Abstract: The present invention relates to determining a treatment response index. In order to improve and facilitate hypertension treatment procedures, a device (10) for determining a treatment response index is provided that comprises a data input (12), a data processor (14) and a data output (16). The data input is configured to receive a value (18) of at least one first measurement of a physiological parameter of a subjects vasculature under a first condition; and to provide a value (20) of at least one second measurement of the physiological parameter of the vasculature under a second condition. In the second condition, a pre-determined stimulation is provided, and the first condition is non-stimulated or at least differently stimulated. The data processor is configured to generate a treatment response index. In an example, the data output is configured to provide a classification of the subject into one of at least two groups of subjects, based on the treatment response index.

Abstract: A biodegradable pressure sensor for measuring vital physiological pressures and for preventing the buildup of dangerous internal forces in impaired organs. The pressure sensor is constructed by depositing Mg or Mo on both sides of a PLLA film. This layered configuration (Mg/PLLA/Mg) or (Mo/PLLA/Mo) may then be encapsulated by layers of high molecular weight PLA. These materials are biodegradable such that after implantation, the sensor does not require invasive removal surgery that can damage directly interfaced tissues.

Abstract: Intravascular catheters that include a handle assembly with first and second handle actuators, where the actuators are adapted to separately control inner and outer catheter shafts in at least one of axial displacement, deflection, or rotation. The catheters may also include a medical tool secured to the outer shaft.

Abstract: The present invention relates to steerable access sheath assembly including at least one electrode. Moreover, the present invention relates to a steerable sheath access device for use in cardiovascular procedures. Embodiments of the present invention including steerable access sheaths or introducers may provide cardiovascular access for various ablation tools and devices for the performance of various ablation procedures or procedures involving alternate energy sources.

Abstract: A treatment tool includes an elongated shaft that has a bending mechanism at a distal end thereof; a bending operation part that is connected to a proximal-end side of the shaft in order to operate the bending mechanism; a connection sleeve that is provided at a connection section of the bending operation part where the bending operation part and the shaft are connected, and that rotatably holds the shaft; a rotation operation member that is provided at the proximal-end side of the shaft and that rotates the shaft; and a stopper member that can be made to slide outside the connection sleeve along a direction of a longitudinal axis of the shaft and that is engaged with both the rotation operation member and the connection sleeve at a specific position in a range of movement thereof, thereby locking rotation of the shaft with respect to the connection sleeve.

Abstract: A catheter and catheter system can use energy tailored for remodeling and/or removal of target material along a body lumen, often of atherosclerotic material of a blood vessel of a patient. An elongate flexible catheter body with a radially expandable structure may have a plurality of electrodes or other electrosurgical energy delivery surfaces to radially engage atherosclerotic material when the structure expands. An atherosclerotic material detector system may measure and/or characterize the atherosclerotic material and its location, optionally using impedance monitoring.

Abstract: Aspects of the present disclosure are directed to, for example, a high-thermal-sensitivity ablation catheter tip including a thermally-insulative ablation tip insert supporting a plurality of temperature sensors positioned within longitudinally-extending sensor channels and a radially-extending sensor channel within the tip insert. The sensor channels position the temperature sensors in thermal communication with a conductive shell that encapsulates, or essentially encapsulates, the ablation tip insert and the plurality of temperature sensors. Also disclosed is a method of controlling the temperature of an ablation catheter tip while creating a desired lesion using various ablative energies and energy delivery methodologies.

Abstract: A circuit system includes a user interface, voltage source, and a terminal bank connected to the voltage source. The circuit can be used in a powered catheter system where the catheter includes a structural reinforcement layer such as a braid comprised of one or more wires. The reinforcement layer can be used to convey a current or signal in a powered catheter. The catheter may utilize a hypotube element which provides integrated sensors in order to power and control multiple systems in the powered catheter.

