ICORPs Support for Development of an Acoustic Implant Protection System to Improve Performance and Longevity of Neural Interfaces
ICORP 支持声学植入保护系统的开发,以提高神经接口的性能和寿命
基本信息
- 批准号:10739498
- 负责人:
- 金额:$ 5.5万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2022
- 资助国家:美国
- 起止时间:2022-09-05 至 2023-06-30
- 项目状态:已结题
- 来源:
- 关键词:AcousticsAmputeesAstrocytesBRAIN initiativeBlood - brain barrier anatomyBrainCentral Nervous SystemCerebrumChemicalsChronicCicatrixClinicalDetectionDevelopmentDevicesDiseaseEffectivenessElectrodesElectronicsEnvironmentEquilibriumEquipment MalfunctionFeedbackForeign BodiesImmune responseImmunityImplantImplanted ElectrodesInjuryLifeLongevityMarketingMeasurableMedicalMicroelectrodesMicrogliaModelingNeuronsNeurophysiology - biologic functionParaplegiaPenetrationPerformancePeripheral Nervous SystemPhasePhysiologic pulseProsthesisResolutionSignal TransductionSiteSmall Business Innovation Research GrantSystemTechnologyTestingTherapeuticThinnessTimeTissuesTransducersTranslationsbrain machine interfacecommercializationcostdesignelectric impedanceglial activationhealingimplantationimprovedinterestmotor controlnervous system disorderneuralneural implantneuroprosthesisneuroprotectionneurotransmissionneurotrophic factornext generationportabilitypre-clinicalpreclinical studypreventprototyperesponseside effectultrasoundverification and validation
项目摘要
This ICORPs project expands market understanding and conducts extensive customer discovery for the
Acoustic Implant Protection system for use with Neural Implants.
Original Abstract: This SBIR Fast-track finalizes, tests, and commercializes the Acoustic Implant Protection
(AIP) system, which uses the application of precision acoustic fields to penetrating neural implants to prevent
electrode impedance rise and improve implant longevity. This submission is in response to: Notice of Special
Interest (NOSI): NOT-MH-21-125 Translation of BRAIN Initiative Technologies to the Marketplace.
Problem to be solved: Chronic neural implants hold great potential for illuminating features of neural function,
treating neurological disorders, and enabling the next generation of brain-machine interface-based
neuroprosthetics. Penetrating microelectrode arrays provide direct access to neural signals with high
temporospatial resolution. However, their preclinical and clinical viability are limited by their poor longevity and
variability in functionality due to the immune response or foreign body response (FBR). The FBR can cause
glial scarring and neural cell loss near the electrode sites of penetrating arrays over a period of several weeks,
which are leading causes of signal recording losses through both electrical isolation and spatial distancing
effects. The FBR begins with electrode insertion, when damage to the blood brain barrier activates astrocytes
and microglia. Although ‘soft’ electrode materials, thinner shanks, and floating arrays have been developed to
minimize the mismatch between brain and implant, none of these have demonstrated sufficient recording life
and immunity to the FBR. Exogenous chemical means have been used to directly suppress the FBR, and
have yielded positive results to varying degrees, but limitations of effectiveness, high costs, and/or undesirable
side-effects still exist. A simple approach is needed to mitigate FBR for both preclinical and clinical use.
Solution: Sub-threshold therapeutic ultrasound has recently been shown to have protective and healing effects
in models of cerebral disease and injury, through promotion of neurotrophic factors. AMI successfully
leveraged this principle in an R21 study evaluating low-intensity pulsed ultrasound (LIPUS) to mitigate the
microglia response and improve longevity of neural interfaces. Product: This Fast-track delivers an AIP
system for preclinical use with a reusable (releasable) annular transducer that delivers LIPUS to produce a
neuro-protective environment around implanted microelectrodes.
Phase I: Aim 1 – Electronics/System Adaptation for Preclinical Study. Aim 2 – Confirm ultrasound parameters
for AIP annulus that safely stimulate cortical tissues comparable to Alpha design from R21.
Phase I to Phase II Go-no-go. Portable, reusable AIP prototype produces measurable improvement in neural
signal longevity over 6 weeks in preclinical microelectrode study. Positive feedback from potential end users.
Aim 3– Integrate End User Design Feedback and Conduct Verification and Validation. Aim 4 – Optimize
stimulation intervals for neural interface performance (SNR, unit detection) and demonstrate additional neuro-
protective effects (glial cell activation, E-I balance) of LIPUS in preclinical studies.
