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公开(公告)号：US08948865B2
公开(公告)日：2015-02-03
申请号：US14081634
申请日：2013-11-15
发明人： Denise Zarins , Hanson Gifford, III
CPC分类号： A61M25/0084 , A61B17/3478 , A61B18/04 , A61B18/1492 , A61B2018/0022 , A61B2018/00434 , A61B2018/00511 , A61B2018/00577 , A61F7/007 , A61K38/4893 , A61M5/00 , A61M2025/0085 , A61M2202/0007 , A61M2210/1082 , A61N1/05 , A61N1/0551 , A61N1/32 , A61N1/36017 , A61N1/36114 , A61N7/02 , C12Y304/24069
摘要： Methods and apparatus are provided for treatment of heart arrhythmia via renal neuromodulation. Such neuromodulation may effectuate irreversible electroporation or electrofusion, ablation, necrosis and/or inducement of apoptosis, alteration of gene expression, action potential attenuation or blockade, changes in cytokine up-regulation and other conditions in target neural fibers. In some embodiments, such neuromodulation is achieved through application of an electric field. In some embodiments, such neuromodulation is achieved through application of neuromodulatory agents, of thermal energy and/or of high intensity focused ultrasound. In some embodiments, such neuromodulation is performed in a bilateral fashion.
摘要翻译： 提供了通过肾脏神经调节治疗心律失常的方法和装置。 这种神经调节可以实现不可逆的电穿孔或电融合，消融，坏死和/或诱导凋亡，基因表达的改变，动作电位衰减或阻断，细胞因子上调的变化和靶神经纤维中的其它条件。 在一些实施例中，通过施加电场来实现这种神经调节。 在一些实施方案中，通过应用神经调节剂，热能和/或高强度聚焦超声来实现这种神经调节。 在一些实施方案中，这种神经调节以双向方式进行。
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公开(公告)号：US20150018821A1
公开(公告)日：2015-01-15
申请号：US14335016
申请日：2014-07-18
发明人： Denise Zarins , Nicolas Zadno , Benjamin J. Clark , Erik Thai
CPC分类号： A61B18/1492 , A61B17/12136 , A61B2018/00083 , A61B2018/00285 , A61B2018/00434 , A61B2018/00613 , A61M25/0108 , A61M25/10 , A61N1/327 , A61N1/36007 , A61N1/36121 , A61N1/36182 , A61N1/37205 , A61N1/40
摘要： Methods and apparatus are provided for intravascularly-induced neuromodulation using a pulsed electric field, e.g., to effectuate irreversible electroporation or electrofusion, necrosis and/or inducement of apoptosis, alteration of gene expression, changes in cytokine upregulation, etc., in target neural fibers. In some embodiments, the intravascular PEF system comprises a catheter having a pair of bipolar electrodes for delivering the PEF, with a first electrode positioned on a first side of an impedance-altering element and a second electrode positioned on an opposing side of the impedance-altering element. A length of the electrodes, as well as a separation distance between the first and second electrodes, may be specified such that, with the impedance-altering element deployed in a manner that locally increases impedance within a patient's vessel, e.g., with the impedance-altering element deployed into contact with the vessel wall at a treatment site within the patient's vasculature, a magnitude of applied voltage delivered across the bipolar electrodes necessary to achieve desired neuromodulation is reduced relative to an intravascular PEF system having similarly spaced electrodes but no (or an undeployed) impedance-altering element. In a preferred embodiment, the impedance-altering element comprises an inflatable balloon configured to locally increase impedance within a patient's vasculature. The methods and apparatus of the present invention may be used to modulate a neural fiber that contributes to renal function.
