CN115671401A - Medical latex balloon - Google Patents
Medical latex balloon Download PDFInfo
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- CN115671401A CN115671401A CN202211346516.2A CN202211346516A CN115671401A CN 115671401 A CN115671401 A CN 115671401A CN 202211346516 A CN202211346516 A CN 202211346516A CN 115671401 A CN115671401 A CN 115671401A
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- 229920000126 latex Polymers 0.000 title claims abstract description 31
- 239000004816 latex Substances 0.000 title claims abstract description 31
- KWYUFKZDYYNOTN-UHFFFAOYSA-M Potassium hydroxide Chemical compound [OH-].[K+] KWYUFKZDYYNOTN-UHFFFAOYSA-M 0.000 claims abstract description 39
- XLOMVQKBTHCTTD-UHFFFAOYSA-N Zinc monoxide Chemical compound [Zn]=O XLOMVQKBTHCTTD-UHFFFAOYSA-N 0.000 claims abstract description 26
- RRHGJUQNOFWUDK-UHFFFAOYSA-N Isoprene Chemical compound CC(=C)C=C RRHGJUQNOFWUDK-UHFFFAOYSA-N 0.000 claims abstract description 17
- 239000003795 chemical substances by application Substances 0.000 claims abstract description 15
- NINIDFKCEFEMDL-UHFFFAOYSA-N Sulfur Chemical compound [S] NINIDFKCEFEMDL-UHFFFAOYSA-N 0.000 claims abstract description 14
- 239000011593 sulfur Substances 0.000 claims abstract description 14
- 229910052717 sulfur Inorganic materials 0.000 claims abstract description 14
- 230000003712 anti-aging effect Effects 0.000 claims abstract description 13
- 239000011787 zinc oxide Substances 0.000 claims abstract description 13
- 239000005018 casein Substances 0.000 claims abstract description 12
- BECPQYXYKAMYBN-UHFFFAOYSA-N casein, tech. Chemical compound NCCCCC(C(O)=O)N=C(O)C(CC(O)=O)N=C(O)C(CCC(O)=N)N=C(O)C(CC(C)C)N=C(O)C(CCC(O)=O)N=C(O)C(CC(O)=O)N=C(O)C(CCC(O)=O)N=C(O)C(C(C)O)N=C(O)C(CCC(O)=N)N=C(O)C(CCC(O)=N)N=C(O)C(CCC(O)=N)N=C(O)C(CCC(O)=O)N=C(O)C(CCC(O)=O)N=C(O)C(COP(O)(O)=O)N=C(O)C(CCC(O)=N)N=C(O)C(N)CC1=CC=CC=C1 BECPQYXYKAMYBN-UHFFFAOYSA-N 0.000 claims abstract description 12
- 235000021240 caseins Nutrition 0.000 claims abstract description 12
- 239000003292 glue Substances 0.000 claims abstract description 12
- 229920000191 poly(N-vinyl pyrrolidone) Polymers 0.000 claims abstract description 10
- 239000006185 dispersion Substances 0.000 claims description 9
- 239000003945 anionic surfactant Substances 0.000 claims description 3
- 230000006837 decompression Effects 0.000 abstract description 5
- 238000001356 surgical procedure Methods 0.000 abstract 1
- 238000009472 formulation Methods 0.000 description 12
- 239000000203 mixture Substances 0.000 description 12
- 210000005077 saccule Anatomy 0.000 description 8
- 239000002994 raw material Substances 0.000 description 5
- 238000002474 experimental method Methods 0.000 description 4
- 238000012360 testing method Methods 0.000 description 4
- 238000004073 vulcanization Methods 0.000 description 4
- 238000013461 design Methods 0.000 description 3
- 230000000694 effects Effects 0.000 description 3
- 239000002313 adhesive film Substances 0.000 description 2
- 230000000052 comparative effect Effects 0.000 description 2
- 230000006835 compression Effects 0.000 description 2
- 238000007906 compression Methods 0.000 description 2
- 201000010099 disease Diseases 0.000 description 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 2
- 238000004519 manufacturing process Methods 0.000 description 2
- 238000005259 measurement Methods 0.000 description 2
- 238000000034 method Methods 0.000 description 2
- 229920006173 natural rubber latex Polymers 0.000 description 2
- 210000004126 nerve fiber Anatomy 0.000 description 2
- 230000000704 physical effect Effects 0.000 description 2
- 239000007787 solid Substances 0.000 description 2
- 210000000427 trigeminal ganglion Anatomy 0.000 description 2
