CN106421897B - Human soft tissue filler, preparation method thereof and special pulverizer - Google Patents

Human soft tissue filler, preparation method thereof and special pulverizer Download PDF

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CN106421897B
CN106421897B CN201610968222.1A CN201610968222A CN106421897B CN 106421897 B CN106421897 B CN 106421897B CN 201610968222 A CN201610968222 A CN 201610968222A CN 106421897 B CN106421897 B CN 106421897B
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soft tissue
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silicon rubber
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CN106421897A (en
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曹京敏
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14—Macromolecular materials
    • A61L27/18—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14—Macromolecular materials
    • A61L27/16—Macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/52—Hydrogels or hydrocolloids
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B02—CRUSHING, PULVERISING, OR DISINTEGRATING; PREPARATORY TREATMENT OF GRAIN FOR MILLING
    • B02C—CRUSHING, PULVERISING, OR DISINTEGRATING IN GENERAL; MILLING GRAIN
    • B02C18/00—Disintegrating by knives or other cutting or tearing members which chop material into fragments
    • B02C18/06—Disintegrating by knives or other cutting or tearing members which chop material into fragments with rotating knives
    • B02C18/14—Disintegrating by knives or other cutting or tearing members which chop material into fragments with rotating knives within horizontal containers
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B02—CRUSHING, PULVERISING, OR DISINTEGRATING; PREPARATORY TREATMENT OF GRAIN FOR MILLING
    • B02C—CRUSHING, PULVERISING, OR DISINTEGRATING IN GENERAL; MILLING GRAIN
    • B02C18/00—Disintegrating by knives or other cutting or tearing members which chop material into fragments
    • B02C18/06—Disintegrating by knives or other cutting or tearing members which chop material into fragments with rotating knives
    • B02C18/16—Details
    • B02C18/18—Knives; Mountings thereof
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B02—CRUSHING, PULVERISING, OR DISINTEGRATING; PREPARATORY TREATMENT OF GRAIN FOR MILLING
    • B02C—CRUSHING, PULVERISING, OR DISINTEGRATING IN GENERAL; MILLING GRAIN
    • B02C18/00—Disintegrating by knives or other cutting or tearing members which chop material into fragments
    • B02C18/06—Disintegrating by knives or other cutting or tearing members which chop material into fragments with rotating knives
    • B02C18/16—Details
    • B02C18/22—Feed or discharge means
    • B02C18/2225—Feed means
    • B02C18/2258—Feed means of screw type
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B02—CRUSHING, PULVERISING, OR DISINTEGRATING; PREPARATORY TREATMENT OF GRAIN FOR MILLING
    • B02C—CRUSHING, PULVERISING, OR DISINTEGRATING IN GENERAL; MILLING GRAIN
    • B02C23/00—Auxiliary methods or auxiliary devices or accessories specially adapted for crushing or disintegrating not provided for in preceding groups or not specially adapted to apparatus covered by a single preceding group
    • B02C23/18—Adding fluid, other than for crushing or disintegrating by fluid energy
    • B02C23/20—Adding fluid, other than for crushing or disintegrating by fluid energy after crushing or disintegrating
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2400/00—Materials characterised by their function or physical properties
    • A61L2400/06—Flowable or injectable implant compositions

Abstract

The invention belongs to the field of medical fillers, and particularly relates to a human soft tissue filler, a preparation method of the filler and a special pulverizer. The filler of the invention takes medical solid silicon rubber micro powder or expanded polytetrafluoroethylene prosthesis as a main material; the method is that the filler containing medical solid silicon rubber micro powder or expanded polytetrafluoroethylene micro powder is implanted into the human body in an injection mode, so that the problems of the sinking of the soft tissues of the human body and the like are solved. The human soft tissue filling material of the invention can well solve the aging states of sagging, sunken and wrinkles of the forehead, temples, nasolabial sulcus, lacrimal sulcus, statuary lines, apple muscles and other parts caused by aging, and the tissue sunken caused by the congenital hypoplasia of the nose, forehead, temples, chin and the like and the unattractive appearance and the human trauma. The sunken filling of the forehead, apple muscle, nasolabial sulcus and other parts which are difficult to operate by the traditional medical silicon rubber prosthesis or the expanded polytetrafluoroethylene prosthesis can be easily carried out.

