CN109825194A - A kind of heat-proof coating material of medical catheter and the preparation method and application thereof - Google Patents
A kind of heat-proof coating material of medical catheter and the preparation method and application thereof Download PDFInfo
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Abstract
The present invention relates to field of medical materials, disclose a kind of heat-proof coating material and the preparation method and application thereof of medical catheter.Heat-proof coating material provided by the present invention, contains boiomacromolecule and silicon dioxide nano hollow sphere；The heat-proof coating material the preparation method comprises the following steps: silicon dioxide nano hollow sphere is added in the boiomacromolecule aqueous solution that quality volume fraction is 6%~7% under stiring, while adding plasticizer relative to silk fibroin water solution volume 1%~20%.When the heat-proof coating material is applied to intravascular intervention class medical catheter, the heat insulating coat formed by the heat-proof coating material can effectively slow down the exchange rate in conduit between perfusion liquid and blood, duct entry perfusion liquid and outlet perfusion liquid temperature difference are reduced, the validity and accuracy of local targeted therapy are improved.
Description
Technical field
The present invention relates to field of medical materials, specifically, being related to the heat-proof coating material and its system of a kind of medical catheter
Preparation Method and application.
Background technique
In recent years, with the development of intravascular intervention class bio-medical material, revascularization of the bolt as representative is taken using machinery
Treatment can effectively reduce cerebral infarction volume, improve the long-term prognosis of patients with acute ischemic cerebral stroke.Mild hypothermia therapy is
Current most potential neuroprotective method, and what is confirmed in clinic at present unique damage global ischemia brain after CPR
Hurt effective treatment method.Mild hypothermia therapy on the basis of clinical research confirmation revascularization is to patients with acute ischemic cerebral stroke
With apparent cerebral protection.
There are many modes of mild hypothermia therapy, wherein intravascular targeted local mild hypothermia therapy can effectively slow down whole body Asia
The adverse reaction of low temperature therapy, this method have many advantages, such as that cooling rate is fast, target area temperature-controllable is strong, and can be better
Bolt operation is taken to combine with clinic.In clinical manipulation, intravascular targeting Mild Hypothermal Cerebral protection is needed using normal in clinic
Importing cerebral infarction dead zone (transmission path about 110cm) (such as Fig. 1 that conduit targets hypothermia perfusion liquid from femoral artery puncture mouth
It is shown).The main problem for restricting technology clinic conversion has: (a) all conduits of current clinical use do not account for heat-insulated
Design, inevitably there are heat exchanging process between perfusion liquid, conduit and blood, so that the temperature of hypothermia perfusion liquid significantly rises
Height, low temperature efficiency substantially reduce, and (b) simultaneously after perfusion liquid is transported to site of action, can mix with blood self in peripheral vessels,
It further increases its temperature, reduces therapeutic effect；Clinically attempt use lower temperature perfusion liquid, improve rate of flooding with
Shorten perfusion liquid in conduit the residence time come alleviate its temperature increase phenomenon, (c) but the former be also easy to produce due to thermal transfer ribbon come
The adverse reactions such as autoblood temperature excessive descent, the problems such as (d) the latter easily causes perfusion position angiorrhoxis.
External one the study found that average 5.4 DEG C of cryogenic liquid is perfused in human body, it is laggard by transportation route heat exchange
The final temperature for entering brain tissue is 25.2 DEG C of (Selective brain cooling with endovascular
intracarotid infusion of cold saline:a pilot feasibility study.American
Journal of Neuroradiology[06Jan 2010,31(5):928-934]).Currently, both at home and abroad to intravascular intervention
The research of bio-medical heat insulating coat is also rarely reported, and traditional heat insulating coat is usually SiC, SiO2、Al2O3Equal inorganic ceramics material
The resin-based materials such as material and phenolic resin, epoxy resin, however not only preparation process is complicated, needs high-temperature process, applies for the type coating
The thicker, poor toughness of layer, bending strength are low, and poor biocompatibility, should not be used in prepare the surface of bio-medical interposing catheter every
Hot coating.
Therefore need to develop new function metaplasia object heat insulating coat, to meet clinical application demand.
Summary of the invention
In order to solve the problems in the existing technology, the object of the present invention is to provide a kind of heat insulating coats of medical catheter
Material and the preparation method and application thereof.
