Method and apparatus for plaque disruption

Abstract

The balloon catheters, sleeves, cages, and endoluminal prostheses include stress application and spacing features coupled to their expandable surfaces. The stress application features may have blunt and / or rounded contact areas that contact tissue or calcified areas within the vasculature. When expanded, the contact areas indent or rupture obstructing material on the walls of the vessel lumen and / or the patient's valve leaflets. The spacing features allow for perfusion of blood, drugs, and contrast media across the expanded structures within the vasculature, particularly the balloon catheter.

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims the benefit of Provisional Application No. 63 / 322,372 (Attorney Docket No. 32106-726.104), filed March 22, 2022, No. 63 / 287,813 (Attorney Docket No. 32106-726.103), filed December 9, 2021, Provisional Application No. 63 / 240,811 (Attorney Docket No. 32106-726.102), filed September 3, 2021, and Provisional Application No. 63 / 200,794 (Attorney Docket No. 32106-726.101), filed March 29, 2021, the entire disclosures of which are incorporated herein by reference.

[0002] The present invention relates generally to medical devices and methods. More specifically, the present invention relates to devices comprising or consisting of expandable structures, including vascular devices, vascular catheters, expandable sleeves, expandable cages, balloon catheters, scaffoldings, stents, vascular grafts, implantable vascular prostheses, configured to open, expand, deliver drugs to, and / or rupture calcified and / or hardened lesions in blood vessels and / or valves and / or body lumens.

[0003] Balloons, cages, stents, grafts, and other prostheses and devices are commonly used to provide or maintain patency in blood vessels and cardiac and venous valve structures that have been narrowed by lesions or other disease conditions. When a lesion is hardened by plaque, calcium, and the like, a "cutting balloon" may be used for an initial treatment step to break up the plaque and calcification, allowing the balloon to widen the lesion prior to stent placement. Optionally, the stent may be post-inflated using a non-compliant angioplasty balloon to ensure good apposition to the vessel wall. The post-inflating balloon is brought to higher ambient pressure using a balloon inflation device. However, stenting after angioplasty with a cutting balloon can be problematic in some respects, especially when followed by post-inflation at higher pressures. In some cases, the vessel wall may be injured or such injury may propagate. In others, debris generated by the cutting balloon may be released as an embolus.

[0004] The use of cutting balloons, cutting cages, and cutting stents have been proposed to disrupt vascular calcification, but are associated with various problems, including poor delivery, tendency to bulkiness, limited access, or patient injury. Cutting stents have been proposed to be used in "primary stenting" procedures that do not involve the use of pre-expansion angioplasty balloons to widen the area to be stented. Primary stenting reduces or eliminates the need to perform two or three sequential interventions, which in turn reduces the risk of vascular injury and embolic release, as discussed above. However, cutting stents have similar limitations, being bulky, causing injury, and poor delivery.

[0005] Cardiac and venous valve function can be adversely affected by the presence of calcifications on the valve leaflets. Valvuloplasty procedures rely on fracturing the lesions by expanding a balloon on the inside of the opposing leaflet surfaces to crack the calcifications. The use of cutting and caged balloons to enhance such valvuloplasty procedures has been proposed but has not found widespread use due to increased risk of damaging the valve and / or valve function.

[0006] Despite significant potential improvements in many instances, such cutting balloons, cages, and stents typically employ sharp blades that are oriented radially outward, presenting a risk of injury to the patient.

[0007] In addition, the cutting blades make the device bulky and less deliverable, and can often limit access to distal vascular regions. The cutting blades also tend to rupture the vessel wall beneath the calcified / hardened plaque lesion, especially at higher inflation pressures, which can result in patient injury.

[0008] Another challenge in performing angioplasty and valvuloplasty procedures is the temporary blockage of the vessel lumen or valve annulus due to balloon dilation. While temporary blockage of blood flow is often acceptable, a more serious concern can be loss of contrast flow downstream of the balloon. Even a brief loss of contrast can make fluoroscopic imaging of the procedure more difficult. Various perfusion catheters have been proposed, but they often require additional flow lumens through the balloon, making the catheters larger and less useful in many situations. For these reasons, it would be desirable to provide improved methods and apparatus for opening, expanding, delivering drugs to, providing improved visualization of, and / or treating calcified or hardened lesions with reduced risk in patients and the like or improved effectiveness in treating calcified or hardened lesions. The improvements would preferably be applied to a wide variety of vascular and cardiac devices, including expandable structures such as vascular catheters, expandable sleeves, expandable cages, balloon catheters, stents, implantable vascular prostheses, drug delivery devices, etc., and the like. It would be even more desirable if the devices and procedures improved the perfusion of both blood and / or contrast during the procedure. At least some of these advantages would be provided by the present invention. [Background technology]

[0009] Patents and printed publications describing different types of plaque disruption and other features on various support structures include US2009 / 0105687, US2006 / 0129229, US2005 / 0137621, US9370644, US9119944, US8992553, US8882790, US8523887, US8323325, US7799043, US6197013, US5242397, and US6242397. Patents and printed publications describing expandable scaffolds with plaque disruption and other features, including EP2919707, include US8876882, US7494497, US9724121, US7731744, US5591197, US2006 / 122684, US2014 / 277562, US2001 / 037146, US2006 / 271161, US2020 / 0323545, US10143452, US102010246, US10143452 ... Patents and printed publications describing multiple surface valvuloplasty include US9717513, US8398662, US8092470, US8080026, US7803168, US6047700, and US5443446, including US2021 / 0378744, US11000299, US10758255, US10478202, US9827096, US8187223, US20210393281, Including US20200197033, US11000299, US10980553, US10342962, US10245419, US9504807, US9375555, US4986830, EP13526772, EP1480709, KR20200077682, WO2020014515, WO2012040225, WO2003 / 084594, and WO2013126779. [Prior art documents] [Patent documents]

[0010] [Patent Document 1] US Patent Application Publication No. 2009 / 0105687 [Patent Document 2] US Patent Application Publication No. 2006 / 0129229 Summary of the Invention [Means for solving the problem]

[0011] The device according to the invention includes stress or force application features, which may have any one of a variety of specific designs and geometries selected to rupture, indent, or otherwise break up areas of calcified or otherwise hardened plaque, expand, deliver drugs to, improve visualization of, and / or enlarge lesions in the patient's vasculature with low to minimal risk to the underlying patient tissue. The device of the invention will often find use in angioplasty, stent placement, drug delivery, improved visualization, and other interventions in the arterial or venous vasculature. In addition, the device of the invention will find use in treating or modifying cardiac and venous valve structures, for example, when performing a valvuloplasty procedure in the patient's aortic valve.

[0012] The stress-applying and force-applying features of the present invention are also referred to herein as plaque-disrupting features, plaque-engaging features, and calcium-engaging features, and these terms will be used interchangeably in the present specification and claims. Other suitable descriptors for these features include plaque-subduction features and stress-inducing features, and unless otherwise stated, these terms and phrases will be used interchangeably. The stress-applying features of the present invention may have any one of a variety of designs as described herein.

[0013] A first type of stress-applying feature will typically comprise a blunt contact area configured to engage plaque or other hardened or calcified material and expand, rupture, depress, or otherwise fracture the material while minimizing risk to underlying tissue or vessel wall, valve annulus, or other patient tissue that would be at risk if pressure were applied by a blade or other sharp structure. Various specific designs for the stress-applying features of the present invention are described below and include disks, plates, balls, spheres, hemispheres, partial spheres, ellipsoids, ovals, etc., and the like. The stress-applying features of the present invention may be solid or comprise hollow interiors. The stress-applying features of the present invention may be (1) pre-formed and attached to a device such as a balloon, sleeve, stent, or cage, or (2) fabricated such as in an integral or component part of a balloon, sleeve, stent, or cage, as described in further detail herein, or (3) a combination of (1) and (2).

[0014] The devices of the present invention will typically further comprise an apparatus or structure for radially advancing or deploying the stress-applying feature within a patient target site, such as a blood vessel, valve annulus, or other body lumen or cavity. In some cases, the preformed stress-applying feature may be directly attached or coupled to the exterior surface of any one of a variety of expandable structures, such as balloons, stents / scaffoldings, stents, cages, sleeves, valve prostheses, valvuloplasty balloon catheters, and the like. In other cases, the stress-applying feature may be directly fabricated as an integral part of such an expandable structure. In still other cases, the stress-applying feature may be attached or fabricated as part of an intermediate structure that is not itself configured to expand, but may be placed over a separate expandable structure. For example, the stress-applying feature of the present invention may be attached or formed as part of a sleeve, sheath, cover, mesh, or other support structure that may be placed to surround or otherwise be supported by an expandable structure, such as an elastic sleeve that is placed over an expandable balloon.

[0015] Exemplary stress-applying features of the invention will typically have a circumscribed "footprint" or base having a maximum length, width, diameter, or other dimension of 4 mm or less, often 3 mm or less, more often 1 mm or less, frequently 0.75 mm or less, and sometimes 0.5 mm or less or 0.25 mm or less. In another embodiment, the base of the stress-applying feature has a length, width, diameter, or configuration ranging from 0.1 mm to 4 mm, preferably ranging from 0.2 mm to 2 mm, and more preferably ranging from 0.3 mm to 0.75 mm. Footprint refers to the maximum area dimension of the stress-applying feature at the base over an underlying supporting surface, such as the exterior surface of a balloon, sleeve, scaffolding, cage, or stent. The contact area or coverage area dimensions of the stress-applying feature may be equal to that of the base, in the case of a disk, ball, sphere, etc., or may be greater than that of the base when the feature is radially outwardly tapered, as in the case of an inverted cone or inverted hemisphere or inverted partial sphere, or may be smaller than that of the base when the feature is radially outwardly tapered, as in the case of a cone, hemisphere, or partial sphere. In one embodiment, the contact area of ​​the stress-applying feature has a length, width, diameter, or configuration ranging from 0.01 mm to 4 mm, preferably ranging from 0.1 mm to 2 mm, more preferably ranging from 0.1 mm to 0.75 mm. In another embodiment, the stress-applying feature is spherical or the like, and the contact area and / or base has a length, width, diameter, or configuration ranging from zero or nearly zero to 0.1 mm, more often ranging from 0.001 to 0.1 mm. The stress-applying features of the present invention are typically not axially extended elongated members such as blades or similar elongated cutters, but rather will have circumferential and axial elongations or configurations that are approximately the same. In a preferred embodiment, the footprint at the base of the stress-applying feature has a maximum axial length to maximum circumferential width ratio in the range of 0.5:1 to 1:0.5, more preferably 0.75:1 to 1:0.75, and most preferably about 1:1. In another preferred embodiment, the dimensions at the base of the stress-applying feature are substantially the same as the dimensions of the contact coverage area dimensions, such as in the case of a ball, hemisphere, partial sphere, sphere, or square.

[0016] Exemplary stress-applying features of the present invention also typically have a height, measured from a base attached to a support surface or substrate to the contact coverage area (contact area), typically at least 0.05 mm, 0.1 mm, 0.15 mm, 0.2 mm, 0.25 mm, or more, and often no more than 1 mm, 0.5 mm, 0.4 mm, 0.3 mm, 0.25 mm, 0.15 mm, 0.1 mm, or less, including all ranges of minimum and maximum recited heights. In preferred embodiments, the height of the feature ranges from 0.1 mm to 1 mm, preferably from 0.2 mm to 0.75 mm, and more preferably from 0.25 to 0.5 mm. Features may have the same height along the entire structure, or different heights along the circumference and / or axial length of the substrate.

[0017] In a preferred embodiment, the stress-applying features are discrete features that enhance flexibility and deliverability of the device within a patient's vasculature or body lumen. Such discrete stress-applying features, when inflated or otherwise expanded, typically have a density of 0.1-20 features / mm 2 , preferably 0.1 to 5 features / mm 2 , more preferably 0.2 to 4 features / mm 2 , more preferably 0.25 to 3 features / mm 2 The particles will be distributed across the expandable surface at a density of

[0018] In preferred embodiments, the stress-applying features are discrete, independent, and / or separate from one another to improve flexibility and deliverability of the device within a patient's vasculature or body lumen. Such stress-applying features typically have a density of 0.1-20 features / mm when inflated or otherwise expanded. 2 , preferably 0.1 to 5 features / mm 2 , more preferably 0.2 to 4 features / mm 2 , more preferably 0.25 to 3 features / mm 2In a preferred embodiment, each feature applies an independent or focused force to plaque, vessel wall, tissue, hardened plaque, or calcified lesion.

[0019] In a preferred embodiment, the stress-applying features are discrete and the feature contact areas, body, and / or base are each blunt, rounded, smooth, and / or atraumatic to enhance flexibility and deliverability of the device within a patient's vasculature or body lumen. Such stress-applying features typically have a density of 0.1-100 features / mm when inflated or otherwise expanded. 2 , preferably 0.1 to 20 features / mm 2 , more preferably 0.1 to 5 features / mm 2 or in some cases, 0.2-4 features / mm 2 , more preferably 0.25 to 3 features / mm 2 In another embodiment, the features including the contact region, base, and body are rounded, blunt, and atraumatic to enhance flexibility and deliverability of the device within a patient's vasculature or body lumen while being capable of fracturing, depressing, or expanding hardened and / or calcified plaque.

[0020] In yet another embodiment, the stress-applying features are coated with one or more materials to provide roundness, smooth surfaces, bluntness, and / or atraumatic surfaces to improve flexibility and deliverability of the device within the patient's vasculature or body lumen while being capable of fracturing, depressing, or expanding hardened and / or calcified plaque. In a preferred embodiment, the material comprises one or more of a metallic material, a ceramic material, a polymeric material, an adhesive material, a hydrophilic material, or others. The material is deposited, soldered, coated, plated, immersed, or otherwise applied to the surface of the stress-applying feature. The material may be degradable or non-degradable in a physiological environment. In yet another instance, the coating material provides an additional means of attachment of the stress-applying feature to the expandable structure surface, the coating covering the feature and portions of the expandable structure surface adjacent to the feature.

[0021] In a preferred embodiment, at least a majority, and preferably all, of the surface of the stress-applying feature exposed above the outer surface of the expandable member or other support surface will be free of irregularities and imperfections that may impede advancement through the target body lumen, and will be rounded and typically configured to present an edge-free, low-friction, smoothed surface to the wall of the vasculature or other body lumen as the expandable structure is advanced therethrough. "At least a majority" means that at least 50%, preferably at least 60%, more preferably at least 70%, even more preferably at least 80%, and most preferably at least 90% of the exposed surface of the stress-applying feature will be rounded, smooth, edge-free, or otherwise configured to present low friction. It has been found by the inventors herein that such smooth, rounded features will still be capable of providing the necessary force to indent / fracture even hardened plaque when deployed as described herein.

[0022] Preformed stress-applying features according to the invention may be attached to the expandable structure, e.g., balloon, or intermediate structure, e.g., scaffold or sleeve or cage, by one or more of soldering, use of adhesives (glues), thermal bonding, fusing, welding, threaded attachment, riveting, crimping, interference fit, etc., and the like. Stress-applying features that are integrally formed as part of the balloon, scaffold, stent, cage, or sleeve may occur in a later or final process or location, e.g., by molding, i.e., deposition process to cause the structure to build up on the outer surface of the scaffold, balloon, or sleeve, or in a preferred alternative, may be formed as tabs or other elements that protrude from a component of the scaffold, such as a crown, strut, or link, and folded over the outer surface of the component after the scaffold is formed, but before implantation. Specific examples of such features are described in more detail as accessory features in the present invention. Preformed stress-applying features according to the present invention may be attached to the expandable structure, e.g., balloon, or intermediate structure, e.g., scaffold or sleeve or cage, by one or more of soldering, use of adhesives (glues), thermal bonding, fusing, welding, threaded attachment, riveting, crimping, interference fit, etc., and the like. Stress-applying features that are integrally formed as part of the balloon, scaffold, stent, cage, or sleeve may occur in a later or final process or location, e.g., by molding, i.e., a deposition process to build a structure on the outer surface of the scaffold, balloon, or sleeve, or in a preferred alternative, may be formed as tabs or other elements that protrude from a component of the scaffold, such as a crown, strut, or link, and folded over the outer surface of the component after the scaffold is formed, but before implantation. Specific examples of such features are described in more detail in the present invention as accessory features.

[0023] In a preferred embodiment, the expandable structure comprises one of the following: a balloon surface, a stent surface, a sleeve surface, a cage surface, or a drug delivery surface. The stress application feature may be applied to at least one of the expandable structure surfaces, the surface comprising an outer surface, an inner surface, or a side surface of the expandable structure. In one embodiment, the feature may be applied to one or more of the following: an outer surface of the balloon, a working length of the balloon, a taper of the balloon, a side surface of the balloon, an inner surface of the balloon, an outer surface of the sleeve, an outer surface of the cage, an outer surface of the stent, an inner surface of the sleeve, an inner surface of the cage, or other surfaces. When the feature is applied to an inner surface of the expandable structure, the feature protrudes radially outward and engages the hardened plaque in response to expansion or inflation of the expandable structure.

[0024] In certain cases, the stress-applying features may be attached, at least in part, to the outer surface of one or more elements of the scaffold ring, such as on the crowns and / or struts, to the expandable structure. Such features can also be attached, at least in part, to the connectors, which connect two adjacent rings of the scaffold. The stress-applying features can be formed from the same material as the scaffold, or from a different material or materials. The stress-applying features can be 3D printed (deposited) or laser cut from a tube, either separately from the scaffold fabrication or as part of the scaffold fabrication. In either case, the stress-applying features project radially outward from the scaffold elements, such as the crowns, struts, or connectors. The stress-applying features may be formed as part of the scaffold and positioned in a fixed position after formation and prior to implantation, for example, as described above, by soldering, welding, adhesives (such as epoxies), interference fits, mechanical interlocking, bonding, or other techniques; the stress-applying features may be fixed or attached to the outer surface of the scaffold, or optionally positioned within recesses, holes, or other receptacles formed in or through the outer surface of the scaffold.

[0025] Attachment of the stress-applying feature may comprise one or more of coating, adhesive, fusing, solder, welding, vapor or chemical deposition, laser deposition, constriction with a sleeve, interference fit or mechanical locking onto the outer surface of the scaffold (on a scaffold surface, recess, or hole indented through the scaffold into or through which a portion of the stress-applying feature is forced), epoxy, or combinations thereof, or others.

[0026] The scaffold can be formed from a degradable or non-degradable material. In a preferred embodiment, the scaffold formed from a metal or metal alloy or other non-degradable material has a Mohs hardness of 2.5 or greater, preferably 3.5 or greater, more preferably 4.5 or greater. In a preferred embodiment, the stress-applying feature will have a Mohs hardness equal to or greater than the Mohs hardness of the scaffold or other expandable structure. In other preferred embodiments, the stress-applying feature will have a Mohs hardness greater than the Mohs hardness of the scaffold or other expandable structure. For example, the stress-applying feature may be formed from a material having a Mohs hardness in the range of 2-10, typically 2.5-10, more typically 3-10, 3.5-10, 4-10, 4.5-10, 5-10, 5.5-10, 6-10, or 6.5-10.

[0027] In preferred embodiments, the expandable structure comprises stress-inducing features having a Mohs hardness of 2.5 or greater, preferably 3.5 or greater, more preferably 4.5 or greater, often 5.5 or greater, and most preferably 6.5 or greater. In yet another embodiment, the stress-inducing features have a Mohs hardness ranging from 2 to 9, preferably ranging from 3 to 9, more preferably ranging from 4 to 9. In yet another embodiment, the Mohs hardness of the stress-applying features will exceed the Mohs hardness of the expandable structure supporting the features.

[0028] In a preferred embodiment, the stress-applying features, spacer features, and all other protruding features and elements as described herein comprise at least one material from the following list: metal, polymer, ceramic, glass, metal alloy, or the like. At least one material may be coated with another material. For example, a stainless steel hemisphere may be coated with an adhesive and / or polymer material, the adhesive and / or polymer material having a Mohs hardness that is less than that of the stainless steel hemisphere. In a preferred embodiment, the stress-applying features comprise a metal or other hard core as disclosed above, partially or completely covered by a coating, the coating preferably having a Mohs hardness less than that of the core. A softer coating may provide any one of roundness, bluntness, lubricity, smoothness, and the like, without sacrificing the ability of the stress-applying features to dent or rupture hardened plaque. In yet another embodiment, the Mohs hardness of the stress-applying features will exceed the Mohs hardness of the expandable structure supporting the features by at least a factor of two. In a preferred embodiment, the expandable structure comprises or consists of a polymeric material, while the stress-inducing feature comprises or consists of a metal or metal alloy material.

[0029] In further preferred embodiments, the stressing features, spacer features, and all other protruding features and elements as described will inherently possess some degree of radiopacity, either as a result of combination with, or coating with, radiopaque materials or fillers, or both, as is the case for many metals, to aid in visualization under fluoroscopy. Suitable radiopaque fillers suitable for combination with polymers include barium salts and iodine salts. Metallic or plated metallic and non-metallic features with high radiopacity suitable for coating include bismuth, gold, tungsten, and silver.

[0030] In other examples, the core may be polymeric and coated with a metallic coating having a Mohs hardness greater than that of the polymer characteristic. A particular combination of core and coating Mohs hardness may be selected to provide sufficient force to dent, fracture, or otherwise dilate hardened or calcified tissue or lesions while being sufficiently flexible and smooth to be safely advanced through the vasculature or other biological structures.

[0031] When multiple adhesives are layered or mixed, one adhesive material may be softer than the adjacent material. Alternatively, or in addition, a first adhesive material may be more compatible with the material of the expandable member and layered directly over the member surface, while one or more additional materials may be layered over the first layer to provide bonding with the stress-applying feature or other properties and improve the overall bonding of the stress-applying feature to the expandable member.

[0032] The material of the stress-applying feature is typically selected and configured to compress 0.2 mm or less, 0.1 mm or less, 0.05 mm or less, and / or 0.01 mm or less when deployed against a calcification or other plaque by a balloon, sleeve, or other expandable member. In other words, the material compressibility against a hard surface when pressurized through the expandable structure ranges from 0.001 mm to 0.2 mm, preferably 0.001 mm to 0.1 mm, and more preferably 0.001 mm to 0.01 mm. In other embodiments, the stress-applying feature has a material compressibility that is less than the compliance of the material of the expandable member when pressurized to a nominal inflation pressure.

[0033] In another embodiment, the stress application characteristic is at least 10 MPa m 1 / 2 , preferably at least 20 MPa m 1 / 2 , more preferably at least 50 MPa m 1 / 2 , most preferably at least 100 MPa m 1 / 2In a preferred embodiment, the stress application characteristics are a Mohs hardness greater than 4 and a fracture toughness of 50 MPa m 1 / 2 In a preferred embodiment, the stress-applying feature is made of a metal or metal alloy. In a preferred embodiment, the stress-applying feature is made of or comprises a radiopaque material that provides radiopacity under x-ray / fluoroscopy. In yet another embodiment, the stress-applying feature is made of or comprises a radiopaque material configured to provide radiopacity sufficient to visualize the feature under fluoroscopy, preferably sufficient to visualize the feature under fluoroscopy without the aid of a radiopaque contrast material. In yet another preferred embodiment, the stress-applying feature is attached to an outer surface of an expandable balloon catheter, the feature is made of or comprises a radiopaque material configured to provide radiopacity sufficient to visualize the feature under fluoroscopy, visualization equal to or exceeding visualization of a contrast-filled balloon under fluoroscopy. These advantages provide for precise sizing of vessels, improved demarcation of expandable structures such as expanded / inflated balloons, and / or improved detection of hardened plaque or plaque morphology.

[0034] The stress application features of the present invention, when expanded by the expandable member, present a generally rounded, blunt, and atraumatic structure above the surface of the expandable structure to facilitate advancement through the vasculature, while still providing the necessary force to indent / fracture the hardened plaque. This is advantageous because many of the prior art cutting features are sharp and would get caught on the vasculature as the catheter is advanced. Thus, in a preferred embodiment of the present invention, at least the entire surface above the substrate (including, sometimes, the feature surface attached to the substrate) is rounded and smooth to present minimal friction as it is advanced.

[0035] The stress application features of the present invention, in another embodiment, present a generally rounded, blunt, peripheral edge-free, and atraumatic structure above the surface of the expandable structure, which upon expansion by the expandable member still provides the necessary force to indent / fracture the hardened plaque, facilitating advancement through the vasculature. The stress application features of the present invention, in another embodiment, present a generally rounded, blunt, peripheral edge-free, peripheral edge-free, and atraumatic structure above the surface of the expandable structure, which upon expansion by the expandable member still provides the necessary force to indent / fracture the hardened plaque, facilitating advancement through the vasculature. The plaque fracture features may, in yet another embodiment, have peripheral edges or rounded (beveled) peripheral edges. However, in a preferred embodiment, the plaque fracture features are peripheral edge-free. In yet another preferred embodiment, the plaque fracture features are peripheral edge-free or peripheral beveled edges.

[0036] In some cases, the stress-applying features of the present invention may comprise a sharp or potentially traumatic core that is covered or coated with another material that provides a rounded, blunt, or otherwise atraumatic engagement surface to avoid injury to the vasculature or other body lumen as the expandable member is advanced therethrough. In such cases, at least the potentially traumatic contact areas of the feature are covered or coated.

[0037] The expandable structure, such as a balloon or scaffold, can have any one of a variety of shapes or configurations, including one or more of cylindrical, generally cylindrical, hourglass, dog-bone, tapered, elliptical, oval, or other shapes, external shapes, profiles, or configurations. In many cases, the balloon, sleeve, cage, or scaffold will be expandable from a crimped or small configuration to an deployed or larger configuration by applying an internal expansion force, usually by fluid or balloon expansion as commonly employed for vascular devices and stents. Alternatively, the scaffold can be constrained and deployed from the constrained configuration by removing or withdrawing the constraint. The constraint may be provided by a catheter, sleeve, sheath, or other conventional or novel constraining structure. Such designs are generally referred to as "self-expanding."

