Implantable Biodegradable RF-Powered Tissue Stimulator and Electrodes

植入式可生物降解射频供电组织刺激器和电极

• 批准号: 8241552
• 负责人: PHIL GORDON CAMPBELL
• 金额: $ 23.22万
• 依托单位: CARNEGIE-MELLON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-01 至 2013-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8241552
• 关键词: Address; Alloys; Animals; Artificial cardiac pacemaker; Biocompatible; Body Fluids; Bone Tissue; Cell Proliferation; Cells; Child; Clinical; Consult; Corrosion; Cosmetics; Coupling; Data; Development; Devices; Drug Delivery Systems; Electric Stimulation; Electrochemistry; Electrodes; Electronics; Evaluation; Excision; Fracture; Frequencies; Goals; Guidelines; Histocompatibility; Image; Implant; In Vitro; Infection; Left; Life; Life Cycle Stages; Magnesium; Medical Device; Methods; Modeling; Monitor; Musculoskeletal Physiology; Natural regeneration; Nerve; Normal tissue morphology; Operative Surgical Procedures; Oryctolagus cuniculus; Pain management; Postoperative Pain; Power Sources; Radio; Rattus; Research; Resources; Services; Simulate; Spinal; Spinal Fusion; Stem cells; Surgeon; System; Systems Development; Technology; Testing; Therapeutic; Time; Tissue Engineering; Tissues; Titania; Titanium; Wireless Technology; base; biomaterial compatibility; bone; bone marrow stromal stem cell; design; implantable device; implantation; in vivo; novel; novel strategies; osteoblast differentiation; platinum electrode; reconstruction; repaired; research study; response; subcutaneous; technology development

DESCRIPTION (provided by applicant): Implantable biodegradable electronic devices for medical applications offer the potential to provide therapeutic or monitoring functions for limited periods of time - weeks to months - degrading in register with the anticipated needs of the application and thus not requiring surgical removal. However, numerous technologies remain to be developed to enable practical biodegradable electronic systems. The goal of this R21 is to develop completely biodegradable radio frequency (RF) power generators and stimulating electrodes as novel platform technology for enabling a variety of surgically implantable biodegradable electronic devices. The generators and electrodes will be designed according to electrical specifications and forms that are compatible with their incorporation into a biodegradable spinal fusion stimulator as a paradigm application of this technology. Our novel approach will be to use RF coil circuits based on biocompatible and bioresorbable magnesium alloy conductive and resistive components, and also use this same alloy as the material for the electrodes. Using the electrical specifications of existing, non-degradable spinal fusion stimulators in clinical use for guidelines, we will design, fabricate, and test RF coil circuits and stimulating electrodes to deliver constant current stimulation. Stem cell proliferative and differentiative responses to the stimulating electrodes will be assessed in vitro and compared with responses to conventional non-degradable electrodes. Pilot experiments to assess electrode degradation and tissue compatibility will be assessed in vivo in a tethered hard-wired subcutaneous rat model. Functionality and coupling efficiency of the RF coil circuit will be assessed in vitro in simulated body fluid. Successful completion of these aims, as demonstrated by confirming predicted cellular responses and component functionalities over time, will establish the basis for follow-on research addressing component optimizations and complete system development, including integration with active electronics, and testing in an animal spinal fusion model. PUBLIC HEALTH RELEVANCE: The objective of this study to demonstrate feasibility of key components for implantable biodegradable electronic devices that need only function temporarily, such as an electrical stimulator for spinal fusion, or in more general terms, for stimulating repair and remodeling of tissue engineered constructs, fractures, or grafts. This technology would make electrical stimulation a more practical and acceptable therapeutic option by overcoming the barriers to clinical acceptance of permanent implants that only need to function for relatively short periods of time after implantation and may require surgical removal at the end of their service life.

描述（由申请人提供）：用于医疗应用的可植入生物可降解电子设备有可能在有限的时间内（数周至数月）提供治疗或监测功能，并根据应用的预期需求进行降解，因此不需要手术切除。然而，仍有许多技术有待开发，以实现实用的可生物降解电子系统。 R21 的目标是开发完全可生物降解的射频 (RF) 发电机和刺激电极，作为新型平台技术，用于实现各种可通过手术植入的可生物降解电子设备。发生器和电极将根据电气规格和形式进行设计，这些规格和形式与它们并入可生物降解的脊柱融合刺激器兼容，作为该技术的范例应用。我们的新颖方法是使用基于生物相容性和可生物再吸收的镁合金导电和电阻组件的射频线圈电路，并使用相同的合金作为电极材料。使用临床使用的现有不可降解脊柱融合刺激器的电气规格作为指导，我们将设计、制造和测试射频线圈电路和刺激电极以提供恒定电流刺激。将在体外评估干细胞对刺激电极的增殖和分化反应，并与对传统不可降解电极的反应进行比较。将在拴系硬连线皮下大鼠模型中进行体内评估电极降解和组织相容性的试点实验。射频线圈电路的功能和耦合效率将在体外模拟体液中进行评估。通过确认随着时间的推移预测的细胞反应和组件功能，成功完成这些目标将为解决组件优化和完整系统开发的后续研究奠定基础，包括与有源电子设备的集成以及在动物脊柱融合模型中的测试。 公共健康相关性：本研究的目的是证明仅需要暂时发挥作用的可植入生物可降解电子设备关键组件的可行性，例如用于脊柱融合的电刺激器，或者更一般地说，用于刺激组织工程结构、骨折或移植物的修复和重塑。这项技术将使电刺激成为更实用和更可接受的治疗选择，克服永久植入物临床接受的障碍，永久植入物只需要在植入后相对较短的时间内发挥作用，并且可能需要在使用寿命结束时进行手术切除。