Abstract: A catheter tip device and methods for manufacturing a catheter tip device are disclosed, the device comprising a transducer module attached to a capsule, wherein the transducer module comprises a carrier including a recessed die-attach area, a transducer die located in the recessed die-attach area, and at least one conductive lead deposited onto the carrier and interconnected to the transducer die. The recessed die-attach area has an outer perimeter greater than the outer perimeter of the transducer die forming a groove between at least one edge of the transducer die and the outer perimeter in which an adhesive agent is located to attach the transducer die to the recessed die-attach area. The methods of manufacturing the catheter tip device involve the use of an array of carriers.

Abstract: A method of in vivo sensor recalibration includes implanting a sensor at an implantation site in a living body; taking a sensor reading with the implanted sensor; taking a first electrical reading across biological material adjacent the implanted sensor; taking a second electrical reading across biological material adjacent the implanted sensor subsequent in time to the taking of the first electrical reading; comparing the first electrical reading with the second electrical reading; and recalibrating the sensor based on the comparison of the first electrical reading to the second electrical reading.

Abstract: A method for performing an in-vivo calibration of a blood pressure sensor that is associated with a balloon of an in-vivo balloon system, the sensor and balloon being associated such that the sensor is in-vivo when the balloon is in-vivo. The balloon is inflated so that a gas pressure in the balloon system is indicative of a patient's blood pressure. The patient's blood pressure is monitored through two channels, the gas pressure and the sensor. The blood pressure measurements obtained by monitoring the gas pressure are used as reference, or “true,” blood pressure measurements to determine a mathematical relationship between blood pressure measurements obtained through the sensor and the reference blood pressure measurements. In this manner, future blood pressure measurements obtained through the sensor can be modified according to the mathematical relationship to generate calibrated blood pressure measurements.

Abstract: An implant assembly is implanted in vivo within a vascular system in the implant assembly has a diameter greater than a vessel and compliance characteristics such that, upon release, the implant assembly forms an interference fit is between the anchor structure and the vessel wall, thereby preventing further distal movement.

Abstract: Embodiments of the invention provide systems and methods for an implantable capacitive pressure sensor. Some embodiments of the invention include a capacitive pressure sensor capsule comprising a substrate, a conductive plate functionally coupled to the substrate, a conductive diaphragm spaced from the conductive plate and functionally coupled to the substrate, a lid hermetically sealed against the substrate, and pressure sensing circuitry disposed within a volume generally defined by the lid and the substrate. Embodiments of the invention also include a lead provided with an implantable pressure sensor capsule and a method of manufacturing a capacitive pressure sensor capsule.

Abstract: An implant assembly is implanted in vivo within a vascular system in which a vessel divides at a furcation into two sub-vessels, each sub-vessel having a diameter smaller than the diameter of said vessel. An implant assembly is released into a vessel such as a pulmonary arterial vessel of a patient. The implant assembly has a diameter smaller than or substantially equal to the inner diameter of the vessel and larger than the inner diameter of each of the sub-vessels. The implant assembly is configured so that it moves downstream within the vessel along with the flow of blood. When the implant assembly reaches a furcation where the vessel divides, the implant assembly is too large and not sufficiently compliant to fit through either of the smaller branch vessels. The implant assembly thus lodges at the furcation, prevented from moving downstream by being too large and stiff to fit into the branch vessels, and prevented from moving upstream by the flow of blood through the arteries.

Abstract: A cardiac rhythm management system provides for ambulatory monitoring of hemodynamic performance based on quantitative measurements of heart sound related parameters for diagnostic and therapeutic purposes. Monitoring of such heart sound related parameters allows the cardiac rhythm management system to determine a need for delivering a therapy and/or therapy parameter adjustments based on conditions of a heart. This monitoring also allows a physician to observe or assess the hemodynamic performance for diagnosing and making therapeutic decisions. Because the conditions of the heart may fluctuate and may deteriorate significantly between physician visits, the ambulatory monitoring, performed on a continuous or periodic basis, ensures a prompt response by the cardiac rhythm management system that may save a life, prevent hospitalization, or prevent further deterioration of the heart.

Abstract: A medical device includes a preload determination unit for determining the preload of a ventricle for a cardiac cycle and providing a preload value representing the preload; a contractility determination unit for determining the contractility of the ventricle for the cardiac cycle and providing a contractility value representing the contractility; and an evaluation unit connected to the preload determination unit and the contractility determination unit, with the evaluation unit being configured to evaluate contractility values versus associated preload values.

