Intelligent controllable super-deformation nose prosthesis

Abstract

An intelligent controllable super-deformation nose prosthesis belongs to the field of plastic surgery medical instruments and is characterized in that a concave hollow omega-shaped structure frame main body shell layer, a Janus interface outer coating and an intelligent response material are combined to construct a'anatomy-structure-function 'integrated nose prosthesis, a micropore design and a hydroxyapatite coating are performed on the ventral side of the nose prosthesis, and the micro-pore design and the hydroxyapatite coating are performed on the ventral side of the nose prosthesis. A nose prosthesis structure with high fitness and high stability is formed, smooth design and spermidine coating are carried out on the back side of the nose prosthesis, so that envelope formation is inhibited, envelope constraint is avoided, and the super-directional deformation performance is achieved in combination with the design of the concave hollow omega-shaped structure. By applying the intelligent response material, non-invasive deformation adjustment can be carried out through temperature signals in an operation or after the operation, and the clinical requirements of fine adjustment in the operation and after the operation are met. The nasal prosthesis can be applied to the scenes of plastic surgery, postoperative modification, repair and reconstruction and the like, and the higher-level medical and aesthetic requirements are met.

Description

Technical Field

[0001] The present invention relates to the field of orthopedic medical devices, and particularly to an intelligent and controllable super-deformable nasal prosthesis. Background Art

[0002] With the continuous improvement of the social and economic level and the increasing aesthetic awareness of people, the demand for facial contour optimization and aesthetic improvement has shown a continuous and rapid growth trend globally. Especially in the Asian region, the acceptance of plastic surgery by people has been continuously increasing. Since the nose has a significant impact on the overall facial contour, rhinoplasty has become one of the most common orthopedic surgery procedures and has ranked among the top five global plastic surgery procedures for many consecutive years. Moreover, the surgical population is gradually becoming younger and more diverse. According to the annual statistical report released by the International Society of Aesthetic Plastic Surgery (ISAPS) in 2024, the total number of global rhinoplasty surgeries reached more than 1 million cases, a 21.6% increase compared to the previous year. And the revision rate of rhinoplasty is as high as 20%, mostly due to dissatisfaction with the postoperative appearance, loss of prosthesis height, and higher aesthetic requirements. Revision surgeries all require methods such as removing or replacing the prosthesis. The surgical difficulty is high, the postoperative recovery period is at least 3 - 5 months, the complication incidence rate is 18.6%, and there is a surgical waiting period of more than 1 year before re-implanting the prosthesis, which brings technical challenges to doctors and also brings huge psychological pressure and heavy economic burden to patients.

[0003] Clinically, rhinoplasty is usually divided into two major categories: one is aesthetic rhinoplasty aimed at aesthetic improvement, such as rhinoplasty, correction of hump nose, and tip shaping; the other is reconstructive rhinoplasty mainly for functional reconstruction or morphological repair, such as correction of congenital nasal deformities and postoperative repair of tumors. Regardless of the surgical type, the nasal prosthesis material, as the core component of rhinoplasty, its performance directly affects the operability of the surgery, the postoperative shape, and the long-term stability, and even determines the risk of complications.

[0004] In traditional rhinoplasty, autologous cartilage transplantation is widely used due to its excellent biocompatibility and low rejection risk. However, autologous cartilage transplantation has limitations such as donor site injury, difficult carving, complex surgical operation, etc., and the supporting force may decrease due to cartilage absorption after transplantation, making it difficult to meet the long-term highly personalized appearance requirements.

[0005] At present, some artificial materials are still used in clinical practice. Commonly used nasal prosthesis materials include silicone, expanded polytetrafluoroethylene (ePTFE) and high-density porous polyethylene (Medpor). Although silicone nasal prostheses have the advantages of easy carving, low cost and convenient implantation, they do not fit tightly with soft tissues and are prone to displacement due to muscle movement, external force and other factors after surgery. The stability of the nasal prosthesis is poor; it cannot form bone integration with the host tissue, and there is a risk of interface friction and chronic rejection reaction. The postoperative infection rate is higher than that of nasal prostheses made of other materials. The expanded polytetrafluoroethylene (ePTFE) nasal prosthesis adopts a unique microporous structure to allow tissue to grow in, significantly improving the stability of the implant. However, the material is difficult to carve and has low flexibility in shaping during surgery; some patients may experience delayed rejection or chronic inflammatory reactions, and once infected or repaired, it is difficult to remove. In order to overcome the disadvantages of silicone and expanded polytetrafluoroethylene, another high-density porous polyethylene (Medpor) nasal prosthesis has appeared in clinical practice. It has good compatibility with human tissues and rarely causes immune rejection reactions. However, Medpor may cause skin thinning after being implanted in the human nose. Although it has strong adhesion to the surrounding soft tissues, it is not firmly bonded to bones or cartilage and is prone to slight mobility problems.