Abstract: The present disclosure provides systems and methods for detecting cardiac activation times of a patient. A system includes a data acquisition system and a processor communicatively coupled thereto. The data acquisition system is configured to detect a plurality of electrograms generated at a plurality of respective electrodes coupled to the patient. The processor is configured to receive the plurality of electrograms from the data acquisition system. The processor is further configured to compute respective energies of the plurality of electrograms. The processor is further configured to detect a cardiac activation time for a first electrogram among the plurality of electrograms based on the respective energy of the first electrogram and the respective energy of a second electrogram that neighbors the first electrogram.

Abstract: A catheter device for ablating biological material is described. The catheter device comprises (a) a longitudinal structure; (b) an applicator for ablating the biological material, wherein the applicator is installed at the longitudinal structure; (c) a first electrode being attached to the longitudinal structure; (d) a second electrode being attached to the longitudinal structure; (e) an interface being connected directly or indirectly to the longitudinal structure; (f) a first lead electrically connecting the first electrode with the interface; and (g) a second lead electrically connecting the second electrode with the interface. The interface is configured for electrically connecting the first lead and the second lead with a measurement device for electrically stimulating the first electrode and the second electrode and for detecting an electric quantity being associated with an electric response of an biological material being located in between the two stimulated electrodes.

Abstract: Methods of treating pain are disclosed, wherein a non-pulsed, low-frequency electrical current is applied to the nerve carrying the pain signals in order to suppress transmission of those signals. In desired embodiments, the current is applied in a direction transverse to the nerve axis. Such currents have been found not to induce motor-neuron recruitment, meaning these methods can treat pain without causing muscle spasm or other muscular responses. A cuff for applying such a current transverse to the nerve axis is also disclosed.

Abstract: A system and method for positioning sheaths into the Coronary Sinus using a guiderail catheter.

Abstract: A drug delivery and monitoring device comprising a nerve stimulating element configured to deliver an electric stimulus, a recording element configured to detect a compound action potential, and a drug-delivery element.

Abstract: A vapor delivery needle is provided that may include any of a number of features. One feature of the energy delivery probe is that it can apply condensable vapor energy to tissue, such as a prostrate, to shrink, damage, or denature tissues of the prostate. Methods associated with use of the energy delivery probe are also covered.

Abstract: A surgical device integrating a suction mechanism with a coagulation mechanism is provided for improving lesion creation capabilities. The device comprises an elongate member having an insulative covering attached about means for coagulating soft tissue. Openings through the covering expose regions of the coagulation-causing elements and are coupled to lumens in the elongate member which are routed to a vacuum source. A fluid source to passively transport fluid along the contacted soft tissue surface may be provided in order to push the maximum temperature deeper into tissue.

Abstract: A surgical instrument including a housing, a shaft, an end effector assembly, a first electrical wire, and a wire guide. The shaft defines a lumen and extends distally from the housing. The end effector assembly is disposed at a distal end portion of the shaft and includes a first electrically-conductive tissue-treating surface. The first electrical wire extends from the housing, through the shaft, and into electrical communication with the first electrically-conductive tissue-treating surface. The electrical wire is adapted to connect to a source of energy and configured to supply energy to the first electrically-conductive tissue-treating surface. The wire guide is disposed within the housing and engaged about a proximal portion of the shaft within the housing. The wire guide is also configured to guide the first electrical wire from the housing into the shaft.

Abstract: An endovascular near critical fluid based cryoablation catheter for creating an elongate lengthwise-continuous lesion in tissue comprises an elongate shaft, a flexible distal tissue treatment section, and a distal tip. A plurality of flexible tubes extend through the distal treatment section to transport a near critical fluid to and from the distal tip. The distal treatment section is controllably deployed to match the contour of an anatomical region to be treated. In embodiments the distal treatment section includes a superelastic material and can assume a plurality of different shapes based on the distance ejected from an outer sleeve member. When the catheter is activated, heat is transferred between a target tissue and the distal treatment section of the catheter thereby creating the elongate lengthwise-continuous lesion in the tissue.

