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1. 发明授权

US06835194B2 Implantable devices and methods for treatment of pain by delivery of fentanyl and fentanyl congeners 失效
标题翻译：通过输送芬太尼和芬太尼同系物治疗疼痛的植入式装置和方法
公开(公告)号：US06835194B2
公开(公告)日：2004-12-28
申请号：US10188325
申请日：2002-06-27
申请人： Randolph Mellus Johnson , Felix Theeuwes , Edward M. Gillis , Dana Litmanovitz , Barbara Laidlaw , James Brown , John Culwell , James A. Filice , Peter Wickman , Su-Il Yum , Andrew Poutiatine , John Dinka
发明人： Randolph Mellus Johnson , Felix Theeuwes , Edward M. Gillis , Dana Litmanovitz , Barbara Laidlaw , James Brown , John Culwell , James A. Filice , Peter Wickman , Su-Il Yum , Andrew Poutiatine , John Dinka
IPC分类号： A61K922
CPC分类号： A61F2/02 , A61F2250/0067 , A61K9/0004 , A61K9/0024 , A61K31/4468 , A61K31/4535 , A61K47/10 , A61K47/14 , A61K47/26 , A61M5/141 , A61M5/14276 , A61M5/1452 , A61M5/168 , A61M5/16804 , A61M5/16881 , A61M31/002 , A61M2005/14264
摘要： The invention features devices and methods for treatment of pain. The drug delivery device is a drug delivery system adapted for whole implantation in a subject and to provide pain relief by delivery of fentanyl or a fentanyl congener (e.g., sufentanil) over a protracted period of time (e.g., at least 3 days or more than 3 days). The device comprises a housing defining a reservoir that contains a drug formulation, a pump operatively connected to the housing so as to facilitate movement of drug out of the reservoir and out of the device, and a thermal expansion element which defines a flow pathway comprising a thermal expansion channel to accommodate thermal expansion of formulation in the reservoir. The device can further comprise a valve positioned within the flow pathway so as to prevent movement of drug out of the reservoir prior to use.
摘要翻译：本发明的特征在于用于治疗疼痛的装置和方法。药物递送装置是适于整个植入受试者的药物递送系统，并通过在持续的时间段内输送芬太尼或芬太尼（例如舒芬太尼）来提供疼痛缓解（例如，至少3天或更多 3天）。该装置包括限定容纳药物制剂的储存器的壳体，可操作地连接到壳体的泵，以促进药物从储存器移出并离开装置;以及热膨胀元件，其限定流动通路，该热膨胀元件包括热膨胀通道，以适应储层中配方的热膨胀。该装置还可以包括位于流动通道内的阀，以便在使用之前防止药物从储存器中移动。

2. 发明申请

US20120239007A1 Implantable Devices and Methods for Treatment of Pain by Delivery of Fentanyl and Fentanyl Congeners 审中-公开
标题翻译：植入式装置和通过递送芬太尼和芬太尼同系物治疗疼痛的方法
公开(公告)号：US20120239007A1
公开(公告)日：2012-09-20
申请号：US13355217
申请日：2012-01-20
申请人： Edward M. Gillis , Barbara J. F. Laidlaw , John Culwell , James A. Filice , Peter Wickman , Andrew J. Poutiatine , John S. Dinka , Randolph M. Johnson , Felix Theeuwes
发明人： Edward M. Gillis , Barbara J. F. Laidlaw , John Culwell , James A. Filice , Peter Wickman , Andrew J. Poutiatine , John S. Dinka , Randolph M. Johnson , Felix Theeuwes
IPC分类号： A61M5/168
CPC分类号： A61F2/02 , A61F2250/0067 , A61K9/0004 , A61K9/0024 , A61K31/4468 , A61K31/4535 , A61K47/10 , A61K47/14 , A61K47/26 , A61M5/141 , A61M5/14276 , A61M5/1452 , A61M5/168 , A61M5/16804 , A61M5/16881 , A61M31/002 , A61M2005/14264 , Y02A50/401
摘要： The invention features devices and methods for treatment of pain. The drug delivery device is a drug delivery system adapted for whole implantation in a subject and to provide pain relief by delivery of fentanyl or a fentanyl congener (e.g., sufentanil) over a protracted period of time (e.g., at least 3 days or more than 3 days). The device comprises a housing defining a reservoir that contains a drug formulation, a pump operatively connected to the housing so as to facilitate movement of drug out of the reservoir and out of the device, and a thermal expansion element which defines a flow pathway comprising a thermal expansion channel to accommodate thermal expansion of formulation in the reservoir. The device can further comprise a valve positioned within the flow pathway so as to prevent movement of drug out of the reservoir prior to use.
摘要翻译：本发明的特征在于用于治疗疼痛的装置和方法。药物递送装置是适于整个植入受试者的药物递送系统，并通过在持续的时间段内输送芬太尼或芬太尼（例如舒芬太尼）来提供疼痛缓解（例如，至少3天或更多 3天）。该装置包括限定容纳药物制剂的储存器的壳体，可操作地连接到壳体的泵，以促进药物从储存器移出并离开装置;以及热膨胀元件，其限定流动通路，该热膨胀元件包括热膨胀通道，以适应储层中配方的热膨胀。该装置还可以包括位于流动通道内的阀，以便在使用之前防止药物从储存器中移动。