Abstract: A lead of an implantable medical device system having an elongated lead body, a sensor coupled to the lead body and extending from a proximal end to a distal end, and a distal lead adaptor having a first arm extending distally from the distal end of the sensor to a first arm end, a second arm extending distally from the distal end of the sensor to a second arm end, and a third arm extending between the first arm end and the second arm end, wherein the first arm, the second arm, and the third arm form an open portion.

Abstract: The present invention provides a multipurpose host system for processing and displaying invasive cardiovascular diagnostic measurement data. The system includes a an external input signal bus interface. The bus interface receives data arising from cardiovascular diagnostic measurement sensors. Measurement processing components receive data from particular sensor types. Based on the received data, the processing components render diagnostic measurement parameter values. A multi-mode graphical user interface includes display components corresponding to data received from particular sensor types. The user interface provides recommended action prompts that guide a user through a series of actions.

Abstract: An ambulatory medical device can include an excitation circuit configured to be electrically coupled to an implantable lead, the excitation circuit configured to provide a non-tissue-stimulating first signal to the implantable lead when the implantable lead is located at or near a tissue site. In an example, the system can include a detection circuit configured to be electrically coupled to the implantable lead and configured to receive a second signal, in response to the first signal, from the implantable lead, the second signal is determined at least in part by a motion of the implantable lead.

Abstract: An implantable medical device is connected to a cardiomechanic sensor implanted in or in connection with a cardiac ventricle. The sensor generates a deformation signal representative of the myocardial deformation. The implantable medical device processes the deformation signal by calculating the derivative thereof to generate a deformation rate signal representative of the rate of myocardial deformation. The deformation rate signal is filtered and respective maximum deformation rate values are identified for multiple cardiac cycles in the filtered deformation rate signal. A value representative of the systemic blood pressure is calculated based on a combination of the respective maximum deformation rate values.

Abstract: A system and method for assessing cardiac performance through cardiac vibration monitoring is described. Cardiac vibration measures are directly collected through an implantable medical device. Cardiac events including at least one first heart sound reflected by the cardiac vibration measures are identified. The first heart sound is correlated to cardiac dimensional measures relative to performance of an intrathoracic pressure maneuver. The cardiac dimensional measures are grouped into at least one measures set corresponding to a temporal phase of the intrathoracic pressure maneuver. The at least one cardiac dimensional measures set is evaluated against a cardiac dimensional trend for the corresponding intrathoracic pressure maneuver temporal phase to represent cardiac performance.

Abstract: Continuous remote monitoring of patients based on data obtained from an implantable hemodynamic monitor provides an interactive patient management system. Using network systems, patients are remotely monitored to continuously diagnose and treat heart-failure conditions. A screen displayable summary provides continuous feedback and information to physicians, patients and authorized third parties. The quick look summary includes various sites and presentation tailored to match the patients' and physicians' needs. The quick look summary further includes intelligent features that understand and retain the user's interests, preferences and use patterns. Patients, physicians and other caregivers are seamlessly connected to monitor and serve the chronic needs of heart-failure patients in a reliable and economic manner.

Abstract: The present invention relates to a device and a method for estimating central systolic blood pressure based on oscillometric signals from brachial artery by the use of a pressure cuff.

Abstract: A system for measuring and converting to an observer intelligible form an internal physiological parameter of a medical patient. The invention allows transcutaneous telemetry of the measured information intracranial pressure via a system which includes a patient implanted sensor module and a processing and display module which is external of the patient and optically coupled to the sensor module via an external coupling module. A sensor within the implanted module transduces the measured information and a near infrared (NIR) emitter transmits this telemetry information when interrogated by the complementary external coupling module. Alternately, a set of tuned inductor-crystal circuits versus inductor-crystal comprised in part of a cylindrical crystal oscillator whose resonant frequency is sensed by a dipper circuit arrangement is provided.

Abstract: Systems, devices and methods for using environmental data to manage health care are disclosed. One aspect is an advanced patient management system. In various embodiments, the system includes at least one implantable medical device (IMD) to acquire at least one IMD parameter indicative of patient wellness, means to acquire at least one environmental parameter from at least one external source, and means to correlate the at least one parameter indicative of patient wellness and the at least one environmental parameter to assist with patient health care decisions. Other aspects and embodiments are provided herein.

Abstract: A method for performing an in-vivo calibration of a blood pressure sensor that is associated with an in-vivo balloon system. The method involves monitoring a patient's blood pressure by observing the system gas pressure while at the same time monitoring the patient's blood pressure through the sensor. The blood pressure measurements obtained by monitoring the system gas pressure are used as reference, or “true,” blood pressure measurements, and an “offset” is determined between the reference blood pressure measurements and the blood pressure measurements obtained through the sensor. The offset can be stored in a memory, which may also store sensor sensitivity data. The offset and/or sensitivity data may be used to adjust future measurements obtained from the sensor, thereby generating calibrated sensor measurements.

