CN103302946A - Processing method for medical cloth with biocompatibility - Google Patents
Processing method for medical cloth with biocompatibility Download PDFInfo
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- CN103302946A CN103302946A CN2012100624330A CN201210062433A CN103302946A CN 103302946 A CN103302946 A CN 103302946A CN 2012100624330 A CN2012100624330 A CN 2012100624330A CN 201210062433 A CN201210062433 A CN 201210062433A CN 103302946 A CN103302946 A CN 103302946A
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Abstract
The invention relates to a processing method for medical cloth with biocompatibility. According to the invention, the manner of film formation of solvent polyurethane is changed from traditional transfer coating to calendering transfer, and then a wet hardening type hot melt adhesive is used to replace a solvent type adhesive for applying; that is to say, no solvent and no bridging agent are used in process flow; and thus, the medical cloth provided by the invention not only has same functions as a polyurethane transfer coating product provides but also avoids harmful influence caused by incapable safe elimination of an irritant solvent, so the medical cloth can pass cytotoxicity test of biocompatibility of medical equipment.
Description
Technical field
The present invention relates to a kind of medical cloth, particularly relate to a kind of processing method with medical cloth of bio-compatibility.
Background technology
The medical mattress material, compared with general ready-made clothes material, need more and higher physical property, for example, need to use high temperature washing, wet sterilization, surface abrasion resistance, antifouling, waterproof etc. in washing part, wherein the most particularly in order to guarantee the bio-compatibility of medical equipment, according to the international evaluation criteria of ISO 10993-1-medical equipment bio-compatibility and the standards of middle several the help medical equipment manufacturer selection materials that propose of FDA blue book memorandum (#G95-1), all medical equipments must be passed through Cytotoxic basic test.
Bio-compatibility refers to medical material and patient's tissue and the interoperability between physiological system.Why medical material can also can be used safely clinical achieving success, main because of its good bio-compatibility.Usually, some medical materials in use can discharge noxious material, cause with patient not " compatibility ".For the purpose of monitoring bio-compatibility, generally can simulate in the worst case use medical material and extract thereof, thereby guarantee the security under regular service conditions.
The medical mattress material is mainly the product that polyurethane transcription coating is fitted on the market, but because raw material sources contain pungent, be solvent borne polyurethane (PU) material such as superficial film, following layer then is two-liquid type solvent bridge formation system, in procedure, can't get rid of completely solvent, produce and make cell line distortion or dead, and be difficult to the cell toxicity test by bio-compatibility.
Summary of the invention
In view of above problem, main purpose of the present invention is to provide a kind of processing method with medical cloth of bio-compatibility, it is the mode transcription film forming with the plastic ethers polyurethane of heat utilization calendering, and with the processing of fitting of wet type constrictive type thermosol adhesive, can solve whereby the excitant solvent and can't get rid of safely the impact that causes, and be able to the cell toxicity test by bio-compatibility.
For reaching the above object, the invention provides a kind of processing method with medical cloth of bio-compatibility, its step is to be posted on polypropylene (PP) cloudy-surface release paper after the plastic ethers polyurethane of heat (ethers TPU) calendering, form hot plastic ethers polyurethane film, replace known solvent borne polyurethane release liners dry transfer processing, then the plastic ethers polyurethane film of heat is separated with release liners, then re-use wet type hardening polyurethane (PUR) adhesive and replace traditional solvent type adhesive, the plastic ethers polyurethane film of heat is fitted on the elastical cloth, this processing method avoids using solvent fully, thereby obtains to have the medical cloth of bio-compatibility.
The present invention adopts technique scheme, has the following advantages:
According to the processing method with medical cloth of bio-compatibility of the present invention, use solvent and bridging agent have been avoided fully, therefore, can obtain by medical equipment among ISO and the FDA defined ISO-10993 about the medical cloth product of the cell toxicity test of bio-compatibility.
Description of drawings
Fig. 1 is the flow chart of the processing method of the medical cloth with bio-compatibility that provides of the embodiment of the invention;
Fig. 2 A～2D is the cell line cultivation pattern before the present invention carries out the cell toxicity test method test, and represents respectively the situation of reagent control group, negative control group, positive controls, sample group;
Fig. 3 A～3D is that the present invention carries out the cell line cultivation pattern of cell toxicity test method after 48 hours, and represents respectively the situation of reagent control group, negative control group, positive controls, sample group.
