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1. 发明授权

US06735474B1 Implantable stimulator system and method for treatment of incontinence and pain 有权
标题翻译：植入式刺激器系统和治疗失禁和疼痛的方法
公开(公告)号：US06735474B1
公开(公告)日：2004-05-11
申请号：US09642979
申请日：2000-08-18
申请人： Gerald E. Loeb , Francis J. R. Richmond , Carla M. Mann , Michael A. Faltys , Todd K. Whitehurst , James P. McGivern
发明人： Gerald E. Loeb , Francis J. R. Richmond , Carla M. Mann , Michael A. Faltys , Todd K. Whitehurst , James P. McGivern
IPC分类号： A61N136
CPC分类号： A61N1/36007 , A61N1/36071 , A61N1/37205
摘要： A method and system for treatment of incontinence and/or pelvic pain includes the injection or laparoscopic implantation of one or more battery- or radio frequency-powered microstimulators (10) beneath the skin of the perineum and/or adjacent the tibial nerve. The devices are programmed using radio-frequency control via an external controller (20, 30)) that can be used by a physician to produce patterns of output stimulation pulses judged to be efficacious by appropriate clinical testing to diminish symptoms. The stimulation program is retained in the microstimulator device (10) or external controller (20) and is transmitted when commanded to start and stop by a signal from the patient or caregiver. The system and method reduce the incidence of unintentional episodes of bladder emptying by stimulating nerve pathways (8) that diminish involuntary bladder contractions, improve closure of the bladder outlet, and/or improve the long-term health of the urinary system by increasing bladder capacity and period between emptying. The incidence of fecal incontinence is similarly reduced or eliminated. Furthermore, the system and method reduce or eliminate the incidence of pelvic pain by chronically stimulating nerve pathways that derive from the sacral roots using a miniature implantable neurostimulator that can be implanted with a minimal surgical procedure. Moreover, the system and method allow a patient to be taught to receive one or more patterns of neural stimulation that can be prescribed by a physician and administered without continuous oversight by a clinical practitioner.
摘要翻译：用于治疗失禁和/或骨盆疼痛的方法和系统包括在会阴皮肤和/或邻近胫神经之下的一个或多个电池或射频激励微刺激器（10）的注射或腹腔镜植入。所述装置通过外部控制器（20,30）使用射频控制进行编程，所述外部控制器（20,30））可由医生用来产生通过适当的临床测试判断为有效的输出刺激脉冲的模式以减少症状。刺激程序被保留在微型刺激器装置（10）或外部控制器（20）中，并且在命令通过来自患者或看护者的信号启动和停止时被传送。该系统和方法通过刺激神经通路（8）减少膀胱排空的无意发作的发生率（8），通过增加膀胱容量来减少非自愿膀胱收缩，改善膀胱出口闭合和/或改善泌尿系统的长期健康和排空之间的时期。大便失禁的发生率同样减少或消除。此外，该系统和方法通过使用可以以最小外科手术植入的微型可植入神经刺激器来减少或消除由骶根引起的长期刺激神经通路的盆腔疼痛的发生。此外，该系统和方法允许患者接受一种或多种神经刺激模式，其可由医师处方并由临床医师进行无持续监督。

