CN104208041A - Plastic silica gel used for preventing and intervening scar and scar proliferation and production method thereof - Google Patents
Plastic silica gel used for preventing and intervening scar and scar proliferation and production method thereof Download PDFInfo
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- CN104208041A CN104208041A CN201410432475.8A CN201410432475A CN104208041A CN 104208041 A CN104208041 A CN 104208041A CN 201410432475 A CN201410432475 A CN 201410432475A CN 104208041 A CN104208041 A CN 104208041A
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Abstract
The invention provides plastic silica gel attached on a skin scar. The plastic silica gel comprises at least two material layers, wherein a first material layer is made of a silica gel main body material and is in direct contact with skin; a second material layer is made of a structural material and used for forming and fixing the shape of the silica gel main body material, and the first material layer is attached onto the second material layer. The invention also provides a production method of the plastic silica gel used for preventing and intervening the scar and scar proliferation. The plastic silica gel used for preventing and intervening the scar and scar proliferation adopts a thermoplastic polyester material as a medical splint material for the silica gel main body material, can be softened after being heated to a certain temperature, can form the required shape at will and can keep and fix the formed shape after being cooled, so that silica gel clings to the skin scar, and good prevention and treatment effects on the scar and scar proliferation are realized.
Description
Technical field
The present invention relates to the application of a kind of plasticity silica gel material in medical field, particularly relate to a kind of for preventing, intervene the plasticity Silica hydrogel of cicatrix and scar hyperplasia and making the method for plasticity Silica hydrogel.
Background technology
In order to prevent and treat scar hyperplasia, extensive use pressure therapy clinically.Nineteen eighty-three Perkin etc. use elastic webbing compressing cicatrix time in order to prevent the direct friction of elastic webbing and cicatrix from putting into silicate gel film between skin and elasticity suit, found that Silica hydrogel (silicone gel) has the effect of control scar hyperplasia, effect is better than alone elastic webbing person greatly.Open Silica hydrogel thus in widespread attention to the inhibitory action of cicatrix.
Need Silica hydrogel need be close on skin, so need the device of similar medical splint to be fixed on skin by Silica hydrogel according to the shape at scar position at scar positions such as some such as face, extremity.When poroplastic splint or traditional stockinette face shield do not carry out pressure therapy, be difficult to be close to human body, especially to recess cicatrix, as near the eyes, by bridge of the nose, the wing of nose, below lower lip, because of pressure after opening reduce, inequality of exerting pressure or without pressure, treating acne poor effect.In addition, wear this type of not poroplastic splint or elastic force face shield time, directly can not observe inside and to exert pressure situation.And easily there is the sticky feelings such as pruritus in long periods of wear.
The thermoplastic fixing for medical treatment at present containing thermoplastic polymer is as natural resin orthotic material, the Chinese patent application that such as publication number is CN9910817.6 provides a kind of ethylene-vinyl acetate copolymer resins self-adhesion immobilization material, and the Chinese patent application that publication number is CN102430156A provides a kind of medical external fixation system with shape memory containing polycaprolactone.The characteristic of above-mentioned two class material use thermoplastic macromolecule materials, play fixing effect, but its single function only has fixation, is medically be applied to orthopaedics extenal fixation, rehabilitation and orthopedic treating device, be to be used for cicatrix face, do not intervene the effect of cicatrix and scar hyperplasia.
Summary of the invention
The present invention solves the aforementioned problems in the prior proposition.
The invention provides a kind of can better for human body face, joint part for preventing, intervening the plasticity Silica hydrogel of cicatrix and scar hyperplasia.
Present invention also offers a kind of method making plasticity Silica hydrogel.
For achieving the above object, the present invention is by the following technical solutions:
First aspect of the present invention is to provide a kind of plasticity Silica hydrogel be attached on cutaneous scars, it is characterized in that, comprises at least materials at two layers, and ground floor material is Silica hydrogel material of main part, with direct skin contact; Second layer material is formed and fix the structural material of described Silica hydrogel material of main part shape, and described ground floor material attachment is on described second layer material.