The specific embodiment
Please refer to Fig. 1, the flow chart of the processing method of the medical cloth of the had bio-compatibility that provides for embodiments of the invention.
Such as step S100, at first, the hot plastic ethers polyurethane (ethers TPU) that has elasticity and non-toxic nature can meet medical supplies, such as the plastic ethers polyurethanes of heat as raw material, use amount is 100 weight portions, behind 140 ℃ of mastications of heating on the second wheel, add again Tissuemat E colorant or the hot plastic polyurethanes colorant of 4 weight portions, mixing even.
Then, such as step S101, hot plastic ethers polyurethane after will be mixing with aforementioned colorant is sent in the L type calender, be calendered to and set thickness 0.06mm～0.10mm, be posted again in polypropylene (PP) cloudy-surface release paper at 140 ℃ and produce the plastic ethers polyurethane film of not solvent-laden heat.In the present embodiment, when reaching medical bedcover and skin contact, smooth effect is wanted on the surface, thus utilize the smooth and special decorative pattern of cloudy-surface release paper to make film, allow hot plastic ethers polyurethane film can reach surfacing, dry and comfortable, do not after-tack and high-quality film attractive in appearance.
Such as step S102, at normal temperatures, with stripping machine the plastic ethers polyurethane film of heat and release liners are done to separate.
Then, such as step S103, use wet type hardening polyurethane (PUR) adhesive, such as the plastic ethers polyurethanes of heat, at 80-110 ℃ the plastic ethers polyurethane film of heat and elastical cloth are fitted.Elastical cloth can be selected from natural fiber cloth, half Artificial Fibers cloth, blend fibre cloth or Artificial Fibers cloth.
At last, such as step S104,25-30 ℃ through 24 hours maturation after, allow wet type hardening polyurethane adhesive and airborne moisture content fully in conjunction with sclerosis, be finished product.
The related description that below can have the check of bio-compatible cytotoxic for embodiments of the invention.
The present invention is according to ISO10993-52009 regulation enforcement cell toxicity test method (EM elutionmethod), utilize NCTC clone 929 cell lines after substances extraction nutrient solution is processed 48 hours, observe growth kenel and the survival number of control group and dosage group cell.In order to the cytotoxicity of evaluation test material for subject cell.
Test method at first is according to ISO10993-12 2007 standard extraction test materials, extractant is cell culture fluid, and test with this extract, and experiment is divided into positive controls (phenol), negative control group (high density polyethylene (HDPE)), reagent control group (cell culture fluid) and sample group (sample), every group is carried out repeated test at least three times, and tests with former times of substances extract.With NCTCclone 929 cell lines after suitably activating, get 10
5Individual cell is in the extraction nutrient solution that contains substances or contain nutrient solution feminine gender and the positive controls nutrient solution of substances.Cell continue to be cultivated 48 and was as a child observed, and carries out qualitative evaluation according to the cell kenel again, and calculates cell and carry out qualitative assessment through 48 as a child survival rates.
See also Fig. 2 A～2D, the cell line that is respectively the front reagent control group of test, negative control group, positive controls, sample group is cultivated pattern.And Fig. 3 A～3D then is that the cell line after 48 hours is cultivated pattern.Not death and modification of the cell line of sample group as seen from the figure.
Table one is the qualitative evaluation result of this test.Can be found by the result, the sample group is unchanged, is judged to be 0 grade of the best according to ISO10993, and positive controls produces the change of severe type, is judged to be level Four the poorest.
Table one
| Group | Processing time (hour) | Cellular morphology | Grade |
| The reagent control group | 0 | Acellular dissolving or form change | 0 |
| Negative control group | 0 | Acellular dissolving or form change | 0 |
| Positive controls | 0 | Acellular dissolving or form change | 0 |
| The sample group | 0 | Acellular dissolving or form change | 0 |
| The reagent control group | 48 | Acellular dissolving or form change | 0 |
| Negative control group | 48 | Acellular dissolving or form change | 0 |
| Positive controls | 48 | Moderate cytolysis or form change | 4 |
| The sample group | 48 | Acellular dissolving or form change | 0 |
Table two is the qualitative assessment result of this test.Can be found by the result, reagent control group, negative control group and sample group do not produce cytolysis, and positive controls produces 92.8% cytolysis.
