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1.
Clin Oral Investig ; 28(5): 294, 2024 May 03.
Article in English | MEDLINE | ID: mdl-38698252

ABSTRACT

OBJECTIVES: To compare ultrasonic scaler prototypes based on a planar piezoelectric transducer with different working frequencies featuring a titanium (Ti-20, Ti-28, and Ti-40) or stainless steel (SS-28) instrument, with a commercially available scaler (com-29) in terms of biofilm removal and reformation, dentine surface roughness and adhesion of periodontal fibroblasts. MATERIALS AND METHODS: A periodontal multi-species biofilm was formed on specimens with dentine slices. Thereafter specimens were instrumented with scalers in a periodontal pocket model or left untreated (control). The remaining biofilms were quantified and allowed to reform on instrumented dentine slices. In addition, fibroblasts were seeded for attachment evaluation after 72 h of incubation. Dentine surface roughness was analyzed before and after instrumentation. RESULTS: All tested instruments reduced the colony-forming unit (cfu) counts by about 3 to 4 log10 and the biofilm quantity (each p < 0.01 vs. control), but with no statistically significant difference between the instrumented groups. After 24-hour biofilm reformation, no differences in cfu counts were observed between any groups, but the biofilm quantity was about 50% in all instrumented groups compared to the control. The attachment of fibroblasts on instrumented dentine was significantly higher than on untreated dentine (p < 0.05), with the exception of Ti-20. The dentine surface roughness was not affected by any instrumentation. CONCLUSIONS: The planar piezoelectric scaler prototypes are able to efficiently remove biofilm without dentine surface alterations, regardless of the operating frequency or instrument material. CLINICAL RELEVANCE: Ultrasonic scalers based on a planar piezoelectric transducer might be an alternative to currently available ultrasonic scalers.


Subject(s)
Biofilms , Dental Scaling , Dentin , Fibroblasts , Periodontal Ligament , Surface Properties , Titanium , Humans , Dental Scaling/instrumentation , In Vitro Techniques , Dentin/microbiology , Periodontal Ligament/cytology , Transducers , Cell Adhesion , Stainless Steel , Equipment Design , Ultrasonic Therapy/instrumentation
2.
Article in English | MEDLINE | ID: mdl-38630571

ABSTRACT

The first commercial dual-chamber leadless pacemaker (LLPM) was introduced recently. The system combines two separate implants situated in the right atrium and the right ventricle of the heart. Implant synchronization is accomplished with conductive intracardiac communication (CIC) using the myocardium and blood as transmission channel. Successful implant synchronization of this dual-chamber LLPM has been demonstrated. However, the continuously active synchronization transceivers, consuming about 800 nA, cause a 25-45% reduction in the projected device longevity. This work proposes an alternative strategy for power-optimized LLPM synchronization, which is based on synchronous duty-cycling of the transceivers and direct-digital CIC (DD-CIC). In line with this strategy, a novel low-power DD-CIC receiver for short-packet communication based on Manchester-encoded data and with fast startup time is presented. The circuit was fabricated in 180 nm CMOS technology and analyzed with respect to sensitivity, current consumption and startup time under highly duty-cycled operation. The receiver achieves a sensitivity of 81.6±7.4 µV at a data rate of 100 kb/s, with an active current consumption of 39.1±0.6 µA and a startup time below 250 µs. Operating the receiver as specified by the proposed LLPM synchronization strategy reduces the current consumption to a measured average value of 73 nA. In conclusion, this work suggests synchronous duty-cycling for CIC-based implant synchronization as a promising concept to severely reduce the current consumption of contemporary dual-chamber LLPMs. Consequently, device longevity may be increased significantly, potentially reducing the frequency of costly and complication-prone re-interventions.

