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11. 发明授权

US09192750B2 Method and device for controlling drug pharmacokinetics 有权
标题翻译：用于控制药物药代动力学的方法和装置
公开(公告)号：US09192750B2
公开(公告)日：2015-11-24
申请号：US12755540
申请日：2010-04-07
申请人： Ronald J. Pettis , Noel Harvey , Barry Ginsberg
发明人： Ronald J. Pettis , Noel Harvey , Barry Ginsberg
IPC分类号： A61M31/00 , A61M37/00
CPC分类号： A61M37/0015 , A61M5/3291 , A61M2037/0023 , A61M2037/0061
摘要： Methods and devices for administration of substances into at least two compartments of skin for systemic absorption and improved pharmacokinetics, based on biphasic or bimodel kinetic profiling.
摘要翻译：基于双相或双模动力学分析，将物质施用至至少两个皮肤区域以进行全身吸收和改善的药代动力学的方法和装置。

12. 发明授权

US08900186B2 Microneedle-based pen device for drug delivery and method for using same 有权
标题翻译：用于药物递送的基于微针的笔式装置及其使用方法
公开(公告)号：US08900186B2
公开(公告)日：2014-12-02
申请号：US12379078
申请日：2009-02-12
申请人： Ronald J. Pettis , Frank E. Martin , Scott A. Kaestner
发明人： Ronald J. Pettis , Frank E. Martin , Scott A. Kaestner
IPC分类号： A61M5/00 , A61M5/28 , A61M5/315 , A61M5/32 , A61M37/00 , A61M5/20 , A61M5/42
CPC分类号： A61M37/0015 , A61M5/20 , A61M5/28 , A61M5/288 , A61M5/31548 , A61M5/31568 , A61M5/31593 , A61M5/32 , A61M5/3298 , A61M5/425 , A61M5/46 , A61M2037/0023 , A61M2037/003
摘要： A system and method is provided for an injectable substance delivery pen comprising a microneedle hub assembly removably engaged with a pen device body which includes a cartridge, a plunger, and a drive mechanism. The hub assembly includes at least one microneedle for intradermal or shallow subcutaneous injection of the contents of the cartridge. The cartridge, plunger and drive mechanism components of the pen body are fabricated of non-compliant and non-compressible materials to allow effective communication of the cartridge contents via the microneedle patient interface.
摘要翻译：提供了一种用于可注射物质输送笔的系统和方法，其包括可拆卸地与包括药筒，柱塞和驱动机构的笔装置主体接合的微针毂组件。轮毂组件包括用于皮内或浅皮下注射筒的内容物的至少一个微针。笔体的盒，柱塞和驱动机构部件由非顺应性和不可压缩材料制成，以允许经由微针患者界面有效地连通药筒内容物。

13. 发明授权

US08465468B1 Intradermal delivery of substances 有权
公开(公告)号：US08465468B1
公开(公告)日：2013-06-18
申请号：US09606909
申请日：2000-06-29
申请人： Ronald J. Pettis , James A. Down , Noel G. Harvey
发明人： Ronald J. Pettis , James A. Down , Noel G. Harvey
IPC分类号： A61M31/00
CPC分类号： A61M5/46 , A61K38/28 , A61K38/29 , A61M5/158 , A61M5/32 , A61M5/3286 , A61M5/3291 , A61M5/3295 , A61M37/0015 , A61M2037/0038 , A61M2037/0061
摘要： The present invention provides improved methods for ID delivery of drugs and other substances to humans or animals. The methods employ small gauge needles, especially microneedles, placed in the intradermal space to deliver the substance to the intradermal space as a bolus or by infusion. It has been discovered that the placement of the needle outlet within the skin and the exposed height of the needle outlet are critical for efficacious delivery of active substances via small gauge needles to prevent leakage of the substance out of the skin and to improve absorption within the intradermal space. The pharmacokinetics of hormone drugs delivered according to the methods of the invention have been found to be very similar to the pharmacokinetics of conventional SC delivery, indicating that ID administration according to the methods of the invention is likely to produce a similar clinical result (i.e., similar efficacy) with the advantage of reduction or elimination of pain for the patient. Delivery devices which place the needle outlet at an appropriate depth in the intradermal space and control the volume and rate of fluid delivery provide accurate delivery of the substance to the desired location without leakage.

