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41. 发明授权

US07676268B2 Medical methods and systems incorporating wireless monitoring 有权
标题翻译：医疗方法和系统结合无线监控
公开(公告)号：US07676268B2
公开(公告)日：2010-03-09
申请号：US11565283
申请日：2006-11-30
申请人： Douglas A. Hettrick , Kenneth C. Gardeski , H. Toby Markowitz , Sameh Sowelam
发明人： Douglas A. Hettrick , Kenneth C. Gardeski , H. Toby Markowitz , Sameh Sowelam
IPC分类号： A61N1/00
CPC分类号： A61B5/076 , A61B5/0031 , A61B5/1107 , A61B5/686 , A61B90/39 , A61B2017/00411 , A61B2090/3908 , A61B2090/397 , A61B2090/3975 , A61B2562/0209 , A61B2562/046
摘要： Medical systems and methods incorporate monitoring of at least two implanted markers, each of which is adapted to wirelessly transmit a signal in response to a wirelessly transmitted excitation signal; the response signals are converted into positional information for the two markers. The systems and methods further incorporate both, or one of, an implanted sensing member and/or an implanted therapy delivery device. Signals received from the sensing member may be collated with the positional information. A therapy delivered from the therapy delivery device may be adjusted according to the positional information.
摘要翻译：医疗系统和方法包括至少两个植入标记的监测，每个植入标记适于响应于无线发送的激励信号无线地发送信号; 响应信号被转换成两个标记的位置信息。所述系统和方法还包括植入的感测构件和/或植入的治疗递送装置中的一个或其中之一。从感测构件接收到的信号可以与位置信息进行整理。可以根据位置信息调整从治疗输送装置输送的治疗。

42. 发明授权

US07596415B2 Medical devices incorporating carbon nanotube material and methods of fabricating same 有权
标题翻译：纳入碳纳米管材料的医疗器械及其制造方法
公开(公告)号：US07596415B2
公开(公告)日：2009-09-29
申请号：US11038731
申请日：2005-01-20
申请人： Scott J. Brabec , Kenneth C. Gardeski , Suping Lyu , James A. Coles, Jr. , Christopher M. Hobot
发明人： Scott J. Brabec , Kenneth C. Gardeski , Suping Lyu , James A. Coles, Jr. , Christopher M. Hobot
IPC分类号： A61N1/18 , A61N1/05
CPC分类号： A61N1/056 , A61N1/0565 , Y10S977/905 , Y10S977/925 , Y10S977/931
摘要： 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 nanostructure or materials therein. The present invention also provides methods for fabricating, deploying, and operating such medical devices.
摘要翻译：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/或性能增强材料的流体冲洗导管，并且其中每个所述装置与其中的纳米结构或材料耦合或结合。本发明还提供了制造，部署和操作这种医疗装置的方法。

43. 发明授权

US07396335B2 Method and apparatus for deflecting a screw-in lead 有权
标题翻译：用于偏转螺钉的方法和装置
公开(公告)号：US07396335B2
公开(公告)日：2008-07-08
申请号：US10844746
申请日：2004-05-13
申请人： Kenneth C. Gardeski , Corinne A. G. Poor , William J. Clemens , Jeremy J. Odegard
发明人： Kenneth C. Gardeski , Corinne A. G. Poor , William J. Clemens , Jeremy J. Odegard
IPC分类号： A61B5/00
CPC分类号： A61N1/0573 , A61M25/0136 , A61N2001/058
摘要： 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.
摘要翻译：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。

44. 发明授权

US07037290B2 Multi-lumen steerable catheter 有权
标题翻译：多腔导管
公开(公告)号：US07037290B2
公开(公告)日：2006-05-02
申请号：US10318624
申请日：2002-12-16
申请人： Kenneth C. Gardeski , Michael R. Leners , Jesse T. Torbert , Ralph J. Thomas
发明人： Kenneth C. Gardeski , Michael R. Leners , Jesse T. Torbert , Ralph J. Thomas
IPC分类号： A61M31/00
CPC分类号： A61M25/0147 , A61M25/0029 , A61M25/0152 , A61M25/0158 , A61M2025/0034 , A61M2025/0037
摘要： Elongated medical devices are disclosed adapted to be inserted through an access pathway into a body vessel, organ or cavity to locate a therapeutic or diagnostic distal segment of the elongated medical device into alignment with an anatomic feature of interest. Multi-lumen steerable catheters having a deflection lumen liner and a delivery lumen liner are adapted to be deflected by a deflection mechanism within or advanced through the deflection lumen liner to enable advancement of the catheter distal end through a tortuous pathway. At least one lumen liner is formed of a no yield elastomer.
摘要翻译：公开了细长的医疗装置，其适于通过进入路径插入身体容器，器官或空腔中，以将细长的医疗装置的治疗或诊断远端段与感兴趣的解剖特征对准。具有偏转内腔衬垫和输送内腔衬垫的多管腔可导向导管适于被偏转腔内偏转机构偏转或穿过偏转内腔衬垫，以使得导管远端能够通过曲折的路径前进。至少一个内腔衬垫由无屈服弹性体形成。