[0038] The stress application features can be formed from one or more of metals, metal alloys, ceramics, minerals, polymers, polymer hybrids, polymer blends, epoxies, diamonds, or combinations thereof, including both degradable and non-degradable materials. Suitable metals and metal alloys include stainless steel, cobalt chrome, platinum chrome, silver, nickel-titanium alloy (NiTi), tungsten, tungsten carbide, palladium, cobalt, gold, platinum, titanium, carbides, titanium carbide, zirconium, chrome, magnesium or magnesium alloys such as magnesium-zinc and magnesium-yttrium, zinc or zinc alloys such as zinc-calcium and zinc-lithium, and the like. In a specific embodiment, particularly useful when placed over balloons and sleeves, a chrome-plated steel ball may be used, which is corrosion resistant and harder than the underlying metal, typically having a hardness comparable to that of a solid chrome ball.

[0039] In some embodiments, the plaque disruption feature comprises one or more materials that coat, cover, plate or otherwise attach to one or more of the feature contact region, the feature base, and / or the feature exterior surface. In preferred embodiments, the materials provide one or more of the following to the surface of the feature, base, or contact region: rounded, blunt, smooth, slippery, frictionless, convex, atraumatic surface, and / or lubricity. In some examples, the material is a polymer including one or more of polyparaxylylenes such as parylene, parylene N, and parylene C, silicones such as polydimethylsiloxane, poly(diphenyl)siloxane, poly(methyl-co-phenyl)siloxane, poly(methyltrifluoropropyl)siloxane, poly(methyl-co-methyltrifluoropropyl)siloxane, or equivalents, polyurethanes and their copolymers such as Tecoflex, Pellethene, Chronoflex, Chronoprene, Chronocene, Chronosyl, polymer hybrids, or equivalents, polyethylene vinyl acetate, polyvinylidene fluoride, polyvinylidene fluoride-co-hexafluoropropene, polybutyl methacrylate, poly(styrene-butadiene-styrene), polylactides, hydrophilic materials, or equivalents, or combinations thereof. Examples of metals or metal alloys for coating include, for example, titanium, Ti-6Al-4V alloy, titanium-magnesium, stainless steel, e.g., 316, 304, 420, or equivalents, magnesium alloys, e.g., yttrium-zirconium-magnesium, chromium, cobalt, cobalt-chromium, CoCrMo, nitinol, tungsten, gold, platinum, silver, zinc, palladium, iridium, ruthenium, rhodium, indium, tin, molybdenum, iron, vanadium, nickel, niobium, zirconium, or equivalents, or combinations thereof, used to provide a hard or harder surface, but smooth, rounded, convex, and / or blunt, applied to the polymeric feature by evaporation, sputtering, vapor deposition, or plasma coating onto the surface of the feature.Examples of polymer features that are rigidified by filling with fine glass, quartz, or silica fibers or particles, such as 40% glass-filled nylon, carbon fibers, carbon nanospheres, carbon nanotubes, carbon nanofibers, carbon nanotubes, talc, aramid, or the like, are further examples.

[0040] In a preferred embodiment, an adhesive is used to attach, adhere, bond and / or join the features or feature bases to the expandable structure surface. Examples include, but are not limited to, light curable materials such as Henkel Loctite 3943, 3973, 3972, 3321, 3311, 3526, Permabond UV610, UV670, UB7141, or equivalents, epoxies such as 5 Minute Epoxy, Epo-tek MED-353ND, Epo-tek MED-HYB-353ND, Masterbond EP41SMed, Henkel Loctite 3981, polyurethanes such as Permabond PT321, PT326, and PT328, epoxy-polyurethane hybrids, and cyanoacrylates such as HB Fuller M2240-05, Permabond ET5393, Permabond 2011, Infinity CA-110-M, Loctite 4014 (primers such as HB Fuller 6070 or Loctite 713), structural acrylic adhesives such as Permabond TA430, TA435, TA437, TA49, TA459, TA4246 (with or without initiator 41 or 46), or equivalents, or combinations thereof. In preferred embodiments, the adhesive material covers at least a footprint the size of the footprint of the feature (or feature base) contacting the expandable structure surface, a footprint larger than and including the footprint of the feature or feature base contacting the expandable structure surface, at least some of the feature surfaces above the expandable structure surface, or at least the entire exterior surface of the feature. In yet another embodiment, the adhesive coats at least the interior surface of a hollow feature.

[0041] In a preferred embodiment, the stress-applying features include blunt contact regions that act to concentrate the force applied to occlusive material, resistive material, plaque, or calcified plaque on or within the wall of a blood vessel as the expandable structure or scaffold expands within a blood vessel or other body lumen.

[0042] In a preferred embodiment, the plaque disruption feature contact area is symmetric. The symmetric configuration provides smooth navigation through the vasculature without causing suspension or vascular injury. In another embodiment, the plaque disruption feature contact area is asymmetric.

[0043] An individual stress application feature will typically have a single blunt contact area, but in some cases may have two, three, or more separately formed blunt contact areas, each defined by a continuous peripheral boundary. An individual blunt contact area is typically within 0.0001 mm. 2 ~5mm 2 , preferably 0.001 mm 2 ~2mm 2 , more preferably 0.001 mm 2 ~0.2mm 2 , most preferably 0.01 mm 2 ~0.2mm 2 In one embodiment, the total outer surface area of ​​the sinusoidal scaffold ring or balloon will typically be within 0.05 mm 2 ~10mm 2 , preferably 0.5 mm 2 ~2.5mm 2 , more preferably 0.5 mm 2 ~1.5mm 2 Depending on both the total number of blunt contact areas and the contact area of ​​each individual blunt contact area, the force (pressure) per unit area applied by the stress application feature will be increased by a factor in the range of 1 to 1,000, often 1 to 100, and preferably 1 to 50.

[0044] The radial distance of the blunt contact region of the stress-applying feature above the outer surface of an expandable structure, such as a scaffold or other structure, may be in the range of 0.05 mm to 1 mm, preferably 0.15 mm to 0.5 mm. The blunt contact region may have a width or diameter (for a circular blunt contact region) ranging from 10 μm to 2.5 mm, preferably 30 μm to 250 μm. In some cases, the blunt contact region may have a width to length ratio in the range of 1:3 to 3:1, often 1:2 to 2:1, and often about 1:1, and is often circular.

[0045] The stress-applying features will typically be positioned directly over the outer surface of the scaffold, i.e., the features will be integrally formed and then deposited or otherwise positioned to extend or protrude radially away from the outer surface of the struts, crowns, links, or other primary components of the scaffold. In other cases, however, the stress-inducing features can be formed as integral, but the attached components of the scaffold have, for example, arms or other integral connectors (similar to the links between adjacent rings) that extend from the features and connect to the primary scaffold elements. Examples include stress-applying features attached to scaffold crowns, struts, or links by arms. In some examples, a single attached stress-applying feature may be attached to two or more primary scaffold components (e.g., crowns, struts, or links) by two or more individual arms.

[0046] Such accessory stress-applying features may be formed with blunt contact areas that project radially outwardly, and may be useful in further reconfiguration or deformation. In this manner, the blunt contact areas may be positioned laterally away from the outer surface of the primary scaffold component. In other cases, the accessory features may be folded, typically by bending them over so that the attachment arms overlie the outer surface of the adjacent primary scaffold component. Optionally, such folded accessory features may be further attached to the primary component by any of the soldering, welding, gluing, interference fit, mechanical interlocking, bonding, or other techniques, as described above.

[0047] In some examples, the stress-applying features are located on opposing surface areas on the balloon surface or on the expandable structure such as the scaffold circumferential rings, such as on opposing crowns and / or struts, i.e., 180° apart. In other examples, the individual stress-applying features may be distributed around the circumference of the balloon, sleeve, cage, or individual rings at other equal angular separations, e.g., 30°, 45°, 60°, 90°, or 120°, typically located on the surfaces of the crowns, struts, axial links, or bridges of two or more of such scaffold structures. In these and other cases, the stress-applying features on the expandable structure or on the individual rings may be circumferentially offset from those on the axial length or one or more axially separated rings, e.g., about 10°, 20°, 30°, 40°, 60°, or 90°. In still further examples, the stress-applying features may be arranged in a helical pattern along a partial or full length of the expandable structure or scaffold. In other examples, the stress-applying features on an expandable structure, stent, or individual rings may be circumferentially and axially offset from one another within the structure, stent, or ring, and / or may be circumferentially and axially offset from those on a region of the expandable structure or one or more other rings. In yet another example, at least one end of the expandable structure or scaffolding may have fewer or no stress-applying features (compared to the central structure or scaffolding region) over at least one, two, three, four, five, six, or more terminal lengths as measured in mm or cm, or circumferential rings on one or both ends of the scaffolding, and often no stress-applying features over these terminal ends or end rings.

[0048] In preferred embodiments, the stress-applying features may be located only on the crown regions; the stress-applying features may be oriented circumferentially around the surface of some or all of the individual rings; the number of stress-applying features per ring may range from 1 to 5, preferably 2 to 5, more preferably 2 to 3 stress-applying features; the stress-applying features may be located only on the crown regions, only on the junction regions, or only on the crown and junction regions; the stress-applying features may be located only on diametrically opposed crown regions, only on diametrically opposed junction regions, or only on diametrically opposed crown and junction regions; or the stress-applying features may be located only on crown regions, junction regions, or crown and junction regions that are circumferentially separated by 30°, 45°, 60°, 90°, 120°, or 180°, on the same ring, or on axially adjacent or separated rings. In yet other embodiments, the stressing features may be present within individual circumferential rings with a ratio of "stressing features" to "crowns" within the range of 1:1 to 1:4, and often 1:2 to 1:3.

[0049] The stress-applying features of the present invention may have any one of a variety of specific shapes and configurations characterized by a blunt contact area at a location spaced radially outward from the outer surface of the expandable structure or scaffold. For example, they may have a disk-like shape, a truncated cone-like shape, a sphere, a ball, an elliptical shape, a truncated prism-like shape, a truncated teardrop shape, or the like. The base of the stress-applying feature may contact the outer surface of the expandable structure or scaffold, with a footprint having an elliptical, triangular, circular, polygonal, or irregular perimeter, and the blunt end positioned radially outward from the outer surface of the expandable structure or scaffold. In some cases, the stress-applying features may be layered, with a base layer affixed to the outer surface of the expandable structure or scaffold, and one, two, three, or more additional layers formed or attached over the base layer. The layers can be formed from the same or different materials, can be applied or deposited in situ or pre-formed and attached by any of the methods described above, and can have the same or different shapes, lengths, widths, or heights. The stress-applying features will typically be symmetrical, but in some cases may be constructed asymmetrically with respect to circumferential and / or axial lines or planes.

[0050] The blunt contact region will typically be circular, but in some cases may be square, rectangular, polygonal, and / or elongated in the axial or lateral directions. For example, the blunt contact region may have a length and a width, with an aspect ratio ranging from 5:1 to 1:10, preferably 3:1 to 1:10, more preferably 2:1 to 1:10. In preferred embodiments, the length to width ratio of the blunt contact region ranges from 2:1 to 1:2, about 1:1, or about 1:2. In yet another preferred embodiment, the width of the stress-applying feature or the stress-applying feature base is greater than the width of the stress-applying feature. In yet another embodiment, the height of the blunt contact region (the distance radially spaced from the outer surface of the expandable structure or scaffold at the attachment point of the stress-applying feature) is greater than the length or width of the blunt contact region, greater than both the length and the width, greater than the length but less than the width, or less than the length but greater than the width. In yet another embodiment, the circumferential width is equal to or greater than the axial length of at least some of the stress-inducing features.

[0051] In most cases where the expandable structure is a stent (scaffolding), the base of the stress-applying feature does not extend beyond the edge of the outer surface of the single crown region, single strut region, or single link region, but in other cases the base may extend beyond the edge of the scaffold surface and / or span two or more adjacent crowns, struts, and / or links.

[0052] The stress application features will be configured to shear, rupture, break, crush, indent, or fragment occlusive material on or within the interior walls of a blood vessel, valve, or body lumen, including both arteries and veins in the heart and peripheral vasculature. The occlusive material may often comprise calcified lesions in the form of calcified plaque that partially or completely occlude or partially or completely surround a blood vessel, valve leaflet, or lumen. In a preferred embodiment, the features comprise or consist of blunt contact areas configured to shear, rupture, indent, break, crush, or fragment occlusive material on or within the interior walls of a vessel or body lumen when the expandable structure, such as a balloon, stent, sleeve, or the like, is inflated or expanded to its radially expanded deployed configuration. For example, the blunt contact region may also have a peripheral edge that shears, breaks, fractures, crushes, or otherwise fragments the occlusive material, while the surface of the blunt contact region prevents the peripheral edge from unintentionally cutting or otherwise causing substantial injury, such as dissection, to the vessel wall, valve leaflet, or body lumen. In yet another example, the stress application feature contact region and peripheral edge are blunt, which dilates, recesses, shears, breaks, fractures, crushes, or otherwise fragments the plaque or occlusive material when the blunt contact surface and peripheral edge are pushed or pressed against the vessel wall, hardened plaque, valve annulus, valve leaflet, or body lumen. In this example, the peripheral edge is blunted by beveling the edge, polishing the edge, or coating the edge or feature surface. In yet another example, the stress-applying feature surface, comprising the contact region, peripheral region, base, and feature body, is blunt such that when the blunt surface is pushed or pressed against a vessel wall, hardened plaque, valve annulus, valve leaflet, or body lumen, it recesses, shears, breaks, fractures, crushes, or otherwise fragments the plaque or occlusive material.In yet another embodiment, the stress-applying features, including the surface contact region, base, and feature body, are blunt and lack peripheral edges such that when the blunt surface is pushed or pressed against a vessel wall, hardened plaque, annulus, leaflet, or body lumen, it will indent, shear, break, fracture, crush, or otherwise fragment the plaque or occlusive material. In yet another embodiment, the stress-applying features on one or more surfaces are blunt, blunt-headed, or otherwise cause little to no injury to the vessel, body lumen, annulus, leaflet when the expandable structure containing the features is expanded or deployed radially or axially against a vessel wall, body lumen, or annulus / leaflet. In yet another embodiment, the stress-applying feature surfaces have the same degree of bluntness or different degrees of bluntness.

[0053] In a preferred embodiment, the stress application feature comprises one or more of applying a force to tissue, resistive tissue, plaque, calcified plaque, and / or fibrous plaque to fracture vascular occlusions, indent vascular tissue and / or occlusions, and / or enlarge a vascular or body lumen.

[0054] In a preferred embodiment, the stress-applying features on the contact area may have one or more of the following configurations: blunt, atraumatic, blunt, and the stress-applying features contact area shears, dents, and / or breaks and / or fractures hardened vascular tissue and / or calcified plaque, enlarging the vascular lumen.

[0055] In another embodiment, the stress-applying feature has a body. In another embodiment, the stress-applying feature comprises a base, the base being separate from the feature body, and the feature and the base being attached together.

[0056] In another embodiment, the stress-applying features are formed on a balloon, expandable member, sleeve, cage, or other device. In another embodiment, the stress-applying features are formed on an outer surface of the balloon, expandable member, sleeve, cage, or on an inner ...

[0057] While in many embodiments and examples, the stress-applying features of the present invention are intended to be placed and attached directly to the exterior of expandable structures such as balloons, stents, and graft structures, in other cases they may be placed on the exterior and / or interior surfaces of an expandable sleeve or similar support structure that may be placed over a conventional balloon or stent or vascular graft. In still other cases, the stress-applying features of the present invention may be placed directly on an angioplasty balloon as a complement or replacement for the blades / elements of a conventional cutting or slitting balloon. In some cases, a balloon having stress-applying features as described herein may be used to expand a stent or vascular graft, and the balloon and stress-applying features are removed from the stent or vascular graft after expansion.

[0058] A wide variety of stress and force applying features are described and claimed herein, such as blunt, domed, those with sharp elements, and the like, as well as a wide variety of expandable structures or components or substrates, such as stents, grafts, balloons, sleeves, cages, and the like. The present invention will include each and every individual type of stress or force applying element, individually and in combination, in combination with each and every expandable structure / component.

[0059] Additionally, in some cases, preferred stress-applying features of the present invention may be incorporated onto scaffolding components that open and splay radially outward from the outer surface of the stent when the stent is radially expanded.

[0060] In yet other cases, the surfaces of the stress-applying features, including the blunt contact regions, can be roughened or otherwise modified to improve adhesion to the surface of the vessel or calcified lesion, e.g., have one or more tissue interface features, i.e., features for stably engaging vessel wall tissue, such as texture, abrasion, friction, barbs, spikes, wedges, microstructured patterns, or the like, on, across, or adjacent the surface before, during, or once occlusive material is fractured to minimize mispositioning or sliding of the expandable structure, such as a balloon, sleeve, cage, or scaffold, at or adjacent to the stress-applying feature. In yet another example, the base of the feature may be roughened to improve bonding between the base and the expandable structure surface.

[0061] In yet other cases, the stress application feature may comprise a sharp element that projects outwardly from the blunt contact region. The sharp element, e.g., a shaft or other body having a sharp tip or edge, is typically configured to focus stress when the blunt contact region is pressed against the surface of the occluding material and engaged against the occluding material on the wall of the vessel lumen. The height of the sharp element will be selected to be sufficient to enhance or "core" the rupture of the hardened lesion while reducing or eliminating the risk of injury to the arterial wall, both underlying the lesion and distal to the lesion. For example, the blunt surface may extend a first distance above the surface of the balloon or scaffold, and the sharp element projects from the surface of the blunt contact region a second distance equal to 0.05-0.1 mm of the first distance. Typically, the sharp element will have a height or length of at least 0.01 mm, typically in the range of 0.01 mm to 0.2 mm, usually in the range of 0.01 mm to 0.1 mm.

[0062] In a first aspect, the present invention provides an endoluminal prosthesis comprising a scaffold and a plurality of stress-applying features coupled to an outer surface of the scaffold. The scaffold is at least partially comprised of a non-degradable material and configured to expand from a crimped configuration to an expanded, deployed configuration. At least some of the stress-applying features comprise blunt contact regions spaced outwardly from the outer surface, the blunt contact regions configured to disrupt occlusive material in a wall of a vascular lumen when the scaffold is expanded from the crimped configuration to an expanded configuration within the vascular lumen. The scaffold, in other examples, may be comprised of a degradable material, such as a degradable polymeric material or a degradable metallic material, or a non-degradable material, such as a non-degradable metal or metal alloy material, the material configured to expand from the crimped configuration to the expanded, deployed configuration.

[0063] In a preferred embodiment, the plaque disruption feature is applied to a non-degradable scaffold structure, hi other embodiments, the plaque disruption feature is applied to a scaffold structure that is degradable within a physiological environment, and the degradable material comprises a degradable polymeric material or a degradable metal or metal alloy material.

[0064] In specific examples, the scaffold or expandable structure may have a tubular geometry, such as a cylindrical shape, an oval shape, a tapered profile, an hourglass shape, a dog-bone shape, other shapes, or the like.

[0065] In particular examples, at least some of the blunt contact regions include a peripheral edge configured to concentrate stress upon engagement against occlusive material on a wall of the vascular lumen when the expandable structure, such as a scaffold, is expanded from a crimped configuration to an expanded configuration within the vascular lumen. Such concentrated stress will shear, break, fracture, crush, or otherwise fragment the occlusive material contacted by the blunt contact region. The peripheral edge may be formed by an intersection between the blunt contact region and a peripheral wall that at least partially surrounds the blunt contact region. The blunt contact region may have a variety of shapes or surfaces, such as flat, rounded, convex, or concave.

[0066] In specific examples, the blunt contact region may be flat and the blunt contact region may be parallel to the outer surface of the scaffold. Alternatively, the blunt contact region may be inclined relative to the outer surface of the expandable structure or scaffold. The peripheral wall may be oriented at an angle in the range of 75° to 105° relative to the blunt contact region. The peripheral edge may extend completely or partially about the blunt contact region and may have a width in the range of 10 μm to 200 μm. In some cases, the peripheral edge may be circular and the width comprises a diameter.

[0067] In specific examples, at least some of the plurality of stress-applying features comprise one or more plates having a total thickness in the range of 0.1 mm to 1 mm, 0.15 mm to 1 mm, or 0.25 mm to 1 mm, and a width in the range of 0.05 mm to 2 mm or 0.1 mm to 2 mm when attached to the surface of the expandable structure or tubular scaffold. At least some of the plates may be configured as disks, stacked disks, truncated cones, disks stacked with truncated cones, elliptical disks, asymmetric cones, and the like. In other examples, the stress-applying features may comprise one or more spheres, balls, hemispheres, partial spheres, or the like forming various shapes such as a "snowman" shape, or other configurations, or combinations thereof.

[0068] In specific examples, the scaffolding may be formed as a conventional intravascular stent, typically comprising multiple struts joined by crowns. The struts and crowns may be formed into circumferential rings, and in some cases the multiple struts joined by crowns may be joined into multiple successive adjacent circumferential rings joined by axial links, and in other cases the rings may be joined in a spiral or other pattern.

[0069] In preferred cases, at least some of the stress-applying features may be located at or adjacent to the crowns, and optionally, at least some of the crowns carrying the stress-applying features may not be joined to adjacent rings. In many cases, the stress-applying features will each be located at or adjacent to a crown.

[0070] In alternative cases, at least some of the stress-applying features may be located on the struts between the crowns, or on one or more links joining adjacent rings.

[0071] In some cases, at least some of the stress-applying features may be arranged in diametrically opposed pairs, and optionally the crowns of successive diametrically opposed pairs may be circumferentially offset. Such crowns of successive diametrically opposed pairs may be circumferentially offset by an angle between 45° and 90°.

[0072] In alternative cases, at least some of the stress-applying features may be arranged in groups of three, four, or five, which may be separated circumferentially about a circumference or circle on the surface of the expanded structure or tubular scaffold by about 120°, 90°, or 72°, respectively. In other cases, at least some of the stress-applying features may be arranged in groups of three, four, or five, which may be separated circumferentially about a circumference or circle on the surface of the expanded structure or tubular scaffold by about 120°, 90°, or 72°, respectively, along the length of the expanded structure or stent.

[0073] In still other cases, the stress-applying features may be arranged in other regular and / or random patterns. For example, in some patterns, successive axially spaced stress-applying features will be circumferentially offset by an angle in the range of 5° to 15°. Alternatively, or in addition, at least some successive circumferentially spaced stress-applying features may be axially offset by the same or different angles in the range of 5° to 15°.

[0074] In specific examples, the scaffolds of the present invention may be formed by patterning a tubular substrate, laser cutting a tubular substrate, rolling a cut substrate, bending wires, by 3D printing, or by other known stent fabrication techniques. The stress-applying features may be preformed and attached by gluing, soldering, welding, threaded attachment, riveting, crimping, or the like. For example, the stress-applying features may comprise preformed plates that are glued to the scaffold with an adhesive. Alternatively, the stress-applying features may be formed in situ by 3D printing, chemical vapor deposition, electrostatic deposition, molding, or folding of the scaffold components. For example, the stress-applying features may comprise tabs that are attached to the scaffold and folded over the outer surface of the scaffold.

[0075] In specific examples, the scaffold may comprise a vascular stent or stent-graft. In other examples, the scaffold may comprise a prosthetic valve, a valvuloplasty device, a sleeve, or the like. In each of such cases, the scaffold may be balloon-expandable or self-expanding.

[0076] In a second aspect, the present invention provides a method for disrupting calcified plaque in a patient's vasculature. A scaffold as in any one of the previous embodiments is expanded from a crimped configuration to an expanded configuration in a calcified body vessel lumen. A plurality of stress-applying features secured to an outer surface of the scaffold are caused to indent, expand, open, or disrupt occlusive material on or in the wall of the vessel lumen as the tubular scaffold is expanded from the crimped configuration to the expanded configuration. The occlusive material typically comprises hardened plaque or calcification.

[0077] In specific cases, expanding the scaffold includes expanding a balloon, expanding the scaffold, or alternatively, allowing the scaffold to self-expand. For example, expanding the scaffold may include expanding the prosthetic heart valve within the heart valve annulus, where the scaffold provides structural support for the heart valve annulus, for example, expanding the prosthetic heart valve may include expanding a balloon and expanding the prosthetic heart valve within the heart valve annulus, or may include removing the crimped elastic scaffold from the radial constraint after positioning within the heart valve annulus.

[0078] In other examples, expanding the scaffolding includes expanding the valvuloplasty device within the heart valve annulus. The scaffolding of the valvuloplasty device may comprise an expandable cage, and expanding the valvuloplasty device includes expanding the cage within the heart valve annulus.

[0079] Cages according to the present invention may be formed from elastic and / or malleable metals and polymers, including, but not limited to, any of the materials described herein for fabrication of scaffolds and stents. Such cages may be self-expanding, balloon-expandable, or the like, and self-expanding cages may be configured to self-expand and / or radially expand upon release from radial constraint in response to mechanical actuation, e.g., by axial shortening. Each of these radial expansion mechanisms is well known and need not be described further.

[0080] In a third aspect, the invention provides a method for fabricating a vascular scaffold. The tubular scaffold comprises a plurality of struts within a tubular envelope joined by crowns. A plurality of tabs extending outwardly from the struts and / or crowns within the tubular envelope are folded over an outer surface of the tubular envelope to form a plurality of stress applying features on the outer surface of the tubular scaffold.

[0081] In a specific case, adjacent tabs of a pair that are folded one over the other form stacked stress-applying features. Adjacent tabs within a pair may be arranged side-by-side on the scaffold prior to folding. Alternatively, adjacent tabs within a pair may be arranged in tandem on the scaffold prior to folding. As a further alternative, adjacent tabs within a pair may be arranged on opposite sides of a strut prior to folding.

