公开(公告)号：US07585271B2

公开(公告)日：2009-09-08

申请号：US10698131

申请日：2003-11-01

申请人： Martin T. Gerber ,  Warren L. Starkebaum ,  John M. Swoyer

发明人： Martin T. Gerber ,  Warren L. Starkebaum ,  John M. Swoyer

IPC分类号： A61F2/02

CPC分类号： A61B17/00234 ,  A61B17/06109 ,  A61B17/3478 ,  A61B90/39 ,  A61B2017/00805 ,  A61B2017/00898 ,  A61B2017/306 ,  A61F2/0036 ,  A61L31/145

摘要： In general, the invention is directed to treatment of urinary incontinence by the implantation of one or more bulking prostheses proximate to a urethral sphincter. These bulking prostheses, which may include biocompatible hydrogel, are implanted into the tissue outside the urethra, proximate to a urethral sphincter. When implanted, the bulking prostheses are in a miniature state. Upon introduction into the body, the devices enter an enlarged state. In their enlarged state, the bulking prostheses supply extra bulk to the tissues proximate to the external urethral sphincter. With the extra bulk, the patient can exercise voluntary control over the external urethral sphincter to close or maintain closure of the urethra and maintain urinary continence.

摘要翻译： 通常，本发明涉及通过植入靠近尿道括约肌的一个或多个膨胀假体来治疗尿失禁。 这些可能包括生物相容性水凝胶的膨胀假体植入尿道外侧的组织中，靠近尿道括约肌。 当植入时，膨胀假体处于微型状态。 引入身体后，设备进入放大状态。 在扩大的状态下，膨胀假体对靠近外部尿道括约肌的组织提供额外的体积。 随着额外的体积，患者可以对外部尿道括约肌进行自愿控制，以关闭或保持尿道闭合并维持尿路。

公开(公告)号：US07381180B2

公开(公告)日：2008-06-03

申请号：US10698216

申请日：2003-10-31

申请人： Martin T. Gerber ,  Warren L. Starkebaum ,  John M. Swoyer

发明人： Martin T. Gerber ,  Warren L. Starkebaum ,  John M. Swoyer

IPC分类号： A61F2/02

CPC分类号： A61F2/0036 ,  A61L31/145

摘要： In general, the invention is directed to treatment of fecal incontinence by the implantation of one or more bulking prostheses proximate to an anal sphincter. These bulking prostheses, which may include biocompatible hydrogel, are inserted into the tissue near the anus through a small opening in the mucosa. When inserted, the bulking prostheses are in a miniature state. Upon introduction into the body, the devices enter an enlarged state. In their enlarged state, the bulking prostheses supply extra bulk to the tissues proximate to the anal sphincters. With the extra bulk, the patient can exercise voluntary control over the external sphincter to close the anus and maintain fecal continence.

摘要翻译： 通常，本发明涉及通过植入靠近肛门括约肌的一个或多个膨胀假体来治疗大便失禁。 这些膨胀假体可以包括生物相容的水凝胶，通过粘膜中的小开口插入到肛门附近的组织中。 当插入时，膨胀假体处于微型状态。 引入身体后，设备进入放大状态。 在扩大的状态下，膨胀假体向靠近肛门括约肌的组织提供额外的体积。 随着额外的体积，患者可以对外括约肌进行自愿控制以闭合肛门并维持粪便的排列。

公开(公告)号：US08260436B2

公开(公告)日：2012-09-04

申请号：US10698291

申请日：2003-10-31

申请人： Martin T. Gerber ,  John M. Swoyer

发明人： Martin T. Gerber ,  John M. Swoyer

IPC分类号： A61N1/00

CPC分类号： A61N1/0558 ,  A61N1/05 ,  A61N1/0534

摘要： An implantable electrical stimulation lead includes an integrated fixation mechanism that expands upon implantation of the lead to fix the lead relative to a target tissue site, such as tissue within the epidural region proximate the spine or the sacral foramen. The fixation mechanism may include one or more expandable wire-like elements, which may be configured in a substantial helical shape. The wire-like elements may be formed from an elastic or super-elastic material, and expand radially outward when a restraint mechanism is removed following implantation of the lead.

