Method and apparatus for plaque disruption

Abstract

Balloon catheters, cannulas, cage structures, cylindrical structures, and endoluminal prostheses are provided with stress application features and spacing features coupled to expandable surfaces thereof. At least one or at least some of the stress applying features are secured to the surface or in preformed notches formed in the expandable surface. The stress application features and spacing features may have blunt and / or rounded contact regions that contact tissue or calcified regions in the vascular system. When expanded, the contact region recesses or ruptures the occlusion material on the wall of the vessel lumen and / or on the patient valve leaflet. The pitch of the features may allow blood, drugs, and contrast agents to be perfused through an expanded structure in the vascular system, in particular a balloon catheter.

Description

[0001] Cross - Reference to Related Applications

[0002] This PCT application claims the benefit of the following provisional applications: U.S. Provisional Application No. 63 / 409,419, filed on September 23, 2022 (Attorney Docket No. 32016-726.105); U.S. Provisional Application No. 63 / 411,095, filed on September 28, 2022 (Attorney Docket No. 32016-726.106); U.S. Provisional Application No. 63 / 421,940, filed on November 2, 2022 (Attorney Docket No. 32016-726.107); U.S. Provisional Application No. 63 / 386,637, filed on December 8, 2022 (Attorney Docket No. 32016-726.108); U.S. Provisional Application No. 63 / 387,636, filed on December 15, 2022 (Attorney Docket No. 32016-726.109); U.S. Provisional Application No. 63 / 514,079, filed on July 17, 2023 (Attorney Docket No. 32016-726.110); and U.S. Provisional Application No. 63 / 579,487, filed on August 29, 2023 (Attorney Docket No. 32016-726.111), the entire disclosures of which are incorporated herein by reference.

[0003] In the United States, the non-provisional application is a partial continuation of U.S. Patent Application No. 17 / 863,265, filed on July 22, 2022 (Attorney Docket No. 32106-726.301), which is a continuation of PCT / US2022 / 022213, filed on March 28, 2022 (Attorney Docket No. 32106-726.601), which claims the benefit of Provisional Application No. 63 / 322,372, filed on March 22, 2022 (Attorney Docket No. 32106-726.101), Provisional Application No. 63 / 287,813, filed on December 9, 2021 (Attorney Docket No. 32106-726.103), Provisional Application No. 63 / 240,811, filed on September 3, 2021 (Attorney Docket No. 32106-726.102), and Provisional Application No. 63 / 200,794, filed on March 29, 2021 (Attorney Docket No. 32106-726.101), the entire disclosures of which are incorporated herein by reference. Background Art

[0004] 1. Field of the Invention The present invention generally relates to medical devices and methods. More particularly,

[0005] The present invention relates to devices comprising or consisting of expandable structures, which include vascular devices, vascular catheters, expandable sheaths, expandable cage structures, balloon catheters, stents, heart stents, vascular grafts, implantable vascular prostheses configured to open, expand, deliver drugs, and / or rupture calcified and / or sclerotic lesions in blood vessels and / or valves and / or body cavities.

[0006] Balloons, cage structures, heart stents, grafts, and other prostheses and devices are commonly used to provide or maintain patency of blood vessels and heart and venous valve structures that have been narrowed due to lesions or other disease conditions. In cases where the lesion is hardened by plaque, calcium, etc., a "cutting balloon" can be used in an initial treatment step to break up the plaque and calcified lesions to allow the balloon to expand the lesion prior to placement of a heart stent. Optionally, the heart stent can be post-dilated using a non-compliant angioplasty balloon to ensure good apposition of the heart stent to the vessel wall. The post-dilation balloon uses a balloon inflation device to achieve a relatively high atmospheric pressure. However, implantation of a heart stent after angioplasty using a cutting balloon can be problematic in several respects, particularly when followed by post-dilation at a higher pressure. In some cases, the vessel wall may be damaged, or such damage may spread. In other cases, debris generated by the cutting balloon may be released as emboli.

[0007] The use of cutting balloons, cutting cage structures, and cutting heart stents has been proposed to disrupt calcified lesions in blood vessels, but there are various problems, including poor deliverability, being often bulky and restricted in access, or causing damage to the patient. Cutting heart stents have been proposed for use in "primary heart stent implantation" procedures without using a pre-dilation angioplasty balloon to expand the area where the heart stent is to be implanted. Primary heart stent implantation reduces or eliminates the need for two or three consecutive interventions, thereby reducing the risk of vessel damage and emboli release discussed above. However, cutting heart stents have similar limitations, such as being bulky, having a risk of causing damage, and being static and difficult to deliver.

[0008] Heart and venous valve function can be adversely affected by the presence of calcified lesions on the valve leaflets. Valvuloplasty procedures rely on disrupting the lesions by internally expanding a balloon on opposite leaflet surfaces to rupture the calcified lesions. The use of cutting balloons and balloon-with-cage structures has been proposed to optimize such valvuloplasty procedures, but they are still not widely used due to the increased risk of damaging the valve and / or valve function.

[0009] Although there are significant potential improvements in many cases, typically such cutting balloons, cage structures, and heart stents employ radially outwardly directed sharp blades and pose a risk of damaging the patient.

[0010] In addition, cutting blades can make the device bulky and less deliverable, often restricting access to distal vascular regions. Cutting blades also tend to rupture the vessel wall beneath calcified / sclerotic plaque lesions, particularly at higher inflation pressures, which can cause patient injury.

[0011] Another challenge in performing angioplasty and valvuloplasty procedures is the temporary occlusion of the vessel lumen or valve annulus by balloon dilation. While temporary occlusion of blood flow is often acceptable, a more serious problem can be the loss of contrast agent flow downstream of the balloon. Even a brief loss of contrast agent can make fluoroscopic imaging of the procedure more difficult. Although various perfusion catheters have been proposed, they often require additional flow lumens through the balloon, making the catheter larger and less practical in many cases.

[0012] Yet another challenge with known cutting balloons is that the elongated blades on the balloon stiffen the balloon, making it difficult to deploy the balloon in tortuous anatomy.

[0013] For these reasons, there is a desire to provide improved methods and devices for opening, dilating, delivering drugs, improving visualization, and / or treating calcified or sclerotic lesions while reducing the risks posed to the patient and achieving equivalent or better efficacy in treating calcified or sclerotic lesions. The improvements will preferably be applied to a wide variety of vascular and cardiac devices, including expandable structures such as vascular catheters, expandable sheaths, expandable cage structures, balloon catheters, cardiac stents, implantable vascular prostheses, drug delivery devices, etc., and particularly to plaque disruption balloon designs. It would be more desirable if the device and procedure could improve blood and / or contrast agent perfusion during the procedure. Additionally, it is desirable to provide a plaque disruption balloon design such that there is limited or no loss of flexibility due to the presence of plaque disruption elements on the balloon. The present invention will provide at least some of these advantages.

[0014] 2. List of Background Art。US7,662,163 describes a reinforced balloon device having one or more reinforcing members with sharp protrusions and other protrusions. Patents and printed publications describing expandable stents with plaque-destroying features and other features include: US8876882, US7494497, US9724121, US7731744, US5591197, US2006 / 122684, US2014 / 277562, US2001 / 037146, US2006 / 271161, US2020 / 0323545, US10143452, US9717513, US8398662, US8092470, US8080026, US7803168, US6047700, US5443446; and patents and printed publications describing multi-surface valvuloplasty include: US2021 / 0378744, US11000299, US10758255, US10478202, US9827096, US8187223, US20210393281, US20200197033, US11000299, US10980553, US10342962, US10245419, US9504807, US9375555, US4986830, EP13526772, EP1480709, KR20200077682, WO2020014515, WO2012040225, WO2003 / 084594, and WO2013126779. Parent application US17 / 863,265 has been published as US2022 / 0338889 and WO2022 / 212290. SUMMARY OF THE INVENTION

[0015] The device according to the present invention includes a stress - applying feature or a force - applying feature, which can have any one of a variety of specific designs and geometries, and the various specific designs and geometries are selected so as to rupture, indent, or otherwise disrupt an area of calcified or other hardened plaque, dilate the area, deliver drugs, enhance visibility, and / or enlarge a lesion in the patient's vascular system, and minimize the risk to the underlying tissue of the patient. The device of the present invention will often be applied in angioplasty, cardiac stent placement, drug delivery, enhanced visibility, and other interventional treatments in the arterial or venous vascular system. In addition, the device of the present invention will be used to treat or trim cardiac and venous valve structures, for example, to perform valvuloplasty procedures in the patient's aortic valve.

[0016] The phrase "stress - applying feature" is intended to encompass a variety of specific force - applying structures, such as plaque - disrupting features, plaque - engaging features, calcification - site - engaging features, and these terms may be used interchangeably herein and in the claims. Other suitable descriptors for these features include plaque - indenting features and stress - inducing features, and these terms and phrases will be used interchangeably unless otherwise noted. The stress - applying feature of the present invention can have any one of the various designs described in the present invention.

[0017] Typically, a first type of stress - applying feature will include a blunt - contact area that is configured to engage plaque or other hardened or calcified material to dilate, rupture, indent, or otherwise disrupt the material while minimizing the risk to the underlying tissue or the vascular wall, valve annulus, or other patient tissue (which would be at risk if a blade or other sharp structure were to apply pressure). Various specific designs for the stress - applying feature of the present invention are described below, including disks, plates, spheres, balls, hemispheres, partial spheres, ellipsoidal solids, rectangles, and others. The stress - applying feature can be solid or include a hollow interior. The stress - applying feature of the present invention can (1) be pre - formed and attached to a device such as a balloon, cannula, cardiac stent, or cage structure, or (2) be manufactured as an integral part or a component part of a balloon, cannula, cardiac stent, or cage structure, as described in more detail in the present invention, or (3) be a combination of (1) and (2).

[0018] The devices of the present invention will generally also include means or structures for radially advancing or deploying the stress-applying feature within a patient target site, such as a blood vessel, valve annulus, or other body cavity or lumen. In some cases, a preformed stress-applying feature may be directly attached or coupled to the outer surface of any of a variety of expandable structures, such as a balloon, cardiac stent / stent graft, cardiac stent, cage structure, cannula, valve prosthesis, valvuloplasty balloon catheter, etc. 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 to or fabricated as part of an intermediate structure, which, although not itself configured to expand, can be placed on a separate expandable structure. For example, the stress-applying feature of the present invention may be attached to or formed as part of a cannula, sheath, covering, mesh structure, or other support structure that can be placed to surround or otherwise be supported by an expandable structure, such as an elastic cannula placed over an expandable balloon.

[0019] Exemplary stress - applying features of the present invention will have a restricted "coverage area" or base, typically with a maximum length, width, diameter, or other dimension of the restricted "coverage area" or base being 4 mm or less, often 3 mm or less, more commonly no greater than 1 mm, and generally no greater than 0.75 mm, and sometimes no greater than 0.5 mm or no greater than 0.25 mm. In another example, the length, width, diameter, or configuration of the base of the stress - applying feature can be in the range of 0.1 mm to 4 mm, preferably in the range of 0.2 mm to 2 mm, and more preferably in the range of 0.3 mm to 0.75 mm. The coverage area refers to the maximum coverage or "contact" area dimension of the stress - applying feature at the base on the underlying support surface (such as the outer surface of a balloon, cannula, stent, cage structure, or heart stent). The contact area or coverage area dimension of the stress - applying feature, such as in the case of a disk, sphere, or ball, can be equal to the contact area or coverage area dimension of the base, or when the feature tapers radially outward in the case of an inverted cone, inverted hemisphere, or partial inverted sphere, the contact area or coverage area dimension of the stress - applying feature can be greater than the contact area and coverage area dimensions of the base, or when the feature tapers radially outward in the case of a cone, hemisphere, or partial sphere, the contact area or coverage area dimension of the stress - applying feature can be less than the contact area and coverage area dimensions of the base. In one example, the length, width, diameter, or configuration of the contact area of the stress - applying feature is in the range of 0.01 mm to 4 mm, preferably in the range of 0.1 mm to 2 mm, and more preferably in the range of 0.1 mm to 0.75 mm. In another example, the stress - applying feature is a sphere or the like, where the length, width, diameter, or configuration of the contact area and / or the base is in the range from zero or approximately zero to 0.1 mm, more commonly in the range of 0.001 mm to 0.1 mm. Typically, the stress - applying features of the present invention will not be axially - extending elongated members (such as blades or similar elongated cutters), but rather will have substantially the same circumferential extension length (or configuration) and axial extension length (or configuration). In a preferred example, the ratio of the maximum axial length to the maximum circumferential width of the coverage area at the base of the stress - applying feature is in the range of 0.5:1 to 1:0.5, more preferably in the range of 0.75:1 to 1:0.75, and most preferably about 1:1. In another preferred example, the dimensions at the base of the stress - applying feature are substantially the same as the dimensions of the contact coverage area, such as in the case of a sphere, hemisphere, partial sphere, ball, or cube. Limiting the length of the stress - applying feature in the axial direction (and optionally maximizing the circumferential extent of the feature) is advantageous because it can reduce stiffness and maximize the flexibility and bendability of the balloon to facilitate insertion into and removal from tortuous anatomical structures.

[0020] Preferred stress - applying features will include a rigid structure, consist essentially of a rigid structure, or consist of a rigid structure formed from a hard material, which is typically a metal or metal alloy. The rigid structure will have a convex rounded upper surface, for example, formed as a convex rounded upper top, a convex upper top, a convex rounded upper top, etc., and will typically have a radius of curvature in the range of 0.1 mm to 1 mm. The rigid structure can have any of a variety of geometries, such as spherical, hemispherical, partial sphere, ellipsoidal, semi - ellipsoidal, partial ellipsoidal or similar geometries. While metals and / or metal alloys (especially steel, stainless steel, tungsten, tungsten carbide, cobalt, cobalt - chromium alloy, platinum) are preferred materials, other metals or metal alloys with a Mohs hardness greater than 4, preferably greater than 5 and more preferably greater than 6, as well as other hard materials (such as minerals, ceramics, hardened polymers, etc.) can also be suitable for use. In other specific examples, the stress - applying feature can include a metal and / or metal alloy, consist of a metal and / or metal alloy, which includes palladium, rhodium, titanium and nickel.

