CN109922860B - 具有集成传感器的可植入医疗装置递送系统 - Google Patents
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Abstract
递送和部署装置可以包括手柄组件和从手柄组件向远侧延伸的轴。装置容纳壳体可以耦合到轴的远侧区域并且可以从那里向远侧延伸。远侧容纳壳体可以被配置为在其中容纳IMD的至少一部分。例如,IMD可以是无引线起搏器、引线、神经刺激装置、传感器或任何其它合适的IMD。多个电极可以在装置容纳壳体的外表面周围分布,使得多个电极中的至少一些可以被定位成在部署IMD之前测试潜在的IMD部署位置。
Description
相关申请的交叉引用
本申请要求于2016年10月27日提交的美国临时专利申请序列号62/413,748的权益,其公开内容通过引用并入本文。
技术领域
本公开涉及医疗装置以及用于制造和/或使用医疗装置的方法。更特别地,本公开涉及无引线装置和方法,诸如无引线心脏起搏装置和方法,以及用于这种无引线心脏起搏装置的递送装置和方法。
背景技术
针对医疗用途(例如心脏用途)已经开发了多种医疗装置。这些装置中的一些包括导管、引线、和起搏器等,以及用于递送这种装置的递送装置和/或系统。这些装置可以通过各种不同的制造方法中的任何一种来制造,并且可以根据各种方法中的任何一种来使用。关于已知的医疗装置、递送系统和方法,每个都具有某些优点和缺点。一直需要提供替代医疗装置和递送装置以及用于制造和使用医疗装置和递送装置的替代方法。
发明内容
本公开提供了用于医疗装置(包括递送装置)的设计、材料、制造方法和使用替代方案。
被配置为将可植入医疗装置(IMD)递送到患者心脏的腔室并部署IMD的示例递送和部署装置可以包括:手柄组件和从手柄组件向远侧延伸的轴,该轴包括远侧区域。装置容纳壳体可以耦合到轴的远侧区域并且可以从那里向远侧延伸。远侧容纳壳体可以被配置为在其中容纳IMD的至少一部分。例如,IMD可以是无引线起搏器、引线、神经刺激装置、传感器或任何其它合适的IMD。多个电极可以在装置容纳壳体的外表面周围分布,使得多个电极中的至少一些可以被定位成在部署IMD之前测试潜在的IMD部署位置。在一些情况下,多个电导体(conductor)可以与多个电极可操作地耦合,并且可以朝向手柄组件沿着轴往回向近侧延伸,多个电导体具有被配置为可操作地耦合到测试装置的近端。
作为上面实施例中的任一个的替代或附加,多个电极可以包括在装置容纳壳体的外表面周围径向设置的至少一些电极。
作为上面实施例中的任一个的替代或附加,多个电极可以包括沿着装置容纳壳体的外表面轴向间隔开的至少四个电极,该至少四个电极包括第一电极、第二电极、第三电极和第四电极。第一电极和第四电极可以间隔开第一距离以形成提供电位差的刺激偶极子(stimulation bipole)。第二电极和第三电极可以间隔开比第一距离更小的第二距离,以通过测量由第一电极和第二电极所施加的电位差引起的第二电极和第三电极之间的电压来提供导电率(conductivity)测量结果,并且第二电极和第三电极设置在第一电极和第四电极之间。
作为上面实施例中的任一个的替代或附加,多个电极可以包括被设置在装置容纳壳体的外表面上以形成刺激偶极子的第一电极和第二电极。
作为上面实施例中的任一个的替代或附加,递送和部署装置还可以包括压力传感器,其被配置为响应于经由第一电极和第二电极递送的刺激电脉冲而获得对患者心脏的腔室中的压力的指示。
作为上面实施例中的任一个的替代或附加,压力传感器可以被设置在装置容纳壳体的近端处或其附近。
作为上面实施例中的任一个的替代或附加,递送和部署装置还可以包括:第一压力传感器,其被配置为获得对患者心脏的腔室中的压力的指示;和第二压力传感器,其被配置为获得对患者心脏的不同腔室中的压力的指示。
作为上面实施例中的任一个的替代或附加,递送和部署装置还可以包括相对于装置容纳壳体固定的加速度计和/或陀螺仪。
作为上面实施例中的任一个的替代或附加,多个电极中的至少一些设置在可延伸组件上,其可移动地固定在装置容纳壳体的外部周围,可延伸组件可移动到部署配置,在该部署配置中多个电极中的至少一些接触心脏组织,以用于在IMD部署之前对患者心脏的腔室的至少一部分进行心内膜标测。
作为上面实施例中的任一个的替代或附加,递送和部署装置还包括用于跟踪目的的相对于装置容纳壳体固定的一个或多个磁跟踪传感器(magnet tracking sensor)。
被配置为将可植入医疗装置(IMD)递送到患者心脏的腔室并在其中部署IMD的示例IMD植入装置可以包括:手柄组件和从手柄组件向远侧延伸的轴,该轴包括远侧区域。装置容纳壳体可以耦合到轴的远侧区域并且可以从那里向远侧延伸。远侧容纳壳体可以被配置为在其中容纳IMD的至少一部分。部署构件可以延伸通过轴并且可以被配置为向IMD施加部署力,以便使IMD从装置容纳壳体移动以将IMD部署在患者的心脏中。多个电极可以在装置容纳壳体的外表面周围分布,使得多个电极中的至少一些可以被定位成在部署IMD之前测试潜在的IMD部署位置。多个电导体可以与多个电极可操作地耦合,并且可以沿着轴朝向手柄组件往回向近侧延伸,多个电导体具有被配置为可操作地耦合到测试装置的近端。
作为上面实施例中的任一个的替代或附加,部署构件可以是推管,并且IMD植入装置还可以包括系绳,其向远侧延伸通过推管并且耦合到IMD,该系绳被配置为如果需要替换的部署位置,则用于将IMD取回到装置容纳壳体内。
作为上面实施例中的任一个的替代或附加,多个电极可以包括沿着装置容纳壳体轴向间隔开的至少四个电极,该至少四个电极包括第一电极、第二电极、第三电极和第四电极。第一电极和第四电极可以间隔开第一距离以形成提供电位差的刺激偶极子,其中第四电极延伸到装置容纳壳体的远端。第二电极和第三电极可以间隔开比第一距离更小的第二距离,以通过测量由第一电极和第二电极所施加的电位差引起的第二电极和第三电极之间的电压来提供导电率测量结果,并且第二电极和第三电极可以被设置在第一电极和第四电极之间。
作为上面实施例中的任一个的替代或附加,多个电极可以包括被设置在装置容纳壳体的外表面上以形成刺激偶极子的第一电极和第二电极。
作为上面实施例中的任一个的替代或附加,IMD植入装置还可以包括压力传感器,其被配置为响应于经由第一电极和第二电极递送的刺激电脉冲而获得对患者心脏的腔室中的压力的指示。
作为上面实施例中的任一个的替代或附加,压力传感器可以被设置在装置容纳壳体的近端处或其附近。
作为上面实施例中的任一个的替代或附加,IMD植入装置还可以包括相对于装置容纳壳体固定的加速度计和/或陀螺仪。
被配置为将无引线心脏起搏器(LCP)递送到患者心脏的腔室并在其中部署LCP的示例植入装置可以包括:手柄组件和从手柄组件向远侧延伸的轴,该轴包括远侧区域。装置容纳壳体可以耦合到轴的远侧区域并且可以从那里向远侧延伸,装置容纳壳体被配置为在其中容纳LCP。部署构件可以延伸通过轴并且可以被配置为向LCP施加部署力,以便使LCP从装置容纳壳体的远端移动以将LCP部署在患者的心脏中。一个或多个跟踪传感器可以相对于装置容纳壳体固定,以便于跟踪装置容纳壳体。
作为上面实施例中的任一个的替代或附加,一个或多个跟踪传感器可以包括便于装置容纳壳体的磁跟踪的磁跟踪传感器和/或便于装置容纳壳体的阻抗跟踪的阻抗跟踪传感器。
作为上面实施例中的任一个的替代或附加,植入装置还可以包括设置在装置容纳壳体内的LCP,并且LCP可以包括便于LCP的磁跟踪的一个或多个LCP磁跟踪传感器,和/或便于LCP的阻抗跟踪的一个或多个LCP阻抗跟踪传感器。
一些说明性实施例的以上概述并非旨在描述本公开的每个公开实施例或每个实施方式。下面的附图和详细描述更特别地例证了这些实施例中的一些。
附图说明
考虑到以下结合附图的详细描述,可以更全面地理解本公开,在附图中:
图1是心脏内植入的示例无引线起搏装置的平面图;
图2是示例可植入无引线心脏起搏装置的侧视图;
图3是图2的可植入无引线心脏起搏装置的剖视图;
图4是用于可植入无引线心脏起搏装置的示例递送装置的平面图;
图5是图4的递送装置的远侧部分的局部横截面侧视图;
图6是图4的说明性递送装置的手柄的俯视图;
图7是图4的说明性递送装置的手柄的仰视图;
图8是图4的说明性递送装置的手柄在图6中的线8-8处截取的横截面视图;
图9是图4的说明性递送装置的手柄的透视图,其中部分被移除;
图10A-10E是说明了使用说明性递送装置来部署可植入无引线心脏起搏装置的示意图;
图11A-11B是说明了说明性递送装置的示例可伸缩(telescoping)特征的示意图;
图12是说明性递送装置的远侧部分的示意图,示出了装置容纳壳体的特征;
图13是说明性递送装置的远侧部分的示意图,示出了装置容纳壳体的特征;
