Abstract: A prosthesis delivery and deployment device includes an elongate and flexible outer catheter. The outer catheter has a tubular wall of layered construction, including translucent layers, opaque layers, and a braid composed of helically wound metal filaments. The outer catheter has a translucent distal adapted to constrain a radially self-expanding prosthesis in a radially reduced, axially elongated state. Because the stent constraining region is translucent, an endoscope can be used to visually monitor the stent when so constrained. Radiopaque markers can be mounted to the outer catheter and to an inner catheter used to deploy the prosthesis, to afford a combined visual and fluoroscopic monitoring for enhanced accuracy in positioning the prosthesis, both before and during its deployment.

Abstract: A prosthesis delivery and deployment device includes an elongate and flexible outer catheter. The outer catheter has a tubular wall of layered construction, including translucent layers, opaque layers, and a braid composed of helically wound metal filaments. The outer catheter has a translucent distal adapted to constrain a radially self-expanding prosthesis in a radially reduced, axially elongated state. Because the stent constraining region is translucent, an endoscope can be used to visually monitor the stent when so constrained. Radiopaque markers can be mounted to the outer catheter and to an inner catheter used to deploy the prosthesis, to afford a combined visual and fluoroscopic monitoring for enhanced accuracy in positioning the prosthesis, both before and during its deployment.

Abstract: A prosthesis delivery and deployment device includes an elongate and flexible outer catheter. The outer catheter has a tubular wall of layered construction, including translucent layers, opaque layers, and a braid composed of helically wound metal filaments. The outer catheter has a translucent distal adapted to constrain a radially self-expanding prosthesis in a radially reduced, axially elongated state. Because the stent constraining region is translucent, an endoscope can be used to visually monitor the stent when so constrained. Radiopaque markers can be mounted to the outer catheter and to an inner catheter used to deploy the prosthesis, to afford a combined visual and fluoroscopic monitoring for enhanced accuracy in positioning the prosthesis, both before and during its deployment.

Abstract: A prosthesis delivery and deployment device includes an elongate and flexible outer catheter. The outer catheter has a tubular wall of layered construction, including translucent layers, opaque layers, and a braid composed of helically wound metal filaments. The outer catheter has a translucent distal adapted to constrain a radially self-expanding prosthesis in a radially reduced, axially elongated state. Because the stent constraining region is translucent, an endoscope can be used to visually monitor the stent when so constrained. Radiopaque markers can be mounted to the outer catheter and to an inner catheter used to deploy the prosthesis, to afford a combined visual and fluoroscopic monitoring for enhanced accuracy in positioning the prosthesis, both before and during its deployment.

Abstract: A system comprising an implantable medical device and a second polymeric layer configured to be disposed on or about the implantable medical device is described. The device includes a first polymeric layer into which a first therapeutic agent is incorporated. A second therapeutic agent is incorporated into the second polymeric layer. The device is sterilized by a first sterilization method. The second polymeric layer is sterilized by a second sterilization method. A method for making a sterile implantable medical system is also described. The method includes incorporating a first therapeutic agent in a first polymeric material and disposing the first polymeric material on or about an implantable medical device. The first polymeric material and the implantable medical device are sterilized by a first sterilization method.

Abstract: A prosthesis delivery and deployment device includes an elongate and flexible outer catheter. The outer catheter has a tubular wall of layered construction, including a translucent inner liner running the complete catheter length, and three outer layers including a translucent distal layer, an opaque medial layer and an opaque proximal outer layer. The outer layers are adjacent one another and are bonded to the liner. A braid composed of helically wound metal filaments is disposed between the liner and the proximal and medial outer layers, and includes a distal portion between the liner and a proximal portion of the distal outer layer. The liner and distal outer layer provide a translucent distal region of the catheter that is adapted to constrain a radially self-expanding prosthesis in a radially reduced, axially elongated state. Because the stent constraining region is translucent, an endoscope can be used to visually monitor the stent when so constrained.

Abstract: A method of coating a microneedle array comprising: providing a microneedle array having a substrate and at least one needle; providing a removable masking layer on the microneedle array such that the substrate is at least partially covered by the masking layer and the at least one needle remains at least partially exposed; and applying a coating material to at least a portion of the exposed portion of the microneedle array.

Abstract: A prosthesis delivery and deployment device includes an elongate and flexible outer catheter. The outer catheter has a tubular wall of layered construction, including a translucent inner liner running the complete catheter length, and three outer layers including a translucent distal layer, an opaque medial layer and an opaque proximal outer layer. The outer layers are adjacent one another and are bonded to the liner. A braid composed of helically wound metal filaments is disposed between the liner and the proximal and medial outer layers, and includes a distal portion between the liner and a proximal portion of the distal outer layer. The liner and distal outer layer provide a translucent distal region of the catheter that is adapted to constrain a radially self-expanding prosthesis in a radially reduced, axially elongated state. Because the stent constraining region is translucent, an endoscope can be used to visually monitor the stent when so constrained.

