CN115944770A - Hydrogel vascular embolization material and preparation method and application thereof - Google Patents
Hydrogel vascular embolization material and preparation method and application thereof Download PDFInfo
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- 230000010102 embolization Effects 0.000 title claims abstract description 49
- 239000000463 material Substances 0.000 title claims abstract description 42
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- 238000002360 preparation method Methods 0.000 title claims abstract description 8
- 239000008367 deionised water Substances 0.000 claims abstract description 25
- 229910021641 deionized water Inorganic materials 0.000 claims abstract description 25
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 25
- 239000002562 thickening agent Substances 0.000 claims abstract description 15
- 239000013008 thixotropic agent Substances 0.000 claims abstract description 11
- 108010010803 Gelatin Proteins 0.000 claims abstract description 10
- 229920000159 gelatin Polymers 0.000 claims abstract description 10
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- 235000019322 gelatine Nutrition 0.000 claims abstract description 10
- 235000011852 gelatine desserts Nutrition 0.000 claims abstract description 10
- 238000000034 method Methods 0.000 claims abstract description 9
- 239000003795 chemical substances by application Substances 0.000 claims abstract description 7
- 239000002994 raw material Substances 0.000 claims abstract description 3
- 238000003756 stirring Methods 0.000 claims description 39
- 239000011259 mixed solution Substances 0.000 claims description 26
- 239000000203 mixture Substances 0.000 claims description 20
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims description 15
- 239000000499 gel Substances 0.000 claims description 13
- 239000000243 solution Substances 0.000 claims description 10
- NIXOWILDQLNWCW-UHFFFAOYSA-N Acrylic acid Chemical compound OC(=O)C=C NIXOWILDQLNWCW-UHFFFAOYSA-N 0.000 claims description 6
- KWYUFKZDYYNOTN-UHFFFAOYSA-M Potassium hydroxide Chemical compound [OH-].[K+] KWYUFKZDYYNOTN-UHFFFAOYSA-M 0.000 claims description 6
- 229920002125 Sokalan® Polymers 0.000 claims description 6
- 229960001631 carbomer Drugs 0.000 claims description 6
- GUVRBAGPIYLISA-UHFFFAOYSA-N tantalum atom Chemical compound [Ta] GUVRBAGPIYLISA-UHFFFAOYSA-N 0.000 claims description 6
- IPGANOYOHAODGA-UHFFFAOYSA-N dilithium;dimagnesium;dioxido(oxo)silane Chemical compound [Li+].[Li+].[Mg+2].[Mg+2].[O-][Si]([O-])=O.[O-][Si]([O-])=O.[O-][Si]([O-])=O IPGANOYOHAODGA-UHFFFAOYSA-N 0.000 claims description 5
- 238000010438 heat treatment Methods 0.000 claims description 5
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 4
- 239000000440 bentonite Substances 0.000 claims description 4
- 229910000278 bentonite Inorganic materials 0.000 claims description 4
- SVPXDRXYRYOSEX-UHFFFAOYSA-N bentoquatam Chemical compound O.O=[Si]=O.O=[Al]O[Al]=O SVPXDRXYRYOSEX-UHFFFAOYSA-N 0.000 claims description 4
- 229910021485 fumed silica Inorganic materials 0.000 claims description 4
- IXPNQXFRVYWDDI-UHFFFAOYSA-N 1-methyl-2,4-dioxo-1,3-diazinane-5-carboximidamide Chemical compound CN1CC(C(N)=N)C(=O)NC1=O IXPNQXFRVYWDDI-UHFFFAOYSA-N 0.000 claims description 3
- 229960001025 iohexol Drugs 0.000 claims description 3
- NTHXOOBQLCIOLC-UHFFFAOYSA-N iohexol Chemical compound OCC(O)CN(C(=O)C)C1=C(I)C(C(=O)NCC(O)CO)=C(I)C(C(=O)NCC(O)CO)=C1I NTHXOOBQLCIOLC-UHFFFAOYSA-N 0.000 claims description 3
- 239000003002 pH adjusting agent Substances 0.000 claims description 3
- 239000000661 sodium alginate Substances 0.000 claims description 3
- 235000010413 sodium alginate Nutrition 0.000 claims description 3
- 229940005550 sodium alginate Drugs 0.000 claims description 3
- 239000000230 xanthan gum Substances 0.000 claims description 3
- 235000010493 xanthan gum Nutrition 0.000 claims description 3
- 229920001285 xanthan gum Polymers 0.000 claims description 3
- 229940082509 xanthan gum Drugs 0.000 claims description 3
- 229920001661 Chitosan Polymers 0.000 claims description 2
- GSEJCLTVZPLZKY-UHFFFAOYSA-N Triethanolamine Chemical compound OCCN(CCO)CCO GSEJCLTVZPLZKY-UHFFFAOYSA-N 0.000 claims description 2
- SNAAJJQQZSMGQD-UHFFFAOYSA-N aluminum magnesium Chemical compound [Mg].[Al] SNAAJJQQZSMGQD-UHFFFAOYSA-N 0.000 claims description 2
- 239000001913 cellulose Substances 0.000 claims description 2
- 229920002678 cellulose Polymers 0.000 claims description 2
- 229940045110 chitosan Drugs 0.000 claims description 2
- 229940014259 gelatin Drugs 0.000 claims description 2
