CN110167629B - 用于选择兼容mri的刺激参数的***和方法 - Google Patents

用于选择兼容mri的刺激参数的***和方法 Download PDF

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CN110167629B
CN110167629B CN201780082355.1A CN201780082355A CN110167629B CN 110167629 B CN110167629 B CN 110167629B CN 201780082355 A CN201780082355 A CN 201780082355A CN 110167629 B CN110167629 B CN 110167629B
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希拉格·沙阿
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Boston Scientific Neuromodulation Corp
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Abstract

本发明涉及用于选择兼容MRI的刺激参数的***和方法。本发明提出了用于至少部分地基于第一刺激程序的第一刺激参数集来生成兼容MRI的刺激程序的方法和***。例如，方法或***(经由处理器)可包括：接收第一刺激参数集，其中第一刺激参数集指示第一刺激电极组；修改第一刺激参数集以通过以下中的至少一个来生成兼容MRI的刺激程序的第二刺激参数集：1)减小第一刺激参数集中的至少一个刺激参数的值或者2)在第一电极组中以引线的至少一个电极替换壳电极；并且发起向IPG提供兼容MRI的刺激程序的信号。

Description

用于选择兼容MRI的刺激参数的***和方法
相关申请的交叉引用
本申请要求于2017年1月3日根据35U.S.C.§119(e)提交的美国临时专利申请序列号62/441,944的权益，所述申请通过引用并入本文。
技术领域
本发明涉及植入式电刺激***以及制造和使用该***的方法的领域。本发明还涉及用于选择兼容磁共振成像(MRI)的刺激参数的***和方法。
背景技术
植入式电刺激***已被证明可治疗多种疾病和病症。例如，脊髓刺激***已被用作治疗慢性疼痛综合征的治疗方式。外周神经刺激已被用于治疗慢性疼痛综合征和尿失禁，其他许多应用正在研究中。已经应用功能性电刺激***来恢复脊髓损伤患者中瘫痪四肢的一些功能。对大脑的刺激(诸如深部脑刺激)可用于治疗各种疾病或病症。
已经开发出刺激器以提供针对各种治疗的疗法。刺激器可包括控制模块(具有脉冲发生器)、一个或多个引线、以及每个引线上的刺激器电极阵列。刺激器电极与要刺激的神经、肌肉或其他组织接触或接近。控制模块中的脉冲发生器生成电脉冲，该电脉冲由电极传递送到身体组织。
发明内容
一个实施例是一种用于创建兼容磁共振成像(MRI)的刺激程序以使用植入式电刺激***对患者进行电刺激的***，所述植入式电刺激***包括植入式脉冲发生器和具有多个电极的引线。用于创建兼容MRI的刺激程序的所述***包括处理器，所述处理器被配置和布置为：接收第一刺激程序的第一刺激参数集，其中所述第一刺激参数集指示用于递送电刺激的第一电极组；至少部分地基于接收到的第一刺激参数集生成兼容MRI的刺激程序，其中所述兼容MRI的刺激程序包括第二刺激参数集，所述第二刺激参数集指示来自所述多个电极的第二电极组以用于递送电刺激，其中生成所述兼容MRI的刺激程序包括由所述处理器修改所述第一刺激参数集以通过以下中的至少一个生成所述第二刺激参数集：1)减小所述第一刺激参数集中的至少一个刺激参数的值，或者2)在所述第一电极组中，以所述引线的所述电极中的至少一个替换所述电刺激***的壳电极；并且发起信号，所述信号向所述电刺激***的所述植入式脉冲发生器提供兼容MRI的刺激程序，以用于对患者产生电刺激。
在至少一些实施例中，所述处理器还被配置为确定指示所述第一刺激程序的能量消耗的值，其中生成所述兼容MRI的刺激程序还包括响应于指示能量消耗的值减小所述第一刺激参数集中的至少一个刺激参数的值。
在至少一些实施例中，生成所述兼容MRI的刺激程序还包括减小所述第一刺激参数集中的至少一个刺激参数的值，其中所述第一刺激参数集中的至少一个刺激参数包括刺激电流、刺激电压、脉冲宽度或脉冲频率中的至少一个。
在至少一些实施例中，生成所述兼容MRI的刺激程序还包括减小所述第一刺激参数集中的至少一个刺激参数的值，其中所述第一刺激参数集中的至少一个刺激参数包括刺激电流。
在至少一些实施例中，所述第一电极组包括所述壳电极，并且其中生成所述兼容MRI的刺激程序包括在所述第一电极组中用所述引线的所述电极中的至少一个替换所述电刺激***的所述壳电极。
在至少一些实施例中，生成所述兼容MRI的刺激程序还包括减小所述第一刺激参数集中的至少一个刺激参数的值，其中所述第一刺激参数集中的至少一个刺激参数包括脉冲宽度。
在至少一些实施例中，生成所述兼容MRI的刺激程序还包括通过将经由用于所述第一刺激程序的所述壳电极的刺激分配在未被用于所述第一刺激程序的所述引线的多个电极上，从而以所述引线的所述电极中的至少一个替换所述电刺激***的所述壳电极。
