Filler material used for internal filling of breast implants
By using bio-cellulose hydrogel as a breast implant filler, the problems of leakage, poor feel, and fibrous capsular contracture of existing materials have been solved, resulting in a softer and safer breast implant design.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- HAINAN GUANGYU BIOTECH
- Filing Date
- 2024-12-31
- Publication Date
- 2026-06-30
AI Technical Summary
Existing breast implant materials have problems such as leakage, poor feel, easy to cause fibrous capsular contracture, and chronic irritation, and their safety and lifespan are insufficient.
Using bio-cellulose hydrogel as a filler, combined with a certain amount of sterile saline and/or silicone gel, a filler with excellent mechanical properties and biocompatibility is prepared for use inside breast implants.
It improves the softness and toughness of the implant, reduces the risk of leakage, reduces inflammatory irritation, extends its service life, and enhances safety.
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Abstract
Description
Technical Field
[0001] This invention relates to the fields of beauty and body shaping and medical technology, and in particular to a filler for internal filling of breast implants. Background Technology
[0002] In 1889, the United States pioneered breast augmentation, with American physician Gersuny injecting liquid paraffin directly into the breasts. The development of breast augmentation materials has a long history, reaching its peak in the 1930s with the application of liquid paraffin injection. However, many patients subsequently experienced serious complications, such as lumps, masses, inflammation, paraffin spreading downwards from the skin surface, poor breast shape after spreading, and paraffin embolism leading to blindness or death. There is also conclusive evidence that it may induce breast cancer. These complications are extremely difficult to treat, often requiring mastectomy to prevent more severe late-stage complications, leading to the prohibition of liquid paraffin injection breast augmentation.
[0003] After the 1940s, some people in Japan and the United States used a mixture of wax and honey, as well as liquid silicone, to inject into the breasts for breast augmentation. Because injectable breast augmentation was simple and easy to master, especially the latter, it was widely used by general practitioners and even non-medical personnel. However, like liquid paraffin, it caused many serious complications; the injection was highly prone to spreading and could even cause death. Therefore, this method was quickly banned. In recent years, some people have begun to use bovine collagen and gelatin matrix for breast augmentation, but most of these are absorbed by the body after a few months, limiting their application.
[0004] In 1951, American physician Pangman began using gel-filled implants for breast augmentation. Although the material was later improved, its widespread use was ultimately hindered by high rates of implant deformation and breast hardening. Pangman first used artificial sponges for breast augmentation in 1951, sculpting the sponge into the desired shape and size and placing it into a submammary cavity to achieve breast augmentation. However, post-operatively, a large amount of fibrous tissue grew into the sponge's spaces, causing the breast to harden, shrink, and deform, and even forming fistulas. Therefore, this breast augmentation technique has been abandoned.
[0005] In 1963, American surgeons Gronin and Gerow pioneered silicone breast implants containing silicone gel. Due to their good tissue compatibility and realistic texture and appearance, they were widely popular, with nearly 100,000 people undergoing breast augmentation with this material annually in the United States alone. Gronin and Gerow achieved excellent results using silicone rubber capsule implants filled with silicone rubber fluid in 1963, promoting the popularization of breast augmentation surgery worldwide. However, many problems have arisen in clinical application, such as capsular contracture, leading to breast deformation, hardening, and pain, especially when placed under the breast tissue; granulomas can form on the chest wall or breast tissue, often related to shallow implant placement, silicone oil leakage leading to skin rupture, and long-term chronic irritation; other drawbacks include bleeding, infection, improper implant placement and displacement, resulting in unsatisfactory breast shape. Nevertheless, it remains a relatively safe breast augmentation method under current circumstances.
[0006] In the early 1970s, single-cavity saline implants emerged. The development of saline implants was primarily driven by concerns about the potential health effects of silicone gel, including immune-mediated connective tissue diseases and possible carcinogenicity. Saline implants offer advantages such as smaller incisions and the ability to determine breast volume intraoperatively. Later studies found that saline implants had a lower rate of capsular contracture compared to silicone gel implants. Disadvantages include a liquid feel, a tendency to leak, difficulty in maintaining the augmentation effect, and the possibility of breast collapse due to saline leakage, affecting appearance. Compared to silicone gel implants, their shape and feel are less desirable, and long-term placement can lead to fungal growth inside the saline capsule. For these reasons, silicone gel implants have remained relatively popular.
