CN106420111B - A kind of Permanent implantation type facial implant and preparation method thereof - Google Patents
A kind of Permanent implantation type facial implant and preparation method thereof Download PDFInfo
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- CN106420111B CN106420111B CN201611044496.8A CN201611044496A CN106420111B CN 106420111 B CN106420111 B CN 106420111B CN 201611044496 A CN201611044496 A CN 201611044496A CN 106420111 B CN106420111 B CN 106420111B
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- nose
- facial implant
- preparation
- wing
- permanent implantation
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/18—Internal ear or nose parts, e.g. ear-drums
- A61F2/186—Nose parts
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/0059—Cosmetic or alloplastic implants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/0077—Special surfaces of prostheses, e.g. for improving ingrowth
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2210/0014—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2240/00—Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2240/001—Designing or manufacturing processes
- A61F2240/002—Designing or making customized prostheses
Landscapes
- Health & Medical Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Engineering & Computer Science (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Biomedical Technology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Otolaryngology (AREA)
- Pulmonology (AREA)
- Prostheses (AREA)
Abstract
The invention discloses a kind of Permanent implantation type facial implant and preparation method thereof, the facial implant is used for nose, include columella nasi prosthesis and two symmetrically arranged wing of nose prostheses, wherein, the columella nasi prosthesis is expended polytetrafluoraethyline, and the wing of nose prosthese has the sandwich construction of sandwich style, and it includes expanded PTFE upper epidermis, expanded PTFE layer, and the intermediate metal layer being disposed there between, the metal are memory metal.Preparation method provided by the invention is in Memorability metal outer coated with expanded PTFE, supported using memory metal, and there is good compliance, the covering of outer layer avoids metal and directly contacted with tissue, embody good biocompatibility, histocyte can be grown into after implantation, realize prosthese " fusion " with autologous tissue；Securely and reliably.Facial implant provided by the invention has good compliance and pliability, postoperative more natural close to human body corium.
Description
Technical field
The invention belongs to medical instruments field, is related to a kind of implant prosthese, it particularly relates to a kind of Permanent implantation type
Facial implant and preparation method thereof.
Background technology
Augmentation rhinoplasty is mentioned, is generally considered that it is filling to bridge of the nose, nose and the small post part of nose.However, in fact, the wing of nose exists
Play the role of in the facial overall profile of people very important.The wing of nose, the part of nose both sides, by skin, sub-dermal soft tissue and
Cartilage forms.
The wing of nose crosses conference and lacks harmonious feeling, and is run counter to the traditional custom of China.To this kind of patient, it will usually take excision
Part wing of nose substrate, the free edge of the wing of nose or nostril edge skin, reach the effect for reducing the wing of nose.It is but injured or born for those
There is the patient of defect of nasal ala, not only lack external beauty, or even have influence on respiratory function, it is necessary to take wing of nose Reconstruction.
Defect of nasal ala can clinically be divided into two major classes, (1) simple defect of skin, (2) holostrome tissue defect.The first
Situation, repairing is relatively easy, is repaired by skin-grafting, local skin flap's transfer.Repaired for holostrome tissue defect relatively multiple
It is miscellaneous, need graft to carry out filling repairing.For second of situation, in wing of nose Reconstruction, because dilator naris itself is as soft
Tissue, lack bony structure, and people may touch the wing of nose in life.Therefore Using prosthesis is needed, prosthese needs to have necessarily
Supportive, while soft or hard appropriateness, it is ensured that postoperative that there is very strong realism.
However, preparation work of the report with supportive and soft or hard appropriate class wing of nose prothesis implant body is there is no in the prior art
Skill.
The content of the invention
It is an object of the invention to provide a kind of method for manufacturing prosthese used in nose reconstructive operation；This method is being remembered
Property metal outer is supported using memory metal coated with expanded PTFE, and has good compliance, the covering of outer layer
Thing avoids metal and directly contacted with tissue, embodies good biocompatibility, and histocyte can be grown into after implantation, realizes
" fusion " of prosthese and autologous tissue；Securely and reliably.
It is small comprising nose for nose the invention provides a kind of Permanent implantation type facial implant to reach above-mentioned purpose
Post prosthese and two symmetrically arranged wing of nose prostheses, wherein, described columella nasi prosthesis is expended polytetrafluoraethyline, described
Wing of nose prosthese there is the sandwich construction of sandwich style, include expanded PTFE upper epidermis, expanded PTFE following table
Layer, and the intermediate metal layer being disposed there between, the metal are memory metal.
Described facial implant is in M shapes, symmetrical, meets the physiological structure of the human body wing of nose.
Preferably, the characteristics of described memory metal refers to Ti-Ni alloy, and the present invention is easy to deformation using memory metal, make
Expected shape is conveniently bent to middle.