在至少一些实施例中，所述***还包括用户界面，其被可通信地耦合到所述计算机处理器，其中所述处理器还被配置为：经由所述用户界面接收指示对所述兼容MRI的刺激程序的用户修改的用户输入；并且响应于所述用户输入，根据所述用户修改对所述兼容MRI的刺激程序进行修改以生成经用户修改的兼容MRI的刺激程序，其中发起向所述电刺激***的所述植入式脉冲发生器提供所述兼容MRI的刺激程序以产生对患者的电刺激的所述信号包括发起向所述电刺激***的所述植入式脉冲发生器提供所述经用户修改的兼容MRI的刺激程序以产生对患者的电刺激的信号。
在至少一些实施例中，所述处理器还被配置为根据所述兼容MRI的程序发起由所述电刺激***对患者进行的电刺激的信号。
另一个实施例是一种非暂时性计算机可读介质，其上存储有计算机可执行指令，当所述指令由处理器执行时，致使所述处理器执行用于创建兼容磁共振成像(MRI)的刺激程序以用于使用植入式电刺激***对患者进行电刺激的方法，所述植入式电刺激***包括植入式脉冲发生器和具有多个电极的引线。所述方法包括：接收第一刺激程序的第一刺激参数集，其中所述第一刺激参数集指示用于递送电刺激的第一电极组；至少部分地基于接收到的第一刺激参数集生成兼容MRI的刺激程序，其中所述兼容MRI的刺激程序包括第二刺激参数集，所述第二刺激参数集指示来自所述多个电极的第二电极组以用于递送电刺激，其中生成所述兼容MRI的刺激程序包括由所述处理器修改所述第一刺激参数集以通过以下中的至少一个生成所述第二刺激参数集：1)减小所述第一刺激参数集中的至少一个刺激参数的值，或者2)在所述第一电极组中，以所述引线的所述电极中的至少一个替换所述电刺激***的壳电极；并且发起信号，所述信号向所述电刺激***的所述植入式脉冲发生器提供兼容MRI的刺激程序，以用于对患者产生电刺激。
在至少一些实施例中，所述方法还包括确定指示所述第一刺激程序的能量消耗的值，其中生成所述兼容MRI的刺激程序还包括响应于指示能量消耗的值减小所述第一刺激参数集中的至少一个刺激参数的值。
在至少一些实施例中，生成所述兼容MRI的刺激程序还包括减小所述第一刺激参数集中的至少一个刺激参数的值，其中所述第一刺激参数集中的至少一个刺激参数包括刺激电流、刺激电压、脉冲宽度或脉冲频率中的至少一个。
在至少一些实施例中，生成所述兼容MRI的刺激程序还包括减小所述第一刺激参数集中的至少一个刺激参数的值，其中所述第一刺激参数集中的至少一个刺激参数包括刺激电流或脉冲中的至少一个。
在至少一些实施例中，生成所述兼容MRI的刺激程序还包括通过将经由用于所述第一刺激程序的所述壳电极的刺激分配在未被用于所述第一刺激程序的所述引线的多个电极上，从而以所述引线的所述电极中的至少一个替换所述电刺激***的所述壳电极。
在至少一些实施例中，所述方法还包括经由用户界面接收指示要从所述第二电极组中排除的一个或多个电极的用户输入；并且响应于所述用户输入，从所述第二电极组中排除所述一个或多个电极。
又一实施例是一种用于创建兼容磁共振成像(MRI)的刺激程序以使用植入式电刺激***对患者进行电刺激的方法，所述植入式电刺激***包括植入式脉冲发生器和具有多个电极的引线。所述方法包括：由处理器接收第一刺激程序的第一刺激参数集，其中所述第一刺激参数集指示用于递送电刺激的第一电极组；由所述处理器至少部分地基于接收到的第一刺激参数集生成兼容MRI的刺激程序，其中所述兼容MRI的刺激程序包括第二刺激参数集，所述第二刺激参数集指示来自所述多个电极的第二电极组以用于递送电刺激，其中生成所述兼容MRI的刺激程序包括由所述处理器修改所述第一刺激参数集以通过以下中的至少一个生成所述第二刺激参数集：1)减小所述第一刺激参数集中的至少一个刺激参数的值，或者2)在所述第一电极组中，以所述引线的所述电极中的至少一个替换所述电刺激***的壳电极；并且由所述处理器发起信号，所述信号向所述电刺激***的所述植入式脉冲发生器提供兼容MRI的刺激程序，以用于对患者产生电刺激。
在至少一些实施例中，所述方法还包括由所述处理器确定指示所述第一刺激程序的能量消耗的值，其中生成所述兼容MRI的刺激程序还包括由所述处理器响应于指示能量消耗的值减小所述第一刺激参数集中的至少一个刺激参数的值。
在至少一些实施例中，生成所述兼容MRI的刺激程序还包括由所述处理器减小所述第一刺激参数集中的至少一个刺激参数的值，其中所述第一刺激参数集中的至少一个刺激参数包括刺激电流、刺激电压、脉冲宽度或脉冲频率中的至少一个。
在至少一些实施例中，生成所述兼容MRI的刺激程序还包括由所述处理器通过将经由用于所述第一刺激程序的所述壳电极的刺激分配在未被用于所述第一刺激程序的所述引线的多个电极上，从而以所述引线的所述电极中的至少一个替换所述电刺激***的所述壳电极。
在至少一些实施例中，发起向所述电刺激***的所述植入式脉冲发生器提供兼容MRI的刺激程序以用于对患者产生电刺激的所述信号包括：经由通信地耦合到所述处理器的用户界面显示以下中的一个或多个：1)所述第二刺激参数集，或者2)基于所述第二刺激参数集的估计刺激区域；由所述处理器经由所述用户界面接收指示接受所述兼容MRI的刺激程序的用户输入；至少部分地响应于所述用户输入，由所述处理器发起向所述电刺激***的所述植入式脉冲发生器提供兼容MRI的刺激程序以用于对患者产生电刺激的信号；至少部分地响应于经历MRI扫描的患者，发起控制所述电刺激***的所述植入式脉冲发生器实施所述兼容MRI的刺激程序的信号；并且至少部分地响应于所述MRI扫描的结论，发起控制所述电刺激***的所述植入式脉冲发生器实施所述第一刺激程序的信号。
