Abstract: One embodiment provides a medical device comprising a base material and a bioactive in contact with the base material, the bioactive having a proton binding site with a non-ionic form and an ionic form, the bioactive being less soluble in water when the proton binding site is in the non-ionic form than when the proton binding site is in the ionic form, wherein at least 5% w/w of the bioactive is present with the proton binding site in the non-ionic form and wherein the bioactive is not an anesthetic. Another embodiment provides such a medical device where the bioactive is an anesthetic and where the device is not a ureteral stent. Another aspect provides method of manufacturing such devices.

Abstract: Non-metallic implantable medical devices including an anesthetic having a proton binding site with a non-ionic form and an ionic form. At least 5% w/w of the anesthetic is present with the proton binding site in the non-ionic form and the remainder of the anesthetic is present with the proton binding site in the ionic form. Methods of preparing such devices are also provided.

Abstract: Medical devices for implantation in a body vessel, and methods of using and making the same, are provided. A medical device can include a frame with a vessel-engaging region on at least a portion of the medical device. The vessel-engaging region may be a particulate coating configured and adapted to engage the interior wall of a body vessel or to attach a material, such as a valve leaflet or graft material, to the frame. Methods of making an implantable medical device and methods of treating a subject are also disclosed.

Abstract: This disclosure relates to endolumenal medical devices coated with a taxane therapeutic agent in one or more solid form(s) having varying dissolution rates. Particularly preferred coatings comprise amorphous paclitaxel, dihydrate paclitaxel, or combinations thereof that provide durable coatings that release paclitaxel over a desired period of time, which can be on the order of hours, days or weeks. Preferred embodiments relate to medical device coatings of paclitaxel, or paclitaxel analogs or derivatives, having one or more polymorph solid forms that provide a prolonged release of paclitaxel within a body vessel without requiring a polymer carrier or barrier layer to achieve the desired rate of paclitaxel elution.

Abstract: An implantable medical device including a nanocomposite coating deposited on at least a portion of a surface of at least one structural element of the device to provide a controlled release of a bioactive agent in one or more dosages is described. The nanocomposite coating includes a matrix, a bioactive agent and inorganic particles. The inorganic particles respond to a stimulus, preferably by generating heat. The response of the particles to the stimulus causes the matrix of the nanocomposite coating to undergo a volume change by, for example, contracting or swelling, thereby releasing at least a portion of the bioactive agent. A method of providing a controlled release of a bioactive agent from a nanocomposite coating on an implantable medical device is described. A method for providing a nanocomposite coating for the controlled release of a bioactive agent on the implantable medical device is also described.

Abstract: A system for delivering and deploying an expandable endoluminal prosthesis comprises a delivery catheter and a sheath. The delivery catheter has a proximal end and a distal end and is slidably disposed within a lumen of the sheath. An operating mechanism comprises a contractible air vessel that couples the sheath and the delivery catheter so that contraction of the air vessel causes the sheath to retract proximally over the delivery catheter. Additional aspects of the invention include a method of deploying an expandable endoluminal prosthesis.

Abstract: A self-expanding or otherwise expandable artificial valve prostheses for deployment within a body passageway, such as a vessel or duct of a patient. The valve prostheses include a support structure having an outer frame, a supporting member and a valve leaflet. The portion of the valve leaflet is supported by the supporting member and is positioned away from the wall of the body passageway when the device is deployed within the body passageway.

Abstract: The invention relates to a prosthetic valve for regulating flow through a body lumen and delivering a therapeutic agent into said lumen. In one embodiment, the prosthesis includes a frame having an exterior wall, a hollow interior space, a valve member, and at least one aperture through the exterior wall that permits a controlled amount of therapeutic agent loaded into the hollow interior into the surrounding body lumen following implantation. In another embodiment, the prosthesis includes a frame having a groove, a valve member, and therapeutic agent loaded in the groove.

Abstract: A stent graft introducer actuation assembly (1) having a fixed handle (3) and at least one sliding handle (5, 7), the sliding handle or handles telescoping within the fixed handle, and a winch arrangement (9) to retract the sliding handle into the fixed handle. There may be provided arrangements to give a mechanical advantage to the winch arrangement.