[0021] Typically, the radius of curvature of the circular convex upper surface of the stress - applying feature will be in the range of 0.1 mm to 3 mm, preferably in the range of 0.1 mm to 2 mm, more preferably in the range of 0.1 mm to 1 mm, and most preferably in the range of 0.1 mm to 0.5 mm. In the case of spherical, hemispherical and partial - spherical convex surfaces, the radius will be uniform. In contrast, for non - spherical, e.g., ellipsoidal, asymmetric or irregular convex upper surfaces, the radius of curvature will typically vary, where the radius of curvature of at least one side of the upper surface will be in the range of 0.1 mm to 3 mm, preferably in the range of 0.1 mm to 2 mm, more preferably in the range of 0.1 mm to 1 mm, and most preferably in the range of 0.1 mm to 0.5 mm, with various types of formed bases, such as asymmetric, irregular or non - circular bases, or in rare cases having a circular or symmetric base. The maximum: minimum size ratio (e.g., length to width ratio) of such non - circular or irregular - shaped bases can be 5:1 or less, typically 3:1 or less, and more commonly 1.9:1 or less, where preferably the length is oriented circumferentially on the outer surface of the balloon and the width is oriented axially on the outer surface of the balloon. Similarly, the maximum: minimum size ratio (e.g., length to width ratio) of the non - circular or irregular - shaped upper surface can be 5:1 or less, typically 3:1 or less, and more commonly 1.9:1 or less, where preferably the length is oriented circumferentially on the outer surface of the balloon and the width is oriented axially on the outer surface of the balloon. Typically, the upper surface refers to the top region of the feature.

[0022] Typically, the circular convex upper surface of the stress application feature will be smooth, with few or almost no irregularities or singularities. The surface can be formed or manufactured to be smooth and circular by, for example, casting, molding, machining, or other standard manufacturing methods. Alternatively, a smooth circular surface can be formed by coating, sputtering, or otherwise depositing a harder material (such as a metal) onto a core structure attached to the outer balloon wall surface. In other cases, a smooth circular surface can be formed by coating, sputtering, or otherwise depositing a material such as a metal / metal alloy, polymer, ceramic, or other material that will cover the core structure attached to the outer balloon wall surface to make the upper surface smooth, make the upper surface circularly convex, or make the upper surface trauma - resistant.

[0023] Typically, the stress application feature will be formed by molding, machining, or otherwise into its preferred spherical, hemispherical (including partial spheres), ellipsoidal, semi - ellipsoidal (including partial ellipsoids), or similar shape, and the stress application feature will have a bottom that is configured to attach directly to the generally flat or slightly concave outer balloon surface described elsewhere herein, or the bottom will conform to the outer balloon surface. Typically, the stress application feature will be formed as a one - piece structure, with no internal seams or breaks that would separate the stress application feature into two or more attached components to form the feature, and wherein the feature is attached to the outer surface of the balloon. However, in other cases, the stress application feature is formed into a spherical, hemispherical (including partial spheres), ellipsoidal, semi - ellipsoidal (including partial ellipsoids), or similar shape by joining two or more parts, where each part is formed separately and then joined together after manufacture or after attachment to the outer balloon surface to form the feature shape, so long as the desired spherical, hemispherical, partial sphere with a convex upper top, ellipsoidal, semi - ellipsoidal, partial ellipsoid with a convex upper top, or similar shape is maintained. That is, the configuration (or shape and size) of the base (which attaches to the outer balloon surface) is equal to or greater than the configuration (or shape and size) of the maximum cross - section of the upper region of the feature.

[0024] The stress - applying feature and other rigid features of the present invention can be integral, i.e., having a continuous and typically homogeneous structure, which is usually formed by molding, machining, casting, or other conventional processes. However, in other cases, the stress - applying feature and other rigid features of the present invention can be "multi - piece", including two or more different parts, sections, elements, laminates, coatings, attachments, etc., consisting of two or more different parts, sections, elements, laminates, coatings, attachments, etc., or consisting essentially of two or more different parts, sections, elements, laminates, coatings, attachments, etc., and usually including a base and an upper region or segment. The base can include parts or segments of the feature, such as parts or segments in a horizontal plane or a vertical plane, and these parts or segments can be attached or integrated together to form a structure, preferably having a smooth convex upper surface, more preferably having a smooth circular convex upper surface, and without an anti - trauma portion.

[0025] In some cases, such a structure includes a base and an upper segment, where preferably, the periphery of the base does not protrude beyond the periphery of the upper segment, i.e., no edge is formed.

[0026] In some cases, the base smoothly transitions or "fits" with the upper segment of the feature and / or the segments of the feature, and the upper segment of the feature and / or the segments of the feature are connected together by adhesion or by welding to form a smooth - circular feature. Such a feature can be formed from any one or more of the materials described elsewhere herein (including but not limited to polymers, ceramics, or mineral materials).

[0027] Such a feature can have one or more convex upper surfaces, one or more circular upper surfaces, etc., and the radius of curvature of these upper surfaces in at least one direction can be in the range of 0.05 mm to 0.5 mm, preferably in the range of 0.05 mm to 0.25 mm. Preferably, at least one upper surface is convex, circular, smooth, or otherwise made anti - trauma to avoid damage to non - calcified lesions and healthy blood vessel walls. Exemplary stress - applying features and other rigid features include spheres, hemispheres, and partial spheres having circular upper surfaces.

[0028] The feature, especially the upper circular segment or other segments of the feature, can be initially formed or manufactured with a smooth surface, or can be initially formed or manufactured with a rough or otherwise irregular surface and then smoothed after initial manufacture, for example, by coating or sputtering with the same material or another material. In a preferred case, the feature can be covered with a harder material.

[0029] In some cases, features having sharp, penetrating, or other exposed "trauma" elements can be covered, coated, polished, or otherwise modified to provide both a trauma area and a trauma-protective area on an upper segment or elsewhere on the element for therapeutic purposes. For example, a cutting, penetrating, or other trauma element can be encapsulated within and / or surrounded by a rounded, convex, and / or smooth upper surface area such that the trauma element will disrupt a calcified lesion, but the surrounding trauma-protective surface will inhibit damage near the plaque. Typically, the surrounding covering will be softer than the trauma element of the feature to allow the trauma element to protrude or apply force through the softer surrounding area when expanded against a calcified plaque or the vessel wall. Alternatively, such a trauma element or component of the feature can protrude or apply force when an adjacent softer covering is pushed against the vessel wall, causing compression of the surrounding covering and allowing the trauma element to protrude and engage a hardened plaque on the vessel wall. In other cases, the surrounding covering can be formed of a rigid material that does not compress when pushed against the vessel wall. In those cases, the trauma element can be configured to protrude fixedly from the covering such that the element will engage the vessel wall before the surrounding covering engages the vessel wall.

[0030] Typically, an exemplary stress-applying feature of the present invention will also have a height that is measured from a base attached to a support surface or substrate to a contact footprint (contact area), and typically, the height is at least 0.05 mm, 0.1 mm, 0.15 mm, 0.2 mm, 0.25 mm or greater, 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 between the recited minimum and maximum heights. In a preferred example, the height of the feature is in the range of 0.1 mm to 1 mm, preferably in the range of 0.2 mm to 0.75 mm, and more preferably in the range of 0.25 mm to 0.5 mm. The feature can have the same height along the entire structure, or can have different heights along the perimeter and / or axial length of the substrate.

[0031] In a preferred example, the stress-applying feature is a discrete feature to enhance the flexibility and deliverability of the device within a patient's vascular system or body cavity. Typically, upon inflation or otherwise expanding, such discrete stress-applying features will be distributed on the expandable surface at a density of from 0.005 features per square millimeter of outer balloon surface to 20 features per square millimeter of outer balloon surface, preferably at a density of 0.005 features / mm 2 to 5 features / mm 2 and more preferably at a density of 0.01 features / mm 2from 0 to 5 features / mm 2 , typically, the density is 0.01 features / mm 2 from 0 to 3 features / mm 2 , more typically, the density is 0.01 features / mm 2 from 0 to 1 feature / mm 2 , and most typically, the density is 0.01 features / mm 2 from 0 to 0.1 features / mm 2 .

[0032] In addition to maintaining the density of the features, it will be preferred to maintain a minimum axial spacing between the bases of circumferentially adjacent stress-applying features during expansion or to maintain a minimum axial spacing between the bases of all stress-applying features along the circumference of the expandable balloon, in order to enhance the flexibility and bendability of the balloon when introduced through the vascular system. In particular, the minimum axial distance between the bases of circumferentially adjacent stress-applying features (or between the bases of all stress-applying features along the circumference of the expandable balloon) should be at least 0.05 mm, preferably at least 0.1 mm, while the maximum axial spacing will be 3 mm, typically 2.5 mm, and typically the spacing is in the range of 0.05 mm to 3 mm, more typically in the range of 0.1 mm to 1 mm.

[0033] In a preferred example, at least one segment or at least one region of the outer surface of the expandable structure (or the outer surface of the inflatable balloon) has stress-applying features that are spheres, hemispheres or partial spheres with a circular convex upper surface, and when the balloon is inflated or otherwise expanded, the stress-applying features are distributed on the expandable surface of the expandable structure (such as an expandable balloon) at a density of from 0.01 features per square millimeter of outer surface to 0.1 features per square millimeter of outer surface, and wherein all circumferentially adjacent stress-applying features along the circumference of the expanded structure (or the outer surface of the inflated balloon) have a minimum axial spacing between their bases in the range of 0.05 mm to 2 mm, and wherein the upper surface of the stress-applying features has a radius of curvature in the range of 0.1 mm to 1 mm.

[0034] In a preferred example, the stress-applying features are discrete, independent and / or separate features to enhance the flexibility and deliverability of the device in the patient's vascular system or body cavity. Typically, during inflation or otherwise expansion, such stress-applying features will be at a density of 0.1 features / mm 2 to 20 features / mm 2 , preferably at a density of 0.1 features / mm 2 to 5 features / mm 2The density, more preferably at 0.2 feature elements / mm 2 to 4 feature elements / mm 2 The density, more preferably at 0.25 feature elements / mm 2 to 3 feature elements / mm 2 The density distribution is on the expandable surface. In a preferred example, each of the feature elements exerts an independent or concentrated force on a plaque, blood vessel wall, tissue, atherosclerotic plaque or calcified lesion.

[0035] In a preferred example, the stress-applying feature elements are discrete, where each of the contact area, body and / or base of the feature element is blunt, rounded, smooth and / or atraumatic to enhance the flexibility and deliverability of the device in the patient's vascular system or body cavity. Typically, upon inflation or otherwise expanding, such stress-applying feature elements will have a density distribution on the expandable surface in the range of 0.1 feature element / mm 2 to 100 feature elements / mm 2 Preferably, the density is in the range of 0.1 feature element / mm 2 to 20 feature elements / mm 2 More preferably, the density is in the range of 0.1 feature element / mm 2 to 5 feature elements / mm 2 In some cases, the density is in the range of 0.2 feature element / mm 2 to 4 feature elements / mm 2 More preferably, the density is in the range of 0.25 feature element / mm 2 to 3 feature elements / mm 2 In another example, the shape of the feature element including the contact area, base and body is circular, blunt and atraumatic to enhance the flexibility and deliverability of the device in the patient's vascular system or body cavity while being able to rupture, indent or expand hardened and / or calcified plaques.

[0036] In yet another example, the stress application feature is coated with one or more materials to provide roundness, a smooth surface, bluntness, and / or a trauma-resistant surface to enhance the flexibility and deliverability of the device within a patient's vascular system or body cavity, while being able to rupture, indent, or dilate hardened and / or calcified plaque. In a preferred example, the material includes one or more of metallic materials, ceramic materials, polymeric materials, adhesive materials, hydrophilic materials, and the like. The material is deposited, welded, coated, electroplated, dip-coated, heat-treated, hardened onto the surface of the stress application feature, or otherwise applied to the surface of the stress application feature. The material can be degradable or non-degradable in a physiological environment. In yet another example, the coating material provides an additional means of attachment between the stress application feature and the surface of the expandable structure, where the coating covers the feature and the portion of the expandable structure surface adjacent to the feature.

[0037] In a preferred example, at least most (preferably all) of the surface of the stress application feature that is exposed above the outer surface of the expandable member or other support surface will be circular, without irregularities and defects (which may impede entry into the target body cavity), and typically, at least most (preferably all) of this surface will be configured to present a low-friction smooth surface when the expandable structure enters the vascular system or other body cavity, without edges that contact the wall of the vascular system or other body cavity wall. "At least most" means that at least 50%, preferably at least 60%, more preferably at least 70%, still more preferably at least 80%, and most preferably at least 90% of the exposed surface of the stress application feature will be circular, smooth, edge-free, or otherwise configured to present low friction. The inventors herein have found that when deployed in the manner described herein, such smooth, circular features will still be able to provide the necessary force to indent or rupture even hardened plaque.

[0038] The preformed stress applying features according to the present invention can be attached to an expandable or non-expandable support structure (usually an expandable structure such as a polymeric balloon) or an intermediate structure (such as a stent or a cannula or a cage structure) by one or more of the following means: soldering, using an adhesive (gluing, typically an acrylic or other polymeric adhesive), thermal bonding, fusing, welding, threaded attachment, riveting, crimping, press fitting, etc. The stress applying features integrally formed as part of a balloon, stent, heart stent, cage structure or cannula can be constructed on the outer surface of the stent, balloon or cannula at a later or final process or location, for example, by molding, deposition processes, or in a preferred alternative, the stress applying features can be formed as tabs or other elements protruding from components of the stent (such as crowns, struts or connectors) and folded onto the outer surface of the component after the stent is formed but before implantation. Specific examples of these features are described in more detail as ancillary features of the present invention. The preformed stress applying features according to the present invention can be attached to an expandable structure (such as a balloon) or an intermediate structure (such as a stent or a cannula or a cage structure) by one or more of the following means: soldering, using an adhesive (gluing), thermal bonding, fusing, welding, threaded attachment, riveting, crimping, press fitting, etc. The stress applying features integrally formed as part of a balloon, stent, heart stent, cage structure or cannula can be constructed on the outer surface of the stent, balloon or cannula at a later or final process or location, for example, by molding, deposition processes, or in a preferred alternative, the stress applying features can be formed as tabs or other elements protruding from components of the stent (such as crowns, struts or connectors) and folded onto the outer surface of the component after the stent is formed but before implantation. The different individual stress applying features on a single support structure can have the same or different coverage areas, shapes, heights, configurations, etc., such that adjacent stress applying features can be the same or different. Specific examples of these features are described in more detail as ancillary features of the present invention.

