Flexible filling body for subcutaneous soft tissue

Abstract

The utility model discloses a flexible filling body for subcutaneous soft tissues, which is a sheet-shaped filling body or a strip-shaped filling body made of flexible materials and is used for filling recesses on the face or the body surface. Wherein the filling body comprises a flexible thin film with the thickness of 0.5-3 mm, protruding particles are distributed on one side or two sides of the flexible thin film, the size of each particle ranges from 0.5 mm to 2 mm, each particle is away from the surface of the flexible thin film and protrudes outwards by 0.5-5 mm, and the gap between every two adjacent particles ranges from 0.5 mm to 3 mm. The subcutaneous soft tissue filling body is essentially characterized in that countless small particle bodies such as silicon rubber small particle bodies are arranged into a certain shape, the small bodies are connected through a layer of thin film, and the formed structure is very soft and hardly resists external force. The shape design of the subcutaneous soft tissue filling body thoroughly changes the overall flexibility of the filling body, so that the filling body can be filled in subcutaneous soft tissue without being touched, and the filling body does not slide and is not easy to shift when being implanted in the soft tissue.

Description

Technical Field

[0001] The utility model relates to a flexible sheet-shaped / strip-shaped filling body of subcutaneous soft tissue used for cosmetic surgery to improve depressions existing on the face or body surface. Background Art

[0002] Medical cosmetology has been widely accepted by the majority of beauty and fashion lovers. On the one hand, there are natural concave defects on the human face or body surface. On the other hand, the human body tissues suffer from various traumas, accidents, etc., which lead to soft tissue deficiency or facial depression or trauma. On the other hand, the forehead, temples, nasolabial grooves, tear grooves, nasolabial folds, apple muscles and other parts of the body are sagging, sunken, wrinkled and other aging conditions caused by aging.

[0003] In the existing technology, the commonly used methods to solve these problems include: hyaluronic acid injection, surgical implantation of medical silicone rubber prosthesis, autologous fat injection, etc., but each has its own advantages and disadvantages. Although hyaluronic acid injection is simple and easy to perform, it often causes edema, depression, insufficient elastic support, and requires repeated injections; autologous fat injection is relatively painful, and fat absorption often occurs after surgery, which also requires repeated injections to supplement, etc. The surgically implanted medical silicone rubber prosthesis sheet is easy to slide in the tissue and is relatively hard. If it is filled in the subcutaneous soft tissue, it is easy to be felt.

[0004] Chinese patent 201210031571.2 discloses a novel silicone rubber-hydroxyapatite composite material for cosmetic surgery, which includes a silicone rubber layer and a hydroxyapatite coating formed into an integrated structure by vulcanization molding. The composite material has both the good biomechanical properties of silicone rubber (SR) and surface activity, and is tightly combined with surrounding tissues, and is not prone to deformation and displacement; at the same time, it also overcomes the shortcomings of capsule contracture, particle migration or material fracture caused by using silicone rubber (SR) and hydroxyapatite (HA) alone. However, the surface of this double-layer composite material is relatively smooth, easy to slide in the tissue, and easy to be felt if filled in the subcutaneous soft tissue.

[0005] The inventor of Chinese patent application No. 201510309026.9 believes that silicone rubber used as a filling material in the field of plastic surgery has poor elasticity, which makes the filled part unnatural. Therefore, a so-called elastic prosthetic material is disclosed. The elastic prosthetic material consists of the following components: 45-58 parts of solid silicone rubber particles, 14-36 parts of plasticizer, 21-29 parts of resorcinol formaldehyde epoxy resin, 5-13 parts of azobisisobutyronitrile, 11-27 parts of ethylene glycol, 6-24 parts of ethylenetriamine, 1-15 parts of calcium stearate and 3-18 parts of dimethylacetamide. The obtained elastic prosthetic material can reduce the compression permanent deformation rate of the material while maintaining good processing performance and appearance, which is beneficial to maintaining the elasticity of the material. However, it uses plasticizers such as BBP, DOP, DEHP, DIBP, as well as resorcinol formaldehyde epoxy resin, azobisisobutyronitrile, ethylene glycol, vinyltriamine, dimethylacetamide, etc., which pose great safety and health risks in the body and are not suitable for direct implantation into the body.

