CN110650756B - 心室内流动可植入pv环路*** - Google Patents
心室内流动可植入pv环路*** Download PDFInfo
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Abstract
一种血泵,该血泵包括壳体,该壳体包括:入口元件,该入口元件具有耦合至该壳体的远侧部分以及大小被设计为被接收在患者的心脏的至少一部分内的近侧部分;以及转子,该转子被配置成用于在该壳体内旋转并且从心脏推动血液。至少一个压力传感器被耦合至入口元件的该近侧部分。
Description
技术领域
本发明涉及用于具有被配置成用于测量心脏的效率的血泵的方法以及***。
背景技术
用作机械循环支持设备(或“MCSD”)的植入式血泵包括用于将血液从心脏移出至身体其他部位的泵送机制。泵送机制可以是离心流泵,诸如,由在美国佛罗里达州迈阿密湖的HeartWare公司制造的HVAD@泵。在美国专利第8,512,013号中进一步讨论了HVAD@泵,该专利的公开内容藉此以其整体并入本文。在操作中,血泵从源(诸如患者心脏的右心室、左心室、右心房或左心房)吸取血液并将该血液推动到主动脉(诸如,患者的升主动脉或外周动脉)中。
然而,在此类设备植入之后,较难确定心脏的病变部分是否正在治愈并且在正常的参数内运转。即,因为血泵正协助将血液从心脏的一部分泵送至另一部分或者从心脏泵送至肺部或身体的剩余部位,所以较难确定例如左心室或右心室是否正在正常运作或其是否保持运转失常。例如,患者可以在医院环境中经历导管***,以用于确定心脏功能,即,PV环路分析,然而,此类手术具有侵入性并且仅提供心脏的健康的简要快照。
发明内容
一些实施例有利地提供了一种用于血泵的方法以及***,该血泵包括壳体,该壳体包括:入口元件,该入口元件具有耦合至该壳体的远侧部分以及大小被设计为被接收在患者的心脏的至少一部分内的近侧部分;以及转子,该转子被配置成用于在该壳体内旋转并且从心脏推动血液。至少一个压力传感器被耦合至入口元件的该近侧部分。
在该实施例的另一方面中,该设备包括法兰构件,该法兰构件至少部分地围绕入口元件的近侧部分设置,并且其中压力传感器被耦合至法兰构件。
在该实施例的另一方面中,入口元件限定了第一直径,并且其中法兰构件限定了比该第一直径大的第二直径。
在该实施例的另一方面中,该设备包括超声换能器,超声换能器耦合至入口元件的远侧部分。
在该实施例的另一方面中,超声换能器被耦合至法兰构件。
在该实施例的另一方面中,超声换能器以及该压力传感器被耦合至微机电***(“MEMS”)。
在该实施例的另一方面中,MEMS被配置成用于粘附至至法兰构件。
在该实施例的另一方面中,壳体进一步包括定子,该定子具有多个线圈,并且其中该定子被配置成用于生成磁力以旋转转子,并且其中该定子包括多个导体,该多个导体被配置成用于与电源耦合。
在该实施例的另一方面中,该多个导体被电耦合至MEMS。
在该实施例的另一方面中,MEMS包括无线发射器,并且其中超声换能器以及压力传感器与耦合至入口元件的无线发射器通信。
在该实施例的另一方面中,该设备进一步包括法兰构件,该法兰构件至少部分地围绕入口元件的近侧部分设置,并且其中超声传感器被耦合至法兰构件。
在另一实施例中,一种用于测量患者心脏的效率的方法包括将血泵的入口部分***至患者心脏的腔室内,该入口元件包括至少一个压力传感器以及至少一个超声换能器。使用该至少一个压力传感器测量腔室的压力。使用该至少一个超声换能器测量该腔室的体积。
在该实施例的另一方面中,该方法进一步包括基于腔室内压力以及体积的测量确定患者心脏的腔室的效率。
在该实施例的另一方面中,血泵进一步包括法兰构件,该法兰构件至少部分地围绕入口元件设置,并且其中该至少一个压力传感器被耦合至法兰构件。
在该实施例的另一方面中,法兰构件包括近侧以及远侧端,并且其中法兰构件的该近侧端被***心脏的腔室内,并且其中该至少一个压力传感器被耦合至法兰构件的近侧端。
在该实施例的另一方面中,该至少一个超声换能器被耦合至法兰构件的近侧端。
