CN112218600A - 用于为搭桥手术配置血管假体的*** - Google Patents
用于为搭桥手术配置血管假体的*** Download PDFInfo
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Abstract
该***包括至少一个支架,该支架的端部被引入到血管中并与其连接,该***包括护套,该护套被设计成被引入到血管中,并且包括用于使血管中的假体定形和稳定的第一可膨胀球囊(8b),以及用于密封假体的所述假体端部与血管之间的连接的第二可膨胀球囊(7),该***还包括用于膨胀球囊(8b,7)的装置。
Description
技术领域
本发明涉及血管手术领域,特别是动脉搭桥术领域,例如在主动脉和股动脉之间。更具体地,本发明涉及一种用于为搭桥手术配置血管假体的***,该***包括至少一个支架。
主动脉和股动脉之间搭桥手术的标准程序是开放手术。因此,存在侵入性较小的手术的需求。从最近的腹腔镜主动脉搭桥手术的早期阶段,这已被许多作者接受为治疗主动脉闭塞性疾病的侵入性较小的替代方法。腹腔镜检查包括通过***腹壁的内窥镜检查腹盆腔(abdominal-pelvic cavity)的内容物。
背景技术
专利号为8,357,190的美国专利描述了一种用于获得血管通路的腹腔镜装置,特别是一种用于腹腔镜导管的配置***,该***包括具有近端和远端的细长的移植管。近端包括至少两个用于保持近端敞开的自扩张支架,设置在两个支架之间的间隔,该间隔提供穿过血管壁上的开口的密封区域,以及细长的未设置支架的远端部分。专利号为8,357,190的美国专利的配置***包含技术构造要求,这使其成为复杂且昂贵的设备。此外,这种腹腔镜装置虽然能够进行微创手术,但尚未在人体上进行测试。从其设计来看,它可能在假体配置期间导致大量出血。尽管对患者有明显的潜在益处,但这是使该技术未能推广的主要困难。因此,需要一种结构更简单并且能够使所有血管外科医生都能进行该手术而不会引起出血的腹腔镜装置。
美国专利申请2003/135257描述了一种用于配置血管假体以进行搭桥手术的***,该***包括两个可膨胀球囊及用于其膨胀的膨胀装置。
类似地,US 2014/277361、EP 0646365或WO 2016/022673的***可包括可膨胀球囊。
但是,从这些出版物中获得的信息仍然不能使所有血管外科医生都可以进行该手术而不会引起出血。
发明内容
已经提出的这个问题,本发明是通过用于配置血管假体的***的新构造来解决主动脉假体吻合的解决方案。术语“吻合”在此指的是打开血管的反向,直接或通过连接(缝合)。
为此,本发明涉及一种用于为搭桥手术配置血管假体的***,该***包括至少一个支架,该支架具有要引入到血管中并与其连接的端部,并且包括被布置为要引入到血管中的护套,并包括用于使血管中的假体定形和稳定的第一可膨胀球囊以及用于密封假体的所述端部与血管之间的连接的第二可膨胀球囊,该***还包括用于膨胀(换句话说,扩张)球囊的装置。
在动脉搭桥手术的情况下,例如在主动脉和股动脉之间,必须使用包括至少一个支架并安装在可膨胀球囊上的血管假体,根据本发明,从而将配备有一个或多个支架的假体的部分安装进入目标动脉中,以及密封目标动脉与动脉外血管假体之间的连接。
在本发明的优选实施例中,用于使球囊膨胀的装置包括用于使第一可膨胀球囊膨胀的第一装置和用于使第二可膨胀球囊膨胀的第二装置。
优选地,用于膨胀的第一装置和第二装置被布置为使球囊膨胀至不同的压力和/或以不同的膨胀动力学使球囊膨胀。在该优选实施例中,球囊可以在时间上以及从压力(膨胀/扩张因子)的角度彼此独立地膨胀。这允许在外科手术过程中更好地调节形状和稳定性,同时有效地密封假体和主动脉之间的连接而没有出血的风险。
