Abstract: An implantable medical device having a soft tissue interfacing surface comprises at least one soft actuatable capsule having a soft tissue interfacing deflectable membrane configured for cyclical deflection upon actuation of the capsule to modulate the biomechanics of the soft tissue interface during use. The actuatable capsule may comprise an actuation chamber containing a first fluid, a therapeutic chamber containing a second fluid, a deflectable membrane separating the actuation chamber and therapeutic chamber, and an actuation conduit in fluidic communication with the actuation chamber for pneumatic actuation of the actuation chamber. The therapeutic chamber comprises the soft tissue interfacing deflectable membrane which is configured to cyclically deflect during actuation of the capsule and modulate the biomechanics of the soft tissue interface by altering one or more of strain, fluid flow and cellular activity in peri-implant tissue at the soft tissue interface.

Abstract: The invention relates to a medical implant (1) that is adapted to repair or close defect (D), in particular an opening in a ventricular, atrial, or septal wall (W). The medical implant (1) may, in particular, be a patch. It comprises an adhesive composition (6). It further comprises two states, wherein in the first state, the medical implant (1) can be deployed to an implant site while the adhesive composition (6) is inactive. It can be brought into a second state by an activation mechanism. The adhesive composition (6), in the second state, is curable by a curing mechanism.

Abstract: The invention relates to medical implant (1) that is adapted to close a defect (D) or a cavity, preferably a defect in an atrial or septal wall (W) or a left atrial appendage. The implant (1) comprises an occlusion device (6) and has two states. It is adapted to, in a first state, be deployed to a defect site (D), where it can be brought into a second state by an activation mechanism. It is adapted to close said defect (D) in said second state.

Abstract: The invention relates to a positioning device (1) comprising a distal part (8) that is adapted to be delivered through a defect, preferably an opening in a ventricular or atrial septum. It comprises a mechanism to selectively expand the distal part (8), such that before expansion, it can be deployed through said defect, and upon expansion, is mechanically prevented from being retracted through the same defect. Thus, the positioning device (1) is temporarily engaged at the defect site.

Abstract: A system includes an elongate catheter having a self-expanding frame disposed at the distal end of the catheter. The frame includes a plurality of longitudinal struts defined by parallel slots. The frame may be constrained into a radially compressed configuration for delivery to a treatment site. A helical balloon is mounted about the frame. Upon release from the constraining mechanism, the frame returns to a heat-set radially expanded configuration to initiate dilation of a treatment site in a patient. Inflating the balloon around the expanded frame further expands the initial radial dilation of the site. Proximal and distal ends of the slots are unobstructed by the balloon to permit flow of a fluid through the slots and through a lumen defined by an interior surface of the balloon when the frame is in the radially expanded configuration.

Abstract: A system includes an elongate catheter having a self-expanding frame disposed at the distal end of the catheter. The frame includes a plurality of longitudinal struts defined by parallel slots. The frame may be constrained into a radially compressed configuration for delivery to a treatment site. A helical balloon is mounted about the frame. Upon release from the constraining mechanism, the frame returns to a heat-set radially expanded configuration to initiate dilation of a treatment site in a patient. Inflating the balloon around the expanded frame further expands the initial radial dilation of the site. Proximal and distal ends of the slots are unobstructed by the balloon to permit flow of a fluid through the slots and through a lumen defined by an interior surface of the balloon when the frame is in the radially expanded configuration.

Abstract: An apparatus for measuring particles generated from a medical device includes a platform configured for retaining at least one medical device and at least one simulated body lumen tubing. The platform includes: a medical device receptacle dimensioned to retain a medical device; a pretest receptacle dimensioned to retain pretest tubing; and a test receptacle dimensioned to retain test tubing. The apparatus can be used for measuring particles generated from a medical device during a simulated clinical application by the following: introducing the medical device into the test tubing; causing fluid to flow through the pretest tubing, past the medical device, and through the test tubing; and counting the particles in the fluid downstream from the medical device.

Abstract: An apparatus for measuring particles generated from a medical device during a simulated clinical application includes a platform configured for retaining at least one medical device and at least one simulated body lumen tubing. The platform includes the following: a medical device receptacle dimensioned to retain the at least one medical device; a pretest receptacle dimensioned to retain pretest tubing; and a test receptacle dimensioned to retain test tubing, said test receptacle having at least one substantially straight portion configured for straightening said test tubing when disposed therein and at least one tortuous portion configured for bending said test tubing into a tortuous pathway when disposed therein. Additionally, the platform includes a junction that interconnects the medical device receptacle, pretest receptacle, and test receptacle.

Abstract: An apparatus for measuring particles generated from a medical device during a simulated clinical application includes a platform configured for retaining at least one medical device and at least one simulated body lumen tubing. The platform includes the following: a medical device receptacle dimensioned to retain the at least one medical device; a pretest receptacle dimensioned to retain pretest tubing; and a test receptacle dimensioned to retain test tubing, said test receptacle having at least one substantially straight portion configured for straightening said test tubing when disposed therein and at least one tortuous portion configured for bending said test tubing into a tortuous pathway when disposed therein. Additionally, the platform includes a junction that interconnects the medical device receptacle, pretest receptacle, and test receptacle.

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: 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: 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: An apparatus for measuring particles generated from a medical device includes a platform configured for retaining at least one medical device and at least one simulated body lumen tubing. The platform includes: a medical device receptacle dimensioned to retain a medical device; a pretest receptacle dimensioned to retain pretest tubing; and a test receptacle dimensioned to retain test tubing. The apparatus can be used for measuring particles generated from a medical device during a simulated clinical application by the following: introducing the medical device into the test tubing; causing fluid to flow through the pretest tubing, past the medical device, and through the test tubing; and counting the particles in the fluid downstream from the medical device.

Abstract: A method for determining the thickness of a coating or a plurality of coatings applied to medical devices. In particular, determining coating thickness of a medical device including an endoprosthesis.