[0082] The stress-applying features can also be placed on extensions to the crowns, struts, links, or other structural elements of the scaffold. The extensions can be supported or connected to the same or different structural elements on the same ring or diametrically opposed rings, and preferably the extensions have free terminal ends and the stress-inducing features are placed on or about such terminal ends. Such extensions can have a width that is the same or different from that of the element from which they extend, and can have any one of a variety of shapes and configurations.

[0083] The stress-inducing features may be located on the struts, strut extensions, crowns, crown extensions, links, and / or link extensions. Preferably, the stress-inducing features are located on the ends or other free ends or side structures of the crowns, struts, links, or extensions that are located on structural elements that are deflectable in a radially outward direction when the scaffold is expanded from the crimped configuration to the deployed configuration, e.g., that are free to deflect as "cantilevered" elements. In further preferred embodiments, the stress-inducing features are located on the terminal ends of the extensions or on hinge elements that comprise the crowns or portions of the links, such as Z-, M-, W-, U-, V-, S-shaped links.

[0084] In some cases, the stress-inducing features can be located on the interior surface of the scaffold, e.g., on the cantilevered ends of the crown regions or extensions, strut regions or extensions, and / or link regions or extensions. In such cases, expansion of a balloon or other expandable element within the scaffold will deflect the cantilevered ends radially outward relative to the remainder of the exterior surface of the scaffold (the features on the interior surface will act as a spacer, causing the exterior surface to expand preferentially), and thus act as if the features were located on the exterior surface of the scaffold. In such cases, the features on the interior surface need not be configured to rupture occlusive material (preferably configured not to damage the expanding balloon), and the exterior surface of the crowns, struts, links, or extensions that are deflected will have a peripheral edge configured to fragment or crack plaque, calcium, or other occlusive material.

[0085] In some cases, the stress-inducing features may be held on the exterior or interior surface of the scaffold by arms, clamps, or other connecting elements that are fabricated with the scaffold. Such stress-inducing features may be bonded and positioned in place (e.g., by bending an attachment arm), but are not affixed. In such cases, the stress-inducing features may contact the surface of the scaffold, or there may be a gap left between the feature and the surface of the scaffold. As in other cases, these stress-inducing features will contact the occluding material upon expansion of the scaffold.

[0086] In some examples, multiple stress-inducing features may be offset circumferentially and axially within a circumferential ring or a single or more row of circumferential features of an expanded structure. For example, three stress-inducing features located on three crowns in a ring would be offset circumferentially, but may or may not be offset axially. They would be offset axially if the crowns were offset axially and / or some of the stress-inducing features were located on struts.

[0087] The stress application features of the present invention will typically have a blunt contact area, but as described above, in alternative cases they may comprise cones or pyramids that are not truncated and may or may not comprise a blunt contact area.

[0088] In a further aspect of the invention, an apparatus for treating hardened plaque or calcification on or in a wall or valve annulus or valve leaflet in a body vessel or lumen of a patient comprises a catheter including a catheter body having a proximal end and a distal section; an expandable structure disposed at or near the distal section of the catheter, the expandable structure having an outer surface configured to be displaced radially outward toward an inner surface of a vessel wall, body lumen wall, or valve annulus; and a plurality of plaque disruption features distributed across the outer or inner surface of the expandable structure, at least some of the plaque disruption features being attached to the outer or inner surface of the expandable structure and in one example having a convex rounded upper or base surface configured to indent, open, dilate, or disrupt calcifications in the vessel or body lumen when the expandable structure is expanded within the vessel or body lumen while minimizing damage to the vessel or body lumen. The expandable structure may be advanced into the target vessel or body lumen prior to advancing a balloon catheter through the expandable structure to expand the expandable structure and disrupt the hardened plaque.

[0089] Alternatively, the expandable structure is advanced over a balloon catheter already in position at the target site, and the expandable structure is then bridged over the balloon section prior to expansion of the balloon, causing the expandable structure to expand and break up the hardened plaque. In yet a third embodiment, the expandable structure is bridged over the balloon section of the balloon catheter prior to insertion into the patient's body, and the system is introduced into the patient's body together. In yet a fourth alternative, the expandable structure is advanced distally to the target site, the balloon catheter is advanced to the target site, and the expandable structure is retracted and bridged over the expandable balloon section to expand the expandable structure. In one preferred embodiment, the expandable structure comprises an elastic tubular body that is expandable from a crimped or compact configuration to an expanded configuration. In another embodiment, the expandable structure comprises a cage comprising two or more elongate members that separately axially and circumferentially connect the distal end of the catheter to the proximal end of the catheter distal section, the strips not connected to adjacent strips except at the proximal and distal ends, and the elongate members are expandable from a small configuration to a larger expanded configuration.

[0090] In another embodiment, such a device may be configured to treat a body lumen, in any of the embodiments, a blood vessel, a valve annulus, a venous valve, or an AV shunt, where hardened plaque or calcification is typically located on or within the inner wall, intimal layer, medial layer, adventitial layer, valve leaflet, valve annulus, venous filter, or implant.

[0091] In some embodiments, the expandable structure may be less rigid when unexpanded and more rigid when fully expanded.

[0092] In some embodiments, the exterior surface of the expandable structure may be generally cylindrical when fully or partially deployed or expanded, hi other embodiments, the expandable structure may be oval, convex, hourglass, tapered, conical, elliptical, or other shape or configuration when expanded or deployed into an expanded configuration.

[0093] In some embodiments, the plaque disruption features comprise convex rounded upper surfaces of the plurality of plaque disruption features that may extend radially outward beyond the outer surface of the expandable structure when fully expanded. For example, the convex rounded upper surfaces of the plurality of plaque disruption features may extend radially outward beyond the outer surface of the expandable structure a distance ranging from 0.25 mm to 3 mm, preferably 0.5 mm to 3 mm, when partially or fully expanded.

[0094] In some examples, the convex, rounded upper surface of the plaque disruption features may be free of edges and irregularities that may damage the wall when the expandable structure is expanded within a body lumen.

[0095] In some embodiments, at least some of the plaque disruption features may have a single convex rounded upper surface and a lower base that is independently attached to the outer surface of the expandable structure.

[0096] In some examples, at least some of the plaque disruption features may have a convex, rounded tissue contacting surface and a base attached to a surface of the expandable structure.

[0097] In some embodiments, at least some of the plaque disruption features may have a concave tissue contacting surface and a base attached to a surface of the expandable structure, while in other embodiments, at least some of the plaque disruption features may have a convex tissue contacting surface and a base attached to a surface of the expandable structure.

[0098] In some examples, at least some of the plaque disruption features may have a convex, rounded tissue contacting surface and a base attached to a surface of the expandable structure, the base having a maximum configuration or dimension of the feature maximum configuration or dimension.

[0099] In some examples, at least some of the plaque disruption features are formed from a metal or metal alloy. In other examples, the features are formed from a polymeric material. In yet a third example, the features are formed from a polymeric material and coated with a harder material, such as a metal or metal alloy material, to provide the necessary hardness to disrupt the hardened plaque. In yet another example, the material forming the features may be ceramic. In yet another example, the material forming the features may be coated with a harder material to provide sufficient strength to disrupt the hardened plaque. In yet another example, the material forming the features may be coated with a softer (lower hardness) material to provide roundness, convexity, lubricity, frictionlessness, or bluntness, such as in examples of such materials that are coated with metallic materials forming the features and adhesive materials, polymeric materials, and / or hydrophilic coatings. In yet another example, the material forming the features may be coated with a similar hardness material to provide one or more of a rounded, convex, blunt, and / or atraumatic surface.

[0100] In another example, the plaque disruption features may have the same or different heights, widths, lengths, diameters, shapes, and / or configurations along the circumference and / or axial length of the expandable structure.

[0101] In some embodiments, at least some of the plaque disruption features consist of or comprise a secondary surface, configuration, or shape. In some embodiments, the base surface of the post-formed feature that is attached to the expandable structure surface is flat, oval, rounded, square, rectangular, or contoured relative to the expandable structure surface. In some embodiments, the maximum height from the contact area to the base of the post-formed feature is approximately equal to half the maximum width, length, or diameter of the base of the feature. In other embodiments, the maximum height from the contact area to the base of the post-formed feature is less than half the maximum width, length, or diameter of the base of the feature. In yet other embodiments, the maximum height from the contact area to the base of the post-formed feature is greater than half the maximum width, length, or diameter of the base of the feature.

[0102] In some examples, at least some of the plaque disruption features comprise a secondary shape or configuration including at least one of a spherical, elliptical, oblate, or prolate structure.

[0103] In some embodiments, at least some of the plaque disruption features consist of or comprise a partial spherical, partial elliptical, partial oblate, or partial prolate structure.

[0104] In preferred embodiments, at least some of the plaque disruption features have contact area surfaces that are formed to have rounded, contoured, blunt, smooth, convex, and / or atraumatic surfaces. In other embodiments, the plaque disruption feature contact area surfaces are coated, covered, or plated with a material to provide the rounded, contoured, blunt, smooth, convex, and / or atraumatic surfaces. In one embodiment, the coated, covered, or plated material is a metal, polymer, ceramic, or other type of material configured to provide the rounded, contoured, blunt, smooth, convex, and / or atraumatic surfaces.

[0105] In a preferred embodiment, at least some of the plaque disruption features have their entire surface above a base surface that is attached to an expandable structure surface that is formed, plated, coated, or covered, and has a rounded, contoured, blunt, smooth, convex, and / or atraumatic surface.

[0106] In preferred embodiments, at least some of the plaque disruption features have their entire surface, including a base surface, attached to an expandable structure surface that is formed, plated, coated, and / or covered, and that is rounded, blunt, smooth, convex, rounded, and / or atraumatic.

[0107] In some examples, at least some of the plaque disruption features may comprise a spherical or elliptical shape.

[0108] In another embodiment, at least some of the plaque disruption features are formed from spheres, partial spheres, or hemispheres. In one embodiment, the maximum height of the partial spheres ranges from 0.1 mm to 3 mm, preferably from 0.25 mm to 2 mm. In one embodiment, the maximum diameter of the partial spheres ranges from 0.1 mm to 2 mm, preferably from 0.25 mm to 1 mm. In yet another preferred embodiment, the partial spheres have a configuration that ranges from 10% to 90% of a spherical configuration, preferably from 25% to 75% of a spherical configuration. In a preferred embodiment, the partial spheres are hemispheres (half of a sphere). In a preferred embodiment, the plaque disruption features comprise a plurality of spheres, and the sphere diameter ranges from 0.20 mm to 2 mm, preferably from 0.25 mm to 1 mm. In another embodiment, the plaque disruption features comprise a plurality of partial spheres or hemispheres. In one embodiment, the partial spheres or hemispheres have a maximum diameter ranging from 0.2 mm to 2 mm, preferably ranging from 0.25 mm to 2 mm. In another embodiment, the multiple spheres, partial spheres, or hemispheres have the same size, height, and / or diameter along the expandable structure circumference and / or axial length. In another embodiment, the plaque disruption spheres, partial spheres, or hemispheres have different sizes, heights, and / or diameters along the expandable structure circumference and / or axial length. The partial spheres may be attached directly to the expandable structure surface in one embodiment. In another embodiment, the partial spheres may have a separate base attached to the expandable structure surface and attached to the partial sphere base. In yet another embodiment, the partial spheres may have an integral base to the partial spheres attached to the expandable structure surface.

[0109] In some examples, at least some of the plaque disruption features may comprise hemispheres having lower surfaces attached to the outer surface of the expandable structure, e.g., the lower surfaces may be flat or contoured relative to the expandable structure surface.

[0110] In some embodiments, at least some of the plaque disruption features may comprise posts having a hemispherical upper surface and a lower surface attached to an outer surface of the expandable structure.

[0111] In some embodiments, the expandable structure may comprise an inflatable balloon, for example, the inflatable balloon may have a distensibility of less than 10% or less when inflated to a pressure of at least 8 atm, at least 10 atm, at least 12 atm, at least 16 atm, at least 18 atm, or at least 20 atm.

[0112] In some embodiments, the plaque disruption features are attached to the exterior surface of the expandable structure by at least one of adhesive bonding, ultrasonic welding, fusing, heat welding, fasteners, solvent bonding, bonding with a polymeric material, or combinations thereof. In preferred embodiments, the plaque disruption features are bonded using two or more adhesives, one adhesive that adheres better to or is more compatible with the expandable structure material while the other adhesive adheres better to or is more compatible with the feature material.

[0113] In some embodiments, the inflatable balloon has a central surface region, a distal tapered surface region, and a proximal tapered surface region, and the stress-applying or plaque-disrupting features are present on one or more of these surface regions. In some embodiments, the inflatable balloon has a central surface region, a distal and / or proximal flat region, one or more radially protruding surface regions, one or more hourglass regions, and / or one or more oval-shaped regions, and the stress-applying or plaque-disrupting features are present on one or more of these surface regions. Usually, the stress-applying or plaque-disrupting features are present on at least the central region. More usually, the plaque-disrupting features are present radially on at least one of the distal and / or proximal flat or tapered regions, or as protruding surface regions formed therein, and sometimes the plaque-disrupting features are present on both the distal and proximal tapered regions. In some cases, the stress-applying features are present on at least the central region, and the central region adjacent the proximal and / or distal tapers of the balloon are voids of stress-applying features. In some cases, the stress-applying features are present on at least the central region, and the central region adjacent the proximal and / or distal tapers of the balloon are voids of stress-applying features, and the region extends from 0.1 mm to 3 mm in length.

[0114] In some examples, the device may further include an outer sleeve having plaque disruption features on an inner or outer surface of the sleeve, where the sleeve is typically advanced or retracted in vivo over an expandable structure, such as a balloon, with the outer sleeve features projecting radially outward prior to or in response to advancing or retracting the sleeve over the balloon, or in response to inflation of the balloon to an expanded configuration, where the sleeve conforms to the plaque disruption features as the expandable structure is expanded, and the elastomeric tubular member is configured to expand and contract with the expandable structure expanding and contracting.

[0115] In another embodiment, the elastomeric tubular member may be placed over an expandable structure, such as a balloon, containing the plaque-disrupting features, and the sleeve shields the plaque-disrupting features as the device is advanced or retracted within a body vessel or lumen. The sleeve may be laminated or attached to at least a portion of the outer surface of the expandable structure. For example, the elastomeric tubular member may be attached to the expandable balloon section, a section distal to the expandable balloon section, or a section proximal to the balloon section. Alternatively, the outer sleeve may comprise an elastic, non-expandable, or semi-compliant sheath that covers or is folded over the balloon before the balloon is inflated. In most cases, the outer sleeve completely covers the clot-disrupting features on the outer surface of the expandable structure, and typically comprises a polymer. In some embodiments, the outer sleeve comprises sufficient perforations to allow at least some of the plaque-disrupting features to protrude radially outward through the perforations when the expandable structure is expanded. In a preferred embodiment, the perforations allow the contact surface area of ​​the stress-applying feature to protrude through the perforations.

[0116] For example, at least some of the plaque disrupting or stress applying features may be attached to an inner surface of the elastomeric tubular member or the expandable balloon. In certain cases, at least some of the plaque disrupting features may be formed as protrusions from the inner surface of the elastomeric tubular member and are urged to protrude radially outward across the elastomeric tubular member or balloon when the expandable structure is advanced or retracted inside the tubular member and / or when the expandable structure is expanded inside the elastomeric tubular member or when the balloon is inflated.

[0117] In some embodiments, the device may further comprise an outer sleeve or balloon member having radially outwardly facing protrusions formed from the same material of the sleeve or balloon, the feature being hollow at its base or comprising holes at its base, the feature covering, encapsulating, or seating on the outer surface of the sleeve or balloon protrusions. The protrusions provide a larger surface area for attachment to the feature. The protrusions typically have a configuration that will fit within or inside the feature, the fit ranging from a loose fit to a tight fit. The height of the protrusions ranges from 10% of the feature height to 100% of the feature height.

[0118] In some embodiments, the device may further comprise an outer sleeve or balloon member having a radially inward facing protrusion, funnel or depression formed from the same material of the sleeve or balloon, the feature seated within the outer surface of the sleeve or balloon depression, the depression partially covering the feature surface ranging from 10% to 60% or more coverage of the feature surface. The depression provides a larger surface area for attachment to and adhering to the feature as the sleeve or balloon is advanced and / or retracted within the patient's body or as the sleeve and / or balloon is expanded to break up the hardened plaque. The depression has a configuration that will typically partially contain the feature. In some embodiments, the feature fits snugly within the depression. In other embodiments, the feature fits tightly within the depression. In certain other embodiments, the feature or the feature base extends the depression. In yet other embodiments, the depression has a shape or configuration that is contoured to the shape of the feature or the feature base. The depression is typically coupled to or attached to the feature by an interference fit and / or one or more adhesive materials that coat the depression surface and / or the feature surface and / or the feature base surface.

[0119] In some embodiments, at least some of the plaque disruption features may have a base attached to the outer surface of the expandable structure, the base having an axial width (Wa) and a circumferential width (Wc), the width ratio Wa:Wc being in the range of 1:0.5 to 1:5, typically 1:1 to 1:5, and more typically 1:1 to 3:1. For example, at least some of the bases may have a circular perimeter or may have an oval perimeter. In other embodiments, Wa:Wc is in the range of 3:1 to 1:3, typically ranging from 2:1 to 1:2, more typically 1.5:1 to 1:1.5, and most typically about 1:1. In some embodiments, the base is an integral part attached to the plaque disruption features and is attached to the expandable structure surface. In other embodiments, the base is a separate piece from the plaque disruption features and is attached to the plaque disruption features and is attached to the expandable structure surface.

[0120] In some embodiments, at least some of the plaque disruption features may be arranged in diametrically opposed pairs. For example, the plaque disruption features of successive diametrically opposed pairs may be circumferentially offset. For example, the plaque disruption features of successive diametrically opposed pairs may be circumferentially offset by an angle between 45° and 90°.

[0121] In some embodiments, at least some of the plaque disruption features may have bases attached to the outer surface of the expandable structure, and the bases of each feature in a group of features centered around the expandable structure circumference do not overlap one another in the expanded configuration. In other embodiments, the bases of each feature do not overlap other bases of features located along an axial length of the expandable structure or along the length of the expandable structure axial length. In yet other embodiments, the bases of each feature do not overlap other feature bases along the circumference of the expandable structure when expanded, and do not overlap axially adjacent features along the axial length of the expandable structure when the structure is expanded.

[0122] In some embodiments, at least some of the plaque disruption features may be arranged in groups of three, which are circumferentially separated by approximately 120° about a circle on the surface of the expandable structure.

[0123] In some embodiments, at least some of the plaque disruption features may be arranged in two groups, which are circumferentially separated by approximately 180° about a circle on the surface of the expandable structure.

[0124] In some embodiments, at least some of the plaque disruption features may be arranged in groups of four, which are separated circumferentially by approximately 90° around a circle on the surface of the expandable structure.

[0125] In some embodiments, at least some of the plaque disruption features may be arranged in two to four groups, respectively, separated circumferentially by about 90° to 180° about a circle on the surface of the expandable structure, with each group forming a helical pattern along the length of the expandable structure when the structure is in the expanded configuration.

[0126] In some examples, at least some of the plaque disruption features may be arranged in groups of 3-10 features per group, separated circumferentially by approximately 36°-120° about a circle on the surface of the expandable structure, such that each feature footprint or base about the circle does not overlap more than one other feature footprint or base along the circle.

[0127] In some embodiments, at least some of the plaque disruption features may be arranged in groups of 3-10 features per group, separated circumferentially by approximately 36°-120° about a circle on the surface of the expandable structure, each feature footprint or base about the circle overlaps no more than two other feature footprints or bases along the circle, and each feature about the circle overlaps no more than 1-5 other features along the axial long path of the expandable structure when the structure is expanded, preferably along the entire length of the expanded structure.

[0128] In some embodiments, at least some of the plaque disruption features may be arranged in groups of 3-10 features per group, separated circumferentially by approximately 36°-120° about a circle on the surface of the expandable structure, such that each feature footprint or base from each group about the circle does not overlap with other feature footprints or bases from the same group along the circle, and such that each feature about the circle also does not overlap with other features from other groups along the axial length of the expandable structure when the structure is expanded, preferably along the entire length of the expanded structure.

[0129] In some embodiments, at least some of the plaque disruption features may be arranged in groups of 3-10 features per group, separated circumferentially by about 36°-120° about a circle on the surface of the expandable structure, and each feature footprint or base from each group about the circle has a gap when the underlying structure is fully expanded between that feature and other feature footprints or bases of the same group, the gap ranging from 0.05 mm to 2.5 mm, preferably ranging from 0.1 mm to 1.5 mm. In preferred embodiments, the gap between any two features of the same group is measured along the axial length between the two feature footprints or base circles.

[0130] In some embodiments, at least some of the plaque disruption features may be arranged in groups of 3-10 features per group, randomly separated about 10°-180° circumferentially around a circular shape on the surface of the expanded structure.

[0131] In some embodiments, the plaque disruption features may be arranged in a helical pattern along the length of the expandable structure, preferably along the entire length of the expandable structure, when the structure is in the expanded configuration. In some cases, the helical pattern of at least some of the plaque disruption features completes 1 to 5 360° turns along the length or along the entire length of the expanded structure. In some embodiments, the plaque disruption features or feature bases do not overlap around the circumference and / or axial length of the expandable structure.

[0132] In some embodiments, the plaque disruption features may be arranged in a linear pattern along the length of the expandable structure, preferably along the entire length of the expandable structure, when the structure is in the expanded configuration.

[0133] In some embodiments, the plaque disruption features may be arranged in one region of the expandable structure, for example, the plaque disruption features may be arranged in a central region of the expandable structure, such as a central region of the balloon working length.

[0134] In other examples, an inflatable balloon coupled to a plaque disruption feature may be arranged to prevent an outer surface of the expandable structure, such as an outer balloon surface, from contacting hardened plaque or tissue, or to have an outer surface of the balloon that does not contact hardened plaque prior to a minimum threshold pressure, which may be any one of the following nominal or rated balloon inflation pressures: 3 atm, 5 atm, 7 atm, 10 atm, 12 atm, 15 atm, or others.

[0135] In other embodiments of the present invention, the expandable structure, such as an inflatable balloon, may be further configured to deliver drugs and other agents. For example, the inflatable balloon may be configured to release an inflation medium comprising the agent in response to an inflation pressure above a minimum threshold, e.g., above 1 atm, 3 atm, 5 atm, or 7 atm. In a specific case, the inflatable balloon may include a plurality of ports or perforations in the balloon material surface adjacent to at least some of the features, which open in response to an inflation pressure above a minimum threshold pressure. In certain other embodiments, the inflatable balloon may have a separate distal conduit formed from an elongated tubular body extending proximally from the distal conduit to the outside of the patient, and may infuse the agent while the balloon is in the expanded configuration. In yet another embodiment, the agent is coated on the stress-applying feature surface, more specifically, on one or more of the engagement or contact surface areas of the stress-applying feature, to provide the agent to the tissue when the feature contacts the vessel or annulus or leaflet tissue. In one embodiment, the agent is directly coated or sprayed onto at least the contact area surfaces of at least some of the features. In other examples, the drug is mixed with the polymeric material and the mixture is then coated or sprayed onto at least the contact areas of the stress-applying features. In yet another example, the drug is sprayed or coated onto the exterior surface of the expandable structure exterior, such as the balloon and / or stress-inducing features. In yet another example, the expandable structure comprises an expandable balloon section, the balloon section is covered by an outer sleeve comprising an elastomeric member, the balloon and / or elastomeric member comprises at least some stress-applying features attached to the exterior surface of the balloon, the exterior surface of the elastomeric member, and / or attached to the interior surface of the elastomeric member, and the exterior surface of the elastomeric member is coated with a drug comprising one or more drugs. The drug coating at least some of the features embeds in the vessel wall, body lumen, or valve annulus when the balloon is inflated, embedding at least a portion of its drug content in adjacent tissue.In a preferred embodiment, the drug comprises one or more of an antiproliferative drug, an mTOR inhibitor drug, a taxol or analog drug, a direct thrombosis inhibitor drug, and a factor Xa inhibitor drug. In yet another embodiment, the drug is located within the space between the balloon compartment outer surface and the elastomeric compartment inner surface and is permitted to permeate the elastomeric member through openings or perforations in the elastomeric member upon expansion of the balloon and release the drug into the vessel wall, body lumen, or valve annulus.

[0136] In yet another aspect, the invention provides a method for treating calcification on a wall in a body lumen of a patient, the method including positioning an expandable structure at a treatment site proximate the calcification to be treated and expanding the expandable structure radially outwardly to press a plurality of plaque disruption features radially outwardly against the calcification, the plaque disruption features being distributed across an outer surface of the expandable structure, at least some of the plaque disruption features being independently attached to the outer surface of the expandable structure and having a convex rounded upper surface, and pressing the plurality of plaque disruption features radially outwardly against the calcification breaks up the calcification while reducing damage to the wall.

[0137] In yet another aspect, the invention provides a method for treating calcification on a valve of a patient having calcified leaflets, the method including positioning an expandable structure at a treatment site proximate the calcification to be treated (such as within or through the calcified leaflet) and expanding the expandable structure radially outwardly such that the plaque disruption features press the calcified leaflet against a wall of the annulus and disrupt the calcified leaflet. The plaque disruption features are distributed across an outer surface of the expandable structure, at least some of the plaque disruption features being independently attached to the outer surface of the expandable structure and having a convex rounded upper surface.