3.
Chest ; 2024 Feb 24.
Article in English | MEDLINE | ID: mdl-38403186

ABSTRACT

BACKGROUND: Electromagnetic stimulation of the phrenic nerve induces diaphragm contractions, but no coils for clinical use have been available. We recently demonstrated the feasibility of ventilation using bilateral transcutaneous noninvasive electromagnetic phrenic nerve stimulation (NEPNS) before surgery in lung-healthy patients with healthy weight in a dose-dependent manner. RESEARCH QUESTION: Is NEPNS feasible in critically ill patients in an ICU setting? STUDY DESIGN AND METHODS: This feasibility nonrandomized controlled study aimed to enroll patients within 36 h of intubation who were expected to remain ventilated for ≥ 72 h. The intervention group received 15-min bilateral transcutaneous NEPNS bid, whereas the control group received standard care. If sufficient, NEPNS was used without pressure support to ventilate the patient; pressure support was added if necessary to ventilate the patient adequately. The primary outcome was feasibility, measured as time to find the optimal stimulation position. Further end points were sessions performed according to the protocol or allowing a next-day catch-up session and tidal volume achieved with stimulation reaching only 3 to 6 mL/kg ideal body weight (IBW). A secondary end point was expiratory diaphragm thickness measured with ultrasound from days 1 to 10 (or extubation). RESULTS: The revised European Union regulation mandated reapproval of medical devices, prematurely halting the study. Eleven patients (five in the intervention group, six in the control group) were enrolled. The median time to find an adequate stimulation position was 23 s (interquartile range, 12-62 s). The intervention bid was executed in 87% of patients, and 92% of patients including a next-day catch-up session. Ventilation with 3 to 6 mL/kg IBW was achieved in 732 of 1,701 stimulations (43.0%) with stimulation only and in 2,511 of 4,036 stimulations (62.2%) with additional pressure support. A decrease in diaphragm thickness was prevented by bilateral NEPNS (P = .034) until day 10. INTERPRETATION: Bilateral transcutaneous NEPNS was feasible in the ICU setting with the potential benefit of preventing diaphragm atrophy during mechanical ventilation. NEPNS ventilation effectiveness needs further assessment. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT05238753; URL: www. CLINICALTRIALS: gov.

4.
Article in English | MEDLINE | ID: mdl-38083213

ABSTRACT

Augmenting the sensing/actuating capabilities of multifunctional catheters used for minimally invasive interventions has been fostered by the reduction of transducers' sizes. However, increasing the number of transducers to benefit from the entire catheter surface is challenging due to the number of connections and/or the required integrated circuits dedicated for multiplexing the transducer signals. Modular concepts enabling personalized catheters are lacking, at all. In this work, we investigated the feasibility of a simple and daisy-chainable transducer node network for active catheters, which overcomes these limitations. Sequentially accessible nodes enabling analog interaction (including signal buffering) with transducers were designed and fabricated using miniature components suited for catheter integration. The effective sampling rate (ESR) per node for acquiring bio-signals from 10 nodes was examined for various signal-to-noise ratios. Thanks to the low circuit complexity, an ESR up to 20 kHz was achieved, which is high enough for many bio-signals.Clinical relevance- Typical daisy-chaining features, namely theoretically indefinite node extension and simple reconfiguration facilitates modularization of the catheter design. The proposed network consequently ensures application and patient-specific requirements while incorporating transducer functions over the entire catheter surface, both may improve minimally invasive interventions.


Subject(s)
Catheters , Transducers , Humans , Phantoms, Imaging , Equipment Design
5.
Intensive Care Med Exp ; 11(1): 20, 2023 Apr 21.
Article in English | MEDLINE | ID: mdl-37081235

ABSTRACT

BACKGROUND: Mechanical ventilation has side effects such as ventilator-induced diaphragm dysfunction, resulting in prolonged intensive care unit length of stays. Artificially evoked diaphragmatic muscle contraction may potentially maintain diaphragmatic muscle function and thereby ameliorate or counteract ventilator-induced diaphragm dysfunction. We hypothesized that bilateral non-invasive electromagnetic phrenic nerve stimulation (NEPNS) results in adequate diaphragm contractions and consecutively in effective tidal volumes. RESULTS: This single-centre proof-of-concept study was performed in five patients who were 30 [IQR 21-33] years old, 60% (n = 3) females and undergoing elective surgery with general anaesthesia. Following anaesthesia and reversal of muscle relaxation, patients received bilateral NEPNS with different magnetic field intensities (10%, 20%, 30%, 40%); the stimulation was performed bilaterally with dual coils (connected to one standard clinical magnetic stimulator), specifically designed for bilateral non-invasive electromagnetic nerve stimulation. The stimulator with a maximal output of 2400 Volt, 160 Joule, pulse length 160 µs at 100% intensity was limited to 50% intensity, i.e. each single coil had a maximal output of 0.55 Tesla and 1200 Volt. There was a linear relationship between dosage (magnetic field intensity) and effect (tidal volume, primary endpoint, p < 0.001). Mean tidal volume was 0.00, 1.81 ± 0.99, 4.55 ± 2.23 and 7.43 ± 3.06 ml/kg ideal body weight applying 10%, 20%, 30% and 40% stimulation intensity, respectively. Mean time to find an initial adequate stimulation point was 89 (range 15-441) seconds. CONCLUSIONS: Bilateral non-invasive electromagnetic phrenic nerve stimulation generated a tidal volume of 3-6 ml/kg ideal body weight due to diaphragmatic contraction in lung-healthy anaesthetized patients. Further perspectives in critically ill patients should include assessment of clinical outcomes to confirm whether diaphragm contraction through non-invasive electromagnetic phrenic nerve stimulation potentially ameliorates or prevents diaphragm atrophy.

