CN101242907A - 用于混合液体和涂覆支架的超声设备和方法 - Google Patents
用于混合液体和涂覆支架的超声设备和方法 Download PDFInfo
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
- B05B—SPRAYING APPARATUS; ATOMISING APPARATUS; NOZZLES
- B05B17/00—Apparatus for spraying or atomising liquids or other fluent materials, not covered by the preceding groups
- B05B17/04—Apparatus for spraying or atomising liquids or other fluent materials, not covered by the preceding groups operating with special methods
- B05B17/06—Apparatus for spraying or atomising liquids or other fluent materials, not covered by the preceding groups operating with special methods using ultrasonic or other kinds of vibrations
- B05B17/0607—Apparatus for spraying or atomising liquids or other fluent materials, not covered by the preceding groups operating with special methods using ultrasonic or other kinds of vibrations generated by electrical means, e.g. piezoelectric transducers
- B05B17/0623—Apparatus for spraying or atomising liquids or other fluent materials, not covered by the preceding groups operating with special methods using ultrasonic or other kinds of vibrations generated by electrical means, e.g. piezoelectric transducers coupled with a vibrating horn
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
- B05B—SPRAYING APPARATUS; ATOMISING APPARATUS; NOZZLES
- B05B5/00—Electrostatic spraying apparatus; Spraying apparatus with means for charging the spray electrically; Apparatus for spraying liquids or other fluent materials by other electric means
- B05B5/025—Discharge apparatus, e.g. electrostatic spray guns
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
- B05B—SPRAYING APPARATUS; ATOMISING APPARATUS; NOZZLES
- B05B17/00—Apparatus for spraying or atomising liquids or other fluent materials, not covered by the preceding groups
- B05B17/04—Apparatus for spraying or atomising liquids or other fluent materials, not covered by the preceding groups operating with special methods
- B05B17/06—Apparatus for spraying or atomising liquids or other fluent materials, not covered by the preceding groups operating with special methods using ultrasonic or other kinds of vibrations
- B05B17/0607—Apparatus for spraying or atomising liquids or other fluent materials, not covered by the preceding groups operating with special methods using ultrasonic or other kinds of vibrations generated by electrical means, e.g. piezoelectric transducers
