Intelligent controllable super-deformable nasal prosthesis

Abstract

The application relates to an intelligent controllable super-deformation nose prosthesis, belonging to the field of plastic surgery medical instruments, which combines an inner concave hollow omega-shaped structure frame main body shell layer, a Janus interface outer coating and intelligent response materials to construct an anatomic-structure-function integrated nose prosthesis, performs micropore design and hydroxyapatite coating on the ventral side of the nose prosthesis to form a high-adhesion and high-stability nose prosthesis structure, performs smooth design and spermidine coating on the dorsal side of the nose prosthesis to inhibit envelope formation and avoid envelope constraint, combines the inner concave hollow omega-shaped structure design to realize super-orientation deformation performance, and the application of the intelligent response materials can realize non-invasive deformation adjustment through a temperature signal during or after surgery to meet the clinical requirements of intraoperative and postoperative fine adjustment. The nose prosthesis can be applied to plastic surgery, postoperative modification, repair and reconstruction scenes to meet higher-level medical and aesthetic requirements.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of orthopedic medical devices, in particular to an intelligent controllable super-deformable nasal prosthesis. BACKGROUND

[0002] With the continuous improvement of social and economic level and the increasing of people's aesthetic consciousness, the demand for facial contour optimization and aesthetic improvement is showing a sustained and rapid growth trend worldwide, especially in the Asian region, people's acceptance of plastic surgery is continuously improving. Since the nose has a significant impact on the overall facial contour, rhinoplasty has become one of the most common plastic surgery procedures, and has ranked among the top five plastic surgery procedures for several consecutive years. 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 rhinoplasty worldwide reached more than 1 million, an increase of 21.6% over the previous year. The revision rate of rhinoplasty is as high as 20%, mostly due to dissatisfaction with the appearance after surgery, loss of prosthesis height, and higher demand for aesthetics. Revision surgery requires the removal or replacement of the prosthesis, which is difficult to operate, has a postoperative recovery period of at least 3-5 months, a complication rate of 18.6%, and a waiting period of more than 1 year before re-implanting the prosthesis. This not only poses a technical challenge to doctors, but also brings huge psychological pressure and heavy economic burden to patients.

[0003] Clinically, rhinoplasty is usually divided into two categories: one is cosmetic rhinoplasty aimed at aesthetic improvement, such as rhinoplasty, hump nose correction, and nose tip shaping; the other is reconstructive rhinoplasty mainly for functional reconstruction or shape repair, such as correction of congenital nasal deformity and post-tumor repair. Regardless of the type of surgery, the performance of the nasal prosthesis material as the core building element of rhinoplasty directly affects the operability of the surgery, the postoperative shape and 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 risk of rejection. However, autologous cartilage transplantation has limitations such as damage to the donor site, difficulty in carving, and complex surgical procedures. In addition, after transplantation, the support may decrease due to cartilage absorption, making it difficult to achieve long-term highly personalized appearance requirements.

[0005] At present, some artificial materials are also used in clinical practice. Commonly used nasal prosthesis materials include silicone, expanded polytetrafluoroethylene (ePTFE) and high-density porous polyethylene (Medpor). Although silicone nasal prosthesis has the advantages of easy carving, low cost, convenient implantation and so on, it is not closely fitted with soft tissue, and is prone to displacement after operation due to muscle movement, external force and other factors. The stability of the nasal prosthesis is poor. Moreover, it cannot form bone integration with the host tissue, and there is a risk of interface friction and chronic rejection reaction, with a higher postoperative infection rate than other materials. The unique microporous structure of ePTFE nasal prosthesis allows tissue ingrowth, significantly improving the stability of the implanted body. However, the material is difficult to carve, and the plasticity is low during the operation. Some patients may develop delayed rejection or chronic inflammatory reaction, and it is difficult to remove once infected or need repair. In order to overcome the disadvantages of silicone and expansion, another high-density porous polyethylene (Medpor) nasal prosthesis has appeared in clinical practice. It has good compatibility with human tissue and rarely causes immune rejection. However, Medpor may cause skin thinning after implantation in the human nose. Although it has strong adhesion to the surrounding soft tissue, it is not firmly combined with bone or cartilage, and is prone to slight mobility problems.