3. 发明申请

US20050070883A1 Devices and methods for controlled delivery from a drug delivery device 审中-公开
标题翻译：用于从药物递送装置控制递送的装置和方法
公开(公告)号：US20050070883A1
公开(公告)日：2005-03-31
申请号：US10433196
申请日：2001-11-21
申请人： James Brown , John Culwell , James Filice , Edward Gillis , Felix Theeuwes , Peter Wickman , Su Il Yum
发明人： James Brown , John Culwell , James Filice , Edward Gillis , Felix Theeuwes , Peter Wickman , Su Il Yum
IPC分类号： A61M37/00 , A61K9/00 , A61K9/22 , A61M5/142 , A61M5/168 , A61M5/36 , A61M31/00
CPC分类号： A61M5/14276 , A61K9/0004 , A61M5/168 , A61M5/16804 , A61M5/36 , A61M31/002 , A61M2205/0294
摘要： The invention features a plug for use with a drug delivery device, wherein the plug defines an expansion control channel, which accommodates thermal expansion of a formulation in a reservoir of a drug delivery device, and an exit channel. In one embodiment, the plug comprises an inner plug member and an outer plug member, which members define an expansion control channel to facilitate release of entrapped air and to accommodate thermal expansion of formulation from the sealed drug reservoir. The plug further defines an exit channel, and may optionally further comprise a frit positioned within the flow pathway just prior to the delivery outlet, or both.
摘要翻译：本发明的特征在于一种用于药物递送装置的塞子，其中塞子限定扩张控制通道，其适应制剂在药物递送装置的储存器中的热膨胀和出口通道。在一个实施例中，塞子包括内塞构件和外塞构件，这些构件限定了膨胀控制通道，以便于捕获的空气的释放和适应制剂从密封的药物储存器的热膨胀。插头进一步限定出口通道，并且可以任选地进一步包括刚刚在输送出口之前或两者位于流动通道内的玻璃料。

4. 发明申请

US20080161356A1 Devices and methods for pain management 审中-公开
公开(公告)号：US20080161356A1
公开(公告)日：2008-07-03
申请号：US11888653
申请日：2007-07-31
申请人： Randolph Mellus Johnson , Felix Theeuwes
发明人： Randolph Mellus Johnson , Felix Theeuwes
IPC分类号： A61K31/4535 , A61P25/04
CPC分类号： A61M37/0069 , A61K9/0004 , A61K9/0014 , A61K9/0019 , A61K9/0024 , A61K31/4468 , A61K31/4535 , A61K47/10 , A61K47/14 , A61K47/26
摘要： The invention features devices and methods for the systemic delivery of fentanyl or a fentanyl congener (e.g., sufentanil) to treat pain. In the present invention, a drug formulation comprising fentanyl or a fentanyl congener is stored within a drug delivery device (e.g., contained in a reservoir or impregnated within a matrix within the controlled drug delivery device). The drug formulation comprises an amount of drug sufficient for treatment and is stable at body temperatures (i.e., no unacceptable degradation) for the entire pre-selected treatment period. The drug delivery devices store the drug formulation safely (e.g., without dose dumping), provide sufficient protection from bodily processes to prevent unacceptable degradation of the formulation, and release the drug formulation in a controlled fashion at a therapeutically effective rate to treat pain. In use, the drug delivery device is implanted in the subject's body at an implantation site, and the drug formulation is released from the drug delivery device to a delivery site. The delivery site may be the same as, near, or distant from the implantation site. Once released at the delivery site, the drug formulation enters the systemic circulation and is transported to the site of action in the body to modulate the pain response (e.g., the brain or other pain sensory location).

