advantage The microporous structure allows it to integrate with tissue, providing good fixation, preventing displacement, a natural feel, and opacity, resulting in a more harmonious overall appearance. However, its disadvantages include higher sculpting difficulty, a slightly higher risk of infection, and the need for complete removal in case of infection, making the procedure more challenging. Both types of implants also generally suffer from limited individualization, require extensive manual adjustments during surgery, involve larger incisions, and have a higher risk of postoperative complications.

[0003] With the development of 3D printing technology, personalized design and manufacturing of nasal prostheses based on patient imaging data has become possible. Meanwhile, origami structures, due to their ability to transform from two-dimensional to three-dimensional structures, show potential advantages in the field of minimally invasive medical devices. However, existing origami structures mostly employ multi-level complex folding units, making them more suitable for implantable devices with larger spaces. For areas like the nose with limited anatomical space and restricted implantation paths, complex origami structures present inconveniences in design, manufacturing, and surgical procedures. Therefore, it is particularly necessary to provide a nasal prosthesis structure and preparation method that is more suitable for the small-scale space of the nose, has a simplified structure, a clear folding path, and is easy to implant and unfold. Summary of the Invention

[0004] To overcome the shortcomings of existing nasal implants due to limitations in structure and manufacturing process, as described in the background art, this invention provides a 3D-printed nasal implant and its manufacturing method based on a pre-set folding line origami structure. This design involves creating a foldable sheet nasal implant with pre-set folding lines during the manufacturing stage, allowing the implant to be easily folded outside the body. After minimally invasive implantation, the implant unfolds along the pre-set folding lines inside the body to form a three-dimensional nasal support structure. This reduces surgical trauma and operational difficulty, and improves the safety, stability, and adaptability of the implant.

[0005] The technical solution adopted by this invention to solve its technical problem is: A 3D-printed nasal prosthesis based on a pre-set folded sheet origami structure is made of biocompatible material and integrally formed in the form of a foldable sheet using 3D printing technology. The nasal prosthesis has several pre-set folded sheets origami structures. The nasal prosthesis can be folded along the pre-set folded sheets and implanted into the body, and unfolds along the pre-set folded sheets after implantation to form a three-dimensional nasal support structure. The overall thickness of the sheet is between 0.3 and 1.2 mm, with the thickness of the folded sheet area being smaller than that of the non-folded area, which can improve folding flexibility and avoid structural damage.

[0006] Furthermore, the preset fold lines are formed by at least one of the following methods: local thinning structure, continuous micropore arrangement structure, material orientation change structure, or material property gradient structure.

[0007] Furthermore, the origami structure is a simplified folding structure adapted to the small-scale anatomical space of the nose, including but not limited to linear folding, fan-shaped folding, V-shaped or W-shaped repeated folding. Before implantation, the prosthesis can be folded into a compact shape along the preset folding line, implanted into the body through a small incision in the nose, and unfolded along the preset folding line under the action of body temperature, material elastic recovery force and tissue constraint force to form a stable three-dimensional nasal support structure.

[0008] Furthermore, the material of the nasal prosthesis body is one of the following: biodegradable polymer material, elastic or flexible polymer material, composite material, or combination of multiple materials.

[0009] Furthermore, the biodegradable polymer material is one of polycaprolactone, polylactic acid, polyglycolic acid, polylactic acid-glycolic acid copolymer, and polydioxanone; the elastic or flexible polymer material is one of thermoplastic polyurethane and polyether ester elastomer.

[0010] Furthermore, the composite material is composed of biodegradable polymer materials and hydroxyapatite, β-tricalcium phosphate, bioactive glass, or absorbable inorganic salt particles.

[0011] Furthermore, the multi-material combination structure uses different materials in different partitions within the same nasal prosthesis, so that the fold line area has a low elastic modulus, while the support area has high mechanical strength.

[0012] Furthermore, the 3D printing technology is one of fused deposition modeling, selective laser sintering, stereolithography, direct ink writing, or multi-nozzle or multi-material collaborative printing processes.

