Medtronic Ardian Luxembourg S.a.r.l.

Ardian, Inc.

Gogo Heel, LLC

Medtronic Ireland Manufacturing Unlimited Company

Other

Medtronic Adrian Luxembourg S.a.r.l.

Nicolas Zadno

Benjamin J Clark

Denise Marie Zarins

Erik Thai

Hanson Gifford

Mark Gelfand

Howard R Levin

Mark E Deem

Denise M Demarais

Andrew H Wu

Kenneth J Michlitsch

Grace Hwang

Hanson S Gifford, Iii

Douglas Sutton

Denise Demarals

Hanson Iii Gifford

Mark Deem

Methods and apparatus are provided for pulsed electric field (PEF) neuromodulation via an intra-to-extravascular approach, e.g., to effectuate irreversible electroporation or electrofusion, necrosis and/or inducement of apoptosis, alteration of gene expression, changes in cytokine upregulation and other conditions in target neural fibers. In some embodiments, an apparatus includes an intravascular catheter having one or more electrodes configured for intra-to-extravascular placement across a wall of patient's vessel into proximity with target neural fibers. With the electrode(s) passing from an intravascular position to an extravascular position prior to delivery of the PEF, a magnitude of applied voltage or energy delivered via the electrode(s) and necessary to achieve desired neuromodulation may be reduced relative to an intravascular PEF system having one or more electrodes positioned solely intravascularly. The methods and apparatus may, for example, be used to modulate one or more target neural fibers that contribute to renal function.

Methods and apparatus for pulsed electric field neuromodulation via an intra-to-extravascular approach

Methods and system 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. In some embodiments, thermally-induced renal neuromodulation is achieved via delivery of a pulsed thermal therapy.

Devices for thermally-induced renal neuromodulation

Heel protector

A shielding cup is provided for use with a self-fusing member or collapsible heat-concentrating accessory. The shielding cup is attached to a shoe heel as a temporary fix for a worn heel tip. The cup can be attached to the heel by a self-fusing member that binds to itself. The cup can also be attached by using a heat source and collapsible heat-concentrating accessory to concentrate heat on the heat-shrink version of the shielding cup. The cup can also be press fit on to the heel tip without the use of a self-fusing member or collapsible heat-concentrating accessory. Embodiments of the cup that can be press fit on to the heel tip include a rigid portion adjacent the base of the cup that engages the heel tip and a flexible portion extending away from the base of the cup. The flexible portion can be achieved by tapering the sidewalls of the cup along a longitudinal axis of the cup. Some embodiments of the cup that can be press fit on to the heel tip include a widened base having an outer periphery that is larger than an inner periphery.

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.

Methods and apparatus for performing a non-continuous circumferential treatment of a body lumen

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.

Methods and apparatus for intravascularly-induced neuromodulation

Methods and apparatus are provided for monopolar neuromodulation, e.g., via a pulsed electric field. Such monopolar 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, monopolar neuromodulation is applied to neural fibers that contribute to renal function. In some embodiments, such monopolar neuromodulation is performed bilaterally.

Methods and apparatus for monopolar renal neuromodulation

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.

Thermally-induced renal neuromodulation and associated systems and methods

A shielding cup is provided for use with a self-fusing member or collapsible heat-concentrating accessory. The shielding cup is attached to a shoe heel as a temporary fix for a worn heel tip. The cup can be attached to the heel by a self-fusing member that binds to itself. The cup can also be attached by using a heat source and collapsible heat-concentrating accessory to concentrate heat on the heat-shrink version of the shielding cup.

Methods for thermally-induced renal neuromodulation

Renal neuromodulation for treatment of human patients

Growing community of inventors

Fremont, CA, United States of America

Nicolas Zadno