6.
Respir Care ; 68(5): 602-610, 2023 05.
Article in English | MEDLINE | ID: mdl-36878642

ABSTRACT

BACKGROUND: Mechanical ventilation is widely used in ICU patients as a lifesaving intervention. Diaphragmatic atrophy and thinning occur from lack of contractions of the diaphragm during mechanical ventilation. It may prolong weaning and increase the risk of respiratory complications. Noninvasive electromagnetic stimulation of the phrenic nerves may ameliorate the atrophy seen with ventilation. The objective of this study was to show that noninvasive repetitive electromagnetic stimulation is safe, feasible, and effective to stimulate the phrenic nerves in both awake individuals and anesthetized patients. METHODS: A single-center study with 10 subjects overall, 5 awake volunteers and 5 anesthetized subjects. We used a prototype electromagnetic, noninvasive, simultaneous bilateral phrenic nerve stimulation device in both groups. In the awake volunteers, we assessed time-to-first capture of the phrenic nerves and safety measures, such as pain, discomfort, dental paresthesia, and skin irritation. In the anesthetized subjects, time-to-first capture as well as tidal volumes and airway pressures at 20%, 30%, and 40% stimulation intensity were assessed. RESULTS: Diaphragmatic capture was achieved in all the subjects within a median (range) of 1 min (1 min to 9 min 21 s) for the awake subjects and 30 s (20 s to 1 min 15 s) for the anesthetized subjects. There were no adverse or severe adverse events in either group, nor any dental paresthesia, skin irritation, or subjective pain in the stimulated area. Tidal volumes increased in all the subjects in response to simultaneous bilateral phrenic nerve stimulation and increased gradually with increasing stimulation intensity. Airway pressures corresponded to spontaneous breathing of ∼2 cm H2O. CONCLUSIONS: Noninvasive phrenic nerve stimulation can be safely performed in awake and anesthetized individuals. It was feasible and effective in stimulating the diaphragm by induction of physiologic and scalable tidal volumes with minimum positive airway pressures.


Subject(s)
Paresthesia , Phrenic Nerve , Humans , Phrenic Nerve/physiology , Feasibility Studies , Respiration, Artificial , Diaphragm/physiology , Pain
7.
Biomed Eng Online ; 22(1): 5, 2023 Jan 30.
Article in English | MEDLINE | ID: mdl-36717872

ABSTRACT

BACKGROUND: Every year, more than 2.5 million critically ill patients in the ICU are dependent on mechanical ventilation. The positive pressure in the lungs generated by the ventilator keeps the diaphragm passive, which can lead to a loss of myofibers within a short time. To prevent ventilator-induced diaphragmatic dysfunction (VIDD), phrenic nerve stimulation may be used. OBJECTIVE: The goal of this study is to show the feasibility of transesophageal phrenic nerve stimulation (TEPNS). We hypothesize that selective phrenic nerve stimulation can efficiently activate the diaphragm with reduced co-stimulations. METHODS: An in vitro study in saline solution combined with anatomical findings was performed to investigate relevant stimulation parameters such as inter-electrode spacing, range to target site, or omnidirectional vs. sectioned electrodes. Subsequently, dedicated esophageal electrodes were inserted into a pig and single stimulation pulses were delivered simultaneously with mechanical ventilation. Various stimulation sites and response parameters such as transdiaphragmatic pressure or airway flow were analyzed to establish an appropriate stimulation setting. RESULTS: Phrenic nerve stimulation with esophageal electrodes has been demonstrated. With a current amplitude of 40 mA, similar response figures of the diaphragm activation as compared to conventional stimulation with needle electrodes at 10mA were observed. Directed electrodes best aligned with the phrenic nerve resulted in up to 16.9 % higher amplitude at the target site in vitro and up to 6 cmH20 higher transdiaphragmatic pressure in vivo as compared to omnidirectional electrodes. The activation efficiency was more sensitive to the stimulation level inside the esophagus than to the inter-electrode spacing. Most effective and selective stimulation was achieved at the level of rib 1 using sectioned electrodes 40 mm apart. CONCLUSION: Directed transesophageal phrenic nerve stimulation with single stimuli enabled diaphragm activation. In the future, this method might keep the diaphragm active during, and even support, artificial ventilation. Meanwhile, dedicated sectioned electrodes could be integrated into gastric feeding tubes.