- 206010044652 trigeminal neuralgia Diseases 0.000 description 2
- 208000010392 Bone Fractures Diseases 0.000 description 1
- 206010017076 Fracture Diseases 0.000 description 1
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 description 1
- 208000002193 Pain Diseases 0.000 description 1
- 208000027418 Wounds and injury Diseases 0.000 description 1
- 239000012190 activator Substances 0.000 description 1
- 239000003963 antioxidant agent Substances 0.000 description 1
- 230000003078 antioxidant effect Effects 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 210000004204 blood vessel Anatomy 0.000 description 1
- 239000002872 contrast media Substances 0.000 description 1
- 230000003013 cytotoxicity Effects 0.000 description 1
- 231100000135 cytotoxicity Toxicity 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 238000001514 detection method Methods 0.000 description 1
- 239000002270 dispersing agent Substances 0.000 description 1
- 238000001647 drug administration Methods 0.000 description 1
- 229920001971 elastomer Polymers 0.000 description 1
- 238000004880 explosion Methods 0.000 description 1
- 230000001815 facial effect Effects 0.000 description 1
- 238000005429 filling process Methods 0.000 description 1
- 238000000227 grinding Methods 0.000 description 1
- 239000002932 luster Substances 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 238000012544 monitoring process Methods 0.000 description 1
- 210000005036 nerve Anatomy 0.000 description 1
- 238000005457 optimization Methods 0.000 description 1
- 238000011056 performance test Methods 0.000 description 1
- 238000002360 preparation method Methods 0.000 description 1
- 239000011734 sodium Substances 0.000 description 1
- 229910052708 sodium Inorganic materials 0.000 description 1
- 239000003381 stabilizer Substances 0.000 description 1
- BDHFUVZGWQCTTF-UHFFFAOYSA-M sulfonate Chemical compound [O-]S(=O)=O BDHFUVZGWQCTTF-UHFFFAOYSA-M 0.000 description 1
- 230000009885 systemic effect Effects 0.000 description 1
- 230000001988 toxicity Effects 0.000 description 1
- 231100000419 toxicity Toxicity 0.000 description 1
- 210000003901 trigeminal nerve Anatomy 0.000 description 1
Landscapes
- Compositions Of Macromolecular Compounds (AREA)
Abstract
The invention belongs to the technical field of medical instruments, and particularly relates to a medical latex balloon which is mainly applied to surgical treatment such as tissue expansion and microvascular decompression in neurosurgery, wherein 100 parts of dry glue is taken as a metering standard, and the formula comprises the following components: 100 parts of natural latex, 0-0.5 part of casein, 0-0.25 part of potassium hydroxide, 0.75-1.5 parts of sulfur, 0.25-1.0 part of accelerator ZDC, 0.5-1.0 part of anti-aging agent 2641.0-2.0 parts of zinc oxide, 0.5-2.0 parts of accelerator PX and 0.15 part of peregal O.
Description
Technical Field
The invention belongs to the technical field of medical instruments, and particularly relates to a medical latex balloon.
Background
The medical latex balloon is made of natural latex, forms a kit with the catheter connecting piece, is mainly applied to tissue dilatation, microvascular decompression and the like in neurosurgery, and is a disposable product. The latex balloon not only requires that various physical indexes of the product meet requirements according to enterprise standards, but also has specific requirements on the tensile pressure of the balloon, the leakage of the balloon and the capacity. According to the classification definition of medical instruments by the national drug administration, the latex balloon is managed according to two types of medical instruments.
