Patent Description:
A wide variety of intracorporeal medical devices have been developed for medical use, for example, surgical and/or intravascular use. Some of these devices include guidewires, catheters, medical device delivery systems (e.g., for stents, grafts, replacement valves, etc.), and the like. These devices are manufactured by any one of a variety of different manufacturing methods and may be used according to any one of a variety of methods. There is an ongoing need to provide alternative medical devices as well as alternative methods for manufacturing medical devices. <CIT> relates to relates to invasive surgical devices which are useful for the incision and dilation of stenoses in a vessel. <CIT> relates to a balloon catheter with integral channels on the surface of the balloon for securing a dilation element.

The disclosure is directed to several alternative designs, materials and methods of manufacturing medical device structures and assemblies, and the use thereof.

In a first example, a balloon catheter may comprise a catheter shaft, an inflatable balloon secured to a distal portion of the catheter shaft, the inflatable balloon including one or more channels formed in an outer surface thereof, an expandable frame disposed over the balloon and at least in part within the one or more channels, the expandable frame comprising a plurality of struts each having proximal section, a distal section, and an intermediate section, wherein the proximal section is pivotably coupled to the intermediate section and the distal section is pivotably coupled to the intermediate section, and one or more cutting members coupled to the expandable frame.

In another example, a balloon catheter may comprise a catheter shaft, an inflatable balloon secured to a distal portion of the catheter shaft, an expandable frame disposed over the balloon, the expandable frame comprising a plurality of struts each having proximal section, a distal section, and an intermediate section, wherein the proximal section is pivotably coupled to the intermediate section and the distal section is pivotably coupled to the intermediate section, and one or more cutting members coupled to the expandable frame.

Alternatively or additionally to any of the examples above, in another example, a plurality of elastomeric bands are circumferentially surrounding the expandable frame at longitudinally spaced apart locations along the balloon.

Alternatively or additionally to any of the examples above, in another example, the plurality of elastomeric bands are in tension when the balloon is in a fully deflated configuration.

Alternatively or additionally to any of the examples above, in another example, the plurality of elastomeric bands apply a radially inward force on the plurality of struts to press the plurality of struts against an outer surface of the balloon.

Alternatively or additionally to any of the examples above, in another example, each strut of the plurality of struts may include two or more cutting members.

Alternatively or additionally to any of the examples above, in another example, the one or more cutting members may be coupled to the intermediate section of the expandable frame.

Alternatively or additionally to any of the examples above, in another example, a distal end of the proximal section of the expandable frame may comprise at least one hook configured to pivotably couple with at least one aperture formed in the intermediate section.

Alternatively or additionally to any of the examples above, in another example, a proximal end of the distal section of the expandable frame may comprise at least one aperture configured to pivotably couple with at least one hook formed in the intermediate section.

Alternatively or additionally to any of the examples above, in another example, each intermediate section of the plurality of struts may have one or more mounting modules configured to receive the one or more cutting members.

Alternatively or additionally to any of the examples above, in another example, the intermediate section may comprise two or more links pivotably coupled together.

Alternatively or additionally to any of the examples above, in another example, each link of the two or more links may comprise a first end having a first coupling mechanism, a second end having a second coupling mechanism, and an intermediate region defining a channel for receiving a cutting member therein.

Alternatively or additionally to any of the examples above, in another example, the first coupling mechanism may comprise an aperture.

Alternatively or additionally to any of the examples above, in another example, the second coupling mechanism may comprise a hook.

Alternatively or additionally to any of the examples above, in another example, the link may be mechanically deformed to secure the cutting member within the channel.

Alternatively or additionally to any of the examples above, in another example, the intermediate section comprises two or more rails pivotably coupling adjacent mounting modules together.

Alternatively or additionally to any of the examples above, in another example, the rail has a width less than a width of the mounting modules.

Alternatively or additionally to any of the examples above, in another example, the cutting member may be adhesively secured to the link.

Alternatively or additionally to any of the examples above, in another example, the expandable frame may be secured to the catheter shaft adjacent to a proximal end of the expandable frame.

Alternatively or additionally to any of the examples above, in another example, the balloon catheter may further comprise a bumper secured to the catheter shaft distal to a distal end of the expandable frame.

Alternatively or additionally to any of the examples above, in another example, a depth of the one or more channels may be equal to or less than a thickness of the plurality of struts of the expandable frame.

Alternatively or additionally to any of the examples above, in another example, the links may be pivotably coupled via a rail.

Alternatively or additionally to any of the examples above, in another example, the links and the rail may form a monolithic structure.

Alternatively or additionally to any of the examples above, in another example, the rail may have a width less than a width of the links.

Alternatively or additionally to any of the examples above, in another example, the balloon may include one or more channels formed in an outer surface thereof.

Alternatively or additionally to any of the examples above, in another example, at least a portion of the expandable frame may be disposed within the one or more channels.

Alternatively or additionally to any of the examples above, in another example, the cutting member may be adhesively secured to the expandable frame.

Alternatively or additionally to any of the examples above, in another example, at least one of a proximal end region or a distal end region of the expandable frame may include a collar.

Alternatively or additionally to any of the examples above, in another example, the collar may include a helical cut extending from an outer surface to an inner surface of the collar.

Alternatively or additionally to any of the examples above, in another example, the collar includes a first end region, a second end region, and an intermediate region between the first and second end regions. The intermediate region includes a helical cut. The first end region is fixedly secured to the catheter shaft and the second end region is axially slidable relative to the catheter shaft. Ends of the plurality of struts are fixedly secured to the second end region of the collar.

In another example, a balloon catheter may comprise a catheter shaft, an inflatable balloon secured to a distal portion of the catheter shaft, the inflatable balloon including one or more channels formed in an outer surface thereof and an expandable frame disposed over the balloon and at least in part within the one or more channels. The expandable frame may comprise a proximal section having a proximal collar and a plurality of struts extending distally from the proximal collar, a distal section having a distal collar and a plurality of struts extending proximally from the distal collar, an intermediate section having a plurality of struts extending between the proximal section and the distal section, and at least one cutting member coupled to each strut of the plurality of struts of the intermediate section. The intermediate section may be pivotably coupled to the plurality of struts of the proximal section and pivotably coupled to the plurality of struts of the distal section. At least one of the proximal collar or distal collar may be fixedly secured to the catheter shaft and the other of the proximal collar or distal collar may be axially slidable along the catheter shaft.

Alternatively or additionally to any of the examples above, in another example, each strut of the plurality of struts the intermediate section may comprise two or more links pivotably coupled to one another.

Alternatively or additionally to any of the examples above, in another example, each strut of the plurality of struts of the intermediate section may comprise two or more mounting modules, each mounting module configured to carry a cutting member.

In another example, a balloon catheter may comprise a catheter shaft, an inflatable balloon secured to a distal portion of the catheter shaft, and an expandable frame disposed over the balloon. The expandable frame may comprise a proximal collar, a distal collar, a plurality of struts extending between the proximal collar and the distal collar, the plurality of struts including a proximal end region, a distal end region, and an intermediate region disposed therebetween and at least one cutting member coupled to each strut of the plurality of struts. The intermediate region may be pivotably coupled to the proximal end region and pivotably coupled to the distal end region and at least one of the proximal collar or distal collar may be fixedly secured to the catheter shaft and the other of the proximal collar or distal collar is axially slidable along the catheter shaft.

Alternatively or additionally to any of the examples above, in another example, each strut of the plurality of struts may comprise two or more links pivotably coupled to one another.

Alternatively or additionally to any of the examples above, in another example, each strut of the plurality of struts may comprise a monolithic structure.

Alternatively or additionally to any of the examples above, in another example, each strut of the plurality of struts may comprise two or more mounting modules, each mounting module configured to carry a cutting member.

Alternatively or additionally to any of the examples above, in another example, a distal end of the proximal end region of the struts may comprise at least one hook configured to pivotably couple with at least one aperture formed in the intermediate section.

Alternatively or additionally to any of the examples above, in another example, a proximal end of the distal end region of the struts may comprise at least one aperture configured to pivotably couple with at least one hook formed in the intermediate section.

In another example, a balloon catheter includes a catheter shaft, an inflatable balloon secured to a distal portion of the catheter shaft, and an expandable frame disposed over the balloon. The expandable frame includes a proximal collar positioned at a proximal end of the balloon, a distal collar positioned at a distal end of the balloon, a plurality of struts extending between the proximal collar and the distal collar, and at least one cutting member coupled to each strut of the plurality of struts. The plurality of struts including a proximal end region, a distal end region, and an intermediate region disposed therebetween. The intermediate region is pivotably coupled to the proximal end region and pivotably coupled to the distal end region. A first one of the proximal collar and distal collar includes a portion fixedly secured to the catheter shaft and a second one of the proximal collar and distal collar includes a portion axially slidable relative to the catheter shaft.

Alternatively or additionally to any of the examples above, in another example, each strut of the plurality of struts comprises a monolithic structure.

Alternatively or additionally to any of the examples above, in another example, the second one of the proximal collar and distal collar includes an intermediate region having a helical cut extending through a sidewall thereof, the intermediate region positioned between a first end region and a second end region thereof.

Alternatively or additionally to any of the examples above, in another example, the first end region is fixedly secured to the catheter shaft and the second end region is axially slidably relative to the catheter shaft.

Alternatively or additionally to any of the examples above, in another example, an axial length of the intermediate region changes when the second end region axially slides relative to the catheter shaft.

Alternatively or additionally to any of the examples above, in another example, ends of the plurality of struts are affixed to the second end region. In another example, a balloon catheter may comprise a catheter shaft, an inflatable balloon secured to a distal portion of the catheter shaft, the inflatable balloon including one or more channels formed in an outer surface thereof, and an expandable frame disposed over the balloon and at least in part within the one or more channels. The expandable frame may comprise a proximal section having a proximal collar and a plurality of struts extending distally from the proximal collar and each strut having a coupling mechanism positioned adjacent to a distal end thereof, a distal section having a distal collar and a plurality of struts extending proximally from the distal collar and each strut having a coupling mechanism positioned adjacent to a proximal end thereof, an intermediate section having a plurality of struts extending between the proximal section and the distal section, each strut having a first coupling mechanism positioned adjacent to a first end and configured to engage the coupling mechanism of the proximal section and a second coupling mechanism positioned adjacent to a second end and configured to engage the coupling mechanism of the distal section, and at least one cutting member coupled to each strut of the plurality of struts of the intermediate section.

The aspects of the disclosure may be more completely understood in consideration of the following detailed description of various embodiments in connection with the accompanying drawings, in which:.

