CN103249452A - 用于无引线心脏起博器的温度传感器 - Google Patents

用于无引线心脏起博器的温度传感器 Download PDF

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CN103249452A
CN103249452A CN2011800583620A CN201180058362A CN103249452A CN 103249452 A CN103249452 A CN 103249452A CN 2011800583620 A CN2011800583620 A CN 2011800583620A CN 201180058362 A CN201180058362 A CN 201180058362A CN 103249452 A CN103249452 A CN 103249452A
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temperature sensor
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A.奥斯特洛夫
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Abstract

本发明涉及一种无引线心脏起博器，包括：壳体、与壳体的外表面相联的多个电极、和密封地包含在壳体内并且与多个电极电联接的脉冲传送***，所述脉冲传送***构造为用于获得壳体内部的能量、产生并传送电脉冲到多个电极。起博器还包括密封地容纳在壳体内并且适于感测温度信息的温度传感器，其中起博器能够至少部分地基于温度信息来控制电脉冲传送。

Description

用于无引线心脏起博器的温度传感器
技术领域
本公开总体上涉及无引线心脏起博器。更具体地，本公开描述了温度传感器在无引线心脏起博器中的使用。
背景技术
在心脏本身的自然起博和/或传导***不能以足以满足患者健康要求的速率和间隔提供同步的心房和心室收缩时，通过人工起博器进行的心脏起博对心脏提供电激励。这样的防心动过缓起博为成百上千的患者提供了症状缓解，甚至提供了生命支持。
起博器提供的激励速率可能需要调节，以匹配患者身体活动的水平。现有的速率响应性起博器在其它参数中依赖于中心静脉温度，以指示关于上下调节激励速率的需求。现有装置通常使用通过引线与起博器主体相连的温度传感器，所述引线从位于心脏外侧的起博器主体的位置处延伸到位于患者心脏内的温度传感器。现有的速率响应性起博器的两个示例可见于美国专利5,411,535和美国专利公开2007/0088400中。
发明内容
在一个实施方式中，提供了无引线心脏起博器，包括：密封式壳体，其适于并且构造成布置在人心脏的腔室中；布置在壳体中的电池；由壳体支撑的至少两个电极；由壳体支撑的温度传感器；和控制器，其布置在壳体中并适于使用两个电极感测心内信息，并且适于使用来自温度传感器的温度信息将激励能从电池传送到电极。
在一些实施方式中，温度传感器包括热敏电阻器。在一个实施方式中，热敏电阻器被结合到壳体的内表面。在一些实施方式中，热敏电阻器安装在壳体的管座组件（header assembly）上。
在起博器的一个实施方式中，控制器包括ASIC，并且温度传感器包括整合到ASIC中的半导体温度传感器。
在一个实施方式中，无引线心脏起博器还包括位于温度传感器和壳体之间的被结合的热路径。在一个实施方式中，被结合的热路径是热焊盘。
在一些实施方式中，温度传感器布置在壳体内。在其它实施方式中，温度传感器不直接附接至壳体。在又一实施方式中，温度传感器布置在罐体外侧。
还提供了一种用于将电起博信号提供到患者心脏的方法，包括：经由与心脏腔室内组织接触并且由布置在腔室内的密封式壳体支撑的两个电极来感测心内信号；使用电极在激励速率下将电激励信号提供到心脏；通过壳体支撑的温度传感器感测温度；以及基于所述温度使用布置在壳体内的控制器来调节电激励信号的激励速率。