Abstract: Medical devices and methods for making and using medical devices are disclosed. An example medical device may include a system for measuring blood pressure. The system may include a pressure sensing guidewire including a pressure sensor and a first optical fiber extending proximally from the pressure sensor. The system may also include an optical connector cable including a distal connector capable of being coupled to the guidewire. The optical connector cable may include a second optical fiber that is capable of optically communicating with the first optical fiber. A coupler may be disposed within the distal connector and disposed between the first optical fiber and the second optical fiber.

Abstract: A surgical instrument system comprising an end effector, a staple cartridge, a cutting member, an electric motor, a sensing system, and a control system is disclosed. The end effector comprises a proximal portion, a distal end, a first iaw, and a second iaw movable relative to the first iaw to clamp tissue between the first and second iaw. The cutting member is configured to move within a longitudinal channel of the staple cartridge. The electric motor is couplable to the cutting member and configured to drive the cutting member. The sensing system comprises a plurality of sensing circuits. Each sensing circuit comprises first and second sensing elements positioned adjacent the longitudinal channel. The control system is configured to determine impedances of the tissue at multiple locations along a staple line as the cutting member progresses distally within the longitudinal channel and automatically control a speed of the electric motor.

Abstract: A medical lead includes a coiled conductor portion that defines at least part of an outer surface of the lead and an expandable coiled fixation element that defines at least a part of the outer surface of the lead. The expandable coiled fixation element is configured to expand from a first dimension in a first state to a second dimension in a second state in a direction away from the coiled conductor portion. In some examples, the expandable coiled fixation element comprises a shape memory material.

Abstract: The multifunctional, electrophysiological diagnostic catheter for electrocardiologic treatments includes a distal end, diagnostic rings, a balloon, a main channel, a manipulation handgrip, functional connection and internal channels. There is an internally-located open central channel, wherein inlet/outlet of an internal channel is located in the distal ring. There is a pumping channel for pumping up and pumping out of the occlusion-stabilizing balloon located after the diagnostic rings. There is a division of a central channel into two branches in the region of the catheter proximal end.

Abstract: A introducer is disclosed that includes an introducer sheath for introducing a catheter into a blood vessel at an insertion point, a plurality of electrodes on the introducer sheath, a flush line coupled to the introducer sheath including a proximal end and a distal end. In addition, the introducer includes an impedance assessment unit coupled to the flush line between the proximal end and the distal end and electrically coupled to the electrodes. The impedance assessment unit is configured to inject a predetermined current or voltage into a first of the plurality of electrodes and measure a resulting voltage or current, respectively, from a second of the plurality of electrodes.

Abstract: Treatment systems are provided, which comprise a treatment element applying a treatment to a tissue, a stimulation element optically stimulating nerves in the tissue, a sensing unit sensing an electrical signal produced by nerves in the tissue in response to the optical stimulation, and a control unit controlling the application of the treatment according to the sensed signal. The systems and methods are used to avoid damaging nerves by sensing them during operation and immediately before local treatment application and preventing energy emission when the treatment tool is too close to specified nerves. Additional electric stimulation may be provided to enable avoidance of nerve damages on a larger scale, the treatment may be applied by a cold laser, and the control unit may control the treatment in realtime and in a closed loop and immediate prevent further treatment upon sensing optically stimulated nerves.

Abstract: A system and method for perfusing a liquid medicament into tissue of a patient requires a catheter having a distal barrier and a proximal barrier mounted on the catheter. A perfusion section is formed into the catheter between these barriers. By way of example of a typical operation, the catheter is advanced through the vasculature of a patient and into the coronary sinus. Advancement continues until the barriers of the catheter are positioned to straddle the ostium of the left atrial vein. As so positioned, a perfusion chamber is established in the coronary sinus between the barriers. Also, the perfusion chamber is positioned for fluid communication with the left atrial vein. Liquid medicament can then be transferred from a source into the perfusion chamber for perfusion of the medicament into tissue of the atrial vein.

Abstract: A system and method for positioning sheaths into the Coronary Sinus using a guiderail catheter.