[0006] Most of the nasal prostheses currently used are prefabricated models, and their size, curvature, tip angle and other parameters are usually obtained by standardized mold processing, and can only be adjusted through limited preoperative selection or intraoperative manual shaping. This "passive adaptation" method cannot fully fit the complex curved surface structure of the patient's nasal bones and soft tissues. Especially for groups with higher personalized demands, the matching degree is seriously insufficient, and the fit is not enough, causing the nasal prosthesis to form micro-movements in the body, forming a capsule, and then leading to capsular contracture. The prosthesis has poor stability, and problems such as prosthesis displacement, rotation, and sinking often occur after surgery. Moreover, if the patient is slightly dissatisfied with the nasal shape after surgery or hopes to make fine adjustments, it can usually only be completed through a secondary operation, which increases the risk of trauma and infection. At present, there is no mature technology in clinical practice that can achieve the function of "non-invasive dynamic plastic surgery".

[0007] Therefore, how to develop a new type of intelligent prosthesis that can be highly personalized, has dynamic response capabilities, postoperative fine-tuning functions and enhanced fitting stability is an urgent need in the field of plastic surgery, especially rhinoplasty.

[0008] In recent years, the negative Poisson's ratio (NPR) structure has attracted extensive attention in the fields of flexible adjustable structures, wearable devices and bionic materials due to its unique deformation characteristics of lateral expansion when stretched and lateral contraction when compressed. Inspired by the NPR structure, the nasal prosthesis is designed as a concave hollow Ω-shaped structural frame, which is expected to achieve greater deformation ability.

[0009] Meanwhile, smart materials have seen explosive growth in fields such as medicine, bionics, and microelectromechanical systems. Smart responsive materials refer to material systems that can undergo reversible changes in response to external environmental stimuli (such as temperature, light, electricity, magnetism, chemical signals, etc.). The development of smart responsive materials has made it possible for nasal prostheses to have controllable deformation during and after surgery, especially suitable for intraoperative adjustment and postoperative fine-tuning, becoming an important direction to address the current limitations of nasal prostheses. However, there is currently no public literature on combining the mechanical structure design of nasal prostheses with smart responsive materials to form an integrated collaborative innovation of structural and functional design. The nasal prosthesis of this invention patent is no longer a stack of single materials or static models, but a nasal prosthesis design that realizes comprehensive performances such as dynamic plastic surgery and postoperative fine-tuning, which is a multi-dimensional integration of "structural mechanics + smart response + biological adaptation". Summary of the Invention

[0010] The purpose of the present invention is to solve problems such as the inability of traditional nasal prostheses to perform dynamic shaping, poor stability, and capsular contracture, and to provide an intelligent controllable super-deformable nasal prosthesis. The core lies in being able to perform personalized design according to the patient's nasal bone and nasal shape, combining the concave hollow Ω-shaped structural framework main body shell layer, Janus interface outer coating with smart responsive materials to construct an "anatomy-structure-function" integrated nasal prosthesis. Micro-hole design and hydroxyapatite coating are carried out on the ventral side of the nasal prosthesis to form a highly conformable and highly stable nasal prosthesis structure. Smooth design and spermidine coating are carried out on the dorsal side of the nasal prosthesis to inhibit the formation of the capsule and avoid capsule constraint. Combined with the concave hollow Ω-shaped structural design, super-directional deformation performance is achieved. The application of smart responsive materials can perform non-invasive deformation adjustment through temperature signals during or after surgery to meet the clinical needs of intraoperative and postoperative fine-tuning. The nasal prosthesis can be applied in scenarios such as plastic surgery, postoperative modification, repair and reconstruction, etc., to meet higher-level medical and aesthetic needs.

