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1. 发明授权

US07490603B2 Method of use of monomeric insulin as a means for improving the reproducibility of inhaled insulin 失效
公开(公告)号：US07490603B2
公开(公告)日：2009-02-17
申请号：US11284579
申请日：2005-11-21
申请人： Igor Gonda , Reid M. Rubsamen , Stephen J. Farr
发明人： Igor Gonda , Reid M. Rubsamen , Stephen J. Farr
IPC分类号： A61M11/00
CPC分类号： A61K9/007 , A61J7/0418 , A61J7/0427 , A61J7/0445 , A61K9/0073 , A61K9/0075 , A61K38/28 , A61M11/001 , A61M15/00 , A61M15/0031 , A61M15/0045 , A61M15/0051 , A61M15/0065 , A61M15/0066 , A61M15/008 , A61M15/0085 , A61M15/009 , A61M16/142 , A61M2016/0021 , A61M2016/0036 , A61M2202/062 , A61M2202/064 , A61M2205/50 , A61M2205/8206
摘要： The need for the delivery of insulin by injection can be reduced or eliminated by delivering an aerosolized monomeric insulin formulation. Repeatability of dosing and more particularly the repeatability of the blood concentration versus time profile is improved relative to regular insulin. The blood concentration versus time profile is substantially unaffected by specific aspects of the patient's breathing maneuver at delivery. Further, the rate at which blood glucose is lowered is increased by the use of monomeric insulin. Particles of insulin and in particular monomeric insulin delivered to the surface of lung tissue will be absorbed into the circulatory system. The monomeric insulin may be a dry powder but is preferably in a liquid formulation delivered to the patient from a hand-held, self-contained device which automatically releases an aerosolized burst of formulation. The device includes a sensor which is preferably electronic which measures inspiratory flow and volume which measurement can be used to control the point of drug release.

2. 发明授权

US07021309B2 Method of use of monomeric insulin as a means for improving the reproducibility of inhaled insulin 失效
公开(公告)号：US07021309B2
公开(公告)日：2006-04-04
申请号：US10682529
申请日：2003-10-08
申请人： Igor Gonda , Reid M. Rubsamen , Stephen J. Farr
发明人： Igor Gonda , Reid M. Rubsamen , Stephen J. Farr
IPC分类号： A61M11/00
CPC分类号： A61K9/007 , A61J7/0418 , A61J7/0427 , A61J7/0445 , A61K9/0073 , A61K9/0075 , A61K38/28 , A61M11/001 , A61M15/00 , A61M15/0031 , A61M15/0045 , A61M15/0051 , A61M15/0065 , A61M15/0066 , A61M15/008 , A61M15/0085 , A61M15/009 , A61M16/142 , A61M2016/0021 , A61M2016/0036 , A61M2202/062 , A61M2202/064 , A61M2205/50 , A61M2205/8206
摘要： The need for the delivery of insulin by injection can be reduced or eliminated by delivering an aerosolized monomeric insulin formulation. Repeatability of dosing and more particularly the repeatability of the blood concentration versus time profile is improved relative to regular insulin. The blood concentration versus time profile is substantially unaffected by specific aspects of the patient's breathing maneuver at delivery. Further, the rate at which blood glucose is lowered is increased by the use of monomeric insulin. Particles of insulin and in particular monomeric insulin delivered to the surface of lung tissue will be absorbed into the circulatory system. The monomeric insulin may be a dry powder but is preferably in a liquid formulation delivered to the patient from a hand-held, self-contained device which automatically releases an aerosolized burst of formulation. The device includes a sensor which is preferably electronic which measures inspiratory flow and volume which measurement can be used to control the point of drug release.