摘要翻译： 提供了使用脉冲电场进行血管内诱导的神经调节的方法和装置，例如，在靶神经纤维中实现不可逆的电穿孔或电融合，坏死和/或诱导细胞凋亡，基因表达的改变，细胞因子上调的变化等 。 在一些实施例中，血管内PEF系统包括导管，其具有用于传送PEF的一对双极电极，第一电极位于阻抗改变元件的第一侧上，第二电极位于阻抗变换元件的相对侧上， 改变元素 可以规定电极的长度以及第一和第二电极之间的间隔距离，使得以阻抗变化元件部署的方式，其局部地增加患者血管内的阻抗，例如阻抗 - 改变元件被部署成与病人血管系统中的治疗部位处的血管壁接触，相对于具有类似间隔开的电极而没有（或一个或多个）的血管内PEF系统，减少了实现所需神经调节所需双极电极的施加电压的大小 未部署）阻抗变化元件。 在优选实施例中，阻抗改变元件包括构造成在患者的脉管系统内局部增加阻抗的可充气球囊。 本发明的方法和装置可用于调节有助于肾功能的神经纤维。
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公开(公告)号：US20150005676A1
公开(公告)日：2015-01-01
申请号：US14298121
申请日：2014-06-06
发明人： Denise Zarins , Nicolas Zadno , Benjamin J. Clark , Erik Thai , Howard R. Levin , Mark Gelfand
CPC分类号： A61N7/022 , A61B18/02 , A61B18/04 , A61B18/12 , A61B18/1492 , A61B2018/0022 , A61B2018/00434 , A61B2018/00511 , A61B2018/00577 , A61F7/007 , A61F7/12 , A61F7/123 , A61F2007/126 , A61M5/44 , A61M2210/1082 , A61N1/28 , A61N1/36007 , A61N1/403 , A61N5/00 , A61N5/025 , A61N5/045 , A61N5/0603 , A61N7/00 , A61N7/02 , A61N2007/003 , A61N2007/0078
摘要： Methods and apparatus are provided for thermally-induced renal neuromodulation. Thermally-induced renal neuromodulation may be achieved via direct and/or via indirect application of thermal energy to heat or cool neural fibers that contribute to renal function, or of vascular structures that feed or perfuse the neural fibers. In some embodiments, parameters of the neural fibers, of non-target tissue, or of the thermal energy delivery element, may be monitored via one or more sensors for controlling the thermally-induced neuromodulation. In some embodiments, protective elements may be provided to reduce a degree of thermal damage induced in the non-target tissues.
摘要翻译： 提供了用于热诱导的肾神经调节的方法和装置。 热诱导的肾神经调节可以通过直接和/或通过间接施加热能来加热或冷却有助于肾功能的神经纤维或者供给或灌注神经纤维的血管结构来实现。 在一些实施例中，神经纤维，非目标组织或热能递送元件的参数可以经由一个或多个传感器来监测，以控制热诱导的神经调节。 在一些实施方案中，可以提供保护元件以减少在非靶组织中诱导的热损伤程度。
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公开(公告)号：US20140172054A1
公开(公告)日：2014-06-19
申请号：US14034434
申请日：2013-09-23
发明人： Denise Zarins , Hanson Gifford, III , Mark Deem , Douglas Sutton , Howard R. Levin , Mark Gelfand
IPC分类号： A61N1/05
CPC分类号： A61N1/0551 , A61B18/12 , A61B18/14 , A61B18/1492 , A61B2018/00267 , A61B2018/00351 , A61B2018/00404 , A61B2018/00434 , A61B2018/00511 , A61B2018/00577 , A61B2018/00613 , A61M5/1408 , A61M5/14276 , A61M2210/1082 , A61N1/0412 , A61N1/05 , A61N1/327 , A61N1/36007 , A61N1/36017 , A61N7/00
摘要： Methods and apparatus are provided for bilateral renal neuromodulation, e.g., via a pulsed electric field, via a stimulation electric field, via localized drug delivery, via high frequency ultrasound, via thermal techniques, etc. Such neuromodulation may effectuate irreversible electroporation or electrofusion, necrosis and/or inducement of apoptosis, alteration of gene expression, action potential attenuation or blockade, changes in cytokine up-regulation and other conditions in target neural fibers. In some embodiments, neuromodulation is applied to neural fibers that contribute to renal function. In some embodiments, such neuromodulation is performed in a bilateral fashion. Bilateral renal neuromodulation may provide enhanced therapeutic effect in some patients as compared to renal neuromodulation performed unilaterally, i.e., as compared to renal neuromodulation performed on neural tissue innervating a single kidney.
