CN1312697A - 用于测量间隔缺损的测量导管 - Google Patents
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Abstract
本发明是一种测量导管(10),和测量病人体内预选的内部开口,以快速、精确的测定该预选内部开口的扩张后直径的方法。该测量导管(10)包括由一薄层能充气膨胀的塑料构成的膨胀球束(26),并被用来测定预选开口的大小。将膨胀球束(26)充气到一充气阈值,该膨胀球束(26)在预选开口附近变形,而连接预选开口的膨胀球束(26)的大小近似于预选开口的扩张后直径。可利用该测量导管(10)和方法来确定合适大小的闭合装置,从而闭合该预选开口。
Description
背景技术
Ⅰ.发明领域
本发明一般涉及用于测定病人中内部开口的大小的装置和非手术方法。更具体的,本发明涉及一种测量导管及其使用方法,其中可用测量导管来测定病人体内通道的扩张后直径。本发明的测量导管特别适用于测定一种病人心脏中的缺损,如间隔缺损的扩张后直径。一旦知道了该缺损的扩张后直径,可选择合适大小的闭合装置,并放置在缺损的开口内。
Ⅱ.相关技术的描述
几年来,对于为在预选的病人体内通道、开口、或缺损的安置,已开发了各种医用装置,包括支架和闭合装置。可在治疗特殊的异常状况时传送并使用复合装置,如用于除去血管闭塞的装置或用于治疗间隔缺损的装置等。虽然各种装置中取得了进步,但尚不能非手术性传送支架和闭合装置。例如,可用某些血管内装置,如导管或指引导丝,将医用装置传送到病人心脏内的特殊位置。另外,可用导管来达到血管系统的选定的冠状动脉,或可用导管和/或指引导丝将装置传送到病人心脏的内腔中。
在传送特殊医用装置前,必须确定内部通道、开口和缺损的大小,以提供合适大小的装置。另外,对开口或缺损“扩张后直径”的测定对提供宜在医用装置和周围组织间更好的密接是需要的。在过去,医生已利用球束导管,来尝试测定体内开口或缺损的大小。通常,医生将球束置于开口内,缓慢使球束充气膨胀,前后推或拉导管上的球束,直到医生感到对球束存在阻力。然后测定与开口大小对应的球束大小。通过开口或缺损拉或推球束导管的技术是不可靠的,而且当周围组织扩张后,也不能确定开口大小。
医生可用具有已知长度的不透射线区域的球束导管和已校准的指引导丝,在预先荧光透视检查中估计缺损大小、形状和缺损附近间隔壁的厚度。虽然有用,当扩张后不能确定缺损的确切大小和形状,因此增加了装置周围渗漏的可能性。
还已用超声心动描记术来估计开口或缺损的直径,但超声测量值总是比“扩张后直径”要显著小。超声测量值和扩张后直径之间的差异范围可在2mm到10.5mm之间。已建议,可以将超声测量值乘以1.05倍,然后加上5.49来估计扩张后直径。虽然该公式在某些情况下证明是足够的,但已观察到在实际扩张后直径和从该公式估计的直径之间差异达到了4.5mm。因大多数通路不是完全圆形的,而球束将变形的通路变成了圆形结构,这个事实可解释超声测量中的误差。如果选择的装置太小,栓塞和残余分流的危险将显著增加。另一方面,如果装置太大,装置将在开口或缺损内不密接。
已描述了其它用于利用球束导管测定内部开口大小的方法。例如,Taheri等,在美国专利号5,591,195中公开了一种测量导管,其中测量了可充气球束中的压力。Taheri等讲授了当球束与要测量的血管接触时,球束中的压力增加。然后可从已知的球束压力和直径曲线图上测定球束大小。如图9所见,即使正测量的实际直径维持不变,球束中的压力还是会变化。因此存在对一种能测定内部通道、开口或缺损的扩张后直径的装置的需要。本发明顺应这些需要,而且其它需要对本领域技术人员来说是清楚的。
发明简述
本发明的目的是提供一种装置和方法,用于测量病人体内开口或缺损的标称和/或“扩张后直径”。本领域技术人员将理解,可用本发明的装置或方法测定病人体内不同的缺损、通道、或内部开口之任一的大小。为了易于讨论,并不受任何限制,本发明的装置和方法可被描述成与测定病人心脏内间隔缺损的扩张后直径相关。
可将本发明的装置和方法与放射学、荧光学、超声心动描记术、和/或其它已知的适用于观察病人心脏中放置的导管远端的方法联用。本发明的测量导管包括具有在管状杆的近端和远端之间沿纵向轴可延伸的管状杆。该管状杆具有一个或多个在管状杆中成形的管腔,其中管腔适合接受诸如指引导丝、装置、加压液等。管腔之一在管状杆的近端和接近远端的区域间延伸,并终止于一系列通过管状杆从管腔延伸到管状杆外表面的孔。该孔系列可以螺旋方式围绕管状杆四周排列。一个细长膨胀球束被固定在管状杆上,贴近管状杆的远端,并包住系列孔。
膨胀球束由对应缺损组织扩张性的具有充气阈值的一薄层能充气膨胀的塑料构成。使用时,当球束被置于预定的开口并充气时,膨胀球束抵抗变形,直到充气阈值,从而导致环绕开口的组织扩张。一旦达到充气阈值,膨胀球束在预定开口上变形,就在预定开口形成显而易见的球束腰部。可用具有已知间隔距离,在导管远端的记号测定邻近预定开口的膨胀球束大小,从而帮助确定预定开口的扩张后直径。
