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    • 32. 发明授权
    • Multilumen body for an implantable medical device
    • 用于可植入医疗器械的多组织体
    • US07130700B2
    • 2006-10-31
    • US10299484
    • 2002-11-19
    • Kenneth C. GardeskiMichael R. Leners
    • Kenneth C. GardeskiMichael R. Leners
    • A61N1/375A61B19/00
    • A61M25/0023A61M25/0021A61M25/0032A61M2025/0036
    • A splined multilumen body for use in elongated medical devices is provided for carrying multiple conductors, wires or cables to multiple device components along the device body. Open lumens may be provided through which medical devices or therapies may be delivered. The multilumen body is constructed from a generally tubular outer member having inward-radiating splines that mate with outward-radiating splines on a generally tubular inner member. Lumens formed between sets of mated splines isolate conductors carried therein. Interaction of mated splines provides good torque transfer between outer and inner members. Materials for fabricating outer and inner members may be selected to achieve desired torque transfer properties, flexibility, and surface friction.
    • 提供用于细长医疗装置的花键多体体,用于沿着装置主体将多个导体,电线或电缆携带到多个装置部件。 可以提供开放的流明,通过该腔可以递送医疗装置或治疗物。 多腔体由大致管状的外部构件构成,该外部构件具有与大致管状的内部构件上的向外辐射花键相配合的向内辐射花键。 在组合的配对花键之间形成的流明隔离导体中的导体。 配对花键的相互作用提供了外部和内部构件之间良好的扭矩传递。 可以选择用于制造外部和内部构件的材料以实现期望的扭矩传递特性,柔性和表面摩擦。
    • 33. 发明授权
    • System and method for placing endocardial leads
    • 放置心内膜导管的系统和方法
    • US06934589B2
    • 2005-08-23
    • US09827108
    • 2001-04-05
    • Stephen SundquistArnold ThorntonRoger DahlDuane ZytkoviczKenneth C. Gardeski
    • Stephen SundquistArnold ThorntonRoger DahlDuane ZytkoviczKenneth C. Gardeski
    • A61N1/05A61N1/00
    • A61N1/056A61N2001/0578A61N2001/0585
    • An improved system and method for deploying medical electrical leads is disclosed. The system includes a guiding device such as a guidewire used to navigate the vascular system of a body. The guiding device includes a fixation member that can be deployed to maintain the guiding device at a desired location within the vascular system. The fixation member may be an inflatable device such as a balloon, or alternatively, may be an expandable device constructed of flexible fibers that has both an expanded and a contracted state. The system may further include a coupling member located adjacent to the guiding device. The coupling member may be a rail extending distally from a proximal end of the guiding device to a point proximal the fixation member. In an alternative embodiment of the invention, the coupling member is a channel included in the body of the guiding device adapted to slidably engage an electrode assembly. The coupling member is adapted to allow the electrode assembly to be slid to the distal end of the coupling member and deployed at a predetermined implant site. In one embodiment of the invention, the coupling member is movable with respect to the guiding device. This allows the coupling member to be re-positioned to multiple implant sites to deploy more than one electrode while the fixation mechanism remains stationary within a patient's vascular system. According to yet another aspect of the invention, the guiding device includes a lumen to delivery fluoro visible medium.
    • 公开了用于部署医疗电引线的改进的系统和方法。 该系统包括诸如用于导航身体的血管系统的导丝的引导装置。 引导装置包括可以部署以将引导装置保持在血管系统内的期望位置的固定构件。 固定构件可以是诸如气囊的可充气装置,或者可替代地,可以是由具有膨胀和收缩状态的柔性纤维构成的可扩张装置。 该系统还可以包括邻近引导装置定位的联接构件。 联接构件可以是从引导装置的近端向靠近固定构件的点向远侧延伸的轨道。 在本发明的替代实施例中,联接构件是包括在引导装置的主体中的通道,其适于可滑动地接合电极组件。 联接构件适于允许电极组件滑动到联接构件的远端并且在预定的植入位置展开。 在本发明的一个实施例中,联接构件可相对于引导装置移动。 这允许将联接构件重新定位到多个植入位置以展开多于一个电极,同时固定机构在患者的血管系统内保持静止。 根据本发明的另一方面,引导装置包括用于输送氟可见介质的内腔。
    • 35. 发明授权
    • Deflectable tip catheter for CS pacing
    • 用于CS起搏的偏转尖端导管
    • US06408214B1
    • 2002-06-18
    • US09614131
    • 2000-07-11
    • Terrell M. WilliamsKenneth C. Gardeski
    • Terrell M. WilliamsKenneth C. Gardeski
    • A61N118
    • A61M25/0662A61M25/0041A61N2001/0578A61N2001/0585
    • A deflectable tip introducer or guide catheter optimized for placement of leads or catheters within the vasculature of the human body is disclosed. The introducer includes inner and outer concentrically located tubular sheaths. The inner and outer sheaths are preferably provided with different curved configurations, allowing the over-all displayed curvature of the introducer over its distal portion to be adjusted by longitudinal movement of the inner and outer sheaths relative to one another. The outer sheath may be fabricated of a thin tube of polyetheretherketone (PEEK) or other material having a relatively large stiffness as compared to the inner sheath. The outer sheath is sized to fit closely around the inner sheath. The inner sheath may be formed of a reinforced polyurethane, and preferably has a thin wall that is of about 0.005 inches in thickness or less. When supported by the inner sheath, the outer sheath transfers torque along the composite introducer assembly and serves to modify the curved configuration displayed by the distal end of the introducer assembly in conjunction with the relative longitudinal movement of the inner and outer sheaths.