摘要翻译： 提供了双侧肾神经调节的方法和装置，例如通过脉冲电场，通过刺激电场，经由局部药物递送，经由高频超声波，通过热技术等。这种神经调节可以实现不可逆的电穿孔或电融合，坏死 和/或诱导细胞凋亡，改变基因表达，动作电位减弱或阻断，细胞因子上调和靶神经纤维中的其他条件的变化。 在一些实施方案中，神经调节被应用于有助于肾功能的神经纤维。 在一些实施方案中，这种神经调节以双向方式进行。 与单侧执行的肾神经调节相比，双侧肾神经调节可以在一些患者中提供增强的治疗效果，即与在支配单个肾脏的神经组织上进行的肾神经调节相比。
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公开(公告)号：US08728138B2
公开(公告)日：2014-05-20
申请号：US13765532
申请日：2013-02-12
发明人： Denise Zarins , Nicolas Zadno , Benjamin J. Clark , Erik Thai , Howard R. Levin , Mark Gelfand
IPC分类号： A61F7/12
CPC分类号： A61N7/022 , A61B18/02 , A61B18/04 , A61B18/12 , A61B18/1492 , A61B2018/0022 , A61B2018/00434 , A61B2018/00511 , A61B2018/00577 , A61F7/007 , A61F7/12 , A61F7/123 , A61F2007/126 , A61M5/44 , A61M2210/1082 , A61N1/28 , A61N1/36007 , A61N1/403 , A61N5/00 , A61N5/025 , A61N5/045 , A61N5/0603 , A61N7/00 , A61N7/02 , A61N2007/003 , A61N2007/0078
摘要： Methods and apparatus are provided for thermally-induced renal neuromodulation. Thermally-induced renal neuromodulation may be achieved via direct and/or via indirect application of thermal energy to heat or cool neural fibers that contribute to renal function, or of vascular structures that feed or perfuse the neural fibers. In some embodiments, parameters of the neural fibers, of non-target tissue, or of the thermal energy delivery element, may be monitored via one or more sensors for controlling the thermally-induced neuromodulation. In some embodiments, protective elements may be provided to reduce a degree of thermal damage induced in the non-target tissues.
摘要翻译： 提供了用于热诱导的肾神经调节的方法和装置。 热诱导的肾神经调节可以通过直接和/或通过间接施加热能来加热或冷却有助于肾功能的神经纤维或者供给或灌注神经纤维的血管结构来实现。 在一些实施例中，神经纤维，非目标组织或热能递送元件的参数可以经由一个或多个传感器来监测，以控制热诱导的神经调节。 在一些实施方案中，可以提供保护元件以减少在非靶组织中诱导的热损伤程度。
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公开(公告)号：US08652133B2
公开(公告)日：2014-02-18
申请号：US13941331
申请日：2013-07-12
发明人： Denise Zarins , Hanson Gifford, III , Mark Deem , Nicolas Zadno , Benjamin J. Clark , Andrew Wu , Kenneth J. Michlitsch
IPC分类号： A61B18/12
摘要： Methods and apparatus are provided for non-continuous circumferential treatment of a body lumen. Apparatus may be positioned within a body lumen of a patient and may deliver energy at a first lengthwise and angular position to create a less-than-full circumferential treatment zone at the first position. The apparatus also may deliver energy at one or more additional lengthwise and angular positions within the body lumen to create less-than-full circumferential treatment zone(s) at the one or more additional positions that are offset lengthwise and angularly from the first treatment zone. Superimposition of the first treatment zone and the one or more additional treatment zones defines a non-continuous circumferential treatment zone without formation of a continuous circumferential lesion. Various embodiments of methods and apparatus for achieving such non-continuous circumferential treatment are provided.