Preferably, described Silica hydrogel material of main part comprises silicone and politef, forms interpenetrating polymer networks structure between the molecule of these two kinds of polymer.
Preferably, described second layer structural material is thermoplastic polyester material.
Preferably, described thermoplastic polyester material be selected from polyethylene terephthalate, polybutylene terephthalate (PBT), PTT, poly terephthalic acid-1,4-CHDM ester, PEN, PBN, polycaprolactone one or more.
In a preferred embodiment, described thermoplastic polyester material is polyethylene terephthalate, and the softening temperature of this material is 150-180 DEG C.This plasticity Silica hydrogel can be made into the transparent mask of applicable human body face feature, for prevention, intervenes face scar and scar hyperplasia, also can be made into various rectification device simultaneously.
In a further preferred embodiment, described thermoplastic polyester material is polycaprolactone, and the softening temperature of this material is 60-75 DEG C, bending strength >=20MPa during room temperature.This plasticity Silica hydrogel, simultaneously also can as arthrodesis and various rectification device for preventing, intervening cicatrix and the scar hyperplasia at the various bending joint place of human body.
Preferably, described plasticity Silica hydrogel comprises Silica hydrogel material of main part and is pasted onto this Silica hydrogel material of main part and to oppose the adherent layer in two faces and formation the structural material of fixing described Silica hydrogel material of main part shape.
Second aspect of the present invention is to provide and a kind ofly it is characterized in that for preventing, intervening the manufacture method of the plasticity Silica hydrogel of cicatrix and scar hyperplasia, and described method comprises the steps:
Step 1, get plasticity Silica hydrogel as previously mentioned;
Step 2, described plasticity Silica hydrogel is heated a period of time, to make this plasticity Silica hydrogel deliquescing;
The plasticity Silica hydrogel of step 3, taking-up heating, and fashion into required shape, after cooling, the side of the Silica hydrogel material of main part of described Silica hydrogel pad pasting is attached on cutaneous scars.
Preferably, when the second layer material of described plasticity Silica hydrogel is polyethylene terephthalate, the heating-up temperature in described step 2 is 150-180 DEG C; When described second layer material is polycaprolactone, the heating-up temperature in described step 2 is 50-75 DEG C.
Specifically, when the second layer material of described plasticity Silica hydrogel is polyethylene terephthalate, this plasticity Silica hydrogel can be made into the transparent mask of applicable human body face feature, and its manufacture method is divided into two class methods according to the difference of D facial modelling method:
Method one:
Step (1), be coated in patient facial region with Sargassum bunt gypsum slurry, solidify the Gypsum Fibrosum former of rear acquisition patient facial region;
Step (2), the slurry perfusion Gypsum Fibrosum former mixed with Gypsum Fibrosum powder and water, obtain the plaster statue of patient facial region's profile;
Step (3), get foregoing plasticity Silica hydrogel;
Step (4), by described plasticity Silica hydrogel 150-180 DEG C heating a period of time, to make this plasticity Silica hydrogel deliquescing;
Step (5), by heating deliquescing plasticity Silica hydrogel be attached on above-mentioned plaster statue, after cooling, the side of the Silica hydrogel material of main part of described plasticity Silica hydrogel is attached on patient facial region's cicatrix face.
Method two:
Step (1), utilization spatial digitizer obtain patient facial region's profile;
Step (2), computer software process is utilized to obtain human facial profile image;
The equipment such as step (3), utilization 3D printer, engraving machine print the plaster statue obtaining patient facial region's profile;
Step (4), get foregoing plasticity Silica hydrogel;
Step (5), by described plasticity Silica hydrogel 150-180 DEG C heating a period of time, to make this plasticity Silica hydrogel deliquescing;
Step (6), by heating deliquescing plasticity Silica hydrogel be attached on above-mentioned plaster statue, after cooling, the side of the Silica hydrogel material of main part of described plasticity Silica hydrogel is attached on patient facial region's cicatrix face.
