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    • 5. 发明授权
    • Implantable device with intravesical tolerability and methods of treatment
    • 具有膀胱内耐受性和治疗方法的植入式装置
    • US08679094B2
    • 2014-03-25
    • US12972364
    • 2010-12-17
    • Michael J. CimaHeejin Lee
    • Michael J. CimaHeejin Lee
    • A61K9/22
    • A61M31/002A61F2/042A61K9/0034A61K9/2072A61K31/00A61K31/167A61L31/16A61L31/18A61L2300/402A61L2300/602A61L2430/22A61M31/00
    • Intravesical devices are provided that are wholly deployable within the bladder of a patient in need of treatment and are well tolerated by the patient. The device may include an elastic body having a retention shape having (i) dimensions that provide intravesical mobility and that prevent voiding of the medical device through the urethra, and (ii) dimensions, buoyancy, or both, that exclude the medical device from entering the orifices of the ureters. The elastic body may exert a maximum acting force less than 1 N when compressed to a shape with a maximum dimension in any dimension of 3 cm. The device may include a drug for controlled release within the bladder, for treatment of the bladder or a regional tissue. Methods of treatment are also provided that include selecting a patient in need of treatment in the bladder where tolerability of the treatment is a primary concern.
    • 提供了可以在需要治疗的患者的膀胱内完全展开并且被患者良好耐受的膀胱内装置。 该装置可以包括具有保持形状的弹性体,其具有(i)提供膀胱内移动性的尺寸并且防止医疗装置通过尿道的排尿,以及(ii)排除医疗装置进入的尺寸,浮力或两者 输尿管孔。 当压缩到任何尺寸为3cm的最大尺寸的形状时,弹性体可发挥小于1N的最大作用力。 该装置可以包括用于膀胱内控制释放的药物,用于膀胱或区域组织的治疗。 还提供了治疗方法,包括在膀胱中选择需要治疗的患者,其中治疗的耐受性是主要关注的。
    • 7. 发明申请
    • Implantable Drug Delivery Device with Bladder Retention Feature
    • 具有膀胱保留特征的可植入药物输送装置
    • US20120089121A1
    • 2012-04-12
    • US13267469
    • 2011-10-06
    • Heejin LeeHong Linh Ho Duc
    • Heejin LeeHong Linh Ho Duc
    • A61M31/00
    • A61M31/002A61K9/0034A61K9/0065A61K9/20A61K31/167A61L31/10A61L31/16A61L2300/402A61M2210/1085
    • Implantable devices and methods for controlled drug delivery are provided. The device includes a device structure deformable between a retention shape and a low profile shape for deployment in the bladder of a patient and has a drug reservoir lumen in which a drug formulation is housed. The device also includes a buoyancy retention portion, which includes a volume of entrapped air or a gas-generating or effervescent powder Which will generate a volume of entrapped air following contact with urine in the bladder. The buoyancy retention portion may include a water permeable and/or biodegradable wall, which can release the entrapped air following drug release, to cause the device to sink into the bladder neck to facilitate device expulsion without the need for a device retrieval medical procedure.
    • 提供了用于受控药物递送的可植入装置和方法。 该装置包括可在保持形状和低轮廓形状之间变形的装置结构,用于展开在患者的膀胱中,并且具有容纳药物制剂的药物储存器腔。 该装置还包括浮力保持部分,其包括一定量的夹带空气或气体产生或泡腾粉末,其将在与膀胱中的尿液接触之后产生一定量的夹带空气。 浮力保持部分可以包括水可渗透的和/或可生物降解的壁,其可以在药物释放之后释放夹带的空气,以使得装置沉入膀胱颈部以促进装置排出而不需要装置取回医学程序。
    • 8. 发明申请
    • Minimally Invasive Systems and Methods for In Vivo Testing of Materials
    • 微创体系和材料体内检测方法
    • US20110052497A1
    • 2011-03-03
    • US12870261
    • 2010-08-27
    • Heejin Lee
    • Heejin Lee
    • A61K49/00C12Q1/02C12M1/34G01N31/00
    • A61M31/002A61M2210/1085
    • Implantable material testing devices and method of testing materials in an animals are provided. In one embodiment, a method of testing a material in an animal includes associating the material with a retention frame to form a testing device. The retention frame movable between a first shape suited for insertion through a deployment instrument and a second shape suited for retention in the animal. The testing device is inserted in the first shape into the deployment instrument and is driven through the deployment instrument into the animal. Once in the animal, the testing device is permitted to assume the second shape so that the testing device is retained in the animal for a testing period. The testing device is removed from the animal after the testing period is complete, and the material is analyzed. The material may be analyzed for biofilm formation, encrustation, or degradation. The animal also may be analyzed for infection or other reactions to the material. Tissue may be collected from the animal, and the tissue may be analyzed. The testing period may be between about 1 day and about 90 days.
    • 提供植入材料测试装置和动物材料测试方法。 在一个实施例中,测试动物中的材料的方法包括将材料与保持框架相关联以形成测试装置。 保持框架可在适于通过展开装置插入的第一形状和适于保持在动物中的第二形状之间移动。 测试装置以第一形状插入到展开仪器中,并通过展开仪器被驱动到动物体内。 一旦在动物中,允许测试装置呈现第二形状,使得测试装置保留在动物中一段测试期间。 试验期间完成后,从动物中取出试验装置,对材料进行分析。 可以分析该材料的生物膜形成,结垢或降解。 也可以分析动物感染或其他反应物质。 可以从动物收集组织,并且可以分析组织。 测试期可在约1天至约90天之间。
    • 10. 发明授权
    • Implantable device for controlled drug delivery
    • 用于受控药物输送的可植入装置
    • US09017312B2
    • 2015-04-28
    • US12851494
    • 2010-08-05
    • Heejin LeeMichael J. CimaKaren DanielCheryl Larrivee-Elkins
    • Heejin LeeMichael J. CimaKaren DanielCheryl Larrivee-Elkins
    • A61K9/22A61M31/00A61K9/00A61K31/167
    • A61K9/0092A61K9/0004A61K9/0034A61K31/167A61M31/002
    • Implantable devices and methods for delivery of lidocaine or other drugs to a patient are provided. In one embodiment, the device includes a first drug portion which has a first drug housing which contains a first drug formulation in a solid form which includes a pharmaceutically acceptable salt of lidocaine; and a second drug portion which includes a second drug housing which contains a second drug formulation which includes lidocaine base. In another embodiment, the device includes a drug reservoir component which has an elastic tube having at least one lumen bounded by a porous sidewall having an open-cell structure, a closed-cell structure, or a combination thereof; and a drug formulation contained within the at least one lumen, wherein the device is deformable between a low-profile deployment shape and a relatively expanded retention shape.
    • 提供了用于将利多卡因或其他药物递送给患者的可植入装置和方法。 在一个实施方案中,该装置包括第一药物部分,其具有第一药物外壳,其包含固体形式的第一药物制剂,其包含利多卡因的药学上可接受的盐; 和第二药物部分,其包括含有包含利多卡因碱的第二药物制剂的第二药物外壳。 在另一个实施方案中,该装置包括药物储存器部件,该药物储存器部件具有弹性管,该弹性管具有由具有开孔结构,闭孔结构或其组合的多孔侧壁限定的至少一个内腔; 以及包含在所述至少一个内腔内的药物制剂,其中所述装置可在低轮廓展开形状和相对扩张的保留形状之间变形。