[0138] In yet another aspect of the invention, a device for treating a valve in a patient having calcified leaflets includes a catheter body and a segmented balloon structure. The catheter body has a proximal end and a distal end. The segmented balloon is disposed at the distal end of the catheter body and has opposing inner walls (side walls) configured to be expanded on opposing surfaces of the calcified leaflets in a manner to break up the calcification on the calcified leaflets. In one embodiment, the inner side walls (or axially facing walls) of the segmented balloon are flat or protrude axially outward when the balloon is expanded and presses against the calcified leaflet surfaces from the opposing sides to break up the calcification on the calcified valve. In yet another embodiment, at least one of the segmented balloon inner side walls includes one or more stress application features coupled to the side wall and configured to engage the calcified leaflets when the balloon is expanded and breaks up the calcification, the features pressing the calcification against the opposing inner side walls of the segmented balloon. In yet another embodiment, the compartmentalized balloon inner sidewall comprises one or more stress-applying features coupled to the wall and configured to engage the calcified leaflets from opposite sides when the balloon is expanded to break up the calcification. In yet another embodiment, the number of stress-applying features ranges from 0.1 to 100 features / mm 2 and preferably 0.1 to 30 features / mm2 of the interior sidewall surface. 2 and more preferably 1-20 features / mm2 of the interior sidewall surface. 2In yet another embodiment, the stress-applying features may be arranged across the side surface of the expandable structure in various configurations, such as a circular pattern, a circle within a circular pattern, a spiral pattern, a leaflet conforming or contoured pattern, or other patterns. In another embodiment, at least some of the stress-applying features on one side of the compartmentalized balloon inner wall are configured (or arranged) to face other stress-applying features on the opposing inner wall. In another embodiment, at least some of the stress-applying features have blunt contact areas on one side of the compartmentalized balloon inner wall that are configured (or arranged) to face other stress-applying feature blunt contact areas on the opposing inner wall when the balloon is expanded to break up the calcifications between the opposing blunt contact areas. In another embodiment, at least some of the stress-applying feature contact areas that are configured to have a convex shape on one side of the compartmentalized balloon inner wall are configured (or arranged) to face other stress-applying feature contact areas on the opposing inner wall that are configured to have a concave shape for fitting into the convex opposing shaped feature when the balloon is expanded to break up the calcifications between the opposing blunt contact areas.

[0139] In yet another embodiment, at least some of the features on one side of the inner wall are configured to invaginate, or at least partially invaginate, into spaces between two, three, four, or more features on the opposing inner sidewall of the compartmentalized balloon when the balloon is inflated to break up calcifications in the leaflets. In another embodiment, the sidewall and / or inner wall may be covered by an elastomeric member that covers at least some of the features, optionally attached to the balloon compartment or other compartment of the balloon catheter and configured to expand when the balloon is expanded.

[0140] In another embodiment, the inner sidewall and / or elastomeric member are configured to expand radially and / or axially when the balloon is inflated (or fully expanded) and presses against the calcified leaflets, fracturing the calcification therein. In an alternative embodiment, sections of the balloon structure are slidably attached to or mounted on the shaft of the catheter and configured to draw the inner sidewalls together after inflation, optionally configured to nest when the balloon structure is expanded, typically having nesting cone-shaped surfaces.

[0141] In yet other embodiments, the opposing inner walls may include flat surfaces that are configured to approximate one another when the balloon structure is inflated and / or expanded. For example, the compartmentalized balloon structure may include a pair of opposing conical balloons having flat bases with flat surfaces.

[0142] In some examples, the calcification breaking features on the opposing inner wall surfaces are axially aligned as the balloon sections are pulled together, which applies a force to the opposing surfaces of the leaflets. In other cases, the calcification breaking features on the opposing surfaces are offset laterally such that they are not axially aligned as the balloon sections are pulled together. In still other cases, the calcification breaking features may be on only one of the two opposing inner wall surfaces.

[0143] In yet another embodiment, at least one region of the inner compartmentalized balloon sidewall and / or at least some of the regions and / or features of the elastomeric member cover are coated with one or more coatings comprising a polymeric material, an adhesive material, an antiproliferative agent, a factor Xa inhibitor agent, and a factor IIa inhibitor agent, the coating material configured to deliver a drug, affix fractured calcium debris to the leaflets or the inner wall of the compartmentalized balloon, or repair a perforated leaflet. In another embodiment, the coated material is configured to attach to the leaflets, transfer a material or drug to the leaflet surface, adhere to the leaflet surface, repair a perforation in the leaflet surface, or hold the leaflets together.

[0144] In another embodiment, at least some of the features on opposing sides of the interior sidewall of the compartmentalized balloon fit into one another, such as concave and convex contact surface areas, ball and socket contact surface areas, or the like. In some embodiments, the calcium fracturing features on an expandable structure, such as an expandable balloon, may be arranged on one or more of the expandable structure surfaces, including side surfaces, interior surfaces, or axially facing surfaces. In some embodiments, the expandable structure, such as an expandable balloon, may have one or more shapes, including tubular, donut, hourglass, tapered, oval, rectangular, square, or the like. In yet another embodiment, the axially facing regions of the expandable structure may have a variety of shapes, including one or more of flat, convex, concave, donut, or the like.

[0145] In another embodiment of the present invention, a device for treating a valve in a patient having calcified leaflets comprises a catheter body having at least two expandable structures, the at least two expandable structures being configured to be expanded together, such as in one embodiment a dual balloon configuration, the dual balloons sharing the same inflation lumen and the same guidewire lumen. In another embodiment, the at least two expandable structures are configured to be expanded independently, such as at least two balloon structures having separate inflation lumens and the same or separate guidewire lumens for the at least two balloon structures. In a preferred embodiment, the dual expandable structures are axially movable over a common axial tubular structure.

[0146] In a specific case, the valvular calcification treatment device will further comprise a plurality of calcification crushing features distributed across at least one of the opposing inner walls of the compartmentalized balloon structure, and preferably across both opposing inner walls (and / or axially facing walls). The calcification crushing features may comprise any of the stress application and calcification crushing features described herein, typically comprising rounded features, including those hemispherical, ball, and spherical features, as described herein.

[0147] Preferred fracturing features will typically have convex rounded leaflet-engaging surfaces configured to fracturing calcifications while minimizing damage to the leaflets when the balloon structure is expanded within a patient's valve. Typically, the convex rounded upper surface of the plaque fracturing feature will be configured to extend from the opposing inner wall to engage the leaflets when they are captured between the walls. The leaflet-engaging rounded surface of the feature will typically have a height or width within the range of 0.01 mm to 3 mm, 0.1 mm to 3 mm, and usually 0.5 mm to 2 mm when the balloon is fully inflated. In most cases, the convex rounded upper surface of the calcification fracturing feature will be free of edges and irregularities that may damage the leaflets when the balloon structure is expanded within a patient's valve.

[0148] However, in some cases, the calcification breaking features may comprise sharp elements that protrude outwardly from the convex rounded upper surface, the sharp elements being configured to concentrate stress when engaged against the calcification on the leaflet as the balloon surface presses against the surface of the leaflet. The sharp features will have a very minimal height or depth such that they will engage and break up the calcification while substantially avoiding any injury to the leaflet. The individual balloon sections may be secured to the catheter body such that when the balloon structure is inflated, they will engage and capture the leaflet without any further manipulation. However, in other cases, the balloon sections may be configured to translate axially relative to each other on the catheter body to provide variable spacing between the inner walls. In such cases, a first one of the sections may be inflated and engaged against the leaflet and an inflated second section, and then pulled against the opposing surface of the leaflet to effect the breakup.

[0149] In yet another aspect, the invention provides a method for disrupting calcification or plaque in a lesion comprising advancing a sleeve over a wire through the lesion, advancing an expandable member over the wire into an interior of the sleeve, and expanding the expandable member within the sleeve to radially displace features on an interior and / or exterior of the sleeve outward relative to the lesion to disrupt the calcification or plaque.

[0150] In some examples, the method further includes removing the expandable member from the sleeve and removing the expandable member and sleeve over the wire, where the expandable structure may comprise either a balloon or other expandable member or one of a stent, where the sleeve is left in place between the stent and the lesion after the stent is expanded. The stress-applying features may protrude radially outward from the sleeve into the vessel wall as the expandable structure displaces them radially outward in response to expansion.

[0151] In yet a further aspect, the invention provides a method for disrupting calcification or plaque in a lesion comprising advancing a cage or basket over a wire across the lesion and expanding the cage of the basket to radially displace stress application features on the cage or basket relative to the lesion to disrupt the calcification or plaque.

[0152] In some examples, expanding the cage or basket includes mechanically reorienting structural components of the cage or basket, hi other examples, expanding the cage or basket includes inflating a balloon within the cage or basket, where the balloon may be advanced to the lesion with or after the cage or basket.

[0153] In yet another aspect of the invention, an apparatus for treating calcifications on a wall in a body lumen of a patient includes a catheter including a catheter body having a proximal end and a distal section. An expandable structure is disposed in the distal section of the catheter body and has an outer surface configured to be displaced radially outward toward an inner surface of the body lumen wall. A plurality of plaque disruption features are distributed across at least a portion of the outer surface of the expandable structure, at least some of the plaque disruption features having convex rounded apexes disposed on the outer surface of the expandable structure and configured to disrupt the calcifications while minimizing damage to the body lumen when the expandable structure is expanded within the body lumen.

[0154] In specific cases, the convex rounded apex of at least some of the plaque disruption features has a radial height above the outer surface of the expandable structure within a range of a minimum of 0.05 mm, 0.1 mm, 0.15 mm, 0.2 mm, or 0.25 mm to a maximum of 1 mm, 0.5 mm, 0.4 mm, 0.3 mm, or 0.25 mm when the expandable structure is expanded, and a radial height above the outer surface of the expandable structure within a range of 0.1 to 5 features / mm. 2 , preferably 0.2 to 4 features / mm 2 , more preferably 0.25 to 3 features / mm 2and a distribution density in the range of

[0155] In other specific cases, the plaque disruption feature may have an area footprint with a maximum width, diameter, or other lateral dimension of 4 mm or less, often 3 mm or less, more often 1 mm or less, frequently 0.75 mm or less, and sometimes 0.5 mm or less.

[0156] The plaque disruption features may have any one or combination of properties including, for example, any one or more of ball, spherical, hemispherical, dome, and elliptical geometric shapes, being solid, being hollow, being coated, being uncoated, having a textured surface, having a smooth surface, being a discrete body, being comprised of a metal, a polymer, or combinations thereof.

[0157] In a preferred aspect, the encapsulation layer may cover some or all of the outer surface of the expandable structure and / or the plaque disruption features, immobilizing the plaque disruption features in a desired pattern on the outer surface of the expandable structure.

[0158] In particular embodiments, the plaque disruption features may be immobilized by only the encapsulation layer, or by an encapsulation layer plus an adhesive between the feature and the exterior surface. The encapsulation layer may encapsulate the entire plaque disruption feature, including the rounded apex of the convex surface, or the encapsulation layer may encapsulate only the lower portion of the plaque disruption feature, excluding the rounded apex of the convex surface.

[0159] In preferred embodiments, the plaque disruption features may be nested within depressions, cavities, recesses, receptacles, or other recesses in the outer surface of the expandable structure, such nesting helping to anchor and stabilize the plaque disruption features during introduction and use.

[0160] The encapsulation layer may comprise one or more polymers selected from the group consisting of thermoplastic fluoropolymer (PVDF), butyl methacrylate (PBMA), and thermoplastic polyester (PLLA), and the like.

[0161] The encapsulation layer is applied over the exterior surface of the plaque disruption feature by any one of coating, direct fluid application, lamination, and fusing.

[0162] The encapsulation layer may have a thickness in the range of 0.01 mm to 0.1 mm (0.5 mils to 5 mils), often 0.01 mm to 0.05 mm (0.4 mils to 2 mils), and more often 0.01 mm to 0.02 mm (0.4 mils to 0.8 mils).

[0163] The plaque disruption features may be constrained across an outer surface of the expandable structure by an elastic sleeve.

[0164] The plaque disruption features are typically attached to the outer surface of the expandable structure, but in some cases may be attached to the inner surface of the elastic sleeve, hi some cases, the plaque disruption features are mounted on posts that are hollow and project radially outward from the outer surface of the expandable structure.

[0165] In another aspect, an apparatus for treating calcification on a wall in a body lumen of a patient according to the present invention comprises a catheter including a catheter body having a proximal end and a distal section. An expandable structure is disposed in the distal section of the catheter body and has an outer surface configured to be displaced radially outward toward an inner surface of the body lumen wall. A plurality of plaque disruption features are distributed across the outer surface of the expandable structure, at least some of the plaque disruption features being present on the outer surface of the expandable structure and having an upper surface configured to disrupt the calcification while minimizing damage to the body lumen when the expandable structure is expanded within the body lumen. An encapsulation layer covers the outer surface of the expandable structure and at least a portion of the plaque disruption features and immobilizes the plaque disruption features on the outer surface of the expandable structure in a desired pattern.

[0166] In some cases, at least some of the upper surfaces of the plaque disruption features may comprise convex rounded apexes, and the encapsulation layer may cover the entire outer surfaces of at least some of the plaque disruption features, including the upper surfaces. Alternatively, the encapsulation layer may cover only lower portions of the outer surfaces of at least some of the plaque disruption features. In many cases, the plaque disruption features will be disposed within depressions, recesses, receptacles, or other indentations on the outer surface of the expandable structure. Alternatively, the plaque disruption features may comprise hemispheres with flat bases bonded to the outer surface of the expandable structure.

[0167] In yet another aspect, the invention provides a method for treating a lesion on a wall within a patient's body lumen comprising providing a catheter having an expandable structure disposed at a distal end thereof, the expandable structure having an outer surface configured to be displaced radially outward toward an inner surface of the body lumen wall, the outer wall having a plurality of spatially separated "spacer" features distributed across the outer surface of the expandable structure, the expandable structure being expanded within the patient's body lumen such that a radially outward force is applied against the wall by the outer surface and the features, while the features maintain a gap between the outer surface of the expandable structure and the inner wall.

[0168] Spacer features are typically configured to create and / or maintain one or more gaps by separating a lesion from an outer surface of the expandable structure adjacent the feature when the structure is in an expanded configuration. Spacer features typically comprise multiple features positioned in a configuration around the circumferential and / or axial length of the expandable structure that provide, create, or maintain the gap.

[0169] In one case, the spacer features have axially aligned through holes that allow the passage of fluids such as contrast agents, blood, and / or drug (drug) solutions therethrough. Typically, the gaps allow fluid perfusion through and beyond the expandable structure as it is expanded. For example, a drug may be perfused into the gaps while the expandable structure is expanded, e.g., the expandable structure comprises a balloon and the drug is perfused through the walls of the balloon. In an alternative case, at least some of the spatial separation features comprise a drug, which is released into the gaps.

[0170] In certain cases, expanding the expandable structure creates one or more gaps between an outer surface and an inner wall of the expandable structure under physiological pressure, allowing fluid perfusion through the one or more gaps.

[0171] In preferred cases, the spacer features may comprise convex rounded apexes for the stress application and plaque disruption features of the present invention, as described above.

[0172] The spacer features, when the expandable structure is expanded, have a radial height above the outer surface of the expandable structure within a range of a minimum of 0.05 mm, 0.1 mm, 0.15 mm, 0.2 mm, or 0.25 mm to a maximum of 1 mm, 0.5 mm, 0.4 mm, 0.3 mm, or 0.25 mm, and a spacing of 0.1 to 5 features / mm. 2 , preferably 0.2 to 4 features / mm 2 , more preferably 0.25 to 3 features / mm 2 and a distribution density in the range of In such perfusion methods, the expandable structure is expanded with sufficient force to create and / or maintain one or more gaps relative to physiological pressure, typically between 0.5 psi and 5 psi, preferably between 1 psi and 3 psi.

[0173] The illustrative aspects, examples, or embodiments described are not meant to be limiting. For example, the examples provided with respect to an implantable scaffold comprising a scaffold structure having a surface configured to be expanded within a patient's body can also be applied to other devices described herein, such as sleeves, balloons, cages, or the like.

[0174] These and other embodiments are described in further detail in the following notes and accompanying drawing description.

[0175] Appendix 1. An intraluminal prosthesis, a scaffold composed at least in part of a non-degradable material and configured to expand from a crimped configuration to an expanded configuration; a plurality of stress-applying features coupled to an outer surface of the scaffold; Equipped with At least some of the stress-applying features have contact surfaces spaced outwardly from an outer surface of the scaffold and include blunt contact regions configured to disrupt occlusive material in a wall of the vascular lumen when the scaffold is expanded from a crimped configuration to an expanded configuration within the vascular lumen.

[0176] Clause 2. The endoluminal prosthesis of clause 1, wherein the scaffold has a tubular geometry.

[0177] Clause 3. The endoluminal prosthesis of clause 2, wherein the tubular scaffold has a cylindrical shape, an elliptical shape, a tapered profile, an hourglass shape, or a dog-bone shape.

[0178] Appendix 4. The endoluminal prosthesis of appendixes 1-3, wherein at least some of the blunt contact regions include a peripheral edge circumscribing the contact surface and configured to concentrate stress upon engagement against occlusive material on a wall of the vascular lumen when the scaffold is expanded from a crimped configuration to an expanded configuration within the vascular lumen.

[0179] Clause 5. The endoluminal prosthesis of clause 4, wherein the peripheral edge is formed by an intersection between the blunt contact region and a peripheral wall that at least partially surrounds the blunt contact region.

[0180] Clause 6. The intraluminal prosthesis of clauses 1-5, wherein the contact surface of the blunt contact area is flat, convex, rounded, or concave.

[0181] Clause 7. The endoluminal prosthesis of clause 6, wherein a contact surface of the blunt contact region is parallel to an outer surface of the scaffold.

[0182] Clause 8. The endoluminal prosthesis of clause 6, wherein the contact surface of the blunt contact region is inclined relative to an outer surface of the scaffold.

[0183] Clause 9. The endoluminal prosthesis according to clause 8, wherein the contact surface of the blunt contact region is inclined at an angle in the range of 5° to 45°, preferably 10° to 30°.

[0184] Clause 10. The endoluminal prosthesis of clauses 1-10, wherein the peripheral wall is oriented at an angle in the range of 75° to 105° relative to the contact surface of the blunt contact region.

[0185] Appendix 11. The endoluminal prosthesis of appendix 4-10, wherein the peripheral edge extends completely around the contact surface of the blunt contact region and has a width in the range of 10 μm to 200 μm.

[0186] Clause 12. The endoluminal prosthesis of clause 11, wherein the peripheral edge is circular and the width comprises a diameter.

[0187] Clause 13. The endoluminal prosthesis of clauses 1-12, wherein at least some of the plurality of stress application features comprise one or more plates having a total thickness in the range of 0.25 mm to 1 mm and a width attached to the surface of the tubular scaffold in the range of 0.1 mm to 2 mm.

[0188] Appendix 14. The endoluminal prosthesis of Appendix 13, wherein at least some of the plates are configured as discs, stacked discs, truncated cones, stacked discs and truncated cones, elliptical discs, and asymmetric cones.

[0189] Addendum 15. The endoluminal prosthesis of any one of claims 1-12, wherein the scaffold comprises a plurality of struts joined by a crown.

[0190] Clause 16. The endoluminal prosthesis of clause 15, wherein the plurality of struts joined by the crowns are joined into a plurality of circumferential rings.

[0191] Appendix 17. The endoluminal prosthesis of Appendix 15, wherein the plurality of struts joined by the crowns are joined in a spiral pattern.

[0192] Clause 18. The endoluminal prosthesis of clauses 13-17, wherein at least some of the stress-applying features are located at or adjacent to the crown.

[0193] Clause 19. The endoluminal prosthesis of clause 18, wherein at least some of the crowns carrying the stress application features are not joined to adjacent rings.

[0194] Clause 20. The endoluminal prosthesis of clause 18 or 19, wherein the stress application feature is located at or adjacent to the crown, respectively.

[0195] Clause 21. The endoluminal prosthesis of clauses 13-17, wherein at least some of the stress-applying features are located on the struts between the crowns or on one or more links joining adjacent rings.

[0196] Clause 22. The endoluminal prosthesis of any preceding clause, wherein at least some of the stress-applying features are arranged in diametrically opposed pairs.

[0197] Clause 23. The endoluminal prosthesis of clause 22, wherein successive diametrically opposed pairs of crowns are circumferentially offset.

[0198] Clause 24. The endoluminal prosthesis of clause 23, wherein successive diametrically opposed pairs of crowns are circumferentially offset by an angle of 45° to 90°.

[0199] Clause 25. The endoluminal prosthesis of clauses 1-21, wherein at least some of the stress-applying features are arranged in groups of three that are circumferentially separated by approximately 120° about a circle on the surface of the tubular scaffold.

[0200] Clause 26. The endoluminal prosthesis of clauses 1-20, wherein at least some of the successive axially spaced stress application features are circumferentially offset by an angle in the range of 5° to 15°.

[0201] Clause 27. The endoluminal prosthesis of clause 26, wherein at least some successive circumferentially spaced stress application features are axially offset by an angle in the range of 5° to 15°.

[0202] Addendum 28. The endoluminal prosthesis of any one of Addendums 1-27, wherein the scaffold is formed by patterning a tubular substrate, laser cutting a tubular substrate, rolling a cut substrate, bending wire, or three-dimensional printing.

[0203] Clause 29. The endoluminal prosthesis of clauses 1-28, wherein the stress-applying features are preformed and attached by gluing, soldering, welding, threaded attachment, riveting, or crimping.

[0204] Clause 30. The endoluminal prosthesis of clause 29, wherein the stress application features comprise preformed plates that are glued to the scaffold using an adhesive.

[0205] Addendum 31. The endoluminal prosthesis of any one of Addendums 1-28, wherein the stress-applying features are formed in situ by three-dimensional printing, chemical vapor deposition, electrostatic deposition, molding, or folding of scaffold components.

[0206] Clause 32. The endoluminal prosthesis of clauses 1-28, wherein the stress application feature comprises a tab attached to the scaffold and folded over and onto an outer surface of the scaffold.

[0207] Clause 33. The endoluminal prosthesis of clauses 1-32, wherein the scaffolding comprises a vascular stent or stent-graft.

[0208] Clause 34. The endoluminal prosthesis of clauses 1-32, wherein the scaffold comprises a prosthetic valve.

[0209] Clause 35. The endoluminal prosthesis of clauses 1-32, wherein the scaffolding comprises a valvuloplasty device.

[0210] Clause 36. The endoluminal prosthesis of clauses 1-35, wherein the scaffold is balloon-expandable.

[0211] Addendum 37. The endoluminal prosthesis of any one of Addendums 1-35, wherein the scaffold is self-expanding.

[0212] Clause 38. The endoluminal prosthesis of any preceding clause, wherein the stress-applying feature is configured to preferentially contact occlusive material within the wall.

[0213] Clause 39. The endoluminal prosthesis of clauses 1-38, wherein the scaffolding comprises a sleeve configured to be placed over a stent or balloon, or to be self-expanding.

[0214] Addendum 40. The endoluminal prosthesis of Addendum 1-39, wherein the stress-applying feature comprises a sharp element protruding outwardly from the blunt contact region, the sharp element being configured to concentrate stress upon engagement against occlusive material on a wall of the vascular lumen when the blunt contact region is pressed against a surface of the occlusive material.

[0215] Clause 41. The endoluminal prosthesis of clause 40, wherein the blunt surface extends above the surface of the scaffold a first distance and the sharp element protrudes from the surface of the blunt contact region a second distance equal to 0.05 mm to 0.1 mm of the first distance.

[0216] Item 42. The endoluminal prosthesis of item 41, wherein the second distance is within a range of 0.01 mm to 0.2 mm or 0.01 mm to 0.1 mm.

[0217] Clause 43. The intraluminal prosthesis of clauses 40-42, wherein the sharp element comprises a point.

[0218] Addendum 44. The intraluminal prosthesis of any one of Addendums 40-42, wherein the sharp element comprises an edge.

[0219] Addendum 45. A method for disrupting calcified plaque in a patient's vasculature, comprising: expanding a scaffold, comprised at least in part of a non-degradable material, from a crimped configuration to an expanded configuration within a calcified body vessel lumen; the scaffold comprising a plurality of stress-applying features secured to an exterior surface thereof; at least some of the stress-applying features comprise blunt contact regions spaced outwardly from the outer surface and having a peripheral edge configured to disrupt occlusive material on a wall of the vascular lumen when the tubular scaffolding is expanded within the vascular lumen from a crimped configuration to an expanded configuration; The stress application feature ruptures the occlusive material as the scaffold is expanded. method.

[0220] Clause 46. The method of clause 45, wherein the occlusive material comprises hardened plaque or calcification.

[0221] Clause 47. The method of clause 45 or 46, wherein expanding the scaffold comprises expanding a balloon within the scaffold or allowing the scaffold to self-expand.

[0222] Addendum 48. The method of Addendum 45, wherein expanding the scaffolding includes expanding the artificial prosthetic heart valve within the heart valve annulus, the scaffolding providing structural support for the heart valve annulus.

[0223] Clause 49. The method of clause 48, wherein expanding the prosthetic heart valve comprises expanding a balloon to expand the prosthetic heart valve within the heart valve annulus.

[0224] Clause 50. The method of clause 45, wherein expanding the scaffolding comprises expanding an annuloplasty device within the heart valve annulus.

[0225] Addendum 51. The method of Addendum 50, wherein the scaffolding of the annuloplasty device comprises an expandable cage, and expanding the annuloplasty device comprises expanding the cage within the heart valve annulus.

[0226] Addendum 52. The method of any one of Addendums 45-51, wherein the tubular scaffold has a cylindrical shape, an elliptical shape, a tapered profile, an hourglass shape, or a dog-bone shape.

[0227] Addendum 53. The method of any one of Addendums 45-52, wherein the peripheral edge is formed by an intersection between the blunt contact area and a peripheral wall that at least partially surrounds the blunt contact area.