The Silica hydrogel that the present invention adopts is a class of silicone, and chemical name is polymethyl siloxane (Polydimethylsiloxan), and molecular formula is (SiC
2h
6o)
n, this polymer water white transparency, odorless, tasteless, there is hydrophobicity, water insoluble and common organic solvents.Also containing a small amount of politef in Silica hydrogel material of main part of the present invention, the effect increasing product pliability and hot strength can be played.
Thermoplastic polyester material's deliquescing generation at a certain temperature deformation that the present invention adopts, shape can be kept again to immobilize, and deformation process can repeat, and has shape memory after cooling, is very suitable for the Silica hydrogel be used on cutaneous scars and attaches.
So-called shape memory, refer to that the goods with original shape (playing primary state) are fixed after (deformation states) through deformation, the characteristic of its original shape can be recovered again by the process of the outside stimulus means such as light, heat, electricity, acid-base value, phase in version reaction, thus complete the cyclic process of " remembered primary state → fixed deformation state → recovered primary state " shape memory; The macromolecule with this characteristic is called photic, thermic, electroluminescent and chemical co-ordination type SMP.Wherein thermotropic SMP controls Shape memory behavior with temperature, easy and simple to handle, and materials processing is easy, most potentiality to be exploited.According to the temperature range producing deformation, suitable thermo-stimulative shape memory polymer is selected to be that Silica hydrogel pad pasting is attached at the key that cutaneous scars is used widely.
The present invention adopts technique scheme, compared with prior art, there is following technique effect: a kind of plasticity Silica hydrogel be attached on cutaneous scars of the present invention, comprise at least materials at two layers, ground floor material is the Silica hydrogel material of main part forming interpenetrating polymer networks structure, directly contacts with cutaneous scars; Second layer material is formed and fix the thermoplastic polyester material of described Silica hydrogel material of main part shape or the cotton mesh fabric of silk screen and/or foamed materials; Thermoplastic polyester material is as the medical splint material of Silica hydrogel material of main part, the meeting deliquescing when being heated to uniform temperature, required shape can be formed arbitrarily, and keep the fixing shape formed after the cooling period, make Silica hydrogel be close on cutaneous scars, well prevention and the effect for the treatment of are played to cicatrix, scar hyperplasia.
Plasticity Silica hydrogel product of the present invention makes separately according to the feature of patient, more meets the characteristics of human body of patient, by pressure and Silica hydrogel to the perfect adaptation of the therapeutic intervention of cicatrix.
Accompanying drawing explanation
Fig. 1 is plasticity Silica hydrogel schematic diagram of the present invention.
In figure, 11, ground floor Silica hydrogel material of main part; 12, second layer structural material.
Detailed description of the invention
The invention provides a kind of plasticity Silica hydrogel be attached on cutaneous scars, as shown in Figure 1, it comprises at least materials at two layers, and ground floor material is Silica hydrogel material of main part 11, directly contacts with cutaneous scars; Second layer material adhesion on described ground floor material, and for being formed and fixing the structural material 12 of described Silica hydrogel material of main part 11 shape.
Carry out detailed and concrete introduction below by specific embodiment to the present invention, to make better to understand the present invention, but following embodiment does not limit the scope of the invention.
embodiment 1
The present embodiment provides one to comprise the plasticity Silica hydrogel of Silica hydrogel material of main part 1 and polyethylene terephthalate (PETG) 2, described Silica hydrogel material of main part 1 comprises silicone and a small amount of politef, forms interpenetrating polymer networks structure between the molecule of these two kinds of polymer.
The product that this embodiment provides has good plasticity, be placed in baking oven, hot plate or other firing equipment, 150-180 DEG C of heating product deliquescing after 2-8 minute, is made into the face shield adapting to anatomical structure, is applied to the nursing of such as facial area cicatrix for patient.