另外,当达到充气阈值而且膨胀球束变形时,可记录膨胀球束内的压力。然后可从心脏除去导管,将远端插入具有已知直径的孔的模板中。然后在估计比间隔缺损扩张后直径大的孔内将球束充气到该记录的压力。如果球束变形,模板中的所选孔可能是近似于间隔缺损的扩张后直径的。可测试下一个更大的孔,来证实球束不在这个更大的孔中变形。如果球束在第一个所选孔中不变形,那么在模板中选择下一个更小的孔,使球束充气到该记录的压力。如果球束在该孔中变形,那么该孔的直径对应于开口的扩张后直径。重复该程序,直到球束在记录压力下在一个孔内变形。以这种方式,可测定缺损或通道的扩张后直径。
为了增强导管远端垂直于缺损平面,延伸通过缺损的可能性,管状杆的远端可与管状杆的纵轴呈45度角。本领域技术人员可理解与管状杆纵轴呈45度角是优选的,因为心脏的平均房间隔有45度的倾斜。还有,当使用不透放射线标记,来估计心脏内的距离和大小时,这种朝向是优选的。
目的
本发明的基本目标是提供一种装置和方法,来明确测定扩张后的内部通道或缺损的大小。
本发明的另一个目的是提供一种装置,用来确定用于闭合缺损的大小正确的闭合装置。
本发明的这些和其它目的,和这些及其它特征和优点对本领域技术人员来说,根据下文详细描述的优选例,联系所附权利要求和附图(其中几个视图中的相同数字代表对应部分),将是容易明白的。
附图简述
图1是本发明测量导管的透视图;
图2是本发明的导管体的部分剖视图和前视图;
图3是本发明测量导管远端的分段透视图;
图4是图3所示类型的测量导管远端的分段透视图,其中球束被充气;
图5是图3所述类型的测量导管远端的分段透视图,其中球束被充气,并置于测量模板的一个孔中;
图6是图3所示类型的测量导管远端的分段透视图,其中球束被充气,并置于心脏的间隔缺损中;和
图7是一张图表,说明在几种测量方法中测定本发明的测量导管球束膨胀大小的准确性的差异。
优选例的详述
首先根据图1,显示了一根用于测量通道、开口或缺损大小的测量导管10。测量导管10包括:一根管状杆12,具有在一近端14和一远端16之间延伸的一根纵轴,该纵轴包括在其中形成的第一腔和第二腔18和20。该近端包括一指引导丝接头22和联接于其上的压力阀组件24。不是为了限定,在优选例中,第一腔18是适应于在其中安装一根指引导丝的(未显示)。在管状杆12中形成第二腔20,该腔从管状杆12的近端14延伸到不到远端16处,终于一系列孔28,这些孔28从腔20通过管状杆12延伸到达管状杆12的外表(见图2)。一个细长的膨胀球束26被固定在管状杆12上,接近管状杆远端处,并覆盖系列孔28(见图3)。第二腔20起球束26和一已知适用于增加腔20内的压力,并联接在压力阀组件24上的结构之间的导管的作用。测量导管10的第一腔18的大小可通过一根0.035英寸指引导丝,并留下足够大的第二腔20的空间,来迅速对球束26充气和放气。
膨胀球束26是由一薄层可膨胀塑料构成,具有一充气阈值,因此当将膨胀球束26置于预定开口并充气时,该膨胀球束在直到充气阈值前一直抵抗变形。不受任何限制,在优选例中管状杆可由一种已知的合适的、不透放射线的基于尼龙的聚合物构成,而球束26可由2密耳厚的可膨胀聚合物,如聚氨基甲酸酯膜构成。一旦达到膨胀阈值,膨胀球束26在预定开口附近变形。毗邻预定开口的膨胀球束的大小近似于该预定开口的扩张后直径。
根据图4,显示了测量导管10的远端16。可将已知合适结构的不透射线的标记36固定或形成于接近膨胀球束26的管状杆12上。管状杆口的远端16对于管状杆的纵轴弯成45度角。以该方式,可将测量导管10远端16的纵轴置于与预定开口平面垂直位。
根据图5,显示测量导管10的远端16被置于模板30的一个孔32中,球束26被充气到充气阈值以上。在模板30中已成形了已知尺寸的不同大小的孔32。如下进一步所述,充气到充气阈值的球束中的压力随着孔32的大小变化。
描述了本发明的结构特征后,下面将结合图6和7描述使用方式。本领域技术人员可理解,可利用本发明的装置和方法来测定病人中不同的缺损,通道或内部开口中的任何一个的大小,然而,为了易于讨论,并不是为了任何限制,将联系测定病人心脏内的间隔缺损的扩张后直径来描述使用方式。在优选例中,虽然可能不是必须的,但在将导管插入病人体内之前,用二氧化碳对球束26充气,然后所有气体从第二腔20抽出。
在获得病人的血液动力学数据后,将一根导引导管通过心房交通插到左肺静脉中,引入一根交换指引导丝。然后除去导引导管和鞘,直接通过皮肤沿交换指引导丝引入测量导管10。为了便于经皮进入,一助手用连接针筒引入强负压。在荧光透视和超声心动描记术指引下,使测量导管10的远端16穿过该缺损。然后用稀释的造影剂使球束26膨胀,直到可观察到腰(达到膨胀阈值)和/或左-至-右分流停止,如用Doppler超声心动描记术观察到的。然后可通过许多已知方法,包括超声心动描记术或放射学测定毗邻缺损的球束26的直径。如图7显示的图表,据预测超声波测量法已经足够,然而还可加上x-射线测量法。另外如需要,可除去测量导管10,将其置于模板30的各种孔中。用已知同样量的造影剂膨胀球束,并可确定哪个孔与缺损内观察到的球束26的变形一致。一旦确定了间隔缺损扩张后直径,可选择置于缺损内的适应大小的闭合装置。