2. 发明授权

US06941171B2 Implantable stimulator methods for treatment of incontinence and pain 有权
标题翻译：用于治疗失禁和疼痛的植入式刺激器方法
公开(公告)号：US06941171B2
公开(公告)日：2005-09-06
申请号：US09931804
申请日：2001-08-16
申请人： Carla M. Mann , Todd K. Whitehurst , James P. McGivern , Gerald E. Loeb , Frances J. R. Richmond
发明人： Carla M. Mann , Todd K. Whitehurst , James P. McGivern , Gerald E. Loeb , Frances J. R. Richmond
IPC分类号： A61N1/00 , A61N1/34 , A61N1/36 , A61N1/372
CPC分类号： A61N1/36007 , A61N1/36017 , A61N1/36071 , A61N1/37205
摘要： A method and system for treatment of incontinence, urgency, frequency, and/or pelvic pain includes implantation of electrodes on a lead or the discharge portion of a catheter adjacent the perineal nerve(s) or tissue(s) to be stimulated. Stimulation pulses, either electrical or drug infusion pulses, are supplied by a stimulator implanted remotely, and through the lead or catheter, which is tunneled subcutaneously between the stimulator and stimulation site. For instance, the system and method reduce or eliminate the incidence of unintentional episodes of bladder emptying by stimulating nerve pathways that diminish involuntary bladder contractions, improve closure of the bladder outlet, and/or improve the long-term health of the urinary system by increasing bladder capacity and period between emptying. Moreover, the system and method allow a patient to be taught to receive one or more patterns of neural stimulation that can be prescribed by a physician and administered without continuous oversight by a clinical practitioner.
摘要翻译：用于治疗失禁，紧迫性，频率和/或骨盆疼痛的方法和系统包括将电极植入导联或导管的排出部分，邻近会阴神经或要刺激的组织。刺激脉冲（电或药物输注脉冲）由远程植入的刺激器和通过刺激器和刺激部位之间皮下隧道穿过的导联或导管提供。例如，该系统和方法通过刺激神经通路降低或消除膀胱排空的无意发作，从而减少无意识的膀胱收缩，改善膀胱出口的闭合，和/或通过增加泌尿系统的长期健康来改善膀胱容量和排空期间。此外，该系统和方法允许患者接受一种或多种神经刺激模式，其可由医师处方并由临床医师进行无持续监督。

3. 发明授权

US08214048B1 Fully implantable neurostimulator for autonomic nerve fiber stimulation as a therapy for urinary and bowel dysfunction 有权
标题翻译：用于自主神经纤维刺激的完全植入式神经刺激器作为尿和肠功能障碍的治疗
公开(公告)号：US08214048B1
公开(公告)日：2012-07-03
申请号：US11373756
申请日：2006-03-10
申请人： Todd K. Whitehurst , James P. McGivern , Carla M. Mann
发明人： Todd K. Whitehurst , James P. McGivern , Carla M. Mann
IPC分类号： A61N1/00 , A61B5/04
CPC分类号： A61N1/36007
摘要： An implantable stimulator(s), small enough to be located near or adjacent to an autonomic nerve(s) innervating urinary and/or gastrointestinal structures, uses a power source/storage device, such as a rechargeable battery. Periodic recharging of such a power source/storage device is accomplished, for example, by inductive coupling with an external appliance. The small stimulator provides a means of stimulating a nerve(s) or other tissue when desired, without the need for external appliances during the stimulation session. When necessary, external appliances are used for the transmission of data to and/or from the stimulator(s) and for the transmission of power, if necessary. In a preferred embodiment, the system is capable of open- and closed-loop operation. In closed-loop operation, at least one implant includes at least one sensor, and the sensed condition is used to adjust stimulation parameters.
摘要翻译：小到足以位于支配尿和/或胃肠结构的自主神经附近或邻近的可植入刺激器使用诸如可再充电电池的电源/存储装置。这样的电源/存储装置的定期再充电例如通过与外部电器的感应耦合来实现。小刺激器提供了在需要时刺激神经或其他组织的手段，而不需要在刺激期间的外部器具。必要时，如果需要，外部设备用于向刺激器传送数据和/或从刺激器传输数据。在优选实施例中，系统能够进行开环和闭环操作。在闭环操作中，至少一个植入物包括至少一个传感器，并且所感测到的条件用于调整刺激参数。

