公开(公告)号：US20150202430A1

公开(公告)日：2015-07-23

申请号：US14161756

申请日：2014-01-23

Applicant: Greatbatch Ltd.

Inventor： James Finley ,  John M. Swoyer

IPC: A61N1/05 ,  D04C1/06 ,  B29C70/24 ,  H01R43/00

CPC classification number: A61N1/05 ,  A61N1/0551 ,  A61N1/0558 ,  A61N1/3605 ,  B29C70/24 ,  D04C1/06 ,  D10B2509/00 ,  Y10T29/49169 ,  Y10T29/49801

Abstract: In some examples, a method of making a therapy delivery element configured for at least partial insertion in a living body includes braiding a plurality of fibers to form an elongated braided structure with a lumen. At least one reinforcing structure is weaved into the fibers of the braided structure. A portion of the reinforcing structure is extended from the braided structure to form at least one fixation structure. At least one of the braided structure or the reinforcing structure can be attached to at least one of an electrode assembly or a connector assembly.

Abstract translation: 在一些实例中，制造用于至少部分插入生物体中的治疗递送元件的方法包括编织多根纤维以形成具有内腔的细长编织结构。 将至少一个加强结构编织到编织结构的纤维中。 加强结构的一部分从编织结构延伸以形成至少一个固定结构。 编织结构或加强结构中的至少一个可以附接到电极组件或连接器组件中的至少一个。

公开(公告)号：US08868210B2

公开(公告)日：2014-10-21

申请号：US14038984

申请日：2013-09-27

Applicant: Greatbatch Ltd.

Inventor： John M. Swoyer ,  Allison M. Kidder ,  Jeffrey Zweber ,  Scott Brainard ,  Valerie Glazier

IPC: A61N1/05 ,  A61B5/00 ,  A61B1/00 ,  A61B5/04

CPC classification number: A61B5/0084 ,  A61B1/00165 ,  A61B5/04 ,  A61N1/0509 ,  A61N1/0551 ,  A61N1/0558 ,  A61N1/0573 ,  A61N1/0587

Abstract: A medical device for placing a medical lead in the human body using minimally invasive techniques is described. One lead includes a lead body connected to a lead head having an aperture for providing fiber optic access to the interior of a helical electrode. The fiber optic shaft may be disposed within or along-side a drive shaft releasably coupled to the lead head to rotate the head. The drive shaft and lead body may be delivered using a delivery catheter. The delivery catheter can be advanced though a small incision to the target tissue site, and the site remotely visualized through the fiber optic scope extending through the lead head aperture. The lead head can be rotated, rotating the helical electrode into the tissue, and the catheter, drive shaft, and fiber optic probe removed.

Abstract translation: 描述了使用微创技术将医用铅放置在人体内的医疗装置。 一个引线包括连接到具有用于提供到螺旋电极的内部的光纤访问的孔的引导头的引线体。 光纤轴可以设置在可释放地联接到引导头的驱动轴内或侧面，以旋转头部。 驱动轴和引线体可以使用输送导管输送。 输送导管可以通过小切口前进到目标组织部位，并且通过穿过引导头孔的光纤镜片远程可视化部位。 引导头可以旋转，将螺旋电极旋转到组织中，导管，驱动轴和光纤探针被移除。

公开(公告)号：US08781603B2

公开(公告)日：2014-07-15

申请号：US14033592

申请日：2013-09-23

Applicant: Greatbatch Ltd.

Inventor： Qingshan Ye ,  John M. Swoyer

IPC: A61N1/00 ,  A61N1/05

CPC classification number: A61N1/0551 ,  A61N1/00 ,  A61N1/0558 ,  A61N1/36057

Abstract: Methods and apparatus for implanting a neural stimulation lead in a patient's body are described. A lead assembly comprises a pointed-tip stylet, a stimulation lead, and an optional tube to deploy a fixation element attached to the lead. One embodiment of the implant methods starts with inserting the pointed-tip lead assembly directly into tissue. After the desired implant position is determined, the pointed-tip component is separated from the stimulation lead and removed from the tissue, leaving the stimulation lead implanted. After confirmation that the stimulation lead is in the right tissue location, the pointed-tip component is removed from the body, leaving the stimulation lead in place. The stimulation lead can be connected to a neurostimulator to delivery therapies to treat neural disorders, such as urinary control disorders, fecal control disorders, sexual dysfunction, and pelvic pain, etc.

