公开(公告)号：US5545182A

公开(公告)日：1996-08-13

申请号：US310281

申请日：1994-09-21

申请人： Lawrence J. Stotts ,  Eckhard Alt

发明人： Lawrence J. Stotts ,  Eckhard Alt

IPC分类号： A61N1/39 ,  A61N1/36

CPC分类号： A61N1/3956

摘要： An implantable automatic cardioverter/defibrillator device for a cardiac patient is automatically responsive to sensing of electrical cardiac activity of the heart of a patient in which the device is implanted for detection and treatment of fibrillation. A prescribed electrical shock waveform regimen is generated as electrical defibrillation therapy for application to the heart in response to detection of fibrillation of the heart. A timing function circuit responds to the detection by timing the delivery of the generated prescribed electrical waveform regimen to be applied at a point in time at which the fibrillation ECG has substantially its highest amplitude and lowest frequency, as a point of high susceptibility to reversion to sinus rhythm upon application of a shock, and with low defibfillation threshold, to enhance the probability of successful defibrillation, and to synchronize the shock delivery to this sensed intracardiac event.

摘要翻译： 用于心脏病患者的可植入式自动心律转复器/除纤颤器装置自动响应于感测装置植入用于检测和治疗原纤维化的患者心脏的心脏心脏活动。 产生规定的电击波形方案作为用于响应于心脏颤动的检测而应用于心脏的电除颤治疗。 定时功能电路通过定时将所产生的规定电波形方案的传送定时作为响应于检测，其在原始心电图基本上具有基本上其最高幅度和最低频率的时间点被施加，作为高回复敏感性的点 应用休克时的窦性心律，并且具有低的除颤阈值，以增加除颤成功的可能性，并使冲击输送与感觉到的心内事件同步。

公开(公告)号：US5578062A

公开(公告)日：1996-11-26

申请号：US425052

申请日：1995-04-19

申请人： Eckhard Alt ,  Lawrence J. Stotts

发明人： Eckhard Alt ,  Lawrence J. Stotts

IPC分类号： A61N1/39 ,  A61N1/362

CPC分类号： A61N1/3956 ,  A61N1/36592

摘要： A defibrillator has a signal generator implemented to deliver output shock waveforms and housed in a case adapted to be implanted in the left pectoral region of a cardiac patient. The case is implemented to interact with internal circuitry of the generator to maintain the case active as an electrode. An electrical transvenous lead has a proximal electrode for electrical connection to the internal circuitry of the signal generator and a distal end adapted to be positioned in the right ventricle (RV) of the patient's heart. The lead includes a sensing tip for contacting the RV to sense the patient's ECG signal and a shocking coil arranged to be located in the RV when the transvenous lead is implanted in the patient. The internal circuitry of the signal generator includes triggerable output circuit for developing an output shock waveform when triggered in response to detection of ventricular fibrillation of the patient's heart from the sensed ECG signal. The internal circuitry also includes a timer responsive to the sensed ECG signal for timing the application of the shock waveform developed by the output circuit across the transvenous lead and the active case with a predetermined delay relative to the occurrence of an R-wave of the sensed ECG signal next following detection of fibrillation until at least about 50% of the R-R cycle length of the ECG signal has elapsed, to optimize the timing of delivery of an electric field vector derived from the shock waveform across a myocardial mass of the patient's heart between the shocking coil and the active case.