图14是说明性递送装置的远侧部分的示意图,示出了装置容纳壳体的特征;
图15是说明性递送装置的远侧部分的示意图,示出了装置容纳壳体的特征;
图16是说明性递送装置的远侧部分的示意图,示出了装置容纳壳体的特征;
图17是说明性递送装置的远侧部分的示意图,示出了装置容纳壳体的特征;
图18是说明性递送装置的远侧部分的示意图,示出了装置容纳壳体的特征;
图19是说明性递送装置的远侧部分的示意图,示出了装置容纳壳体的特征;并且
图20是说明性成像系统的示意图。
虽然本公开可以进行各种修改和替换形式,但是其细节已经在附图中通过示例被示出并且将被详细描述。然而,应该理解的是,意图不是将本公开限制于所描述的特定实施例。相反,意图是覆盖落入本公开的精神和范围内的所有修改、等同物和替代物。
具体实施方式
对于以下定义的术语,除非在权利要求或本说明书的其它地方给出不同的定义,否则应当应用这些定义。
无论是否明确指出,本文假设所有数值均由术语“约”修饰。术语“约”通常是指本领域技术人员会认为等同于所述值的数字范围(即,具有相同的功能或结果)。在许多情况下,术语“约”可以包括四舍五入到最接近的有效数的数字。
通过端点叙述的数值范围包括该范围内的所有数字(例如1至5包括1、1.5、2、2.75、3、3.80、4和5)。
如在本说明书和所附权利要求中使用的,单数形式“一”,“一个”和“该”包括复数指示物,除非内容另有明确指示。如在本说明书和所附权利要求中使用的,术语“或”通常以其包括“和/或”的含义使用,除非内容另有明确指示。
注意的是,说明书中对“实施例”、“一些实施例”、“其它实施例”等的引用指示出所描述的实施例可以包括一个或多个特定的特征、结构和/或特性。然而,这种叙述不一定意味着所有实施例都包括特定的特征、结构和/或特性。另外,当结合一个实施例描述特定的特征、结构和/或特性时,应该理解的是,无论是否明确描述,这种特征、结构和/或特性也都可以与其它实施例结合使用,除非明确相反地说明。
应该参考附图阅读以下详细描述,其中不同附图中的类似结构编号相同。不一定按比例的附图描绘了说明性实施例,并且不旨在限制本公开的范围。
心脏起搏器向心脏组织提供电刺激以使心脏收缩并因此将血液泵送通过血管系统。传统的起搏器可以包括电引线,该电引线从经皮下或肌肉下植入的脉冲发生器延伸到邻近心脏腔室的内壁或外壁定位的电极。作为传统起搏器的替代方案,已经提出了自给式(self-contained)或无引线心脏起搏器。无引线心脏起搏器是小胶囊(capsule),其可以例如固定到心脏腔室中的心内植入部位。在一些情况下,小胶囊可以包括偶极子起搏/感测电极、电源(例如电池)、以及用于控制起搏/感测电极的相关联电路,并因此可以向心脏组织提供电刺激和/或感测生理状况。可以使用递送装置将胶囊递送到心脏,所述递送装置可以前进通过股静脉、进入下腔静脉、进入右心房、通过三尖瓣、并进入右心室。因此,可能需要提供便于前进通过脉管系统的递送装置。
图1示出了心脏H中植入的示例可植入无引线心脏起搏装置10(例如,无引线起搏器)。说明性可植入医疗装置(IMD)10显示在右心室RV内,而另一IMD 10显示在左心室LV内,这是因为IMD 10可以被配置用于植入在任一心室中,或者植入在另一个腔室(诸如右心房RA或左心房LA)中。取决于治疗需要,患者可以具有在适当腔室中植入的单个IMD 10或可以具有两个或更多个IMD 10。图2中示出了说明性可植入医疗装置(IMD)10的侧视图,并且图3中说明了图2中的线3-3处截取的说明性IMD 10的剖视图。可植入医疗装置10可以包括具有近端14和远端16的外壳或壳体12。在一些情况下,IMD 10可以包括被定位为邻近壳体12的远端16的第一电极20和被定位为邻近壳体12的近端14的第二电极22。在一些情况下,壳体12可以包括导电材料并且可以沿着其长度的至少一部分绝缘。沿着近端14的区部可以不绝缘,以便限定第二电极22。电极20、22可以是感测和/或起搏电极,以提供电治疗和/或感测能力。第一电极20可以被配置为抵靠心脏H的心脏组织而被定位或者可以以其它方式接触心脏H的心脏组织,而第二电极22可以与第一电极20间隔开,并且因此与心脏组织间隔开。
IMD 10可以包括壳体12内的脉冲发生器(例如,电路)和电源(例如,电池)以向电极20、22提供电信号,并从而控制起搏/感测电极20、22。在一些情况下,脉冲发生器和电极20、22之间的电通信可以向心脏组织提供电刺激和/或感测生理状况。
IMD 10可以包括接近壳体12的远端16的固定机构24,其被配置为将IMD 10附接到心脏H的组织壁,或以其它方式将IMD 10锚定到患者的解剖结构。如图1所示,在一些情况下,固定机构24可以包括锚定到心脏H的心脏组织中以将IMD 10附接到组织壁的一个或更多的钩或尖齿26或多个钩或尖齿26。在其它情况下,固定机构24可以包括:被配置为与心脏H的腔室内的小梁(trabeculae)缠绕的一个或更多的被动尖齿或多个被动尖齿;和/或被配置为拧入组织壁以将IMD 10锚定到心脏H的螺旋固定锚定件。
IMD 10可以包括接近壳体12的近端14的对接(docking)构件30,其被配置为便于IMD 10的递送和/或取回。例如,对接构件30可以从壳体12的近端14沿着壳体12的纵轴延伸。对接构件30可以包括头部32和在壳体12和头部32之间延伸的颈部34。头部32可以是相对于颈部的扩大部分。例如,头部32可以具有距IMD 10的纵轴的径向尺寸,该径向尺寸大于颈部34距IMD 10的纵轴的径向尺寸。对接构件30还可以包括从头部32延伸的系绳保持结构(tether retention structure)36。系绳保持结构36可以限定开口38,开口38被配置为接收穿过其中的系绳或其它锚定机构。虽然保持结构36被示出为具有大致“U形”配置,但是保持结构36可以采取以下任何形状,其提供了围绕开口38的封闭周边以使得系绳可以被固定地和可释放地通过(例如,环状(looped)通过)开口38。保持结构36可以沿着颈部34延伸通过头部32,并且延伸到或进入壳体12的近端14,如图3中更清楚地示出的。对接构件30可以被配置为便于将IMD 10递送到心内部位和/或从心内部位取回IMD 10。预期了其它对接构件30。
在一些情况下,IMD 10可以包括一个或多个传感器或其它装置以助于在递送期间和/或递送之后跟踪IMD 10。在一些情况下,如示意性示出的,IMD 10可以包括设置在IMD10上或IMD 10内的传感器200。在一些情况下,传感器200可以被认为表示一个或多个磁跟踪传感器,其可以助于使用诸如将参考图20描述的系统来进行对IMD 10的磁跟踪。这种系统的说明性但非限制性的示例是可从Boston Scientific获得的系统。在一些情况下,传感器200可以被认为表示一个或多个阻抗跟踪传感器,其可以助于对IMD 10的阻抗跟踪。在一些情况下,传感器200可以被认为表示一个或多个磁跟踪传感器以及一个或多个阻抗跟踪传感器,这两者都可以有助于对IMD 10的阻抗跟踪。
在一些情况下,可以使用递送装置将IMD 10递送到心脏H,其可以前进通过股静脉、进入下腔静脉、进入右心房、通过三尖瓣、并进入右心室。因此,将理解的是,递送装置可能需要导航通过相对曲折的解剖结构以将IMD 10递送到合适的位置。用于递送IMD 10的目标区域可以是右心室的一部分,例如,心尖附近的右心室的一部分。目标区域还可以包括心脏的其它区域(例如,右心房、左心房或左心室)、血管或其它合适的目标。可能希望的是为递送系统提供某些特征,该某些特征可以允许更容易或更好地控制以用于导航或递送目的。
图4是可以用于递送IMD 10的说明性递送装置100(诸如导管)的平面图。将理解的是,递送装置100仅仅是说明性的,这是因为IMD 10可以与可以包括或可以不包括关于递送装置100所描述的一些特征的其它递送装置一起被递送。如所示出的,递送装置100可以包括具有近侧区部104和远侧区部106的外管状构件102。中间管状构件110可以纵向可滑动地设置在外管状构件102的内腔150内(参见例如图5)。内管状构件116可以纵向可滑动地设置在中间管状构件110的内腔152内(参见例如图5)。远侧保持区部或装置容纳壳体108可以附接到中间管状构件110的远端部分114,如图5所示。递送装置100还可以包括被定位为邻近外管状构件102的近侧区部104的手柄组件120。在一些情况下,外管状构件102可以至少包括其区部,所述区部具有小于装置容纳壳体108的至少一部分的外径D1的外径D2(参见例如图5)。
