Schneider (usa) Inc.

Boston Scientific Scimed, Inc.

Edwards Lifesciences Corporation

Harbor Medical Devices, Inc.

Baxter International Inc.

Scimed Life Systems, Inc.

Boston Scientific Corporation

Schneider Gmbh

Michael N Helmus

Ni Ding

Michael R Forman

Fritz Hostettler

David Rhum

Crystal M Cunanan

Shrirang V Ranade

Robert E Richard

Lillian J Quintero

Christine Loshbaugh

H Chris Sarner

Alain F Carpentier

Sophie M Carpentier

Yixin Xu

Barron Tenney

Jonathan Swift Stinson

Sheng-Ping Zhong

M Joshua Tolkoff

Patrice Tremble

Carol L Raleigh

Jan Weber

Daniel M Lafontaine

Scott Raymond Smith

Maria Palasis

Rudolf Faust

Paul L Valint, Jr

Marlene C Schwarz

Frederick H Strickler

Mark T Ungs

Robert Stobie

Gordon Kocur

Michael Robert Forman

Joseph E Laptewicz, Jr

Paul Valint

Bruce E Hammer

Albert Starr

Melissa Dixon

Gordon J Kocur

Ranade V Shrirang

Rodolf Faust

Shrirang V Renade

A hemostatic insert is provided for closing a puncture site in a blood vessel wall. The insert includes an expandable hemostatic member comprising a biocompatible water soluble gel configured to expand from a compressed state when exposed to body fluid and seal the puncture site in the blood vessel wall. A control layer surrounds the hemostatic member and delays expansion of the hemostatic member.

Puncture hole sealing device

According to an aspect of the present invention, implantable or insertable medical devices are provided which contain (a) one or more depressions that contain at least one therapeutic agent, and (b) a nanoporous coating, disposed over the therapeutic-agent-containing depressions, which regulate transport of species between the therapeutic-agent-containing depressions and the exterior of the device. The implantable or insertable devices are configured to preform a role beyond mere drug delivery, for example, providing mechanical and/or electrical functions within the body, among other functions. An advantage of the present invention is that medical devices may be provided, which release therapeutic agents in quantities far exceeding the void volume within the nanoporous coating, while at the same time providing functionality that extends beyond drug delivery. Such release may further approach or achieve a zero order kinetic drug release profile.

Medical devices having nanoporous coatings for controlled therapeutic agent delivery

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

A method of treating a biological tissue including crosslinking with glutaraldehyde; immersing the biological tissue in a first solution containing glutaraldehyde and heat in the first solution to a temperature of about 50&#xb0; C. for a first period of time; immersing the biological tissue in a second solution containing a mixture of a crosslinking agent, a denaturing agent and a surfactant; and immersing the biological tissue in a sterilizing solution containing glutaraldehyde and heating the sterilizing solution to a temperature of 37.5&#xb1;2.5&#xb0; C. for a sterilizing period of time. The method may include a terminal sterilization step in a method for fixation of biological tissues, and bioprosthetic devices may be prepared by such fixation method. The fixation method may include the steps of A) fixing the tissue, B) treating the tissue with a mixture of i) a denaturant, ii) a surfactant and iii) a crosslinking agent, C) fabricating or forming the bioprosthesis (e.g., forming the tissue and attaching any non-biological components thereto) and D) subjecting the bioprosthesis to the terminal sterilization method.

Treating biological tissues to mitigate post-implantation calcification

Described herein are implantable medical devices comprising a biocompatible polymer comprising a triggerable bioadhesive property that allows the device to adhere to body tissue. The triggerable bioadhesive property of the polymer can be triggered or activated by exposure to a stimulus. Also, the present invention pertains to methods of making an implantable medical device comprising a biocompatible polymer comprising a triggerable bioadhesive property that allows the device to adhere to body tissue.

Medical devices with triggerable bioadhesive material

According to an aspect of the present invention, medical devices are provided, which contain (a) a substrate and (b) a polymeric region disposed over the substrate which contains at least one block copolymer. The block copolymer, in turn, contains at least two polymer blocks which phase separate into two or more immiscible phase domains within the polymeric region. Moreover, a bioactive species is covalently attached to at least one of the polymer blocks. By attaching the bioactive species selectively to at least one polymer block, self-assembled clusters of the bioactive species are created as the blocks phase separate into immiscible phase domains.

Medical devices having bioactive surfaces

According to an aspect of the present invention, implantable or insertable medical devices are provided, which contain polymeric release regions that control the release of one or more therapeutic agents. The polymeric release regions, in turn, contain one or more polymers that contain one or more rigid, nonplanar polycyclic molecular structures. The therapeutic agent is disposed beneath or within the polymeric release region.