Description

Human soft tissue filler, preparation method thereof and special pulverizer
Technical Field
The invention belongs to the field of medical fillers, and particularly relates to a human soft tissue filler, a preparation method of the filler and a special pulverizer.
Background
The human tissue is subjected to various wounds, accidents and the like to cause the default of soft tissues, or facial depressions or wounds, and also comprises the aging states of sag, depressions, wrinkles and the like of the forehead, temples, nasolabial sulcus, lacrimal sulcus, statuary lines, apple muscles and other parts caused by the increase of age, and the unattractive clinical symptoms caused by the congenital underdevelopment of the nose, forehead, temples, chin and the like, and the following methods are commonly used for solving the problems at present: hyaluronic acid injection, medical silicon rubber prosthesis surgical implantation, or expanded polytetrafluoroethylene prosthesis surgical implantation, autologous fat injection and the like, but all have advantages and disadvantages.
The injection of the hyaluronic acid is simple and easy to implement, and can be injected by adopting acupuncture, but the hyaluronic acid injection often has the defects of edema, depression, insufficient elastic supporting force, one-time effective period of injection only one year, repeated injection and the like;
the medical silicon rubber prosthesis and the expanded polytetrafluoroethylene are implanted into the face in an operation mode, so that the problems that the depression of temples, the nose and the chin is solved, the wound is large, the recovery period is long, and the operation is difficult to implement on the forehead, the nasolabial sulcus, the lacrimal sulcus and other parts are solved;
autologous fat injection needs to extract autologous cells, so that pain is increased, fat absorption often occurs after operation, repeated injection and supplement are needed, and the like. How to solve the defects of the method and perfectly solve the problems of the incomplete depression and the molding of each part of the face become a problem to be solved urgently.
Shen, et al, in the article "application of expanded polytetrafluoroethylene in soft tissue filling of maxillofacial region", disclose that different specifications and shapes are selected according to different conditions of patients, including soft tissue filling patches, wrinkle filling prostheses, nasolabial sulcus filling prostheses, nose frame prostheses and mandible filling prostheses. This method has the disadvantages of requiring a large skin incision, requiring exfoliation of the treated area, having a large trauma, and having an excessively pronounced circumferential profile after implantation of the prosthesis, which limits its clinical use.
Therefore, there is a need to develop a bulking agent suitable for small area recessed implants (lacrimal canals, french marks), for sites with thin subcutaneous tissue (forehead), and to overcome the above-mentioned disadvantages of large skin incision, need to be peeled off in the treatment area, large trauma, and excessively pronounced contour after implantation of the prosthesis.
Disclosure of Invention
In order to solve the technical problems, the invention provides a filling agent which can effectively solve the problem of the human body, particularly the depression and the fullness caused by the wound, the accident and the like of the soft tissues of the face; the filler can be well applied to human soft tissues, particularly forehead, nasolabial sulcus, lacrimal groove and other parts of the face, and overcomes the defects that the common medical silicon rubber prosthesis and the expanded polytetrafluoroethylene prosthesis can only be used for implanting large depressions and need to be stripped by an operation to cause large wounds.
The invention also provides a preparation method of the human soft tissue filler; meanwhile, a special crusher for the filler is also provided.
The filler for human soft tissue comprises medical solid silicon rubber micro powder or expanded polytetrafluoroethylene micro powder.
The filler comprises the following raw materials in parts by volume:
60-150 parts of medical solid silicone rubber micro powder
Gel 1-10
1-100 parts of normal saline/distilled water;
or expanded polytetrafluoroethylene 60-150
Gel 1-10
Normal saline/distilled water 1-100.
