CN108210064A - 具有优选的弯曲轴的挤出物 - Google Patents
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Abstract
本发明题为“具有优选的弯曲轴的挤出物”。导管通过将第一熔融聚合物与第二熔融聚合物共挤出来制备,其中第二熔融聚合物形成柔性内芯,并且第一熔融聚合物形成在内芯的相对侧上的恰好两个带。编织内芯,并且将第三熔融聚合物挤出到编织物上以形成包围编织物、带和内芯的柔性护套。带比内芯更具刚性,并且它们提供优先的平面内弯曲。
Description
版权声明
本专利文献的公开内容的一部分包括受版权保护的材料。版权所有者不反对任何人照专利和商标办公室专利文件或记录原样复制本专利文件或专利公开内容,但除此之外版权所有者保留所有相关的版权。
背景技术
1.技术领域.
本发明涉及用于执行身体的腔或管的内部的医疗检查的器械。更具体地,本发明涉及通过将流体材料施加到表面或表面的一部分的过程来构造医疗导管。
2.相关领域的描述.
标测并且消融受检者中具有电传导异常的心内膜组织是常见的。该规程用细长导管执行,该导管具有纵向延伸穿过该导管的管腔。在美国专利号5,993,462中所述的一种技术涉及经由管腔将芯线材插入到导管中。芯线材包括预成型区域。此类导管包括近侧节段,该近侧节段足够刚性以在将芯线材设置在近侧节段内时将芯线材拉直。导管的远侧节段比近侧节段显著更具柔性。
可偏转导管广泛用于多种应用。在电生理学领域。然而,由于其固有的柔性,导管可难以按所期望的一样精确控制。因此,需要具有增强用户控制导管的偏转程度和偏转方向的能力的机构的可偏转导管。此外,期望提供优选的心脏导管的平面内双向偏转。目前,这种导管通过挤出来生产。挤出物的平面内双向偏转通过使用为挤出物提供沿一个轴的优选弯曲的刀片设计或两个聚酰亚胺支撑物来实现。两种方法都依赖于将多管腔可偏转挤出物附接到单个管腔杆挤出物的远侧端部。两种方法都不与连续过程相容,由此杆和可偏转部件被制成为一体件。
发明内容
根据本发明的公开实施方案,通过在编织的多管腔导管的外护套上间歇挤出来形成导管,该编织的多管腔导管沿其长度产生可变的坚硬程度。间歇挤出物与共挤出物耦接,由此相对较刚硬的树脂的带沿杆的外部彼此相对地挤出。在杆的近侧节段上,较刚硬的树脂在性能上接近用于外护套上的树脂,所以存在较少的优先弯曲。在远侧节段上,刚硬的共挤出带与相对松软的护套之间的较大差异允许优先平面内弯曲。
此外,该过程允许相同的多管腔构型沿导管的整个长度延伸,使得给定路线的线材、管和线圈绝不会发生缠结。该过程比常规方法便宜。它完全消除了使用聚酰亚胺用于加劲件或用于偏转,以及消除了收缩套管,因为不需要回流步骤。
根据本发明的实施方案提供了一种方法,该方法通过将第一熔融聚合物与第二熔融聚合物共挤出来进行,其中第二熔融聚合物形成柔性内芯,并且第一熔融聚合物形成在内芯的相对侧上的恰好两个带,该带比内芯更具刚性。该方法还通过将编织物覆盖在内芯和带上以及将第三熔融聚合物挤出到编织物上以形成包围编织物、带和内芯的柔性护套来进行。
根据该方法的一个方面,第一熔融聚合物是聚酰胺。
根据该方法的一个方面,第二熔融聚合物和第三熔融聚合物是聚醚嵌段酰胺和硫酸钡。