- B05B17/0623—Apparatus for spraying or atomising liquids or other fluent materials, not covered by the preceding groups operating with special methods using ultrasonic or other kinds of vibrations generated by electrical means, e.g. piezoelectric transducers coupled with a vibrating horn
- B05B17/063—Apparatus for spraying or atomising liquids or other fluent materials, not covered by the preceding groups operating with special methods using ultrasonic or other kinds of vibrations generated by electrical means, e.g. piezoelectric transducers coupled with a vibrating horn having an internal channel for supplying the liquid or other fluent material
Abstract
公开了用于混合两种或更多种液体的超声方法和设备。该超声方法和设备可混合包括药物、聚合物以及涂料的各种组分,以应用到多种医疗设备表面。该设备和技术可产生被不中断地/连续地输送到医疗设备表面的适当的混合物。该设备可包括专用的超声换能器/尖端结构,该超声换能器/尖端结构可允许在设置于振动尖端内部的混合室内混合不同液体。本发明的设备和方法可混合不同的药物,使用类似超声空化和辐射力的不同效应将它们应用到支架表面。此外,所公开的方法和设备可产生混合物,并可输送针对目标的、缓和的且分配可控性高的连续液体喷射,这种连续液体喷射能够减少昂贵药物的损耗。
Description
发明背景
发明领域
本发明涉及用于医疗器械的涂覆,且更具体地说,涉及采用超声能量来混合两种或更多种不同液体并涂覆任意的医疗器械表面的设备和方法。
相关技术背景
支架是一种通常小型的、圆柱形状的网状管,其被永久地插入到动脉中。支架有助于使动脉保持打开,以致血液能够穿过其流动。支架一般分为两类:a)金属裸支架;和b)药物洗脱支架。药物洗脱支架包含有潜在地减少动脉会再次变得阻塞的可能性的药物。
设计上支架通常是管状的,由细网和/或线构成,这些细网和/或线具有小直径并在各个部分之间界定了大量的狭窄空间。通常,支架因各种原因并利用各种工艺涂覆有一定范围的材料。由于支架的特定结构、设计和材料,因此可重复性地在无网纹(webbing)、拉丝(stringing)并在可控剂量的药物-聚合物涂料的情况下来均匀地涂覆支架的内表面和外表面一直是成问题的。
公开过支架的专利的例子包括Palmaz的美国专利No.4,739,762;Wiktor的美国专利No.5,133,732;Boneau的美国专利No.5,292,331;Barry等人的美国专利No.6,908,622;Hossayniy等人的美国专利No.6,908,624;和Reiss的美国专利No.6,913,617。
有多个涉及支架涂覆的美国公布专利申请,包括,例如:Sundar的美国专利公布No.2003/0225451 A1;Udipi等人的美国专利公布No.2004/0215336 A1;Pacetti等人的美国专利公布No.2004/0224001 A1;Stenzel的美国专利公布No.2004/0234748 A1;Sundar的美国专利公布No.2004/0236399 A1;和Byun的美国专利公布No.2004/0254638 A1。
根据上面所提到的专利和申请,通过不同的方法,如机械涂覆、气体喷涂、浸渍、极化涂覆、电荷(静电)涂覆或超声涂覆等,将涂料应用于支架的内表面和外表面。其中有一些如美国专利No.6,656,506利用了浸渍和喷射的组合。其中有几个利用了超声能量,例如美国专利No.6,767,673;而美国专利No.2005/0064088利用了超声喷射。在另一方法中,美国专利No.5,891,507公开了通过浸渍入超声浴来涂覆支架表面。
尽管存在这些涂覆技术和方法,但是这些相关技术存在许多缺陷和问题。例如,涂覆厚度的不均匀性、网纹、拉丝、支架表面上的裸点(bare spot)、药物浪费、过度喷射、难于控制药物流量、粘合性问题、长的干燥时间以及需要灭菌/卫生措施等等。
超声喷射器(Sonic and Materials Inc.,Misonix Inc.,Sono-Tek Inc.;美国专利No.4,153,201、4,655,393和5,516,043)通常通过使液体穿过超声仪器的尖端的中心孔来工作。已知的来自美国工程的申请使用气流来将气溶胶颗粒(aerosol particle)输送到涂覆表面。根据Sono-Tek网站,AccuMist和MicroMist系统是通过经由空气喷射或气流输送气溶胶颗粒来用于超声支架涂覆的。