The average diameter value of the medical solid silicon rubber micro powder or expanded polytetrafluoroethylene micro powder is 5-50 microns.
Preferably, the average diameter of the medical solid silicone rubber or expanded polytetrafluoroethylene micro powder is 25-45 micrometers.
Specifically, the gel is at least one of glycerol, chitosan, hyaluronic acid/sodium hyaluronate, chitosan gel, sodium carboxymethylcellulose, chondroitin sulfate, polyacrylamide hydrogel, polyvinyl alcohol, polyacrylic acid, polyhydroxyethyl methacrylate, hydroxypropyl methylcellulose, divinyl sulfone, 1, 4-butanediol diglycidyl ether (BDDE), hydroxyethyl starch, hydroxyethyl cellulose, and polyvinylpyrrolidone.
The mass concentration of the physiological saline is 0.9%.
The preparation method of the human soft tissue filler comprises the following steps: (1) putting the medical solid silicone rubber/expanded polytetrafluoroethylene into a special pulverizer to pulverize into micro-powder particles, wherein the diameter of the micro-powder particles is 5-50 microns;
(2) mixing medical solid silicon rubber/expanded polytetrafluoroethylene micro powder particles with medical glycerin or chitosan, hyaluronic acid/sodium hyaluronate, chitosan gel, sodium carboxymethylcellulose, chondroitin sulfate, polyacrylamide hydrogel gel, polyvinyl alcohol, polyacrylic acid, polyhydroxyethyl methacrylate, hydroxypropyl methyl cellulose, divinyl sulfone, 1, 4-butanediol diglycidyl ether (BDDE), hydroxyethyl starch, hydroxyethyl cellulose and polyvinylpyrrolidone physiological saline water in a proportion of 60-150: 1-10: mixing at a volume ratio of 1-100.
The special crusher for preparing the human soft tissue filler comprises a cabinet body, wherein a feeding pre-cooling bin is installed in the cabinet body, the feeding pre-cooling bin is connected with a crushing mechanism through a screw feeder, the crushing mechanism is communicated with a fan through the feeder, the fan is connected with a cyclone separator through a pipeline, and the crushing mechanism comprises a crushing cavity provided with a cutter disc;
specifically, a cutter head is arranged in a crushing cavity, blades are uniformly arranged on the cutter head, a protruding part is arranged on the inner wall of the crushing cavity and meshed with the blades, the number of the blades is at least 10, and the length of each blade is 32-45 mm;
the cutter head comprises a reinforcing plate, and the reinforcing plate is connected between adjacent blades;
the reinforcing plate and the blade are integrally formed;
the crushing mechanism is electrically connected with the crushing motor, the fan is electrically connected with the fan motor, and the screw motor is installed at the end part of the screw feeder.
The crushing cavity is provided with an air door regulating valve.
The crushing cavity is connected with a ventilating duct, a ventilation valve is arranged on the ventilating duct, and the end part of the ventilating duct is provided with a ventilation hole.
The crushing mechanism comprises a transmission shaft, and the transmission shaft is connected with the cutter head key.
Medical pure glycerin or chitosan, hyaluronic acid/sodium hyaluronate, chitosan gel, sodium carboxymethylcellulose, chondroitin sulfate, polyacrylamide hydrogel, polyvinyl alcohol, polyacrylic acid, polyhydroxyethyl methacrylate, hydroxypropyl methylcellulose, divinyl sulfone, 1, 4-butanediol diglycidyl ether (BDDE), hydroxyethyl starch, hydroxyethyl cellulose and polyvinylpyrrolidone can be used as a medical lubricant, and can form a gel suspension with medical solid silicone rubber micro powder or expanded polytetrafluoroethylene micro powder without changing the physicochemical properties of the medical solid silicone rubber or expanded polytetrafluoroethylene.