14. 发明申请

US20090157041A1 Microneedel-based pen device for drug delivery and method for using same 有权
标题翻译：用于药物递送的基于Micoroneedel的笔式装置及其使用方法
公开(公告)号：US20090157041A1
公开(公告)日：2009-06-18
申请号：US12379078
申请日：2009-02-12
申请人： Ronald J. Pettis , Frank E. Martin , Scott A. Kaestner
发明人： Ronald J. Pettis , Frank E. Martin , Scott A. Kaestner
IPC分类号： A61M5/46 , A61B6/00 , A61M5/31
CPC分类号： A61M37/0015 , A61M5/20 , A61M5/28 , A61M5/288 , A61M5/31548 , A61M5/31568 , A61M5/31593 , A61M5/32 , A61M5/3298 , A61M5/425 , A61M5/46 , A61M2037/0023 , A61M2037/003
摘要： A system and method is provided for an injectable substance delivery pen comprising a microneedle hub assembly removably engaged with a pen device body which includes a cartridge, a plunger, and a drive mechanism. The hub assembly includes at least one microneedle for intradermal or shallow subcutaneous injection of the contents of the cartridge. The cartridge, plunger and drive mechanism components of the pen body are fabricated of non-compliant and non-compressible materials to allow effective communication of the cartridge contents via the microneedle patient interface.
摘要翻译：提供了一种用于可注射物质输送笔的系统和方法，其包括可拆卸地与包括药筒，柱塞和驱动机构的笔装置主体接合的微针毂组件。轮毂组件包括用于皮内或浅皮下注射筒的内容物的至少一个微针。笔体的盒，柱塞和驱动机构部件由非顺应性和不可压缩材料制成，以允许经由微针患者界面有效地连通药筒内容物。

15. 发明授权

US07252651B2 Disposable injection device 有权
标题翻译：一次性注射装置
公开(公告)号：US07252651B2
公开(公告)日：2007-08-07
申请号：US10337413
申请日：2003-01-07
申请人： M. Ishaq Haider , Timothy Erskine , Ronald J. Pettis
发明人： M. Ishaq Haider , Timothy Erskine , Ronald J. Pettis
IPC分类号： A61M5/32
CPC分类号： A61M5/3234 , A61M5/2033 , A61M5/2429 , A61M5/46 , A61M5/502 , A61M2005/2013 , A61M2005/3247 , A61M2037/0023
摘要： An injection device is provided. The device includes a housing having a first end defining a first opening. A plunger is received within the first opening of the housing to move between first and second positions. A cartridge is disposed in the housing and has an interior serving as a reservoir for a drug. A delivery needle is disposed within the housing and is in fluid communication with the reservoir via an interruptible fluid channel. A locking mechanism is disposed in the housing. In the first position of the plunger the delivery needle is enclosed by the plunger and in the second position of the plunger the delivery needle is placed in an injection position and the plunger activates the locking mechanism whereby when the plunger returns to the first position the locking mechanism prevents the needle from being placed in the injection position.
摘要翻译：提供注射装置。该装置包括具有限定第一开口的第一端的壳体。柱塞被容纳在壳体的第一开口内以在第一和第二位置之间移动。盒体设置在壳体中，并且具有用作药物的储存器的内部。输送针设置在壳体内并且经由可中断流体通道与储存器流体连通。锁定机构设置在壳体中。在柱塞的第一位置，输送针由柱塞封闭，并且在柱塞的第二位置中，输送针被放置在注射位置，并且柱塞启动锁定机构，由此当柱塞返回到第一位置时，锁定机构防止针头置于注射位置。