附图说明
参考以下附图描述本发明的非限制性和非穷举性实施例。在附图中，除非另有说明，否则相同的附图标记在各个附图中指代相同的部件。
为了更好地理解本发明，将参考以下结合附图进行阅读的详细描述，其中：
图1是根据本发明的电刺激***的一个实施例的示意图；
图2是根据本发明的电刺激引线的一个实施例的示意性侧视图；
图3是根据本发明的用于确定刺激参数的***的一个实施例的示意框图；
图4是根据本发明的确定兼容MRI的刺激参数的方法的一个实施例的流程图；
图5是根据本发明的确定兼容MRI的刺激参数的方法的第二实施例的流程图；
图6是根据本发明的确定兼容MRI的刺激参数的方法的一个实施例的示意图。
具体实施方式
本发明涉及植入式电刺激***以及制造和使用该***的方法的领域。本发明还涉及用于选择兼容MRI的刺激参数的***和方法。
适合的植入式电刺激***包括但不限于至少一个引线，其中一个或多个电极设置在引线的远端上，并且一个或多个端子设置在引线的一个或多个近端上。引线包括例如经皮引线、桨状引线、袖带引线或引线上的任何其他电极布置。具有引线的电刺激***的示例可见于例如美国专利号6,181,969；6,516,227；6,609,029；6,609,032；6,741,892；7,244,150；7,450,997；7,672,734；7,761,165；7,783,359；7,792,590；7,809,446；7,949,395；7,974,706；8,175,710；8,224,450；8,271,094；8,295,944；8,364,278；8,391,985；和8,688,235；以及美国专利申请公开号2007/0150036；2009/0187222；2009/0276021；2010/0076535；2010/0268298；2011/0005069；2011/0004267；2011/0078900；2011/0130817；2011/0130818；2011/0238129；2011/0313500；2012/0016378；2012/0046710；2012/0071949；2012/0165911；2012/0197375；2012/0203316；2012/0203320；2012/0203321；2012/0316615；2013/0105071；和2013/0197602，所有这些都通过引用并入本文。在下面的讨论中，将举例说明经皮引线，但应理解，本文所描述的方法和***也适用于桨状引线和其他引线。
用于电刺激的经皮引线(例如，深部脑或脊髓刺激)包括刺激电极，该刺激电极可以是环形电极，仅部分地围绕引线的圆周延伸的分段电极，或任何其他类型的电极，或其任何组合。分段电极可以被提供为电极组，其中每组具有在特定纵向位置处围绕引线周向分布的电极。为了说明的目的，本文相对于用于深部脑刺激对这些引线进行了描述，但是应当理解，这些引线中的任何引线可以用于除深部脑刺激之外的应用，包括脊髓刺激、外周神经刺激或对其他神经、肌肉和组织的刺激。特别地，刺激可以刺激特定目标。此类目标的示例包括但不限于丘脑底核(STN)、苍白球内部(GPi)、苍白球外部(GPe)等。在至少一些实施例中，解剖结构由其物理结构限定，并且生理目标由其功能属性限定。在各种实施例中的至少一个中，引线可以至少部分地定位在目标内，但是在其他实施例中，引线可以在目标附近但不在目标内。
转到图1，电刺激***10的一个实施例包括一个或多个刺激引线12和植入式脉冲发生器(IPG)14。***10还可以包括外部远程控制(RC)16，临床医生的编程器(CP)18、外部试验刺激器(ETS)20或外部充电器22中的一个或多个。
IPG 14可选地经由一个或多个引线延伸部24物理地连接到一个或多个刺激引线12。每个引线承载被布置成阵列的多个电极26。IPG 14包括脉冲发生电路，其根据刺激参数集以例如脉冲电波形(即，一个时间序列的电脉冲)的形式将电刺激能量递送到电极阵列26。IPG 14可以植入患者体内，例如，植入患者的锁骨区域下方或患者的臀部或腹腔内。IPG14可以具有八个刺激通道，其可以是独立可编程的，以控制来自每个通道的电流刺激的幅度。在至少一些实施例中，IPG 14可具有多于或少于八个刺激通道(例如，4个、6个、16个、32个或更多个刺激通道)。IPG 14可以具有一个、两个、三个、四个或更多个连接器端口，以用于容纳引线的端子。
ETS 20还可以可选地经由经皮引线延伸部28和外部电缆30物理地连接到刺激引线12。可以具有与IPG 14类似的脉冲发生电路的ETS 20还根据刺激参数集以例如脉冲电波形的形式将电刺激能量递送到电极阵列26。ETS 20和IPG14之间的一个区别在于ETS 20通常是非植入式设备，其在已经植入神经刺激引线12之后并且在植入IPG 14之前试验性地进行使用以测试对待提供的刺激的响应性。本文所描述的关于IPG 14的任何功能可同样地关于ETS 20执行。
RC 16可用于经由单向或双向无线通信链路32与IPG 14或ETS 20遥测通信或者控制IPG 14或ETS 20。一旦植入IPG 14和神经刺激引线12，RC 16就可用于经由单向或双向通信链路34与IPG 14遥测通信或控制IPG 14。这种通信或控制允许IPG 14被打开或关闭并且被以不同的刺激参数集进行编程。还可以操作IPG 14以修改编程的刺激参数以主动控制IPG 14输出的电刺激能量的特性。CP 18允许用户(诸如临床医生)在手术室和后续会话中针对IPG 14和ETS20编程刺激参数的能力。