Currently, the balloons which are clinically common include three types of non-compliance balloons, semi-compliance balloons and compliance balloons, and the balloons are mainly semi-compliance balloons which are used for tissue expansion, microvascular decompression and other treatment means in neurosurgery operations.
However, the existing latex balloon has poor elasticity, poor filling and expanding performance and poor compliance, and has poor use effect in surgical operations such as tissue expansion in neurosurgery, microvascular decompression and the like.
Disclosure of Invention
Aiming at the defects in the prior art, the invention provides a medical latex balloon, which is used for solving the existing problems.
In order to solve the technical problems, the invention adopts the following technical scheme:
a medical latex balloon takes 100 parts of dry glue as a measurement standard, and comprises the following formula components: 100 parts of natural latex, 0-0.5 part of casein, 0-0.25 part of potassium hydroxide, 0.75-1.5 parts of sulfur, 0.25-1.0 part of accelerator ZDC, 2641.0-2.0 parts of anti-aging agent, 0.5-1.0 part of zinc oxide, 0.5-2.0 parts of accelerator PX and 0.15 part of peregal O.
The formula is optimized, 100 parts of dry glue is taken as a metering standard, and the formula comprises the following components: 100 parts of natural latex, 0.25 part of casein, 0.1 part of potassium hydroxide, 1.5 parts of sulfur, 0.5 part of accelerator ZDC, 5363 parts of anti-aging agent 2641.0 parts, 0.5 part of zinc oxide, 0.75 part of accelerator PX, peregal O:0.15 part.
Further, the natural rubber latex is natural rubber latex with the dry rubber content of 60%.
Further, the zinc oxide, the anti-aging agent 264, the sulfur, the accelerator ZDC and the accelerator PX are all prepared by grinding 50% aqueous dispersions, and the aqueous dispersions are ground by a vertical nano-grinder until the D90 is not more than 1 micron.
Further, 0.5 to 1.5% of an anionic surfactant is added to the aqueous dispersion.
Further, the potassium hydroxide and casein are 10% solution.
Compared with the prior art, the invention has the following beneficial effects:
1. the medical latex balloon has consistent appearance color and luster, and clean and flawless surface;
2. the expansion ratio of the medical latex saccule before filling to the expansion ratio of the medical latex saccule before filling is more than or equal to 800 percent, the medical latex saccule can be repeatedly filled for at least 60 times without leakage according to the actual capacity of a product within the range of +/-10 percent of a nominal value, and the retraction rate is less than or equal to 105 percent;
3. the maximum burst pressure of the medical latex balloon filling is more than or equal to 150MPa;
4. the medical latex balloon product disclosed by the invention is subjected to cytotoxicity detection according to GB/T16886.5-2017, the toxicity is not more than two-stage, and the product has excellent elasticity and good compliance in the using process and meets the expected design requirements of the product.
Detailed Description
The invention is mainly applied to surgical operations such as tissue expansion and microvascular decompression in neurosurgery, and discloses a medical latex balloon which is described below by combining specific embodiments.
The embodiment is as follows:
a medical latex balloon takes 100 parts of dry glue as a measurement standard, and comprises the following formula components: 100 parts of natural latex, 0-0.5 part of casein, 0-0.25 part of potassium hydroxide, 0.75-1.5 parts of sulfur, 0.25-1.0 part of accelerator ZDC, 2641.0-2.0 parts of anti-aging agent, 0.5-1.0 part of zinc oxide, 0.5-2.0 parts of accelerator PX and 0.15 part of peregal O.