Described intermediate metal layer is wire.
Preferably, the intermediate metal layer is made up of some discontinuous wires, and the discontinuous wire is parallel, interval
Arrangement.
Described expanded PTFE upper epidermis, expanded PTFE layer, and pass through between intermediate metal layer
Binding agent is fixed, to strengthen fixation；Described binding agent selection perfluoroethylene-propylene or silica gel.
Some fixing holes are provided with described columella nasi prosthesis.
The aperture of described fixing hole is 1-2mm.
Present invention also offers a kind of preparation method according to above-mentioned Permanent implantation type facial implant, this method bag
Contain：
Step 1, at a temperature of no more than 19 DEG C, using dispersion resin polytetrafluoroethylgranule granule as raw material, pressed with extrusion aid
It is 10 according to weight ratio:2~10:5 ratio uniform mixing, to ensure that extrusion aid fully permeates, and stands overnight at low temperature.
Step 2, raw material step 1 stood overnight, 28 DEG C ~ 35 DEG C is warming up to, is pre-formed as bar-shaped；
Step 3, by the club of step 2, pushed, form the thick sheet materials of 3 ~ 5 mm；
Step 4, the sheet material described in step 3 is carried out roll-in at 50 ~ 80 DEG C, form the thick sheet materials of 1 ~ 2 mm；
Step 5, dried sheet material is stretched at 180 ~ 270 DEG C, 5-8 times of draw ratio, average pore size is
25um；
Step 6, the both ends of the sheet material after step 5 stretching are respectively arranged memory wire, then cover corresponding size
Sheet material, the superposition of " sandwich " formula is carried out, heat-shaping, forms the facial implant comprising wing of nose prosthese and columella nasi prosthesis；
Step 7, temperature is raised to 360 ~ 390 DEG C, and along sheet material Direction of superposition press perpendicular, and shape 30 minutes；
Step 8, in the small post part manufacture 1-2 mm of nose circular hole, prosthese is sutured in convenient operation；
Step 9, by facial implant symmetrical fold so that two wing of nose prostheses are full symmetric, fixed in 360 ~ 390 DEG C of pressurizations
Type 20 minutes.
Preferably, described step 6 passes through binding agent and fixes e-PTFE second also before heat-shaping after superposition
Alkene upper epidermis, expanded PTFE layer, and intermediate metal layer.
The present invention extrudes using dispersed polyflon as raw material by pasty state, pushes, roll-in, dries, stretching etc.
Step, memory metal is introduced in two layers of expanded PTFE material.Permanent implantation type facial implant provided by the invention
Both there is the characteristics of expanded PTFE good biocompatibility, directly contacted with nasal tissue cell, its length can be induced
Enter, while the introducing of memory metal, meet demand clinically, wing of nose part is softer, and metal good conformability can be according to trouble
The situation of person, bent in operation, be folded into required shape, postoperative return tension force is small.
Brief description of the drawings
Fig. 1 is the front view of Permanent implantation type facial implant provided by the invention.
Fig. 2 is the structural representation of a part of wing of nose prosthese 20 of Permanent implantation type facial implant provided by the invention
Figure.
Fig. 3 is the structural representation of the facial implant before columella nasi prosthesis 10 provided by the invention folds.
Embodiment
Below in conjunction with accompanying drawing, by specific embodiment, the invention will be further described, and these embodiments are merely to illustrate
The present invention, it is not limiting the scope of the invention.
As shown in figure 1, to be provided by the invention the invention provides a kind of Permanent implantation type facial implant, face plant
Enter thing to be integrally formed, for nose, comprising columella nasi prosthesis 10 and two symmetrically arranged wing of nose prostheses 20, wherein, it is described
Columella nasi prosthesis 10 is expended polytetrafluoraethyline, and described wing of nose prosthese 20 has the sandwich construction of sandwich style, comprising
Expanded PTFE upper epidermis, expanded PTFE layer, and the intermediate metal layer 21 being disposed there between, such as scheme
Shown in 2, wherein, the metal is memory metal.
Described facial implant is in M shapes, symmetrical, meets the physiological structure of the human body wing of nose.
The preferred Ti-Ni alloy of described memory metal, the characteristics of being easy to deformation using memory metal, convenient bending in use
For the shape expected.
Described intermediate metal layer is wire.
The intermediate metal layer is made up of some discontinuous wires, and the discontinuous wire is parallel, arranged for interval.
Described expanded PTFE upper epidermis, expanded PTFE layer, and pass through between intermediate metal layer
Binding agent is fixed, to strengthen fixation；Described binding agent selection perfluoroethylene-propylene or silica gel.
Some fixing holes are provided with described columella nasi prosthesis.
The aperture of described fixing hole is 1-2mm.