[0013] The preparation method of a 3D-printed nasal prosthesis based on a pre-set fold line thin-sheet origami structure includes the following steps: S1: Acquire medical imaging data of the patient's nose and establish a three-dimensional model; S2: Design the shape of the thin-sheet nasal prosthesis based on the three-dimensional model and set the pre-set fold lines; S3: Select biocompatible materials and use 3D printing technology to integrally print the nasal prosthesis thin sheet; S4: Clean, dry and sterilize the printed nasal prosthesis; S5: Fold the nasal prosthesis along the pre-set fold lines and aseptically package it.

[0014] Compared with the prior art, the present invention has the following advantages: (1) The manufacturing and surgical operation difficulty is significantly reduced by the thin sheet structure and the pre-set folding line design; (2) It is suitable for the narrow anatomical space of the nose and can be implanted through a small incision, reducing the surgical wound and infection rate; (3) The folding and unfolding path is controllable and the shape is stable after unfolding; (4) The range of materials and printing processes is wide and the adaptability is strong; (5) It is conducive to realizing personalized customization and clinical application. Attached Figure Description

[0015] Figure 1 This is a schematic diagram of the V-shaped top view of the 3D-printed nasal prosthesis based on the pre-set folding line thin sheet origami structure of the present invention; Figure 2 This is a top view schematic diagram of the 3D-printed nasal prosthesis folding fan-shaped structure based on the pre-set folding line thin sheet origami structure of the present invention; Figure 3 This is a top view schematic diagram of the W-shaped nasal prosthesis based on the pre-set folding line thin sheet origami structure of the present invention. Detailed Implementation

[0016] Figure 1 , 2As shown in Figure 3, a 3D-printed nasal prosthesis based on a pre-set folded sheet origami structure is described. The nasal prosthesis 1 is made of biocompatible material and integrally formed in the form of a foldable sheet using 3D printing technology. The nasal prosthesis 1 has several pre-set folded sheets forming an origami structure. The nasal prosthesis 1 can be folded along the pre-set folded sheets and implanted into the body, and then unfolded along the pre-set folded sheets after implantation to form a three-dimensional nasal support structure. The overall thickness of the sheet is between 0.3 and 1.2 mm, with the thickness of the folded sheet area being less than that of the non-folded area to improve folding flexibility and avoid structural damage. The pre-set folded sheets are formed through at least one of the following methods: partial thinning structure, continuous microporous arrangement structure, material orientation variation structure, or material property gradient structure. The origami structure is a simplified folding structure adapted to the small-scale anatomical space of the nose, including but not limited to linear folding, fan-shaped folding, and V-shaped or W-shaped repeated folding. Before implantation, the nasal prosthesis can be folded into a compact shape along a pre-set folding line, implanted through a tiny incision in the nose, and unfolds along the pre-set folding line under the influence of body temperature, material elasticity, and tissue constraint, forming a stable three-dimensional nasal support structure. The main material of the nasal prosthesis is one of the following: biodegradable polymer, elastic or flexible polymer, composite material, or a combination of multiple materials. Biodegradable polymers include polycaprolactone (PCL), polylactic acid (PLA), polyglycolic acid (PGA), polylactic acid-glycolic acid copolymer (PLGA), and poly(p-dioxanone) (PDO); elastic or flexible polymers include thermoplastic polyurethane (TPU) and polyether ester elastomer (PEBA). Composite materials are formed by combining biodegradable polymers with hydroxyapatite, β-tricalcium phosphate, bioactive glass, or absorbable inorganic salt particles. The multi-material composite structure uses different materials in different zones within the same nasal prosthesis, resulting in a lower elastic modulus in the folded area and higher mechanical strength in the supporting area. The 3D printing technology employed is one of the following: Fused Deposition Modeling (FDM / FFF), Selective Laser Sintering (SLS), Stereolithography (SLA or DLP), Direct Ink Writing (DIW), or multi-nozzle or multi-material collaborative printing processes (these 3D processes allow for the integral molding of thin sheet structures and pre-set folded lines during printing, avoiding subsequent machining steps).