While the aspects of the disclosure amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit aspects of the disclosure to the particular embodiments described.

The following description should be read with reference to the drawings, which are not necessarily to scale, wherein like reference numerals indicate like elements throughout the several views. The detailed description and drawings are intended to illustrate but not limit the claimed invention. Those skilled in the art will recognize that the various elements described and/or shown may be arranged in various combinations and configurations without departing from the scope of the disclosure. The detailed description and drawings illustrate example embodiments of the claimed invention. However, in the interest of clarity and ease of understanding, while every feature and/or element may not be shown in each drawing, the feature(s) and/or element(s) may be understood to be present regardless, unless otherwise specified.

Although some suitable dimensions, ranges and/or values pertaining to various components, features and/or specifications are disclosed, one of skill in the art, incited by the present disclosure, would understand desired dimensions, ranges and/or values may deviate from those expressly disclosed.

Still other relative terms, such as "axial", "circumferential", "longitudinal", "lateral", "radial", etc. and/or variants thereof generally refer to direction and/or orientation relative to a central longitudinal axis of the disclosed structure or device.

Heart and vascular disease are major problems in the United States and throughout the world. Conditions such as atherosclerosis result in blood vessels becoming blocked or narrowed. This blockage can result in lack of oxygenation of the heart, which has significant consequences since the heart muscle must be well oxygenated in order to maintain its blood pumping action, or lack of oxygenation and/or circulation to other regions of the body.

Occluded, stenotic, or narrowed blood vessels, as well as native or synthetic arteriovenous dialysis fistulae, may be treated in a recanalization procedure, such as with an angioplasty balloon catheter advanced over a guidewire to an occlusion so that the balloon is positioned across the occlusion. The balloon is then inflated to enlarge the passageway through the occlusion.

One of the major obstacles in treating coronary artery disease and/or treating blocked blood vessels or fistulae is re-stenosis or re-narrowing of the passageway through the occlusion subsequent to an angioplasty procedure or other recanalization procedure. Evidence has shown that cutting or scoring the stenosis, for example, with an angioplasty balloon equipped with a cutting element, during treatment can reduce incidence of re-stenosis. Additionally, cutting or scoring the stenosis may reduce trauma at the treatment site and/or may reduce the trauma to adjacent healthy tissue. Cutting elements may also be beneficial additions to angioplasty procedures when the targeted occlusion is hardened or calcified. It is believed typical angioplasty balloons, alone, may not be able to expand certain of these hardened lesions. Thus, angioplasty balloons equipped with cutting elements having cutting edges have been developed to attempt to enhance angioplasty treatments. Depending on the level of plaque (thickness and length) in peripheral vessels it may be difficult for a physician to expand the internal diameter of the vessel sufficiently to successfully restore blood flow. The compliance of the vessel may need to be improved such that an inflated balloon will cause an expansion in the internal diameter of the vessel that will remain after the balloon is removed.

Accordingly, there is an ongoing need for improved cutting elements, such as cutting blades, and methods of mounting cutting elements onto an inflatable angioplasty balloon of an angioplasty balloon catheter which creates long, continuous disruptions in the plaque that creates a plane for the lesion to crack when the balloon is inflated. Namely, it would be desirable to provide a cutting member for use with an angioplasty balloon that will create a long cutting plane when the balloon is inflated.

<FIG> is a partial cross-sectional side view of an illustrative catheter <NUM> disposed in a blood vessel <NUM> and positioned adjacent to an intravascular lesion <NUM>. The catheter <NUM> may include a balloon <NUM> coupled to a catheter shaft <NUM>. One or more cutting members or blades 20a, 20b, 20c (collectively, <NUM>) may be mounted on the balloon <NUM>. In some cases, the one or more cutting members <NUM> may be mounted on an expandable frame or basket <NUM> which, in turn, may be coupled to the balloon <NUM> and/or catheter shaft <NUM>. In general, the catheter <NUM> may be advanced over a guidewire <NUM>, through the vasculature, to a target area. Once positioned at the target location in the vasculature, the balloon <NUM> can be inflated to exert a radially outward force on the lesion <NUM>, as the cutting members <NUM> engage the lesion <NUM>. Thus, the cutting members <NUM> may cut or score the lesion <NUM> to facilitate enlarging the lumen proximate the lesion <NUM>. The target area may be within any suitable peripheral or cardiac vessel lumen location.

The balloon <NUM> may have a length in the range of about <NUM> to <NUM> millimeters (mm), about <NUM> to <NUM>, or about <NUM>. In some instances, the balloon <NUM> may have an outer diameter in the range of about <NUM> to <NUM>, about <NUM> to <NUM> or about <NUM>.

The cutting members <NUM> may vary in number, position, and arrangement about the balloon <NUM>. For example, the catheter <NUM> may include one, two, three, four, five, six, or more cutting members <NUM> that are disposed at any position along the balloon <NUM> and in a regular, irregular, or any other suitable pattern. For example, in some embodiments the balloon <NUM> may include a plurality of cutting members <NUM> longitudinally arranged symmetrically around the circumference of the balloon <NUM>.

The cutting members <NUM> may be made from any suitable material such as a metal, metal alloy, polymer, metal-polymer composite, and the like, or any other suitable material. For example, cutting members <NUM> may be made from stainless steel, titanium, nickel-titanium alloys, tantalum, iron-cobalt-nickel alloys, or other metallic materials in some instances.

The balloon <NUM> may be made from typical angioplasty balloon materials including polymers such as polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), polybutylene terephthalate (PBT), polyurethane, polyvinylchloride (PVC), polyether-ester, polyester, polyamide, elastomeric polyamides, polyether block amide (PEBA), as well as other suitable materials, or mixtures, combinations, copolymers thereof, polymer/metal composites, and the like. In some instances, the balloon <NUM> may include a single layer of material, whereas in other instances the balloon <NUM> may be of a multi-layer construction, including a plurality of layers of materials. For instance, the balloon <NUM> may be formed as a co-extrusion or tri-layer extrusion in some instances.

The balloon <NUM> may be configured so that the balloon <NUM> includes one or more "wings" or wing-shaped regions when the balloon <NUM> is deflated. In some instances, the wings may be configured so that the cutting members <NUM> can be positioned at the inwardmost positions of the deflated balloon <NUM>, with the wings of the balloon folds positioned between adjacent cutting members <NUM>. This arrangement may reduce the exposure of the cutting members <NUM> to the blood vessel during delivery of the balloon <NUM> to the lesion <NUM>.

The shaft <NUM> may be a catheter shaft, similar to typical catheter shafts. For example, the catheter shaft <NUM> may include an outer tubular member <NUM> and an inner tubular member <NUM> extending through at least a portion of the outer tubular member <NUM>. The tubular members <NUM>, <NUM> may be manufactured from a number of different materials. For example, the tubular members <NUM>, <NUM> may be made of metals, metal alloys, polymers, metal-polymer composites or any other suitable materials.

The tubular members <NUM>, <NUM> may be arranged in any appropriate way. For example, in some embodiments the inner tubular member <NUM> can be disposed coaxially within the outer tubular member <NUM>. According to these embodiments, the inner and outer tubular members <NUM>, <NUM> may or may not be secured to one another along the general longitudinal axis of the catheter shaft <NUM>. Alternatively, the inner tubular member <NUM> may follow the inner wall or otherwise be disposed adjacent the inner wall of the outer tubular member <NUM>. In other embodiments, the tubular members <NUM>, <NUM> may be arranged in another desired fashion.

The inner tubular member <NUM> may include an inner lumen <NUM>. In at least some embodiments, the inner lumen <NUM> is a guidewire lumen for receiving the guidewire <NUM> therethrough. Accordingly, the catheter <NUM> can be advanced over the guidewire <NUM> to the desired location. The guidewire lumen <NUM> may extend along essentially the entire length of the catheter shaft <NUM> such that catheter <NUM> resembles traditional "over-the-wire" catheters. Alternatively, the guidewire lumen <NUM> may extend along only a portion of the catheter shaft <NUM> such that the catheter <NUM> resembles "single-operator-exchange" or "rapid-exchange" catheters.

The catheter shaft <NUM> may also include an inflation lumen <NUM> that may be used, for example, to transport inflation media to and from the balloon <NUM> to selectively inflate and/or deflate the balloon <NUM>. The location and position of the inflation lumen <NUM> may vary, depending on the configuration of the tubular members <NUM>, <NUM>. For example, when the outer tubular member <NUM> surrounds the inner tubular member <NUM>, the inflation lumen <NUM> may be defined within the space between the tubular members <NUM>, <NUM>. In embodiments in which the outer tubular member <NUM> is disposed alongside the inner tubular member <NUM>, then the inflation lumen <NUM> may be the lumen of the outer tubular member <NUM>.

The balloon <NUM> may be coupled to the catheter shaft <NUM> in any of a number of suitable ways. For example, the balloon <NUM> may be adhesively or thermally bonded to the catheter shaft <NUM>. In some embodiments, a proximal waist <NUM> of the balloon <NUM> may be bonded to the catheter shaft <NUM>, for example, bonded to the distal end of the outer tubular member <NUM>, and a distal waist <NUM> of the balloon <NUM> may be bonded to the catheter shaft <NUM>, for example, bonded to the distal end of the inner tubular member <NUM>. The exact bonding positions, however, may vary.

<FIG> illustrates a perspective view of the illustrative catheter <NUM>. The one or more cutting members <NUM> may be mounted relative to the balloon <NUM> using an expandable frame <NUM>. Referring additionally to <FIG> which illustrates a perspective view of the illustrative expandable frame <NUM>, the expandable frame <NUM> may include a plurality of struts 37a, 37b, 37c (collectively, <NUM>) extending axially along a longitudinal axis of the catheter <NUM> from a proximal end region <NUM> to a distal end region <NUM>. While the expandable frame <NUM> is illustrated as having three struts <NUM>, it is contemplated that the frame <NUM> may include any number of struts <NUM> desired, such as, but not limited to, one, two, three, four, or more. In some embodiments, the struts <NUM> may be configured to be uniformly positioned about a circumference of the balloon <NUM>. For example, the struts <NUM> may be configured to have an (or approximately) even or equal spacing between adjacent struts <NUM>. Alternatively, the struts <NUM> may be eccentrically positioned about the circumference of the balloon <NUM>. For example, the struts <NUM> may have unequal spacing between adjacent struts <NUM>.