Abstract: The present invention relates to a medical device having a surface with a uniform or non-uniform layer posited thereon that includes a mono- or disaccharide sugar and at least one therapeutic agent. The present invention further relates to materials and a method of making such a medical device and methods of delivering a therapeutic agent.

Abstract: A device for delivering and deploying a radially expandable prosthesis is disclosed and comprises a proximal prosthesis release mechanism having a first resistance and a distal prosthesis release mechanism having a second resistance. The device further comprises an actuation mechanism for actuating the distal and proximal release mechanisms in a single coordinated movement and a biasing compensator for regulating the relationship between the first resistance and the second resistance. Additional aspects of the invention include devices and methods for delivering and deploying a radially expandable prosthesis.

Abstract: This invention relates to a medical device and, in particular, to a prosthesis or stent graft assembly for use within the human or animal body and, more particularly, to the fastening of a stent to the graft material of the stent graft assembly or prosthesis.

Abstract: This disclosure relates to implantable medical devices coated with a taxane therapeutic agent, such as paclitaxel, in one or more solid form(s) having varying dissolution rates. Particularly preferred coatings comprise amorphous and/or solvated solid forms of taxane therapeutic agents that provide durable coatings that release the taxane over a desired period of time, which can be varied in the absence of a polymer by selecting the type and amount of solid forms of the taxane therapeutic agent in the coating. Other preferred embodiments relate to methods of coating medical devices and methods of treatment. The coatings can provide a sustained release of the taxane therapeutic agent within a body vessel without containing a polymer to achieve the desired rate of paclitaxel elution.

Abstract: The invention relates to medical devices coated with zein. The medical device may include further a therapeutic agent in contact with zein. Zein allows the therapeutic agent to be retained on the device during delivery and also controls the elution rate of the therapeutic agent following implantation. The invention further relates to methods of delivering a therapeutic agent on said medical devices as well as their use especially in the form of stents for prevention of restenosis.

Abstract: The present invention provides an implantable medical device comprising a bioactive agent and poly(alkyl cyanoacrylate) polymer. In one embodiment of the invention, the bioactive agent is a water-soluble material, such as an antisense agent.

Abstract: A coated medical device, such as a stent, that elutes a therapeutic agent in a controlled manner is provided. The medical device may be coated with a layer of therapeutic agent and a layer of bioabsorbable elastomer over the layer of therapeutic agent. Methods of manufacturing a coated medical device and of coating a medical device are also provided.

Abstract: Methods of making coated implantable medical devices are provided. The methods include positioning a first layer comprising a bioactive on at least a portion of a structure, and positioning at least one porous layer over the first layer. The at least one porous layer has a thickness adequate to provide a controlled release of the bioactive.

Abstract: Methods of making coated implantable medical devices are provided. The methods include positioning a first layer comprising a bioactive on at least a portion of a structure, and positioning at least one porous layer over the first layer. The at least one porous layer has a thickness adequate to provide a controlled release of the bioactive.

Abstract: An intraluminal device is provided with a porous structure. The porous structure may be loaded with a bioactive substance to treat surrounding tissues after the intraluminal device has been implanted. The porous structure may be made by depositing a metal film on a foam structure using chemical vapor deposition. Porous structures may also be made by sintering or applying a ceramic layer to the intraluminal device. An intraluminal device is also provided with a ceramic material applied to generally straight portions of the device structure but not to portions adapted to bend. One advantage is that the ceramic material is less likely to fracture since it is applied to regions that experience less strain.

Abstract: A coated implantable medical device 10 includes a structure 12 adapted for introduction into the vascular system, esophagus, trachea, colon, biliary tract, or urinary tract; at least one coating layer 16 posited on one surface of the structure; and at least one layer 18 of a bioactive material posited on at least a portion of the coating layer 16, wherein the coating layer 16 provides for the controlled release of the bioactive material from the coating layer. In addition, at least one porous layer 20 can be posited over the bioactive material layer 18, wherein the porous layer includes a polymer and provides for the controlled release of the bioactive material therethrough. Preferably, the structure 12 is a coronary stent. The porous layer 20 includes a polymer applied preferably by vapor or plasma deposition and provides for a controlled release of the bioactive material.