[0006] Most of the currently used nasal prostheses are pre-made models, and their size, curvature, and tip degree are usually obtained by standardized mold processing. They can only be adjusted by preoperative limited selection or manual modification during the operation. This "passive fitting" method cannot completely match the complex curved surface structure of the patient's nasal bone and soft tissue, especially for groups with high individualization demand. The matching degree is seriously insufficient, and the fitting degree is not enough, which leads to micro-motion of the nasal prosthesis in the body, formation of a capsule, and further capsular contracture. The stability of the prosthesis is poor, and postoperative problems such as prosthesis displacement, rotation, and sinking often occur. Moreover, if the patient is slightly dissatisfied with the nasal shape after the operation or wants to make minor adjustments, they usually have to undergo a second operation, which increases the risk of trauma and infection. Currently, there is no mature technology that can achieve "non-invasive dynamic shaping" function in clinical practice.

[0007] Therefore, how to develop a new type of intelligent prosthesis with high individualization adaptation, dynamic response capability, postoperative fine-tuning function, and enhanced fitting stability is an urgent need in the field of plastic surgery, especially in the field of rhinoplasty.

[0008] In recent years, negative Poisson's ratio (NPR) structure has attracted widespread attention in the fields of flexible adjustable structure, wearable devices and biomimetic materials due to its unique deformation characteristics of lateral expansion during stretching and lateral contraction during compression. Inspired by NPR structure, the nasal prosthesis is designed as an inner concave hollow Ω-shaped structural framework, which is expected to achieve greater deformation capability.

[0009] Meanwhile, intelligent materials show explosive growth in the fields of medical treatment, bionics, micro-electro-mechanical systems, etc. The intelligent response material refers to a material system capable of reversible change according to external environmental stimulation (such as temperature, light, electricity, magnetism, chemical signal, etc.). The development of the intelligent response material makes it possible for the nasal prosthesis to be controllably deformed during and after the operation, especially suitable for intraoperative adjustment and postoperative fine adjustment, and becomes an important direction for solving the current limitations of the nasal prosthesis. However, there is no public literature combining the mechanical structure design of the nasal prosthesis with the intelligent response material to form the collaborative innovation of the structure and function design integration. The nasal prosthesis of the present application is no longer a single material or a stack of static models, but a nasal prosthesis design for realizing the comprehensive performance of dynamic reshaping and postoperative fine adjustment, which is a multi-dimensional fusion of "structure mechanics + intelligent response + biological adaptation". SUMMARY

[0010] The purpose of the present application is to solve the problems of the conventional nasal prosthesis, such as inability to dynamically reshape, poor stability, capsule contracture, etc., and to provide an intelligent controllable super-deformation nasal prosthesis. The core is to be able to design individually according to the patient's nasal bone and nasal shape. The inner concave hollow Ω-shaped structural frame body shell, Janus interface outer coating and intelligent response material are combined to construct an "anatomy-structure-function" integrated nasal prosthesis. The micro-pore design and hydroxyapatite coating are performed on the ventral side of the nasal prosthesis to form a high-fitting and high-stable nasal prosthesis structure. The smooth design and spermidine coating are performed on the dorsal side of the nasal prosthesis to inhibit the formation of the capsule and avoid the constraint of the capsule. The application of the intelligent response material can be used to adjust the non-invasive deformation during or after the operation through the temperature signal to meet the clinical needs of intraoperative and postoperative fine adjustment. The nasal prosthesis can be applied to the scenes of plastic surgery, postoperative modification, repair and reconstruction, etc. to meet the higher level of medical and aesthetic needs.

[0011] An intelligent controllable super-deformation nasal prosthesis is composed of a nasal prosthesis abdomen, a nasal prosthesis back and two sides of a nasal prosthesis side, which form an inner concave hollow Ω-shaped structure.

[0012] The nasal prosthesis abdomen is concave inward, and the outer side is provided with a micro-pore structure and coated with a hydroxyapatite coating to facilitate bone integration, stabilize the prosthesis and realize directional deformation.