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公开(公告)号：US20210259760A1
公开(公告)日：2021-08-26
申请号：US17314894
申请日：2021-05-07
发明人： Sowmya Ballakur , Robert J. Beetel , Paul Friedrichs , David Herzfeld , Andrew Wu , Denise Zarins , Mark S. Leung
摘要： The present disclosure relates to devices, systems and methods for evaluating the success of a treatment applied to tissue in a patient, such as a radio frequency ablative treatment used to neuromodulate nerves associated with the renal artery. A system monitors parameters or values generated during the course of a treatment. Feedback provided to an operator is based on the monitored values and relates to an assessment of the likelihood that a completed treatment was technically successful. In other embodiments, parameters or values generated during the course of an incomplete treatment (such as due to high temperature or high impedance conditions) may be evaluated to provide additional instructions or feedback to an operator.
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28.发明申请公开(公告)号：US20200214765A1
公开(公告)日：2020-07-09
申请号：US16820444
申请日：2020-03-16
发明人： Andrew Wu , Benjamin J. Clark , Denise Zarins , Erik Thai
摘要： Apparatus, systems, and methods for achieving thermally-induced renal neuromodulation by intravascular access are disclosed herein. One aspect of the present application, for example, is directed to apparatuses, systems, and methods that incorporate a treatment device comprising an elongated shaft. The elongated shaft is sized and configured to deliver a thermal element to a renal artery via an intravascular path. Thermally-induced renal neuromodulation may be achieved via direct and/or via indirect application of thermal energy to heat or cool neural fibers that contribute to renal function, or of vascular structures that feed or perfuse the neural fibers,
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29.发明授权公开(公告)号：US10420606B2
公开(公告)日：2019-09-24
申请号：US15793741
申请日：2017-10-25
发明人： Denise Zarins , Hanson Gifford, III , Mark Deem , Nicolas Zadno , Benjamin J. Clark , Andrew Wu , Kenneth J. Michlitsch
摘要： Methods and apparatus are provided for non-continuous circumferential treatment of a body lumen. Apparatus may be positioned within a body lumen of a patient and may deliver energy at a first lengthwise and angular position to create a less-than-full circumferential treatment zone at the first position. The apparatus also may deliver energy at one or more additional lengthwise and angular positions within the body lumen to create less-than-full circumferential treatment zone(s) at the one or more additional positions that are offset lengthwise and angularly from the first treatment zone. Superimposition of the first treatment zone and the one or more additional treatment zones defines a non-continuous circumferential treatment zone without formation of a continuous circumferential lesion. Various embodiments of methods and apparatus for achieving such non-continuous circumferential treatment are provided.
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公开(公告)号：US10376311B2
公开(公告)日：2019-08-13
申请号：US16141042
申请日：2018-09-25
发明人： Denise Zarins , Nicolas Zadno , Benjamin J. Clark , Erik Thai
IPC分类号： A61B18/14 , A61N1/36 , A61N1/372 , A61M25/10 , A61N1/32 , A61N1/40 , A61B17/12 , A61M25/01 , A61B18/00
摘要： Methods and apparatus are provided for intravascularly-induced neuromodulation using a pulsed electric field, e.g., to effectuate irreversible electroporation or electrofusion, necrosis and/or inducement of apoptosis, alteration of gene expression, changes in cytokine upregulation, etc., in target neural fibers. In some embodiments, the intravascular PEF system comprises a catheter having a pair of bipolar electrodes for delivering the PEF, with a first electrode positioned on a first side of an impedance-altering element and a second electrode positioned on an opposing side of the impedance-altering element. A length of the electrodes, as well as a separation distance between the first and second electrodes, may be specified such that, with the impedance-altering element deployed in a manner that locally increases impedance within a patient's vessel, e.g., with the impedance-altering element deployed into contact with the vessel wall at a treatment site within the patient's vasculature, a magnitude of applied voltage delivered across the bipolar electrodes necessary to achieve desired neuromodulation is reduced relative to an intravascular PEF system having similarly spaced electrodes but no (or an undeployed) impedance-altering element. In a preferred embodiment, the impedance-altering element comprises an inflatable balloon configured to locally increase impedance within a patient's vasculature. The methods and apparatus of the present invention may be used to modulate a neural fiber that contributes to renal function.
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