[0017] Figure 1 , 2As shown in Figure 3, Example 1 describes the preparation method of a 3D printed nasal prosthesis based on a pre-set folded sheet origami structure (FDM printed sheet origami nasal prosthesis based on polycaprolactone material). In this example, polycaprolactone (PCL) is selected as the manufacturing material for nasal prosthesis 1, and the process includes the following steps: (1): First, collect CT image data of the patient's nose and establish an anatomical model of the patient's nose using three-dimensional reconstruction software. (2): Design the two-dimensional unfolded shape of the sheet nasal prosthesis 1 according to the nasal model, and set multiple linear pre-set folded lines in the prosthesis design model. The folded lines are achieved through a local thinning structure. (3): Use fused deposition modeling (FDM) 3D printing technology to print the nasal prosthesis 1 in one piece (the sheet structure and pre-set folded lines can be printed in one piece during the printing process, avoiding subsequent machining steps). The printing layer thickness is set to 0.1 mm, the overall thickness of the prosthesis sheet is 0.6 mm, and the thickness of the folded line area is 0.3 mm. (4): After printing, the nasal prosthesis 1 is cleaned and sterilized. Before the specific surgical implantation, the nasal implant 1 is folded along the preset folding line to form a compact shape and implanted into the body through a small incision in the nose; after implantation, under the action of body temperature and material elasticity, the nasal implant 1 naturally unfolds along the preset folding line to form a stable three-dimensional nasal support structure.

[0018] Figure 1 , 2 As shown in Figure 3, Example 2, a method for preparing a 3D printed nasal prosthesis based on a pre-set fold line thin sheet origami structure (DIW-printed gradient folded nasal prosthesis based on multi-material combination). In this example, a multi-material combination structure is used to prepare nasal prosthesis 1, wherein the fold line area is made of thermoplastic polyurethane (TPU) material and the non-folded support area is made of polylactic acid-glycolic acid copolymer (PLGA) material, including the following process. (1): After establishing a three-dimensional model through the patient's nasal imaging data, the nasal prosthesis 1 is designed as a thin sheet structure, and the fold line area and the support area are divided in the model. The fold line area achieves smooth folding through the difference in material properties, without the need for additional thinning. (2): Multi-material collaborative printing is carried out using direct ink writing (DIW) 3D printing technology, so that the fold line area has a lower elastic modulus, while the support area has a higher mechanical strength. The overall thickness of the printed nasal prosthesis sheet is 0.8 mm. (3): After cleaning and sterilization, the nasal prosthesis 1 is folded along the fold line and implanted into the nose. Before the specific surgical implantation, the nasal implant 1 is folded into a compact shape along the preset folding line and implanted into the body through a small incision in the nose; after implantation, the nasal implant 1 unfolds under the combined effect of tissue constraint and material elasticity difference, and maintains the expected three-dimensional shape.

[0019] Figure 1 , 2As shown in Figure 3, Example 3 describes the preparation method of a 3D-printed nasal prosthesis based on a pre-set fold line thin sheet origami structure (a microporous fold line nasal prosthesis based on high-precision SLA printing). In this example, a photocurable biocompatible resin material is selected, and the nasal prosthesis is prepared by stereolithography (SLA) 3D printing process. The specific steps are as follows: (1): Design a thin sheet nasal prosthesis structure according to the three-dimensional model of the patient's nose, and set a continuous microporous array structure at the predetermined fold line position. The micropores are used to reduce the local bending stiffness, thereby forming the pre-set fold line. (2): High-precision printing is performed using SLA process with a printing resolution of 50 μm and an overall thickness of 0.5 mm for the thin sheet of nasal prosthesis 1. (3) After printing, it is subjected to post-curing and sterilization treatment. Before implantation, the nasal prosthesis 1 can be folded along the microporous fold line and implanted into the nose through a minimally invasive incision. After implantation, the nasal prosthesis 1 unfolds under the action of the in vivo environment and promotes tissue ingrowth through the porous structure, thereby improving implantation stability.

[0020] Figure 1 , 2 As shown in Figure 3, the present invention has a wide range of material and printing process options and strong adaptability; through the thin sheet structure and pre-designed folding lines, the manufacturing and surgical operation difficulty is significantly reduced; it is suitable for the narrow anatomical space of the nose and can be implanted through a small incision, reducing the surgical wound and the chance of infection; the folding and unfolding path is controllable when implanted into the surgical site, and the shape is stable after unfolding; it is conducive to realizing personalized customization and clinical application.

