Wireless Implantable Monitor for Improved Neuromodulation

用于改善神经调节的无线植入式监视器

基本信息

批准号：
8840062
负责人：
MARGOT S. DAMASER
金额：
--
依托单位：
LOUIS STOKES CLEVELAND VA MEDICAL CENTER
依托单位国家：
美国
项目类别：
财政年份：
2012
资助国家：
美国
起止时间：
2012-04-01 至 2016-03-31
项目状态：
已结题

项目摘要

DESCRIPTION (provided by applicant): Control of urine leakage is of major importance after spinal cord injury (SCI) since SCI patients are highly susceptible to pressure ulcers. Pressure ulcers exposed to urine are more susceptible to infection since urine alters the pH balance of the skin and reduces resistance to bacterial invasion. Septicemia resulting from infected pressure ulcers is a major cause of rehospitalization or death among individuals with SCI. SCI patients characteristically develop detrusor overactivity and striated sphincter dyssynergia, leading to uncontrolled leakage of urine, putting the patient at increased risk for contact dermatitis and infected pressure ulcers. In addition, these bladder complications of SCI can lead to autonomic dysreflexia, renal failure, and stroke. Therefore, control of urine leakage is of major importance after SCI. Electrical stimulation of pudendal sensory pathways can arrest unwanted reflex bladder contractions in SCI patients. Open-loop continuous electrical stimulation can inhibit overactive bladder activity and several devices are approved by the FDA. However, patients must frequently return to the doctor to have their electrical stimulation system adjusted when its effectiveness wanes due to habituation or accommodation to an electrical stimulation signal that is always on. Conditional or closed-loop stimulation that only stimulates when triggered to do so has been shown to be more effective than open-loop continuous stimulation, resulting in greater bladder capacity and utilizing less power. However, conditional stimulation is presently only utilized acutely for research purposes using a catheter-based pressure-sensing system since a chronic bladder sensor is not currently available. During the initial VA Merit funding period of this project, we developed a miniature, implantable, wireless, catheter-free, battery-powered, rechargeable pressure monitor for chronic submucosal implantation which could provide the feedback for chronic conditional stimulation. We have achieved most of the objectives of the initial proposal period. However, several hurdles remain to be overcome for application of the pressure monitor to provide closed-loop control for prevention of urinary incontinence, including assessment of feasibility of implantation, optimization of the pressure monitor for chronic implantation, creation of an algorithm for differentiating important bladder events from artifacts, validating our micro-packaging method for chronic implantation, and testing of this novel system in a chronic in vivo model. The goal of this extensively revised design and development renewal proposal is to accomplish these goals, thereby optimizing our pressure monitor for chronic submucosal implantation in the bladder for closed-loop bladder control after SCI. Four specific objectives are designed to accomplish the necessary work: 1. Assess clinical aspects of pressure monitor implantation; 2. Optimize the implantable pressure monitor for chronic implantation; 3. Develop feature extraction methods for distinguishing important bladder events from artifact; and 4. Develop micro-packaging for chronic implantation of the pressure monitor. Completion of the proposed research will put us in a strong position to proceed to clinical testing of our closed loop control system, after which, we will begin clinical trials of our pressure monitor.

描述（由申请人提供）：脊髓损伤（SCI）后，尿液泄漏的控制至关重要，因为SCI患者极易受到压力溃疡的影响。暴露于尿液的压力溃疡更容易感染，因为尿液会改变皮肤的pH平衡并降低对细菌侵袭的耐药性。受感染压力溃疡引起的败血症是SCI患者重新寄养或死亡的主要原因。 SCI患者的特征是逼尿肌的过度活动性和横纹括约肌障碍性，导致尿液泄漏不受控制，这使患者处于接触性皮炎和感染压力溃疡的风险增加。此外，这些SCI的膀胱并发症会导致自主性逆转录病毒，肾衰竭和中风。因此，对尿液泄漏的控制在SCI后至关重要。刺激底座的感觉途径可以阻止SCI患者的不良反射膀胱收缩。开环连续电刺激可以抑制过度活跃的膀胱活性，并且FDA批准了几种设备。但是，患者必须经常返回医生，以使其电气刺激系统在其有效性降低，原因是习惯或对始终处于启用的电刺激信号的适应性降低。有条件或闭环刺激仅在触发时才刺激，这比开环连续刺激更有效，从而导致更大的膀胱容量并利用更少的功率。但是，目前仅使用基于导管的压力感应系统急性地将条件刺激用于研究目的，因为目前尚不可用慢性膀胱传感器。在该项目的最初VA优点资金期间，我们开发了一种微型，可植入，无线，无导管，电池供电，可充电压力监测器，用于慢性粘膜下植入，这可以为慢性条件刺激提供反馈。我们已经实现了初始提案期的大多数目标。然而，要应用压力监测器以提供预防尿失禁的闭环控制，包括评估植入的可行性，优化压力监测量的慢性植入，创建算法以使重要的膀胱脱离了人工的方法，验证我们的微型模型，并测试了量子模型，还需要克服几个障碍。这项经过广泛修订的设计和开发续订建议的目标是实现这些目标，从而优化了我们的压力监测器，以在膀胱中慢性粘膜粘膜植入SCI后的闭环膀胱控制。四个特定目标旨在完成必要的工作：1。评估压力监测室植入的临床方面； 2。优化可植入压力监测仪的慢性植入； 3。开发特征提取方法，以区分重要的膀胱事件和伪影；和4。开发用于压力监测器的慢性植入的微包装。拟议的研究的完成将使我们处于强大的位置，可以继续对封闭环控制系统进行临床测试，之后，我们将开始对压力监测仪进行临床试验。

项目成果

期刊论文数量（9）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

Wireless Bladder Pressure Monitor for Closed-Loop Bladder Neuromodulation.

用于闭环膀胱神经调节的无线膀胱压力监测仪。

DOI：
10.1109/icsens.2016.7808967
发表时间：
2016
期刊：
Proceedings of IEEE Sensors. IEEE International Conference on Sensors
影响因子：
0
作者：
Majerus,Steve;Basu,AnishaS;Makovey,Iryna;Wang,Peng;Zhui,Hui;Zorman,Christian;Ko,Wen;Damaser,MargotS
通讯作者：
Damaser,MargotS

Suburothelial Bladder Contraction Detection with Implanted Pressure Sensor.

使用植入压力传感器检测膀胱上皮下收缩情况。

DOI：
10.1371/journal.pone.0168375
发表时间：
2017
期刊：
PloS one
影响因子：
3.7
作者：
Majerus,SteveJA;Fletter,PaulC;Ferry,ElizabethK;Zhu,Hui;Gustafson,KennethJ;Damaser,MargotS
通讯作者：
Damaser,MargotS

Automatic Drift Cancellation of Implanted Bladder Pressure Sensor.

植入式膀胱压力传感器的自动漂移消除。