[0011] An intelligent controllable super-deformable nasal prosthesis is composed of the abdominal part of the nasal prosthesis, the dorsal part of the nasal prosthesis, and the lateral parts of the nasal prosthesis on both sides, and the four form a concave hollow Ω-shaped structure; The abdominal part of the nasal prosthesis is concave and curved inward, with a micro-hole structure on the outer side and is covered with a hydroxyapatite coating to facilitate bone integration, stabilize the prosthesis, and achieve directional deformation; The dorsal part of the nasal prosthesis protrudes outward, and the outer side is a smooth surface to prevent soft tissue from growing in and restricting the deformation of the nasal prosthesis; during shaping, the skin will not adhere to the prosthesis and affect the appearance of the nose after plastic surgery; The outer side of the dorsal part of the nasal prosthesis is covered with a spermidine coating to reduce the formation of the capsule and avoid capsule contracture from affecting the long-term dynamic shaping of the nasal prosthesis; The sides of the nasal prosthesis are concave inwards, and the outer side is a smooth surface to prevent soft tissue from growing in and restrain the prosthesis from deforming. During shaping, the skin will not adhere to the prosthesis and affect the appearance of the nose after plastic surgery. The concave design of the bottom on both sides gives the nasal prosthesis greater deformation performance.

[0012] The intelligent controllable super-deformable nose prosthesis is designed by Rhino software and manufactured by 4D printing.

[0013] The intelligent controllable super-deformable nose prosthesis is made of shape memory polyurethane material. The shape memory behavior of the material is optimized and the degradation rate is regulated. The intelligent response material realizes controllable deformation during and after surgery, breaking the static morphological limitations of traditional prostheses, providing non-invasive dynamic plastic surgery capabilities, facilitating intraoperative shape adjustment by doctors and postoperative fine-tuning by patients, and avoiding multiple surgeries.

[0014] The porosity of the microporous structure arranged on the outer side of the abdomen of the nasal prosthesis is 100-600 μm, which prevents the prosthesis from micro-movement, breaks the annular capsule structure, and reduces the capsule binding force.

[0015] The deformation angle of the intelligent controllable super-deformable nose prosthesis is 30 degrees to 120 degrees, which is used for fine nose bridge adjustment.

[0016] The microporous structure arranged on the outer side of the abdomen of the nasal prosthesis is a bionic trabecular structure or a deer antler microporous structure or a TPMS (three-periodic minimal surface structure) structure. Working process and working principle of the present invention: The Janus interface is a special three-dimensional multi-layered structure composed of two or more components with different physical properties. The uniqueness of this structure is that its two surfaces (facing opposite directions) have different properties, which brings a series of functional advantages. The Janus interface has been widely used in the medical field. In the present invention, the spermidine coating is coated on the dorsal side of the nasal prosthesis by the bionic mussel method, and the hydroxyapatite coating is coated on the ventral side of the nasal prosthesis by the bionic mineralization method; the Janus interface outer coating is introduced to describe that the outer side of the ventral side of the nasal prosthesis is covered with a hydroxyapatite coating and the outer side of the back of the nasal prosthesis is covered with a spermidine coating. The two coatings face in two directions, synergistically inhibiting the formation of the capsule around the prosthesis, and ultimately achieving the dual effects of prosthesis stability and capsule reduction.

[0017] Hydroxyapatite (HA) is the main inorganic component of the bones and teeth of vertebrates. It is a commonly used bone repair material in clinical practice with good biocompatibility. Its main function is to promote the growth of the surrounding bone tissue, and it can effectively form a chemical bond with natural bone. The hydroxyapatite coating can improve the biocompatibility and bioactivity of biomaterials and enhance the bone integration ability of biomaterials. Therefore, hydroxyapatite is regarded as an ideal coating on the surface of implants and is often used in bone tissue regeneration engineering. To promote bone ingrowth of nasal prostheses, a hydroxyapatite coating is applied to the ventral side of the nasal prosthesis to make the nasal prosthesis fit and fix perfectly with the human nasal dorsum, improve the stability of the nasal prosthesis, thus achieving directional deformation and reducing the risk of nasal prosthesis displacement at the same time.

