CN104208041B - It is a kind of for preventing, intervening the plasticity Silica hydrogel and its production method of scar and scar hyperplasia - Google Patents

It is a kind of for preventing, intervening the plasticity Silica hydrogel and its production method of scar and scar hyperplasia Download PDF

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Publication number
CN104208041B
CN104208041B CN201410432475.8A CN201410432475A CN104208041B CN 104208041 B CN104208041 B CN 104208041B CN 201410432475 A CN201410432475 A CN 201410432475A CN 104208041 B CN104208041 B CN 104208041B
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silica hydrogel
plasticity
scar
main part
shape
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CN201410432475.8A
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CN104208041A (en
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叶珉
王振红
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SHANGHAI SAILIANG MEDICAL EQUIPMENT Co Ltd
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SHANGHAI SAILIANG MEDICAL EQUIPMENT Co Ltd
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Abstract

The present invention provides a kind of plasticity Silica hydrogel being attached on cutaneous scars comprising at least materials at two layers, the first layer material is Silica hydrogel material of main part, in direct contact with the skin;Second layer material is the structural material to form and fix the Silica hydrogel material of main part shape, and the first layer material attachment is on second layer material.The present invention also provides a kind of for preventing, intervening the production method of the plasticity Silica hydrogel of scar and scar hyperplasia.The present invention uses medical splint material of the thermoplastic polyester material as Silica hydrogel material of main part, it can soften when being heated to certain temperature, required shape can arbitrarily be formed, and it is kept fixed is formed by shape after the cooling period, it is tightly attached to Silica hydrogel on cutaneous scars, plays the role of good prevention and treatment to scar, scar hyperplasia.

Description

A kind of plasticity Silica hydrogel for preventing, intervening scar and scar hyperplasia and its Production method
Technical field
The present invention relates to a kind of plasticity silica gel material medical field application, more particularly to it is a kind of for preventing, Intervene the method for the plasticity Silica hydrogel and production plasticity Silica hydrogel of scar and scar hyperplasia.
Background technique
In order to prevent with treatment scar hyperplasia, pressure therapy is clinically widely applied.Nineteen eighty-three Perkin etc. is using bullet Property band compressing scar when in order to prevent the direct friction of elastic webbing and scar and be put into Silica hydrogel between skin and elastic suit Film, as a result, it has been found that Silica hydrogel (silicone gel) plays the role of preventing and treating scar hyperplasia, effect is much better than the person that is applied alone elastic webbing. Thus Silica hydrogel has been opened to the inhibiting effect of scar and in widespread attention.
Need Silica hydrogel that need to be tightly attached to skin according to the shape at scar position at some scar positions such as face, four limbs On skin, so needing the device of similar medical splint that Silica hydrogel is fixed on the skin.Not poroplastic splint or traditional elastic force When fabric mask carries out pressure therapy, it is difficult to it is close to human body, especially to recess scar, by eye circumference, bridge of the nose, the wing of nose, Below lower lip, because pressure reduces, pressure is uneven after opening or no pressure, treating acne are ineffective.It can not in addition, wearing is such When plasticity clamping plate or elastic force mask, internal pressure situation cannot be directly observed.Moreover, itch etc. easily occur uncomfortable for long periods of wear Sense.
The thermoplastic material such as natural resin orthotic material fixed for medical treatment containing thermoplastic polymer at present, such as The Chinese patent application of Publication No. CN9910817.6 provides a kind of fixed material of ethylene-vinyl acetate copolymer resins self-adhesion, And the Chinese patent application of Publication No. CN102430156A provides a kind of doctor with shape memory containing polycaprolactone Use external fixation system.The characteristic of above-mentioned two classes material use thermoplastic macromolecule material, plays fixed effect, however its is single Function be only fixed function, be medically to be applied to fixed, rehabilitation and orthopedic treating device outside orthopaedics, be that can not be used for scar The effect of scar and scar hyperplasia is not intervened in trace face.
Summary of the invention
The present invention is to solve the above problem in the prior art to propose.
The present invention provides one kind can more preferably be directed to human body face, joint part for preventing, intervening scar and scar The plasticity Silica hydrogel of hyperplasia.