摘要翻译： 植入式电刺激引线包括整体固定机构，其在植入引线时膨胀，以相对于目标组织部位固定引线，例如在靠近脊柱或骶骨孔的硬膜外区域内的组织。 固定机构可以包括一个或多个可扩展的线状元件，其可被构造成大致螺旋形状。 线状元件可以由弹性或超弹性材料形成，并且在植入引线之后去除约束机构时，径向向外扩张。

公开(公告)号：US08000805B2

公开(公告)日：2011-08-16

申请号：US11589407

申请日：2006-10-30

申请人： John M. Swoyer ,  Keith R. Carlton ,  Martin T. Gerber ,  George J. Mamo ,  Michele Spinelli ,  Steven D. Hartle

发明人： John M. Swoyer ,  Keith R. Carlton ,  Martin T. Gerber ,  George J. Mamo ,  Michele Spinelli ,  Steven D. Hartle

IPC分类号： A61N1/05

CPC分类号： A61N1/0558 ,  A61N1/0551

摘要： An implantable medical electrical lead particularly for stimulation of the sacral nerves comprises a lead body extending between a distal end and a proximal end, and the distal end having at least one electrode of an electrode array extending longitudinally from the distal end toward the proximal end. The lead body at its proximal end may be coupled to a pulse generator, additional intermediate wiring, or other stimulation device. A fixation mechanism is formed on or integrally with the lead body proximal to the electrode array that is adapted to be implanted in and engage subcutaneous tissue, particularly muscle tissue, to inhibit axial movement of the lead body and dislodgement of the stimulation electrodes.

摘要翻译： 特别是用于刺激骶神经的可植入医用电气引线包括在远端和近端之间延伸的引线体，并且远端具有从远端向近端纵向延伸的电极阵列的至少一个电极。 其近端的引线体可以耦合到脉冲发生器，附加的中间布线或其它刺激装置。 在与电极阵列接近的引线体上形成一体的固定机构，该固定机构适于被植入并接合皮下组织，特别是肌肉组织，以抑制引线体的轴向移动和刺激电极的移动。

公开(公告)号：US08036756B2

公开(公告)日：2011-10-11

申请号：US11352552

申请日：2006-02-13

申请人： John M. Swoyer ,  Martin T. Gerber ,  Keith Carlton ,  George J. Mamo ,  Michele Spinelli ,  Steven David Hartle

发明人： John M. Swoyer ,  Martin T. Gerber ,  Keith Carlton ,  George J. Mamo ,  Michele Spinelli ,  Steven David Hartle

IPC分类号： A61N1/05

CPC分类号： A61N1/0558 ,  A61N1/0551

摘要： An implantable medical electrical lead particularly for stimulation of the sacral nerves comprises a lead body extending between a distal end and a proximal end, and the distal end having at least one electrode of an electrode array extending longitudinally from the distal end toward the proximal end. The lead body at its proximal end may be coupled to a pulse generator, additional intermediate wiring, or other stimulation device. A fixation mechanism is formed on or integrally with the lead body proximal to the electrode array that is adapted to be implanted in and engage subcutaneous tissue, particularly muscle tissue, to inhibit axial movement of the lead body and dislodgement of the stimulation electrodes.

摘要翻译： 特别是用于刺激骶神经的可植入医用电气引线包括在远端和近端之间延伸的引线体，并且远端具有从远端向近端纵向延伸的电极阵列的至少一个电极。 其近端的引线体可以耦合到脉冲发生器，附加的中间布线或其它刺激装置。 在与电极阵列接近的引线体上形成一体的固定机构，该固定机构适于被植入并接合皮下组织，特别是肌肉组织，以抑制引线体的轴向移动和刺激电极的移动。

公开(公告)号：US20080188917A1

公开(公告)日：2008-08-07

申请号：US12099326

申请日：2008-04-08

申请人： Martin T. Gerber ,  John M. Swoyer

发明人： Martin T. Gerber ,  John M. Swoyer

IPC分类号： A61N1/05

CPC分类号： A61N1/0551 ,  A61N1/0558

摘要： An implantable medical lead for stimulation of the sacral nerves comprises a lead body which includes a distal end and a proximal end, and the distal end having at least one electrode contact extending longitudinally from the distal end toward the proximal end. The lead body at its proximal end may be coupled to a pulse generator, additional intermediate wiring, or other stimulation device. The electrode contact of the permanently implantable neurostimulation lead comprises an elongated, flexible, coiled wire or mesh electrode having an exposed electrode length that is adapted to be inserted through the foramen from a posterior access to locate the coiled wire electrode alongside the sacral nerve extending anteriorly and/or posteriorly therefrom. The coiled wire or mesh electrode structure is flexible and bendable to enable its placement through the foramen and alongside the sacral nerve and to conform to the surrounding nerves and tissue. Preferably, further shorter length electrodes are provided along the distal segment of the lead body to enable testing of the positioning of the elongated wire coil or mesh electrode or to provide alternate stimulation electrodes upon dislocation of the elongated wire coil or mesh electrode.