During use, take off the separate paper on this plasticity Silica hydrogel.Then silica gel being faced down is placed in square position, heats 150-180 DEG C of 2-8 minute in baking oven, hot plate or other firing equipment.Take out plasticity Silica hydrogel with proximity gloves, after obtaining patient's (as face) model, be shaped as desired and cool.Patient's cicatrix place is spread on after cooling.It is noted that can not in direct forming with it patient.Obtain patient model medical gypsum can be adopted to directly act on patient facial region or print the face contour model of patient by spatial digitizer scan patients face contour, then equipment such as utilization 3D printer or engraving machine etc.
The plasticity Silica hydrogel product of the present embodiment can prolonged and repeatedly use, within 24 hours, use can being worn, as there is the situation such as sweat stain, dust, cleaning, dry after can continue to wear use.Available shears is pruned to obtain required shape.Be not suitable for use same with facial cream, cleaning agent and ointment, product usefulness can be affected, and cause skin irritation.And can not use on the wound do not healed.
After wounds healing, start in early days to wear the treatment of transparent plasticity Silica hydrogel mask, scar hyperplasia is not obvious, has better effect; Even if the later stage occurs starting to wear after scar hyperplasia in various degree again, effect is also better than the elastic force mask therapeutic person in the past observed, especially for recess cicatrix.
The cicatrix plump for local and hypertrophy is serious, is not affecting in facial wholistic therapy effect situation, and special mask can be adopted to exert pressure treatment to local emphasis.The plasticity Silica hydrogel product of the present embodiment also can be repaired repeatedly, and the moment allows cicatrix be in best pressured state.
The plasticity Silica hydrogel product of the present embodiment can coordinate co-therapy with Silica hydrogel pad pasting series products.The facial scar of hypertrophy, the treatment of application mask can make it soften and suppress it to continue hypertrophy, makes the shape of face that patient keeps certain, to some contracted scars, also can limit its contracture and be corrected.
embodiment 2
The present embodiment provides one to comprise the translucent Silica hydrogel pad pasting of Silica hydrogel material of main part 1 and polycaprolactone (PCL) 2, described Silica hydrogel material of main part 1 comprises silicone and a small amount of politef, forms interpenetrating polymer networks structure between the molecule of these two kinds of polymer.This Silica hydrogel pad pasting is cut into different specification size.
The product that this embodiment provides has good plasticity, product deliquescing can be made in the warm water sufficiently long time being placed in 50-75 DEG C, be made into the pad pasting at applicable bending joint place, for patient be applied to such as bend arms, the cicatrix nursing of the bending joint such as ankle.Bending strength >=the 20MPa of this material when room temperature, has the activity of enough bending strength limit flexion joints.
During use, take off the separate paper on this plasticity Silica hydrogel.Then this product is put into 50-75 DEG C of water sufficiently long time, make this gel deliquescing.Take out from basin and determine which face of this product is silica gel face, slight the sticking together of thermoplastic face possibility, and another side silica gel face can not be glued mutually with oneself and thermoplastic face.Clamping plate are pressed the shape formable of needs of patients, keep its shape before hardening.Patient's cicatrix place is spread on after cooling.Some common elastic bandages can be used for bending clamping plate, make the shape that it keeps before hardening required for it.Available shears is pruned to obtain required shape.Be not suitable for use same with facial cream, cleaning agent and ointment, product usefulness can be affected, and cause skin irritation.And can not use on the wound do not healed.
properties of product are tested
Properties of product test data asks for an interview table 1.