[0006] Chinese patent application 201610637104.2 discloses a particle-filled artificial prosthesis, which has a capsule surrounded by a soft silicone membrane, which can be filled with many soft small balls, and the capsule is provided with a filling tube for the small balls to enter and exit. The patent application can change the size of the prosthesis by filling or removing small balls into the silicone capsule bag; the small balls can be filled with other materials to reduce costs and are not easy to wear and break; the silicone capsule bag and the small balls are both formed in vitro, and there is no process of liquid intervening in the human body, and they can be placed in the human body for a long time. This technology is suitable for women's breast augmentation, rhinoplasty, buttock augmentation and other plastic surgeries, but is not suitable for filling depressions on the face or body surface.

[0007] Chinese patent 201610968222.1 discloses a human soft tissue filler, including medical solid silicone rubber powder, lubricant and physiological saline, wherein the average diameter of the medical solid silicone rubber powder is 25-45 microns, and the lubricant is at least one of glycerol, chitosan, hyaluronic acid / sodium hyaluronate, sodium carboxymethyl cellulose, chondroitin sulfate, polyacrylamide, polyvinyl alcohol, polyacrylic acid, polyhydroxyethyl methacrylate, hydroxypropyl methylcellulose, hydroxyethyl starch, hydroxyethyl cellulose, and polyvinyl pyrrolidone. This filler is suitable for small depressions in the forehead, nasolabial groove, tear groove and other parts. For larger depressions, the small particles after injection are easily deformed due to pressure.

[0008] Chinese patent 201710738323.4 also discloses an elastic prosthetic material, which includes 65-85 parts of solid silicone rubber particles, 45-60 parts of polymethyl methacrylate, 36-48 parts of polytrimethylene cyclocarbonate, 25-30 parts of diisononyl phthalate, 30-35 parts of pyrogallol triglycidyl ether epoxy resin, 15-25 parts of dimethyl sulfoxide, 10-18 parts of triethylenetetramine, and 10-15 parts of p-toluenesulfonyl hydrazide. Although the patent claims that its materials are non-cytotoxic and non-allergic, on the one hand, its test samples are too small (only 20 people per group), and on the other hand, the entire test process and test time are not explained. In fact, p-toluenesulfonyl hydrazide is an acute toxic substance, triethylenetetramine is a subacute or chronic toxic substance, and dimethyl sulfoxide, although less toxic, is also an organic solvent. Materials with such a formula will not be allowed to be implanted in the body.

[0009] Chinese utility model 202321218449.6 discloses a buttocks silicone gel prosthesis, which includes a prosthesis, a concave inner side surface is provided in the middle position of the left side of the prosthesis, a first concave is provided on the left side of the prosthesis and located above the concave inner side surface, a second concave is provided on the left side of the prosthesis and located below the concave inner side surface, and a convex surface is provided on the right side of the prosthesis. The prosthesis includes a silicone membrane bag, a shaped silicone membrane and medical silicone gel. The utility model limits the contour of the medical silicone gel by setting a shaped silicone membrane, thereby ensuring that the shape of the prosthesis changes within a certain range, so that it can be formed into an elliptical pancake shape, which conforms to the tissue defect morphology of the buttocks concave, and ensures that the shape of the buttocks is always upright. However, similar prostheses are too rigid for filling soft tissues and are not suitable for filling soft tissues.

