Minimally Invasive Laser Treatment of Female Stress Urinary Incontinence

微创激光治疗女性压力性尿失禁

基本信息

批准号：
8686509
负责人：
Nathaniel M Fried
金额：
$ 43.39万
依托单位：
UNIVERSITY OF NORTH CAROLINA CHARLOTTE
依托单位国家：
美国
项目类别：
财政年份：
2014
资助国家：
美国
起止时间：
2014-07-01 至 2018-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8686509
关键词：
Acute Adverse effects Animal Experiments Animal Model Back Caliber Cells Chronic Clinical Research Computer Simulation Cosmetics Dermatology Dimensions Family suidae Fascia Feedback Female Fright Future General Anesthesia Head Heating Hematoxylin and Eosin Staining Method Histologic Incontinence Lasers Light Measurement Measures Methods Modeling Mucous Membrane Necrosis Needles Nerve Operative Surgical Procedures Optics Patients Penetration Photons Physiologic pulse Physiological Procedures Process Property Recovery Rectum Role Sampling Sapphire Shapes Side Spatial Distribution Spottings Staining method Stains Stress Urinary Incontinence Structure Surface Surgical incisions Symptoms Techniques Temperature Testing Time Tissue Sample Tissues Treatment Failure Urethra Vagina Woman coping cost design improved in vivo in vivo Model light microscopy miniaturize minimally invasive pre-clinical pressure public health relevance radiofrequency research clinical testing sensor simulation soft tissue success time use transmission process

项目摘要

Abstract Over 6.5 million women in the U.S. suffer from Stress Urinary Incontinence (SUI), and yet only 200,000 women (3%) seek surgical intervention. The need for general anesthesia, prolonged recovery time, fear of incisions, and concerns about treatment failures are just some of the reasons behind patient hesitation to seek SUI therapy. As a result, the remaining women afflicted with SUI use disposable absorbable products with an estimated cost of billions of dollars to cope with, but not cure, their symptoms. Recently, radiofrequency (RF) energy has been used for transurethral thermal shrinkage and micro-remodeling of the endopelvic fascia as a nonsurgical treatment for SUI. The main limitation of RF energy is its limited tissue penetration depth, and hence, the need to invasively insert multiple RF needles into the submucosal tissue for thermal remodeling. We propose to develop a less invasive alternative procedure for treatment of SUI using deeply penetrating near-infrared laser energy in combination with applied contact cooling of the tissue surface, delivered through an endoscopic laser probe as a transvaginal approach to SUI treatment. The technique of delivering laser energy in combination with applied cooling has been exploited with great success in cosmetic dermatology applications. However, this technique has not yet been extended to other applications where targeting of deeper tissue structures is necessary. Our preliminary studies in a variety of soft tissues have demonstrated, both ex vivo and in vivo, that targeting and thermal alteration of subsurface tissues can be achieved using a laser in conjunction with contact cooling of the tissue surface, preserving 1-2 mm of the tissue surface from thermal necrosis. We hypothesize that for treatment of SUI, the vaginal mucosa can be completely preserved while the submucosal tissue is thermally remodeled, using an endoscopic laser probe with integrated cooling. We propose to design and test an endoscopic laser probe for minimally invasive transvaginal thermal treatment of female stress urinary incontinence. This project will involve: (1) experimental measurements and computer simulations of optical and thermal parameters of tissues; (2) design of an endoscopic transvaginal laser probe for use in treating female incontinence; (3) optimization of the laser and cooling treatment parameters; and (4) pre-clinical evaluation of the endoscopic laser probe for thermal tissue denaturation, shrinkage, and remodeling in a short-term, chronic porcine model.

抽象的美国超过650万妇女遭受压力尿失禁（SUI），但只有200,000名妇女（3％）寻求手术干预。需要全身麻醉，延长恢复时间，担心切口，对治疗失败的担忧只是患者犹豫寻求SUI背后的一些原因治疗。结果，遭受SUI折磨的其余妇女使用可支配的可吸收产品估计要应付数十亿美元的成本，但不能治愈它们的症状。最近，射频（RF）能量已用于尿道热收缩和内植物筋膜的微型重新塑造作为一个 SUI的非外科治疗。 RF能量的主要局限性是其组织渗透深度有限，并且因此，需要将多个RF针头插入粘膜下组织进行热重塑。我们建议开发一种侵入性较小的替代程序，以使用深度穿透性治疗SUI 近红外激光能将组织表面的施加的接触冷却结合内窥镜激光探针作为SUI治疗的经阴道方法。传递激光的技术与应用冷却结合使用的能源在化妆品皮肤病学方面得到了巨大成功申请。但是，该技术尚未扩展到针对目标的其他应用更深的组织结构是必要的。我们在各种软组织中的初步研究表明，在体内和体内，都可以使用A地下组织的靶向和热改变激光与组织表面的接触冷却，从而保留1-2 mm的组织表面热坏死。我们假设为了治疗SUI，可以完全保存阴道粘膜虽然粘膜下组织进行热重塑，但使用具有集成冷却的内窥镜激光探针。我们建议设计和测试内窥镜激光探针，以最低侵入性的经阴道热热治疗女性压力尿失禁。该项目将涉及：（1）实验测量和组织光和热参数的计算机模拟；（2）内窥镜阴道的设计激光探针用于治疗女性尿失禁；（3）优化激光和冷却处理参数; （4）内镜激光探针对热组织变性的临床前评估，收缩，并在短期的慢性猪模型中进行重塑。

项目成果

期刊论文数量（7）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

Optical Clearing of Vaginal Tissues in Cadavers.

尸体阴道组织的光学清除。

DOI：
10.1117/12.2285079
发表时间：
2018
期刊：
Proceedings of SPIE--the International Society for Optical Engineering
影响因子：
0
作者：
Chang,Chun-Hung;Hardy,LukeA;Peters,MichaelG;Bastawros,DinaA;Myers,ErinnM;Kennelly,MichaelJ;Fried,NathanielM
通讯作者：
Fried,NathanielM

LASER PROBE WITH INTEGRATED CONTACT COOLING FOR SUBSURFACE TISSUE THERMAL REMODELING.

DOI：
发表时间：
2018-04
期刊：
Journal of the Mississippi Academy of Sciences. Mississippi Academy of Sciences
影响因子：
0
作者：
Chun-Hung Chang;N. Fried
通讯作者：
Chun-Hung Chang;N. Fried

Diffusing, Side-Firing, and Radial Delivery Laser Balloon Catheters for Creating Subsurface Thermal Lesions in Tissue.

扩散、侧射和径向传输激光球囊导管，用于在组织中产生表面下热损伤。