3. 发明授权

US06408854B1 Insulin delivery enhanced by coached breathing 失效
标题翻译：通过辅导呼吸增强胰岛素输送
公开(公告)号：US06408854B1
公开(公告)日：2002-06-25
申请号：US09553693
申请日：2000-04-21
申请人： Igor Gonda , Reid M. Rubsamen
发明人： Igor Gonda , Reid M. Rubsamen
IPC分类号： A61B1900
CPC分类号： A61M15/00 , A61J7/0418 , A61J7/0427 , A61J7/0445 , A61K9/007 , A61K9/0073 , A61K38/28 , A61M11/001 , A61M15/0031 , A61M15/0045 , A61M15/0051 , A61M15/0055 , A61M15/0066 , A61M15/008 , A61M15/0085 , A61M15/009 , A61M16/142 , A61M2016/0021 , A61M2016/0036 , A61M2202/062 , A61M2202/064 , A61M2205/50 , A61M2205/8206
摘要： The need for the delivery of insulin by injection can be reduced or eliminated by a method whereby an aerosolized insulin formulation is delivered to a patient's lungs and the rate at which the insulin is absorbed into the blood is increased by the use of an inhale-exhale breathing maneuver. Particles of insulin delivered to the surface of lung tissue will be absorbed into the circulatory system. The rate of absorption is enhanced by instructing the patient to inhale maximally and thereafter exhale maximally. This maneuver causes a spike in the rate at which insulin enters the circulatory system thereby increasing the rate at which glucose is removed from the circulatory system. The insulinmay be a dry powder but is preferably in a liquid formulation delivered to the patient from a hand-held, self-contained device which automatically releases an aerosolized burst of formulation. The device includes a sensor which is preferably electronic which measures inspiratory flow and volume which measurement can be used to control the point of drug release. The sensor can also assist the patient in the inhale-exhale maneuver.
摘要翻译：可以通过以下方法减少或消除对通过注射递送胰岛素的需要：将雾化的胰岛素制剂输送到患者的肺中，并且通过使用吸入呼气来增加胰岛素被吸收到血液中的速率呼吸机动输送到肺组织表面的胰岛素颗粒将被吸收到循环系统中。通过指导患者最大限度吸入，然后最大程度地呼气，提高吸收率。这种操作导致胰岛素进入循环系统的速率的峰值，从而增加从循环系统中除去葡萄糖的速率。胰岛素可以是干粉，但是优选地是从手持式独立装置输送到患者的液体制剂，其自动释放雾化的制剂爆发。该装置包括传感器，其优选是电子的，其测量吸气流量和体积，该测量可用于控制药物释放点。传感器还可以帮助患者进行吸气呼气操作。

4. 发明授权

US6123068A Systems for the intrapulmonary delivery of aerosolized aqueous formulations 失效
标题翻译：用于肺内递送雾化水性制剂的系统
公开(公告)号：US6123068A
公开(公告)日：2000-09-26
申请号：US65753
申请日：1998-04-24
申请人： Lester John Lloyd , Peter M. Lloyd , Reid M. Rubsamen , Jeffrey Arthur Schuster
发明人： Lester John Lloyd , Peter M. Lloyd , Reid M. Rubsamen , Jeffrey Arthur Schuster
IPC分类号： B65D81/24 , A61J1/03 , A61J1/14 , A61J3/00 , A61J7/04 , A61K51/12 , A61M11/00 , A61M13/00 , A61M15/00 , A61M16/00 , B65D81/32 , B65D83/00
CPC分类号： A61K51/1206 , A61M15/00 , A61M15/001 , A61M15/0031 , A61M15/0043 , A61M15/0051 , A61M15/0055 , A61M15/008 , B65D81/32 , A61J1/035 , A61J7/0418 , A61M11/002 , A61M15/0085 , A61M2016/0021 , A61M2016/0039 , A61M2205/8206 , A61M2230/40
摘要： A disposable package, tape, and cassette are provided which makes it possible to hold and disperse therefrom liquid, flowable formulations including aqueous formulations (solutions or dispersions with particles less than 0.25 microns in diameter) of a pharmaceutically active drug. In one embodiment formulation is packaged in individual dosage unit containers which containers are preferably interconnected. The package is designed to be integrated into a cassette which can be loaded into a dispersing device capable of individually opening dosage unit containers and aerosolizing the contents through a porous membrane, into a mouth piece on the cassette, for delivery to a patient. In addition to and alongside of each porous membrane, the package may include one or more openings through which air is forced in order to aid in avoiding the accumulation of aerosolized particles. The package may be configured so that the formulation is held in a container not positioned directly vertical to and below the porous membrane, thus making it necessary to channel formulation horizontally to the porous membrane and making it possible to include a vibrating mechanism directly below a chamber covered by the porous membrane. Release of aerosolized drug is breath actuated based on simultaneous measurements of inspiratory flow and volume so as to provide for repeatable dosing of drug to the patient.
摘要翻译：提供了一次性包装，胶带和盒，其使得可以将含有药物活性药物的水性制剂（直径小于0.25微米的溶液或分散体）的液体可流动制剂保持并分散。在一个实施方案中，将制剂包装在单独的剂量单位容器中，这些容器优选地互连。包装被设计成集成到盒子中，该盒子可以装载到能够单独打开剂量单位容器并通过多孔膜将内容物雾化到分离盒中的口件中的分散装置中，用于递送给患者。除了每个多孔膜之外并且旁边，包装可以包括一个或多个开口，通过该开口迫使空气以帮助避免雾化颗粒的积聚。包装可以被配置成使得制剂保持在不直接垂直于多孔膜的下方的容器中，因此使得必须水平地配制到多孔膜上，并且使得可以在腔室的正下方包括振动机构被多孔膜覆盖。基于吸气流量和体积的同时测量，气雾化药物的释放是呼吸启动的，以便向患者提供药物的可重复剂量。