在该实施例的另一方面中,血泵进一步包括壳体,并且其中该壳体包括定子,该定子具有多个线圈,并且其中该定子被配置成用于生成磁力以旋转转子,并且其中该定子包括多个导体,该多个导体被配置成用于与电源耦合。
在该实施例的另一方面中,该至少一个超声换能器以及该至少一个压力传感器被耦合至MEMS。
在该实施例的另一方面中,MEMS被配置成粘附至法兰构件。
在另一实施例中,一种血泵***包括壳体,该壳体包括入口元件,该入口元件具有耦合至壳体的远侧部分以及大小被设计成被接收在患者的心脏的至少一部分内的近侧部分。转子被配置成用于在该壳体内旋转并且从心脏推动血液。包括两个定子,每一个定子具有多个线圈,并且每一个定子被配置成用于生成磁力以旋转该转子并且包括多个导体,该多个导体被配置成用于与电源耦合。法兰构件围绕入口元件的近侧部分的圆周设置,该法兰构件包括MEMS,该MEMS耦合至该多个导体并且粘附至该法兰构件的近侧表面。压力传感器以及超声换能器被耦合至MEMS。
附图说明
在结合附图考虑时,通过参考以下详细说明,将更容易地理解本文所述实施例的更完整的理解以及其所伴随的优点和特征,其中:
图1是根据本申请的原理构造的示例性血泵的分解视图;
图2是具有安装元件、法兰构件以及MEMS设备的图1中示出的组装的血泵的一部分的前视图;
图3是MEMS设备安装至MEMS设备的图1中示出的组件的前视图;
图4是心脏循环的压力-体积(PV)环路;并且
图5示出了植入在心脏的左心室内的图2的设备。
具体实施方式
如本文所使用的,诸如“第一”和“第二”、“顶部”和“底部”等等之类的关系术语可单独地用于将一个实体或要素与另一实体或要素区别开来,而不一定要求或暗示这些实体或要素之间的任何物理或逻辑关系或顺序。
现在参见各附图,其中相同的附图标记表示相同的元件,在图1中示出的是根据本申请的原理构造的并一般地指定成“10”的示例性血泵。根据本公开的一个实施例的血泵10包括容纳血泵10的组件的静态结构或壳体12。在一个配置中,壳体12包括下部壳体或第一部分14、上部壳体或第二部分16以及入口部分或流入插管18,该流入插管18包括外管18a以及内管18b。第一部分14以及第二部分16协同地限定螺旋(volute)形腔室20,该螺旋形腔室20具有延伸通过第一部分以及流入插管18的主纵向轴22。腔室20限定了围绕轴22逐渐增加到腔室20的***上的出口位置的半径。第一部分14以及第二部分16限定了与腔室20通信的出口24。第一部分14以及第二部分16还限定了通过磁透(magnetically permeable)壁与螺旋形腔室20分离的隔离腔室(未示出)。流入插管18大体上是圆柱形的并且从第一部分14延伸并且大体上沿着轴22延伸。流入插管18具有远离第二部分16的上游端或近侧端26以及靠近腔室20的下游端或远侧端28。上文所提到的壳体12的各个部分彼此固定地连接,由此使得壳体12整体限定了连续的封闭流动路径。流动路径在流动路径的上游端处从上游端26延伸至流动路径的下游端处的出口24。沿着流动路径的上游和下游方向分别由箭头U以及D指示。沿着轴22将柱30安装至第一部分14。具有中心孔34的大体上为盘形状的铁磁转子32被安装在腔室20内以用于绕着轴22旋转。转子32包括永磁体并且还包括用于将血液从转子32的中心附近转移至转子32的***的流动通道。在组装的情况下,在转子32的中心孔中接收柱30。具有多个线圈的第一定子36可被设置在转子32下游的第一部分14内。第一定子36可以沿着轴22与转子轴向地对齐,由此使得当将电流施加至第一定子36中的多个线圈时,由第一定子36生成的电磁力旋转转子32并且泵送血液。第二定子38可被设置在转子32上游的第二部分16内。第二定子38可被配置成用于结合第一定子36操作或独立于第一定子36操作以用于旋转转子32。