手柄组件120可以包括:第一或远侧毂(hub)部分126,其附接到诸如固定地附接到外管状构件102的近端区部104;第二或中间毂部分128,其附接到诸如固定地附接到中间管状构件110的近端区部;以及第三或近侧毂部分130其附接到诸如固定地附接到内管状构件116的近端区部(参见例如图5)。第一毂部分126、第二毂部分128和第三毂部分130可以以大致伸缩的布置进行定位并且是相对于彼此纵向可滑动的。如下面将更详细讨论的,第一毂部分126、第二毂部分128和第三毂部分130中的每一个可以是相对于彼此纵向可滑动的和可旋转的,使得外管状构件102、中间管状构件110、内管状构件116可以被单独致动。在一些情况下,可能希望同时移动外管状构件102、中间管状构件110和内管状构件116。手柄组件120可以包括多级部署机构或第一锁定机构134,以将第二毂部分128可释放地耦合到第三毂部分130,以防止它们之间的相对纵向移动,并从而防止中间管状构件110和内管状构件116之间的相对纵向移动,如下面将更详细讨论的。手柄组件120还可以包括第二锁定机构132,以将第一毂部分126可释放地耦合到第二毂部分128,以防止它们之间的相对纵向移动,并从而防止外管状构件102和中间管状构件110之间的相对纵向移动,如下面将更详细讨论的。
装置容纳壳体108可以被配置为在其中接收IMD 10。例如,参考示出了递送装置100的远侧部分的剖视图的图5,装置容纳壳体108可以限定用于可滑动地接收IMD 10的腔142,并且可以包括用于将IMD 10可滑动地插入到腔142中和/或将其抽出腔142外的远侧开口144。装置容纳壳体108可以包括主体部分138和远侧尖端部分140,其可以例如被配置为对解剖结构是防止创伤的,诸如缓冲器尖端(bumper tip)。例如,当导管导航通过解剖结构时,远侧尖端可以与解剖结构接触。另外,当导管用于递送可植入医疗装置10时,递送装置100的尖端140将可能与邻近目标部位的组织(例如心脏的心脏组织)接触。
在一些情况下,由外管状构件102和/或中间管状构件110的材料形成的硬远侧尖端可能损伤血管壁或心脏组织。因而,可以期望为递送装置100提供更软的远侧尖端140,其可以被引入到解剖结构中并与邻近目标位置的解剖结构接触而不会引起不必要的创伤。在一些情况下,远侧尖端140可以由比装置容纳壳体108的主体部分138更软的材料制成。在一些情况下,远侧尖端140可以包括具有比主体部分138的材料的硬度更小的硬度的材料。在一些特定实施例中,远侧尖端140中使用的材料的硬度可以在约5D至约70D的范围内,或者例如在约25D至约65D的范围内。另外,远侧尖端140可以包括可以使其对组织创伤较小的形状或结构。例如,远侧尖端140可以具有远侧表面,诸如组织接触表面,其是圆形的或包括被配置为对组织更防止创伤的曲率。
在一些情况下,装置容纳壳体108的全部或一部分可以包括内表面,其可以被配置为抵抗被卡住在固定机构24(诸如可植入医疗装置10上的一个或更多的钩或尖齿26、或多个钩或尖齿26)上。例如,装置容纳壳体108可以包括更硬或更光滑的材料的内层或涂层,以抵抗由固定机构24施加到装置容纳壳体108的内表面上的力。例如,装置容纳壳体108可以包括多层结构,并且内层可以由比外层更硬的材料制成。
内管状构件116可以设置(例如,可滑动地设置)在中间管状构件110的内腔152内。内管状构件116可以由用户接近第三毂部分130或在第三毂部分130处接合,并且延伸通过中间管状构件110的内腔152并进入装置容纳壳体108。内管状构件116的远侧部分118可以能够接合IMD 10,并且内管状构件116可以用于将IMD 10从装置容纳壳体108“推”出,以便将IMD 10部署并锚定在目标区域(例如,心脏的区域诸如右心室)内。内管状构件116可以具有从其近端117延伸到远侧部分118的内腔154。系绳112或其它保持特征可以用于将IMD 10可释放地固定到递送装置100。在一些情况下,系绳112可以是单个长度或整体长度的材料,其可以从内腔154的近端117延伸、通过远侧部分118出来、通过IMD 10的开口38、并通过内腔154返回到内管状构件116的近端117,使得系绳112的两端被定位为邻近第三毂部分130。在一些情况下,如将在下面更详细讨论的,系绳112的端部可以固定在第三毂部分130中的锁定特征内。
为了更具体地将递送装置100放置或引向到邻近预期目标的位置,递送装置100可以被配置为是可偏转的或可铰接的或可引向的。参考图4,例如,外管状构件102和/或中间管状构件110可以包括一个或多个铰接或偏转机构,其可以允许递送装置100或其部分以期望的方式被偏转、铰接、引向和/或控制。例如,外管状构件102可以包括可以在期望或预定方向上选择性地弯曲和/或偏转的其至少一部分。例如,这可以允许用户定向递送装置100,使得装置容纳壳体108处于用于将IMD 10导航或递送到目标位置的期望位置或取向。外管状构件102可以例如沿着偏转区域进行偏转。
可以使用各种偏转机构。在一些示例实施例中,偏转可以通过一个或多个致动构件(诸如在外管状构件102的远侧部分和靠近外管状构件102的近端的致动机构122之间延伸的一个或多个拉线)来实现。因而,一个或多个拉线可以在期望的偏转或弯曲区域或点的近侧和远侧两者延伸。这允许用户致动(例如,“拉动”)拉线中的一个或多个以将压缩力和/或偏转力施加到外管状构件102的至少一部分,并从而使外管状构件102以期望的方式偏转或弯曲。另外,在一些情况下,一个或多个线可以足够硬,使得它们也可以用于在外管状构件102上提供推力和/或张力,例如,以将轴“推”或“拉直”到期望的位置或方向。
在一些实施例中,致动构件采用连续线的形式,该连续线环绕通过或以其它方式耦合到外管状构件102的远端区域,以便限定一对线区部。然而,其它实施例被预期,包括其中致动构件包括一个或多个单独线的实施例,所述单独线例如被附接到邻近外管状构件102的远端区域的金属或金属合金环。
致动机构122可以包括期望的机构,其可以允许在一个或多个致动构件上施加张力(即,拉力)或压缩(即,推力)或两者。在一些实施例中,致动机构122可以包括外部可旋转构件124,其连接到手柄组件120的纵轴并且可绕手柄组件120的纵轴旋转。可旋转构件124可以螺纹地接合被附接到拉线或一个或多个致动构件的近端的内部构件。当外部可旋转构件124在第一旋转方向上旋转时,内部构件在第一纵向方向上平移,从而将张力施加到一个或多个拉线,以将压缩力施加到轴,以便使外管状构件102从初始位置偏转到偏转位置。当外部可旋转构件124在第二旋转方向上旋转时,内部构件在第二纵向方向上平移,从而减小和/或释放一个或多个拉线上的张力,并允许外管状构件102松弛回到初始位置。另外,在一些情况下,如上所述,在一个或多个线可以足够硬的情况下,可旋转构件124在第二旋转方向上的使得内部构件在第二纵向方向上平移的旋转可以对一个或多个线施加压缩,使得一个或多个线可以对外管状构件102施加张力并将外管状构件102“推”回到初始位置,并且可能进入超出初始位置的额外位置。
一个或多个铰接和/或偏转机构还可以需要外管状构件102包括当施加压缩力或张力时可以提供期望偏转程度和/或偏转位置的结构和/或材料。例如,外管状构件102可以包括一个或多个区部,其包括被配置为当施加某个预定的压缩力和/或张力时允许轴以某种方式弯曲和/或偏转的结构和/或材料。例如,轴可以包括比其它区部更灵活的一个或多个区部,从而限定弯曲或铰接的区域或位置。一些这种区域可以包括许多改变或变化的柔性特征,当施加预定力时,其可以限定某些弯曲形状。这种特征可以通过选择用于外管状构件102的不同区部的材料或结构来实现。
在其它实施例中,其它一个或多个铰接和/或偏转机构可以被预期。例如,递送装置100的全部或一部分诸如外管状构件102可以由形状记忆材料制成,诸如形状记忆聚合物和/或形状记忆金属。当被致动机构刺激(诸如温度变化或施加电流)时,这种材料可以从第一形状变化或移动到第二形状。因而,这些材料和机构可以用于以期望的方式使外管状构件102偏转或弯曲。也可以使用能够使递送装置100偏转的其它合适的一个或多个偏转机构。这种替代机构可以适用于本文所示和/或讨论的所有其它实施例,以及其它实施例,视情况而定。
此外,外管状构件102可以包括沿其长度的一个或多个预定义或固定的弯曲部分。在一些情况下,这种弯曲区部可以被配置为与特定解剖结构配合或者被配置用于更好地导航或递送IMD 10。另外或可替换地,一些这种弯曲区部可以被配置为,允许外管状构件102被预先设置为当向其施加压缩力和/或张力时,在某个方向或配置上弯曲和/或偏转。在一些情况下,外管状构件102可以是激光切割金属管、编织增强聚合物管或根据期望的其它柔性管状结构。
