Unl Holdings LLC

Unitract Syringe Pty Ltd

Amgen Inc.

Gautam N Shetty

Lou Castagna

Robert Decker

Ian B Hanson

Paul F Bente, Iv

Sean M O'connor

Mark A Destefano

Lance W Wetzel

Tod Brenner

Aaron M Weir

Sheldon B Moberg

Scott Robert Gibson

Daniel Davenport

Margaux Frances Boyaval

Kevin Lee Bokelman

John Christian Love

Daniel Shawn Codd

Ryan Michael Agard

Rajan Ramaswamy

Matthew J Clemente

Scott Beaver

Basel Hasan Taha

Nicholas J Ciccarelli

Christian Perry Brandt

Robert Scott Russo

Devin Sell

Christopher Charles Rafferty

Jeffrey M Johnson

Tod H Brenner

Nathaniel Ryan Young

Gary Richardson

Iv Bente Paul F

Paul F Bente Iv

Christian P Brandt

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 The cannula may be retained in the patient at an injection site created by the needle after the needle is withdrawn from the patient.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

A mixing syringe including a valve mechanism is configured and configurable to enable one or more substances to be prefilled into the syringe. The valve mechanism may be an aspect of a distal seal assembly. Actuation of the valve mechanism permits opening of a fluid passage for mixing of the one or more substances, and a resulting mixed substance can be delivered by the syringe, for example, for administration of a pharmaceutical to a subject.

Syringes for prefilled and fill-at-use mixing and drug delivery

An insertion mechanism for a drug pump includes an insertion mechanism housing; a manifold guide; an insertion biasing members 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 manifold guide; and a manifold having a septum and a cannula, wherein the annular space between the septum and the cannula defines a manifold header. The needle and cannula are inserted into the body of a user by the insertion biasing member(s), after which only the needle is retracted. Retraction of the needle may open a fluid pathway from the manifold header to the body through the cannula. A drug delivery pump includes an activation mechanism, a drive mechanism, a fluid pathway connection, and the insertion mechanism. Assembly and operation methods are provided.

Insertion mechanism for a drug delivery pump

A vial adapter is provided for interconnecting a vial having a closure and a fluid delivery device such as a safety syringe. The vial adapter comprises an adapter housing having a base, a shroud extending or projecting from the base and a cannula extending or projecting from the base for penetrating a rubber seal on the vial closure to thereby establish fluid communication between the vial and the vial adapter. The shroud may comprise a plurality of latitudinal slits or windows within each of which resides a flexion arm connected to the shroud, each flexion arm capable of engaging and/or retaining vial closures of any of a variety of different sizes. The vial adapter may comprise a conduit tip in fluid communication with the cannula to allow transfer of fluid to or from the safety syringe while also preventing inadvertent activation of a safety syringe needle retraction mechanism.

Vial adapters

A barrel adapter mountable to a syringe barrel includes a barrel tip, a needle assembly, a stylet assembly slidably disposed within a needle lumen of the needle assembly, and a plug within the lumen of the needle. An implant delivery syringe includes a barrel, a plunger assembly, and the barrel adapter. The syringe may include a needle retraction mechanism having a biasing member and an actuable locking arrangement. When the actuable locking arrangement is actuated, the biasing member causes the needle to axially translate over the stylet during retraction to dislodge the plug and cause delivery of an implant to a target location. The plug may be a biodegradable polymer plug such as a water-soluble polymer, PLGA, and/or CARP. The stylet may be retracted following delivery. Methods of assembling implant delivery syringes with drug implants are also provided.

Devices for targeted delivery of therapeutic implants

An automatic accurate dose syringe includes a barrel, a plunger seal, a barrel adapter assembly having a barrel tip and a needle, and a dose control mechanism having a plunger having a coarse pitch screw on its exterior surface, a housing having a corresponding coarse pitch guide along the interior surface of the housing, a screw having a fine pitch screw which interfaces with a fine pitch nut of an adapter, wherein the plunger has an internal annular space within which screw at least partially resides. The syringe further includes a locking mechanism, an activation button, and a biasing member such as a compression and/or a torsional spring. The components are configured such that actuation of the activation button by the user manipulates the locking mechanism to permit the biasing member to move from an initial energized state to a lower energy state, thereby automating drug delivery from the syringe.

