公开(公告)号：US07912555B2

公开(公告)日：2011-03-22

申请号：US12023817

申请日：2008-01-31

Applicant: John M. Swoyer ,  Keith Carlson ,  Martin T. Gerber ,  George J. Mano ,  Michele Spinelli ,  Steven David Hartle

Inventor： John M. Swoyer ,  Keith Carlson ,  Martin T. Gerber ,  George J. Mano ,  Michele Spinelli ,  Steven David Hartle

IPC: A61N1/18

CPC classification number: A61N1/0558 ,  A61N1/0551

Abstract: 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. A fixation mechanism is formed on or integrally with the lead body proximal to the electrode array that is adapted to be implanted in an engage subcutaneous tissue, particularly muscle tissue, to inhibit axial movement of the lead body and dislodgement of the stimulation electrodes.

Abstract translation: 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。 固定机构形成在靠近电极阵列的引线体上或整体上，其适于被植入到接合的皮下组织，特别是肌肉组织中，以抑制引线体的轴向移动和刺激电极的移动。

公开(公告)号：US20050060014A1

公开(公告)日：2005-03-17

申请号：US10833761

申请日：2004-04-28

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

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

IPC: A61N1/05

CPC classification number: A61N1/0558 ,  A61N1/0551

Abstract: 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.

Abstract translation: 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：US06847849B2

公开(公告)日：2005-01-25

申请号：US09827740

申请日：2001-04-07

Applicant: George Mamo ,  Michele Spinelli ,  John Matthew Swoyer ,  Martin Theodore Gerber ,  Keith Richard Carlton

Inventor： George Mamo ,  Michele Spinelli ,  John Matthew Swoyer ,  Martin Theodore Gerber ,  Keith Richard Carlton

IPC: A61N1/05 ,  A61N1/08 ,  A61N1/00

CPC classification number: A61N1/0551 ,  A61N1/08

Abstract: 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.

公开(公告)号：US07330764B2

公开(公告)日：2008-02-12

申请号：US10833761

申请日：2004-04-28

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

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

IPC: A61N1/18

CPC classification number: A61N1/0558 ,  A61N1/0551

Abstract: 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.

Abstract translation: 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

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

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

IPC: A61N1/05

CPC classification number: A61N1/0558 ,  A61N1/0551

Abstract: 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：US06999819B2

公开(公告)日：2006-02-14

申请号：US10004732

申请日：2001-11-09

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

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

IPC: A61N1/05

CPC classification number: A61N1/0558 ,  A61N1/0551

Abstract: 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：US08000805B2

公开(公告)日：2011-08-16

申请号：US11589407

申请日：2006-10-30

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

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

IPC: A61N1/05

CPC classification number: A61N1/0558 ,  A61N1/0551

Abstract: 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.

Abstract translation: 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：US07328068B2

公开(公告)日：2008-02-05

申请号：US10723316

申请日：2003-11-26

Applicant: Michele Spinelli ,  Sylvia Malaguti ,  Martin T. Gerber ,  Gianluca Giardiello

Inventor： Michele Spinelli ,  Sylvia Malaguti ,  Martin T. Gerber ,  Gianluca Giardiello

IPC: A61N1/00

CPC classification number: A61N1/36071 ,  A61N1/0512 ,  A61N1/0514 ,  A61N1/0521 ,  A61N1/36007 ,  A61N1/36017 ,  A61N1/36107

Abstract: Described are implantable devices and methods for treating various disorders of the pelvic floor by means of electrical stimulation of the pudendal or other nerves, and optional means for delivering drugs in association therewith. A method of precisely positioning and implanting a medical electrical lead so as to provide optimal stimulation of the pudendal nerve or a portion thereof is also described. Placement of a stimulation lead next to or on the pudendal nerve may be performed using conventional prior art techniques through gross anatomical positioning, but usually does not result in truly optimal lead placement. One method of the present invention utilizes neurophysiological monitoring to assess the evoked responses of the pudendal nerve, and thereby provide a method for determining the optimal stimulation site. Additionally, one or more electrical stimulation signals are applied, and optionally one or more drugs are infused, injected or otherwise administered, to appropriate portions of a patient's pelvic floor and pudendal nerve or portions thereof in an amount and manner effective to treat a number of disorders, including, but not limited to, urinary and/or fecal voiding dysfunctions such as constipation, incontinence disorders such as urge frequency and urinary retention disorders, sexual dysfunctions such as orgasmic and erectile dysfunction, pelvic pain, prostatitis, prostatalgia and prostatodynia.

Abstract translation: 描述了通过电刺激阴部或其他神经来治疗骨盆底部各种疾病的可植入装置和方法，以及用于递送与之相关的药物的任选装置。 还描述了精确地定位和植入医用电引线以便提供阴部神经或其一部分的最佳刺激的方法。 可以使用传统的现有技术通过大体解剖定位进行刺激引线在阴部神经旁边或其上的放置，但是通常不会导致真正的最佳引导位置。 本发明的一种方法利用神经生理学监测来评估阴部神经的诱发反应，从而提供确定最佳刺激部位的方法。 另外，施加一个或多个电刺激信号，并且可选地，一种或多种药物以有效治疗数个或多个的刺激信号的量和方式输注，注射或以其他方式施用于患者的盆底和阴部神经或其部分的适当部分 包括但不限于尿和/或粪便排泄功能障碍如便秘，失禁症例如呼吸频率和尿潴留障碍，性功能障碍如高血压和勃起功能障碍，盆腔疼痛，前列腺炎，前列腺痛和前列腺痛。

公开(公告)号：US08626314B2

公开(公告)日：2014-01-07

申请号：US13183289

申请日：2011-07-14

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

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

IPC: A61N1/05

CPC classification number: A61N1/0558 ,  A61N1/0551

Abstract: 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.

Abstract translation: 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：US20110270269A1

公开(公告)日：2011-11-03

申请号：US13183289

申请日：2011-07-14

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

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

IPC: A61N1/05 ,  A61B19/00

CPC classification number: A61N1/0558 ,  A61N1/0551

Abstract: 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.

Abstract translation: 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。