Comprised the steps of provided by the present invention for the preparation method of the ose implant of wing of nose reconstruction：
Step 1, at a temperature of no more than 19 DEG C, using dispersion resin polytetrafluoroethylgranule granule as raw material, pressed with extrusion aid
It is 10 according to weight ratio:2~10:5 ratio uniform mixing, to ensure that extrusion aid fully permeates；Stand overnight at low temperature.
Step 2, by above-mentioned well mixed raw material, 28 DEG C ~ 35 DEG C is warming up to, is pre-formed as bar-shaped；
Step 3, by above-mentioned club, pushed, form the thick sheet materials of 3 ~ 5 mm；
Step 4, the sheet material described in step 3 is carried out roll-in at 50 ~ 80 DEG C, form the thick sheet materials of 1 ~ 2 mm；
Step 5, dried sheet material is stretched at 180 ~ 270 DEG C, produces the microcellular structure of " section and fiber ", stretching
5-8 times of multiple, average pore size 25um.
Step 6, by memory metal（Such as, Ti-Ni alloy）" sandwich " mode is carried out with the sheet material after above-mentioned stretching to be superimposed,
Heat-shaping；Wherein, outer layer（Upper epidermis and layer）For expanded PTFE, intermediate layer is memory wire.Wherein,
The placement of wire can continuously or discontinuously, can be laid out and place according to different decorative patterns.Prioritizing selection is discontinuous, takes
Parallel mode places wire.To facilitate surgeon in use, according to the actual conditions of patient, wing of nose part is cut out
Cut.In order to strengthen the bonding of its wire and outer layer fluoropolymer and the combination of both sides fluoropolymer, using adhesive bonding.Bonding
Agent can select fluoropolymer such as：Perfluoroethylene-propylene, silica gel also may be selected.
Step 7, temperature is raised to 360 ~ 390 DEG C, and along sheet material Direction of superposition press perpendicular, and shape 30 minutes, sizing
Facial implant afterwards is as shown in figure 3, wing of nose prosthese 20 is symmetrical along center line.Preferably, can also be in the small post part manufacture 1-2 of nose
Mm circular hole（Do not show in figure）, prosthese is sutured with facilitating in operation.
Step 8, facial implant after step 7 is shaped is along center line（See Fig. 3）Symmetrical fold, add at 360 ~ 390 DEG C
Pressure sizing 20 minutes, obtains facial implant as shown in Figure 1.Preferably, can also be in superposed surfaces coated with adhesive.
Facial implant provided by the invention contains substantial amounts of microcellular structure, can inducing cell grow into, it is solid so as to play
Determine the effect of prosthese, human body can be chronically implanted without being absorbed by body；And in Memorability metal outer coated with e-PTFE
Ethene, supported using memory metal, and there is good compliance, the covering of outer layer is also avoided that metal and tissue
Directly contact；Adhesive is introduced between the layers, and nose pillar is provided with fixing hole, steadiness is good.
Although present disclosure is discussed in detail by above preferred embodiment, but it should be appreciated that above-mentioned
Description is not considered as limitation of the present invention.After those skilled in the art have read the above, for the present invention's
A variety of modifications and substitutions all will be apparent.Therefore, protection scope of the present invention should be limited to the appended claims.
Claims (7)
1. a kind of preparation method of Permanent implantation type facial implant, it is characterised in that the facial implant is integrally formed, and is used for
Nose, comprising columella nasi prosthesis and two symmetrically arranged wing of nose prostheses, wherein, described columella nasi prosthesis is e-PTFE
Ethene prosthese, described wing of nose prosthese have the sandwich construction of sandwich style, gathered comprising expanded PTFE upper epidermis, varicosity
Tetrafluoroethene layer, and the intermediate metal layer being disposed there between, the metal that the intermediate metal layer uses for memory metal,
Some fixing holes are provided with described columella nasi prosthesis；This method includes：
Step 1, at a temperature of no more than 19 DEG C, using dispersion resin polytetrafluoroethylgranule granule as raw material, with extrusion aid according to weight
Amount is than being 10:2~10:5 ratio uniform mixing, to ensure that extrusion aid fully permeates, and stands overnight at low temperature；
Step 2, raw material step 1 stood overnight, 28 DEG C~35 DEG C is warming up to, is pre-formed as bar-shaped；
Step 3, by the club of step 2, pushed, form the thick sheet materials of 3~5mm；
Step 4, the sheet material described in step 3 is carried out roll-in at 50~80 DEG C, form the thick sheet materials of 1~2mm；
Step 5, dried sheet material is stretched at 180~270 DEG C, 5-8 times of draw ratio, average pore size 25um；
Step 6, the both ends of the sheet material after step 5 stretching are respectively arranged memory wire, then cover the sheet material of corresponding size,
The superposition of " sandwich " formula of progress, heat-shaping, form the facial implant comprising wing of nose prosthese and columella nasi prosthesis；
Step 7, temperature is raised to 360~390 DEG C, and along sheet material Direction of superposition press perpendicular, and shape 30 minutes；
Step 8, some 1-2mm fixing hole is manufactured in columella nasi prosthesis, prosthese is sutured with facilitating in operation；
Step 9, by facial implant symmetrical fold so that two wing of nose prostheses are full symmetric, in 360~390 DEG C of pressurization sizings
20 minutes.
