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    • 112. 发明授权
    • Method and system to graphically display programming parameters for multi-chamber devices
    • 用于图形显示多室设备的编程参数的方法和系统
    • US07333856B1
    • 2008-02-19
    • US10847709
    • 2004-05-17
    • Siew Bee ErQiuju HuangEuljoon ParkPaul A. Levine
    • Siew Bee ErQiuju HuangEuljoon ParkPaul A. Levine
    • A61N1/362
    • A61N1/37247
    • A method and system for programming an implantable therapeutic stimulation device sensing from and delivering therapeutic stimulations to multiple sites within a patient under a plurality of programmable parameters. The method includes automatically determining which parameters need to be programmed, graphically indicating specific parameters that need to be programmed in a spatial correspondence to the affected sites in the patient and/or displaying a waveform corresponding to expected physiological activity with the programming, and providing control inputs to program the specific parameters. The method can also include automatically evaluating the programmed parameters, and if errors exist in the programming, indicating the errors and awaiting corrective input, else programming the implantable device. The method can also include automatically determining a number of sensing and stimulation electrodes connected to the device.
    • 一种用于编程可植入治疗刺激装置的方法和系统,其在多个可编程参数下感测并向患者内的多个部位递送治疗刺激。 该方法包括自动确定哪些参数需要被编程,以图形方式指示需要编程的具体参数与病人的受影响部位的空间对应,和/或显示与编程有关的预期生理活动的波形,以及提供控制 输入来编程具体参数。 该方法还可以包括自动评估编程参数,并且如果编程中存在错误,指示错误并等待校正输入,则编程可植入设​​备。 该方法还可以包括自动确定连接到该装置的感测和刺激电极的数量。
    • 114. 发明授权
    • System and method for monitoring cardiac function via cardiac sounds using an implantable cardiac stimulation device
    • 使用可植入心脏刺激装置通过心脏声音监测心脏功能的系统和方法
    • US07139609B1
    • 2006-11-21
    • US10346809
    • 2003-01-17
    • Xiaoyi MinPaul A. LevineEuljoon Park
    • Xiaoyi MinPaul A. LevineEuljoon Park
    • A61B5/02A61N1/365
    • A61N1/36585A61B5/02A61B5/04004A61B5/0402A61B5/7239A61B7/04A61N1/3627
    • Techniques are provided for performing internal measurement of heart sounds to estimate patient cardiac function in terms of stroke volume, cardiac output, or a maximum rate of change of aortic pressure with time (max dP/dt). Control parameters of the medical device are then automatically adjusted so as to optimize overall cardiac function or to provide for ventricular resynchronization therapy. In one example, heart sound signals are derived from acceleration signals received from an accelerometer. The heart sound signals are analyzed to identify S1 and S2 heart sounds as well as ejection period and isovolumic interval (ISOV). Proxies for max dP/dt, stroke volume and cardiac output are then derived from the S1 and S2 heart sounds, the ejection period and the ISOV. Alternative techniques, not requiring detection of ISOV, are employed for use if the patient has heart value regurgitation.
