CN101785900A - Medicinal balloon catheter and preparation method thereof - Google Patents
Medicinal balloon catheter and preparation method thereof Download PDFInfo
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- CN101785900A CN101785900A CN201010121627A CN201010121627A CN101785900A CN 101785900 A CN101785900 A CN 101785900A CN 201010121627 A CN201010121627 A CN 201010121627A CN 201010121627 A CN201010121627 A CN 201010121627A CN 101785900 A CN101785900 A CN 101785900A
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- balloon catheter
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Abstract
The invention discloses a medicinal balloon catheter and a preparation method thereof. The balloon outside surface of the medicinal balloon catheter has a concave-convex non-planar structure. The balloon outside surface of the medicinal balloon catheter is grinded and processed through ultraviolet laser to form the concave-convex non-planar structure on the balloon outside surface. As the laser grinding is characterized by no contact and no processing heat, the processed balloon can maintain the original intensity. Owning to the concave-convex non-planar structure of the balloon outside surface of the medicinal balloon catheter in the invention, the medicinal adsorption storage capacity is fundamentally improved, namely firstly, the amount of the adsorbed medicine is greatly increased, secondly when medicine adsorbed on balloon passes through blood vessels to reach the site of lesion, the medicine adsorbed on the outer wall of the balloon can be maintained as much as possible and can not be washed off by blood in the blood vessels and cause loss, and can be effectively transferred to the site of lesion by the balloon so as to have effectively therapeutic action. The medicinal balloon catheter of the invention can be used in not only coronary heart disease, but also various diseases caused by other narrow vessels such as lower extremity arterial stenosis or occlusion caused by diabetes.
Description
Technical field
The present invention relates to a kind of medicinal balloon catheter and preparation method thereof.
Background technology
Coronary heart disease (coronary Atherosclerotic heart disease, CAHD) be called for short coronary heart disease, be a kind of modal heart disease, be meant the myocardial dysfunction that causes because of coronary stricture, blood supply insufficiency and (or) organic disease, so claim ischemic cardiomyopathy (IHD) again.Its cause of disease be since the coronary artery tube wall formation atheromatous plaque of supply heart itself cause lumen of vessels narrow due to heart change.Because the position of coronary stricture, length and degree different, its clinical symptoms also has difference.
The treatment of coronary heart disease comprises three therapeutic schemes, i.e. Drug therapy, interventional therapy and Cardiac Surgery bypass surgery.Drug therapy is the most basic treatment, and in a single day any patient makes a definite diagnosis, and Drug therapy will be kept all the life.But should not do coronary angiography as early as possible when medication effect is good enough or invalid, the arteria coronaria pathological changes is made detailed evaluation, according to patient's arteria coronaria pathological changes situation, whether decision selects interventional therapy and/or bypass surgery then.Bypass surgery is reliable for effect, but needs open chest surgery, and wound is bigger, and recovery time is longer.The interventional therapy wound is little, recovery is fast, can solve coronary stricture rapidly, alleviate myocardial ischemia, and the quality of making the life better, shortcoming are that cost is big, part patient is not suitable for doing interventional therapy.
In the interventional therapy mode, need use foley's tube, foley's tube is a kind of instrument of blood vessel internal shaping art, by seal wire and guiding catheter sacculus is sent into atherosclerosis and narrow position, use pressure expanded sacculus, make the speckle cracking, blood vessel dilating, improving blood flow, is a highly effective new technique of cardiovascular disease therapies in recent years.But, at blood vessel internal shaping postoperative 30～40% patient is arranged, owing to the blood vessel shortage of vascular endothelial injury, smooth muscle cell hyperplasia and expansion supports to make vascular restenosis.On this basis, the intravascular stent treatment technology is arisen at the historic moment.This technology is to load onto netted metal rack in the sacculus outside, by foley's tube support tube is delivered to diseased region, behind the dilating sacculus support is for good and all embedded patient's coronary endometrium, but the 10-20% patient's blood vessel of still having an appointment can cause the vascular restenosis after proliferation of smooth muscle produces the support expansion owing to the immunoreation of human body.Because support for good and all embeds patient's coronary endometrium, take out implant frame, it is impossible to carry out once more the support implantation.Implant the caused angiostenosis in back for solving support, plating medicine support becomes the main means of angiocarpy bracket implanted treatment technology in recent years rapidly.Suppress smooth muscle growth medicine owing to plated one deck at metal support surface, patient's postoperative restenosis rate can be reduced to below 5%.But compare with the common bare bracket that does not plate medicine, plating medicine support is very expensive and because the influence of macromolecular material on the coating, some patients can produce thrombosis and cause serious adverse effects.Plating medicine ball capsule vascular reconstructive surgery is a kind of improved sacculus vascular reconstructive surgery, this technology is at sacculus outer surface plating one deck medicine, by conduit sacculus is sent into diseased region, dilating sacculus, make the medicine that plates rest on diseased region, playing blood vessel dilating makes it keep unimpeded effect, the obstruction even this mode patient's blood vessel can narrow down again, also can carry out the secondary treatment by the foley's tube that plates medicine once more, but, how in the process of sacculus being sent into diseased region by conduit, how to keep medicine by the flushing of the blood in the blood vessel loss medicine medicine that is plated to the outer surface of sacculus and is plated to the sacculus outer surface as much as possible, become the difficult problem of this technology, also do not have solution preferably at present.
