Medtronic Minimed, Inc.

Unl Holdings LLC

Amgen Inc.

Unitract Syringe Pty Ltd

Other

Insulet Corporation

Ian B Hanson

Paul F Bente, Iv

Sheldon B Moberg

Cary D Talbot

Sean M O'connor

Kevin Lee Bokelman

Julian D Kavazov

Paul F Bente

R Paul Mounce

John Christian Love

Mark A Destefano

Lawton Laurence

Ryan Michael Agard

Nicholas J Ciccarelli

Afshin Bazargan

Pablo Vazquez

Paul S Cheney, Ii

Scott Beaver

Matthew J Clemente

Salman Monirabbasi

Christopher G Griffin

Rajan Ramaswamy

Hsiao-Yu S Kow

Daniel Shawn Codd

Paul H Kovelman

Colin A Chong

Juan M Alderete, Jr

Bradley J Enegren

Kun-Chi Wu

Truong Gia Luan

Antonio Ubach

Melissa D Norton

Rafael Bikovsky

Mark Dominis Holt

Matthew James Clemente

Ian P Dardani

Danielle Feldman

Scott Robert Gibson

Margaux Frances Boyaval

Eric M Lorenzen

William H Stutz, Jr

Gautam N Shetty

Susie E Maule

Basel Hasan Taha

Robert Decker

Jeffrey Ireland

Robert M Guezuraga

Steven P Cardinali

Daniel Allis

Maureen McCaffrey

Lothar R Westerweck

Dmitry Yudovsky

Jacques L Favreau

Thomas P Miller

Mark Majette

Kaezad J Mehta

Mike Teang Lee

Christopher Edward Hatch

Kenny J Long

Chris Goetchius

Ruth Marie Tieck

Vincent E Mandes

William H Stutz

Daniel Davenport

Sean E Daley

Andrew Nathan King

Neil Quitoviera

Philip J Hudak

Susie E Buckman

Robert Trzybinski

Paul Bente

Jaimin B Shah

Dore Mark

Thomas Miller

Scott W Beaver

Paul R Mounce

Paul S Cheney

Paul F Bente Iv

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 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

Examples of fluid delivery drive system and/or pump system that creates a vacuum in a fluid line for drawing and expelling fluid are provided. The vacuum may be created by separating two components that are positioned within the sealed fluid line. Once the two components are separated and the fluid is contained within the volume created between the separated components, the two components may be shuttled within the sealed volume. The movement of the two components can seal off an inlet to the fluid line and then open a pathway to an outlet from the fluid line while ensuring the created volume between the two components is maintained constant. The two components can then be moved back together to expel the fluid from the created volume through the outlet for delivery, for example, to a patient. Other examples are disclosed and described.

Linear shuttle pump for drug delivery

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

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 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

Growing community of inventors

Wayne, PA, United States of America

Ian B Hanson