Subject(s)
Diaphragm , Phrenic Nerve , Animals , Swine , Phrenic Nerve/physiology , Feasibility Studies , Diaphragm/innervation , Diaphragm/physiology , Respiration, Artificial , Electrodes , Electric Stimulation
8.
IEEE Trans Biomed Circuits Syst ; 16(3): 419-429, 2022 06.
Article in English | MEDLINE | ID: mdl-35622811

ABSTRACT

Conductive intracardiac communication (CIC) has been demonstrated as a promising concept for the synchronization of multi-chamber leadless cardiac pacemakers (LLPMs). To meet the 2-5 µW power budget of a LLPM, highly specialized CIC-transceivers, which make optimal use of the cardiac communication channel, need to be developed. However, a detailed investigation of the optimal communication parameters for CIC-based LLPM synchronization is missing so far. This work analyzes the intracardiac communication performance of two low-power modulation techniques, namely On-Off-Keying (OOK) and Manchester-encoded baseband transmission (BB-MAN), as a function of the transmitted bit-energy. The bit error rate (BER) of a prototype dual-chamber LLPM was determined both in simulation and in-vitro experiments on porcine hearts. A BER of 1e -4 was achieved with a median bit-energy in the range of 3-16 pJ (interquartile range: 4-15 pJ) for data rates from 75-500 kbps and a receiver input noise density of 7 nV/ √{Hz}. Both modulation schemes showed comparable performance, with BB-MAN having a slight bit-energy advantage (1-2 dB at 150-500 kbps) under equalized transceiver characteristics. This study demonstrates that reliable CIC-based LLPM synchronization is feasible at transmitted power levels 10 nW under realistic channel conditions and receiver noise performance. Therefore, modulation techniques such, as BB-MAN or OOK, are preferable over recently proposed alternatives, such as pulse position modulation or conductive impulse signaling, since they can be realized with fewer hardware resources and smaller bandwidth requirements. Ultimately, a baseband communication approach might be favored over OOK, due to the more efficient cardiac signal transmission and reduced transceiver complexity.


Subject(s)
Arrhythmias, Cardiac , Pacemaker, Artificial , Animals , Communication , Equipment Design , Heart , Humans , Swine
9.
Pediatr Res ; 91(3): 572-580, 2022 02.
Article in English | MEDLINE | ID: mdl-34601494

ABSTRACT

BACKGROUND: Apnea of prematurity cannot be reliably measured with current monitoring techniques. Instead, indirect parameters such as oxygen desaturation or bradycardia are captured. We propose a Kalman filter-based detection of respiration activity and hence apnea using multichannel esophageal signals in neonatal intensive care unit patients. METHODS: We performed a single-center observational study with moderately preterm infants. Commercially available nasogastric feeding tubes containing multiple electrodes were used to capture signals with customized software. Multichannel esophageal raw signals were manually annotated, processed using extended Kalman filter, and compared with standard monitoring data including chest impedance to measure respiration activity. RESULTS: Out of a total of 405.4 h captured signals in 13 infants, 100 episodes of drop in oxygen saturation or heart rate were examined. Median (interquartile range) difference in respiratory rate was 0.04 (-2.45 to 1.48)/min between esophageal measurements annotated manually and with Kalman filter and -3.51 (-7.05 to -1.33)/min when compared to standard monitoring, suggesting an underestimation of respiratory rate when using the latter. CONCLUSIONS: Kalman filter-based estimation of respiratory activity using multichannel esophageal signals is safe and feasible and results in respiratory rate closer to visual annotation than that derived from chest impedance of standard monitoring.