The present invention also provides a kind of methods for making plasticity Silica hydrogel.
To achieve the above object, the invention adopts the following technical scheme:
The first aspect of the invention is to provide a kind of plasticity Silica hydrogel being attached on cutaneous scars, and feature exists In, including at least materials at two layers, the first layer material is Silica hydrogel material of main part, in direct contact with the skin;Second layer material is shape At and the fixed Silica hydrogel material of main part shape structural material, the first layer material attachment is in second layer material On.
Preferably, the Silica hydrogel material of main part includes silicone and polytetrafluoroethylene (PTFE), the molecule of the two kinds of polymer it Between formed interpenetrating polymer networks structure.
Preferably, the second layer structural material is thermoplastic polyester material.
Preferably, the thermoplastic polyester material is selected from polyethylene terephthalate, polybutylene terephthalate Ester, polypropylene terephthalate, poly terephthalic acid -1,4 cyclohexane dimethanol ester, gather at polyethylene naphthalate One of naphthalenedicarboxylic acid butanediol ester, polycaprolactone are a variety of.
In a preferred embodiment, the thermoplastic polyester material be polyethylene terephthalate, the material it is soft Changing temperature is 150-180 DEG C.The plasticity Silica hydrogel can be fabricated to the transparent mask of suitable human body face feature, for preventing, Intervene face scar and scar hyperplasia, while various rectification devices can also be fabricated to.
In a further preferred embodiment, the thermoplastic polyester material is polycaprolactone, and the softening temperature of the material is 60- 75 DEG C, bending strength >=20MPa when room temperature.The plasticity Silica hydrogel is for preventing, intervening the scar at the various bending joints of human body Trace and scar hyperplasia, while can also be used as arthrodesis and various rectification devices.
Preferably, the plasticity Silica hydrogel includes Silica hydrogel material of main part and is pasted onto the Silica hydrogel material of main part pair The adherent layer in vertical two faces and the structural material for forming and fixing the Silica hydrogel material of main part shape.
It is solidifying that the second aspect of the invention is to provide a kind of plasticity silicon for preventing, intervening scar and scar hyperplasia The production method of glue, which is characterized in that described method includes following steps:
Step 1 takes plasticity Silica hydrogel as previously described;
The plasticity Silica hydrogel is heated a period of time by step 2, so that the plasticity Silica hydrogel softens;
Step 3, the plasticity Silica hydrogel for taking out heating, and required shape is fashioned into, by the Silica hydrogel after cooling The side of the Silica hydrogel material of main part of pad pasting is attached on cutaneous scars.
Preferably, when the second layer material of the plasticity Silica hydrogel is polyethylene terephthalate, the step 2 In heating temperature be 150-180 DEG C;When second layer material is polycaprolactone, the heating temperature in the step 2 is 50- 75℃。
Specifically, when the second layer material of the plasticity Silica hydrogel is polyethylene terephthalate, this is plastic Property Silica hydrogel can be fabricated to the transparent mask of suitable human body face feature, and production method is divided into according to the difference of D facial modelling method Two class methods:
Method one:
Step (1) is coated in patient facial region with seaweed bunt gypsum slurry, and the gypsum former of patient facial region is obtained after solidification;
Step (2), the slurry perfusion gypsum former mixed with land plaster and water, obtain the plaster statue of patient facial region's profile;
Step (3) takes foregoing plasticity Silica hydrogel;
Step (4), by the plasticity Silica hydrogel in 150-180 DEG C of heating a period of time so that the plasticity Silica hydrogel Soften;
The plasticity Silica hydrogel that heating softens is attached on above-mentioned plaster statue by step (5), by the plasticity after cooling The side of the Silica hydrogel material of main part of Silica hydrogel is attached on patient facial region's scar face.