优选地,第一可膨胀球囊由可变形的生物相容性聚合物材料形成,优选地为弹性体,例如聚氨酯、乳胶或硅胶弹性体,第二可膨胀球囊由非变形的生物相容性聚合物材料形成,例如半结晶聚合物,如聚乙烯、聚对苯二甲酸乙二酯或聚酰胺。
优选地,护套在从其远端开始的长度方向上是透明的和/或可撕开的。
在本发明的另一个优选实施例中,将血管假体分叉,以提供严格的解剖学动脉搭桥手术。优选地,分叉的一分支被包括可膨胀球囊的组件交叉,而另一分支保持自由。
最后,血管假体的近端部分可以配备有用于抓住血管内壁的装置。
本发明的配置***比已经引用的专利号为8,357,190的美国专利更简单,因为它不包括能刺穿目标血管的装置,例如弯曲针。
附图说明
通过附图将更好地理解和说明本发明,但是附图仅示出了本发明的一个特定实施例,因此不应被理解为限制本发明的范围,本发明的范围仅由权利要求书限定。
在附图中:
-图1示出了本发明的用于配置血管假体的***的优选实施例;
-图2示出了可膨胀球囊的***,能够将血管内部和外部的血管假体定形和稳定并密封假体和血管之间的连接;
-图3示出了根据本发明的可与配置***一起使用的分叉的血管假体的示例,以及
-图4A和图4B示出了根据本发明的配置***的入口锥体在手术过程的两个阶段,分别是在配置之前和之后。
具体实施方式
在以下描述中:
-术语“远侧的(distal)”和“近侧的(proximal)”应在本领域中常规地理解,即,例如在专利号为8,357,190的美国专利中的定义,
-术语“内腔”,指的是血管,指代的是其壁所容纳的内部空间,以及
-术语“支架”是指可以***血管尤其是动脉的内腔中的任何线(wire)或管,或任何轴、杆(stick)或杆(rod)。
现在参考图1,描绘了一种用于配置血管假体2的***1,在这种情况下,根据所提出的血管外科手术的要求,该***的长度约为20至150cm。血管假体2可以具有不同的形式和长度,并且可以如图3中更详细地示出的那样被分叉。一方面,血管假体2在其近端14包括一个或多个支架15(图1中未详细示出),另一方面,在其远端处包括未设置支架(non-stented)的部分16。支架15的数量取决于患者和所提出的手术过程,并且通常可达到10。例如,支架15的数量可以在2至10,或3至9,或4至8,甚至5至7的范围内。支架15的特征,特别是其几何形状、其尺寸和形成它们的材料不是本发明的关键因素,并且可以在本领域常规地选择,特别是从市面上有售的型号中选择。支架15的尺寸,特别是其直径,将基于所考虑的目标血管来选择。每个支架15的宽度通常为0.5至3cm。作为非限制性示例,血管假体2的远端直径可以在18至24mm的量级,并且其远端的长度通常在6至10cm之间。具有不同部分14、15和16的血管假体2被设计成被引入到诸如动脉,特别是主动脉的血管中。因此,血管假体2优选地由聚四氟乙烯(缩写为PTFE,商标)、聚对苯二甲酸乙二醇酯(缩写为PET,商标)或任何其他生物相容性聚合物材料形成,以便实施动脉搭桥手术。血管假体2的不同部分14、15、16被包括在护套11中,护套11被布置为被引入到血管中。在优选的实施例中,护套11是透明的,以便能够看到配备有血管假体2的支架15的区域,并因此使其能够完美地定位在动脉中。在另一个有利的实施例中,护套11的远端13在长度方向上是可撕开的,例如在存在撕开引导件20的情况下,以便在已经配置了血管假体2时促进其抽出,如图1所示。