已有气体超声喷射器之一是Celleration创面治疗申请(美国专利#5076266;64788754;6569099;6601581;6663554),其产生喷射。在1986年颁予Babaev的苏联专利#1237261能够混合超声换能器尖端(ultrasonictransducer tip)外部的不同液体。
通常,支架需要涂覆有单层药物和/或聚合物。现今的技术要求在涂覆之前混合药物或聚合物。这可能导致耗时问题,例如聚合物在混合后会聚合。
因此,需要一种用于将两种或更多种不同药物与聚合物混合在一起的方法和装置以及支架的无缺陷、可控的涂覆过程。
发明内容
根据本发明,描述了用于支架涂覆的超声方法和设备。本超声方法和设备可在由超声换能器尖端界定的混合室(腔)内提供两种或更多种不同液体的适当的混合。根据本发明的设备可产生用于表面涂覆的均匀、缓和以及针对目标的喷射(targeted spray)。
一方面,本发明涉及不中断地混合不同液体,并用可控厚度层涂覆支架而无网纹和拉丝。
另一方面,本发明可提供包含设置在超声换能器尖端内部的混合室(腔)的设备。来自不同贮存器的受控量的不同液体可供应给超声尖端的混合室(腔)。超声尖端可以是圆柱形的、矩形的或以其他方式成形以产生适当的混合物。所产生的混合物可经中心孔输送到尖端的远端以产生细的喷射。
可采用精确注射泵通过毛细管作用和/或重力作用将液体可控地输送入混合室。当使用注射泵时,所输送的液体量可与涂层的体积或重量近似相同。
用于涂覆医疗器械的、包括支架的本发明的方法能够在超声尖端内由不同液体、药物、聚合物还有其他材料产生所期望的混合物,并且能不中断地向表面提供喷射。
根据本发明的方法还可在超声尖端的混合室内使用多种低频超声波的声效应,例如空化、微流动和驻波,而这些声效应通常未应用于液体混合或涂覆技术中。
该方法可包括在涂覆过程中使支架旋转并移动超声混合和涂覆头,以产生特殊的超声-声效应,这将在下面详细描述。为了达到高品质的效果,所有涂覆操作均通过专用软件程序来控制。
该方法和设备可混合不同液体例如药物、聚合物等,并可涂覆由不同材料制成的刚性、柔性、自膨式支架。
该方法还可包括将另外的气流引入混合和涂覆区域。气流可以是热的或是冷的,并可被引导通过混合室和/或在颗粒内喷射或独自喷射。
本发明的装置部分包括允许混合不同液体并不中断地产生喷射的超声尖端的特定结构。
超声频率范围可在20KHz到20MHz之间或更高。优选的频率是20KHz到200KHz,推荐的频率是30KHz。超声波振幅范围可在2微米到300微米之间或更大。因此,提供了一种用于通过不同液体的适当混合来不中断地超声涂覆支架而无网纹和拉丝的方法和装置。
本发明的一个方面提供了一种用于混合两种或更多种不同液体的方法和装置。
本发明的另一方面提供了一种用于混合两种或更多种不相容液体的方法和装置。
本发明的另一方面提供了一种用于混合两种或更多种不同药物、聚合物或药物与聚合物以用于涂覆医疗植入物例如支架的改进的方法和装置。
本发明的另一方面提供了一种用于混合两种或更多种不同液体如药物、聚合物或药物与聚合物并采用超声来涂覆支架的方法和装置。
本发明的另一方面提供了用于混合两种或更多种不同药物与聚合物的方法和装置,其提供涂覆层的可控厚度。
本发明的另一方面提供了用于同时混合不同液体、由适当的支架混合物涂料形成连续、均匀和定向喷射的方法和装置。
本发明的另一方面提供了用于同时混合不同液体、由适当的支架混合物涂料形成连续、均匀和定向喷射的方法和装置,其能避免如网纹、拉丝等的涂覆缺陷。
本发明的另一方面提供了用于同时混合不同液体、由适当的支架混合物涂料形成连续、均匀和定向喷射的方法和装置,其不用化学制品增强了支架的粘着性能。
本发明的另一方面提供了用于同时混合不同液体、由适当的支架混合物涂料形成连续、均匀和定向喷射的方法和装置,其在涂覆过程的同时沿结构的纵轴提供涂层的干燥。
本发明的另一方面提供了用于同时混合不同液体、由适当的支架混合物涂料形成连续、均匀和定向喷射的方法和装置,其在涂覆过程的同时沿结构的纵轴提供涂层的灭菌。
本发明的另一方面提供了用于形成适当的混合两种或更多种不同液体、产生喷射和涂覆表面的不中断过程的方法和装置。
从以下的书面描述和附图,本发明的这些和其他方面将变得更加明显。
附图说明
将参考优选实施方案的附图来显示和描述本发明,且可清楚地理解本发明的细节。
图1是根据本发明用于喷射的超声混合设备的实施方案的截面图。
图2展示了根据本发明将液体直接输送到超声尖端内部混合腔的设备的实施方案截面的前视图。液体输送管设置在垂直于尖端轴的一个径平面(platan)上。
图3展示了根据本发明将液体直接输送到超声尖端内部混合腔的设备的实施方案的截面。液体输送管沿超声尖端的纵轴设置在径平面上。
图4是根据本发明在超声尖端内部具有螺纹混合腔的设备的实施方案的截面图示。
图5展示了根据本发明的设备的实施方案的截面的前视图,其中一种液体通过超声换能器的中心孔输送到混合腔,而另一种液体通过垂直于超声尖端轴的管来输送。
图6A和6B以放大截面展示了具有圆形辐射壁(rounded radiation wall)的混合室的实施方案。
图7展示了超声尖端的实施方案,其为a)扩展平面、b)圆锥形、c)指数(exponential)、d)外部圆形、e)内部圆形聚焦和f)矩形远端构型。
发明详述
