CN114366854B - Silica gel nose augmentation material of composite decalcified bone matrix - Google Patents

Abstract

The invention discloses a silica gel nose augmentation material compounded with decalcified bone matrix. Comprises silica gel, decalcified bone meal, curing agent and reinforcing adhesive. The invention adopts silica gel and decalcified bone matrix to construct the nose-enlarging prosthesis, the probability of complication occurrence of long-term implantation of silica gel is reduced by using allogeneic tissues, compared with the silica gel, the decalcified bone matrix has better biocompatibility and is easier to degrade, and the autologous tissues can grow into the silica gel by using pores generated by degradation of the decalcified bone matrix, so that the prosthesis is activated, the complication occurrence is reduced, and compared with other nose-enlarging prostheses, the silica gel prosthesis is relatively easy to completely take out the prosthesis.

Description

Silica gel nose augmentation material of composite decalcified bone matrix

Technical Field

The invention belongs to the technical field of nose augmentation prosthesis materials, and particularly relates to a silica gel nose augmentation material of a composite decalcified bone matrix.

Background

According to the white paper of the 2019 doctor and American industry released by APP in more America, the market scale of Chinese pure doctor and American industry in 2019 is as high as 2560 hundred million yuan, the average speed increase of nearly five years is about 30%, and the consumption of the Chinese doctor and American industry in the treatment course reaches 2500 ten thousand cases. The Chinese medical and American market is expected to break through trillion yuan in 2025. The projects such as nasal synthesis are one of the first ten sales in APP of more beauty, and the nasal plastic market has great development potential.

The most commonly used materials for prosthetic augmentation of the nose are solid silica gel, expanded and autologous cartilage and biological augmentation of the nose. And the biological humped nose is generally considered as the development direction of the humped nose in the future by the medical field. The silica gel has good histocompatibility, is similar to cartilage in texture, is easy to carve and shape, has no discomfort for patients after being filled to the back of nose, rarely generates organism rejection reaction, and is an ideal prosthesis substitute. However, the complication rate can reach 5 to 20 percent after more than twenty years of observation. The bulk material has easy shaping, strong sense of reality and better compatibility with tissues, and human tissue cells and blood vessels can grow into micropores of the bulk material to form tissue connection, which is the same as autologous tissues. Has wide application prospect in augmentation rhinoplasty, but is expensive. The autologous cartilage has the main advantages that the augmentation rhinoplasty prosthesis material is easy to survive after transplantation and does not generate rejection reaction. However, the patient needs to be incised, and scars may appear. There is a possibility that the plastic surgery for autologous cartilaginous augmentation rhinoplasty may be deformed by absorption. The biological nose humping material mainly refers to a nose humping material extracted from a living body, and mainly refers to a dermal nose humping material. The dermal augmentation nose material is divided into autologous dermis and artificial dermis, the autologous dermis is taken from a patient, and the dermal augmentation nose material has the characteristics of no rejection, natural shape, strong repair function and the like. The disadvantage is a certain absorption rate. The artificial dermis has the tendency of replacing autologous dermis and costal cartilage, and the shaping of the artificial dermis has advantages in height over the autologous dermis and costal cartilage, so that the trouble of leaving scars on the body of a person is avoided. The artificial dermis has a disadvantage in that it has some absorption problems during the tissue replacement process.

In 1955, Nishihata successfully applied the solid silicone rubber material for nose augmentation for the first time. The solid silicone rubber has stable performance, easy sculpture, low incidence of tissue rejection reaction, no toxicity, no carcinogenicity and easy taking out once complications occur. This method is quickly becoming established and popular with physicians around the world. To date, solid silicone rubber remains the primary prosthetic material for augmentation rhinoplasty.

In 1963, Counay and Goulian reported that nose augmentation with liquid silicone rubber was successful. Because the liquid silicon rubber can be used for humping the nose by adopting an injection mode, the shaping is random, the shaping is ideal, no operation is needed, the pain is little, and the liquid silicon rubber is popular all over the world. However, over 10 years of clinical practice has found that liquid silicone rubber is also prone to rejection, and once complications occur, the prosthesis is not easy to clean, often with serious adverse consequences. The nasal back skin ulceration and necrosis are common and cause deformity. The use of the united states has been banned in the 80's of the 20 th century. Although not prohibited in China, the Chinese plastic surgery society has called for stopping use many times.

