Abstract: 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.

Abstract: Catheter apparatuses, systems, and methods for achieving renal neuromodulation by intravascular access are disclosed herein. One aspect of the present technology, for example, is directed to a treatment device having a multi-electrode array configured to be delivered to a renal blood vessel. The array is selectively transformable between a delivery or low-profile state (e.g., a generally straight shape) and a deployed state (e.g., a radially expanded, generally spiral/helical shape). The multi-electrode array is sized and shaped so that the electrodes or energy delivery elements contact an interior wall of the renal blood vessel when the array is in the deployed (e.g., spiral/helical) state. The electrodes or energy delivery elements are configured for direct and/or indirect application of thermal and/or electrical energy to heat or otherwise electrically modulate neural fibers that contribute to renal function.

Abstract: A method of using a cryotherapeutic system in accordance with a particular embodiment includes advancing an elongate shaft of a catheter toward a treatment location within a body lumen of a human patient and directing a flow of refrigerant toward a cryotherapeutic element at a distal end portion of the shaft. The directed refrigerant is expanded to cause cooling within a balloon of the cryotherapeutic element. The pressure within the balloon is monitored and its rate of change calculated. The rate of change is then processed using different feedback loops during different monitoring windows of a treatment cycle. The individual feedback loops include an upper and a lower threshold and are configured to cause the flow of refrigerant to the cryotherapeutic element to stop if the rate of change falls outside a range between the upper and the lower threshold.

Abstract: A neuromodulation catheter includes an elongate shaft and a neuromodulation element operably connected to the shaft. The neuromodulation element includes an elongate support member and a plurality of bow springs operably connected to the support member. The individual bow springs are configured to independently expand radially outward from the support member when the neuromodulation element transitions from a low-profile delivery state to a deployed state at a treatment location within a body lumen. The individual bow springs include a distal leg and a proximal leg and carry an electrode and/or a transducer between their respective distal and proximal legs. The distal and proximal legs of the plurality of bow springs are longitudinally interdigitated. The plurality of bow springs is configured to urge the electrodes and/or the transducers into contact with an inner surface of a wall of the body lumen at a series of contact regions.

Abstract: 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. In some embodiments, thermally-induced renal neuromodulation is achieved via delivery of a pulsed thermal therapy.

Abstract: Apparatus and methods for determining positioning of a energy delivery element include deploying a energy delivery element at a treatment site proximal to a vessel wall; using a multi-region pressure sensing apparatus to sense pressures applied in a plurality of directions about the energy delivery element; and determining an orientation of the energy delivery element based on the pressures measured in the plurality of directions about the energy delivery element.

Abstract: Catheters including elements configured to deliver energy to nerves at or near a treatment location within a body lumen. A treatment assembly is transformable between a low-profile delivery configuration wherein a pair of electrodes are in a staggered arrangement relative to each other along the longitudinal axis, and an expanded deployed configuration wherein the pair of electrodes is aligned along an electrode axis that is orthogonal relative to the longitudinal axis.

Abstract: Apparatus, systems, and methods of controlling energy delivered to electrodes used in electrically and/or thermally induced neuromodulation are provided to improve neuromodulation. In particular, a catheter treatment device having a control algorithm that regulates current or current density delivered to an electrode is provided. The electrode may maintain a known and consistent electrode contact surface area with the vessel. The control algorithm controls energy delivery to provide consistent current or current density to the treatment site, even though the tissue impedance Z may vary from patient to patient and vessel to vessel, and despite changes in impedance of the treatment site during the course of the treatment. The controlled delivery of energy can be used to control and maintain placement of the zone of thermal treatment and reduce undesirable energy delivery to unwanted locations near the treatment site.

Abstract: 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.

Abstract: 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.

Abstract: Methods for treating a hypertensive human patient are disclosed herein. A method in accordance with one embodiment comprises delivering a neuromodulatory agent to a renal nerve of the patient via an intravascularly positioned drug delivery catheter. The method includes at least partially blocking neural activity along the renal nerve with the neuromodulatory agent, which results in a therapeutically beneficial reduction in blood pressure of the patient.

Abstract: 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.