配置***的远端包括组件21(图2),该组件在这种情况下包括可膨胀球囊8a,当球囊位于主动脉中时,该球囊8a用于打开假体,并设计成可完善远端部分16的配置(图3),另一个可膨胀的密封球囊7,用于密封假体的端部14和血管之间的连接,特别是用于使假体定形的可膨胀球囊8b,被设计成当其在主动脉中时将其打开并压在主动脉上并确保其稳定性。该球囊8b在上文已被描述为第一球囊;作为第二球囊的球囊7因此位于球囊8a和8b之间,配置***1的近端被入口锥体9覆盖,入口锥体9的端部10是斜角形的,或者是适合于便于将其引入血管而不损坏血管的任何其他形式。护套11的远端13具有张开的形状,以在配置血管假体2之后使得***能够抽出或促进***抽出。在这一端,配置***1包括用于使球囊膨胀的装置5、6、25、26。在相同的一端,配置***1还可以包括用于将生理血清或在血管内手术中使用的任何其他液体产品注射到轴内腔中以确保有利润滑的装置4。
因此,在组件21中,可膨胀球囊7布置在两个可膨胀球囊8a和8b之间。球囊的数量和尺寸不是本发明的要求,并且可以在考虑到所提出的具体手术过程的情况下进行改变。即使在某些情况下,从理论上讲,更多数量的球囊可以提高***的效率,但应该理解,通常,球囊的数量不必大于3。
在这里描述的实施例中,可膨胀球囊8a和8b由可变形的生物相容性聚合物材料形成。使这种聚合物材料变形的可能性是使得第一球囊8b能够在支撑(moulding)血管(例如主动脉)的直径的同时打开假体(包括一个或多个支架15)而不会使其尺寸过大,从而避免在血管壁(动脉)上施加太大的压力。对于球囊8a,其确保了假体的未设置支架的远端部分16在血管外部的配置。可变形的生物相容性聚合物材料的许多实例是本领域技术人员已知的并且在市面上有售的,例如生物相容性弹性体。在本发明的一个实施方案中,所述可变形的生物相容性聚合物材料包括聚氨酯弹性体,在适用时与另一弹性体结合,或者主要由聚氨酯形成。在另一个实施方案中,所述可变形的生物相容性聚合物材料可以是乳胶或硅胶弹性体。
第二可膨胀密封球囊7在此由主要非变形的生物相容性聚合物材料形成。这种聚合材料的非变形性使得第二球囊7能够将装有血管假体2的支架/多个支架15的部分稳定地施加到目标血管(动脉)内部,并有效地密封假体末端与血管之间的连接区域。非变形的生物相容性聚合物材料的许多实例是本领域技术人员已知的并且市面上有售的,例如生物相容性半结晶聚合物。与无定形材料相反,半结晶材料具有高度有序的分子结构,这种分子结构具有高熔点。它们不会随着温度的升高而逐渐软化。相反,它们保持固态,直到吸收了一定量的热量为止。在本发明的一个实施例中,这种半结晶聚合物的实例包括聚酰胺、聚乙烯、聚丙烯、乙烯-丙烯共聚物和生物相容性聚酯,例如聚对苯二甲酸乙二酯和聚羟基链烷酸酯。
现在再次参考图1,现在更详细地描述球囊膨胀***。用于使球囊膨胀的装置包括压力供应源,例如导管5、6,压力供应源具有截止阀或通过阀25、26,根据不同的压力和/或根据不同的膨胀动力学,通过导管5、6以扩张球囊。以这种方式,有可能面对血管外科医生在屏幕上观看配置过程时可能出现的困难,例如,在调节施加于每个部分膨胀系数的时候,对动脉的压力太大和/或对假体的压力太大。在本发明的优选实施例中,球囊7具有预定的直径,用于密封假体和血管之间的连接。作为非限制性示例,对于5mm的直径通常适合于6个大气压的压力,对于5.1mm的直径通常适合于8个大气压的压力。这里的图1示出了在导管24打开时,用于将生理性血清或在血管内手术中使用的任何其他液体产品注射到轴内腔中的中央导管4。