[0007] In 1970, American researcher Ashley reported a new type of implant—the polyurethane implant, which consisted of a silicone gel implant coated with polyurethane foam. The initial purpose of developing polyurethane implants was to prevent silicone gel leakage and to serve as a fixation layer. Later, with improvements in manufacturing technology, many clinical researchers believed that this implant could reduce capsular contracture in both breast augmentation and breast reconstruction. After five years of clinical practice, American physician Hester et al. pointed out that polyurethane implants could reduce but not completely eliminate capsular contracture. The disadvantage of this type of implant was that it was more difficult to insert, and the polyurethane coating was fragile during insertion, easily detaching from the silicone gel shell. Skepticism about polyurethane implants led to further research into the surface structure of the implant, resulting in textured implants. Numerous studies have confirmed that textured implants are more effective than smooth implants in delaying or reducing capsular contracture.
[0008] In 1987, American physician Bircoll first reported on breast augmentation using fat injection. Autologous fat transfer for breast augmentation can transfer excess fat accumulated in the abdomen, thighs, and buttocks to the breasts, making it a dream for many women. Autologous fat grafting for breast augmentation has long been a focus of attention for plastic surgeons. Autologous fat injection has advantages such as no immune rejection and soft breast texture after surgery; however, complications such as fat liquefaction, infection, hematoma, and fat absorption also exist in clinical application. With the advancement of equipment and injection techniques, autologous fat grafting has become a relatively ideal autologous filler material for breast augmentation. Summary of the Invention
[0009] To address the aforementioned technical problems, this invention provides a filler specifically designed for internal filling of breast implants. It offers advantages such as low leakage rate, good feel, minimal chronic irritation during long-term placement, low risk of bleeding and infection, and low likelihood of fibrous capsular contracture.
[0010] To achieve the above-mentioned technical objectives, the technical solution adopted by the present invention is as follows: A filler for internal filling of breast implants, wherein the filler contains a bio-cellulose hydrogel. Further, the filler may also contain a certain amount of sterile saline and / or silicone gel. Bio-cellulose (also known as bacterial cellulose) is a novel type of cellulose mainly produced by the fermentation of bacteria of the genus *Acetobacter*. It is produced by culturing *Acetobacter* microorganisms in a liquid culture medium, causing them to metabolize and produce a hydrogel-like product. Compared with plant cellulose, bio-cellulose has high purity, contains virtually no byproducts such as lignin and hemicellulose, has an ultra-fine network structure, and high crystallinity, thus exhibiting excellent mechanical properties. Furthermore, as a biomaterial, it has advantages in biocompatibility and biodegradability. Currently, bio-cellulose is typically produced through static or dynamic fermentation. Static fermentation produces a white, semi-transparent hydrogel film on the surface of the liquid culture medium, with a water content exceeding 95%. Dynamic fermentation, due to surface tension, usually produces small spherical bio-cellulose hydrogels, which can be processed into sheet or film-like bio-cellulose materials through crushing and pressing. This invention innovatively discovers that adding it to the internal filling of breast implants, replacing a portion of silicone gel or sterile saline, can produce excellent technical effects. For example, it makes the implant feel softer and more resilient, with a more realistic appearance; it also allows for a tighter integration with the implant's sac-like shell, reducing leakage and the likelihood of long-term chronic irritation and inflammation, thus extending the lifespan and increasing safety of the breast implant. Furthermore, because bio-cellulose itself has excellent biocompatibility and biodegradability, even if leakage occurs, it will not cause harm or irritation to the user.
[0011] The aforementioned bio-cellulose hydrogel can be prepared by various known methods, such as bio-cellulose hydrogels obtained by microbial fermentation, preferably using dynamic fermentation culture, and then washed and purified. The washing and purification of the bio-cellulose hydrogel can employ any known method, such as the common method of repeated rinsing or soaking with deionized water and a weak alkaline solution.
