Abstract: In various examples, an apparatus is configured for subcutaneously inserting an implantable device within a patient. The apparatus includes a dilator portion including a dilator including a dilator length. The dilator portion is configured to separate tissue to create a subcutaneous pocket within the patient sized and shaped to accommodate an implantable device within the subcutaneous pocket. A sheath portion includes a sheath sized and shaped to accommodate the dilator within a sheath lumen. The sheath is configured to accommodate an antenna of the implantable device with the dilator removed from within the sheath. The sheath includes a sheath length that is at least substantially as long as an antenna length. The sheath is configured to separate to allow removal of the sheath around the implantable device to remove the sheath from and leave the implantable device within the subcutaneous pocket within the patient.

Abstract: In various examples, an apparatus is configured for subcutaneously inserting an implantable device within a patient. The apparatus includes a dilator portion including a dilator including a dilator length. The dilator portion is configured to separate tissue to create a subcutaneous pocket within the patient sized and shaped to accommodate an implantable device within the subcutaneous pocket. A sheath portion includes a sheath sized and shaped to accommodate the dilator within a sheath lumen. The sheath is configured to accommodate an antenna of the implantable device with the dilator removed from within the sheath. The sheath includes a sheath length that is at least substantially as long as an antenna length. The sheath is configured to separate to allow removal of the sheath around the implantable device to remove the sheath from and leave the implantable device within the subcutaneous pocket within the patient.

Abstract: Embodiments of the present disclosure describe a method of monitoring a patient comprising generating an accelerometer signal of a patient via a patient medical device and capturing and sampling the accelerometer signal at a sampling rate that utilizes non-regular timing intervals. Embodiments further describe a patient medical device comprising sensors for monitoring an accelerometer signal of a patient and circuitry for sampling the accelerometer signal at a sampling rate that utilizes non-regular timing intervals. Embodiments also describe a method of processing physiological signals comprising monitoring ECG signals and accelerometer signals of a patient via a patient medical device and capturing an ECG segment and sampling the accelerometer signal at a sampling rate that utilizes non-regular timing intervals.

Abstract: A medical device is utilized to monitor physiological parameters of a patient and capture segments of the monitored physiological parameters. The medical device includes circuitry configured to monitor one or more physiological parameters associated with the patient and an analysis module that includes a buffer and a processor. The buffer stores monitored physiological parameters and the processor analyzes the monitored physiological parameters and triggers capture of segments from the buffer in response to a triggering criteria being satisfied. The analysis module selects a pre-trigger duration based at least in part on the triggering criteria.

Abstract: Embodiments of the present disclosure describe methods of adaptive arrhythmia detection comprising monitoring ECG signals of a patient via a patient medical device, detecting and capturing ECG segments based on a heart rate threshold and an initial sensitivity level associated with the heart rate threshold; and adjusting the sensitivity level based on previously captured ECG segments. Embodiments of the present disclosure further describe patient medical devices comprising one or more electrodes and sensing circuitry for monitoring ECG signals of a patient; and a processing module configured to receive the monitored ECG signal, wherein the processing module detects and captures ECG segments based on a plurality of heart rate thresholds and one or more sensitivity levels associated with each of the heart rate thresholds, and adjusts at least one of the one or more sensitivity levels associated with each of the heart rate thresholds.

Abstract: A system and method for detecting arrhythmic electrocardiogram (ECG) signals includes defining a plurality of threshold heart rates and rate-dependent sensitivity levels for detecting arrhythmic ECG episodes, wherein more clinically relevant heart rates are assigned rate-dependent sensitivity levels with higher sensitivities. ECG signals are monitored by a medical device, and monitored ECG signals are processed using the plurality of threshold heart rates and rate-dependent sensitivity levels to detect and capture arrhythmic ECG segments.