[0228] Clause 54. The method of clauses 45-53, wherein the blunt contact area is flat.

[0229] 55. The method of claim 54, wherein the blunt contact area is parallel to the outer surface of the tubular scaffold.

[0230] Clause 56. The method of clause 55, wherein the blunt contact region is inclined relative to the outer surface of the tubular scaffold.

[0231] Addendum 57. The method of any one of Addendums 45-56, wherein the peripheral edge is formed by an intersection between the blunt contact area and a peripheral wall that at least partially surrounds the blunt contact area.

[0232] Addendum 58. The method of Addendum 57, wherein the blunt contact area is a plane.

[0233] Addendum 59. The method of Addendum 57, wherein the peripheral wall is oriented at an angle within the range of 75° to 105° relative to the blunt contact area.

[0234] Addendum 60. The method of any one of Addendums 57-59, wherein the peripheral edge has a width in the range of 10 μm to 200 μm.

[0235] Addendum 61. The method of any one of Addendums 57-60, wherein at least some of the plurality of stress application features comprise one or more plates having a total thickness in the range of 0.5 mm to 1 mm and a width attached to the surface of the tubular scaffold in the range of 0.01 mm to 2 mm.

[0236] Addendum 62. The method of Addendum 61, wherein at least some of the plates are configured as disks, stacked disks, truncated cones, stacked disks and truncated cones, elliptical disks, and asymmetric cones.

[0237] Addendum 63. The method of any one of Addendums 45-57, wherein the scaffold comprises a plurality of struts joined by a crown.

[0238] Addendum 64. The method of Addendum 63, wherein the plurality of struts joined by crowns are joined into a plurality of circumferential rings.

[0239] Addendum 65. The method of Addendum 63, wherein the multiple struts joined by the crown are joined in a spiral pattern.

[0240] Clause 66. The method of clauses 63-65, wherein at least some of the stress application features are located at or adjacent to the crown.

[0241] Addendum 67. The method of Addendum 66, wherein each stress application feature is located at or adjacent to a crown.

[0242] Clause 68. The method of any one of clauses 63-65, wherein at least some of the stress application features are located on the struts between the crowns.

[0243] Clause 69. The method of clauses 63-68, wherein at least some of the stress-applying features are arranged in diametrically opposed pairs.

[0244] Addendum 70. The method of any one of Addendums 63-69, wherein successive diametrically opposed pairs of crowns are rotatably offset relative to the longitudinal axis of the scaffold.

[0245] Addendum 71. The method of Addendum 70, wherein successive diametrically opposed pairs of crowns are rotatably offset relative to the longitudinal axis of the scaffold by an angle between 75° and 105°.

[0246] Addendum 72. A method for fabricating a vascular scaffold, the method comprising: patterning a tubular scaffold comprising a plurality of struts joined by crowns within a tubular envelope, the tubular scaffold having a plurality of tabs extending outwardly from the struts and / or crowns within the tubular envelope; folding the plurality of tabs over an outer surface of the tubular envelope to form a plurality of stress application features on the outer surface of the tubular scaffold; A method comprising:

[0247] Clause 73. The method of clause 72, wherein adjacent tabs of a pair are folded one over the other to form a stacked stress application feature.

[0248] Item 74. The method of item 73, wherein adjacent tabs within a pair are arranged side-by-side on the scaffold prior to folding.

[0249] Item 75. The method of item 73, wherein adjacent tabs within a pair are aligned in tandem on the scaffold prior to folding.

[0250] Clause 76. The method of clause 73, wherein adjacent tabs within a pair are arranged on opposite sides of the post prior to folding.

[0251] Apparatus 77. An apparatus for treating calcifications on a wall in a body lumen of a patient, the system comprising: a catheter including a catheter body having a proximal end and a distal section; an expandable structure disposed in a distal section of the catheter, the expandable structure having an outer surface configured to be displaced radially outward toward an inner surface of a body lumen wall; a plurality of plaque disruption features distributed across an outer surface of the expandable structure, at least some of the plaque disruption features being present on the outer surface of the expandable structure and having convex rounded upper surfaces configured to disrupt calcifications while minimizing damage to the body lumen when the expandable structure is expanded within the body lumen; An apparatus comprising:

[0252] Addendum 78. The device of Addendum 77, wherein the body lumen comprises a blood vessel, a valve annulus, a venous valve, or an AV shunt.

[0253] Addendum 79. The device of any one of claims 77 to 78, wherein the calcification is located within the inner wall, intimal layer, medial layer, adventitial layer, valve leaflet, valve annulus, venous filter, or implant.

[0254] Addendum 80. The device of any one of Addendums 77-79, wherein the expandable structure is less rigid when unexpanded and more rigid when fully expanded.

[0255] Clause 81. The device of any one of clauses 77-80, wherein the outer surface of the expandable structure is approximately cylindrical when fully expanded.

[0256] Addendum 82. The device of any one of Addendums 77-81, wherein the convex, rounded upper surfaces of the plurality of plaque disruption features extend radially outward beyond the outer surface of the expandable structure when fully expanded.

[0257] Addendum 83. The device of Addendum 82, wherein the convex rounded upper surface of the plurality of plaque disruption features, when fully expanded, extends radially outward beyond the outer surface of the expandable structure a distance in the range of 0.15 mm to 3 mm, preferably 0.25 mm to 3 mm, and more preferably 0.5 mm to 3 mm.

[0258] Addendum 84. The device of any one of Addendums 77-83, wherein the convex, rounded upper surface of the plaque disruption feature is free of edges and irregularities that could damage the wall when the expandable structure is expanded within the body lumen.

[0259] Addendum 85. The device of any one of Addendums 77-84, wherein at least some of the plaque disruption features have a single convex rounded upper surface and a lower base that is independently attached to the outer surface of the expandable structure.

[0260] Addendum 86. The device of any one of Addendums 77-85, wherein at least some of the plaque disruption features comprise a sphere, a hemisphere, a truncated sphere, or an ellipse.

[0261] Clause 87. The device of any one of clauses 77-86, wherein at least some of the plaque disruption features are independently attached to an outer surface of the expandable structure.

[0262] Addendum 88. The device of any one of Addendums 77-87, wherein at least some of the plaque disruption features comprise hemispheres having lower surfaces attached to the outer surface of the expandable structure.

[0263] Clause 89. The apparatus of clause 88, wherein the lower surface is flat.

[0264] Addendum 90. The apparatus of Addendum 88, wherein the lower surface is contoured.

[0265] Addendum 91. The device of any one of Addendums 77-88, wherein at least some of the plaque disruption features comprise a post having a hemispherical upper surface and a lower surface attached to the outer surface of the expandable structure.

[0266] Addendum 92. The device of any one of Addendums 77-91, wherein the plaque disruption feature comprises a sharp element protruding outwardly from the convex rounded upper surface, the sharp element being configured to concentrate stress when engaged against a calcification on a wall of a vascular lumen when the convex rounded upper surface is pressed against the surface of the calcification.

[0267] Clause 93. The apparatus of clause 92, wherein the convex rounded upper surface extends above the surface of the scaffold a first distance and the sharp element protrudes from the surface of the convex rounded upper surface a second distance equal to 0.05 to 0.1 of the first distance.

[0268] Addendum 94. The apparatus of Addendum 92 or 93, wherein the second distance is in the range of 0.01 mm to 0.2 mm or 0.01 mm to 0.1 mm.

[0269] Addendum 95. The apparatus of any one of Addendums 92-94, wherein the sharp element comprises a point.

[0270] Addendum 96. The apparatus of any one of Addendums 92-94, wherein the sharp element comprises an edge.

[0271] Addendum 97. The device of any one of Addendums 77-96, wherein the expandable structure comprises an inflatable balloon.

[0272] Addendum 98. The device of Addendum 97, wherein the inflatable balloon has a central region, a distal tapered region, and a proximal tapered region, and the plaque disruption feature is present on one or more of these regions.

[0273] Addendum 99. The device of any one of Addendums 97 and 98, wherein the plaque disruption feature is present on at least the central region.

[0274] Clause 100. The device of clauses 97-99, wherein the plaque disruption feature is present on at least one of the distal and proximal tapered regions.

[0275] Clause 101. The device of clause 100, wherein the plaque disruption features are present on both the distal and proximal tapered regions.

[0276] Addendum 102. The apparatus of any one of Addendums 97-101, wherein the inflatable balloon has a distensibility of less than 10% when inflated to a pressure of at least 8 atm, at least 10 atm, at least 12 atm, at least 16 atm, at least 18 atm, or at least 20 atm.

[0277] Addendum 103. The device of any one of Addendums 77-102, wherein the plaque disruption feature is attached to the outer surface of the expandable structure by at least one of adhesive bonding, ultrasonic welding, heat welding, interference fit, solvent bonding, bonding with a polymeric material, use of fasteners, and combinations thereof.

[0278] Clause 104. The device of any one of clauses 77-103, further comprising an outer sleeve positioned over the plaque disruption feature on the outer surface of the expandable structure.

[0279] Clause 105. The device of clause 104, wherein the outer sleeve comprises a retractable sheath configured to shield the plaque disruption feature as the device is advanced and / or retracted through a body lumen.

[0280] Addendum 106. The device of Addendum 105, wherein the outer sleeve is positioned over an outer surface of the expandable structure and comprises an elastomeric tubular member that conforms to the plaque disruption characteristics when the expandable structure is expanded, the elastomeric tubular member being configured to expand and contract with the expandable structure.

[0281] Clause 107. The device of clause 104, wherein the elastomeric tubular member is laminated to or attached to at least a portion of the outer surface of the expandable structure.

[0282] Clause 108. The apparatus of clause 104, wherein the outer sleeve comprises a non-expandable or semi-compliant sheath that is folded over the balloon before the balloon is inflated.

[0283] Clause 109. The device of any one of clauses 104-108, wherein the outer sleeve completely covers the clot-breaking features on the outer surface of the expandable structure.

[0284] Clause 110. The device of any one of clauses 104-109, wherein the outer sleeve comprises a polymer.

[0285] Clause 111. The device of any one of clauses 106-110, wherein at least some of the plaque disruption features are attached to an inner surface of the elastomeric tubular member.

[0286] Clause 112. The device of clause 111, wherein at least some of the plaque disruption features are formed as protrusions from an inner surface of the elastomeric tubular member.

[0287] Addendum 113. The device of any one of Addendums 77-112, wherein at least some of the plaque disruption features have a base attached to the outer surface of the expandable structure, the base having an axial width (Wa) and a circumferential width (Wc), wherein the width ratio Wa:Wc is within the range of 1:0.5 to 1:5, typically 1:1 to 1:5, and more typically 1:1 to 3:1.

[0288] Clause 114. The device of clause 113, wherein at least some of the bases have circular peripheries.

[0289] Clause 115. The device of clause 113, wherein at least some of the bases have an oval periphery.

[0290] Clause 116. The device of any one of clauses 77-115, wherein at least some of the plaque disruption features are arranged in diametrically opposed pairs.

[0291] Clause 117. The device of clause 116, wherein successive diametrically opposed pairs of plaque disruption features are circumferentially offset.

[0292] Item 118. The device of item 117, wherein successive diametrically opposed pairs of plaque disruption features are circumferentially offset by an angle of between 45° and 90°.

[0293] Addendum 119. The device of any one of Addendums 77-115, wherein at least some of the plaque disruption features are arranged in groups of three that are separated circumferentially by approximately 120° about a circle on the surface of the expandable structure.

[0294] Addendum 120. The device of any one of Addendums 77-119, wherein the inflatable balloon is configured to release an inflation medium comprising a drug in response to an inflation pressure above a minimum threshold.

[0295] Clause 121. The apparatus of clause 120, wherein the minimum threshold is greater than 3 atm, 5 atm, or 7 atm.

[0296] Addendum 122. The device of any one of Addendums 120-121, wherein the inflatable balloon comprises a plurality of ports that open in response to an inflation pressure above a minimum threshold.

[0297] Addendum 123. A method for treating calcifications on a wall in a body lumen of a patient, the method comprising: positioning the expandable structure at a treatment site adjacent the calcification to be treated; expanding the expandable structure radially outwardly to press a plurality of plaque disruption features radially outwardly against the calcification, the plaque disruption features being distributed across an outer surface of the expandable structure, at least some of the plaque disruption features having convex rounded upper surfaces, and pressing the plurality of plaque disruption features radially outwardly against the calcification disrupts the calcification while reducing damage to the wall; A method comprising:

[0298] Addendum 124. The method of Addendum 123, wherein the body lumen comprises a blood vessel, a valve annulus, a venous valve, or an AV shunt.

[0299] Addendum 125. The method of any one of Addendums 123 to 124, wherein the calcification is located within the inner wall, intimal layer, medial layer, adventitial layer, valve leaflet, valve annulus, venous filter, or implant.

[0300] Addendum 126. The method of any one of Addendums 123-125, wherein the convex, rounded upper surface of the plaque disruption feature is free of edges and irregularities that may damage the vascular wall when the expandable structure is expanded within the body lumen.

[0301] Addendum 127. The method of any one of Addendums 123-126, wherein the plaque disruption feature comprises a sharp element protruding outwardly from a convex rounded upper surface, the sharp element being configured to concentrate stress when engaged against a calcification on a wall of a vascular lumen when the convex rounded upper surface is pressed against the surface of the calcification.

[0302] Addendum 128. The method of Addendum 127, wherein the convex rounded upper surface extends above the surface of the scaffold a first distance and the sharp element protrudes from the surface of the convex rounded upper surface a second distance equal to 0.05 to 0.1 of the first distance.

[0303] Addendum 129. The method of Addendum 127 or 128, wherein the second distance is in the range of 0.01 mm to 0.2 mm or 0.01 mm to 0.1 mm.

[0304] Addendum 130. The method of any one of Addendums 127-129, wherein the sharp element comprises a point.

[0305] Addendum 131. The method of any one of Addendums 127-129, wherein the sharp element comprises an edge.

[0306] Clause 132. The method of any one of clauses 123-131, wherein expanding comprises inflating a balloon having a plurality of plaque disruption features independently attached to the outer surface of the balloon.

[0307] Addendum 133. The method of any one of Addendums 123-132, wherein at least some of the plaque disruption features comprise a spherical or elliptical shape having an underlying surface attached to the outer surface of the expandable structure.

[0308] Addendum 134. The method of any one of Addendums 123-132, wherein at least some of the plaque disruption features comprise hemispheres having lower surfaces attached to the outer surface of the expandable structure.

[0309] Addendum 135. The method of any one of Addendums 123-132, wherein at least some of the plaque disruption features comprise posts having a hemispherical upper surface and a lower surface attached to the outer surface of the expandable structure.

[0310] Clause 136. The method of any one of clauses 123-135, wherein the lower surface is directly attached to the outer surface of the expandable structure.

[0311] Addendum 137. The method of any one of Addendums 123-135, wherein the lower surface comprises a base, which is directly attached to the outer surface of the expandable structure.

[0312] Addendum 138. The method of any one of Addendums 123-137, wherein at least some of the plaque disruption features have a base attached to the outer surface of the expandable structure, the base having an axial width (Wa) and a circumferential width (Wc), wherein the width ratio Wa:Wc is in the range of 1:0.5 to 1:5, typically 1:1 to 1:5, and more typically 1:1 to 3:1.

[0313] Addendum 139. The method of Addendum 138, wherein at least some of the bases have circular peripheries.

[0314] Addendum 140. The method of Addendum 138, wherein at least some of the bases have oval perimeters.

[0315] Clause 141. The method of any one of clauses 123-140, wherein at least some of the plaque disruption features are arranged in diametrically opposed pairs.

[0316] Clause 142. The method of clause 141, wherein successive diametrically opposed pairs of plaque disruption features are circumferentially offset.

[0317] Addendum 143. The method of Addendum 142, wherein successive diametrically opposed pairs of plaque disruption features are circumferentially offset by an angle between 45° and 90°.

[0318] Addendum 144. The method of any one of Addendums 123-140, wherein at least some of the plaque disruption features are arranged in groups of three that are separated circumferentially by approximately 120° about a circle on the surface of the expandable structure.

[0319] Clause 145. The method of any one of clauses 123-144, wherein expanding the expandable slit structure radially outward comprises inflating an inflatable balloon.

[0320] Addendum 146. The method of Addendum 145, wherein the inflatable balloon has a distensibility of less than 10% when inflated to 8 atm, at least 10 atm, at least 12 atm, at least 16 atm, at least 18 atm, or at least 20 atm.

[0321] Addendum 147. The method of any one of Addendums 145-146, wherein the inflatable balloon is inflated to a pressure by pressing the convex rounded upper surface of the plaque disruption feature against the inner wall of the body lumen without engaging the outer surface of the inflatable balloon against the inner wall of the body lumen.

[0322] Clause 148. The method of any one of clauses 145-147, wherein prior to inflation, the inflatable balloon remains sufficiently flexible to be advanced through a body lumen.

[0323] Addendum 149. The method of any one of Addendums 123-148, wherein the plaque disruption feature is attached to the outer surface of the expandable structure by at least one of an adhesive, ultrasonic welding, heat welding, fasteners, solvent bonding, bonding with a polymeric material, or a combination thereof.

[0324] Clause 150. The method of any one of clauses 123-149, further comprising an outer sleeve positioned over the plaque disruption feature on the outer surface of the expandable structure.

[0325] Clause 151. The method of clause 150, wherein the outer sleeve comprises a retractable sheath configured to shield the plaque disruption feature as the expandable member is advanced and / or retracted through the body lumen.

[0326] Addendum 152. The method of Addendum 150, wherein the outer sleeve comprises an elastomeric tubular member positioned over an outer surface of the expandable structure and conforming to the plaque disruption feature, the elastomeric tubular member configured to expand and contract with the expandable structure, and the plaque disruption feature remains configured to disrupt plaque when expanded against the plaque.

[0327] Clause 153. The method of clause 152, wherein the elastomeric tubular member is laminated to at least a portion of an outer surface of the expandable structure.

[0328] Addendum 154. The method of addendum 150, wherein the outer sleeve comprises a non-expandable or semi-compliant sheath that is folded over the balloon before the balloon is inflated.

[0329] Clause 155. The method of clauses 123-154, wherein the outer sleeve completely covers the clot-breaking features on the outer surface of the expandable structure.

[0330] Clause 156. The method of clauses 153-155, wherein at least some of the plaque disruption features are attached to an inner surface of the elastomeric tubular member.

[0331] Addendum 157. The method of Addendum 156, wherein at least some of the plaque disruption features are formed as protrusions from an inner surface of the elastomeric tubular member.

[0332] Addendum 158. The method of any one of Addendums 123-155, wherein at least some of the plaque disruption features have a base attached to the outer surface of the expandable structure, the base having an axial width (Wa) and a circumferential width (Wc), wherein the width ratio Wa:Wc is in the range of 1:0.5 to 1:5, typically 1:1 to 1:5, and more typically 1:1 to 3:1.

[0333] Clause 159. The method of clause 158, wherein at least some of the bases have circular peripheries.

[0334] Addendum 160. The method of Addendum 158, wherein at least some of the bases have oval perimeters.

[0335] Clause 161. The method of any one of clauses 123-160, wherein at least some of the plaque disruption features are arranged in diametrically opposed pairs.

[0336] Clause 162. The method of clause 161, wherein successive diametrically opposed pairs of plaque disruption features are circumferentially offset.

[0337] Addendum 163. The method of Addendum 162, wherein successive diametrically opposed pairs of plaque disruption features are circumferentially offset by an angle between 45° and 90°.

[0338] Addendum 164. The method of any one of Addendums 123-160, wherein at least some of the plaque disruption features are arranged in groups of three that are separated circumferentially by approximately 120° about a circle on the surface of the expandable structure.

[0339] Addendum 165. The method of any one of Addendums 123-164, wherein the plaque disruption features are arranged in multiple circumferential ring patterns, each ring pattern including 1-10 features, preferably ranging from 2-5 features, and more preferably ranging from 3-4 features.

[0340] Clause 166. The method of clause 165, wherein the circumferential ring patterns are axially spaced across the length of the expandable structure and separated by gaps in the range of 0.1 mm to 3 mm.

[0341] Addendum 167. The method of any one of Addendums 165 to 166, wherein the number of features ranges from 2 to 200 per mm of axial length.

[0342] Clause 168. The method of any one of clauses 123-167, further comprising releasing an inflation medium, comprising a medicinal agent, through the inflatable balloon in response to an inflation pressure above a minimum threshold.

[0343] Addendum 169. The method of Addendum 168, wherein the minimum threshold is greater than 3 atm, 5 atm, or 7 atm.

[0344] Addendum 170. The method of any one of Addendums 168 to 169, wherein the inflatable balloon comprises a plurality of ports that open in response to an inflation pressure above a minimum threshold.

[0345] Item 171. A device for treating a valve in a patient having a calcified valve leaflet, the device comprising: a catheter body having a proximal end and a distal end; a compartmentalized balloon structure disposed at a distal end of the catheter body, the compartmentalized balloon structure having opposed inner walls configured to expand over opposed surfaces of the valve leaflets and to disrupt calcification on the calcified valve; An apparatus comprising:

[0346] Addendum 172. The device of Addendum 171, wherein the opposing inner walls are configured to approximate each other when the balloon structure is expanded.

[0347] Addendum 173. The device of Addendum 172, wherein the opposing inner walls are configured to nest when the balloon structure is expanded.

[0348] Clause 174. The apparatus of clause 173, wherein the nested opposing inner walls comprise nested conical surfaces.

[0349] Addendum 175. The device of Addendum 172, wherein the opposing inner walls have flat surfaces configured to approach each other when the balloon structure is expanded.

[0350] Addendum 176. The device of Addendum 175, wherein the compartmentalized balloon structure comprises a pair of opposing conical balloons having flat bases with flat surfaces.

[0351] Addendum 177. The device of any one of Addendums 171-176, further comprising a plurality of calcification crushing features distributed across at least one of the opposing inner walls of the compartmentalized balloon structure.

[0352] Addendum 178. The device of Addendum 177, wherein the calcification crushing features are distributed across both opposing inner walls of the compartmentalized balloon structure.

[0353] Addendum 179. The device of Addendum 177 or 178, wherein at least some of the calcification-breaking features have convex, rounded leaflet-engaging surfaces configured to break up calcifications while minimizing damage to the leaflets when the balloon structure is expanded within the patient's valve.

[0354] Addendum 180. The device of any one of Addendums 177-179, wherein the convex rounded upper surfaces of the plurality of plaque disruption features are configured to extend from opposing inner walls of the expandable balloon when the balloon is inflated.

[0355] Addendum 181. The device of Addendum 180, wherein the convex rounded upper surface extends from the opposing inner wall a distance in the range of 0.1 mm to 3 mm, preferably 0.25 mm to 3 mm, and more preferably 0.5 mm to 3 mm, when the balloon is fully inflated.

[0356] Addendum 182. The device of any one of Addendums 204-206, wherein the convex rounded upper surface of the calcification-breaking feature is free of edges and irregularities that could damage the valve leaflets when the balloon structure is inflated within the patient's valve.

[0357] Addendum 183. The device of any one of Addendums 179-182, wherein the calcification-breaking feature comprises a sharp element protruding outwardly from a convex rounded upper surface, the sharp element being configured to concentrate stress when engaged against calcification on the leaflet when pressed against the surface of the leaflet.

[0358] Addendum 184. The device of any one of Addendums 171-183, wherein the balloon section is fixed onto the catheter body with a fixed spacing between opposing inner walls.

[0359] Addendum 185. The device of any one of Addendums 171-183, wherein the balloon sections are configured to translate axially relative to one another on the catheter body with variable spacing between opposing inner walls.

[0360] Clause 186. The device of any one of clauses 171-185, wherein the calcification fracturing features on the opposing surfaces are axially aligned as the balloon sections are pulled together.

[0361] Clause 187. The device of any one of clauses 171-186, wherein the calcification fracturing features on the opposing surfaces are offset laterally so that as the balloon sections are pulled together they are not axially aligned.

[0362] 188. A method for treating a valve in a patient having a calcified leaflet, the method comprising: providing a catheter body having a compartmentalized balloon structure disposed at a distal end thereof; advancing the segmented balloon structure intravascularly to a patient's valve; expanding opposing inner walls of the segmented balloon over opposing surfaces of the valve leaflets to disrupt calcification on the calcified valve; A method comprising:

[0363] Addendum 189. The method of Addendum 188, wherein the opposing inner walls are configured to approximate each other when the balloon structure is expanded.

[0364] Addendum 190. The method of Addendum 189, wherein the opposing inner walls are configured to nest when the balloon structure is expanded.

[0365] Clause 191. The method of clause 189, wherein the nested opposing inner walls comprise nested conical surfaces.

[0366] Addendum 192. The method of Addendum 189, wherein the opposing inner walls comprise flat surfaces configured to approach each other when the balloon structure is expanded.

[0367] Addendum 193. The method of Addendum 192, wherein the compartmentalized balloon structure comprises a pair of opposing conical balloons having flat bases with flat surfaces.

[0368] Addendum 194. The method of any one of Addendums 188-193, wherein the plurality of calcification fracture features are distributed across at least one of the opposing interior walls of the compartmentalized balloon structure.

[0369] Addendum 195. The method of Addendum 194, wherein the calcification fracture features are distributed across both opposing inner walls of the compartmentalized balloon structure.

[0370] Addendum 196. The method of any one of Addendums 188-195, wherein at least some of the calcification-breaking features have convex, rounded leaflet-engaging surfaces configured to break up calcifications while minimizing damage to the leaflets when the balloon structure is expanded within the patient's valve.

[0371] Addendum 197. The method of any one of Addendums 194-196, wherein the convex rounded upper surfaces of the plurality of plaque disruption features are configured to extend from opposing inner walls of the expandable balloon when the balloon is inflated.

