CN110898255A - Method for manufacturing expanded polytetrafluoroethylene facial implant with coated surface - Google Patents

Method for manufacturing expanded polytetrafluoroethylene facial implant with coated surface Download PDF

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Publication number
CN110898255A
CN110898255A CN201911243072.8A CN201911243072A CN110898255A CN 110898255 A CN110898255 A CN 110898255A CN 201911243072 A CN201911243072 A CN 201911243072A CN 110898255 A CN110898255 A CN 110898255A
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China
Prior art keywords
coating
emulsion
sintering
expanded
solvent
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Pending
Application number
CN201911243072.8A
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Chinese (zh)
Inventor
徐润卿
李锦蓓
朱庆
马陆军
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SHANGHAI KANGNING MEDICAL DEVICE CO Ltd
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SHANGHAI KANGNING MEDICAL DEVICE CO Ltd
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Priority to CN201911243072.8A priority Critical patent/CN110898255A/en
Publication of CN110898255A publication Critical patent/CN110898255A/en
Pending legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14Macromolecular materials
    • A61L27/16Macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/28Materials for coating prostheses
    • A61L27/34Macromolecular materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2430/00Materials or treatment for tissue regeneration
    • A61L2430/34Materials or treatment for tissue regeneration for soft tissue reconstruction

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Transplantation (AREA)
  • Dermatology (AREA)
  • Medicinal Chemistry (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Materials For Medical Uses (AREA)
  • Prostheses (AREA)

Abstract

The invention discloses a method for manufacturing an expanded polytetrafluoroethylene facial implant with a coated surface. It includes: (1) preparation of a base material: preparing a base material to be subjected to outer surface coating, namely a swelling material; (2) preparing a coating emulsion: preparing the emulsion and a solvent according to the mass ratio of 1:0.5-1:10 to obtain a coating emulsion; (3) coating of a coating: coating the prepared coating emulsion on the outer surface of the substrate; (4) and (3) solvent volatilization: naturally volatilizing or drying to volatilize the solvent on the surface of the expanded material; (5) sintering and curing: the sintering and curing temperature range is 280-400 ℃, and the sintering and curing time is 30 minutes-1.5 hours; (6) and (6) cooling. The method for manufacturing the bulked product carries out coating treatment on the outer surface of the bulk, nose or mandible bulked product, can effectively reduce the friction with human tissues, is convenient to implant during operation, and relieves the pain of a user; meanwhile, the attractiveness of the product is improved.