5. 发明授权

US6012450A Intrapulmonary delivery of hematopoietic drug 失效
标题翻译：肺内输送造血药物
公开(公告)号：US6012450A
公开(公告)日：2000-01-11
申请号：US673963
申请日：1996-07-01
申请人： Reid M. Rubsamen
发明人： Reid M. Rubsamen
IPC分类号： A61J7/04 , A61M15/00 , A61M16/00 , A61M16/10 , A61M11/00
CPC分类号： A61M15/009 , A61M15/001 , A61M15/0045 , A61M15/0048 , A61M15/0051 , A61M15/0066 , A61M15/008 , A61M16/108 , A61J7/0445 , A61M2016/0021 , A61M2202/062 , A61M2202/064 , A61M2205/52 , A61M2205/8206
摘要： A method of treating human patients is provided by the intrapulmonary delivery of a formulation containing a hematopoietic drug. The formulation is automatically released in an aerosolized form from a hand-held, self-contained, portable device comprised of a means for automatically releasing a measured amount of drug into the inspiratory flow path of a patient in response to information obtained from a means for measuring the inspiratory flow rate and determining the inspiratory volume of a patient. Reproducible dosing is obtained by providing for automatic release at the same inspiratory flow rate and inspiratory volume each time drug is released. The device includes a timer to enable a patient to take a drug at the same time each day. Further, overadministration of a hematopoietic drug formulation is avoided by providing a pre-programmed microprocessor designed to avoid overdosing.
摘要翻译：通过肺内递送含有造血药物的制剂来提供治疗人类患者的方法。该制剂以手持式独立式便携式装置自动释放，包括用于响应于从患者的吸入流动路径获得的信息自动释放测量量的药物到患者的吸气流动路径中的装置，测量吸气流速并确定患者的吸气体积。通过在药物释放时以相同的吸气流速和吸气量提供自动释放，可以获得可再现的剂量。该装置包括能够使患者每天同时服用药物的计时器。此外，通过提供设计用于避免过量的预编程微处理器来避免造血药物制剂的过度给药。

6. 发明授权

US5941240A Inhaled insulin dosage control delivery enhanced by controlling total inhaled volume 失效
公开(公告)号：US5941240A
公开(公告)日：1999-08-24
申请号：US160909
申请日：1998-09-25
申请人： Igor Gonda , Reid M. Rubsamen , Stephen J. Farr
发明人： Igor Gonda , Reid M. Rubsamen , Stephen J. Farr
IPC分类号： A61M11/02 , A61J7/04 , A61K9/00 , A61K38/28 , A61M15/00 , A61M16/00 , A61M16/14 , A61M11/00
CPC分类号： A61K9/007 , A61K38/28 , A61K9/0073 , A61M11/001 , A61M15/00 , A61M15/0031 , A61M15/0043 , A61M15/0045 , A61M15/0051 , A61M15/0066 , A61M15/008 , A61M16/142 , A61J7/0418 , A61J7/0427 , A61J7/0445 , A61M15/0085 , A61M15/009 , A61M2016/0021 , A61M2016/0036 , A61M2202/062 , A61M2202/064 , A61M2205/50 , A61M2205/8206 , Y10S514/866
摘要： Dosages of inhaled insulin are controlled within a narrow range by controlling the total volume of air inhaled by a patient. By repeatedly delivering aerosolized insulin with the same total inhaled volume of air, the amount of insulin delivered to the patient each time is consistent. A device for delivering insulin by inhalation is disclosed which device comprises a means for measuring inhaled volume and for halting inhalation at a pre-determined point. The device also comprises an adjustable means for applying various amounts of force to a container of formulation to expel different amounts of drug from the container based on the force applied.

