Abstract: A balloon catheter configured for delivery of a prosthetic heart valve is provided. The balloon catheter is configured to deploy a prosthetic heart valve through inflation. The balloon catheter is provided with a reinforcing member configured to increase the rigidity of the balloon catheter over an operational portion of the device. The increased rigidity serves to prevent damage to an introducer sheath, patient anatomy, or the prosthetic heart valve during delivery of the prosthetic heart valve.

Abstract: A cryotherapeutic device having an integral multi-helical balloon section and methods of making the same. A method of forming the cryotherapeutic device can include forming an extruded integral shaft having first and second substantially parallel lumens. The method can further include twisting a distal section of the shaft such that the first and second lumens form intertwined helical portions. The first and second helical portions can be plastically enlarged to form an inflatable body configured to deliver therapeutically effective cryogenic cooling to a treatment site.

Abstract: Anatomical models are provided with simulated plaque, lesion, chronic total occlusion, as well as other vascular diseases that more accurately replicate these abnormalities. In such embodiment, the vascular disease may be formed separate from the structured anatomical model. The formed vascular disease material may then be bonded to or within a PVA material in a separate process from forming this simulated vascular disease, thus providing a replicated specific anatomy structure with an abnormality for demonstrating, testing, and/or developing medical functions and/or devices.

Abstract: Embodiments provide for partially cured, preformed pieces of PVA capable of later being formed into more specific models. The partially cured, pre-made pieces of PVA can take on many forms and shapes. For example, the shape may be a flat, tubular, cone, spherical, or other similar shape. In fact, more complex shapes such as full organs are also contemplated herein. Nevertheless, such pre-molded components are considered common or general shaped in that the particular shape is produced using standard or common molds, and then later formed into a more specific or desired shape. As such, the preformed pieces of PVA are only partially cured or cross-linked such that they can later be formed into the more specific models that then have additional processing (e.g., freeze-thaw cycle) to retain the new shape.

Abstract: Models are made through a process that provides for a bonding mechanism of pre-made PVA parts to create more complex structures. The components are bonded together by wetting the surfaces to be connected with a PVA solution. The components are then adjoined together and bonded through an additional processing or curing, e.g., freeze-thaw cycle. This process can be repeated multiple times to create more complex structures or models. In another embodiment, a textile or fabric type material is used to increase the radial strength of the models. In such an embodiment, a usually thin piece of textile material, such as a nylon fabric, may be placed within the core molding. Liquid PVA then flows through the nylon hosiery or textile material and one or more curing process are then applied, which allows the PVA solution to bond or otherwise adhere with the material.

Abstract: The invention concerns methods for effectively sterilizing packaged or unpackaged medical devices such as drug- and/or polymer-coated stents. The method is well-suited to sterilizing medical devices that would be degraded by steam or irradiation sterilization. The present invention involves the placing of a packaged or unpackaged medical device into a pressure, temperature, and humidity controlled environment and exposing the device to a liquid or gaseous sterilizer for a given period of time. An example of a liquid or gaseous sterilizer is ethylene oxide. Given the right temperature, humidity, pressure, sterilizer concentration, and sufficient time, the sterilizer is able to effectively sterilize the device by contacting the exposed surfaces. In the case of packaged medical devices, the sterilizer contacts the device by diffusing through the packaging material.

Abstract: An elongate medical device packaging system can include a sheath, a clasp, and/or a container. The sheath can be configured to releasably retain an elongate medical device, and can be comprised of a first material and an antistatic material in an amount and distribution within the first material so as to inhibit generating static electricity when the elongate medical device is withdrawn from the lumen. The clasp can include at least two recesses configured to hold the sheath in a coiled orientation. The clasp also has a configured to hold at least one object in an inwardly planar orientation with respect to the coiled elongate tube. The container can be a multi-compartment container, which includes one compartment to hold the coiled sheath and one compartment to hold components of the medical device, wherein each compartment can be fluid-tight.