Targeted Temperature Modulation with Smart Radiometric Monitoring for Effective and Long-Lasting Opioid-Free Pelvic Pain Relief - A Novel Low-Cost, Portable, Tampon-sized Thermal Transfer Device.

通过智能辐射监测进行有针对性的温度调节，可有效且持久地缓解无阿片类药物的盆腔疼痛 - 一种新型低成本、便携式、卫生棉条大小的热转印设备。

• 批准号: 10760002
• 负责人: Zachary W Lyon
• 金额: $ 38.47万
• 依托单位: H3PELVIC THERAPY SYSTEMS, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-25 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10760002
• 关键词: Absence of pain sensation; Acute; Acute Pain; Affect; Afferent Neurons; Analgesics; Anesthesia procedures; Animals; Anti-Inflammatory Agents; Antidepressive Agents; Area; Atopobium vaginae; Bladder; Chronic Prostatitis; Clinical; Computer software; Data; Devices; Economics; Effectiveness; Energy Transfer; Eucalyptol; Excision; Family; Family member; Family suidae; Feedback; Food; Frequencies; Goals; Happiness; Heating; Histology; Hospitals; Human; Increased frequency of micturition; Interstitial Cystitis; Life; Link; Machine Learning; Membrane; Menthol; Monitor; Mucous Membrane; Muscle Cramp; Muscle strain; Needles; Nociceptors; Normalcy; Opioid; Outcome; Overactive Bladder; Pain; Pain management; Pathway interactions; Patients; Pelvic Pain; Pelvic floor structure; Pelvis; Performance; Peripheral; Personal Satisfaction; Pharmaceutical Preparations; Phase; Productivity; Psychotropic Drugs; Public Health; Quality of life; Radiometry; Rectum; Refractory; Resources; Schools; Sensory Receptors; Sex Behavior; Spasm; Suicide; System; TRP channel; Tampons; Technology; Temperature; Testing; Therapeutic; Thermal Conductivity; Thermometry; Time; Tissues; Topical application; Urinary tract infection; Urination; Vagina; Validation; Visceral; Water; Woman; Work; chronic pain; chronic pelvic pain; clinical translation; cohort; cost; design; disabling symptom; drinking water; effective therapy; endometriosis; functional electrical stimulation; improved; men; microwave electromagnetic radiation; micturition urgency; neural stimulation; novel; opioid abuse; optimal treatments; overdose death; pain reduction; pain relief; patient home care; patient oriented; portability; pre-clinical; prototype; receptor; rectal; sensor; skin burn; socioeconomics; somatosensory; success; targeted delivery; treatment planning

ABSTRACT Pelvic pain (PP) is associated with more than 20 different, clinically identified, maladies, such as Urinary Tract Infection (UTI), Menstrual Cramps (MC), Endometriosis (EM), Overactive Bladder (OAB) and Interstitial cystitis/Painful bladder syndrome (IC/PBS). These painful and debilitating conditions often have a dramatic negative impact on the quality of life (QOL) of millions of PP sufferers, from decreased work productivity and school performance, to declined sexual life and happiness. PP has been also associated with increased abuse of opioids and psycho-pharmaceuticals, ultimately leading to death by overdose and suicides. In addition to the burden to patients and their family, the economic direct and indirect PP cost is a significant fraction (>20%) of the 635B$ linked to chronic pain in US. Globally, pelvic pain affects one in five women and one in twelve men. Although treatments, including neural stimulation, are available, they are costly and lose effectiveness over time in >30% of patients. Patients with current untreatable chronic PP require a novel treatment approach that can relieve them from their debilitating symptoms. Significant relief of pain and reduced urination frequency has been recently associated with thermal modulation of pelvic floor. H3Pelvic has successfully developed a Contrast Applied Therapy (CAT) system modulating rapidly and comfortably temperature (cold/warm) via a water- circulating perineal membrane in a soft seat. When a properly sized vaginal or rectal probe with superior thermal conductivity is combined with the CAT system, the pain relief can be remarkable: an initial cohort of patients with refractory IC, unresponsive to drugs or neural stimulation, with a daily 45min vaginal cooling, resumed normal undertakings, restarted school, work and sexual activity, leading to an overall happier and productive life. We propose to optimize a probe design to maximize targeted delivery of thermal modulation using heatpipe technology, including real-time temperature tracking by passive microwave radiometry. RICAT (Radiometry Integrated CAT) will use probe-integrated smart radiometry to monitor deep tissue temperature. By leveraging machine learning, a minimal set of sensors shall accurately reconstruct temperature in the target region and maximize pain reduction. The Specific Aims for this first Phase are: 1) Optimally integrate radiometric sensors and smart planning/control software in a RICAT prototype; 2) Compare radiometric profiles with invasive needle sensors and perform histology in ex-vivo tissues and 7 pigs undergoing vaginal or rectal cooling/warming cycle. The goal of this Phase I is to integrate radiometric sensing into the thermal probe and test the probe’s ability to deliver consistent cooling and heating in the pelvic region in pre-clinical settings using healthy pigs. The data collected will allow us to move to Phase II, which will include a human trial in refractory IC patients. We expect that the animal study will show that RICAT optimally delivers pain-relieving thermal modulation to the pelvic region(s) effectively and reliably. Successful Phase I completion will pave the path towards clinical translational of a safe and effective pain-relieving technology to millions of patients suffering from debilitating pelvic pain.