[0372] Addendum 198. The method of Addendum 197, wherein the convex rounded upper surface extends from the opposing inner wall a distance ranging from 0.25 mm to 3 mm, preferably 0.5 mm to 3 mm, when the balloon is fully inflated.

[0373] Addendum 199. The method of any one of Addendums 196-198, wherein the convex rounded upper surface of the calcification fracture feature is free of edges and irregularities that may damage the valve leaflets when the balloon structure is inflated within the patient's valve.

[0374] Addendum 200. The method of any one of Addendums 196-198, wherein the calcification breaking feature comprises a sharp element protruding outwardly from a convex rounded upper surface, the sharp element being configured to concentrate stress when engaged against calcification on the leaflet when pressed against the surface of the leaflet.

[0375] Addendum 201. The method of any one of Addendums 188-200, wherein the balloon section is fixed on the catheter body with a fixed spacing between opposing inner walls.

[0376] Addendum 202. The method of any one of Addendums 188-200, wherein the balloon sections are configured to translate axially relative to one another on the catheter body, and further comprising moving the balloon sections together and compressing the wall surfaces against the valve leaflets after the balloon structure is inflated.

[0377] Addendum 203. A method for disrupting calcification or plaque in a lesion, the method comprising: advancing the sleeve over the wire and through the lesion; advancing an expandable member over the wire and into an interior of the sleeve; expanding the expandable member within the sleeve to radially displace features on the interior and / or exterior of the sleeve outwardly relative to the lesion to disrupt the calcification or plaque; A method comprising:

[0378] Clause 204. The method of clause 203, further comprising removing the expandable member from the sleeve and removing the expandable member and sleeve over the wire.

[0379] Clause 205. The method of clause 204, wherein the expandable structure is a balloon or other expandable member.

[0380] Clause 206. The method of clause 203, wherein the expandable structure comprises a stent and the sleeve is left in place between the stent and the lesion after the stent is expanded.

[0381] Addendum 207. The method of any one of Addendums 203-206, wherein the stress application features protrude radially outward from the sleeve into the vessel wall as the expandable structures displace them radially outward in response to expansion.

[0382] Addendum 208. A method for disrupting calcification or plaque in a lesion, the method comprising: advancing a cage or basket over the wire and across the lesion; expanding a cage of the basket to radially displace a stress application feature on the cage or basket relative to the lesion to disrupt the calcification or plaque; A method comprising:

[0383] Addendum 209. The method of Addendum 208, wherein expanding the cage or basket includes mechanically reorienting a structural component of the cage or basket.

[0384] Addendum 210. The method of Addendum 208, wherein expanding the cage or basket includes inflating a balloon within the cage or basket.

[0385] 211. The method of claim 210, wherein the balloon is advanced with a cage or basket through the lesion.

[0386] 212. The method of claim 210, wherein the balloon is advanced to the lesion after the cage or basket.

[0387] Addendum 213. A device for treating calcifications on a wall in a body lumen of a patient, the device comprising: a catheter including a catheter body having a proximal end and a distal section; an expandable structure disposed in a distal section of the catheter body, the expandable structure having an outer surface configured to be displaced radially outward toward an inner surface of a body lumen wall; a plurality of plaque disruption features distributed across an outer surface of the expandable structure, at least some of the plaque disruption features being disposed on the outer surface of the expandable structure and having convex rounded apexes configured to disrupt calcifications while minimizing damage to the body lumen when the expandable structure is expanded within the body lumen; Equipped with The convex rounded apex of the plaque disruption features, when the expandable structure is expanded, has a radial height in the range of a minimum of 0.05 mm, 0.1 mm, 0.15 mm, 0.2 mm, or 0.25 mm to a maximum of 1 mm, 0.5 mm, 0.4 mm, 0.3 mm, or 0.25 mm above the outer surface of the expandable structure, and a spacing of 0.1 to 5 features / mm. 2 , preferably 0.2 to 4 features / mm 2 , more preferably 0.25 to 3 features / mm 2 and a distribution density in the range of.

[0388] Addendum 214. The device of Addendum 213, wherein the plaque disruption feature has an area having a maximum width, diameter, or other lateral dimension of 4 mm or less, often 3 mm or less, more often 1 mm or less, frequently 0.75 mm or less, and sometimes 0.5 mm or less.

[0389] Clause 215. The apparatus of clause 213 or 214, wherein the plaque disruption features comprise any one or more of a ball, a sphere, a hemisphere, a dome, and an ellipsoid.

[0390] Clause 216. The device of clauses 213-215, wherein the plaque disruption feature is solid.

[0391] Addendum 217. The device of any one of Addendums 213-215, wherein the plaque disruption feature is hollow.

[0392] Clause 218. The device of any one of clauses 213-217, further comprising an encapsulation layer covering the outer surface of the expandable structure and the plaque disruption features and immobilizing the plaque disruption features on the outer surface of the expandable structure in a desired pattern.

[0393] Clause 219. The device of clause 218, wherein the plaque disruption feature comprises a discrete body.

[0394] Clause 220. The apparatus of clause 219, wherein the discrete bodies comprise a metal.

[0395] Clause 221. The device of clauses 218-220, wherein the plaque disruption feature is immobilized only by the encapsulation layer.

[0396] Clause 222. The device of any one of clauses 218-220, wherein the plaque disruption feature is immobilized by an adhesive between the feature and the exterior surface in addition to the encapsulation layer.

[0397] Addendum 223. The device of any one of Addendums 218-222, wherein the encapsulation layer encapsulates the entire plaque disruption feature, including the convex rounded apex.

[0398] Addendum 224. The device of any one of Addendums 218-222, wherein the encapsulation layer encapsulates only a lower portion of the plaque disruption feature, excluding the rounded apex of the convex surface.

[0399] Clause 225. The device of any one of clauses 213-224, wherein the plaque disruption feature is contained within a recess in an outer surface of the expandable structure.

[0400] Clause 226. The apparatus of clauses 213-225, wherein the encapsulation layer comprises a polymer selected from the group consisting of thermoplastic fluoropolymer (PVDF), butyl methacrylate (PBMA), and thermoplastic polyester (PLLA).

[0401] Addendum 227. The device of any one of Addendums 218-226, wherein the encapsulation layer is applied over the outer surface and the plaque disruption features by any one of coating, direct fluid application, lamination, and fusing.

[0402] Clause 228. The apparatus of clauses 218-227, wherein the encapsulation layer has a thickness in the range of 0.01 mm to 0.1 mm (0.4 mils to 4 mils), often 0.01 mm to 0.05 mm (0.4 mils to 2 mils), and more often 0.01 mm to 0.02 mm (0.4 mils to 0.8 mils).

[0403] Clause 229. The device of any one of clauses 213-228, wherein the plaque disruption feature is disposed within a recess formed in the outer surface of the expandable structure.

[0404] Clause 230. The device of clauses 213-229, wherein the plaque disruption feature is constrained across an outer surface of the expandable structure by an elastic sleeve.

[0405] Clause 231. The device of clause 230, wherein the plaque disruption feature is further attached to an outer surface of the expandable structure.

[0406] Clause 232. The device of clause 230, wherein the plaque disruption feature is attached to an inner surface of the elastic sleeve.

[0407] Clause 233. The device of any one of clauses 213-228, wherein the plaque disruption features are mounted on posts that are hollow and protrude radially outward from the outer surface of the expandable structure.

[0408] 234. A device for treating calcifications on a wall in a body lumen of a patient, the device comprising: a catheter including a catheter body having a proximal end and a distal section; an expandable structure disposed in a distal section of the catheter body, the expandable structure having an outer surface configured to be displaced radially outward toward an inner surface of a body lumen wall; a plurality of plaque disruption features distributed across an outer surface of the expandable structure, at least some of the plaque disruption features being on the outer surface of the expandable structure and having an upper surface configured to disrupt calcifications while minimizing damage to the body lumen when the expandable structure is expanded within the body lumen; an encapsulation layer covering at least a portion of the exterior surface of the expandable structure and the plaque disruption features and immobilizing the plaque disruption features on the exterior surface of the expandable structure in a desired pattern; An apparatus comprising:

[0409] Clause 235. The device of clause 234, wherein at least some of the upper surfaces of the plaque disruption features include convex rounded apexes.

[0410] Addendum 236. The device of any one of Addendums 234 and 235, wherein the encapsulation layer covers the entire outer surface of at least some of the plaque disruption features, including the upper surface.

[0411] Clause 237. The device of any one of clauses 234 and 235, wherein the encapsulation layer covers only a lower portion of an outer surface of at least some of the plaque disruption features.

[0412] Clause 238. The device of any one of clauses 234-237, wherein the plaque disruption feature is disposed within a recess on an outer surface of the expandable structure.

[0413] Clause 239. The device of clause 234, wherein the plaque disruption feature comprises a hemisphere with a flat bottom bonded to the outer surface of the expandable structure.

[0414] Clause 240. The device of any one of clauses 234-239, wherein the plaque disruption features comprise discrete bodies.

[0415] Clause 241. The apparatus of Clause 240, wherein the discrete bodies comprise a metal.

[0416] Clause 242. The apparatus of clauses 234-240, wherein the plaque disruption features comprise any one or more of a ball, a sphere, a hemisphere, an ellipsoid, and a dome.

[0417] Clause 243. The device of clauses 234-242, wherein the plaque disruption feature is immobilized only by the encapsulation layer.

[0418] Clause 244. The device of any one of clauses 234-243, wherein the plaque disruption feature is immobilized by an adhesive between the feature and the exterior surface in addition to the encapsulation layer.

[0419] Clause 245. The apparatus of clauses 234-244, wherein the encapsulation layer comprises a polymer selected from the group consisting of thermoplastic fluoropolymer (PVDF), butyl methacrylate (PBMA), and thermoplastic polyester (PLLA).

[0420] Addendum 246. The device of any of Addendums 234-245, wherein the encapsulation layer is applied over the outer surface and the plaque disruption features by any one of coating, direct fluid application, lamination, and fusing.

[0421] Clause 247. The apparatus of clauses 234-246, wherein the encapsulation layer has a thickness in the range of 0.01 mm to 0.1 mm (0.4 mils to 5 mils), often 0.01 mm to 0.05 mm (0.4 mils to 2 mils), and more often 0.01 mm to 0.02 mm (0.4 mils to 0.8 mils).

[0422] Addendum 248. The convex rounded apex of the plaque disruption feature, when the expandable structure is expanded, has a radial height within a range of 0.05 mm, 0.1 mm, 0.15 mm, 0.2 mm, or 0.25 mm minimum to 1 mm, 0.5 mm, 0.4 mm, 0.3 mm, or 0.25 mm maximum above the outer surface of the expandable structure, and a radial height within a range of 0.1 to 5 features / mm. 2 , preferably 0.2 to 4 features / mm 2 , more preferably 0.25 to 3 features / mm 2 and a distribution density in the range of.

[0423] Addendum 249. The device of Addendum 248, wherein the plaque distribution characteristic has an area having a maximum width, diameter, or other lateral dimension of 4 mm or less, often 3 mm or less, more often 1 mm or less, frequently 0.75 mm or less, and sometimes 0.5 mm or less.

[0424] Addendum 250. A method for treating a lesion on a wall in a body lumen of a patient, comprising: providing a catheter having an expandable structure disposed at a distal end thereof, the expandable structure having an outer surface configured to be displaced radially outward toward an inner surface of a body lumen wall, the outer wall having a plurality of spatial separation features distributed across an outer surface of the expandable structure; expanding the expandable structure within the patient's body lumen such that a radially outward force is applied by the outer surface and the features against the wall while the features maintain a gap between the outer surface of the expandable structure and an inner wall; A method comprising:

[0425] Addendum 251. The method of Addendum 250, wherein the spacer feature has axially aligned through holes that allow the passage of contrast agent therethrough.

[0426] Addendum 252. The method of any one of Addendums 277 to 278, wherein the gaps allow for fluid perfusion through and beyond the expandable structure while the expandable structure is expanded.

[0427] Clause 253. The method of clause 277 or 278, further comprising perfusing a drug into the gap while the expandable structure is expanded.

[0428] Addendum 254. The method of Addendum 253, wherein the expandable structure comprises a balloon and the drug is perfused through the wall of the balloon.

[0429] Clause 255. The method of clause 254, wherein at least some of the spatial separation features comprise a drug that is released into the interstices.

[0430] Addendum 256. The method of any one of Addendums 250-255, wherein expanding the expandable structure creates one or more gaps between an outer surface and an inner wall of the expandable structure under physiological pressure, allowing fluid perfusion through the one or more gaps.

[0431] Addendum 257. The method of any one of Addendums 250-256, wherein the body lumen comprises a blood vessel and the fluid perfusion comprises blood.

[0432] Addendum 258. The method of Addendum 257, wherein the fluid perfusion further includes at least one of a contrast agent and a drug.

[0433] Addendum 259. The method of any one of Addendums 250-258, wherein at least some of the features have convex rounded apexes.

[0434] Addendum 260. The features, when the expandable structure is expanded, have a radial height above an outer surface of the expandable structure within a range of a minimum of 0.05 mm, 0.1 mm, 0.15 mm, 0.2 mm, or 0.25 mm to a maximum of 1 mm, 0.5 mm, 0.4 mm, 0.3 mm, or 0.25 mm, and a number of features per mm ranging from 0.1 to 5. 2 , preferably 0.2 to 4 features / mm 2 , more preferably 0.25 to 3 features / mm 2 The method of claim 250-259, having a distribution density in the range of

[0435] Addendum 261. The method of any one of Addendums 250-260, wherein the expandable structure is expanded with a force sufficient to create and / or maintain one or more gaps relative to a physiological pressure of 0.5 psi to 5 psi, preferably 1 psi to 3 psi.

[0436] Addendum 262. The method of any one of Addendums 250-261, wherein the feature is configured to create and / or maintain one or more gaps by separating the lesion from an outer surface of the expandable structure adjacent the feature when the structure is in the expanded configuration.

[0437] Clause 263. The method of any one of clauses 250-262, comprising a plurality of features positioned in a configuration around the circumferential and / or axial length of the expandable structure to provide, create, or maintain the gap. (Incorporated by reference)

[0438] All publications, patents, and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference. [Brief description of the drawings]

[0439] [Figure 1] 1A and 1B illustrate a scaffold having multiple stress-applying features distributed across its exterior surface in accordance with the principles of the present invention.

[0440] [Figure 2-1] 2A-2E illustrate different design and location embodiments for the stress application features of the present invention.

[0441] [Figure 2-2] 2F-1A-2F-3B illustrate additional configuration embodiments of the stress application features of the present invention.

[0442] [Figure 2-3] 2G-1A-2G-4B illustrate examples of placement of points, edges, and other sharp features on the stress-applying features of the present invention.

[0443] [Figure 2-4] 2H-1-2H-22 illustrate various design embodiments for the stress application features of the present invention. [Figure 2-5] 2H-1-2H-22 illustrate various design embodiments for the stress application features of the present invention. [Figure 2-6] 2H-1-2H-22 illustrate various design embodiments for the stress application features of the present invention.

[0444] [Diagram 3] FIG. 3 illustrates an expandable sleeve embodiment having a helical pattern of stress-applying features on its exterior surface.

[0445] [Figure 4] 4A and 4B illustrate a tubular scaffold or sleeve having a first array of stress-applying features on its exterior surface.

[0446] [Diagram 5] 5A and 5B illustrate a tubular scaffold or sleeve having a second array of stress-applying features on its exterior surface.

[0447] [Figure 6] 6A-6C illustrate a first method for folding integral scaffolding elements into stress-applying features on the outer surface of a scaffold.

[0448] [Figure 7] 7A-7C illustrate a second method for folding integral scaffolding elements into stress-applying features on the outer surface of the scaffold.

[0449] [Figure 8] 8A-8C illustrate a third method for folding integral scaffolding elements into stress-applying features on the outer surface of the scaffold.

[0450] [Figure 9] 9A and 9B illustrate an example of how the stress-applying features of the present invention disrupt calcified plaque when radially engaged against the plaque.

[0451] [Figure 10] 10A-10C illustrate an alternative embodiment of the present invention in which a plurality of plaque disruption features are present on the exterior surface of an expandable structure, such as an inflatable angioplasty balloon or other medical balloon.

[0452] [Figure 11] 11A-11C illustrate an embodiment of the present invention having multiple plaque disruption features similar to those illustrated in FIGS. 10A-10C, but arranged in yet another pattern.

[0453] [Figure 12-1] 12A-12C illustrate an embodiment of the present invention having multiple plaque disruption features similar to those illustrated in FIGS. 10A-10C, but arranged in a different pattern, in accordance with the principles of the present invention.

[0454] [Figure 12-2]12D-12H illustrate yet further variations of the plaque disruption feature patterns of the present invention. [Figure 12-3] 12D-12H illustrate yet further variations of the plaque disruption feature patterns of the present invention.

[0455] [Figure 12-4] 12I-12L illustrate different balloon shapes and stress-induced feature distribution patterns in accordance with the principles of the present invention.

[0456] [Figure 13] 13A and 13B illustrate a tubular template that can be used in placing multiple plaque disruption features on the exterior surface of a balloon or other expandable structure.

[0457] [Figure 14] 14A and 14B illustrate spherical plaque disruption features mounted within a circular base (FIG. 14A) and a cylindrical base (FIG. 14B) present on the exterior surface of an angioplasty balloon in accordance with the principles of the present invention.

[0458] [Figure 15] FIG. 15 illustrates exemplary perimeter dimensions for the plaque disruption features and / or support base of the present invention.

[0459] [Figure 16-1] 16A-16H illustrate exemplary attachment methods for spherical, hemispherical and other plaque disruption features in accordance with the principles of the present invention.

[0460] [Figure 16-2]16D-1-16D-6 illustrate exemplary attachment methods for spherical, conical, or other plaque disruption features according to the principles of the present invention, where the features are attached within preformed depressions in the outer surface of a balloon or other expandable member, which provide a receptacle or "mount" for immobilizing the features using one or more adhesives or polymeric materials. FIG. 16D-1 is a perspective view. FIG. 16D-2 is a cross-sectional view of the balloon, and FIGS. 16D-3-6 are detailed views of the features within the depressions taken along lines 1603-1603, 1604-1604, 1605-1605, and 1606-1606 in FIG. 16D-2, respectively. These examples are similar to those illustrated in FIG. 16D. [Figure 16-3] 16D-1-16D-6 illustrate exemplary attachment methods for spherical, conical, or other plaque disruption features according to the principles of the present invention, where the features are attached within preformed depressions in the outer surface of a balloon or other expandable member, which provide a receptacle or "mount" for immobilizing the features using one or more adhesives or polymeric materials. FIG. 16D-1 is a perspective view. FIG. 16D-2 is a cross-sectional view of the balloon, and FIGS. 16D-3-6 are detailed views of the features within the depressions taken along lines 1603-1603, 1604-1604, 1605-1605, and 1606-1606 in FIG. 16D-2, respectively. These examples are similar to those illustrated in FIG. 16D.

[0461] [Figure 17] 17A-17D illustrate a spherical plaque fracture feature that is restrained or otherwise held on the outer surface of a balloon using an elastic sleeve.

[0462] [Figure 18] 18A-18C illustrate the attachment of spherical plaque disruption features onto the inner surface of an elastic sleeve and a method for expansion using an inflatable balloon.

[0463] [Figure 19]FIG. 19 illustrates plaque disruption features present on the exterior surface of a drug delivery balloon catheter.

[0464] [Figure 20] 20A and 20B are cross-sectional views of the drug delivery balloon catheter of FIG. 19 shown in pre-inflation and post-inflation configurations, respectively, as used in drug delivery.

[0465] [Figure 21] 21A-21D illustrate alternative structures and methods for intravascular delivery of drugs using the plaque disruption features of the present invention. The structures of Figures 21C and 21D incorporate an elastic sleeve.

[0466] [Figure 22] FIG. 22 illustrates the plaque disruption feature of the present invention placed on the exterior of a balloon-expandable scaffold or "cage" of the type intended for temporary placement within a target vascular location for plaque disruption and subsequent removal.

[0467] [Figure 23A] FIG. 23A shows placement of the expandable scaffold of FIG. 22 onto a balloon catheter prior to expansion of the balloon catheter.

[0468] [Figure 23B] FIG. 23B shows the expandable scaffold of FIG. 23A onto a balloon catheter following expansion of the balloon catheter.

[0469] [Figure 24] FIG. 24 is an end view of an expandable structure, such as a balloon catheter, having features, such as metal spheres, contacting and / or expanding plaque tissue and showing the space created by the features, such as metal spheres, for fluid and / or contrast material to pass through between the outer surface of the expanded structure and the inner surface of the vessel (or plaque).

[0470] [Figure 24-1]24A-24D are cross-sectional views of an expandable structure, such as a balloon catheter, having features, such as metal spheres, that contact and / or expand plaque tissue, with space created for, e.g., fluid and / or contrast material, to pass through between the outer surface of the expanded structure and the inner surface of the vessel (or plaque) by the features, such as metal spheres. [Figure 24-2] 24A-24D are cross-sectional views of an expandable structure, such as a balloon catheter, having features, such as metal spheres, that contact and / or expand plaque tissue, with space created for, e.g., fluid and / or contrast material, to pass through between the outer surface of the expanded structure and the inner surface of the vessel (or plaque) by the features, such as metal spheres.

[0471] [Figure 24-3] 24D-1-24D-3 illustrate features of the type illustrated in FIG. 24D having holes through the feature that further facilitate perfusion of contrast agent beyond the balloon when inflated within the vasculature. [Figure 24-4] 24D-1-24D-3 illustrate features of the type illustrated in FIG. 24D having holes through the feature that further facilitate perfusion of contrast agent beyond the balloon when inflated within the vasculature.

[0472] [Diagram 25] FIG. 25 shows a conventional balloon angioplasty catheter within a simulated blood vessel (clear plastic tube) that is perfused with a dyed or contrast fluid, and flow is blocked by an inflated balloon.

[0473] [Figure 26] FIG. 26 shows a simulated blood vessel perfused with a colored or contrast fluid, with flow bypassing the expanded balloon through spaces created between the outer surface of the expanded balloon and the inner surface of the simulated vessel by metal spheres or other features.

[0474] [Figure 27] 27, 28, 29, 30A, 30B, 31A and 31B illustrate different embodiments of catheters having a segmented balloon design or a multi-balloon design, with opposing surfaces with plaque disruption features configured to capture cardiac or other valve leaflets and disrupt calcification in a patient's valve. [Figure 28] 27, 28, 29, 30A, 30B, 31A and 31B illustrate different embodiments of catheters having a segmented balloon design or a multi-balloon design, with opposing surfaces with plaque disruption features configured to capture cardiac or other valve leaflets and disrupt calcification in a patient's valve. [Figure 29] 27, 28, 29, 30A, 30B, 31A and 31B illustrate different embodiments of catheters having a segmented balloon design or a multi-balloon design, with opposing surfaces with plaque disruption features configured to capture cardiac or other valve leaflets and disrupt calcification in a patient's valve. [Figure 30A] 27, 28, 29, 30A, 30B, 31A and 31B illustrate different embodiments of catheters having a segmented balloon design or a multi-balloon design, with opposing surfaces with plaque disruption features configured to capture cardiac or other valve leaflets and disrupt calcification in a patient's valve. [Figure 30B] 27, 28, 29, 30A, 30B, 31A and 31B illustrate different embodiments of catheters having a segmented balloon design or a multi-balloon design, with opposing surfaces with plaque disruption features configured to capture cardiac or other valve leaflets and disrupt calcification in a patient's valve. [Figure 31A] 27, 28, 29, 30A, 30B, 31A and 31B illustrate different embodiments of catheters having a segmented balloon design or a multi-balloon design, with opposing surfaces with plaque disruption features configured to capture cardiac or other valve leaflets and disrupt calcification in a patient's valve. [Figure 31B]27, 28, 29, 30A, 30B, 31A and 31B illustrate different embodiments of catheters having a segmented balloon design or a multi-balloon design, with opposing surfaces with plaque disruption features configured to capture cardiac or other valve leaflets and disrupt calcification in a patient's valve. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0475] Detailed Description of the Invention 1A and 1B, an expandable structure comprising an endoluminal prosthesis comprises a radially expanding scaffolding 10, illustrated in the form of a stent, including a plurality of ring structures 12. The stent scaffolding 10 includes three discrete circumferential rings 12, joined by axial connections 18 as illustrated in FIGS. 1A and 1B, which together form a cylindrical or other envelope with free ends. Although three rings are illustrated, it should be understood that a stent scaffold according to the present invention may include any number of ring structures, from a single circumferential ring structure to five, ten, or even more ring structures. The ring structures are typically joined into a cylinder having a generally circular cross-sectional shape, but may be other tubular geometries such as elliptical, tapered, hourglass, dog-bone, oval, etc., and the like, as is well known in the art of vascular and other endoluminal scaffolds.

[0476] Each ring structure 12 comprises a plurality of struts 14, typically straight struts, joined by U-shaped or other crowns 16. Such "serpentine" ring structures are most common in the fabrication of vascular stents, although other geometries, including zigzag rings, spiral wire, helical wire, bent wire, diamond shaped cells, etc., and the like, are also well known in the vascular stent art and may be used in the present invention.

[0477] As shown in FIG. 1A, the scaffold 10 will initially be in a "crimped" or small configuration, i.e., having a thin profile suitable for introduction into a patient's blood vessel or other body lumen. Once in place, the scaffold 10 will be forced to assume a radially expanded profile, as shown in FIG. 1B. Such radial expansion can be affected in any conventional manner, typically by balloon expansion, or by "self-expansion," where an elastic stent is first radially compressed and subsequently released from compression to allow expansion at a target location within the vasculature or other body lumen.

