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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.

摘要在美国，超过650万女性患有压力性尿失禁（SUI），但只有20万女性（3%）寻求手术干预。需要全身麻醉，恢复时间延长，害怕切口，对治疗失败的担忧只是患者犹豫寻求SUI的原因之一疗法因此，其余患有SUI的妇女使用一次性可吸收产品，估计花费数十亿美元来应对，但不能治愈他们的症状。最近，射频（RF）能量已经被用于经尿道的热收缩和骨盆内筋膜的微重塑， SUI的非手术治疗。射频能量的主要限制是其有限的组织穿透深度，因此，需要将多个RF针侵入性地插入粘膜下组织中以进行热重塑。我们建议开发一种微创的替代手术，使用深穿透近红外激光能量与组织表面的接触冷却相结合，通过内窥镜激光探针作为SUI治疗的经阴道方法。激光传输技术能量与应用冷却相结合已经在美容皮肤病学中取得了巨大成功应用.然而，该技术尚未扩展到其他应用，需要更深的组织结构。我们对各种软组织的初步研究已经证明，无论是离体还是体内，表面下组织的靶向和热改变都可以使用激光结合组织表面的接触冷却，保留1 - 2 mm的组织表面，热坏死我们假设治疗SUI时，可以完全保留阴道粘膜同时使用具有集成冷却的内窥镜激光探针对粘膜下组织进行热重塑。我们建议设计和测试一种内窥镜激光探头，用于微创经阴道热疗。女性压力性尿失禁的治疗该项目将包括：（1）实验测量和组织的光学和热学参数的计算机模拟;（2）内窥镜经阴道用于治疗女性失禁的激光探针;（3）优化激光和冷却治疗参数;和（4）用于热组织变性的内窥镜激光探针的临床前评价，收缩和重塑。

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。