The human soft tissue filling material overcomes the defects of the prior clinical commonly used method for repairing caves, human soft tissue defects, unattractive faces and the like, does not need to strip wound surfaces, does not need incisions and can be operated by a needling method. The aging state of sag, depression, wrinkles and the like of the forehead, temples, nasolabial sulcus, lacrimal sulcus, statuary lines, apple muscles and other parts caused by aging is perfectly solved, and the tissue depression caused by the congenital hypoplasia of the nose, forehead, temples, chin and the like and the unattractive appearance and the human body trauma is also solved. The sunken filling of the parts which are difficult to operate, such as forehead, apple muscle, nasolabial sulcus and the like, of the traditional medical silicon rubber prosthesis or the expanded polytetrafluoroethylene prosthesis can be easily carried out.
The invention has the advantages that the human soft tissue filling material solves the defects described in the background technology, does not need to strip the wound surface or cut, and can be operated by a needling method. Can well solve the aging states of sag, depression, wrinkles and the like of the forehead, temples, nasolabial sulcus, lacrimal sulcus, statute lines, apple muscles and other parts caused by aging, and the tissue depression caused by congenital hypoplasia of the nose, forehead, temples, chin and the like and the unattractive appearance and the human body trauma. The sunken filling of the parts which are difficult to operate of the traditional medical silicon rubber prosthesis or the expanded polytetrafluoroethylene prosthesis, such as forehead, apple muscle, nasolabial sulcus and the like, can also be easily carried out.
Drawings
FIG. 1 is a schematic structural view of a pulverizer for preparing a filler for soft tissues of a human body according to the present invention;
FIG. 2 is a schematic side view of a cutting head in cross-section for use in preparing a bulking agent for soft tissue of a human body according to the present invention;
FIG. 3 is a front view of a cutter head for preparing a filler for soft tissue of human body according to the present invention.
The device comprises a feeding pre-cooling bin 1, a feeding pre-cooling bin 11, an air flow hole 2, a screw feeder 21, a screw motor 3, a crushing cavity 31, a cutter head 311, a blade 312, a reinforcing plate 313, a spline 32, an installation shaft 33, an air hole 34, an air vent valve 35, an air door adjusting valve 4, a crushing motor 5, a fan 6, a fan motor 7, a cyclone separator 71, an air vent valve 72, a discharge valve 8, a cabinet body 9 and a feeder.
Detailed Description
The present invention will be further described with reference to specific examples so that those skilled in the art may better understand the present invention, but the present invention is not limited thereto.
Example 1
The raw materials used are:
medical solid silicone rubber: medical grade, denna medical silicone rubber product factory;
expanded polytetrafluoroethylene: shanghai Sookang medical materials, Inc.;
medical glycerin (for injection): zhejiang tunnel Huikang pharmaceutical Co. The following glycerin refers to medical glycerin if not noted;
the invention relates to a human soft tissue filling material, namely a solid silicon rubber micro powder or expanded polytetrafluoroethylene micro powder gel suspension, the composition of which is expressed by the following table (unit: milliliter):
TABLE 1 Silicone rubber micropowder + Glycerol + distilled Water
Figure DEST_PATH_IMAGE002
TABLE 2 expanded PTFE micropowder + Glycerol + physiological saline
Figure DEST_PATH_IMAGE003
The preparation method of the solid silicone rubber micro powder gel suspension as the human soft tissue filling material comprises the following steps:
(1) crushing medical solid silicon rubber into micro-powder particles with the particle diameter of 5-25 microns by using a crusher; the structure of the pulverizer is shown in the attached drawings;
(2) mixing medical solid silicon rubber micro powder particles, medical glycerin and physiological saline in a proportion of 100: 7: 60, mixing and stirring uniformly; and sterilizing after packaging for later use.