Summary of the invention
Technical problem to be solved by this invention provides and a kind ofly can preferably medicine be plated to medicinal balloon catheter of sacculus outer surface and preparation method thereof.
The present invention addresses the above problem the technical scheme that is adopted: medicinal balloon catheter, its sacculus outer surface is for having concavo-convex nonplanar structure.This special concavo-convex nonplanar structure adopts the method for laser grinding to produce, this nonplanar structure can be a shape various rules or irregular, as long as the gap that can play between the nonplanar structure can store or keep more medicine as much as possible.
The sacculus wall thickness of described medicinal balloon catheter is 15～25 microns, and the thickness of nonplanar structure is 8～12 microns.The thickness of nonplanar structure is the lamellated thickness that nonplanar structure constitutes, and the form of its thickness and surface texture can be controlled by the adjustment to laser processing parameter in the laser grinding process.Thickness when above-mentioned parameter is used for coronary artery disease for this medicinal balloon catheter, the wall thickness of sacculus can respective change when being used for the interventional therapy of other disease.
The gap that forms between the described nonplanar structure constitutes the storage layer of medicine.
Medicinal balloon catheter of the present invention since the sacculus outer surface for having concavo-convex nonplanar structure, therefore the medicine absorbability is obtained the improvement of essence, the one, the amount of absorption medicine is increased greatly, the 2nd, the medicine of sacculus absorption in blood vessel by conduit in the process of diseased region, can remain on as much as possible in the drug storage layer of sacculus outer surface and greatly reduced because losing of causing of blood flushing, can effectively be transported to diseased region, play effective therapeutical effect by sacculus.Medicinal balloon catheter of the present invention not only can be applicable to coronary heart disease, is equally applicable to the various diseases that other various pipelines narrow down, and stops up as the artery of lower extremity that is caused by diabetes.
A kind of preparation method of said medicine foley's tube comprises following treatment step, adopts Ultra-Violet Laser grinding sacculus outer surface, the sacculus outer surface is formed have concavo-convex nonplanar structure.
The wave-length coverage of described Ultra-Violet Laser is 10～400nm.
The wavelength of preferred Ultra-Violet Laser is 10～248nm herein.
Further, reach or be lower than the 193nm better effects if when its wavelength.The wavelength that is described Ultra-Violet Laser is 10～193nm.
Its Laser Processing direction and medicinal balloon catheter axially parallel during described Ultra-Violet Laser grinding sacculus outer surface.Because medicinal balloon needs pressurization to make its expansion after being delivered to diseased region, the structure that this processing mode produced can keep the intensity of medicinal balloon as much as possible.Furthermore, even medicinal balloon can not bear corresponding pressure when carrying out interventional therapy, since nonplanar structure be along with the direction of medicinal balloon catheter axially parallel, sacculus can axially break along it, because such breaking makes whole sacculus still keep as a whole, so can easily the medicinal balloon after breaking be taken out by conduit, can not occur remaining in the intravital problem of people after medicinal balloon breaks.
The zone of described any two Ultra-Violet Laser institutes grinding does not all overlap.Add the uniformity that to note grinding man-hour, avoiding the overlapping of machining area edge and the strength reduction band of generation.