[0010] Therefore, it is necessary to provide a filling body which is suitable for filling local depressions on the face or body surface, is used for subcutaneous soft tissue, is flexible, does not easily slide in the tissue, and has safe chemical composition. Summary of the invention

[0011] The utility model aims to completely change the flexibility of the filling body for filling the depression, so that it can be filled in the subcutaneous soft tissue without being touched and not easily displaced after being implanted in the soft tissue, and the implantation of the filling body itself is safe and reliable.

[0012] In order to achieve the above-mentioned purpose of the utility model, the utility model provides a flexible filling body for subcutaneous soft tissue, which is a sheet-like filling body or a strip-like filling body formed of a flexible material, and can fill depressions on the face or body surface; wherein the filling body is a flexible film with a thickness of 0.5mm-3mm, and raised granular objects are distributed on one side or both sides of the flexible film, and the size of each granular object is between 0.5mm-2mm, and each granular object protrudes outward from the surface of the flexible film by 0.5-5mm, and the gap between adjacent granular objects is between 0.5-3mm.

[0013] The inventors of the present application realize that, from a safety perspective, the safest and most reliable filler should be made of a material that has been long-proven and widely verified in the plastic surgery industry, such as silicone rubber; any filler that adds components that have not been long-proven will have varying degrees of risk.

[0014] Therefore, in the long-term plastic surgery practice, the inventors realized that if one wants to change the flexibility of the filler so that it can be filled in the subcutaneous soft tissue without being felt, it is best not to change the chemical composition of the filler or add other chemical components to the filler. The inventors unexpectedly found that by changing the shape of the filler, its flexibility can also be changed without introducing other chemical components with unknown risks.

[0015] The inventors found that the film thickness of the filler should be controlled within 3mm, otherwise its mechanical strength is too great and it is easy to be felt when filled in the subcutaneous soft tissue; if the film thickness of the filler is less than 0.2mm, its mechanical strength is insufficient and it is not suitable as a filler. Preferably, the film thickness of the filler is controlled between 0.5-1.5mm.

[0016] The inventors further discovered that in order to prevent the filler from sliding in the soft tissue, one or both surfaces of the filler must be distributed with raised granular objects; the inventors also discovered that whether the filler can prevent it from sliding in the soft tissue is closely related to the size of each granular object, the degree of outward protrusion of the surface away from the film, and the distribution density of the granular objects.

[0017] The inventors found that the size of each granular object on the surface of the film should be controlled between 0.5mm-2mm: if it is too large, for example, larger than 3mm, it means that a single particle is larger. Although the contact area between a single particle and the soft tissue is larger and the adhesion is also larger, the number of particles per unit area is smaller; and if it is too small, for example, less than 0.5mm, it means that a single particle is relatively small, the contact area between a single particle and the soft tissue is smaller, the adhesion is also smaller, but the number of particles per unit area is larger. The binding force between the filler and the soft tissue per unit area is the sum of the binding forces of each particle per unit area. The inventors found that particles that are too small or too large are not conducive to increasing the total binding force. Preferably, the size of each granular object on the surface of the film should be controlled between 0.8mm-1.8mm.

[0018] The inventors found that the outward protrusion of each particle from the surface of the flexible film should be controlled between 0.5mm and 5mm: if the protrusion is too large, for example, greater than 5mm, it means that the particle protrudes outward from the surface to a greater extent, and its bonding surface with the tissue is larger, and it is less likely to shift when implanted in soft tissue, but it is easy to be felt when filled in subcutaneous soft tissue; and if the protrusion is too small, for example, less than 0.5mm, it means that the particle protrudes outward from the surface to a smaller extent, and its bonding surface with the tissue is smaller, and it is relatively easy to shift when implanted in soft tissue, but it is less likely to be felt when filled in subcutaneous soft tissue. The inventors found that the protrusion of each particle from the surface of the flexible film to the outside should comprehensively consider its difficulty in being perceived when filled in subcutaneous soft tissue and its difficulty in sliding when implanted in soft tissue. Preferably, the protrusion should be controlled between 1mm and 3mm.

