公开(公告)号：US11771830B2

公开(公告)日：2023-10-03

申请号：US17085761

申请日：2020-10-30

申请人： kaleo, Inc.

发明人： Eric S. Edwards ,  Evan T. Edwards ,  Glen L. Kelley ,  Paul F. Meyers

IPC分类号： A61M5/20 ,  A61M5/32 ,  A61K31/137 ,  A61M5/24 ,  A61M5/142 ,  A61M5/315 ,  A61M5/28

CPC分类号： A61M5/2033 ,  A61K31/137 ,  A61M5/2066 ,  A61M5/24 ,  A61M5/3202 ,  A61M5/2046 ,  A61M5/285 ,  A61M5/31533 ,  A61M2005/14288 ,  A61M2005/206 ,  A61M2005/2013 ,  A61M2005/2026 ,  A61M2005/2474 ,  A61M2005/31588 ,  A61M2205/3306 ,  A61M2205/3317 ,  A61M2205/3561 ,  A61M2205/581 ,  A61M2205/584

摘要： A method of delivering epinephrine includes placing a distal end surface of a medical injector into contact with a target location of a patient. The medical injector includes a housing, an energy storage member, and a medicament container containing a dose of epinephrine effective for administration to the patient experiencing anaphylaxis and having a weight of less than 15 kg. The medicament container is coupled to a needle. The medical injector is actuated such that the energy storage member produces a force to move the needle from a first needle position to a second needle position. A distal tip of the needle extends from the distal end surface by a distance of between 7 millimeters and 8 millimeters when the needle is in the second needle position. A portion of the force is exerted to expel the dose of epinephrine when the needle is in the second position.

公开(公告)号：US10220158B2

公开(公告)日：2019-03-05

申请号：US15371515

申请日：2016-12-07

申请人： kaleo, Inc.

发明人： Frank E. Blondino ,  Eric S. Edwards ,  Evan T. Edwards ,  Glen L. Kelley ,  Paul F. Meyers

IPC分类号： A61M5/32 ,  A61M5/20 ,  A61K31/485 ,  A61K9/00 ,  A61M11/02

摘要： An apparatus includes a container, a needle, and an actuation assembly. The container contains a dose of a naloxone composition having a delivered volume of at least about 0.34 mL. The actuation assembly includes an energy storage member that produces a force on a movable member to move the needle and to deliver the dose of the naloxone composition. The 90% confidence interval of at least one of the relative mean maximum naloxone plasma concentration after dose delivery into the body (Cmax), time to reach the maximum naloxone plasma concentration (Tmax), area under the plasma concentration-time curve from pre-dose (time 0) extrapolated to infinity (AUC0-∞), or area under the plasma concentration-time curve from pre-dose (time 0) to the time of the last quantifiable concentration (Tlast) (AUC0-t) of the delivered dose to a delivered dose of a corresponding naloxone composition delivered via a manually-actuated syringe is within 80% to 125%.

公开(公告)号：US20160015895A1

公开(公告)日：2016-01-21

申请号：US14335490

申请日：2014-07-18

申请人： Kaleo, Inc.

发明人： Frank E. Blondino ,  Eric S. Edwards ,  Evan T. Edwards ,  Glen L. Kelley ,  Paul F. Meyers

IPC分类号： A61M5/20 ,  A61M5/32 ,  A61K31/485

CPC分类号： A61M5/3234 ,  A61K9/0019 ,  A61K31/485 ,  A61M5/2033 ,  A61M5/2053 ,  A61M5/3287 ,  A61M11/02 ,  Y02A50/465

摘要： An apparatus includes a container, a needle, and an actuation assembly. The container contains a dose of a naloxone composition having a delivered volume of at least about 0.34 mL. The actuation assembly includes an energy storage member that produces a force on a movable member to move the needle and to deliver the dose of the naloxone composition. The 90% confidence interval of at least one of the relative mean maximum naloxone plasma concentration after dose delivery into the body (Cmax), time to reach the maximum naloxone plasma concentration (Tmax), area under the plasma concentration-time curve from pre-dose (time 0) extrapolated to infinity (AUC0-∞), or area under the plasma concentration-time curve from pre-dose (time 0) to the time of the last quantifiable concentration (Tlast) (AUC0-t) of the delivered dose to a delivered dose of a corresponding naloxone composition delivered via a manually-actuated syringe is within 80% to 125%.