Abstract translation: 描述了将神经刺激引线植入患者体内的方法和装置。 引线组件包括尖尖探针，刺激引线和用于展开附接到引线的固定元件的可选管。 植入方法的一个实施方案是将尖尖引线组件直接插入组织中。 在确定期望的植入位置之后，将尖端部件与刺激引线分离并从组织中移出，留下刺激引线。 在确认刺激引线处于正确的组织位置之后，将尖端部件从身体移除，使刺激引线保持在适当的位置。 刺激引线可以连接到神经刺激器以传递治疗以治疗神经障碍，例如尿控制障碍，粪便控制障碍，性功能障碍和骨盆疼痛等。

公开(公告)号：US08738153B2

公开(公告)日：2014-05-27

申请号：US14019653

申请日：2013-09-06

Applicant: Greatbatch Ltd.

Inventor： Shahn S. Sage ,  John M. Swoyer ,  Jesse Geroy

IPC: A61N1/04

CPC classification number: A61N1/05 ,  A61N1/0551 ,  A61N1/0558 ,  A61N1/36071 ,  H01B7/048

Abstract: In some examples, an extension includes a connector adapted to electrically couple to a proximal end of the therapy delivery element. An elongated extension body is attached to the connector. The elongated extension body includes a stylet coil having a stylet coil lumen. The stylet coil extends within the elongated extension body to the connector. A conductor assembly includes a plurality of insulated electrical conductors braided to extend around the stylet coil and electrically coupled to the connector. The conductor assembly includes an inner lumen with a diameter greater than an outside diameter of the stylet coil, wherein axial elongated of the elongated extension body reduces the inner diameter of the conductor assembly. A low durometer insulator extends around the conductor assembly. A stylet is sized to slide freely within the stylet coil lumen during implantation of the extension in the living body.

Abstract translation: 在一些示例中，延伸部包括适于电耦合到治疗递送元件的近端的连接器。 细长的延伸体连接到连接器上。 细长延伸体包括具有探针线圈腔的探针线圈。 探针线圈在细长延伸体内延伸到连接器。 导体组件包括多个绝缘电导体，编织成围绕管心针线圈延伸并电耦合到连接器。 导体组件包括直径大于通管线圈外径的内腔，其中细长延伸体的轴向细长减小了导体组件的内径。 低硬度绝缘体围绕导体组件延伸。 探针的尺寸可以在植入生物体内的延伸部分时在探针线圈腔内自由滑动。

公开(公告)号：US09002476B2

公开(公告)日：2015-04-07

申请号：US14024668

申请日：2013-09-12

Applicant: Greatbatch Ltd.

Inventor： Jesse Geroy ,  John M. Swoyer

IPC: A61N1/05 ,  H01B7/04

CPC classification number: A61N1/0551 ,  A61N1/05 ,  H01B7/048 ,  Y10T29/49169

Abstract: A biomedical conductor assembly adapted for at least partial insertion in a living body. The conductor assembly includes a plurality of the first electrical conductors each covered with an insulator and helically wound in a first direction to form an inner coil with a lumen. A plurality of second electrical conductors each including a plurality of un-insulated wires twisted in a ropelike configuration around a central axis to form a plurality of cables. Each cable is covered with an insulator and helically wound in a second opposite direction forming an outer coil in direct physical contact with the inner coil. The inner and outer coils are covered by an insulator. A method of making the conductor assembly and implanting a neurostimulation system is also disclosed.