[0039] It will generally be preferred to select a polymeric adhesive and other polymeric layers formed on the outer wall surface of the inflatable polymeric balloon to have a hardness less than that of the polymer or other material of the balloon. A lower hardness typically corresponds to a greater compliance. In a preferred example, the Shore D hardness of the inflatable balloon is in the range of 60D to 80D (a typical range for nylon), and the Shore D hardness of the polymeric adhesive upon curing is in the range of 50D to 65D (a typical range for acrylic). For comparison, typically, the Mohs hardness of a rigid stress applying feature will be greater than 4, usually greater than 8.

[0040] In a preferred example, the expandable structure includes one or more of an inflatable polymeric balloon, a cardiac stent, a cannula, a cage structure, a drug delivery balloon, etc. A stress applying feature can be applied to one or more surfaces or surface regions of the expandable structure, where the surface can include the outer surface, inner surface, and side surface of the expandable structure. When the feature is applied to the inner surface of the expandable structure, the feature projects radially outward to engage with atherosclerotic plaque when the expandable structure expands or inflates.

[0041] In some cases, a stress applying feature can be applied to one or more outer surface regions of the inflatable polymeric balloon, such as the balloon in the working length (typically the central region of the cylindrical or other tapered or non-tapered tubular surface of the inflatable polymeric balloon) and / or the conical or other tapered end regions of the balloon. Additionally or alternatively, a stress applying feature can be applied to opposing sidewalls or surfaces, such as sidewalls or surfaces configured to capture valve leaflets to perform valvuloplasty formed by gaps or annular notches formed in the wall of the inflatable polymeric balloon, as described in detail below herein.

[0042] As used herein and in the claims, the phrase "outer surface" of an inflatable polymeric balloon includes the outer surface of the inflatable polymeric balloon itself, and any outer surface of a base layer or other layer formed and fixedly attached or adhered to the outer surface of the inflatable polymeric balloon. For example, the phrase "outer surface" of an inflatable polymeric balloon will specifically include the outer surface of any base layer formed on the underlying balloon wall, which base layer can include one, two, three, or more sheets, coatings, or films applied simultaneously or sequentially, consisting essentially of one, two, three, or more sheets, coatings, or films applied simultaneously or sequentially, or consisting of one, two, three, or more sheets, coatings, or films applied simultaneously or sequentially.

[0043] In particular, stress-applying features may be fixed to the expandable structure, for example, at least partially fixed to the outer surface of one or more elements of the stent rings such as on the crown and / or struts. Such features may also be at least partially fixed to a connector, wherein the connector connects two adjacent rings of the stent. Stress-applying features may be formed of the same material as the stent or formed of one or more materials different from the stent. Stress-applying features may be 3D printed (deposited) or laser cut from a tube, either manufactured separately from the stent or manufactured as a part of the stent. In either case, stress-applying features protrude radially outward from stent elements (such as crowns, struts or connectors). Stress-applying features may be formed as a part of the stent and positioned in place after formation and before implantation, for example, by soldering, welding, adhesives (such as epoxy resins), press fits, mechanical fits, knotting or other aforementioned techniques, wherein stress-applying features may be fixed or attached to the outer surface of the stent, or may be optionally positioned in a groove, hole or other socket formed in the outer surface of the stent or through the outer surface of the stent.

[0044] Methods for fixing the stress-applying feature include one or more of the following: coating, bonding, fusing, brazing, welding, vapor deposition or chemical deposition, laser deposition, clamping with a sleeve, press fitting or mechanical locking to the outer surface of the bracket (serrated bracket surface, grooves or holes through the bracket (part of the stress-applying feature is forced into or through the hole)), epoxy resin or a combination thereof or other methods.

[0045] The stent may be formed of a degradable material or a non-degradable material. In a preferred example, the stent is formed of a metal or metal alloy or other non-degradable material having a Mohs hardness of 2.5 or greater, preferably 3.5 or greater, and more preferably 4.5 or greater. In a preferred example, the Mohs hardness of the stress-applying feature will be equal to or greater than the Mohs hardness of the stent or other expandable structure. In other preferred examples, the Mohs hardness of the stress-applying feature will be greater than the Mohs hardness of the stent or other expandable structure. For example, the stress-applying feature may be formed of a material having a Mohs hardness in the range of 2 to 10, which is typically in the range of 2.5 to 10, more commonly in the range of 3 to 10, in the range of 3.5 to 10, in the range of 4 to 10, in the range of 4.5 to 10, in the range of 5 to 10, in the range of 5.5 to 10, in the range of 6 to 10, or in the range of 6.5 to 10.

[0046] In a preferred example, the expandable structure includes stress-induced 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 another example, the Mohs hardness of the stress-induced features is in the range of 2 to 9, preferably in the range of 3 to 9, more preferably in the range of 4 to 9. In another example, the Mohs hardness of the stress-applying feature will be greater than the Mohs hardness of the expandable structure that supports the feature.

[0047] In a preferred example, the stress-applying features, spacer features, and all other prominent features and elements described herein include at least one of the following materials: metals, polymers, ceramics, glasses, metal alloys, etc. The at least one material may be coated with another material. For example, a stainless-steel hemisphere may be coated with an adhesive and / or a polymeric material, where the Mohs hardness of the adhesive and / or polymeric material is less than the Mohs hardness of the stainless-steel hemisphere. In a preferred example, the stress-applying feature includes a metal or other hard core as disclosed above, which is partially or fully covered with a coating, where preferably the Mohs hardness of the coating is less than the Mohs hardness of the core. The softer coating may provide any one of roundness, bluntness, lubricity, smoothness, etc., without sacrificing the ability of the stress-applying feature to indent or rupture a hardened plaque. In another example, the Mohs hardness of the stress-applying feature will be at least twice the Mohs hardness of the expandable structure that supports the feature. In a preferred example, the expandable structure includes or consists of a polymeric material, while the stress-induced features include or consist of a metal or metal-alloy material.

[0048] In a further preferred example, the stress-applying features, spacer features, and all other prominent features and elements as described will have a degree of radiopacity to assist in visualization under fluoroscopy, either inherently (as is the case with many metals), or due to the incorporation, alloying, electroplating, or coating with radiopaque materials or fillers, or both. Suitable radiopaque fillers suitable for incorporation with polymers include salts or particles made of tungsten, gold, platinum, iridium, bismuth, barium, and / or iodide salts. Metals with high radiopacity suitable for coating or electroplating metal and non-metal features include bismuth, gold, platinum, tungsten, and iridium.

[0049] In other examples, the core may be polymeric and coated with a metal coating having a Mohs hardness greater than the Mohs hardness of the polymeric feature. A specific combination of core Mohs hardness and coating Mohs hardness may be selected to provide sufficient force to indent, rupture, or otherwise expand hardened or calcified tissue or lesions, while being flexible and smooth enough to safely enter the vascular system or other anatomical structures.

[0050] When stratifying or mixing multiple adhesives, one adhesive material can be softer than an adjacent material. Alternatively or additionally, a first adhesive material can be more compatible with the material of the expandable member and be stratified directly on the surface of the member, while one or more additional materials can be stratified on the first layer to provide adhesion to the stress application feature or provide other properties to enhance the overall adhesion between the stress application feature and the expandable member.

[0051] Typically, the material of the stress application feature is selected and configured to compress by 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 calcification or other plaque by a balloon, cannula, or other expandable member. In other words, when the material is pressurized by the expandable structure, the compressibility of the material against a hard surface is in the range of 0.001 mm to 0.2 mm, preferably in the range of 0.001 mm to 0.1 mm, and more preferably in the range of 0.001 mm to 0.01 mm. In other examples, the stress application feature has a material compressibility that is less than the compliance of the material of the expandable member when pressurized to the nominal inflation pressure.

[0052] In another example, the fracture toughness of the stress application feature 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 , and most preferably at least 100 MPa·m 1 / 2 . In a preferred example, the stress application feature has a Mohs hardness greater than 4 and greater than 50 MPa·m 1 / 2Fracture toughness. In a preferred example, the stress application feature is composed of a metal or metal alloy. In a preferred example, the stress application feature is composed of or includes a radiopaque material that provides radiopacity under X-ray / fluoroscopy. In another example, the stress application feature is composed of or includes a radiopaque material that is configured to provide sufficient radiopacity to visualize the feature under fluoroscopy, preferably sufficient to visualize the feature under fluoroscopy without the aid of a radiopaque contrast agent material. In another preferred example, the stress application feature is attached to the outer surface of an expandable balloon catheter, where the feature is composed of or includes a radiopaque material that is configured to provide sufficient radiopacity to visualize the feature under fluoroscopy, where under fluoroscopy, the visualization effect is equal to or greater than the visualization effect of a contrast agent-filled balloon. These advantages provide precise measurement of blood vessels, enhanced boundary definition of expandable structures (such as expanded / inflated balloons), and / or enhanced detection of atherosclerotic plaques or plaque morphology.

[0053] The stress application feature of the present invention presents a generally circular, non-sharp, and atraumatic structure above the surface of the expandable structure to facilitate entry into the vascular system while still providing the necessary force to indent / fracture atherosclerotic plaques when expanded by the expandable member. This is advantageous because many cutting features of the prior art are sharp and can snag the vascular system during catheter entry. Thus, in a preferred example of the present invention, at least the entire surface above the base (sometimes including the surface of the feature attached to the base) is circular, smooth, and creates minimal friction during its entry.

[0054] In another example, the stress application feature of the present invention presents a generally circular, non-sharp, non-peripheral-edge, and atraumatic structure above the surface of the expandable structure to facilitate entry into the vascular system while still providing the necessary force to indent / fracture atherosclerotic plaques when expanded by the expandable member. In another example, when expanded by the expandable member, the stress application feature of the present invention presents a generally circular, non-sharp, non-peripheral-edge, non-circular (beveled) peripheral-edge, and atraumatic structure above the surface of the expandable structure to facilitate entry into the vascular system while still providing the necessary force to indent / fracture atherosclerotic plaques. In another example, the plaque disruption feature may have a peripheral edge or a circular (beveled) peripheral edge. However, in a preferred example, the stress application feature has no peripheral edge. In another preferred example, the stress application feature may have no peripheral edge or peripheral beveled edge.

[0055] In some cases, the stress applying feature of the present invention may include a sharp or potentially traumatic core that is covered or coated with another material that provides a rounded, non-sharp, or otherwise trauma-protective engagement surface to avoid damage to the vascular system or other body cavity when the expandable member enters the vascular system or other body cavity. In such cases, at least the potentially damaging contact area of the feature is covered or coated.

[0056] Expandable structures (such as balloons or stents) can have any of a variety of shapes or configurations, including cylindrical, substantially cylindrical, hourglass-shaped, dogbone-shaped, conical, ellipsoidal, rectangular, or one or more of other shapes, outer shapes, profiles, or configurations. In many cases, by applying an internal expansion force (commonly by fluid or balloon expansion generally used for vascular devices and cardiac stents), a balloon, cannula, cage structure, or stent will expand from a crimped configuration or small configuration to an expanded configuration or larger configuration. Alternatively, a stent can be constrained and deployed from a constrained configuration by removing or withdrawing the constraint. The constraint can be provided by a catheter, cannula, sheath, or other conventional or novel constraint structure. This design is commonly referred to as "self-expanding".

[0057] The stress applying feature can be formed of one or more of metals, metal alloys, ceramics, minerals, polymers, polymer blends, mixtures of polymers, epoxies, diamond, or combinations thereof, including degradable and non-degradable materials. Suitable metals and metal alloys include stainless steel, cobalt-chromium alloy, platinum-chromium alloy, platinum-iridium alloy, silver, nitinol (NiTi), tungsten, tungsten carbide, palladium, cobalt, gold, platinum, iridium, titanium carbide, zirconium, chromium, magnesium, or magnesium alloys (such as magnesium-zinc alloy and magnesium-yttrium alloy), zinc, or zinc alloys (such as zinc-calcium alloy and zinc-lithium alloy), etc. In a specific example, chrome-plated steel balls can be used, which are particularly useful when placed on a balloon and cannula. The chrome-plated steel balls are corrosion-resistant and harder than the underlying metal. Typically, the chrome-plated steel balls have a hardness comparable to that of solid chromium balls.

[0058] In some examples, the plaque disrupting feature includes one or more materials that are coated, overmolded, electroplated, or otherwise attached to one or more of the contact area of the feature, the base of the feature, and / or the outer surface of the feature. In a preferred example, the material provides one or more of the following properties to the surface of the feature, base, or contact area: round, non-sharp, smooth, slippery, low friction, convex, trauma-resistant surface, and / or lubricity. In some examples, the material is a polymer that includes parylene (such as parylene, parylene N, and parylene C), silicone (such as polydimethylsiloxane, poly(diphenyl)siloxane, poly(methyl-co-phenyl)siloxane, poly(methyltrifluoropropyl)siloxane, poly(methyl-co-methyltrifluoropropyl)siloxane, etc.), polyurethane and its copolymers (such as thermoplastic polyurethane (tecoflex), thermoplastic polyurethane (pellathane), thermoplastic polyurethane (chronoflex), thermoplastic elastomer (chronoprene), thermoplastic polyurethane (chronothane), thermoplastic silicone (chronosil), polymer blends, etc.), polyethylene-vinyl acetate, polyvinylidene fluoride, polyvinylidene fluoride-co-hexafluoropropylene, polybutyl methacrylate, poly(styrene-butadiene-styrene), polylactide, hydrophilic materials, etc. or a combination of one or more thereof. Examples of metals or metal alloys are used for coating to provide a hard or harder but smooth, round, convex, and / or non-sharp surface that is applied to the feature, for example, by evaporation, sputtering, vapor deposition, or plasma coating of the metal or alloy on the surface of the polymer feature, such as titanium, Ti-6Al-4V alloy, titanium-magnesium alloy, stainless steel (such as 316, 304, 420, etc.), magnesium alloy (such as yttrium-zirconium-magnesium alloy), chromium, cobalt, cobalt-chromium alloy, CoCrMo, nitinol, tungsten, gold, platinum, silver, zinc, palladium, iridium, ruthenium, rhodium, indium, tin, molybdenum, iron, vanadium, nickel, niobium, zirconium, etc. or a combination thereof. Examples of polymer features hardened by filling with fine glass, quartz, or silica fibers or particles (such as 40% glass-filled nylon, carbon fiber, carbon nanospheres, carbon nanotubes, carbon nanofibers, carbon nanotubes, talc, aramid, etc.) are another example.