- 229960004359 iodixanol Drugs 0.000 claims description 2
- NBQNWMBBSKPBAY-UHFFFAOYSA-N iodixanol Chemical compound IC=1C(C(=O)NCC(O)CO)=C(I)C(C(=O)NCC(O)CO)=C(I)C=1N(C(=O)C)CC(O)CN(C(C)=O)C1=C(I)C(C(=O)NCC(O)CO)=C(I)C(C(=O)NCC(O)CO)=C1I NBQNWMBBSKPBAY-UHFFFAOYSA-N 0.000 claims description 2
- 229960004647 iopamidol Drugs 0.000 claims description 2
- XQZXYNRDCRIARQ-LURJTMIESA-N iopamidol Chemical compound C[C@H](O)C(=O)NC1=C(I)C(C(=O)NC(CO)CO)=C(I)C(C(=O)NC(CO)CO)=C1I XQZXYNRDCRIARQ-LURJTMIESA-N 0.000 claims description 2
- 210000004204 blood vessel Anatomy 0.000 abstract description 15
- 239000004005 microsphere Substances 0.000 abstract description 7
- 239000007788 liquid Substances 0.000 abstract description 5
- 230000000694 effects Effects 0.000 abstract description 4
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- 210000005259 peripheral blood Anatomy 0.000 abstract description 3
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- 239000002861 polymer material Substances 0.000 abstract description 2
- 208000007536 Thrombosis Diseases 0.000 abstract 1
- 238000003860 storage Methods 0.000 description 5
- 230000003073 embolic effect Effects 0.000 description 4
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- 208000005189 Embolism Diseases 0.000 description 2
- 230000009286 beneficial effect Effects 0.000 description 2
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- 239000006185 dispersion Substances 0.000 description 2
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- 239000004372 Polyvinyl alcohol Substances 0.000 description 1
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- 239000003814 drug Substances 0.000 description 1
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Abstract
The invention discloses a hydrogel vascular embolization material, which relates to the technical field of medical high polymer materials and comprises the following raw materials in parts by weight: 60-95 parts of deionized water, 0.1-15 parts of thickening agent, 0.1-10 parts of thixotropic agent and 5-30 parts of developing agent. The invention also provides a preparation method and application of the hydrogel vascular embolization material. According to the hydrogel vascular embolization material, the thixotropic agent and the thickening agent are added, the shear thinning effect of the hydrogel can be increased by matching the thixotropic agent and the thickening agent, the viscosity can be instantly reduced under certain pressure to be in a liquid state, the hydrogel is conveniently conveyed in a catheter, the hydrogel loses external pressure after entering a blood vessel, the viscosity can be instantly increased to be in a solid state, and the blood vessel is embolized, so that the hydrogel vascular embolization material can be smoothly conveyed through the catheter without blocking the blood vessel and can effectively embolize the blood vessel; compared with gelatin sponge and microspheres, the thrombus can better embolize peripheral blood vessels, and the risk of collateral circulation is reduced; the production process has simple process, high production efficiency and more controllable product quality.
Description
Technical Field
The invention relates to the technical field of medical high polymer materials, in particular to a hydrogel vascular embolization material and a preparation method and application thereof.
Background
The vascular embolization operation is mainly to embolize a target blood vessel by using embolization materials through a catheter and a guide wire so as to treat diseases such as aneurysm, abnormal blood vessel, hemorrhage, blood-rich tumor and the like. The common embolic materials at present are spring rings, embolic microspheres, iodized oil and gelatin sponge.
The existing embolic agent still has some problems, and the cost of the spring ring is high and the price is expensive; gelatin sponge and microsphere embolization agents such as polyvinyl alcohol microspheres, sodium alginate microspheres and the like cannot embolize peripheral blood vessels due to limited size distribution, collateral circulation is easily formed after embolization, and the gelatin sponge and microsphere embolization agents do not have X-ray developing capacity, so that difficulties are brought to doctor operation and postoperative follow-up; liquid embolic agents such as iodized oil only temporarily embolize blood vessels and are quickly removed, resulting in recanalization of blood flow, and after recanalization, the risk of ectopic embolization also increases.