[0019] The inventors found that the distribution density of the particles in the flexible film is related to the size of the particles, and the gap between adjacent particles should be controlled between 0.5-3mm: if the gap is too large, for example, greater than 3mm, there are fewer particles per unit area, and the contact area with the soft tissue is smaller, the adhesion is also relatively small, and it is relatively easy to shift when implanted in the soft tissue; while if the gap is too small, for example, less than 0.5mm, although there are more particles per unit area, the space for the growth of new tissue between the particles becomes smaller, which is not conducive to the growth of new tissue and also makes it relatively easy to shift when implanted in the soft tissue. The inventors found that the gap between large adjacent particles can be slightly larger, and the gap between small adjacent particles can be slightly smaller; but the gap size is neither proportional to the particle size nor a unidirectional change relationship. Preferably, the gap should be controlled between 1mm-2.5mm.

[0020] Compared with fillers, the filler of the present invention has the advantages of being safer, without the risk of filler particles wandering in the body or even being absorbed, and without the need for repeated injections; when the patient needs to remove or replace the filler, it is relatively easy and thorough.

[0021] In the filler of the utility model, the shape of the granular material used can be bead-shaped, hemispherical, columnar, or polyhedral. The bead-shaped is spherical, irregularly spherical, ellipsoidal, droplet-shaped, etc., but connected to the surface of the flexible film. For bead-shaped or hemispherical granular materials, their size can be measured by their particle diameter. Columnar granular materials can be cylindrical, and their size can be measured by the diameter of the cross-sectional circle; bead-shaped granular materials can also be polyhedral columns, and their size can be measured by the maximum diagonal of the cross-sectional polyhedron. The size of polyhedral granular materials can be measured by the maximum diagonal of the polyhedron.

[0022] For example, the shape of the granular material used is cylindrical, and the top of the cylinder is a curved surface, more preferably a curved surface with a relatively large curvature.

[0023] In the filling body of the utility model, the raised granular objects may be distributed only on one side of the flexible film, or on both sides of the flexible film; when the raised granular objects are distributed on both sides of the flexible film, the shapes of the granular objects on both sides may be the same or different, and each pair of granular objects on both sides may correspond to the same position of the flexible film, that is, a aligned distribution, or a staggered distribution.

[0024] For example, in the filling body of the present invention, hemispherical particles may be distributed on both sides of the flexible film; further, the hemispherical particles distributed on both sides are distributed in a counter-positioned manner on both sides of the flexible film, and two opposite hemispherical particles form a spherical body.

[0025] For another example, in the filling body of the present invention, semi-ellipsoidal particles may be distributed on both sides of the flexible film; further, the semi-ellipsoidal particles distributed on both sides are distributed in a counter-position on both sides of the flexible film, and two opposite semi-ellipsoidal particles form an ellipsoidal body.

[0026] In the utility model, the top of the semi-ellipsoidal particles or ellipsoidal particles can be in a flattened shape.

[0027] In the filler of the present application, an indentation line for easy cutting can be provided on the flexible film, so that the doctor can cut a sheet or strip filler of appropriate size according to the specific situation. Such indentation lines can be provided in a plurality of parallel indentations in only one direction, or in two directions perpendicular to each other.

[0028] The subcutaneous soft tissue filler of the utility model is essentially a structure in which numerous small particles, such as silicone rubber particles, are arranged into a certain shape, and the small particles are connected by a thin membrane. The structure formed is very soft and has almost no resistance to external forces. Overall, the subcutaneous soft tissue filler of the utility model is soft, even super soft, because the shape design of the filler completely changes the overall flexibility of the filler, so that it can be filled in the subcutaneous soft tissue without being touched, and it does not slide or shift easily after being implanted in the soft tissue.