CP 18可以经由无线通信链路36经由RC 16与IPG 14或ETS 20间接通信来执行该功能。可替选地，CP 18可以经由无线通信链路(未示出)而与IPG 14或ETS 20直接通信。由CP 18提供的刺激参数也用于对RC 16进行编程，使得随后可以通过RC 16在独立模式下(即，在没有CP 18的帮助的情况下)的操作来修改刺激参数。
为简要起见，RC 16、CP 18、ETS 20和外部充电器22的细节不在此另外描述。这些设备的示例性实施方案的细节公开于美国专利号6,895,280，其通过引用明确地并入本文。电刺激***的其他示例可以在以下专利中找到：美国专利号6,181,969；6,516,227；6,609,029；6,609,032；6,741,892；7,949,395；7,244,150；7,672,734；和7,761,165；7,974,706；8,175,710；8,224,450；和8,364,278；以及美国专利申请公开号2007/0150036，以及上面引用的其他参考文献，所有这些都通过引用并入本文。
图2示出了引线100的一个实施例，其中电极125沿着引线100的远端部分至少部分地围绕引线100的圆周设置，并且端子135沿着引线100的近端部分设置。引线100可以被植入在待刺激的身体的期望的部分(例如脑、脊髓或其他身体器官或组织)附近或内部。在针对深部脑刺激的操作的一个示例中，可以通过用颅骨钻(通常称为骨钻)在患者的颅骨或头盖中钻孔并且凝固和切割硬脑膜或大脑覆盖物来实现对脑中的期望位置的访问。可以在探针(未示出)的帮助下将引线100***颅骨和脑组织中。可以使用例如立体定向框架和微驱动器电机***将引线100引导到脑内的目标位置。在至少一些实施例中，微驱动器电机***可以是完全或部分自动的。微驱动器电机***可以被配置为执行以下一个或多个动作(单独或组合)：***引线100、推进引线100、缩回引线100、或旋转引线100。
在至少一些实施例中，耦合到由目标神经元刺激的肌肉或其他组织的测量设备，或响应于患者或临床医生的单元，可以耦合到IPG 14或微驱动器电机***。测量设备、用户或临床医生可以指示目标肌肉或其他组织对一个或多个刺激或记录电极的响应，以进一步识别目标神经元并促进对一个或多个刺激电极的定位。例如，如果目标神经元被引导至经历震颤的肌肉，则可以使用测量设备来观察肌肉并指示例如响应于神经元刺激的震颤频率或幅度的变化。可替选地，患者或临床医生可以观察肌肉并提供反馈。
用于深部脑刺激的引线100可包括刺激电极、记录电极或两者。在至少一些实施例中，引线100是可旋转的，使得在使用记录电极定位神经元之后，刺激电极可以与目标神经元对准。
刺激电极可以设置在引线100的圆周上以刺激目标神经元。刺激电极可以是环形的，使得电流沿着引线100的长度在来自电极的位置的每个方向上从每个电极均等地突出。在图2的实施例中，电极125中的两个是环形电极120。环形电极通常不能使刺激电流仅从引线周围的有限角度范围引导。然而，分段电极130可用于将刺激电流引导到引线周围的选定角度范围。当分段电极与递送恒定电流刺激的植入式脉冲发生器结合使用时，可以实现电流转向以更精确地将刺激递送到围绕引线轴线的位置(即，围绕引线轴线径向定位)。为了实现电流转向，除了环形电极之外或作为环形电极的替代，可以使用分段电极。
引线100包括引线主体110、端子135、一个或多个环形电极120、以及一组或多组分段电极130(或任何其他电极组合)。引线主体110可以由生物相容的非导电材料(诸如例如聚合材料)形成。适合的聚合物材料包括但不限于硅树脂、聚氨酯、聚脲、聚氨酯-脲、聚乙烯等。一旦植入体内，引线100就可以长时间与身体组织接触。在至少一些实施例中，引线100的横截面直径不大于1.5mm并且可以在0.5至1.5mm的范围内。在至少一些实施例中，引线100具有至少10cm的长度，并且引线100的长度可以在10至70cm的范围内。
电极125可以使用金属、合金、导电氧化物或任何其他适合的导电生物相容性材料制成。适合材料的示例包括但不限于铂、铂铱合金、铱、钛、钨、钯、钯铑等。优选地，电极125由生物相容的材料制成，并且在预期的操作条件下，在预期的使用持续时间内在操作环境中基本上不会腐蚀。
可以使用或不使用(OFF)电极125中的每个。当使用电极时，电极可用作阳极或阴极并带有阳极或阴极电流。在一些情况下，电极可以在一段时间内是阳极，并且在一段时间内是阴极。
深部脑刺激引线可包括一组或多组分段电极。分段电极可提供优于环形电极的电流转向，这是因为深部脑刺激中的目标结构通常不对称于远侧电极阵列的轴线。相反，目标可以位于穿过引线轴线的平面的一侧。通过使用径向分段电极阵列(“RSEA”)，电流转向不仅可以沿着引线的长度而且可以围绕引线的圆周进行。这提供了精确的三维靶向和将电流刺激递送到神经目标组织，同时可能避免对其他组织的刺激。具有分段电极的引线的示例包括美国专利号8,473,061；8,571,665；和8,792,993；美国专利申请公开号2010/0268298；2011/0005069；2011/0130803；2011/0130816；2011/0130817；2011/0130818；2011/0078900；2011/0238129；2012/0016378；2012/0046710；2012/0071949；2012/0165911；2012/197375；2012/0203316；2012/0203320；2012/0203321；2013/0197424；2013/0197602；2014/0039587；2014/0353001；2014/0358208；2014/0358209；2014/0358210；2015/0045864；2015/0066120；2015/0018915；2015/0051681；美国专利申请序列号14/557,211和14/286,797；以及美国临时专利申请序列号62/113,291，所有这些都通过引用并入本文。
