Timing Cycles

Hayes, David L.; Wang, Paul J.; Asirvatham, Samuel J.; Friedman, Paul A.

doi:10.1002/9781119264002.ch7

Cited by 3 publications

(11 citation statements)

References 54 publications

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“…These leads are passive fixation, quadripolar, coaxial design type with lengths of 78 and 88 cm. These leads use polyurethane as an outer insulator and SI-polyimide as an inner insulator [2] and are manufactured by Medtronic, Minneapolis, MN, USA. The testing was conducted using the Test Resources Q series system, which applies specific displacements or loads to various samples and measures the corresponding load or displacement.…”

Section: Methodsmentioning

confidence: 99%

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Mechanical Behavior of Polyurethane Insulation of CRT Leads in Cardiac Implantable Electronic Devices: A Comparative Analysis of In Vivo Exposure and Residual Properties

Salih,

Goswami

2024

Bioengineering

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Left ventricle leads are designed for the purpose of long-term pacing in the left ventricle. This study investigated the leads that use polyurethane as an outer insulator and SI-polyimide as an inner insulator. Polyurethane is commonly used for the outer insulation of cardiac leads due to its flexibility and biocompatibility. SI-polyimide (SI-PI) is a high-performance material known for its electrical insulation properties and is used for the inner insulation to maintain the integrity of the electrical pathways within the lead. Ten leads were received from the Wright State University Anatomical Gift Program. The duration of in vivo implantation varied for each lead, from less than a month to 108 months, with an average in vivo duration of 41 ± 31 months. We used the Test Resources Q series system for conducting our tests, as well as samples prepared to ensure compliance with the ASTM Standard D 1708-02a and the ASTM Standard D 412-06a. During the test, the load was applied to the intact lead. Before conducting individual tests, each lead was carefully inspected for surface defects. After conducting the tests, the load to failure, percentage of elongation, percentage of elongation at 5 N, ultimate tensile strength, and modulus of elasticity were calculated. There was no significant difference in load to failure, the percentage of elongation to failure, ultimate tensile strength, and modulus of elasticity (p-value = 0.82, p-value = 0.62, p-value = 0.82, and p-value = 0.12), respectively, when compared to in vivo exposure time. On the other hand, the percentage of elongation at 5 N force showed a significant difference (p-value = 0.0066) after 60 months in an in vivo environment. As the duration of in vivo exposure increased, the load to failure, percentage of elongation, ultimate tensile strength, and modulus of elasticity decreased insignificantly. The residual properties of these left ventricle leads remained relatively stable after 108 months of in vivo exposure duration, with no statistically significant degradation or changes in performance.

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Section: Methodsmentioning

confidence: 99%

“…These leads are serving the same purpose; however, they differ in shape, as shown in Figure 1. These leads use polyurethane (55D) as an outer insulator and SI-polyimide as an inner insulator [2]. These leads received FDA approval in 2014, and since then, there have been more than 218,000 leads implanted in the United States alone [1].…”

Section: Introductionmentioning

confidence: 99%

Mechanical Behavior of Polyurethane Insulation of CRT Leads in Cardiac Implantable Electronic Devices: A Comparative Analysis of In Vivo Exposure and Residual Properties

Salih,

Goswami

2024

Bioengineering

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“…The ICD continuously tracks the heart's activity, detecting irregular rhythms such as tachycardia or 2 of 14 fibrillation. When an abnormal rhythm is identified, the device delivers an electric shock to restore a normal heartbeat [2,3]. The 6935M Sprint Quattro Secure S and 6947M Sprint Quattro Secure (Medtronic, Minneapolis, MN, USA) are high voltage leads designed to deliver a maximum of 40 joules of energy to terminate ventricular tachycardia or ventricular fibrillation.…”

Section: Introductionmentioning

confidence: 99%

“…The 6935M Sprint Quattro Secure S and 6947M Sprint Quattro Secure (Medtronic, Minneapolis, MN, USA) are high voltage leads designed to deliver a maximum of 40 joules of energy to terminate ventricular tachycardia or ventricular fibrillation. These leads play a crucial role in delivering therapeutic energy to address serious cardiac arrhythmias, providing a significant intervention in the management of these life-threatening conditions [3]. As illustrated in Figure 1, the 6935M Sprint Quattro Secure S functions as an 8.6 F (2.8 mm) active fixation true bipolar ICD lead with a single coil.…”