The expandable frame <NUM> may have a proximal section <NUM>, a distal section <NUM>, and an intermediate region <NUM>. The proximal section <NUM> may be laser cut from a straight hypotube to form a proximal collar <NUM> with a plurality of tines or arms 46a, 46b, 46c (not shown in <FIG>) (collectively, <NUM>) extending distally therefrom. Similarly, the distal section <NUM> may be also be a laser cut from a straight hypotube to form a distal collar <NUM> with a plurality of tines or arms 50a, 50b, 50c (not shown in <FIG>) (collectively, <NUM>) extending proximally therefrom. In other instances, the proximal section <NUM> and/or the distal section <NUM> may be cut from a flat sheet and rolled into the desired shape. The proximal section <NUM> and/or the distal section <NUM> may be formed from spring steel or nitinol and heat set or stress relieved in a collapsed configuration (not explicitly shown). However, other materials may be used, as desired. The proximal section <NUM> and the distal section <NUM> of the expandable frame <NUM> may be moved from the collapsed configuration into the expanded configuration shown in <FIG> through expansion of the balloon <NUM>.

The intermediate section <NUM> may include a plurality of struts 54a, 54b, 54c (not shown in <FIG>) (collectively, <NUM>) configured to extend between the proximal section <NUM> and the distal section <NUM>. The proximal section <NUM> may be coupled, such as pivotably coupled, to the intermediate section <NUM>. Furthermore, the distal section <NUM> may be coupled, such as pivotably coupled, to the intermediate section <NUM>. In some instances, the proximal section <NUM> may include one or more hooks <NUM> configured to be releasably coupled within one or more mating apertures <NUM> of the intermediate section <NUM>. The reverse configuration is also contemplated in which the proximal section <NUM> includes one or more apertures configured to receive one or more mating hooks on the intermediate section <NUM>. In some embodiments, the distal section <NUM> may include one or more apertures <NUM> configured to be releasably coupled with one or more hooks <NUM> of the intermediate section <NUM>. The reverse configuration is also contemplated in which the distal section <NUM> includes one or more hooks configured to be received within one or more mating apertures on the intermediate section <NUM>. The hooks <NUM>, <NUM> and/or the apertures <NUM>, <NUM> may allow the links <NUM> to pivotably couple with the proximal section <NUM> and/or the distal section <NUM> which may allow the expandable frame <NUM> to move between a collapsed generally linear configuration and expanded configuration generally conforming to an outer shape of the balloon <NUM>. For example, the pivotable linkage between the proximal section <NUM> and the intermediate section <NUM> as well as the pivotable linkage between the distal section <NUM> and the intermediate section <NUM> may allow the intermediate section <NUM> to extend generally parallel to a longitudinal axis of the balloon <NUM> while the proximal and distal section <NUM>, <NUM> extend at a nonparallel angle to the longitudinal axis of the balloon <NUM>.

Each strut <NUM> may include a plurality of links 52a, 52b, 52c (collectively, <NUM>) with each link <NUM> carrying a cutting member <NUM>. In some cases, the links <NUM> may be releasably pivotably coupled to one another, the proximal section <NUM> and/or the distal section <NUM>. In other embodiments, the struts <NUM> may form a single link. Alternatively, or additionally, the intermediate section <NUM> may include a combination of struts <NUM> having either a single link or a plurality of links.

The expandable frame <NUM> may be secured to the balloon <NUM> and/or catheter shaft <NUM> at one end thereof. For example, the expandable frame <NUM> may be fixedly secured to the outer tubular member <NUM> at or adjacent to the proximal collar <NUM> while the distal collar <NUM> may be axially slidable about the inner tubular member <NUM> along a longitudinal axis of the catheter <NUM>. This may allow the expandable frame <NUM> to lengthen (along the longitudinal axis of the catheter <NUM>) when in the collapsed configuration and shorten when in the expanded configuration. The reverse configuration is also contemplated in which the distal collar <NUM> is fixedly secured to the inner tubular member <NUM> while the proximal collar <NUM> is free to slide axially along the outer tubular member <NUM>. In some cases, both the proximal collar <NUM> and the distal collar <NUM> may be fixedly secured to the catheter <NUM>. In other cases, both the proximal collar <NUM> and the distal collar <NUM> may be free to slide relative to the catheter <NUM>. It is further contemplated that the expandable frame <NUM> may be coupled (additionally or alternatively to the proximal and/or distal collars <NUM>, <NUM>) at locations other than the proximal or distal collars <NUM>, <NUM>, as desired.

In some embodiments a ramp or bumper <NUM> may be provided at a location adjacent to the distal collar <NUM>. The bumper <NUM> may be structured to prevent the distal collar <NUM> from catching on a vessel wall (which may result in accidental expansion of the expandable frame <NUM>) while navigating the catheter <NUM> to the desired treatment location. It is contemplated that the distal collar <NUM> may butt up against a proximal end of the bumper <NUM>. In other embodiments, the bumper <NUM> may include a recess configured to receive the distal collar <NUM> therein.

The intermediate section <NUM> of the expandable frame <NUM> may be configured to be positioned within recesses or channels <NUM> formed in an outer surface of the balloon <NUM>. <FIG> illustrates a perspective view of the illustrative catheter <NUM> with the expandable frame <NUM> removed. The channels <NUM> are configured to remain when the balloon <NUM> is expanded. The channels <NUM> may be substantially parallel to a longitudinal axis of the balloon <NUM>, or the channels may be arranged in other configurations. For example, the channels <NUM> may be sized and shaped to accommodate at least the intermediate section <NUM> of the expandable frame <NUM>. If the intermediate section <NUM> of the expandable frame <NUM> has a helical or spiral shape, it is contemplated that the channels <NUM> may also have a helical or spiral shape such that the intermediate section <NUM> may rest within the channel <NUM>. In some examples, the channels <NUM> may have a tapered, or dovetail, configuration in which a base of the channel <NUM> is wider than a top opening into the channel <NUM> measured between opposite side surfaces of the channel <NUM>. This may allow the frame <NUM> to be slid longitudinally into the channels <NUM> while limiting radial movement of the frame <NUM>, such as preventing the frame <NUM> from being radially removed from the channel <NUM> in a radial direction. Thus, the radially outwardly facing opening into the channel <NUM> through which the cutting member <NUM> extends through may have a width less than the width of the frame <NUM>.

During assembly, the expandable frame <NUM> may be positioned about the balloon <NUM> such that the intermediate section <NUM> (e.g., struts <NUM>) of the expandable frame <NUM> aligns with the channels <NUM>. Securement of the proximal collar <NUM> and/or the distal collar <NUM> may prevent or limit rotational movement of the expandable frame <NUM> relative to the balloon <NUM>. It is contemplated that once deflated or unexpanded, if the intermediate section <NUM> of the expandable frame <NUM> becomes unaligned with the channels <NUM> as the balloon <NUM> is expanded, the struts <NUM> may automatically fall into the grooves <NUM>.

In some embodiments, the expandable frame <NUM> may help control bulges within the balloon <NUM> as the balloon <NUM> is expanded. For example, it is contemplated that the bulges may first occur at or adjacent to the channels <NUM>. Bulges occurring at or adjacent to the channels <NUM> may provide an additional radially outward extending force on the cutting elements <NUM> to further score an adjacent lesion. It is contemplated that while bulges may first occur at the channels <NUM> some bulges may then move towards the region between adjacent struts <NUM> and/or to proximal or distal cones <NUM>, <NUM>. The configuration of the expandable frame <NUM> may be selected to control how and where bulges may occur.

In the embodiments illustrated, the balloon <NUM> may have three channels <NUM> extending axially along the balloon <NUM>. Any number of channels <NUM> may be included in the balloon <NUM>. For example, the balloon <NUM> may include the same number of channels <NUM> as the frame <NUM> has struts <NUM>, although this is not required. In some instances, the balloon <NUM> may include more channels <NUM> than struts <NUM> with some channels <NUM> not occupied by struts <NUM>, or the balloon <NUM> may include fewer channels <NUM> than struts <NUM> with some struts <NUM> not positioned in channels <NUM>. The channels <NUM> may be spaced apart in a manner that coincides to or matches the spacing of the struts <NUM> of the expandable frame <NUM> such that the struts <NUM> may be at least partially positioned within the channels <NUM>.

The balloon <NUM> may include a central body portion <NUM>, the proximal cone <NUM>, and the distal cone <NUM>. The channels <NUM> may extend from a distal portion of the proximal cone <NUM>, through the body portion <NUM> to a proximal portion of the distal cone <NUM>. The channel <NUM> may be sized and shaped to allow the intermediate section <NUM> of the frame <NUM> to lie flat on an outer surface of the balloon <NUM> when the balloon <NUM> is in the expanded configuration. In some embodiments, the intermediate section <NUM> may extend proximally or distally beyond the body portion <NUM>. This may allow the proximal section <NUM> and/or the distal section <NUM> of the expandable frame <NUM> to be movably (e.g., pivotably) coupled with the intermediate section <NUM> without placing a bending stress on any of the proximal section <NUM>, distal section <NUM> and/or intermediate section <NUM>. It is contemplated that the length of the channels <NUM> may vary depending on the structure of the frame <NUM>. For example, the channels <NUM> need not extend an entire length of the body portion <NUM> or into the proximal and/or distal cones <NUM>, <NUM>.

<FIG> illustrates a cross-sectional view of the illustrative catheter <NUM> taken at line <NUM>-<NUM> of <FIG>. The balloon <NUM> may include three channels 56a, 56b, 56c (collectively, <NUM>) each configured to receive a portion 42a, 42b, 42c of the expandable frame <NUM>. The channels <NUM> may be sized such that the cutting members 20a, 20b, 20c extend radially beyond the outer diameter (in a region free of channels <NUM>) of the body portion <NUM> of the balloon <NUM>. For example, the depth D of the channels <NUM> may be selected such that the sharpened tip or edge of the cutting members <NUM> extend radially outward beyond a maximum outer diameter of the balloon <NUM>. This may allow the cutting members <NUM> to penetrate a lesion when the balloon <NUM> is inflated adjacent to the lesion.

In some embodiments, the channels <NUM> may be molded into the balloon <NUM> such that the balloon <NUM> has a uniform wall thickness in both the channels <NUM> and the regions free from the channels <NUM>. However, it is contemplated that the channels <NUM> may be formed using other methods, such as removal of material in the wall of the balloon <NUM> to form the channels <NUM>, as desired.