Table two
| Group | Absorbance (570nm) | Dissolving percentage |
| The reagent control group | 1.37±0.13 | 0 |
| Negative control group | 1.37±0.05 | 0 |
| Positive controls | 0.08±0.00 | 92.8 |
| The sample group | 1.32±0.18 | 0 |
Table three is experimental result and the analysis result of this test.After testing thus the interleave comparison, judge procedure of the present invention, can be by the cell toxicity test of bio-compatibility.
Table three
| Group | Inclusion | Qualitative evaluation | Grade | Qualitative assessment | Solubility |
| The reagent control group | Blank | Without changing | 0 | 1.37 | 0 |
| Negative control group | Polyethylene | Without changing | 0 | 1.13 | 0 |
| Positive controls | Phenol | Severe deformation | 4 | 0.08 | 92.8 |
| The sample group | Sample of the present invention | Without changing | 0 | 1.32 | 0 |
Above these embodiment only are exemplary, scope of the present invention are not consisted of any restriction.It will be understood by those skilled in the art that lower without departing from the spirit and scope of the present invention and can make amendment or replace the details of technical solution of the present invention and form, but these modifications and replacing all fall within the scope of protection of the present invention.
Claims (6)
1. processing method with medical cloth of bio-compatibility, its step comprises:
One hot plastic ethers polyurethane is provided;
Should be posted on a release liners after the plastic ethers polyurethane calendering of heat, and form a hot plastic ethers polyurethane film;
Should separate with this release liners by the plastic ethers polyurethane film of heat; And
Use a wet type hardening polyurethane adhesive, should fit in an elastical cloth by the plastic ethers polyurethane film of heat, and obtain a medical cloth.
2. the processing method with medical cloth of bio-compatibility as claimed in claim 1, it is characterized in that, the plastic ethers polyurethane of this heat adds Tissuemat E colorant or hot plastic colorant, and should the plastic ethers polyurethane of heat and the proportion of composing of this Tissuemat E colorant or hot plastic colorant be 100 weight portions: 4 weight portions.
3. the processing method with medical cloth of bio-compatibility as claimed in claim 2 is characterized in that, the plastic ethers polyurethane of this heat is first through second wheel heating mastication, adds this Tissuemat E colorant or hot plastic colorant mixing evenly again.
4. the processing method with medical cloth of bio-compatibility as claimed in claim 1 is characterized in that, this release liners is the polypropylene cloudy-surface release paper.
5. the processing method with medical cloth of bio-compatibility as claimed in claim 1, it is characterized in that, the plastic ethers polyurethane film of this heat is fitted in after the step of this elastical cloth, also comprise a step of waiting for maturation, make this wet type hardening polyurethane adhesive finish sclerosis.
6. the processing method with medical cloth of bio-compatibility as claimed in claim 1 is characterized in that, this elastical cloth is selected from natural fiber cloth, half Artificial Fibers cloth, blend fibre cloth or Artificial Fibers cloth.
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| Application Number | Priority Date | Filing Date | Title |
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| CN2012100624330A CN103302946A (en) | 2012-03-09 | 2012-03-09 | Processing method for medical cloth with biocompatibility |
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| Application Number | Priority Date | Filing Date | Title |
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| CN2012100624330A CN103302946A (en) | 2012-03-09 | 2012-03-09 | Processing method for medical cloth with biocompatibility |
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| CN2012100624330A Pending CN103302946A (en) | 2012-03-09 | 2012-03-09 | Processing method for medical cloth with biocompatibility |
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| TW200742751A (en) * | 2006-05-12 | 2007-11-16 | Formosan Rubber Group Inc | The manufacturing method of water proof film with mist surface |
| TWI309658B (en) * | 2001-02-23 | 2009-05-11 | ||
| CN101992888A (en) * | 2009-08-21 | 2011-03-30 | 翁文桂 | Laminated material without metal foil for blocking package |
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2012
- 2012-03-09 CN CN2012100624330A patent/CN103302946A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| TWI309658B (en) * | 2001-02-23 | 2009-05-11 | ||
| TW200742751A (en) * | 2006-05-12 | 2007-11-16 | Formosan Rubber Group Inc | The manufacturing method of water proof film with mist surface |
| CN101992888A (en) * | 2009-08-21 | 2011-03-30 | 翁文桂 | Laminated material without metal foil for blocking package |
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Application publication date: 20130918 |