7. 发明授权

US5823178A Disposable package for use in aerosolized delivery of drugs 失效
标题翻译：一次性包装，用于雾化交付药物
公开(公告)号：US5823178A
公开(公告)日：1998-10-20
申请号：US693593
申请日：1996-08-02
申请人： Lester John Lloyd , Peter M. Lloyd , Reid M. Rubsamen , Jeffrey Arthur Schuster
发明人： Lester John Lloyd , Peter M. Lloyd , Reid M. Rubsamen , Jeffrey Arthur Schuster
IPC分类号： B65D81/24 , A61J1/03 , A61J1/14 , A61J3/00 , A61J7/04 , A61K51/12 , A61M11/00 , A61M13/00 , A61M15/00 , A61M16/00 , B65D81/32 , B65D83/00
CPC分类号： A61K51/1206 , A61M15/00 , A61M15/001 , A61M15/0031 , A61M15/0043 , A61M15/0051 , A61M15/0055 , A61M15/008 , B65D81/32 , A61J1/035 , A61J7/0418 , A61M11/002 , A61M15/0085 , A61M2016/0021 , A61M2016/0039 , A61M2205/8206 , A61M2230/40
摘要： A disposable package, tape, and cassette are provided which makes it possible to hold and disperse therefrom liquid, flowable formulations including aqueous formulations (solutions or dispersions with particles less than 0.25 microns in diameter) of a pharmaceutically active drug. In one embodiment formulation is packaged in individual dosage unit containers which containers are preferably interconnected. The package is designed to be integrated into a cassette which can be loaded into a dispersing device capable of individually opening dosage unit containers and aerosolizing the contents through a porous membrane, into a mouth piece on the cassette, for delivery to a patient. In addition to and alongside of each porous membrane, the package may include one or more openings through which air is forced in order to aid in avoiding the accumulation of aerosolized particles. The package may be configured so that the formulation is held in a container not positioned directly vertical to and below the porous membrane, thus making it necessary to channel formulation horizontally to the porous membrane and making it possible to include a vibrating mechanism directly below a chamber covered by the porous membrane. Release of aerosolized drug is breath actuated based on simultaneous measurements of inspiratory flow and volume so as to provide for repeatable dosing of drug to the patient.
摘要翻译：提供了一次性包装，胶带和盒，其使得可以将含有药物活性药物的水性制剂（直径小于0.25微米的溶液或分散体）的液体可流动制剂保持并分散。在一个实施方案中，将制剂包装在单独的剂量单位容器中，这些容器优选地互连。包装被设计成集成到盒子中，该盒子可以装载到能够单独打开剂量单位容器并通过多孔膜将内容物雾化到分离盒中的口件中的分散装置中，用于递送给患者。除了每个多孔膜之外并且旁边，包装可以包括一个或多个开口，通过该开口迫使空气以帮助避免雾化颗粒的积聚。包装可以被配置成使得制剂保持在不直接垂直于多孔膜的下方的容器中，因此使得必须水平地配制到多孔膜上，并且使得可以在腔室的正下方包括振动机构被多孔膜覆盖。基于吸气流量和体积的同时测量，气雾化药物的释放是呼吸启动的，以便向患者提供药物的可重复剂量。