再次返回到图5,装置容纳壳体108可以被固定到中间管状构件110的远端部分114。装置容纳壳体108可以包括毂部分136和管状主体部分138。在一些情况下,毂部分136可以由金属或金属合金形成,而主体部分138可以由聚合材料形成,但这不是必需的。在一些情况下,主体部分138的近侧区域143可以热结合到毂部分136的远端部分137,或以其它方式黏附。毂部分136可以包括锥形中间区域145,其设置在近端部分139和远端部分137之间。
在一些情况下,外管状构件102可以包括邻近其远端103的用于将一个或多个拉线附接到其的金属环或尖端。在一些情况下,外管状构件102还可以包括光滑衬垫(liner),诸如但不限于聚四氟乙烯(PTFE)衬垫。毂部分136的近端部分139可以向近侧延伸到外管状构件102的内腔150中。在一些情况下,近端部分139的外表面可以与外管状构件102的内表面形成过盈配合。在一些情况下,近端部分139的外表面和外管状构件102的内表面可以以锥形接合的方式耦合。例如,外管状构件102的远端103可以在远侧方向上径向向外张开和/或近端部分139可以在近侧方向上径向向内逐渐变细。当近端部分139向近侧缩回外管状构件102内时,两个成角度的表面可以接合。其它耦合布置可以根据需要来使用。
在一些情况下,当外管状构件102弯曲以将IMD 10导航到期望位置时,近端部分139可以远侧前进并从外管状构件102的内表面脱离,从而创建邻近结合区域146的弱化区域或扭结点。向近侧缩回中间管状构件110以使中间区域145在接触点148处与外管状构件102接触和/或将近端部分139带入外管状构件102中并且以这种配置固定中间管状构件110,可以有助于防止在将递送装置100导航到期望位置期间装置容纳壳体108的移动。这种配置还可以使中间管状构件110处于张紧状态,同时装置容纳壳体108在外管状构件102上施加压缩力,如下面将更详细地讨论的。如上所讨论的,手柄组件120中的锁定机构132可以用于将外管状构件102和中间管状构件110可释放地保持在期望的取向中。
图6示出了递送装置100的手柄组件120的俯视图。图7示出了从图6所示的视图大约180°的手柄组件的仰视图。手柄组件120可以包括一个或多个端口158、160、162,其用于将流体(诸如但不限于造影流体和/或冲洗流体)递送到装置容纳壳体108的腔142。冲洗端口158、160、162可以根据需要与外管状构件102、中间管状构件110或内管状构件116的内腔150、152、154流体连通。例如,冲洗端口158可以与外管状构件102的内腔150流体连通,冲洗端口160可以与中间管状构件110的内腔152流体连通,并且冲洗端口162可以与内管状构件116的内腔154流体连通。
手柄组件120还可以包括系绳锁164。系绳锁164可以在锁定配置和解锁配置之间是可致动的,以将系绳112保持在期望的取向中。系绳112的端部可以黏附到、固定到或以其它方式接合被定位在第三毂部分130的近端处的系绳盖166。系绳盖166可以可移除地固定到第三毂部分130以允许临床医生接近系绳112的端部。当系绳锁164处于锁定配置时,系绳盖166可以不从第三毂部分130移除。当系绳锁164处于解锁配置时,系绳盖166可以被移除并且系绳112的端部可以被致动。例如,一旦IMD 10已经被植入并且其位置已验证,系绳112可以通过以下方式而从IMD 10的系绳保持特征36移除:通过拉动端部之一直到相反端部已经穿过开口38使得IMD 10摆脱系绳112为止。
在一些情况下,手柄组件120还可以包括视觉标记,诸如但不限于在170、172、174处示出的标记。这些标记170、172、174可以向临床医生提供视觉指令或指示。例如,在170处示出的标记可以被定位在致动机构122的可旋转构件124附近,以指示可旋转构件124控制外管状构件102的偏转和/或指示当致动机构122的可旋转构件124在给定方向上旋转时远侧区部106将在哪个方向偏转。172处示出的标记可以提供第二锁定机构132是否处于解锁配置和/或锁定配置的指示。类似地,174处所示的标记可以提供系绳锁164是否处于解锁配置和/或锁定配置的指示。
图8示出了递送装置的手柄组件120的剖视图。如上所讨论的,手柄组件120可以包括:附接到外管状构件102的近端区部104的第一毂部分126、附接到中间管状构件110的近端区部的第二毂部分128、以及附接到内管状构件116的近端区部的第三毂部分130。第一毂部分126、第二毂部分128和第三毂部分130中的每一个可以是相对于彼此可滑动和可旋转的,使得外管状构件102、中间管状构件110和内管状构件116可以被单独地纵向致动。
内管状构件116可以从近端117远侧延伸。内管状构件116的近端117可以被定位在系绳锁164内或邻近系绳锁164。系绳锁164可以包括端口162,其可以与内管状构件116的内腔154流体连通。内腔154可以从近端117延伸到远侧部分118,以用于将流体(诸如但不限于造影流体和/或冲洗流体)递送到装置容纳壳体108的腔142。在一些情况下,内管状构件116可以耦合或黏附到邻近内管状构件116的近端117的第三毂部分130,但这不是必需的。在一些情况下,内管状构件116可以被黏附到期望的任何纵向位置处的第三毂部分130。在一些情况下,用于将IMD 10固定到内管状构件116的远侧部分118的系绳(诸如系绳112)可以被设置在内腔154内并且可以通过系绳盖166或邻近系绳盖166而离开递送装置100,但这不是必需的。
中间管状构件110可以从近端111远侧延伸。中间管状构件110的近端111可以被定位在第二毂部分128内。中间管状构件110可以包括从中间管状构件110的近端111延伸到远端的内腔152。内管状构件116可以被可滑动地设置在中间管状构件110的内腔152内。在一些情况下,中间管状构件110可以耦合或黏附到邻近中间管状构件110的近端111的第二毂部分128,但这不是必需的。在一些情况下,中间管状构件110可以被黏附到期望的任何纵向位置处的第二毂部分128。
外管状构件102可以从近端105远侧延伸。外管状构件102的近端105可以被定位在第一毂部分126内。外管状构件102可以包括从外管状构件102的近端105延伸到远端103的内腔150。中间管状构件110可以被纵向可滑动地设置在外管状构件102的内腔150内。在一些情况下,外管状构件102可以耦合或黏附到邻近外管状构件102的近端105的第一毂部分126,但这不是必需的。在一些情况下,外管状构件102可以被黏附到期望的任何纵向位置处的第一毂部分126。
在一些情况下,第一毂部分126可以包括被定位为邻近第一毂部分126的近端的扣环(retaining ring)182。在一些情况下,扣环182可以围绕手柄组件120的纵轴旋转。在一些情况下,扣环182可以包括锁定特征,其被配置为与锁定机构132的其它锁定特征接合。当扣环182接合锁定机构132的其它特征时,可以防止第一毂部分126和第二毂部分128相对于彼此的纵向移动。旋转扣环182可以使扣环182与锁定机构132的其它特征脱离。这可以允许第一毂部分126和第二毂部分128相对于彼此的纵向移动,如下面将更详细描述的。虽然第二锁定机构132被描述为旋转扣环182,但是可以使用能够可释放地固定第一毂部分126和第二毂部分128并因此固定外管状构件102和中间管状构件110的其它锁定机构。
在一些情况下,第一锁定机构134可以包括可按压按钮131。可按压按钮131可以包括:被配置为接合第三毂部分130的区域的第一向外突出部分133、和被配置为接合第二毂部分128的区域的第二向内突出部分135。例如,第二突出部分135可以被设置在第二毂部分128中形成的凹槽或凹部178中并与其接合。第一锁定机构134的接合可以防止或减少当第一锁定机构134未被临床医生主动致动(例如,按下)时第二毂部分128和第三毂部分130的相对移动。向下的力186可以被施加到按钮131。力186可以使第一突出部分133从第三毂部分130的表面下降和/或脱离,并使第二突出部分135从第二毂部分128的表面上升和/或脱离。如184处所示,这可以允许第三毂部分130沿着手柄组件120的纵轴相对于第二毂部分128纵向移动(例如,向近侧和/或向远侧),如下面将更详细讨论的。第三毂部分130相对于第二毂部分128的纵向致动可以导致内管状构件(和因此IMD 10)相对于中间管状构件110和装置容纳壳体108的对应纵向致动。这种致动可以被用于递增地部署IMD 10。图8示出了被设置在凹部178的中间的第二突出部分135。然而,在一些情况下,在递送装置100前进到期望的治疗位置期间,第二突出部分135可以被定位在凹部178的近端处,以确保IMD 10被完全设置在装置容纳壳体108中。这仅是示例。虽然第一锁定机构134被描述为可按压按钮131,但在一些情况下,可以使用能够可释放地固定第二毂部分128和第三毂部分130并因此固定中间管状构件110和内管状构件116的其它锁定机构。