本发明提供了一种包含超声尖端1的设备,该超声尖端1界定混合室(腔)4。贯穿附图展示了有关方法和设备的本发明的优选实施方案。本领域的技术人员在审阅了本公开内容后将会立即理解由本发明提供的混合两种或更多种不同液体如药物和/或聚合物并不中断地涂覆支架的优势。
超声尖端1使用由超声换能器2提供的超声能量来混合材料并涂覆医疗设备。该方法在应用到涂覆支架和其他具有错综复杂的细部和复杂形状的装置时特别有用。根据本发明的超声尖端1能够提供两种或更多种药物和聚合物的高度精确可控的混合,且精细的、针对目标的喷射允许涂覆支架而无实质上的网纹、拉丝以及因混合而造成的昂贵药物的浪费。
本发明提供了一种新颖的超声尖端1和用于混合两种或更多种不同流体以涂覆支架的方法。在图1到7中展示了根据本发明的超声尖端1的实施方案。根据本发明,超声尖端1包括在超声尖端1内部的混合室/腔4。混合室4提供超声活动空间以用于在声力(acoustic force)作用下混合不同液体,该声力包括可在室4内部发生的空化现象。通常,室4是围绕超声尖端1纵轴的圆柱形形状。空化现象可发生在垂直于纵轴的室壁18和19之间。可提供一个或更多个注射泵(未显示),用于通过设置在与纵轴垂直的径平面上的管5、6、7、8(图2)将不同液体输送入室4。液体输送管6、7、8可沿纵轴设置是本发明的一个实施方案(图3)。一方面,输送管6、7、8中的一个或更多个可提供加压流体。药物和/或聚合物的混合物可通过孔9以不中断的方式输送到尖端1的辐射表面11,用于产生喷射10并输送到涂覆表面/支架12。孔9的直径优选地必须小于混合室的直径。为了简化制造,超声换能器尖端1可包括远端部分3,该远端部分3经平面16上的螺纹连接以形成室4。远端部分3可配备有不同直径的中心孔9以按所需的颗粒大小来产生喷射10。为了避免远端部分3的松动,远端部分3必须优选地在振幅节点(amplitude node point)14上连接到尖端1。液体输送管(5、6、7、8)也必须优选地在振幅节点20上连接到尖端1。为了获得高质量的混合物,混合腔中心可匹配或接近振幅反节点(amplitude anti node point)15。
必须注意的是,不同温度的气流可通过管(5、6、7、8)中的一个输送入混合室/腔4,以改进液体混合和喷射涂覆过程。这可改变喷射体积、质量并可加快干燥过程。
不同液体的超声混合以及不中断地喷射过程、方法和设备的说明和描述:当不同液体(a、b、c)被供应到激活的混合室4时,壁19在超声辐射力作用下向前输送液滴/流。从壁18后退或弹回的加压液体流与新输送的不同液体流遭遇,并在超声辐射/压力和空化作用下产生适当的混合物。
混合室充满液体混合物之后,超声压力推动混合物通过中心孔9以形成喷射10,并将其输送到辐射表面11。当液体被输送且尖端振动时,混合和喷射涂覆过程不中断地进行。
在本发明的一个方面中,为了更有效且适当的混合过程,混合室4包含至少一个螺纹22、槽式环(groove ring)或波动形状(图5)。在这种情况下,螺纹的根部作为混合叶片(mixing blade)或勺,与超声能量一起推动待混合的不同液体。远端孔9也可被车螺纹(23)以用于更好的混合过程。
在另一方面中(图6),为了更有效且适当的混合过程,混合室壁18和19可使内部成圆形(图6.a),以产生很强的聚焦超声效应。室壁也可使外部成圆形(图6.b),用于产生强力的空化效应来获得更适当的混合过程。在这种情况下,从混合室的放射状圆柱形壁反射的超声波使不同液体颗粒彼此相对地推。这些在超声空化和辐射压力作用下提供不同液体的适当的混合。
图7是超声尖端的a)扩展平面、b)圆锥形状、c)指数、d)外部圆形、e)内部圆形聚焦和f)矩形远端构型的图示。这些构型允许根据涂覆要求来控制喷射角度和质量。
Claims (15)
1.一种用于混合至少两种不同液体并涂覆至少一个支架的至少一部分的设备,其包括:
a)超声换能器,其具有尖端;
b)超声换能器尖端,其具有在振动尖端内部的混合室;
c)超声换能器尖端混合室,其具有管以将液体输送入室;以及
d)超声换能器尖端混合室,其具有中心孔以给待喷射的所述尖端的远端提供液体混合物。
2.如权利要求1所述的设备,其中超声尖端混合室具有螺纹或槽。
3.如权利要求1所述的设备,其中超声尖端混合室具有前端部分,所述前端部分在节点处经螺纹连接到尖端。
4.如权利要求1所述的设备,其中超声尖端混合室具有液体输送管,所述液体输送管在节点处连接到尖端。
5.如权利要求1所述的设备,其中超声尖端前端部分具有不同的几何形式/形状。
6.如权利要求1所述的设备,其中超声尖端混合室具有螺纹或槽。
7.如权利要求1所述的设备,其中液体混合室的后壁和/或前壁中的至少一个是平坦的。
8.如权利要求1所述的设备,其中液体混合室的后壁和/或前壁中的至少一个是圆形的或椭圆形的。
9.如权利要求1所述的设备,其中液体混合室的直径大于前端部分的中心孔直径。
10.一种用于混合至少两种不同液体的方法,其包括:
a)具有带有混合室的超声换能器尖端,所述混合室设置在振动尖端内部;
b)将至少两种不同液体输送入混合腔;
c)经由液体输送管中的一个输送至少两种不同液体和至少一种气流;
c)使用超声空化和辐射力由两种不同液体产生混合物;
d)经由中心孔将所述混合物输送到尖端的远端以产生喷射;
e)将混合物涂覆喷射引导并应用到支架上。
11.如权利要求10所述的方法,其包括:使用不同的超声波频率来混合在振动尖端内部的不同液体。