The photo-crosslinked hydrogel described in patent CN114230678A needs to be cross-linked to form gel by conducting visible light through optical fiber after being implanted into blood vessels. The pre-gel needs to be stored away from light before and during the operation, which increases the difficulty of storage and operation. The pre-gel needs to be cured by light induction in the blood vessel, and if the optical fiber fails or is not cured in time, the risk that the pre-gel is dispersed by blood flow and ectopic embolism occurs can be caused.
The PH sensitive hydrogel described in patent CN115212343A realizes vascular embolization by adjusting the PH of the mixed solution to 5 to 7 to convert the mixed solution from a liquid state to a gel state. The process needs to strictly control the pH value of the mixed solution, when the overall pH value of the mixed solution is not in the range, the mixed solution cannot be converted from a liquid state to a gel state, the difficulty of the operation is increased, and the gelation of the mixed solution needs a certain time if the control does not have the risk of ectopic embolism.
The thermotropic hydrogel material disclosed in patent CN114984296A generates sol-gel phase transition under the stimulation of body temperature, and is converted into a semi-solid substance with the function of slowly releasing drugs, thereby completing the embolization of a target blood vessel. The hydrogel needs to be stored in a low-temperature environment before operation, and brings difficulty to storage and transportation of instruments.
However, the photo-crosslinked hydrogels, PH sensitive hydrogels and thermal hydrogels of the above patents need to become gels in blood vessels under the intervention of external conditions. This process is prone to failure, presents the risk of ectopic embolization, and is not conducive to preoperative storage and transport of the product.
Therefore, those skilled in the art have endeavored to develop a hydrogel vascular embolization material which is not disturbed by the outside, can avoid the risk of ectopic embolization, and is advantageous for preoperative storage and transportation of the product.
Disclosure of Invention
In view of the above-mentioned defects of the prior art, the technical problem to be solved by the present invention is to provide a hydrogel vascular embolization material which is not interfered by the outside, can avoid the risk of ectopic embolization, and is beneficial to the preoperative storage and transportation of the product, and a preparation method and an application thereof.
In order to realize the technical purpose, the hydrogel vascular embolization material provided by the invention comprises the following raw materials in parts by weight: 60-95 parts of deionized water, 0.1-15 parts of thickening agent, 0.1-10 parts of thixotropic agent and 5-30 parts of developing agent.
In a preferred embodiment of the invention, the thickener is a mixture of one or more of xanthan gum, gelatin, carbomer, chitosan, sodium alginate and cellulose-based thickeners.
In another preferred embodiment of the present invention, the thixotropic agent is a mixture of one or more of fumed silica, bentonite, nano magnesium aluminum silicate and nano magnesium lithium silicate.
In another preferred embodiment of the present invention, the developer is a mixture of one or more of iohexol, iodixanol, iopamidol and tantalum powder.
Furthermore, the hydrogel vascular embolization material also comprises 0-2 parts of pH regulator.
In a preferred embodiment of the present invention, the pH adjuster is one of sodium hydroxide, potassium hydroxide and triethanolamine.
The invention also provides a preparation method of the hydrogel vascular embolization material, which comprises the following steps:
s1: dividing the deionized water into a first part of deionized water and a second part of deionized water;
s2: uniformly stirring a first part of deionized water and a thixotropic agent to obtain a first mixed solution; adding a second part of deionized water into the thickening agent, heating and stirring to dissolve the second part of deionized water to obtain a second mixed solution;
s3: adding the second mixed solution into the first mixed solution while the second mixed solution is hot, and uniformly stirring to obtain a third mixed solution;
s4: and adding a developer into the third mixed solution, and uniformly stirring to obtain the hydrogel vascular embolization material.
Further, between steps S2 and S3, a step of adjusting PH is further included: and dripping a pH regulator into the second mixed solution under the stirring state until the second mixed solution forms gel, then adding the gel into the first mixed solution, and uniformly stirring.
Further, the pH regulator is a 20% NaOH solution, and the thickener is carbomer.
The invention also provides application of the hydrogel vascular embolization material in preparation of embolization treatment materials.
Compared with the prior art, the invention has the following beneficial effects:
according to the hydrogel vascular embolization material, the thixotropic agent and the thickening agent are added, the shear thinning effect of the hydrogel can be increased by matching the thixotropic agent and the thickening agent, the viscosity can be instantly reduced under certain pressure to be in a liquid state, the hydrogel is conveniently conveyed in a catheter, the hydrogel loses external pressure after entering a blood vessel, the viscosity can be instantly increased to be in a solid state, the blood vessel is embolized, and the hydrogel vascular embolization material can be smoothly conveyed through the catheter without blocking the blood vessel and can effectively embolize the blood vessel.
