A medical device includes a balloon expanded scaffold crimped to a catheter having a balloon. The scaffold has a network of rings formed by struts connected at crowns and links connecting adjacent rings. The scaffold is crimped to the balloon by a process that includes using protective polymer sheaths or sheets during crimping, and adjusting the sheaths or sheets during the crimping to avoid or minimize interference between the polymer material and scaffold struts as the scaffold is reduced in size.

A serration balloon can have a number of different components and can be made in a number of different manners. One or more longitudinally extending members with periodic raised wedges can be attached to a medical balloon. They can be attached with a fiber coating, a polymer coating, or other methods. A polymer matrix can be used to bond the longitudinally extending member to the surface of the balloon. The fiber coating can be, for example, a thread or mesh that secures the longitudinally extending member to the balloon. The medical balloon can be an angioplasty balloon, such as an off-the-shelf angioplasty balloon.

In at least one embodiment of the present invention a balloon catheter is provided. The balloon catheter comprises a shaft having a lumen formed therethrough. Connected to the shaft is an inflatable balloon. The inflatable balloon has a balloon wall defining a balloon interior surface and a balloon exterior surface that is opposite the interior surface. In fluid communication with the balloon wall is the lumen for inflating the balloon to define an inflated state and for collapsing the balloon to define a deflated state. The balloon wall is textured in the deflated state such that the balloon interior surface is spatially registered with the balloon exterior surface. The balloon in the inflated state is tensioned to have a surface roughness substantially less than a surface roughness of the balloon in the deflated state.

A balloon catheter is provided that may be used to dilate hardened regions of a stenosis. The balloon catheter is provided with one or more dilation elements that extend along a surface of a balloon. Each dilation element is monolithically connected to an outer surface of the balloon by a connector. The connector is sufficiently sized and designed to undergo stress-induced plastic deformation incurred during blow molding so that a significant portion of each of the dilation elements does not become absorbed into the wall of the final blow molded balloon, thereby maintaining the structural integrity of each of the dilation elements. The dilation element has a flattened outer surface along at least proximal and distal neck portions of the balloon.

An example medical device includes a balloon that is inflatable to an inflated configuration. The balloon includes a non-compliant layer coextruded on an inner layer, and an outer layer coextruded on the non-compliant layer. The non-compliant layer is configured to delaminate from the inner and the outer layers in the inflated configuration. The non-compliant layer may be configured to rupture in the inflated configuration. An example technique includes inflating the balloon to a predetermined pressure sufficient to rupture the non-compliant layer and insufficient to rupture both the inner and outer layers. The example technique further includes deflating the balloon, and introducing the balloon into a vasculature. Another example technique includes coextruding a non-compliant layer on an inner layer, coextruding an outer layer on the non-compliant layer, and forming a balloon from the inner layer, the non-compliant layer, and the outer layer.

Methods for making medical devices and portions of medical devices (e.g., intravascular catheters, catheter shafts, and tubular guiding members) are provided. Example methods may include providing a first ribbon comprising one or more thermoplastic materials and a piece of shrink tubing defining a shrink tube lumen and forming a first assembly by positioning the first ribbon inside the shrink tube lumen and urging the first ribbon to assume a tubular shape in which the first ribbon defines a ribbon lumen. A second assembly may be formed by loading an inner tubular member over a mandrel and forming or placing a support structure over an outer surface of the inner tubular member. A third assembly may be formed by inserting the second assembly into the ribbon lumen defined by the first ribbon of the first assembly. The third assembly may be heated to a process temperature.

A device for guiding and supporting a stent delivery catheter and other catheters is disclosed. The device may comprise a tubular guiding member and an elongated positioning member extending in a proximal direction beyond the tubular guiding member for advancing and retracting the tubular guiding member in distal and proximal directions. A distal portion of the elongate positioning member may be coupled to the proximal portion of the tubular guide. In embodiments, the device includes a ribbon having a distal portion and a proximal portion. In embodiments, the distal portion of the ribbon extends distally into the tubular guiding member and the proximal portion of the ribbon overlays an inner surface of the elongate positioning member.

A medical device includes a scaffold crimped to a catheter having an expansion balloon. The scaffold is crimped to the balloon by a process that includes inflating the delivery balloon during a diameter reduction to improve scaffold retention and maintaining an inflated balloon during the diameter reduction and prior and subsequent dwell periods.

A process for fixing an implant to a balloon includes providing, in an interior of a sleeve, a heated balloon having a pressurizable balloon interior and an implant crimped to the balloon. The implant has a supporting structure with a multiplicity of through openings. A negative pressure is applied in the interior of the sleeve and a positive pressure is applied to the balloon interior, so that the balloon is deep-drawn into the openings of the implant, producing a form-locking connection between the balloon and the implant. A configuration for carrying out the process and an apparatus for fixing an implant to a balloon are also provided.

A method fixes an implant on a balloon. The balloon, together with an implant, which is crimped onto a balloon surface of the balloon such that the implant by an inner side contacts a contact region of the balloon surface, is provided in the interior of a mold. The balloon interior is acted on by a pressure and the implant is inductively heated so that the contact region over the implant is heated and plastically deformed. The inner side of the implant is embedded in the balloon surface. Additionally, an assembly is produced by the method and an apparatus are provided for carrying out the method.