在第一部分14以及第二部分16上分别提供了电连接器41以及43(图1)以用于将线圈连接至电源,诸如控制器(未示出)。控制器被布置成将电力施加至泵的线圈以用于创建旋转的磁场,该旋转的磁场将转子32以预定的第一旋转方向绕着轴22旋转,诸如由箭头所指示的方向R是如从流入插管18的上游看到的逆时针方向。在血泵10的其他配置中,第一方向可以是顺时针的。转子32的旋转沿着流动路径向下游推动血液,由此使得血液以下游方向D沿着流动路径移动并且通过出口24离开。在旋转期间,流体动力以及磁性轴承(未示出)支持转子32并且维持转子32在操作期间不与第一部分14以及第二部分16的元件的表面接触。第一非铁磁盘40可被设置在转子32上游的第一部分14内在第一定子36与转子32之间,并且第二非铁磁盘42可被设置在转子32下游的第二部分16内在第二定子38与转子32之间。转子32被配置成用于在不接触任一盘的情况下在第一盘40与第二盘42之间旋转。上文所描述的组件的一般布置可与本申请的受让人HeartWare,Inc.以HVAD的名义出售的MCSD中所使用的血泵10相似。在此类泵以及大体设计相同的变体中所使用的诸如磁体、电磁线圈以及流体动力轴承之类的组件的布置在美国专利第6,688,861号;第7,575,423号;第7,976,271号;以及第8,419,609号中描述,上述专利的公开通过引用结合于此。
现在参考图2-图3,压力传感器44可被耦合至入口元件18的近侧端26,该压力传感器44被配置成用于测量心脏的任意一个腔室内的血压。例如,近侧端26可包括一个压力换能器或压力换能器的阵列,所述一个压力换能器或压力换能器的阵列被配置成用于测量当心脏收缩以及舒张时心脏的特定腔室内的改变的压力。在一个配置中,压力传感器44被耦合至入口元件18a的最近侧端,而不会阻挡入口元件18的开口,并且被接收在左心室内,但是入口元件18可至少部分地可***至心脏的任何腔室内。压力传感器44可被耦合至法兰构件46(图3),如美国专利申请第15/471,575号中所描述的,该专利申请以其全文通过引用并入本文,该法兰构件46的功能是阻止血栓进入入口18。法兰构件46被配置成用于被耦合至入口元件18的近侧端,并且限定了与入口元件18相比更大的直径。法兰构件46的最近侧端,即,法兰构件46的表面,该表面面向该法兰构件46所***的特定腔室的内部。超声换能器48可进一步耦合至近侧端26入口元件18或法兰构件46。超声换能器48可包括一个超声换能器或超声换能器的阵列,该一个超声换能器或超声换能器的阵列被配置成用于测量当心脏收缩以及舒张时心脏的腔室内的体积。在一个配置中,微机电***(MEMS)设备50可被粘附至或以其他方式耦合至法兰构件46的表面,并且压力传感器44以及超声换能器48可集成为MEMS设备50的表面中的阵列。例如,MEMS设备50可以是粘附至法兰构件46的贴片(sticker)或替代地可被附接或蚀刻进法兰构件的表面。MEMS设备50可被耦合至被配置成用于为泵10供电的独立电压源(未示出)或电压源,并且可进一步包括无线发射器以及接收器(未示出),由此使得由超声换能器48和/或压力传感器40测量的信息可被传送至患者体外的远程控制器。
在示例性配置中,入口元件18的最近侧端26被***至患者的左心室内。如上文中讨论的美国专利申请第15/471,575号所描述的,法兰构件46可被定位于近侧端26上。在附连(affixation)至入口元件18之前,MEMS设备50可被粘附至法兰构件46。压力传感器44以及超声换能器48以在阵列中的独立激活的传感器的形式,使得可沿着多个向量测量多个测量。例如,压力传感器44可被包括在MEMS设备50上或被直接包括在法兰构件46上。由于测量的压力可在舒张以及收缩周期期间是可变的,并且基于传感器44相对于腔室的位置是可变的,故MEMS设备50可被配置成用于单独地激活MEMS设备上的阵列中的传感器44以同时地或顺序地进行多个测量。相似地,超声换能器48可以以在MEMS设备50上面向不同的方向的超声换能器48的阵列的形式,以在例如左心室内创建不同的测量向量。例如,由于当植入至左心室内时超声换能器48在MEMS设备50上的位置并且由于左心室的形状,为了测量左心室的体积,超声换能器48的阵列可被配置成用于扫过(sweep across)左心室,即,具有扫描范围或可以是可移动以调整自身角度以用于测量左心室的体积。在一个配置中,第一多个超声换能器48可被计时以用于在收缩期间测量左心室的体积,并且另一多个超声换能器48可被计时以用于在舒张期间测量左心室的体积。组合的压力以及体积测量可被用于产生PV环路,如图4中所示,以用于实时地测量心脏的特定腔室的效率。