[0478] Of particular note to the present invention, the scaffold 10 of the present invention will have a plurality of stress-applying features 24 across its exterior surface 26. The stress-applying features 24 may be pre-formed and attached to the exterior surface of the scaffold after the scaffold has been separately fabricated, for example, by gluing with an adhesive, soldering, welding, mechanical crimping, interference fit, threaded attachment, or the like. Alternatively, the stress-applying features may be formed as part of the scaffold during fabrication of the scaffold, for example, by cutting, machining, depositing, deforming, or combinations thereof. Particular methods for forming the stress-applying features are described with reference to Figures 6A-6C, 7A-7C, and 8A-8C.

[0479] 1A and 1B, the stress-applying features 24 are disk-shaped and have a generally circular blunt contact area 30 on their radially outwardly exposed surface. While generally preferred, such stress-applying features may have a variety of other geometric shapes, some of which are described throughout the present invention with reference to FIGS. 2A-2E, 2F, 2G, and 2F.

[0480] Although some of the stress application features and / or plaque disruption features described herein are illustrated in conjunction with specific radially expanding scaffoldings, such as stents, sleeves, balloons, valvuloplasty balloons, and the like, it should be understood that the stress application features and plaque disruption features described herein may be useful with and / or applied to at least some or any radially expanding structures, including at least balloons, stents, sleeves, valvuloplasty balloons, and the like.

[0481] 1A and 1B, the stress-applying features 24 are attached across the "free" ends of the crowns 16, located on opposite sides of the ring structure 12. "Free" ends means that the crowns have no attachment to adjacent crowns or other structures of the scaffold 10.

[0482] Successive pairs of stress-applying features 24 are located 180° apart on each ring structure 12, although the alignment is typically staggered by 90° on each successive ring 12. While this is the preferred arrangement, it should be understood that the number and arrangement of individual stress-applying features 24 may vary widely, as described herein above.

[0483] As shown in the examples of Figures 2A-2E, the geometry and location of the stress-applying features may vary significantly. As shown in Figure 2A, the stress-applying feature 24a may be shaped as a truncated cone, with the truncated portion forming a blunt contact area 30a.

[0484] As shown in the example of Figure 2B, the truncated cone 24a may be located on the strut 14, for example, at the center of the strut. Additionally or alternatively, stress-applying features can be located anywhere along the strut length and at different locations on the individual scaffolds 10, including crowns, struts, connectors, and the distribution of individual stress-applying features may vary across different axial and circumferential regions of the outer scaffold surface.

[0485] 2C-2E, the geometry of the individual stress-applying features 24b-24d may vary. For example, as shown in FIG. 2C, stress-applying feature 24b may be formed asymmetrically as a truncated cone with blunt contact area 30b displaced to align with the outer distal tip of crown 16. As shown in FIG. 2D, stress-applying feature 24c may be formed as two or more stacked disks or other stacked features having other shapes, each of which may have the same or different configurations, for example, including a larger diameter base disk 34 and a smaller diameter upper disk 32 with blunt contact area 30c on the exposed surface of the smaller diameter upper disk 32. As shown in FIG. 2E, the larger diameter base disk 34 may be combined with a smaller upper truncated cone 36, with blunt contact area 30d formed by the truncation. The one or more features may also be of the convex, rounded, blunt, and / or atraumatic type, shaped as described in the present invention.

[0486] In most cases, the blunt contact region 30 will be located at or near the top of the stress-applying feature 24, i.e., at the most radially outward location on the outer surface of the scaffold (or other expandable balloon, sleeve, or equivalent, as discussed below). Thus, the blunt contact region 30 will be the first area on the scaffold 10 to engage any occlusive material present on the interior wall of a blood vessel or other body lumen when the scaffold is radially expanded therein, as discussed further with reference to Figures 9A and 9B below.

[0487] As described at this point, the stress-applying features of the present invention are shown to have blunt contact areas that are generally parallel to the surface on which they are mounted. In other cases, the blunt contact areas may be inclined relative to the surface on which they are mounted. As shown in FIG. 2F-1A / 1B, an exemplary disk-shaped stress-applying feature 210 has a blunt contact area 212 that is inclined at an angle α relative to the surface 214 on which it is mounted. The angle α is typically in the range of 5°-45°, usually 10°-35°. The cone-shaped stress-applying feature 216 and the stacked stress-applying feature 218 may also have inclined contact areas, as shown in FIG. 2F-2A / 2B and 3A / 3B, respectively.

[0488] As shown in Figures 2G-1A and 2G-1B, an exemplary stress-applying feature 220 includes a sharp element 222 mounted on and projecting upwardly from a blunt contact region 224. The stress-applying feature 220 may be mounted on a surface 226 of any one of a scaffold, sleeve, or angioplasty or other balloon, as described in detail elsewhere herein. The sharp element 222 typically comprises a short shaft with a sharp tip 228 configured to initiate fracturing of the plaque or calcification as the stress-applying feature is pressed against the plaque or calcification. Preferred dimensions for the sharp element are provided elsewhere herein.

[0489] 2G-2A and 2G-2B, the stress-applying feature 230 comprises a domed or hemispherical body with a rounded upper surface 234 for engaging plaque or calcification, as described in detail elsewhere herein. A sharp element 232 projects upwardly from the rounded upper surface 234, typically from the apex of the rounded upper surface. The stress-applying feature 230 is mounted on a surface 236 of a scaffold, sleeve, balloon, or other structure, as described in further detail elsewhere herein. The sharp element 232 is a short shaft with a sharp distal tip, similar to the sharp element 222.

[0490] The sharp element may also comprise a blade with one or more elongated sharp edges to initiate calcification fracturing. As shown in Figures 2G-3A and 3B, the stress-applying feature 240 comprises a disk-shaped blunt contact area 244 with a sharp element 242 protruding upward therefrom. The sharp element 242 consists of a single blade with a sharp edge, and the stress-applying feature is mounted on a surface 246 of a scaffold, balloon, cage, or sleeve, as in other embodiments herein. As shown in Figures 2G-4A and 4B, the stress-applying feature 250 may comprise a disk-shaped blunt contact area 254 with a sharp element 252 that includes a pair of sharp blades. As in the previous embodiment, the stress-applying feature 250 is configured to be mounted on a surface 256 of a scaffold, balloon, cage, or sleeve.

[0491] The stress application features of the present invention may have any one of a variety of forms and designs, including blunt tissue-engaging surfaces, curved tissue-engaging surfaces, stacked tissue-engaging structures, compartmentalized tissue-engaging structures, and the like, some specific designs have been shown and described above. Some additional example designs are shown in Figures 2H-1-2H-22 as will be described herein. All specific stress application feature designs illustrated herein, including but not limited to those shown in Figures 2F-1A-2H-22, may be used in conjunction with any of the expandable structures described herein, including but not limited to scaffolds, balloons, sleeves, cages, prosthetic valves, cages, and the like.

[0492] A stress application feature comprising a cylindrical post is shown in Figures 2H-1 and 2H-2. Figure 2H-1 illustrates a cylindrical post 350 having a flat cylindrical top 350a and a flared base 350b configured for attachment to the outer surface of a radially expanding structure. The flared base increases the surface area available for attachment to the surface of the expandable structure. The flat cylindrical top may have a peripheral edge (as shown), but in other cases may have a rounded or beveled peripheral edge (not shown). The contact area of ​​the cylindrical top may be coated with a material to provide one or more of an adhesive (increased friction) surface, a smooth surface, a low friction surface, or the like. Materials can be bonded, fused, coated, laminated, or otherwise added to the surface to modify the surface geometry, for example, to make the surface flatter, more rounded, add texture, or the like. FIG. 2H-2 illustrates a cylindrical post 352 having a domed top 352a and a flared base 352b configured for attachment to the exterior surface of a radially expanding structure.

[0493] Exemplary stress application features comprising tapered cylindrical posts are shown in Figures 2H-3 and 2H-4. Figure 2H-3 illustrates a post 354 having a flat circular bottom 354a that tapers radially outward in the upward direction to a flat circular top 354b that is larger than the bottom. Figure 2H-4 illustrates a post 356 having a flat rounded bottom 356a that tapers radially inward in the upward direction to a flat rounded top 356b that is smaller than the bottom.

[0494] Exemplary stress-applying features comprising stacked structures having upper spherical or generally spherical plaque-engaging elements and various lower support elements are illustrated in FIGS. 2H-5-2H-9. FIG. 2H-5 illustrates stress-applying feature 360 ​​having lower spherical support element 360a and upper spherical plaque-engaging element 360b. FIG. 2H-6 illustrates stress-applying feature 362 having lower truncated cone-shaped element 362a and upper spherical plaque-engaging element 362b. The truncated cone-shaped element 326a may provide additional plaque-breaking features, and the truncated upper portion 362c may have a flat surface or other type of surface for contacting hardened plaque tissue. FIG. 2H-7 illustrates stress-applying feature 364 having lower truncated spherical support element 364a and upper spherical plaque-engaging element 364b. The truncated upper portion 364c of the truncated spherical element 364a may provide an additional plaque disruption feature for contacting hardened plaque tissue. FIG. 2H-8 illustrates a stress application feature 366 having a lower dome-shaped support element 366a and an upper spherical plaque engaging element 366b. FIG. 2H-9 illustrates a stress application feature 368 having a lower support post 368a, which has a reduced waist diameter (a "concave" central section) and an upper spherical plaque engaging element 368b.

[0495] Stress-applying features comprising a stacked structure having an upper dome-shaped plaque-engaging element and various lower support elements are illustrated in Figures 2H-10-2H-13. Figure 2H-10 illustrates a stress-applying feature 370 having a lower spherical support element 370a and an upper dome-shaped plaque-engaging element 370b. Figure 2H-11 illustrates a stress-applying feature 372 having a lower truncated hemispherical element 372a and an upper partially spherical plaque-engaging element 372b, which together form an integrated dome structure. Typically, the upper and lower elements will be formed from different materials and / or have different hardness or other material properties, although in some instances they may be formed from the same material having similar or the same material properties. FIGURE 2H-12 illustrates a stress application feature 374 having a lower support post 374a and an upper dome-shaped plaque engaging element 374b that tapers about a central section thereof. FIGURE 2H-13 illustrates a stress application feature 376 having a lower truncated tapered conical support element 376a and an upper dome-shaped plaque engaging element 376b.

[0496] FIG. 2H-14 illustrates a stress-applying feature 378 that comprises a monolithic dome 378a having a rounded top portion 378b that is asymmetrically positioned relative to a circular or oval peripheral base 378c.

[0497] Stress application features having channeled plaque engaging elements and various lower support elements are illustrated in Figures 2H-15-2H-18. Figure 2H-15 illustrates a stress application feature 380 similar to that shown in Figure 2H-11, having an integrated structure with orthogonally oriented channels 380a and 380b that divide the structure into four symmetrical quadrants. Figure 2H-16 illustrates a stress application feature 382 comprising a cylindrical post 382a with orthogonally oriented channels 382b and 382c that divide the structure into four symmetrical quadrants. The top of each quadrant includes smaller features 382d that aid in gripping and breaking the clot engaged by the post. 2H-17 illustrates a stress application feature 384 similar to that illustrated in FIG. 2H-16, comprising a cylindrical post 384a with orthogonally oriented channels 384b and 384c dividing the structure into four symmetrical quadrants. Such channels, gaps, or spacers are axially oriented along the axial length of the expandable structure and may allow a drug or contrast agent to flow across the expandable structure from its proximal region toward its distal region when the structure is expanded or expanded to an expanded configuration, at or above physiological pressures and conditions when such drug or contrast agent is injected proximally to the expandable structure.

[0498] In yet another alternative embodiment (not shown), a feature, which may be hollow or solid, such as a sphere, is inserted inside the post and secured to the interior surface of the post by glue or other adhesive material. This provides additional securing of the feature to the expandable structure surface while providing a hardened feature, such as formed from a metal or metal alloy, to fracture the plaque when the expandable structure is expanded and pushes the feature against the plaque or hardened tissue while the feature is encapsulated by the expandable structure exterior surface. In yet another alternative or embodiment (not shown), the feature comprises holes through the feature that extend axially and / or circumferentially to the expandable structure, the feature holes forming a cavity in the base of the feature and the posts 260 on the exterior surface of the expandable structure project into the cavity. The posts would optionally be glued to the cavity surface of the feature in such an embodiment, providing additional securing of the feature to the expandable structure posts. The posts may be preformed, e.g., molded as part of the balloon or other substrate 254, or may be formed separately and attached to the balloon, or may be formed or molded into the balloon exterior surface after the balloon is formed and when the balloon is in the expanded configuration. The top of each quadrant includes smaller features 384c that aid in gripping and breaking up clots that are engaged by posts 384b, which are mounted on the expanded base 384d. Channels 384b and 384c provide a path for fluid to pass therethrough when the expandable structure is in the expanded configuration. FIG. 2H-18 illustrates stress-applying feature 386 that is the same in all respects as stress-applying feature 384 of FIG. 2H-17, except that two of the post quadrants have a shorter height than the other two quadrants. In other embodiments, any two, three, or four quadrants may have the same or different heights, widths, diameters, symmetries, asymmetries, or combinations thereof.

[0499] A stress-applying feature having a plurality of plaque-engaging elements on its upper surface is illustrated in Figs. 2H-19-2H-21. Fig. 2H-19 illustrates a stress-applying feature 388 having four spherical plaque-engaging elements 388a on the upper surface of a cylindrical base 388b. Fig. 2H-20 illustrates a stress-applying feature 390 having four spherical plaque-engaging elements 390a supported by a cylindrical base 390b. The four spherical plaque-engaging elements 390a are mounted on a tapered cone-shaped support having a plaque-piercing tip 390c at its center. Fig. 2H-21 illustrates a stress-applying feature 392, which is the same as that of Fig. 2H-20 including four spherical plaque-engaging elements 392b surrounding a plaque-piercing tip 392c, but does not include a cylindrical or other base. It should be understood that the different elements of the stress application features of FIGS. 2H-1-2H-21 can be combined and substituted in various ways to provide additional designs that are within the scope of the present invention.

[0500] FIG. 2H-22 illustrates a stress application feature 394 that comprises a simple arcuate bar 394a having a lower surface 394b that is attached, directly or indirectly, to the outer surface of the radially expanding structure.

[0501] As shown in FIG. 3 and subsequent figures herein, the stress-applying features of the present invention may be attached to a variety of expandable structures, including balloons, cages, sleeves, prosthetic valve bodies, valvuloplasty members, drug delivery members, and the like, in addition to stents and scaffoldings, as described above. For example, the expandable structure of the present invention may comprise a radially expandable sleeve 40, as shown in FIG. 3. The sleeve may be a tubular elastic membrane 42 configured to be placed over a balloon, stent, graft, or any other primary structure configured to be expanded within the lumen of a blood vessel or other body passageway or lumen. The stress-applying features 24 may be attached to an outer surface 44 of the sleeve 40 in any one of a variety of configurations. As illustrated in FIG. 3, the stress-applying features 24 are arranged in a helical pattern, with a region 46 at one end of the sleeve being devoid of stress-applying features.

[0502] 4A, a sleeve scaffold 40a comprises a similar tubular elastic membrane 42 having individual stress-applying features 24 arranged in a diametrically opposed pattern on the exterior surface of the tubular elastic membrane 42. Each successive pair of diametrically opposed stress-applying features 24 are staggered by 90°, as shown in FIG.

[0503] 5A and 5B, an elastic sleeve 40b comprises a tubular elastic membrane 42 having individual stress-applying features 24 arranged in groups of three ("triplets"), with each stress-applying feature in a triplet spaced 120° from a circumferentially adjacent feature. Typically, consecutive "triplets" are staggered by 60°, as best seen in FIG. 5B.

[0504] Although the patterns of stress-applying features shown in Figures 3, 4A, 4B, 5A, and 5B are shown on elastic sleeve 40, it will be apparent to one of ordinary skill in the art that these feature patterns may be employed on any expandable structure, including, in addition to the sleeves shown, stents, grafts, scaffolding, expandable valvuloplasty cages, cages for implementing expandable angioplasty balloons, and the like.

[0505] In some cases, the stress-applying features 24 may be formed as part of the scaffold fabrication process, as shown in Figures 6A-8C. Now referring to Figures 6A-6C, the scaffold may be patterned in any conventional serpentine or other pattern with struts 14 joined by a U-shaped crown 16 by laser cutting, photochemical etching, or the like. In accordance with the present invention, the stress-applying features 50a may be provided by forming protruding elements 52a and 52b on the outer curve of the crown 16 during the initial fabrication of the tubular scaffold body, as shown in Figure 6A. The protruding elements 52a and 52b are formed as disks that are joined to the crown by arms 54a and 54b. The disk 54b is first folded over the outer surface of the crown 16 by bending the arms 54b, as shown in Figure 6B. The disk 54a is then folded over the exposed surface of the disk 52b, as shown in Figure 6C. Thus, the exposed surface of disk 52a provides blunt contact area 30. Although circular disks 52a and 52b are illustrated, a variety of other plate geometries may be utilized, such as square, rectangular, polygonal, oval, teardrop shaped, irregular shapes, and the like.

[0506] As can be seen from Figs. 6A-6C, the protruding elements 50a are formed within the cylindrical envelope of the scaffold as it is fabricated, which would require a slight deviation from conventional scaffold fabrication methods. In particular, a tubular blank can be used as the starting structure. The individual disks 52a and 52b are then folded over and onto the outer surface of the crown 16 by bending the arms 54 in turn to provide a blunt contact area 30". In this way, the two disks are stacked on top of each other, creating a stress application feature having a height twice the thickness of the struts 14 and crown 16. What was initially the lower surface of the disk 52a then becomes the blunt contact area 30 of the resulting stress application feature, as shown in Fig. 6C.

[0507] As shown in Figures 7A-C, the protruding element 50b includes two disks 52a and 52b that join the crown 16 in tandem by arms 54 and 56. A stress application feature is then formed across the exterior surface of the crown 16 by first folding the outer disk 52b over the inner disk 52a by bending the arms 56, as shown in Figure 7B. The pair of stacked disks 52a and 52b are then folded across the exterior surface of the crown 16 to provide the blunt contact area 30, as shown in Figure 7C.

[0508] In a third embodiment, as seen in Figures 8A-8C, a pair of disks 52a and 52b are located on opposite sides of the post 14 and are attached by arms 54a and 54b. A first of the disks 52a is then folded over the outer surface of the post 14 as shown in Figure 8B, and a second disk 52b is then folded over the first disk 52a as shown in Figure 8C. The exposed surface of the second disk 52b thus provides the blunt contact area 30 of the present invention.

[0509] As shown in Figures 9A and 9B, the blunt contact region 30 of the stress-applying feature 24 is pressed radially outward against the region of plaque P or other occlusive material within the vessel lumen. As an expandable structure, such as the scaffolding struts 14 shown in this figure, is radially expanded, the peripheral edge 60 of the blunt contact region 30 contacts the exposed surface of the plaque region P, as shown in Figure 9A. As the crown 16 is further deflected by the balloon or other expansion force, the peripheral edge 60 is forced through the surface of the plaque region PR, causing the plaque region to fracture along the fracture line FL, while the blunt contact region 30 prevents injury to the vessel wall. In other embodiments (not shown), the peripheral edge of the plaque disruption feature may be beveled or rounded, or may be coated with one or more materials to provide a beveled, rounded, or smoother surface. In yet another embodiment (not shown), the plaque disruption features have rounded, convex, blunt, or otherwise atraumatic contact areas, bodies, or bases, and are free of any edges that may impede advancement of the system into the body's vasculature.

[0510] 10A-10C, a balloon catheter 100 has an inflatable balloon 102 at the distal end of a shaft 104. A plurality of spherical plaque disruption features 106 are distributed across an outer surface 108 of the inflatable balloon 102. The spherical plaque disruption features 106 are arranged in pairs of disruption features 106a and 106b located on opposite sides of the balloon surface 108. In addition, each pair of features 106a and 106b is rotatably or circumferentially displaced by 90 degrees from the adjacent pair, as best seen in FIGS. 10B and 10C.

[0511] 11A-11C, a balloon catheter 120 has an inflatable balloon 122 at the distal end of a shaft 124. A plurality of spherical plaque disruption features 126a and 126b are distributed across an outer surface 128 of the inflatable balloon 122. The spherical plaque disruption features 126a-b are arranged in triplets of disruption features 126a and 126b spaced 120° apart on the balloon surface 128. In addition, each triplet of features 126a and 126b is rotatably or circumferentially displaced by 60° from an adjacent pair, as best seen in FIGS. 11B and 11C.

[0512] As shown in Figures 12A-12C, a balloon catheter 140 has an inflatable balloon 142 at the distal end of a shaft 144. A plurality of spherical plaque disruption features 146a and 146b are distributed across an outer surface 148 of the inflatable balloon 142. However, in contrast to the previous environment, the plaque disruption features 146a / b are not arranged symmetrically. Instead, they are arranged in two axial lines with features 146a and 146b, respectively, spaced 90° apart along the edge of one quadrant of the balloon. The spherical plaque disruption features 146 are also axially staggered such that they lie on different axially spaced circumferential lines 150 around the balloon surface 148.

[0513] Although specific symmetric and asymmetric fracture feature patterns are illustrated, it should be understood that a wide variety of patterns are possible and that some patterns may be configured out of alignment. For example, in FIG. 12D, the fracture features 162 are generally positioned along axial lines 164 on the balloon surface 160 (shown in an unfolded state), but may be configured to deviate circumferentially from those lines. As shown in FIG. 12E, those fracture features 172 that are generally positioned along circumferential lines 174 on the balloon surface 170 may deviate circumferentially from those lines by a small angle α. Similarly, as shown in FIG. 12F, those fracture features 172 that are generally positioned along axial lines 175 may deviate axially from those lines by a small angle β. Such small misalignments help to space the features apart and minimize or avoid interference between the features when the expandable structure is radially crimped or crushed prior to expansion. For example, if multiple features are all attached along a single circumferential line, the features may collapse circumferentially relative to one another when the expandable member is radially crimped or crushed prior to expansion. Such interference can be reduced or eliminated by moving some or all of the features away from the circumferential line, even by only a small distance, such as the width of a feature.

[0514] 12G and 12H, the fracture features 172 may be distributed in a variety of patterns across the balloon surface 170 of the fully formed balloon catheter 171. The fracture features 172 will typically be distributed across all or a portion of at least the central region 170a of the balloon surface. Optionally, the fracture features 172 may also be distributed across the tapered distal region 170b (FIG. 12G) of the balloon surface 170, as well as across the tapered proximal region 170c thereof. The specific distribution pattern may be any of those described elsewhere in this application, including at least those shown in FIGS. 12G and 12H.

[0515] As shown in Figures 12I-12L, the plaque disruption features 172 of the present invention may be placed on balloons and other expandable structures having a variety of different geometries and configurations. For example, as shown in Figure 12I, the plaque disruption features 172 may be placed on an enlarged central section 170b of an inflatable support balloon 170a, or on an adjacent cylindrical or tapered end section (not shown). As shown in Figure 12J, the plaque disruption features 172 may be placed on an adjacent section 170d of a balloon 170c having a recessed waist 170e at its center. In some cases, the recessed section 170e may have multiple plaque disruption features, while the adjacent section 170d may be devoid of plaque disruption features. As shown in Figure 12K, the plaque disruption features 172 may be placed on a balloon or other expandable support 170f having an oval or spheroid shape. 12L, the plaque disruption features 172 may be located on a balloon support 170g that has a tapered cone shape on one side and a flat surface at its proximal end. In some cases, the tapered cone surface of the balloon or other support may have plaque disruption features on the flat end (not shown), while the conical tapered section is devoid of plaque disruption features (not shown).

[0516] In such exemplary arrangements, the preferred hemispherical or spherical plaque disruption features are circumferentially and axially "discrete," i.e., separated from one another, and protrude radially outward from the outer surface of the balloon or other expandable structure before and after expansion of the expandable structure. Hemispherical or spherical plaque disruption features may be located only on the working length of the balloon (as shown in Figures 10A, 11A, 12A, and 12H), on both the working length and the proximal and / or distal regions (Figure 12G), or, in some cases, only on the proximal and / or distal regions (not shown).

[0517] As shown in Figures 13A and 13B, the plaque disruption features may be positioned on the outer surface of a balloon, sleeve, or other expandable member using a tubular template. The tubular tube 400 shown in Figure 13A includes a PTFE sheath 402 with a preselected pattern of circular or other cutouts 404 configured to be placed over the outer surface of an expanded balloon or sleeve, the cutouts allowing for placement of adhesive material, such as adhesive droplets, on a surface of an expandable structure, such as the outer surface of a balloon, sleeve, or other expandable structure, for attachment of the plaque disruption features, as shown, for example, in Figure 16A described below. A smaller tubular template 410 including a PTFE or other sheath 412 with circular or other cutouts 414 may be provided for placement over an uninflated or unexpanded balloon and sleeve or a smaller expanded balloon and sleeve. After placement of the adhesive droplets, the tubular template is removed and the features are placed, typically along the length and circumference of the outer expandable member while still partially or fully expanded, to fit snugly over the droplets.

[0518] 14A, a spherical plaque fracture feature 180 may be secured to a balloon surface 184 using a circular base 182. The circular base 182 serves to stabilize the fracture feature 180 on the balloon surface and may be secured by adhesive attachment, laser welding, heat welding, or other means known in the art. Additionally, the entire structure of the fracture feature 180 and circular base 182 may be further held in place by the placement of a cover (not shown) over the structure as previously described herein.