Subject(s)
Apnea , Infant, Premature, Diseases , Apnea/diagnosis , Heart Rate/physiology , Humans , Infant , Infant, Newborn , Infant, Premature/physiology , Infant, Premature, Diseases/diagnosis , Monitoring, Physiologic/methods , Respiratory Rate
10.
IEEE Trans Biomed Eng ; 68(6): 1903-1912, 2021 06.
Article in English | MEDLINE | ID: mdl-33044926

ABSTRACT

OBJECTIVE: Autonomic dysregulation in preterm infants requires continuous monitoring of vital signs such as heart rate over days to months. Unfortunately, common surface electrodes are prone to electrocardiography (ECG) signal artifacts and cause serious skin irritations during long-term use. In contrast, esophageal ECG is known to be very sensitive due to the proximity of electrodes and heart and insensitive to external influences. This study addresses if multichannel esophageal ECG qualifies for heart rate monitoring in preterm infants. METHODS: We recorded esophageal leads with a multi-electrode gastric feeding tube in a clinical study with 13 neonates and compared the heartbeat detection performance with standard surface leads. A computationally simple and versatile ECG wave detection algorithm was used. RESULTS: Multichannel esophageal ECG manifested heartbeat sensitivity and positive predictive value greater than 98.5% and significant less false negative (FN) ECG waves as compared to surface ECG due to site-typical electrode motion artifacts. False positive bradycardia as indicated with more than 13 consecutive FN ECG waves was equally expectable in esophageal and surface channels. No adverse events were reported for the multi-electrode gastric feeding tube. CONCLUSION: Heart rate monitoring of preterm infants with multiple esophageal electrodes is considered as feasible and reliable. Less signal artifacts will improve the detection of bradycardia, which is crucial for immediate interventions, and reduce alarm fatigue. SIGNIFICANCE: Due to the possibility to integrate the multichannel ECG into a gastric feeding tube and meanwhile omit harmful skin electrodes, the presented system has great potential to facilitate future intensive care of preterm infants.


Subject(s)
Electrocardiography , Infant, Premature , Artifacts , Electrodes , Heart Rate , Humans , Infant , Infant, Newborn , Monitoring, Physiologic
11.
PLoS One ; 15(9): e0239667, 2020.
Article in English | MEDLINE | ID: mdl-32986751

ABSTRACT

Life expectancy of contemporary cardiac pacemakers is limited due to the use of an internal primary battery. Repeated device replacement interventions are necessary, which leads to an elevated risk for patients and an increase of health care costs. The aim of our study is to investigate the feasibility of powering an endocardial pacemaker by converting a minimal amount of the heart's kinetic energy into electric energy. The intrinsic cardiac muscle activity makes it an ideal candidate as continuous source of energy for endocardial pacemakers. For this reason, we developed a prototype able to generate enough power to supply a pacing circuit at different heart rates. The prototype consists of a mass imbalance that drives an electromagnetic generator while oscillating. We developed a mathematical model to estimate the amount of energy harvested from the right ventricle. Finally, the implemented prototype was successfully tested during in-vitro and in-vivo experiments.


Subject(s)
Electric Power Supplies , Electromagnetic Radiation , Endocardium/physiology , Equipment Design , Models, Theoretical , Pacemaker, Artificial , Animals , Blood Flow Velocity , Feasibility Studies , Heart Rate , Swine , Ventricular Function, Right/physiology
12.
Ann Noninvasive Electrocardiol ; 24(5): e12652, 2019 09.
Article in English | MEDLINE | ID: mdl-30977583