Abstract: Systems and methods for evaluating neuromodulation via hemodynamic responses are disclosed herein. A system configured in accordance with embodiments of the present technology can include, for example, a neuromodulation catheter comprising an elongated shaft having a distal portion, and a plurality of electrodes spaced along a distal portion. The system can further include a controller communicatively coupled to the electrodes. The controller can be configured to apply first and second stimuli at and/or proximate to a target site within a blood vessel before and after delivering neuromodulation energy to the target site, and detect, via at least one of the electrodes, vessel impedance resulting from the first and second stimuli to determine a baseline impedance and a post-neuromodulation impedance. The controller can further be configured to assess the efficacy of the neuromodulation based, at least in part, on a comparison of the baseline impedance and the post-neuromodulation impedance.

Abstract: Catheter apparatuses, systems, and methods for achieving 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 catheter treatment device comprising an elongated shaft. The elongated shaft is sized and configured to deliver an energy delivery element to a renal artery via an intravascular path. Thermal or electrical renal neuromodulation may be achieved via direct and/or via indirect application of thermal and/or electrical energy to heat or cool, or otherwise electrically modulate, neural fibers that contribute to renal function, or of vascular structures that feed or perfuse the neural fibers.

Abstract: Methods for treating a patient using therapeutic renal neuromodulation and associated devices, systems, and methods are disclosed herein. One aspect of the present technology is directed to methods including selectively neuromodulating afferent or efferent renal nerves. One or more measurable physiological parameters corresponding to systemic sympathetic overactivity or hyperactivity in the patient can thereby be reduced. Selectively neuromodulating afferent renal nerves can include inhibiting sympathetic neural activity in nerves proximate a renal pelvis. This can include, for example, neuromodulating via fluid within the renal pelvis. Selectively neuromodulating efferent renal nerves can include inhibiting sympathetic neural activity in nerves proximate a portion of a renal artery or a renal branch artery proximate a renal parenchyma. This can include, for example, neuromodulating via a therapeutic element within the portion of the renal artery or the renal branch artery.

Abstract: Neuromodulation systems with nerve monitoring assemblies and associated devices, systems, and methods are disclosed herein. A neuromodulation system configured in accordance with some embodiments of the present technology can include, for example, a generator, a nerve monitoring assembly configured to detect electroneurogram (ENG) signals, and a neuromodulation catheter. The neuromodulation catheter can include an elongated shaft with a distal portion and a proximal portion. The distal portion of the shaft can include an array of electrodes configured to detect nerve activity from within a blood vessel of a human. The proximal portion of the shaft can include at least one connector that operably couples the electrodes to the generator and to the nerve monitoring assembly.

Abstract: Methods for treating dyspnea with therapeutic renal neuromodulation and associated system and methods are disclosed herein. One aspect of the present technology, for example, is directed to methods that block, reduce, and/or inhibit renal sympathetic nerve activity to achieve a reduction in central sympathetic tone. Renal sympathetic nerve activity may be altered or modulated along the afferent and/or efferent pathway. The achieved reduction in central sympathetic tone may carry therapeutic benefits for patients with dyspnea.

Abstract: 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.

Abstract: Catheter assemblies for neuromodulation proximate a renal artery bifurcation and associated systems and methods are disclosed herein. A catheter assembly configured in accordance with a particular embodiment of the present technology can include a shaft having a proximal portion, a distal portion, and two therapeutic arms extending from the distal portion. The shaft can be configured to deliver the distal portion to a treatment site proximate a branch point or bifurcation in a renal blood vessel. The therapeutic arms can include energy delivery elements that are configured to deliver the therapeutically-effective energy to renal nerves proximate the branch point.

Abstract: Methods and apparatus are provided for renal neuromodulation using a pulsed electric field to effectuate electroporation or electrofusion. It is expected that renal neuromodulation (e.g., denervation) may, among other things, reduce expansion of an acute myocardial infarction, reduce or prevent the onset of morphological changes that are affiliated with congestive heart failure, and/or be efficacious in the treatment of end stage renal disease. Embodiments of the present invention are configured for percutaneous intravascular delivery of pulsed electric fields to achieve such neuromodulation.