Amgen Inc.

Unl Holdings LLC

Animas Corporation

Unitract Syringe Pty Ltd

Eli Lilly and Company

Bilibaby, LLC

Matthew J Clemente

Ian B Hanson

Paul F Bente, Iv

Ryan Michael Agard

Nicholas J Ciccarelli

Kevin Lee Bokelman

Daniel Shawn Codd

Sean M O'connor

Rajan Ramaswamy

Scott Beaver

Sheldon B Moberg

Scott Robert Gibson

Margaux Frances Boyaval

John Christian Love

Lawton Laurence

Mark A Destefano

Basel Hasan Taha

Antonio Ubach

Danielle Feldman

Kun-Chi Wu

Daniel Davenport

Gautam N Shetty

Ian P Dardani

Ryan T Walsh

Noureddine Melikechi

Andrew Nathan King

Robert Decker

George Stavis

Robert Stavis

Shaun Robert Devitt

William G Saulenas

Marion Butz

Mark DeStefano

Jeremy Peter Clements

Gerald E Kuehl

James Angus Boonzaier

Robert Eugene Trzybinski

Uri Eliezer Baruch

Jeremy Clements

William King

Mary Elizabeth Lemma

Daniel L Baker

Xorge Castro Pelayo

Marion Gertraud Butz

Mark Anthony Destefano

Gerald Kuehl

James Alexander Davies

Sean M O`CONNOR

Paul F Bente Iv

Paul F Bente

Disclosed herein is a wearable drug delivery device including a container filled at least partially with a drug including at least one of a PCSK9 (Proprotein Convertase Subtilisin/Kexin Type 9) specific antibody, a granulocyte colony-stimulating factor (G-CSF), a sclerostin antibody, or a calcitonin gene-related peptide (CGRP) antibody. The wearable drug delivery device may include a needle and an insertion mechanism configured to insert the needle into a patient. A fluid pathway connector may define a sterile fluid flowpath between the container and the insertion mechanism. Optionally, a cannula initially disposed about the needle may be included. The cannula may be retained in the patient at an injection site created by the needle after the needle is withdrawn from the patient. Methods of assembly and operation are also provided.

Drug delivery device, method of manufacture, and method of use

The present invention provides devices and methods for establishing aseptic connections between two or more components or subassemblies. The devices may be used in medical devices such as drug delivery pumps (). In some embodiments, a connection is made between a drug container () and a fluid pathway connection assembly (). The fluid pathway connection assembly may include a connection hub (), a piercing member (), and a piercing member retainer (). The assembly may further include a first film () covering a cavity (A,A,A), thereby maintaining the aseptic condition of the cavity. The drug container may hold a fluid drug and include a pierceable seal (). A second film () may cover a recess () formed by the seal and thereby maintain the aseptic condition of the interior of the chamber. The piercing member may be caused to pierce the first and second film and the pierceable seal to open a fluid pathway for delivery of the fluid drug through the fluid pathway connection assembly.

Device and method for making aseptic connections

A system including a computing device, a software application stored in a memory of the computing device and configured to run on a processor of the computing device, and a module in communication with the computing device, said module including a data communication capability, where the data includes light intensity or wavelength information, a light source configured to provide light capable of penetrating the patient's skin to a subcutaneous level, a light sensor configured to detect the light from the light source reflected and scattered from the patient's skin including from the subcutaneous level at a single point in time or sequentially at multiple points in time, and a power source, where the software application is configured to determine levels or concentrations of a substance in a patient's skin based on a measurement of light intensity or wavelength from the light sensor.

Systems and methods for determining and communicating levels of bilirubin and other subcutaneous substances

A medication delivery device with a sensing system to determine at least one of a dose set and a dose delivery. The sensing system is operable to detect relative rotational positions of first and second members of the device which are indicative of at least one of an amount of a dose set and an amount of a dose delivered by operation of the device, and generate outputs correlated to such relative rotational positions. The system includes a wiper coupled to the first member, and a sensing band coupled to the second member for physically contacting the wiper as the second member rotates relative to the first member. A controller electrically communicates with the sensing system to determine, based on the generated outputs of the sensing system, at least one of the amount of the dose set and the amount of the dose delivered by operation of the device.

Medication delivery device with sensing system

A rotary sub-assembly for pumping of fluid is provided. The sub-assembly includes a hollow body defining a cavity having a longitudinal axis, the body comprising a cavity wall with at least two ports passing therethrough. At least a portion of the cavity has a non-circular cross-section such that a first constant or varying radial distance from the longitudinal axis to inwardly-offset segments of the cavity wall surrounding the two ports is less than a second constant or varying radial distance from the longitudinal axis to second segments of the cavity wall spaced apart from the two ports. A rotatable plunger is housed in the cavity. The plunger is sized and shaped such that a side wall of the plunger can establish a liquid-tight seal against the inwardly-offset segments of the cavity wall, but does not establish a liquid-tight seal with the second segments of the cavity wall spaced apart from the two ports.