Method two:
Step (1) obtains patient facial region's profile with spatial digitizer;
Step (2) handles acquisition human facial profile's image using computer software;
Step (3) prints the plaster statue for obtaining patient facial region's profile with equipment such as 3D printer, engraving machines;
Step (4) takes foregoing plasticity Silica hydrogel;
Step (5), by the plasticity Silica hydrogel in 150-180 DEG C of heating a period of time so that the plasticity Silica hydrogel Soften;
The plasticity Silica hydrogel that heating softens is attached on above-mentioned plaster statue by step (6), by the plasticity after cooling The side of the Silica hydrogel material of main part of Silica hydrogel is attached on patient facial region's scar face.
The Silica hydrogel that the present invention uses is one kind of silicone, and chemical name is polymethyl siloxane (Polydimethylsiloxan), molecular formula is (SiC2H6O)n, the polymer is colorless and transparent, it is odorless, tasteless, have it is hydrophobic Property, not soluble in water and common organic solvents.Also contain a small amount of polytetrafluoroethylene (PTFE) in Silica hydrogel material of main part of the invention, it can Play the role of increasing product flexibility and tensile strength.
The thermoplastic polyester material that the present invention uses softens at a certain temperature, and deformation occurs, can keep shape again after cooling Shape immobilizes, and deformation process is repeatable, has shape memory, is very suitable for being pasted with the Silica hydrogel on cutaneous scars It is attached.
So-called shape memory refers to that the product with original shape (playing primary state) after (deformation states) are fixed in deformation, leads to It crosses the processing of outside stimulus means such as light, heat, electricity, pH value, phase transition reaction and the characteristic of its original shape can be restored, thus Complete the cyclic process of " remembered primary state → fixed deformation state → recovery and played primary state " shape memory;Macromolecule with the characteristic It is referred to as photic, thermotropic, electroluminescent and chemical co-ordination type SMP.Wherein thermotropic SMP controls Shape memory behavior, behaviour with temperature Make easy, material handling ease, most potentiality to be exploited.According to the temperature range for generating deformation, the suitable thermotropic shape note of selection Recalling macromolecule is the key that Silica hydrogel pad pasting is attached on cutaneous scars and is used widely.
The present invention by adopting the above technical scheme, compared with prior art, has the following technical effect that a kind of patch of the invention The plasticity Silica hydrogel on cutaneous scars, including at least materials at two layers are invested, the first layer material is to form interpenetrating polymer networks The Silica hydrogel material of main part of structure is directly contacted with cutaneous scars;Second layer material is to be formed and fix the Silica hydrogel main body The thermoplastic polyester material of material shape or silk screen cotton mesh fabric and/or foamed material;Thermoplastic polyester material is solidifying as silicon The medical splint material of glue material of main part, can soften when being heated to certain temperature, can arbitrarily form required shape, and cold But it is kept fixed afterwards and is formed by shape, be tightly attached to Silica hydrogel on cutaneous scars, scar, scar hyperplasia are played pre- well The anti-effect with treatment.
Plasticity Silica hydrogel product of the invention is fabricated separately according to the characteristics of patient, more meets the characteristics of human body of patient, By pressure and Silica hydrogel to the perfect combination of the therapeutic intervention of scar.
Detailed description of the invention
Fig. 1 is plasticity Silica hydrogel schematic diagram of the invention.
In figure, 11, first layer Silica hydrogel material of main part;12, second layer structural material.
Specific embodiment
The present invention provides a kind of plasticity Silica hydrogels being attached on cutaneous scars, as shown in Figure 1 comprising at least two Layer material, the first layer material are Silica hydrogel material of main part 11, are directly contacted with cutaneous scars;Second layer material is adhered to described On layer of material, and to form and fixing the structural material 12 of 11 shape of Silica hydrogel material of main part.
The present invention is described in more detail below by specific embodiment, for a better understanding of the present invention, But following embodiments are not intended to limit the scope of the invention.
Embodiment 1
It include Silica hydrogel material of main part 1 and polyethylene terephthalate (PETG) 2 the present embodiment provides one kind Plasticity Silica hydrogel includes silicone and a small amount of polytetrafluoroethylene (PTFE), point of the two kinds of polymer in the Silica hydrogel material of main part 1 Interpenetrating polymer networks structure is formed between son.