The preparation method of the expanded polytetrafluoroethylene micro powder gel suspension as the filling material for the soft tissues of the human body comprises the following steps:
(1) crushing medical expanded polytetrafluoroethylene into micro-powder particles with the diameter of 5-25 microns by using a crusher;
(2) mixing expanded polytetrafluoroethylene micro powder particles with medical glycerin and physiological saline in a ratio of 80: 6: 75, mixing and stirring uniformly; and sterilizing after packaging for later use.
When in use, the filler is injected into a proper position of a patient by using a 15-20-gauge needle or a special injection tool to obtain the human soft tissue filler.
The pulverizer used in the invention is shown in the attached drawings, and the structure of the pulverizer is specifically as follows:
rubbing crusher is used in preparation of human soft tissue filler, the intelligent cabinet temperature adjusting device comprises a cabinet body 8, install reinforced precooling storehouse 1 and rubbing crusher structure in the cabinet body 8, when treating kibbling medical silicon rubber, medical expanded polytetrafluoroethylene get into reinforced precooling storehouse 1 and meet and transport rubbing crusher structure through screw feeder 2 after cold treatment, medical silicon rubber, medical expanded polytetrafluoroethylene passes through rubbing crusher structure's shredding and collects and transports the silicon rubber granule to fan 5 through feeder 9, the rethread pipeline transports 7 final discharge gate discharge from cyclone, cyclone 7's bottom is provided with bleeder valve 72.
The crushing mechanism is electrically connected with the crushing motor 4, the fan is electrically connected with the fan motor 6, and the screw motor 21 is installed at the end part of the screw feeder 2.
The crushing mechanism comprises a crushing cavity 3, and a cutter head 31 is arranged in the crushing cavity 3. The cutter head 31 is evenly provided with blades 311, the inner wall of the crushing cavity 3 is provided with a convex part, and the convex part is meshed with the blades 311.
The number of the blades 311 is at least 10, the length of the blades 311 is 32-45 mm, the thickness of the blades 311 is 5-8 mm, and the width of the blades 311 is 50-80 mm.
The cutter head 31 includes a reinforcing plate 312, the reinforcing plate 312 is connected between adjacent blades 311, and the reinforcing plate 312 is integrally formed with the blades 311.
The crushing mechanism comprises a transmission shaft 32, and the transmission shaft 32 is in key connection with the cutter head 31.
The crushing chamber 3 is provided with a damper valve 35.
The crushing cavity 3 is of a relatively closed structure so as to ensure that the crushing cavity 3 is connected with a ventilating pipeline, the ventilating pipeline is provided with a ventilating valve 34, and the end part of the ventilating pipeline is provided with a ventilating hole 33.
The medical silicon rubber and the medical expanded polytetrafluoroethylene are crushed by a common crusher, the fineness and the quality required by the medical silicon rubber micro powder and the medical expanded polytetrafluoroethylene micro powder cannot be achieved, the special crusher is needed to crush the raw materials by the crusher with a specific structure to be used as the raw materials of the invention, and the effect described in the invention is further achieved.
Example 2
The preparation method of the solid silicone rubber micro powder gel suspension of the human soft tissue filling material comprises the following steps:
(1) crushing medical solid silicon rubber into micro-powder particles with the particle diameter of 5-25 microns by using a crusher;
(2) mixing medical solid silicon rubber micro powder particles, medical glycerin and physiological saline in a proportion of 60: 1: 1, mixing and stirring uniformly; and sterilizing after packaging for later use.
Example 3
The preparation method of the solid silicone rubber micro powder gel suspension of the human soft tissue filling material comprises the following steps:
(1) crushing medical solid silicon rubber into micro-powder particles with the particle diameter of 5-25 microns by using a crusher;
(2) mixing medical solid silicon rubber micro powder particles with medical glycerin and normal saline in a proportion of 15: 1: 1, mixing and stirring uniformly; and sterilizing after packaging for later use.