Drug release regions for medical devices, which include polycyclic-structure-containing polymers

Implantable or insertable medical devices comprising a surface region that is modified by covalently coupling a molecular species (or a combination of molecular species) to the same. The molecular species are selected such that the resulting modified surface region has critical surface energy between 20 and 30 dynes/cm. In certain embodiments, the covalently coupled molecular species comprise one or more methyl groups. An advantage of the present invention is that novel medical devices are provided, which have a surface with a critical surface energy value that has been shown to display enhanced biocompatibility, including enhanced thromboresistance, relative to other surfaces.

Implantable or insertable medical articles having covalently modified, biocompatible surfaces

The present invention relates to novel biomaterials and methods of using these new biomaterials to facilitate wound healing. The novel biomaterial may be a biocompatible polymer to which at least one bioactive polymer is covalently bonded by graft polymerization, copolymerization or cross-linking. Alternatively, the novel biomaterial may be a polymer blend comprising at least one biocompatible polymer and at least one bioactive polymer.

Biomaterials for enhanced healing

According to an aspect of the invention, implantable or insertable medical devices are provided which contain the following: (a) one or more porous regions comprising pores and (b) one or more therapeutic agents which are (i) contained within the porous region, (ii) disposed beneath the porous region, or (iii) both. Moreover, the porous regions are capable of undergoing a change in configuration, such that the pores undergo a change in configuration, upon subjecting the porous regions to activating stimuli.

Medical devices having porous regions for controlled therapeutic agent exposure or delivery

According to an aspect of the present invention, bioactive polymers are provided which have (a) a hydrophilic bioactive portion and (b) at least one hydrophobic polymer group that is linked to the hydrophilic bioactive portion by a covalent linkage that contains a chain transfer agent residue. According to another aspect of the present invention, medical articles are provided with bioactive surface by coating them with a coating material that contains such bioactive polymers.

Bioactive polymers for imparting bioactive character to hydrophobic medical article surfaces

Medical devices, such as stents, having a surface, a coating layer comprising a polymer disposed on at least a portion of the surface, and a composition comprising a biologically active material injected into or under the coating layer at one or more locations in the coating layer to form at least one pocket containing a biologically active material are disclosed. The composition may be injected using a nanometer- or micrometer-sized needle. Methods for making such medical devices are also disclosed. Using this method, a precise amount of the biologically active material may be disposed accurately and efficiently on the medical device at predefined locations.

Method of making a coated medical device

Medical devices incorporate therein imaging materials having selected MRI detectable nuclei to provide useful magnetic resonance images of the medical devices and proximate body tissue. Also, a method generates MRI images of such a medical device, and involves performing first and second MRI processes on a body portion including at least a portion of the medical device to obtain, respectively, first and second image data. The first MRI process is adapted to detect MRI detectable nuclei present in the proximate body tissue, and the second MRI process is adapted to detect the selected MRI detectable nuclei contained in the device's imaging material. The selected MRI detectable nuclei incorporated in the imaging material is not the same nuclei that the first MRI process is adapted to detect. The second image data are combined with the first image data to produce image data for the medical device and the proximate body tissue.

Magnetic resonance imaging of a medical device and proximate body tissue

A method of treating a biological tissue including contacting the biological tissue with an aqueous sterilizing solution, and maintaining the aqueous sterilizing solution at a temperature of about 50&#xb0; C. for a time period of about 1 to 2 days. The method of treating a biological tissue may be utilized as a terminal sterilization step in a method for fixation of biological tissues, and bioprosthetic devices may be prepared by such fixation method. The fixation method may include the steps of A) fixing the tissue, B) treating the tissue with a mixture of i) a denaturant, ii) a surfactant and iii) a crosslinking agent, C) fabricating or forming the bioprosthesis (e.g., forming the tissue and attaching any non-biological components thereto) and D) subjecting the bioprosthesis to the terminal sterilization method. The aqueous sterilizing solution may be glutaraldehyde of about 0.625 weight percent buffered to a pH of about 7.4.

Method for treatment of biological tissues to mitigate post-implantation calcification and thrombosis

The present invention relates to a system and method for the delivery of therapeutic agents, such as therapeutic drugs or genetic material, into the muscle or tissue that minimizes the loss of therapeutic agents due to contraction of the muscle. In one embodiment, an implant for delivering therapeutic agents into a muscle is provided, wherein the implant has at least one rod for insertion and delivery of therapeutic agents into the muscle and a patch that can be attached to the exterior surface of the muscle for preventing or minimizing therapeutic agent being expelled due to the contraction of the muscle, such as the beating of a heart muscle.

Patch stabilization of rods for treatment of cardiac muscle

Growing community of inventors

Worcester, MA, United States of America

Michael N Helmus