The product that the embodiment provides has good plasticity, is placed in baking oven, heating plate or other heating equipments, 150-180 DEG C of product after heating 2-8 minutes softens, and is fabricated to the mask for adapting to anatomical structure, is applied to such as face for patient The nursing of face scar.
In use, removing the separate paper on the plasticity Silica hydrogel.Then silica gel is placed in square position downwards, is being dried 150-180 DEG C is heated in case, heating plate or other heating equipments 2-8 minutes.Plasticity Silica hydrogel is taken out with proximity gloves, is passed through After obtaining patient (such as face) model, it is shaped as desired and cools down.It is spread on after cooling at patient's scar.It should be noted Be, can not with patient direct forming.Acquisition patient model can be used medical gypsum and directly act on patient facial region or logical The face wheel crossed spatial digitizer scanning patient facial region's profile, then print patient with equipment such as 3D printer or engraving machines Wide model.
The plasticity Silica hydrogel product of the present embodiment can be repeatedly used for a long, and can wear within 24 hours use, such as occur sweat stain, Situations such as dust, can continue to wear use after cleaning, drying.It can be trimmed with scissors to obtain required shape.Be not suitable for Face cream, detergent and ointment will affect product efficiency, and lead to skin irritatin with using.And it can not make on the wound not healed With.
After wounds healing, start to wear transparent plasticity Silica hydrogel mask treatment in early days, scar proliferation is unobvious, effect Fruit it is further preferred that;Even if the later period starts to wear again after there is different degrees of scar proliferation, effect is also better than the elastic force face observed in the past Curer is covered, particularly with recess scar.
Spy can be used when not influencing facial wholistic therapy effect for part plumpness and the serious scar of hyperplasia Mask processed presses to local emphasis and treats.The plasticity Silica hydrogel product of the present embodiment can also be modified repeatedly, and the moment allows at scar In best pressured state.
The plasticity Silica hydrogel product of the present embodiment can cooperate co-therapies with Silica hydrogel pad pasting class product.Hyperplasia Facial scar can be such that it softens and it is inhibited to continue hyperplasia, so that patient is kept certain shape of face, to some contractions using mask treatment Contracting scar can also limit its contracture and be corrected.
Embodiment 2
The present embodiment provides the translucent Silica hydrogels that one kind includes Silica hydrogel material of main part 1 and polycaprolactone (PCL) 2 Pad pasting includes silicone and a small amount of polytetrafluoroethylene (PTFE), shape between the molecule of the two kinds of polymer in the Silica hydrogel material of main part 1 At interpenetrating polymer networks structure.The Silica hydrogel pad pasting is cut into different specification size.
The product that the embodiment provides has good plasticity, is placed in 50-75 DEG C of warm water in the sufficiently long time Product can be made to soften, the pad pasting being fabricated at suitable bending joint, for patient be applied to such as bend arms, bending ankle close The scar of section is nursed.Bending strength >=20MPa of this material in room temperature, there is enough bending strength limit flexion joints Activity.
In use, removing the separate paper on the plasticity Silica hydrogel.Then the product is put into long enough in 50-75 DEG C of water Time, make the gel soften.It is taken out from basin and determines which face of the product is silica gel face, thermoplastic face slight may be sticked to Together, and another side silica gel face will not mutually be glued with oneself and thermoplastic face.Clamping plate is pressed into the shape formable that patient needs, before being hardened Keep its shape.It is spread on after cooling at patient's scar.Some common elastoplasts can be used to be bent clamping plate, become it Its required shape is kept before hard.It can be trimmed with scissors to obtain required shape.Be not suitable for and face cream, detergent and medicine Cream will affect product efficiency, and lead to skin irritatin with using.And it can not be used on the wound not healed.
Properties of product test
Properties of product test data is see table 1.
The performance test data of each embodiment product of table 1
Application examples 1
Using plasticity Silica hydrogel of the invention and according to this hair after 40 operations or in burnt degree healing scar patient The treatment group that the bright method is handled, and scar is oppressed with elastic fabric cover;Other 10 control groups are only adopted It is oppressed with elastic fabric cover, two groups of compressive pressure is identical.When using 1 month, there are 36 (90%) patients in treatment group Overall feeling surface of a wound pain, symptom of itching improve, but two groups of appearance is without significant difference;When using 3 months, there are 32 in treatment group (80%) the scar face of patient is more smooth, and congested situation is obviously lighter than control group;When using 6 months, two groups are compared significant difference, Treatment group's scar is obviously more smooth than control group, and color also shows light, and 38 (95%) patients indicate scar surface in treatment group Soft flexible, then scar surface is uneven control group, and pigmentation is obvious, and scar is stiff.