16. 发明授权

US06689100B2 Microdevice and method of delivering or withdrawing a substance through the skin of an animal 有权
标题翻译：通过动物皮肤递送或取出物质的微型装置和方法
公开(公告)号：US06689100B2
公开(公告)日：2004-02-10
申请号：US09971145
申请日：2001-10-05
申请人： Robert I. Connelly , Ronald J. Pettis
发明人： Robert I. Connelly , Ronald J. Pettis
IPC分类号： A61M500
CPC分类号： A61M37/0015 , A61B5/14514 , A61M2037/0023 , A61M2037/003
摘要： A device for withdrawing or delivering a substance through the skin of a patient includes a body and a skin penetrating device having a plurality of skin penetrating members, such microneedles. The body includes a bottom surface having a first inner surface area supporting the skin penetrating members and a second outer surface having an adhesive for attaching the device to the skin. In one embodiment, the firs inner surface is spaced outwardly from the second outer surface when the device is attached to the skin. The inner surface can have a textured visually wettable surface, such as an etched surface, to provide a visual indication of leakage from the interface between the skin penetrating members and the skin.
摘要翻译：用于通过患者皮肤抽出或递送物质的装置包括具有多个皮肤穿透构件的这种微针的身体和皮肤穿透装置。本体包括具有支撑皮肤穿透构件的第一内表面区域和具有用于将装置附接到皮肤的粘合剂的第二外表面的底表面。在一个实施例中，当装置附接到皮肤时，第一内表面与第二外表面向外间隔开。内表面可以具有织构化的视觉上可润湿的表面，例如蚀刻表面，以提供从皮肤穿透构件和皮肤之间的界面渗漏的视觉指示。

17. 发明授权

US08708994B2 Method for altering drug pharmacokinetics based on medical delivery platform 有权
标题翻译：基于医疗交付平台改变药物药代动力学的方法
公开(公告)号：US08708994B2
公开(公告)日：2014-04-29
申请号：US13072824
申请日：2011-03-28
申请人： Ronald J. Pettis , Noel G. Harvey , James A. Down
发明人： Ronald J. Pettis , Noel G. Harvey , James A. Down
IPC分类号： A61M31/00
CPC分类号： A61M5/46 , A61K38/28 , A61K38/29 , A61M5/158 , A61M5/32 , A61M5/3286 , A61M5/3291 , A61M5/3295 , A61M37/0015 , A61M2037/0038 , A61M2037/0061
摘要： A method for directly delivering whereby a substance is introduced into an intradermal space within mammalian skin which involves administering the substance through at least one small gauge hollow needle having an outlet with an exposed height between 0 and 1 mm. The outlet is inserted into the skin to a depth of between 0.3 mm and 2 mm such that the delivery of the substance occurs at a depth between 0.3 mm and 2 mm.
摘要翻译：一种用于直接递送的方法，其中物质被引入到哺乳动物皮肤内的真皮内空间，其涉及通过至少一个具有暴露高度在0和1mm之间的出口的小规模中空针管来施用该物质。将出口插入到皮肤中至0.3mm至2mm之间的深度，使得物质的输送发生在0.3mm和2mm之间的深度。

18. 发明申请

US20090312722A1 INJECTION FLUID LEAKAGE COLLECTION SYSTEM AND METHOD 审中-公开
标题翻译：注射液泄漏收集系统及方法
公开(公告)号：US20090312722A1
公开(公告)日：2009-12-17
申请号：US11997663
申请日：2006-08-03
申请人： Philippe E. Laurent , Ronald J. Pettis , William A. Easterbrook, III , Julie Berube
发明人： Philippe E. Laurent , Ronald J. Pettis , William A. Easterbrook, III , Julie Berube
IPC分类号： A61F13/15
CPC分类号： A61B10/0045 , A61B10/0096 , A61B17/205 , A61B2090/063 , A61M2205/15
摘要： A system and method for collection of fluids, as may be used in evaluation of drag dose delivery completeness after parenteral injection by measuring fluid volume leakage from the injection site is provided. The system and method optionally separate the collection and measurement steps, which make the system and method easy to use in multi-site clinical trials, and for batch weighing operations.
摘要翻译：提供了一种用于收集流体的系统和方法，其可用于通过测量从注射部位的流体体积泄漏来评估肠胃外注射后的阻力剂量递送完整性。该系统和方法可选择分离收集和测量步骤，这使得系统和方法在多站点临床试验中容易使用，以及批量称重操作。