Abstract translation: 适用于至少部分插入生物体内的生物医学导体组件。 导体组件包括多个第一电导体，每个第一电导体覆盖有绝缘体并沿第一方向螺旋缠绕以形成具有内腔的内部线圈。 多个第二电导体，每个第二电导体包括围绕中心轴线缠绕成线形构造的多条绝缘线，以形成多条电缆。 每个电缆被绝缘体覆盖，并且在第二相反方向上螺旋缠绕，形成与内部线圈直接物理接触的外部线圈。 内外线圈由绝缘体覆盖。 还公开了制造导体组件和植入神经刺激系统的方法。

公开(公告)号：US20140228920A1

公开(公告)日：2014-08-14

申请号：US14258365

申请日：2014-04-22

Applicant: Greatbatch Ltd.

Inventor： Shahn S. Sage ,  John M. Swoyer ,  Jesse Geroy

IPC: A61N1/05

CPC classification number: A61N1/05 ,  A61N1/0551 ,  A61N1/0558 ,  A61N1/36071 ,  H01B7/048

Abstract: In some examples, an extension includes a connector adapted to electrically couple to a proximal end of the therapy delivery element. An elongated extension body is attached to the connector. The elongated extension body includes a stylet coil having a stylet coil lumen. The stylet coil extends within the elongated extension body to the connector. A conductor assembly includes a plurality of insulated electrical conductors braided to extend around the stylet coil and electrically coupled to the connector. The conductor assembly includes an inner lumen with a diameter greater than an outside diameter of the stylet coil, wherein axial elongated of the elongated extension body reduces the inner diameter of the conductor assembly. A low durometer insulator extends around the conductor assembly. A stylet is sized to slide freely within the stylet coil lumen during implantation of the extension in the living body.

公开(公告)号：US20140081365A1

公开(公告)日：2014-03-20

申请号：US14083591

申请日：2013-11-19

Applicant: Greatbatch Ltd.

Inventor： Lawrence Kane ,  John M. Swoyer

IPC: A61N1/05

CPC classification number: A61N1/05 ,  A61B17/0401 ,  A61B2017/0084 ,  A61B2017/00858 ,  A61B2017/00964 ,  A61B2017/0417 ,  A61B2017/0475 ,  A61N1/0558 ,  A61N2001/0582

Abstract: Suture anchors for securing therapy delivery elements, such as stimulation leads or catheters, within a living body. The suture anchor includes an inner sleeve constructed with an inner layer of a softer, more pliable material that easily conforms to the therapy delivery element to reduce slippage and an outer layer constructed from a harder, stiffer durometer material that protects the therapy delivery elements from damage due to over-tightening the tie down sutures. A suture material located in the suture groove is tensioned to apply a radial compressive force. The reinforcing structure spreads the radial compressive force along a greater surface area of the therapy delivery element.

Abstract translation: 用于固定活体内的治疗递送元件（例如刺激引线或导管）的缝合锚。 缝合锚包括内套筒，该内套筒具有较软，更柔韧的材料的内层，其容易地符合治疗递送元件以减少滑脱，以及由更硬，更硬的硬度材料构成的外层，其保护治疗递送元件免受损伤 由于过度紧固缝合缝合。 位于缝合槽中的缝合材料被张紧以施加径向压缩力。 加强结构沿着治疗递送元件的较大表面积扩展径向压缩力。

公开(公告)号：US20150238752A1

公开(公告)日：2015-08-27

申请号：US14712073

申请日：2015-05-14

Applicant: Greatbatch Ltd.

Inventor： John M. Swoyer ,  James Finley ,  Lawrence Kane

IPC: A61N1/05

CPC classification number: A61N1/05 ,  A61N1/0551 ,  A61N1/3605 ,  A61N1/36053

Abstract: A therapy assembly configured for at least partial insertion in a living body. At least one fixation structure is attached to the therapy delivery element proximate the electrodes. The fixation structure is configured to collapse radially inward and wrap circumferentially around the therapy delivery element to a collapsed configuration when inserted into a lumen of an introducer. The fixation structures deploy to a deployed configuration when the introducer is retracted. The fixation structure includes major surfaces generally parallel with, and extending radially outward from, a central axis of the therapy delivery element, proximal edge surface oriented toward the proximal end, and a distal edge surface oriented toward the distal end. The proximal and distal edge surfaces provide generally symmetrical resistance to displacement of the therapy delivery element within the living body in either a proximal direction or a distal direction along the central axis.