    • 提供技术用于进行心脏声音的内部测量,以根据中风量,心输出量或主动脉压随时间的最大变化率(最大dP / dt)来估计患者心脏功能。 然后自动调节医疗装置的控制参数,以便优化整体心脏功能或提供心室再同步治疗。 在一个示例中,从加速度计接收的加速度信号导出心音信号。 分析心音信号以识别S1和S2心音,以及射血期和等容间隔(ISOV)。 然后从S1和S2心脏声音,射血期和ISOV导出最大dP / dt,搏出量和心输出量的代理。 如果患者有心脏反流,则采用不需要检测ISOV的替代技术。
    • 115. 发明授权
    • Implantable cardiac stimulation device having autocapture/autothreshold capability
    • US07099716B1
    • 2006-08-29
    • US10160510
    • 2002-06-03
    • Paul A. Levine
    • Paul A. Levine
    • A61N1/362
    • A61N1/3712
    • An improved system and method for performing autocapture/autothreshold detection in an implantable cardiac stimulation device or any device capable of stimulating some organ or tissue in the body. In some existing systems, loss-of-capture and capture decisions are based upon two consecutive cardiac events. However, such systems may be subject to subthreshold stimulation pulses that capture and lose capture on alternating pulses, trigeminy PVC sequences, or the like that require a higher stimulation pulse amplitude but cannot make this determination due to the two consecutive event requirement. Accordingly, in the present invention, the determination of whether there is a loss-of-capture is determined only according to paced events, i.e., ignoring intrinsic and PVC beats. Furthermore, the loss-of-capture determination is based upon X out of the last Y beats, where Y is greater than 2 and X is less than Y. Accordingly, consecutive loss-of-capture events are no longer required in determining the threshold level. In a further aspect, a preferred embodiment monitors cardiac events to detect a sequence of patterns that could indicate a trigeminy pattern and, if detected, the pacing rate is increased to attempt to break the pattern and thus permit the threshold level to be detected.
    • 116. 发明授权
    • Implantable cardiac stimulation system providing autocapture and lead impedance assessment and method
    • 可植入式心脏刺激系统,提供自体电位和引线阻抗评估及方法
    • US07031773B1
    • 2006-04-18
    • US10340099
    • 2003-01-10
    • Paul A. LevineBalakrishnan ShankarKenneth R. McNeil, IIJoseph J. Florio
    • Paul A. LevineBalakrishnan ShankarKenneth R. McNeil, IIJoseph J. Florio
    • A61N1/362
    • A61N1/3686A61N1/3712
    • An implantable cardiac stimulation system provides autocapture assessment and lead impedance surveillance. The system includes a pulse generator that provides pacing stimulation pulses and a lead system including a plurality of electrodes that provide a plurality of different electrode configurations. The system further includes a switch that selectively couples the pulse generator to any one of the plurality of pacing electrode configurations and an autocapture circuit that performs autocapture tests with the pulse generator. The autocapture circuit includes a capture detector that detects evoked responses with an evoked response electrode configuration. When there is a failure to detect an evoked response, an impedance measuring circuit measures the lead impedance of the evoked response electrode configuration. If the measured lead impedance is outside of a given range, the switch couples the pulse generator to an electrode configuration other than the evoked response electrode configuration. Thereafter, the autocapture circuit performs a further autocapture and impedance measuring test or sets the pacing output to a level which assures capture.
    • 可植入心脏刺激系统提供自体电位评估和引线阻抗监测。 该系统包括提供起搏刺激脉冲的脉冲发生器和包括提供多个不同电极配置的多个电极的引导系统。 所述系统还包括将所述脉冲发生器选择性地耦合到所述多个起搏电极配置中的任一个的开关和使用所述脉冲发生器进行自动俘获测试的自动俘获电路。 自动俘获电路包括捕获检测器,其通过诱发的响应电极配置来检测诱发的反应。 当无法检测到诱发反应时,阻抗测量电路测量诱发响应电极配置的引线阻抗。 如果测量的引线阻抗在给定范围之外,则开关将脉冲发生器耦合到除了​​诱发响应电极配置之外的电极配置。 此后,自动捕获电路进一步进行自动捕获和阻抗测量测试,或将起搏输出设置为确保捕获的水平。
    • 117. 发明授权
    • Implantable lead and method for stimulating the vagus nerve
    • 植入式铅和刺激迷走神经的方法
    • US06934583B2
    • 2005-08-23
    • US10000333
    • 2001-10-22
    • Lisa P. WeinbergPaul A. Levine
    • Lisa P. WeinbergPaul A. Levine
    • A61N1/05A61N1/36A61N1/362
    • A61N1/36114A61N1/056A61N2001/0585
    • Methods and apparatus for stimulating the right vagal nerve within a living body via positioning an electrode portion of a lead proximate to the portion of the vagus nerve where the right cardiac branch is located (e.g., near or within an azygos vein, or the superior vena cava near the opening of the azygos vein) and delivering an electrical signal to an electrode portion adapted to be implanted therein. Stimulation of the right vagus nerve and/or the cardiac branch thereof act to slow the atrial heart rate. Exemplary embodiments include deploying an expandable or self-oriented electrode (e.g., a basket, an electrode umbrella, and/or an electrode spiral electrode, electrode pairs, etc). Various dedicated and single-pass leads are disclosed, as well as, various electrodes, and stabilization means. The methods include preserving sinus rhythm, avoiding asystole, preserving A-V synchrony, automatically determining parameter combinations that achieve these features, and further (in one embodiment) automatically determining parameter combinations achieve these features and reduce current drain.
