Intravesical Drug Delivery Device

描述（由申请人提供）：我们的目标是利用新开发的器械和材料技术来构建用于泌尿外科适应症的药物输送器械。我们将展示设备，以取代膀胱内治疗，需要频繁滴注药物溶液到膀胱，也开发一个类似的设备，可以提供局部药物治疗的精囊和前列腺。我们的药物输送装置将对数百万患有泌尿系统疾病的人的生活质量产生重大影响，这些疾病包括膀胱过度活动症（OAB）、间质性膀胱炎/膀胱疼痛综合征（IC/PBS）、慢性前列腺炎/慢性骨盆疼痛综合征（CP/CPPS）和浅表性膀胱癌。我们的方法是制造被动的不可吸收和可吸收的释放装置，可以部署和检索的传统膀胱镜程序。用于这些应用的可溶性药物将以固体形式储存在装置内，以最大化药物有效载荷并最小化装置尺寸。药物的释放将通过微加工孔和用于构建装置主体的材料的透水性的组合来控制。不可吸收器械的设计应使其可通过微创手术取出，并由膀胱内已使用的材料制成。完全可吸收的器械将由新的弹性材料制成，这些材料已经过生物相容性试验，但尚未用于泌尿外科目的。将采用该器械的体内植入和释放实验来证明与用于此类疾病的当前膀胱内治疗相当的药物暴露。公共卫生相关性：作为本研究主题的药物输送装置将对数百万患有泌尿系统疾病的人的生活质量产生重大影响，这些泌尿系统疾病包括膀胱过度活动症（OAB）、间质性膀胱炎/膀胱疼痛综合征（IC/PBS）、慢性前列腺炎/慢性骨盆疼痛综合征（CP/CPPS）和浅表性膀胱癌。

DESCRIPTION (provided by applicant): Our aim is to exploit newly developed device and material technologies to build drug delivery devices for urological indications. We will demonstrate devices to replace intravesical therapies that require frequent instillations of drug solutions into the bladder and also to develop a similar device that can provide localized drug therapy to the seminal vesicle and the prostate gland. Our drug delivery device will have a significant impact on the quality of life for millions of people that suffer from urinary diseases such as overactive bladder (OAB), interstitial cystitis/painful bladder syndrome (IC/PBS), chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS), and superficial bladder cancer. Our approach is to fabricate passive nonresorbable and resorbable release devices that can be deployed and retrieved by conventional cystoscopic procedures. The soluble drugs used for these applications will be stored in the solid form within the device to maximize drug payload and minimize device size. Release of the drug will be controlled by a combination of micro machined orifice and the water permeability of the materials used to construct the device body. Nonresorbable devices will be designed so that they can be retrieved by minimally invasive procedures and constructed from materials that are already used within the bladder. Fully resorbable devices will be fabricated from new elastomeric materials that have been tested for biocompatibility but have not yet been used for urological purposes. In vivo implantation and release experiments of the device will be employed to demonstrate comparable drug exposure to the current intravesical therapies in use for such conditions. PUBLIC HEALTH RELEVANCE: The drug delivery device that is the subject of this research will have a significant impact on the quality of life for millions of people that suffer from urinary diseases such as overactive bladder (OAB), interstitial cystitis/painful bladder syndrome (IC/PBS), chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS), and superficial bladder cancer.