Described ultraviolet light adopts pulse scanning or continuous sweep mode grinding sacculus outer surface.
The sacculus outer surface of Ultra-Violet Laser grinding medicinal balloon catheter forms the sacculus outer surface to have concavo-convex nonplanar structure to belong to noncontact cold working mode to macromolecular material, and this mode can solve heterogeneity that other contacts processing (as machine cut) are produced thin-walled high voltage junction member and to the influence of sacculus macromolecular material physical property.Sacculus is made by macromolecular material, the energy that provides during by the Ultra-Violet Laser grinding interrupts the strand of sacculus outmost surface one deck macromolecular material as thin as a wafer, the part macromolecular material forms steam raising, makes the sacculus outer wall surface form concavo-convex nonplanar structure.Because empty calory produces in the course of processing, so the material property of sacculus is not produced any influence.
In sum, the invention has the beneficial effects as follows: medicinal balloon catheter of the present invention since the sacculus outer wall surface for having concavo-convex nonplanar structure, therefore the medicine absorbability is obtained the improvement of essence, the one, the amount of absorption medicine is increased greatly, the 2nd, sacculus adsorbed medicine in blood vessel by conduit in the process of diseased region, the medicine that can keep as much as possible being adsorbed on the sacculus outer surface can not lost by the flushing of the blood in the blood vessel, can effectively be transported to diseased region, play effective therapeutical effect by sacculus.Medicinal balloon catheter of the present invention not only can be applicable to coronary heart disease, is equally applicable to that other various pipelines narrow down and the disease that causes is blocked as the artery of lower extremity that is caused by diabetes, is commonly called as diabetic foot.
Description of drawings
Fig. 1 is the structural representation of medicinal balloon catheter of the present invention;
Labelling and corresponding parts title in the accompanying drawing 1: 1-conduit; The 2-base; The 3-sacculus; The 4-nonplanar structure; The 5-storage layer.
Fig. 2 is the section enlarged diagram of nonplanar structure among Fig. 1.
The specific embodiment
Below in conjunction with embodiment and accompanying drawing, to the detailed description further of the present invention's do, but embodiments of the present invention are not limited thereto.
Extremely shown in Figure 2 referring to Fig. 1, the sacculus outer surface of medicinal balloon catheter of the present invention is for having concavo-convex nonplanar structure, this nonplanar structure is formed along the direction grinding with the medicinal balloon catheter axially parallel balloon surface by Ultra-Violet Laser, wherein, the balloon tube wall thickness is 12～25 microns, and the thickness of nonplanar structure is 8～12 microns.
A kind of preparation method of said medicine foley's tube, adopt the pulsed scan mode with 10～400nm Ultra-Violet Laser grinding sacculus outer surface, the sacculus outer surface is formed have concavo-convex nonplanar structure, scan along direction spacing during Ultra-Violet Laser grinding sacculus outer surface with the medicinal balloon catheter axially parallel, in the course of processing, the zone of Ultra-Violet Laser institute grinding does not overlap, in order to avoid cause the local weakness of sacculus.
Zhi Bei medicinal balloon catheter shows that by stress test significant change does not take place its compressive resistance of sacculus after the surface laser grinding according to the method described above.Show below 5 diameters be 2.5mm through the arteria coronaria sacculus of the Ultra-Violet Laser Surface Machining of 193nm when pressure when 4 atmospheric pressure increase to 15 atmospheric pressure, its diameter is linear increasing with pressure, any breaking do not taken place in experimentation, can fully satisfy the requirement of arteria coronaria plasty to foley's tube.
| Pressure | Sample 1 | Sample 2 | Sample 3 | Sample 4 | |
On average |
| Atmospheric pressure | External diameter, mm | External diameter, mm | External diameter, mm | External diameter, mm | External diameter, mm | External diameter, mm |
| ??4 | ??2.506 | ??2.506 | ??2.591 | ??2.568 | ??2.584 | ??2.551 |
| ??7 | ??2.606 | ??2.595 | ??2.708 | ??2.696 | ??2.718 | ??2.665 |
| ??10 | ??2.701 | ??2.690 | ??2.846 | ??2.783 | ??2.816 | ??2.767 |
| ??13 | ??2.780 | ??2.765 | ??2.899 | ??2.876 | ??2.925 | ??2.849 |
| ??15 | ??2.845 | ??2.818 | ??2.965 | ??2.943 | ??3.001 | ??2.914 |
In addition because can be in the course of processing by the energy of pulse frequency and pulse strength control laser projections, the thickness of the nonplanar structure layer that is processed to form can obtain controlling more accurately, even the control by laser energy, the form of nonplanar structure also can change.