根据该方法的附加方面,在固态下,第一熔融聚合物的硬度比第二熔融聚合物高。
根据该方法的又一方面,第三熔融聚合物还包含色母料。
该方法的另外的方面通过在共挤出期间将第三熔融聚合物的第一组合物改为第三熔融聚合物的第二组合物,以限定杆的近侧段和远侧段以及在近侧段和远侧段之间的过渡段来进行,近侧段比远侧段更具刚性。
根据该方法的还有的另一方面,在近侧段中编织物具有第一构型,在远侧段中编织物具有第二构型,并且在过渡区域中编织物在第一构型和第二构型之间过渡。第一构型与第二构型相比为杆提供更多的抗屈曲性。
根据本发明的实施方案另外提供了包括导管杆的设备,该导管杆通过将第一熔融聚合物与第二熔融聚合物共挤出进行的过程来制备,其中第二熔融聚合物形成柔性内芯,并且第一熔融聚合物形成在内芯的相对侧上的恰好两个带,该带比内芯更具刚性。该过程还通过将编织物覆盖在内芯和带上以及将第三熔融聚合物共挤出到编织物上以形成包围编织物、带和内芯的柔性护套来进行。
附图说明
为更好地理解本发明,就本发明的详细说明以举例的方式做出参考,该详细说明应结合以下附图来阅读,其中类似的元件用类似的附图标号来表示,并且其中:
图1为可根据本发明的实施方案构造的医疗导管的示意图;
图2为根据本发明的实施方案的图1中所示导管的杆的剖视图;
图3为穿过根据本发明的实施方案生产的导管的杆的示意性剖面图;并且
图4为示出根据本发明的另选实施方案的共挤出导管杆的编织物的图示。
具体实施方式
在下文的描述中,列出了许多具体细节,以便提供对本发明的各种原理的全面理解。然而,对于本领域的技术人员而言将显而易见的是,并非所有这些细节都是实践本发明所必需的。在这种情况下,未详细示出熟知的电路、控制逻辑部件以及用于常规算法和过程的计算机程序指令的细节,以免不必要地使一般概念模糊不清。
以引用方式并入本文的文献将被视作本申请的整体部分,不同的是,就任何术语在这些并入文件中以与本说明书中明确或隐含地作出的定义矛盾的方式定义而言,应仅考虑本说明书中的定义。
现在回到附图,首先参见图1,该图为可根据本发明的实施方案构造的医疗导管10的示意图。导管10包括细长的导管杆12,该导管杆12具有近侧节段14、远侧节段16和中间节段18。为了执行标测、消融或另一种期望的功能,将一个或多个电极或其它装置安装在远侧节段16上,并且控制手柄20位于杆12的近侧节段14处。提供输注管22以通过杆12的管腔(未示出)注入流体。将鲁尔(luer)轮毂24安装在输注管22的近侧端部上,以便于将流体注入到导管10中。
现在参见图2,该图为根据本发明的实施方案的杆12的剖视图。杆通过挤出来构造,如下面的详细描述中所述。在所描绘的实施方案中,杆12包括被相对柔软的内挤出物34围绕的管腔26,28,30,32,该内挤出物34被牵拉穿过金属编织物36。虽然示出了4个管腔,但是取决于预期的应用,导管可包括更多或更少的管腔。
内挤出物34和编织物36被外护套38围绕,该外护套38比内挤出物34更具刚性。如在下文中所说明的,在近侧节段14中护套38最具刚性,并且在远侧节段16中护套38最不具刚性。中间节段18(其通常为约7cm长)形成具有中间刚性的过渡区。
共挤出物.