<FIG> is a perspective view of an illustrative cartridge or link <NUM> forming a portion of the intermediate section <NUM> of the expandable frame <NUM>. The link <NUM> may include a first or proximal end region <NUM>, a second or distal end region <NUM>, and an intermediate region <NUM>. In some embodiments, the links <NUM> may be cut and bent from a flat sheet of metal. The proximal end region <NUM> of the link <NUM> may include an aperture <NUM> configured to receive a loop or hook on adjacent structure. In some cases, the adjacent structure may be the proximal section <NUM> of the expandable frame <NUM>, the distal section <NUM> of the expandable frame <NUM>, and/or an adjacent link <NUM>. The distal end region <NUM> of the link <NUM> may include a loop or hook <NUM> configured to engage an aperture on an adjacent structure. In some cases, the adjacent structure may be the proximal section <NUM> of the expandable frame <NUM>, the distal section <NUM> of the expandable frame <NUM>, and/or an adjacent link <NUM>. For example, the link <NUM> may be configured to engage an adjacent link to form a chain of links <NUM> having a plurality of pivotable hinge points between adjacent links <NUM>, as shown in the intermediate section <NUM> of the expandable frame <NUM> in <FIG> and <FIG>. It is further contemplated that other coupling mechanisms besides hooks and apertures may be used to releasably couple and/or pivotably couple adjacent links and/or the intermediate section <NUM> to the proximal and/or distal section <NUM>, <NUM>.

Referring additionally to <FIG>, which illustrates a cross-sectional view of the illustrative link of <FIG> taken at line 6A-6A, the intermediate region <NUM> of the link <NUM> may include a pair of U-shaped arms 74a, 74b (collectively, <NUM>). The U-shaped arms <NUM> in combination with the bottom wall <NUM> of the link <NUM> may define an axially extending channel <NUM> extending generally parallel to a longitudinal axis of the link <NUM>. The channel <NUM> may be configured to slidably receive a cutting member <NUM> therein. A gap or opening <NUM> may be defined between a top portion 80a, 80b (collectively, <NUM>) of the respective arms <NUM>. The opening <NUM> may allow the cutting member <NUM> to extend beyond the top portion <NUM> of the arms <NUM> in a direction generally perpendicular to the longitudinal axis of the link <NUM>. As described herein, when the cutting member <NUM> is mounted relative to the balloon <NUM>, the cutting member <NUM> may be configured to extend radially outward beyond the greatest extent of the outer diameter of the balloon <NUM>.

In some instances, the cutting member <NUM> may be secured within the channel <NUM> using a number of different techniques including, for example, adhesives, soldering, brazing, welding, etc. In other instances, the arms <NUM> may be squeezed or crimped onto the cutting member <NUM> to create a mechanical interlock or friction fit between the arms <NUM> and the cutting member <NUM>. It is further contemplated that the arms <NUM> may include a downward extending tab or lip configured to engage a groove within a mounting pad <NUM> of the cutting member <NUM>, for example. As shown in <FIG>, a surface of the arms <NUM> may press against or contact a surface of the cutting member <NUM> to retain the cutting member <NUM> in the channel <NUM>.

As described herein, any number of links <NUM> may be coupled together to provide a cutting member system that will create a long cutting plane. To couple the links <NUM>, a hook <NUM> of a first link <NUM> may be looped through an aperture <NUM> of a second or adjacent link <NUM>. Once the hook <NUM> is engaged with the aperture <NUM>, the hook <NUM> may be mechanically deformed to secure the first link <NUM> relative to the second link <NUM>. In some embodiments, it is contemplated that the hook <NUM> may have a generally straight configuration, or slightly curved configuration, prior to assembly with another link <NUM>, proximal section <NUM> of the frame <NUM>, and/or distal section <NUM> of the frame <NUM>. In such an instance, the hook <NUM> may be mechanically deformed into the looped configuration illustrated in <FIG> after assembly with a corresponding aperture <NUM>, <NUM>.

It is contemplated that as any number of links <NUM> may be coupled together, the expandable frame <NUM> may be customizable for a variety of lengths of balloons <NUM>. It is further contemplated that as the cutting elements <NUM> are not secured directly to the cutting balloon <NUM>, bulges or other deformations in the balloon <NUM>, as the balloon <NUM> is being expanded, may not impact the securement and/or positioning of the cutting elements <NUM>. For example, as the expandable frame <NUM> is coupled to the balloon <NUM> at one end of the frame <NUM> (e.g., proximal collar <NUM> or distal collar <NUM>), the opposing end and/or the intermediate struts <NUM> may be free to shift axially about the longitudinal axis and/or circumferentially about the balloon <NUM> as necessary.

In some embodiments it may be desirable for the cutting element <NUM> to extend radially beyond an outer diameter of the balloon <NUM> to a similar extent or degree as if it were mounted directly to the outer surface of the balloon <NUM> (for example, without the link <NUM>). In some embodiments, the channel <NUM> may have a depth D (see, for example, <FIG>) that is approximately equal to a thickness of the bottom wall <NUM> of the link <NUM>. For example, the channel may have a depth that is in the range of <NUM> to about <NUM> inches (about <NUM> to <NUM>) or about <NUM> inches (<NUM>).

<FIG> is a perspective view of another illustrative expandable frame <NUM> for mounting one or more cutting members relative to an expandable balloon. The expandable frame <NUM> may include a plurality of struts 108a, 108b, 108c (collectively, <NUM>) extending axially along a longitudinal axis of the frame <NUM> from a proximal end region <NUM> to a distal end region <NUM>. While the expandable frame <NUM> is illustrated as having three struts <NUM>, it is contemplated that the frame <NUM> may include any number of struts <NUM> desired, such as, but not limited to, one, two, three, four, or more. In some embodiments the struts <NUM> may be configured to be uniformly positioned about a circumference of a balloon. For example, the struts <NUM> may be configured to have an (or approximately) even or equal spacing between adjacent struts <NUM>. Alternatively, the struts <NUM> may be eccentrically positioned about the circumference of the balloon. For example, the struts <NUM> may have unequal spacing between adjacent struts <NUM>.

The expandable frame <NUM> may have a proximal section <NUM>, a distal section <NUM>, and an intermediate region <NUM>. The proximal section <NUM> may be laser cut from a straight hypotube to form a proximal collar <NUM> with a plurality of tines or arms 118a, 118b, 118c (collectively, <NUM>) extending distally therefrom. Similarly, the distal section <NUM> may be also be a laser cut from a straight hypotube to form a distal collar <NUM> with a plurality of tines or arms 122a, 122b, 122c (collectively, <NUM>) extending proximally therefrom. In other instances, the proximal section <NUM> and/or the distal section <NUM> may be cut from a flat sheet and rolled into the desired shape. The proximal section <NUM> and/or the distal section <NUM> may be formed from spring steel or nitinol and heat set or stress relieved in a collapsed configuration (not explicitly shown). However, other materials may be used, as desired. The proximal section <NUM> and the distal section <NUM> of the expandable frame <NUM> may be moved from the collapsed configuration into the expanded configuration shown in <FIG> through expansion of the balloon <NUM>.

The intermediate section <NUM> may include a plurality of struts 124a, 124b, 124c (collectively, <NUM>) configured to extend between the proximal section <NUM> and the distal section <NUM>. In some instances, the proximal section <NUM> may include a hook or loop 126a, 126b, 126c (collectively, <NUM>) adjacent to a distal end of the tines <NUM>. The hooks <NUM> may be configured to be releasably and pivotably coupled within one or more mating apertures 128a, 128b, 128c (collectively, <NUM>) formed in a proximal end region of the struts <NUM> of the intermediate section <NUM>. The reverse configuration is also contemplated in which the proximal section <NUM> includes one or more apertures configured to receive one or more mating hooks on the intermediate section <NUM>. In some embodiments, the distal section <NUM> may include an aperture 130a, 130b, 130c (collectively, <NUM>) adjacent to a proximal end of the tines <NUM>. The apertures <NUM> may be configured to be releasably and pivotably coupled with one or more hooks or loops 132a, 132b, 132c (collectively, <NUM>) formed in a distal end region of the struts <NUM> of the intermediate section <NUM>. The reverse configuration is also contemplated in which the distal section <NUM> includes one or more hooks configured to be received within one or more mating apertures on the intermediate section <NUM>. The hooks <NUM>, <NUM> and/or the apertures <NUM>, <NUM> may be similar in form and function to those described with respect to <FIG> and <FIG>. The hooks <NUM>, <NUM> and/or the apertures <NUM>, <NUM> may allow the intermediate section <NUM> to pivotably couple with the proximal section <NUM> and/or the distal section <NUM> which may allow the expandable frame <NUM> to move between a collapsed generally linear configuration and expanded configuration generally conforming to an outer shape of the balloon. For example, the pivotable linkage between the proximal section <NUM> and the intermediate section <NUM> as well as the pivotable linkage between the distal section <NUM> and the intermediate section <NUM> may allow the intermediate section <NUM> to extend generally parallel to a longitudinal axis of the balloon while the proximal and distal section <NUM>, <NUM> extend at a nonparallel angle to the longitudinal axis of the balloon.

Each strut <NUM> may include a plurality of mounting modules 134a, 134b, 134c, 134d (collectively, <NUM>) configured to secure a cutting element or member 138a, 138b, 138c, 138d (collectively, <NUM>) to the expandable frame <NUM>. <FIG> illustrates a perspective view of an illustrative strut <NUM> of the intermediate section <NUM>. A base member <NUM> may extend from a proximal end <NUM> to a distal end <NUM> of the strut <NUM>. The aperture <NUM> for receiving a hook <NUM> of the proximal section <NUM> of the expandable basket <NUM> may be formed in the proximal end region <NUM> of the strut <NUM>. The hook <NUM> for coupling to an aperture of the distal section <NUM> of the expandable basket <NUM> may be formed in the distal end region <NUM> of the strut <NUM>. In some embodiments the configuration may be reversed in which the aperture <NUM> is formed in the distal end region <NUM> of the strut <NUM> and the hook <NUM> is formed in the proximal end region <NUM> of the strut <NUM>.

It is contemplated that the mounting modules <NUM> may be formed as a unitary or monolithic structure with the base member <NUM>. For example, the strut <NUM> may be stamped or cut from a flat sheet of metal and bent to form the illustrated structure. In other embodiments, the mounting modules <NUM> may be formed as separate components that are secured to the base member <NUM>. Each of the mounting modules <NUM> may include a pair of U-shaped arms 136a, 136b (collectively, <NUM>). The U-shaped arms <NUM> in combination with the base member of the strut <NUM> may define an axially extending channel 146a, 146b, 146c, 146d (collectively, <NUM>) extending generally parallel to a longitudinal axis of the strut <NUM>. Each channel <NUM> may be configured to slidably receive a respective cutting member <NUM> therein along the longitudinal axis. A gap or opening 148a, 148b, 148c, 148d (collectively, <NUM>) may be defined between a top portion 150a, 150b (collectively, <NUM>) of the respective arms <NUM>. The opening <NUM> may allow the cutting member <NUM> to extend beyond the top portion <NUM> of the arms <NUM> in a direction generally perpendicular to the longitudinal axis of the strut <NUM>. As described herein, when the cutting member <NUM> is mounted relative to the balloon, a sharpened tip or edge of the cutting member <NUM> may be configured to extend radially outward beyond the largest extent of the outer diameter of the balloon.