虽然上文中的实施例是相对于双定子***描述的,但是所设想的是,可以以本文中所描述的方式在具有单个定子的轴流泵中使用上文中的传感器,该具有单个定子的轴流泵如在美国专利第8,007,254号以及美国专利申请公开第2015/0051438号A1中所描述的并且由本申请的受让人HeartWare,Inc.以HVAD的名义出售。此外,上文所描述的实施例独立于泵的类型。例如,上文所描述的传感器阵列可被定位于被配置成用于将泵保持至心脏或保持在心脏内的任意支持设备上。在一个配置中,传感器阵列在泵被移除并且由例如插头替换后可继续工作,因为植入在心脏的尖端(apex)中的索环/缝合环将保持在原位。
本发明的某些实施例包括:
实施例1.一种血泵,包括:
壳体,该壳体包括:入口元件,该入口元件具有耦合至该壳体的远侧部分以及大小被设计为被接收在心脏的至少一部分内的近侧部分;以及转子,该转子被配置成用于在壳体内旋转并且从心脏推动血液;以及压力传感器,该压力传感器耦合至入口元件的近侧部分。
实施例2.根据实施例1中的血泵,进一步包括法兰构件,该法兰构件至少部分地围绕入口元件的近侧部分设置,并且其中压力传感器被耦合至法兰构件。
实施例3.根据实施例2的血泵,其中入口元件限定了第一直径,并且该法兰构件限定了比第一直径大的第二直径。
实施例4.根据实施例1-3中任一项的血泵,进一步包括超声换能器,该超声换能器耦合至入口元件的远侧部分。
实施例5.根据实施例3或4中的血泵,其中超声换能器被耦合至法兰构件。
实施例6.根据实施例5中的血泵,其中超声换能器以及压力传感器被耦合至微机电***(“MEMS”)。
实施例7.根据实施例6中的血泵,其中MEMS被配置成用于被粘附至法兰构件。
实施例8.根据实施例1中的血泵,其中壳体进一步包括定子,该定子具有多个线圈,并且其中该定子被配置成用于生成磁力以旋转转子,并且其中该定子包括多个导体,该多个导体被配置成用于与电源耦合。
实施例9.根据实施例8中的血泵,其中该多个导体电耦合至MEMS。
实施例10.根据实施例6-7中任一个中的血泵,其中MEMS包括无线发射器,并且其中超声换能器以及压力传感器与耦合至该入口元件的无线发射器通信。
实施例11.根据实施例1中的血泵,进一步包括法兰构件,该法兰构件至少部分地围绕入口元件的该近侧部分设置,并且其中超声传感器被耦合至法兰构件。
实施例12.一种用于测量患者心脏的效率的方法,包括:
将血泵的入口部分***至患者心脏的腔室内,该入口元件包括至少一个压力传感器以及至少一个超声换能器;
使用压力传感器在该腔室的压力内测量压力;并且
使用超声换能器测量该腔室的体积。
本领域技术人员应当理解,本实施例不限于以上在本文中已具体示出并描述的内容。另外,除非作出与以上相反的提及,应该注意所有附图都不是按比例的。鉴于以上传授内容,在不背离所附权利要求范围的情况下,多种修改和变化是可能的。
Claims (9)
1.一种血泵,包括:
壳体,所述壳体包括:入口元件,所述入口元件具有耦合至所述壳体的远侧部分以及大小被设计为被接收在患者的心脏的至少一部分内的近侧部分;以及转子,所述转子被配置成用于在所述壳体内旋转并且从所述心脏推动血液;
法兰构件,所述法兰构件至少部分地围绕所述入口元件的所述近侧部分设置;以及
压力传感器,所述压力传感器被耦合至所述法兰构件,所述法兰构件限定孔径,所述入口元件被配置成延伸通过所述孔径。
2.根据权利要求1所述的血泵,其特征在于,所述入口元件限定了第一直径,并且其中所述法兰构件限定了比所述第一直径大的第二直径。
3.根据权利要求2所述的血泵,进一步包括超声换能器,所述超声换能器耦合至所述入口元件的所述远侧部分。
4.根据权利要求3所述的血泵,其特征在于,所述超声换能器被耦合至所述法兰构件。
5.根据权利要求4所述的血泵,其特征在于,所述超声换能器以及所述压力传感器被耦合至微机电***(“MEMS”)。
6.根据权利要求5所述的血泵,其特征在于,所述微机电 ***(“ MEMS”) 被配置成用于被粘附至所述法兰构件。
7.根据权利要求1所述的血泵,其特征在于,所述壳体进一步包括定子,所述定子具有多个线圈,并且其中所述定子被配置成用于生成磁力以旋转所述转子,并且其中所述定子包括多个导体,所述多个导体被配置成用于与电源耦合。
