Medtronic Minimed, Inc.

Unl Holdings LLC

Amgen Inc.

Unitract Syringe Pty Ltd

Paul F Bente, Iv

Ian B Hanson

Sean M O'connor

Kevin Lee Bokelman

Sheldon B Moberg

R Paul Mounce

John Christian Love

Ryan Michael Agard

Mark A Destefano

Nicholas J Ciccarelli

Julian D Kavazov

Lawton Laurence

Matthew J Clemente

Scott Beaver

Daniel Shawn Codd

Christopher G Griffin

Paul H Kovelman

Rajan Ramaswamy

Kun-Chi Wu

Bradley J Enegren

Melissa D Norton

Scott Robert Gibson

Margaux Frances Boyaval

Mark Dominis Holt

Gautam N Shetty

Basel Hasan Taha

Robert Decker

Ian P Dardani

Colin A Chong

William H Stutz, Jr

Susie E Maule

Robert M Guezuraga

Afshin Bazargan

Daniel Davenport

Pablo Vazquez

Lothar R Westerweck

Truong Gia Luan

Mark Majette

Antonio Ubach

Jacques L Favreau

Christopher Edward Hatch

Danielle Feldman

Ruth Marie Tieck

Vincent E Mandes

Eric M Lorenzen

Rafael Bikovsky

Matthew William Yavorsky

Arsen Ibranyan

Sean E Daley

Andrew Nathan King

Mona-Lisa Alexander

Philip J Hudak

Susie E Buckman

Dore Mark

Jaimin B Shah

Robert Trzybinski

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 The cannula may be retained in the patient at an injection site created by the needle after the needle is withdrawn from the patient.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

A drive mechanism () for use with a drug container () in a drug pump, the drug container () having a barrel () and a plunger seal (), including a tether, an electrical actuator () and a gear interface. Rotation of the gear interface is controlled by the actuator (). A gear assembly rotationally engages with the gear interface. The gear assembly includes a main gear and a regulating mechanism. Release of the tether is metered by the gear assembly through the regulating mechanism. A piston () is connected to the tether and is disposed in the barrel () and configured to translate axially within the container. A biasing member is disposed at least partially within the barrel () and is retained in an energized state between the piston () and drive housing, wherein the release of the tether controls the free expansion of the biasing member from its energized state and the axial translation of the piston ().

Drug delivery device and method

An insertion mechanism for a drug pump includes an insertion mechanism housing; a sleeve; a rotational biasing member initially held in an energized state; a retraction biasing member and a hub connected to a proximal end of a needle, wherein the retraction biasing member is held initially in an energized state between the hub and the sleeve. The needle is inserted into a target tissue by the rotational biasing member and interaction between the hub and housing. Retraction of the needle is caused by decompressing or de-energizing of the retraction biasing member. A drug delivery pump includes an activation mechanism, a drive mechanism, a sterile access connection, and the insertion mechanism. Assembly and operation methods are provided.

Rotationally biased insertion mechanism for a drug delivery pump

A medical device includes a first housing portion (FHP) and a second housing portion (SHP) configured to be to be movable relative to each other from a first position to operatively engage at a second position to couple at least one of a drive device and a needle-inserting device supported by one of the FHP and the SHP to a reservoir supported by the other of the FHP and the SHP. Electronic circuitry configured to detect at least one of a first magnetic interaction between a magnet and at least one of a first magnetically attractive material and a first magnet-responsive device and a second magnetic interaction between the magnet and at least one of a second magnetically attractive material and a second magnet-responsive device, and to provide a signal or a change in state in response to detecting at least one of the interactions.

Connection and alignment detection systems and methods

Power and control systems for a drug delivery device allow for the activation, control of, and communication with the drug delivery device. The power and control system allows for a delay between device activation, and optionally needle insertion, and commencing drug delivery. The delay may be for a predetermined time. In addition, the power and control system may communicate with one or more external sensors and devices. The inputs from the sensors and devices may automatically, or on demand, adjust the delivery parameters of the device. The power and control systems may control a drive system that delivers a fluid at a variable rate or profile, allowing for the delivery to be tailored to maximize the effectiveness of the treatment.

Systems and methods for controlled drug delivery pumps

Handheld drug delivery devices for injection of a medicament into a target location are disclosed herein. The drug delivery devices of the present disclosure include drive mechanisms, needle insertion mechanisms, and fluid pathway connectors. These components may be arranged within a housing. The arrangement of these components may provide an easy to use device that is capable of delivering volumes larger than traditionally injected using syringes. Translation of a drug container of the device may cause connection of a fluid pathway from the drug container for delivery of a medicament to a target location.

Handheld drug delivery device

A user-initiated fluid pathway connection includes: a connection hub, a piercing member, a sterile sleeve, and a drug container having a cap, a pierceable seal, a barrel, and a plunger seal, wherein the piercing member is initially retained within the sterile sleeve between the connection hub and the pierceable seal of the drug container. The connection hub may include an internal aperture within the connection hub which functions as a flow restrictor and wherein a piercing member is connected to one end of the internal aperture and a fluid conduit is connected to another end of the internal aperture. A drug delivery pump with integrated sterility maintenance features includes a housing, upon which an activation mechanism, an insertion mechanism, a fluid pathway connection as described above, a power and control system, and a drive mechanism connected to a drug container are mounted. Methods of assembly and operation are also provided.

Sterile fluid pathway connection to drug containers for drug delivery pumps

A drive mechanism includes a housing, a piston adapted to impart movement to a plunger seal within a drug container, a plurality of biasing members disposed in parallel, and a retainer. The biasing members are disposed to release energy to cause movement of the piston from a retracted first position to the extended second position, the piston bearing against the plunger seal to dispense medicine. The retainer is disposed to maintain the biasing members in the energized position and to release the biasing members to permit the piston to dispense the medicine. The drive mechanism may also include an end-of-dose indicator to identify at least one of when the sleeve assembly is disposed subjacent a window in the housing, the relative motion of the sleeve assembly with reference to the window or another reference component, the stoppage of such motion, and the rated or change of rate of motion.

Drive mechanism for drug delivery pumps with integrated status indication

Drive mechanisms for drug delivery pumps

A controlled delivery drive mechanism includes a drug container having a barrel and a plunger seal; a drive housing within which at least initially partially resides a piston having an interface surface and a drive rack; and a power spring. The piston is configured to contact and axially translate the plunger seal within barrel. The mechanism may be configured to convert rotational movement of a drive pinion to axial translation of the drive rack, or to convert axial force of a linear power spring into torsional motion of a drive pinion. A regulating mechanism meters the drive pinion such that the piston is axially translated at a controlled rate. The drug container may contain a drug fluid within a drug chamber for drug delivery at a controlled rate. The regulating mechanism may be an escapement regulating mechanism. A drug delivery pump includes such controlled delivery drive mechanisms.

Controlled delivery drive mechanisms for drug delivery pumps

Growing community of inventors

Wayne, PA, United States of America

Paul F Bente, Iv