Compared with gelatin sponge and microspheres, the hydrogel vascular embolization material provided by the invention can better embolize peripheral blood vessels, and reduces the risk of collateral circulation.
The hydrogel vascular embolization material is added with the developer, has X-ray developing capability, can be seen under angiography, and is convenient for doctors to follow up after operation.
The hydrogel vascular embolization material has the advantages of simple production process, high production efficiency and controllable product quality.
The conception, specific method, and technical effects of the present invention will be further described with reference to specific embodiments so that the objects, features, and effects of the present invention can be fully understood.
Detailed Description
The following describes several preferred embodiments of the present invention to make the technical contents thereof clearer and easier to understand. The present invention may be embodied in many different forms of embodiments and the scope of the invention is not limited to the embodiments set forth herein.
Example 1
30g of deionized water and 3g of nano lithium magnesium silicate are added into a stirring kettle, a dispersion disc is set to rotate at 1500rpm, and the mixture is stirred until the mixture is uniformly dispersed. Adding 1g of gelatin and 32g of deionized water into a beaker, heating, stirring and dissolving, pouring the mixture into a stirring kettle while the mixture is hot, continuously stirring until the mixture is uniformly dispersed, adding 16.5g of tantalum powder, and stirring until the mixture is uniformly dispersed to obtain the hydrogel vascular embolization material.
Example 2
30g of deionized water and 3g of nano lithium magnesium silicate are added into a stirring kettle, a dispersion disc is set to rotate at 1500rpm, and the mixture is stirred until the mixture is uniformly dispersed. Adding 1g of gelatin and 32g of deionized water into a beaker, heating, stirring and dissolving, pouring into a stirring tank while the solution is hot, stirring until the solution is uniformly dispersed, adding 7.3g of iohexol, and stirring until the solution is uniformly dispersed to obtain the hydrogel vascular embolization material.
Example 3
29g of deionized water and 4g of bentonite were added to a stirring tank, and a planetary gravity stirrer was used at a set rotation speed of 1500rpm for 10min. And adding 0.3g of xanthan gum and 32.7g of deionized water into a beaker, stirring and dissolving, pouring into a stirring tank, setting the rotating speed to be 1500rpm, dispersing for 10min, adding 16.5g of tantalum powder, setting the rotating speed to be 1500rpm, and dispersing for 10min again to obtain the hydrogel vascular embolization material.
Example 4
Adding 30g of deionized water and 0.25g of fumed silica into a stirring kettle, setting the rotating speed to be 1500rpm, stirring until the mixture is uniformly dispersed, adding 3g of nano lithium magnesium silicate, and stirring until the mixture is uniformly dispersed. Adding 1g of gelatin and 32g of deionized water into a beaker, heating, stirring and dissolving, pouring the mixture into a stirring kettle while the mixture is hot, stirring until the mixture is uniformly dispersed, adding 16.5g of tantalum powder, and stirring again until the mixture is uniformly dispersed to obtain the hydrogel vascular embolization material.
Example 5
And adding 30g of deionized water and 0.25g of fumed silica into a stirring kettle, setting the rotating speed to be 1500rpm, stirring until the materials are uniformly dispersed, adding 4g of bentonite, and dispersing for 30min. Adding 0.16g of carbomer and 32g of deionized water into a beaker, stirring and dissolving, dropwise adding 20 percent of NaOH solution while stirring until the carbomer solution forms gel, pouring into a stirring kettle, stirring until the solution is uniformly dispersed, adding 16.5g of tantalum powder, and stirring again until the solution is uniformly dispersed to obtain the hydrogel vascular embolization material.
Test examples
The extrusion force test of the hydrogel vascular embolization material prepared in examples 1-5 of the present invention was carried out by the following method: the hydrogel was filled in a 3ml syringe with a luer connector, left to stand overnight, and then attached to a 4.7F PE catheter, the extrusion rate was set to 1ml/min, and the yield force and average extrusion force were measured. The results are shown in the following table.
| Sample (I)Name (R) | Yield strength (N) | Average extrusion force (N) |
| Example 1 | 17.21 | 16.79 |
| Example 2 | 8.00 | 7.88 |
| Example 3 | 13.91 | 11.51 |
| Example 4 | 25.88 | 23.27 |
| Example 5 | 17.54 | 11.21 |
The foregoing detailed description of the preferred embodiments of the invention has been presented. It should be understood that numerous modifications and variations could be devised by those skilled in the art in light of the present teachings without departing from the inventive concepts. Therefore, the technical solutions available to those skilled in the art through logic analysis, reasoning and limited experiments based on the prior art according to the concept of the present invention should be within the scope of protection defined by the claims.