In order to achieve the object of the present invention, technical scheme is as follows:
In a first aspect, the present invention provides a kind of heat-proof coating material of medical catheter, contain boiomacromolecule and titanium dioxide
Silicon nano-hollow ball.
Heat-proof coating material provided by the present invention, can interposing catheter surface construct heat insulation it is good and with
The heat insulating coat of good biological cell compatibility and blood compatibility reaches the heat exchange slowed down in conduit between perfusion liquid and blood
Rate, reduce duct entry perfusion liquid and outlet perfusion liquid temperature difference, it is ensured that perfusion liquid still have when arriving at site of action compared with
Low sub-cooled effect improves part targeting to reduce the adverse reactions such as the autoblood temperature decline of thermal transfer ribbon
The validity and accuracy (effectively control perfusion liquid temperature) of mild hypothermia therapy.
Further, boiomacromolecule of the present invention is selected from fibroin albumen, polyglycolic acid (PGA), polylactic acid
(PLA), l-polylactic acid (PLLA), polycaprolactone (PCL), polybutylcyanoacrylate (PACA), poly- para-dioxane ketone,
Polyanhydride, poly phosphazene, polymer-amino-acid, poly- butyric ester and one of hydroxyl valerate and its copolymer or more
Kind.
Wherein, the fibroin albumen be silkworm or tussah silk cocoon, it is contour using lithium bromide (LiBr) after degumming process
After the organic acids such as fluorinated organic solvents or acetic acid such as chaotropic salt, hexafluoroisopropanol (HFIP) are dissolved, it is molten that fibroin albumen is made
Liquid.
Above-mentioned high chaotropic salt mainly includes but is not limited to lithium, strontium, the chloride of barium, bromide, iodide etc.；Above-mentioned fluorination
Organic solvent mainly includes but is not limited to hexafluoroisopropanol；Above-mentioned organic acid mainly includes but is not limited to acetic acid.
In a specific embodiment of the invention, used fibroin albumen is the experiment side according to provided by Rockwood
What method was extracted from silkworm, i.e., mulberry cocoon (Bombyx mori cocoon) is shredded and is placed on 0.02M Na2CO3Boil 30min
Silk surface sericin is removed, uses deionized water cleaning and degumming fibroin albumen for several times after boiling and naturally dry, then
Fibroin albumen is dissolved in 9M LiBr under the conditions of 60 DEG C, after fibroin albumen is completely dissolved (about 4h), with dialysis membrane dialysis 3
It, obtains the silk fibroin water solution that quality volume fraction is 6~7w/v%, is stored in 4 DEG C of refrigerators stand-by.
Further, it is template that silicon dioxide nano hollow sphere of the present invention, which is using suitable polyeletrolyte,
It is self-assembled into nanosphere aggregation in poor solvent, and using the aggregation as matrix, in alcohol/ammonia-water systems, silicon is added
Source presoma, using sol-gal process, obtained silicon dioxide nano hollow sphere.
Above-mentioned polyeletrolyte mainly includes but is not limited to polyacrylic acid, polymethylacrylic acid, sodium polymethacrylate etc.；
Above-mentioned silicon source presoma mainly includes but is not limited to sodium metasilicate, ethyl orthosilicate, multi-polysiloxane etc..
Preferably, the partial size of silicon dioxide nano hollow sphere of the present invention is 500nm~30 μm, the silica
The wall thickness of nano-hollow ball is 100nm~1000nm.The silicon dioxide nano hollow sphere for meeting the condition can be used as the present invention
Raw material uses.
Further, by taking boiomacromolecule is preferably fibroin albumen as an example, heat-proof coating material of the present invention is molten
Glue, the colloidal sol the preparation method comprises the following steps:
It is water-soluble that the fibroin albumen that quality volume fraction is 6%~7% is added in silicon dioxide nano hollow sphere under stiring
In liquid, while adding plasticizer；
The quality for the silicon dioxide nano hollow sphere being added is the 0.1%~99% of silk fibroin water solution quality；It is excellent
It is selected as 10%~60%；More preferably 30%~40% or 40%~50% or 50%~60% or 45%~55%；It is added
The volume of the plasticizer entered is the 1%~20% of silk fibroin water solution volume.
The plasticizer can be glycerol, propylene glycol, ethylene glycol etc., preferably glycerol.