    • 通过将铅极的电极部分靠近右心分支所位于的迷走神经的部分(例如,靠近或内侧的一个或多个静脉或上部的静脉内)来定位在活体内刺激右迷走神经的方法和装置 并且将电信号传送到适于植入其中的电极部分。 正确的迷走神经和/或心脏分支的刺激起作用以减慢心房心率。 示例性实施例包括展开可膨胀或自取向电极(例如,篮,电极伞和/或电极螺旋电极,电极对等)。 公开了各种专用和单通引线,以及各种电极和稳定装置。 这些方法包括保留窦性心律,避免心律停滞,保持A-V同步,自动确定实现这些特征的参数组合,以及进一步(在一个实施例中)自动确定参数组合实现这些特征并减少电流消耗。
    • 118. 发明授权
    • Multi-chamber ventricular automatic capture method and apparatus for minimizing true and blanking period induced ventricular undersensing
    • 多腔室自动捕获方法和装置,用于最小化真实和消隐期引起的心室不足感
    • US06819955B2
    • 2004-11-16
    • US09973300
    • 2001-10-09
    • Paul A. Levine
    • Paul A. Levine
    • A61N118
    • A61N1/3712A61N1/3684
    • An implantable cardiac stimulation device and associated method perform a true or blanking period ventricular undersensing detection algorithm in response to ventricular loss of capture not associated with fusion or a change in capture threshold. The test identifies an originating cause of loss of capture, which may be ventricular undersensing of intrinsic R-waves or premature ventricular contractions occurring during a ventricular blanking period or atrial undersensing of P-waves resulting in blanking period ventricular undersensing. A corrective action is taken to reduce the likelihood of blanking period ventricular undersensing by automatically adjusting device operating parameters. The corrective action may include automatic adjustment of atrial sensitivity, shortening of the ventricular blanking period, or adjustment of the base stimulation rate. Minimizing the blanking period ventricular undersensing improves device performance by avoiding back-up stimulation and minimizing the risk of pacemaker competition-induced arrhythmias.
    • 可植入心脏刺激装置和相关联的方法执行真实或消隐期间心室不足检测算法以响应与融合无关的捕获的心室丢失或捕获阈值的变化。 该测试确定了捕获丧失的原因,其可能是内部R波的心室不足或在心室消融期间发生的室性早搏或P波的心房不足,导致消隐期心室不足感。 采取纠正措施,通过自动调整装置的工作参数,减少消融期心室不足的可能性。 纠正措施可以包括自动调整心房敏感性,缩短心室消隐期,或调整基础刺激率。 最小化消隐期心室不足可以通过避免备用刺激和最小化起搏器竞争引起的心律失常的风险来改善器械性能。
    • 119. 发明授权
    • Method and apparatus for generating and displaying location-specific diagnostic information using an implantable cardiac stimulation device and an external programmer
    • 用于使用可植入心脏刺激装置和外部编程器产生和显示位置特异性诊断信息的方法和装置
    • US06633776B2
    • 2003-10-14
    • US09822887
    • 2001-03-30
    • Paul A. LevineGregory C. Bevan
    • Paul A. LevineGregory C. Bevan
    • A61B5044
    • A61N1/37252A61N1/37A61N1/37247
    • Location-specific diagnostic information is detected and recorded by the cardiac stimulation device for subsequent display using the external programmer device. The diagnostic information includes location-specific event records, counters and IEGM signals. The event records include event codes that distinguish among events occurring in the four chambers of the heart, such as sensed or paced events occurring within the left or right atria or the left or right ventricles. The counters separately count events occurring within the chambers of the heart. The IEGM signals are separately detected within the four chambers of the heart using a multiple sensing lead arrangement. The location-specific event records, counters and IEGM signals are ultimately transmitted to the external programmer, which displays graphic representations of the diagnostic information. The event records are displayed using distinct event marker icons which distinguish among the four chambers of the heart. The distinct event marker icons are displayed along with location-specific IEGM displays or surface ECG displays to permit a physician operating the programmer to easily identify the specific chambers of the heart in which events the occurred. Additionally, the programmer displays the values of the various counters to provide, for example, a set of location-specific histograms. The diagnostic information detected and recorded by the stimulation device and displayed by the external programmer device may further distinguish among events detected at multiple locations within each chamber of the heart. Method and apparatus embodiments are described.
