Abstract: Methods of manufacturing a flexible force sensor include forming a first sensor part providing a plurality of spaced first electrode plates in an electrically non-conductive material. A second sensor part is also formed and includes a plurality of second electrode plates in an electrically non-conductive material. The second electrode plates are identical to the first electrode plates at least in terms of spacing. The first part is assembled to the second part such that each of the first electrode plates are aligned with and parallel to, yet spaced from, respective ones of the second electrode plates, establishing a plurality of capacitive sensing components. The first electrode plates are movable relative to the corresponding second electrode plates, establishing a variable gap therebetween. The sensor parts can be ring-shaped. The sensor parts can be formed via MEMS techniques, with the non-conductive material being a polymer.

Abstract: A compensation circuit has a predetermined, known complex impedance and is located in a handle of a catheter or in a distal end of a cable that connects to the catheter. The compensation circuit is probed with a pilot signal produced by a compensation control. The compensation control measures the complex impedance, which is the combination of the circuit's known impedance as well as that of the cable and then determines the difference between the measured and the known complex impedances which represents that which is attributable to the cable, and is used to cancel out such cable-related contributions to complex impedance in other electrical connections in the same cable. In another aspect, an unknown tissue is identified as one of a plurality of possible tissue types such as regular myocardium, scar and fat based on the measured phase angle of the complex impedance of the unknown tissue.

Abstract: A catheter system including an accelerometer-based sensing assembly is provided. In particular the present teachings relate to an accelerometer based assembly used to determine contact between a catheter and surrounding proximate tissue, such as cardiac tissue. An embodiment of such a system may, for example, be used for visualization, mapping, ablation, or other methods of diagnosis and treatment of tissue and/or surrounding areas.

Abstract: A medical device utilizing temperature sensing to identify or assess anatomical bodies or structures includes an elongate tubular member, at least one electrode, a thermal sensor, and a temperature response assessment system or component. The at least one electrode may be connected to the distal portion of the elongate tubular member, and the one or more electrode can be configured to provide energy or heat to a portion of an anatomical body or structure. The thermal sensor may be configured to measure the thermal response of the portion of an anatomical body or structure, e.g., tissue or blood pools. The temperature response assessment system or component can be coupled to the thermal sensor. In embodiments, the device may include a lumen and port opening, which may accommodate a tool, such as a needle. Methods for using temperature sensing to identify an anatomical body or structure are also disclosed.

Abstract: A catheter assembly for assessing contact between the catheter assembly and tissue is disclosed. The assembly includes a catheter shaft and a pressure sensitive conductive composite member whose electrical resistance varies with pressure applied to the catheter assembly. The assembly also includes at least one measurement terminal to permit the measurement of changes in the electrical characteristics of the pressure sensitive conductive composite member. The assembly may optionally include a measurement device to measure resistance, impedance and/or other electrical characteristics. The assembly may utilize a reference electrode secured to the patient's tissue, which permits the measurement device to measure changes between the reference electrode and the at least one measurement terminal. Optionally, the assembly may include a conductive outer layer.

Abstract: A system that automatically detects a myocardial barotrauma (i.e., tissue pop) event so that proper post-procedure care can be given includes an electronic control unit (ECU), a computer-readable memory coupled with the ECU, and detection logic stored in the memory configured to be executed by the ECU. The detection logic is configured to receive a signal generated by an electro-acoustic transducer related to acoustic activity within the patient, monitor the signal for a pre-determined indication of a barotrauma event, and output a notification when the pre-determined indication is detected. The transducer can be integrated with an extra-body patch that includes one or more electrodes for use with a medical device navigation system.

Abstract: An electrode catheter and a method for assessing electrode-tissue contact and coupling are disclosed. An exemplary electrode catheter comprises an electrode adapted to apply electrical energy. A measurement circuit is adapted to measure impedance between the electrode and ground as the electrode approaches a target tissue. A processor determines a contact and coupling condition for the target tissue based at least in part on reactance of the impedance measured by the measurement circuit. In another exemplary embodiment, the electrode catheter determines the contact and coupling condition based at least in part on a phase angle of the impedance.