As mentioned above, just can realize the present invention preferably.
Claims (10)
1. medicinal balloon catheter is characterized in that, the sacculus outer surface of described medicinal balloon catheter is for having concavo-convex nonplanar structure.
2. medicinal balloon catheter according to claim 1 is characterized in that, the sacculus wall thickness of described medicinal balloon catheter is 15～25 microns, and the thickness of nonplanar structure is 8～12 microns.
3. medicinal balloon catheter according to claim 1 is characterized in that, the gap that forms between the described nonplanar structure constitutes the storage layer of medicine.
4. the preparation method of any described medicinal balloon catheter of claim 1 to 3 is characterized in that, comprises following treatment step, adopts Ultra-Violet Laser grinding sacculus outer surface, the sacculus outer surface is formed have concavo-convex nonplanar structure.
5. the preparation method of medicinal balloon catheter according to claim 4 is characterized in that, the wave-length coverage of described Ultra-Violet Laser is 10～400nm.
6. the preparation method of medicinal balloon catheter according to claim 5 is characterized in that, the wavelength of described Ultra-Violet Laser is 10～248nm.
7. the preparation method of medicinal balloon catheter according to claim 5 is characterized in that, the wavelength of described Ultra-Violet Laser is 10～193nm.
8. according to the preparation method of any described medicinal balloon catheter of claim 4 to 7, it is characterized in that its Laser Processing direction and medicinal balloon catheter axially parallel during described Ultra-Violet Laser grinding sacculus outer surface.
9. according to the preparation method of any described medicinal balloon catheter of claim 4 to 7, it is characterized in that the zone of described any two Ultra-Violet Laser institutes grinding does not all overlap.
10. according to the preparation method of any described medicinal balloon catheter of claim 4 to 7, it is characterized in that described ultraviolet light adopts pulse scanning or continuous sweep mode grinding sacculus outer surface.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 201010121627 CN101785900B (en) | 2010-03-10 | 2010-03-10 | Medicinal balloon catheter and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 201010121627 CN101785900B (en) | 2010-03-10 | 2010-03-10 | Medicinal balloon catheter and preparation method thereof |
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| Publication Number | Publication Date |
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| CN101785900A true CN101785900A (en) | 2010-07-28 |
| CN101785900B CN101785900B (en) | 2013-01-02 |
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| CN 201010121627 Expired - Fee Related CN101785900B (en) | 2010-03-10 | 2010-03-10 | Medicinal balloon catheter and preparation method thereof |
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Cited By (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101987222A (en) * | 2010-12-03 | 2011-03-23 | 上海硕创生物医药科技有限公司 | Catheter with strip saccule on surface |
| CN103611212A (en) * | 2013-11-21 | 2014-03-05 | 先健科技(深圳)有限公司 | Drug balloon preparation method |
| CN103800987A (en) * | 2012-11-08 | 2014-05-21 | 上海微创医疗器械（集团）有限公司 | Medical sacculus and preparation method thereof |
| CN104055610A (en) * | 2014-06-24 | 2014-09-24 | 深圳市金瑞凯利生物科技有限公司 | Cardiovascular intervention balloon catheter and preparation method thereof |
| CN108187212A (en) * | 2018-03-14 | 2018-06-22 | 董鹏 | A kind of medicinal balloon |
| CN109731206A (en) * | 2018-04-12 | 2019-05-10 | 中国医学科学院阜外医院 | A kind of sacculus for biological body vessel bifurcated lesions and application thereof and operation method |