[0018] Spermidine (SPD) is a naturally occurring polyamine compound. In recent years, spermidine has shown a wide range of antifibrotic effects through multiple mechanisms, including inducing autophagy, activating antioxidant pathways, inhibiting inflammatory responses and apoptosis, etc., especially showing good therapeutic potential in fibrosis models of organs such as the lungs, liver and kidneys. Applying a spermidine coating to the dorsal side of the nasal prosthesis can effectively reduce capsule formation and inhibit capsule fibrosis.

[0019] A spermidine coating is applied to the dorsal side of the nasal prosthesis by a mussel-inspired method, and a hydroxyapatite coating is applied to the ventral side of the nasal prosthesis by a biomimetic mineralization method to prepare a Janus interface, which synergistically inhibits the formation of the capsule around the prosthesis, and finally realizes the dual effects of prosthesis stability and reduction of the capsule. The authors Jungki Ryu, Sook Hee Ku, Haeshin Lee, and Chan Beum Park published an article titled "Mussel-Inspired Polydopamine Coating as a Universal Route to Hydroxyapatite Crystallization" in the journal *Advanced functional materials* (2010, 20, 2132–2139), which discloses a method for preparing a biomimetic mineralized hydroxyapatite coating through polydopamine.

[0020] Customized modeling is designed using Rhino software according to facial CT scan data, and 4D printing accurately realizes personalized nasal prostheses, adapting to personalized facial dynamic features. After the nasal prosthesis is implanted into a human nasal simulation model, the rhinoplasty shape can be intelligently adjusted by deforming the nasal prosthesis under temperature control.

[0021] 4D printing technology is "3D printing technology + time".

[0022] Based on 3D printing, 4D printing uses intelligent materials that can respond to changes in the external environment (i.e., electric field, magnetic field, temperature, humidity, pH, etc.). 4D printing technology is an integrated technology based on intelligent materials and 3D printing, and has great application value in the field of biomedicine. 4D printing technology has broken through the technical bottleneck of personalized customization, providing new opportunities for the further development of the biomedical field.

[0023] Advantages of the present invention: 1. By mimicking mussels, spermidine coating is applied to the dorsal side of the nasal prosthesis, and hydroxyapatite coating is applied to the ventral side of the nasal prosthesis by biomimetic mineralization to prepare a Janus interface, which synergistically inhibits the formation of the capsule around the prosthesis, and finally realizes the dual effects of prosthesis stability and reduction of the capsule.

[0024] 2. 4D printing accurately realizes personalized customization of nasal prostheses, adapting to personalized facial dynamic features.

[0025] 3. The use of intelligent response materials realizes controllable deformation during and after surgery, breaks the limitation of the static shape of traditional prostheses, provides non-invasive dynamic plastic surgery capabilities, facilitates intraoperative shaping by doctors and postoperative fine-tuning by patients, and avoids multiple surgeries.

[0026] 4. Realize the linkage of "structural mechanics + intelligent response + biological adaptation", and construct an "anatomy-structure-function" integrated nasal prosthesis. Description of the drawings

[0027] Figure 1 It is a transverse sectional view of the nasal prosthesis described in the present invention.

[0028] Figure 2 It is a transverse sectional view of the nasal prosthesis described in the present invention when hydroxyapatite coating is laid on the abdomen.

[0029] Figure 3 It is a transverse sectional view of the nasal prosthesis described in the present invention when spermidine coating is laid on the back.

[0030] Figure 4 It is a transverse sectional view of the nasal prosthesis described in the present invention when it is adjusted to become higher.

[0031] Figure 5 It is a transverse sectional view of the nasal prosthesis described in the present invention when it is adjusted to become lower.

[0032] Figure 6 It is a comparison schematic diagram of the nasal prosthesis described in the present invention before and after implantation in the simulation model and after adjustment.

[0033] Figure 7 It is a three-dimensional schematic diagram of the velvet antler microporous structure described in the present invention.

[0034] Figure 8This is a schematic diagram of the installation position of the nasal prosthesis implantation simulation model described in the present invention. DETAILED DESCRIPTION

[0035] See also Figures 1 to 8 Shown is an embodiment of the present invention.