[0021] The foregoing has shown and described the basic principles and main features of the present invention, as well as its advantages. It will be apparent to those skilled in the art that the present invention is limited to the details of the exemplary embodiments described above, and that the invention can be implemented in other specific forms without departing from its spirit or basic characteristics. Therefore, the embodiments should be considered exemplary and non-limiting in all respects, and the scope of the invention is defined by the appended claims rather than the foregoing description. Thus, it is intended that all variations falling within the meaning and scope of equivalents of the claims be included within the present invention.

[0022] Furthermore, it should be understood that although this specification describes embodiments, not every embodiment contains only one independent technical solution. This narrative style is merely for clarity. Those skilled in the art should consider the specification as a whole, and the technical solutions in the embodiments can also be appropriately combined to form other embodiments that can be understood by those skilled in the art.

Claims

1. A 3D-printed nasal prosthesis based on a pre-defined folded sheet origami structure, characterized in that, The nasal prosthesis is made of biocompatible material and is integrally formed in the form of a foldable sheet using 3D printing technology. The nasal prosthesis has a paper-folding structure with several preset fold lines. The nasal prosthesis can be folded along a preset folding line and implanted into the body, and unfolds along the preset folding line after implantation to form a three-dimensional nasal support structure. The overall thickness of the sheet is between 0.3 and 1.2 mm, with the thickness of the folded area being less than that of the non-folded area, which improves folding flexibility and avoids structural damage.

2. The 3D-printed nasal prosthesis based on a pre-set folded line thin-sheet origami structure according to claim 1, characterized in that, The pre-defined fold lines are formed through at least one of the following methods: local thinning structure, continuous micropore arrangement structure, material orientation change structure, or material property gradient structure.

3. The 3D-printed nasal prosthesis based on a pre-set folded line thin-sheet origami structure according to claim 1, characterized in that, The origami structure is a simplified folding structure adapted to the small-scale anatomical space of the nose, including but not limited to linear folding, fan-shaped folding, V-shaped or W-shaped repeated folding. Before implantation, the prosthesis can be folded into a compact shape along the preset folding line, implanted into the body through a small incision in the nose, and unfolded along the preset folding line under the action of body temperature, material elasticity and tissue constraint to form a stable three-dimensional nasal support structure.

4. The 3D-printed nasal prosthesis based on a pre-set folded line thin-sheet origami structure according to claim 1, characterized in that, The main body of the nasal implant is made of one of the following materials: biodegradable polymer, elastic or flexible polymer, composite material, or combination of multiple materials.

5. The 3D-printed nasal prosthesis based on a pre-set folded line thin-sheet origami structure according to claim 1, characterized in that, Biodegradable polymer materials are one of polycaprolactone, polylactic acid, polyglycolic acid, polylactic acid-glycolic acid copolymer, and polydioxanone; elastic or flexible polymer materials are one of thermoplastic polyurethane and polyether ester elastomers.

6. The 3D-printed nasal prosthesis based on a pre-set folded line thin-sheet origami structure according to claim 1, characterized in that, The composite material is composed of biodegradable polymer materials and hydroxyapatite, β-tricalcium phosphate, bioactive glass or absorbable inorganic salt particles.

7. The 3D-printed nasal prosthesis based on a pre-set folded line thin-sheet origami structure according to claim 1, characterized in that, The multi-material combination structure uses different materials in different zones within the same nasal implant, so that the fold line area has a low elastic modulus, while the support area has high mechanical strength.

8. The 3D-printed nasal prosthesis based on a pre-set folded line thin-sheet origami structure according to claim 1, characterized in that, 3D printing technology is one of the following processes: fused deposition modeling, selective laser sintering, stereolithography, direct ink writing, or multi-nozzle or multi-material collaborative printing.

9. The method for preparing a 3D-printed nasal prosthesis based on a pre-set folded sheet origami structure according to any one of claims 1 to 8, characterized in that, Specifically, the steps are as follows: S1: Collect medical imaging data of the patient's nose and establish a three-dimensional model; S2: Design the shape of the thin-film nasal implant based on the three-dimensional model and set the preset fold lines; S3: Select biocompatible materials and use 3D printing technology to integrally print the thin-film nasal implant; S4: Clean, dry and sterilize the printed nasal implant; S5: Fold the nasal implant along the preset fold lines and aseptically package it.

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