Amgen Inc.

Alfred E. Mann Foundation for Scientific Research

Medallion Therapeutics, Inc.

Medtronic Minimed, Inc.

Perqflo, LLC

Pacesetter, Inc.

Infusion Systems, LLC

Scott Robert Gibson

Ferry Tamtoro

Lawrence Scott Ring

Mehran Mojarrad

Brian Michael Shelton

Peter Carl Lord

Adam B McCullough

Stephanie Toy

Christopher R Folk

Basel Hasan Taha

Donald Busby

Sheldon B Moberg

Roger E Smith

Daniel Eduardo Groszmann

Mark Ka Lai Lee

Huaying Yang

Peter V Shultz

Desheng Yin

Jimmie L Ward

Keith P Kogler

Daniel H Villegas

Dhairya K Mehta

Sam William Bowman

Alexander Stuart Cairns

Steven William Badelt

James Causey

Paul D Faucher

Sudeshna Dutta Ray

Stephen D Das

Ian B Hanson

Paul F Bente, Iv

Margaux Frances Boyaval

Kevin Lee Bokelman

Tom Xiaohai He

John Christian Love

Daniel Shawn Codd

Sean M O'connor

Rajan Ramaswamy

Matthew J Clemente

Scott Beaver

Scott M Loftin

Mark A Destefano

Joseph Wayne Vandegriff

Timothy John Payne

Buehl E Truex

Scott L Conway

Lawrence Eric Ong

William Andrew Brandt

Ali Nekouzadeh

John Paul D'Brot

Jose P Bernardo

Lance Hussey

Ravi K Sawhney

Daniel Davenport

Lawton Laurence

Kurt Gregory Botsai

Ryan Michael Agard

Richard E Purvis

Alan B Vogel

Shushuo Wu

Francisca Tan-Malecki

Gautam N Shetty

Suhas Krishna

Nicholas J Ciccarelli

Alvin H Weinberg

Antonio Ubach

Balakrishnan Shankar

Valerie M Fenster

Robert Decker

Benjamin X Shen

Kenneth R McNeil, Ii

Joshua Tamsky

Alan D Payne

Carl Conrath

Ian P Dardani

Danielle Feldman

Denise Meyer

Mikhail Tikh

Nathan Thomas Balcom

Alejandro Campillo-Agusti

Robert Allen Dees

Erik Timpers

Rajiv Shah

John Dixon Gray

Heejin Lee

Eric M Lorenzen

Charles L Byers

Robert W Bosley

Brian J Intoccia

Neal Davis Johnston

Susan McConnell

Wael Mismar

Michael N Friedman

Joshua Jay Dudman

Jakob Halkjaer Pedersen

Edward Chernoff

Rodney J Hawkins

Matthew Wayne Janke

Adam Joseph Livingston

Jon Douglas Newbill

Methods, devices, and components are provided to reduce tissue resistive pressure during a subcutaneous drug delivery operation by increasing the size of the injection cavity by partially retracting the drug delivery member after inserting the drug delivery member to a subcutaneous position. The drug delivery devices described herein include a motor operably coupled to a drug delivery member. The motor can be selectively activated by a controller to retract the drug delivery member a predetermined distance to relieve pressure in an injection cavity in a patient. A force sensor can provide the controller with a drug delivery member insertion force. The controller can then estimate a tissue resistive pressure based on the drug delivery member insertion force and determine the predetermined distance for the partial drug delivery member retraction based on the tissue resistive pressure.

Drug delivery devices with partial drug delivery member retraction

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

An injector may include a container having a wall with an interior surface defining a closed sterile reservoir filled with a medical fluid or drug product. The injector may also include a fluid delivery system comprising a sterile container needle that is in fluid communication with the container in a delivery state, but may or may not be in fluid communication with the container in a storage state. The sterile container needle is attached to a connector, the connector mechanically coupled to the container to secure the sterile container needle to the container with the needle in the storage state. Further, the injector may include an actuator that is adapted to move the container needle from the storage state to the delivery state.

Injector and method of assembly

A drug delivery system includes a packaging housing a first component including at least one of a drug product, a diluent, a saline solution, or an IV stabilizing solution ('IVSS') and a second component comprising at least one of the drug product, the diluent, the saline solution, and the IVSS, the first component being different than the second component. The first component is disposed in a first container in a storage state and the first container is positioned in a first compartment of the packaging housing. The second component is disposed in a second container in a storage state and the second container is positioned in a second compartment of the packaging housing. At least one of the first compartment and the second compartment may include an individual seal and wherein each of the individual seals and the first and second compartments are sterilized.

Systems and methods for drug delivery

A drug delivery device includes a blunt cannula and a reservoir. The blunt cannula has a cylindrical wall that defines an axial passage between a first end and a second end of the blunt cannula. The wall has at least a first tapered region at the first end to define an opening in fluid communication with the axial passage and adapted at the first end to resist interruption of fluid flow through the axial passage and out of the first end of the blunt cannula. The reservoir is connected to the second end of the blunt cannula.