4. 发明授权

US08588917B2 Fully implantable neurostimulator for autonomic nerve fiber stimulation as a therapy for urinary and bowel dysfunction 失效
标题翻译：用于自主神经纤维刺激的完全植入式神经刺激器作为尿和肠功能障碍的治疗
公开(公告)号：US08588917B2
公开(公告)日：2013-11-19
申请号：US13493753
申请日：2012-06-11
申请人： Todd K. Whitehurst , James P. McGivern , Carla M. Mann
发明人： Todd K. Whitehurst , James P. McGivern , Carla M. Mann
IPC分类号： A61N1/00 , A61B5/103
CPC分类号： A61N1/36007
摘要： An implantable stimulator(s), small enough to be located near or adjacent to an autonomic nerve(s) innervating urinary and/or gastrointestinal structures, uses a power source/storage device, such as a rechargeable battery. Periodic recharging of such a power source/storage device is accomplished, for example, by inductive coupling with an external appliance. The small stimulator provides a means of stimulating a nerve(s) or other tissue when desired, without the need for external appliances during the stimulation session. When necessary, external appliances are used for the transmission of data to and/or from the stimulator(s) and for the transmission of power, if necessary. In a preferred embodiment, the system is capable of open- and closed-loop operation. In closed-loop operation, at least one implant includes at least one sensor, and the sensed condition is used to adjust stimulation parameters.
摘要翻译：小到足以位于支配尿和/或胃肠结构的自主神经附近或邻近的可植入刺激器使用诸如可再充电电池的电源/存储装置。这样的电源/存储装置的定期再充电例如通过与外部电器的感应耦合来实现。小刺激器提供了在需要时刺激神经或其他组织的手段，而不需要在刺激期间的外部器具。必要时，如果需要，外部设备用于向刺激器传送数据和/或从刺激器传输数据。在优选实施例中，系统能够进行开环和闭环操作。在闭环操作中，至少一个植入物包括至少一个传感器，并且所感测到的条件用于调整刺激参数。

5. 发明授权

US06871099B1 Fully implantable microstimulator for spinal cord stimulation as a therapy for chronic pain 有权
标题翻译：用于脊髓刺激的完全可植入的微刺激作为慢性疼痛的治疗
公开(公告)号：US06871099B1
公开(公告)日：2005-03-22
申请号：US09929597
申请日：2001-08-13
申请人： Todd K. Whitehurst , James P. McGivern , Carla M. Mann , Janusz A. Kuzma
发明人： Todd K. Whitehurst , James P. McGivern , Carla M. Mann , Janusz A. Kuzma
IPC分类号： A61N1/34 , A61N1/18
CPC分类号： A61N1/36071
摘要： An implantable stimulator(s), small enough to be located near or within an area of the spine responsible for sensations in a region experiencing chronic pain uses a power source/storage device, such as a rechargeable battery. Periodic recharging of such a power source/storage device is accomplished, for example, by inductive coupling with an external appliance. The small stimulator provides a means of stimulating a nerve(s) or other tissue when desired, without the need for external appliances during the stimulation session. When necessary, external appliances are used for the transmission of data to and/or from the stimulator(s) and for the transmission of power, it necessary. In a preferred embodiment, the system is capable of open- and closed-loop operation. In closed-loop operation, at least one implant includes at least one sensor, and the sensed condition is used to adjust stimulation parameters.
摘要翻译：小到足以位于脊柱区域内的负责在慢性疼痛区域感觉的植入式刺激器使用诸如可再充电电池的电源/存储装置。这样的电源/存储装置的定期再充电例如通过与外部电器的感应耦合来实现。小刺激器提供了在需要时刺激神经或其他组织的手段，而不需要在刺激期间的外部器具。必要时，必须使用外部设备将数据传送到和/或从激励器传输，并传输电力。在优选实施例中，系统能够进行开环和闭环操作。在闭环操作中，至少一个植入物包括至少一个传感器，并且所感测到的条件用于调整刺激参数。