摘要翻译： 除颤器具有实现的输出冲击波形的信号发生器，并且容纳在适于植入心脏病人的左胸部区域的壳体中。 该情况被实现以与发电机的内部电路相互作用以将壳体作为电极保持活动。 电经静电引线具有用于与信号发生器的内部电路电连接的近端电极和适于定位在患者心脏的右心室（RV）中的远端。 引线包括用于接触RV以感测患者的ECG信号的感测尖端，以及当将经静脉导管插入患者时布置成位于RV中的震动线圈。 信号发生器的内部电路包括可触发输出电路，用于响应于从感测到的ECG信号中检测到患者心脏的心室颤动而触发输出冲击波形。 内部电路还包括响应于感测到的ECG信号的定时器，用于定时将由输出电路产生的冲击波形施加于经静电引线和有源外壳上，相对于感测到的R波的出现具有预定的延迟 心电图信号接下来检测到原纤维化，直到ECG信号的RR周期长度的至少约50％已经过去，以优化递送来自患者心脏的心肌质量的冲击波形的电场矢量的时间 令人震惊的线圈和活动盒。

公开(公告)号：US6080187A

公开(公告)日：2000-06-27

申请号：US55212

申请日：1998-04-06

申请人： Eckhard Alt ,  Lawrence J. Stotts

发明人： Eckhard Alt ,  Lawrence J. Stotts

IPC分类号： A61N1/372 ,  A61N1/368

CPC分类号： A61N1/37211 ,  A61N1/37258

摘要： An interventional medical device has a capability to sense cardiac dysrhythmias and to selectively respond with one among a hierarchy of therapies appropriate to terminate the sensed dysrhythmia and return the heart of the patient in whom the device is adapted to be implanted to normal sinus rhythm. The device includes a therapy generator having a housing and electronics for conducting bidirectional communication with the patient. The bidirectional communication is carried out by detecting the occurrence of a predetermined dysrhytlnia, such as atrial fibrillation, to alert the patient of such occurrence, and by responding to instructions from the patient following such alert for addressing the detected predetermined dysrhythmia. The detection is performed by electrodes mounted directly on the header of the device housing to both detect occurrence of the atrial fibrillation and for alerting the patient thereof by stimulating body tissue such as pectoral muscle in the vicinity of the header electrodes. Response to patient-initiated instructions is implemented by triggering certain device functions such as storage of ECG events detected by the header electrodes, or deliver of a therapy appropriate to terminate the atrial defibrillation, or delay of delivery of the appropriate therapy, according to the nature of the patient-initiated instructions.

摘要翻译： 介入医疗装置具有感测心脏心律失常的能力，并且选择性地响应适于终止感测到的心律失常的治疗层级中的一种，并将该装置适合植入的患者的心脏返回到正常窦性心律。 该装置包括具有用于与患者进行双向通信的壳体和电子装置的治疗发生器。 双向通信是通过检测诸如心房纤维性颤动之类的预定的呼吸困难的发生来警告患者这种发生，并且通过响应来自患者的指示，以响应该警报以解决检测到的预先确定的心律失常。 通过直接安装在装置壳体的头部上的电极进行检测，以检测房颤的发生，并且通过刺激头部电极附近的诸如胸肌的身体组织来警告患者。 对患者发起的指令的响应通过触发某些设备功能来实现，例如由头部电极检测到的ECG事件的存储，或根据自然状况提供适合于终止心房除颤的延迟或适当治疗的延迟 的患者发起的指示。