| CN110478601A (en) * | 2019-08-28 | 2019-11-22 | 赛诺医疗科学技术股份有限公司 | Foley's tube |
| CN112426612A (en) * | 2019-08-26 | 2021-03-02 | 上海康德莱医疗器械股份有限公司 | Balloon and preparation and application thereof |
| CN112641489A (en) * | 2020-12-31 | 2021-04-13 | 华中科技大学 | Nasal cavity filling balloon for nasal septum orthopaedy and manufacturing method and system thereof |
| CN113144389A (en) * | 2021-03-16 | 2021-07-23 | 科塞尔医疗科技（苏州）有限公司 | Double-layer sand blasting balloon, preparation method thereof and multi-layer sand blasting balloon |
| CN113577509A (en) * | 2021-06-16 | 2021-11-02 | 上海脉全医疗器械有限公司 | Medicine balloon |
| CN114377278A (en) * | 2022-01-14 | 2022-04-22 | 浙江介尔欣医疗科技有限公司 | Medicine balloon and preparation method thereof |
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| US6048332A (en) * | 1998-10-09 | 2000-04-11 | Ave Connaught | Dimpled porous infusion balloon |
| CN1780658A (en) * | 2003-05-19 | 2006-05-31 | 株式会社钟化 | Balloon catheter and method of manufacturing the same |
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| CN201643340U (en) * | 2010-03-10 | 2010-11-24 | 成都维德医疗器械有限责任公司 | Drug balloon catheter |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| US6048332A (en) * | 1998-10-09 | 2000-04-11 | Ave Connaught | Dimpled porous infusion balloon |
| CN1780658A (en) * | 2003-05-19 | 2006-05-31 | 株式会社钟化 | Balloon catheter and method of manufacturing the same |
| US20060182873A1 (en) * | 2005-02-17 | 2006-08-17 | Klisch Leo M | Medical devices |
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Cited By (17)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101987222A (en) * | 2010-12-03 | 2011-03-23 | 上海硕创生物医药科技有限公司 | Catheter with strip saccule on surface |
| CN103800987A (en) * | 2012-11-08 | 2014-05-21 | 上海微创医疗器械（集团）有限公司 | Medical sacculus and preparation method thereof |
| CN103800987B (en) * | 2012-11-08 | 2016-03-30 | 上海微创医疗器械（集团）有限公司 | Medical balloon and preparation method thereof |
| CN103611212A (en) * | 2013-11-21 | 2014-03-05 | 先健科技(深圳)有限公司 | Drug balloon preparation method |
| CN103611212B (en) * | 2013-11-21 | 2015-10-28 | 先健科技(深圳)有限公司 | The preparation method of medicinal balloon |
| CN104055610A (en) * | 2014-06-24 | 2014-09-24 | 深圳市金瑞凯利生物科技有限公司 | Cardiovascular intervention balloon catheter and preparation method thereof |
| CN104055610B (en) * | 2014-06-24 | 2017-05-10 | 深圳市金瑞凯利生物科技有限公司 | Cardiovascular intervention balloon catheter and preparation method thereof |
| CN108187212A (en) * | 2018-03-14 | 2018-06-22 | 董鹏 | A kind of medicinal balloon |
| CN109731206A (en) * | 2018-04-12 | 2019-05-10 | 中国医学科学院阜外医院 | A kind of sacculus for biological body vessel bifurcated lesions and application thereof and operation method |
| CN109731206B (en) * | 2018-04-12 | 2020-08-11 | 中国医学科学院阜外医院 | Balloon for bifurcation lesion of biological body pipeline and application thereof |
| CN112426612A (en) * | 2019-08-26 | 2021-03-02 | 上海康德莱医疗器械股份有限公司 | Balloon and preparation and application thereof |
| CN112426612B (en) * | 2019-08-26 | 2022-12-06 | 上海康德莱医疗器械股份有限公司 | Sacculus and preparation and application thereof |
| CN110478601A (en) * | 2019-08-28 | 2019-11-22 | 赛诺医疗科学技术股份有限公司 | Foley's tube |
| CN112641489A (en) * | 2020-12-31 | 2021-04-13 | 华中科技大学 | Nasal cavity filling balloon for nasal septum orthopaedy and manufacturing method and system thereof |
| CN113144389A (en) * | 2021-03-16 | 2021-07-23 | 科塞尔医疗科技（苏州）有限公司 | Double-layer sand blasting balloon, preparation method thereof and multi-layer sand blasting balloon |
| CN113577509A (en) * | 2021-06-16 | 2021-11-02 | 上海脉全医疗器械有限公司 | Medicine balloon |
| CN114377278A (en) * | 2022-01-14 | 2022-04-22 | 浙江介尔欣医疗科技有限公司 | Medicine balloon and preparation method thereof |
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