[0012] Preferably, the bio-cellulose hydrogel accounts for 1-60% of the contents. More preferably, the bio-cellulose hydrogel accounts for 15-50% of the contents. The bio-cellulose hydrogel is preferably in the form of microparticles with a particle size of 10 micrometers or less. This produces a more realistic and flexible feel, and allows for a tighter bond with the capsule-like outer shell of the prosthesis, reducing leakage.
[0013] Furthermore, this invention has found that adding a certain amount of hyaluronic acid to the bio-cellulose hydrogel is more beneficial for its shaping, feel, biocompatibility with human tissues, and degradation. Preferably, the bio-cellulose hydrogel contains hyaluronic acid with a molecular weight of less than 500,000 Daltons.
[0014] Hyaluronic acid (HA), also known as hyaluronic acid, is an acidic mucopolysaccharide. It is a disaccharide unit composed of D-glucuronic acid and N-acetylglucosamine. Hyaluronan, also called glucuronic acid or hyaluronic acid, has a basic structure consisting of two disaccharide units: D-glucuronic acid and N-acetylglucosamine, making it a large polysaccharide. Its molecular formula is (C...). 14 H 21 NO 11 Unlike other mucopolysaccharides, it is sulfur-free. Its hyaluronic acid molecules can carry more than 500 times their weight in water, making it the best recognized moisturizing ingredient, and it is widely used in skincare and cosmetic products. However, due to factors such as hyaluronidase and free radical degradation in the human body, exogenous hyaluronic acid has a short lifespan in the body, thus limiting its application in subcutaneous tissue filling or skin treatments. This invention incorporates hyaluronic acid into the three-dimensional network structure of bio-cellulose, making it more water-retaining and elastic, and also reducing the degradation of hyaluronic acid in the human body.
[0015] The preparation method of the bio-cellulose hydrogel containing hyaluronic acid includes the following steps: 1) Prepare bio-cellulose hydrogels and clean and purify them; 2) Dry the bio-cellulose hydrogel prepared in step 1) into powder for later use; 3) Disperse the dried bio-cellulose hydrogel in an organic solvent by stirring; separately dissolve hyaluronic acid with a molecular weight of less than 500,000 Daltons in water; 4) Mix the two solutions from step 3) thoroughly and stir well. Then add a buffer system with a pH of 7-8. Continue to add the phase transfer catalyst under slow stirring. Maintain the reaction under weakly alkaline conditions and stir well for 12-24 hours, controlling the reaction temperature at 60-80 degrees Celsius. Finally, evaporate the reaction product to remove the organic solvent and concentrate it to obtain a bio-cellulose hydrogel containing hyaluronic acid.
[0016] The organic solvent is acetone, chloroform, 1,4-dioxane, or tetrahydrofuran, etc.; the phase transfer catalyst is tetrabutylammonium bromide, tetrabutylammonium chloride, benzyltriethylammonium chloride, dodecyltrimethylammonium chloride, 18-crown ether-6, 15-crown ether-5, etc.
[0017] The ratio of bio-cellulose to hyaluronic acid is 1:1 by weight.
[0018] In step 2) of the above method, the drying of biological cellulose can be carried out by any drying method, such as mechanical compression, hot air drying or a combination of both, as long as the drying conditions do not damage the basic structure of the product.