Description

Method for manufacturing expanded polytetrafluoroethylene facial implant with coated surface
Technical Field
The invention belongs to the technical field of production of expanded polytetrafluoroethylene facial implants, and relates to a manufacturing method of an expanded polytetrafluoroethylene facial implant with a coated surface.
Background
The expanded polytetrafluoroethylene is prepared from polytetrafluoroethylene dispersion resin by a special processing technology, has a node-fiber ultrastructure, and can induce the in-growth of self tissue cells by controlling node spacing. The expanded polytetrafluoroethylene facial implant (block type, nose type or mandible type expanded product) made of the material is used for soft tissue filling operation including nose augmentation operation, and has the advantages of vivid and natural appearance, no displacement and degeneration of prosthesis, few complications and the like.
However, the existing expanded polytetrafluoroethylene facial implant has the following defects:
1. the existing expanded polytetrafluoroethylene facial implant has rough and unattractive surface after being processed and molded;
2. the existing expanded polytetrafluoroethylene facial implant is a process of bonding layer by layer, has a rough appearance, has too large resistance during implantation and is difficult to place.
Disclosure of Invention
The invention aims to overcome the defects of the prior art and provide a method for manufacturing an expanded polytetrafluoroethylene facial implant with a coated surface.
The purpose of the invention is realized by the following technical scheme:
a method for manufacturing an expanded polytetrafluoroethylene facial implant with a coated surface comprises the following steps:
(1) preparation of a base material: preparing a base material (namely an expanded polytetrafluoroethylene facial implant, which is called an expanded material for short) needing to be coated on the outer surface; the shape of the substrate may be a block shape, or may be a nose shape or a chin shape.
(2) Preparing a coating emulsion: and (3) preparing (diluting) the emulsion and the solvent according to the mass ratio of 1:0.5-1:10 to obtain the coating emulsion for later use.
The emulsion may be polytetrafluoroethylene emulsion (PTFE emulsion), polyperfluoroethylene propylene emulsion (FEP emulsion), or meltable polytetrafluoroethylene emulsion (PFA emulsion).
The solvent can be distilled water, or organic solvent such as ethyl acetate, petroleum ether, alcohol, etc. which is easy to volatilize, difficult to residue and harmless to human body.
In this step, attention is paid to: the viscosity of the coating emulsion is appropriate, and if the coating emulsion is too thin, the coating is not thin enough, and if the coating emulsion is too thick, cracks can appear. Viscosity of coating emulsion: depending on the coating chosen and the solvent, the viscosity may also vary. The viscosity range of the formulated coating emulsion was: 20cP to 100 cP.
(3) Coating of a coating: the prepared (diluted) coating emulsion can be coated on the outer surface of the base material by adopting a compressed gas spraying method, a roller coating method and the like.
The function of the coating not only makes the surface of the bulked product smoother, is easy to implant in an operation, increases the self-beauty of the bulked product, but also can effectively reduce bacterial adhesion, is more beneficial to disinfection and reduces infection probability; moreover, the surface of the expanded product is smooth, so that the surface of the expanded product has no obvious frizzy feeling and corner surface, and the effect is more natural and vivid after implantation.
(4) And (3) solvent volatilization: and (3) placing the swelling material coated with the coating emulsion at a proper temperature to volatilize the solvent on the surface of the swelling material, namely naturally volatilizing or drying until no liquid residue exists on the surface of the swelling material.
Suitable temperature ranges for solvent evaporation: the temperature of solvent volatilization is different according to the type of the selected solvent, and the range is from normal temperature to 105 ℃, so that the solvent is completely volatilized.
(5) Sintering and curing: and sintering and solidifying the expanded material with the coating on the surface.
The sintering curing temperature and time are different according to the selected coating material, the sintering curing temperature ranges from 280 ℃ to 400 ℃ (preferably from 320 ℃ to 380 ℃), and the sintering curing time ranges from 30 minutes to 1.5 hours.
(6) And (3) cooling: and taking the expanded material out of the sintering oven, and placing the expanded material at room temperature to cool to the room temperature.
The invention has the beneficial effects that:
the invention provides a method for manufacturing an expanded polytetrafluoroethylene facial implant with a coated surface, which is used for coating the outer surface of a block-type, nose-type or lower jaw-type expanded product, so that the friction with human tissues can be effectively reduced, the implant is convenient during operation, and the pain of a user is relieved; meanwhile, the attractiveness of the product is improved.
The method of the invention has the following advantages:
1. the surface of the implant is coated, so that the friction coefficient with human tissues can be reduced, and the implant is easy to implant in an operation.
2. The surface of the implant is coated, so that foreign body feeling caused by rough surface can be effectively reduced, and the appearance is attractive.
3. The surface of the implant is coated, so that the bacterial adhesion can be reduced, the surgical disinfection is facilitated, and the infection rate is reduced.
Detailed Description
The present invention will be further described with reference to the following examples.
Example 1
The invention relates to a method for manufacturing an expanded polytetrafluoroethylene facial implant with a coated surface, which comprises the following steps:
(1) preparation of a base material: preparing a base material (namely an expanded polytetrafluoroethylene facial implant, which is called an expanded material for short) needing to be coated on the outer surface; the shape of the substrate is a block.
(2) Preparing a coating emulsion: and (3) preparing (diluting) the emulsion and the solvent according to the mass ratio of 1:10, and uniformly stirring to obtain the coating emulsion for later use.