    • 公开了一种针对人体脉管系统中引线或导管放置的可偏转尖端引导器或引导导管。 引导器包括内部和外部同心的管状护套。 内护套和外护套优选地设置有不同的弯曲构造,允许通过内护套和外护套相对于彼此的纵向运动来调节引导器在其远侧部分上的全部显示的曲率。 外护套可以由聚醚醚酮(PEEK)的薄管或与内护套相比具有相对较大刚度的其他材料制成。 外护套的尺寸设计成紧密地配合在内护套周围。 内护套可以由增强的聚氨酯形成,并且优选地具有厚度为约0.005英寸或更小的薄壁。 当由内护套支撑时,外护套沿着复合导引器组件传递扭矩,并用于结合内护套和外护套的相对纵向运动来修改由导引器组件的远端显示的弯曲构型。
    • 36. 发明授权
    • Method and apparatus for deflecting a screw-in-lead
    • 用于偏转螺旋导线的方法和装置
    • US06027462A
    • 2000-02-22
    • US126569
    • 1998-07-30
    • Corinne A. GreeneKenneth C. GardeskiAndrzej MalewiczBrett R. Johnson
    • Corinne A. GreeneKenneth C. GardeskiAndrzej MalewiczBrett R. Johnson
    • A61M25/01A61B5/00
    • A61M25/0147A61M25/0136
    • An apparatus for deflecting a catheter or lead, for example a deflectable stylet or guidewire. The device includes an outer tubular member, a tension member mounted within the outer tubular member and coupled to the outer member and a handle mounted at the proximal end of the tubular member. The handle includes a major handle portion which has a rotatable knob located at its distal end, surrounding a proximal portion of the outer tubular member and provided with inwardly directed threading and an inner slider member provided with outwardly directed threading engaging the inwardly directed threading of the knob. The slider is advanced or retracted longitudinally within the handle by rotation of the knob but is rotationally fixed with regard to the major handle portion. The outer tubular member is engaged at its proximal end with the inner slider member and the tension wire is fixedly engaged with the major handle portion, whereby rotation of the knob results in advancement or retraction of the outer tubular member relative to the tension wire and the major portion of the handle, which in turn causes the deflection of the outer tubular member.