摘要翻译： 一种装置包括容器，针和致动组件。 容器含有一定量的纳洛酮组合物，其输送体积至少约为0.34mL。 致动组件包括能量存储构件，其在可移动构件上产生力以移动针并输送纳洛酮组合物的剂量。 剂量输送到体内的相对平均最大纳洛酮血浆浓度（Cmax），到达最大纳洛酮血浆浓度（Tmax）的时间的至少一个的90％置信区间，来自预先测定的血浆浓度 - 时间曲线下的面积， 或剂量（时间0）外推至无穷大（AUC0-∞），或者从给药前（时间0）到最后可量化浓度（Tlast）时间（AUC 0-t）的血浆浓度 - 时间曲线下的面积 通过手动致动的注射器递送的相应的纳洛酮组合物的递送剂量的剂量在80％至125％之内。

公开(公告)号：US10688244B2

公开(公告)日：2020-06-23

申请号：US16071203

申请日：2017-12-21

申请人： kaleo, Inc.

发明人： Eric S. Edwards ,  Evan T. Edwards ,  Glen L. Kelley ,  Paul F. Meyers

IPC分类号： A61M5/20 ,  A61M5/32 ,  A61K31/137 ,  A61M5/24 ,  A61M5/142 ,  A61M5/315 ,  A61M5/28

摘要： A method of delivering epinephrine includes placing a distal end surface of a medical injector into contact with a target location of a patient. The medical injector includes a housing, an energy storage member, and a medicament container containing a dose of epinephrine effective for administration to the patient experiencing anaphylaxis and having a weight of less than 15 kg. The medicament container is coupled to a needle. The medical injector is actuated such that the energy storage member produces a force to move the needle from a first needle position to a second needle position. A distal tip of the needle extends from the distal end surface by a distance of between 7 millimeters and 8 millimeters when the needle is in the second needle position. A portion of the force is exerted to expel the dose of epinephrine when the needle is in the second position.

公开(公告)号：US09517307B2

公开(公告)日：2016-12-13

申请号：US14335490

申请日：2014-07-18

申请人： kaleo, Inc.

发明人： Frank E. Blondino ,  Eric S. Edwards ,  Evan T. Edwards ,  Glen L. Kelley ,  Paul F. Meyers

IPC分类号： A61M5/20 ,  A61K31/485 ,  A61M5/32

CPC分类号： A61M5/3234 ,  A61K9/0019 ,  A61K31/485 ,  A61M5/2033 ,  A61M5/2053 ,  A61M5/3287 ,  A61M11/02 ,  Y02A50/465

摘要： An apparatus includes a container, a needle, and an actuation assembly. The container contains a dose of a naloxone composition having a delivered volume of at least about 0.34 mL. The actuation assembly includes an energy storage member that produces a force on a movable member to move the needle and to deliver the dose of the naloxone composition. The 90% confidence interval of at least one of the relative mean maximum naloxone plasma concentration after dose delivery into the body (Cmax), time to reach the maximum naloxone plasma concentration (Tmax), area under the plasma concentration-time curve from pre-dose (time 0) extrapolated to infinity (AUC0-∞), or area under the plasma concentration-time curve from pre-dose (time 0) to the time of the last quantifiable concentration (Tlast) (AUC0-t) of the delivered dose to a delivered dose of a corresponding naloxone composition delivered via a manually-actuated syringe is within 80% to 125%.

摘要翻译： 一种装置包括容器，针和致动组件。 容器含有一定量的纳洛酮组合物，其输送体积至少约为0.34mL。 致动组件包括能量存储构件，其在可移动构件上产生力以移动针并输送纳洛酮组合物的剂量。 剂量输送到体内的相对平均最大纳洛酮血浆浓度（Cmax），到达最大纳洛酮血浆浓度（Tmax）的时间的至少一个的90％置信区间，来自预先测定的血浆浓度 - 时间曲线下的面积， 或剂量（时间0）外推到无穷远（AUC0-∞）或者从剂量（时间0）到最后可量化浓度（Tlast）时间（T10）的血浆浓度 - 时间曲线下的面积（AUC 0-t） 通过手动致动的注射器递送的相应的纳洛酮组合物的递送剂量的剂量在80％至125％之内。