Abstract: Devices, systems, and methods associated with pressure sensing are described herein. In one or more embodiments, an intravascular pressure sensing device includes a magnetic sensing element fixedly positioned within a sensor tube, a magnet located a distance from the magnetic sensing element within the sensor tube, the magnet movably positioned within the sensor tube via a ferrofluid magnetically attached to the magnet, and an amount of compressible fluid sealed between the magnetic sensing element and the magnet.

Abstract: The present invention provides a multipurpose host system for processing and displaying invasive cardiovascular diagnostic measurement data. The system includes a an external input signal bus interface. The bus interface receives data arising from cardiovascular diagnostic measurement sensors. Measurement processing components receive data from particular sensor types. Based on the received data, the processing components render diagnostic measurement parameter values. A multi-mode graphical user interface includes display components corresponding to data received from particular sensor types. The user interface provides recommended action prompts that guide a user through a series of actions.

Abstract: Techniques are provided for monitoring thoracic fluid levels based on thoracic impedance (ZT) and cardiogenic impedance (ZC). In one example, the implantable device tracks the maximum time rate of change in cardiogenic impedance (i.e. max(dZC/dt)) to detect trends toward hypervolemic or hypovolemic states within the patient based on changes in heart contractility. The detection of these trends in combination with trends in thoracic impedance allows for a determination of whether the thoracic cavity of the patient is generally “too wet” or “too dry,” and thus allows for the titration of diuretics to avoid such extremes. In particular, a decrease in thoracic impedance (ZT) in combination with a decrease in max (dZC/dt) is indicative of the thorax being “too wet” (i.e. a fluid overload). Conversely, an increase in thoracic impedance (ZT) in combination with a decrease in max (dZC/dt) is indicative of the thorax being “too dry” (i.e. a fluid underload).

Abstract: A delivery system for fixation of an implant assembly having an intracorporeal device at a deployment site using an anchoring structure. This invention provides an implant assembly having a an anchor for fixation within a vessel. The anchoring structure adapted to be delivered via a catheter.

Abstract: Techniques are provided for exploiting left atrial pressure (LAP) measurements to determine various ventricular mechanical and electromechanical contraction intervals and for evaluating ventricular dyssynchrony based on those intervals. In one example, LAP measurements are combined with right ventricular pressure (RVP) measurements to determine the interventricular mechanical delay, which is the primary parameter representative of ventricular dyssynchrony. Other intervals determined based, in part, on LAP measurements include the electromechanical delay for the left ventricle (LV), as well as the LV systolic and diastolic intervals. Techniques are also described herein for detecting various RV intervals including the electromechanical delay for the RV, as well as the RV systolic and diastolic intervals.

Abstract: A method of monitoring physiological parameters for diagnosis and treatment of congestive heart failure in a patient. The method includes implanting at least one sensing device in a cavity of the patient's cardiovascular system, preferably so that the sensing device passes through and is anchored to a septum of the heart and, to minimize the risk of thrombogenicity, a larger portion of the sensing device is located in the right side of the heart and a smaller portion of the sensing device is located in the left side of the heart. Electromagnetic telecommunication and/or wireless powering of the sensing device is performed with an external readout device. The method can be used to perform effective monitoring, management, and tailoring of treatments for patients suffering from congestive heart failure, as well as many other diseases.

Abstract: The invention relates to the management of vascular patency by the use of implanted devices delivering one or more energies to a target vascular tissue wherein such energy delivery sources are substantially located in the vicinity of a target vascular region. The invention preferably employs electric currents as energy and utilizes one or more electrodes positioned in the vicinity of a target region and one or more electrodes located elsewhere. Such devices may be useful in the management of stenotic lesion formation adversely associated with a loss of patency in a variety of disease states or conditions, including vascular patency needed for hemodialysis used in the treatment of kidney failure.

Abstract: An anchored implantable pressure monitor.

Abstract: An implantable pressure monitor.

Abstract: A transmitter unit with a detachable energy source is provided for a sensor guidewire. The transmitter unit is adapted to be connected to a proximal end of a sensor guidewire provided, at its distal end, with a sensor to measure a physiological parameter inside a patient. In some embodiments, the transmitter unit is adapted to wirelessly communicate by a communication signal with a communication unit, arranged in connection with an external device, in order to transfer measured physiological data to the external device. The detachable energy source can be a battery pack provided with connecting electrical connecting surfaces. Preferably, the connection is protected from penetrating fluids by a protective seal.