    • 用于使导管或引线偏转的装置,例如可偏转的探针或导丝。 该装置包括外部管状构件,安装在外部管状构件内并联接到外部构件的张紧构件和安装在管状构件的近端处的手柄。 手柄包括主把手部分,其具有位于其远端处的可旋转旋钮,围绕外部管状构件的近侧部分并且设置有向内引导的螺纹和设置有向外指向的螺纹的内部滑动构件, 旋钮 滑块通过旋钮旋转而在手柄内纵向前进或缩回,但相对于主把手部分旋转固定。 外部管状构件在其近端处与内部滑动构件接合,并且张力线与主把手部分固定地接合,由此旋钮的旋转导致外部管状构件相对于张力线的前进或缩回,并且 手柄的主要部分又导致外部管状构件的偏转。
    • 37. 发明授权
    • Method and apparatus for deflecting a screw-in lead
    • 用于偏转螺钉的方法和装置
    • US08142367B2
    • 2012-03-27
    • US12037692
    • 2008-02-26
    • Kenneth C. GardeskiCorinne A. G. PoorWilliam J. ClemensJeremy J. Odegard
    • Kenneth C. GardeskiCorinne A. G. PoorWilliam J. ClemensJeremy J. Odegard
    • A61B5/00
    • A61N1/0573A61M25/0136A61N2001/058
    • A deflectable stylet system optimized for use in conjunction with a lead of the type having a fixation helix that is screwed into body tissue by rotation of the lead's connector pin is disclosed. The system includes an attachment that is rotatable and longitudinally slidable with respect to the handle of a deflectable stylet. A lead coupled to the attachment may be moved longitudinally with respect to a stylet to account for slight variances in the lead length. In one embodiment, the attachment couples to the lead via a pushbutton mechanism that can be locked to the lead using one hand. The attachment may be rotated to thereby rotate the lead connector. This allows for retraction and extension of a retractable fixation helix, and for further attachment or detachment of a fixation helix to adjacent tissue. In one embodiment, the attachment may be longitudinally rigidly positioned in predetermined locations with respect to the handle. According to another aspect of the system, a deflection device is coupled to the handle to facilitate deflection of the stylet. In one embodiment, this deflection device may be rotatably and/or slidably activated to accomplish the stylet deflection. The system allows a user to adjust lead length with respect to the stylet length, and to further perform stylet deflection and lead rotation all with one hand.
    • 公开了一种可弯曲的探针针系统,其优化用于与具有通过引线的连接器销的旋转而旋入身体组织的固定螺旋的类型的引线结合使用。 该系统包括可相对于可偏转探针的手柄旋转并纵向滑动的附件。 耦合到附件的引线可以相对于探针沿纵向移动以考虑引线长度的微小变化。 在一个实施例中,附件经由按钮机构耦合到引线,该按钮机构可以用一只手锁定到引线。 可以旋转附件从而使引线连接器旋转。 这允许缩回固定螺旋的缩回和延伸,并且用于将固定螺旋进一步附接或分离到相邻组织。 在一个实施例中,附件可以相对于手柄纵向刚性地定位在预定位置。 根据系统的另一方面,偏转装置联接到手柄以便于探针的偏转。 在一个实施例中,该偏转装置可以可旋转和/或可滑动地启动以完成探针的偏转。 该系统允许用户相对于探针长度调节引线长度,并且用一只手进一步执行探针偏转和引导旋转。
    • 38. 发明申请
    • Steerable Stylet with Guidewire Tip
    • 带导轨提示的方向导管
    • US20110270169A1
    • 2011-11-03
    • US12771265
    • 2010-04-30
    • Kenneth C. GardeskiRonald A. Drake
    • Kenneth C. GardeskiRonald A. Drake
    • A61M25/01
    • A61M25/0138A61M25/0133A61M25/0136A61M25/0147A61M2025/0161
    • According to an embodiment of the present invention, a steerable elongated medical device includes an outer tube extending between an outer tube proximal segment and an outer tube distal segment, and having an outer tube wall forming an outer tube lumen and an elongated outer tube slot through the outer tube wall to the outer tube lumen. The elongated outer tube slot has a first portion and a second portion and is formed between an outer tube slot proximal end and an outer tube slot distal end and extends axially along the outer tube distal segment through an outer tube slot length to define a cutaway portion of the outer tube. A reinforcing sleeve is positioned within the outer tube lumen and extends between a reinforcing sleeve proximal end and a reinforcing sleeve distal end. The reinforcing sleeve forms a reinforcing sleeve slot portion aligned with and extending along the first portion of the outer tube slot and includes a reinforcing sleeve overlap portion extending over the second portion of the outer tube slot. A handle is coupled to the outer tube proximal end, and a pull wire is positioned within the outer tube lumen and extends between a pull wire proximal end coupled to the handle and a pull wire distal end comprising a guidewire tip. The pull wire extends through the reinforcing sleeve lumen, the outer tube lumen, and a distal pull wire stop, and the guidewire tip extending distally from the distal pull wire stop and the pull wire proximal end is adapted to be manipulated to separate the pull wire proximal end from the outer tube proximal end to induce a bend in the cutaway portion.