Rotary plunger pump subsystems

Disclosed herein is a wearable drug delivery device including a container filled at least partially with a drug including at least one of a PCSK9 (Proprotein Convertase Subtilisin/Kexin Type 9) specific antibody, a granulocyte colony-stimulating factor CSF), a sclerostin antibody, or a calcitonin gene-related peptide (CGRP) antibody. The wearable drug delivery device includes a needle and an insertion mechanism configured to insert the needle into a patient. A fluid pathway connector defines a sterile fluid flowpath between the container and the insertion mechanism. A cannula initially disposed about the needle is included.

A sterile fluid pathway connector includes a piercing member, a connector hub, and a pierceable seal; wherein at least a portion of the pierceable seal is configured to move from a first position in which the piercing member is retained within a sterile cavity between the pierceable seal and the connector hub, to a second position in which the pierceable seal has been penetrated by the piercing member. A filter may be utilized to enclose the sterile cavity from the outside environment. Such fluid pathway connections may be integrated into a fluid container having a barrel and a plunger seal. The components of the fluid pathway connector may further be capable of transmitting a signal to the user upon completion of fluid delivery, for example, upon contact between the plunger seal and the pierceable seal. A fluid delivery pump includes such integrated fluid pathway connectors and fluid containers.

Integrated pierceable seal fluid pathway connection and drug containers for drug delivery pumps

A fluid pathway assembly includes a needle insertion mechanism, a fluid conduit, and a fluid pathway connection. The fluid pathway assembly may further include a drug container to hold a drug fluid prior to initiation of the injection. The assembly may include a carrier disposed along at least a portion of the fluid pathway assembly, and/or a drug container. The fill-finish cartridge functions to retain the components of the fluid pathway assembly in a sterile condition, while allowing for easy integration of the fluid pathway assembly and the drug container into a standard fill-finish process. Methods of constructing a cartridge, filling a drug container included in a cartridge, and incorporating the same into a drug delivery device are disclosed.

Fill-finish cartridges for sterile fluid pathway assemblies and drug delivery devices incorporating fill-finish cartridges

A fluid pathway connection includes a piercing member, a connection hub, and a sliding pierceable seal, wherein the sliding pierceable seal is configured to move from a first position, where the piercing member is initially retained within a sterile cavity between the connection hub and the sliding pierceable seal, to a second position, where the pierceable seal has been penetrated by the piercing member. A filter may be utilized to enclose the sterile cavity from the outside environment. The fluid pathway connection may further be configured to move to a third position where one or more interconnects and/or one or more corresponding contacts are permitted to transmit a signal to the user. Such fluid pathway connections may be integrated into a drug container having a barrel and a plunger seal. A drug delivery pump includes such integrated fluid pathway connections and drug containers.

Integrated sliding seal fluid pathway connection and drug containers for drug delivery pumps

Drug delivery pump

A replaceable fluid restriction mechanism includes: an aperture residing adjacent to a fluid pathway connection and configured to permit flow of a drug fluid through the aperture when the fluid pathway connection is open; an entry point of a fluid channel configured such that the flow of drug fluid can travel through aperture to the entry point and through the fluid channel to an exit point; and an outlet aperture of a port through which the flow of drug fluid may travel after exiting the exit point, wherein a fluid conduit is connected to the fluid restriction mechanism at the outlet aperture. A configurable fluid restriction mechanism includes a plurality of fluid channels, selectable to align with the entry point and an exit point of the fluid restriction mechanism.

Fluid restriction mechanisms for drug delivery pumps

The present invention provides a system and method for determining bilirubin levels in an individual based on skin coloration using a smartphone or other personal device and an attached ancillary apparatus. The device, such as a smartphone or tablet, is capable of storing and running software. The device is also coupled to both a camera and light source to obtain data regarding the skin's coloration. Software is installed on the device to control the light source and calculate bilirubin levels in the individual based on the input received from the camera. The ancillary apparatus is a mechanism surrounding the light source and camera that is placed on the skin of the individual when the system is in use. The ancillary apparatus thus creates a light tight seal between the skin, light source and camera, enabling the system to receive the most accurate data from the camera.

System and method for determining bilirubin levels in newborn babies

Growing community of inventors

Downingtown, PA, United States of America

Matthew J Clemente