6. 发明授权

US06605094B1 Integrated subcutaneous tunneling and carrying tool 有权
标题翻译：综合皮下隧道和携带工具
公开(公告)号：US06605094B1
公开(公告)日：2003-08-12
申请号：US09702422
申请日：2000-10-31
申请人： Carla M. Mann , Kenny K. Chinn
发明人： Carla M. Mann , Kenny K. Chinn
IPC分类号： A61B1900
CPC分类号： A61B17/3415 , A61B17/3401 , A61B2017/320044 , A61N1/0551
摘要： A subcutaneous tunneling and carrying tool has a handle, a rod, and a carrier. The tool is used in connection with the implantation of electrical stimulators within the body, and more particularly facilitates the surgical procedure in the connection of an electrode lead extension to the implantable stimulator when the electrode and stimulator may not be co-located. In one embodiment, tunneling is accomplished by a tip that also serves to connect the tool to a disposable carrier in which the lead extension connector is packaged. In another embodiment the carrier comprises a carrier body and a removable cover, wherein the carrier cover covers a carrier cavity during tunneling and includes a tunneling end, and the carrier cover is removed after tunneling to expose the carrier cavity, into which carrier cavity the electrode lead extension is inserted to carry back through the tunnel.
摘要翻译：皮下隧道和携带工具具有手柄，杆和载体。该工具用于在体内植入电刺激器，并且当电极和刺激器可能不位于同一位置时，更特别地便于将电极引线延伸部连接到可植入刺激器的外科手术。在一个实施例中，通过尖端实现隧道掘进，该尖端还用于将工具连接到一次性载体中，其中引线延伸连接器被封装在该一次性载体中。在另一个实施例中，载体包括载体主体和可移除盖，其中载体覆盖物在隧穿期间覆盖载体空腔并且包括隧道端，并且在隧穿之后移除载体盖以暴露载体腔，载体腔中的电极插入导线延长线穿过隧道。

7. 发明授权

US06553263B1 Implantable pulse generators using rechargeable zero-volt technology lithium-ion batteries 有权
标题翻译：使用可充电零伏技术的锂离子电池的可植入脉冲发生器
公开(公告)号：US06553263B1
公开(公告)日：2003-04-22
申请号：US09627803
申请日：2000-07-28
申请人： Paul M. Meadows , Carla M. Mann , Hisashi Tsukamoto , Joey Chen
发明人： Paul M. Meadows , Carla M. Mann , Hisashi Tsukamoto , Joey Chen
IPC分类号： A61N140
CPC分类号： A61N1/3787 , A61N1/08 , A61N1/36071
摘要： An implantable medical device, such as an implantable pulse generator (IPG) used with a spinal cord stimulation (SCS) system, includes a rechargeable lithium-ion battery having an anode electrode with a substrate made substantially from titanium. Such battery construction allows the rechargeable battery to be discharged down to zero volts without damage to the battery. The implantable medical device includes battery charging and protection circuitry that controls the charging of the battery so as to assure its reliable and safe operation. A multi-rate charge algorithm is employed that minimizes charging time while ensuring the battery cell is safely charged. Fast charging occurs at safer lower battery voltages (e.g., battery voltage above about 2.5 V), and slower charging occurs when the battery nears full charge higher battery voltages (e.g., above about 4.0 V). When potentially less-than-safe very low voltages are encountered (e.g., less than 2.5 V), then very slow (trickle) charging occurs to bring the battery voltage back up to the safer voltage levels where more rapid charging can safely occur. The battery charging and protection circuitry also continuously monitors the battery voltage and current. If the battery operates outside of a predetermined range of voltage or current, the battery protection circuitry disconnects the battery from the particular fault, i.e. charging circuitry or load circuits.
摘要翻译：诸如与脊髓刺激（SCS）系统一起使用的可植入脉冲发生器（IPG）的可植入医疗装置包括具有阳极电极的可再充电锂离子电池，其具有基本上由钛制成的衬底。这种电池结构允许可再充电电池被放电到零伏特而不损坏电池。可植入医疗装置包括电池充电和保护电路，其控制电池的充电，以确保其可靠和安全的操作。使用多速率充电算法，其最小化充电时间，同时确保电池单元被安全地充电。快速充电发生在更安全的较低的电池电压（例如，电池电压高于约2.5V）时，并且当电池接近充满更高的电池电压（例如高于约4.0V）时，发生较慢的充电。当遇到潜在的不太安全的非常低的电压（例如，小于2.5V）时，发生非常慢的（涓流）充电，以使电池电压恢复到更安全的电压水平，其中可以安全地发生更快速的充电。电池充电和保护电路还连续监测电池电压和电流。如果电池在预定的电压或电流范围之外运行，则电池保护电路将电池与特定故障（即充电电路或负载电路）断开连接。

