Boston Scientific Scimed, Inc.

Cardiac Pacemakers, Inc.

University of Massachusetts

Boston Scientific Neuromodulation Corporation

Boston Scientific Corporation

Frederick H Strickler

Mark W Boden

Robert E Richard

Marlene C Schwarz

Shaina Brito

Rudolf Faust

Shrirang V Ranade

Mohan Krishnan

Shrojalkumar Desai

Daniel J Cooke

Umaprasana Ojha

Michael C Smith

Tomoya Higashihara

Anne Margaret Pianca

Ronald A Sahatjian

Peter L Dayton

Jeffrey S Lindquist

Michael N Helmus

Wendy Naimark

Edward Holman Overstreet

William George Orinski

Paul James Miller

Janusz Kuzma

Robert Herrmann

Jan D Seppala

Lan Pham

Barron Tenney

Kerri DiPietro

Aditya Pandit

Janusz A Kuzman

Jan Seppala

Ranade V Shrirang

Rodolf Faust

Alden Flanagan

Barron W Tenney

The present invention pertains to copolymers having one or more polyisobutylene segments and one or more biodegradable polymer segments, to methods of making such copolymers, to medical articles that contain such copolymers, and to methods of making such medical articles. According to certain aspects of the invention, copolymers are provided, which comprise a plurality of polyisobutylene segments and a plurality of biodegradable polymer segments. According to certain aspects of the invention, copolymers are provided, which comprise urethane linkages, urea linkages, amide linkages, ester linkages, anhydride linkages, carbonate linkages, linkages commonly described as 'click' chemistry linkages, and combinations of two or more types of such linkages.

Copolymers having polyisobutylene and biodegradable polymer segments

In various aspects, the present invention is directed to implantable neurostimulation leads and methods for their formation. In various additional aspects, the present invention is directed to medical devices having silicone-containing regions with overlying polymeric layers and to methods of forming the same.

Implantable or insertable medical devices

In accordance with various aspects of the invention, implantable and insertable medical devices are provided, which contain one or more polymeric regions. In one aspect, the polymeric regions comprise (a) a block copolymer that comprises a polyaromatic block and a polyalkene block admixed with (b) a sulfonated high Tg polymer. In another aspect, the polymeric regions comprise a block copolymer that comprises (a) a sulfonated polymer block and (b) fluorinated polymer block.

Medical devices having improved performance

Implantable or insertable medical devices are described. The medical devices comprise (a) a therapeutic agent and (b) a polymeric release region, which controls the release of the therapeutic agent upon administration to a patient. The polymeric release region further comprises a silicone copolymer that contains a plurality of siloxane units and a plurality of non-siloxane units. Also described are methods for administering a therapeutic agent to a patient using the above implantable or insertable medical devices as well as methods of making the above devices.

Implantable or insertable medical devices containing silicone copolymer for controlled delivery of therapeutic agent

According to an aspect of the present invention, medical devices are provided that contain at least one polymeric region which contains (a) at least one block copolymer that contains at least three polymer blocks that differ from one another and (b) at least one therapeutic agent.

The present invention relates to phase separated polymeric regions and to their use in conjunction with implantable or insertable medical devices. In some aspects of the invention, phase separated polymeric regions are provided that include (a) at least one biostable polymeric phase and (b) at least one biodisintegrable polymeric phase, which is of nanoscale dimensions and which undergoes biodisintegration such that the phase separated polymeric region becomes a nanoporous polymeric region in vivo. Other aspects of the invention are directed to methods of making implantable or insertable medical devices having at least one nanoporous polymeric region. These methods include (a) providing a phase separated polymeric region comprising a stable polymeric phase and a disintegrable polymeric phase of nanoscale dimensions, (b) selectively removing the disintegrable polymeric phase thereby producing the nanoporous polymeric region. In still other aspects, implantable or insertable medical devices are provided which have phase separated polymeric regions that include (a) at least one block copolymer having at least one biostable polymer block and at least one biodisintegrable polymer block and (b) at least one therapeutic agent which is released in vivo upon implantation or insertion of the medical device.

Medical devices having porous polymeric regions for controlled drug delivery and regulated biocompatibility

The present invention pertains to polyisobutylene urethane, urea and urethane/urea copolymers, to methods of making such copolymers and to medical devices that contain such polymers. According to certain aspects of the invention, polyisobutylene urethane, urea and urethane/urea copolymers are provided, which comprise a polyisobutylene segment, an additional polymeric segment that is not a polyisobutylene segment, and a segment comprising a residue of a diisocyanate. According to other aspects of the invention, polyisobutylene urethane, urea and urethane/urea copolymers are provided, which comprise a polyisobutylene segment and end groups that comprise alkyl-, alkenyl- or alkynyl-chain-containing end groups.

Polyisobutylene urethane, urea and urethane/urea copolymers and medical devices containing the same

According to an aspect of the present invention, implantable or insertable medical devices are provided, which contain at least one polymeric region in contact with a metallic region. The polymeric region contains at least one block copolymer that contains at least one low Tg block and at least one high Tg block. The polymeric region contains at least one polymer that contains at least one adhesion promoting group selected from one or more of halo-silane, alkoxy-silane, epoxy, anhydride, phenoxy, hydroxyl, amino, sulfonate and carboxyl groups, which at least one polymer may correspond to the block copolymer, a supplemental polymer, or both.

Medical devices having polymeric regions with improved adhesion

In one aspect, the present invention provides implantable or insertable medical devices, which contain at least one polymeric region. The polymeric region contains at least one fluorocarbon-containing block copolymer, which, in turn, contains (a) at least one fluorocarbon-containing, low glass transition temperature (low T) copolymer chain and (b) at least one glass transition temperature (high T) polymer chain.

Medical devices having polymeric regions that contain fluorocarbon-containing block copolymers

A medical device with a therapeutic agent-releasing polymer coating. The medical device is provided by a method that comprises: (a) attaching at least one reactive species to a medical device surface, which reactive species leads to chain growth polymerization in the presence of monomer; (b) contacting the reactive species with at least one monomer species, thereby forming a polymer coating on the surface of the medical device; and (c) providing at least one therapeutic agent within the polymer coating. The therapeutic agent may be incorporated during formation of the polymer coating or after formation of the polymer coating. The at least one reactive species can comprise, for example, a free radical species, a carbanion species, a carbocation species, a Ziegler-Natta polymerization complex, a metallocene complex, and/or an atom transfer radical polymerization initiator. Alternatively, the medical device is provided by a process comprising: (a) immobilizing least one polymerization catalyst at a medical device surface, which polymerization catalyst leads to polymerization in the presence of monomer; (b) contacting the medical device surface with at least one monomer species, thereby forming a polymer coating at the surface of the medical device; and (c) providing at least one therapeutic agent within the polymer coating.

Processes for producing polymer coatings through surface polymerization

According to an aspect of the present invention, medical devices are provided that contain at least one polymeric region which contains (a) at least one block copolymer that contains at least at least three polymer blocks that differ from one another and (b) at least one therapeutic agent.

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Natick, MA, United States of America

Frederick H Strickler