5. 发明申请

US20080161357A1 Devices and methods for pain management 审中-公开
标题翻译：疼痛管理的设备和方法
公开(公告)号：US20080161357A1
公开(公告)日：2008-07-03
申请号：US11888654
申请日：2007-07-31
申请人： Randolph Mellus Johnson , Felix Theeuwes
发明人： Randolph Mellus Johnson , Felix Theeuwes
IPC分类号： A61K31/4535 , A61P25/00
CPC分类号： A61M37/0069 , A61K9/0004 , A61K9/0014 , A61K9/0019 , A61K9/0024 , A61K31/4468 , A61K31/4535 , A61K47/10 , A61K47/14 , A61K47/26
摘要： The invention features devices and methods for the systemic delivery of fentanyl or a fentanyl congener (e.g., sufentanil) to treat pain. In the present invention, a drug formulation comprising fentanyl or a fentanyl congener is stored within a drug delivery device (e.g., contained in a reservoir or impregnated within a matrix within the controlled drug delivery device). The drug formulation comprises an amount of drug sufficient for treatment and is stable at body temperatures (i.e., no unacceptable degradation) for the entire pre-selected treatment period. The drug delivery devices store the drug formulation safely (e.g., without dose dumping), provide sufficient protection from bodily processes to prevent unacceptable degradation of the formulation, and release the drug formulation in a controlled fashion at a therapeutically effective rate to treat pain. In use, the drug delivery device is implanted in the subject's body at an implantation site, and the drug formulation is released from the drug delivery device to a delivery site. The delivery site may be the same as, near, or distant from the implantation site. Once released at the delivery site, the drug formulation enters the systemic circulation and is transported to the site of action in the body to modulate the pain response (e.g., the brain or other pain sensory location).
摘要翻译：本发明的特征在于用于系统递送芬太尼或芬太尼（例如舒芬太尼）以治疗疼痛的装置和方法。在本发明中，包含芬太尼或芬太尼同系物的药物制剂储存在药物递送装置内（例如，包含在储存器中或浸入受控药物递送装置内的基质内）。药物制剂包含一定量的用于治疗的药物，并且在整个预选治疗期间在体温下稳定（即，不可接受的降解）。药物递送装置安全地存储药物制剂（例如，没有剂量倾倒），提供足够的保护以防止身体过程以防止制剂的不可接受的降解，并以治疗有效的速率以受控的方式释放药物制剂以治疗疼痛。在使用中，将药物递送装置植入到受试者的身体中的植入部位，并且药物制剂从药物递送装置释放到递送部位。输送部位可以与植入部位相同，接近或远离植入部位。一旦在递送部位释放，药物制剂进入体循环并被运送到身体中的作用部位以调节疼痛反应（例如，脑或其它疼痛感觉位置）。

6. 发明授权

US06689373B2 Devices and methods for pain management 失效
公开(公告)号：US06689373B2
公开(公告)日：2004-02-10
申请号：US10306727
申请日：2002-11-26
申请人： Randolph Mellus Johnson , Felix Theeuwes
发明人： Randolph Mellus Johnson , Felix Theeuwes
IPC分类号： A61F1300
CPC分类号： A61M37/0069 , A61K9/0004 , A61K9/0014 , A61K9/0019 , A61K9/0024 , A61K31/4468 , A61K31/4535 , A61K47/10 , A61K47/14 , A61K47/26
摘要： The invention features devices and methods for the systemic delivery of fentanyl or a fentanyl congener (e.g., sufentanil) to treat pain. In the present invention, a drug formulation comprising fentanyl or a fentanyl congener is stored within a drug delivery device (e.g., contained in a reservoir or impregnated within a matrix within the controlled drug delivery device). The drug formulation comprises an amount of drug sufficient for treatment and is stable at body temperatures (i.e., no unacceptable degradation) for the entire pre-selected treatment period. The drug delivery devices store the drug formulation safely (e.g., without dose dumping), provide sufficient protection from bodily processes to prevent unacceptable degradation of the formulation, and release the drug formulation in a controlled fashion at a therapeutically effective rate to treat pain. In use, the drug delivery device is implanted in the subject's body at an implantation site, and the drug formulation is released from the drug delivery device to a delivery site. The delivery site may be the same as, near, or distant from the implantation site. Once released at the delivery site, the drug formulation enters the systemic circulation and is transported to the site of action in the body to modulate the pain response (e.g., the brain or other pain sensory location).