The formula is optimized, 100 parts of dry glue is taken as a metering standard, and the formula comprises the following components: 100 parts of natural latex, 0.25 part of casein, 0.1 part of potassium hydroxide, 1.5 parts of sulfur, 0.5 part of accelerator ZDC, 5363 parts of anti-aging agent 2641.0 parts, 0.5 part of zinc oxide, 0.75 part of accelerator PX, peregal O:0.15 part.
The natural latex is natural latex with dry glue content of 60%.
The zinc oxide, the anti-aging agent 264, the sulfur, the accelerator ZDC and the accelerator PX are all ground into 50 percent aqueous dispersion, and the aqueous dispersion is ground into D90 of not more than 1 micron by a vertical nano-grinder.
To the aqueous dispersion is added 0.5-1.5% of an anionic surfactant, for example: a dispersing agent NF (sodium dimethyldinaphthalene sulfonate).
The potassium hydroxide and casein are 10% solution.
At present, more and more neurosurgery operations in the global range can cause structural damage to nerve fibers through compression of a saccule so as to achieve the effect of relieving pain, the saccule can be torn off to separate blood vessels from nerves so as to achieve the purpose of reducing pressure and finally achieve the purpose of minimally invasive treatment of related diseases, in the percutaneous trigeminal ganglion micro saccule compression, a microballoon sac is introduced into the semilunar ganglion of the trigeminal nerve of a Meckle's cavity through a sheath tube under X-ray perspective monitoring, then contrast agent is slowly injected to fill the saccule so as to relieve the clamping pressure of the nerve fibers causing trigeminal neuralgia, and the expanded microballoon sac is pressed to be damaged, so that the trigeminal neuralgia is treated. The whole steps are usually completed within 15mins, the wound is small, the facial touch can be kept, the operation is simple and convenient, the safety is high, and the complications are few, so that the optimal scheme is preferred for old people or people with serious systemic diseases and cannot tolerate larger operators.
The invention selects the Thailand three-tree natural latex with optimal performance, and solves the problem of stability in the preparation process of the natural latex through formulation design and debugging. In addition, the production efficiency is optimized through controlling the solid content and the density, and the thickness uniformity is poor when the solid content is too high; if the gel rate is too low, the surface of the adhesive film is not smooth enough, and the production efficiency is reduced.
The three Thailand tree natural latex is used as a main raw material, has the characteristics of good film forming performance, compact adhesive film, excellent tensile property and low retraction deformation rate, and is an optimal raw material for producing the latex balloon.
The sulfur acts as a vulcanizing agent; zinc oxide acts as a vulcanizing activator; the anti-aging agent 264 acts as an antioxidant; the potassium hydroxide (10% solution) is used for adjusting the pH value of the solution; peregal O acts as a stabilizer; the accelerator ZDC acts as an accelerator, so that the vulcanization time is shortened; the accelerant PX acts as an accelerant, and the vulcanization time is shortened.
Three different formulations were tested as listed in table 1 below:
TABLE 1 three latex balloon formulations, calculated as 100 parts dry glue (dry ratio, parts)
| Raw materials | Formulation A | Formulation B | Formulation C | |
| 1 | Natural latex | 100 portions of | 100 portions of | 100 portions of |
| 2 | Casein | 0 portion of | 0.25 part | 0.5 portion |
| 3 | Potassium hydroxide | 0 portion of | 0.125 portion | 0.25 part |
| 4 | Sulfur | 0.75 portion | 1.0 part | 1.5 parts of |
| 5 | Accelerator ZDC | 0.25 part | 0.7 portion of | 1.0 part |
| 6 | Anti-aging agent 264 | 1.0 part | 1.5 parts of | 2.0 part by weight |
| 7 | Zinc oxide | 0.5 portion | 0.75 portion | 1.0 part |
| 8 | Promoter PX | 0.5 portion | 1.0 part of | 2.0 part by weight |
| 9 | Peregal O | 0.15 part | 0.15 part of | 0.15 part |
The latex balloons prepared according to the three formulas were subjected to relevant physical property experiments, and the results are shown in table 2.