在一些实施方式中，感测步骤包括用热敏电阻器感测所述温度。在其它实施方式中，感测步骤包括用结合到壳体内表面的热敏电阻器感测所述温度。在另外的实施方式中，感测步骤包括通过安装在壳体的管座组件上的热敏电阻器感测所述温度。在又一实施方式中，感测步骤包括通过整合到包含控制器的ASIC中的半导体温度传感器来感测所述温度。在另一实施方式中，感测步骤包括通过布置在壳体内的温度传感器感测所述温度。在一个实施方式中，感测步骤包括通过布置在壳体外侧的温度传感器感测所述温度。
附图说明
在随后的权利要求书中具体阐述本发明的新颖性特征。通过参考阐述了利用本发明原理的说明性实施方式的以下详细说明以及附图，将获得对本发明的特征和优点的更好理解，在图中：
图1示出了包括温度传感器的无引线心脏起博器。
图2示出了布置在无引线心脏起博器的密封式壳体内的温度传感器。
图3示出了无引线心脏起博器中的整合到ASIC中的半导体温度传感器。
图4示出了无引线心脏起博器中的整合到ASIC中的半导体温度传感器的另一实施方式。
图5A和5B示出了带有热敏电阻器温度传感器的无引线心脏起博器的一个实施方式。
图6是无引线心脏起博器中使用的热回路的一个实施方式。
图7示出了基于图6中热回路的热模型。
图8示出了基于图5A-5B中温度传感器的一个实施方式的热模型。
图9示出了基于图5A-5B中温度传感器的另一实施方式的热模型。
图10示出了基于图5A-5B中温度传感器的再一实施方式的热模型。
图11示出了基于图5A-5B中温度传感器的一个实施方式的热模型。
图12示出了基于图5A-5B中温度传感器的另一实施方式的热模型。
图13是无引线心脏起博器中使用的热回路的另一实施方式。
图14示出了基于图13中热回路的热模型。
具体实施方式
本公开涉及速率响应性无引线心脏起博器或者其它的无引线生物激励器（biostimulator）。无引线生物激励器能够植入患者心脏的腔室中。替代于使用从生物激励器壳体延伸的引线上的温度传感器来测量中心静脉温度，本公开的速率响应性无引线生物激励器的实施方式能够采用由生物激励器壳体支撑的温度传感器。本公开的无引线生物激励器能够使用所测量的温度，以使用布置在壳体内的控制器来调节其电激励信号的速率。
无引线生物激励器的一些实施方式可包括布置在人心脏的腔室中的密封式壳体、布置在壳体中的电池、由壳体支撑的至少两个电极、由壳体支撑的温度传感器和布置在壳体中的控制器。控制器能够适于使用两个电极来感测心内信息，并且适于使用来自温度传感器的温度信息将激励能从电池传送到电极。温度传感器可以由无引线生物激励器以与***的热时间常数要求相一致的任意方式支撑。温度传感器可以是整合在控制器中的热敏电阻器或半导体温度传感器。
为将中心静脉温度用作速率响应算法的代谢参数，无引线生物激励器可以能够在临床上显著的时间段内感测并响应中心静脉温度的变化，该时间段诸如小于30秒。由于无引线生物激励器将被布置成与患者心脏内的患者血液接触，生物激励器设计能够提供从血液到温度感测元件的热传导路径，其中温度感测元件的时间常数足够小，以允许传感器在所选择的临床显著时间内达到其终值。由此，例如，如果理想的临床显著时间为30秒，则温度感测部件的热时间常数可以选择为10秒。
图1示出了无引线心脏起博器或者无引线生物激励器1。生物激励器1可包括壳体6，壳体6具有由电绝缘材料制成并且从例如钛制成的密封罐体3和4延伸的管座部2。罐部3能够被电绝缘，并且罐部4可以不被绝缘从而其能够用作电极。罐体3和4中的电气舱能够容纳生物激励器工作所必需的电子部件，包括电池和控制器。如所示的，螺旋固定装置5能够延伸通过罐体3中的通道，到达并穿过管座2。在一些实施方式中，固定装置5可包括电极，并且在其它实施方式中，远端电极能够与螺旋固定装置隔开。无引线生物激励器的其它细节可见于上面引用的以及通过引用合并于此的共同未决申请中。