[0029] In order to make the purpose, technical solution and advantages of the utility model more clear, the utility model is further described in detail below in conjunction with the accompanying drawings and embodiments. It should be understood that the specific embodiments described here are only used to explain the utility model and are not used to limit the utility model. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] Figure 1 This is a schematic diagram of a subcutaneous soft tissue filler in one embodiment of the utility model;

[0031] Figure 2 for Figure 1 A front view of the subcutaneous soft tissue filler shown;

[0032] Figure 3 for Figure 1 A side view of the subcutaneous soft tissue filler is shown;

[0033] Figure 4 This is a schematic diagram of a subcutaneous soft tissue filler in another embodiment of the present invention;

[0034] Figure 5 for Figure 4 A front view of the subcutaneous soft tissue filler shown;

[0035] Figure 6 for Figure 4 A side view of the subcutaneous soft tissue filler is shown;

[0036] Figure 7 for Figure 4 A top view of the subcutaneous soft tissue filler shown;

[0037] Figure 8 This is a facial photo of a patient after the subcutaneous soft tissue filler of the utility model was used to fill the subcutaneous part of the lower eyelid margin;

[0038] Fig. 9 This is a facial photo of another patient after the subcutaneous soft tissue filler of the utility model was used to fill the subcutaneous part of the lower eyelid margin;

[0039] In the figure, the description of each reference numeral is as follows:

[0040] 1 Granular matter

[0041] 2 Membrane

[0042] 3 Indentation lines DETAILED DESCRIPTION

[0043] The silicone rubber used in this application is medical solid silicone rubber Nusil 473 produced by Nusil Corporation of the United States.

[0044] Preparation Example 1

[0045] Silicone rubber is selected as the flexible material for preparing the filling body of this embodiment. Figure 1 to Figure 3 As shown, a silicone rubber subcutaneous soft tissue sheet filler is prepared in this embodiment. The soft tissue sheet filler includes a flexible film 2 with a thickness of 1 mm. Raised granular objects 2 are distributed on both sides of the flexible film. The size of each granular object 1 is about 1.5 mm. Each granular object 1 protrudes outward from the surface of the flexible film 2 by about 1.5 mm, and the gap between adjacent granular objects 1 is about 1 mm.

[0046] The above-mentioned granular objects 1 are hemispherical in shape, and the protruding granular objects 1 are distributed on both sides of the flexible film 2, and each pair of granular objects on both sides corresponds to the same position of the flexible film, and the two approximately form a sphere.

[0047] In the soft tissue sheet filling body of this embodiment, the distribution of the granular material 1 is uniform, and its left view, right view, top view and bottom view are the same, as shown in FIG. Figure 3 shown.

[0048] Preparation Example 2

[0049] Silicone rubber is selected as the flexible material for preparing the filling body of this embodiment. Figures 4 to 7 As shown, the present embodiment also prepares a silicone rubber subcutaneous soft tissue sheet filler, which includes a flexible film 2 with a thickness of 0.8 mm, and protruding granular objects 1 are distributed on both sides of the flexible film. The size of each granular object 1 is about 3.0 mm, and each granular object 1 protrudes outward from the surface of the flexible film 2 by about 2 mm, and the gap between adjacent granular objects 1 is about 1.5 mm.

[0050] The granular material 1 is in the shape of a semi-ellipsoid, and the top of the semi-ellipsoid is flattened. Both sides of the flexible film 2 are distributed with raised granular materials 1, and each pair of granular materials on both sides corresponds to the same position of the flexible film, and the two approximately form an ellipsoid with both sides flattened.

[0051] In the soft tissue sheet filling body of this embodiment, the distribution of the granules 1 in a part of the area is uniform, and no granules 1 are provided in another part. During the operation, the film without granules 1 is basically cut off. The left view is the same as the right view, as shown in FIG. Figure 6 As shown; its top view is the same as the bottom view, as shown Figure 7 shown.

[0052] In this embodiment, a plurality of parallel indentation lines 3 are further provided on the flexible film 2 of the soft tissue sheet filler to facilitate cutting by the doctor during surgery. For example, the doctor can conveniently cut out a strip of the filler along the indentation lines 3 .