8.根据权利要求7所述的血泵,其特征在于,所述多个导体电耦合至所述微机电 ***(“ MEMS”) 。
9.根据权利要求5所述的血泵,其特征在于,所述微机电 ***(“ MEMS”) 包括无线发射器,并且其中所述超声换能器以及所述压力传感器与耦合至所述入口元件的无线发射器通信。
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US9192702B2 (en) * | 2013-06-12 | 2015-11-24 | Wilmo C Orejola | Autonomous artificial heart |
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EP3131615B1 (en) * | 2014-04-15 | 2021-06-09 | Tc1 Llc | Sensors for catheter pumps |
EP2962710A1 (de) * | 2014-07-03 | 2016-01-06 | Berlin Heart GmbH | Verfahren und Herzunterstützungssystem zur Bestimmung eines Auslassdrucks |
WO2016004466A1 (en) * | 2014-07-10 | 2016-01-14 | Thorvascular Pty Ltd | Low cost ventricular device and system thereof |
WO2017041102A1 (en) * | 2015-09-04 | 2017-03-09 | Flodesign Sonics, Inc. | Acoustic blood separation processes and devices |
US10159772B2 (en) | 2016-03-30 | 2018-12-25 | Heartware, Inc. | Flanged heart tissue blocker |
EP3624867B1 (en) | 2017-05-16 | 2022-03-30 | Heartware, Inc. | Blood pump |
-
2018
- 2018-05-10 EP EP18727593.8A patent/EP3624867B1/en active Active
- 2018-05-10 US US15/975,936 patent/US10856745B2/en active Active
- 2018-05-10 WO PCT/US2018/031971 patent/WO2018213089A1/en unknown
- 2018-05-10 CN CN201880032538.7A patent/CN110650756B/zh not_active Expired - Fee Related
-
2020
- 2020-11-03 US US17/087,744 patent/US11826127B2/en active Active
Also Published As
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US20210045639A1 (en) | 2021-02-18 |
CN110650756A (zh) | 2020-01-03 |
WO2018213089A1 (en) | 2018-11-22 |
US10856745B2 (en) | 2020-12-08 |
EP3624867B1 (en) | 2022-03-30 |
US11826127B2 (en) | 2023-11-28 |
EP3624867A1 (en) | 2020-03-25 |
US20180333059A1 (en) | 2018-11-22 |
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