公开(公告)号：US5725559A

公开(公告)日：1998-03-10

申请号：US648707

申请日：1996-05-16

申请人： Eckhard Alt ,  Lawrence J. Stotts

发明人： Eckhard Alt ,  Lawrence J. Stotts

IPC分类号： G06F21/22 ,  A61N1/362 ,  A61N1/372 ,  A61N1/39 ,  G06F9/445 ,  G06Q50/00

CPC分类号： A61N1/37264 ,  A61N1/37211 ,  A61N1/3962 ,  G06F8/64 ,  G06F8/65 ,  Y10S128/903

摘要： An implantable cardioverter/defibrillator device is implemented to be selectively non-invasively upgraded from time to time after implantation to enable the device to provide additional therapy for arrhythmia treatment as the patient's need for such treatment undergoes change. The device is adapted to provide a plurality of functions corresponding to different levels of therapy for treating arrhythmias, and to respond to each different type of arrhythmia that may be sensed, to supply a function which is designated as being appropriate to relieve that respective arrhythmia. Each function is not necessarily unique to treating a particular arrhythmia, and, in at least some instances, may be used to treat more than one of the plurality of different types of arrhythmias. At the time of its implant, the device is restricted from providing those of the plurality of functions which are deemed as being non-essential to the patient's needs at that time. From time to time thereafter, however, as the patient experiences periodic need for additional therapy, restricted functions of the device are selectively restored by external programming, but only if the programmer is able to supply to the device an enabling code which is substantially unique to that device. In this way, restoration of the restricted functions is locked out except with a prescribed key.

摘要翻译： 植入式心脏复律器/除纤颤器装置被实施为在植入后不时地选择性地非侵入性地升级，以使得该装置能够在患者对这种治疗的需要发生变化时为心律失常治疗提供额外的治疗。 该装置适于提供对应于用于治疗心律失常的不同水平的治疗的多个功能，并且对可被感测的每种不同类型的心律失常作出响应，以提供被指定为适于减轻相应的心律失常的功能。 每个功能不一定是治疗特定心律失常的独特之处，并且在至少一些情况下可用于治疗多种不同类型的心律失常中的一种以上。 在其植入时，该装置被限制为提供被认为对该病人的需要非必要的多个功能中的那些。 然而，随后，随着患者经历对额外治疗的定期需要，通过外部程序选择性地恢复了器件的限制功能，但是只有当程序员能够向器件提供基本上独特的启用代码 那个设备。 以这种方式，限制功能的恢复被锁定，除了规定的键。

公开(公告)号：US5609613A

公开(公告)日：1997-03-11

申请号：US433788

申请日：1995-05-03

申请人： Drury Woodson ,  Michael Lee ,  Joseph Vandegriff ,  Eckhard Alt ,  Lawrence J. Stotts

发明人： Drury Woodson ,  Michael Lee ,  Joseph Vandegriff ,  Eckhard Alt ,  Lawrence J. Stotts

IPC分类号： A61N1/362 ,  A61N1/365 ,  A61N1/368 ,  A61N1/00

CPC分类号： A61N1/36542 ,  A61N1/3622 ,  A61N1/368

摘要： A programmable dual-chamber artificial cardiac pacemaker senses atrial activity and normally tracks the sensed atrial activity in pacing the ventricular activity. An accelerometer located in the case of the pulse generator portion senses physical exercise by a patient when the pacemaker is implanted in the patient, and generates a rate control signal indicative of extent of the sensed physical exercise. The pulse generator is programmed for ventricular pacing rate control in multiple rate zones bounded by rate limits including a ventricular tracking limit (VTL) that varies dynamically with sensed physical exercise and a higher mode switch rate. The ventricular pacing rate tracks the sensed atrial activity on a 1:1 basis for atrial rates below the dynamic VTL (DVTL) during a predetermined interval of time for which the DVTL applies, and tracks the sensed atrial activity in Wenckebach behavior for atrial rates above the DVTL up to the mode switch rate with the ventricular pacing rate limited by the DVTL. The mode switch rate is set to effect a switch from dual-chamber to single-chamber mode when the sensed rate of atrial activity exceeds the mode switch rate for a programmed number of cardiac cycles, in which the ventricular pacing rate is controlled solely by sensed spontaneous ventricular activity without regard to the DVTL or sensed physical exercise. The mode switch rate also effects a reversion to the dual-chamber mode when the sensed rate of atrial activity drops below the mode switch rate for a programmed number of cardiac cycles, in which the ventricular pacing rate is controlled according to the respective one of the multiple rate zones in which the atrial activity rate is present.