按照专利法,并如所需,提供给本领域技术人员实施该新原理,构建和使用实施例需要的信息,本文以可观的细节描述了本发明。然而,可理解的是,本发明可用特殊的不同装置进行,不违背本发明的范围,可完成各种修改。
Claims (11)
1.一种用于测量心脏内开口的大小的测量导管,其特征在于,所述测量导管包括:具有在所述测量导管近端和远端之间纵向轴延伸的管状杆,所述管状杆还具有一管腔,所述管腔在管状杆的近端和接近远端处之间延伸,并终止于一系列通过管状杆从管腔延伸到管状杆外表的孔,一个拉长的膨胀球束被固定在管状杆上,贴近管状杆的远端,并包住系列孔,所述膨胀球束由一薄层可膨胀塑料构成,并具有充气阈值,当所述球束被置于预定开口内并被充盈膨胀时,所述膨胀球束抵抗变形,直到充气阈值,从而导致当达到充气阈值时,所述膨胀球束在预定开口周围变形,毗邻预定开口的膨胀球束大小近似于预定开口的扩张后直径。
2.如权利要求1所述的测量导管,其特征在于,该测量导管还包括固定在接近膨胀球束的管状杆上的,不透射线的标记。
3.如权利要求1所述的测量导管,其特征在于,所述管状杆远端相对于管状杆纵轴倾斜45度角。
4.如权利要求1所述的测量导管,其特征在于,所述膨胀球束是由可膨胀聚合物构成的。
5.如权利要求1所述的测量导管,其特征在于,所述膨胀球束是由聚氨基甲酸酯构成的。
6.如权利要求1所述的测量导管,其特征在于,所述系列孔围绕管状杆的周围以螺旋方式排列。
7.一种测量心脏内开口的方法,其特征在于,所述方法包括步骤:
a)提供一种用于定径测量病人预定体内开口的大小的装置,该测量装置包括由一薄层可膨胀塑料构成的细长膨胀球束,所述球束可膨胀到近似预定开口的大小;
b)提供了一种观测装置,用于观测细长可膨胀球束在病人体内的位置;
c)将测量装置的膨胀球束置于预定开口中;
d)使所述膨胀球束充盈膨胀到膨胀阈值,从而使膨胀球束在预定开口周围变形,并且毗邻预定开口的膨胀球束的大小近似于预定开口的扩张后直径;和
e)测定毗邻预定开口的膨胀球束大小。
8.如权利要求7所述的方法,其特征在于,放置膨胀球束的步骤还包括将球束纵轴置于与预定开口平面相对垂直面。
9.如权利要求7所述的方法,其特征在于,所述测量装置包括可被所述观测装置观察的标记,所述测量装置通过预定开口,从而所述标记可被用来测定预定开口的厚度。
10.如权利要求8所述的方法,其特征在于,所述测量装置还包括可被所述观测装置观测的标记,所述测量装置通过预定开口,从而所述标记可被用来测定预定开口的厚度。
11.如权利要求7所述的方法,其特征在于,所述观测装置利用超声心动描记术来观测细长膨胀球束的体内位置。
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US09/137,949 | 1998-08-21 | ||
US09/137,949 US6241678B1 (en) | 1998-08-21 | 1998-08-21 | Sizing catheter for measuring septal defects |
Publications (2)
Publication Number | Publication Date |
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CN1312697A true CN1312697A (zh) | 2001-09-12 |
CN1170508C CN1170508C (zh) | 2004-10-13 |
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CNB998095699A Expired - Lifetime CN1170508C (zh) | 1998-08-21 | 1999-07-30 | 用于测量间隔缺损的测量导管 |
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Country | Link |
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US (1) | US6241678B1 (zh) |
EP (1) | EP1113751B1 (zh) |
JP (1) | JP3643309B2 (zh) |
KR (1) | KR100428820B1 (zh) |
CN (1) | CN1170508C (zh) |
AT (1) | ATE357181T1 (zh) |
AU (1) | AU752585B2 (zh) |
CA (1) | CA2341228C (zh) |
CY (1) | CY1106536T1 (zh) |
DE (1) | DE69935601T2 (zh) |
DK (1) | DK1113751T3 (zh) |
EA (1) | EA002415B1 (zh) |