Application examples 2
It carries out the transparent mask of plasticity Silica hydrogel to 43 patients to treat, wherein male 32, female 11, age 7-46 Year.The burn gross area is 16.0%-86.0%, wherein III degree of area 8.5%-67.0% [(23.8 ± 5.6) %] TBSA, head III degree of portion area is 0.3%-4.0% [(2.3 ± 0.3) %] TBSA.Traumatogenic reason: flame burn 35, Yellow Phosphorus Burn 2, High-temperature cement is burnt 6.Wherein 30 are in 2-3 weeks (early stage) after wound healing, face part such as mouth week, lower jaw, the wing of nose two There are different degrees of scar proliferation, plumpness, drawing phenomenon in side, palpebra inferior etc..
1) mask production and wearing:
1.1) facial modulus: patient goes pillow to lie down, and face applies a little liquid paraffin as diaphragm agent, and hollow conduit is inserted in nostril Ventilation, advises it to loosen and closes eyes;The seaweed salt paste modulated is spread on into face, slightly dry rear plaster bandage is fixed and removed Formpiston is made in the alginate former of solidification, perfusion gypsum.
1.2) it repairs a die and shapes: after formpiston is dry, repairing its surface convex portion due to scar, entire model polishing is thrown Light;Plasticity Silica hydrogel product of the invention is heated to softening for 150-180 DEG C of 2-8 minutes, gypsum formpiston uplink is placed in and opens Negative-pressure ward forming, removes mask periphery redundance according to the big light maintenance of patient's shape of face.
1.3) aperture is assembled: mask is put on for patient, it is drawn out on mask, after the position of nose, mouth etc. and size, With electric drill bistrique aperture;Sharpened edge is allowed to smooth, disposes rivet and elastic band.
1.4) wear and modify: wearing a mask for patient makes it sufficiently be attached at skin of face, buckles elastic band, elasticity The raised hyperplastic scar that is subject to, which is pressurized, to be whitened;Fail to be pressurized if any small part scar, can repair a die adjustment repeatedly;It can also wouldn't Processing, the compression of higher position scar flattens after mask wears 1 week, and former pocket scar can gradually be pressurized.Using initial stage because of scar Epidermis is poor, and wear time is preferably relatively short, 5h/d or so;Patient can be extended for 10-12h/d or even longer, dining after adapting to And it can be taken off when bathing.Per daily low temperature clear water, cleaning mask and skin are allowed to keep cleaning.
2) efficacy result:
After 43 patients are using the transparent mask treatment of plasticity Silica hydrogel of the invention, facial scar surfacing, scar Softening, hyperplasia are suppressed, without obvious contracture.Wherein 30 early stages start the patient worn, and scar is more smooth after treatment 1 year, increases Life is unobvious, has better effect.The patient of the different degrees of scar proliferation of another 13 faces, treatment 1-2 curative effect is also preferable, especially It intraocularly gives a tongue-lashing, nasolabial groove, lower lip etc. scar obtain preferably controlling pressure;Established hyperplastic scar softening before treatment, not See that continuation hyperplasia, patient's shape of face keep preferable;The contracture drawing degree of some contracted scars is obviously improved;Certain parts are plump And the serious scar of hyperplasia, through preferable using transparent semi-area and local emphasis pressure area treatment, effect.
Specific embodiments of the present invention are described in detail above, but it is merely an example, the present invention is simultaneously unlimited It is formed on particular embodiments described above.To those skilled in the art, any couple of present invention carries out equivalent modifications and Substitution is also all among scope of the invention.Therefore, without departing from the spirit and scope of the invention made by equal transformation and Modification, all should be contained within the scope of the invention.