Abstract: A medical device includes a housing configured for implantation within a body of a patient. Detection circuitry is disposed in the housing and coupled to an electrode arrangement. The detection circuitry is configured to sense a cardiac electrical signal from the patient. A processor is coupled to the detection circuitry and configured to compute a first measure of heart rate variability (HRV) using the cardiac electrical signal, and compute a second measure of HRV using the cardiac electrical signal, the second measure of HRV differing from the first measure of HRV. The processor is also configured to produce an index of patient status derived from a ratio of the first and second measures of HRV, such that the index is a normalized HRV metric personalized to the patient. The processor or a remote system can use the index to assess acute and chronic changes in patient status.

Abstract: In various examples, an apparatus includes an apparatus configured for implantation within a body of a patient. The apparatus, in some examples, includes a housing. At least one antenna extends from the housing, the antenna being flexible such that the antenna conforms to the body of the patient. In some examples, the apparatus includes at least three electrodes, wherein at least a first electrode is disposed on the antenna and at least a second electrode is disposed on the housing. The at least three electrodes are disposed in a non-linear configuration, allowing for differential processing of signals recorded by the at least three electrodes.

Abstract: In various examples, an apparatus includes an apparatus configured for implantation within a body of a patient. The apparatus, in some examples, includes a housing. At least one antenna extends from the housing, the antenna being flexible such that the antenna conforms to the body of the patient. In some examples, the apparatus includes at least three electrodes, wherein at least a first electrode is disposed on the antenna and at least a second electrode is disposed on the housing. The at least three electrodes are disposed in a non-linear configuration, allowing for differential processing of signals recorded by the at least three electrodes.

Abstract: Methods and apparatus to determine the presence of and track functional chronotropic incompetence (hereinafter “CI”) in an in-home setting under conditions of daily living. The functional CI of the patient may be determined with one or more of a profile of measured patient heart rates, a measured maximum patient heart rate, or a peak of the heart rate profile. The functional CI of the patient may be determined with the measured heart rate profile, in which the measured heart rate profile may correspond to heart rates substantially less than the maximum heart rate of the patient, such that the heart rate can be safely measured when the patient is remote from a health care provider. The functional CI of the patient may be determined based a peak of the remotely measured heart rate profile, for example a peak corresponding to the mode of the heart rate distribution profile.

Abstract: Embodiments relate to a method of monitoring physiological parameters of a patient with renal dysfunction. The method includes electrically connecting one or more medical device electrodes with a measurement site of a patient, generating one or more first stimulation signals sufficient to provide input physiological parameters specific to the patient, measuring one or more first bioimpedance values from the generated signals, analyzing at least one of the input physiological parameters within the one or more first bioimpedance values and generating a personalized dialysis program. The systems and methods can further provide essentially real-time data of patient undergoing treatment and control of treatment to a patient.

Abstract: Methods and apparatus to determine the presence of and track functional chronotropic incompetence (hereinafter “CI”) in an in-home setting under conditions of daily living. The functional CI of the patient may be determined with one or more of a profile of measured patient heart rates, a measured maximum patient heart rate, or a peak of the heart rate profile. The functional CI of the patient may be determined with the measured heart rate profile, in which the measured heart rate profile may correspond to heart rates substantially less than the maximum heart rate of the patient, such that the heart rate can be safely measured when the patient is remote from a health care provider. The functional CI of the patient may be determined based a peak of the remotely measured heart rate profile, for example a peak corresponding to the mode of the heart rate distribution profile.

Abstract: A chronically implanted medical device, connected to a medical electrical lead that includes a sensor, is used to detect diastolic dysfunction. A LV accelerometer signal is sensed through the sensor. Based on the LV accelerometer signal, a determination is made as to whether diastolic dysfunction data exists.

Abstract: Embodiments relate to a method of monitoring physiological parameters of a patient with renal dysfunction. The method includes electrically connecting one or more medical device electrodes with a measurement site of a patient, generating one or more first stimulation signals sufficient to provide input physiological parameters specific to the patient, measuring one or more first bioimpedance values from the generated signals, analyzing at least one of the input physiological parameters within the one or more first bioimpedance values and generating a personalized dialysis program. The systems and methods can further provide essentially real-time data of patient undergoing treatment and control of treatment to a patient.