In some instances, the cutting member <NUM> be secured within the channel <NUM> using a number of different techniques including, for example, adhesives, soldering, brazing, welding, etc. In other instances, the arms <NUM> may be squeezed or crimped onto the cutting member <NUM> to create a mechanical interlock or friction fit between the arms <NUM> and the cutting member <NUM>. It is further contemplated that the arms <NUM> may include a downward extending tab or lip configured to engage a groove within a mounting pad 152a, 152b, 152c, 152d (collectively, <NUM>) of the cutting member <NUM>.

The expandable frame <NUM> may be secured to a balloon and/or a catheter shaft at one end thereof. For example, the expandable frame <NUM> may be secured to the catheter shaft at or adjacent to the proximal collar <NUM> while the distal collar <NUM> may be axially slidable about the catheter shaft along a longitudinal axis of the catheter. This may allow the expandable frame <NUM> to lengthen (along the longitudinal axis of the catheter) when in the collapsed configuration and shorten when in the expanded configuration. The reverse configuration is also contemplated in which the distal collar <NUM> is coupled to the catheter shaft while the proximal collar <NUM> is free to slide axially along the catheter shaft. In some cases, both the proximal collar <NUM> and the distal collar <NUM> may be coupled to the catheter. It is further contemplated that the expandable frame <NUM> may be coupled (additionally or alternatively to the proximal and/or distal collars <NUM>, <NUM>) at locations other than the proximal or distal collars <NUM>, <NUM>, as desired.

The strut <NUM> may include any number of mounting modules <NUM> to provide a cutting member system that will create a long cutting plane. For example, the strut <NUM> may include one, two, three, four or more mounting modules <NUM> to provide any length of cutting plane desired. It is further contemplated that as the cutting elements <NUM> are not secured directly to the balloon, bulges or other deformations in the balloon, as the balloon is being expanded, may not impact the securement and/or positioning of the cutting elements <NUM>. For example, as the expandable frame <NUM> is coupled to the balloon at one end of the frame <NUM> (e.g., proximal collar <NUM> or distal collar <NUM>), the opposing end and/or the intermediate struts <NUM> may be free to shift axially about the longitudinal axis and/or circumferentially about the balloon as necessary.

The intermediate section <NUM> of the expandable frame <NUM> may be configured to be positioned within recesses or channels formed in the balloon in a similar manner to that described herein. In some embodiments it may be desirable for the cutting element <NUM> to extend radially beyond an outer diameter of the balloon to a similar extent or degree as if it were mounted directly to the outer surface of the balloon <NUM> (for example, without the strut <NUM>).

<FIG> is a perspective view of another illustrative catheter <NUM>. The catheter <NUM> may include a balloon <NUM> coupled to a catheter shaft <NUM>. One or more cutting members or blades 206a-j (collectively, <NUM>) may be mounted on the balloon <NUM>. In some cases, the one or more cutting members <NUM> may be mounted on an expandable frame or basket <NUM> which, in turn, may be coupled to the balloon <NUM> and/or catheter shaft <NUM>. In general, the catheter <NUM> may be advanced over a guidewire (not explicitly shown), through the vasculature, to a target area. Once positioned at the target location in the vasculature, the balloon <NUM> can be inflated to exert a radially outward force on a lesion, as the cutting members <NUM> engage the lesion. Thus, the cutting members <NUM> may cut or score the lesion to facilitate enlarging the lumen proximate the lesion. The target area may be within any suitable peripheral or cardiac vessel lumen location.

The catheter <NUM> and/or balloon <NUM> may be sized for use in critical limb ischemia with very small vessels (e.g., having a diameter in the range of about <NUM>-<NUM>). The balloon <NUM> may have a length in the range of about <NUM> to <NUM>, about <NUM> to <NUM>, or about <NUM>, for example. In some instances, the inflated balloon <NUM> may have an outer diameter in the range of about <NUM> to <NUM>, about <NUM> to <NUM> or about <NUM>, for example.

The balloon <NUM> may be configured so that the balloon <NUM> includes one or more "wings" or wing-shaped regions when the balloon <NUM> is deflated. In some instances, the wings may be configured so that the cutting members <NUM> can be positioned at the inwardmost positions of the deflated balloon <NUM>, with the wings of the balloon folds positioned between adjacent cutting members <NUM>. This arrangement may reduce the exposure of the cutting members <NUM> to the blood vessel during delivery of the balloon <NUM> to the lesion.

The inner tubular member <NUM> may include an inner lumen (not explicitly shown). In at least some embodiments, the inner lumen is a guidewire lumen for receiving a guidewire therethrough. Accordingly, the catheter <NUM> can be advanced over the guidewire to the desired location. The guidewire lumen may extend along essentially the entire length of the catheter shaft <NUM> such that catheter <NUM> resembles traditional "over-the-wire" catheters. Alternatively, the guidewire lumen may extend along only a portion of the catheter shaft <NUM> such that the catheter <NUM> resembles "single-operator-exchange" or "rapid-exchange" catheters.

The catheter shaft <NUM> may also include an inflation lumen (not explicitly shown) that may be used, for example, to transport inflation media to and from the balloon <NUM> to selectively inflate and/or deflate the balloon <NUM>. The location and position of the inflation lumen may vary, depending on the configuration of the tubular members <NUM>, <NUM>. For example, when the outer tubular member <NUM> surrounds the inner tubular member <NUM>, the inflation lumen may be defined within the space between the tubular members <NUM>, <NUM>. In embodiments in which the outer tubular member <NUM> is disposed alongside the inner tubular member <NUM>, then the inflation lumen may be the lumen of the outer tubular member <NUM>.

The one or more cutting members <NUM> may be mounted relative to the balloon <NUM> using an expandable frame <NUM>. While not explicitly shown, the balloon <NUM> may include channels similar in form and function to the channels <NUM> described herein. Referring additionally to <FIG> which illustrates a perspective view of the illustrative expandable frame <NUM>, the expandable frame <NUM> may include a plurality of struts 218a, 218b, 218c (collectively, <NUM>) extending axially along a longitudinal axis of the catheter <NUM> from a proximal end region <NUM> to a distal end region <NUM>. While the expandable frame <NUM> is illustrated as having three struts <NUM>, it is contemplated that the frame <NUM> may include any number of struts <NUM> desired, such as, but not limited to, one, two, three, four, or more. In some embodiments, the struts <NUM> may be configured to be uniformly positioned about a circumference of the balloon <NUM>. For example, the struts <NUM> may be configured to have an (or approximately) even or equal spacing between adjacent struts <NUM>. Alternatively, the struts <NUM> may be eccentrically positioned about the circumference of the balloon <NUM>. For example, the struts <NUM> may have unequal spacing between adjacent struts <NUM>.

The expandable frame <NUM> may have a proximal section <NUM>, a distal section <NUM>, and an intermediate region <NUM>. The expandable frame <NUM> may be laser cut from a straight metallic tube (e.g., a hypotube) to form a proximal collar <NUM>, a distal collar <NUM>, and the plurality of struts <NUM> therebetween. In other instances, the proximal section <NUM>, the distal section <NUM>, and/or intermediate section <NUM> may be cut from a flat sheet and rolled into the desired shape. In yet other embodiments, the proximal collar <NUM>, distal collar <NUM> and/or struts <NUM> may be individually formed from a variety of methods and subsequently coupled together. The proximal section <NUM> and/or the distal section <NUM> may be formed from spring steel or nitinol and heat set or stress relieved in a collapsed configuration (not explicitly shown). However, other materials may be used, as desired. The proximal section <NUM> and the distal section <NUM> of the expandable frame <NUM> may be moved from the collapsed configuration into the expanded configuration shown in <FIG> through inflation and thus radial expansion of the balloon <NUM>.

Each strut <NUM> of the expandable frame <NUM> may include a proximal end region 232a, 232b, 232c (collectively, <NUM>), a distal end region 234a, 234b, 234c (collectively, <NUM>), and an intermediate region 236a, 236b, 236c (collectively, <NUM>) disposed therebetween. As described herein, the struts <NUM> may be individually cut from a flat sheet or cut from a straight metallic tube (e.g., a hypotube), as desired. In some embodiments, the struts <NUM> may be formed as a monolithic structure. The proximal end regions <NUM> and/or the distal end regions <NUM> may be formed from spring steel or nitinol and heat set or stress relieved in a collapsed configuration (not explicitly shown). However, other materials may be used, as desired.

In some cases, the proximal end regions <NUM> and/or the distal end regions <NUM> may be pivotably coupled with the intermediate regions <NUM>. For example, the proximal end regions <NUM> and/or the distal end regions <NUM> may bend, flex, and/or pivot relative to the intermediate regions <NUM> such that the expandable frame <NUM> may move between a collapsed generally linear configuration and an expanded configuration generally conforming to an outer shape of the balloon <NUM>. For example, the pivotable linkage between the proximal end regions <NUM> and the intermediate regions <NUM> as well as the pivotable linkage between the distal end regions <NUM> and the intermediate section <NUM> may allow the intermediate section <NUM> to extend generally parallel to a longitudinal axis of the balloon <NUM> while the proximal and distal end regions <NUM>, <NUM> extend at a nonparallel angle to the longitudinal axis of the balloon <NUM> for at least a portion of their respective lengths.

Each strut <NUM> may include a plurality of links or mounting modules 238a-j (collectively <NUM>) with each mounting module carrying a cutting member <NUM>. While each strut <NUM> is illustrated as including ten mounting modules <NUM>, it is contemplated that the struts <NUM> may include fewer than ten or more than ten mounting modules <NUM> to form a cutting member system having the desired cutting length. In some cases, the mounting modules <NUM> may be pivotably coupled to one another, the proximal end region <NUM>, and/or the distal end region <NUM>. For instance, the mounting modules <NUM> may be separate structures linked or coupled together, or the mounting modules <NUM> may be formed as a single monolithic or unitary structure with living hinges. Alternatively, or additionally, the intermediate region <NUM> may include a combination of struts <NUM> having either a unitary structure including a plurality of mounting modules <NUM> or a plurality of coupled individual mounting modules <NUM>.