In the early 90 s of the 20 th century, some manufacturers introduced liquid hydroxyapatite injection for nasal augmentation. Hydroxyapatite is also called artificial bone, has been used in orthopedics for many years, and has good effect, low tissue reaction and easy shaping. However, since liquid hydroxyapatite can diffuse along the interstitial spaces, the shape after coagulation is not very regular, and complete removal of the prosthesis is difficult once rejection and other complications occur. Therefore, the method is limited in its use and spread. The silica gel material is the most ideal biological tissue substitute from the medical point of view, and is mainly used for revascularization during human organ transplantation before. The silica gel material is best compatible with human body, is nontoxic, non-carcinogenic and non-allergenic, and does not need to be replaced for life.

Disclosure of Invention

The invention aims to provide a silica gel nose-humping material compounded with decalcified bone matrix.

A silica gel nose-humping material compounded with decalcified bone matrix is composed of silica gel, decalcified bone powder, solidifying agent and reinforcing adhesive.

The weight percentage of the decalcified bone meal in the hump nose material is less than 60 percent.

The reinforcing adhesive accounts for less than 8 percent of the mass fraction of the hump nose material.

The mass fraction of the curing agent in the hump nose material is less than 10%, and the curing agent is selected from calcium phosphate bone cement or calcium sulfate bone cement.

The reinforcing adhesive is prepared from the following components in percentage by mass: 1, mixing the mixture.

The aloe gel is Aloe Barbadensis Miller gel.

The konjac glucomannan is prepared by mixing konjac gum powder with 5-15 times of deionized water.

The particle size of the decalcified bone meal is 150-270 microns.

The preparation method of the silica gel nose-swelling material of the composite decalcified bone matrix comprises the following steps:

(1) mixing silica gel and decalcified bone powder, heating to 35-55 deg.C, adding reinforcing binder, stirring and mixing;

(2) heating to 65-75 deg.C, adding curing agent, stirring and mixing;

(3) and (3) manufacturing a mold, adding the material prepared in the step (2) into the mold, curing for 1-3h at the temperature of 65-75 ℃, and cooling to room temperature to obtain the product.

The invention has the beneficial effects that: the invention adopts silica gel and decalcified bone matrix to construct the augmentation rhinoplasty prosthesis together, the probability of the occurrence of the complications after the long-term implantation of the silica gel is reduced by using the allogeneic tissues, compared with the silica gel, the decalcified bone matrix has better biocompatibility and is easier to degrade, the autologous tissues can grow into the silica gel by using the pores generated by the degradation of the decalcified bone matrix, and then the prosthesis is activated to reduce the occurrence of the complications, and compared with other augmentation rhinoplasty prostheses, the prosthesis is easier to completely take out.

Drawings

FIG. 1 shows 60% DBM by mass of the composite.

FIG. 2 is an apparent graph of composites with different DBM content.

Fig. 3 is a silicone mold.

FIG. 4A: left 0% DBM-silica gel composite, right 10% DBM-silica gel composite; b: 20% DBM (270-.

FIG. 555% (150-270 μm) DBM-silica gel with DBM content > 85% by volume.

Detailed Description

In order that the invention may be more fully understood, reference will now be made to the following description. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete.

Example 1

Human decalcified bone powder (DBM, less than 150 microns) is selected to be compounded with silica gel in different mass ratios, and when the mass content of the DBM reaches 60 percent, the DBM cannot be bonded (figure 1), and when the mass content of the DBM reaches 70 percent, the Soranoia gel and the konjac glucomannan (mass ratio of 1: 1) cannot be bonded, so that the DBM in the subsequent composite material prepared later accounts for less than 60 percent of the total mass.