图9示出了手柄组件120的局部透视图,其中第三毂部分130的部分被移除以更清楚地示出第二毂部分128的特征。第二毂部分128的近侧部分127可以包括在其中形成的凹槽或者凹部178。凹槽178可以从近端179延伸到远端181。在一些实施例中,凹槽178可以包括近侧部分177和远侧部分183,其可以在圆周上彼此偏移。可以在近端179和远端181之间的区域处设置硬止挡件(hard stop)180。硬止挡件180可以是壁或其它突出部,其被配置为接合第一锁定机构134的第二突出部分135,使得为了使第二突出部分135从近侧部分177向远侧前进经过硬止挡件180,用户旋转第三毂部分130以使第二突出部分135与凹槽178的远侧部分183对准。这可以允许可植入医疗装置10被递增部署。在递送装置100前进通过脉管系统期间,第二突出部分135可以被设置在邻近近端179的近侧部分177内。如上所讨论的,第二突出部分135可以接合第二毂部分128的表面,以防止和/或最小化第二毂部分和第三毂部分128、130相对于彼此的相对运动。
凹槽178还可以包括在近侧部分177和远侧部分183之间的成角度区域198,其大致被定位为与硬止挡件180相反。当第三毂部分130从远端181向近侧缩回到近端179时,成角度区域198可以在单个流体运动中将第二突出部分135从凹槽178的远侧部分183引导到凹槽的近侧部分177。例如,在不阻止第二突出部分135从远侧部分183行进到近侧部分177的情况下,第三毂部分130可以在单个近侧运动中相对于第二毂部分128从远端181向近侧缩回到近端179(如果需要的话)。
第二毂部分128的远侧部分129可以包括凹槽或凹部188,其被配置为接收被设置在第一毂部分126上的配合特征。这可允许第一毂部分126向近侧缩回到第二毂部分128上方,如下面将更详细讨论的。第二毂部分128的近侧部分127和远侧部分129可以由抓握区域176分开,抓握区域176被配置为向临床医生提供用于握住的区域。
现在参考图10A-10E,现在将描述使用说明性递送装置100部署IMD 10的方法。为简单起见,这些图示出了被递送到右心室RV的IMDS 10。递送装置100可以通过先前引入的引导导管通过股静脉被引入到脉管系统中。这只是示例。将理解的是,例如,IMD 10可以通过左心房LA经由主动脉内途径被递送和部署在左心室LV中。递送装置100可以被引入通过任何期望的位置,并且根据需要使用或不使用引导导管。递送装置100可以通过脉管系统前进到期望的治疗位置,在无引线心脏起搏装置的情况下,该期望的治疗位置可以是心脏的腔室。临床医生可以使用致动机构122可以以期望的方式使外管状构件102的远侧区部106偏转,以便于递送装置100的前进。在递送装置100的前进期间,手柄组件120可以处于完全延伸配置中,如图10A所示。在这种配置中,第三毂部分130可以处于其相对于第二毂部分128的最近侧位置,并且第一毂部分126可以处于其相对于第二毂部分128的最远侧位置。当手柄组件120处于其完全延伸配置中时,内管状构件116、中间管状构件110和外管状构件102可以以图5中所示的方式被取向。递送装置100可以使用已知技术进行成像以确保准确放置IMD 10。
一旦装置容纳壳体108的远侧尖端部分140已经被定位为邻近期望IMD 10所处的心脏组织,就可以开始IMD 10的部署。部署IMD 10的第一阶段可以实现对固定机构24的启动。为了发起部署的第一阶段,临床医生可以相对于患者稳定第一毂部分126并按下第一锁定机构134的按钮131。然后临床医生可以向远侧滑动第三毂部分130,如190处所示,直到第一锁定机构134接合在第二毂部分128中设置的硬止挡件180为止,从而导致图10B中所示的手柄组件120配置。第三毂部分130的远侧致动还可以使内管状构件116向远侧移动相同的距离。当内管状构件116向远侧前进时,远侧部分118可以“推动”可植入医疗装置10的近端14。当IMD 10被向远侧推动时,钩26接合心脏组织,如图10C所示。IMD 10可以向远侧推出装置容纳壳体108,以将来自装置容纳壳体108的钩或尖齿26部署为接合心脏组织中的钩或尖齿26,而同时IMD 10的近侧部分保持在装置容纳壳体108内。在一些情况下,IMD 10可以在1至5毫米的范围内向远侧前进,但这仅是说明性的。这可以允许IMD 10被部署,同时使施加到心脏壁的压力的量最小化。此外,第一锁定机构134可以防止IMD 10的意外或无意部署,这是因为在使第三毂部分130前进的同时必须致动按钮131。
简要地参考图11A和11B,在一些情况下,可能希望在不使外管状构件102(即,伸缩中间管状构件110)前进的情况下,使装置容纳壳体108和中间管状构件110前进。例如,这可以有助于递送装置100在心脏内的前进,或者一旦装置容纳壳体108被放置抵靠心脏壁,就保持装置容纳壳体108的位置。为了使中间管状构件110相对于外管状构件102向远侧前进或伸缩,第二锁定机构132可以被致动以“解锁”第一毂部分126和第二毂部分128。如上所述,旋转扣环182可以被旋转,如194处所示,以将第二锁定机构132从锁定配置移动到解锁配置。一旦第一锁定机构已经被解锁,临床医生就可以使第二毂部分128和第三毂部分130一起向远侧前进196,以使装置容纳壳体108向远侧前进与所期望和/或需要的一样远。第二毂部分128和第三毂部分130的致动也可以同时移动中间管状构件110和内管状构件116。这可以在递送装置100通过脉管系统前进期间、在发起部署IMD 10的第一阶段之前、和/或在已经完成部署IMD 10的第一阶段之后,根据期望或需要而进行。
在对IMD 10的部署的第一阶段(其中尖齿或钩26已经从装置容纳壳体108部署成与心脏壁接合)之后,系绳112可以用于执行拖曳测试(tug test)以确定是否IMD 10与心脏壁充分接合。换句话说,IMD 10的固定(例如,钩26固定到心脏组织的程度如何)可以通过轻轻地拖曳系绳112的端部来测试。如果确定IMD 10与心脏壁充分接合,则用户可以进行到部署IMD 10的第二阶段(其中IMD 10的剩余部分从装置容纳壳体108中排出)。否则,如果拖曳测试失败并且确定IMD 10与心脏壁没有充分接合,则用户可以使用系绳将IMD 10(包括尖齿或钩26)拉回(缩回)到装置容纳壳体108中以从心脏壁释放可植入医疗装置10。然后IMD10可以被重新定位并重复部署的第一阶段。
返回到图10B,部署IMD 10的第二阶段可以向近侧缩回装置容纳壳体108,并因此使中间管状构件110相对于内管状构件116缩回以完全部署IMD 10。一旦临床医生已经确定IMD 10的位置是满意的并且固定机构24与心脏组织牢固地接合,递送装置100的中间管状构件110(包括装置容纳壳体108)就可以向近侧缩回。为了发起部署的第二阶段,临床医生可以首先旋转第三毂部分130,如192处所示,使得按钮131与凹槽178的远侧部分183对准。然后临床医生可以使第三毂部分130相对于患者稳定并且向近侧缩回第一毂部分126和第二毂部分128。应当注意的是,虽然此时可以向远侧致动第三毂部分130,但这可能导致额外的和不必要的力被施加到心脏壁。此外,第三毂部分130的这种远侧运动可以使内管状构件116(并且因此可植入医疗装置10)向远侧移动而不是向近侧缩回中间管状构件110和/或外管状构件102。第一毂部分126和第二毂部分128可以向近侧缩回,直到第一锁定机构134与凹槽178的远端181接合为止,从而产生如图10D中所示的手柄组件120配置。第一毂部分126和第二毂部分128的这种致动可以完全部署可植入医疗装置10,使得IMD 10位于装置容纳壳体108的外部并与心脏壁接合,如图10E所示。
如图10E中可以看出的,IMD 10仍然可以通过系绳112黏附到递送装置100。一旦临床医生已经验证了IMD 10的位置、IMD 10的固定和/或IMD 10的电气性能,系绳112就可以被移除。在一些情况下,IMD 10的固定(例如,钩26固定到心脏组织的程度如何)可以通过轻轻地拖拽系绳112的端部来测试。系绳112可以通过以下方式来移除:解锁系绳锁164,移除系绳盖166,沿系绳112的长度在某个位置切断系绳112,并拉动端部之一,直到相反端已经穿过IMD 10的开口38使得IMD 10摆脱系绳112为止。在一些情况下,系绳112可以被黏附到系绳盖166的一部分(例如,形成环),使得系绳112必须被切断以允许IMD 10摆脱系绳112。
