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。

公开(公告)号：US06901294B1

公开(公告)日：2005-05-31

申请号：US10133771

申请日：2002-04-26

申请人： Todd K. Whitehurst ,  James P. McGivern ,  Janusz A. Kuzma

发明人： Todd K. Whitehurst ,  James P. McGivern ,  Janusz A. Kuzma

IPC分类号： A61N1/08 ,  A61N1/20 ,  A61N1/32 ,  A61N1/36 ,  A61N1/372

CPC分类号： A61N1/36007 ,  A61N1/37205

摘要： A small implantable stimulator(s) includes at least two electrodes for delivering electrical stimulation to surrounding tissue. The small stimulator provides means of stimulating the prostate with direct electrical current, such as relatively low-level direct current, without the need for external appliances during the stimulation session. The stimulator may be configured to be small enough to be implanted entirely within the prostate. Open- and closed-loop systems are disclosed.

摘要翻译： 一个小的植入式刺激器包括至少两个用于向周围组织传递电刺激的电极。 小型刺激器提供了在直接电流（例如相对低水平的直流）刺激前列腺的手段，而在刺激期间不需要外部装置。 刺激器可以被配置为足够小以完全植入前列腺。 公开了开环和闭环系统。

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。

公开(公告)号：US06582441B1

公开(公告)日：2003-06-24

申请号：US09761934

申请日：2001-01-17

申请人： Tom Xiaohai He ,  James P. McGivern ,  Todd K. Whitehurst

发明人： Tom Xiaohai He ,  James P. McGivern ,  Todd K. Whitehurst

IPC分类号： A61B1900

CPC分类号： A61N1/05 ,  A61N1/0551

摘要： A tool is provided for facilitating determining a proper location for an implantable device or medication, and for then delivering the implant to the precise location determined with the tool. To determine the target location, the tool may include a component for testing target locations, such as a stimulating probe for simulating a miniature implantable stimulator. In one embodiment, the tool is used to test a miniature implantable stimulator prior to depositing the implant precisely at the target location. The components of the tool are configured to maintain the implant at the target location while the tool is withdrawn. In one embodiment, a push rod assembly of the tool keeps the implant in position while it retracts the implant holder from around the implant. The ergonomic and light-weight tool leads to reduced surgical time, number and size of incisions, risk of infection, and likelihood of error.

摘要翻译： 提供了一种用于便于确定可植入装置或药物的适当位置的工具，然后将植入物递送到由工具确定的精确位置。 为了确定目标位置，该工具可以包括用于测试目标位置的部件，例如用于模拟微型可植入刺激器的刺激探针。 在一个实施例中，该工具用于在将植入物精确地放置在目标位置之前测试微型可植入刺激器。 该工具的组件被配置为在撤回工具时将植入物保持在目标位置。 在一个实施例中，该工具的推杆组件将植入物保持在适当位置，同时使植入物保持器从植入物周围缩回。 符合人体工程学和轻量级工具可减少手术时间，切口数量和大小，感染风险和误差的可能性。

公开(公告)号：US09409028B2

公开(公告)日：2016-08-09

申请号：US13546873

申请日：2012-07-11

申请人： Todd K. Whitehurst ,  Rafael Carbunaru ,  Kerry Bradley ,  James P. McGivern ,  Matthew I. Haller ,  Tom Xiaohai He ,  Janusz A. Kuzma

发明人： Todd K. Whitehurst ,  Rafael Carbunaru ,  Kerry Bradley ,  James P. McGivern ,  Matthew I. Haller ,  Tom Xiaohai He ,  Janusz A. Kuzma

IPC分类号： A61N1/372 ,  A61N1/05 ,  A61N1/36

CPC分类号： A61N1/37217 ,  A61N1/0556 ,  A61N1/36071 ,  A61N1/37205 ,  A61N1/37288

摘要： Miniature implantable stimulators (i.e., microstimulators) with programmably configurable electrodes allow, among other things, steering of the electric fields created. In addition, the microstimulators are capable of producing unidirectionally propagating action potentials (UPAPs).

摘要翻译： 具有可编程可配置电极的微型可植入刺激器（即，微型激励器）除了别的以外还允许所产生的电场的转向。 此外，微型激励器能够产生单向传播动作电位（UPAP）。

公开(公告)号：US08401634B2

公开(公告)日：2013-03-19

申请号：US12873170

申请日：2010-08-31

申请人： Todd K. Whitehurst ,  James P. McGivern ,  Kelly H. McClure

发明人： Todd K. Whitehurst ,  James P. McGivern ,  Kelly H. McClure

IPC分类号： A61N1/00

CPC分类号： A61M5/14276 ,  A61K9/0085 ,  A61M2205/3523 ,  A61M2205/3569 ,  A61M2210/0693 ,  A61N1/0529 ,  A61N1/0534 ,  A61N1/325 ,  A61N1/36082 ,  A61N1/37205

摘要： Systems for treating a movement disorder include a system control unit configured to be implanted at least partially within a patient and to generate at least one stimulus in accordance with one or more stimulation parameters adjusted to treat the movement disorder. The systems further include a programmable memory unit in communication with the system control unit and programmed to store the one or more stimulation parameters to at least partially define the stimulus such that the stimulus is configured to treat the movement disorder. A means for applying the stimulus to one or more stimulation sites within the patient is operably connected to the system control unit.