ABSTRACT

AIMS: Supraventricular arrhythmia diagnosis using the surface electrocardiogram (sECG) is often cumbersome due to limited atrial signal quality. In some instances, use of esophageal electrocardiography (eECG) may facilitate the diagnosis. Here, we present a novel approach to reconstruct cardiac activation maps from eECG recordings. METHODS: eECGs and sECGs were recorded from 19 individuals using standard acquisition tools. From the recordings, algorithms were developed to estimate the esophageal ECG catheter's position and to reconstruct high-resolution mappings of the cardiac electric activity projected in the esophagus over time. RESULTS: Esophageal two-dimensional activation maps were created for five healthy individuals and 14 patients suffering from different arrhythmias. The maps are displayed as time-dependent contour plots, which not only show voltage over time as conventional ECGs, but also the location, direction, and projected propagation speed of the cardiac depolarization wavefront in the esophagus. Representative examples of sinus rhythm, atrial flutter, and ventricular pre-excitation are shown. CONCLUSION: The methodology presented in this report provides a high-resolution view of the cardiac electric field in the esophagus. It is the first step toward a three-dimensional mapping system, which shall be able to reconstruct a three-dimensional view of the cardiac activation from recordings within the esophagus.


Subject(s)
Electrocardiography/methods , Esophagus , Tachycardia, Supraventricular/diagnosis , Aged , Algorithms , Female , Humans , Male , Middle Aged , Prospective Studies , Signal Processing, Computer-Assisted , Tachycardia, Supraventricular/physiopathology
13.
Heart Rhythm ; 16(6): 936-942, 2019 06.
Article in English | MEDLINE | ID: mdl-30639936

ABSTRACT

BACKGROUND: Contemporary leadless pacemakers (PMs) only feature single-chamber ventricular pacing. However, the majority of patients require dual-chamber pacing or cardiac resynchronization therapy (CRT). Several leadless PMs implanted in the same heart would make that possible if they were able to synchronize their activity in an efficient, safe, and reliable way. Thus, a dedicated ultra-low-power wireless communication method for PM synchronization is required. OBJECTIVE: The purpose of this study was to develop a leadless CRT system and to evaluate its function in vivo. METHODS: Device synchronization was implemented using conductive intracardiac communication (CIC). Communication frequencies were optimized for intracardiac device-device communication. Energy consumption, safety, and reliability of the leadless PM system were tested in animal experiments. RESULTS: We successfully performed CRT pacing with 3 independent devices synchronizing their action using CIC. No arrhythmias were induced by the novel communication technique. Ninety-eight percent of all communication impulses were transmitted successfully. The optimal communication frequency was around 1 MHz, with a corresponding transmitted power of only 0.3 µW at a heart rate of 60 bpm. CONCLUSION: Leadless PMs are able to synchronize their action using CIC and may overcome the key limitation of contemporary leadless PMs.


Subject(s)
Arrhythmias, Cardiac/therapy , Cardiac Resynchronization Therapy/methods , Pacemaker, Artificial , Animals , Disease Models, Animal , Equipment Design , Reproducibility of Results , Swine
14.
Annu Int Conf IEEE Eng Med Biol Soc ; 2019: 6163-6166, 2019 Jul.
Article in English | MEDLINE | ID: mdl-31947250

ABSTRACT

Diagnostic and therapeutic catheters play an inevitable role in minimal invasive medical procedures. Unfortunately, standard catheters show a limited transducer density and high production efforts. We propose a novel catheter design and manufacturing method using a liquid crystal polymer (LCP)-based flexible printed circuit board (FPCB) and a thermoplastic polyurethane (TPU) elastomer tube. Both components are bond together with a low cost, additive free lamination process at a re-flow temperature of 250° C. The lamination process is improved with a laser welding seam and LCP-integrated microholes preventing delamination. Standardized Mechanical tests were conducted to characterize the bonding. A Peel strength of up to 8.5 N in the radial direction and a non plastic elongation in the axial direction of 10% provide evidence that the thermobonding process is suitable for the production of flexible and mechanically durable medical catheters featuring high electrode densities.


Subject(s)
Catheters , Electrodes , Polymers , Polyurethanes
15.
IEEE Trans Biomed Eng ; 66(2): 530-538, 2019 02.
Article in English | MEDLINE | ID: mdl-29993502