45. 发明授权

US06607496B1 Steerable stylet with enhanced torsional transfer strength 有权
标题翻译：具有增强的扭转传递强度的方向导管
公开(公告)号：US06607496B1
公开(公告)日：2003-08-19
申请号：US09659286
申请日：2000-09-12
申请人： Corinne A. G. Poor , Kenneth C. Gardeski
发明人： Corinne A. G. Poor , Kenneth C. Gardeski
IPC分类号： A61B500
CPC分类号： A61M25/0012 , A61M25/005 , A61M25/0052 , A61M25/0054 , A61M25/0138 , A61M25/0147 , A61M2025/09116
摘要： A steerable guidewire or stylet that has increased torsional strength is disclosed. A braided structure located in the vicinity of at least the distal end of the guidewire or stylet provides for a more efficient transfer of rotational force over the length of the guidewire or stylet. The braided structure may be comprised of a flat metal ribbon wire that may optionally be reinforced with a polyimide. According to one aspect of the invention, the stylet includes an outer member, and a pull-wire located within the outer member. The pull-wire is coupled to the distal tip of the outer member such that when tension is applied to the pull-wire, the distal tip of the outer member is deflected. The distal tip of the outer member may be formed of a material having superelastic properties such as a nickel titanium alloy, whereas the proximal portion of the stylet may be formed of a material having more torsional strength. The distal tip of the outer member may further include at least one aperture to provide a preferred bending direction when tension is applied to the pull-wire. Pull-wire is retained within the at least one aperture by the braided structure. According to another aspect of the invention, a handle is provided that includes both rotatable and slidable mechanisms to facilitate deflection of the distal tip portion of the outer member. In one embodiment, the handle may be adapted for use with a lead extension tool.
摘要翻译：公开了具有增加的扭转强度的可导向的导丝或探针。位于导线或管心针的至少远端附近的编织结构提供了在导线或探针的长度上更有效的转动力。编织结构可以由可以任选地用聚酰亚胺增强的扁平金属带状丝线组成。根据本发明的一个方面，探针包括外部构件和位于外部构件内的拉线。拉线联接到外部构件的远侧末端，使得当拉力施加到拉线时，外部构件的远侧末端被偏转。外部构件的远端可以由具有超弹性特性的材料形成，例如镍钛合金，而探针的近端部分可以由具有更大扭转强度的材料形成。外部构件的远侧末端还可以包括至少一个孔，以便当拉力施加到拉线时提供优选的弯曲方向。拉丝由编织结构保持在至少一个孔内。根据本发明的另一方面，提供一种手柄，其包括可旋转和可滑动的机构，以便于外部构件的远侧末端部分的偏转。在一个实施例中，手柄可以适于与引线延伸工具一起使用。

46. 发明授权

US06280433B1 Introducer system 有权
标题翻译：介绍系统
公开(公告)号：US06280433B1
公开(公告)日：2001-08-28
申请号：US09392715
申请日：1999-09-09
申请人： Michael E. McIvor , Kenneth C. Gardeski , Pedro A. Meregotte , Mathew D. Bonner , Timothy G. Laske , Linda L. Lach
发明人： Michael E. McIvor , Kenneth C. Gardeski , Pedro A. Meregotte , Mathew D. Bonner , Timothy G. Laske , Linda L. Lach
IPC分类号： A61M2500
CPC分类号： A61M25/0668 , A61M25/01 , A61M2025/0675
摘要： An introducer or guide catheter for directing an implantable medical device such as a lead or catheter to a desired location within a patient's body. In one embodiment of the invention, the introducer comprises a two-lumen tube. A first lumen is configured to receive the implantable medical device that is to be introduced. A second lumen is provided to receive an insertable, elongated guiding member such as a stylet, which may be shapable in various orientations, and which may be used to alter the configuration of the introducer. The second lumen may be provided with an internal coil or other tubular reinforcement member to prevent perforation of this lumen by the guiding member when the introducer is in the patient's body. In order to facilitate removal of the introducer over an implantable medical device having a connector or fitting that is larger than the internal diameter of the first lumen, the introducer may be adapted to be slit or split along its length. In some embodiments of the invention, the introducer may be rendered splittable by provision of a weakened zone along its length. According to yet another aspect of the invention, the introducer may be provided with a luer lock at its proximal end to facilitate connection of the introducer to a hemostasis valve, t-fitting, or the like.
摘要翻译：导引器或引导导管，用于将诸如引线或导管的可植入医疗装置引导到患者体内的期望位置。在本发明的一个实施例中，导引器包括两腔管。第一管腔被配置为接收待引入的可植入医疗装置。提供第二内腔以接收可插入的细长引导构件，例如探针，其可以以各种取向成形，并且其可以用于改变导引器的构造。第二内腔可以设置有内部线圈或其他管状加强构件，以在导引器位于患者体内时防止引导构件对该内腔穿孔。为了便于在具有大于第一内腔的内径的连接器或配件的可植入医疗装置上移除导引器，导引器可以适于沿着其长度被切割或分开。在本发明的一些实施例中，导引器可以通过沿着其长度提供弱化区域而被分解。根据本发明的另一方面，导引器在其近端可以设置有鲁尔锁，以便于将导引器连接到止血阀，t形配件等。