在图1的实施方式中，热敏电阻器7能够布置在管座2中。热敏电阻器可包括用于将热敏电阻器7与无引线生物激励器的控制器电连接的至少两个热敏电阻器引线。在该实施方式中，至少一个热敏电阻器引线能够穿过罐部3中的穿通部（feedthrough）延伸到罐体中的控制器。另一热敏电阻器引线可以电连接到罐体，并且能够可选地穿过穿通部到达罐体内部。在该实施方式中，热敏电阻器7能够与管座2的内表面接触，由此能够通过管座2与生物激励器周围的血液热接触。壳体6内的控制器能够适于使用电极4和5感测心内信息，并且适于使用来自热敏电阻器7的温度信息将激励能从电池传递到无引线生物激励器上的电极。在一些实施方式中，起博器提供的激励速率可能需要调节，以匹配患者的身体活动或温度的水平。例如，温度信息能够确定患者的温度，并且调节激励速率以解释因发烧或锻炼引起的温度变化。
在图2的实施方式中，温度传感器能够是布置在壳体的密封罐体100内的热敏电阻器126。如该横截面图中所示，热敏电阻器126能够被结合，以热连接到密封罐体100的内侧表面，并且热敏电阻器能够经由引线128和基板124连接到ASIC控制器120。由此，热敏电阻器126能够构造成通过壳体100感测生物激励器周围的血液的温度。密封罐体100内的其它元件包括ASIC基板124、其它的电子部件122和电池（未示出）。在图1的实施方式中，至少两个电极能够由壳体支撑在壳体外部。在一些实施方式中，ASIC120能够适于使用电极感测心内信息，并且适于使用来自热敏电阻器126的温度信息将激励能从电池传送到电极之一。
在图3的实施方式中，温度传感器能够是整合到ASIC124中的半导体温度传感器。导热焊盘125能够从ASIC124中的温度传感器延伸到壳体100的内表面。由此，温度传感器能够利用导热焊盘125通过壳体100感测生物激励器周围的血液的温度。如图2的实施方式中那样，至少两个电极能够由壳体支撑在壳体外部。ASIC120能够适于使用电极感测心内信息，并且适于使用来自整合的温度传感器的温度信息将激励能从电池传送到电极之一。
图4中的实施方式类似于图3中的实施方式，但略去了导热焊盘。由此，整合到ASIC120中的温度传感器经由在ASIC120和罐体100之间的热阻感测生物激励器周围的血液的温度。类似地，在该实施方式中，ASIC120能够适于使用电极感测心内信息，并且适于使用来自整合的温度传感器的温度信息将激励能从电池传送到电极之一。
示例1
进行测试，以观察这些实施方式中的一些实施方式的热响应时间的比较情况。图5A和5B示出了具有壳体200的第一原型组件，其中壳体200由在端部202和204处被用硅酮封盖的管制成。该管能够例如是8mm的不锈钢管。热敏电阻器206用氰基丙烯酸酯封闭，以在端部204处的硅酮内将其结合到壳体200的内侧。硅脂被施加到热敏电阻器和壳体壁接触点之间。从热敏电阻器206延伸的配线208被绝缘。壳体200内的空腔210被填充水。壳体200具有7mm的直径和25.5mm的长度。端部204处的硅酮延伸到壳体200中6.5mm。
两个烧杯被灌注500ml的蒸馏水，并且将热敏电阻器浸没在每个烧杯中以监测温度。然后，第二烧杯被置于热板/搅拌器上，并且温度被调节成比第一烧杯高近似10℃。搅拌器运动以搅动溶液。原型组件被浸没在第一烧杯中至少5分钟，并且在不到1秒内将该原型组件转运到第二烧杯。在将该原型组件转运到第二烧杯之后，以大于或等于1秒/样品的采样速率从全部三个传感器（每个烧杯上一个，原型组件上一个）记录温度至少1分钟。确认在步骤过程中，第二烧杯中的温度变化不超过5%。
测量的温度与基于图6所示的热回路的热模型比较。结果显示在图7中。模型时间常数通过使Tm(t)-Tt(t)在全部时间上的RMS误差最小化来得出。对于每个试验，赋予所得出的时间常数。在本情况中，槽和热敏电阻器之间的热时间常数被确定为4.3秒。
令：t=自浸没在槽中开始的时间；Th=槽温度；Tc=起始温度；Tm(t)=测量的热敏电阻器温度；Tt(t)=模拟的热敏电阻器温度；Te(t)=模拟的粘合剂+硅酮温度；τbt=槽到热敏电阻器时间常数；τbe=槽到粘合剂+硅酮时间常数；τte=热敏电阻器到粘合剂+硅酮时间常数。