ABSTRACT

Contemporary cardiac implantable electronic devices such as pacemakers or event recorders are powered by primary batteries. Device replacement due to battery depletion may cause complications and is costly. The goal of energy harvesting devices is to power the implant with energy from intracorporeal power sources such as vibrations and blood flow. By replacing primary batteries with energy harvesters, reinterventions can be avoided and the size of the total device might be reduced. This paper introduces a device with a lever, which is deflected by the blood stream within the right ventricular outflow tract (RVOT), an attractive site for cardiac pacing. The resulting torque is converted to electrical energy by an electromagnetic mechanism. The blood flow harvester weighs 6.4 g and has a volume of 2 cm3, making the harvester small enough for catheter implantation. It was tested in an experimental setup mimicking flow conditions in the RVOT. The blood flow harvester generated a mean power of 14.39 ± 8.38 µW at 60 bpm (1 Hz) and up to 82.64 ± 17.14 µW at 200 bpm (3.33 Hz) during bench experiments at 1 m/s peak flow velocity. Therefore, it presents a viable alternative to power batteryless and leadless cardiac pacemakers.


Subject(s)
Electric Power Supplies , Hemodynamics/physiology , Models, Cardiovascular , Pacemaker, Artificial , Signal Processing, Computer-Assisted , Heart/physiology , Humans
16.
Neurourol Urodyn ; 38(1): 87-96, 2019 01.
Article in English | MEDLINE | ID: mdl-30178576

ABSTRACT

AIMS: To explore the feasibility of minimally invasive catheter-based electrophysiology studies in the urinary tract. This is a well-known method used in cardiology to investigate and treat arrhythmias. METHODS: We developed an experimental platform which allows electrophysiological recordings with cardiac catheters and conventional needle electrodes in ex vivo pig ureters. The action potential was triggered by a stimulating electrode. We considered 13 porcine ureters (freshly collected and harvested in organ bath), 7 of which were used to optimize the setup and define the stimulation parameters; we performed the recordings in the remaining six ureters. The electrical propagation of the generated action potential was tracked with multiple sensing electrodes, from which propagation directions, velocities, refractory periods, and pacing thresholds were extracted. RESULTS: We recorded propagating electrical activity in four ureters using needle electrodes and in two ureters using cardiac catheters. Propagation velocities for forward direction (from kidney to bladder) derived by the two methods were similar (15.1 ± 2.6 mm/s for cardiac catheters, 15.6 ± 2.3 mm/s for needle recordings). Pacing thresholds, activation patters, and refractory times were provided for the ureteric smooth muscle. Retrograde propagations and corresponding velocities were also observed and measured. CONCLUSIONS: This study is a proof-of-concept showing that electrical activity can be measured "from the inside" of urinary cavities using catheters and that obtained results are comparable with the more invasive needle recordings. Catheter-based electrophysiology may allow, in the clinical setting, for: i) a more differentiated understanding of urological disorders such as overactive bladder and ii) new therapeutic approaches (e.g., targeted tissue ablation).


Subject(s)
Cardiac Catheters , Ureter/physiology , Urinary Tract Physiological Phenomena , Action Potentials , Animals , Catheterization , Electric Stimulation , Electrodes , Electrophysiological Phenomena , In Vitro Techniques , Kidney/physiology , Refractory Period, Electrophysiological/physiology , Swine
17.
IEEE Trans Biomed Circuits Syst ; 13(1): 237-247, 2019 02.
Article in English | MEDLINE | ID: mdl-30530338

ABSTRACT

OBJECTIVE: A new generation of leadless cardiac pacemakers effectively overcomes the main limitations of conventional devices, but only offer single-chamber pacing, although dual-chamber or multisite pacing is highly desirable for most patients. The combination of several leadless pacemakers could facilitate a leadless multisite pacemaker but requires an energy-efficient wireless communication for device synchronization. This study investigates the characteristics of conductive intracardiac communication between leadless pacemakers to provide a basis for future designs of leadless multisite pacemaker systems. METHODS: Signal propagation and impedance behavior of blood and heart tissue were examined by in vitro and in vivo measurements on domestic pig hearts and by finite-element simulations in the frequency range of 1 kHz to 1 MHz. RESULTS: A better signal transmission was obtained for frequencies higher than 10 kHz. The influence of a variety of practical parameters on signal transmission could be identified. A larger distance between pacemakers increases signal attenuation. A better signal transmission is obtained through larger inter-electrode distances and a larger electrode surface area. Furthermore, the influence of pacemaker encapsulation and relative device orientation was assessed. CONCLUSION: This study suggests that conductive intracardiac communication is well suited to be incorporated in leadless pacemakers. It potentially offers very low power consumption using low communication frequencies. SIGNIFICANCE: The presented technique enables highly desired leadless multisite pacing in near future.


