Intravesical Drug Delivery Device

描述（由申请人提供）：我们的目标是利用新开发的设备和材料技术来构建泌尿外科适应症的药物输送装置。我们将展示替代膀胱内治疗的设备，这些设备需要经常向膀胱内注入药物溶液，同时我们还将开发一种类似的设备，可以为精囊和前列腺提供局部药物治疗。我们的药物输送装置将对数百万患有膀胱过动症（OAB）、间质性膀胱炎/膀胱疼痛综合征（IC/PBS）、慢性前列腺炎/慢性盆腔疼痛综合征（CP/CPPS）和浅表性膀胱癌等泌尿系统疾病的患者的生活质量产生重大影响。我们的方法是制造被动的不可吸收和可吸收的释放装置，可以通过传统的膀胱镜检查程序部署和回收。用于这些应用的可溶性药物将以固体形式存储在设备内，以最大化药物有效载荷并最小化设备尺寸。药物的释放将通过微机械孔和用于构造装置主体的材料的透水性的组合来控制。不可吸收装置将被设计成可以通过微创手术取出，并由膀胱内已经使用的材料制成。完全可吸收装置将由新型弹性材料制成，这些材料已经过生物相容性测试，但尚未用于泌尿外科用途。该装置的体内植入和释放实验将被用来证明在这种情况下，与目前使用的膀胱内治疗相比的药物暴露。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膀胱过动症（OAB）、间质性膀胱炎/膀胱疼痛综合征（IC/PBS）、慢性前列腺炎/慢性盆腔疼痛综合征（CP/CPPS）和浅表性膀胱癌等泌尿系统疾病的患者的生活质量产生重大影响。

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.