    • 由心脏刺激装置检测并记录位置特异性诊断信息,以便随后使用外部编程器装置进行显示。 诊断信息包括位置特定事件记录,计数器和IEGM信号。 事件记录包括区分发生在心脏四个腔室中的事件的事件代码,例如发生在左心房或右心房或左心室或右心室内的感觉或起搏事件。 计数器分别计算在心脏室内发生的事件。 使用多感测引线装置在心脏的四个腔室内分别检测IEGM信号。 位置特定事件记录,计数器和IEGM信号最终传输到外部编程器,该程序器显示诊断信息的图形表示。 事件记录使用不同的事件标记图标显示,区分心脏的四个房间。 显示不同的事件标记图标以及位置特异的IEGM显示器或表面ECG显示器,以允许医师操作程序员容易地识别发生事件的心脏的特定腔室。 此外,程序员显示各种计数器的值,以提供例如一组位置特定的直方图。 由刺激装置检测和记录并由外部编程装置显示的诊断信息可以进一步区分在心脏的每个室内的多个位置处检测的事件。 描述了方法和设备实施例
    • 120. 发明授权
    • Implantable cardiac stimulation system with high threshold response and patient notification method
    • 具有高阈值响应和患者通知方法的植入式心脏刺激系统
    • US06546288B1
    • 2003-04-08
    • US09884697
    • 2001-06-18
    • Paul A. Levine
    • Paul A. Levine
    • A61N1362
    • A61N1/3712
    • An implantable cardiac stimulation device and associated method provide automatic capture verification and threshold testing capabilities with an added high-threshold response algorithm and patient notification process. The stimulation device responds to higher than normal capture thresholds by permitting the stimulation pulse energy to be set above the fixed maximum pulse energy normally allowed by automatic capture verification techniques. In order to maintain comfortable yet effective stimulation, the high-energy stimulation is delivered in a bipolar configuration. The stimulation device alerts the patient of the change to high-energy output when it occurs. After the high-energy output is automatically set, one or more high-energy stimulation pulses are delivered in a unipolar configuration on a scheduled or event-triggered basis. A unipolar high-energy stimulation pulse is typically perceptible by the patient due to stimulation of excitable tissue surrounding the device housing. Sensation of a periodic high-energy pulse alerts the patient that stimulation conditions have changed and medical attention should be sought.
    • 可植入心脏刺激装置和相关方法通过增加的高阈值响应算法和患者通知过程来提供自动捕获验证和阈值测试功能。 刺激装置通过允许将刺激脉冲能量设置在通过自动捕获验证技术通常允许的固定最大脉冲能量以上来响应于高于正常捕获阈值。 为了保持舒适而有效的刺激,高能刺激以双极配置递送。 刺激装置在发生时警告患者对高能量输出的变化。 在自动设置高能量输出之后,一个或多个高能量刺激脉冲以预定或事件触发的基础在单极配置中传送。 单极高能量刺激脉冲通常由于刺激围绕设备外壳的可激发组织而被患者察觉。 感觉周期性高能量脉冲警告患者刺激条件已经改变,应该寻求医疗护理。