Abstract: Devices and methods that regulate the innervation of the kidney by detection and modification of the aorticorenal ganglion. Devices for percutaneous detection and treatment of the aorticorenal ganglion via a blood vessel to modify renal sympathetic activity.

Abstract: A medical system may include a shaft member and a structure physically coupled to the shaft member. A portion of the shaft member may be sized to be delivered through a bodily opening leading to a bodily cavity. The structure may include at least two flexible couplings, each flexible coupling extending transversely from an intermediate portion of a respective one of at least two elongate members of the structure. The flexible coupling extending transversely from the intermediate portion of a first one of the at least two elongate members forms at least a part of a first closed loop arranged to receive a portion of the flexible coupling of a second one of the at least two elongate members therethrough to limit a spacing between the intermediate portions of the first and the second ones of the at least two elongate members.

Abstract: Methods, systems, and apparatus for quantifying the quality of a fiducial time marker for a candidate heart beat, quantifying the quality of a candidate heart beat, or determining a time of beat sequence of the patient's heart. A fiducial time marker is obtained for a candidate heart beat. A quality index of said candidate heart beat is set to a first value. The candidate heart beat is tested with at least one beat validity test. At least a second value is added to said quality index of said candidate heart beat if said candidate heart beat passes said at least one beat validity test. The candidate heart beat is tested with at least a second heart beat validity test. At least a third value is added to said quality index of said candidate heart beat if said candidate heart beat passes said at least second heart beat validity test.

Abstract: The invention relates to electrophysiology catheter systems and their use, such as in an MRI environment, and in particular to analysis of electric signals from such. An electrophysiology (EP) catheter with a plurality of electrically isolated electrode segments arranged in longitudinally spaced bands around the catheter is used to detect electric signals. A workstation receives the electrical signals which are then processed by a processing unit. Electric signals from electrode segments can be used to determine roll angle information of the catheter in relation to patient anatomy by determining signals from electrode segments in contact with tissue. Also, electric signals can be used to extract a reference signal that can be used to correct for gradient induced artifacts.

Abstract: An electrical connector includes a male insertion piece and a female insertion piece. The male insertion piece has an insulation base, an insulation tube being hollow and formed on one end of the insulation base, an outer electrode securely mounted around the insulation tube, and a conductive needle mounted in the insulation tube. The female insertion piece has an insulation sleeve having a guiding slot for the insulation tube to be inserted therein, an outer connection electrode mounted inside the insulation sleeve and mounted around the outer electrode, and an inner connection electrode having a first conductive part abutting against a top portion of the conductive needle and at least two second conductive parts holding two lateral portions of the conductive needle. When the male insertion piece engages the female insertion piece, there are at least three contact positions forming a firm and stable triangular connection.

Abstract: A multi-pole synchronous pulmonary artery radiofrequency ablation catheter may comprise a control handle, a catheter body and an annular ring. One end of the catheter body may be flexible, and the flexible end of the catheter body may be connected to the annular ring. The other end of the catheter body may be connected to the control handle. A shape memory wire may be arranged in the annular ring. One end of the shape memory wire may extend to an end of the annular ring and the other end of the shape memory wire may pass through a root of the annular ring and be fixed on the flexible end of the catheter body. The annular ring may be provided with an electrode group. The device possesses advantages of simple operation, short operation time and controllable precise ablation. The device can be used to treat pulmonary hypertension with pulmonary denervation.

Abstract: A sizing device for a collapsible prosthetic heart valve, the sizing device includes a collapsible and expandable balloon having a proximal end, a distal end. At least one microelectromechanical sensor is coupled to the balloon, the at least one sensor being capable of measuring information related to size and stiffness of tissue.

Abstract: A system to generate and sense electrical energy to and from tissue within a mammalian body. The system includes a flexible shaft and an electrical generator disposed on or embedded within the flexible shaft. Radially displaceable arcuate arm members forming electrodes are displaceable responsive to actuation of the electrical generator.