The proximal collar <NUM> and/or the distal collar <NUM> may include one or more circumferentially extending cuts <NUM>, <NUM> to form a resilient or spring-like ring element <NUM>, <NUM>. The spring-like elements <NUM>, <NUM> may allow for bending and/or flexing at or near the proximal and/or distal end sections <NUM>, <NUM> of the expandable frame <NUM> which may facilitate navigation within the vasculature. While the expandable frame <NUM> is illustrated as including both a proximal spring-like ring element <NUM> and a distal spring-like ring element <NUM>, it is contemplated that only one spring element <NUM>, <NUM> or no spring elements <NUM>, <NUM> may be provided. Referring additionally to <FIG>, which illustrates an enlarged perspective view of the proximal end region <NUM> of the expandable frame <NUM>, the proximal spring element <NUM> may have a generally tubular configuration. For brevity, the structure of the spring elements <NUM>, <NUM> are described with respect to the proximal spring element <NUM>. However, it should be understood that, when so provided, the distal spring element <NUM> may include any of the structural features described with respect to the proximal spring element <NUM>. In the illustrated embodiment, the cut <NUM> may be generally helical and extend through the thickness of the proximal spring element <NUM> (e.g., from an outer surface to an inner surface thereof). The cut <NUM> may extend along an entire length of the proximal spring element <NUM> or may extend along less than an entire length of the proximal spring element <NUM>, as desired. It is contemplated that a configuration and/or number of cuts <NUM> may be varied to change the properties of the proximal spring element <NUM>. For example, the pitch of a helical cut <NUM> and/or the width of material between adjacent winding of the cut <NUM> may be varied to adjust a strength and/or flexibility of the proximal spring <NUM>. It is further contemplated that the spring elements <NUM>, <NUM> may be formed from a wound filament or ribbon.

The proximal spring element <NUM> may include a plurality of channels 244a, 244b, 244c (collectively, <NUM>) extending from a proximal end <NUM> to a distal end <NUM> of the proximal spring element <NUM>. In some cases, the channels <NUM> may extend over less than an entire length of the proximal spring element <NUM>. For example, the channels <NUM> may extend proximally from the distal end <NUM> and terminate distal to the proximal end <NUM> or the channels <NUM> may extend distally from the proximal end <NUM> and terminate proximal to the distal end <NUM>. In yet other examples, the channels <NUM> may extend over an intermediate region of the proximal spring element <NUM>. In some embodiments, the channels <NUM> may be configured to receive a proximal end region <NUM> of the struts <NUM>. For example, when the struts <NUM> are formed as separate components from the spring elements <NUM>, <NUM>, the proximal end region <NUM> and/or the distal end region <NUM> may be secured to the spring elements <NUM>, <NUM> within the channels <NUM>. It is contemplated that the struts <NUM> may be adhered, glued, brazed, welded, soldered, etc., within the channels <NUM>.

The expandable frame <NUM> may be secured to the balloon <NUM> and/or catheter shaft <NUM> at one end or both ends thereof. For example, the expandable frame <NUM> may be fixedly secured to the outer tubular member <NUM> at or adjacent to the proximal spring element <NUM> while the distal spring element <NUM> may be axially slidable about the inner tubular member <NUM> along a longitudinal axis of the catheter <NUM>. This may allow the expandable frame <NUM> to lengthen (along the longitudinal axis of the catheter <NUM>) when in the collapsed configuration and shorten when in the expanded configuration. The reverse configuration is also contemplated in which the distal spring element <NUM> is fixedly secured to the inner tubular member <NUM> while the proximal spring element <NUM> is free to slide axially along the outer tubular member <NUM>. In some cases, both the proximal spring element <NUM> and the distal spring element <NUM> may be fixedly secured to the catheter <NUM>. It is contemplated that the spring elements <NUM>, <NUM> may allow the expandable frame <NUM> to shorten as the balloon <NUM> is expanded and elongate when the balloon <NUM> is collapsed, even when both spring elements <NUM>, <NUM> are coupled to the catheter <NUM>. In other cases, both the proximal spring element <NUM> and the distal spring element <NUM> may be free to slide relative to the catheter <NUM>. It is further contemplated that the expandable frame <NUM> may be coupled (additionally or alternatively to the proximal and/or distal spring elements <NUM>, <NUM>) at locations other than the proximal or distal spring elements <NUM>, <NUM>, as desired.

Referring briefly to <FIG>, in some cases, one or more elastomeric or flexible bands 250a, 250b, 250c, 250d (collectively, <NUM>) may be circumferentially positioned over the struts <NUM> and over an outer surface of the balloon <NUM> to limit circumferential and/or radial movement of the struts <NUM>. For example, a plurality of bands <NUM>, each of which extends circumferentially around the balloon <NUM>, may be positioned at spaced apart locations along the length of the balloon <NUM>. The bands <NUM> may be axially arranged to reside between adjacent cutting members <NUM>. The struts <NUM> may be sandwiched between an inner surface of the bands <NUM> and an outer surface of the balloon <NUM>. The bands <NUM> may retain the struts in circumferentially spaced apart locations around the balloon <NUM> to help prevent the struts <NUM> from crossing over each other. The bands <NUM> may be held in tension even with the balloon <NUM> in a fully deflated state such that the bands <NUM> continuously apply a radially inward force against the struts <NUM> to push the struts <NUM> against the deflated balloon <NUM>. The bands <NUM> may be flexible so as to stretch and continue to apply a radially inward force on the struts <NUM> as the balloon <NUM> is expanded. It is further contemplated that the bands <NUM> may return to their smaller, delivery configuration when the balloon <NUM> is deflated.

Returning to <FIG> and <FIG>, the mounting modules <NUM> may be interconnected by rails 252a-i (collectively, <NUM>). In some embodiments, the struts <NUM> are formed from a single monolithic structure such that the mounting modules <NUM> and the rails <NUM> are formed as a single structure. The mounting modules <NUM> may have a first width <NUM> and the rails <NUM> may have a second width <NUM> smaller than the first width <NUM>. In some cases, the mounting modules <NUM> may have a width <NUM> in the range of about <NUM> inches (in) (<NUM>) to about <NUM> in (<NUM>), about <NUM> in (<NUM>) to about <NUM> in (<NUM>), or about <NUM> in (<NUM>). The rails <NUM> may have width <NUM> in the range of about <NUM> in (<NUM>) to about <NUM> in (<NUM>), about <NUM> in (<NUM>) to about <NUM> in (<NUM>), or about <NUM> in (<NUM>). The thinner rails <NUM> may pivotably couple adjacent mounting modules <NUM>. For example, the rails <NUM> may bend, flex, and/or pivot relative to the mounting modules <NUM> such that the expandable frame <NUM> may move between a collapsed generally linear configuration and an expanded configuration generally conforming to an outer shape of the balloon <NUM>.

In some embodiments, the mounting modules <NUM> may have a length <NUM> that is longer than a length <NUM> of the rails <NUM>, although this is not required. It is contemplated that the length (and/or width) of the mounting modules <NUM> may be selected to support the desired cutting member <NUM>. In some embodiments, the mounting modules <NUM> may have a length in the range of about <NUM> in (<NUM>) to about <NUM> in (<NUM>), about <NUM> in (<NUM>) to about <NUM> in (<NUM>), or about <NUM> in (<NUM>). The rails <NUM> may have a length in the range of about <NUM> in (<NUM>) to about <NUM> in (<NUM>), about <NUM> in (<NUM>) to about <NUM> in (<NUM>), or about <NUM> in (<NUM>).

<FIG> illustrates a cross-sectional view of the illustrative expandable frame <NUM> taken at line <NUM>-<NUM> of <FIG>. The mounting modules <NUM> may each be configured to receive or carry a cutting member <NUM>. However, it is not required for each mounting module <NUM> to include a cutting member <NUM>. The mounting module <NUM> may include a generally U-shaped structure having a bottom wall <NUM>, a first side wall <NUM> extending generally orthogonally from the bottom wall <NUM>, and a second side wall <NUM> extending generally orthogonally from the bottom wall <NUM> and spaced from the first side wall <NUM>. Together, the side walls <NUM>, <NUM> and the bottom wall <NUM> may from a channel or trough for receiving the cutting member <NUM>. The cutting member <NUM> may be adhesively secured to the mounting module <NUM> within the trough. Other securing techniques may be used as desired, including but not limited to, soldering, brazing, welding, etc. In other embodiments, the cutting member <NUM> may be formed as a single monolithic structure with the mounting module <NUM>.

<FIG> is a perspective view of another illustrative expandable frame <NUM> for mounting one or more cutting members 306a-j (collectively, <NUM>) relative to an expandable balloon. The expandable frame <NUM> may include a plurality of struts 308a, 308b, 308c (collectively, <NUM>) extending axially along a longitudinal axis of the frame <NUM> from a proximal end region <NUM> to a distal end region <NUM>. While the expandable frame <NUM> is illustrated as having three struts <NUM>, it is contemplated that the frame <NUM> may include any number of struts <NUM> desired, such as, but not limited to, one, two, three, four, or more. In some embodiments the struts <NUM> may be configured to be uniformly positioned about a circumference of a balloon. For example, the struts <NUM> may be configured to have an (or approximately) even or equal spacing between adjacent struts <NUM>. Alternatively, the struts <NUM> may be eccentrically positioned about the circumference of the balloon. For example, the struts <NUM> may have unequal spacing between adjacent struts <NUM>.

The expandable frame <NUM> may have a proximal section <NUM>, a distal section <NUM>, and an intermediate region <NUM>. The expandable frame <NUM> may be laser cut from a straight metallic tube (e.g., a hypotube) to form a proximal collar <NUM>, a distal collar <NUM>, and the plurality of struts <NUM> therebetween. In other instances, the proximal section <NUM>, the distal section <NUM>, and/or intermediate section <NUM> may be cut from a flat sheet and rolled into the desired shape. In yet other embodiments, the proximal collar <NUM>, distal collar <NUM> and/or struts <NUM> may be individually formed from a variety of methods and subsequently coupled together. The proximal section <NUM> and/or the distal section <NUM> may be formed from spring steel or nitinol and heat set or stress relieved in a collapsed configuration, as shown in <FIG>. However, other materials may be used, as desired. The proximal section <NUM> and the distal section <NUM> of the expandable frame <NUM> may be moved from the collapsed configuration into an expanded configuration through inflation and thus radial expansion of the balloon, the expanded configuration generally conforming to an outer profile of the balloon.