摘要翻译： 可编程双室人工心脏起搏器感测心房活动，并通常跟踪感觉到的心房活动起搏心室活动。 位于脉冲发生器部分的情况下的加速度计在起搏器植入患者体内时感测到患者的体育锻炼，并产生指示感测体育运动程度的速率控制信号。 脉冲发生器被编程用于由速率限制限定的多个速率区域中的心室起搏速率控制，包括随感测到的身体运动而动态变化的心室跟踪极限（VTL）和更高的模式切换速率。 在DVTL应用的预定时间间隔内，心室起搏速率以1：1的速度跟踪动态VTL（DVTL）以下的心房率的感觉到的心房活动，并跟踪Wenckebach行为中感觉到的心房活动的心房率 DVTL达到DVTL限制的心室起搏速率的模式切换速率。 当所感测的心房活动速率超过编程的心脏周期数的模式切换速率时，模式切换速率被设置为实现从双室模式到单室模式的切换，其中心室起搏速率仅由感测器控制 自发心室活动，不考虑DVTL或感觉到的身体运动。 当所感测的心房活动速率降低到编程的心脏周期数的模式切换速率时，模式切换速率也影响到双室模式的逆转，其中心室起搏速率根据 存在心房活动率的多个速率区。

公开(公告)号：US06370427B1

公开(公告)日：2002-04-09

申请号：US09121523

申请日：1998-07-23

申请人： Eckhard Alt ,  Lawrence J. Stotts ,  Richard Sanders

发明人： Eckhard Alt ,  Lawrence J. Stotts ,  Richard Sanders

IPC分类号： A61N139

CPC分类号： A61N1/3627 ,  A61N1/0563 ,  A61N1/368 ,  A61N1/395 ,  A61N1/3962

摘要： Device and method are disclosed in which leads with pacing and defibrillating electrodes are implanted into both the right and left ventricles of a patient's heart to enable simultaneous pacing of both ventricles to reduce the width of the QRS complex of the patient's cardiac activity to a more normal duration, and, when appropriate, to apply electrical shock waveforms to both ventricles simultaneously for lower energy defibrillation of the ventricles. In applying the defibrillation therapy, the defibrillating electrode in the left ventricle may be used as the anode and the defibrillating electrode in the right ventricle may be used as the cathode, or both ventricular defibrillating electrodes may be the anode and the metal case in which the shock waveform generator is implanted may be the cathode. Implanting a lead with pacing and defibrillating electrodes in the right atrium enables selective pacing and defibrillation of the atria, in which atrial fibrillation is treated by applying the shock waveform across the right atrial and left ventricular defibrillation electrodes.

摘要翻译： 公开了一种装置和方法，其中具有起搏和除颤电极的引线植入患者心脏的右心室和左心室，以使得能够同时起搏两个心室，以将患者心脏活动的QRS复合体的宽度减小到更正常 持续时间，并且在适当的时候同时对两个心室施加电击波形，以进行心室的较低能量除颤。 在进行除颤治疗时，可以使用左心室的除颤电极作为阳极，右心室的除颤电极可以用作阴极，或者两个心室除颤电极都可以是阳极，其中金属壳体 冲击波形发生器植入可能是阴极。 在右心房植入具有起搏和除颤电极的引线，可使心房的选择性起搏和除颤，其中心房颤动通过将冲击波形应用于右心房和左心室除颤电极来治疗。

