CN105327437A - Hydrophilic type super-lubricity urinary catheter and preparation method thereof - Google Patents
Hydrophilic type super-lubricity urinary catheter and preparation method thereof Download PDFInfo
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- CN105327437A CN105327437A CN201510799928.5A CN201510799928A CN105327437A CN 105327437 A CN105327437 A CN 105327437A CN 201510799928 A CN201510799928 A CN 201510799928A CN 105327437 A CN105327437 A CN 105327437A
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Abstract
The invention relates to a hydrophilic type super-lubricity urinary catheter and a preparation method thereof, and belongs to the technical field of medical product processing. The hydrophilic type super-lubricity urinary catheter consists of a hydrophilic type super-lubricity coating, a polyurethane polymer outer layer and a pipe main body layer, wherein the hydrophilic type super-lubricity coating is arranged on the polyurethane polymer outer layer; the pipe main body layer is positioned at the inner side of the polyurethane polymer outer layer, and is integrally formed with the polyurethane polymer outer layer; and the hydrophilic type super-lubricity coating, the polyurethane polymer outer layer and the pipe main body layer form a concentric layer structure. The hydrophilic type super-lubricity urinary catheter provided by the invention is applied to clinical infusion and has the advantages of being integrally formed, strong in adhesive force, good in wetting property, good in water retention property, low in friction coefficient, high in mechanical strength, excellent in safety and the like.
Description
Technical field
The present invention relates to a kind of hydrophilic ultra-smooth urinary catheter and preparation method thereof, belong to medical product processing technique field.
Background technology
Usually need tube placing operation the patient of hospital surgical and clinical generation urine retention, namely use catheter, through per urethram inserting bladder so that by urine drainage out.Clinical usual employing insert saccule urinary catheter (Foley catheter or the method such as coude catheter or suprapubic puncture fistulation, but adopt indwelling catheter time, need connector external drainage device (as urine drainage bag), cause the inconvenience of activity and life.Except saccule urinary catheter places art, research shows, it is intermittent that oneself cleans urethral catheterization (Cleanintermittentself-catheterization, being called for short CISC) safe, simple to operate, technology is easy to grasp, the chance recovering automatic micturition is higher than indwelling catheter person, and urinary tract infection chance is lower; Its sharpest edges are to wear device outside, and life is convenient, and it also can allow patient to attempt automatic micturition simultaneously.
For a long time, have a lot of research institutions to study for a long time, have developed multiple take polrvinyl chloride as base material, and the catheter carrying out surface treatment (as hydrophilic superslide coating) is applied to clinical.Such as EP0093093 application discloses that the method manufacturing PVC catheter, and this catheter has hydrophilic external surface coating, and this catheter demonstrates low-friction coefficient when wet.
Then since entering 21 century, due to the toxicity of plasticizer (class hormonal substances) of adding in environmental problem particularly PVC, the suitability that PVC is used for catheter is subject to extensive query; In addition, cause producing in the longitudinal direction of PVC conduit obviously shrinking by the method coating PVC conduit in such as EP0093093, its shrinkage factor can reach the 8-10% of raw footage, and this causes due to the heating process adopted in the stretching and coating process of conduit extrusion; Meanwhile, this coating process needs to adopt secondary coating, and the quality of this coating process is remarkable by technogenic influences such as coating, stoving processes, and product quality homogeneity is poor.
Be proposed other base materials, such as CN101222946A proposes the compositions of the molecule comprising polyolefin and contain reactive hydrogen as matrix material, the blend of such as polyethylene or SEBS and polyamide or polyurethane etc.But inevitably problem is the high manufacturing expense of these materials; All mention when carrying out the coating process of hydrophilic superslide coating to base material at CN101222946A and CN1537643A, need to adopt two step method: namely first matrix conduit is flooded in 1# solution after drying, in 2# solution, dipping makes catheter with hydrophilic superslide coating after drying again, and this just inevitably causes the difficulty of the complexity of production technology, the increase of production cost and quality control.
Still there is a lot of defect in application and the processing of catheter, based on this, makes subject application.
Summary of the invention
In order to overcome the above-mentioned defect existing for existing catheter, first the present invention provides the hydrophilic ultra-smooth urinary catheter that a kind of compatibility is good, mechanical strength is high.