Example 4
The preparation method of the expanded polytetrafluoroethylene micro powder gel suspension as the filling material for the soft tissues of the human body comprises the following steps:
(1) crushing medical expanded polytetrafluoroethylene into micro-powder particles with the diameter of 5-25 microns by using a crusher;
(2) mixing expanded polytetrafluoroethylene micro powder particles with medical glycerin and physiological saline in a ratio of 60: 1: 1, mixing and stirring uniformly; and sterilizing after packaging for later use.
Example 5
The preparation method of the expanded polytetrafluoroethylene micro powder gel suspension as the filling material for the soft tissues of the human body comprises the following steps:
(1) crushing medical expanded polytetrafluoroethylene into micro-powder particles with the diameter of 5-25 microns by using a crusher;
(2) mixing expanded polytetrafluoroethylene micro powder particles with medical glycerin and normal saline in a ratio of 15: 1: 1, mixing and stirring uniformly; and sterilizing after packaging for later use.
Example 6
Clinical application
Long-term experimental research and practice prove that the human soft tissue filling material has good effect, and the following brief introduction of the conditions of several patients is as follows:
liu surname patient, woman, 65 years old, formed a depression due to atrophy and loss of the forehead and temple soft tissue, affecting the appearance. Puncturing the skin with 18-gauge needle at the edges of hairline at both sides to form a 0.3mm small opening, and performing Fengfu and Fengyang acupoint operation under local anesthesia. When 20ml of the human soft tissue filling material (medical solid silicone rubber micro powder particles + glycerol + physiological saline) in the embodiment 1 of the invention is injected into the depressed area, the forehead and the temple after operation are obviously full and natural, the human face is much younger, the double eyelids are natural, and the canthus lines are obviously lightened. After 1 year, no complications occurred.
The patient named Liangjian, woman, 62 years old, underwent facial filling in local anesthesia due to the aging states of sagging, wrinkles, etc. at the forehead, temple, french marks, nasolabial sulcus, lacrimal sulcus, apple muscle, etc. 40ml of the human soft tissue filling material of the embodiment 1 (the group of expanded polytetrafluoroethylene micro powder particles, glycerin and normal saline) is injected into the relevant parts to be filled through a small incision of 0.5mm on the skin of the depressed part of the face, the face is obviously improved, natural and full after the operation, and the patient is satisfied with the facial youthful state. After 3 years of operation, no complications occurred.
For the patient who is old 38, the nose, nasolabial sulcus, lacrimal sulcus and nasopharynx are developed under local anesthesia due to facial aging. 50ml of the human soft tissue filling material of example 3 of the present invention was injected subcutaneously into the relevant part through a small 0.5mm opening of the skin. The face after operation is obviously younger, natural and soft. Patients are satisfied and have strengthened self-confidence. At 12 months of follow-up, no complications occurred.
The Dong surname patient, female, aged 32 years old, had reduced cheekbones due to the wide cheekbones on both sides affecting the appearance. The conventional zygomatic bone reduction is not adopted, and 20ml of the human soft tissue filling material of the embodiment 4 of the invention is injected into the forehead and the temple through a small opening of 0.3mm of the forehead hairline under local anesthesia, so that the face becomes soft after the operation, and the zygomatic bones are not widened any more. The guest is satisfied with the design and treatment effect. After 5 years of operation, no complications occurred.
The traditional soft tissue filling method has the following characteristics:
the injection of hyaluronic acid has the retention time of at most one year, and the postoperative edema is easy, the pressing can generate flow, and the supporting force is too soft, so the nasal augmentation and lower jaw augmentation effects are worse.
Fat injection needs to extract autologous cells, which increases pain, and after operation, the cells are not sufficiently viable to absorb, the maintenance time after operation is not enough, which needs repeated injection, and the nasal augmentation and the lower jaw augmentation are not good enough due to too soft cells and insufficient support force, which results in poor treatment effect.