8. 发明授权

US5819726A Method for the delivery of aerosolized drugs to the lung for the treatment of respiratory disease 失效
标题翻译：将雾化药物递送至肺部治疗呼吸系统疾病的方法
公开(公告)号：US5819726A
公开(公告)日：1998-10-13
申请号：US794481
申请日：1997-02-04
申请人： Reid M. Rubsamen , Lester John Lloyd
发明人： Reid M. Rubsamen , Lester John Lloyd
IPC分类号： A61J7/04 , A61M11/04 , A61M15/00 , A61M16/00 , A61M11/00
CPC分类号： A61M15/0045 , A61M11/001 , A61M11/005 , A61M11/042 , A61M15/0051 , A61M15/009 , A61J7/0418 , A61M2016/0021 , A61M2202/062 , A61M2205/52 , A61M2205/6045
摘要： A method of treating patients suffering from a respiratory disease using a programmable, hand-held, self-contained drug dispensing device is disclosed. A patient's inspiratory flow rate is measured and a determination is made of a typical and preferred rate and volume for the release of respiratory drug. To obtain repeatability in dosing the drug is repeatedly released at the same rate and volume. To maximize the amount of drug delivered based on the amount released the drug is released at a rate of from about 0.10 to about 2.0 liters/second and (2) a volume of about 0.15 to about 0.8 liters. Parameters such as rate, volume, and particle size of the aerosolized formulation are adjusted to obtain repeatable dosing of the maximum amount of drug to the desired area of the lung. Lung function is measured and use parameters are adjusted in order to improve lung function.
摘要翻译：公开了一种使用可编程手持式独立药物分配装置治疗患有呼吸系统疾病的患者的方法。测量患者的吸气流速，并确定释放呼吸药物的典型和优选的速率和体积。为了在给药中获得重复性，药物以相同的速率和体积重复释放。为了最大限度地发挥药物的释放量，以药物释放量为约0.10至约2.0升/秒，（2）体积约0.15至约0.8升。调整诸如雾化制剂的速率，体积和粒度的参数，以获得最大量的药物到肺的期望区域的可重复给药。测量肺功能，调整使用参数以改善肺功能。

9. 发明授权

US5813397A Delivery of aerosol medication for inspiration 失效
标题翻译：提供气雾剂用于灵感
公开(公告)号：US5813397A
公开(公告)日：1998-09-29
申请号：US845802
申请日：1997-04-25
申请人： David E. Goodman , Reid M. Rubsamen
发明人： David E. Goodman , Reid M. Rubsamen
IPC分类号： A61M11/00 , A61J7/04 , A61M15/00 , A61M16/00 , A61M16/20 , B01F3/04 , B01F15/02 , B05B9/04 , F16H35/00 , G01F1/36 , G01F1/40 , G01F1/44 , G01F1/50 , G01F7/00 , G01F13/00 , G01F15/00 , G01F25/00
CPC分类号： A61M15/0091 , A61M15/00 , A61M15/0021 , A61M15/0066 , A61M15/008 , A61M16/202 , B01F15/0201 , B01F15/0254 , B01F3/04049 , F16H35/00 , G01F1/363 , G01F1/40 , G01F1/44 , G01F1/50 , G01F13/006 , G01F15/002 , G01F25/0007 , G01F7/005 , A61J7/0418 , A61M11/002 , A61M15/009 , A61M2016/0021 , A61M2016/0036 , A61M2016/0039 , A61M2205/50 , A61M2205/60 , A61M2205/6018 , A61M2205/6027 , A61M2205/6036 , A61M2205/6045 , A61M2205/8206 , A61M2205/8212
摘要： Apparatus and methods for delivering an amount of aerosolized medicine for inspiration by a patient in response to the occurrence of appropriate delivery point or points in the patient's detected breath flow. The aerosol medication may be administered as one or more pulses having a pulse width, shape, and frequency that will maximize the respirable fraction of the aerosolized compound being administered. The delivery point or points may be predetermined or determined from a prior inspiratory flow for depositing the selected medication at one or more desired locations in the patient's airway. Determined delivery points are recursively lowered for each inspiratory flow that does not satisfy one of the predetermined and previously lowered threshold. Changes in the patient's breath flow patterns during the course of an aerosolized medication inspiration therapy program may be detected and used to adjust the controlled amount of medication to be delivered in a given administration and/or to inform the patient of the patient's condition or change in condition. The device also may contain a library of administration protocols or operating parameters for different medications and a means for identifying from the canister the medicinal contents of the canister for customizing operation of the apparatus.
摘要翻译：用于响应于患者检测到的呼吸流中合适的递送点或点的发生而递送一定量的雾化药物以供患者启发的装置和方法。气溶胶药物可以以具有脉冲宽度，形状和频率的一个或多个脉冲施用，其将使所施用的雾化化合物的可呼吸部分最大化。递送点或点可以是预先确定的，也可以从先前的吸气流确定，以便将所选择的药物沉积在患者气道中的一个或多个所需位置。对于不满足预定和先前降低的阈值之一的每个吸气流，确定的递送点递归地降低。可以检测在雾化药物启动治疗程序过程中患者呼吸气流模式的变化，并用于调整在给定给药中待输送的药物的受控量和/或向患者通知患者的状况或改变条件。该装置还可以包含用于不同药物的管理协议或操作参数的库，以及用于从罐识别用于定制装置的操作的罐的药物内容物的装置。

