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：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：US20110270269A1

公开(公告)日：2011-11-03

申请号：US13183289

申请日：2011-07-14

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

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

IPC分类号： A61N1/05 ,  A61B19/00

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：US06999819B2

公开(公告)日：2006-02-14

申请号：US10004732

申请日：2001-11-09

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

发明人： John Matthew Swoyer ,  Keith Carlton ,  Martin T. Gerber ,  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. 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.

公开(公告)号：US20080125844A1

公开(公告)日：2008-05-29

申请号：US12023817

申请日：2008-01-31

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

发明人： John Matthew Swoyer ,  Keith Carlton ,  Martin T. Gerber ,  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. 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：US20050060014A1

公开(公告)日：2005-03-17

申请号：US10833761

申请日：2004-04-28

申请人： John Swoyer ,  Keith Carlton ,  Martin Gerber ,  George Mamo ,  Michele Spinelli ,  Steven Hartle

发明人： John Swoyer ,  Keith Carlton ,  Martin Gerber ,  George Mamo ,  Michele Spinelli ,  Steven 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. 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：US20060129218A1

公开(公告)日：2006-06-15

申请号：US11352552

申请日：2006-02-13

申请人： John Swoyer ,  Keith Carlton ,  Martin Gerber ,  George Mamo ,  Michele Spinelli ,  Steven Hartle

发明人： John Swoyer ,  Keith Carlton ,  Martin Gerber ,  George Mamo ,  Michele Spinelli ,  Steven 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. 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.

公开(公告)号：US20070050004A1

公开(公告)日：2007-03-01

申请号：US11589407

申请日：2006-10-30

申请人： John Swoyer ,  Keith Carlton ,  Martin Gerber ,  George Mamo ,  Michele Spinelli ,  Steven Hartle

发明人： John Swoyer ,  Keith Carlton ,  Martin Gerber ,  George Mamo ,  Michele Spinelli ,  Steven Hartle

IPC分类号： A61N1/00

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：US20050240238A1

公开(公告)日：2005-10-27

申请号：US11042807

申请日：2005-01-25

申请人： George Mamo ,  Michele Spinelli ,  John Swoyer ,  Martin Gerber ,  Keith Carlton

发明人： George Mamo ,  Michele Spinelli ,  John Swoyer ,  Martin Gerber ,  Keith Carlton

IPC分类号： A61N1/05 ,  A61N1/08

CPC分类号： A61N1/0551 ,  A61N1/08

摘要： Methods and apparatus for implanting a stimulation lead in a patient's sacrum to deliver neurostimulation therapy that can reduce patient surgical complications, reduce patient recovery time, and reduce healthcare costs. A surgical instrumentation kit for minimally invasive implantation of a sacral stimulation lead through a foramen of the sacrum in a patient to electrically stimulate a sacral nerve comprises a needle and a dilator and optionally includes a guide wire. The needle is adapted to be inserted posterior to the sacrum through an entry point and guided into a foramen along an insertion path to a desired location. In one variation, a guide wire is inserted through a needle lumen, and the needle is withdrawn. The insertion path is dilated with a dilator inserted over the needle or over the guide wire to a diameter sufficient for inserting a stimulation lead, and the needle or guide wire is removed from the insertion path. The dilator optionally includes a dilator body and a dilator sheath fitted over the dilator body. The stimulation lead is inserted to the desired location through the dilator body lumen or the dilator sheath lumen after removal of the dilator body, and the dilator sheath or body is removed from the insertion path. If the clinician desires to separately anchor the stimulation lead, an incision is created through the entry point from an epidermis to a fascia layer, and the stimulation lead is anchored to the fascia layer. The stimulation lead can be connected to the neurostimulator to delivery therapies to treat pelvic floor disorders such as urinary control disorders, fecal control disorders, sexual dysfunction, and pelvic pain.

摘要翻译： 用于将刺激引线植入患者骶骨中的方法和装置，以提供可减少患者手术并发症，减少患者恢复时间并降低医疗成本的神经刺激疗法。 用于微创植入骶骨刺激的手术器械套件穿过患者骶骨的孔以电刺激骶神经包括针和扩张器，并且可选地包括引导线。 针适于通过入口点插入到骶骨后面并且沿着插入路径被引导到孔中到期望的位置。 在一个变型中，引导线穿过针管内腔，并且针被抽出。 插入路径用插入针上或导丝上的扩张器扩张到足以插入刺激引线的直径，并且将针或导丝从插入路径移除。 扩张器可选地包括安装在扩张器主体上的扩张器体和扩张器护套。 在移除扩张器主体之后，将刺激引线通过扩张器体腔或扩张器鞘腔插入到期望的位置，并且扩张器鞘或体从插入路径移除。 如果临床医生希望单独锚定刺激引线，则通过从表皮到筋膜层的入口点产生切口，并且将刺激引线锚定到筋膜层。 刺激引线可以连接到神经刺激器以进行治疗盆底疾病如泌尿系统疾病，粪便控制障碍，性功能障碍和盆腔疼痛的递送疗法。

公开(公告)号：US08260425B2

公开(公告)日：2012-09-04

申请号：US11871468

申请日：2007-10-12

申请人： Scott Kokones ,  Keith Carlton ,  Alan Greszler

发明人： Scott Kokones ,  Keith Carlton ,  Alan Greszler

IPC分类号： A61N1/36

CPC分类号： A61N1/37252 ,  A61B5/0476 ,  A61B5/1116 ,  A61B5/1121 ,  A61B5/1127 ,  A61B5/16 ,  A61B5/224 ,  A61B5/4094 ,  A61B5/6885 ,  A61N1/36082 ,  A61N1/37247

摘要： A stimulation system can have a first sensor to generate a first reading and a second sensor to generate a second reading. An analysis module of a programmer such as a patient programmer, which programs a stimulation signal to be delivered to a patient, conducts an evaluation of the patient based on the first and second readings. Evaluations may include determinations such as range of motion determinations, posture determinations, physical task-specific brain activity determinations, cognitive task-specific brain activity determinations, and brain activity-specific movement determinations.

摘要翻译： 刺激系统可以具有第一传感器以产生第一读数和第二传感器以产生第二读数。 诸如病人编程器的程序员的分析模块，其对要传送给患者的刺激信号进行编程，基于第一和第二读数对患者进行评估。 评估可以包括诸如运动测定范围，姿势确定，物理任务特定的脑活动测定，认知任务特定的脑活动测定和脑活动特异性运动测定的确定。