TABLE 2 three latex balloon experiments described above (comparative formulation)
According to the three formulas, the performance test results show that only the formula B meets the design requirements, the explosion pressure of the formula A is less than 150KPa, the vulcanization degree is insufficient, and the problem of insufficient addition of the vulcanizing agent exists; the elongation at break of the formula C is less than 800%, the vulcanization degree is relatively too high, and the risk of breakage exists in the filling process of the product.
In order to further prove the superiority of the invention and optimize the optimal formula system, the invention is optimized again on the basis of the formula B, and the product performances of three groups of formulas are compared, as shown in Table 3.
TABLE 3 three latex balloon formulations, calculated as 100 parts dry glue (parts dry)
| Raw materials | Formulation A1 | Formulation A2 | Formulation A3 | |
| 1 | Natural latex | 100 portions of | 100 portions of | 100 portions of |
| 2 | Casein | 0.25 part | 0.25 part | 0.5 portion |
| 3 | Potassium hydroxide | 0.125 portion | 0.2 part | 0.25 part |
| 4 | Sulfur | 1.0 part of | 1.25 parts | 1.25 parts |
| 5 | Accelerator ZDC | 0.7 portion of | 0.7 portion of | 1.0 part |
| 6 | Anti-aging agent 264 | 1.5 parts of | 1.5 parts of | 2.0 part by weight |
| 7 | Zinc oxide | 0.75 portion | 0.75 portion | 1.0 part |
| 8 | Promoter PX | 1.0 part | 1.5 parts of | 2.0 part by weight |
| 9 | Peregal O | 0.15 part of | 0.15 part of | 0.15 part of |
The latex balloons prepared according to the three formulas were subjected to relevant physical property experiments, and the results are shown in table 4.
TABLE 4 three latex balloon experiments described above (comparative formulation)
From the analysis results in the table above, the higher the sulfur content in the raw material components is, the greater the tensile strength of the test piece is, and the greater the burst pressure is; but the elongation at break of the corresponding test piece is reduced, the maximum filling volume of the product is reduced, the fracture risk of the saccule in the using process is increased, and the product performance is unfavorable. According to the expected use requirement of the balloon, the breaking elongation of the test piece at least reaches 800% to meet the use requirement, so that the formula A2 is optimal through 3 optimization systems.
And (4) conclusion: the optimum formula system optimized according to the above test is formula A2, which is calculated by 100 parts of dry glue and comprises the following components:
the foregoing are merely exemplary embodiments of the present invention, and no attempt is made to show structural details of the invention in more detail than is necessary for the fundamental understanding of the art, the description taken with the drawings making apparent to those skilled in the art how the several forms of the invention may be embodied in practice with the teachings of the invention. It should be noted that, for those skilled in the art, without departing from the structure of the present invention, several changes and modifications can be made, which should also be regarded as the protection scope of the present invention, and these will not affect the effect of the implementation of the present invention and the practicability of the patent.
Claims (6)
1. The medical latex balloon is characterized in that 100 parts of dry glue is taken as a metering standard, and the formula comprises the following components: 100 parts of natural latex, 0-0.5 part of casein, 0-0.25 part of potassium hydroxide, 0.75-1.5 parts of sulfur, 0.25-1.0 part of accelerator ZDC, 1.0-2.0 parts of anti-aging agent 264, 0.5-1.0 part of zinc oxide, 0.5-2.0 parts of accelerator PX and 0.15 part of peregal O.
2. The medical latex balloon as claimed in claim 1, wherein: the formula comprises the following components by taking 100 parts of dry glue as a metering standard: 100 parts of natural latex, 0.25 part of casein, 0.1 part of potassium hydroxide, 1.5 parts of sulfur, 0.5 part of accelerator ZDC, 1.0 part of anti-aging agent, 0.5 part of zinc oxide, 0.75 part of accelerator PX and 0.15 part of peregal O.
3. The medical latex balloon as claimed in claim 2, wherein: the natural latex is natural latex with dry glue content of 60%.