则：
Th - Te ( t ) Th - Tc = e - t τbe
Te ( t ) = Th - ( Th - Tc ) · e - t τbe
Tt ( t 2 ) - Tt ( t 1 ) = [ Th - Tt ( t 1 ) τbt - Tt ( t 1 ) - Te ( t 1 ) τte ] · ( t 2 - t 1 )
示例2
使用与图5A-5B的原型类似的原型执行另一测试，但是使用少得多的氰基丙烯酸酯粘合剂来将热敏电阻器结合到罐体。如示例1中使用同样的测试方案。结果在图8中示出。槽和热敏电阻器之间的热时间常数被确定为3.0秒。
示例3
使用示例1中的测试方案利用与图5A-5B的原型类似但灌注空气而不是水的原型执行测试。结果在图9中示出。槽和热敏电阻器之间的热时间常数被确定为4.0秒，因此电池的热质并不被期望明显地改变这些结果。
示例4
使用示例1中的测试方案利用与图5A-5B中的原型类似但带有在硅酮塞和粘合剂/热敏电阻器之间的气隙并且仅使用非常少量的氰基丙烯酸酯粘合剂来将热敏电阻器结合到罐体的原型执行测试。结果在图10中示出。槽和热敏电阻器之间的热时间常数被确定为3.4秒。
示例5
使用示例1中的测试方案利用与图5A-5B的原型类似但其中热敏电阻器在罐体中浮动而不结合到罐体并且其中罐体被灌注空气而非水的原型执行测试。结果在图11中示出。槽和热敏电阻器之间的热时间常数被确定为5.5秒。
示例6
使用示例1中的测试方案利用与图5A-5B的原型类似但其中热敏电阻器在罐体中浮动、被绝缘的配线从包含在茎管内的热敏电阻器引出以进一步将配线从槽温度隔离并且其中罐体被灌注空气而非水的原型执行测试。结果在图12中示出。槽和热敏电阻器之间的热时间常数被确定为11.8秒。
示例7
使用示例1中的测试方案利用与图5A-5B的原型类似但其中热敏电阻器结合到罐体内的半导体芯片的原型执行测试。芯片尺寸为4mm×5mm×20mils。半导体/热敏电阻器组件被包绕在一层聚酰亚胺带中，并且热敏电阻器配线使用茎管从槽隔热。罐体被灌注空气，而不是水。在该模拟中，模型被变换以允许半导体芯片（模拟ASIC）以第一时间常数从槽获取热，热敏电阻器以第二时间常数从ASIC获取热，并且热敏电阻器以第三时间常数将热发散到配线。该热模型在图13中示出。该测试的结果在图14中示出。槽到ASIC时间常数被确定为12.9秒。该测试表明整合的ASIC热传感器与罐体和ASIC之间的非指定热连接之间的热时间常数提供了在无引线心脏起博器的壳体内的可接受热结果。
在一些实施方式中，温度传感器可以是热敏电阻器、半导体温度传感器或者包含控制器的ASIC的一部分。无引线激励器控制回路使用感测的温度来调节生物激励器提供到患者心脏的电激励的速率。
温度传感器可以感测在36℃至42℃范围内的温度。温度范围的下限允许正常的体温（37℃）、低的生理节奏变化以及低的因锻炼引起的温度起伏。温度范围的上限允许正常的体温、加上发烧、加上因锻炼引起的温度升高。辨识度可以是大约0.023℃。这表示好于锻炼期间的最小预期起伏幅值的1/5（0.15℃）。
除非另外限定，本文使用的全部技术术语的含义与心脏技术领域中普通技术人员通常所理解的含义相同。本申请可描述具体的方法、装置和材料，但与本文所述的相类似或等同的任意方法和材料能够用在本发明的实践中。虽然已经通过一些细节并通过示例性说明描述了本发明的实施方式，但这样的说明仅用于清楚理解的目的，并不旨在是限定性的。说明书中已经使用了各种术语以传递对于本发明的理解；将理解，这些各种术语的含义延展至其通常的语言或语法变形或形式。同样将理解，当专门词汇指代已经通过商标名、品牌名或者常用名引述的装置、器械或者药物时，这些术语或名称被提供作为当前的示例，本发明并不受这样的文字范围的限制。可以合理性地理解为由当前术语涵盖的分级子集的当前术语或设计的派生物的在后面日期介绍的专门词汇将理解为已经由现在的当前专有词汇描述。另外，虽然为促进对本发明的理解，已经提出了一些理论上的考虑，但本发明的权利要求不受这些理论的限制。而且，在不偏离本发明范围的情况下，本发明的任意实施方式中的任意一个或更多个特征能够与本发明的任意其它实施方式的任意一个或更多个特征组合。再另外，应理解，本发明不局限于为了例示性的目的已经阐述的实施方式，但仅由专利申请所附权利要求的良好阅读来限定，包括赋予其每个元件的等同物的全部范围。