Each strut <NUM> of the expandable frame <NUM> may include a proximal end region 320a, 320b, 320c (collectively, <NUM>), a distal end region 322a, 322b, 322c (collectively, <NUM>), and an intermediate region 324a, 324b, 324c (collectively, <NUM>) disposed therebetween. As described herein, the struts <NUM> may be individually cut from a flat sheet or cut from a straight metallic tube (e.g., a hypotube), as desired. In some embodiments, the struts <NUM> may be formed as a monolithic structure. The proximal end regions <NUM> and/or the distal end regions <NUM> may be formed from spring steel or nitinol and heat set or stress relieved in a collapsed configuration (not explicitly shown). However, other materials may be used, as desired. In some cases, the proximal end regions <NUM> and/or the distal end regions <NUM> may be pivotably coupled with the intermediate regions <NUM>. For example, the proximal end regions <NUM> and/or the distal end regions <NUM> may bend, flex, and/or pivot relative to the intermediate regions <NUM> such that the expandable frame <NUM> may move between a collapsed generally linear configuration and an expanded configuration generally conforming to an outer shape of the balloon. For example, the pivotable linkage between the proximal end regions <NUM> and the intermediate regions <NUM> as well as the pivotable linkage between the distal end regions <NUM> and the intermediate section <NUM> may allow the intermediate section <NUM> to extend generally parallel to a longitudinal axis of the balloon while the proximal and distal end regions <NUM>, <NUM> extend at a nonparallel angle to the longitudinal axis of the balloon for at least a portion of their respective lengths.

Each strut <NUM> may include a plurality of links or mounting modules 326a-j (collectively <NUM>) with each mounting module carrying a cutting member <NUM>. While each strut <NUM> is illustrated as including ten mounting modules <NUM>, it is contemplated that the struts <NUM> may include fewer than ten or more than ten mounting modules <NUM> to form a cutting member system having the desired cutting length. In some cases, the mounting modules <NUM> may be pivotably coupled to one another, the proximal end region <NUM>, and/or the distal end region <NUM>. For instance, the mounting modules <NUM> may be separate structures linked or coupled together, or the mounting modules <NUM> may be formed as a single monolithic or unitary structure with living hinges. Alternatively, or additionally, the intermediate region <NUM> may include a combination of struts <NUM> having either a unitary structure including a plurality of mounting modules <NUM> or a plurality of coupled individual mounting modules <NUM>.

The proximal collar <NUM> and/or the distal collar <NUM> may include one or more circumferentially extending cuts <NUM>, <NUM> to form a resilient or spring-like ring element <NUM>, <NUM>. The spring-like elements <NUM>, <NUM> may allow for bending and/or flexing at or near the proximal and/or distal end regions <NUM>, <NUM> of the expandable frame <NUM> which may facilitate navigation within the vasculature. While the expandable frame <NUM> is illustrated as including both a proximal spring-like ring element <NUM> and a distal spring-like ring element <NUM>, it is contemplated that only one spring element <NUM>, <NUM> or no spring elements <NUM>, <NUM> may be provided. Referring additionally to <FIG>, which illustrates an enlarged perspective view of the proximal end region <NUM> of the expandable frame <NUM>, the proximal spring element <NUM> may have a generally tubular configuration. For brevity, the structure of the spring elements <NUM>, <NUM> are described with respect to the proximal spring element <NUM>. However, it should be understood that, when so provided, the distal spring element <NUM> may include any of the structural features described with respect to the proximal spring element <NUM>. In the illustrated embodiment, the cut <NUM> may be generally helical and extend through the thickness of the proximal spring element <NUM> (e.g., from an outer surface to an inner surface thereof). The cut <NUM> may extend along an entire length of the proximal spring element <NUM> or may extend along less than an entire length of the proximal spring element <NUM>, as desired. For example, in the illustrated embodiment, the cut <NUM> extends over an intermediate or central region <NUM> of the proximal spring element <NUM>. It is contemplated that a configuration and/or number of cuts <NUM> may be varied to change the properties of the proximal spring element <NUM>. For example, the pitch of a helical cut <NUM> and/or the width of material between adjacent winding of the cut <NUM> may be varied to adjust a strength and/or flexibility of the proximal spring <NUM>. It is further contemplated that the spring elements <NUM>, <NUM> may be formed from a wound filament or ribbon.

The proximal spring element <NUM> may include a plurality of channels 336a, 336b, 336c (collectively, <NUM>) extending from a proximal end <NUM> to a distal end <NUM> of the proximal spring element <NUM>. In some cases, the channels <NUM> may extend over less than an entire length of the proximal spring element <NUM>. For example, the channels <NUM> may extend proximally from the distal end <NUM> and terminate distal to the proximal end <NUM> or the channels <NUM> may extend distally from the proximal end <NUM> and terminate proximal to the distal end <NUM>. In yet other examples, the channels <NUM> may extend over an intermediate region of the proximal spring element <NUM>. In some embodiments, the channels <NUM> may be configured to receive a proximal end region <NUM> of the struts <NUM>. For example, when the struts <NUM> are formed as separate components from the spring elements <NUM>, <NUM>, the proximal end region <NUM> and/or the distal end region <NUM> may be secured to the spring elements <NUM>, <NUM> within the channels <NUM>, as illustrated in <FIG> and <FIG>. It is contemplated that the struts <NUM> may be adhered, glued, brazed, welded, soldered, etc., within the channels <NUM>.

The expandable frame <NUM> may be secured to the balloon and/or catheter shaft at one end or both ends thereof. For example, the expandable frame <NUM> may be fixedly secured to an outer tubular member at or adjacent to the proximal spring element <NUM> while the distal spring element <NUM> may be axially slidable about an inner tubular member along a longitudinal axis of the catheter. This may allow the expandable frame <NUM> to lengthen (along the longitudinal axis of the catheter) when in the collapsed configuration and shorten when in the expanded configuration. The reverse configuration is also contemplated in which the distal spring element <NUM> is fixedly secured to the inner tubular member while the proximal spring element <NUM> is free to slide axially along the outer tubular member. In some cases, both the proximal spring element <NUM> and the distal spring element <NUM> may be fixedly secured to the catheter. It is contemplated that the spring elements <NUM>, <NUM> may allow the expandable frame <NUM> to shorten as the balloon is expanded and elongate when the balloon is collapsed, even when both spring elements <NUM>, <NUM> are coupled to the catheter. In other cases, both the proximal spring element <NUM> and the distal spring element <NUM> may be free to slide relative to the catheter. It is further contemplated that the expandable frame <NUM> may be coupled (additionally or alternatively to the proximal and/or distal spring elements <NUM>, <NUM>) at locations other than the proximal or distal spring elements <NUM>, <NUM>, as desired.

Referring additionally to <FIG>, in some cases, one or more elastomeric or flexible bands 338a, 338b, 338c, 338d (collectively, <NUM>) may be circumferentially positioned over the struts <NUM> and may be configured to be disposed over an outer surface of the balloon to limit circumferential and/or radial movement of the struts <NUM>. For example, a plurality of bands <NUM>, each of which extends circumferentially around the balloon, may be positioned at spaced apart locations along the length of the balloon. The bands <NUM> may be axially arranged to reside between adjacent cutting members <NUM>. The struts <NUM> may be sandwiched between an inner surface of the bands <NUM> and an outer surface of the balloon. The bands <NUM> may retain the struts in circumferentially spaced apart locations around the balloon to help prevent the struts <NUM> from crossing over each other. The bands <NUM> may be held in tension even with the balloon in a fully deflated state such that the bands <NUM> continuously apply a radially inward force against the struts <NUM> to push the struts <NUM> against the deflated balloon. The bands <NUM> may be flexible so as to stretch and apply a radially inward force on the struts <NUM> as the balloon is expanded. It is further contemplated that the bands <NUM> may return to their smaller, delivery configuration when the balloon is deflated.

The mounting modules <NUM> may be interconnected by rails 340a-i (collectively, <NUM>). In some embodiments, the struts <NUM> are formed from a single monolithic structure such that the mounting modules <NUM> and the rails <NUM> are formed as a single structure. The rails <NUM> may provide a living hinge between adjacent mounting modules <NUM>, permitting adjacent mounting modules <NUM>, and thus cutting members <NUM>, to pivot relative to one another. The mounting modules <NUM> may have a first width <NUM> and the rails <NUM> may have a second width <NUM> smaller than the first width <NUM>. In some cases, the mounting modules <NUM> may have a width <NUM> in the range of about <NUM> inches (in) (<NUM>) to about <NUM> in (<NUM>), about <NUM> in (<NUM>) to about <NUM> in (<NUM>), or about <NUM> in (<NUM>). The rails <NUM> may have width <NUM> in the range of about <NUM> in (<NUM>) to about <NUM> in (<NUM>), about <NUM> in (<NUM>) to about <NUM> in (<NUM>), or about <NUM> in (<NUM>). The thinner rails <NUM> may pivotably couple adjacent mounting modules <NUM>. For example, the rails <NUM> may bend, flex, and/or pivot relative to the mounting modules <NUM> such that the expandable frame <NUM> may move between a collapsed generally linear configuration and an expanded configuration generally conforming to an outer shape of the balloon.

In some embodiments, the mounting modules <NUM> may have a length <NUM> that is longer than a length <NUM> of the rails <NUM>, although this is not required. It is contemplated that the length (and/or width) of the mounting modules <NUM> may be selected to support the desired cutting member <NUM>. In some embodiments, the mounting modules <NUM> may have a length <NUM> in the range of about <NUM> in (<NUM>) to about <NUM> in (<NUM>), about <NUM> in (<NUM>) to about <NUM> in (<NUM>), or about <NUM> in (<NUM>). The rails <NUM> may have a length <NUM> in the range of about <NUM> in (<NUM>) to about <NUM> in (<NUM>), about <NUM> in (<NUM>) to about <NUM> in (<NUM>), or about <NUM> in (<NUM>).

The mounting modules <NUM> may each be configured to receive or carry a cutting member <NUM>. However, it is not required for each mounting module <NUM> to include a cutting member <NUM>. The mounting module <NUM> may include a generally planar structure having a bottom wall 362a, 362b (collectively, <NUM>) (see, for example, <FIG>). The cutting member <NUM> may be adhesively secured to the mounting module <NUM> on the planar bottom wall <NUM>. Other securing techniques may be used as desired, including but not limited to, soldering, brazing, welding, etc. In other embodiments, the cutting member <NUM> may be formed as a single monolithic structure with the mounting module <NUM>.