在一些情况下,可能期望在部署和固定IMD 10之前测试可能的植入部位。在一些情况下,诸如递送装置100的递送装置可以包括以下结构或其它结构,其被配置为能够通过向可能的植入部位附近的心脏组织递送电脉冲并测量作为结果的心脏参数来电测试可能的植入部位。如果测量到的心脏参数指示出良好的植入部位,则IMD 10可以在该植入部位处部署并固定,如关于图10A-10E所讨论的。否则,可以将递送装置100移动到另一个可能部位,然后可以对其进行测试。这可以重复,直到找到可接受的部位为止。图12-19提供了大致地递送装置100(特别是装置容纳壳体108)可以被如何修改以帮助测试可能的植入部位的说明性但非限制性的示例。
图12是说明性递送装置202的一部分的示意图,其可以被认为是递送装置100的示例。在一些情况下,如所示出的,递送装置202包括从轴206向远侧延伸的装置容纳壳体204。在一些情况下,装置容纳壳体204可以被认为是装置容纳壳体108的示例,而轴206可以被认为大致表示中间管状构件110和外管状构件102的至少一部分,并且在一些情况下可以被认为向手柄组件120近侧延伸。在一些情况下,如所示出的,装置容纳壳体204包括可以用于对可能的植入部位进行电测试的若干电极。例如,电极可以设置在装置容纳壳体204的外表面208上,并且在一些情况下可以在外表面208上轴向和/或径向间隔开。如所示出的,存在第一电极210、第二电极212、第三电极214和第四电极216。在一些情况下,电极210、212、214和216中的一个或多个可以至少部分地围绕外表面208径向延伸。
在一些情况下,第一电连接器218从第一电极210向近侧延伸,第二电连接器220从第二电极212向近侧延伸,第三电连接器222从第三电极214向近侧延伸,并且第四电连接器从第四电极216向近侧延伸。在一些情况下,电连接器218、220、222和224延伸到手柄组件120并使得诸如但不限于编程器或测试器的装置能够经由电连接器218、220、222和224电耦合到电极210、212、214和216。
在一些情况下,第一电极210和第四电极216可以组合地被认为形成刺激偶极子。可以在第一电极210和第四电极216之间施加电位差,从而在它们之间产生电压。在一些情况下,第二电极212和第三电极214可以用于通过检测由第一电极210和第四电极216之间施加的电位差引起的第二电极212和第三电极214之间的电压来提供电阻测量结果。在一些情况下,如所示出的,第二电极212和第三电极214可以设置在第一电极210和第四电极216之间。将理解的是,在一些情况下,当在第一电极210和第四电极216之间施加电流时,在第二电极212和第三电极214之间的检测到的电阻与心脏的对应腔室的当前腔室容积之间可能存在关系。在一些情况下,例如,可以使用第一电极210和第三电极214来刺激和使用第二电极212和第四电极216,以测量例如导电率。在一些情况下,诸如临时贴片电极的外部电极可以由患者佩戴并且可以例如用作刺激电路的一部分。
在一些情况下,第一电极210可以比第四电极216更小。当如此提供时,第一电极210可以是刺激偶极子的阴极并且第四电极216可以是刺激偶极子的阳极(阴极刺激)。虽然没有明确示出,但是在一些情况下,第一电极210可以延伸遍布装置容纳壳体204的远端213,以便当装置容纳壳体204的远端213被上推抵靠心脏壁时直接接合组织。
在一些情况下,经由装置容纳壳体204上的电极获得的导电率值可以例如用于确定心脏壁接触。例如,血液具有与诸如心脏组织的组织相比而言更低的导电率。例如,相对较低的导电率值可以指示出组织接触不足,而相对较高的导电率值可以指示出组织接触。在一些情况下,组织成分可能影响导电率。例如,梗塞组织具有比健康心肌更多的胶原,并因此导电率值可以用于确定可能的植入部位是否包括健康心肌或不健康心肌,这对于实现较低起搏阈值可以是重要的。
图13是说明性递送装置226的一部分的示意图,其可以被认为是递送装置100的示例。在一些情况下,如所示出的,递送装置226包括从轴230向远侧延伸的装置容纳壳体228。在一些情况下,装置容纳壳体228可以被认为是装置容纳壳体108的示例,而轴230可以被认为通常表示中间管状构件110和外管状构件102的至少一部分,并且在一些情况下可以被认为向近侧延伸到手柄组件120。在一些情况下,如所示出的,装置容纳壳体228包括可以用于电测试可能的植入部位的若干电极。例如,电极可以设置在装置容纳壳体228的外表面232上,并且在一些情况下可以在外表面232上轴向和/或径向间隔开。如所示出的,存在可以一起用作刺激偶极子的第一电极234和第二电极236。虽然没有明确示出,但是在一些情况下,第一电极234可以延伸遍布装置容纳壳体228的远端235,以便当装置容纳壳体228的远端235被上推抵靠心脏壁时直接接合组织。在一些情况下,第一电连接器238从第一电极234向近侧延伸,并且第二电连接器240从第二电极212向近侧延伸。在一些情况下,电连接器238和240延伸到手柄组件120并使诸如但不限于编程器或测试器的装置能够经由电连接器238和240电耦合到电极234和236。
在一些情况下,传感器242可以设置在轴230上,靠近装置容纳壳体228。电连接器244可以从传感器242向近侧延伸并且可以延伸到手柄组件120,并因此可以与编程器、测试器或其它装置可操作地耦合。在一些情况下,例如,传感器242可以是压力传感器诸如压电压力传感器,并且可以被配置为提供表示心脏腔室内的血压的信号,其是由被施加作为例如第一电极234和第二电极236之间的电位差的刺激脉冲而产生的。在一些情况下,传感器242可以代替地表示加速度计或声学传感器,其可以响应于所施加的刺激脉冲(例如,心音、心脏壁加速度等)而输出表示心脏性能的信号。在一些情况下,传感器242可以表示陀螺仪,其可以响应于所施加的刺激脉冲而输出表示心脏性能(例如扭转)的信号。在一些情况下,传感器242可以包括电子组件以放大、过滤或以其它方式调节原始传感器信号。在一些情况下,传感器242可以是双向换能器(例如,用于促进超声测量的双向声换能器)。
在一些情况下,不是使用装置容纳壳体228上的电极进行刺激,而是IMD 10上的一个或多个电极可以代替地用于刺激心脏组织(提供起搏脉冲),并且电极234和236可以代替地用于提供所得的导电率值。在一些情况下,IMD 10可以用于刺激心脏组织,并且诸如传感器242的传感器可以用于测量所得的心脏参数。在一些情况下,装置容纳壳体228可以不包括任何电极。
在一些情况下,递送装置可以包括两个压力传感器。如例如图14中所示,递送装置250可以包括从轴254向近侧延伸的装置容纳壳体252,并且可以被认为是递送装置100的示例。在一些情况下,装置容纳壳体252可以被认为是装置容纳壳体108的示例,而轴254可以被认为通常表示中间管状构件110和外管状构件102的至少一部分,并且在一些情况下可以被认为向近侧延伸到手柄组件120。在一些情况下,如所示出的,装置容纳壳体252具有外表面256并且包括第一电极234和第二电极236。在一些情况下,第一电连接器238从第一电极234向近侧延伸并且第二电连接器240从第二电极212向近侧延伸。
在一些情况下,传感器242可以代表第一压力传感器,并且传感器258可以代表第二压力传感器。传感器242被示出为可操作地耦合到电连接器244,而传感器258被示出为可操作地耦合到电连接器260,其从传感器258向近侧延伸,并因此可以与编程器、测试器或其它装置可操作地耦合。在一些情况下,例如,传感器242和传感器258每个都可以是压电压力传感器或其它类型的压力传感器,并且每个都可以被配置为提供表示心脏腔室内的血压的信号,其是由所施加的作为例如第一电极234和第二电极236之间的电位差的刺激脉冲产生的。在一些情况下,将理解的是,取决于递送装置250相对于患者心脏的确切位置,传感器242和传感器258可以看到不同的压力波形,其可以用于确定特定可能的植入部位的适当性。例如,在一些情况下,传感器242可以看到心房压力波形,而传感器258可以看到心室压力波形。这些可以例如用于确定A-V延迟。
图15和16提供了电极配置的说明性但非限制性示例,其可以例如被认为示出了可与装置容纳壳体204(图12)、228(图13)和252(图14)中的任一个一起使用的可能电极配置。图15示出了具有外表面272的装置容纳壳体270。可以看到第一环形电极274和第二环形电极276设置在外表面272上。将理解的是,通过具有在外表面272周围至少部分(如果不是完全地的话)延伸的电极,不管装置容纳壳体204的旋转取向如何,都使组织/血液接触的问题可以更少。虽然没有明确示出,但是在一些情况下,第一环形电极274可以延伸遍布装置容纳壳体270的远端273,以便当装置容纳壳体270的远端273被上推抵靠心脏壁时直接接合组织。虽然示出了两个电极274、276,但是将理解的是,装置容纳壳体204可以包括三个、四个或更多个电极。在一些情况下,装置容纳壳体204还可以包括一个或多个传感器,其被配置为提供表示心脏性能的信号。