[0059] In a preferred example, the adhesive is used to attach, cover, fix, couple, and / or bond a feature or the base of a feature to the surface of an expandable structure. Examples include, but are not limited to, photocurable materials (such as Henkel Loctite 3943, 3973, 3972, 3321, 3311, 3526, Permabond UV610, UV670, UB7141, etc.), moisture-resistant photocurable materials (such as Loctite EA 3335, 4310, 3525, 3494, etc.), epoxy resins (such as 5-minute epoxy resin, EPO-tek MED-353ND, EPO-tek MED-HYB-353ND, Masterbond EP41SMed, Henkel Loctite 3981), polyurethanes (such as Permabond PT321, PT326, and PT328), epoxy-polyurethane blends, and cyanoacrylates (such as HB Fuller M2240-05, Permabond ET5393, Permabond 2011, Infinity CA-110-M), Loctite 4014 with or without an undercoat (such as HB Fuller 6070 or Loctite 713), structural acrylic adhesives with or without initiators 41 or 46 (such as Permabond TA430, TA435, TA437, TA49, TA459, TA4246), etc., or one or more combinations thereof. In a preferred example, the covered area covered by the adhesive material is at least the size of the covered area of the feature (or the base of the feature) in contact with the surface of the expandable structure, and this covered area is greater than and includes the covered area of the feature or the base of the feature in contact with the surface of the expandable structure, at least a portion of the surface of the feature above the surface of the expandable structure, or at least the entire outer surface of the feature. In yet another example, the adhesive at least covers the inner surface of the hollow feature.

[0060] In a preferred example, the stress-applying feature has a blunt contact area that serves to concentrate the force applied to the occlusive material, resistant material, plaque, or calcified plaque on or within the vessel wall when the expandable structure or stent expands in a blood vessel or other body cavity.

[0061] In a preferred example, the plaque-destroying feature contact area is symmetric. The symmetric configuration provides smooth passage through the vascular system without causing blockage or vessel damage. In other examples, the plaque contact area is asymmetric.

[0062] Typically, each stress application feature will have a single blunt contact area, but in some cases, it may have two, three, or more separately formed blunt contact areas, each blunt contact area being defined by a continuous peripheral boundary. Typically, the area of each blunt contact area will be in the range of 0.0001 mm 2 to 5 mm 2 preferably in the range of 0.001 mm 2 to 2 mm 2 more preferably in the range of 0.001 mm 2 to 0.2 mm 2 and most preferably in the range of 0.01 mm 2 to 0.2 mm 2 In one example, typically, the total outer surface area of a sinusoidal stent ring or balloon will have an area in the range of 0.05 mm 2 to 10 mm 2 preferably in the range of 0.5 mm 2 to 2.5 mm 2 more preferably in the range of 0.5 mm 2 to 1.5 mm 2 Based on both the total number of blunt contact areas and the contact area of each blunt contact area, the force (pressure) per unit area applied by the stress application feature will increase from 1-fold to 1000-fold, often from 1-fold to 100-fold, preferably from 1-fold to 50-fold.

[0063] The radial distance of the blunt contact area of the stress application feature above the outer surface of the expandable structure (such as a stent or other structure) can be in the range of 0.05 mm to 1 mm, preferably in the range of 0.15 mm to 0.5 mm. The blunt contact area can have a width or diameter (in the case of a circular blunt contact area) in the range of 10 μm to 2.5 mm, preferably in the range of 30 μm to 250 μm. In some cases, the blunt contact area can have a ratio of width to length in the range of 1:3 to 3:1, often in the range of 1:2 to 2:1, and approximately 1:1 (often circular).

[0064] Typically, the stress application feature will be positioned directly on the outer surface of the stent, i.e., the feature will be integrally formed, subsequently deposited, or otherwise positioned such that the feature extends or projects radially away from the outer surface of the struts, crown, connectors, or other major components of the stent. However, in other cases, the stress-inducing feature may be formed as an integral but accessory component of the stent, such as having an arm or other integral connector (similar to the connectors between adjacent rings) extending from the feature and connecting the feature to the main stent element. Examples include stress application features attached to the stent crown, struts, or connectors by an arm. In some examples, a single accessory stress application feature may be attached to two or more main stent components (e.g., crown, struts, or connectors) by two or more separate arms.

[0065] Such accessory stress application features may be formed with a blunt contact region that projects radially outward and may be used to further reconfigure or deform. In this way, the blunt contact region may be positioned laterally away from the outer surface of the main stent component. In other cases, the accessory features may be folded, typically by bending the connecting arms, such that they are placed on the outer surface of adjacent main stent components. Optionally, such folded accessory features may be further attached to the main component by any one of the techniques described previously, such as soldering, welding, gluing, press-fitting, mechanical fitting, tying knots, or other techniques.

[0066] In some examples, the stress application features are placed on relatively surface regions of an expandable structure, such as on a balloon surface or a stent circumferential ring, such as on substantially opposite crowns and / or struts, i.e., separated by 180°. In other examples, the respective stress application features can be distributed around the perimeter of a balloon, cannula, cage structure, or separate ring at other equal angular spacings (e.g., 30°, 45°, 60°, 90°, or 120°), typically, each stress application feature is located on the surface of a crown, strut, axial connection, or on the surface bridging two or more such stent structures. In these and other cases, the stress application features on the expandable structure or on a separate ring can be circumferentially offset, e.g., by about 10°, 20°, 30°, 40°, 60°, or 90°, from the stress application features on the axial length or on one or more axially spaced rings. In yet another example, the stress application features can be arranged in a helical pattern along a partial or entire length of the expandable structure or stent. In other examples, the stress application features on the expandable structure, cardiac stent, or separate ring can be circumferentially and axially offset from each other within the structure, cardiac stent, or ring, and / or can be circumferentially and axially offset from the stress application features 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 stent can have fewer stress application features (compared to the intermediate structure or stent region) or no stress application features on at least one, two, three, four, five, six, or more end lengths (measured in mm or cm) or circumferential rings at either or both ends of the stent, typically having no stress application features on these end ends or end rings.

[0067] In a preferred example, the stress application features can be placed only on the crown region. The stress application features can be circumferentially oriented around the surface of some or all of the separate rings; the number of stress application features per ring can range from 1 to 5 stress application features, preferably, 2 to 5 stress application features, and more preferably, 2 to 3 stress application features; the stress application features can be located only on the crown region, only on the connection region, or only on the crown and connection regions; the stress application features can be located only on diametrically opposite crown regions, only on diametrically opposite connection regions, or only on diametrically opposite crown regions and connection regions; or, the stress application features can be located only on the crown region, connection region, or on the crown region and connection regions, with the stress application features circumferentially spaced 30°, 45°, 60°, 90°, 120°, or 180° on the same ring or on axially adjacent or spaced rings. In yet some other examples, the stress application features can be presented within a single circumferential ring at a ratio of "stress application feature" to "crown", with the ratio ranging from 1:1 to 1:4, often 1:2 to 1:3.

[0068] The stress-applying feature of the present invention can have any of a variety of specific shapes and configurations, characterized by a blunt contact region at a position radially outwardly spaced from the outer surface of the expandable structure or stent. For example, the stress-applying feature can have a disc shape, a frustoconical shape, a spherical shape, a spheroidal shape, an ellipsoidal shape, a frustopyramidal shape, a frustotear-drop shape, etc. The base of the stress-applying feature can contact the outer surface of the expandable structure or stent, where the coverage area has a periphery in an oval, triangular, circular, polygonal, or irregular shape, and the blunt end is positioned radially outward from the outer surface of the expandable structure or stent. In some cases, the stress-applying feature can be attached to a base layer that is fixed to the outer surface of the expandable structure or stent, and one, two, three, or more additional layers can be formed or attached on the base layer. The layers can be formed of the same or different materials and can be applied or deposited in situ or preformed and attached by any of the foregoing methods, and can have the same or different shapes, lengths, widths, or heights. Typically, the stress-applying feature will be symmetric, but in some cases, the stress-applying feature can be configured asymmetrically with respect to a circumferential and / or axial line or plane.

[0069] Typically, the blunt contact region will be circular, but in some cases, it can be square, rectangular, polygonal, and / or elongated in the axial direction or the transverse direction. For example, the blunt contact region can have a length and a width, where the aspect ratio is in the range of 5:1 to 1:10, preferably in the range of 3:1 to 1:10, more preferably in the range of 2:1 to 1:10. In a preferred example, the ratio of the length to the width of the blunt contact region is in the range of 2:1 to 1:2, about 1:1, or about 1:2. In another preferred example, the width of the base of the stress-applying feature or the stress-applying feature is longer than the width of the stress-applying feature. In another example, the height of the blunt contact region (the distance radially spaced from the outer surface of the expandable structure or stent 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 another example, the circumferential width is equal to or longer than the axial length of at least some of the stress-inducing features.

[0070] In most cases where the expandable structure is a cardiac stent (stent), the base of the stress-applying feature will not extend beyond the edge of the outer surface of a single crown region, a single strut region, or a single connection region, but in other cases, the base can extend beyond the edge of the stent surface and / or can span two or more adjacent crowns, struts, and / or connectors.

[0071] The stress - applying feature will be configured to break, rupture, shatter, disrupt, dent, or fragment occlusive material on or within the inner wall of a blood vessel, valve, or body cavity (including arteries and veins in the heart and peripheral vascular system). The occlusive material can include calcified lesions, which are often in the form of calcified plaques that partially or completely occlude or partially or completely surround a blood vessel, valve leaflet, or lumen. In a preferred example, the feature consists of or includes a blunt - contact area that is configured to break, rupture, dent, shatter, disrupt, or fragment occlusive material on or within the inner wall of a blood vessel or body cavity when an expandable structure (such as a balloon, cardiac stent, cannula, etc.) expands or dilates to its radially expanded deployed configuration. For example, the blunt - contact area can also have a peripheral edge that breaks, ruptures, shatters, disrupts, or otherwise fragments the occlusive material, while the surface of the blunt - contact area prevents the peripheral edge from accidentally cutting the blood vessel wall, valve leaflet, or body cavity or otherwise causing substantial damage (such as tearing) to the blood vessel wall, valve leaflet, or body cavity. In another example, the contact area and the peripheral edge of the stress - applying feature are blunt, and when the blunt contact surface and periphery are pushed or pressed against the blood vessel wall, atherosclerotic plaque, valve annulus, valve leaflet, or body cavity, they expand, dent, break, rupture, shatter, disrupt, or otherwise fragment the plaque or occlusive material. In this example, the edge is made blunt by beveling the peripheral edge or polishing the peripheral edge or coating the peripheral edge or the surface of the feature. In another example, the surface of the stress - applying feature, which includes a contact area, a peripheral area, a base, and a feature body, is blunt, and when the blunt surface is pushed or pressed against the blood vessel wall, atherosclerotic plaque, valve annulus, valve leaflet, or body cavity, it dents, breaks, ruptures, shatters, disrupts, or otherwise fragments the plaque or occlusive material. In another example, the surface of the stress - applying feature, which includes a contact area, a base, and a feature body, is blunt and has no peripheral edge, and when the blunt surface is pushed or pressed against the blood vessel wall, atherosclerotic plaque, valve annulus, valve leaflet, or body cavity, it dents, breaks, ruptures, shatters, disrupts, or otherwise fragments the plaque or occlusive material. In another example, when the expandable structure containing the feature expands or deploys radially or axially against the blood vessel wall, body cavity, or valve annulus / valve leaflet, the stress - applying feature on one or more surfaces is blunt, non - sharp, or otherwise causes minimal or no damage to the blood vessel, body cavity, valve annulus, valve leaflet. In another example, the surfaces of the stress - applying feature have the same bluntness or different bluntnesses.

[0072] In a preferred example, the stress - applying feature includes one or more of the following aspects: applying a force to tissue, resistant tissue, plaque, calcified plaque, and / or fibrotic plaque to disrupt vascular occlusion, dent vascular tissue and / or the occlusive material, and / or enlarge the vascular lumen or body cavity.

[0073] In a preferred example, the stress application feature on the contact area may include one or more of the following configurations: blunt, anti-injury, not sharp, wherein the feature contact area of the stress application feature fractures, dents, and / or disrupts and / or ruptures the hardened vascular tissue and / or calcified plaque to expand the vascular lumen.

[0074] In another example, the stress application feature has a body. In another example, the stress application feature includes a base, wherein the base is separated from the feature body, and wherein the feature and the base are attached together.

[0075] In another example, the stress application feature is formed on a balloon, an expandable member, a cannula, a cage structure, or other device. In other examples, the stress application feature is formed on the outer surface of a balloon, an expandable member, a cannula, or a cage structure, or on the inner surface of a balloon, an expandable member, a cannula, or a cage structure. In one example, the stress application feature is formed on the inner surface of a balloon, a cannula, a cage structure, or an expandable member, and the feature is configured to radially protrude outward above the surface of the balloon, cannula, cage structure, or expandable member when the balloon, cannula, cage structure, or expandable member expands from a crimped configuration or a small configuration to an expanded configuration. In another example, the stress application feature is formed on the inner surface of a balloon, a cannula, a cage structure, or an expandable member, and then the balloon, cannula, cage structure, or expandable member is turned inside out before the balloon, cannula, cage structure, or expandable member expands from a crimped configuration or a small configuration to an expanded configuration, so as to set the feature on the outer surface of the balloon, cannula, cage structure, or expandable member.