[0019] The bio-cellulose hydrogel of this invention, along with a bio-cellulose hydrogel containing hyaluronic acid, is mixed with an appropriate amount of silicone gel or saline solution and then added to the implant shell to create a filling-type breast implant. The implant shell material can include, but is not limited to, silicone rubber, phenyl silicone rubber, polyurethane, thermoplastic polyurethane, and silicone polyurethane rubber. Experiments have shown that the filling-type breast implant prepared by this invention possesses high elasticity and toughness, as well as good biocompatibility, while reducing leakage of implant contents and inflammatory reactions. Detailed Implementation
[0020] To further illustrate the present invention in more detail, specific embodiments of the present invention will be described below. It should be understood that the specific embodiments described below should not constitute any limitation on the present invention. In fact, any conventional changes or adjustments made based on them should be within the scope of the present invention. Example 1:
[0021] Bio-cellulose hydrogel membranes were prepared using a static shallow-tray fermentation method with *Acetobacter xylinum* as the bacterial strain. Fermentation was carried out at 29°C in coconut water medium for 7 days. The bio-cellulose hydrogel membranes on the surface of the medium were collected, rinsed three times with deionized water, soaked in a weak alkaline solution for 20 minutes, removed, and then rinsed three more times with deionized water for purification. After cutting, the bio-cellulose hydrogel membranes were obtained and dried into powder at 50°C for later use. Example 2:
[0022] Bio-cellulose hydrogel membranes were prepared using a static shallow-tray fermentation method with *Acetobacter xylinum* as the inoculum. Fermentation was carried out at 30°C in coconut water medium for 5 days. The bio-cellulose hydrogel membranes on the surface of the medium were collected, rinsed three times with deionized water, and then soaked in a weak alkaline solution for 15 minutes. After purification, the membranes were rinsed three more times with deionized water. The bio-cellulose hydrogel membranes were cut to obtain the final product. 60% of the water was squeezed out by mechanical compression. The partially dehydrated bio-cellulose hydrogel was then dried into powder at 50°C with hot air for later use. Example 3:
[0023] Bio-cellulose hydrogel membranes were prepared using a static shallow-tray fermentation method with *Acetobacter xylinum* as the strain. Fermentation was carried out at 28°C on a molasses-based culture medium for 9 days. The bio-cellulose hydrogel membranes on the surface of the culture medium were collected, rinsed three times with deionized water, and then soaked in a weak alkaline solution for 30 minutes. After purification, the membranes were rinsed three more times with deionized water and cut to obtain the bio-cellulose hydrogel membranes. 75% of the water was removed by a low-temperature drying method (65°C), and the partially dehydrated bio-cellulose hydrogel was then dried into powder at 50°C with hot air for later use. Example 4:
[0024] 100g of hyaluronic acid with a molecular weight of 400,000 Daltons was dissolved in 5000mL of deionized water. 100g of the bio-cellulose from Examples 1-3 was weighed and dispersed in 5000mL of chloroform. The two were mixed thoroughly and stirred until homogeneous. After stirring, tetrabutylammonium chloride, equivalent to 10% of the mass of hyaluronic acid, was added as a phase transfer catalyst. The reaction system was stirred thoroughly. A weakly alkaline buffer solution was added to the reaction system to control the pH value of the reaction system at 7-8. The reaction temperature was controlled at 60-80 degrees Celsius, and the mixture was stirred thoroughly for 36 hours. The reaction product was evaporated to remove the solvent, and after drying and concentration, a bio-cellulose hydrogel containing hyaluronic acid was obtained for later use. Example 5:
[0025] 150g of hyaluronic acid with a molecular weight of 300,000 Daltons was dissolved in 5000mL of deionized water. 150g of the bio-cellulose from Examples 1-3 was weighed and dispersed in 5000mL of acetone. The two were mixed and stirred thoroughly until homogeneous. After stirring, 18-crown ether-6, equivalent to 15% of the mass of hyaluronic acid, was added as a phase transfer catalyst. The reaction system was stirred thoroughly. A weakly alkaline buffer solution was added to the reaction system to control the pH value of the reaction system at 7-8. The reaction temperature was controlled at 60-80 degrees Celsius, and the mixture was stirred thoroughly for 36 hours. The reaction product was evaporated to remove the solvent, and after drying and concentration, a bio-cellulose hydrogel containing hyaluronic acid was obtained for later use.
[0026] Example 6: Preparation of Filler Breast Implants The products obtained in Examples 1-5 are mixed with an appropriate amount of silicone gel or saline solution and then added to the implant shell (the implant shell is uniformly made of silicone rubber) to produce filling breast implant products 6-1 to 6-6. The implant shell materials that can be used include, but are not limited to, silicone rubber, phenyl silicone rubber, polyurethane, thermoplastic polyurethane, and silicone polyurethane rubber. The proportions of each substance in the filler are shown in the table below:
[0027] Experiment Example 1: Sensory Experiment: Fifteen female volunteers (aged 18-55) were recruited to conduct sensory experiments on the appearance and feel of breast implants 6-1 to 6-6 in Example 6, as well as control 1 (filled with silicone gel only) and control 2 (filled with saline only). A total of eight breast implant products were randomly shuffled, and 20 volunteers observed their appearance and feel in turn. The main observation indicators were: ① Appearance: Whether the breast implant had a round and natural shape, and whether it could fill all the gaps in a teardrop-shaped mold. ② Feel: Whether it was soft and elastic, and whether it could rebound promptly after being pressed. Feedback was categorized into four levels: excellent, good, average, and poor. The results of the collected feedback, after being organized according to the product numbers, are shown in the table below.