图3示出了用于实践本发明的***的一个实施例。该***可以包括计算设备300或任何其他类似设备(其包括处理器302和存储器304)、显示器306、输入设备308、以及可选地电刺激***312。***300还可以可选地包括一个或多个成像***310。
计算设备300可以是计算机、平板电脑、移动设备或用于处理信息的任何其他适合的设备。计算设备300可以是用户本地的，或者可以包括计算机非本地的组件，包括处理器302或存储器304(或其部分)中的一个或两个。例如，在至少一些实施例中，用户可以操作连接到非本地计算设备的终端。在其他实施例中，存储器对于用户来说是非本地的。
计算设备300可以利用包括可以是用户本地的或者是计算设备的其他组件的一个或多个硬件处理器的任何适合的处理器302。处理器302被配置为执行提供给处理器302的指令，如下所述。
任何适合的存储器304可以用于计算设备302。存储器304示出了一种类型的计算机可读介质，即计算机可读存储介质。计算机可读存储介质可以包括但不限于以用于存储信息(诸如计算机可读指令、数据结构、程序模块或其他数据)的任何方法或技术实现的非易失性、非暂时性、可移动和不可移动介质。计算机可读存储介质的示例包括RAM、ROM、EEPROM、闪存或其他存储器技术、CD-ROM，数字通用盘(“DVD”)或其他光学存储器、磁带盒、磁带、磁盘存储器或其他磁存储设备、或可用于存储所需信息并且可由计算设备访问的任何其他介质。
通信方法提供另一种类型的计算机可读介质；即通信介质。通信介质通常以诸如载波、数据信号或其他传输机制等已调制数据信号来体现计算机可读指令、数据结构、程序模块或其他数据，并且包括任何信息递送介质。术语“已调制数据信号”和“载波信号”包括其特征中的一个或多个以这样的方式进行设置或改变以将信息、指令、数据等编码在信号中的信号。举例来说，通信介质包括有线介质(诸如例如双绞线、同轴电缆、光纤、波导和其他有线介质)和无线介质(诸如声学、RF、红外和其他无线介质)。
显示器306可以是任何适合的显示设备(诸如监视器、屏幕、显示器等)，并且可以包括打印机。输入设备308可以是例如键盘、鼠标、触摸屏、跟踪球、操纵杆、音识别***或其任何组合等。
可以使用一个或多个成像***310，包括但不限于MRI、计算机断层扫描(CT)、超声或其他成像***。成像***310可以通过与计算设备300的有线或无线连接进行通信，或者可选地或另外地，用户可以使用计算机可读介质或通过一些其他机制从成像***310提供图像。
电刺激***312可包括例如图1中所示的任何组件。电刺激***312可以通过有线或无线连接与计算设备300通信，或者可选地或另外地，用户可以使用计算机可读介质或通过一些其他机制在电刺激***312和计算设备300之间提供信息。在至少一些实施例中，计算设备300可以包括电刺激***的一部分，诸如例如IPG 14、CP 18、RC 16、ETS 20或其任何组合。
本文描述的方法和***可以以许多不同的形式体现，并且不应该被解释为限于这里阐述的实施例。因此，这里描述的方法和***可以采用完全硬件实施例、完全软件实施例或组合软件和硬件方面的实施例的形式。这里引用的***通常包括存储器，并且通常包括用于与包括移动设备的其他设备通信的方法。通信方法可以包括有线和无线(例如，RF、光学或红外)通信方法，并且这种方法提供另一种类型的计算机可读介质；即通信介质。有线通信可以包括通过在双绞线、同轴电缆、光纤、波导等或其任何组合上的通信。无线通信可以包括RF、红外、声学、近场通信，蓝牙TM等或其任何组合。
在正常操作条件下，实施刺激程序的刺激***将刺激患者组织的期望部分。然而，已经发现，在MRI扫描期间，刺激***的电源对于相同刺激程序可能以相当高的速率消耗。因此，刺激***可能无法充分刺激或可能完全无法刺激期望的患者组织。
为了解决这个问题，本***或方法可以生成兼容MRI的刺激程序，其将在仍然对患者组织提供有用的刺激的同时至少部分地减轻电池消耗。在至少一些实施例中，刺激可能不如使用原始刺激程序的刺激有效，但目的是在MRI程序期间提供至少一些有效刺激。
图4示出了创建兼容MRI的刺激程序的方法的一个实施例的流程图。在步骤402中，接收第一刺激程序的第一刺激参数集。刺激程序可以由产生刺激程序的刺激的刺激参数集来描述。刺激参数可以包括但不限于对用于产生刺激的一个或多个电极的选择、刺激幅度(当使用多个电极产生刺激时每个电极的总幅度或个体幅度)、脉冲宽度、脉冲频率等。在至少一些实施例中，至少一个刺激参数可指示最小可允许参数值(例如，表示刺激组织的估计的最小电流量的最小刺激电流)、最大允许参数值(例如，表示***可以采用的脉冲宽度范围的上限的最大脉冲宽度)等。一些刺激程序也可能更复杂，其中电极的选择可能在程序期间改变(例如，在第一电极选择和第二电极选择之间交替)或者幅度、脉冲宽度、脉冲频率等的改变。此外，一些刺激程序还可以包括刺激脉冲的猝发，其中至少一个刺激参数指示猝发频率、猝发宽度、占空比、猝发模式等。