摘要翻译： 用于刺激骶神经的可植入医疗引线包括引线主体，其包括远端和近端，并且远端具有从远端朝向近端纵向延伸的至少一个电极接触。 其近端的引线体可以耦合到脉冲发生器，附加的中间布线或其它刺激装置。 永久可植入的神经刺激引线的电极接触包括细长的，柔性的，盘绕的线或网状电极，其具有暴露的电极长度，该电极长度适于从后路进入孔中插入孔，以将线圈电极定位在向前延伸的骶神经 和/或从其后面。 螺旋线或网状电极结构是柔性和可弯曲的，以使其能够穿过孔和骶神经旁边并且与周围的神经和组织一致。 优选地，沿着引线主体的远端部分提供更短的电极长度，以便能够测试细长的线圈或网状电极的定位，或者在细长的线圈或网状电极脱位时提供交替的刺激电极。

公开(公告)号：US07330764B2

公开(公告)日：2008-02-12

申请号：US10833761

申请日：2004-04-28

申请人： John M. Swoyer ,  Keith Carlton ,  Martin T. Gerber ,  George J. Mamo ,  Michele Spinelli ,  Steven David Hartle

发明人： John M. Swoyer ,  Keith Carlton ,  Martin T. Gerber ,  George J. Mamo ,  Michele Spinelli ,  Steven David Hartle

IPC分类号： A61N1/18

CPC分类号： A61N1/0558 ,  A61N1/0551

摘要： An implantable medical electrical lead particularly for stimulation of the sacral nerves comprises a lead body extending between a distal end and a proximal end, and the distal end having at least one electrode of an electrode array extending longitudinally from the distal end toward the proximal end. The lead body at its proximal end may be coupled to a pulse generator, additional intermediate wiring, or other stimulation device. A fixation mechanism is formed on or integrally with the lead body proximal to the electrode array that is adapted to be implanted in and engage subcutaneous tissue, particularly muscle tissue, to inhibit axial movement of the lead body and dislodgement of the stimulation electrodes. The fixation mechanism comprises a M tine elements arrayed in a tine element array along a segment of the lead proximal to the stimulation electrode array. Each tine element comprises at least N flexible, pliant, tines, each tine having a tine width and thickness and extending through a tine length from an attached tine end to a free tine end. The attached tine end is attached to the lead body from a tine attachment site and supports the tine extending outwardly of the lead body and proximally toward the lead proximal end. The M×N tines are adapted to be folded inward against the lead body when fitted into and constrained by the lumen of an introducer such that the tine free ends of more distal tines of more distal tine elements are urged toward or alongside the attached tine ends of the adjacent more proximal tines of more proximal tine elements, and the folded tines do not overlap one another.

摘要翻译： 特别是用于刺激骶神经的可植入医用电气引线包括在远端和近端之间延伸的引线体，并且远端具有从远端向近端纵向延伸的电极阵列的至少一个电极。 其近端的引线体可以耦合到脉冲发生器，附加的中间布线或其它刺激装置。 在与电极阵列接近的引线体上形成一体的固定机构，该固定机构适于被植入并接合皮下组织，特别是肌肉组织，以抑制引线体的轴向移动和刺激电极的移动。 固定机构包括沿着靠近刺激电极阵列的引线的段排列在齿元件阵列中的M元件。 每个齿元件包括至少N个柔性，柔韧的尖齿，每个齿具有齿的宽度和厚度并且延伸穿过齿长从附接的齿端延伸到游离齿端。 附着的尖端从齿附着位置附接到引线本体，并且支撑从引线主体向外延伸并向近端朝向引线近端的齿。 MxN齿适合于当插入导引器的内腔并被约束的引导体时向内折叠，使得更远端的尖齿元件的更远远的尖齿的齿自由端朝着或与其相连的齿端被推向 相邻的更接近的尖齿元件的近端齿，并且折叠的齿不相互重叠。

公开(公告)号：US07065412B2

公开(公告)日：2006-06-20

申请号：US10424032

申请日：2003-04-25

申请人： John M. Swoyer ,  Martin T. Gerber

发明人： John M. Swoyer ,  Martin T. Gerber

IPC分类号： A61N1/18

CPC分类号： A61N1/36071 ,  A61N1/36017 ,  A61N1/378 ,  A61N1/3787

摘要： The invention provides an implantable trial neurostimulator. The implantable trial neurostimulator may be equipped with limited, short-term battery resources. The limited battery resources are designed to last for a finite period of time, thereby preventing a patient or physician from prolonging the trial neurostimulation period. For example, the implantable trial neurostimulator may be designed to stop functioning after a number of days or weeks, upon exhaustion of the battery resources. Alternatively, the implantable trial neurostimulator may be disabled upon expiration of a timer. The trial neurostimulator may be temporarily implanted in a subdural pocket in which the chronic stimulator is ultimately implanted. In this manner, the trial neurostimulator can be coupled to a chronic lead and avoid any percutaneous connections, reducing the risk of infection and affording greater convenience and comfort to patients.

