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1. 发明授权

US10532132B2 Implantable drug delivery device and methods 有权
公开(公告)号：US10532132B2
公开(公告)日：2020-01-14
申请号：US13910730
申请日：2013-06-05
申请人： Irene Sophie Tobias , Heejin Lee , Michael J. Cima , Jordan Dimitrakov
发明人： Irene Sophie Tobias , Heejin Lee , Michael J. Cima , Jordan Dimitrakov
IPC分类号： A61L31/06 , A61L31/16
摘要： A method is provided for local controlled delivery of a drug to the seminal vesicle, the prostate, the ejaculatory duct, or the vas deferens of a patient in need of treatment. In one embodiment, the method includes implanting a resorbable drug delivery device within the seminal vesicle, the prostate, the ejaculatory duct, or the vas deferens of the patient. The drug delivery device may include an elastic device body housing at least one drug reservoir which contains at least one drug. In a preferred embodiment, the method further includes releasing the drug from the device in a controlled manner to, typically directly to, the seminal vesicle, the prostate, the ejaculatory duct, or the vas deferens.

2. 发明授权

US09107816B2 Implantable device for controlled dissolution and diffusion of low solubility drug 有权
标题翻译：用于低溶解度药物的受控溶解和扩散的可植入装置
公开(公告)号：US09107816B2
公开(公告)日：2015-08-18
申请号：US13366981
申请日：2012-02-06
申请人： Heejin Lee , Hong Linh Ho Duc , Matthew Sansone
发明人： Heejin Lee , Hong Linh Ho Duc , Matthew Sansone
IPC分类号： A61M31/00 , A61K9/00 , A61K31/337 , A61K31/407 , A61K31/46 , A61K31/555 , A61K31/7064 , A61K33/24 , A61M37/00
CPC分类号： A61K9/0024 , A61K9/0034 , A61K31/337 , A61K31/407 , A61K31/46 , A61K31/555 , A61K31/7064 , A61K33/24 , A61M31/002 , A61M37/0069 , A61M2210/1085 , A61M2210/1089
摘要： Implantable drug delivery devices are provided that are deformable between a relatively straightened shape suitable for deployment and a retention shape suited to retain the device within the bladder or other body cavity. While in the body cavity, the devices release drug from solid drug units housed in the devices. The devices are designed to house the solid drug units in a way that exposes one or more sides of the solid drug units to the fluid at the in vivo site of deployment. Methods for using the devices for administering drug and making the devices also are provided.
摘要翻译：提供可植入药物递送装置，其可在适于展开的相对矫直形状和适于将装置保持在囊或其它体腔内的保持形状之间变形。在体腔中，装置将药物从容纳在装置中的固体药物单元释放出来。这些装置被设计成以固定药物单元的一侧或多侧将暴露在体内部位的液体的方式容纳固体药物单元。还提供了使用用于给药的装置和制造装置的方法。

3. 发明授权

US08679094B2 Implantable device with intravesical tolerability and methods of treatment 有权
标题翻译：具有膀胱内耐受性和治疗方法的植入式装置
公开(公告)号：US08679094B2
公开(公告)日：2014-03-25
申请号：US12972364
申请日：2010-12-17
申请人： Michael J. Cima , Heejin Lee
发明人： Michael J. Cima , Heejin Lee
IPC分类号： A61K9/22
CPC分类号： A61M31/002 , A61F2/042 , A61K9/0034 , A61K9/2072 , A61K31/00 , A61K31/167 , A61L31/16 , A61L31/18 , A61L2300/402 , A61L2300/602 , A61L2430/22 , A61M31/00
摘要： 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.
摘要翻译：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。

4. 发明授权

US08343516B2 Solid drug tablets for implantable drug delivery devices 有权
标题翻译：用于可植入药物递送装置的固体药物片剂
公开(公告)号：US08343516B2
公开(公告)日：2013-01-01
申请号：US12825238
申请日：2010-06-28
申请人： Karen Danielle Daniel , Burleigh M. Hutchins, III , Cheryl Larrivee-Elkins , Heejin Lee
发明人： Karen Danielle Daniel , Burleigh M. Hutchins, III , Cheryl Larrivee-Elkins , Heejin Lee
IPC分类号： A61F13/00 , A61F2/02
CPC分类号： A61K9/0004 , A61K9/0034 , A61K9/2004 , A61K9/2027 , A61K9/2031 , A61K9/2072 , A61K9/2095 , A61K31/16 , A61K31/165 , A61K31/167 , A61M31/002 , A61M31/007 , A61M2202/06 , B65B1/16
摘要： A drug dosage form is provided in the form of a solid tablet which is greater than 50% by weight the local anesthetic agent. The local anesthetic agent may be selected from the group consisting of an aminoamide, an aminoester, and a combination thereof. The drug tablet may be in the form of a mini-tablet which is greater than 70 wt % drug, with the balance being excipient. For example, the anesethetic agent may include lidocaine, in a salt or base form, combined with binder and lubricant excipients. Implantable drug delivery devices including the tablets are also provided, e.g., one or more of the drug tablets may be contained in a biocompatible housing. The drug tablets may be substantially cylindrical with flat end faces, and the device may have from 10 to 100 drug tablets aligned in the housing with the flat end faces of adjacent tablets abutting one another.
摘要翻译：以固体片剂的形式提供药物剂型，其大于当量麻醉剂的50重量％。局部麻醉剂可以选自氨基酰胺，氨基酯及其组合。药片可以是大于70重量％的药物的微型片剂，其余为赋形剂。例如，麻醉剂可以包括盐或碱形式的利多卡因，与粘合剂和润滑剂赋形剂组合。还提供了包括片剂在内的可植入药物递送装置，例如药物片剂中的一种或多种可以包含在生物相容的壳体中。药物片剂可以是具有平坦端面的大致圆柱形，并且该装置可以具有在壳体中对齐的10至100个药物片剂，相邻片剂的平坦端面彼此邻接。