抽象的 盆腔疼痛 (PP) 与 20 多种临床确定的不同疾病有关，例如尿路疾病 感染 (UTI)、月经痉挛 (MC)、子宫内膜异位症 (EM)、膀胱过度活动症 (OAB) 和间质性病变 膀胱炎/膀胱疼痛综合征 (IC/PBS) 这些疼痛且使人衰弱的病症通常会造成严重的后果。 工作效率下降以及对数百万 PP 患者生活质量 (QOL) 的负面影响 学校表现、性生活和幸福感的下降也与虐待的增加有关。 阿片类药物和精神药物，最终导致过量死亡和自杀。 PP 的经济直接和间接成本占患者及其家人的负担的很大一部分 (>20%) 在美国，635B$ 与慢性疼痛有关 在全球范围内，五分之一的女性和十二分之一的男性受到盆腔疼痛的影响。 尽管可以使用包括神经刺激在内的治疗方法，但它们成本高昂，并且随着时间的推移会失去效力 目前无法治疗的慢性 PP 患者需要一种新的治疗方法。 显着缓解疼痛并减少排尿频率。 最近，H3Pelvic 成功开发了与盆底热调节相关的 Contrast。 应用治疗 (CAT) 系统通过水调节器快速、舒适地调节温度（冷/暖） 当尺寸合适的阴道或直肠探头具有卓越的热力时，会阴膜处于软座中。 电导率与 CAT 系统相结合，可以显着缓解疼痛：最初的一组患者 难治性IC，对药物或神经刺激无反应，每日45分钟阴道降温，恢复正常 事业，重新开始学校、工作和性活动，带来整体上更加幸福和富有成效的生活。 我们建议优化探头设计，以最大限度地利用热管进行热调制的目标传递 技术，包括通过无源微波辐射测量进行实时温度跟踪。 Integrated CAT）将利用探头集成的智能辐射测量来监测深层组织温度。 机器学习，最少的传感器集应准确地重建目标区域的温度，并且 第一阶段的具体目标是： 1) 优化集成辐射传感器。 RICAT 原型中的智能规划/控制软件；2) 将辐射分布与侵入式针进行比较； 传感器并对离体组织和 7 头经历阴道或直肠冷却/加温循环的猪进行组织学分析。 第一阶段的目标是将辐射传感集成到热探头中并测试探头的能力 使用健康猪的数据在临床前环境中为骨盆区域提供一致的冷却和加热。 收集到的数据将使我们能够进入第二阶段，其中包括对难治性 IC 患者进行人体试验。 动物研究将表明 RICAT 可以最佳地向骨盆提供缓解疼痛的热调节 有效且可靠地完成第一阶段将为临床转化铺平道路。 为数百万患有骨盆疼痛的患者提供安全有效的止痛技术。