Optionally, above-mentioned stirring can be 500 revs/min of magnetic agitation, and in practical operation, other stirring sides can also be used
Method or other stirring conditions are substituted, it is not limited to this.
Second aspect, the present invention provides aforementioned heat-proof coating materials in the medical catheter that preparation has heat insulating function
Using.
The medical catheter with heat insulating function includes but is not limited to the medical catheter for being used for the protection of Mild Hypothermal brain, is used for
The medical catheter etc. of oncotherapy thermochemotherapy.
The third aspect, as a kind of specific manifestation form of aforementioned applications, the present invention provides a kind of heat-insulated medical catheter,
With the heat insulating coat formed by heat-proof coating material of the present invention.
Further, the heat-insulated medical catheter by successively wrapping from inside to outside on common medical catheter, Ji Qi outer tube wall
The poly-dopamine film layer covered is formed with the heat insulating coat.
The effect of the poly-dopamine film layer is to improve the binding force of heat-proof coating material and conduit.
Preferably, the poly-dopamine film layer with a thickness of 1nm~500nm.
Preferably, the heat insulating coat with a thickness of 500 μm~1500 μm.
The common medical catheter includes but is not limited to that the central venous catheter of peripheral puncture, the vein through peripheral puncture are led
Pipe, central venous catheter, intravenous catheter, scalp vein conduit and umbilical venous catheter etc..
The tube body of the medical catheter can be contracted by polyether co-polyamide, polycarbonate, silicone resin ring, polytetrafluoroethylene (PTFE), second
Aldehyde, polyvinyl chloride, polystyrene, polysulfones, polyethylene, ultra-high molecular weight polyethylene, polyethylene terephthalate, organosilicon
One or more any combination material such as rubber, polypropylene, polyimides, perfluoroethylene-propylene is made.
Fourth aspect, the present invention provides a kind of preparation methods of heat-insulated medical catheter, include the following steps:
(1) common medical catheter is pre-processed using dehydrated alcohol, is soaked in after dry containing dopamine
Oxidative polymerization is carried out in alkaline medium, obtains the medical catheter of surface attachment poly-dopamine film layer；
(2) on the medical catheter of the resulting surface attachment poly-dopamine film layer of step (1), coating/cladding claim 1
~4 described in any item heat-proof coating materials, after drying to obtain the final product.
In step (1), the pretreatment is chosen as conduit being immersed in 5~20min of ultrasonic treatment in dehydrated alcohol, repeatedly
3~5 times；Subsequent drying step can be placed on air at room temperature drying to take out conduit from dehydrated alcohol.
In step (1), the alkaline medium containing dopamine be 0.01mol/L Tris-HCl buffer, pH about 8.5,
Dopamine is 2mg/mL in concentration wherein.
In step (1), the oxidative polymerization is chosen as being carried out in the dark 12h under the conditions of magnetic agitation.
In step (2).Coating/the cladding includes but is not limited to the coatings such as sol-gal process, spraying, extraction preparation side
Method.
As an example property illustrate, by extraction for, the step (2) concretely: step (1) is resulting medical
Conduit immerses in the heat-proof coating material, after 5~60 seconds, uniformly proposes (as shown in Figure 2) using Best-Effort request machine, 50~
It air-dries, and repeats the operation (Best-Effort request-drying) 1~5 time in 80 DEG C of baking oven.
5th aspect, the present invention furthermore provide heat-insulated medical catheter of the present invention or use system of the present invention
The many-sided application for the heat-insulated medical catheter that Preparation Method is prepared, including but not limited to:
(1) Mild Hypothermal brain protection field Endovascular hypothermia interposing catheter is prepared；
(2) oncotherapy thermochemotherapy interposing catheter is prepared.
The present invention relates to raw material or reagent be unless otherwise specified ordinary commercial products, the operation being related to for example without
Specified otherwise is this field routine operation.
On the basis of common knowledge of the art, above-mentioned each optimum condition, can be combined with each other, obtain specific embodiment party
Formula.
The beneficial effects of the present invention are:
The present invention is reacted using dopamine auto polymerization, is pre-processed to catheter surface, is improved the knot of heat insulating coat and conduit
With joint efforts；Later, using boiomacromolecule (such as natural fibroin albumen) as host material, silicon dioxide nano hollow sphere is utilized
As functional stuffing, makes gained heat insulating coat while having both cell compatibility, blood compatibility and bacteria resistance, also increase
The strong thermal insulation of coating.