5. 发明申请

US20120089121A1 Implantable Drug Delivery Device with Bladder Retention Feature 有权
标题翻译：具有膀胱保留特征的可植入药物输送装置
公开(公告)号：US20120089121A1
公开(公告)日：2012-04-12
申请号：US13267469
申请日：2011-10-06
申请人： Heejin Lee , Hong Linh Ho Duc
发明人： Heejin Lee , Hong Linh Ho Duc
IPC分类号： A61M31/00
CPC分类号： A61M31/002 , A61K9/0034 , A61K9/0065 , A61K9/20 , A61K31/167 , A61L31/10 , A61L31/16 , A61L2300/402 , A61M2210/1085
摘要： 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.
摘要翻译：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。

6. 发明申请

US20110052497A1 Minimally Invasive Systems and Methods for In Vivo Testing of Materials 审中-公开
标题翻译：微创体系和材料体内检测方法
公开(公告)号：US20110052497A1
公开(公告)日：2011-03-03
申请号：US12870261
申请日：2010-08-27
申请人： Heejin Lee
发明人： Heejin Lee
IPC分类号： A61K49/00 , C12Q1/02 , C12M1/34 , G01N31/00
CPC分类号： A61M31/002 , A61M2210/1085
摘要： 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.
摘要翻译：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。

7. 发明申请

US20100152704A1 Method for Intravesical Drug Delivery 有权
标题翻译：膀胱内给药方法
公开(公告)号：US20100152704A1
公开(公告)日：2010-06-17
申请号：US12709551
申请日：2010-02-22
申请人： Heejin Lee , Karen Daniel , Hong Linh Ho Duc , Michael J. Cima , Mario Castillo , Steven Froelich , Jordan Dimitrakov , Grace Y. Kim
发明人： Heejin Lee , Karen Daniel , Hong Linh Ho Duc , Michael J. Cima , Mario Castillo , Steven Froelich , Jordan Dimitrakov , Grace Y. Kim
IPC分类号： A61M25/00 , A61K31/167 , A61K33/04 , A61K31/737 , A61K31/24 , A61K31/407
CPC分类号： A61M31/002 , A61K9/0034 , A61L29/06 , A61L29/16 , A61L2300/402 , A61L2300/406 , A61L2300/45 , A61L2300/63 , A61M2202/06 , A61M2205/0216 , A61M2210/1085 , C08L83/04
摘要： Implant devices for intravesical administration and local drug delivery. The device has a body which includes a hollow tube formed of a biocompatible material; at least one reservoir in the tube which contains a drug; and one or more apertures through which the drug can be released. The device is configured for minimally invasive insertion into a body cavity, such as the bladder. The hollow tube may be elastomeric to permit the device to be elastically deformed from its initial shape into an elongated shape for passage through a catheter, where following such passage the device can return to or toward its initial shape to facilitate retention of the device in the body cavity. The body may have a narrow, elongated shape effective to permit insertion of the drug delivery device through a catheter without necessarily deforming the body, yet include flexible projections which effect retention within the body cavity.
摘要翻译：用于膀胱内给药和局部药物输送的植入装置。该装置具有包括由生物相容性材料形成的中空管的主体; 管中含有药物的至少一个储存器; 以及可以释放药物的一个或多个孔。该装置构造成用于微创地插入诸如膀胱的体腔中。中空管可以是弹性的，以允许该装置从其初始形状弹性变形成细长形状以便通过导管，其中随后通过该装置可以返回或朝向其初始形状，以便于将装置保持在体腔。身体可以具有有效的狭窄的细长形状，以允许药物递送装置通过导管插入，而不必使身体变形，而包括有效地保持在体腔内的弹性突起。