公开(公告)号：US5876408A

公开(公告)日：1999-03-02

申请号：US874037

申请日：1997-06-12

申请人： Eckhard Alt ,  Lawrence J. Stotts

发明人： Eckhard Alt ,  Lawrence J. Stotts

IPC分类号： A61N1/05 ,  A61B17/22

CPC分类号： A61N1/056

摘要： A method of implanting small diameter conductive leads for an artificial cardiac pacemaker or other body-implantable medical device includes inserting the lead to be implanted into a predetermined path within the patient's body with the assistance of a stylet for guiding the lead along the path. At least a portion of the stylet which is to traverse the path has an enhanced radiopaque characteristic attributable to the application or addition to the material of which the stylet is composed, of a substance having such radiopaque characteristic. When viewed under fluoroscopy external to the patient's body as the lead is maneuvered along the path, although the thin lead itself may be difficult to see, the stylet is readily discernible by virtue of its enhanced radiopacity, thereby enabling the physician to position the lead at a desired location within the patient's body. For various reasons, the thin lead itself may not be amenable to similar enhancement, which makes the stylet a suitable solution. A portion of the distal end of the stylet, such as its distal tip or a plurality of spaced apart points along its distal end, is provided with the enhanced radiopacity, as by application or addition of gold to the stylet material.

摘要翻译： 一种用于人造心脏起搏器或其它可植入医疗装置的小直径导电引线的方法包括：借助于用于沿着路径引导引线的插针，将要植入的导线插入病人体内的预定路径中。 穿过路径的管心针的至少一部分具有归因于由具有这种不透射线特性的物质的应用或添加到探针组成的材料的增强的不透射线特性。 当在穿过病人身体的外部透视下观察时，由于导线沿着路径进行操作，尽管薄的引线本身可能很难看到，但由于其增强的射线不透性，探针很容易识别，从而使医师能够将引线置于 患者体内所需的位置。 由于各种原因，细铅本身可能不适合类似的增强，这使得探针成为合适的解决方案。 探针的远端的一部分，例如其远端尖端或沿着其远端的多个间隔开的点，具有增强的射线不透性，如通过将金应用或添加到探针材料。

公开(公告)号：US5792205A

公开(公告)日：1998-08-11

申请号：US733552

申请日：1996-10-21

申请人： Eckhard Alt ,  Lawrence J. Stotts

发明人： Eckhard Alt ,  Lawrence J. Stotts

IPC分类号： A61N1/372 ,  A61N1/368 ,  A61N1/375

CPC分类号： A61N1/37211 ,  A61N1/37258

摘要： An interventional medical device has a capability to sense cardiac dysrhythmias and to selectively respond with one among a hierarchy of therapies appropriate to terminate the sensed dysrhythmia and return the heart of the patient in whom the device is adapted to be implanted to normal sinus rhythm. The device includes a therapy generator having a housing and electronics for conducting bidirectional communication with the patient. The bidirectional communication is carried out by detecting the occurrence of a predetermined dysrhythmia, such as atrial fibrillation, to alert the patient of such occurrence, and by responding to instructions from the patient following such alert for addressing the detected predetermined dysrhythmia. The detection is performed by electrodes mounted directly on the header of the device housing to both detect occurrence of the atrial fibrillation and for alerting the patient thereof by stimulating body tissue such as pectoral muscle in the vicinity of the header electrodes. Response to patient-initiated instructions is implemented by triggering certain device functions such as storage of ECG events detected by the header electrodes, or deliver of a therapy appropriate to terminate the atrial defibrillation, or delay of delivery of the appropriate therapy, according to the nature of the patient-initiated instructions.

摘要翻译： 介入医疗装置具有感测心脏心律失常的能力，并且选择性地响应适于终止感测到的心律失常的治疗层级中的一种，并将该装置适合植入的患者的心脏返回到正常窦性心律。 该装置包括具有用于与患者进行双向通信的壳体和电子装置的治疗发生器。 双向通信是通过检测预定的心律失常（例如心房颤动）的发生来进行的，以警告患者这种发生，并且通过响应来自患者的指示，用于解决检测到的预先确定的心律失常的警报。 通过直接安装在装置壳体的头部上的电极进行检测，以检测房颤的发生，并且通过刺激头部电极附近的诸如胸肌的身体组织来警告患者。 对患者发起的指令的响应通过触发某些设备功能来实现，例如由头部电极检测到的ECG事件的存储，或根据自然状况提供适合于终止心房除颤的延迟或适当治疗的延迟 的患者发起的指示。