Abstract: A catheter and catheter system can use energy tailored for remodeling and/or removal of target material proximate to a body lumen, often of stenotic material or tissue in the luminal wall of a blood vessel of a patient. An elongate flexible catheter body with a radially expandable structure may have a plurality of electrodes or other electrosurgical energy delivery surfaces to radially engage the luminal wall when the structure expands. Feedback using one or parameters of voltage, current, power, temperature, impedance magnitude, impedance phase angle, and frequency may be used to selectively control the delivery of energy.

Abstract: Aspects of the present disclosure are directed to detecting Atrial Fibrillation (AF). As may be implemented in accordance with one or more embodiments, a time series of inter-beat intervals is computed from a recording of activity of a beating heart. The time series is decomposed into subcomponents, and an envelope of at least one of the subcomponents is computed. The presence of atrial fibrillation (AF) is detected based upon characteristics of the envelope that are indicative of AF.

Abstract: A system, device and method are presented for utilizing stretchable active integrated circuits with inflatable bodies. The invention allows for such operative features to come into direct contact with body structures, such as the inner wall of a lumen. Such direct contact increases accuracy of measurement and delivery of therapy.

Abstract: The invention is a method of identifying a preferred location for an electrode array to the neural characteristics of an individual subject. The response to electrical neural stimulation varies from subject to subject and array location to array location. Measure of impedance may be used to predict the electrode height from the neural tissue and, thereby, predict the preferred location. Alternatively, electrode height may be measured directly to predict the preferred location.

Abstract: The present invention is a device for providing an enhanced bioelectric sensing probe tip to facilitate locating and obtaining a bioelectric resistance value from a patient for therapeutic and/or diagnostic purpose. One embodiment of the present invention is a probe tip that comprises a uniform array of bristles that contacts a surface layer of a patient's skin to enable the bioelectric probe tip to locate and obtain a bioelectric resistance value from the patient. Another embodiment of the invention is to provide a probe tip cover that prevents foreign material from contaminating the probe tip and to assist in attaching the probe tip to a probe.

Abstract: Medical devices, systems, and methods reduce the distance between two points in tissue, often for treatment of congestive heart failure and often in a minimally invasive manner. An anchor is inserted along an insertion path through a first wall of the heart. An arm of the anchor is deployed and rotationally positioned according to a desired alignment. Application of tension to the anchor may draw the first and second walls of the heart into contact along a desired contour so as to effect a desired change in the geometry of the heart. Additional anchors may be inserted and aligned with the first anchor to close off a portion of a ventricle such that the ventricle is geometrically remodeled and disease progression is reversed, halted, and/or slowed.

Abstract: The systems and methods of the present disclosure calibrate impedance loss model parameters associated with an electrosurgical system and compensate for impedance losses in an electrosurgical system using the calibrated impedance loss model parameters. A computer system stores voltage and current sensor data for different test loads and calculates impedance values for each test load. The computer system predicts a phase value for each test load using a respective load impedance value. The computer system back calculates impedance loss model parameters based upon the voltage and current sensor data, the predicted phase values, and the impedance values of the test loads. During operation, the electrosurgical device senses a voltage and a current, predicts a phase value based upon the sensed voltage and current, and calculates metrics at the tissue site based upon the sensed voltage and current, the predicted phase value, and the impedance loss model parameters.

Abstract: A surgical device integrating a suction mechanism with a coagulation mechanism is provided for improving lesion creation capabilities. The device comprises an elongate member having an insulative covering attached about means for coagulating soft tissue. Openings through the covering expose regions of the coagulation-causing elements and are coupled to lumens in the elongate member which are routed to a vacuum source. A fluid source to passively transport fluid along the contacted soft tissue surface may be provided in order to push the maximum temperature deeper into tissue.

Abstract: A catheter including a proximal end and a distal end. An expandable element coupled to the distal end is included, the expandable element including a proximal portion and a distal portion, the expandable element defining an exterior surface. A first plurality of electrodes coupled to the exterior surface of the distal portion of the expandable element are included, each of the first plurality of electrodes being selectively operable to transmit unipolar radiofrequency energy. A second plurality of electrodes coupled to the exterior surface of the proximal portion of the expandable element are included, each of the second plurality of electrodes being selectively operable to transmit bipolar radiofrequency energy.

