A 4-Pole Micro-Leadwire for Multi-Chamber Cardiac Pacing

用于多腔心脏起搏的 4 极微导联线

• 批准号: 6404374
• 负责人: GEOFFREY M KOTZAR
• 金额: $ 15.12万
• 依托单位: ELECTROSONICS MEDICAL INC.
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-09-07 至 2003-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6404374
• 关键词: biomaterial development /preparation; biomaterial evaluation; electrical conductance; electrodes; electronic pacemaker; heart rate; physical property; tachycardia

Multiple chamber and bi-ventricular pacing is becoming a common therapeutic method for extending the life of patients with particular cardiac deficiencies. In order to achieve multiple chamber pacing, two or more leads are inserted into the same vein and guided through to the heart. Patients with implanted pacemakers may develop partial venous thrombosis as a result of leadwires residing in the veins. This occlusion can potentially interrupt the blood supply and become life-threatening. A promising solution to this problem are smaller leadwires, as they occlude less of the vein than larger diameter wires. BIOMEC's goal is to fabricate a micro stimulation leadwire, quantify its fatigue life relative to a reference coil, and statistically qualify its suitability for cardiac pacing. We will develop a new quad-polar pacing leadwire, which employs a construction that differs from conventional coaxial bipolar coiled wire leads. Our Four-Pole Micro-Stimulation Leadwire design is under 3 French (Fr) in diameter, occupying 90% less of the vein crossection than the 9 French coaxial bipolar leads in common use. We propose to fabricate samples and quantify the in-vitro fatigue characteristics of the MSL as the first step in demonstrating its effectiveness for three and four chamber stimulation of the heart. PROPOSED COMMERCIAL APPLICATIONS: The total arrhythmia management exceeded $4.5 billion last year. This market includes bradycardia implants, implantable cardioverter defibrillators (ICD), and external automated defibrillators. Specifically, in 1998 the forecast for bradycardial pacemaker implants exceeded 540,000 units worldwide, resulting in $2.6 billion in sale. The congestive heart failure market is expected to equal the bradycardia market annually. We expect that the benefit of smaller size and equivalent functionality will allow the MSL to be used in 10,000 procedures within the first year, or 2% of the total market. These sales will provide revenues greater than $22.5 million.

多个腔室和双室起搏正在成为一种常见的治疗方法，用于延长特定心脏不足患者的寿命。为了实现多个腔室起搏，将两个或更多的导线插入相同的静脉中，并引导到心脏。植入起搏器的患者可能由于居住在静脉中的铅球而导致部分静脉血栓形成。这种阻塞可能会中断血液供应并威胁生命。解决此问题的一个有希望的解决方案是较小的铅球，因为它们闭塞的静脉比较大的直径线更少。 BioMec的目标是制造微刺激的铅线，量化其相对于参考线圈的疲劳寿命，并从统计学上鉴定其对心脏起搏的适用性。我们将开发一种新的四极节奏线路，该链条采用与常规同轴性双极盘绕线导线不同的结构。我们的四极微型刺激的Leadwire设计的直径低于3法国（FR），比共同用途的9个法国同轴双极导线占据静脉交叉的90％。我们建议制造样品并量化MSL的体外疲劳特征，作为证明其对心脏三个和四个腔室刺激的有效性的第一步。拟议的商业申请：去年心律失常总管理层超过45亿美元。该市场包括心动过缓的植入物，植入式心脏逆转除颤器（ICD）和外部自动除颤器。具体而言，在1998年，对心动过缓起搏器植入物的预测超过了全球540,000个单位，销售额为26亿美元。充血性心力衰竭市场预计每年将等于心动过缓市场。我们预计，较小的尺寸和同等功能的好处将使MSL在第一年内使用10,000个程序，占总市场的2％。这些销售将提供超过2250万美元的收入。