CN114366854A - 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 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.

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 compounded with decalcified bone matrix.

Background

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

The commonly used prosthetic augmentation nasal materials are mainly solid silica gel, expanded and autologous cartilage and biological augmentation nasal materials. And biological hump nose is also generally considered by the medical field as the development direction of future hump nose. 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 rejection reaction of organisms, and is an ideal prosthesis substitute. However, through observation for more than twenty years, the complication incidence rate can reach 5-20%. 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 the plastic operation of hump nose, but the price is expensive. The autologous cartilage has the main advantages that the augmentation rhinoplasty material is easy to survive after transplantation and does not generate rejection reaction. However, the scar will appear when the patient needs to be cut. 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 is mainly 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 in 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 glucomannan 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 and 270 microns) DBM-silica gel with DBM volume content > 85%.

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, when the mass content of the DBM reaches 60 percent, the DBM cannot be bonded (figure 1), the aloe vera gel and the konjac glucomannan (mass ratio of 1: 1) are added, and when the mass content of the DBM reaches 70 percent, the DBM cannot be bonded, so that the DBM in a subsequently prepared continuous composite material 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, uniformly stirring, heating to 70 ℃, adding 0.05g of aloe vera gel and 0.05g of konjac glucomannan, and uniformly stirring and mixing; 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 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 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; addition to a 24-well plate and curing at 70 ℃ for 2h gave comparative material 2 having 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; addition to a 24-well plate and curing at 70 ℃ for 2h gave comparative material 3 having 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 extracted at 37 ℃ for 24 hours to obtain an extract. Taking normally cultured L929 cells, adjusting cell density to 2 × 10⁴Inoculating the culture medium to a 96-well culture plate, culturing for 24h, removing the original culture medium, and adding 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 materials for in vivo implantation

12 male SD rats are selected, before the test, the two lateral hairs of the rat spine 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 the conventional surgical operation, 4 implantation points are respectively selected at the position of about 2.5cm away from the two sides of the rat spine at equal intervals, each point is 2.5cm away, 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 Studies

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 microns, and meanwhile, the DBM becomes soft after being added with water, so that the DBM composite material with the mass content of 55% and the DBM composite material with water (10% of the DBM mass) are respectively prepared, and the figure 5 shows.

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 (9)

1. A silica gel nose-humping material compounded with decalcified bone matrix is characterized by comprising silica gel, decalcified bone powder, a curing agent and a reinforcing adhesive.

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-raising material according to claim 1, wherein the reinforcing binder is less than 8% by mass of the nose-raising material.

4. The silica gel nasal augmentation material of claim 1, wherein the curing agent is less than 10% by weight of the nasal augmentation material, and the curing agent is selected from calcium phosphate cement or calcium sulfate cement.

5. The silica gel nose-raising material according to claim 1, wherein the reinforcing adhesive is a mixture of konjac gum and konjac gum in a mass ratio of 1: 1, mixing the mixture.

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

7. The silica gel hump nose material according to claim 5, wherein the konjac glucomannan is prepared by mixing konjac glucomannan powder with 5-15 times of deionized water.

8. 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.

9. 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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