Claims (10)
1. The hydrogel vascular embolization material is characterized by comprising the following raw materials in parts by weight: 60-95 parts of deionized water, 0.1-15 parts of thickening agent, 0.1-10 parts of thixotropic agent and 5-30 parts of developing agent.
2. The hydrogel vascular embolization material of claim 1, wherein: the thickening agent is one or a mixture of xanthan gum, gelatin, carbomer, chitosan, sodium alginate and cellulose thickening agent.
3. The hydrogel vascular embolization material of claim 1, wherein: the thixotropic agent is one or a mixture of more of fumed silica, bentonite, nano magnesium aluminum silicate and nano magnesium lithium silicate.
4. The hydrogel vascular embolization material of claim 1, wherein: the developer is one or a mixture of more of iohexol, iodixanol, iopamidol and tantalum powder.
5. The hydrogel vascular embolization material of claim 1, further comprising 0-2 parts of a pH adjusting agent.
6. The hydrogel vascular embolization material of claim 5, wherein: the pH regulator is one of sodium hydroxide, potassium hydroxide and triethanolamine.
7. A method of preparing a hydrogel vascular embolization material according to claim 1, comprising the steps of:
s1: dividing the deionized water into a first part of deionized water and a second part of deionized water;
s2: uniformly stirring a first part of deionized water and a thixotropic agent to obtain a first mixed solution; adding a second part of deionized water into the thickening agent, heating and stirring to dissolve the deionized water to obtain a second mixed solution;
s3: adding the second mixed solution into the first mixed solution while the second mixed solution is hot, and uniformly stirring to obtain a third mixed solution;
s4: and adding a developer into the third mixed solution, and uniformly stirring to obtain the hydrogel vascular embolization material.
8. The method for preparing a hydrogel vascular embolization material according to claim 7, wherein: between the steps S2 and S3, the method further comprises the steps of: and dripping a pH regulator into the second mixed solution under the stirring state until the second mixed solution forms gel, then adding the gel into the first mixed solution, and uniformly stirring.
9. The method for preparing a hydrogel vascular embolization material according to claim 8, wherein: the pH adjusting agent is 20% NaOH solution, and the thickening agent is carbomer.
10. Use of a hydrogel vascular embolization material according to claim 1 in the preparation of an embolization treatment material.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202310093940.9A CN115944770A (en) | 2023-02-03 | 2023-02-03 | Hydrogel vascular embolization material and preparation method and application thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202310093940.9A CN115944770A (en) | 2023-02-03 | 2023-02-03 | Hydrogel vascular embolization material and preparation method and application thereof |
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Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0133391A1 (en) * | 1983-07-13 | 1985-02-20 | Guerbet S.A. | Composition for therapeutic embolisation |
| WO2004035022A2 (en) * | 2002-10-15 | 2004-04-29 | Microtherapeutics, Inc. | Prepolymeric materials for site specific delivery to the body |
| US20050025707A1 (en) * | 2003-02-27 | 2005-02-03 | Patterson William R. | Fumed silica embolic compositions |
| CN114129763A (en) * | 2021-11-01 | 2022-03-04 | 卫纳塞德(北京)医疗科技有限公司 | Gel medical adhesive and preparation method and application thereof |
| CN115645635A (en) * | 2022-10-24 | 2023-01-31 | 杭州旸顺医疗科技有限公司 | Liquid-phase embolic agent, preparation method and application thereof |
-
2023
- 2023-02-03 CN CN202310093940.9A patent/CN115944770A/en active Pending
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0133391A1 (en) * | 1983-07-13 | 1985-02-20 | Guerbet S.A. | Composition for therapeutic embolisation |
| WO2004035022A2 (en) * | 2002-10-15 | 2004-04-29 | Microtherapeutics, Inc. | Prepolymeric materials for site specific delivery to the body |
| US20050025707A1 (en) * | 2003-02-27 | 2005-02-03 | Patterson William R. | Fumed silica embolic compositions |
| CN114129763A (en) * | 2021-11-01 | 2022-03-04 | 卫纳塞德(北京)医疗科技有限公司 | Gel medical adhesive and preparation method and application thereof |
| CN115645635A (en) * | 2022-10-24 | 2023-01-31 | 杭州旸顺医疗科技有限公司 | Liquid-phase embolic agent, preparation method and application thereof |
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