[0028]
[0029] The results above show that most volunteers had excellent feedback on the breast implant of the present invention. The breast contour was full and rounded, and it was a full teardrop shape in the mold. The contour was natural and beautiful, and the feel was soft and elastic. The feedback on the feel and elasticity were all between excellent and good, with excellent being the majority.
[0030] Experiment Example 2: Long-term storage leakage experiment The breast implants 6-1 to 6-6 in Example 6, as well as control 1 (filled with silicone gel only) and control 2 (filled with saline only), were placed under constant temperature and humidity conditions for a long period of time, with a temperature of 35-36 degrees and a humidity of 55-65%. After 12 months of placement, the implants were checked for leakage. The results showed that the breast implants 6-1 to 6-6 in Example 6 had no leakage or seepage after 12 months of placement, while control 1 had a small amount of bead-like liquid leaking out on the surface of the implant, and control 2 had a small amount of liquid-like seepage on the surface of the implant.
[0031] The embodiments described above are merely preferred embodiments of the present invention and are not intended to limit the scope of the present invention. Various modifications and improvements made to the technical solutions of the present invention by those skilled in the art without departing from the spirit of the present invention should fall within the protection scope defined by the claims of the present invention.
Claims
1. A filler for internal filling of breast implants, characterized in that, The filler contains bio-cellulose hydrogel.
2. The filler according to claim 1, characterized in that, The filler also contains sterile saline and / or silicone gel.
3. The filler according to claim 1 or 2, characterized in that, The content of the bio-cellulose hydrogel is 1-60% by weight.
4. The filler according to claim 3, characterized in that, The content of the bio-cellulose hydrogel is 15-50% by weight.
5. The filler according to claim 3, characterized in that, The bio-cellulose hydrogel is in the form of microparticles with a particle size of less than or equal to 10 micrometers.
6. The filler according to any one of claims 1-5, characterized in that, The bio-cellulose hydrogel also contains hyaluronic acid with a molecular weight of less than 500,000 Daltons.
7. The filler according to claim 6, characterized in that, The method for preparing the bio-cellulose hydrogel containing hyaluronic acid includes the following steps: 1) Prepare bio-cellulose hydrogels and clean and purify them; 2) Dry the bio-cellulose hydrogel prepared in step 1) into powder for later use; 3) Disperse the dried bio-cellulose hydrogel in an organic solvent by stirring; separately dissolve hyaluronic acid with a molecular weight of less than 500,000 Daltons in water; 4) Mix the two solutions from step 3) thoroughly and stir well. Then add a buffer system with a pH of 7-8. Continue to add the phase transfer catalyst under slow stirring. Maintain the reaction under weakly alkaline conditions and stir well for 12-24 hours, controlling the reaction temperature at 60-80 degrees Celsius. Finally, evaporate the reaction product to remove the organic solvent and concentrate it to obtain a bio-cellulose hydrogel containing hyaluronic acid.
8. The filler according to claim 7, characterized in that, The organic solvent is one of acetone, chloroform, 1,4-dioxane, or tetrahydrofuran; the phase transfer catalyst is one of tetrabutylammonium bromide, tetrabutylammonium chloride, benzyltriethylammonium chloride, dodecyltrimethylammonium chloride, 18-crown ether-6, or 15-crown ether-5.
9. The filler according to claim 7, characterized in that, The ratio of bio-cellulose to hyaluronic acid is 1:1 by weight.
10. A type of infill breast implant, characterized in that, The prosthesis is made by filling the prosthesis shell with the filler according to any one of claims 1-9, wherein the material of the prosthesis shell includes, but is not limited to, silicone rubber, phenyl silicone rubber, polyurethane, thermoplastic polyurethane, and silicone polyurethane rubber.