这个ICORP项目扩大了市场的了解,并进行了广泛的客户发现
用于神经植入物的声学植入物保护系统。
原始摘要:此SBIR快速通道完成、测试和商业化声学植入物保护
(AIP)系统,该系统使用精密声场的应用穿透神经植入物,以防止
电极阻抗升高并改善植入物寿命。此提交是为了回应:特别通知
兴趣(NOSI):NOT-MH-21-125将BRAIN Initiative技术转化为市场。
待解决的问题:慢性神经植入物具有阐明神经功能特征的巨大潜力,
治疗神经系统疾病,并使下一代基于脑机接口的
神经修复术穿透性微电极阵列提供了对神经信号的直接访问,
时空分辨率然而,它们的临床前和临床可行性受限于它们较差的寿命,
由于免疫反应或异物反应(FBR)导致的功能性变异。FBR会导致
在几周的时间内穿透阵列的电极部位附近的神经胶质瘢痕形成和神经细胞损失,
这是由于电隔离和空间距离引起的信号记录损失的主要原因
方面的影响. FBR开始于电极插入,此时血脑屏障的损伤激活星形胶质细胞
和小胶质细胞。尽管已经开发了“软”电极材料、更薄的柄和浮动阵列,
最大限度地减少大脑和植入物之间的不匹配,这些都没有证明足够的记录寿命
和联邦调查局的豁免权外源化学手段已被用于直接抑制FBR,
已经在不同程度上产生了积极的结果,但是有效性的限制、高成本和/或不期望的
副作用仍然存在。需要一种简单的方法来减轻临床前和临床使用的FBR。
解决方案:亚阈值治疗超声最近被证明具有保护和愈合作用
在脑疾病和损伤模型中,通过促进神经营养因子。AMI成功
在一项R21研究中利用这一原理,评价低强度脉冲超声(LIPUS)缓解
小胶质细胞反应和改善神经接口的寿命。产品:此快速通道提供AIP
用于临床前使用的系统,其具有可重复使用的(可释放的)环形换能器,该环形换能器输送LIPUS以产生
植入微电极周围的神经保护环境。
第一阶段:目标1 -临床前研究的电子/系统适应性。目标2 -确认超声参数
用于安全刺激皮质组织的AIP瓣环,与R21的Alpha设计相当。
第一阶段到第二阶段去不去。便携式,可重复使用的AIP原型产生了可衡量的改善神经
在临床前微电极研究中,信号寿命超过6周。来自潜在最终用户的积极反馈。
目标3-整合最终用户设计反馈并进行验证和确认。目标4 -优化
神经接口性能(SNR,单位检测)的刺激间隔,并证明额外的神经-
LIPUS在临床前研究中的保护作用(神经胶质细胞活化、E-I平衡)。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Maureen L. Mulvihill其他文献
Maureen L. Mulvihill的其他文献
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{{ truncateString('Maureen L. Mulvihill', 18)}}的其他基金
Development of an Acoustic Implant Protection System to Improve Performance and Longevity of Neural Interfaces
开发声学植入保护系统以提高神经接口的性能和寿命
- 批准号:
10552838 - 财政年份:2022
- 资助金额:
$ 5.5万 - 项目类别:
Development of an Acoustic Implant Protection System to Improve Performance and Longevity of Neural Interfaces
开发声学植入保护系统以提高神经接口的性能和寿命
- 批准号:
10763996 - 财政年份:2022
- 资助金额:
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Expansion of Engineering and Testing for 'Locally Targeted Acoustic Neuropathy Medication Delivery System for Pain Relief without Large Systemic Doses and Side Effects'
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- 批准号:
9925224 - 财政年份:2018
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Neural Implant Insertion System using Ultrasonic Vibration to Reduce Tissue Dimpling and Improve Insertion Precision of Floating Arrays in the Neocortex
使用超声波振动的神经植入物插入系统减少组织凹陷并提高新皮质中浮动阵列的插入精度
- 批准号:
9565293 - 财政年份:2018
- 资助金额:
$ 5.5万 - 项目类别:
Active Disposable Cap for Endoscope Tip Stabilization and Complete Visualization and Dissection of Serrated Sessile Polyps
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- 批准号:
10708957 - 财政年份:2018
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Microelectrode Array Insertion System using Ultrasonic Vibration to Improve Insertion Mechanics, Reduce Tissue Dimpling and Trauma, and Improve Placement Precision in the Neocortex
使用超声波振动的微电极阵列插入系统改善插入力学,减少组织凹陷和创伤,并提高新皮质的放置精度
- 批准号:
10021212 - 财政年份:2018
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$ 5.5万 - 项目类别:
Microelectrode Array Insertion System using Ultrasonic Vibration to Improve Insertion Mechanics, Reduce Tissue Dimpling and Trauma, and Improve Placement Precision in the Neocortex
使用超声波振动的微电极阵列插入系统改善插入力学,减少组织凹陷和创伤,并提高新皮质的放置精度
- 批准号:
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- 批准号:
10611153 - 财政年份:2018
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