摘要翻译： 用于治疗运动障碍的系统包括系统控制单元，该系统控制单元被配置为至少部分地植入患者体内，并根据被调整以治疗运动障碍的一个或多个刺激参数产生至少一个刺激。 系统还包括与系统控制单元通信的可编程存储器单元，并被编程为存储一个或多个刺激参数以至少部分地限定刺激，使得刺激被配置为治疗运动障碍。 将刺激施加到患者体内的一个或多个刺激部位的手段可操作地连接到系统控制单元。

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。

公开(公告)号：US08204595B2

公开(公告)日：2012-06-19

申请号：US12207184

申请日：2008-09-09

申请人： Anne M. Pianca ,  Todd K. Whitehurst ,  James P. McGivern

发明人： Anne M. Pianca ,  Todd K. Whitehurst ,  James P. McGivern

IPC分类号： A61N1/375

CPC分类号： H01R43/16 ,  A61N1/05 ,  H01R13/5224 ,  Y10T29/49204

摘要： A lead assembly for a small implantable medical device (a.k.a, microdevice 10) provides means to attach a remote electrode to microdevice, which means inhibit fluid ingress when microdevice is not attached to lead assembly. Microdevices may provide either or both tissue stimulation and sensing. Known microdevices include spaced apart electrodes on the outer surface of the microdevice. Lead assembly includes an insulated lead including a proximal end and a distal end, with at least one conductor therebetween; at least one electrode at the distal end of the lead and electrically connected to the at least one conductor, and a connector attached to the proximal end of the lead and adapted to be removably connectable to microdevice. Connector includes at least one contact to electrically connect at least one device electrode on microdevice to at least one conductor, thereby electrically connecting at least electrode and the at least one electrode at the distal end of lead. Lead assembly is configured to inhibit fluid ingress into the connector. A number of embodiments of the invention, capable of inhibiting fluid ingress into connector, are taught.

摘要翻译： 用于小型可植入医疗装置（a.k.a，微器件10）的引线组件提供将远程电极附接到微器件的装置，这意味着当微器件未附接到引线组件时抑制流体进入。 微器件可以提供组织刺激和感测之一或两者。 已知的微器件在微器件的外表面上包括间隔开的电极。 引线组件包括绝缘引线，其包括近端和远端，其间具有至少一个导体; 在所述引线的远端处的至少一个电极并且电连接到所述至少一个导体，以及连接到所述引线的近端并适于可移除地连接到微器件的连接器。 连接器包括至少一个接触件，用于将微器件上的至少一个器件电极电连接到至少一个导体，由此至少电极和至少一个电极在铅的远端处电连接。 引线组件被配置为抑制流体进入连接器。 教导了能够抑制流体进入连接器的本发明的许多实施例。

公开(公告)号：US20110152988A1

公开(公告)日：2011-06-23

申请号：US13036278

申请日：2011-02-28

申请人： Todd K. Whitehurst ,  James P. McGivern ,  Rafael Carbunaru ,  Matthew I. Haller ,  Tom Xiaohai He ,  Kerry Bradley

发明人： Todd K. Whitehurst ,  James P. McGivern ,  Rafael Carbunaru ,  Matthew I. Haller ,  Tom Xiaohai He ,  Kerry Bradley

IPC分类号： A61N1/05

CPC分类号： A61N1/0556 ,  A61N1/0551 ,  A61N1/36071 ,  A61N1/37205

摘要： Methods of using unidirectionally propagating action potentials (UPAPs) for cavernous nerve stimulation and for certain disorders are provided. Stimulators capable of creating such UPAPs include, but are not limited to, miniature implantable stimulators (i.e., microstimulators), possibly with programmably configurable electrodes.

摘要翻译： 提供了使用单向传播动作电位（UPAP）用于海绵神经刺激和某些疾病的方法。 能够产生这种UPAP的刺激器包括但不限于微型可植入刺激器（即，微型刺激器），可能具有可编程配置的电极。

公开(公告)号：US07925353B1

公开(公告)日：2011-04-12

申请号：US11374799

申请日：2006-03-13

申请人： Todd K. Whitehurst ,  James P. McGivern

发明人： Todd K. Whitehurst ,  James P. McGivern

IPC分类号： A61N1/08 ,  A61N1/00

CPC分类号： A61N1/3787 ,  A61N1/36003

摘要： Introducing one or more stimulating drugs to the vagus nerve and/or one or more branches of the vagus nerve to treat movement disorders uses at least one implantable system control unit (SCU) with an implantable pump with at least one infusion outlet. Optional electrical stimulation may additionally be supplied by an implantable signal/pulse generator (IPG) with one or more electrodes. In certain embodiments, a single SCU provides one or more stimulating drugs and the optional electrical stimulation. In some embodiments, one or more sensed conditions are used to adjust stimulation parameters.

摘要翻译： 向迷走神经和/或迷走神经的一个或多个分支引入一种或多种刺激性药物以治疗运动障碍使用具有至少一个输注出口的可植入泵的至少一个可植入系统控制单元（SCU）。 可选的电刺激可另外由具有一个或多个电极的可植入信号/脉冲发生器（IPG）提供。 在某些实施方案中，单个SCU提供一种或多种刺激性药物和任选的电刺激。 在一些实施例中，使用一个或多个感测到的条件来调整刺激参数。