现在参见图3,该图为穿过根据本发明的实施方案生产的导管的杆40的示意性剖面图。杆40的共挤出是同时完成的。两个料斗(每个料斗具有其自己的树脂)给一个模具进料,该模具同时接收材料并且生产具有圆形外径且具有两个露出的带的挤出物,以生产图2所示的结构。在该示例中,内挤出物42具有四个管腔44。
带46的刚性大于内挤出物42的刚性,这允许伸开的杆优先远离其纵轴屈曲。杆40在如箭头50所指示的带46中任一个的方向上相对于轴48具有最大抗屈曲性,并且该抗屈曲性随着弯曲角度从该方向偏离而减小。当弯曲方向垂直于如箭头54所指示的连接两个带46的线时,抗屈曲性最小。抗弯曲性为杆40产生优先弯曲平面,并且有助于克服由管腔位置或壁厚的不对称性产生的任何不期望的弯曲偏差。管腔44与箭头54对齐,即,在垂直于穿过带46的直径的内挤出物42的直径上。该布置便于由通过穿过管腔44插入的芯线材来操纵杆,如在以上提到的美国专利号5,993,462所述,因为由操纵芯线材产生的力主要沿优先弯曲平面施加。
内挤出物42和带46用编织机编织。在编织后,杆40被牵拉穿过第二挤出机,该第二挤出机挤出另一种熔融聚合物,以在编织物上形成护套56。护套56的挤出可通过被称为“TotalIntermittentExtrusion”(TIE)的过程来执行,该方法已被(PutnamPlastics,130LouisaViensDriveDayville,CT06241)推广。该过程能够生产沿长度具有可变硬度的挤出物。其通过根据计划表在不同树脂之间快速切换来运作。这允许挤出机在小的独立步骤中改变护套的刚度,并且因此以几乎连续的方式改变导管杆的刚性。另选地,如果需要,可从通过挤出机生产的连续卷轴中切出节段(导管的近侧刚硬节段和远侧松软节段),并且将该节段重新接合以形成导管的杆。
实施例.
导管杆可通过如上所述的共挤出生产为以下规格:
带: Care聚酰胺ML21)
护套(聚合物60)近侧节段
96%:预合成:
50%:80%聚醚嵌段酰胺(6333Sa01Med及20%BaSO450%):
80%Pebax7233Sa01Med及20%BaSO4
4%:
PMS3005c色母料Cs5916(蓝色)
护套(聚合物60)远侧节段
96%:预合成
80%Pebax4033Sa01Med及20%BaSO4
4%:
PMS2190CP色母料(淡蓝色)
内挤出物:
100%:预合成,80%Pebax4033Sa01Med及20%BaSO4
另选实施方案.
在该实施方案中,使用参见图3所述的规程执行共挤出,不同的是,不需要实施TIE规程。相反,通过聚合物的合适选择来挤出恒定硬度在40D至55D范围内的护套。通过改变编织物的特性来实现杆的不同节段中的可变刚度。
现在参见图4,该图为示出根据本发明的另选实施方案的导管杆62的编织物的图示。杆62的近侧节段64示出在附图的左手侧;杆62的远侧节段66示出在右手侧,并且过渡区域68示出在附图的中间,其连接近侧节段和远侧节段。
编织物包含一组线材70,该组线材70是以交叉编织构型织造的。在远侧节段中,同一组线材70的密度增加,从而增加了编织角度并且使远侧节段以扭矩的代价更具轴向顺应性。选择性的定向刚性与先前实施方案中一样通过带(图4中未示出)来提供。
近侧节段64和远侧节段66两者将围绕导管轴72的旋转扭矩传递到导管远侧末端,从而使得操作者能够根据需要来旋转导管。
本领域技术人员应当理解,本发明不限于上文具体示出和描述的内容。相反,本发明的范围包括上文所述各种特征的组合与子组合两者,以及本领域的技术人员在阅读上述说明书时可想到的未在现有技术范围内的上述各种特征的变型和修改。
Claims (18)
1.一种方法,包括以下步骤:
将第一熔融聚合物与第二熔融聚合物共挤出,其中所述第二熔融聚合物形成柔性内芯,并且所述第一熔融聚合物形成在所述内芯的相对侧上的恰好两个带,所述带比所述内芯更具刚性。
2.根据权利要求1所述的方法,其特征在于,还包括将编织物覆盖在所述内芯和所述带上。
3.根据权利要求2所述的方法,其特征在于,还包括将第三熔融聚合物共挤出到所述编织物上以形成包围所述编织物、所述带和所述内芯的柔性护套。
4.根据权利要求3所述的方法,其特征在于,还包括:
在执行所述共挤出步骤时,将所述第三熔融聚合物的第一组合物改为所述第三熔融聚合物的第二组合物,以限定杆的近侧段和远侧段以及在所述近侧段和所述远侧段之间的过渡段,所述近侧段比所述远侧段更具刚性。