The performance test data of each embodiment product of table 1
application examples 1
In 40 routine Post operation or burnt degree healing cicatrix patient, adopt plasticity Silica hydrogel of the present invention and carry out the treatment group that processes according to the method described in the present invention, and with elastic fabric cover, cicatrix is oppressed; Other 10 routine matched groups only adopt elastic fabric cover to oppress, and the compressive pressure of two groups is identical.When using 1 month, in treatment group, have that 36 (90%) entire patient feel wound surface pain, symptom of itching is improved, but the outward appearance of two groups is without obvious difference; When using 3 months, have the cicatrix face of 32 (80%) patients more smooth in treatment group, congested situation is obviously lighter than matched group; When using 6 months, two groups are compared significant difference, and treatment group cicatrix is obviously level and smooth than matched group, color and luster is also aobvious light, and in treatment group, 38 (95%) patients represent that scar surface softness is flexible, and matched group then scar surface is uneven, pigmentation is obvious, and cicatrix is stiff.
application examples 2
Carry out the transparent mask of plasticity Silica hydrogel to 43 routine patients to treat, wherein man 32 example, female 11 example, 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, and Head And Face III degree of area is 0.3%-4.0% [(2.3 ± 0.3) %] TBSA.Traumatogenic reason: flame burn 35 example, Yellow Phosphorus Burn 2 example, high-temperature cement burn 6 example.Wherein 30 examples are in 2-3 week (in early days) after wound healing, and, as places such as mouth week, lower jaw, wing of nose both sides, palpebra inferiors, there are scar hyperplasia, plumpness, tractive phenomenon in various degree in face local.
1) mask makes and wears:
1.1) facial delivery: patient goes pillow flat sleeping, and face is coated with a little liquid Paraffin as barrier film agent, and hollow conduit ventilation is inserted in nostril, advises it to loosen and closes eyes; The Sargassum salt paste modulated is spread on face, and slightly dry rear plaster bandage is fixed and is taken off the alginate former solidified, and perfusion Gypsum Fibrosum makes formpiston.
1.2) repair a die and shaping: after formpiston drying, repair its surface because of cicatrix bossing, the polishing of whole model, polishing; Plasticity Silica hydrogel product of the present invention is heated to 150-180 DEG C of deliquescing in 2-8 minute, is placed in the up negative pressure-pumping of opening of Gypsum Fibrosum formpiston and is shaped, remove mask periphery redundance according to the large light maintenance of patient's shape of face.
1.3) perforate assembling: for patient puts on mask, mask is drawn out it, after the position of nose, mouth etc. and size, with the perforate of electric drill bistrique; Sharpened edge makes it smooth, settles rivet and elastic band.
1.4) wear and repair: making it fully be attached at skin of face for patient wears a mask, buckle elastic band, its elasticity is turned white with the hypertrophic cicatrix pressurized of projection and is as the criterion; Fail pressurized if any small part cicatrix, can repair a die adjustment repeatedly; Also can process, after mask wears 1 week, higher position cicatrix pressurized flattens, and former pocket cicatrix can pressurized gradually.The use initial stage because of scar cuticle belittle, wear time should be relatively short, about 5h/d; It is even longer that patient can be extended for 10-12h/d after adapting to, and can take off when dining and bathing.Every daily low temperature clean water mask and skin make it to keep clean.
2) efficacy result:
After 43 routine patients adopt the transparent mask treatment of plasticity Silica hydrogel of the present invention, facial scar surfacing, cicatrix is softening, hypertrophy is suppressed, without obvious contracture.Wherein 30 examples start the patient that wears in early days, treat that after 1 year, cicatrix is more smooth, hypertrophy is not obvious, have better effect.The patient of another 13 example faces scar hyperplasia in various degree, treatment 1-2 curative effect is also better, and especially ophthalmic is given a tongue-lashing, place's cicatrix such as nasolabial fold, lower lip obtains controlling preferably to exert pressure; Before treatment, established hypertrophic cicatrix softens, and has no continuation hypertrophy, and patient's shape of face keeps better; The contracture tractive degree of some contracted scars is obviously improved; Some cicatrix that local is plump and hypertrophy is serious, through adopting transparent half area and the long-pending treatment of local emphasis pressure surface, effect is better.