4. The medical latex balloon as claimed in claim 3, wherein: the zinc oxide, the anti-aging agent 264, the sulfur, the accelerator ZDC and the accelerator PX are all ground 50% aqueous dispersions, and the aqueous dispersions are ground to D90 not more than 1 micron by a vertical nano-grinder.
5. The medical latex balloon as claimed in claim 4, wherein: 0.5-1.5% of anionic surfactant is added to the aqueous dispersion.
6. The medical latex balloon as claimed in claim 5, wherein: the potassium hydroxide and casein are 10% solution.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202211346516.2A CN115671401A (en) | 2022-10-31 | 2022-10-31 | Medical latex balloon |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202211346516.2A CN115671401A (en) | 2022-10-31 | 2022-10-31 | Medical latex balloon |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN115671401A true CN115671401A (en) | 2023-02-03 |
Family
ID=85045605
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202211346516.2A Pending CN115671401A (en) | 2022-10-31 | 2022-10-31 | Medical latex balloon |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN115671401A (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN116462890A (en) * | 2023-05-23 | 2023-07-21 | 深圳市慧极创新医疗科技有限公司 | High-pressure-resistant medical latex balloon |
Citations (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB696404A (en) * | 1950-11-25 | 1953-08-26 | Metallgesellschaft Ag | Improved process for the vulcanisation of natural rubber latices |
| JPH08118377A (en) * | 1994-10-21 | 1996-05-14 | Okamoto Ind Inc | Production of balloon for ultrasonic endoscope |
| US20070082152A1 (en) * | 2003-11-21 | 2007-04-12 | Kazumi Kodama | Dip forming composition and dip formed article |
| CN105358618A (en) * | 2013-07-10 | 2016-02-24 | Ttk防护设备有限公司 | A binary process for manufacture of dipped latex products |
| CN108245222A (en) * | 2018-01-23 | 2018-07-06 | 青岛星创医疗科技有限公司 | The medical preparation method for taking stone sacculus |
| CN109453435A (en) * | 2018-11-27 | 2019-03-12 | 广州新诚生物科技有限公司 | A kind of preparation method of catheter-balloon |
| CN113845704A (en) * | 2021-09-30 | 2021-12-28 | 中国热带农业科学院橡胶研究所 | Natural latex ultrathin condom and preparation method thereof |
-
2022
- 2022-10-31 CN CN202211346516.2A patent/CN115671401A/en active Pending
Patent Citations (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB696404A (en) * | 1950-11-25 | 1953-08-26 | Metallgesellschaft Ag | Improved process for the vulcanisation of natural rubber latices |
| JPH08118377A (en) * | 1994-10-21 | 1996-05-14 | Okamoto Ind Inc | Production of balloon for ultrasonic endoscope |
| US20070082152A1 (en) * | 2003-11-21 | 2007-04-12 | Kazumi Kodama | Dip forming composition and dip formed article |
| CN105358618A (en) * | 2013-07-10 | 2016-02-24 | Ttk防护设备有限公司 | A binary process for manufacture of dipped latex products |
| CN108245222A (en) * | 2018-01-23 | 2018-07-06 | 青岛星创医疗科技有限公司 | The medical preparation method for taking stone sacculus |
| CN109453435A (en) * | 2018-11-27 | 2019-03-12 | 广州新诚生物科技有限公司 | A kind of preparation method of catheter-balloon |
| CN113845704A (en) * | 2021-09-30 | 2021-12-28 | 中国热带农业科学院橡胶研究所 | Natural latex ultrathin condom and preparation method thereof |
Non-Patent Citations (1)
| Title |
|---|
| 胡又牧等: "胶乳应用技术", 化学工业出版社, pages: 25 * |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN116462890A (en) * | 2023-05-23 | 2023-07-21 | 深圳市慧极创新医疗科技有限公司 | High-pressure-resistant medical latex balloon |
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