For achieving the above object, the technical scheme taked of the present invention is as follows:
Hydrophilic ultra-smooth urinary catheter, be made up of hydrophilic superslide coating, polyether polyols with reduced unsaturation skin and tube body layer, hydrophilic superslide coating is arranged on polyether polyols with reduced unsaturation skin, tube body layer is positioned at inside polyether polyols with reduced unsaturation skin, and tube body layer and polyether polyols with reduced unsaturation skin one-body molded, by hydrophilic superslide coating, polyether polyols with reduced unsaturation, outer and tube body layer is concentric layered shell polysaccharide structure.
Further, as preferably:
Described polyether polyols with reduced unsaturation skin is made up of PAUR or EU or polycarbonate polyurethane.
Described tube body layer is formed by PVC material or containing the blend of PVC.
Described hydrophilic superslide coating is that the solution oven dry formed by hydrophilic high molecular polymer, adhesive polymer, film former and solvent forms.Preferred, described hydrophilic high molecular polymer is polyvinyl alcohol, one or two or more kinds combination of polyethylene glycol oxide, polyvinylpyrrolidone etc., preferably polyethylene ketopyrrolidine; Described adhesive polymer is one or more mixture of polyester, PVB, acrylic resin, vinylacetate etc., preferred acrylic resins; Described film former is one or more mixture of cellulose esters, PEG etc., preferred nitrocellulose; Described solvent is that methanol, ethanol, isopropyl alcohol, acetone, butanone, MIBK, THF, ethyl acetate, toluene, dimethyl formamide etc. obtain more than two kinds combinations.
Described polyether polyols with reduced unsaturation outer layer thickness is 0.02-0.5mm, and tube body layer thickness is 0.1-1.5mm.
Simultaneously, present invention also offers a kind of preparation method with above-mentioned feature hydrophilic ultra-smooth urinary catheter, first by polyether polyols with reduced unsaturation and PVC material or drop into during co-extrusion machine lifts one's head containing the blend of PVC, and the one-body molded basic body with the outer and tube body Rotating fields of polyether polyols with reduced unsaturation; Then on this basic body, hydrophilic superslide coating is processed to form.
As preferably:
Described is preferably PAUR or EU, and thickness is 0.02-0.5mm.
Described catheter main body layer thickness is 0.1-1.5mm.
The described concentric feeding manner of one-body molded employing, impregnation method or spraying method, make tube body layer covers polyether polyols with reduced unsaturation skin.When adopt concentric feeding manner time, tube body layer and the charging of polyether polyols with reduced unsaturation outer field raw material concentric manner, and when adopt dipping or spraying method time, be tube body layer outside use dipping or spray mode cover one deck polyether polyols with reduced unsaturation skin.
Described hydrophilic superslide coating adopts the mode of dipping or spraying post-drying to be arranged on basic body.When adopting impregnation method, basic body being inserted in hydrophilic superslide coating solution, after dipping 2-60s, drying.
Operation principle of the present invention and beneficial effect as follows:
(1) processing of catheter is applied the present invention to, polyether polyols with reduced unsaturation, PVC or the mixture containing PVC adopt concentric feeding manner to extrude, the outer tube body layer formed with PVC or the mixture containing PVC of the catheter polyether polyols with reduced unsaturation that this kind of mode is formed is formed in one structure, therefore, each interlayer, without the need to adding binding agent, can ensure its tear strength.
(2) in the application, after basis body is inserted into and floods 2-60s in hydrophilic superslide coating solution, dry in an oven and can obtain good with basic body strong adhesion, wettability, good water-retaining property, low-friction coefficient hydrophilic superslide coating, this hydrophilic superslide coating passes through physical action, instead of be combined on catheter substrate by chemical reaction, hydrophilic solution can not cause the change of physical index because there is chemical reaction, solution-stabilized, integral processing is simple, there is not the problem of mass uniformity, and low cost of manufacture.