图16示出了具有外表面282的装置容纳壳体280。可以看到第一电极群284和第二电极群286设置在外表面282上。在一些情况下,如所示出的,第一电极群284包括电极284a、电极284b和电极284c。第一电极群284可以包括在该视图中不可见的附加电极。类似地,第二电极群286可以包括电极286a、电极286b和电极286c。第二电极群286可以包括在该视图中不可见的附加电极。在一些情况下,电极284a、284b、284c中的每个可以电耦合在一起。在一些情况下,电极284a、284b、284c中的每个可以是可单独寻址的。虽然没有明确示出,但是在一些情况下,电极284a、284b、284c中的每个可以延伸遍布装置容纳壳体280的远端283,以便当装置容纳壳体280的远端283被上推抵靠心脏壁时直接接合组织。在一些情况下,电极286a、286b、286c中的每个可以电耦合在一起。在一些情况下,电极286a、286b、286c中的每个可以是可单独寻址的。
将理解的是,通过具有在外表面282周围至少部分(如果不是完全地的话)延伸的电极,不管装置容纳壳体280相对于心脏H的旋转取向如何,都使组织/血液接触的问题可以更少。虽然示出了两个电极群284、286,但是将理解的是,装置容纳壳体280可以包括三个、四个或更多个电极群。在一些情况下,装置容纳壳体280还可以包括一个或多个传感器,其被配置为提供表示心脏性能的信号。
图17是装置容纳壳体290的示意图,其包括可以与装置容纳壳体204(图12)、228(图13)和252(图14)中的任一个进行组合的特征。说明性装置容纳壳体290包括从远端294延伸到近端296的外表面292。在一些情况下,装置容纳壳体290可以包括使医生或其它用户能够实际可视化可能植入部位的视觉系统。视觉系统可以例如利用心内超声、红外成像、方向视觉等。远端294包括第一可视化元件298和第二可视化元件300。这些元件中的一个可以例如是或以其它方式包括光源,而另一个元件包括相机、或光缆和可操作地耦合到位于近侧的相机以进行可视化的透镜。
图18和19是递送装置302的一部分的示意图,其可以被认为是递送装置100的示例,其中图18示出了处于递送配置的递送装置302,而图19示出了处于标测配置的递送装置302。在一些情况下,如所示出的,递送装置302可以包括从轴306向远侧延伸的装置容纳壳体304。在一些情况下,装置容纳壳体304可以被认为是装置容纳壳体108的示例,而轴306可以被认为通常表示中间管状构件110和外管状构件102的至少一部分,并且在一些情况下可以被认为向近侧延伸到手柄组件120。在一些情况下,如所示出的,装置容纳壳体304包括可以用于电测试可能的植入部位的电极。
在一些情况下,装置容纳壳体304包括电极组件310,其包括远侧环312和近侧环314,其中多个电极支撑件316在远侧环312和近侧环314之间延伸。多个电极支撑件316中的每个包括多个可单独寻址的电极318。在一些情况下,远侧环312相对于装置容纳壳体304固定,而近侧环314可以相对于装置容纳壳体304滑动。在一些情况下,部署构件320可以可操作地耦合到近侧环314并且向近侧延伸通过轴306,使得近侧环314可以通过推动和拉动部署构件320而向前和向后移动。在其它情况下,远侧环312可以是可滑动的,并且部署构件320可以代替地可操作地耦合到远侧环312。在任一种情况下,在部署状态下,刺激脉冲(例如起搏脉冲)可以被顺序地施加到多个可单独寻址的电极318中的每个,并且响应可以被感测和记录。这可以帮助确定IMD的合适植入部位。一旦已经确定了合适的植入部位,就可以移动部署构件320以缩回电极支撑件316,并且装置容纳壳体304可以被定位在合适的部位上,并且装置容纳壳体304中的IMD可以被部署和植入在该部位。
将理解的是,电极组件310允许对心内膜表面的标测。在一些情况下,这可以用于确定或以其它方式识别内在激活模式。在一些情况下,映射心内膜表面可以有助于识别当部署IMD 10时要避免的瘢痕组织和可能的其它受损组织。将理解的是,虽然没有传感器被示出作为递送装置302的一部分,但是一个或多个传感器诸如压力传感器、加速度计和/或陀螺仪可以被包括作为递送装置302的一部分,以便例如经由两个或更多个可单独寻址的电极318中的每个来测量对所施加的刺激的心脏响应。
如关于图2所指出的,在一些情况下,IMD 10可以包括一个或多个磁跟踪传感器和/或阻抗跟踪传感器。图20示意性地示出了系统400,其中包括心脏H的患者P被置于磁场发生器402的前面(或在其顶部)。在一些情况下,设置在心脏H内的装置包括磁跟踪传感器和/或阻抗跟踪传感器404。在一些情况下,当磁场发生器402正在生成磁场并且装置内的磁跟踪传感器404接通时,磁跟踪传感器404能够确定其相对于磁场线的位置,并且传送该信息以在监视器406上显示。当电流发生器(未示出)向身体提供电流(例如,经由两个或更多个电极贴片)时,装置内的阻抗跟踪传感器可以能够确定其相对于电场线的位置,并传送该信息以在监视器406上显示。在一些情况下,磁跟踪和阻抗跟踪两者都可以用于识别并跟踪装置的位置。在一些情况下,包括磁跟踪传感器和/或阻抗跟踪传感器404的装置可以是无引线心脏起搏器(LCP)或其它心脏内植入装置,并且系统400可以提供对身体内的装置的位置的指示。在一些情况下,包括磁跟踪传感器和/或阻抗跟踪传感器404的装置可以代替地是递送装置,并且磁跟踪传感器和/或阻抗跟踪传感器404可以提供对递送装置的位置的指示。在一些情况下,磁跟踪传感器和/或阻抗跟踪传感器404不仅可以提供位置(X,Y,Z),还可以提供与装置的位置有关的倾斜、偏航、速度、加速度、扭曲和/或其它参数。
如所示出的,系统400可以是患者P躺在或可能站在前面的结构。在一些情况下,预期的是磁场发生器402可以结合到可以用于移动测量的可穿戴背心中。在一些情况下,系统400提供的信息可以用于帮助指导初始植入并验证装置(诸如IMD 10)的固定。在一些情况下,当以其它方式的心脏运动可能干扰检测患者的物理运动时,所提供的数据可以用于确定速率响应传感器校准。在一些情况下,共同植入的装置(诸如但不限于皮下可植入复律器-除颤器(SICD))可以用于生成磁场和/或电场(例如,电流)。在一些情况下,SICD可以注入电流,其可以由IMD 10检测到,并且该信息可以用于经由阻抗跟踪来改善位置检测。
递送装置100、202、226、250、302或其组件可以由金属、金属合金、聚合物(其一些示例在下面公开)、金属—聚合物复合材料、陶瓷、其组合、和类似物、或其它合适的材料制成。合适的聚合物的一些示例可以包括聚四氟乙烯(PTFE)、乙烯四氟乙烯(ETFE)、氟化乙烯丙烯(FEP)、聚甲醛(POM,例如,从DuPont获得的)、聚醚嵌段酯、聚氨酯(例如,聚氨酯85A)、聚丙烯(PP)、聚氯乙烯(PVC)、聚醚酯(例如,可从DSM Engineering Plastics获得的/>)、醚基或酯基共聚物(例如,丁烯/聚(亚烷基醚)邻苯二甲酸酯和/或其它聚酯弹性体(诸如可从DuPont获得的/>)、聚酰胺(例如,可从Bayer获得的或可从Elf Atochem获得的/>)、弹性体聚酰胺、嵌段聚酰胺/醚、聚醚嵌段酰胺(PEBA,例如在商品名/>下获得的)、乙烯醋酸乙烯酯共聚物(EVA)、有机硅、聚乙烯(PE)、Marlex高密度聚乙烯、Marlex低密度聚乙烯、线性低密度聚乙烯(例如/>)、聚酯、聚对苯二甲酸丁二醇酯(PBT)、聚对苯二甲酸乙二醇酯(PET)、聚对苯二甲酸丙二醇酯、聚萘二甲酸乙二醇酯(PEN)、聚醚醚酮(PEEK)、聚酰亚胺(PI)、聚醚酰亚胺(PEI)、聚苯硫醚(PPS)、聚苯醚(PPO)、聚对苯二甲酰对苯二胺(例如,/>)、聚砜、尼龙、尼龙-12(诸如可从EMS American Grilon获得的/>)、全氟(丙基乙烯基醚)(PFA)、乙烯乙烯醇、聚烯烃、聚苯乙烯、环氧树脂、聚偏二氯乙烯(PVdC)、聚(苯乙烯-b-异丁烯-b-苯乙烯)(例如,SIBS和/或SIBS 50A)、聚碳酸酯、离聚物、生物相容性聚合物、其它合适的材料、或混合物、组合、其共聚物、聚合物/金属复合物等。在一些实施例中,聚合物可以与液晶聚合物(LCP)混合。例如,混合物可以含有高达约6%的LCP。