Preparing composite materials with different DBM mass ratios of 0%, 10%, 20%, 25% and 40%, respectively:

weighing 1.8g of silica gel, adding 0.1g of calcium phosphate cement, stirring uniformly, heating to 70 ℃, adding 0.05g of aloe vera gel and 0.05g of konjac glucomannan, and stirring and mixing uniformly; adding the mixture into a 24-hole plate, and curing for 2 hours at 70 ℃ to obtain the composite material 1 with 0% of DBM content.

Weighing silica gel 1.6g, adding decalcified bone powder 0.2g (less than 150 μm), stirring, heating to 45 deg.C, adding Aloe Barbadensis Miller gel 0.05g and konjac glucomannan 0.05g, stirring and mixing; heating to 70 ℃, adding 0.1g of calcium phosphate cement, and stirring and mixing uniformly; adding the mixture into a 24-hole plate, and curing for 2 hours at 70 ℃ to obtain the composite material 2 with 10 percent of DBM content.

Weighing silica gel 1.4g, adding decalcified bone powder 0.4g (less than 150 μm), stirring, heating to 45 deg.C, adding Aloe Barbadensis Miller gel 0.05g and konjac glucomannan 0.05g, stirring and mixing; heating to 70 ℃, adding 0.1g of calcium phosphate cement, and stirring and mixing uniformly; adding the mixture into a 24-hole plate, and curing for 2 hours at 70 ℃ to obtain the composite material 3 with the DBM content of 20%.

Weighing silica gel 1.3g, adding decalcified bone powder 0.5g (less than 150 μm), stirring, heating to 45 deg.C, adding Aloe barbadensis gel 0.05g and konjac glucomannan 0.05g, stirring, and mixing; heating to 70 ℃, adding 0.1g of calcium phosphate cement, and stirring and mixing uniformly; adding the mixture into a 24-hole plate, and curing for 2 hours at 70 ℃ to obtain the composite material 4 with the DBM content of 25%.

Weighing silica gel 1.0g, adding decalcified bone powder 0.8g (less than 150 μm), stirring, heating to 45 deg.C, adding Aloe Barbadensis Miller gel 0.05g and konjac glucomannan 0.05g, stirring and mixing; heating to 70 ℃, adding 0.1g of calcium phosphate cement, and stirring and mixing uniformly; adding the mixture into a 24-hole plate, and curing for 2 hours at 70 ℃ to obtain the composite material 5 with the DBM content of 40%.

The appearance of the composite material with different DBM contents is shown in figure 2, and the color is gradually deepened and the hardness is gradually increased along with the gradual increase of the addition amount of the decalcified bone powder.

Weighing silica gel 1.0g, adding decalcified bone powder 0.8g (less than 150 μm), stirring, heating to 45 deg.C, adding aloe vera gel 0.1g, stirring, and mixing; heating to 70 ℃, adding 0.1g of calcium phosphate cement, and stirring and mixing uniformly; addition to a 24-well plate and curing at 70 ℃ for 2h gave comparative material 1 having a DBM content of 40%.

Weighing silica gel 1.0g, adding decalcified bone powder 0.8g (less than 150 μm), stirring, heating to 45 deg.C, adding konjac glucomannan 0.1g, stirring, and mixing; heating to 70 ℃, adding 0.1g of calcium phosphate cement, and stirring and mixing uniformly; added to a 24-well plate and cured at 70 ℃ for 2h to provide comparative material 2 with 40% DBM content.

Weighing silica gel 1.0g, adding decalcified bone powder 0.9g (less than 150 μm), and stirring; heating to 70 ℃, adding 0.1g of calcium phosphate cement, and stirring and mixing uniformly; added to a 24-well plate and cured at 70 ℃ for 2h to provide comparative material 3 with 40% DBM content.