The emulsion is a polytetrafluoroethylene emulsion (PTFE emulsion). The solvent is distilled water. The viscosity of the coating emulsion is: 20.1 + -5 cP.
(3) Coating of a coating: and spraying a layer of prepared coating emulsion on the outer surface of the base material by adopting a compressed air spraying method.
(4) And (3) solvent volatilization: and (3) placing the swelling material coated with the coating emulsion at the temperature of 90 +/-15 ℃ to volatilize the solvent on the surface of the swelling material, namely drying the swelling material at the temperature of 90 +/-15 ℃ until no liquid residue exists on the surface of the swelling material.
(5) Sintering and curing: and sintering and solidifying the expanded material with the coating on the surface.
And adjusting the temperature of the sintering oven to 370 +/-20 ℃ for sintering and curing, wherein the sintering time is 1-1.5 hours.
(6) And (3) cooling: and taking the expanded material out of the sintering oven, and placing the expanded material at room temperature to cool to the room temperature.
In the above manufacturing method, attention is paid to: the viscosity of the coating emulsion is appropriate, and if the coating emulsion is too thin, the coating emulsion is not sufficiently thin, and if the coating emulsion is too thick, cracks can appear. Viscosity of coating emulsion: depending on the coating chosen and the solvent, the viscosity may also vary.
Example 2
The invention relates to a method for manufacturing an expanded polytetrafluoroethylene facial implant with a coated surface, which comprises the following steps:
(1) preparation of a base material: preparing a base material (namely an expanded polytetrafluoroethylene facial implant, which is called an expanded material for short) needing to be coated on the outer surface; the shape of the substrate is a mandible.
(2) Preparing a coating emulsion: and (3) preparing (diluting) the emulsion and the solvent according to the mass ratio of 1:5, and uniformly stirring to obtain the coating emulsion for later use.
The emulsion is a fluorinated ethylene propylene emulsion (FEP emulsion). The solvent is ethyl acetate. The viscosity of the coating emulsion is: 49.5 + -5 cP.
(3) Coating of a coating: and spraying a layer of prepared coating emulsion on the outer surface of the base material by adopting a compressed air spraying method.
(4) And (3) solvent volatilization: and (3) placing the swelling material coated with the coating emulsion in a temperature range of 20-50 ℃ to volatilize the solvent on the surface of the swelling material, namely drying the swelling material at 20-50 ℃ until no liquid residue exists on the surface of the swelling material.
(5) Sintering and curing: and sintering and solidifying the expanded material with the coating on the surface.
And adjusting the temperature of the sintering oven to 325 +/-20 ℃ for sintering and curing, wherein the sintering time is 1-1.5 hours.
(6) And (3) cooling: and taking the expanded material out of the sintering oven, and placing the expanded material at room temperature to cool to the room temperature.
Example 3
The invention relates to a method for manufacturing an expanded polytetrafluoroethylene facial implant with a coated surface, which comprises the following steps:
(1) preparation of a base material: preparing a base material (namely an expanded polytetrafluoroethylene facial implant, which is called an expanded material for short) needing to be coated on the outer surface; the shape of the substrate is nose-shaped.
(2) Preparing a coating emulsion: and (3) preparing (diluting) the emulsion and the solvent according to the mass ratio of 1:0.5, and uniformly stirring to obtain the coating emulsion for later use.
The emulsion is a meltable polytetrafluoroethylene emulsion (PFA emulsion). The solvent is an alcohol. The viscosity of the coating emulsion is: 95 + -5 cP.
(3) Coating of a coating: and coating a layer of prepared coating emulsion on the outer surface of the base material by adopting a roll coating method.
(4) And (3) solvent volatilization: and (3) placing the swelling material coated with the coating emulsion at normal temperature to volatilize the solvent on the surface of the swelling material, namely naturally volatilizing until no liquid residue exists on the surface of the swelling material.
(5) Sintering and curing: and sintering and solidifying the expanded material with the coating on the surface.
And adjusting the temperature of the sintering oven to 375 +/-20 ℃ for sintering and curing, wherein the sintering time is 0.5-1 hour.
(6) And (3) cooling: and taking the expanded material out of the sintering oven, and placing the expanded material at room temperature to cool to the room temperature.
Example 4
The invention relates to a method for manufacturing an expanded polytetrafluoroethylene facial implant with a coated surface, which comprises the following steps:
(1) preparation of a base material: preparing a base material (namely an expanded polytetrafluoroethylene facial implant, which is called an expanded material for short) needing to be coated on the outer surface; the shape of the substrate is a block.
(2) Preparing a coating emulsion: and (3) preparing (diluting) the emulsion and the solvent according to the mass ratio of 1:8, and uniformly stirring to obtain the coating emulsion for later use.
The emulsion is a fluorinated ethylene propylene emulsion (FEP emulsion). The solvent is petroleum ether. The viscosity of the coating emulsion is: 31.6 + -5 cP.
(3) Coating of a coating: and coating a layer of prepared coating emulsion on the outer surface of the base material by adopting a roll coating method.
(4) And (3) solvent volatilization: and (3) placing the bulked material coated with the coating emulsion at the temperature of between normal temperature and 40 ℃ to volatilize the solvent on the surface of the bulked material, namely volatilizing at the normal temperature or drying within the range of between the normal temperature and 40 ℃ until no liquid residue exists on the surface of the bulked material.
(5) Sintering and curing: and sintering and solidifying the expanded material with the coating on the surface.
And adjusting the temperature of the sintering oven to 360 +/-20 ℃ for sintering and curing, wherein the sintering time is 0.5-1 hour.
(6) And (3) cooling: and taking the expanded material out of the sintering oven, and placing the expanded material at room temperature to cool to the room temperature.