19. 发明申请

US20090124997A1 METHODS AND DEVICES FOR IMPROVING DELIVERY OF A SUBSTANCE TO SKIN 审中-公开
标题翻译：改善皮肤物质输送的方法和装置
公开(公告)号：US20090124997A1
公开(公告)日：2009-05-14
申请号：US12139757
申请日：2008-06-16
申请人： Ronald J. Pettis , Dians E. Sutter , Richard P. Clarke
发明人： Ronald J. Pettis , Dians E. Sutter , Richard P. Clarke
IPC分类号： A61M5/32
CPC分类号： A61M5/46 , A61M5/1452 , A61M5/484 , A61M2205/3351
摘要： A method of delivery of a substance to a human subject's skin comprising deposition into a specific compartment of the skin, wherein the delivery occurs at a controlled rate and pressure. The methods of the invention provide accurate deposition of s pre-selected volume of the substance, e.g., greater than 90% of the pre-selected volume. The methods of the invention encompass varying one or more parameters including but not limited to configurations of the delivery device, volume, pressure, and flow rate of delivery, to enhance the efficacy of delivery of the substance to the human skin. Substances delivered in accordance with the methods of the invention result in a more efficacious deposition of the substance into the targeted compartment, improved delivery performance, i.e., completeness of delivery as measured by quantification of the substance not delivered or the amount of the substance leaked out from the injection site, and enhanced safety as measured by the occurrence of minimal adverse cutaneous events at the site of injection.
摘要翻译：将物质递送至人受试者的皮肤的方法，包括沉积到皮肤的特定隔室中，其中递送以受控的速率和压力发生。本发明的方法提供物质的预选体积的精确沉积，例如大于预选体积的90％。本发明的方法包括改变一个或多个参数，包括但不限于递送装置的配置，体积，压力和输送流速，以增强物质递送至人皮肤的功效。根据本发明的方法递送的物质导致物质进入目标隔室的更有效的沉积，改善的输送性能，即通过定量未输送的物质或泄露的物质的量测量的输送的完整性从注射部位，并通过在注射部位的最小不良皮肤事件的发生所测量的增强的安全性。

20. 发明授权

US07060059B2 System and method for initiating and maintaining continuous, long-term control of a concentration of a substance in a patient using a feedback or model-based controller coupled to a single-needle or multi-needle intradermal (ID) delivery device 有权
标题翻译：用于使用耦合到单针或多针皮内（ID）递送装置的反馈或基于模型的控制器来启动和维持对患者物质浓度的连续长期控制的系统和方法
公开(公告)号：US07060059B2
公开(公告)日：2006-06-13
申请号：US10683466
申请日：2003-10-14
申请人： Steven Keith , Robert S. Parker , Noel G. Harvey , Ronald J. Pettis , John D. DeNuzzio , Glenn Vonk
发明人： Steven Keith , Robert S. Parker , Noel G. Harvey , Ronald J. Pettis , John D. DeNuzzio , Glenn Vonk
IPC分类号： A61M31/00
CPC分类号： A61K38/28 , A61M5/172 , A61M31/002 , A61M2005/14208 , A61M2230/201 , G06F19/00 , G06F19/3468 , G16H40/63
摘要： A closed loop therapy system for controlling a concentration of a substance, such as blood glucose concentration, in the body of a user. The system and method employ a sensor system that measures a glucose level in the body, a controller that uses the measured glucose levels to generate an output that can be used to automatically or manually control an intradermal insulin infusion system to set a constant or time-varying profile of target blood glucose concentrations in a user, and then infuse an appropriate amount of insulin into the body of the user so as to reach and maintain the target values of the blood glucose concentration.
摘要翻译：一种闭环治疗系统，用于控制使用者身体中物质的浓度，例如血糖浓度。该系统和方法采用测量体内葡萄糖水平的传感器系统，使用测量的葡萄糖水平产生输出的控制器，该输出可用于自动或手动地控制皮内胰岛素输注系统以设定恒定或时间 - 使用者的目标血糖浓度变化，然后将适量的胰岛素注入使用者的身体，以达到和维持血糖浓度的目标值。

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