5.根据权利要求4所述的方法,其特征在于,在所述近侧段中所述编织物具有第一构型,在所述远侧段中所述编织物具有第二构型,并且在所述过渡段中所述编织物在所述第一构型和所述第二构型之间过渡,其中所述第一构型与所述第二构型相比为所述杆提供更多的抗屈曲性。
6.根据权利要求3所述的方法,其特征在于,所述第三熔融聚合物包含聚醚嵌段酰胺和硫酸钡。
7.根据权利要求3所述的方法,其特征在于,所述第三熔融聚合物包含色母料。
8.根据权利要求1所述的方法,其特征在于,所述第一熔融聚合物包含聚酰胺。
9.根据权利要求1所述的方法,其特征在于,在固态下,所述第一熔融聚合物的硬度比所述第二熔融聚合物高。
10.根据权利要求1所述的方法,其特征在于,所述内芯具有穿过所述内芯形成的两个管腔,所述管腔在垂直于穿过所述带的直径的所述内芯的直径上对齐,并且尺寸被设计为容纳芯线材。
11.一种包括通过包括以下步骤的过程来制备的导管杆的设备:
将第一熔融聚合物与第二熔融聚合物共挤出,其中所述第二熔融聚合物形成柔性内芯,并且所述第一熔融聚合物形成在所述内芯的相对侧上的两个带,所述带比所述内芯更具刚性;
将编织物覆盖在所述内芯和所述带上;以及
将第三熔融聚合物共挤出到所述编织物上以形成包围所述编织物、所述带和所述内芯的柔性护套。
12.根据权利要求11所述的设备,其特征在于,所述第一熔融聚合物包含聚酰胺。
13.根据权利要求11所述的设备,其特征在于,所述第三熔融聚合物包含聚醚嵌段酰胺和硫酸钡。
14.根据权利要求11所述的设备,其特征在于,所述第一聚合物的硬度比所述第二聚合物高。
15.根据权利要求13所述的设备,其特征在于,所述第三熔融聚合物还包含色母料。
16.根据权利要求11所述的设备,其特征在于,还包括:
当执行所述共挤出步骤时,将所述第三熔融聚合物的第一组合物改为所述第三熔融聚合物的第二组合物,以限定所述杆的近侧段和远侧段以及所述近侧段和所述远侧段之间的过渡段,所述近侧段比所述远侧段更具刚性。
17.根据权利要求16所述的设备,其特征在于,所述编织物在所述近侧段具有第一构型,且在所述远侧段中具有第二构型,并且在所述过渡段中所述编织物在所述第一构型和所述第二构型之间过渡,其中所述第一构型与所述第二构型相比为所述杆提供更多的抗屈曲性。
18.根据权利要求11所述的设备,其特征在于,所述内芯具有穿过所述内芯形成的两个管腔,所述管腔在垂直于穿过所述带的直径的所述内芯的直径上对齐,并且尺寸被设计为容纳芯线材。
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- 2017-11-22 IL IL255862A patent/IL255862B/en active IP Right Grant
- 2017-12-15 CA CA2989352A patent/CA2989352A1/en not_active Abandoned
- 2017-12-20 JP JP2017243587A patent/JP7080628B2/ja active Active
- 2017-12-21 EP EP17209464.1A patent/EP3338994B1/en active Active
- 2017-12-21 CN CN201711394838.3A patent/CN108210064A/zh active Pending
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AU2017264999A1 (en) | 2018-07-05 |
US20200215302A1 (en) | 2020-07-09 |
IL255862A0 (en) | 2017-12-31 |
EP3338994A1 (en) | 2018-06-27 |
JP7080628B2 (ja) | 2022-06-06 |
IL255862B (en) | 2021-01-31 |
US10589060B2 (en) | 2020-03-17 |
JP2018099888A (ja) | 2018-06-28 |
EP3338994B1 (en) | 2020-09-23 |
CA2989352A1 (en) | 2018-06-21 |
US20180169376A1 (en) | 2018-06-21 |
US11491304B2 (en) | 2022-11-08 |
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