Claims (9)

1. A method for manufacturing an expanded polytetrafluoroethylene facial implant with a coated surface is characterized by comprising the following steps:
(1) preparation of a base material: preparing a base material needing to be coated on the outer surface, namely an expanded polytetrafluoroethylene facial implant, which is called an expanded material for short;
(2) preparing a coating emulsion: preparing the emulsion and the solvent according to the mass ratio of 1:0.5-1:10 to obtain coating emulsion for later use;
(3) coating of a coating: coating the prepared coating emulsion on the outer surface of a base material;
(4) and (3) solvent volatilization: placing the swelling material coated with the coating emulsion at a proper temperature to volatilize the solvent on the surface of the swelling material, namely naturally volatilizing or drying until no liquid residue exists on the surface of the swelling material;
(5) sintering and curing: sintering and curing the expanded material with the coating on the surface;
(6) and (3) cooling: and taking the expanded material out of the sintering oven, and placing the expanded material at room temperature to be cooled to the normal temperature.
2. The method of claim 1, wherein in step (1) the substrate is in the shape of a block, nose or chin.
3. The method of claim 1 or 2, wherein in step (2), the emulsion is a polytetrafluoroethylene emulsion, a polyfluoroethylene-propylene emulsion, or a meltable polytetrafluoroethylene emulsion.
4. The method of claim 1 or 2, wherein in step (2), the solvent is distilled water, ethyl acetate, petroleum ether or alcohol.
5. The method of claim 1 or 2, wherein in step (2), the coating emulsion is formulated to have a viscosity in the range of: 20cP to 100 cP.
6. The method for manufacturing an expanded polytetrafluoroethylene facial implant with a coated surface according to claim 1 or 2, wherein in the step (3), the prepared coating emulsion is coated on the outer surface of the substrate by a compressed air spraying or roll coating method.
7. The method for manufacturing an expanded polytetrafluoroethylene facial implant with a coated surface according to claim 1 or 2, wherein in the step (4), the temperature range of solvent evaporation is from normal temperature to 105 ℃, so that the solvent evaporation is complete.
8. The method for manufacturing an expanded polytetrafluoroethylene facial implant with a coated surface according to claim 1 or 2, wherein in the step (5), the sintering curing temperature is in the range of 280 ℃ to 400 ℃, and the sintering curing time is in the range of 30 minutes to 1.5 hours.
9. The method of claim 8 wherein the sintering and curing temperature is in the range of 320 ℃ to 380 ℃.
CN201911243072.8A 2019-12-06 2019-12-06 Method for manufacturing expanded polytetrafluoroethylene facial implant with coated surface Pending CN110898255A (en)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN111529130A (en) * 2020-05-30 2020-08-14 周锋杰 Method for manufacturing surface micropore composite lower jaw prosthesis

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN2904982Y (en) * 2006-01-26 2007-05-30 上海索康医用材料有限公司 A nose prosthesis used for human body
CN201727611U (en) * 2010-07-22 2011-02-02 上海索康医用材料有限公司 Formed nasal prosthesis
CN201759700U (en) * 2010-08-24 2011-03-16 上海索康医用材料有限公司 Mandible prosthesis
CN203122683U (en) * 2012-12-29 2013-08-14 上海索康医用材料有限公司 Mandible prosthesis for men
CN203736350U (en) * 2014-01-09 2014-07-30 上海索康医用材料有限公司 Mandible angle implant
CN103992700A (en) * 2014-05-23 2014-08-20 中国人民武装警察部队杭州士官学校 Preparation method and product of wear-resistant polymer coating with soft light sensation
CN107206119A (en) * 2014-12-09 2017-09-26 实体科学有限责任公司 Medical Devices coating with biocompatible layer
CN107446156A (en) * 2017-08-22 2017-12-08 江苏泛亚微透科技股份有限公司 Composite, its preparation method and its preparation facilities of graphite ene coatings are coated with eptfe membrane face

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN2904982Y (en) * 2006-01-26 2007-05-30 上海索康医用材料有限公司 A nose prosthesis used for human body
CN201727611U (en) * 2010-07-22 2011-02-02 上海索康医用材料有限公司 Formed nasal prosthesis
CN201759700U (en) * 2010-08-24 2011-03-16 上海索康医用材料有限公司 Mandible prosthesis
CN203122683U (en) * 2012-12-29 2013-08-14 上海索康医用材料有限公司 Mandible prosthesis for men
CN203736350U (en) * 2014-01-09 2014-07-30 上海索康医用材料有限公司 Mandible angle implant
CN103992700A (en) * 2014-05-23 2014-08-20 中国人民武装警察部队杭州士官学校 Preparation method and product of wear-resistant polymer coating with soft light sensation
CN107206119A (en) * 2014-12-09 2017-09-26 实体科学有限责任公司 Medical Devices coating with biocompatible layer
CN107446156A (en) * 2017-08-22 2017-12-08 江苏泛亚微透科技股份有限公司 Composite, its preparation method and its preparation facilities of graphite ene coatings are coated with eptfe membrane face

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN111529130A (en) * 2020-05-30 2020-08-14 周锋杰 Method for manufacturing surface micropore composite lower jaw prosthesis

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Application publication date: 20200324