Abstract: A tunneling tool for implanting a medical device into body tissue is described. The tunneling tool comprises a first leg and a second leg. An intermediate portion of the second leg is shaped to nest a medical device therein. A hub connects the first and second distal leg ends together. A sheath providing a lumen extends from the hub to an open end distal of the first and second legs. The first and second legs are manipulatable to separate the hub and the sheath into two portions, a first split portion connected to the first leg and a second split portion connected to the second leg. When a medical device is nested in the tunneling tool, breaking the tunneling tool apart enables the first and second split portions to be removed from body tissue, leaving the implanted medical device behind.

Abstract: In various examples, an apparatus is configured for subcutaneously inserting an implantable device within a patient. The apparatus includes a dilator portion including a dilator including a dilator length. The dilator portion is configured to separate tissue to create a subcutaneous pocket within the patient sized and shaped to accommodate an implantable device within the subcutaneous pocket. A sheath portion includes a sheath sized and shaped to accommodate the dilator within a sheath lumen. The sheath is configured to accommodate an antenna of the implantable device with the dilator removed from within the sheath. The sheath includes a sheath length that is at least substantially as long as an antenna length. The sheath is configured to separate to allow removal of the sheath around the implantable device to remove the sheath from and leave the implantable device within the subcutaneous pocket within the patient.

Abstract: A medical device includes a housing configured for implantation within a body of a patient. Detection circuitry is disposed in the housing and coupled to an electrode arrangement. The detection circuitry is configured to sense a cardiac electrical signal from the patient. A processor is coupled to the detection circuitry and configured to compute a first measure of heart rate variability (HRV) using the cardiac electrical signal, and compute a second measure of HRV using the cardiac electrical signal, the second measure of HRV differing from the first measure of HRV. The processor is also configured to produce an index of patient status derived from a ratio of the first and second measures of HRV, such that the index is a normalized HRV metric personalized to the patient. The processor or a remote system can use the index to assess acute and chronic changes in patient status.

Abstract: In various examples, an apparatus includes a needle assembly including an outer cannula including a tubular sidewall disposed around a lumen. At least a portion of the sidewall includes an exterior including a polymeric material configured to inhibit skiving of an interior of a dilator with movement of the outer cannula within the dilator. An inner cannula is disposed within the lumen and is selectively slidable with respect to the outer cannula. A handle is disposed at a proximal portion of the needle assembly. The handle includes a first handle portion coupled to and movable with the outer cannula. A second handle portion is coupled to and movable with the inner cannula, wherein the first handle portion is selectively movable with respect to the second handle portion to extend a distal end of the inner cannula from within the lumen of the outer cannula.

Abstract: A medical device includes a housing configured for implantation within a body of a patient, and detection circuitry disposed in the housing and coupled to an electrode arrangement. The detection circuitry is configured to sense cardiac signals from the patient. A processor is coupled to the detection circuitry. The processor is configured to compare the cardiac signals to an initial detection threshold, automatically generate an additional detection threshold in response to a predetermined number of the cardiac signals meeting or exceeding the initial detection threshold or a previously generated detection threshold, count each occurrence of a cardiac signal meeting or exceeding each of the respective detection thresholds, and record cardiac signal data only for a cardiac signal that meets or exceeds the highest of the detection thresholds.

Abstract: A tunneling tool for implanting a medical device into body tissue is described. The tunneling tool comprises a first leg and a second leg. An intermediate portion of the second leg is shaped to nest a medical device therein. A hub connects the first and second distal leg ends together. A sheath providing a lumen extends from the hub to an open end distal of the first and second legs. The first and second legs are manipulatable to separate the hub and the sheath into two portions, a first split portion connected to the first leg and a second split portion connected to the second leg. When a medical device is nested in the tunneling tool, breaking the tunneling tool apart enables the first and second split portions to be removed from body tissue, leaving the implanted medical device behind.