[0053] Preparation Example 3

[0054] This example is basically the same as Preparation Example 2, except that:

[0055] The thickness of the flexible film 2 is 1.5 mm, the size of each particle 1 is about 2.0 mm, each particle 1 protrudes outward from the surface of the flexible film 2 by about 1.5 mm, and the gap between adjacent particles 2 is about 1.8 mm.

[0056] Preparation Example 4

[0057] This example is basically the same as Preparation Example 2, except that:

[0058] The plurality of parallel indentation lines 3 further arranged on the flexible film 2 include both a plurality of transverse parallel indentation lines 3 and a plurality of vertical parallel indentation lines 3 .

[0059] Surgical Clinical Trials1

[0060] The applicant submitted the sample prepared in Example 1 to Guangzhou Boshi Plastic Surgery Hospital for clinical trial. The prepared sheet-like filler was cut into strip-like fillers, and the length and width were appropriately cut according to individual conditions for the test. One patient was selected for the test, and the specific situation is as follows:

[0061] Ms. Xu, who lacked "eye bags" in her lower eyelid, used the strip-shaped "silicone rubber particle arrangement filler" obtained after cutting to fill the subcutaneous part of the lower eyelid margin. She did not feel any discomfort or adverse reactions after the operation. After a follow-up examination six months later, she found that her appearance was natural, with obvious "eye bags" morphology. Figure 8 The patient felt that the surgery met her needs.

[0062] Surgical Clinical Trials 2

[0063] The applicant submitted the sample prepared in Example 2 to Guangzhou Boshi Plastic Surgery Hospital for clinical trial. The prepared sheet filler was cut into strip fillers, and the length and width were appropriately cut according to individual conditions for the test. One patient was selected for the test, and the specific situation is as follows:

[0064] Ms. Wang, who lacked "bag under the eyes", used the strip-shaped "silicone rubber particle arrangement filler" obtained after cutting to fill the subcutaneous part of the lower eyelid margin. She did not feel any discomfort or adverse reactions after the operation. After a follow-up examination 3 months later, the appearance was natural, with obvious "bag under the eyes". Fig. 9 The patient felt that the surgery met her needs.

Claims

1. A flexible filler for subcutaneous soft tissue, which is a sheet-shaped filler or a strip-shaped filler formed of a flexible material and is used to fill depressions on the face or body surface; wherein: The filling body comprises a flexible film with a thickness of 0.5-3mm, and protruding granules are distributed on one or both sides of the flexible film. The size of each granule is between 0.5mm and 2mm, and each granule protrudes outward from the surface of the flexible film by 0.5-5mm, and the gap between adjacent granules is between 0.5-3mm.

2. The filling body according to claim 1, characterized in that The granular material is in the shape of beads, hemispheres, columns or polyhedrons.

3. The filling body according to claim 1, characterized in that Hemispherical particles are distributed on both sides of the flexible film.

4. The filling body according to claim 3, characterized in that The hemispherical particles distributed on both sides are distributed in a counter-positioned manner on both sides of the flexible film, and two opposite hemispherical particles form a sphere.

5. The filling body according to claim 1, characterized in that: Semi-ellipsoidal particles are distributed on both sides of the flexible film.

6. The filling body according to claim 5, characterized in that The semi-ellipsoidal particles distributed on both sides are distributed in a counter-position on both sides of the flexible film, and two opposite semi-ellipsoidal particles form an ellipsoidal body.

7. The filling body according to claim 5 or 6, characterized in that: The top of the semi-ellipsoidal particle is in a flattened shape.

8. The filling body according to claim 1, characterized in that: The flexible film is provided with an indentation line for easy cutting, so as to facilitate trimming the filler into a smaller sheet-shaped filler or a strip-shaped filler.

9. The filling body according to claim 1, characterized in that: The raised granular objects are only distributed on a partial area of ​​one or both sides of the flexible film.

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