7. 发明授权

US06541021B1 Devices and methods for pain management 失效
标题翻译：疼痛管理的设备和方法
公开(公告)号：US06541021B1
公开(公告)日：2003-04-01
申请号：US09522535
申请日：2000-03-10
申请人： Randolph Mellus Johnson , Felix Theeuwes
发明人： Randolph Mellus Johnson , Felix Theeuwes
IPC分类号： A61F1300
CPC分类号： A61M37/0069 , A61K9/0004 , A61K9/0014 , A61K9/0019 , A61K9/0024 , A61K31/4468 , A61K31/4535 , A61K47/10 , A61K47/14 , A61K47/26
摘要： The invention features devices and methods for the systemic delivery of fentanyl or a fentanyl congener (e.g., sufentanil) to treat pain. In the present invention, a drug formulation comprising fentanyl or a fentanyl congener is stored within a drug delivery device (e.g., contained in a reservoir or impregnated within a matrix within the controlled drug delivery device). The drug formulation comprises an amount of drug sufficient for treatment and is stable at body temperatures (i.e., no unacceptable degradation) for the entire pre-selected treatment period. The drug delivery devices store the drug formulation safely (e.g., without dose dumping), provide sufficient protection from bodily processes to prevent unacceptable degradation of the formulation, and release the drug formulation in a controlled fashion at a therapeutically effective rate to treat pain. In use, the drug delivery device is implanted in the subject's body at an implantation site, and the drug formulation is released from the drug delivery device to a delivery site. The delivery site may be the same as, near, or distant from the implantation site. Once released at the delivery site, the drug formulation enters the systemic circulation and is transported to the site of action in the body to modulate the pain response (e.g., the brain or other pain sensory location).
摘要翻译：本发明的特征在于用于系统递送芬太尼或芬太尼（例如舒芬太尼）以治疗疼痛的装置和方法。在本发明中，包含芬太尼或芬太尼同系物的药物制剂储存在药物递送装置内（例如，包含在储存器中或浸入受控药物递送装置内的基质内）。药物制剂包含一定量的用于治疗的药物，并且在整个预选治疗期间在体温下稳定（即，不可接受的降解）。药物递送装置安全地存储药物制剂（例如，没有剂量倾倒），提供足够的保护以防止身体过程以防止制剂的不可接受的降解，并以治疗有效的速率以受控的方式释放药物制剂以治疗疼痛。在使用中，将药物递送装置植入到受试者的身体中的植入部位，并且药物制剂从药物递送装置释放到递送部位。输送部位可以与植入部位相同，接近或远离植入部位。一旦在递送部位释放，药物制剂进入体循环并被运送到身体中的作用部位以调节疼痛反应（例如，脑或其它疼痛感觉位置）。