2. the preparation method of Permanent implantation type facial implant as claimed in claim 1, it is characterised in that described step 6
Also it is included in after being superimposed before heat-shaping, is fixed by binding agent under expanded PTFE upper epidermis, expanded PTFE
Top layer, and intermediate metal layer.
3. the preparation method of Permanent implantation type facial implant as claimed in claim 1, it is characterised in that described face plant
It is in M shapes to enter thing, symmetrical.
4. the preparation method of Permanent implantation type facial implant as claimed in claim 1, it is characterised in that described memory gold
Category refers to Ti-Ni alloy.
5. the preparation method of Permanent implantation type facial implant as claimed in claim 1, it is characterised in that gold among described
Category layer is wire.
6. the preparation method of Permanent implantation type facial implant as claimed in claim 1, it is characterised in that the intermetallic metal
Layer is made up of some discontinuous wires, and the discontinuous wire is parallel, arranged for interval.
7. the preparation method of Permanent implantation type facial implant as claimed in claim 1, it is characterised in that e-PTFE second
Alkene upper epidermis, expanded PTFE layer, and fixed between intermediate metal layer by binding agent, the selection of described binding agent
Perfluoroethylene-propylene or silica gel.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201611044496.8A CN106420111B (en) | 2016-11-24 | 2016-11-24 | A kind of Permanent implantation type facial implant and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201611044496.8A CN106420111B (en) | 2016-11-24 | 2016-11-24 | A kind of Permanent implantation type facial implant and preparation method thereof |
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| Publication Number | Publication Date |
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| CN106420111A CN106420111A (en) | 2017-02-22 |
| CN106420111B true CN106420111B (en) | 2018-02-16 |
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Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP7173986B2 (en) * | 2017-04-13 | 2022-11-17 | スピロックス，インク． | Nasal implants, delivery tools, systems, and methods of use |
| CN107812238A (en) * | 2017-11-27 | 2018-03-20 | 上海索康医用材料有限公司 | A kind of medical high-strength degree eptfe membrane flake products and preparation method thereof |
| CN117224284B (en) * | 2023-11-14 | 2024-01-23 | 吉林大学 | 4D printing bionic nose prosthesis capable of being reshaped in body |
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| DE202006007898U1 (en) * | 2006-05-17 | 2006-07-27 | Heinz Kurz Gmbh Medizintechnik | Cover-shaped implant for spreading (sic, supporting) nose bridge which can be fixed to triangular cartilage of nose in form of bent cover-shaped strips, useful in nose treatment, which can be made from material having memory effect |
| RU2007108894A (en) * | 2007-03-09 | 2008-09-20 | Владислав Геннадьевич Галонский (RU) | NOSE ECTOPROTHESIS AND METHOD FOR PRODUCING ECTOPROTHESIS |
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| CN204016556U (en) * | 2014-08-07 | 2014-12-17 | 上海索康医用材料有限公司 | A kind of medical facial implant |
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| DE202006007898U1 (en) * | 2006-05-17 | 2006-07-27 | Heinz Kurz Gmbh Medizintechnik | Cover-shaped implant for spreading (sic, supporting) nose bridge which can be fixed to triangular cartilage of nose in form of bent cover-shaped strips, useful in nose treatment, which can be made from material having memory effect |
| RU2007108894A (en) * | 2007-03-09 | 2008-09-20 | Владислав Геннадьевич Галонский (RU) | NOSE ECTOPROTHESIS AND METHOD FOR PRODUCING ECTOPROTHESIS |
| CN201290360Y (en) * | 2008-09-08 | 2009-08-19 | 吴恩思 | Multi-purpose nose rack |
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| WO2011119084A1 (en) * | 2010-03-23 | 2011-09-29 | Sanda Hadziavdic | Adjustable nasal implant |
| CN201727611U (en) * | 2010-07-22 | 2011-02-02 | 上海索康医用材料有限公司 | Formed nasal prosthesis |
| CN202477901U (en) * | 2011-12-20 | 2012-10-10 | 上海索康医用材料有限公司 | Three-section type nasal prosthesis |
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| CN205198212U (en) * | 2015-12-02 | 2016-05-04 | 上海索康医用材料有限公司 | Formed nasal prosthesis |
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| CN106420111A (en) | 2017-02-22 |
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