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.

Methods and apparatus for thermally-induced renal neuromodulation

An adherent device to monitor a patient for an extended period comprises a breathable tape. The breathable tape comprises a porous material with an adhesive coating to adhere the breathable tape to a skin of the patient. At least one electrode is affixed to the breathable tape and capable of electrically coupling to a skin of the patient. A printed circuit board is connected to the breathable tape to support the printed circuit board with the breathable tape when the tape is adhered to the patient. Electronic components electrically are connected to the printed circuit board and coupled to the at least one electrode to measure physiologic signals of the patient. A breathable cover and/or an electronics housing is disposed over the circuit board and electronic components and connected to at least one of the electronics components, the printed circuit board or the breathable tape.

Adherent device with multiple physiological sensors

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 to a body lumen

Methods and apparatus are provided for pulsed electric field 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, the ITEV PEF system comprises 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 of the present invention 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 apparatus are provided for intravascularly-induced neuromodulation or denervation. Neuromodulation may be achieved via direct and/or via indirect application of energy or neuromodulatory agents to target neural matter, or to vascular structures that support the target neural matter. In some embodiments, parameters of the target neural matter, of non-target tissue, or of the apparatus may be monitored via one or more sensors for controlling the neuromodulation or denervation. Such monitoring data optionally may be utilized for feedback control of the neuromodulation or denervation.

Methods and apparatus for intravascularly-induced neuromodulation or denervation

Various embodiments provide an implantable medical device comprising a detector, a neural stimulator, and a controller. The detector is configured to detect a pathological condition indicated for an acute neural stimulation therapy. The neural stimulator is capable of delivering a chronic neural stimulation therapy and the acute neural stimulation therapy. The controller is configured to control the neural stimulator to provide the chronic neural stimulation therapy, receive an indicator from the detector that the pathological condition is detected, and control the neural stimulator to integrate the acute neural stimulation therapy with the chronic neural stimulation therapy in response to the indicator.

Neurostimulation systems and methods for cardiac conditions

Cardiac monitoring and/or stimulation methods and systems that provide one or more of monitoring, diagnosing, defibrillation, and pacing. Cardiac signal separation is employed for automatic capture verification using cardiac activation sequence information. Devices and methods sense composite cardiac signals using implantable electrodes. A source separation is performed using the composite signals. One or more signal vectors are produced that are associated with all or a portion of one or more cardiac activation sequences based on the source separation. A cardiac response to the pacing pulses is classified using characteristics associated with cardiac signal vectors and the signals associated with the vectors. Further embodiments may involve classifying the cardiac response as capture or non-capture, fusion or intrinsic cardiac activity. The characteristics may include an angle or an angle change of the cardiac signal vectors, such as a predetermined range of angles of the one or more cardiac signal vectors.

Automatic capture verification using electrocardiograms sensed from multiple implanted electrodes

Cardiac monitoring and/or stimulation methods and systems that provide one or more of monitoring, diagnosing, defibrillation, and pacing. Cardiac signal separation is employed to detect, monitor, track and/or trend ischemia using cardiac activation sequence information. Ischemia detection may involve sensing composite cardiac signals using implantable electrodes, and performing a signal separation that produces one or more cardiac activation signal vectors associated with one or more cardiac activation sequences. A change in the signal vector may be detected using subsequent separations. The change may be an elevation or depression of the ST segment of a cardiac cycle or other change indicative of myocardial ischemia, myocardial infarction, or other pathological change. The change may be used to predict, quantify, and/or qualify an event such as an arrhythmia, a myocardial infarction, or other pathologic change. Information associated with the vectors may be stored and used to track the vectors.

Cardiac activation sequence monitoring for ischemia detection

Methods and devices for classifying a cardiac response to pacing involve establishing a plurality of classification windows relative to and following a pacing pulse. One or more characteristics of a cardiac signal sensed following the pacing pulse are detected within one or more particular classification windows. The characteristics may be compared to one or more references. Classification of the cardiac response may be performed based on the comparison of the one or more characteristics to the one or more references and the particular classification windows in which the one ore more characteristics are detected.

Cardiac response classification using multiple classification windows

Cardiac monitoring and/or stimulation methods and systems provide monitoring, diagnosis, and defibrillation and/or pacing therapies. A signal processor receives a plurality of composite signals associated with a plurality of sources, performs a source separation, and produces one or more cardiac signal vectors associated with all or a portion of one or more cardiac activation sequences based on the source separation. A method of signal separation involves detecting a change in a characteristic of the cardiac signal vector relative to a baseline. One or more vectors and/or activation sequences may be selected, and information associated with the vectors and/or activation sequences may be stored and tracked.

Scott A. Meyer

Papers

Neurostimulation systems and methods for cardiac conditions

Automatic capture verification using electrocardiograms sensed from multiple implanted electrodes

Cardiac activation sequence monitoring for ischemia detection

Cardiac response classification using multiple classification windows

Cardiac activation sequence monitoring and tracking