[0076] The stress-inducing feature will be adhered to the outer balloon surface by one or more layers of adhesive polymer or adhesive polymer "dots", and the compliance of the adhesive polymer is equal to or less than the compliance of the balloon polymer (e.g., as described herein with reference to Figure 16E -A to Figure 16E -G), to maintain the flexibility of the inflatable balloon during the passage of the balloon catheter in a crimped configuration. The adhesive polymer layer can be applied by spraying, dip coating, brushing, or other conventional techniques, typically with a thickness in the range of 1 μm to 50 μm, usually in the range of 1 μm to 20 μm. Typically, at the position where the stress application feature adheres (attaches) to the outer surface of the balloon, the adhesive dots will be applied or dispensed as small droplets, and the volume of the small droplets is typically in the range of 0.1 μl to 1 μl, usually in the range of 0.1 μl to 0.5 μl.

[0077] Typically, the balloon wall will consist of or consist essentially of a single layer of polymer, copolymer, or polymer blend, the thickness of which depends on the material of manufacture and the expected inflation pressure. For example, nylon will typically require a thicker wall compared to a balloon made of a stiffer material such as PET. Typically, nylon and nylon blend balloons will have a bilayer wall thickness in the range of 0.02 mm to 0.1 mm, typically having a bilayer wall thickness in the range of 0.02 mm to 0.07 mm, while typically, PET balloons will have a bilayer wall thickness in the range of 0.01 mm to 0.025 mm, typically having a bilayer wall thickness in the range of 0.01 mm to 0.015 mm. The balloon wall thickness will typically (but not necessarily always) be uniform or substantially uniform over most or all of the balloon surface or the balloon working length surface, which is typically (but not necessarily) cylindrical. For example, when the balloon is inflated or when the balloon is deflated, the balloon has a uniform or substantially uniform wall thickness over at least the cylindrical middle portion of the balloon surface, typically having a uniform average wall thickness, where when the balloon is inflated or when the balloon is deflated, over the length of the cylindrical surface, the deviation of the wall thickness from the average value does not exceed ±20%, more commonly not exceeding ±10%.

[0078] Typically, the thickness of the adhesive layer and other polymer layers formed on the balloon surface will be 75% or less (for a single layer) of the thickness of the balloon wall, typically 60% or less, and preferably 50% or less. However, the cumulative thickness of multiple layers can be greater, for example, the cumulative thickness of a bilayer is 150% or less of the thickness of the balloon wall, typically 120% or less, and preferably 100% or less.

[0079] Typically, the balloon wall will consist of or consist essentially of a single layer of polymer, copolymer, or polymer blend, without any additional materials, additives, or features that would change or substantially change the balloon properties, including balloon compliance, dilation force, or flexibility.

[0080] Typically, the balloon wall will consist of or consist essentially of a single layer of polymer, copolymer, or polymer blend, which is configured to maximize flexibility for passage through the vascular anatomy. In this example, the balloon surface consists of a single layer without features or materials that would reinforce the balloon or the balloon surface.

[0081] Stress-inducing features can be arranged on the outer surface of the balloon in any one or more of a variety of regular and irregular (random) patterns, and one or more of the patterns can be the same or can vary over different regions of the outer surface. Generally, the stress-inducing features will be arranged in straight rows (referred to herein as "axial rows") that are aligned with the central balloon axis, the straight rows being circumferentially spaced apart on at least the cylindrical central region of the outer balloon surface and generally circumferentially spaced apart over the entire outer balloon surface. In such cases, it will generally be advantageous for at least some of the stress-applying features in one axial row to be "axially offset" relative to the stress-applying features in other axial rows to reduce the circumferential overlap of the stress-applying features after balloon folding, thereby providing a smaller profile for insertion, as described in more detail below. Thus, when the balloon is inflated, no two stress-applying features will be located on a common circumference of the balloon, i.e., the centers of each pair of axially adjacent stress-applying features will be on a circumferential line (circle) that is axially spaced apart from the circumferential line on which the nearest adjacent stress-applying feature is located. Preferably, depending on the diameter or width of the stress-applying features, the centers of adjacent stress-applying features will be axially spaced apart by a sufficient distance such that there will be a space or "gap" between the features, i.e., the centers and / or bases of the features will not axially overlap, thereby reducing the potential circumferential overlap of the features when the balloon is deflated. Most preferably, when the balloon is deflated and folded, no two features on the outer surface of the balloon will axially or circumferentially overlap. The broad, exemplary, and preferred dimensional ranges are listed in Table 1 below.

[0082] Table 1

[0083]

[0084] Since the preferred balloon of the present invention will have limited compliance (stretchability at high inflation pressures), its nominal size when inflated will be at most slightly larger than its nominal size when deflated, thus typically requiring the balloon to be folded or pleated for delivery on a deployment catheter. Typically, the number of creases or pleats will depend on the number of axial rows of stress-applying features on the outer balloon surface. For example, typically, a balloon having three axial rows of stress-applying features will be folded to have three creases or pleats, with each row of stress-applying features disposed between each circumferentially adjacent pair of axial pleat rows. In another example, a balloon having four axial rows of stress-applying features can have four creases or pleats, with each row of stress-applying features disposed between each circumferentially adjacent pair of pleats. In other alternative examples, when the balloon is folded prior to inflation, some or all of the axial rows of stress-applying features can be disposed on the creases or pleats of the balloon.

[0085] Typically, the balloon of the present invention will be free of reinforcing members or other components that would affect the compliance or other properties of the balloon, such that one segment of the balloon is different from other segments of the balloon. Thus, the balloon will generally have uniform compliance and other physical properties, including but not limited to compliance (stretchability) and flexibility (ability to bend, pass through anatomical structures, and / or fold without breaking), at least at its circumferential center and generally throughout its structure.

[0086] Typically, the balloon of the present invention will be inflated to a relatively high pressure so that the stress - applying feature can rupture the calcified plaque, generally inflated to a pressure of at least 2 atm, typically inflated to a pressure of at least 5 atm, more commonly inflated to a pressure of at least 8 atm, still more commonly inflated to a pressure of at least 12 atm, and often inflated to a pressure of 15 atm or higher.

[0087] While in many embodiments and examples, the stress - applying feature of the present invention is intended to be placed and directly attached to the outer surface of an expandable structure such as a balloon, a cardiac stent, and a graft structure, in other cases, the stress - applying feature can be placed on the outer surface and / or inner surface of an expandable cannula or similar support structure that can be placed on a conventional balloon, cardiac stent, or vascular graft. In still other cases, the stress - applying feature of the present invention can be placed directly on an angioplasty balloon as a supplement or alternative to the blades / elements of a conventional cutting balloon or scored balloon. In some cases, a balloon having a stress - applying feature as described herein can be used to expand a cardiac stent or vascular graft, and the balloon and stress - applying feature are removed from the cardiac stent or vascular graft after expansion.

[0088] A variety of stress - applying features and force - applying features are described and claimed herein, such as blunt, dome - shaped, features having sharp elements, etc., and a variety of expandable structures or components or substrates are described and claimed herein, such as cardiac stents, grafts, balloons, cannulas, cage structures, etc. The present invention will include each individual type of stress - applying element or force - applying element, each stress - applying element or force - applying element being combined with each expandable structure / component either individually or in combination.

[0089] Additionally, in some cases, the preferred stress - applying feature of the present invention can be incorporated into a stent member that radially expands outwardly from the outer surface of the cardiac stent when the cardiac stent is radially expanded. In another case, a cardiac stent or stent having a stress - applying feature can radially contract after being radially expanded outwardly.

[0090] In still other cases, the surface of the stress-applying feature (including the blunt contact area) can be roughened or otherwise modified to enhance adhesion to the surface of the blood vessel or the calcified lesion, for example having one or more tissue interface features on, in, above, or near the surface, such as texture, polish, friction, barbs, spikes, wedge structures, microstructural patterns, etc. These features stably engage with the blood vessel wall tissue before, during, or once the occlusive material ruptures, thereby minimizing misalignment or sliding of the expandable structure (such as a balloon, cannula, cage structure) or stent at or near the stress-applying feature. In yet another example, the base of the feature can be roughened, etched, grooved, patterned, sandblasted, or micro-patterned to enhance the adhesion of the base to the surface of the expandable structure.

[0091] In still other cases, the stress-applying feature can include a sharp element protruding outward from the blunt contact area. The sharp element (such as a shaft or other body having a sharp tip or sharp edge) is typically configured to concentrate stress when the blunt contact area bears against the surface of the occlusive material and engages with the occlusive material on the wall of the blood vessel lumen. The height of the sharp element will be selected to be sufficient to enhance the rupture or "nucleate" the rupture of the hardened lesion while reducing or eliminating the risk of damage to the underlying layer of the lesion and the arterial wall away from the lesion. For example, the blunt surface can extend a first distance above the surface of the balloon or stent, and the sharp element protrudes a second distance from the surface of the blunt contact area, and the second distance is equal to the first distance (0.05 mm to 0.1 mm). 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, and usually in the range of 0.01 mm to 0.1 mm.

[0092] In a first aspect, the present invention provides an endoprosthesis that includes a stent and a plurality of stress-applying features coupled to the outer surface of the stent. The stent is at least partially composed of a non-degradable material and is configured to expand from a crimped configuration to an expanded, deployed configuration. At least some of the stress-applying features include a blunt contact area spaced outwardly from the outer surface, wherein the blunt contact area is configured to rupture the occlusive material in the wall of the blood vessel lumen when the stent expands from the crimped configuration to the expanded configuration in the blood vessel lumen. In other examples, the stent can be composed of a degradable material (such as a degradable polymer material or a degradable metal material), or can be composed of a non-degradable material (such as a non-degradable metal or metal alloy material), wherein the material is configured to expand from the crimped configuration to the expanded, deployed configuration.

[0093] In a preferred example, the plaque disrupting feature is applied to a non - degradable stent structure. In other examples, the plaque disrupting feature is applied to a degradable stent structure in a physiological environment, where the degradable material includes a degradable polymeric material or a degradable metal or metal alloy material.

[0094] In certain examples, the stent or expandable structure can have a tubular geometry, such as a cylindrical shape, an ellipsoidal shape, a tapered profile, an hourglass shape, a dog - bone shape, other shapes, etc.

[0095] In certain examples, at least some of the blunt contact regions include a peripheral edge that is configured to concentrate stress when the expandable structure (such as a stent) expands from a crimped configuration to an expanded configuration in a blood vessel lumen and engages an occlusive material on the wall of the blood vessel lumen. This concentrated stress will cause the occlusive material contacted by the blunt contact region to fracture, break, shatter, disrupt, or otherwise fragment. The peripheral edge can be formed by the junction between the blunt contact region and a peripheral wall that at least partially surrounds the blunt contact region. The blunt contact region can have various shapes or surfaces, such as flat, circular, convex, or concave.

[0096] In certain examples, the blunt contact region can be flat and the blunt contact region can be parallel to the outer surface of the stent. Alternatively, the blunt contact region can be inclined with respect to the outer surface of the expandable structure or stent. The peripheral wall can be oriented at an angle in the range of 75° to 105° with respect to the blunt contact region. The peripheral edge can extend completely or partially around the blunt contact region and can have a width in the range of 10 μm to 200 μm. In some cases, the peripheral edge can be circular and the width includes the diameter.

[0097] In certain examples, at least some of the plurality of stress - applying features include one or more plates, the total thickness of the one or more plates ranging from 0.1 mm to 1 mm, 0.15 mm to 1 mm, or 0.25 mm to 1 mm, and having a width ranging from 0.05 mm to 2 mm or 0.1 mm to 2 mm when attached to the surface of the expandable structure or tubular stent. At least some of the plates can be configured as disks, stacked disks, frustoconical bodies, disks stacked with frustoconical bodies, ellipsoidal disks, asymmetric cones, etc. In other examples, the stress - applying features can include one or more spheres, spherical balls, hemispheres, partial spheres, etc. that form various shapes (“snowman” shape or other configurations or combinations thereof).

[0098] In certain examples, the stent can be formed as a conventional intravascular stent, typically including a plurality of struts connected by a crown. The struts and the crown can be formed as a circumferential ring, and in some cases, the plurality of struts connected by the crown can be connected into a plurality of continuous, adjacent circumferential rings connected by axial connectors, and in other cases, the rings can be connected into a helical pattern or other pattern.

[0099] In a preferred case, at least some of the stress application features can be located at or adjacent to the crown, and optionally, at least some of the crowns with stress application features can be unconnected to adjacent rings. Often, each of the stress application features will be located at or adjacent to the crown.

[0100] In an alternative case, at least some of the stress application features can be located on the struts between the crowns, or can be located on one or more connectors connecting adjacent rings.

[0101] In some cases, at least some of the stress application features can be arranged as diametrically opposed pairs of stress application features, and optionally, successive, diametrically opposed pairs of crowns can be circumferentially offset. Such successive, diametrically opposed pairs of crowns can be circumferentially offset by an angle of 45° to 90°.

[0102] In an alternative case, at least some of the stress application features can be arranged as groups of three, four, or five stress application features, which can be circumferentially spaced apart by approximately 120°, 90°, or 72° respectively around the perimeter or circle on the surface of the expandable structure or tubular stent. In another case, at least some of the stress application features can be arranged as groups of three, four, or five stress application features, which can be circumferentially spaced apart by approximately 120°, 90°, or 72° respectively around the perimeter or circle on the surface of the expandable structure or cardiac stent along the length of the expandable structure or tubular stent.

[0103] In still other cases, the stress application features can be arranged in other regular and / or random patterns. For example, in some patterns, successive, axially spaced stress application features will be circumferentially offset by an angle within the range of 5° to 15°. Alternatively or additionally, at least some successive, circumferentially spaced stress application features can be axially offset by the same or a different angle within the range of 5° to 15°.

[0104] In certain examples, the stent of the present invention can be formed by patterning a tubular substrate, laser cutting the tubular substrate, rolling the cut substrate, bending wires, three-dimensional printing, or other known cardiac stent manufacturing techniques. The stress applying feature can be preformed and attached by gluing, soldering, welding, threaded attachment, riveting, crimping, etc. For example, the stress applying feature can include a preformed plate glued to the stent with an adhesive. Alternatively, the stress applying feature can be formed in-situ by three-dimensional printing, chemical vapor deposition, electrostatic deposition, molding, or folding of the components of the stent. For example, the stress applying feature can include a tab attached to the stent and folded onto the outer surface of the stent.

[0105] In certain examples, the stent can include a vascular stent or a stent-graft. In other examples, the stent can include an artificial valve, a valvuloplasty device, a cannula, etc. In each such example, the stent can be balloon-expandable or self-expandable.