8. 发明授权

US09017312B2 Implantable device for controlled drug delivery 有权
标题翻译：用于受控药物输送的可植入装置
公开(公告)号：US09017312B2
公开(公告)日：2015-04-28
申请号：US12851494
申请日：2010-08-05
申请人： Heejin Lee , Michael J. Cima , Karen Daniel , Cheryl Larrivee-Elkins
发明人： Heejin Lee , Michael J. Cima , Karen Daniel , Cheryl Larrivee-Elkins
IPC分类号： A61K9/22 , A61M31/00 , A61K9/00 , A61K31/167
CPC分类号： A61K9/0092 , A61K9/0004 , A61K9/0034 , A61K31/167 , A61M31/002
摘要： 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.
摘要翻译：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。

9. 发明授权

US08801694B2 Intravesical drug delivery device 有权
标题翻译：膀胱内药物输送装置
公开(公告)号：US08801694B2
公开(公告)日：2014-08-12
申请号：US11463956
申请日：2006-08-11
申请人： Heejin Lee , Karen Daniel , Hong Linh Ho Duc , Michael J. Cima , Mario Castillo , Steven Froelich , Jordan Dimitrakov , Grace Y. Kim
发明人： Heejin Lee , Karen Daniel , Hong Linh Ho Duc , Michael J. Cima , Mario Castillo , Steven Froelich , Jordan Dimitrakov , Grace Y. Kim
IPC分类号： A61F2/00 , A61M31/00 , A61L29/16 , A61K9/00 , A61L29/06
CPC分类号： A61M31/002 , A61K9/0034 , A61L29/06 , A61L29/16 , A61L2300/402 , A61L2300/406 , A61L2300/45 , A61L2300/63 , A61M2202/06 , A61M2205/0216 , A61M2210/1085 , C08L83/04
摘要： Implant devices for intravesical administration and local drug delivery. The device has a body which includes a hollow tube formed of a biocompatible material; at least one reservoir in the tube which contains a drug; and one or more apertures through which the drug can be released. The device is configured for minimally invasive insertion into a body cavity, such as the bladder. The hollow tube may be elastomeric to permit the device to be elastically deformed from its initial shape into an elongated shape for passage through a catheter, where following such passage the device can return to or toward its initial shape to facilitate retention of the device in the body cavity. The body may have a narrow, elongated shape effective to permit insertion of the drug delivery device through a catheter without necessarily deforming the body, yet include flexible projections which effect retention within the body cavity.
摘要翻译：用于膀胱内给药和局部药物输送的植入装置。该装置具有包括由生物相容性材料形成的中空管的主体; 管中含有药物的至少一个储存器; 以及可以释放药物的一个或多个孔。该装置构造成用于微创地插入诸如膀胱的体腔中。中空管可以是弹性的，以允许该装置从其初始形状弹性变形成细长形状以便通过导管，其中随后通过该装置可以返回或朝向其初始形状，以便于将装置保持在体腔。身体可以具有有效的狭窄的细长形状，以允许药物递送装置通过导管插入，而不必使身体变形，而包括有效地保持在体腔内的弹性突起。

10. 发明授权

US08690840B2 Time-selective bioresorbable or collapsible drug delivery systems and methods 有权
标题翻译：时间选择性生物可吸收或可折叠药物递送系统和方法
公开(公告)号：US08690840B2
公开(公告)日：2014-04-08
申请号：US13267560
申请日：2011-10-06
申请人： Heejin Lee , Michael J. Cima , Cheryl Larrivee-Elkins , Dennis Giesing , Jessica K. Anderson , Sarma Duddu
发明人： Heejin Lee , Michael J. Cima , Cheryl Larrivee-Elkins , Dennis Giesing , Jessica K. Anderson , Sarma Duddu
IPC分类号： A61M31/00
CPC分类号： A61M31/002 , A61K9/0034 , A61K9/0039 , A61L29/148 , A61L29/16 , A61L31/148 , A61L31/16 , A61L2300/00
摘要： Implantable medical devices and treatment methods are provided, particularly for use in the bladder. The device is configured for retention in the bladder for at least a portion of the drug delivery period and includes at least one biodegradable component such that following a biodegradation at a selected time, the retention function is lost and the device or portions thereof are resorbed and/or excreted. The method may include deploying into the bladder of a patient a device having a device structure housing a drug formulation comprising at a drug; releasing drug from the device structure into the bladder; and then, changing the composition of urine in the bladder, e.g., by altering the pH, to trigger degradation of at least part of the device structure to enable the device structure or parts thereof to be excreted from the bladder.
摘要翻译：提供了可植入的医疗装置和治疗方法，特别用于膀胱。该装置构造成在膀胱中保留药物递送期的至少一部分，并且包括至少一种可生物降解的组分，使得在选定时间内经过生物降解后，保留功能丧失并且其装置或部分被吸收， /或排泄。该方法可以包括向患者的膀胱中部署具有容纳包含药物的药物制剂的装置结构的装置; 将药物从装置结构释放到膀胱中; 然后，例如通过改变pH来改变膀胱中尿液的组成，以触发装置结构的至少一部分的降解，使装置结构或其部分能够从膀胱排出。

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