Abstract: A system improves detection and diagnosis of blood pressure based cardiac function and tissue activities by analyzing and characterizing cardiac blood pressure signals (including non-invasive and invasive blood pressure, discrete values and continuous waveforms) using pressure signal variation and variability calculation and evaluation. The system combines blood pressure analysis with multi clinical related factors and parameters to detect and quantify cardiac health status and arrhythmia severity. The system determines an accurate time, location and severity of cardiac pathology and events by calculating blood pressure variability and statistical variation. The accurately and reliably identifies cardiac disorders, differentiates cardiac arrhythmias, characterizes pathological severity, predicts the life-threatening events, and supports evaluation of drug delivery effects.

Abstract: Apparatus and methods are described including an implantable device shaped to define (a) at least two artery-contact regions, the artery-contact regions comprising struts that are configured to stretch an arterial wall by applying pressure to the arterial wall, and (b) at least two crimping regions that comprise locking mechanisms configured to prevent the crimping regions from becoming crimped due to pressure from the wall of the artery on the artery-contact regions. The crimping regions are configured to be crimped during insertion of the device, via a catheter, by the locking mechanisms being unlocked during insertion of the device. Other embodiments are also described.

Abstract: An optical coherence tomography system and method with integrated pressure measurement. In one embodiment the system includes an interferometer including: a wavelength swept laser; a source arm in communication with the wavelength swept laser; a reference arm in communication with a reference reflector; a first photodetector having a signal output; a detector arm in communication with the first photodetector, a probe interface; a sample arm in communication with a first optical connector of the probe interface; an acquisition and display system comprising: an A/D converter having a signal input in communication with the first photodetector signal output and a signal output; a processor system in communication with the A/D converter signal output; and a display in communication with the processor system; and a probe comprising a pressure sensor and configured for connection to the first optical connector of the probe interface, wherein the pressure transducer comprises an optical pressure transducer.

Abstract: Devices and systems for determining fractional flow reserve.

Abstract: Devices, systems, and methods for determining fractional flow reserve. At least one method for determining fractional flow reserve of the present disclosure comprises the steps positioning a device comprising at least two sensors within a luminal organ at or near a stenosis, wherein the at least two sensors are separated a predetermined distance from one another, operating the device to determine flow velocity of a second fluid introduced into me luminal organ to temporarily displace a first fluid present within the luminal organ, and determining fractional flow reserve at or near the stenosis based upon the flow velocity, a mean aortic pressure within the luminal organ, and at least one cross-sectional area at or near the stenosis. Devices and systems useful for performing such exemplary methods are also disclosed herein.

Abstract: An apnea classification system provides for apnea monitoring and differentiation based on several sleep apnea related parameters for diagnostic and therapeutic purposes. Monitoring of such sleep apnea related parameters allows the apnea classification system to differentiate among the different types of apnea. This information may then be used to determine the best method of therapy, or adjust current therapy parameters to more effectively treat a subject.

Abstract: A pressure sensor is deployed in the right atrium and is in contact with the tissue of the fossa ovalis. The fossa ovalis acts as a membrane and the pressure sensor determines the relative and/or absolute pressure within the left atrium while remaining within the right atrium. A variety of embodiment are provided to deploy and anchor the sensor into the proper position.

Abstract: A method of measuring blood pressure and velocity proximally and distally of a stenosis in a vessel carrying blood includes the steps of providing a guide wire having both a pressure sensor and a velocity sensor disposed on a distal region of the guide wire, introducing the guide wire into the vessel, advancing the guide wire to position the pressure sensor and the velocity sensor proximally and distally of the stenosis, and measuring the blood pressure and velocity proximally and distally of the stenosis with the pressure sensor and the velocity sensor.

Abstract: Implantable medical device with an impedance determination unit with constant current/voltage source having current feed terminals connected to electrodes for intracorporal placement which generates measuring current pulses having constant current/voltage, for causing a current through a body via intracorporally placed electrodes, a measuring unit for measuring voltage/current strength of voltage/current fed through body, an impedance value determination unit connected to the current/voltage source and adapted to determine an impedance value for each measuring current pulse, and an impedance measuring control and evaluation unit connected to the impedance determination unit which controls the unit and evaluates a sequence of consecutive impedance values, the impedance determination unit further adapted to determine at least intrathoracic and intracardiac impedance values for same period of time, the intrathoracic values sampled with a lower sampling rate than the intracardiac values.