The surgical implantation of the medical silicon rubber prosthesis needs to be operated to strip the wound surface and the skin incision is generally 0.5cm to 3cm, the skin injury is large, the part with thicker subcutaneous soft tissue can be used, the part with thinner subcutaneous tissue, such as forehead, lacrimal groove and the like, is difficult to use, the implant is a whole implant, the outline is often too clear, the prosthesis can be touched, the naturalness is not enough, the nose tip part is often burst even because the tension is too large, the prosthesis is taken out, and the treatment fails. The invention can be implanted with minimal trauma no matter the subcutaneous tissue is thin, and the skin can not be burst, the appearance is natural after the implantation, the skin elasticity is increased, and the prosthesis can not be touched by hands.
Compared with the existing micro-finishing mode, the facial soft tissue filling material has the advantages that:
A. and (4) safety. The invention uses medical silicon rubber material or expanded polytetrafluoroethylene, the clinical use is very safe and mature, the invention of this technology is: the block medical silicon rubber or expanded polytetrafluoroethylene which is clinically used at present is changed into tiny powder, and then medical glycerol and other lubricants are mixed with the powder to form gel, so that the application of the medical silicon rubber or expanded polytetrafluoroethylene is brought into play in the more fashionable and popular micro-plastic field. B. And (5) minimally invasive. The human soft tissue filling material abandons the wound mode that the prosthesis can be implanted only by stripping in the operation in the past, carries out rapid treatment through minimally invasive noon break beauty, is more efficient, minimally invasive and quick to recover compared with the operation implantation, only needs a 0.5mm incision in the treatment process, can implant the human soft tissue filling material easily, and the gel and saline can be absorbed gradually after the implantation, and the medical solid silicon rubber micro powder or expanded polytetrafluoroethylene micro powder still keeps the solid state before the implantation and does not flow. C. And (4) lasting. Compared with the existing slightly popular hyaluronic acid, the human soft tissue filling material has a more lasting effect, can be treated once, and can maintain life. The injection of hyaluronic acid often has the defects of edema, depression, insufficient elastic supporting force and the like, and also avoids the defects that autologous cells need to be extracted and pain is increased, and absorption and repeated treatment are needed after treatment. Therefore, the human soft tissue filling material is more durable and has higher cost performance. D. And (4) performing biomimetic operation. Because the human soft tissue filling material is tightly combined with human tissues, after 3 weeks, the surrounding of the human soft tissue filling material can form self collagen tissue wrapping, thereby ensuring more natural treatment effect, recovering the elasticity of young tissues, having no depression when pressed, having firm position and not sliding away and moving. The defects of edema, over-soft tissues and the like of hyaluronic acid are avoided, and the elastic supporting force is stronger; the defect that the materials such as massive medical silicon rubber or expanded polytetrafluoroethylene prosthesis or artificial bone powder and the like are too hard is also avoided, so that the bionic engineering is true.
TABLE 3 comparison table of several face contour shaping methods commonly used at present
Figure DEST_PATH_IMAGE004
Example 7
(1) Crushing medical solid silicon rubber into micro-powder particles with the average diameter of about 20 microns by a crusher; the structure of the pulverizer is shown in the attached drawings;
(2) mixing medical solid silicon rubber micro powder particles, chitosan and normal saline in a proportion of 100: 7: 60, mixing and stirring uniformly; and sterilizing after packaging for later use.
Example 8
(1) Crushing medical solid silicon rubber into micro-powder particles with the average diameter of 15 microns by a crusher; the structure of the pulverizer is shown in the attached drawings;
(2) mixing medical solid silicon rubber micro powder particles, sodium carboxymethylcellulose and normal saline in a proportion of 100: 7: 60, mixing and stirring uniformly; and sterilizing after packaging for later use.
Example 9
(1) Crushing medical solid silicon rubber into micro-powder particles with the average diameter of 10 microns by a crusher; the structure of the pulverizer is shown in the attached drawings;
(2) mixing medical solid silicon rubber micro powder particles, hydroxyethyl starch and normal saline in a proportion of 100: 7: 60, mixing and stirring uniformly; and sterilizing after packaging for later use.