Abstract: A catheter assembly for assessing contact between the catheter assembly and tissue is disclosed. The assembly includes a catheter shaft and a pressure sensitive conductive composite member whose electrical resistance varies with pressure applied to the catheter assembly. The assembly also includes at least one measurement terminal to permit the measurement of changes in the electrical characteristics of the pressure sensitive conductive composite member. The assembly may optionally include a measurement device to measure resistance, impedance and/or other electrical characteristics. The assembly may utilize a reference electrode secured to the patient's tissue, which permits the measurement device to measure changes between the reference electrode and the at least one measurement terminal. Optionally, the assembly may include a conductive outer layer.

Abstract: The present invention is directed to bipolar ablation systems. A bipolar electrode system for ablation therapy is disclosed, including a pressure-sensitive conducting composite layer and a pair of electrodes in electrical conductive contact or communication with the pressure-sensitive conducting composite layer. Energy (e.g., ablation energy) is delivered via the pressure-sensitive conductive composition when sufficient pressure is applied to transform the pressure-sensitive conductive composite to an electrical conductor. An electrically insulative flexible layer, which may include a passageway for a fill material is also disclosed. In some embodiments, the systems can also be used for targeted delivery of compounds, such as drugs, using a bipolar electrode.

Abstract: A monitoring, managing and protecting system is provided that includes a monitoring probe working in conjunction with an ablating device. The probe is configured to be positioned in close proximity to a region of non-targeted tissue proximate an ablation site of targeted tissue and to be operatively connected to an electrical response assessment system or component. The probe includes an elongate shaft having proximal and distal ends, with a handle disposed at the proximal end thereof and a tissue monitoring and protecting apparatus disposed at the distal end thereof. The ablating device includes an elongate shaft having proximal and distal ends, with a handle mounted at the proximal end thereof and an ablation element mounted at the distal end thereof. The monitoring probe measures electrical characteristics of the non-targeted tissue and/or of the tissue between the monitoring electrode and the ablation electrode.

Abstract: A contact sensing assembly including a catheter and an electrode including a tip portion and a base portion, and a generally central axis, with the electrode being connected to a distal end of the catheter. Optical sensor(s) may be provided for emitting and/or receiving an optical signal, with a part of the optical signal being transverse to the central axis. Optical interference member(s) may be provided for interfering with the optical signal. A method for sensing contact force exerted by an electrode on a tissue includes directing an optical signal along a portion of a catheter, emitting and/or receiving an optical signal, with a part of the optical signal being at a predetermined angle relative to the central axis, and sensing changes in intensity of the optical signal based on displacement associated with the electrode tip portion based on the contact force exerted by the electrode on the tissue.

Abstract: A transseptal medical device is provided including a dilator, a needle, and a needle control mechanism. The needle may be disposed within the dilator, and the needle control mechanism may be operably connected to a proximal end of the needle or the dilator for selective adjustment of the distal end of the needle from a first position within the dilator to a second position external to the dilator. The needle control mechanism may include an actuator configured for rotation within the dilator in one embodiment. In another embodiment, the proximal end of the dilator may incorporate internal threads and the proximal end of the needle may incorporate external threads, such that the needle may be configured for rotation during selective adjustment of the distal end of the needle from a first position to a second position. A method for puncturing a septum of a heart is also disclosed.

Abstract: The present invention is directed to bipolar ablation systems. A bipolar electrode system for ablation therapy is disclosed, including a pressure-sensitive conducting composite layer and a pair of electrodes in electrical conductive contact or communication with the pressure-sensitive conducting composite layer. Energy (e.g., ablation energy) is delivered via the pressure-sensitive conductive composition when sufficient pressure is applied to transform the pressure-sensitive conductive composite to an electrical conductor. An electrically insulative flexible layer, which may include a passageway for a fill material is also disclosed. In some embodiments, the systems can also be used for targeted delivery of compounds, such as drugs, using a bipolar electrode.