Abstract: An implantable medical device system including an implantable blood pressure sensor extracts a baseline signal from the sensed blood pressure signal and subtracts the extracted baseline signal from the sensed blood pressure signal to obtain a corrected pressure monitoring signal. The corrected pressure signal is monitored to detect a cardiac-related condition.

Abstract: A method of measuring pressure within the human body including implanting a pressure sensing assembly having a flexible structure and first and second sensor elements having self-contained power supplies coupled to the flexible structure. Periodic data collection events are performed to collect data from the sensor elements. A data collection event includes a request for data from a remote communication device, a transfer of sensor data to the remote communication device and a processing of the sensor data. The invention also includes a sensor assembly for implantation into a human body. The sensor assembly includes a first sensor having a self-contained power supply, a sensing element and an integral communication device capable of communicating with a remote communication device. The sensor assembly also includes a second sensor and a flexible structure to which the first and second sensor are attached.

Abstract: An implantable system senses a pulmonary artery pressure (PAP) signal using an implantable sensor placed in the pulmonary artery and isolates a plurality of signals from the PAP signal for diagnostic and/or therapeutic use. Each signal is extracted from the PAP signal using its known frequency characteristics and/or timing relationship with one or more detectable events.

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 system and method of determining the status of an adverse cardiac condition of a medical patient based on circadian variation of one or more hemodynamic parameters are provided. In some embodiments, the system and method calculate a first average value of a series of first values during a first time period, a second average value of a series of second values during a second time period, and a difference between the first average value and the second average value. The method provides an indication of an adverse cardiac condition when the difference is less than a predetermined threshold.

Abstract: Measurement system comprising a sensor wire provided, at its distal end, with a physiological condition sensor to measure a physiological condition inside a patient, and to provide measured data to an external device, the measurement system comprises a transceiver unit adapted to be connected to the proximal end of the sensor wire, and a communication unit arranged in connection with the external device. The transceiver unit is adapted to communicate, by a communication signal, with the communication unit, in order to transfer measured data to the external device. The communication signal, including the measured data, is generated by the transceiver unit and transferred as an output signal and the communication unit is arranged to be connected to a standard input/output connector of the external device and to communicate with the external device in accordance with an established standard, or in accordance with relevant parts of an established standard, e.g. BP22 or USB.

Abstract: Valve assemblies and valved catheters including pressure sensors, and related methods for treating patients, are disclosed. The valve assembly includes a valve member extending across a first lumen and includes a planar flexible member with an internal slit acting as a valve. The valve assembly further includes a pressure sensor located distally from the valve member and in fluid communication with the first lumen.

Abstract: A blood pressure measurement device is characterized in that the said device is designated to arithmetically apply to the computed blood pressure value a correction value that is in accordance with the difference in atmospheric pressure between the position of the blood pressure transmitting part and the position of the heart of the subject wearing the blood pressure transmitting part as obtained from the sensor signal, on the basis of the internal pressure variation of the blood pressure transmitting part.

Abstract: An implantable pressure monitor.

Abstract: An anchored implantable pressure monitor.

Abstract: A pressure sensor is deployed in the right atrium and is in contact with the tissue of the fossa ovalis. The fossa ovalis acts as a membrane and the pressure sensor determines the relative and/or absolute pressure within the left atrium while remaining within the right atrium. A variety of embodiment are provided to deploy and anchor the sensor into the proper position.

Abstract: Methods, systems and devices for processing blood pressure measurements are disclosed. An illustrative method includes transmitting a command to an implantable medical device including a blood pressure sensor. The method includes receiving a response from the implantable medical device, the response indicating that the device initiated the sensing of blood pressure measurements. The method includes receiving one or more data packets from the implantable medical device. The one or more data packets can include a base pressure measurement that is representative of a starting point of a blood pressure waveform. The one or more data packets further include a delta value measurement representative of a difference between another blood pressure measurement and the base pressure measurement, or a difference between a current measurement and one or more previous measurements. Additionally, the method includes generating a pressure waveform from the one or more data packets.

Abstract: A method for measuring pressure within a heart includes the steps of: (1) providing a passive wireless pressure sensor having a characteristic impedance and a deflectable surface, the characteristic impedance changing in response to deflection of the deflectable surface; (2) inserting the sensor to a location within the body of a patient at which the sensor can detect pressure within the heart; (3) affixing the sensor relative to the heart; (4) interrogating the sensor with an electromagnetic field; (5) receiving a signal from the sensor corresponding to a sensed pressure; and (6) leaving the sensor in situ so that future pressure measurements can be made.