8. 发明授权

US06381496B1 Parameter context switching for an implanted device 有权
标题翻译：植入设备的参数上下文切换
公开(公告)号：US06381496B1
公开(公告)日：2002-04-30
申请号：US09668925
申请日：2000-09-25
申请人： Paul M. Meadows , Carla M. Mann
发明人： Paul M. Meadows , Carla M. Mann
IPC分类号： A61N108
CPC分类号： A61N1/08
摘要： An implant device provides context switching, meaning the ability to change one set of operational parameters for another. The implant device is controlled by a set of operational parameters. The patient may swap the current set of operational parameters with another set of operational parameters. Further, the implant device may include a time-of-day clock, and/or a sensor, and is configured to automatically change its operational parameters from one set of operational parameters to another at certain times of the day, week, or month, or upon the occurrence of certain prescribed events. In one embodiment, the patient may define selected operational parameters within a new set of operational parameters for use with the implant device, providing such patient-defined parameters remain within set limits. The ability to change the current operational parameter set (OPS) is achieved, in a first embodiment, by including memory circuitry within the implant device wherein a plurality of OPS's are stored. Upon receipt of an appropriate command, manually provided by the patient user through a hand-help programmer, or automatically generated by time-of-day or sensor circuits within the implant device, the current OPS is exchanged by another OPS. In a second embodiment, a plurality of OPS's are externally stored, e.g., in a hand-held programming device, and only the currently-used OPS is stored in the implant device. Changes to the OPS are made by transmitting the replacement OPS to the implant device through a telemetry link established with the implant device from the hand-held programming device. When the patient wishes to change the OPS, he manually activates the appropriate controls on the hand-held programming device, and such activation causes the new OPS to be telemetered to the implant device, where it replaces the current OPS.
摘要翻译：植入装置提供上下文切换，意味着改变另一组操作参数的能力。植入装置由一组操作参数控制。患者可以用另一组操作参数来交换当前的一组操作参数。此外，植入装置可以包括日时钟和/或传感器，并且被配置为在白天，周或月的某些时间自动地将其操作参数从一组操作参数改变到另一组，或发生某些规定事件时。在一个实施例中，患者可以在新的一组操作参数内定义所选择的操作参数，以便与植入装置一起使用，从而提供这样的患者定义的参数保持在设定的限度内。在第一实施例中，通过在存储多个OPS的植入装置内包括存储器电路来实现改变当前操作参数集（OPS）的能力。当接收到由患者用户通过手助程序员手动提供或由植入装置内的时间或传感器电路自动产生的适当命令时，当前OPS由另一OPS交换。在第二实施例中，多个OPS被外部存储在例如手持编程设备中，并且只有当前使用的OPS被存储在植入装置中。通过从手持编程设备通过植入装置建立的遥测链路将替换OPS发送到植入装置来进行对OPS的改变。当患者希望改变OPS时，他手动激活手持编程设备上的适当控制，并且这种激活使得新的OPS被遥测到植入装置，其中它替代当前的OPS。