相关申请的交叉引用
本申请要求2010年10月12日提交的标题为“用于无引线心脏起博器的温度传感器（Temperature Sensor for a Leadless Cardiac Pacemaker）”的美国临时专利申请61/392,382的优先权，该申请的全部内容通过引用合并于此。
本申请的全部内容通过引用将Peter M.Jacobson的所有下列专利申请合并于此，用于所有目的：美国专利申请(1)US2007/0088394A1，(2)US2007/0088396Al，(3)US2007/0088397Al，(4)US2007/0088398Al，(5)US2007/0088400Al，(6)US2007/0088405A1，(7)US200710088418Al；以及国际公开WO/2007/047681A2。
参考引用
本说明书中提及的全部公开和专利申请在同一程度上通过引用合并于此，如同每个单独的公开或者专利申请被具体地并且单独地专用于通过引用进行合并。

Claims (17)

1.一种无引线心脏起博器，包括：
密封式壳体，所述密封式壳体适于并且构造成布置在人心脏的腔室中；
布置在所述壳体中的电池；
由所述壳体支撑的至少两个电极；
由所述壳体支撑的温度传感器；和
控制器，所述控制器布置在所述壳体中并适于使用所述两个电极感测心内信息，并且适于使用来自所述温度传感器的温度信息将激励能从电池传送到所述电极。
2.根据权利要求1所述的无引线心脏起博器，其中，所述温度传感器包括热敏电阻器。
3.根据权利要求2所述的无引线心脏起博器，其中，所述热敏电阻器被结合到所述壳体的内表面。
4.根据权利要求2所述的无引线心脏起博器，其中，所述热敏电阻器安装在所述壳体的管座组件上。
5.根据权利要求1所述的无引线心脏起博器，其中，所述控制器包括ASIC，并且所述温度传感器包括整合到所述ASIC中的半导体温度传感器。
6.根据权利要求4所述的无引线心脏起博器，还包括位于所述温度传感器和所述壳体之间的被结合的热路径。
7.根据权利要求6所述的无引线心脏起博器，其中，所述被结合的热路径是热焊盘。
8.根据权利要求1所述的无引线心脏起博器，其中，所述温度传感器布置在所述壳体内。
9.根据权利要求1所述的无引线心脏起博器，其中，所述温度传感器不直接附接至所述壳体。
10.根据权利要求1所述的无引线心脏起博器，其中，所述温度传感器布置在罐体外侧。
11.一种用于将电起博信号提供到患者心脏的方法，包括：
经由两个电极来感测心内信号，所述两个电极与心脏腔室内的组织接触并且由布置在腔室内的密封式壳体支撑；
使用所述电极在激励速率下将电激励信号提供到心脏；
通过所述壳体支撑的温度传感器感测温度；以及
基于所述温度使用布置在所述壳体内的控制器来调节电激励信号的所述激励速率。
12.根据权利要求11所述的方法，其中，感测步骤包括用热敏电阻器感测所述温度。
13.根据权利要求12所述的方法，其中，感测步骤包括用结合到所述壳体的内表面的热敏电阻器来感测所述温度。
14.根据权利要求12所述的方法，其中，感测步骤包括通过安装在所述壳体的管座组件上的热敏电阻器来感测所述温度。
15.根据权利要求11所述的方法，其中，感测步骤包括通过整合到包含所述控制器的ASIC中的半导体温度传感器来感测所述温度。
16.根据权利要求11所述的方法，其中，感测步骤包括通过布置在所述壳体内的温度传感器感测所述温度。
17.根据权利要求11所述的方法，其中，感测步骤包括通过布置在所述壳体外侧的温度传感器感测所述温度。
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