[0036] An intelligent controllable super-deformable nose prosthesis, which is composed of a nose prosthesis belly 1, a nose prosthesis back 2 and two sides of the nose prosthesis side 3, the four forming a concave hollow Ω-shaped structure; The abdomen 1 of the nasal prosthesis is concave inwards, and the outer side is provided with a deer antler microporous structure and covered with a hydroxyapatite coating 11 to facilitate bone integration, stabilize the prosthesis, and achieve directional deformation; The back 2 of the nasal prosthesis is convex outward, and the outer side is a smooth surface to prevent the growth of soft tissue and restrain the deformation of the nasal prosthesis; during shaping, the skin will not adhere to the prosthesis and affect the appearance of the nose after plastic surgery; the outer side of the back 2 of the nasal prosthesis is covered with a spermidine coating 21 to reduce capsule formation and avoid capsule contracture affecting the long-term dynamic shaping of the nasal prosthesis; The side portion 3 of the nasal prosthesis is concave inwardly curved, and the outer side is a smooth surface to prevent the growth of soft tissue and restrain the prosthesis from deformation. During shaping, the skin will not adhere to the prosthesis and affect the appearance of the nose after plastic surgery. The concave design of the bottom on both sides gives the nasal prosthesis greater deformation performance.

[0037] This embodiment uses PLA-PU-NH2, which uses four-arm star-shaped PLA as the soft segment, and the reaction product of hexamethylene diisocyanate and ethylenediamine as the hard segment to synthesize SMPU (shape memory polyurethane) intelligent material to prepare an intelligent controllable super-deformable nose prosthesis, which is designed by Rhino software and produced by 4D printing. The shape memory behavior of the material is optimized and the degradation rate is regulated. The intelligent response material realizes controllable deformation during and after surgery, breaking the static morphology limitations of traditional prostheses, providing non-invasive dynamic plastic surgery capabilities, facilitating doctors' intraoperative shape adjustment and patients' postoperative fine-tuning, and avoiding multiple surgeries. The PLA-PU-NH2 used in this embodiment is an existing sales product.

[0038] The porosity of the microporous structure arranged on the outer side of the abdomen 1 of the nasal prosthesis is 400 μm, which prevents the prosthesis from micro-movement, breaks the annular capsule structure, and reduces the capsule binding force.

[0039] The deformation angle of the intelligent controllable super-deformable nose prosthesis is 30 degrees to 120 degrees, which is used for fine nose bridge adjustment.

[0040] For the 4D-printed intelligent controllable super-deformable nasal prosthesis, it is necessary to cover the outer side of the belly 1 of the nasal prosthesis with a hydroxyapatite coating 11 to facilitate bone integration, stabilize the prosthesis, and achieve directional deformation; and cover the outer side of the back 2 of the nasal prosthesis with a spermidine coating 21 to reduce capsule formation and avoid capsule contracture affecting the long-term dynamic shaping of the nasal prosthesis.

[0041] Preparation of spermidine coating by biomimetic mussel method: (1) The shape memory polyurethane nasal prosthesis is sterilized with ethylene oxide for standby; (2) Dopamine hydrochloride is dissolved in 10 mmol / L Tris-HCl buffer to prepare a dopamine solution with a mass concentration of 2 g / L, and the pH value is adjusted to 8.5 with 1 mol / L sodium hydroxide solution; (3) The above nasal prosthesis is placed under an infrared lamp for irradiation, ensuring irradiation for 30 seconds at a temperature of 42 °C. At this time, adjust the abdomen 1 of the nasal prosthesis to be horizontal, and immerse the sterilized abdomen 1 of the nasal prosthesis in it, ensuring that the side 3 of the nasal prosthesis is not contaminated with the above solution. After incubating in the dark at room temperature for 16 h, take out the nasal prosthesis, rinse it repeatedly with deionized water to remove the unbound dopamine, air-dry it at room temperature, and sterilize it with ethylene oxide; (4) Transfer the prepared polydopamine-shape memory polyurethane nasal prosthesis to a container filled with spermidine solution, immerse the abdomen 1 of the nasal prosthesis in it, ensuring that the side 3 of the nasal prosthesis is not contaminated with the spermidine solution, soak for 24 h, take out the nasal prosthesis after 24 h, rinse it with a large amount of deionized water, and the spermidine coating on the abdomen 1 of the nasal prosthesis is completed.