9. 发明授权

US07004948B1 Cranial sealing plug 有权
公开(公告)号：US07004948B1
公开(公告)日：2006-02-28
申请号：US10052331
申请日：2002-01-18
申请人： Anne M. Pianca , Carla M. Mann , Tom Xiaohai He , Michael Dogali
发明人： Anne M. Pianca , Carla M. Mann , Tom Xiaohai He , Michael Dogali
IPC分类号： A61B19/00 , A61B5/04 , A61N1/00
CPC分类号： A61N1/0539 , A61B17/3462 , A61B90/11 , A61B2017/3419 , A61B2090/103 , A61F2/2875 , A61N1/0534
摘要： Various embodiments of a burr hole plug assembly offer significant improvements for allowing lead and/or cannula access through a burr hole drilled through a patient's skull in connection with a Deep Brain Stimulation system, and subsequent sealing of such burr hole. The various burr hole plug assemblies described: (a) accommodate various burr hole sizes and provide a secure fit in the burr hole; (b) accommodate various locations for lead positioning and adjustment; (c) allow the lead to remain in a static position when the burr hole plug assembly is placed; (d) protect the lead from fracture at the exit location of the plug; (e) remain flush with the skull to avoid skin erosion and to eliminate unsightly flange protrusion from the patients' skull; (f) adequately hold the lead in place over time; and (g) provide a selection of various types of burr hole plug assemblies and sizes for use by the implanting surgeon, thereby eliminating the need for surgeons to resort to custom plugs and plug assemblies made in the operating room specifically to fit a given patient.

10. 发明授权

US06920359B2 Deep brain stimulation system for the treatment of Parkinson's Disease or other disorders 有权
标题翻译：深脑刺激系统用于治疗帕金森病或其他疾病
公开(公告)号：US06920359B2
公开(公告)日：2005-07-19
申请号：US09936803
申请日：2001-01-12
申请人： Paul M. Meadows , Carla M. Mann
发明人： Paul M. Meadows , Carla M. Mann
IPC分类号： A61N1/05 , A61N1/36
CPC分类号： A61N1/36082 , A61N1/0534 , A61N1/0539
摘要： A deep brain stimulation (DBS) system (10) provides a multiplicity of stimulation channels through which stimulation may be delivered deep within the brain of the patient. The DBS system is powered by a rechargeable battery (27). In one embodiment, the system has four channels driving sixteen electrodes (32). The DBS system is easily programmed for use by a clinician using a clinician programming system (60), and further affords a simple but highly advanced hand held programmer (50) control interface through which the patient may easily change stimulation parameters within acceptable limits. The DBS system (10) includes a small, implantable pulse generator (20) that is small enough to be implanted directly in the cranium of the patient, thereby eliminating the long lead wires and tunneling procedures that have been used in the past. Further, the DBS system allows up to two electrode arrays (30, 30′) to be attached to the implantable pulse generator (20), thereby eliminating the requirement for implanting two independent implantable pulse generators for bilateral stimulation of deep brain structures.
摘要翻译：深部脑刺激（DBS）系统（10）提供了多种刺激通道，通过该刺激通道刺激可以在患者的脑部深处递送。 DBS系统由可充电电池（27）供电。在一个实施例中，系统具有驱动十六个电极（32）的四个通道。 DBS系统易于编程以供临床医生使用临床医师编程系统（60）使用，并进一步提供简单但高度先进的手持编程器（50）控制接口，通过该控制接口，患者可以容易地将刺激参数改变到可接受的限度内。 DBS系统（10）包括小到可植入的脉冲发生器（20），该脉冲发生器（20）足够小以直接植入患者的颅骨中，从而消除过去已经使用的长引线和隧道过程。此外，DBS系统允许多达两个电极阵列（30,30'）附接到可植入脉冲发生器（20），从而消除了植入两个独立的可植入脉冲发生器用于双侧刺激深部脑结构的要求。

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