Claims (8)

1. a kind of plasticity Silica hydrogel being attached on cutaneous scars, which is characterized in that including at least materials at two layers, first layer material Material is Silica hydrogel material of main part, in direct contact with the skin;Second layer material is to be formed and fix the Silica hydrogel material of main part shape The structural material of shape, the first layer material attachment is on second layer material;The Silica hydrogel material of main part is by poly- silicon Ketone and polytetrafluoroethylene (PTFE) form, and interpenetrating polymer networks structure is formed between the molecule of the two kinds of polymer;The second layer knot Structure material is thermoplastic polyester material;
The thermoplastic polyester material is selected from polyethylene terephthalate, polybutylene terephthalate (PBT), gathers to benzene two Formic acid propylene glycol ester, poly terephthalic acid -1,4 cyclohexane dimethanol ester, polyethylene naphthalate, poly- naphthalenedicarboxylic acid fourth One of diol ester, polycaprolactone are a variety of.
2. plasticity Silica hydrogel according to claim 1, which is characterized in that the thermoplastic polyester material is poly- to benzene two Formic acid glycol ester, the softening temperature of the material are 150-180 DEG C.
3. plasticity Silica hydrogel according to claim 1, which is characterized in that the thermoplastic polyester material is to gather in oneself Ester, the softening temperature of the material are 50-75 DEG C, bending strength >=20MPa when room temperature.
4. plasticity Silica hydrogel according to claim 1, which is characterized in that the plasticity Silica hydrogel includes Silica hydrogel master Body material and the adherent layer and formation and the fixed Silica hydrogel main body for being pasted onto two faces of Silica hydrogel material of main part opposition The structural material of material shape.
5. a kind of suitable human body face feature being made using such as the described in any item plasticity Silica hydrogels of claim 2-4 Transparent mask, for preventing, intervening face scar and scar hyperplasia.
6. a kind of for preventing, intervening the production method of the plasticity Silica hydrogel of scar and scar hyperplasia, which is characterized in that institute The method of stating includes the following steps:
Step 1 takes plasticity Silica hydrogel described in claim 1;
The plasticity Silica hydrogel is heated a period of time by step 2, so that the plasticity Silica hydrogel softens;
Step 3, the plasticity Silica hydrogel for taking out heating, and fashion into required shape.
7. according to the method described in claim 6, it is characterized in that, the second layer material of plasticity Silica hydrogel described in claim 1 When material is polyethylene terephthalate, the heating temperature in the step 2 is 150-180 DEG C;Second layer material is When polycaprolactone, the heating temperature in the step 2 is 50-75 DEG C.
8. according to the method described in claim 6, it is characterized in that, the plasticity silicon after taking out heating is solidifying in the step 3 Glue fashions into required shape by being attached on mold, the mold using medical gypsum directly act on skin or Skeleton pattern is printed by spatial digitizer scan skin profile, then with 3D printer or engraving machine equipment.
CN201410432475.8A 2014-08-28 2014-08-28 It is a kind of for preventing, intervening the plasticity Silica hydrogel and its production method of scar and scar hyperplasia Expired - Fee Related CN104208041B (en)

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CN105030401A (en) * 2015-08-26 2015-11-11 深圳齐康医疗器械有限公司 Personalized wound surface shape righting instrument and manufacturing method thereof
CN105662709A (en) * 2016-01-09 2016-06-15 清华大学深圳研究生院 Scar proliferation inhibiting method and intelligent pressure system
CN106351018A (en) * 2016-08-30 2017-01-25 山东同大海岛新材料股份有限公司 Method for the preparation of solvent-free synthetic leather by 3D printing
CN106510918A (en) * 2016-11-25 2017-03-22 上海赛琅医药科技有限公司 Orthopedic tool for preventing and treating scars and 3D manufacturing system and method of orthopedic tool
CN106983599A (en) * 2017-04-20 2017-07-28 谢卫国 It is used for the micropore pressure shield and manufacture method for treating scar based on 3D printing
CN110917179B (en) * 2019-12-19 2021-04-27 温州医科大学附属第一医院 Scar-resistant silicone gel patch and preparation method thereof

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