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：US20050096497A1

公开(公告)日：2005-05-05

申请号：US10698216

申请日：2003-10-31

申请人： Martin Gerber ,  Warren Starkebaum ,  John Swoyer

发明人： Martin Gerber ,  Warren Starkebaum ,  John Swoyer

IPC分类号： A61F2/00 ,  A61L31/14 ,  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：US20050096550A1

公开(公告)日：2005-05-05

申请号：US10698676

申请日：2003-10-31

申请人： Martin Gerber ,  John Swoyer

发明人： Martin Gerber ,  John Swoyer

IPC分类号： A61B1/31 ,  A61B17/00 ,  A61B19/00 ,  A61M25/00 ,  A61B8/14

CPC分类号： A61M25/0084 ,  A61B1/31 ,  A61B2017/00274 ,  A61B2018/00547 ,  A61B2090/378

摘要： The invention is directed to a technique for delivering a denervating agent to a patient's prostate gland. In particular, the invention is directed to a transrectal technique for delivering the denervating agent. Devices and systems are also described for use in implementing the technique.

摘要翻译： 本发明涉及一种将去神经抑制剂递送至患者前列腺的技术。 特别地，本发明涉及用于递送去神经抑制剂的经直肠技术。 还描述了用于实施该技术的设备和系统。

公开(公告)号：US20050096549A1

公开(公告)日：2005-05-05

申请号：US10698213

申请日：2003-10-31

申请人： Martin Gerber ,  John Swoyer

发明人： Martin Gerber ,  John Swoyer

IPC分类号： A61B17/00 ,  A61M25/00 ,  A61B8/14

CPC分类号： A61M25/0084 ,  A61B2017/00274 ,  A61B2018/00547

摘要： The invention is directed to a technique for delivering a denervating agent to a patient's prostate gland. In particular, the invention is directed to a transperineal technique for delivering the denervating agent. Devices and systems are also described for use in implementing the technique.

摘要翻译： 本发明涉及一种将去神经抑制剂递送至患者前列腺的技术。 特别地，本发明涉及用于递送去神经抑制剂的经腹穿刺技术。 还描述了用于实施该技术的设备和系统。

公开(公告)号：US20070179496A1

公开(公告)日：2007-08-02

申请号：US11343967

申请日：2006-01-31

申请人： John Swoyer ,  Martin Gerber

发明人： John Swoyer ,  Martin Gerber

IPC分类号： A61B18/14

CPC分类号： A61B18/1492 ,  A61B18/1477 ,  A61B2017/00274 ,  A61B2018/00285 ,  A61B2018/00547 ,  A61B2018/1425 ,  A61B2018/1472 ,  A61B2018/1475

摘要： The disclosure describes a system that may be used to deliver ablation therapy to a target tissue within a patient. The system uses a flexible catheter to navigate through a passage and reach a target tissue. Once at the desired location, a side of the flexible catheter is forced against a wall of the passage to allow a needle to be extended from the side of the flexible catheter and into the target tissue. A pull-wire or inflatable balloon may be used as the control mechanism that forces the flexible catheter against the passage wall. In the case of the pull-wire, the flexible catheter may also be steered through the passage. As an example, the flexible catheter may be inserted into the urethra and the needle may be deployed into the prostate to treat benign prostatic hypertrophy (BPH).

摘要翻译： 本公开描述了可用于向患者内的靶组织递送消融治疗的系统。 该系统使用柔性导管穿过通道并到达目标组织。 一旦在期望的位置，柔性导管的一侧被迫抵靠通道的壁，以允许针从柔性导管的一侧延伸并进入目标组织。 可以使用拉线或可膨胀气囊作为将柔性导管压靠通道壁的控制机构。 在拉线的情况下，柔性导管也可以通过通道转向。 作为示例，柔性导管可以插入尿道中，针可以部署到前列腺中以治疗良性前列腺肥大（BPH）。

公开(公告)号：US20050096629A1

公开(公告)日：2005-05-05

申请号：US10698100

申请日：2003-10-31

申请人： Martin Gerber ,  John Swoyer

发明人： Martin Gerber ,  John Swoyer

IPC分类号： A61B17/00 ,  A61B17/34 ,  A61M5/142 ,  A61M5/168 ,  A61M31/00

CPC分类号： A61M5/14216 ,  A61B17/3478 ,  A61B2017/00274 ,  A61B2018/00547 ,  A61M5/16809

摘要： The invention is directed to a technique for delivering a denervating agent to a patient's prostate gland. In particular, the invention is directed to a transurethral technique for delivering the denervating agent. Devices and systems are also described for use in implementing the technique.

摘要翻译： 本发明涉及一种将去神经抑制剂递送至患者前列腺的技术。 特别地，本发明涉及用于递送去神经纤维素的经尿道技术。 还描述了用于实施该技术的设备和系统。

公开(公告)号：US20050096751A1

公开(公告)日：2005-05-05

申请号：US10698131

申请日：2003-11-01

申请人： Martin Gerber ,  Warren Starkebaum ,  John Swoyer

发明人： Martin Gerber ,  Warren Starkebaum ,  John Swoyer

IPC分类号： A61B17/00 ,  A61B17/30 ,  A61B19/00 ,  A61F2/00 ,  A61L31/14 ,  A61F2/04

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。 随着额外的大量，患者可以对外部尿道括约肌进行自愿控制，以关闭或维持尿道闭合并维持尿路。