(3) the hydrophilic ultra-smooth urinary catheter in the application is from outside to inside primarily of hydrophilic superslide coating, polyether polyols with reduced unsaturation skin and three layers, tube body layer formation, as used more than three layers structural conductor, the polymer being suitable for PVC material co-extrusion or blend polymer then can be used as tube body layer inside structure layer, concentric feeding manner is adopted to extrude together with polyether polyols with reduced unsaturation, PVC or the mixture containing PVC, easy to process, use motility strong.
The multi-layer compound structure outermost layer that the present invention is formed is hydrophilic superslide coating, facilitate insertion and the taking-up of catheter, this coating has good lubricity, water-retaining property and low frictional properties, thus, when directly contacting with skin or organ, the impact caused health is minimum, improves comfort, tube body layer is formed primarily of PVC, this PVC ensure that supportive and the requirement of strength of body, but easily introduce heavy metal, therefore, in the application, secondary skin is that the polyether polyols with reduced unsaturation that polyether polyols with reduced unsaturation is formed is outer, stop skin to contact with the direct of tube body layer, and play the effect of stop, in transfusion, in water conservancy diversion process, the surface that polyether polyols with reduced unsaturation skin contacts with tissue adherence is non-PVC material, there is excellent biocompatibility, thus avoid plasticizer in polyvinyl chloride conduit, heat stabilizer contacts mucosa with Vinyl Chloride Monomer, the problem be detrimental to health, also overcome the problems such as latex biocompatibility is bad, silica gel mechanical strength is low simultaneously.
Accompanying drawing explanation
Fig. 1 is the first structural representation of the present invention;
Fig. 2 is the second structural representation of the present invention.
Number in the figure: 1. polyether polyols with reduced unsaturation is outer; 2. tube body layer; 3. polyurethane polymerization internal layer; 4. hydrophilic superslide coating.
Detailed description of the invention
Embodiment 1
The present embodiment hydrophilic ultra-smooth urinary catheter, composition graphs 1, be made up of polyether polyols with reduced unsaturation skin 1, tube body layer 2 and hydrophilic superslide coating 4, be hydrophilic superslide coating 4 outside polyether polyols with reduced unsaturation skin 1, inner side then arranges tube body layer 2, and polyether polyols with reduced unsaturation outer 1 is arranged with tube body layer 2 is concentric, wherein, in the present embodiment, outer 1 thickness of polyether polyols with reduced unsaturation is 0.05-0.5mm, and tube body layer 2 thickness is 0.1-1mm; Polyether polyols with reduced unsaturation skin 1 is made up of PAUR, tube body layer 2 is made up of PVC, hydrophilic superslide coating 4 is that the solution oven dry formed by hydrophilic high molecular polymer, adhesive polymer, film former and solvent forms, hydrophilic high molecular polymer is wherein polyvinylpyrrolidone, adhesive polymer is acrylic resin, film former is nitrocellulose, and solvent is methanol.
The preparation method of above-mentioned hydrophilic ultra-smooth urinary catheter is as follows: (1) first by polyether polyols with reduced unsaturation and PVC material or drop into during co-extrusion machine lifts one's head containing the blend of PVC, and with the one-body molded basic body with polyether polyols with reduced unsaturation outer 1 and tube body Rotating fields 2 of concentric feeding manner; (2) insert in hydrophilic superslide coating solution by this basic body, after dipping 5-60s, oven dry can form hydrophilic superslide coating 4 on basic body.
What the present embodiment is applied to catheter adds man-hour, polyether polyols with reduced unsaturation, PVC or the mixture containing PVC adopt concentric feeding manner to extrude, the tube body layer 2 that the catheter polyether polyols with reduced unsaturation that this kind of mode is formed outer 1 and PVC or the mixture containing PVC are formed is formed in one structure, therefore, each interlayer, without the need to adding binding agent, can ensure its tear strength.
Then basic body is inserted in hydrophilic superslide coating solution and floods, dry again and can obtain good with basic body strong adhesion, wettability, good water-retaining property, low-friction coefficient hydrophilic superslide coating 4, this hydrophilic superslide coating 4 is attached on polyether polyols with reduced unsaturation skin 1 by physical action, instead of be combined on catheter substrate by chemical reaction, hydrophilic solution can not cause the change of physical index because there is chemical reaction, solution-stabilized, integral processing is simple, there is not the problem of mass uniformity, and low cost of manufacture.