12.如权利要求10所述的方法,其进一步包括:使用不同的超声波振幅来混合在振动尖端内部的不同液体。
13.如权利要求10所述的方法,其中所述液体中的至少一种是治疗剂/药物。
14.如权利要求10所述的方法,其中所述液体中的至少一种是聚合物。
15.如权利要求10所述的方法,其中所述液体中的一种是混合物。
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US11/204,872 US7896539B2 (en) | 2005-08-16 | 2005-08-16 | Ultrasound apparatus and methods for mixing liquids and coating stents |
US11/204,872 | 2005-08-16 |
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US (2) | US7896539B2 (zh) |
EP (1) | EP1915218B1 (zh) |
JP (1) | JP2009504396A (zh) |
KR (1) | KR20080040728A (zh) |
CN (1) | CN101242907A (zh) |
AT (1) | ATE460230T1 (zh) |
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2006
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- 2006-07-18 CN CNA2006800296818A patent/CN101242907A/zh active Pending
- 2006-07-18 DE DE602006012847T patent/DE602006012847D1/de active Active
- 2006-07-18 JP JP2008526940A patent/JP2009504396A/ja active Pending
- 2006-07-18 AT AT06787746T patent/ATE460230T1/de not_active IP Right Cessation
- 2006-07-18 WO PCT/US2006/027895 patent/WO2007021427A2/en active Application Filing
- 2006-07-18 CA CA002659974A patent/CA2659974A1/en not_active Abandoned
- 2006-07-18 EP EP06787746A patent/EP1915218B1/en not_active Not-in-force
-
2007
- 2007-12-17 US US11/957,557 patent/US20080091108A1/en not_active Abandoned
Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
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CN108348699A (zh) * | 2015-10-30 | 2018-07-31 | 强生消费者公司 | 无菌气溶胶雾化装置 |
CN108348697A (zh) * | 2015-10-30 | 2018-07-31 | 强生消费者公司 | 无菌气溶胶雾化装置 |
CN108348697B (zh) * | 2015-10-30 | 2021-09-10 | 强生消费者公司 | 无菌气溶胶雾化装置 |
CN114606499A (zh) * | 2022-04-07 | 2022-06-10 | 燕山大学 | 一种表面具有微孔结构的金属及其制备方法与应用 |
Also Published As
Publication number | Publication date |
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EP1915218A4 (en) | 2008-09-03 |
KR20080040728A (ko) | 2008-05-08 |
WO2007021427A3 (en) | 2007-12-06 |
CA2659974A1 (en) | 2007-02-22 |
EP1915218A2 (en) | 2008-04-30 |
WO2007021427A2 (en) | 2007-02-22 |
DE602006012847D1 (de) | 2010-04-22 |
US7896539B2 (en) | 2011-03-01 |
EP1915218B1 (en) | 2010-03-10 |
US20080091108A1 (en) | 2008-04-17 |
ATE460230T1 (de) | 2010-03-15 |
JP2009504396A (ja) | 2009-02-05 |
US20070051307A1 (en) | 2007-03-08 |
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