In some embodiments, the catheter <NUM>, the balloon <NUM>, the expandable frame <NUM>, the expandable frame <NUM>, the expandable frame <NUM>, the expandable frame <NUM>, and/or components thereof, may be made from a metal, metal alloy, polymer (some examples of which are disclosed below), a metal-polymer composite, ceramics, combinations thereof, and the like, or other suitable material. Some examples of suitable metals and metal alloys include stainless steel, such as 444V, <NUM>, and 314LV stainless steel; mild steel; nickel-titanium alloy such as linear-elastic and/or super-elastic nitinol; other nickel alloys such as nickel-chromium-molybdenum alloys (e.g., UNS: N06625 such as INCONEL® <NUM>, UNS: N06022 such as HASTELLOY® C-<NUM>®, UNS: N10276 such as HASTELLOY® C276®, other HASTELLOY® alloys, and the like), nickel-copper alloys (e.g., UNS: N04400 such as MONEL® <NUM>, NICKELVAC® <NUM>, NICORROS® <NUM>, and the like), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R44035 such as MP35-N® and the like), nickel-molybdenum alloys (e.g., UNS: N10665 such as HASTELLOY® ALLOY B2®), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys, and the like; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (e.g., UNS: R44003 such as ELGILOY®, PHYNOX®, and the like); platinum enriched stainless steel; titanium; platinum; palladium; gold; combinations thereof; and the like; or any other suitable material.

For example, across a broad temperature range, the linear elastic and/or non-super-elastic nickel-titanium alloy maintains its linear elastic and/or non-super-elastic characteristics and/or properties.

In at least some embodiments, portions or all of the catheter <NUM>, the balloon <NUM>, the expandable frame <NUM>, the expandable frame <NUM>, the expandable frame <NUM>, the expandable frame <NUM>, and/or components thereof, may also be doped with, made of, or otherwise include a radiopaque material. Radiopaque materials are understood to be materials capable of producing a relatively bright image on a fluoroscopy screen or another imaging technique during a medical procedure. This relatively bright image aids a user in determining the location of the catheter <NUM>, the balloon <NUM>, the expandable frame <NUM>, the expandable frame <NUM>, the expandable frame <NUM>, the expandable frame <NUM>, etc. Some examples of radiopaque materials can include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloy, polymer material loaded with a radiopaque filler, and the like. Additionally, other radiopaque marker bands and/or coils may also be incorporated into the design of the catheter <NUM>, the balloon <NUM>, the expandable frame <NUM>, the expandable frame <NUM>, the expandable frame <NUM>, the expandable frame <NUM>, etc. to achieve the same result.

In some embodiments, a degree of Magnetic Resonance Imaging (MRI) compatibility is imparted into the catheter <NUM>, the balloon <NUM>, the expandable frame <NUM>, the expandable frame <NUM>, etc. For example, the catheter <NUM>, the balloon <NUM>, the expandable frame <NUM>, the expandable frame <NUM>, the expandable frame <NUM>, the expandable frame <NUM>, and/or components or portions thereof, may be made of a material that does not substantially distort the image and create substantial artifacts (e.g., gaps in the image). Certain ferromagnetic materials, for example, may not be suitable because they may create artifacts in an MRI image. The catheter <NUM>, the balloon <NUM>, the expandable frame <NUM>, the expandable frame <NUM>, the expandable frame <NUM>, the expandable frame <NUM>, etc., or portions thereof, may also be made from a material that the MRI machine can image. Some materials that exhibit these characteristics include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS: R44003 such as ELGILOY®, PHYNOX®, and the like), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R44035 such as MP35-N® and the like), nitinol, and the like, and others.

In some embodiments, the catheter <NUM>, the balloon <NUM>, the expandable frame <NUM>, the expandable frame <NUM>, the expandable frame <NUM>, the expandable frame <NUM>, and/or components thereof, etc., and/or portions thereof, may be made from or include a polymer or other suitable material. Some examples of suitable polymers may include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, for example, DELRIN® available from DuPont), polyether block ester, polyurethane (for example, Polyurethane 85A), polypropylene (PP), polyvinylchloride (PVC), polyether-ester (for example, ARNITEL® available from DSM Engineering Plastics), ether or ester based copolymers (for example, butylene/poly(alkylene ether) phthalate and/or other polyester elastomers such as HYTREL® available from DuPont), polyamide (for example, DURETHAN® available from Bayer or CRISTAMID® available from Elf Atochem), elastomeric polyamides, block polyamide/ethers, polyether block amide (PEBA, for example available under the trade name PEBAX®), ethylene vinyl acetate copolymers (EVA), silicones, polyethylene (PE), Marlex high-density polyethylene, Marlex low-density polyethylene, linear low density polyethylene (for example REXELL®), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), poly paraphenylene terephthalamide (for example, KEVLAR®), polysulfone, nylon, nylon-<NUM> (such as GRILAMID® available from EMS American Grilon), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefin, polystyrene, epoxy, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (for example, SIBS and/or SIBS 50A), polycarbonates, ionomers, biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers thereof, polymer/metal composites, and the like. In some embodiments the sheath can be blended with a liquid crystal polymer (LCP). For example, the mixture can contain up to about <NUM> percent LCP.

In some embodiments the catheter <NUM>, the balloon <NUM>, the expandable frame <NUM>, the expandable frame <NUM>, the expandable frame <NUM>, the expandable frame <NUM>, and/or components thereof, etc. disclosed herein may include a fabric material disposed over or within the structure. The fabric material may be composed of a biocompatible material, such a polymeric material or biomaterial, adapted to promote tissue ingrowth. In some embodiments, the fabric material may include a bioabsorbable material. Some examples of suitable fabric materials include, but are not limited to, polyethylene glycol (PEG), nylon, polytetrafluoroethylene (PTFE, ePTFE), a polyolefinic material such as a polyethylene, a polypropylene, polyester, polyurethane, and/or blends or combinations thereof.

In some embodiments, the catheter <NUM>, the balloon <NUM>, the expandable frame <NUM>, the expandable frame <NUM>, the expandable frame <NUM>, the expandable frame <NUM>, and/or components thereof, etc. may include and/or be formed from a textile material. Some examples of suitable textile materials may include synthetic yarns that may be flat, shaped, twisted, textured, pre-shrunk or un-shrunk. Synthetic biocompatible yarns suitable for use in the present invention include, but are not limited to, polyesters, including polyethylene terephthalate (PET) polyesters, polypropylenes, polyethylenes, polyurethanes, polyolefins, polyvinyls, polymethylacetates, polyamides, naphthalene dicarboxylene derivatives, natural silk, and polytetrafluoroethylenes. Moreover, at least one of the synthetic yarns may be a metallic yarn or a glass or ceramic yarn or fiber. Useful metallic yarns include those yarns made from or containing stainless steel, platinum, gold, titanium, tantalum or a Ni-Co-Cr-based alloy. The yarns may further include carbon, glass or ceramic fibers. Desirably, the yarns are made from thermoplastic materials including, but not limited to, polyesters, polypropylenes, polyethylenes, polyurethanes, polynaphthalenes, polytetrafluoroethylenes, and the like. The yarns may be of the multifilament, monofilament, or spun-types. The type and denier of the yarn chosen may be selected in a manner which forms a biocompatible and implantable prosthesis and, more particularly, a vascular structure having desirable properties.

In some embodiments, the catheter <NUM>, the balloon <NUM>, the expandable frame <NUM>, the expandable frame <NUM>, the expandable frame <NUM>, the expandable frame <NUM>, and/or components thereof, etc. may include and/or be treated with a suitable therapeutic agent. Some examples of suitable therapeutic agents may include anti-thrombogenic agents (such as heparin, heparin derivatives, urokinase, and PPack (dextrophenylalanine proline arginine chloromethylketone)); anti-proliferative agents (such as enoxaparin, angiopeptin, monoclonal antibodies capable of blocking smooth muscle cell proliferation, hirudin, and acetylsalicylic acid); anti-inflammatory agents (such as dexamethasone, prednisolone, corticosterone, budesonide, estrogen, sulfasalazine, and mesalamine); antineoplastic/antiproliferative/anti-mitotic agents (such as paclitaxel, <NUM>-fluorouracil, cisplatin, vinblastine, vincristine, epothilones, endostatin, angiostatin and thymidine kinase inhibitors); anesthetic agents (such as lidocaine, bupivacaine, and ropivacaine); anticoagulants (such as D-Phe-Pro-Arg chloromethyl ketone, an RGD peptide-containing compound, heparin, anti-thrombin compounds, platelet receptor antagonists, anti-thrombin antibodies, anti-platelet receptor antibodies, aspirin, prostaglandin inhibitors, platelet inhibitors, and tick antiplatelet peptides); vascular cell growth promoters (such as growth factor inhibitors, growth factor receptor antagonists, transcriptional activators, and translational promoters); vascular cell growth inhibitors (such as growth factor inhibitors, growth factor receptor antagonists, transcriptional repressors, translational repressors, replication inhibitors, inhibitory antibodies, antibodies directed against growth factors, bifunctional molecules consisting of a growth factor and a cytotoxin, bifunctional molecules consisting of an antibody and a cytotoxin); cholesterol-lowering agents; vasodilating agents; and agents which interfere with endogenous vascoactive mechanisms.

Claim 1:
A balloon catheter (<NUM>; <NUM>; <NUM>) comprising:
a catheter shaft (<NUM>; <NUM>);
an inflatable balloon (<NUM>; <NUM>) secured to a distal portion of the catheter shaft (<NUM>; <NUM>); and
an expandable frame (<NUM>; <NUM>; <NUM>; <NUM>) disposed over the balloon (<NUM>; <NUM>), the expandable frame (<NUM>; <NUM>; <NUM>; <NUM>) including a proximal section (<NUM>; <NUM>; <NUM>; <NUM>), a distal section (<NUM>; <NUM>; <NUM>; <NUM>), and an intermediate section (<NUM>; <NUM>; <NUM>; <NUM>), wherein the proximal section (<NUM>; <NUM>; <NUM>; <NUM>) includes a coupling mechanism and is pivotably coupled to a first coupling mechanism of the intermediate section (<NUM>; <NUM>; <NUM>; <NUM>) and the distal section (<NUM>; <NUM>; <NUM>; <NUM>) includes a coupling mechanism that is pivotably coupled to a second coupling mechanism of the intermediate section (<NUM>; <NUM>; <NUM>; <NUM>);
wherein the expandable frame includes a plurality of channels (<NUM>; <NUM>; <NUM>) configured to slidably receive one or more cutting members (<NUM>; <NUM>; <NUM>) therein.