    • 根据本发明的实施例,可操纵的细长医疗装置包括在外管近端段和外管远端段之间延伸的外管,并且具有形成外管内腔的外管壁和细管外管槽 外管壁到外管腔。 细长的外管狭槽具有第一部分和第二部分,并且形成在外管狭缝近端和外管狭槽远端之间,并且通过外管狭槽长度沿着外管远端段轴向延伸以限定切除部分 的外管。 加强套筒定位在外管腔内并且在加强套管近端和加强套管远端之间延伸。 加强套管形成与外管槽的第一部分对准并沿其延伸的加强套管槽部分,并且包括在外管槽的第二部分上延伸的加强套管重叠部分。 手柄耦合到外管近端,并且拉线定位在外管腔内并且在联接到手柄的拉线近端和包括导丝末端的拉线远端之间延伸。 拉线延伸穿过加强套管腔,外管腔和远端拉线止动器,并且从远端牵引线止动件和拉线近端向远侧延伸的导丝末端适于被操纵以分离拉线 近端从外管近端引起切口部分中的弯曲。
    • 39. 发明申请
    • IMPLANTABLE MEDICAL DEVICE LEAD
    • 可植入医疗器械引线
    • US20100331938A1
    • 2010-12-30
    • US12825647
    • 2010-06-29
    • John L. SommerKenneth C. GardeskiXiaonan ShenJon D. Schell
    • John L. SommerKenneth C. GardeskiXiaonan ShenJon D. Schell
    • A61N1/05
    • A61N1/056A61N1/05A61N1/0534A61N1/0551A61N1/0558A61N1/086
    • An implantable lead including a lead body including an outer surface, a proximal end, a distal end, and at least one electrode; an electrically insulating member that extends axially over a first portion of the outer surface of the lead body between the proximal end and distal end, the electrically insulating member defining at least one aperture that exposes a first portion of the at least one electrode when in a first position over the lead body; and a reinforcement member formed at least partially of a different material than the insulating member and coupled to the insulating member, the reinforcement member extending axially over the outer surface of the lead body between the insulating member and proximal end. The reinforcement member may be configured to transfer at least one of a radial or axial force from a proximal portion of the reinforcement member to the insulating member, wherein the at least one of radial or axial force transferred to the insulating member is sufficient to move the insulating member over the outer surface of the lead body. In some examples, the lead may further include a deployable lobe member configured to anchor the reinforcement member and insulating member adjacent a tissue site within a patient.
    • 一种可植入引线,包括:引线本体,其包括外表面,近端,远端和至少一个电极; 电绝缘构件,其在所述近端和远端之间轴向延伸到所述引线本体的外表面的第一部分上方,所述电绝缘构件限定在至少一个孔处暴露所述至少一个电极的第一部分, 领先身体的第一位; 至少部分地由与所述绝缘构件不同的材料形成并且与所述绝缘构件连接的加强构件,所述加强构件在所述绝缘构件和所述绝缘构件与所述绝缘构件之间的所述引线本体的外表面上轴向延伸。 加强构件可以构造成将径向或轴向力中的至少一个从加强构件的近侧部分传递到绝缘构件,其中传递到绝缘构件的径向或轴向力中的至少一个足以使 绝缘构件在引线体的外表面上。 在一些示例中,引线还可包括可展开的隆起部件,其构造成将加强部件和绝缘部件固定在患者体内的组织部位附近。
    • 40. 发明申请
    • Medical Devices Incorporating Carbon Nanotube Material and Methods of Fabricating Same
    • 纳入碳纳米管材料的医疗器械及其制造方法
    • US20100324643A1
    • 2010-12-23
    • US12873389
    • 2010-09-01
    • Scott J. BrabecKenneth C. Gardeski
    • Scott J. BrabecKenneth C. Gardeski
    • A61N1/05
    • A61N1/0556A61N1/056A61N1/0565
    • The present invention relates generally to medical devices; in particular and without limitation, to unique electrodes and/or electrical lead assemblies for stimulating cardiac tissue, muscle tissue, neurological tissue, brain tissue and/or organ tissue; to electrophysiology mapping and ablation catheters for monitoring and selectively altering physiologic conduction pathways; and, wherein said electrodes, lead assemblies and catheters optionally include fluid irrigation conduit(s) for providing therapeutic and/or performance enhancing materials to adjacent biological tissue, and wherein each said device is coupled to or incorporates nanotube structures or materials therein. The present invention also provides methods for fabricating, deploying, and operating such medical devices.
    • 本发明一般涉及医疗器械; 特别是但不限于用于刺激心脏组织,肌肉组织,神经组织,脑组织和/或器官组织的独特电极和/或电引线组件; 用于电生理测绘和消融导管,用于监测和选择性地改变生理传导途径; 并且其中所述电极,引线组件和导管可选地包括用于向相邻生物组织提供治疗和/或增强性能的材料的流体冲洗导管,并且其中每个所述装置在其中耦合或纳入其中的纳米管结构或材料。 本发明还提供了制造,部署和操作这种医疗装置的方法。