The multi-layer compound structure outermost layer that the present embodiment is formed is hydrophilic superslide coating 4, facilitate insertion and the taking-up of catheter, this coating has good lubricity, water-retaining property and low frictional properties, thus, when directly contacting with skin or organ, the impact caused health is minimum, improves comfort, tube body layer 2 is formed primarily of PVC, this PVC ensure that supportive and the requirement of strength of body, but easily introduce the harmful factors such as heavy metal, therefore, in the application, secondary skin is the polyether polyols with reduced unsaturation skin 1 that polyether polyols with reduced unsaturation is formed, stop skin to contact with the direct of tube body layer, and play the effect of stop, in transfusion, in water conservancy diversion process, the surface that polyether polyols with reduced unsaturation outer 1 contacts with tissue adherence is non-PVC material, there is excellent biocompatibility, thus avoid plasticizer in common polyvinyl chloride conduit, heat stabilizer contacts mucosa with Vinyl Chloride Monomer, the problem be detrimental to health, also overcome the problems such as latex biocompatibility is bad, silica gel mechanical strength is low simultaneously.
Embodiment 2
The present embodiment is identical with operation principle with the setting of embodiment 1, difference is: in the present embodiment, basis body adopts impregnation method to realize one-body molded: tube body layer 2 is immersed in polyether polyols with reduced unsaturation, thus on tube body layer 2, cover one deck polyether polyols with reduced unsaturation skin 1.
Hydrophilic superslide coating 4 adopts impregnation method to be arranged on basic body: inserted by basic body in hydrophilic superslide coating solution, after dipping 5-60s, dry.
Embodiment 3
The present embodiment is identical with operation principle with the setting of embodiment 1, difference is: in the present embodiment, basis body adopts spraying method to realize one-body molded: be sprayed on by polyether polyols with reduced unsaturation on tube body layer 2, makes it to cover on tube body layer 2 to form one deck polyether polyols with reduced unsaturation skin 1.
Hydrophilic superslide coating 4 adopts impregnation method to be arranged on basic body: inserted by basic body in hydrophilic superslide coating solution, after dipping 5-60s, dry.
Embodiment 4
The present embodiment is identical with operation principle with the setting of embodiment 1, difference is: in the present embodiment, basis body adopts impregnation method to realize one-body molded: tube body layer 2 is immersed in polyether polyols with reduced unsaturation, thus on tube body layer 2, cover one deck polyether polyols with reduced unsaturation skin 1.
Hydrophilic superslide coating 4 adopts irradiation under ultraviolet ray mode mode to be arranged on basic body.
Embodiment 5
The present embodiment is identical with operation principle with the setting of embodiment 1, difference is: in the present embodiment, basis body adopts spraying method to realize one-body molded: be sprayed on by polyether polyols with reduced unsaturation on tube body layer 2, makes it to cover on tube body layer 2 to form one deck polyether polyols with reduced unsaturation skin 1.
Hydrophilic superslide coating 4 adopts irradiation under ultraviolet ray mode mode to be arranged on basic body.
Embodiment 6
The present embodiment is identical with operation principle with the setting of embodiment 1, difference is: composition graphs 2, hydrophilic ultra-smooth urinary catheter in the application is from outside to inside by hydrophilic superslide coating 4, polyether polyols with reduced unsaturation skin 1, tube body layer 2 and polyurethane polymerization internal layer 3 amount to four-layer structure, polyether polyols with reduced unsaturation skin 1 is made up of EU, tube body layer 2 is made up of the mixed polymer containing PVC, polyurethane polymerization internal layer 3 can use the polymer that is suitable for PVC material co-extrusion or blend polymer such as PAUR to make, hydrophilic superslide coating 4 is by hydrophilic high molecular polymer, adhesive polymer, the solution that film former and solvent are formed is dried and is formed, hydrophilic high molecular polymer is wherein polyethylene glycol oxide, adhesive polymer is vinylacetate, film former is PEG, solvent is isopropyl alcohol, ethyl acetate, PAUR, polyether polyols with reduced unsaturation, PVC or the mixture three containing PVC adopt concentric feeding manner to extrude together, form integrated basic body, and overall processing is convenient, use motility strong.