用于选择刺激程序的不同刺激程序和方法和***的示例可以在例如以下专利中找到：美国专利号8,326,433；8,675,945；8,831,731；8,849,632；和8,958,615；美国专利申请公开号2009/0287272；2009/0287273；2012/0314924；2013/0116744；2014/0122379；和2015/0066111；以及美国临时专利申请序列号62/030,655；美国临时专利申请序列号62/186,184，所有这些都通过引用并入本文。
可以以任何适合的方式接收第一刺激参数集。例如，可以从内部或外部存储器检索第一刺激参数集。作为另一个示例，临床医生或用户可以经由本文所述的任何方式输入或以其他方式生成第一刺激程序。可以从IPG或其他设备获得第一刺激参数集。这些方法的组合或用于提供刺激参数集的任何其他适合的布置也可用于获得第一刺激参数集。
在步骤404中，基于第一刺激程序生成兼容MRI的刺激程序。在至少一些实施例中，通过修改那些刺激参数中的一个或多个，至少部分地基于第一刺激程序的第一刺激参数集来生成兼容MRI的刺激程序。兼容MRI的刺激程序包括第二刺激参数集。第二刺激参数集的刺激参数中的至少一些与第一刺激参数集中的对应刺激参数相关或相同。在至少一些实施例中，通过修改第一刺激参数集中的一个或多个以生成第二刺激参数集来生成兼容MRI的刺激程序。
生成兼容MRI的刺激程序以增加刺激***在MRI扫描期间减轻对***或患者的一种或多种有害影响的同时在MRI扫描期间提供对患者的适合的刺激的可能性。在至少一些实施例中，第一刺激程序可用于在正常或非MRI条件下(例如，在患者的MRI扫描之前或之后)刺激患者，并且兼容MRI的刺激程序可用于刺激MRI扫描条件下的患者(例如，在患者的MRI扫描期间)。
在至少一些实施例中，生成兼容MRI的刺激程序可以涉及减少或以其他方式改变第一刺激参数集中的至少一个刺激参数的值。例如，可以减小或改变该值，使得其不超过预定阈值、最大值或上限。在使用电流限定刺激量的至少一些实施例中，在刺激期间递送的总电流(或与任何特定电极相关联的电流)可以限于兼容MRI的程序中的预定阈值(例如，不大于1mA、0.75mA、0.5mA或0.25mA)。如果在第一刺激程序期间递送的电流超过该阈值，则兼容MRI的刺激程序中的电流减小到阈值量(或更低)。可以以与上述刺激电流类似的方式改变的刺激参数的其他示例包括但不限于刺激电压、脉冲宽度、脉冲频率、猝发宽度和猝发频率。在MRI扫描期间减少这些参数中的一个或多个可能是有益的。
在至少一些实施例中，生成兼容MRI的刺激程序可以涉及改变对用于提供刺激的电极的选择。例如，兼容MRI的刺激程序可以仅允许单相刺激(即，仅一个阳极和一个阴极)。在这种情况下，如果第一刺激程序提供双相或多相刺激(使用两个或更多个阳极或两个或更多个阴极)，则在兼容MRI的刺激程序中改变对电极的选择以仅选择那些阳极/阴极中的一个用于刺激递送。
作为另一个示例，IPG 14的壳体通常在刺激期间用作阳极或阴极，但是兼容MRI的刺激程序可能不允许这种使用并且可能需要将在IPG 14的壳体上的阴极或阳极的布置改变为在引线12上的一个或多个电极。
在步骤406中，计算设备300将兼容MRI的刺激程序递送到IPG 14、ETS 20或其他设备。例如，计算设备300可以发起向IPG 14、ETS 20或其他设备提供兼容MRI的刺激程序的信号。
在步骤408中，IPG 14、ETS 20或其他设备使用第一刺激程序刺激患者。除了MRI扫描期间之外，提供该刺激。
在步骤410中，引导IPG 14、ETS 20或其他设备使用兼容MRI的刺激程序刺激患者。在至少一些实施例中，IPG 14、ETS 20或其他设备耦合到可以检测MRI扫描正在发生或即将发生的传感器或其他设备(例如，检测MRI设备的大静磁场或改变与MRI扫描相关联的磁场梯度或RF场)，并且响应于该检测，自动引导IPG 14、ETS 20或其他设备切换到兼容MRI的刺激程序。在至少一些实施例中，使用诸如CP 18、RC 16或其他设备的外部设备的用户(临床医生、患者或其他人)可以与IPG 14、ETS 20或其他设备通信以手动引导IPG 14、ETS 20或其他设备切换到兼容MRI的刺激程序。在至少一些实施例中，***可以提供对IPG 14、ETS20或其他设备的自动或手动引导以切换到兼容MRI的刺激程序。
在步骤412中，引导IPG 14、ETS 20或其他设备返回第一刺激程序以刺激患者。在至少一些实施例中，IPG 14、ETS 20或其他设备可在预定时间段之后自动切换到第一刺激程序。在至少一些实施例中，IPG 14、ETS 20或其他设备耦合到传感器或其他设备，该传感器或其他设备可以检测MRI扫描何时完成，并且响应于该检测，自动引导IPG 14、ETS 20或其他设备切换回第一刺激程序。在至少一些实施例中，使用诸如CP 18、RC 16或其他设备的外部设备的用户(临床医生、患者或其他人)可以与IPG 14、ETS 20或其他设备通信以手动引导IPG14、ETS 20或其他设备切换回第一刺激程序。在一些***中，这些机制中的两个或三个的组合可以可用于引导IPG 14、ETS 20或其他设备切换回第一刺激程序。