The heat insulating coat can effectively slow down the exchange rate in conduit between perfusion liquid and blood, reduce duct entry perfusion
Liquid and outlet perfusion liquid temperature difference, improve the validity and accuracy of local targeted therapy.
When being applied to local mild hypothermia targeted therapy, the conduit for being coated with heat insulating coat of the present invention can ensure that perfusion
Liquid still has lower sub-cooled effect when arriving at site of action, thus at a temperature of reducing the autoblood of thermal transfer ribbon
The adverse reactions such as drop.
With required equipment, simple, at low cost, easy to operate, technological parameter is easy to control preparation method provided by the present invention
The advantages that processed, is conducive to industrialized production and application.
Detailed description of the invention
Fig. 1 is the application schematic diagram that heat-insulated medical catheter of the present invention is used for hypothermia cerebral protection.
Fig. 2 is schematic diagram of the heat-insulated medical catheter of the present invention in cladding heat insulating coat step: surface being adhered to poly-
The medical catheter of dopamine film layer is immersed in coating sol, lifts out by conduit uniform speed slow using Best-Effort request machine, and
It dries in an oven.
Fig. 3 is the naked sample (a, c) of 5F guiding catheter, and is coated with the photograph of heat-proof coating material of the present invention (b, d)
Piece.
Fig. 4 is photo of the 5F guiding catheter coated with heat-proof coating material of the present invention after strongly bending；Wherein,
(a) it is the resulting heat-insulated medical catheter of embodiment 1, (b) is the resulting heat-insulated medical catheter of embodiment 5.
Specific embodiment
The fibroin albumen (aqueous solution) that following embodiment uses is the experimental method according to provided by Rockwood from silkworm
Middle extraction, i.e., mulberry cocoon (Bombyx mori cocoon) is shredded and is placed on 0.02M Na2CO3Boil 30min removal silk
Surface sericin uses deionized water cleaning and degumming fibroin albumen for several times and naturally dry, then by fibroin egg after boiling
It is white to be dissolved in 9M LiBr under the conditions of 60 DEG C, after fibroin albumen is completely dissolved (about 4h), is dialysed 3 days with dialysis membrane, obtain matter
The silk fibroin water solution that volume fraction is 6~7w/v% is measured, is stored in 4 DEG C of refrigerators stand-by.
The silicon dioxide nano hollow sphere that following embodiment uses is graduate high-intensitive empty purchased from general sharp composite material
Heart silica series microballoon, article No. FR-O-008-1,21 μm of average grain diameter, purity 99.9%, compression strength 40MPa, pine dress
Density 0.13g/cm3, density 0.38g/cm3, crystal form is spherical, colours white.
(medical) conduit that following embodiment uses is 5F guiding catheter (internal diameter 1.4224mm/ outer diameter 1.65mm, length
100cm)。
The preferred embodiment of the present invention is described in detail below in conjunction with embodiment.It will be appreciated that following real
Providing merely to play the purpose of explanation for example is applied, is not used to limit the scope of the present invention.The skill of this field
Art personnel without departing from the spirit and purpose of the present invention, can carry out various modifications and replace to the present invention.
Experimental method used in following embodiments is conventional method unless otherwise specified.
The materials, reagents and the like used in the following examples is commercially available unless otherwise specified.
Embodiment 1
1, medical catheter pretreatment and the attachment of poly-dopamine film layer
Medical catheter is immersed in 20min in dehydrated alcohol to be ultrasonically treated, it is dry to take out air at room temperature.
PH of buffer=8.5 0.01mol/L Tris-HCl are prepared, dopamine is added into solution makes its concentration 2mg/
ML obtains the alkaline medium containing dopamine.
Medical catheter is soaked in the alkaline medium containing dopamine, is kept away under the conditions of 500 revs/min of magnetic agitations
Oxidative polymerization can occur for light reaction 12h, dopamine, obtain strength and be attached to catheter surface poly-dopamine film layer.Through examining
It surveys, which is about 500nm.