Section: Introductionmentioning

confidence: 99%

“…Nevertheless, it tends to be adhesive to the touch, making the operation of two leads composed of this material within a vein challenging. This inconvenience, however, can be mitigated through the application of diverse surface coatings on the silicon insulation, enhancing the ease of handling and addressing the sticky nature associated with this material [3]. Polyurethane demonstrates notable resistance to tearing and is less prone to stickiness.…”

Section: Introductionmentioning

confidence: 99%

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In Vivo Durability of Polyurethane Insulated Implantable Cardioverter Defibrillator (ICD) Leads

Salih,

Goswami

2024

Polymers

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The 6935M Sprint Quattro Secure S and 6947M Sprint Quattro Secure are high voltage leads designed to administer a maximum of 40 joules of energy for terminating ventricular tachycardia or ventricular fibrillation. Both leads utilize silicone insulation and a polyurethane outer coating. The inner coil is shielded with polytetrafluoroethylene (PTFE) tubing, while other conductors are enveloped in ethylene tetrafluoroethylene (ETFE), contributing to the structural integrity and functionality of these leads. Polyurethane is a preferred material for the outer insulation of cardiac leads due to its flexibility and biocompatibility, while silicone rubber ensures chemical stability within the body, minimizing inflammatory or rejection responses. Thirteen implantable cardioverter defibrillator (ICD) leads were obtained from the Wright State University Anatomical Gift Program. The as-received devices exhibited varied in vivo implantation durations ranging from less than a month to 89 months, with an average in vivo duration of 41 ± 27 months. Tests were conducted using the Test Resources Q series system, ensuring compliance with ASTM Standard D 1708-02a and ASTM Standard D 412-06a. During testing, a load was applied to the intact lead, with careful inspection for surface defects before each test. Results of load to failure, percentage elongation, percentage elongation at 5 N, ultimate tensile strength, and modulus of elasticity were calculated. The findings revealed no significant differences in these parameters across all in vivo exposure durations. The residual properties of these ICD leads demonstrated remarkable stability and performance over a wide range of in vivo exposure durations, with no statistically significant degradation or performance changes observed.

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Electromagnetic force from electric vehicles: Potential electromagnetic interference source for subcutaneous implantable defibrillator

Salih,

Salam,

Goswami

et al. 2024

Pacing Clinical Electrophis

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BackgroundElectromagnetic interference (EMI) encompasses electromagnetic field signals that can be detected by a device's circuitry, potentially resulting in adverse effects such as inaccurate sensing, pacing, device mode switching, and defibrillation. EMI may impact the functioning of Cardiac Implantable Electronic Devices (CIEDs) and lead to inappropriate therapy.MethodAn experimental measuring device, a loop antenna mimicking the implantable cardioverted defibrillator (ICD) antenna, was developed, and validated at the US Food and Drug Administration (FDA) and sent to Wright State University for testing. Two sets of measurements were conducted while the vehicle was connected to a 220‐Volt outlet with charging at ON and OFF. Each measurement set involved three readings at various locations, with the antenna oriented in three different positions to account for diverse patient postures. The experiment utilized a Tesla Model 3 electric vehicle (EV), assessing scenarios both inside and outside the car, including the driver's seat, driver's seat floor, passenger's seat, rear seat, rear seat floor, cup holder, charging port (car), and near the charging station.ResultsThe detected voltage (max 400 to 504 millivolts) around the cup holder inside the car differed from all other measurement scenarios.ConclusionThe investigation highlights the identification of EMI signals originating from an EV) that could potentially interrupt the functionality of a Subcutaneous Implantable Cardioverter‐Defibrillator (S‐ICD). These signals fell within the R‐wave Spectrum of 30–300 Hz. Further in‐vivo studies are essential to determine accurately the level of interference between S‐ICDs and EMI from Electric Vehicles.

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Timing Cycles

Cited by 3 publications

References 54 publications

Mechanical Behavior of Polyurethane Insulation of CRT Leads in Cardiac Implantable Electronic Devices: A Comparative Analysis of In Vivo Exposure and Residual Properties

Mechanical Behavior of Polyurethane Insulation of CRT Leads in Cardiac Implantable Electronic Devices: A Comparative Analysis of In Vivo Exposure and Residual Properties

In Vivo Durability of Polyurethane Insulated Implantable Cardioverter Defibrillator (ICD) Leads

Electromagnetic force from electric vehicles: Potential electromagnetic interference source for subcutaneous implantable defibrillator

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