Automatic self-dispensing accurate dose drug delivery syringes

A barrel adapter for a syringe having a barrel and plunger. The adapter comprises a barrel tip and a needle retraction mechanism having a needle subassembly with a needle and a lumen, actuator subassembly, and biasing member. The needle subassembly moves from an injection to a retracted position within the barrel tip. The actuator subassembly includes a retainer connected to the barrel tip, a stylet held in a stylet disc, and a prong passing into the retainer. The stylet slides within the needle lumen and is spaced from the needle tip in the injection position. The biasing member biases the NOM from the retainer. A locking arrangement compresses the biasing member when locked and releases the biasing member when actuated by depression of the plunger, which moves the prong against the retainer. The biasing member moves the needle and stylet from the injection position to the retracted position when released.

A dose control mechanism for a syringe includes an engaging screw thread arrangement between an exterior surface of a plunger and a longitudinally extending channel of a housing. The engaging screw thread arrangement includes at least one thread segment and a pitch guide including a variable pitch thread. At least a portion of the longitudinally extending channel of the housing including one of the pitch guide and the at least one thread segment, and the plunger includes the other of the pitch guide and the at least one thread segment. The plunger resides at least partially within the housing with the at least one thread segment engaged with the pitch guide. An accurate dose drug delivery syringe includes such a dose control mechanism, a barrel, a plunger seal, and a barrel adapter assembly having a barrel tip and a needle. The syringe may be a fill-at-time-of-use syringe, a pre-filled syringe, or a safety syringe having integrated needle retraction or needle sheathing safety features, or a combination thereof. Methods of assembly, manufacturing, and operation are similarly disclosed.

Accurate dose control mechanisms and drug delivery syringes

A cannula for administration of a medicine to a target location includes a tube with at least one nodule disposed along the circumferential surface and spaced at a defined distance from the distal end of the tube. An arrangement for delivery of a medicine to a target location includes the cannula and a pump fluidly coupled to the cannula. The distal end of the cannula may be inserted into a target location until the nodule reaches a surface that limits a depth of penetration before delivery of the medication.

Injectable drug delivery arrangement with controlled delivery cannula position relative to point of delivery

Mixing syringes including a valve mechanism are configured and configurable to enable one or more substances to be prefilled into the syringe. The valve mechanism may be an aspect of a distal seal assembly. Actuation of the valve mechanism permits opening of a fluid passage for the mixing of one or more substances, and the resulting mixed substance can be delivered by the syringe, for example, for administration of a pharmaceutical to a subject.

Mixing syringes including a valve mechanism are configured and configurable to enable one or more substances to be prefilled into the syringe. The valve mechanism may be an aspect of a distal seal assembly. Actuation of the valve mechanism permits opening of a fluid passage for the mixing of one or more substances, and the resulting mixed substance can be delivered by the syringe, for example, for administration of a pharmaceutical to a subject. The repetitive mixing of substances contained in a distal and proximal chamber is also provided, where the plunger rod is configured to releasably engage a locking mechanism to actuate the valve, and can axially displace the distal seal assembly while the fluid passage is open.

Syringes for repetitive mixing and delivery of injectables

Sequential delivery syringes including a valve mechanism are configured and configurable to enable one or more substances to be prefilled into the syringe. The valve mechanism may be an aspect of a distal seal assembly. Actuation of the valve mechanism permits opening of a fluid passage for the mixing of one or more substances, and the resulting mixed substance can be delivered by the syringe, for example, for administration of a pharmaceutical to a subject. The sequential delivery of substances contained in a distal and proximal chamber is also provided, where a second substance from the distal chamber is delivered followed by the delivery of a first substance from the distal chamber after the first substance from the proximal chamber is transferred into the distal chamber involving the actuation of the valve mechanism.

Syringes for sequential delivery of injectables

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Pikesville, MD, United States of America

Gautam N Shetty