[0106] In a second aspect, the present invention provides a method for rupturing calcified plaque in a patient's vascular system. A stent as in any of the foregoing embodiments expands from a crimped configuration to an expanded configuration within a calcified native vascular lumen. When the tubular stent expands from the crimped configuration to the expanded configuration, a plurality of stress applying features fixed to the outer surface of the stent cause indentation, dilation, cracking, or rupture of occlusive material on or within the wall of the vascular lumen. Typically, the occlusive material includes atherosclerotic plaque or calcified deposits.

[0107] In certain cases, expanding the stent includes expanding a balloon to expand the stent, or alternatively, allowing the stent to self-expand. For example, expanding the stent can include expanding an artificial heart valve within a cardiac valve annulus, where the stent includes a structural support for the cardiac valve annulus. For example, expanding the artificial heart valve can include expanding a balloon to expand the artificial heart valve within the cardiac valve annulus, or can include releasing the radial constraint on a crimped elastic stent after positioning the crimped elastic stent within the cardiac valve annulus.

[0108] In other examples, expanding the stent includes expanding a valvuloplasty device within a cardiac valve annulus. The stent of the valvuloplasty device can include an expandable cage structure, and expanding the valvuloplasty device includes expanding the cage structure within the cardiac valve annulus.

[0109] The cage structure according to the present invention can be formed from elastic and / or ductile metals, metal alloys, and polymers, including but not limited to any of the materials described herein for manufacturing stents and heart stents. Such cage structures can be self-expanding, balloon-expandable, etc., and the self-expanding cage structures can be configured to self-expand when released from radial constraint and / or radially expand in response to mechanical actuation (e.g., by axial shortening). Each of these radial expansion mechanisms is well known and does not require further description.

[0110] In a third aspect, the present invention provides a method of manufacturing a vascular stent. The tubular stent includes a plurality of struts connected by a crown within a tubular envelope. A plurality of tabs extending outwardly from the struts, crown, and / or connectors within the tubular envelope are folded onto the outer surface of the tubular envelope to form a plurality of stress-applying features on the outer surface of the tubular stent.

[0111] In certain instances, pairs of adjacent tabs form stacked stress-applying features by one tab being folded over the other. Prior to folding, the pairs of adjacent tabs can be arranged side by side on the stent. Alternatively, prior to folding, the pairs of adjacent tabs can be arranged one in front of the other on the stent. As a further alternative, prior to folding, the pairs of adjacent tabs can be arranged on opposite sides of the strut.

[0112] The stress-applying features can also be placed on extensions of the crown, struts, connectors, or other structural elements of the stent. The extensions can be supported or connected to the same ring or to the same or different structural elements on diametrically opposite rings, and preferably, the extensions have free end portions where the stress-inducing features are placed on or around the end portions. Such extensions can have the same or different widths as the elements from which they extend and can have any of a variety of shapes and configurations.

[0113] The stress-inducing features can be placed on struts, strut extensions, crowns, crown extensions, connectors, and / or connector extensions. Preferably, the stress-inducing features are placed on structural elements that are deflectable in a radially outward direction when the stent expands from a crimped configuration to a deployed configuration, such as at the end portions or other free ends or side structures of the crown, struts, connectors, or extensions that are free to deflect as "cantilever" elements. In a further preferred example, the stress-inducing features are placed on the end portions of extensions or on hinge elements, where the hinge elements include a portion of the crown or connector, such as a Z-shaped, M-shaped, W-shaped, U-shaped, V-shaped, S-shaped connector.

[0114] In some cases, the stress-inducing feature may be located on the inner surface of the stent, such as in the crown region or extensions, strut regions or extensions and / or connection regions or extensions at the cantilever ends. In such cases, the expansion of the balloon or other expandable element within the stent will cause the cantilever ends to deflect radially outward relative to the remainder of the outer surface of the stent (the feature on the inner surface will act as a spacer to preferentially expand the outer surface), thereby serving to place the feature on the outer surface of the stent. In such cases, the feature on the inner surface need not be configured to rupture the occlusive material (preferably configured not to damage the expanded balloon), but the outer surface of the deflected crown, strut, connection or extension will have a peripheral edge configured to fragment or rupture plaque, calcification or other occlusive material.

[0115] In some cases, the stress-inducing feature may be held on the outer or inner surface of the stent by an arm, clamp or other connecting element manufactured with the stent. Such stress-inducing feature may be coupled and positioned in place (e.g., by bending the attachment arm), but not fixed. In such cases, the stress-inducing feature may contact the surface of the stent, or a gap may be left between the feature and the surface of the stent. As in other cases, these stress-inducing features will contact the occlusive material upon stent expansion.

[0116] In some examples, multiple stress-inducing features may be circumferentially and axially offset within a single row or multiple rows of features on the circumferential ring or perimeter of the expandable structure. For example, three stress-inducing features on three crowns placed within a ring will be circumferentially offset, but may or may not be axially offset. If the crowns are axially offset and / or some of the stress-inducing features are located on struts, they will be axially offset.

[0117] Although the stress-applying features of the present invention will generally have blunt contact regions as described above, in alternative cases, the stress-applying features may include non-truncated cones or pyramids and may or may not include blunt contact regions.

[0118] In another aspect of the present invention, a device for treating a sclerotic plaque or calcified lesion on or in the wall of a body blood vessel or body cavity or valve annulus or leaflet of a patient includes a catheter, an expandable structure, and a plurality of stress-applying features. The catheter includes a catheter body having a proximal end and a distal segment. The expandable structure is disposed at or near the distal segment of the catheter. The expandable structure has an outer surface configured to radially outwardly displace toward the inner surface of the blood vessel wall, body cavity wall, or valve annulus. The plurality of stress-applying features are distributed on the outer surface or inner surface of the expandable structure. At least some of the stress-applying features are attached to the outer surface or inner surface of the expandable structure and, in one example, have a convex circular upper surface or base surface configured to indent, crack, expand, or rupture a calcified lesion of the blood vessel or body cavity while minimizing damage to the blood vessel or body cavity when the expandable structure expands within the blood vessel or body cavity. Before the balloon catheter enters the expandable structure to expand the expandable structure to disrupt the sclerotic plaque, the expandable structure may enter the target blood vessel or body cavity.

[0119] Alternatively, before balloon dilation to expand the expandable structure to disrupt the sclerotic plaque, the expandable structure is advanced over a balloon catheter already in place at the target site, and then the expandable structure is bridged (placed) over the balloon segment. In yet a third example, before inserting the expandable structure into the patient, the expandable structure is placed (bridged) over the balloon segment of a balloon catheter, and the entire system is introduced into the patient. In yet a fourth alternative, the expandable structure advances distally to the target site, the balloon catheter enters the target site, and the expandable structure retracts to bridge (place) over the expandable balloon segment to cause the expandable structure to expand. In a preferred example, the expandable structure includes an elastic tubular body that can expand from a curled, folded, or otherwise width-reduced configuration to an expanded configuration. In another example, the expandable structure includes a cage structure that includes two or more elongated members axially and circumferentially separated, the two or more elongated members connecting the distal end of the catheter and the proximal end of the distal segment of the catheter, and the strips not connecting to adjacent strips except at the proximal and distal ends, wherein the elongated members can expand from a small configuration to a larger expanded configuration.

[0120] In another example, the device in at least some of the examples can be configured for treating blood vessels, valve annuli, venous valves, or AV shunts, body cavities, where typically the sclerotic plaque or calcified lesion is located on or within the inner wall, intimal layer, medial layer, adventitial layer, valve leaflets, valve annulus, venous filter, or implant.

[0121] In some examples, the expandable structure can have relatively low stiffness when unexpanded and relatively high stiffness when fully expanded.

[0122] In some examples, when the expandable structure is fully or partially deployed or unfolded or expanded, the outer surface of the expandable structure can be generally cylindrical. In other examples, when the expandable structure is expanded or unfolded into an expanded configuration, the expandable structure can be in a rectangular, convex, hourglass, conical, frustoconical, ellipsoidal shape or other shape or configuration.

[0123] In some examples, the stress application feature includes a convex rounded upper surface of a plurality of stress application features that can extend radially outward beyond the outer surface of the expandable structure when fully expanded. For example, the convex rounded upper surface of the plurality of stress application features can extend radially outward beyond the outer surface of the expandable structure when partially or fully expanded by a distance within the range of 0.25 mm to 3 mm, preferably within the range of 0.5 mm to 3 mm.

[0124] In some examples, the convex rounded upper surface of the stress application feature can be free of edges and irregularities that may damage the wall when the expandable structure is expanded within the body cavity.

[0125] In some examples, at least some of the stress application features can have a single convex rounded upper surface and a lower base that is independently attached to the outer surface of the expandable structure.

[0126] In some examples, at least some of the stress application features can have a convex rounded tissue contact surface (typically an upper surface) and a base (typically a lower base) attached to the surface of the expandable structure. The base typically has a lower surface that is flat or otherwise configured to be attached directly or indirectly to the outer surface of the balloon by a polymeric adhesive.

[0127] In some examples, at least some of the stress application features can have a concave tissue contact surface and a base attached to the surface of the expandable structure. In other examples, at least some of the stress application features can have a convex tissue contact surface and a base attached to the surface of the expandable structure.

[0128] In some examples, at least some of the stress application features can have a convex rounded tissue contact surface and a base attached to the surface of the expandable structure, wherein the base has the largest configuration or dimension among the largest configurations or dimensions of the feature.

[0129] In some examples, at least some of the stress-applying features are formed of metal or metal alloy. In other examples, the features are formed of a polymeric material. In yet a third example, the features are formed of a polymeric material and coated with a harder material such as a metal or metal alloy material to provide the necessary hardness to disrupt hardened plaque. In yet another example, the material forming the features can be ceramic. In yet another example, the material forming the features can be coated with a harder material to provide sufficient strength to disrupt hardened plaque. In yet another example, the material forming the features can be coated with a softer (less hard) material to provide roundness, convexity, lubricity, low friction, or bluntness, such as in the example of a metallic material forming the features, which is coated with an adhesive material, a polymeric material, and / or a hydrophilic coating. In yet another example, the material forming the features can be coated with a material of similar hardness to provide one or more of roundness, convexity, bluntness, and / or a trauma-protective surface.

[0130] In another example, the plaque-disrupting features along the circumference and / or axial length of the expandable structure can have the same or different heights, widths, lengths, diameters, shapes, and / or configurations.

[0131] In some examples, at least some of the stress-applying features consist of or include a quadric surface, a quadratic construction, or a quadratic shape. In some examples, the base surface of the quadratic-shaped feature attached to the surface of the expandable structure is flat, oval, circular, square, rectangular, or conforms to the contour of the surface of the expandable structure. In some examples, the maximum height from the contact area to the base of the quadratic-shaped feature is approximately equal to half of the maximum width, maximum length, or maximum diameter of the base of the feature. In other examples, the maximum height from the contact area to the base of the quadratic-shaped feature is less than half of the maximum width, maximum length, or maximum diameter of the base of the feature. In other examples, the maximum height from the contact area to the base of the quadratic-shaped feature is greater than half of the maximum width, maximum length, or maximum diameter of the base of the feature.

[0132] In some examples, at least some of the stress-applying features include a quadratic shape or a quadratic construction that includes at least one of a sphere, an ellipsoid, an oblate spheroid, or a prolate structure.

[0133] In some examples, at least some of the stress-applying features consist of or include a partial sphere, a partial ellipsoid, a partial oblate spheroid, or a partial prolate structure.

[0134] In preferred examples, at least some of the plaque disrupting features of metal, rigid polymer, ceramic, or other materials have a contact area surface that is formed as circular, wavy profiled, non-sharp, smooth, convex, symmetric, asymmetric, concave, regular, irregular, faceted, polyhedral, and / or other surface geometries. The polyhedral faceted surface can include from 4 to 100 or more facets, where each facet can be triangular, square, rectangular, pentagonal, hexagonal, heptagonal, octagonal, etc. The exposed surface of the plaque disrupting feature can be irregular, for example, having grooves, cracks, notches, etc. on all or part of it. The exposed surface of the plaque disrupting feature can be textured, for example, sandblasted, to impart a desired surface irregularity.

[0135] Optionally, the irregular surfaces of the plaque disrupting features of metal, rigid polymer, ceramic, or other materials as described above can be partially or fully coated to smooth and / or lubricate the surface portions, thereby facilitating entry of a balloon or other expandable element with such features into tortuous anatomical structures in the vascular system or elsewhere.

[0136] In other examples, the contact area surface of the plaque disrupting feature is coated, covered, or electroplated with a material to provide a circular, wavy profiled, non-sharp, smooth, convex, and / or atraumatic surface. In one example, the material being coated, covered, or electroplated is metal, polymer, ceramic, or other type of material that is configured to provide a circular, wavy profiled, non-sharp, smooth, convex, and / or atraumatic surface.

[0137] In preferred examples, at least some of the plaque disrupting features have an entire surface above a base surface that is attached to the surface of the expandable structure and that, by means such as molding or by means such as electroplating, such as coating or such as covering, has a circular, wavy profiled, non-sharp, smooth, convex, and / or atraumatic surface.

[0138] In preferred examples, at least some of the plaque disrupting features have an entire surface that includes a base surface attached to the surface of the expandable structure and that, by means such as molding or by means such as electroplating, such as coating or such as covering, is circular, non-sharp, smooth, convex, circular, and / or atraumatic.

[0139] In some examples, at least some of the stress applying features can include spheres or ellipsoids.

