Abstract: The present invention provides improved methods for positioning of an implantable lead in a patient with an integrated EMG and stimulation clinician programmer. The integrated clinician programmer is coupled to the implantable lead, wherein the implantable lead comprises at least four electrodes, and to at least one EMG sensing electrode minimally invasively positioned on a skin surface or within the patient. The method comprises delivering a test stimulation at a stimulation amplitude level from the integrated clinician programmer to a nerve tissue of the patient with a principal electrode of the implantable lead. Test stimulations are delivered at a same stimulation amplitude level for a same period of time sequentially to each of the four electrodes of the implantable lead.

Abstract: An integrated catheter placement system for accurately placing a catheter within a patient's vasculature is disclosed. In one embodiment, the integrated system comprises a system console, a tip location sensor for temporary placement on the patient's chest, and an ultrasound probe. The tip location sensor senses a magnetic field of a stylet disposed in a lumen of the catheter when the catheter is disposed in the vasculature. The ultrasound probe ultrasonically images a portion of the vasculature prior to introduction of the catheter. ECG signal-based catheter tip guidance is included in the integrated system to enable guidance of the catheter tip to a desired position with respect to a node of the patient's heart. Various aspects for visualizing and manipulating display of the ECG signal data acquired via the present system, together with aspects of various ECG sensor configurations, are also disclosed.

Abstract: A method and system which includes a minimally invasive, implantable device with a sensor configured for collecting electrical data associated with cardiac performance, a sensor configured for collecting mechanical data associated with cardiac performance, a sensor for collecting optical data associated with cardiac performance, a sensor for collecting biochemical data associated with cardiac performance, and a processor for deriving cardiac conditions and actuating an alarm upon identifying a cardiac event.

Abstract: An exemplary method includes generating, by an external control device selectively and communicatively coupled to an implantable stimulator, a calibration table indicating transmit power levels required to achieve a plurality of distinct combinations of compliance voltages and maximum stimulation current levels by the implantable stimulator, determining, by the external control device, a maximum stimulation current level to be delivered by the implantable stimulator via one or more electrodes to one or more stimulation sites within a patient during a stimulation frame, determining, by the external control device, an optimal compliance voltage that allows the implantable stimulator to deliver the determined maximum stimulation current level, and selecting, by the external control device in accordance with the calibration table, a transmit power level that results in the implantable stimulator operating at substantially the optimal compliance voltage during the stimulation frame.

Abstract: A first fluid status indicator of a pulmonary fluid status associated with pulmonary edema and a second fluid status indicator of a non-pulmonary fluid status can be used to provide an alert or to control a therapy for pulmonary edema. Additionally, intermittent cardiac blood volume redistribution therapy can be used to provide cardiac conditioning in heart failure patients.

Abstract: A system and method for evaluating a patient status from sampled physiometry for use in heart failure assessment is presented. Physiological measures, including at least one of direct measures regularly recorded on a substantially continuous basis by a medical device and measures derived from the direct measures are stored. At least one of those of the physiological measures, which relate to a same type of physiometry, and those of the physiological measures, which relate to a different type of physiometry are sampled. A status is determined for a patient through analysis of those sampled measures assembled from a plurality of recordation points. The sampled measures are evaluated. Trends that are indicated by the patient status, including one of a status quo and a change, which might affect cardiac performance of the patient, are identified. Each trend is compared to worsening heart failure indications to generate a notification of parameter violations.

Abstract: A spindle assembly of a surgical instrument is provided which includes a body and a cutter pin. The body has at least one wall forming first and second channels therein. The cutter pin is disposed within the second channel and operably coupled to a knife rod extending therethrough and is operatively coupled at its distal end to a knife. When the knife rod is moved between a retracted position and a deployed position, the spindle assembly is moved between a first and a second position along the shaft. The cutter pin is configured to deform and exit the body when the knife is deployed and disposed in a trapped condition and in response to an applied force, thereby decoupling the knife from the spindle assembly.

Abstract: The energy harvester module of the capsule comprises: a primary oscillating structure subjected to an external low-frequency stress; a secondary oscillating structure comprising an elastic element and able to vibrate in high-frequency resonance; and an electrostatic structure with a first electrode coupled to the primary structure and a second electrode coupled to the secondary structure. The electrodes exert a mutual attraction between them driving the secondary structure away from its stable equilibrium position with tensioning of the elastic element, up to a limit beyond which the secondary structure is released by relaxation effect to vibrate at a resonance frequency. A transducer coupled to the secondary structure converts these high frequency vibration movements into electrical energy.

Abstract: An atrial fibrillation analyzer includes: an acquisition unit that acquires a waveform signal indicating a temporal change of a pulse wave or an electrocardiogram; an RR interval calculation unit that calculates a parameter corresponding to an average RR interval for each frame on the basis of a spectrum of each frame obtained by frequency analysis of the acquired waveform signal, and calculates an RR waveform signal indicating a temporal change of the parameter; a power calculation unit that calculates a temporal change of power of a predetermined frequency band in a frequency spectrum of the RR waveform signal; a variation coefficient calculation unit that calculates a variation coefficient of the average RR interval; an analysis unit that analyzes presence of atrial fibrillation on the basis of a set of the power and the variation coefficient; and a measurement unit that measures an amount of activity of a user.