ES (1) | ES2285858T3 (zh) |
HK (1) | HK1037945A1 (zh) |
PT (1) | PT1113751E (zh) |
WO (1) | WO2000010452A1 (zh) |
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- 1999-07-30 DK DK99941988T patent/DK1113751T3/da active
- 1999-07-30 KR KR10-2001-7001323A patent/KR100428820B1/ko not_active IP Right Cessation
- 1999-07-30 JP JP2000565780A patent/JP3643309B2/ja not_active Expired - Lifetime
- 1999-07-30 ES ES99941988T patent/ES2285858T3/es not_active Expired - Lifetime
- 1999-07-30 AT AT99941988T patent/ATE357181T1/de active
- 1999-07-30 AU AU55457/99A patent/AU752585B2/en not_active Expired
- 1999-07-30 PT PT99941988T patent/PT1113751E/pt unknown
- 1999-07-30 DE DE69935601T patent/DE69935601T2/de not_active Expired - Lifetime
- 1999-07-30 CA CA002341228A patent/CA2341228C/en not_active Expired - Lifetime
- 1999-07-30 WO PCT/US1999/017406 patent/WO2000010452A1/en active IP Right Grant
- 1999-07-30 CN CNB998095699A patent/CN1170508C/zh not_active Expired - Lifetime
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2001
- 2001-11-16 HK HK01108087A patent/HK1037945A1/xx not_active IP Right Cessation
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2007
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Publication number | Publication date |
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AU752585B2 (en) | 2002-09-26 |
CA2341228C (en) | 2005-10-11 |
JP3643309B2 (ja) | 2005-04-27 |
DE69935601T2 (de) | 2007-12-06 |
ATE357181T1 (de) | 2007-04-15 |
EP1113751A4 (en) | 2005-05-04 |
EA200100166A1 (ru) | 2001-08-27 |
CN1170508C (zh) | 2004-10-13 |
CA2341228A1 (en) | 2000-03-02 |
PT1113751E (pt) | 2007-04-30 |
KR20010072136A (ko) | 2001-07-31 |
US6241678B1 (en) | 2001-06-05 |
EP1113751A1 (en) | 2001-07-11 |
EA002415B1 (ru) | 2002-04-25 |
EP1113751B1 (en) | 2007-03-21 |
ES2285858T3 (es) | 2007-11-16 |
KR100428820B1 (ko) | 2004-04-29 |
WO2000010452A1 (en) | 2000-03-02 |
HK1037945A1 (en) | 2002-03-01 |
DE69935601D1 (de) | 2007-05-03 |
JP2002523121A (ja) | 2002-07-30 |
DK1113751T3 (da) | 2007-05-07 |
AU5545799A (en) | 2000-03-14 |
CY1106536T1 (el) | 2012-01-25 |
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