2, the preparation of heat-proof coating material (colloidal sol)
Under the conditions of 500 revs/min of magnetic agitation, it is by silicon dioxide nano hollow sphere addition quality volume fraction
In 6%~7% silk fibroin water solution, while glycerol is added as plasticizer.
The quality for the silicon dioxide nano hollow sphere being added is the 50% of silk fibroin water solution quality, the increasing being added
The volume for moulding agent is the 1% of silk fibroin water solution volume.
3, conduit coats heat insulating coat
The resulting conduit for being attached with poly-dopamine film layer of step 1 is immersed in the heat-proof coating material that step 2 is prepared, 30
It after second, is uniformly proposed using Best-Effort request machine, is air-dried in 50 DEG C of baking oven, repeated the operation 3 times, obtain outer layer with heat-insulated
The conduit of coating.Through detecting, which is about 900 μm.
Embodiment 2
The present embodiment and the difference of embodiment 1 are only that: when preparing heat-proof coating material (colloidal sol), the titanium dioxide that is added
The quality of silicon nano-hollow ball is the 10% of silk fibroin water solution quality.
Embodiment 3
The present embodiment and the difference of embodiment 1 are only that: when preparing heat-proof coating material (colloidal sol), the titanium dioxide that is added
The quality of silicon nano-hollow ball is the 30% of silk fibroin water solution quality.
Embodiment 4
The present embodiment and the difference of embodiment 1 are only that: when preparing heat-proof coating material (colloidal sol), the titanium dioxide that is added
The quality of silicon nano-hollow ball is the 60% of silk fibroin water solution quality.
Embodiment 5
The present embodiment and the difference of embodiment 1 are only that: when preparing heat-proof coating material (colloidal sol), the titanium dioxide that is added
The quality of silicon nano-hollow ball is the 80% of silk fibroin water solution quality.
Embodiment 6
The present embodiment and the difference of embodiment 1 are only that: when preparing heat-proof coating material (colloidal sol), the titanium dioxide that is added
The quality of silicon nano-hollow ball is the 99% of silk fibroin water solution quality.
Embodiment 7
The present embodiment and the difference of embodiment 1 are only that: when preparing heat-proof coating material (colloidal sol), the plasticizer that is added
Volume be silk fibroin water solution volume 20%.
Experiment proves that the present embodiment and 1 resulting Heat insulated conduit heat-blocking action having the same of embodiment, the cause of coating
Close property is also suitable.
Experimental example 1
Intravascular targeting Mild Hypothermal Cerebral protection needs are moved hypothermia perfusion liquid from stock using conduit common in clinic
The importing cerebral infarction dead zone of arteries and veins puncture orifice targeting.
In order to simulate the application environment, and tests and coat the medical catheter of heat-proof coating material of the present invention whether can be real
Existing good heat insulating function.The heat-insulated medical catheter that this experimental example prepares Examples 1 to 4, and without heat-proof coating material packet
The 5F guiding catheter (comparative example) covered is placed in 36.5 DEG C of water bath, and the catheter length submerged in a water bath is about 80cm.
Using one end of conduit as water inlet, the other end is water outlet, injects 0.5 DEG C in water inlet with the flow velocity of 0.5mL/s
Cooling water, and water outlet using electric thermo-couple temperature tester measure leaving water temperature, it is as a result as follows.
Table 1
Remarks: 22.4 DEG C of room temperature.
Experimental example 2
It is heat-insulated by experimental example 1 as it can be seen that when the mass fraction of silicon dioxide nano hollow sphere (silica) is 50% or so
Effect is best.
The concrete operations of reference experiment example 1, this experimental example are injected using the cooling water of different inflows, comparing embodiment
1 with the heat insulation of comparative example, it is as a result as follows.
Table 2
Remarks: 22.4 DEG C of room temperature.
It can be seen that heat-proof coating material provided by the present invention can obviously reduce the heating rate of cooling water in conduit,
Make the cooling water of injection in the environment of 36.5 DEG C by 100cm distance, can still keep not higher than on 20 DEG C, even up to 15 DEG C
Under Mild Hypothermal, provide good solution for the clinical problem of hypothermia cerebral protection.
Experimental example 3
This experimental example is intended to carry out finished product for the heat insulating coat of different silicon dioxide nano hollow sphere mass fractions (heat-insulated
Conduit) coating compactness comparison, comparison other is respectively embodiment 1 and embodiment 5.