47. 发明授权

US09572982B2 Techniques for placing medical leads for electrical stimulation of nerve tissue 有权
标题翻译：放置用于电刺激神经组织的医疗线的技术
公开(公告)号：US09572982B2
公开(公告)日：2017-02-21
申请号：US12433766
申请日：2009-04-30
申请人： John E. Burnes , Kenneth C. Gardeski , Ruth N. Klepfer , Patrick E. Macaulay , Mary M. Morris , Avram Scheiner
发明人： John E. Burnes , Kenneth C. Gardeski , Ruth N. Klepfer , Patrick E. Macaulay , Mary M. Morris , Avram Scheiner
IPC分类号： A61B19/00 , A61N1/36 , A61N1/05 , A61M25/09
CPC分类号： A61N1/36053 , A61M25/09 , A61N1/05 , A61N1/0551 , A61N1/0558 , A61N1/057 , A61N1/36085 , A61N1/36114 , A61N1/36125 , A61N1/36128
摘要： This disclosure is directed to extra, intra, and transvascular medical lead placement techniques for arranging medical leads and electrical stimulation and/or sensing electrodes proximate nerve tissue within a patient.
摘要翻译：本公开涉及用于在患者体内靠近神经组织布置医疗引线和电刺激和/或感测电极的额外的，内部的和经血管内的医疗引线放置技术。

48. 发明授权

US09067042B2 Steerable stylet with guidewire tip 有权
标题翻译：导丝针尖的导向通心针
公开(公告)号：US09067042B2
公开(公告)日：2015-06-30
申请号：US12771265
申请日：2010-04-30
申请人： Kenneth C. Gardeski , Ronald A. Drake
发明人： Kenneth C. Gardeski , Ronald A. Drake
IPC分类号： A61M25/01
CPC分类号： A61M25/0138 , A61M25/0133 , A61M25/0136 , A61M25/0147 , A61M2025/0161
摘要： 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.
摘要翻译：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。

49. 发明授权

US08734397B2 System and method for positioning implantable medical devices within coronary veins 有权
标题翻译：将植入式医疗器械定位在冠状静脉内的系统和方法
公开(公告)号：US08734397B2
公开(公告)日：2014-05-27
申请号：US12357810
申请日：2009-01-22
申请人： Stanten C. Spear , James F. Kelley , Kenneth C. Gardeski , Mohmoud K. Seraj , Eric K. Y. Chan
发明人： Stanten C. Spear , James F. Kelley , Kenneth C. Gardeski , Mohmoud K. Seraj , Eric K. Y. Chan
IPC分类号： A61M5/178
CPC分类号： A61M25/0668 , A61B18/1492 , A61B2017/22038 , A61B2018/00386 , A61M25/005 , A61M25/0051 , A61M25/0054 , A61M25/008 , A61M25/0138 , A61M25/0141 , A61M25/0147 , A61M2025/0042 , A61M2025/0047 , A61M2025/0081 , A61M2025/0161 , A61M2025/0681 , A61M2025/1052 , A61M2025/1079 , A61N1/056 , A61N2001/0578 , A61N2001/0585
摘要： An improved system and method for placing implantable medical devices (IMDs) such as leads within the coronary sinus and branch veins is disclosed. In one embodiment, a slittable delivery sheath and a method of using the sheath are provided. The sheath includes a slittable hub, and a substantially straight body defining an inner lumen. The body comprises a shaft section and a distal section that is distal to, and softer than, the shaft section. A slittable braid extends adjacent to at least a portion of one of the shaft section and the distal section. In one embodiment of the invention, the sheath further includes a transition section that is distal to the shaft section, and proximal to the distal section. The transition section is softer than the shaft section, but stiffer than the distal section.
摘要翻译：公开了用于在冠状窦和分支静脉内放置诸如引线的可植入医疗装置（IMD）的改进的系统和方法。在一个实施例中，提供了可切割的输送护套和使用护套的方法。护套包括可切割的毂，以及限定内腔的基本上直的身体。主体包括轴部分和远离轴部分的远端部分和远端部分。狭缝编织物相邻于轴部和远端部分中的一个的至少一部分延伸。在本发明的一个实施例中，护套还包括在轴部分的远侧并且靠近远端部分的过渡部分。过渡部分比轴部分软，但比远端部分更硬。

50. 发明授权

US08340783B2 Implantable medical device lead with selectively exposed electrodes and reinforcement member 有权
标题翻译：植入式医疗器械引线带有选择性暴露的电极和加强构件
公开(公告)号：US08340783B2
公开(公告)日：2012-12-25
申请号：US12825647
申请日：2010-06-29
申请人： John L. Sommer , Kenneth C. Gardeski , Xiaonan Shen , Jon D. Schell
发明人： John L. Sommer , Kenneth C. Gardeski , Xiaonan Shen , Jon D. Schell
IPC分类号： A61N1/05
CPC分类号： A61N1/056 , A61N1/05 , A61N1/0534 , A61N1/0551 , A61N1/0558 , A61N1/086
摘要： 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.
摘要翻译：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。

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