图5示出了用于创建兼容MRI的刺激程序的方法的另一实施例。在步骤502中，如步骤402中那样接收第一刺激程序的第一刺激参数集。
在步骤504中，确定指示能量消耗的值。该确定可以由IPG 14、ETS 20、CP 18、RC16或其他设备执行。在至少一些实施例中，该值可以是已知的或先前计算或估计的。在至少一些实施例中，该值可以指示在正常条件下的能量消耗或刺激***在MRI扫描条件下实施第一刺激程序时的能量消耗。在至少一些实施例中，可以使用数据库中的预定义公式或信息(例如，通过观察在正常条件下各种刺激***的能量消耗的差异与在MRI扫描条件下的各种刺激***的能量消耗的差异获得的经验数据)来确定该值。
指示能量消耗的值的一个示例是脉冲宽度乘以刺激电流的平方或脉冲宽度乘以最小刺激电流的平方。可以使用其他值和针对值的计算。除了计算值之外或作为另外一种选择，可以在计算中使用至少一个参数值或者作为能量消耗的表示(例如，脉冲宽度、刺激电流、最小刺激电流阈值或上面讨论的那些中的另一个)。另外，应该理解，可以考虑多个值来描述能量消耗。在至少一些实施例中，指示能量消耗的值可以是测量值(例如，电池电荷随时间的变化)。
在步骤506中，基于第一刺激程序和指示在步骤504中确定的能量消耗的值生成兼容MRI的刺激程序。在确定兼容MRI的刺激程序时，***可以确定如何修改第一刺激参数集以将能量消耗减少到阈值或目标值(或更低)。在至少一些实施例中，生成兼容MRI的刺激程序可以涉及减少或以其他方式改变第一刺激参数集中的至少一个刺激参数的值或改变电极的选择，或其任何组合。以上关于图4中的步骤404提供了这种改变的示例。在至少一些实施例中，***可以迭代地改变刺激参数，直到新刺激程序的能量消耗的值等于或小于阈值或目标值为止。
步骤508到514分别与步骤406到412相同。
图6是创建兼容MRI的刺激程序的一种方法的流程图。在步骤602中，***提供图形用户界面(GUI)。用户界面可以在例如CP 18或RC 16上。在步骤604中，接收第一刺激程序的第一刺激参数集，并生成兼容MRI的刺激程序。例如，可以如上面在图4的步骤402-404或图5的步骤502-506中所描述的那样执行步骤604。可选地，用户界面可以允许用户在生成兼容MRI的刺激程序之前对兼容MRI的刺激程序设置用户定义的限制。例如，可以允许用户对刺激参数设置限制，或者可以能够指定不能用于刺激的电极或指定必须用于刺激的电极。
在步骤606中，在用户界面中显示兼容MRI的刺激程序(例如，兼容MRI的刺激程序的刺激参数)。这允许诸如临床医生或患者的用户查看兼容MRI的程序。
在其他实施例中，***可以基于兼容MRI的程序的刺激参数显示估计的刺激区域。可选地，用户界面还可以显示第一刺激程序的估计刺激区域。
在步骤608中，用户界面允许用户修改兼容MRI的刺激程序。例如，可以允许用户修改刺激参数中的一个或多个的值或修改电极选择(添加或删除要用于刺激的电极)或其任何组合。然后可以在用户界面中显示修改的兼容MRI的刺激程序。
在至少一些实施例中，如果调整在先前设置的阈值或兼容MRI的刺激程序的规则之外，则***可以提供至少一个警告。例如，如果调整的刺激参数超过预定值，或者如果针对该组刺激参数的指示能量消耗的结果值超过阈值，则可以发出警告。作为其他示例，如果当兼容MRI的刺激程序旨在是单相时，或者当在兼容MRI的刺激程序旨在不使用壳电极时将壳电极修改为用作阳极或阴极时，如果修改的电极选择是双相的或多相的，则可以发出警告。可以使用任何适合的警告，包括但不限于视觉、听觉或触觉警告或其任何组合。可替选地，***可以简单地阻止超出先前设置的阈值或限制或者违反兼容MRI的刺激程序的规则的调整。在至少一些实施例中，一些调整可以被阻止，而其他调整可以被允许并向用户发出警告。
在基于兼容MRI的程序的刺激参数显示估计刺激区域的实施例中，可以通过改变刺激参数来改变估计刺激区域。在至少一些实施例中，用户界面还可以基于未修改的兼容MRI的程序的刺激参数显示估计的刺激区域。估计的刺激区域中的每个可以以视觉或图形差异(诸如不同的着色、形状等)显示。
步骤610至616分别与步骤406至412相同。
在至少一些实施例中，***可以要求临床医生或用户在递送或使用兼容MRI的刺激程序之前批准兼容MRI的刺激程序。在至少一些实施例中，***可能需要在批准之前经由ETS 20进行测试。
应当理解，该***可以以任何组合包括上文关于图4-6描述的一种或多种方法。本文描述的方法、***和单元可以以许多不同的形式体现，并且不应该被解释为限于这里阐述的实施例。因此，这里描述的方法、***和单元可以采用完全硬件实施例、完全软件实施例或组合软件和硬件方面的实施例的形式。可以使用任何类型的处理器或处理器的任何组合来执行本文描述的方法，其中每个处理器执行该过程的至少一部分。
将理解，流程图图示的每个块以及本文公开的流程图图示和方法中的块的组合可以由计算机程序指令实现。可以将这些程序指令提供给处理器以产生机器，使得在处理器上执行的指令创建用于实施在本文公开的一个或多个流程图块中指定的动作的手段。计算机程序指令可以由处理器执行，以致使处理器执行一系列操作步骤，以产生计算机实施的过程。计算机程序指令还可以致使操作步骤中的至少一些并行执行。此外，步骤中的一些也可以跨多于一个处理器执行，诸如可能出现在多处理器计算机***中。另外，在不脱离本发明的范围或精神的情况下，还可以与其他过程同时执行一个或多个过程，或者甚至以不同于所示的顺序执行。