As shown in Figure 4, the heat insulating coat compactness of embodiment 1 is good, without cracking, obscission, and embodiment 5 after bending
It is then difficult to resist strength bending.
Illustrate that the proportion of fibroin albumen and silicon dioxide nano hollow sphere is critically important, the proportion determine coating material at
The compactness of film property and coating, and the compactness of coating is also to the heat insulation of Heat insulated conduit that there are positive influences.
Therefore, when preparing the heat-proof coating material, silicon dioxide nano hollow sphere that the present invention is preferably added
Quality is the 10%~60% of silk fibroin water solution quality.
Although above the present invention is described in detail with a general description of the specific embodiments,
On the basis of the present invention, it can be made some modifications or improvements, this will be apparent to those skilled in the art.Cause
This, these modifications or improvements, fall within the scope of the claimed invention without departing from theon the basis of the spirit of the present invention.
Claims (10)
1. a kind of heat-proof coating material of medical catheter, which is characterized in that hollow containing boiomacromolecule and silica nanometer
Ball.
2. heat-proof coating material according to claim 1, which is characterized in that the boiomacromolecule is fibroin albumen.
3. heat-proof coating material according to claim 1 or 2, which is characterized in that the silicon dioxide nano hollow sphere
Partial size is 500nm~30 μm,
And/or the wall thickness of the silicon dioxide nano hollow sphere is 100nm~1000nm.
4. according to the described in any item heat-proof coating materials of Claims 2 or 3, which is characterized in that the heat-proof coating material is
Colloidal sol, the colloidal sol the preparation method comprises the following steps:
Silicon dioxide nano hollow sphere is added in the silk fibroin water solution that quality volume fraction is 6%~7% under stiring,
Plasticizer is added simultaneously；The plasticizer is preferably glycerol；
The quality for the silicon dioxide nano hollow sphere being added is the 0.1%~99% of silk fibroin water solution quality；Preferably
10%~60%；More preferably 30%~40% or 40%~50% or 50%~60% or 45%~55%；
The volume for the plasticizer being added is the 1%~20% of silk fibroin water solution volume.
5. the described in any item heat-proof coating materials of Claims 1 to 4 answering in the medical catheter that preparation has heat insulating function
With.
6. a kind of heat-insulated medical catheter, which is characterized in that it has by any one of Claims 1 to 4 heat-proof coating material
The heat insulating coat of formation.
7. heat-insulated medical catheter according to claim 6, which is characterized in that the heat-insulated medical catheter is led by commonly medical
The poly-dopamine film layer successively coated from inside to outside on pipe, Ji Qi outer tube wall is formed with the heat insulating coat；
Preferably, the poly-dopamine film layer with a thickness of 1nm~500nm, and/or, the heat insulating coat with a thickness of 500
μm~1500 μm.
8. a kind of preparation method of heat-insulated medical catheter, which comprises the steps of:
(1) common medical catheter is pre-processed using dehydrated alcohol, is soaked in the alkalinity containing dopamine after dry
Oxidative polymerization is carried out in medium, obtains the medical catheter of surface attachment poly-dopamine film layer；
(2) on the medical catheter of the resulting surface attachment poly-dopamine film layer of step (1), coating/cladding Claims 1 to 4
Described in any item heat-proof coating materials, after drying to obtain the final product.
9. preparation method according to claim 8, which is characterized in that the alkaline medium containing dopamine is
0.01mol/L Tris-HCl buffer, pH 8.5, dopamine are 2mg/mL in concentration wherein.
10. heat-insulated medical catheter described in claim 6 or 7 or the preparation method of claim 8 or 9 are prepared heat-insulated
The application of medical catheter, which is characterized in that the application includes but is not limited to:
(1) Mild Hypothermal brain protection field Endovascular hypothermia interposing catheter is prepared；
(2) oncotherapy thermochemotherapy interposing catheter is prepared.
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| CN110882469A (en) * | 2019-12-05 | 2020-03-17 | 徐隋意 | Low-temperature brain protection interventional catheter and preparation method thereof |
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| CN113827784A (en) * | 2021-09-27 | 2021-12-24 | 东劢医疗科技(苏州)有限公司 | Medical nano heat-non-conductive composite material and preparation method and application thereof |
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