[0140] In other examples, at least some of the stress applying features are formed by spheres, partial spheres or hemispheres. In one example, the maximum height of the partial sphere is in the range of 0.1 mm to 3 mm, preferably in the range of 0.25 mm to 2 mm. In one example, the maximum diameter of the partial sphere is in the range of 0.1 mm to 2 mm, preferably in the range of 0.25 mm to 1 mm. In yet another preferred example, the structure of the partial sphere is in the range of 10% to 90% of the sphere structure, preferably in the range of 25% to 75% of the sphere structure. In a preferred example, the partial sphere is a hemisphere (half sphere). In a preferred example, the plaque disrupting feature includes a plurality of spheres, where the sphere diameter is in the range of 0.20 mm to 2 mm, preferably in the range of 0.25 mm to 1 mm. In another example, the plaque disrupting feature includes a plurality of partial spheres or hemispheres. In one example, the maximum diameter of the partial sphere or hemisphere is in the range of 0.2 mm to 2 mm, preferably in the range of 0.25 mm to 2 mm. In another example, the plurality of spheres, plurality of partial spheres or plurality of hemispheres have the same size, height and / or diameter along the circumference and / or axial length of the expandable structure. In other examples, the plaque disrupting spheres, plaque disrupting partial spheres or plaque disrupting hemispheres have different sizes, heights and / or diameters along the circumference and / or axial length of the expandable structure. In one example, the partial sphere can be directly attached to the surface of the expandable structure. In another example, the partial sphere can have a separate base that is attached to the surface of the expandable structure and attached to the bottom of the partial sphere. In yet another example, the partial sphere can have a base that is integrally formed with the partial sphere and is attached to the surface of the expandable structure.

[0141] In some examples, at least some of the stress applying features can include a hemisphere having a lower surface attached to the outer surface of the expandable structure. For example, the lower surface can be flat or can conform to the contour of the surface of the expandable structure.

[0142] In some examples, at least some of the stress applying features can include a cylinder having a hemispherical upper surface and a lower surface attached to the outer surface of the expandable structure.

[0143] In some examples, the expandable structure can include an inflatable balloon. For example, when the inflatable balloon is 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, the inflatable balloon can have an expansibility of less than or no more than 10%.

[0144] In some examples, the stress application feature is attached to the outer surface of the expandable structure by at least one of adhesive bonding, ultrasonic welding, fusion welding, thermal welding, fasteners, solvent bonding, bonding with a polymeric material, or combinations thereof. In a preferred example, two or more adhesives are used to bond the plaque disrupting feature, one adhesive bonding better or being more compatible with the material of the expandable structure and the other adhesive bonding better or being more compatible with the material of the feature.

[0145] In some examples, the inflatable balloon has a central surface region, a distal tapered surface region, and a proximal tapered surface region, wherein the stress application feature or features are present on one or more of these surface regions. In some examples, the inflatable balloon has a central surface region, a distal flat region and / or a proximal flat region, one or more radially projecting surface regions, one or more hourglass regions, and / or one or more rectangular regions, wherein the stress application feature or features are present on one or more of these surface regions. Typically, the stress application feature or features are present on at least the central region. More commonly, the stress application feature is present on at least one of the distal flat region and / or the proximal flat region or the tapered region or the shaped radially projecting surface region, and sometimes, the stress application feature is present on at least both the distal tapered region and the proximal tapered region. In some cases, the stress application feature is present on at least the central region, wherein the central region adjacent to the proximal and / or distal taper of the balloon has no stress application feature. In some cases, the stress application feature is present on at least the central region, wherein the central region of the balloon near the proximal and / or distal taper has no stress application feature, and the region having a length in the range of 0.1 mm to 3 mm has no stress application feature.

[0146] In some examples, the device may further include an outer sleeve that has plaque disrupting features on the inner or outer surface of the sleeve, wherein the sleeve advances or retracts over an expandable structure (such as a balloon typically in vivo), and wherein the features of the outer sleeve project radially outward before, after, or after the balloon is inflated to an expanded configuration. When the expandable structure expands, the sleeve aligns with the stress application feature, wherein the elastomeric tubular member is configured to expand and contract with the expansion and contraction of the expandable structure.

[0147] In another example, an elastomeric tubular member can be placed on an expandable structure, such as a balloon that includes plaque disrupting features, where the cannula protects the stress applying features as the device is advanced or retracted within a blood vessel or body cavity in the body. The cannula can be laminated or attached to at least a portion of the outer surface of the expandable structure. For example, the elastomeric tubular member can be attached to an expandable balloon segment, a segment distal to the expandable balloon segment, or a segment proximal to the balloon segment. Alternatively, the outer cannula can include an elastic, non-expandable, or semi-compliant sheath that covers or is folded over the balloon prior to balloon inflation. In most cases, the outer cannula completely covers the clot disrupting features on the outer surface of the expandable structure, which typically includes a polymer. In some examples, the outer cannula includes perforations that are sized to allow at least some of the stress applying features to radially protrude outwardly through the perforations when the expandable structure is expanded. In a preferred example, the perforations permit the contact surface area of the stress applying features to protrude through the perforations.

[0148] The cannula can be formed from a non-compliant polymer, a semi-compliant polymer, and / or a shape memory polymer, where preferably the polymer has a glass transition temperature below body temperature. Such a polymer cannula can be reinforced with an expandable / retractable metal or metal alloy frame (such as shape memory nitinol or superelastic nitinol), supported by an internal metal or metal alloy frame (such as shape memory nitinol or superelastic nitinol), or a combination thereof. If the metal or metal alloy is not self-expanding, these polymer cannulas with reinforcement can be opened by first expanding an internal balloon to an appropriate diameter. Then the balloon is deflated and inserted into the aortic valve. The cannula can be folded or crimped so that it self-expands in vivo at a glass transition temperature above at least 30°C. A polymer cannula with nitinol reinforcement can have any glass transition temperature because the metal or metal alloy reinforcement enables the cannula to expand. Polymer materials include, but are not limited to, high-hardness silicones (such as polydimethylsiloxane, poly(diphenyl)siloxane, poly(methyl-co-phenyl)siloxane, poly(methyltrifluoropropyl)siloxane, poly(methyl-co-methyltrifluoropropyl)siloxane, etc.), polyethylene, polypropylene, polyamide, nylon elastomer (Pebax), polyurethane and its copolymers (such as polycarbonate polyurethane (bionate), linear hydroxyl polyurethane (desmocoll), thermoplastic polyurethane elastomer (Texalan), ultra-soft thermoplastic polyurethane (Neusoft), thermoplastic polyurethane (tecoflex), thermoplastic polyurethane (pellathane), thermoplastic polyurethane (chronoflex), thermoplastic elastomer (chronoprene), thermoplastic polyurethane (chronothane), thermoplastic silicone (chronosil), polymer blends, etc.), polyethylene-vinyl acetate, polyvinylidene fluoride, polyvinylidene fluoride-co-hexafluoropropylene, polybutyl methacrylate, poly(styrene-butadiene-styrene), etc.

[0149] For example, at least some of the stress application or stress application features can be attached to the inner surface of an elastomeric tubular member or an expandable balloon. In certain cases, at least some of the stress application features can be formed as protrusions protruding from the inner surface of the elastomeric tubular member, and when the expandable structure advances or retracts within the tubular member and / or when the expandable structure expands within the elastomeric tubular member, or when the balloon inflates, at least some of the stress application features are pushed to protrude radially outward on the elastomeric tubular member or the balloon.

[0150] In some examples, the device may further include an outer sleeve or balloon member having radially outwardly facing protrusions formed of the same material as the sleeve or balloon, where the feature is hollow at its base or includes a hole at its base, and where the feature covers, encapsulates, or sits on the outer surface of the protrusion of the sleeve or balloon. The protrusions provide a larger surface area for attachment to the feature. Typically, the configuration of the protrusions may mate within or with the interior of the feature, with the degree of mating ranging from loose to tight. The height of the protrusions is in the range of 10% to 100% of the height of the feature.

[0151] In some examples, the device may further include an outer sleeve or balloon member having radially inwardly facing protrusions, indentations, or notches formed of the same material as the sleeve or balloon, where the feature will sit within the outer surface of the notch of the sleeve or balloon, and where the notch partially covers the surface of the feature, covering from 10% to 60% or more of the surface of the feature. The notch provides a larger surface area for attachment to the feature to secure the feature when the sleeve or balloon is advanced and / or retracted within the patient, or when the sleeve and / or balloon is expanded to disrupt atherosclerotic plaque. Typically, the notch has a configuration that will partially contain the feature. In some examples, the feature fits snugly within the notch. In other examples, the feature fits tightly within the notch. In yet other examples, the feature or the base of the feature stretches the notch. In still another example, the shape or configuration of the notch conforms to the contour of the shape of the feature or the base of the feature. In the notch, typically, the notch is joined or attached to the feature by a press fit and / or one or more adhesive materials that cover the surface of the notch and / or the surface of the feature and / or the surface of the base of the feature.

[0152] In another aspect, a device for treating atherosclerotic lesions and / or calcified lesions on the walls in a body cavity of a patient according to the present invention includes a catheter having a catheter body with a proximal end and a distal segment. An expandable structure (typically an inflatable balloon, more typically a non-inflatable balloon used in angioplasty procedures and valvuloplasty procedures) is disposed on or near the distal segment of the catheter body and has an outer surface configured to radially outwardly displace toward the inner surface of the body cavity wall and / or configured to radially displace and axially displace, and / or configured to axially displace. One or more (typically a plurality) of notches (such as cavities, grooves, recesses, holes, pockets, slots, or other concave surfaces) are distributed on at least a portion of the outer surface of the expandable structure, and at least one (more typically at least some) of the notches in each notch receives (typically holds and secures) a plurality of stress applying features.

[0153] In some cases, when the expandable structure expands, the distribution density of the stress applying features on at least a portion of the outer surface of the expandable structure ranges from 0.001 feature / mm 2 to 5 features / mm 2 and often ranges from 0.1 feature / mm 2 to 5 features / mm 2 and preferably ranges from 0.2 feature / mm 2 to 4 features / mm 2 and more preferably ranges from 0.25 feature / mm 2 to 3 features / mm 2 and within this range.

[0154] In some cases, at least some of the stress applying features have a convex rounded top that protrudes above the outer surface, and the convex rounded top is configured to rupture calcified deposits while minimizing damage to the body cavity when the expandable structure expands within the body cavity.

[0155] In some cases, the convex rounded top of the stress applying feature has a radial height above the outer surface of the expandable structure, and the radial height ranges from the minimum value of 0.05mm, 0.1mm, 0.15mm, 0.2mm, 0.25mm, 0.5mm and 0.75mm to the maximum value of 1mm, 0.5mm, 0.4mm, 0.3mm or 0.25mm.

[0156] In some cases, at least some of the stress applying features have an upper surface flush with the outer surface, and optionally, at least some of the stress applying features are fixed by adhesion, press fit, encapsulation, ultrasonic welding and / or a combination thereof.

[0157] In some cases, at least some of the stress applying features have an upper surface that is recessed below the outer surface of the expandable structure.

[0158] In some cases, at least a portion of the outer surface of the expandable structure and the stress applying features do not have any covering structure.

[0159] In some cases, an encapsulation layer covers at least a portion of the outer surface of the expandable structure and the stress applying features to fix the stress applying features on the outer surface of the expandable structure in a desired pattern.

[0160] In some cases, the average width and / or depth of the notch ranges from 0.05mm to 1mm, preferably from 0.1mm to 0.5mm, and more preferably from 0.1mm to 0.25mm.

[0161] In some cases, at least some of the notches in the balloon wall are configured to inhibit dimensional change when the balloon is inflated. For example, at least some of the notches in the balloon wall can be configured to inhibit dimensional change when the balloon is inflated to its nominal diameter. Alternatively, at least some of the notches in the balloon wall can be configured to inhibit dimensional change when the balloon is inflated to its maximum rated diameter.

[0162] In some cases, at least some of the notches in the balloon wall are reinforced.

[0163] In some cases, at least some of the notches in the balloon wall are configured to constrict the neck of the notch when the balloon is inflated to its nominal diameter. For example, at least some of the notches in the balloon wall are configured to constrict the neck of the notch when the balloon is inflated. Alternatively, at least some of the notches in the balloon wall can be configured to constrict the neck of the notch when the balloon is inflated to its maximum rated diameter.

[0164] In some cases, the notches are staggered or patterned along the length and / or circumference of the balloon.

[0165] In some cases, the balloon has one or more of a cylindrical surface, a conical surface, and an opposing surface, and the stress-applying feature is provided on one, some, or all of these surfaces.

[0166] In some cases, the stress-applying feature is harder than the outer surface of the expandable structure.

[0167] In some cases, the stress-applying feature includes at least one of a metallic material, a polymeric material, or a ceramic material.

[0168] In some cases, the stress-applying feature can be atraumatic, atraumatic and coated, non-sharp, blunt, smooth, atraumatic or other coatings, encapsulations, or other housings.

[0169] In some cases, the stress-applying feature can be roughened by sandblasting or other means to enhance rupture or enhance adhesion or enhance encapsulation of the material.

[0170] In some cases, the stress-applying feature includes a magnet or a magnetizable material.

[0171] In some cases, the stress-applying feature includes one or more of a sphere, a hemisphere, a portion of a sphere, a disk, a cylinder, and a cone.

[0172] In some cases, the stress-applying feature has a base and a crown, wherein the base of at least some of the stress-applying features is disposed in at least some of a plurality of preformed notches.

[0173] In some cases, at least some of the stress-applying features include a core material encapsulated in a hardened material.

[0174] In some cases, at least part of the base of at least some of the stress-applying features is encapsulated in a hardened material.

[0175] In some cases, at least part of the crown of at least some of the stress-applying features is encapsulated in a hardened material. For example, at least part of each of the base and the crown of at least some of the stress-applying features is encapsulated in a hardened material. In other examples, the entire outer surface of at least some of the stress-applying features is encapsulated in a hardened material. Typically, the core material includes at least one of a polymeric material, a metallic material, and a ceramic material, and the hardened material includes at least one of a polymeric material, a metallic material, and a ceramic material having a hardness greater than the hardness of the core material.

[0176] In some cases, the stress-applying features are partially or fully distributed on the surface of at least one part of an expandable balloon, the at least one part being selected from a group of parts including a central cylindrical part, a central depression, a central waist part, a flat end part, a tapered end part, and a conical end part.

[0177] In some cases, there are no stress-applying features distributed on at least one surface of at least one part of the expandable balloon, the at least one part being selected from a group of parts including a central cylindrical part, a central depression, a central waist part, a flat end part, a tapered end part, and a conical end part.

[0178] In some cases, the expandable balloon includes a segmented balloon structure disposed at the distal end of a catheter body, the segmented balloon structure having opposing inner walls configured to expand against opposing surfaces of the valve leaflets of a calcified valve to disrupt calcified deposits on the calcified valve.

[0179] After the expandable structure is fully expanded to its maximum expanded configuration, each stress-applying feature can be held and fixed by at least some of the respective notches, or otherwise received in at least some of the respective notches.