[0013] The nasal prosthesis back is convex outward, and the outer side is a smooth surface to prevent soft tissue from growing into the nasal prosthesis and restricting the deformation of the nasal prosthesis. During shaping, the skin will not adhere to the prosthesis to affect the appearance of the nose after reshaping.

[0014] The outer side of the nasal prosthesis back is coated with a spermidine coating to reduce the formation of the capsule and avoid the capsule contracture affecting the long-term dynamic reshaping of the nasal prosthesis.

[0015] The side of the nasal prosthesis is inwardly concave, the outer side is a smooth surface, the soft tissue is prevented from growing in, the nasal prosthesis is prevented from being deformed, when shaping, the skin is prevented from adhering to the nasal prosthesis and affecting the appearance of the nose after plastic surgery, and the bilateral bottom is designed to be concave, so that the nasal prosthesis has greater deformation performance.

[0016] The intelligent controllable super-deformation nasal prosthesis is designed through Rhino software and is made through 4D printing.

[0017] The intelligent controllable super-deformation nasal prosthesis is a shape memory polyurethane material, realizes optimization of shape memory behavior of the material and regulation of a degradation rate, realizes controllable deformation during and after surgery through the intelligent response material, breaks the limitation of a traditional static form of the prosthesis, provides non-invasive dynamic plastic surgery capacity, facilitates intraoperative shape adjustment of a doctor and postoperative fine adjustment of a patient, and avoids multiple surgeries.

[0018] The microporous structure is arranged on the outer side of the abdomen of the nasal prosthesis, the porosity of the microporous structure is 100-600 mu m, the micromovement of the prosthesis is prevented, the ring-shaped envelope structure is broken, and the envelope restraint force is reduced.

[0019] The deformation angle of the intelligent controllable super-deformation nasal prosthesis is 30 degrees-120 degrees, and is used for fine nose ridge adjustment.

[0020] The microporous structure arranged on the outer side of the abdomen of the nasal prosthesis is a bionic trabecular structure or a velvet microporous structure or a TPMS (three-periodic minimal surface structure) structure.

[0021] The working process and working principle of the present application are as follows:

[0022] Janus interface is a special three-dimensional multi-level structure composed of two or more components with different physical properties. The unique feature of this structure is that its two surfaces (facing opposite directions) have different properties, thus bringing a series of functional advantages. Janus interface has been widely used in the medical field. In the present application, spermidine coating is coated on the dorsal side of the nasal prosthesis by imitating mussels, and hydroxyapatite coating is coated on the ventral side of the nasal prosthesis by imitating mineralization; the Janus interface outer coating is introduced to describe that the hydroxyapatite coating is arranged on the outer side of the abdomen of the nasal prosthesis and the spermidine coating is arranged on the outer side of the dorsal side of the nasal prosthesis, the two coatings face two directions, and the two coatings are used for synergistically inhibiting the formation of the envelope around the prosthesis, so that the dual effects of stabilizing the prosthesis and reducing the envelope are realized.

[0023] Hydroxyapatite (HA) is the main inorganic component of the skeleton and teeth of vertebrates, and is a commonly used bone repair material in clinical practice with good biocompatibility. Its main role is to promote the growth of the surrounding bone tissue, and it can effectively form a chemical bond with natural bone. Hydroxyapatite coating can improve the biocompatibility and bioactivity of biomaterials, and improve the bone integration ability of biomaterials. Therefore, hydroxyapatite is considered as an ideal coating for the surface of implants, and is often used in bone tissue regeneration engineering. In order to promote the bone growth of the nasal prosthesis, hydroxyapatite coating is applied to the ventral side of the nasal prosthesis, so that the nasal prosthesis is perfectly matched and fixed with the human nose, the stability of the nasal prosthesis is improved, directional deformation is realized, and the risk of displacement of the nasal prosthesis is reduced.

[0024] Spermidine (SPD) is a naturally occurring polyamine compound. In recent years, spermidine has shown extensive anti-fibrosis effects through various mechanisms, including inducing autophagy, activating antioxidant pathways, inhibiting inflammatory responses and apoptosis, etc. It has shown good therapeutic potential in fibrosis models of organs such as lungs, livers and kidneys. Spermidine coating is applied to the dorsal side of the nasal prosthesis, which can effectively reduce the formation of the envelope and inhibit the fibrosis of the envelope.