[0519] 14B, a hemispherical plaque fracturing feature 190 may be secured to the outer surface of an expandable structure, such as a balloon, cage, or sleeve, using a cylindrical base or post 192. The base 192 stabilizes the fracturing feature 190 on the balloon surface and also elevates the surface of the fracturing feature 190 a predetermined height or elevation above the balloon surface 194. In this manner, the radially outward extent of the fracturing feature can be elevated above the balloon surface at any desired distance, with exemplary extents described above. As described above, the base or post 192 and hemispherical feature 190 may be secured to the balloon service 194 using adhesive attachment, laser welding, heat welding, or other means known in the art. Additionally, the entire structure of the fracturing feature 190 and base or post 192 may be further held in place by the installation of a cover (not shown) over the structure as previously described herein.

[0520] 15, the plaque disruption features of the present invention, as described above, will preferably be discrete and directly affixed to the surface of the expandable structure, preferably to the outer surface of the expandable structure, such as a balloon, sleeve, cage, or other consumable member. In particular, the disruption features and optional base will not extend any significant axial distance along the surface of the balloon, sleeve, cage, or other expandable member. In contrast, the cutting elements on a typical cutting balloon are elongated blades that extend axially over a major portion of the balloon length to improve sequential cutting performance. The disruption features of the present invention preferably do not extend significantly in either the axial or circumferential directions on the surface of the expandable member, have a relatively small footprint on the balloon surface, and are physically independent of one another (i.e., not bonded or connected to one another except by the expandable member itself). In particular, as shown in FIG. 15, the axial width W of the peripheral footprint 200 is approximately 10 mm. a and circumferential width W c The ratio of Wa:Wc is in the range of 0.5 to 5, usually 1 to 5, more usually 2 to 5, and typically 1 to 1, which is characteristic of the circular base or footprint. In rare cases, the Wa:Wc ratio is 3:1 to 1.5:1.

[0521] 16A-16H, the plaque disruption features may be attached to the exterior or interior surface of an expandable structure or other underlying substrate in a variety of ways. For example, solid or hollow metal or other spherical plaque disruption features 252 may be glued, welded, or otherwise attached to the surface of a substrate 254, which can be either a balloon catheter, elastic sleeve, cage, valvuloplasty balloon, or equivalent scaffolding, elastic, semi-elastic, or non-expandable membrane structure.

[0522] As shown in FIG. 16A, the spherical stress application or plaque disruption feature 252 may be secured in place by the use of an adhesive and / or polymer coating and / or by partially or completely encapsulating the feature. The adhesive / coating material may comprise a single material or a combination of two or more materials. For example, an adhesive, polymer, or cement may be formed to provide a base or "pedestal" 255 that surrounds and adheres to a lower portion of the spherical stress application feature 252. The adhesive may be contoured to and partially or completely surround the lower portion of the stress application feature 252 (as shown) and may extend beyond the footprint of the feature (as shown). The adhesive typically surrounds the feature boundary. In some cases (not shown), the adhesive material may be contoured to and surround the outer surface of the upper portion of the feature and / or partially cover or encapsulate it.

[0523] 16B, the plaque-breaking feature 252 may be secured in place by an adhesive or polymer coating 257 that covers and encapsulates the entire surface of the plaque-breaking feature 252 that is exposed across the surface. The adhesive or coating 257 adheres the substrate 254 to the bottom perimeter 258 of the feature.

[0524] As shown in FIG. 16C, a hollow feature, such as a hollow sphere 259 with a truncated or open bottom, may be mounted on a post 260 that projects outward from a surface of a substrate, typically the outer surface of the substrate 254. The post may be preformed, e.g., molded as part of the balloon or other substrate 254, or may be formed separately and attached to the balloon using adhesive, cement, ultrasonic bonding, or other conventional techniques. The post will typically be formed to conform to a cavity within the hollow sphere 259 and attached using adhesive, cement, ultrasonic bonding, or other conventional techniques (as shown). Optionally, a hollow truncated sphere may be attached to the balloon surface, with adhesive and / or polymeric material partially or completely coating the inside of the sphere (not shown).

[0525] As shown in FIG. 16D, a spherical plaque fracture feature 252 may be attached to the outer surface 254 of the substrate in a preformed depression 262, which provides a receptacle or "pedestal" for immobilizing the feature using one or more adhesives or polymeric materials. The pedestal may be shaped to closely conform to the feature and improve attachment. The feature may have a slightly wider base than the pedestal to provide additional support or anchoring.

[0526] 16D-1-16D-6 illustrate further examples of features mounted within preformed depressions in the outer surface of a balloon, providing a receptacle or "mount" for immobilizing multiple stress-inducing features using one or more adhesives or polymeric materials. Although a balloon is illustrated, it should be understood that the use of depressions to immobilize stress-inducing features may also be applicable to other expandable members comprising polymeric films or sheets forming an expandable surface, specifically including, but not limited to, elastomeric and non-elastomeric sleeves.

[0527] A catheter 600 having an angioplasty or other inflatable intervention balloon 602 at the distal end of a shaft 604 is illustrated in Figs. 16D-1 and 16D-2. A plurality of stress-inducing features 606a-606d are held within depressions 610a-610d formed in the outer surface 612 of the balloon. The depressions in the surface 612 may be preformed or molded over the bottom surfaces of the stress-inducing features, and in both cases will preferably conform closely to the geometry of the lower portions of the features 606a-606d. The stress-applying features 606a, 606c, and 606d are shown as spherical. In contrast, the stress-applying feature 606b has a conical shape with a rounded apex 614a (Fig. 16D-4) protruding from the depression 606b and over the surface 612. The conical stress-applying feature 610b has an enlarged base 614b that is retained within a conforming recess 606b. All of the stress-applying features 606a-606d are shown as solid structures, typically metal or other hard materials as described above, but may also be formed as hollow structures, for example, as shown in FIG. 16C.

[0528] In an exemplary case, the adhesive will cover at least a portion of the surface or "interface" of the recesses 610a-610d between the features 606a-606d and the balloon 602 or other expandable structure. In other examples, the adhesive may protrude above the expandable structure surface and further embrace or encapsulate at least a portion of the outer surface of the feature, and sometimes encapsulate the entire outer surface of the feature. In some cases, as shown in Figs. 16D-4-16D-6, the lower portion of the recesses 610b-610d is larger than the constriction of the recess, providing more protection in holding the feature in place. As shown in Fig. 16D-6, the expandable surface has a rim 616 that protrudes above the surface 612 of the balloon 602, surrounds the constriction, and improves retention when the balloon is inflated by pressing the rim against the surface of the feature adjacent the constriction.

[0529] As shown in FIG. 16E, features 252 may be encapsulated or integrated into the exterior surface of the balloon or other substrate 254, optionally by fusing or laminating the features into one, two, or more layers of one or more balloon materials that are fused to form one inseparable layer.

[0530] As shown in FIG. 16F, a solid metal or other hemispherical plaque disruption feature 266 may be attached to the surface of the membrane 254 in any of the ways just described, and is typically fixed in place by the use of an adhesive, a polymer coating, and / or by partially encapsulating the feature.

[0531] Alternatively, the hemispheres and other plaque disruption features 268 may be molded or otherwise formed integrally with the polymer membrane 270, as shown in FIG. 16G.

[0532] As a further alternative, the plaque disruption features 272 may be integrally molded or otherwise formed as part of an elastic constraining sleeve or sheath 274, typically on the inner surface of the sleeve, as shown in FIG. 16H. The sleeve or sheath 274 may be placed over the surface 254 of any expandable member of the type described elsewhere herein, typically a balloon, scaffold, or tubular elastic sleeve, such that the features cause the outer surface of the sleeve to protrude radially outward as the expandable member is expanded. The sleeve provides an atraumatic surface or covering for the plaque disruption features 272.

[0533] As an alternative or in addition to the use of adhesives, welding, or the like, the stress application or plaque disruption features of the present invention, such as spherical features 252, may be immobilized on the surface of substrate 254 using elastic restraining sleeves or sheaths 276a-276d, as shown in Figures 17A-17D. The sleeves conform to the surface and shape of features 252, retaining and immobilizing the features as the expandable member or other substrate is expanded or otherwise expanded from an initial narrow width or diameter configuration to a radially expanded or expanded configuration.

[0534] As shown in FIG. 17A, sleeve 276a may be attached to a cylindrical working length of a balloon or other substrate. In other embodiments (not shown), the sleeve may be attached to only one side (proximal or distal) of a cylindrical working length of a balloon or other substrate. As shown in FIG. 17B, sleeve 276b may be attached to tapered / conical proximal and distal portions 278 of expandable substrate 254. As shown in FIG. 17C, sleeve 276c is attached at its distal end to tapered / conical distal tip 280 of expandable substrate 254. As shown in FIG. 17D, proximal end 282 of sleeve 276d is attached to the proximal conical / tapered end of expandable structure 254 or proximal shaft 283.

[0535] In other embodiments, the stress application and plaque disruption features 252 of the present invention may be placed on the interior surface of an expandable structure, such as the interior surface of an elastic sleeve 290 or other expandable cage or structure, as shown in Figures 18A-18C. A folded or otherwise unexpanded balloon 292 is advanced into the interior of the sleeve 290, as shown in Figure 18B, or the sleeve is advanced or retracted over the balloon to the center of the balloon within the interior of the sleeve prior to inflation or expansion of the balloon. The balloon 292 may be inflated, as shown in Figure 18C, causing the features 252 to protrude radially outward, partially or completely, through the sleeve or balloon membrane.

[0536] 19, 20A, and 20B, a drug delivery catheter 300 includes a balloon 302 having both a plurality of plaque disruption features 304 and a plurality of expandable ports 306 disposed across its exterior surface. The balloon 302 will typically be elastic or semi-compliant, allowing the ports 306 to expand in response to balloon inflation from a closed or substantially closed configuration, as shown in FIG. 20A, to an open or expanded configuration, as shown in FIG. 20B. The balloon 302 may be inflated with an inflation medium carrying a drug or other agent that is introduced into the interior 308 of the balloon, resulting in both balloon expansion and release of the agent medium through the ports 306 as they open in response to pressure application. The ports 306 will typically be configured to open in response to an internal pressure above a minimum threshold, typically above 3 atm, 5 atm, or 7 atm.

[0537] 21A-21D, a drug delivery catheter 310 carrying the stress application and plaque disruption features 252 of the present invention and having an alternative structure is illustrated. As shown in FIG. 21A, a drug delivery balloon 312 carries a plurality of features 252 that protrude radially outward from the outer surface of the balloon. Drug particles 314 are coated over and / or incorporated within the features 252, e.g., the drug may be absorbed within a porous feature or may be retained within a reservoir or hollow interior of the feature. As shown in FIG. 21B, the drug may be coated over and / or releasably absorbed within the features 252 and one or both of the surfaces of the delivery balloon 312. As shown in FIG. 21C, the drug 314 may be coated over and / or absorbed within an elastic membrane 316, which in turn is placed over the balloon 312 in a manner similar to that described above with reference to FIGS. 17A-17C. In some cases, the drug 314 may be held within a porous elastic membrane 318, as shown in Figure 21D. In such cases, the drug 314 will be released through holes or perforations in the membrane of the elastic member 318 as the balloon 312 is expanded.

[0538] 22, the plaque disruption features 340 of the present invention may be placed on the exterior surface of a balloon-expandable scaffold or "cage" 342 of the type intended for temporary placement at a target vascular location for plaque disruption and subsequent removal. The cage may be formed from a resilient polymeric material, from a resilient metal such as a nickel-titanium alloy, or from another material that expands and contracts as the expandable structure expands and contracts (or collapses) inside the cage.

[0539] Referring now to FIG. 23A, the expandable scaffold 342 of FIG. 22 has a central lumen or passageway that can be placed over the balloon 342 (FIG. 23B) of a balloon catheter 344 prior to expansion of the balloon.

[0540] 23B, the balloon 342 may be inflated, expanding the expandable scaffold 342 and pushing plaque disruption features 342 on the scaffold radially outward to engage the plaque. The scaffold will be formed from an elastic material, typically a resilient metal or polymer such as a nickel-titanium alloy, e.g., Nitinol® or other superelastic metal, such that when the balloon is inflated, it will open with the balloon and close radially inward over the balloon as the balloon is deflated.

[0541] As shown in end view in FIG. 24, the balloon or other expanded member 440 has a plurality of discrete stress application or plaque disruption features 252 distributed around its circumference and length, the features acting as spacers and arranged in a distinctive pattern, density, size, shape, and / or footprint to create a plurality of potential pathways 442 along the length of the balloon between the outer surface of the expanded member and the inner surface of the lesion 444, providing a plurality of channels or gaps that allow for perfusion (flow) of blood, contrast, drugs, and the like under anticipated vascular conditions across the inflated outer surface of the expanded member. In a preferred embodiment, the channels conduct fluids, such as contrast fluid, delivered at pressures ranging from 1 psi to 10 psi, preferably from 1 psi to 5 psi, and more preferably from 1 psi to 3 psi. In some cases, the channels may not allow for flow of blood or contrast at physiological pressures. In such situations, it may be necessary to pressurize the vessel or body lumen 1 psi to 3 psi above physiological pressure. Compare FIG. 25, which shows how an inflated conventional balloon would block the flow of staining medium within the simulated vessel, with FIG. 26, where staining medium would flow over balloon 440 having the surface features of the present invention.

[0542] In some cases, the spacer features are configured or arranged to allow passage of contrast agents through channels around or adjacent to the features and / or through-holes therein (see FIGS. 24D, 24D-1, 24D-3, and 24D-3) at pressures ranging from 10 mmHg to 500 mmHg, preferably 10 mmHg to 200 mmHg, and more preferably 10 mmHg to 100 mmHg. Alternatively, the spacer features may be configured to allow passage of fluids, contrast agents, and / or drugs at pressures ranging from 0.5 psi to 5 psi, preferably 0.5 psi to 3 psi, and more preferably 0.5 psi to 2 psi when the expandable structure is expanded to a nominal expanded configuration or diameter.

[0543] 24A-24D illustrate balloons 440a-440d having different feature patterns, creating bypass channels or gaps G, in accordance with the present invention. Such constructs are particularly advantageous when performing fluoroscopy or medication injections across an expanded member in a blood vessel or other lumen, where a contrast or drug solution is injected into the vessel proximal to the expandable member at a pressure above physiological pressure sufficient to allow the channels to conduct the fluid across the axial length of the expanded structure. FIG. 24A shows multiple features configured to provide sufficient channels to allow contrast fluid to bypass across the axial length of the expandable structure when the structure is in an expanded configuration, such as an expanded state (fully inflated balloon). FIG. 24B is another example of dual adjacent features along the circumference and / or axial length of the expandable structure to provide channels for conducting contrast fluid or drugs across the axial length of the expandable structure when the structure is in an expanded configuration. The embodiment of Figure 24C shows another embodiment of multiple features oriented in the axial and / or circumferential directions to create channels (gaps) between the features. Figure 24D shows holes 253 (Figures 24D-1 and 24D-2) oriented axially (as shown) and formed within the features to allow contrast agents, fluids, and / or drugs to bypass an expanded structure such as an expanded balloon.

[0544] 24D-1-24D-3 illustrate a feature of the type illustrated in FIG. 24D having holes 253 through the feature 252d, which further encourages perfusion of contrast agent past the balloon when inflated in the vasculature. As shown in FIGS. 24D-1 and 24D-2, the spherical feature 252d has through holes 253, which further encourages and allows flow of contrast agent past the outer surface of the balloon 440d. Similarly, as shown in FIG. 24D-3, through holes 253 may be provided in a hemisphere or other spacer feature 252e on the outer surface of the balloon 440e or other expandable structure. By arranging the spacer features along an axial line, an extension gap is effectively created along an axial path on the balloon surface. However, such an axial path may sometimes be blocked by the spacer features 252d and 252e themselves. Such blockage can be reduced or eliminated by including through or bypass holes in the spacer features, preferably axially aligned with the balloon.

[0545] It has been found that the use of spacer features (even without holes) can be effective in allowing contrast perfusion past a balloon inflated to a nominal pressure (typically 7 atm to 11 atm or higher) within the vasculature. In particular, the spacer feature reduces the pressure required to cause contrast to flow past the balloon, aiding in imaging the vasculature downstream of the balloon and reducing backflow of contrast into the aorta or anywhere else. The inclusion of through holes has been found to still further reduce the required contrast delivery pressure, further protecting the patient from over-delivery of toxic contrast. Similarly, the inclusion of channels through features, such as those shown in Figures 2H-15-2H-21, for example, will similarly aid in contrast and blood perfusion as compared to features lacking such internal flow paths.

[0546] 27, a valvuloplasty catheter 320 includes a compartmentalized balloon structure 322 mounted on the distal end of a catheter shaft 328. The compartmentalized balloon structure 322 includes both a proximal compartment 324 and a distal compartment 326, the compartments having opposing interior surfaces 330a and 330b. These opposing surfaces each have a plurality of plaque disruption features 332 distributed therethrough. By inflating each of the compartments and trapping a calcified cardiac or other leaflet therebetween, the calcified plaque can be disrupted to improve valve function. In some instances, the compartments 324 and 326 will be inflated simultaneously, while in other cases, one of the compartments may be inflated first, the inflated compartment pulled against one side of the leaflet, and the other compartment then inflated, resulting in the disruption of the calcification.

[0547] Valvuloplasty devices having other patterns of plaque disruption features are shown in Figures 28-31B. As shown in Figure 28, a valvuloplasty catheter 440 includes a catheter shaft 441 having a proximal balloon 442 and a distal balloon 444, each having flat surfaces with opposing balloon surfaces 446a and 446b, each having a plurality of plaque disruption features 448 distributed thereover. The paired plaque disruption features 448 are arranged such that the opposing service features directly engage each other and apply a force to a cardiac or other valve leaflet captured therebetween.

[0548] The valvuloplasty catheter 460 illustrated in Figure 29 is similar to that illustrated in Figure 28, having a proximal balloon 462 and a distal balloon 464 with opposing surfaces 466a and 466b thereon. However, the plaque disruption features 468 are arranged such that they do not engage each other, but instead directly engage the opposing balloon surfaces.

[0549] Balloons 322, 324, 442, 444, 462, and 464 may be fixedly attached to their respective catheter shafts such that the leaflets are captured by simply inflating the balloons, but more often the balloons will be slidably mounted relative to one another so that they are spaced apart to capture the leaflets and then brought together to capture the leaflets and apply a focused force through the features to stress and fracture the calcification and plaque on the leaflets.

[0550] As shown in Figures 30A and 30B, a valvuloplasty catheter 480 has a pair of nested balloons 484 and 486 mounted on a shaft 482. The proximal balloon 484 has a concave conical surface 488a with a plurality of stress-applying features 486 distributed thereover. The distal balloon 486 has a convex conical surface 488b with a plurality of stress-applying features 489 distributed thereover. A heart or other valve leaflet L may be trapped between the balloon surfaces 488a and 488b when the surfaces are spaced apart, as shown in Figure 30A, and plaque or other calcification on the leaflet may be disrupted by pulling the distal and proximal balloons 486 and 484 together, as shown in Figure 30B.

[0551] 31A-31B, valvuloplasty catheter 490 has a proximal balloon 494 and a distal balloon 496 mounted for sliding movement relative to one another on shaft 492. Opposing surfaces 498a and 498b of the balloons can be separated to capture a leaflet and brought together to engage stress-applying features 499 against the leaflet captured therebetween. As can be seen, only surface 498b carries a stress-applying feature, while surface 498a is devoid of such features. Balloons 494 and 496 are shown to be conical, which may be advantageous in accessing smaller areas.

[0552] The valvuloplasty balloon structure will typically be configured to compress or "squeeze" the leaflets between opposing surfaces. In some cases, the surfaces will be positioned by inflation alone, i.e., the opposing surfaces will deploy and compress the leaflets as they reconfigure in response to inflation alone. In other cases, sections of the balloon structure having opposing surfaces may first be deployed by inflation or otherwise and then axially pulled together to compress the leaflets between the opposing surfaces and engage the stress application features. The valvuloplasty balloon structure will typically be configured to compress or "squeeze" the leaflets between opposing surfaces of the balloon or expandable structure axial length.

[0553] Although certain embodiments or examples of the present disclosure have been described in detail, variations and modifications will be apparent to those skilled in the art, including embodiments or examples that may not provide all of the features and benefits described herein. It will be understood by those skilled in the art that the present disclosure extends to other alternative or additional examples or embodiments and / or uses and obvious modifications and equivalents thereof beyond the specifically disclosed embodiments or examples. In addition, while some variations have been shown and described in varying details, other modifications that are within the scope of the present disclosure will be readily apparent to those skilled in the art based on the present disclosure. It is also contemplated that various combinations or subcombinations of the specific features and aspects of the embodiments and examples may be made and still fall within the scope of the present disclosure. Thus, it should be understood that various features and aspects of the disclosed embodiments can be combined with or substituted for one another to form variable modes or examples of the present disclosure. It is therefore intended that the scope of the present disclosure disclosed herein should not be limited by the specific disclosed embodiments or examples described above. With respect to all of the embodiments and examples described above, the steps of any method need not be performed sequentially, for example.

Claims

1. 1. An apparatus for treating calcifications on a wall in a body lumen of a patient, the apparatus comprising: a catheter including a catheter body having a proximal end and a distal section; an expandable structure disposed in the distal section of the catheter, the expandable structure having an outer surface configured to be displaced radially outward toward an inner surface of the body lumen wall; a plurality of plaque disruption features distributed across the outer surface of the expandable structure, at least some of the plurality of plaque disruption features having convex rounded upper surfaces configured to disrupt the calcifications when the expandable structure is expanded within the body lumen; An apparatus comprising:

2. The device described in claim 1, wherein the expandable structure comprises an inflatable balloon.

3. The device described in claim 2, wherein the inflatable balloon has a stretchability of less than 10% when inflated to a pressure of at least 8 atm, at least 10 atm, at least 12 atm, at least 16 atm, at least 18 atm, or at least 20 atm.

4. The device of claim 2 or 3, wherein the inflatable balloon is configured to release an inflation medium comprising a drug in response to an inflation pressure above a minimum threshold, the minimum threshold being greater than 3 atm, 5 atm, or 7 atm.

5. An apparatus as described in any one of claims 1 to 4, wherein at least some of the plurality of plaque disruption features comprise a sphere, a hemisphere, a truncated sphere, or an ellipse.

6. The device described in claim 5, wherein at least some of the plurality of plaque disruption features comprise hemispheres having lower surfaces attached to the outer surface of the expandable structure.

7. The device of claim 1, wherein each of the convex rounded upper surfaces of the plurality of plaque disruption features has a radial height above the outer surface of the expandable structure when the expandable structure is expanded in the range of a minimum of 0.05 mm, 0.1 mm, 0.15 mm, 0.2 mm, or 0.25 mm to a maximum of 1 mm, 0.5 mm, 0.4 mm, 0.3 mm, or 0.25 mm, and wherein a distribution density of the plurality of plaque disruption features is in the range of 0.1 to 5 features / mm2, preferably 0.2 to 4 features / mm2, and more preferably 0.25 to 3 features / mm2 when the expandable structure is expanded.

8. The device of any one of claims 1 to 7, wherein each of the plurality of plaque disruption features has a base attached to the outer surface of the expandable structure, the base having an axial width (Wa) and a circumferential width (Wc), the width ratio Wa:Wc being in the range of 1:0.5 to 1:5, typically 1:1 to 1:1 to 1:5, and more typically 1:1 to 3:

1.

9. The device of claim 8, wherein at least some of the bases of the plurality of plaque disruption features have a circular or oval periphery.

10. An apparatus as described in any one of claims 1 to 9, wherein at least some of the plurality of plaque disruption features have a single convex rounded upper surface and a lower base independently attached to the outer surface of the expandable structure.

11. An apparatus as described in any one of claims 1 to 10, wherein the plurality of plaque disruption features are attached directly to the outer surface of the expandable structure.

12. A device as described in any one of claims 1 to 11, wherein the convex rounded upper surface extends radially outward beyond the outer surface of the expandable structure when fully expanded.

13. An apparatus as described in any one of claims 1 to 12, wherein at least some of the plaque disruption features include at least one sharp element protruding outwardly from a rounded upper surface of the convex surface, the at least one sharp element being configured to concentrate stress when engaged against the calcification on the wall of the body lumen when the rounded upper surface of the convex surface is pressed against the surface of the calcification.

14. The apparatus of claim 13, wherein the convex rounded upper surface extends above a surface of the scaffold a first distance, and the at least one sharp element protrudes from the surface of the convex rounded upper surface a second distance equal to 0.05 to 0.1 of the first distance, the second distance being in the range of 0.01 mm to 0.2 mm or 0.01 mm to 0.1 mm.

15. An apparatus as described in any one of claims 1 to 14, further comprising an outer sleeve positioned over the plurality of plaque disruption features on the outer surface of the expandable structure.

16. The device of claim 15, wherein the outer sleeve comprises a retractable sheath configured to shield the plurality of plaque disruption features as the device is advanced and / or retracted through the body lumen.

17. The device of claim 15 or 16, wherein the outer sleeve comprises an elastomeric tubular member positioned across the outer surface of the expandable structure, the elastomeric tubular member configured to conform to the plurality of plaque disruption features when the expandable structure is expanded, and the elastomeric tubular member configured to expand and contract with the expandable structure.

18. The device described in claim 15, wherein the expandable structure comprises an inflatable balloon and the outer sleeve comprises a non-inflatable or semi-compliant sheath that is folded over the inflatable balloon before the inflatable balloon is inflated.

19. A device as described in any one of claims 1 to 18, wherein the plurality of plaque disruption features have an occupying area having a maximum width, diameter, or other lateral dimension of 4 mm or less, often 3 mm or less, more often 1 mm or less, frequently 0.75 mm or less, and sometimes 0.5 mm or less.

20. An apparatus as described in any one of claims 1 to 19, further comprising an encapsulation layer covering the outer surface of the expandable structure and the plurality of plaque disruption features and immobilizing the plurality of plaque disruption features in a desired pattern on the outer surface of the expandable structure.

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