计算机程序指令可以存储在任何适合的计算机可读介质上，包括但不限于RAM、ROM、EEPROM、闪存或其他存储器技术、CD-ROM、数字通用盘(“DVD”)或其他光学存储器、磁带盒、磁带、磁盘存储器或其他磁存储设备、或可用于存储所需信息并且可由计算设备访问的任何其他介质。
以上说明书提供了对本发明的结构、制造和用途的描述。由于可以在不脱离本发明的精神和范围的情况下做出本发明的许多实施例，因此本发明也存在于下文所附的权利要求中。

Claims (10)

1.一种用于创建兼容MRI的刺激程序以使用植入式电刺激***对患者进行电刺激的***，所述植入式电刺激***包括植入式脉冲发生器和具有多个电极的引线，所述用于创建兼容MRI的刺激程序的***包括：
处理器，其被配置为：
接收第一刺激程序的第一刺激参数集，其中所述第一刺激参数集指示用于递送电刺激的第一电极组；
至少部分地基于接收到的第一刺激参数集生成兼容MRI的刺激程序，其中所述兼容MRI的刺激程序包括第二刺激参数集，所述第二刺激参数集指示来自所述多个电极的第二电极组以用于递送电刺激，其中生成所述兼容MRI的刺激程序包括由所述处理器修改所述第一刺激参数集以通过以下中的至少一个生成所述第二刺激参数集：1)减小所述第一刺激参数集中的至少一个刺激参数的值，或者2)在所述第一电极组中，以所述引线的所述电极中的至少一个替换所述电刺激***的壳电极；并且
发起信号，所述信号向所述电刺激***的所述植入式脉冲发生器提供兼容MRI的刺激程序，以用于对患者产生电刺激。
2.根据权利要求1所述的***，其中，所述处理器还被配置为确定指示所述第一刺激程序的能量消耗的值，其中生成所述兼容MRI的刺激程序还包括响应于指示能量消耗的值减小所述第一刺激参数集中的至少一个刺激参数的值。
3.根据权利要求1或2所述的***，其中，生成所述兼容MRI的刺激程序还包括减小所述第一刺激参数集中的至少一个刺激参数的值，其中所述第一刺激参数集中的至少一个刺激参数包括刺激电流、刺激电压、脉冲宽度或脉冲频率中的至少一个。
4.根据权利要求1或2所述的***，其中，所述第一电极组包括所述壳电极，并且其中生成所述兼容MRI的刺激程序包括在所述第一电极组中用所述引线的所述电极中的至少一个替换所述电刺激***的所述壳电极，其中，可选地，所述引线的所述电极中的至少一个是在所述第一刺激程序中未使用的所述引线的多个电极。
5.根据权利要求1或2所述的***，还包括用户界面，其被可通信地耦合到所述处理器，其中所述处理器还被配置为：
经由所述用户界面接收指示对所述兼容MRI的刺激程序的用户修改的用户输入；并且
响应于所述用户输入，根据所述用户修改对所述兼容MRI的刺激程序进行修改以生成经用户修改的兼容MRI的刺激程序，其中发起向所述电刺激***的所述植入式脉冲发生器提供所述兼容MRI的刺激程序以产生对患者的电刺激的所述信号包括发起向所述电刺激***的所述植入式脉冲发生器提供所述经用户修改的兼容MRI的刺激程序以产生对患者的电刺激的信号。
6.一种非暂时性计算机可读介质，其上存储有计算机可执行指令，当所述指令由处理器执行时，致使所述处理器执行用于创建兼容MRI的刺激程序以用于使用植入式电刺激***对患者进行电刺激的方法，所述植入式电刺激***包括植入式脉冲发生器和具有多个电极的引线，所述方法包括：
接收第一刺激程序的第一刺激参数集，其中所述第一刺激参数集指示用于递送电刺激的第一电极组；
至少部分地基于接收到的第一刺激参数集生成兼容MRI的刺激程序，其中所述兼容MRI的刺激程序包括第二刺激参数集，所述第二刺激参数集指示来自所述多个电极的第二电极组以用于递送电刺激，其中生成所述兼容MRI的刺激程序包括由所述处理器修改所述第一刺激参数集以通过以下中的至少一个生成所述第二刺激参数集：1)减小所述第一刺激参数集中的至少一个刺激参数的值，或者2)在所述第一电极组中，以所述引线的所述电极中的至少一个替换所述电刺激***的壳电极；并且
发起信号，所述信号向所述电刺激***的所述植入式脉冲发生器提供兼容MRI的刺激程序，以用于对患者产生电刺激。
7.根据权利要求6所述的非暂时性计算机可读介质，其中，所述方法还包括确定指示所述第一刺激程序的能量消耗的值，其中生成所述兼容MRI的刺激程序还包括响应于指示能量消耗的值减小所述第一刺激参数集中的至少一个刺激参数的值。
8.根据权利要求6或7所述的非暂时性计算机可读介质，其中，生成所述兼容MRI的刺激程序还包括减小所述第一刺激参数集中的至少一个刺激参数的值，其中所述第一刺激参数集中的至少一个刺激参数包括刺激电流、刺激电压、脉冲宽度或脉冲频率中的至少一个。
9.根据权利要求6或7所述的非暂时性计算机可读介质，其中，生成所述兼容MRI的刺激程序还包括通过将经由用于所述第一刺激程序的所述壳电极的刺激分配在未被用于所述第一刺激程序的所述引线的多个电极上，从而以所述引线的所述电极中的至少一个替换所述电刺激***的所述壳电极。
10.根据权利要求6或7所述的非暂时性计算机可读介质，其中，所述方法还包括：
经由用户界面接收指示要从所述第二电极组中排除的一个或多个电极的用户输入；并且
响应于所述用户输入，从所述第二电极组中排除所述一个或多个电极。
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