[0025] By mimicking the method of mussels, a spermidine coating is applied to the dorsal side of the nasal prosthesis, and by mimicking the method of mineralization, a hydroxyapatite coating is applied to the ventral side of the nasal prosthesis, to prepare a Janus interface, which can synergistically inhibit the formation of the envelope around the prosthesis, and ultimately achieve the dual effects of prosthesis stability and reduction of the envelope. The authors Jungki Ryu, Sook Hee Ku, Haeshin Lee, and Chan Beum Park published an article entitled "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 mineralization hydroxyapatite coating by polydopamine.

[0026] According to the facial CT scan data, Rhino software is used for design and customization modeling, and 4D printing is used to accurately realize personalized customization of the nasal prosthesis, which can adapt to the dynamic characteristics of the personalized face. After the nasal prosthesis is implanted into the human nose simulation model, the shape of the rhinoplasty can be intelligently adjusted by deforming the nasal prosthesis under temperature control.

[0027] 4D printing technology is a combination of "3D printing technology + time".

[0028] Based on 3D printing, 4D printing adopts intelligent materials capable of responding to changes in external environment (i.e. electric field, magnetic field, temperature, humidity, PH, etc.). 4D printing technology is a comprehensive technology based on intelligent materials and 3D printing, which has great application value in the field of biomedicine. 4D printing technology breaks through the technical bottleneck of personalized customization, and provides a new opportunity for the further development of the field of biomedicine.

[0029] The beneficial effects of the present application are:

[0030] 1. By mimicking the method of mussels, a spermidine coating is applied to the dorsal side of the nasal prosthesis, and by mimicking the method of mineralization, a hydroxyapatite coating is applied to the ventral side of the nasal prosthesis, to prepare a Janus interface, which synergistically inhibits the formation of a periprosthetic envelope, ultimately achieving the dual effects of prosthesis stability and reduction of the envelope.

[0031] 2. 4D printing precisely realizes personalized customization of the nasal prosthesis, and adapts to individualized facial dynamic features.

[0032] 3. The use of intelligent response materials realizes controllable deformation during and after surgery, breaks the limitation of traditional prosthesis static form, provides non-invasive dynamic plastic ability, facilitates intraoperative shape adjustment by doctors and postoperative fine adjustment by patients, and avoids multiple surgeries.

[0033] 4. Realize the linkage of "structural mechanics + intelligent response + biological adaptation", and build an integrated nasal prosthesis of "anatomy-structure-function". BRIEF DESCRIPTION OF DRAWINGS

[0034] Figure 1 is a transverse sectional view of the nasal prosthesis described in the present application.

[0035] Figure 2 is a transverse sectional view of the nasal prosthesis described in the present application when the ventral part is covered with a hydroxyapatite coating.

[0036] Figure 3 is a transverse sectional view of the nasal prosthesis described in the present application when the dorsal part is covered with a spermidine coating.

[0037] Figure 4 is a transverse sectional view of the nasal prosthesis described in the present application when the height is adjusted.

[0038] Figure 5 is a transverse sectional view of the nasal prosthesis described in the present application when the height is adjusted.

[0039] Figure 6 is a contrast schematic diagram of the nasal prosthesis described in the present application before and after implantation of the simulation model and adjustment.

[0040] Figure 7 is a three-dimensional schematic diagram of the deer horn microporous structure described in the present application.

[0041] Figure 8 Figure 1 is a schematic diagram of the installation position of the nasal prosthesis implant simulation model according to the present application. DETAILED DESCRIPTION

[0042] Referring to Figures 1 to 8 Figure 1 is a schematic diagram of the installation position of the nasal prosthesis implant simulation model according to the present application.

[0043] An intelligent controllable super-deformation nasal prosthesis, which is composed of a nasal prosthesis abdomen 1, a nasal prosthesis back 2, and two sides of a nasal prosthesis side 3, and the four form a concave hollow Ω-shaped structure.

