Surmodics, Inc.

Joram Slager

David E Babcock

Robert W Hergenrother

Nathan Lockwood

Joseph Schmidt McGonigle

Toni M Heyer

Aleksey V Kurdyumov

Bruce M Jelle

Gary Rabindranath Maharaj

Gary W Opperman

Dale G Swan

Rick Murphy

Shannon Wadman

Joseph Ventura

Aron B Anderson

Andrew G Bach

Timothy M Kloke

Teryl L Woodwick Sides

Jeffrey Missling

Charles Olson

Sean Lundquist

Charlie Olson

Joe McGonigle

Ambereen Angamuthu

Shawn Fuller

Bryan A Claseman

Anh Tri La

Ralph A Chappa

Gregg Stuart Sutton

John Wall

Jeffrey J Missling

Darin DuMez

Joseph S Mcgonigle

Paula Bushendorf

Amy Trocke

Darin Dumez

Joseph Schmidt Mcgonigle

Bruce Jelle

Gary Opperman

Nathan A Lockwood

Embodiments herein relate to active agent depots formed in situ and related methods. In various embodiments, a method of forming an active agent depot in situ is included. The method can include contacting a composition with a vessel wall, wherein the composition includes an active agent and a fibrin promoting vessel wall transfer agent wherein the ratio of active agent to fibrin promoting vessel wall transfer agent (wt./wt.) is at least 5:1. The method also includes transferring the composition from a device surface to the vessel wall surface. The method also includes forming a fibrin matrix around the composition. Other embodiments are also included herein.

Active agent depots formed in situ

Embodiments of the invention include drug delivery coatings and devices including the same. In an embodiment, the invention includes a drug delivery coating including a polymeric layer. The polymeric layer can include a hydrophilic outer surface. The coating can also include a matrix contacting the hydrophilic outer surface. The matrix can include a particulate hydrophobic therapeutic agent and a cationic agent. The polymeric layer can further include a hydrophilic polymer having pendent photoreactive groups and a photo-crosslinker including two aryl ketone functionalities. Other embodiments are also included herein.

Delivery of hydrophobic active agent particles

The disclosure provides insertion tools and articles that facilitate entry of a medical device, such as a balloon catheter, into the body, and that can provide advantages in terms of balloon insertion, safety, and drug delivery. The insertion tool includes a tubular portion that accommodates a balloon portion of a balloon catheter, and one or more separation margin(s) in the wall of the tubular portion or one or more split(s) in the tubular wall. The insertion tool also includes a proximal tab that extends from a second lengthwise half having a portion at an angle skew to the lengthwise axis, or that is in the form of a solid article comprising a concave surface that is fastened to an outer surface of the second lengthwise half of the tubular portion; or first and second tabs that extend from first and second lengthwise halves of the tubular portion, respectively.

Lubricious insertion tools for medical devices and methods for using

The disclosure provides insertion tools and articles that facilitate entry of a medical device, such as a balloon catheter, into the body. In embodiments the insertion tools have an elongate hollow body () that is able to protect a portion of a medical device, such as a balloon of a balloon catheter, during an insertion procedure. In one embodiment the insertion tool has an elongate hollow body (), a tapered distal end (), and a locking mechanism () at the proximal end which can secure a portion of a balloon catheter. An opening at the distal end can allow passage of the balloon in a folded uninflated state.

Insertion tools for medical device

A hemodialysis vascular access device includes a proximal end sized and shaped to sealably couple to a hemodialysis catheter, a movable structure coupled to the proximal end, a fixation structure coupled to the movable region and sized and shaped for fixation on a patient, an elongated sleeve coupled to the fixation structure and sized and shaped for insertion into a patient's vasculature, and a valve at a distal end of the internal lumen. When a hemodialysis catheter is inserted into the device and coupled to the proximal end, distal movement of the proximal end relative to the fixation structure biases a distal end of the hemodialysis catheter from a position inside the elongated sleeve through a valve out of the device and into the patient's blood.

Hemodialysis catheter sleeve

Disclosed herein is a delivery composition for administering a hydrophobic active agent. In one embodiment, a delivery composition for local administration of a hydrophobic active agent to a tissue or organ of a patient is disclosed. In one embodiment, the delivery composition includes a cationic delivery agent, a therapeutically effective amount of a hydrophobic active agent and a pharmaceutically acceptable aqueous carrier. In one embodiment, the cationic delivery agent includes polyethyleneimine (PEI). In an embodiment, the invention includes a drug delivery device including a substrate; and coated therapeutic agent particles disposed on the substrate, the coated therapeutic agent particles comprising a particulate hydrophobic therapeutic agent; and a vinyl amine polymer. Methods of making the delivery composition, as well as kits and methods of use are also included herein.

Compositions and methods for delivery of hydrophobic active agents

Embodiments herein include coated medical devices and coatings with salt groups. In an embodiment, a coated medical device is included, the coated medical device including a substrate and a polymeric layer disposed over the substrate. The polymeric layer includes a polymer and has an exterior surface. The coated medical device further includes a plurality of salt groups bonded to the polymer of the polymeric layer and disposed on the exterior surface of the polymeric layer. The salt groups can be the reaction product of a reactive group with an acid or base. In an embodiment, a method of making a medical device is included. Other embodiments are also included herein.

Lubricious coatings with surface salt groups

Drug delivery coatings and devices including the same are described herein. The drug delivery coating has a first coated layer with non-ionic polymer and photogroups, a second coated layer with acid polymer in contact and hydrogen bonded with the first layer, particles with hydrophobic therapeutic agent, and cationic agent. The coating can be provided on a balloon catheter, and the particles and cationic agent can be transferred to tissue during a medical procedure, such as an angioplasty procedure, for a therapeutic effect.

Hydrophobic active agent particle coatings and methods for treatment

Embodiments herein include an insertion tool for inserting a medical device into another medical device, such as a hemostasis sealing valve, and related methods. In an embodiment, an insertion tool includes a guide sheath and a protection tube. The guide sheath can include a flared proximal end. The guide sheath can further include a central lumen. The guide sheath can further include a locking notch disposed on the inner surface between the proximal end and the distal end. The protection tube can include a flared proximal end. A portion of the protection tube can be situated within the central lumen of the guide sheath. The flared proximal end of the protection tube can be sized to fit within the locking notch and can have an outer diameter larger than portions of the inner surface immediately adjacent to the locking notch. Other embodiments are also included herein.

Two-part insertion tool and methods

Insertion tools for medical devices and methods for using

The disclosure provides macrolide particulates including a macrolide therapeutic agent such as rapamycin at high concentration in the particulate. In one method the particulates are made by adding a composition containing an polyoxyethylene sorbitan n-acyl ester, poly(ethyleneimine), or alkylated quaternary ammonium salt to a composition including macrolide dissolved in an alcohol such as ethanol. In another method the particulates are made by adding a non-solvent composition to a composition including macrolide and an alkyl-substituted chromanol dissolved in an alcohol such as ethanol. The formed macrolide particulates have one or more desirable properties including sizes in the range of 0.1 &#x3bc;m to 10 &#x3bc;m, spherical or near spherical shapes, low polydispersity, and/or stability. The macrolide particulates can be used for therapeutic compositions, or in association with an implantable or insertable medical device, such as associated with a polymeric coating on a device.

Macrolide particulates, methods for preparation, and medical devices associated therewith

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St. Louis Park, MN, United States of America

Joram Slager