Embodiment 7
The present embodiment is identical with operation principle with the setting of embodiment 6, difference is: in the present embodiment, basis body adopts impregnation method to realize one-body molded: tube body layer 2 is immersed in polyether polyols with reduced unsaturation, thus on tube body layer 2, cover one deck polyether polyols with reduced unsaturation skin 1.
Hydrophilic superslide coating 4 adopts impregnation method to be arranged on basic body: inserted by basic body in hydrophilic superslide coating solution, after dipping 5-60s, dry.
Embodiment 8
The present embodiment is identical with operation principle with the setting of embodiment 6, difference is: in the present embodiment, basis body adopts spraying method to realize one-body molded: be sprayed on by polyether polyols with reduced unsaturation on tube body layer 2, makes it to cover on tube body layer 2 to form one deck polyether polyols with reduced unsaturation skin 1.
Hydrophilic superslide coating 4 adopts impregnation method to be arranged on basic body: inserted by basic body in hydrophilic superslide coating solution, after dipping 5-60s, dry.
Embodiment 9
The present embodiment is identical with operation principle with the setting of embodiment 6, difference is: in the present embodiment, basis body adopts impregnation method to realize one-body molded: tube body layer 2 is immersed in polyether polyols with reduced unsaturation, thus on tube body layer 2, cover one deck polyether polyols with reduced unsaturation skin 1.
Hydrophilic superslide coating 4 adopts irradiation under ultraviolet ray mode mode to be arranged on basic body.
Embodiment 10
The present embodiment is identical with operation principle with the setting of embodiment 6, difference is: in the present embodiment, basis body adopts spraying method to realize one-body molded: be sprayed on by polyether polyols with reduced unsaturation on tube body layer 2, makes it to cover on tube body layer 2 to form one deck polyether polyols with reduced unsaturation skin 1.
Hydrophilic superslide coating 4 adopts irradiation under ultraviolet ray mode mode to be arranged on basic body.
Above content is the further description done provided technical scheme in conjunction with the preferred embodiment of the present invention; can not assert that the present invention specifically implements to be confined to these explanations above-mentioned; for general technical staff of the technical field of the invention; without departing from the inventive concept of the premise; some simple deduction or replace can also be made, all should be considered as belonging to protection scope of the present invention.
Claims (10)
1. hydrophilic ultra-smooth urinary catheter, it is characterized in that: be made up of hydrophilic superslide coating, polyether polyols with reduced unsaturation skin and tube body layer, hydrophilic superslide coating is arranged on polyether polyols with reduced unsaturation skin, tube body layer is positioned at inside polyether polyols with reduced unsaturation skin, and tube body layer and polyether polyols with reduced unsaturation skin one-body molded, by hydrophilic superslide coating, polyether polyols with reduced unsaturation, outer and tube body layer is concentric layered shell polysaccharide structure.
2. hydrophilic ultra-smooth urinary catheter as claimed in claim 1, is characterized in that: described polyether polyols with reduced unsaturation skin is made up of PAUR or EU or polycarbonate polyurethane.
3. hydrophilic ultra-smooth urinary catheter as claimed in claim 1, is characterized in that: described tube body layer is formed by PVC material or containing the blend of PVC.
4. hydrophilic ultra-smooth urinary catheter as claimed in claim 1, is characterized in that: described hydrophilic superslide coating is that the solution oven dry formed by hydrophilic high molecular polymer, adhesive polymer, film former and solvent forms.
5. hydrophilic ultra-smooth urinary catheter as claimed in claim 4, it is characterized in that: described hydrophilic high molecular polymer is polyvinyl alcohol, polyethylene glycol oxide, one or more combinations of polyvinylpyrrolidone etc., described adhesive polymer is polyester, PVB, acrylic resin, one or more mixture of vinylacetate etc., described film former is cellulose esters, one or more mixture of PEG etc., described solvent is methanol, ethanol, isopropyl alcohol, acetone, butanone, MIBK, THF, ethyl acetate, toluene, dimethyl formamides etc. obtain more than two kinds combinations.
6. hydrophilic ultra-smooth urinary catheter as claimed in claim 1, it is characterized in that: described polyether polyols with reduced unsaturation outer layer thickness is 0.02-0.5mm, tube body layer thickness is 0.1-1.5mm.