Example 10
(1) Pulverizing medical solid silicon rubber into micro-powder particles with the average diameter of 22 microns by a pulverizer; the structure of the pulverizer is shown in the attached drawings;
(2) mixing medical solid silicon rubber micro powder particles, polyvinylpyrrolidone and normal saline in a proportion of 100: 7: 60, mixing and stirring uniformly; and sterilizing after packaging for later use.
Example 11
(1) Crushing medical solid silicon rubber into micro-powder particles with the average diameter of 15 microns by a crusher; the structure of the pulverizer is shown in the attached drawings;
(2) mixing medical solid silicon rubber micro powder particles, polyacrylamide hydrogel and normal saline in a proportion of 100: 7: 60, mixing and stirring uniformly; and sterilizing after packaging for later use.
Example 12
(1) Crushing medical solid silicon rubber into micro-powder particles with the average diameter of 15 microns by a crusher; the structure of the pulverizer is shown in the attached drawings;
(2) mixing medical solid silicon rubber micro powder particles with polyacrylic acid and normal saline in a ratio of 100: 7: 60, mixing and stirring uniformly; and sterilizing after packaging for later use.
Example 13
(1) Crushing medical solid silicon rubber into micro-powder particles with the average diameter of 15 microns by a crusher; the structure of the pulverizer is shown in the attached drawings;
(2) mixing medical solid silicon rubber micro powder particles, polyhydroxyethyl methacrylate and normal saline in a proportion of 100: 7: 60, mixing and stirring uniformly; and sterilizing after packaging for later use.

Claims (3)

1. The filler for the soft tissue of the human body is characterized by comprising the following raw materials in parts by volume:
60-150 parts of medical solid silicone rubber micro powder
Lubricants 1 to 10
1-100 parts of normal saline;
the average diameter value of the medical solid silicone rubber micro powder is 25-45 micrometers;
the human soft tissue filler is applied to the depressed filling of human nasolabial sulcus, lacrimal groove, facia, apple muscle, nose, forehead, temple and chin;
the preparation method of the human soft tissue filler comprises the following steps:
(1) putting the medical solid silicon rubber into a special pulverizer to pulverize into micro-powder particles, wherein the diameter of the micro-powder particles is 25-45 microns;
(2) mixing the medical solid silicon rubber particles with a lubricant and normal saline in a ratio of 60-150: 1-10: 1-100 volume ratio, and uniformly stirring; sterilizing for later use after packaging;
the pulverizer comprises a cabinet body (8), install reinforced precooling storehouse (1) in the cabinet body (8), reinforced precooling storehouse (1) is connected with rubbing crusher through screw feeder (2), rubbing crusher passes through feeder (9) and fan (5) intercommunication, fan (5) are connected with cyclone (7) through the pipeline, rubbing crusher constructs crushing chamber (3) including installing blade disc (31), evenly is provided with blade (311) on blade disc (31), and crushing chamber (3) inner wall is provided with the bellying, bellying and blade (311) meshing.
2. The human soft tissue filler according to claim 1, wherein the lubricant is at least one of glycerol, chitosan, hyaluronic acid/sodium hyaluronate, sodium carboxymethylcellulose, chondroitin sulfate, polyacrylamide, polyvinyl alcohol, polyacrylic acid, polyhydroxyethylmethacrylate, hydroxypropylmethylcellulose, hydroxyethyl starch, hydroxyethyl cellulose, polyvinylpyrrolidone.
3. The human soft tissue bulking agent of claim 1, wherein said normal saline is present at a concentration of 0.9% by weight.
CN201610968222.1A 2016-10-26 2016-10-26 Human soft tissue filler, preparation method thereof and special pulverizer Active CN106421897B (en)

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