公开(公告)号：US5529579A

公开(公告)日：1996-06-25

申请号：US242742

申请日：1994-05-12

申请人： Eckhard Alt ,  Lawrence J. Stotts

发明人： Eckhard Alt ,  Lawrence J. Stotts

IPC分类号： A61N1/375 ,  A61N1/39

CPC分类号： A61N1/375 ,  A61N1/3918

摘要： An automatic defibrillator is arranged and adapted to be implanted in a cardiac patient. The defibrillator includes a stimulus generator for sensing fibrillation of the patient's heart and for responding by delivering defibrillation energy to the patient's heart via a defibrillation electrode positioned in the right ventricle of the heart. An electrically conductive case houses the stimulus generator, and a conforming biocompatible electrically non-conductive layer is coated over only a predetermined portion less than all of the case to produce a predetermined shape of electric field between the intracardiac defibrillation electrode and the case when the case is used as an electrode for defibrillation. The predetermined portion of the case coated with the non-conductive layer includes a side of the case to be implanted in a direction facing the heart of the patient, with the non-conductive layer being confined solely to the central portion of that side.

摘要翻译： 自动除颤器被布置并适于植入心脏病人。 除颤器包括用于感测患者心脏颤动的刺激发生器，并且用于通过定位在心脏右心室中的除颤电极向病人的心脏递送除颤能量进行响应。 导电壳体容纳刺激发生器，并且一个符合生物相容性的非导电层仅涂覆在小于所有情况的预定部分上，以在心内除颤电极与壳体之间产生预定形状的电场 用作除颤电极。 涂有非导电层的外壳的预定部分包括要沿面向患者心脏的方向植入的外壳的一侧，其中非导电层仅限于该侧的中心部分。

公开(公告)号：US6096061A

公开(公告)日：2000-08-01

申请号：US874032

申请日：1997-06-12

申请人： Eckhard Alt ,  Lawrence J. Stotts

发明人： Eckhard Alt ,  Lawrence J. Stotts

IPC分类号： A61N1/365 ,  A61N1/39

CPC分类号： A61N1/3962 ,  A61N1/36585

摘要： An implantable medical interventional device responds to detection of any of a plurality of cardiac dysrhythmias in a human patient by performing an appropriate therapy which may include cardiac pacing, cardioversion or defibrillation according to the nature of the detected dysrhythmia. A first sensor detects whether and what type of dysrhythmia is occurring. A generator produces pulses and/or shocks for delivery to the patient's heart according to whether a detected dysrhythmia is bradycardia or slow pathologic tachycardia on the one hand, or fast tachycardia or fibrillation on the other hand. An optimizer in the device at all times maintains a substantial match of the cardiac pacing rate to the hemodynamic needs of the implant patient under conditions of rest and physical activity; including sensing and distinguishing periods of patient physical activity and rest, and generating a signal representative thereof to control the cardiac pacing rate accordingly. In this way, the device focuses on correction of cardiac pacing problems before they become sufficiently aggravated to require more aggressive cardioversion and defibrillation therapies.

摘要翻译： 可植入医疗介入装置通过根据检测到的心律失常的性质进行包括心脏起搏，心脏复律或除颤的适当治疗来响应人类患者的多种心律失常中的任何一种的检测。 第一个传感器检测是否发生了什么类型的心律失常。 发生器根据检测到的心律失常是一方面是心动过缓还是缓慢的病理性心动过速，另一方面产生快速心动过速或颤动，产生脉冲和/或冲击以递送到患者的心脏。 在休息和身体活动的条件下，器械中的优化器始终保持心脏起搏速率与植入物患者的血液动力学需求的实质性匹配; 包括感测和区分患者身体活动和休息的周期，以及产生代表其的信号以相应地控制心脏起搏速率。 以这种方式，该装置在心脏起搏问题变得充分恶化以前需要进行更积极的心脏复律和除颤疗法，其重点是矫正心脏起搏问题。