Example 2

The cell compatibility of each composite of example 1 was evaluated using L929 cells. The sample of example 1 was added to the medium at a ratio of 0.2g/1ml, and the mixture was extracted at 37 ℃ for 24 hours to obtain a leach solution. Taking normally cultured L929 cells, adjusting cell density to 2 × 10 ⁴ Per ml, inoculating into a 96-hole culture plate, culturing for 24h, removing the original culture medium, and adding the corresponding leaching liquor; after 72h, removing the original culture medium, adding 100ul of culture medium containing 10% CCK8 into each well, detecting absorbance at the wavelength of 450nm after 30min, and calculating the cell growth state and the relative proliferation rate of the cells in the sample group (the control group is the culture medium without adding leaching liquor).

The results of the relative proliferation rates of the cells of the composites 1-5 and the comparative materials 1-3 are shown in Table 1:

TABLE 1

EXAMPLE 3 safety of composite in vivo Implantation

12 male SD rats are selected, before the test, two side hairs of the spine of the rat are cut off, pentobarbital sodium is used for intravenous injection anesthesia during the test, the skin of the operation area is disinfected by iodophor according to the requirement of a conventional surgical operation, 4 implantation points are respectively selected at the positions of about 2.5cm on two sides of the spine of the rat at equal intervals, each point is 2.5cm, and four materials with the DBM content of 0%, 10%, 20% and 40% by mass are implanted into subcutaneous tissues. The materials are taken in 6 months and 12 months respectively, and the degradation, inflammation and adhesion condition with the surrounding tissues of the materials are observed by histological staining. The results prove that all the composite materials are implanted safely without degradation and inflammation.

Example 4 composite injection Molding study

A customized mold is shown in figure 3, the DBM-silica gel composite material is prepared according to the compounding proportion of the embodiment 1, the DBM-silica gel composite material is added into the mold, and the DBM-silica gel composite material is cured for 2 hours at 70 ℃, and the figure 4A is shown. Since the bone powder with the particle size less than 150 microns cannot show the granular feeling of the decalcified bone matrix, the particle size of 425 microns is changed to 270-425 microns to prepare the 20% DBM-silica gel composite material shown in figure 4B. The bone meal particles are too large, the composite material is easy to delaminate, the particle size of the bone meal is reduced to 150-270 micrometers, and meanwhile, the DBM becomes soft after being added with water, and the DBM composite material with the mass content of 55% and the DBM composite material with the water content (10% of the mass of the DBM) are respectively prepared, as shown in figure 5.

The above-mentioned embodiments only express several embodiments of the present invention, and the description thereof is more specific and detailed, but not construed as limiting the scope of the invention. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention. Therefore, the protection scope of the present patent shall be subject to the appended claims.

Claims (8)

1. A silica gel nose-humping material of compound decalcified bone matrix is characterized in that the nose-humping material is composed of silica gel, decalcified bone powder, a curing agent and a reinforcing adhesive; the curing agent is calcium phosphate bone cement or calcium sulfate bone cement; the reinforced adhesive is prepared from aloe vera gel and konjac glucomannan according to a mass ratio of 1: 1, mixing the mixture.

2. The silica gel nasal augmentation material of claim 1, wherein the decalcified bone meal comprises less than 60% of the nasal augmentation material by weight.

3. The silica gel nose-humping material according to claim 1, wherein said reinforcing binder accounts for less than 8% by mass of the nose-humping material.

4. The silica gel nose-raising material according to claim 1, wherein the curing agent is less than 10% by mass of the nose-raising material.

5. The nasal augmentation material of claim 1, wherein the aloe vera gel is aloe vera gel.

6. The silica gel hump nose material according to claim 1, wherein said konjac gum is prepared by blending 5-15 times of deionized water with konjac gum powder.

7. The silica gel hump nose material according to claim 1, characterized in that the particle size of said decalcified bone meal is 150-270 microns.

8. The method for preparing the silica gel nose-humping material with composite decalcified bone matrix as claimed in claim 1, characterized by comprising the following steps:

(1) mixing silica gel and decalcified bone powder, heating to 35-55 deg.C, adding reinforcing binder, stirring and mixing;

(2) heating to 65-75 deg.C, adding curing agent, stirring and mixing;

(3) and (3) manufacturing a mold, adding the material prepared in the step (2) into the mold, curing for 1-3h at the temperature of 65-75 ℃, and cooling to room temperature to obtain the product.

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