Drug delivery device

Drug reconstitution systems and related methods are disclosed herein. A drug reconstitution system may include a first component in a first container in a storage state and a second component in a second container in a storage state. The first component may be selected from a group of a drug product, a diluent, a saline solution, and an IV stabilizing solution ('IVSS'). The second component may be selected from a group of the drug product, the diluent, the saline solution, and the IVSS. The first component may be different than the second component. At least one fluid path may be configured to at least selectively fluidly connect the first container and the second container. An urging assembly may be configured to selectively urge at least a portion of the first component from the first container and into contact with the second component.

Systems and approaches for drug delivery device reconstitution

Modular fluid path assemblies are provided that include conduit, coupling, and needle portions of a fluid path fluidly coupled to an outlet of a container. The modular fluid path assemblies further include a needle shield having a tip of the needle embedded therein. So configured, in embodiments, the modular fluid path assemblies can be sterilized, a medicament can be filled in the container, and a stopper inserted in the container so that the pre-sterilized and pre-filled modular fluid path assemblies can have a closed container integrity (CCI) seal.

Modular fluid path assemblies for drug delivery devices

Fluid path assemblies for drug delivery devices and methods of establishing a fluid flow path for drug delivery devices are described that include a needle shield valve member that couples to a reservoir having a needle mounted thereto. The needle shield valve member includes an internal barrier that protects the needle and/or contains a drug within the reservoir until activation of the drug delivery device. Upon activation, there is relative movement between the reservoir and needle shield valve member until the needle pierces the barrier to establish a fluid flow path from the reservoir through the needle shield valve member.

Fluid path assembly for a drug delivery device

Drug delivery devices are configured to include a gas-driven piston assembly having a flexible pushrod, a non-linear guide include a non-linear guide pathway at least partially surrounding the flexible pushrod, a cylinder at least partially surrounding the flexible pushrod, and a piston movable within the cylinder in response to the pressurized gas entering the cylinder. Some arrangements include a roller pushrod guide system and/or a gear pushrod guide system.

Drug delivery system with flexible piston assembly

Drug delivery devices are described that include an escapement activation assembly. The escapement activation assembly includes a slide having a plurality of pallet engagement portions and a switch engagement portion and a pallet having a plurality of slide engagement portions. A drive is coupled to the pallet to cause the pallet to move relative to the slide to move the plurality of slide engagement portions into and out of engagement with the plurality of pallet engagement portions to allow the slide to move along a path within the drug delivery device. Movement of the slide can cause the switch engagement portion to move out of engagement with an activation trigger of a mechanism of the drug delivery device.

Muscle wire escapement activation assembly for a drug delivery device

An injection device, method, and system for drug delivery includes a primary container for storing a drug, the container having a stopper movably disposed in the container for expelling the drug, an injection drive mechanism comprising a plunger for acting on the stopper and an energy source for exerting a force on the plunger to cause the plunger to act on the stopper to expel the drug, the force causing the plunger to accelerate to a velocity prior to acting on the stopper, and a damping mechanism for reducing the velocity of the plunger prior to acting on the stopper. The damping mechanism can include a dashpot or an energy absorbing material associated with the plunger. Alternatively or additionally, the damping mechanisms can include absorbing material disposed between support members of an outer casing of the injection device and the primary container.

Autoinjector with shock reducing elements

A drug delivery system is disclosed that includes a drug delivery device having a reservoir, a delivery cannula having a proximal end in fluid communication with the reservoir and a distal end to be received within a patient, and one or more controllable elements. The drug delivery system may further include one or more sensors coupled to the drug delivery device, and a controller coupled to the one or more sensors and the one or more controllable elements. The controller may be configured to use the one or more sensors to determine a condition or an operational state of the drug delivery device. Furthermore, the controller may be configured to control the controllable element based on the condition or the operational state of the drug delivery device and/or identity information stored in a memory onboard the device. A method for use with a drug delivery device is also disclosed.

Controllable drug delivery system and method of use

A drug delivery device includes a housing defining a shell and an inner volume, a container, a drive mechanism, a needle assembly, a fluid flow connection, and a backflow prevention mechanism. The container has an inner volume to contain a medicament to be administered to a user. The drive mechanism is at least partially disposed within the housing and exerts a force to urge the medicament out the container. The fluid flow connection is coupled to the container and the needle assembly and allows the medicament to flow from the container to the needle assembly to be administered. The backflow prevention mechanism is associated with at least one of the container, the fluid flow connection, or the needle assembly and includes at least one flow restrictor to restrict a fluid from flowing from the needle assembly to the container.

Backflow prevention mechanism for drug delivery device

Growing community of inventors

Granada Hills, CA, United States of America

Scott Robert Gibson