合适的金属和金属合金的一些示例包括不锈钢,诸如304V、304L和316LV不锈钢;软钢;镍钛合金,诸如线弹性和/或超弹性镍钛合金;其它镍合金,诸如镍铬钼合金(例如UNS:N06625,诸如625,UNS:N06022,诸如/>UNS:N10276,诸如/>其它/>合金等)、镍—铜合金(例如,UNS:N04400,诸如/>400,/>400,/>400等)、镍—钴—铬—钼合金(例如,UNS:R30035,诸如/>等)、镍钼合金(例如UNS:N10665,诸如 )、其它镍铬合金、其它镍钼合金、其它镍钴合金、其它镍铁合金、其它镍铜合金、其它镍钨合金或钨合金等;钴铬合金;钴—铬—钼合金(例如,UNS:R30003,诸如/>等);富铂不锈钢;钛;其组合;和类似物;或任何其它合适的材料。
在至少一些实施例中,递送装置100、202、226、250、302或其组件的部分或全部可以掺杂有不透射线材料、由不透射线材料制成或以其它方式包括不透射线材料。不透射线材料被理解为能够在医疗手术期间在荧光透视屏或另一成像技术上产生相对明亮的图像的材料。该相对明亮的图像帮助递送装置100、202、226、250、302的用户确定其位置。不透射线材料的一些示例可以包括但不限于金、铂、钯、钽、钨合金、负载有不透射线填料的聚合物材料等。另外,其它不透射线标记带和/或线圈也可以结合到递送装置100、202、226、250、302或其组件的设计中,以实现相同的结果。
应该理解的是,本公开在许多方面仅是说明性的。在不超出本公开范围的情况下,可以进行细节上的改变,特别是在形状、尺寸和步骤布置方面。在适当的程度上,这可以包括使用在其它实施例中使用的一个示例实施例的任何特征。当然,本公开的范围被定义在表达所附权利要求的语言中。
Claims (15)
1.一种递送和部署装置,该递送和部署装置被配置为将可植入医疗装置(IMD)递送到患者心脏的腔室并且在其中部署IMD,所述递送和部署装置包括:
手柄组件;
从所述手柄组件向远侧延伸的轴,所述轴包括远侧区域;
装置容纳壳体,所述装置容纳壳体被耦合到所述轴的远侧区域并且从那里向远侧延伸至所述装置容纳壳体的远端,所述装置容纳壳体被配置为在其中容纳所述IMD的至少一部分;
多个电极,所述多个电极在所述装置容纳壳体的外表面周围分布,使得所述多个电极中的至少一些电极能够被定位成在部署所述IMD之前测试潜在的IMD部署位置,其中,所述多个电极中的第一电极在所述装置容纳壳体的远端上延伸,以在当所述装置容纳壳体的远端被上推抵靠心脏壁时直接与组织接合;以及
多个电导体,所述多个电导体与所述多个电极可操作地耦合并且沿着所述轴朝向所述手柄组件往回向近侧延伸,所述多个电导体具有被配置为可操作地耦合到测试装置的近端。
2.根据权利要求1所述的递送和部署装置,其中,所述多个电极包括沿着所述装置容纳壳体的外表面轴向间隔开的至少四个电极,所述至少四个电极包括第一电极、第二电极、第三电极、以及第四电极;
所述第一电极和所述第四电极间隔开第一距离以形成提供电位差的刺激偶极子;
所述第二电极和所述第三电极间隔开比所述第一距离更小的第二距离,以通过测量由所述第一电极和所述第二电极施加的电位差而引起的所述第二电极与所述第三电极之间的电压来提供导电率测量结果;并且
所述第二电极和所述第三电极被设置在所述第一电极和所述第四电极之间。
3.根据权利要求1所述的递送和部署装置,其中,所述多个电极包括第一电极和第二电极,所述第一电极和第二电极被设置在所述装置容纳壳体的外表面上以形成刺激偶极子。
4.根据权利要求3所述的递送和部署装置,还包括压力传感器,所述压力传感器被配置为响应于经由所述第一电极和所述第二电极递送的刺激电脉冲而获得对所述患者的心脏的腔室中的压力的指示。
5.根据权利要求3所述的递送和部署装置,还包括:
第一压力传感器,其被配置为获得对所述患者的心脏的腔室中的压力的指示;和
第二压力传感器,其被配置为获得对所述患者的心脏的不同腔室中的压力的指示。
6.根据权利要求3所述的递送和部署装置,还包括相对于所述装置容纳壳体固定的加速度计和/或陀螺仪。
7.根据权利要求1至6中任一项所述的递送和部署装置,其中,所述多个电极中的至少一些电极被设置在可延伸组件上,所述可延伸组件能移动地固定在所述装置容纳壳体的外部周围,所述可延伸组件能移动到部署配置,在所述部署配置中,所述多个电极中的至少一些电极接触心脏组织,以用于在IMD部署之前对所述患者的心脏的腔室的至少部分的心内膜标测。
8.一种IMD植入装置,被配置为将可植入医疗装置(IMD)递送到患者的心脏的腔室并在其中部署所述IMD,所述IMD植入装置包括:
手柄组件;
从所述手柄组件向远侧延伸的轴,所述轴包括远侧区域;
装置容纳壳体,所述装置容纳壳体被耦合到所述轴的远侧区域并从那里向远侧延伸至所述装置容纳壳体的远端,所述装置容纳壳体被配置为在其中容纳所述IMD的至少一部分;
延伸通过所述轴的部署构件,所述部署构件被配置为向所述IMD施加部署力,以便使所述IMD从所述装置容纳壳体移动,以将所述IMD部署在所述患者的心脏中;
多个电极,所述多个电极在所述装置容纳壳体的外表面周围分布,使得所述多个电极中的至少一些电极能够被定位成在部署所述IMD之前测试潜在的IMD部署位置,其中,所述多个电极中的第一电极在所述装置容纳壳体的远端上延伸,以在当所述装置容纳壳体的远端被上推抵靠心脏壁时直接与组织接合;以及
多个电导体,所述多个电导体与所述多个电极可操作地耦合并且沿着所述轴朝向所述手柄组件往回向近侧延伸,所述多个电导体具有被配置为可操作地耦合到测试装置的近端。
9.根据权利要求8所述的IMD植入装置,其中,所述部署构件是推管,并且其中,所述IMD植入装置还包括:
向远侧延伸通过所述推管并耦合到所述IMD的系绳,所述系绳被配置为,如果需要替换的部署位置,则所述系绳用于将所述IMD取回到所述装置容纳壳体中。
10.根据权利要求8或9中任一项所述的IMD植入装置,其中,所述多个电极包括沿着所述装置容纳壳体轴向间隔开的至少四个电极,所述至少四个电极包括第一电极、第二电极、第三电极、以及第四电极;
所述第一电极和所述第四电极间隔开第一距离以形成提供电位差的刺激偶极子,其中所述第四电极延伸到所述装置容纳壳体的远端;
所述第二电极和所述第三电极间隔开比所述第一距离更小的第二距离,以通过测量由所述第一电极和所述第四电极施加的电位差而引起的所述第二电极与所述第三电极之间的电压来提供导电率测量结果;并且
所述第二电极和所述第三电极被设置在所述第一电极和所述第四电极之间。
11.根据权利要求8至10中任一项所述的IMD植入装置,还包括压力传感器,所述压力传感器被配置为响应于经由所述第一电极和所述第二电极递送的刺激电脉冲而获得对所述患者的心脏的腔室中的压力的指示。
12.根据权利要求11所述的IMD植入装置,还包括相对于所述装置容纳壳体固定的加速度计和/或陀螺仪。
13.一种植入装置,所述植入装置被配置为将无引线心脏起搏器(LCP)递送到患者的心脏的腔室并在其中部署LCP,所述植入装置包括:
手柄组件;
从所述手柄组件向远侧延伸的轴,所述轴包括远侧区域;
装置容纳壳体,所述装置容纳壳体被耦合到所述轴的远侧区域并从那里向远侧延伸至所述装置容纳壳体的远端,所述装置容纳壳体被配置为在其中容纳所述LCP;
延伸通过所述轴的部署构件,所述部署构件被配置为向所述LCP施加部署力,以便使所述LCP从所述装置容纳壳体的远端移动,以将所述LCP部署在所述患者的心脏中;
多个电极,所述多个电极在所述装置容纳壳体的外表面周围分布,使得所述多个电极中的至少一些电极能够被定位成在部署所述LCP之前测试潜在的LCP部署位置,其中,所述多个电极中的第一电极在所述装置容纳壳体的远端上延伸,以在当所述装置容纳壳体的远端被上推抵靠心脏壁时直接与组织接合;以及
一个或多个跟踪传感器,所述一个或多个跟踪传感器相对于所述装置容纳壳体固定以便于跟踪所述装置容纳壳体。
14.根据权利要求13所述的植入装置,其中,所述一个或多个跟踪传感器包括便于对所述装置容纳壳体的磁跟踪的磁跟踪传感器,和/或便于对所述装置容纳壳体的阻抗跟踪的阻抗跟踪传感器。
15.根据权利要求13或14中任一项所述的植入装置,还包括被设置在所述装置容纳壳体内的LCP,所述LCP包括:便于对LCP的磁跟踪的一个或多个LCP磁跟踪传感器,和/或便于对LCP的阻抗跟踪的一个或多个LCP阻抗跟踪传感器。
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CN109922860A (zh) | 2019-06-21 |
US20180117304A1 (en) | 2018-05-03 |
WO2018081225A1 (en) | 2018-05-03 |
EP3532159A1 (en) | 2019-09-04 |
US10758724B2 (en) | 2020-09-01 |
EP3532159B1 (en) | 2021-12-22 |
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