10. 发明授权

US5672581A Method of administration of insulin 失效
标题翻译：胰岛素的给药方法
公开(公告)号：US5672581A
公开(公告)日：1997-09-30
申请号：US331056
申请日：1994-10-28
申请人： Reid M. Rubsamen , Lester John Lloyd
发明人： Reid M. Rubsamen , Lester John Lloyd
IPC分类号： A61J7/02 , A61J7/04 , A61K9/00 , A61K9/12 , A61K38/02 , A61K38/28 , A61K39/12 , A61M11/00 , A61M15/00 , A61M16/00 , A61M16/14 , C07K5/00 , C07K7/00 , C07K17/00 , A61K38/26
CPC分类号： A61M15/00 , A61K38/28 , A61K9/007 , A61K9/0073 , A61K9/008 , A61M11/001 , A61M15/0031 , A61M15/0051 , A61M15/0055 , A61M15/0066 , A61M15/008 , A61M16/142 , A61J7/0418 , A61J7/0427 , A61J7/0445 , A61M15/0085 , A61M15/009 , A61M2016/0021 , A61M2202/062 , A61M2202/064 , A61M2205/8206
摘要： A method for treating a patient suffering from diabetes mellitus by delivering aerosolized insulin to the patient and a programmed, portable, hand-held device used in such treatment methodology is disclosed. Two basic types of drug delivery devices are disclosed for use in connection with the present invention. In accordance with the first type of device the insulin is contained within a low boiling point propellant which is held within a canister under pressure. In accordance with the second type of device the insulin is present within a container in solution and the solution is moved through a porous membrane to create an aerosolized formulation which is inhaled by the patient. In accordance with both devices a measured amount of insulin containing formulation is automatically released into the inspiratory flow path of a patient in response to information obtained from determining the inspiratory flow rate and inspiratory volume of a patient. The determination of values and release of drugs are carried out in real time. Reproducibly dosing of insulin to the patient is obtained by repeatedly providing for automatic release of insulin formulation at the same inspiratory flow rate and inspiratory volume. To maximize the efficiency of the delivery of the insulin formulation the formulation is released at an inspiratory flow rate in the range of from about 0.1 to about 2.0 liters/second and a measured inspiratory volume in the range of about 0.1 to about 0.8 liters.
摘要翻译：公开了一种通过将雾化的胰岛素递送到患者来治疗患有糖尿病的患者的方法，以及用于这种治疗方法的程序化的便携式手持装置。公开了与本发明结合使用的两种基本类型的药物输送装置。根据第一类型的装置，胰岛素被包含在低沸点推进剂中，该推进剂在压力下保持在罐内。根据第二类型的装置，胰岛素存在于溶液中的容器内，并且溶液移动通过多孔膜以产生由患者吸入的雾化制剂。根据两个装置，响应于从确定患者的吸气流速和吸气体积获得的信息，将测量量的含胰岛素制剂自动释放到患者的吸气流动路径中。价值观的确定和药物的释放是实时进行的。通过重复提供相同吸气流速和吸气体积的胰岛素制剂的自动释放，可以获得对患者的胰岛素的再次给药。为了使胰岛素制剂的输送效率最大化，制剂以约0.1至约2.0升/秒的吸气流速和约0.1至约0.8升范围内的测量吸气体积释放。

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