Abstract: A system, device and method are presented for utilizing stretchable active integrated circuits with inflatable bodies. The invention allows for such operative features to come into direct contact with body structures, such as the inner wall of a lumen. Such direct contact increases accuracy of measurement and delivery of therapy.

Abstract: A system and method for quickly detaching an implant and for locating the detachment zone of a detachable implant. A sensor determines a sudden change in the local environment as the sensor passes from within a microcatheter to being exposed to the vasculature. The sensor may be a temperature sensor, ultrasonic sensor, pressure sensor or the like. If the detachable implant assembly uses a heater coil to detach the implant, the heater coil may be used as a sensor. Additionally, the implant itself may be used as a sensor if a change in electrical resistance is detectable as the implant exits the microcatheter and changes shape.

Abstract: A microlead has a distal active portion formed by a microcable including an electrically conductive core coated with an insulation layer, with a plurality of exposed areas forming the stimulation electrodes. The microcable has a three-dimensional preshape inscribed in a cylindrical envelope volume so as to match the target vessel wall. The microcable includes a plurality of exposed areas regularly distributed over the circumference of the cylindrical envelope volume considered in axial projection, the exposed zones extending only over an angular sector of the microcable considered in cross section, said angular sector facing the outside of the envelope volume of the preshape.

Abstract: An intravascular catheter for peri-vascular nerve activity sensing or measurement includes multiple needles advanced through supported guide tubes (needle guiding elements) which expand with open ends around a central axis to contact the interior surface of the wall of the renal artery or other vessel of a human body allowing the needles to be advanced though the vessel wall into the perivascular space. The system also may include means to limit and/or adjust the depth of penetration of the needles. The catheter also includes structures which provide radial and lateral support to the guide tubes so that the guide tubes open uniformly and maintain their position against the interior surface of the vessel wall as the sharpened needles are advanced to penetrate into the vessel wall.

Abstract: A pacing lead for a left cavity of the heart, implanted in the coronary system. This lead (24) includes a lead body with a hollow sheath (26, 28) of deformable material, having a central lumen open at both ends, and at least one telescopic microcable (42) of conductive material. The microcable slides along the length of the lead body and extends beyond the distal end (32) thereof. The party emerging beyond the distal end is an active free part (34) comprising a plurality of distinct bare areas (36, 38, 50, 50?, 50?), intended to come into contact (40) with the wall of a target vein (22) of the coronary system (14-22), so as to form a network of stimulation electrodes electrically connected together in parallel. The microcable further comprises, proximally, a connector to a generator of active implantable medical device such as a pacemaker or a resynchronizer.

Abstract: Apparatus, systems and methods employing a contact lens that generates information indicative of a hydration level of an eye in which the lens is worn, are provided. In some aspects, a contact lens includes a substrate that forms at least part of a body of the contact lens and a hydration component that generates information associated with a hydration level of an eye in which the contact lens is worn.

Abstract: An implantable medical device system and associated method receive a signal from an implantable sensor operatively positioned relative to a vein, the signal being responsive to changes in a diameter of the vein. A diameter of the vein is determined in response to the sensor signal and used in estimating central venous pressure (CVP).

Abstract: An electrophysiology catheter includes an elongate catheter body having an elastically-deformable distal region predisposed to assume a spiral shape and a first plurality of electrodes disposed thereon. Each of the first plurality of electrodes includes an electrically active region limited to the inner surface of the spiral shape for use in non-contact electrophysiology studies. A second plurality of electrodes may also be disposed on the distal region interspersed (e.g., alternating) with the first plurality of electrodes, with each of the second plurality of electrodes having an electrically active region extending into the outer surface of the spiral shape for use in contact electrophysiology studies. The distal region may be deformed into a straight configuration for insertion into and navigation through the patient's vasculature, for example via use of a tubular introducer. As the distal region deploys beyond the distal end of the introducer, it resumes the spiral shape.