Abstract: A system comprising an implantable medical device and a second polymeric layer configured to be disposed on or about the implantable medical device is described. The device includes a first polymeric layer into which a first therapeutic agent is incorporated. A second therapeutic agent is incorporated into the second polymeric layer. The device is sterilized by a first sterilization method. The second polymeric layer is sterilized by a second sterilization method. A method for making a sterile implantable medical system is also described. The method includes incorporating a first therapeutic agent in a first polymeric material and disposing the first polymeric material on or about an implantable medical device. The first polymeric material and the implantable medical device are sterilized by a first sterilization method.

Abstract: A method of coating a microneedle array comprising: providing a microneedle array having a substrate and at least one needle; providing a removable masking layer on the microneedle array such that the substrate is at least partially covered by the masking layer and the at least one needle remains at least partially exposed; and applying a coating material to at least a portion of the exposed portion of the microneedle array.

Abstract: A prosthesis delivery and deployment device includes an elongated and flexible outer catheter. The outer catheter has a tubular wall of layered construction, including a translucent inner liner running the complete catheter length, and three outer layers including a translucent distal layer, an opaque medial layer and an opaque proximal outer layer. The outer layers are adjacent one another and are bonded to the liner. A braid composed of helically wound metal filaments is disposed between the liner and the proximal and medial outer layers, and includes a distal portion between the liner and a proximal portion of the distal outer layer. The liner and distal outer layer provide a translucent distal region of the catheter that is adapted to constrain a radially self-expanding prosthesis in a radially reduced, axially elongated state. Because the stent constraining region is translucent, an endoscope can be used to visually monitor the stent when so constrained.

Abstract: A prosthesis delivery and deployment device includes an elongate and flexible outer catheter. The outer catheter has a tubular wall of layered construction, including a translucent inner liner running the complete catheter length, and three outer layers including a translucent distal layer, an opaque medial layer and an opaque proximal outer layer. The outer layers are adjacent one another and are bonded to the liner. A braid composed of helically wound metal filaments is disposed between the liner and the proximal and medial outer layers, and includes a distal portion between the liner and a proximal portion of the distal outer layer. The liner and distal outer layer provide a translucent distal region of the catheter that is adapted to constrain a radially self-expanding prosthesis in a radially reduced, axially elongated state. Because the stent constraining region is translucent, an endoscope can be used to visually monitor the stent when so constrained.

Abstract: The invention is directed to medical devices having a drug-releasing coating and methods for making such coated devices. The coating permits timed or prolonged pharmacological activity on the surface of medical devices through a reservoir concept. Specifically, the coating comprises at least two layers: an outer layer containing at least one drug-ionic surfactant complex overlying a reservoir layer containing a polymer and the drug which is substantially free of an ionic surfactant. Upon exposure to body tissue of a medical device covered with such coating, the ionically bound drug in the outer layer is released into body fluid or tissue. Following release of such bound drug, the ionic surfactant binding sites in the outer layer are left vacant.

Abstract: A body implantable stent is formed of a plurality of strands arranged in two sets of coaxial helices, wound in opposite directions to form multiple crossings. At selected crossings, the adjacent strands are welded to one another, while at the remaining crossings the strands are free for limited movement relative to one another. The welds are formed in patterns that preferably enhance radial strength and rigidity, while having a minimal impact on axial bending flexibility. Preferred weld patterns in this regard include rings or circumferential rows, and helices, particularly with a steeper pitch than that of the strands. Stent fabrication preferably involves resistance welding at the crossings, and use of a tool to reuniformly compress the stent around and against the distal end region of a balloon catheter used later to deliver the stent to a treatment site.

Abstract: The invention is directed to medical devices having a drug-releasing coating and methods for making such coated devices. The coating permits timed or prolonged pharmacological activity on the surface of medical devices through a reservoir concept. Specifically, the coating comprises at least two layers: an outer layer containing at least one drug-ionic surfactant complex overlying a reservoir layer containing a polymer and the drug which is substantially free of an ionic surfactant. Upon exposure to body tissue of a medical device covered with such coating, the ionically bound drug in the outer layer is released into body fluid or tissue. Following release of such bound drug, the ionic surfactant binding sites in the outer layer are left vacant.

Abstract: A body implantable stent is formed of a plurality of strands arranged in two sets of coaxial helices, wound in opposite directions to form multiple crossings. At selected crossings, the adjacent strands are welded to one another, while at the remaining crossings the strands are free for limited movement relative to one another. The welds are formed in patterns that preferably enhance radial strength and rigidity, while having a minimal impact on axial bending flexibility. Preferred weld patterns in this regard include rings or circumferential rows, and helices, particularly with a steeper pitch than that of the strands. Stent fabrication preferably involves resistance welding at the crossings, and use of a tool to reuniformly compress the stent around and against the distal end region of a balloon catheter used later to deliver the stent to a treatment site.

Abstract: The invention is directed to medical devices having a drug-releasing coating and methods for making such coated devices. The coating permits timed or prolonged pharmacological activity on the surface of medical devices through a reservoir concept. Specifically, the coating comprises at least two layers: an outer layer containing at least one drug-ionic surfactant complex overlying a reservoir layer containing a polymer and the drug which is substantially free of an ionic surfactant. Upon exposure to body tissue of a medical device covered with such coating, the ionically bound drug in the outer layer is released into body fluid or tissue. Following release of such bound drug, the ionic surfactant binding sites in the outer layer are left vacant.