[0044] The nasal prosthesis abdomen 1 is concave inward, and the outer side is provided with a velvet micro-porous structure, which is coated with a hydroxyapatite coating 11 to facilitate bone integration, stabilize the prosthesis, and realize directional deformation.

[0045] The nasal prosthesis back 2 is convex outward, and the outer side is a smooth surface to prevent soft tissue from growing in and binding the deformation of the prosthesis; during shaping, the skin will not adhere to the prosthesis to affect the appearance of the nose after shaping; the outer side of the nasal prosthesis back 2 is coated with a spermidine coating 21 to reduce the formation of a capsule and avoid the influence of capsule contracture on long-term dynamic shaping of the nasal prosthesis.

[0046] The nasal prosthesis side 3 is concave inward, and the outer side is a smooth surface to prevent soft tissue from growing in and binding the deformation of the prosthesis; during shaping, the skin will not adhere to the prosthesis to affect the appearance of the nose after shaping, and the bilateral bottom is designed to be concave to give the nasal prosthesis greater deformation performance.

[0047] The present embodiment uses PLA-PU-NH2, which uses a four-arm star-shaped PLA as the soft segment part, and a reaction product of hexamethylene diisocyanate and ethylenediamine as the hard segment, to synthesize an intelligent material of SMPU (shape memory polyurethane) to prepare an intelligent controllable super-deformation nasal prosthesis, which is designed by Rhino software and made by 4D printing. The optimization of the shape memory behavior of the material and the regulation of the degradation rate are realized. The intelligent response material realizes controllable deformation during and after the operation, breaks the limitation of the static form of the traditional prosthesis, provides non-invasive dynamic shaping ability, is convenient for the doctor to adjust the shape during the operation and the patient to fine-tune after the operation, and avoids multiple operations. The PLA-PU-NH2 used in the present embodiment is a product that is currently on the market.

[0048] The porosity of the micro-porous structure provided on the outer side of the nasal prosthesis abdomen 1 is 400 μm, which prevents micro-movement of the prosthesis, breaks the ring-shaped capsule structure, and reduces the binding force of the capsule.

[0049] The deformation angle of the intelligent controllable super-deformation nasal prosthesis is 30 degrees-120 degrees, which is used for fine adjustment of the nasal bridge.

[0050] For the 4D printed intelligent controllable super-deformable nasal prosthesis, a hydroxyapatite coating 11 needs to be covered on the outer side of the abdominal part 1 of the nasal prosthesis to facilitate bone integration, stabilize the prosthesis, and realize directional deformation; a spermidine coating 21 needs to be covered on the outer side of the back part 2 of the nasal prosthesis to reduce capsule formation and avoid capsule contracture affecting the long-term dynamic shaping of the nasal prosthesis.

[0051] The spermidine coating is prepared by the biomimetic mussel method: (1) an oxirane sterilized shape memory polyurethane nasal prosthesis is prepared for standby; (2) dopamine hydrochloride is dissolved in a 10 mmol / L Tris-HCl buffer to prepare a dopamine solution with a mass concentration of 2 g / L, and a 1 mol / L sodium hydroxide solution is used to adjust the pH value to 8.5; (3) the above nasal prosthesis is irradiated under an infrared baking lamp to ensure that the temperature is 42°C and the irradiation time is 30 seconds, at this time, the abdominal part 1 of the nasal prosthesis is adjusted to be horizontal, the sterilized nasal prosthesis abdominal part 1 is soaked therein, and the side part 3 of the nasal prosthesis is ensured not to be contaminated by the above solution; after incubation at room temperature in the dark for 16 hours, the nasal prosthesis is taken out, repeatedly washed with deionized water to remove unattached dopamine, air-dried at room temperature, and sterilized with oxirane; (4) the above prepared polydopamine-shape memory polyurethane nasal prosthesis is transferred to a spermidine solution, the nasal prosthesis abdominal part 1 is soaked therein, and the nasal prosthesis side part 3 is ensured not to be contaminated by the spermidine solution; after 24 hours of soaking, the nasal prosthesis is taken out and washed with a large amount of deionized water, and the spermidine coating on the nasal prosthesis abdominal part 1 is completed.