摘要翻译： 本发明提供一种可植入式试验神经刺激器。 可植入的试验神经刺激器可能配备有限的短期电池资源。 有限的电池资源被设计为持续有限的时间，从而防止患者或医师延长试验神经刺激期。 例如，可植入的试验神经刺激器可以设计成在耗尽电池资源之后几天或几周后停止运作。 或者，可以在定时器期满时禁用可植入的试验神经刺激器。 试验性神经刺激器可以临时植入到其中最终植入慢性刺激器的硬膜下袋中。 以这种方式，试验神经刺激器可以连接到慢性铅并且避免任何经皮连接，降低感染的风险并为患者提供更大的便利和舒适。

公开(公告)号：US08626314B2

公开(公告)日：2014-01-07

申请号：US13183289

申请日：2011-07-14

申请人： John M. Swoyer ,  Keith R. Carlton ,  Martin T. Gerber ,  George J. Mamo ,  Michele Spinelli ,  Steven D. Hartle

发明人： John M. Swoyer ,  Keith R. Carlton ,  Martin T. Gerber ,  George J. Mamo ,  Michele Spinelli ,  Steven D. Hartle

IPC分类号： A61N1/05

CPC分类号： A61N1/0558 ,  A61N1/0551

摘要： An implantable medical electrical lead comprises a lead body extending between a distal end and a proximal end, and the distal end having at least one electrode of an electrode array extending longitudinally from the distal end toward the proximal end. The lead body at its proximal end may be coupled to a pulse generator, additional intermediate wiring, or other stimulation device. A fixation mechanism is formed on or integrally with the lead body proximal to the electrode array that is adapted to be implanted in and engage subcutaneous tissue, particularly muscle tissue, to inhibit axial movement of the lead body and dislodgement of the stimulation electrodes. The fixation mechanism comprises a plurality of tine elements arrayed in a tine element array along a segment of the lead.

摘要翻译： 可植入医疗电引线包括在远端和近端之间延伸的引线主体，并且远端具有至少一个电极阵列的电极，该电极阵列从远端向近端纵向延伸。 其近端的引线体可以耦合到脉冲发生器，附加的中间布线或其它刺激装置。 在与电极阵列接近的引线体上形成一体的固定机构，该固定机构适于被植入并接合皮下组织，特别是肌肉组织，以抑制引线体的轴向移动和刺激电极的移动。 固定机构包括沿引线的一段排列在齿元件阵列中的多个齿元件。

公开(公告)号：US06876885B2

公开(公告)日：2005-04-05

申请号：US10046011

申请日：2002-01-11

申请人： John M. Swoyer ,  Warren Starkebaum ,  Martin T. Gerber ,  Tim Herbert

发明人： John M. Swoyer ,  Warren Starkebaum ,  Martin T. Gerber ,  Tim Herbert

IPC分类号： A61N1/05

CPC分类号： A61N1/05 ,  A61N1/0509 ,  A61N1/0551 ,  A61N1/0558

摘要： Bifurcated, active fixation, gastrointestinal leads adapted to be implanted within the body at a site of the GI tract to conduct electrical stimulation and electrical signals of the GI tract between the gastrointestinal stimulator and the site are disclosed. The GI tract lead has a lead body comprising a common lead body trunk extending from a lead body trunk proximal end to a junction with a first plurality of lead body legs that extend from the junction to a like first plurality of lead body leg distal ends. An electrode head is formed at each lead body leg distal end having a plate and supporting at least one stimulation/sense electrode and an active fixation mechanism, whereby a plurality of active fixation attachment mechanisms are supported by a like plurality of electrode heads. The plurality of electrode heads can be affixed by the fixation mechanism at a plurality of spaced apart locations of the GI tract. The plurality of electrode heads can be affixed spaced apart an optimal distance for efficacious sensing and/or stimulation accommodating the physiology and any defects or surgical interventions of the physiology or other therapeutic equipment or IMDs that restrict full access to the GI tract.

摘要翻译： 公开了分叉，活动固定，适于植入位于胃肠道部位的体内的胃肠道以进行胃肠道刺激器与部位之间的电刺激和胃肠道的电信号。 胃肠道引线具有引线体，该引线体包括从引线主体体近端延伸到与第一多个引线主体腿的连接处的公共引线体躯干，所述第一多个引线主体腿从连接处延伸到类似的第一多个引线主体腿部末端。 电极头形成在每个引线体腿部末端具有板并且支撑至少一个刺激/感测电极和主动固定机构，由此多个主动固定附接机构由相同的多个电极头支撑。 多个电极头可以通过定位机构在GI道的多个间隔开的位置处固定。 多个电极头可以被隔开一段最佳距离，用于有效的感测和/或刺激，以适应生理学以及限制完全进入胃肠道的生理学或其他治疗设备或IMD的任何缺陷或手术干预。