Abstract translation: 一种治疗组件，其构造成用于至少部分地插入生物体内。 至少一个固定结构附接到靠近电极的治疗递送元件。 固定结构构造成当插入到导引器的内腔中时，径向向内折叠并围绕治疗递送元件周向地折叠成折叠构造。 当导引器缩回时，固定结构部署到展开配置。 固定结构包括与治疗递送元件的中心轴大致平行并且从其径向向外延伸的主表面，朝向近端定向的近端边缘表面和朝向远端定向的远端边缘表面。 近端和远端边缘表面提供对沿着中心轴线的近端方向或远端方向上的治疗递送元件在生物体内的移位的大致对称的阻力。

公开(公告)号：US20140324144A1

公开(公告)日：2014-10-30

申请号：US14327962

申请日：2014-07-10

Applicant: Greatbatch Ltd.

Inventor： Qingshan Ye ,  John M. Swoyer

IPC: A61N1/05

CPC classification number: A61N1/0551 ,  A61N1/00 ,  A61N1/0558 ,  A61N1/36057

Abstract: Methods and apparatus for implanting a neural stimulation lead in a patient's body are described. A lead assembly comprises a pointed-tip stylet, a stimulation lead, and an optional tube to deploy a fixation element attached to the lead. One embodiment of the implant methods starts with inserting the pointed-tip lead assembly directly into tissue. After the desired implant position is determined, the pointed-tip component is separated from the stimulation lead and removed from the tissue, leaving the stimulation lead implanted. After confirmation that the stimulation lead is in the right tissue location, the pointed-tip component is removed from the body, leaving the stimulation lead in place. The stimulation lead can be connected to a neurostimulator to delivery therapies to treat neural disorders, such as urinary control disorders, fecal control disorders, sexual dysfunction, and pelvic pain, etc.

Abstract translation: 描述了将神经刺激引线植入患者体内的方法和装置。 引线组件包括尖尖探针，刺激引线和用于展开附接到引线的固定元件的可选管。 植入方法的一个实施方案是将尖尖引线组件直接插入组织中。 在确定期望的植入位置之后，将尖端部件与刺激引线分离并从组织中移出，留下刺激引线。 在确认刺激引线处于正确的组织位置之后，将尖端部件从身体移除，使刺激引线保持在适当的位置。 刺激引线可以连接到神经刺激器以传递治疗以治疗神经障碍，例如尿控制障碍，粪便控制障碍，性功能障碍和骨盆疼痛等。

公开(公告)号：US20140068936A1

公开(公告)日：2014-03-13

申请号：US14077239

申请日：2013-11-12

Applicant: Greatbatch Ltd.

Inventor： James Finley ,  John M. Swoyer

IPC: A61N1/05

CPC classification number: A61N1/0551 ,  A61N1/05 ,  Y10T29/49208 ,  Y10T29/4921

Abstract: A therapy delivery element configured for at least partial insertion in a living body. A braided structure surrounds the conductor assembly. A distal end of the braided structure is attached to an electrode assembly and a free floating proximal end is located near a connector assembly. An outer tubing surrounds the braided structure. The outer tubing includes a proximal end attached to the connector assembly and a distal end attached to the braided structure near the electrode assembly. A proximal tension force applied to the connector assembly acts substantially on the outer tubing and the conductor assembly and a proximal tension force applied to the free floating proximal end acts substantially on the braided structure.

Abstract translation: 治疗递送元件，其构造成用于至少部分插入生物体。 编织结构围绕导体组件。 编织结构的远端附接到电极组件，并且自由浮动近端位于连接器组件附近。 外管围绕编织结构。 外管包括附接到连接器组件的近端和在电极组件附近附接到编织结构的远端。 施加到连接器组件的近侧张力基本上作用在外管和导体组件上，并且施加到自由浮动近端的近侧张力基本上作用在编织结构上。