8. 发明授权

US08246977B2 Transdermal delivery systems 有权
标题翻译：透皮递送系统
公开(公告)号：US08246977B2
公开(公告)日：2012-08-21
申请号：US11665813
申请日：2005-10-21
申请人： Su Il Yum , Felix Theeuwes
发明人： Su Il Yum , Felix Theeuwes
IPC分类号： A61K9/70 , A61K31/445
CPC分类号： A61K9/703 , A61F2013/0296 , A61K9/7053 , A61K9/7061 , A61K9/7084 , A61K31/445 , A61K31/4535 , A61M35/00
摘要： Transdermal delivery systems for administering sufentanil through the skin are provided. The systems contain a sufficient amount of sufentanil to induce and maintain a constant state of analgesia when applied to a subject. The systems are characterized as having one or more features including a high degree of dosage form rate control over flux of sufentanil from the system, a high net flux of sufentanil from the system through the skin, lack of a permeation enhancer, an adhesive member demonstrating superior shear time, a low coefficient of variation in the net flux of sufentanil from the system, a high delivery efficiency, and a substantially constant steady state net flux of sufentanil from the system. Methods of using the transdermal delivery systems to administer a sufficient amount of sufentanil to induce and maintain analgesia for extended periods when applied to a subject are also provided.
摘要翻译：提供了通过皮肤施用舒芬太尼的透皮递送系统。当施用于受试者时，该系统含有足量的舒芬太尼以诱导和保持恒定的止痛状态。该系统的特征在于具有一个或多个特征，其包括对来自系统的舒芬太尼的通量的高剂量形式速率控制，来自系统通过皮肤的舒芬太尼的高净通量，缺乏渗透促进剂，优异的剪切时间，来自系统的舒芬太尼的净通量的低变异系数，高的输送效率和来自系统的舒芬太尼的稳定的稳态净通量。还提供了使用透皮递送系统施用足够量的舒芬太尼以在施用于受试者时延长期间诱导和维持止痛的方法。

9. 发明申请

US20080260811A1 Transdermal delivery systems 有权
标题翻译：透皮递送系统
公开(公告)号：US20080260811A1
公开(公告)日：2008-10-23
申请号：US11888661
申请日：2007-07-31
申请人： Su Il Yum , Felix Theeuwes
发明人： Su Il Yum , Felix Theeuwes
IPC分类号： A61K31/4436 , A61K9/70 , A61P43/00
CPC分类号： A61K31/4535 , A61F2013/0296 , A61K9/7053 , A61K9/7061 , A61K9/7084
摘要： Transdermal delivery systems for administering sufentanil through the skin are provided. The systems contain a sufficient amount of sufentanil to induce and maintain a constant state of analgesia when applied to a subject. The systems are characterized as having one or more features including a high degree of dosage form rate control over flux of sufentanil from the system, a high net flux of sufentanil from the system through the skin, lack of a permeation enhancer, an adhesive member demonstrating superior shear time, a low coefficient of variation in the net flux of sufentanil from the system, a high delivery efficiency, and a substantially constant steady state net flux of sufentanil from the system. Methods of using the transdermal delivery systems to administer a sufficient amount of sufentanil to induce and maintain analgesia for extended periods when applied to a subject are also provided.
摘要翻译：提供了通过皮肤施用舒芬太尼的透皮递送系统。当施用于受试者时，该系统含有足量的舒芬太尼以诱导和保持恒定的止痛状态。该系统的特征在于具有一个或多个特征，其包括对来自系统的舒芬太尼的通量的高剂量形式速率控制，来自系统通过皮肤的舒芬太尼的高净通量，缺乏渗透促进剂，优异的剪切时间，来自系统的舒芬太尼的净通量的低变异系数，高的输送效率和来自系统的舒芬太尼的稳定的稳态净通量。还提供了使用透皮递送系统施用足够量的舒芬太尼以在施用于受试者时延长期间诱导和维持止痛的方法。

10. 发明申请

US20080175890A1 Transdermal delivery systems 有权
公开(公告)号：US20080175890A1
公开(公告)日：2008-07-24
申请号：US11888650
申请日：2007-07-31
申请人： Su Il Yum , Felix Theeuwes
发明人： Su Il Yum , Felix Theeuwes
IPC分类号： A61K31/4535 , A61K9/70 , A61P31/00
CPC分类号： A61K31/4535 , A61F2013/0296 , A61K9/7053 , A61K9/7061 , A61K9/7084
摘要： Transdermal delivery systems for administering sufentanil through the skin are provided. The systems contain a sufficient amount of sufentanil to induce and maintain a constant state of analgesia when applied to a subject. The systems are characterized as having one or more features including a high degree of dosage form rate control over flux of sufentanil from the system, a high net flux of sufentanil from the system through the skin, lack of a permeation enhancer, an adhesive member demonstrating superior shear time, a low coefficient of variation in the net flux of sufentanil from the system, a high delivery efficiency, and a substantially constant steady state net flux of sufentanil from the system. Methods of using the transdermal delivery systems to administer a sufficient amount of sufentanil to induce and maintain analgesia for extended periods when applied to a subject are also provided.

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