Subject(s)
Computer Communication Networks , Heart Conduction System/physiology , Pacemaker, Artificial , Animals , Computer Simulation , Electric Impedance , Electrodes , Humans , Swine
18.
JACC Basic Transl Sci ; 3(6): 813-823, 2018 Dec.
Article in English | MEDLINE | ID: mdl-30623141

ABSTRACT

Contemporary leadless pacemakers only feature single-chamber pacing capability. This study presents a prototype of a leadless dual-chamber pacemaker. Highly energy-efficient intrabody communication was implemented for wireless pacemaker synchronization. Optimal communication parameters were obtained by in vivo and ex vivo measurements in the heart and blood. The prototype successfully performed dual-chamber pacing in vivo. The presented wireless communication method may in the future also enable leadless cardiac resynchronization therapy.

19.
Neurourol Urodyn ; 37(2): 823-831, 2018 02.
Article in English | MEDLINE | ID: mdl-28745806

ABSTRACT

AIMS: To explore the use of time-frequency analysis as an analytical tool to automatically detect pattern changes in bladder pressure recordings of patients with overactive bladder (OAB). To provide quantitative data on the bladder's non-voiding activity which could improve the current diagnosis and potentially the treatment of OAB. METHODS: We developed an algorithm, based on time-frequency analysis, to analyze bladder pressure during the filling phase of urodynamic studies. The algorithm was used to generate a bladder overactivity index (BOI) for a quantitative estimation of the average bladder non-voiding-activity. We tested the algorithm with one control group and two groups of patients with OAB symptoms: one group with detrusor overactivity (DO), assessed by an experienced urologist (OAB-with-DO group), and another group for which detrusor overactivity was not diagnosed (OAB-without-DO group). RESULTS: The algorithm identified diagnostically significant data on the bladder non-voiding activity in a specified frequency range. BOI was significantly higher for both OAB groups compared to the control group: the median value of BOI was twice as big in OAB-without-DO and more than four times higher in OAB-with-DO compared to control group. Moreover the algorithm was successfully tested to detect episodes of detrusor overactivity. CONCLUSIONS: We have shown that a simple algorithm, based on time-frequency analysis of bladder pressure, may be a promising tool in the clinical setting. The algorithm can provide quantitative data on non-voiding bladder activity in patients and quantify the changes according to phenotype. Moreover the algorithm can detect DO, showing potential for triggering conditional bladder stimulation.


Subject(s)
Algorithms , Urinary Bladder, Overactive/diagnosis , Urinary Bladder, Overactive/therapy , Adult , Female , Humans , Male , Middle Aged , Pressure , Retrospective Studies , Urodynamics , Wavelet Analysis
20.
J Electrocardiol ; 49(4): 496-503, 2016.
Article in English | MEDLINE | ID: mdl-27016257

ABSTRACT

PURPOSE: Paroxysmal atrial fibrillation (PAF) often remains undiagnosed. Long-term surface ECG is used for screening, but has limitations. Esophageal ECG (eECG) allows recording high quality atrial signals, which were used to identify markers for PAF. METHODS: In 50 patients (25 patients with PAF; 25 controls) an eECG and surface ECG was recorded simultaneously. Partially A-V blocked atrial runs (PBARs) were quantified, atrial signal duration in eECG was measured. RESULTS: eECG revealed 1.8‰ of atrial premature beats in patients with known PAF to be PBARs with a median duration of 853ms (interquartile range (IQR) 813-1836ms) and a median atrial cycle length of 366ms (IQR 282-432ms). Even during a short recording duration of 2.1h (IQR 1.2-17.2h), PBARs occurred in 20% of PAF patients but not in controls (p=0.05). Left atrial signal duration was predictive for PAF (72% sensitivity, 80% specificity). CONCLUSIONS: eECG reveals partially blocked atrial runs and prolonged left atrial signal duration - two novel surrogate markers for PAF.


Subject(s)
Asymptomatic Diseases , Atrial Fibrillation/diagnosis , Diagnosis, Computer-Assisted/methods , Electrocardiography/methods , Aged , Algorithms , Biomarkers , Esophagus , Female , Humans , Longitudinal Studies , Male , Middle Aged , Reproducibility of Results , Sensitivity and Specificity
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