[0042] Preparation of hydroxyapatite coating by biomimetic mineralization method: (1) The shape memory polyurethane nasal prosthesis is sterilized with ethylene oxide for standby; (2) Dopamine hydrochloride is dissolved in 10 mmol / L Tris-HCl buffer to prepare a dopamine solution with a mass concentration of 2 g / L, and the pH value is adjusted to 8.5 with 1 mol / L sodium hydroxide solution; (3) Immerse the back 2 of the sterilized shape memory polyurethane nasal prosthesis in it, ensuring that the side 3 of the nasal prosthesis is not contaminated with the above solution. After incubating in the dark at room temperature for 16 h, take out the nasal prosthesis, rinse it repeatedly with deionized water to remove the unbound dopamine, air-dry it at room temperature, and sterilize it with ethylene oxide; (4) Transfer the prepared polydopamine-shape memory polyurethane nasal prosthesis to a 50 mL centrifuge tube containing 1.5 times simulated body fluid, ensuring that the side 3 of the nasal prosthesis is not contaminated with the above simulated body fluid. Incubate in the dark at 37 °C for 7 days, changing the fresh simulated body fluid daily. After 7 days, take out the nasal prosthesis, rinse it with a large amount of deionized water, and the hydroxyapatite coating on the back 2 of the nasal prosthesis is completed.

[0043] The preparation of the intelligent controllable super-deformable nasal prosthesis is completed.

[0044] After implanting this intelligent controllable super-deformable nasal prosthesis into the simulation model, the nasal augmentation shape can be intelligently adjusted by the deformation of the nasal prosthesis under temperature control. Usually, the method of irradiating with an infrared lamp is adopted to ensure irradiation for 30 seconds at a temperature of 42 °C. At this time, the intelligent controllable super-deformable nasal prosthesis is in the best plastic adjustment state, and the nasal prosthesis can be adjusted according to needs to complete nose shaping.

[0045] Please refer to Figure 6, for the four states of the simulation model, measure the angle of the nasofrontal angle, that is, the angle between the nasal dorsum line and the slope from the forehead to the nasal root: First, before rhinoplasty, the nasofrontal angle of the simulation model is 147.5°; Second, after rhinoplasty, after implanting the nasal prosthesis into the simulation model, the nasofrontal angle of the simulation model is 166.0°; Third, fine-tuning for heightening, adjusting the shape of the nasal prosthesis in the simulation model to a higher position, the nasofrontal angle of the simulation model is 170.1°; Fourth, fine-tuning for lowering, adjusting the shape of the nasal prosthesis in the simulation model to a lower position, the nasofrontal angle of the simulation model is 159.9°.

[0046] Before each state adjustment, use an infrared heat lamp to irradiate in such a way that it is irradiated at a temperature of 42°C for 30 seconds.

[0047] This method facilitates the later adjustment after the nasal prosthesis is implanted into the human body and avoids secondary surgery.

Claims

1. An intelligent and controllable super-deformable nasal prosthesis, characterized in that: It is composed of a nasal prosthesis abdomen (1), a nasal prosthesis back (2) and two nasal prosthesis sides (3) on both sides, and the four form a concave hollow Ω-shaped structure; The nasal prosthesis abdomen (1) is concave inward, with a microporous structure on the outer surface and is coated with a hydroxyapatite coating (11); The nasal prosthesis back (2) protrudes outward, with a smooth outer surface and is coated with a spermidine coating (21); The nasal prosthesis side (3) is concave inward, with a smooth outer surface.

2. The intelligent controllable super-deformable nasal prosthesis according to claim 1, wherein: The intelligent controllable super-deformable nasal prosthesis is designed by Rhino software and manufactured by 4D printing.

3. The intelligent controllable super-deformable nasal prosthesis according to claim 1, characterized in that: The intelligent controllable super-deformable nasal prosthesis is made of shape memory polyurethane material.

4. The intelligent controllable super-deformable nasal prosthesis according to claim 1, characterized in that: The porosity of the microporous structure provided on the outer surface of the nasal prosthesis abdomen (1) is 100 - 600 μm.

5. An intelligent controllable super-deformable nasal prosthesis according to claim 1, characterized in that: The deformation angle of the intelligent controllable super-deformable nasal prosthesis is 30 degrees - 120 degrees.

6. The intelligent controllable super-deformable nasal prosthesis according to claim 1, characterized in that: The microporous structure provided on the outer surface of the nasal prosthesis abdomen (1) is a bionic trabecular bone structure or a velvet antler microporous structure or a TPMS structure.

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