Be described in detail specific embodiments of the invention above, but it is just as example, the present invention is not restricted to specific embodiment described above.To those skilled in the art, any equivalent modifications that the present invention is carried out and substituting also all among category of the present invention.Therefore, equalization conversion done without departing from the spirit and scope of the invention and amendment, all should contain within the scope of the invention.
Claims (12)
1. be attached at the plasticity Silica hydrogel on cutaneous scars, it is characterized in that, comprise at least materials at two layers, ground floor material is Silica hydrogel material of main part, with direct skin contact; Second layer material is formed and fix the structural material of described Silica hydrogel material of main part shape, and described ground floor material attachment is on described second layer material.
2. plasticity Silica hydrogel according to claim 1, is characterized in that, described Silica hydrogel material of main part comprises silicone and politef, forms interpenetrating polymer networks structure between the molecule of these two kinds of polymer.
3. plasticity Silica hydrogel according to claim 1, is characterized in that, described second layer structural material is thermoplastic polyester material.
4. plasticity Silica hydrogel according to claim 3, it is characterized in that, described thermoplastic polyester material be selected from polyethylene terephthalate, polybutylene terephthalate (PBT), PTT, poly terephthalic acid-1,4-CHDM ester, PEN, PBN, polycaprolactone one or more.
5. plasticity Silica hydrogel according to claim 4, is characterized in that, described thermoplastic polyester material is polyethylene terephthalate, and the softening temperature of this material is 150-180 DEG C.
6. plasticity Silica hydrogel according to claim 5, is characterized in that, described plasticity Silica hydrogel is made into the transparent mask of applicable human body face feature, for prevention, intervenes face scar and scar hyperplasia.
7. plasticity Silica hydrogel according to claim 4, is characterized in that, described thermoplastic polyester material is polycaprolactone, and the softening temperature of this material is 50-75 DEG C, bending strength >=20MPa during room temperature.
8. plasticity Silica hydrogel according to claim 7, is characterized in that, described plasticity Silica hydrogel is for preventing, intervening cicatrix and the scar hyperplasia at the various bending joint place of human body.
9. plasticity Silica hydrogel according to claim 1, it is characterized in that, described plasticity Silica hydrogel comprises Silica hydrogel material of main part and is pasted onto this Silica hydrogel material of main part and to oppose the adherent layer in two faces and formation the structural material of fixing described Silica hydrogel material of main part shape.
10. for preventing, intervening a manufacture method for the plasticity Silica hydrogel of cicatrix and scar hyperplasia, it is characterized in that, described method comprises the steps:
Step 1, get plasticity Silica hydrogel described in claim 1;
Step 2, described plasticity Silica hydrogel is heated a period of time, to make this plasticity Silica hydrogel deliquescing;
The plasticity Silica hydrogel of step 3, taking-up heating, and fashion into required shape.
11. methods according to claim 10, is characterized in that, when described in claim 1, the second layer material of plasticity Silica hydrogel is polyethylene terephthalate, the heating-up temperature in described step 2 is 150-180 DEG C; When described second layer material is polycaprolactone, the heating-up temperature in described step 2 is 50-75 DEG C.
12. methods according to claim 10, it is characterized in that, in described step 3, take out the plasticity Silica hydrogel after heating, fashion into required shape by being attached on mould, described mould adopts medical gypsum to directly act on skin or prints skeleton pattern by spatial digitizer scan skin profile, then equipment such as utilization 3D printer or engraving machine etc.
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| CN201410432475.8A CN104208041B (en) | 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 |
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| CN201410432475.8A CN104208041B (en) | 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 |
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| 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 |
| CN107847633A (en) * | 2015-04-23 | 2018-03-27 | 佛罗里达大学研究基金会公司 | For strengthening the bi-layered device of healing |
| CN110917179A (en) * | 2019-12-19 | 2020-03-27 | 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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| CN110917179A (en) * | 2019-12-19 | 2020-03-27 | 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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