参照图3,现在描述适于本发明的配置***1的分叉的血管假体2的示例。在本发明的该优选实施例中,血管假体在其未设置支架部分16的远端水平处(level)被分叉,以便能够提出严格的解剖搭桥手术。例如,它分叉成6至8厘米,分成两个不同的枝(分支)17a,17b,每个枝的长度在15到40厘米之间,直径在7到10毫米之间。未连接到配备有支架15的部分的杆17b优选在其远端是封闭的,以避免在配置期间泄漏。也可以用手术夹夹住该枝。图3还示出了在血管假体2的另一近端处的夹紧装置18,这里示出的是手术钩或钉,用于夹紧血管的内壁。
参考图4a和4b,其更详细地示出了包括至少一个支架15的***1的近端部分如何配备锥体9,所述支架15位于护套11的近端。优选地,如在这些图中示出的,锥体9的端部10是倾斜的,以便于在不损坏血管壁的情况下将其引入患者的动脉中。作为非限制性示例,圆锥体9的远端的外径为0.8mm,并且逐渐达到超过2至5cm,即护套11的直径。
在此仅提及根据本发明的部署***的不同组件的所有尺寸(长度、直径等),作为与最常见情况相对应的指示,但不应解释为本发明的限制参数。
Claims (9)
1.一种用于为搭桥手术配置血管假体(2)的***(1),其包括至少一个支架(15),所述支架(15)具有要引入血管中并与所述血管连接的端部(14),所述***(1)包括被布置成被引入到所述血管中的护套(11),并且包括用于使所述血管中的所述假体定形和稳定的第一可膨胀球囊(8b)和用于密封所述假体的所述端部(14)与所述血管之间的连接的第二可膨胀球囊(7),所述***还包括用于使所述球囊(8b,7)膨胀的装置(5、6、25、26),其特征在于,所述第一可膨胀球囊(8b)由可变形的生物相容性聚合物材料形成,所述第二可膨胀球囊(7)由非变形的生物相容性聚合物材料形成。
2.根据权利要求1所述的用于配置血管假体(2)的***(1),其中,所述假体(2)包括远端部分(16),提供了第三可膨胀球囊(8a),所述第三可膨胀球囊(8a)被布置为当其被定位在所述血管中时,以打开所述假体并完善所述远端部分(16)的配置。
3.根据权利要求1或2所述的配置***(1),其中,提供了用于将生理润滑血清注射到所述***中的装置(4)。
4.根据权利要求1至3中任意一项所述的***,其中,所述护套(11)在其远端(13)处包括撕开引导件(20)。
5.根据权利要求1至4中任意一项所述的配置***(1),其中,所述用于使所述球囊膨胀的装置(5、6、25、26)包括用于使所述第一球囊(8b)膨胀的第一装置(5、25)和用于使所述第二球囊(7)膨胀的第二装置(6、26)。
6.根据权利要求5所述的部署***(1),其中,所述第一膨胀装置(5、25)和所述第二膨胀装置(6、26)被布置成将所述球囊膨胀至不同的压力和/或以不同的膨胀动力学使得所述球囊膨胀。
7.根据权利要求1至6中的一项所述的配置***(1),其中,所述血管假体(2)是分叉的,以能够进行严格的解剖搭桥手术。
8.根据权利要求7所述的配置***(1),其中,所述假体包括被所述组件21交叉的分支(17a),所述分支包括可膨胀球囊(7、8b,8a),以及保持自由的另一个分支(17b)。
9.根据权利要求1至8中任意一项所述的配置***(1),其中,所述血管假体(2)配备有用于夹紧血管的内壁的装置(18)。
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KR20200138739A (ko) | 2020-12-10 |
BE1025571B1 (fr) | 2019-04-12 |
EP3781089A1 (fr) | 2021-02-24 |
US20210015644A1 (en) | 2021-01-21 |
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