Abstract: A catheter system including an accelerometer-based sensing assembly is provided. In particular the present teachings relate to an accelerometer based assembly used to determine contact between a catheter and surrounding proximate tissue, such as cardiac tissue. An embodiment of such a system may, for example, be used for visualization, mapping, ablation, or other methods of diagnosis and treatment of tissue and/or surrounding areas.

Abstract: An electrode coupling output system provides indication to the physician, via electrode guidance instrumentation, concerning the electrical coupling of an electrode, such as an ablative or mapping electrode, with a patient. The output can be provided to the physician via an output device incorporated into the handle set of the electrode catheter. For example, a visual, audio or mechanical output can be provided via the handle set. Additionally or alternatively, the output can be provided to the physician via a navigation system. The indication may be provided by changing the color or other display characteristics of the electrode on the navigation system display or by way of providing a waveform indicating the electrode coupling. In this manner, electrode coupling information is provided to a physician in a manner that minimizes physician distraction.

Abstract: A monitoring, managing and protecting system is provided that includes a monitoring probe working in conjunction with an ablating device. The probe is configured to be positioned in close proximity to a region of non-targeted tissue proximate an ablation site of targeted tissue and to be operatively connected to an electrical response assessment system or component. The probe includes an elongate shaft having proximal and distal ends, with a handle disposed at the proximal end thereof and a tissue monitoring and protecting apparatus disposed at the distal end thereof. The ablating device includes an elongate shaft having proximal and distal ends, with a handle mounted at the proximal end thereof and an ablation element mounted at the distal end thereof. The monitoring probe measures electrical characteristics of the non-targeted tissue and/or of the tissue between the monitoring electrode and the ablation electrode.

Abstract: Methods, devices, and systems for predicting, diagnosing, and preventing adverse events during an ablation procedure are described. A method for providing ablation energy includes receiving a first signal based on biological activity of a tissue of a patient. The method further includes analyzing the first signal to yield a first data set, establishing a threshold parameter according to the first data set, and providing ablation energy for the ablation of a biological site.

Abstract: A care unit can include a base member and a plurality of petal members. Each petal member can extend from a first end, engaged with the base member, to a second end, spaced from the base member. Inward-facing surfaces of at least two petal members and the base member can collectively define a cavity for receiving at least a portion of the patient. The care unit can further include one or both of a therapy component, configured to provide a treatment to the patient, or a sensor component, configured to monitor a condition of the patient. The therapy component can be coupled to, or integrated with, one or both of the base member or a petal member and can include an optical light source, a thermal energy source, an oxygen or air source, a sound wave source, a sound wave-cancelling source, or a pulsating source, for example.

Abstract: An electrode catheter device with indifferent electrode for direct current tissue therapies is disclosed. An example of the catheter device has a flexible tubing with at least one ablation electrode. The catheter device also may also be used with a sheath for introducing the flexible tubing inside a patient's body. An indifferent electrode on the sheath can provide a ground for a direct current (DC) pulse to deliver electrical energy and create an electrical field adjacent a tissue. Various other embodiments are also disclosed.

Abstract: A contact sensing assembly including a catheter and an electrode including a tip portion and a base portion, and a generally central axis, with the electrode being connected to a distal end of the catheter. Optical sensor(s) may be provided for emitting and/or receiving an optical signal, with a part of the optical signal being transverse to the central axis. Optical interference member(s) may be provided for interfering with the optical signal. A method for sensing contact force exerted by an electrode on a tissue includes directing an optical signal along a portion of a catheter, emitting and/or receiving an optical signal, with a part of the optical signal being at a predetermined angle relative to the central axis, and sensing changes in intensity of the optical signal based on displacement associated with the electrode tip portion based on the contact force exerted by the electrode on the tissue.