Abstract: A cannula for moving fluids between a pump and the circulatory system of a patient. The cannula includes a liner having an intermediate portion between a proximal portion and a distal portion, and a lumen extending between the proximal and distal portions. At least the intermediate portion of the liner is constructed from a tissue in-growth material for supporting the growth of endothelial cells. A jacket surrounds at least part of the liner.

Abstract: A system comprises an implantable medical device and an actively deployable clip attached to the implantable medical device that restricts movement of the implantable medical device once the clip is deployed within a body of a patient. In one embodiment, the implantable medical device is a lead and a clip that includes electrically conductive portion is an electrode of the lead. The implantable medical device may be implanted proximate to any suitable tissue site within the patient, and in one embodiment, the implantable medical device is implanted proximate to an occipital nerve or a trigeminal nerve of the patient.

Abstract: An apparatus and method for the recording of physiological variables in small animals are described. The apparatus is an integrated self-contained recorder including a converter of biological signals into a digital form, a data storage unit, a data output for transporting the stored data from the recorder after the end of recording session, a power source and an electrical connector arranged for connection of the recorder with at least one sensor of biological signal and mechanical fixation of the recorder at the head of an animal. The recorder may contain a sensor, which receives signals from an external source for synchronization of the stored data with external equipment or observed/registered animal behavior.

Abstract: An ablation apparatus includes a flexible probe adapted for insertion into a heart of a living subject. The probe has a distally disposed ablation electrode to be brought into contact with a target tissue in the heart, and has facilities for measuring contact force with the target tissue. The apparatus includes a transmitter, operative to transmit an indication of the contact force to a wearable device having an actuator operative to haptically stimulate the operator responsively to the indication.

Abstract: An embodiment of the invention comprises a method of monitoring cardiac electrical activity with two or more ECG devices and computing an enhanced cardiac electrical signal from the cardiac electrical signals obtained from the two or more ECG devices. Electrodes of the two or more ECG devices are positioned in a manner to provide an electrical potential difference that is large enough to give useful information about a given ECG signal. The method further includes recommending addition of a supplemental ECG device when it is determined that the one or more of the existing ECG devices are inadequate for providing cardiac electrical data that identifies a specific cardiac event.

Abstract: A method for treating intractable pain via electrical stimulation of the spinal cord. Remote, non-contact stimulation of a selected region of spinal cord is achieved by placement of a transceiver patch directly on the surface of that region of spinal cord, with said patch optionally being inductively coupled to a transmitter patch of similar size on either the outer or inner wall of the dura surrounding that region of the spinal cord. By inductively exchanging electrical power and signals between said transmitter and transceiver patches, and by carrying out the necessary electronic and stimulus signal distribution functions on the transceiver patch, the targeted dorsal column axons can be stimulated without the unintended stray stimulation of nearby dorsal rootlets. Novel configurations of a pliable surface-sheath and clamp or dentate ligament attachment features which realize undamaging attachment of the patch to the spinal cord are described.

Abstract: A method of performing a medical procedure comprises introducing a medical device through a cranial burr hole into the brain tissue, mounting a plug base around a cranial burr hole, securing the medical device within the aperture of the plug base, seating a proximal end of the medical device within a first groove of the plug base, such that the proximal end exits the aperture of the plug base through the first groove, looping the proximal end from the first groove to a second groove in the plug base, seating the proximal end within the second groove, such that the proximal end extends across the aperture of the plug base from the second groove, and seating the proximal end within a third groove of the plug base, such that the proximal end exits the plug base aperture through the third groove.

Abstract: A defibrillator is described which executes a resuscitation protocol having a CPR pause period. The CPR pause period may be interrupted for the acquisition of ECG signal data which is not contaminated by chest compression artifacts. Following the acquisition of ECG signal data, the CPR period resumes and continues for its full period. The ECG signal data acquired during the interruption of the CPR period is analyzed and, if a shockable rhythm is identified, a shock sequence is initiated immediately upon conclusion of the CPR period.

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: In specific embodiments, a method to monitor left atrial pressure and/or intra-thoracic fluid volume of a patient, comprises (a) monitoring posture of the patient using a posture sensor implanted within the patient, and (b) using portions of an impedance signal, obtained using implanted electrodes, to monitor the left atrial pressure and/or intra-thoracic fluid volume of the patient. Each portion of the impedance signal used to monitor the left atrial pressure and/or intra-thoracic fluid volume of the patient corresponds to a period after which the patient has maintained a predetermined posture for at least a predetermined period of time, and during which the patient has remained in the predetermined posture.

Abstract: A clamp for clamping a brain electrode extending through a burr hole formed in a skull of a patient. The clamp includes a first retainer element having a flange extending around an outer end for engaging an outer table of the skull and a jaw extending across the inner end. The clamp includes a second retainer element shaped complementarily to the first retainer element. The second retainer element has a flange extending around an outer end for engaging the outer table of the skull and a jaw extending across the inner end for cooperating with the jaw of the first retainer to clamp the electrode. The clamp has a cap for maintaining the jaws of the first and second retainer elements in cooperation to clamp the electrode adjacent an inner table of the skull. The cap includes an opening for receiving the electrode to hold the electrode against movement.