[0052] The hydroxyapatite coating is prepared by the biomimetic mineralization method: (1) an oxirane sterilized shape memory polyurethane nasal prosthesis is prepared for standby; (2) dopamine hydrochloride is dissolved in a 10 mmol / L Tris-HCl buffer to prepare a dopamine solution with a mass concentration of 2 g / L, and a 1 mol / L sodium hydroxide solution is used to adjust the pH value to 8.5; (3) the sterilized shape memory polyurethane nasal prosthesis back part 2 is soaked therein, and the nasal prosthesis side part 3 is ensured not to be contaminated by the above solution; after incubation at room temperature in the dark for 16 hours, the nasal prosthesis is taken out, repeatedly washed with deionized water to remove unattached dopamine, air-dried at room temperature, and sterilized with oxirane; (4) the above prepared polydopamine-shape memory polyurethane nasal prosthesis is transferred to a 50 mL centrifuge tube containing 1.5 times of simulated body fluid, and the nasal prosthesis side part 3 is ensured not to be contaminated by the above simulated body fluid; after incubation at 37°C in the dark for 7 days, the nasal prosthesis is taken out and washed with a large amount of deionized water, and the hydroxyapatite coating on the nasal prosthesis back part 2 is completed.

[0053] The intelligent controllable super-deformable nasal prosthesis is prepared.

[0054] After the intelligent controllable super-deformation nose prosthesis is implanted into the simulation model, the shape of the rhinoplasty can be intelligently adjusted by deforming the nose prosthesis under temperature control. Usually, the infrared baking lamp irradiation method is used to ensure that the temperature is 42°C for 30 seconds. At this time, the intelligent controllable super-deformation nose prosthesis is in the best plastic adjustment state, and the adjustment of the nose prosthesis can be made according to the needs to complete the rhinoplasty.

[0055] Please refer to Figure 6 The four states of the simulation model are measured by the nasofrontal angle, which is the angle between the nasal dorsum line and the forehead to the nasal root inclined plane:

[0056] First, before rhinoplasty, the nasofrontal angle of the simulation model is 147.5°.

[0057] Second, after rhinoplasty, the nasofrontal angle of the simulation model is 166.0° after the nose prosthesis is implanted into the simulation model.

[0058] Third, fine-tune the height, adjust the shape of the nose prosthesis in the simulation model, and the nasofrontal angle of the simulation model is 170.1°.

[0059] Fourth, fine-tune the height, adjust the shape of the nose prosthesis in the simulation model, and the nasofrontal angle of the simulation model is 159.9°.

[0060] Before each state adjustment, the infrared baking lamp irradiation method is used to ensure that the temperature is 42°C for 30 seconds.

[0061] This method is convenient for post-adjustment of the nose prosthesis implanted into the human body, and avoids secondary surgery.

Claims

1. A smart, controllable, highly deformable nasal prosthesis, characterized in that: It consists of the nasal implant abdomen (1), the nasal implant back (2) and the two nasal implant side parts (3), which together form a concave hollow Ω-shaped structure; The nasal implant has an inwardly concave abdomen (1) and a microporous structure on its outer side, covered with a hydroxyapatite coating (11). The back (2) of the nasal prosthesis protrudes outward, and the outer side is a smooth surface covered with a spermidine coating (21). The nasal implant side (3) is concave inward, and the outer side is a smooth surface.

2. The intelligent controllable hyperdeformable nasal prosthesis according to claim 1, characterized in that: The aforementioned intelligent and controllable super-deformable nasal prosthesis was designed using Rhino software and manufactured via 4D printing.

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

4. The intelligent controllable hyperdeformable nasal prosthesis according to claim 1, characterized in that: The porosity of the microporous structure on the outer side of the abdominal part (1) of the nasal prosthesis is 100-600μm.

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

6. The intelligent controllable hyperdeformable nasal prosthesis according to claim 1, characterized in that: The microporous structure on the outer side of the abdomen (1) of the nasal prosthesis is a biomimetic bone trabecular structure, a deer antler microporous structure, or a TPMS structure.

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