7. the preparation method of hydrophilic ultra-smooth urinary catheter as claimed in claim 1, it is characterized in that: first by polyether polyols with reduced unsaturation and PVC or drop into during co-extrusion machine lifts one's head containing the blend of PVC, and the one-body molded basic body with the outer and tube body Rotating fields of polyether polyols with reduced unsaturation; Hydrophilic superslide coating is formed at this basic body.
8. the preparation method of hydrophilic ultra-smooth urinary catheter as claimed in claim 7, is characterized in that: described polyether polyols with reduced unsaturation is PAUR or EU or polycarbonate polyurethane, and thickness is 0.02-0.5mm.
9. the preparation method of hydrophilic ultra-smooth urinary catheter as claimed in claim 7, is characterized in that: described catheter main body layer thickness is 0.1-1.5mm.
10. the preparation method of hydrophilic ultra-smooth urinary catheter as claimed in claim 7, is characterized in that: the described concentric feeding manner of one-body molded employing, impregnation method or spraying method, makes tube body layer covers polyether polyols with reduced unsaturation skin; Described hydrophilic superslide coating adopts dipping or to spray and the mode of drying is arranged on basic body.
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| CN201510799928.5A CN105327437A (en) | 2015-11-19 | 2015-11-19 | Hydrophilic type super-lubricity urinary catheter and preparation method thereof |
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Cited By (8)
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| CN105597217A (en) * | 2016-02-29 | 2016-05-25 | 浙江曙光科技有限公司 | PVC ultra-smooth hydrophilic catheter and preparation method thereof |
| WO2018120982A1 (en) * | 2016-12-26 | 2018-07-05 | 上海英诺伟医疗器械有限公司 | Double-layered drainage tube |
| CN108744067A (en) * | 2018-08-25 | 2018-11-06 | 费宇奇 | A kind of preparation method of biological chitosan composite medical conduit |
| CN109550087A (en) * | 2018-11-01 | 2019-04-02 | 河南驼人贝斯特医疗器械有限公司 | A kind of load sustained release superslide analgesia catheter and preparation method thereof |
| CN110721392A (en) * | 2019-09-29 | 2020-01-24 | 深圳泰睿仕医疗科技有限公司 | Disposable ureter guide sheath |
| CN111365534A (en) * | 2020-03-13 | 2020-07-03 | 中国热带农业科学院农产品加工研究所 | Polymer coating natural latex tube and preparation method thereof |
| CN112156266A (en) * | 2020-10-13 | 2021-01-01 | 湖南平安医械科技有限公司 | Disposable venous indwelling needle catheter |
| CN116138924A (en) * | 2022-10-20 | 2023-05-23 | 深圳朗医科技有限公司 | Anti-compression corrosion-resistant tumor ureteral stent |
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Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105597217A (en) * | 2016-02-29 | 2016-05-25 | 浙江曙光科技有限公司 | PVC ultra-smooth hydrophilic catheter and preparation method thereof |
| WO2018120982A1 (en) * | 2016-12-26 | 2018-07-05 | 上海英诺伟医疗器械有限公司 | Double-layered drainage tube |
| CN108744067A (en) * | 2018-08-25 | 2018-11-06 | 费宇奇 | A kind of preparation method of biological chitosan composite medical conduit |
| CN109550087A (en) * | 2018-11-01 | 2019-04-02 | 河南驼人贝斯特医疗器械有限公司 | A kind of load sustained release superslide analgesia catheter and preparation method thereof |
| CN110721392A (en) * | 2019-09-29 | 2020-01-24 | 深圳泰睿仕医疗科技有限公司 | Disposable ureter guide sheath |
| CN111365534A (en) * | 2020-03-13 | 2020-07-03 | 中国热带农业科学院农产品加工研究所 | Polymer coating natural latex tube and preparation method thereof |
| CN112156266A (en) * | 2020-10-13 | 2021-01-01 | 湖南平安医械科技有限公司 | Disposable venous indwelling needle catheter |
| CN116138924A (en) * | 2022-10-20 | 2023-05-23 | 深圳朗医科技有限公司 | Anti-compression corrosion-resistant tumor ureteral stent |
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