[0180] After the expandable structure is at least partially expanded to an expanded configuration, each stress-applying feature can be held and fixed by the respective notch, or otherwise received in the respective notch.

[0181] After the expandable structure has been expanded to its expanded configuration, each stress-applying feature can be cradled and held, or otherwise received, in each notch, or at the location where such a notch was previously located, and each stress-applying feature can be secured or attached to the outer surface of the expandable structure by adhesive bonding, fusing, or other attachment means.

[0182] Although, as previously described, one or both of the opposing inner wall surfaces of the valvuloplasty balloon or other inflatable or expandable segmented structure of the present invention will typically include stress-applying features, in some cases, one or both of the opposing inner wall surfaces may not have stress-applying features. In such cases, even in the absence of stress-applying features, capturing and optionally squeezing the calcified leaflets between the opposing surfaces will be sufficient to rupture the calcified deposits on the valve leaflets.

[0183] In some cases, the valvuloplasty catheter can include a non-expandable segmented structure disposed at the distal end of the catheter body. Typically, such a non-expandable segmented structure will have opposing inner walls that are configured to converge on the opposing surfaces of the valve leaflets of the calcified valve to disrupt the calcified deposits on the calcified valve. The segmented structure can include a solid body, a rigid hollow shell, etc. Although, for an expandable structure, either of the two opposing inner wall surfaces can include stress-applying features as described above, in some cases, one or both of the opposing surfaces will not have stress-applying features. These segmented, non-expandable structures can be formed from polymeric materials, metallic materials, ceramic materials, or other materials or combinations thereof.

[0184] In yet another aspect, an apparatus for treating calcified deposits on a wall in a body cavity of a patient according to the present invention includes a catheter that includes a catheter body having a proximal end and a distal segment. An expandable structure is disposed at the distal segment of the catheter body, the expandable structure having an outer surface that is configured to radially outwardly displace toward the inner surface of the body cavity wall. A plurality of stress-applying features are distributed on the outer surface of the expandable structure, and an energy source within the interior of the expandable structure is configured to deliver energy to or through the plaque disrupting features to enhance the plaque disrupting effect.

[0185] The stress application features of the present invention can be combined with or integrated into the balloon structures of known "lithotripsy" catheters that induce cavitation effects, such as the balloon structures described in PCT Publication Nos. WO2013 / 070750, WO2015 / 017499, WO2018 / 194752, WO2021 / 061451, WO2020 / 256949, WO2021 / 18367, and WO2022 / 216488, the entire disclosures of which are incorporated herein by reference. In particular, the surface of the outer balloon or other expandable member of such a lithotripsy catheter can incorporate any of the stress application features described herein, where the features will enhance the calcified lesion disruption performance of the catheter.

[0186] In yet another aspect, an apparatus for treating atherosclerotic plaque or calcified lesions on the wall in a body cavity of a patient according to the present invention includes a catheter that includes a catheter body having a proximal end and a distal segment. An expandable structure is disposed at the distal segment of the catheter and has an outer surface that is configured to radially outwardly displace toward the inner surface of the body cavity wall and / or is configured to axially displace. One or more stress application features are distributed on the outer surface of the expandable structure, where at least some of the stress application features are harder than the outer surface of the expandable structure.

[0187] In some cases, the stress application features include at least one of a metallic material, a polymeric material, or a ceramic material.

[0188] In some cases, the stress application features are atraumatic, coated, non-sharp, or blunt.

[0189] In some cases, all or part of the stress application features can be roughened by sandblasting or other means to enhance rupture or enhance adhesion or enhance encapsulation of the material.

[0190] In some cases, the stress application features can include magnets or magnetizable materials.

[0191] In some cases, the stress application features can include spheres, hemispheres, portions of spheres, disks, cylinders, and cones.

[0192] In some cases, the stress application features can include a core covered by a hardened shell.

[0193] After the expandable structure is fully expanded to its maximum expanded configuration, the individual stress application features or groups of stress application features can be mounted and typically fixed on protrusions that are molded or otherwise formed into the outer surface of the balloon.

[0194] After the expandable structure has been expanded at least partially to an expanded configuration, individual stress-applying features or groups of stress-applying features can be installed and typically secured on protrusions that are molded or otherwise formed into the outer surface of the balloon.

[0195] After the expandable structure has been expanded to an expanded configuration, individual stress-applying features or groups of stress-applying features can be installed on the outer surface of the expandable structure (e.g., secured on protrusions), molded on the outer surface of the expandable structure, or otherwise secured or attached to the outer surface of the expandable structure, or otherwise formed into the outer surface of the balloon, by adhesive bonding, fusing, or other attachment means.

[0196] In an additional aspect, an apparatus for treating calcified deposits on the walls in a patient's body cavity according to the present invention includes a catheter that includes a catheter body having a proximal end and a distal segment. The balloon has a plurality of preformed notches formed on at least a portion of its outer surface. The balloon is attached to or attached to the distal segment of the catheter body, and bases of a plurality of stress-applying features are disposed in at least some of the plurality of preformed notches, and when the balloon is at least partially expanded or fully expanded, crowns of at least some of the stress-applying features are exposed above, on, or below the outer surface of the balloon.

[0197] In some cases, at least some of the stress-applying features include a core material encapsulated in a hardened material.

[0198] In some cases, at least a portion of the base of at least some of the stress-applying features is encapsulated in a hardened material.

[0199] In some cases, at least a portion of the crown of at least some of the stress-applying features is encapsulated in a hardened material.

[0200] In some cases, at least a portion of each of the base and the crown of at least some of the stress-applying features is encapsulated in a hardened material.

[0201] In some cases, the entire outer surface of at least some of the stress-applying features is encapsulated in a hardened material.

[0202] In some cases, the core material includes at least one of a polymeric material and a ceramic material, and the hardened material includes at least one of a metallic material, a polymeric material, and a ceramic material having a hardness greater than the hardness of the core material.

[0203] In some examples, at least some of the stress application features may have a base attached to the outer surface of the expandable structure, the base having a width (Wa) in the axial direction and a width (Wc) in the circumferential direction, where the width ratio Wa:Wc ranges from 1:0.5 to 1:5, typically in the range of 1:1 to 1:5, and more commonly in the range of 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 examples, Wa:Wc ranges from 3:1 to 1:3, typically in the range of 2:1 to 1:2, and more commonly in the range of 1.5:1 to 1:1.5, and most commonly is about 1:1. In some examples, the base is an integral part of the stress application feature and is attached to the surface of the expandable structure. In other examples, the base is a separate part from the plaque disruption feature and is attached to the plaque disruption feature as well as to the surface of the expandable structure.

[0204] In some examples, at least some of the stress application features may be arranged as diametrically opposed pairs of stress application features. For example, successive, diametrically opposed pairs of stress application features may be circumferentially offset. For example, successive, diametrically opposed pairs of stress application features may be circumferentially offset by an angle of 45° to 90°.

[0205] In some examples, at least some of the stress application features may have a base attached to the outer surface of the expandable structure, wherein the bases of each feature in a group of features around the perimeter of the expandable structure in the expanded configuration do not overlap each other. In other examples, the base of each of the features does not overlap the base of other features located along a certain axial length of the expandable structure or along the length of the axial length of the expandable structure. In yet another example, when the expandable structure expands, the base of each feature does not overlap the base of another feature along the perimeter of the expandable structure, and when the structure expands, the base of each feature does not overlap the axially adjacent feature along the axial length of the expandable structure.

[0206] In some examples, at least some of the stress application features may be arranged as triplets of stress application features that are circumferentially spaced apart by about 120° around a circle on the surface of the expandable structure.

[0207] In some examples, at least some of the stress application features may be arranged as pairs of stress application features that are circumferentially spaced apart by about 180° around a circle on the surface of the expandable structure.

[0208] In some examples, at least some of the stress applying features can be arranged in groups of four stress applying features that are circumferentially spaced apart by about 90° around a circle on the surface of the expandable structure.

[0209] In some examples, at least some of the stress applying features can be arranged in groups of two to four stress applying features, with each group of stress applying features being circumferentially spaced apart by about 90° to 180° around a circle on the surface of the expandable structure, wherein when the structure is in the expanded configuration, each group of stress applying features forms a helical pattern along the length of the expandable structure.

[0210] In some examples, at least some of the stress applying features can be arranged in groups of three to ten features per group, with each group of stress applying features being circumferentially spaced apart by about 36° to 120° around a circle on the surface of the expandable structure, wherein the coverage area or base of each feature around the circle overlaps with the coverage area or base of no more than one other feature along the circle.

[0211] In some examples, at least some of the stress applying features can be arranged in groups of three to ten features per group, with each group of stress applying features being circumferentially spaced apart by about 36° to 120° around a circle on the surface of the expandable structure, wherein the coverage area or base of each feature around the circle overlaps with the coverage area or base of no more than two other features along the circle, and wherein when the structure expands, each feature around the circle overlaps with no more than one to five other features along the axial length path of the expandable structure (preferably along the entire length of the expandable structure).

[0212] In some examples, at least some of the stress applying features can be arranged in groups of three to ten features per group, with each group of stress applying features being circumferentially spaced apart by about 36° to 120° around a circle on the surface of the expandable structure, wherein the coverage area or base of each feature from each group around the circle does not overlap with the coverage area or base of other features from the same group along the circle, and wherein when the structure expands, each feature around the circle also does not overlap with other features from other groups along the axial length path of the expandable structure (preferably along the entire length of the expandable structure).

[0213] In some examples, at least some of the stress application features may be arranged in groups of 3 to 10 features per group, with each group of stress application features circumferentially spaced about 36° to 120° around a circle on the surface of the expandable structure, wherein when the underlying structure is fully expanded, the coverage area or base of each feature from each group around the circle has a gap between the coverage area or base of the feature and the coverage area or base of other features in the same group, the gap ranging from 0.05 mm to 2.5 mm, preferably from 0.1 mm to 1.5 mm. In a preferred example, the gap between any two features in the same group is measured along the axial length between the coverage area or base circles of the two features.

[0214] In some examples, at least some of the stress application features may be arranged in groups of 3 to 10 features per group, with each group of stress application features circumferentially randomly spaced about 10° to 180° around a circle on the surface of the expandable structure.

[0215] In some examples, when the structure is in the expanded configuration, the stress application features may be arranged in a helical pattern along the length of the expandable structure (preferably along the entire length of the expandable structure). In some cases, the helical pattern of at least some of the stress application features completes one to five 360° turns along the length or along the entire length of the expandable structure. In some examples, the plaque disruption features or feature bases do not overlap on the circumference and / or axial length of the expandable structure.

[0216] In some examples, when the structure is in the expanded configuration, the stress application features may be arranged in a linear pattern along the length of the expandable structure (preferably along the entire length of the expandable structure).

[0217] In some examples, the stress application features may be arranged in a region of the expandable structure. For example, the plaque disruption features may be arranged in an intermediate region (such as a cylindrical working length or other working length structure) of the expandable structure (such as an inflatable balloon).

[0218] In other examples, the inflatable balloon coupled to the plaque disruption features may be arranged to prevent the outer surface of the expandable structure (such as the outer balloon surface) from contacting the hardened plaque or tissue, or to keep the outer surface of the balloon from contacting the hardened plaque until a minimum threshold pressure is reached, where the minimum threshold pressure may be any of the following nominal or rated balloon inflation pressures: 3 atm, 5 atm, 7 atm, 10 atm, 12 atm, 15 atm, etc.

[0219] In other examples of the present invention, expandable structures (such as inflatable balloons) can also be configured to deliver drugs and other agents. For example, an inflatable balloon can be configured to release an inflation medium comprising an agent in response to an inflation pressure above a minimum threshold (e.g., where the minimum threshold is above 1 atm, 3 atm, 5 atm, or 7 atm). In certain cases, the inflatable balloon can include a plurality of ports or perforations within the balloon material surface adjacent to at least some features, which open in response to an inflation pressure above the minimum threshold pressure. In other examples, the inflatable balloon can have a separate distal catheter formed from an elongate tubular body that extends proximally from the distal catheter outside the patient to infuse an agent when the balloon is in an expanded configuration. In yet another example, an agent is coated onto one or more of the surfaces of the stress-applying features, more particularly, onto the engagement surface area or contact surface area of the stress-applying features, to provide the agent to the tissue when the feature contacts vascular tissue or valve annulus tissue or leaflet tissue. In one example, the agent is directly coated or sprayed onto at least the contact area surface of at least some of the features. In other examples, the agent is mixed with a polymeric material and then the mixture is coated or sprayed onto at least the contact area of the stress-applying features. In yet another example, the agent is sprayed or coated onto the outer surface of an expandable structure (such as a balloon and / or stress-inducing feature). In yet another example, the expandable structure includes expandable balloon segments, where the balloon segments are covered by an outer sleeve comprising an elastomeric member, and where the balloon and / or the elastomeric member includes at least some stress-applying features that are attached to the outer surface of the balloon, the outer surface of the elastomeric member, and / or attached to the inner surface of the elastomeric member, where the outer surface of the elastomeric member is coated with an agent comprising one or more drugs. When the balloon expands to embed at least a portion of its drug content into adjacent tissue, the drug covering at least some of the features embeds into the vessel wall, body cavity, or valve annulus. In a preferred example, the agent includes one or more of an anti-proliferative drug, an m-tor inhibitor drug, a paclitaxel or analogue drug, a direct thrombin inhibitor drug, and a factor Xa inhibitor drug. In yet another example, the agent is located in the space between the outer surface of the balloon segment and the inner surface of the elastomeric segment, and when the balloon expands to release the agent into the vessel wall, body cavity, or valve annulus, the agent is allowed to penetrate the elastomeric member through openings or perforations in the elastomeric member.

[0220] In certain examples, the expandable structure includes a balloon having an outer surface. Typically, the outer surface includes a plurality of stress applying features as described elsewhere herein. The outer surface of the balloon and / or the stress applying features are coated with a formulation of one or more drugs, the formulation of one or more drugs including an anti-proliferative agent, an anticoagulant, and an antiplatelet agent. Examples of anticoagulants include direct factor Xa inhibitors, direct factor IIa inhibitors, and the like. Examples of anti-proliferative agents include rapamycin, analogs and derivatives of rapamycin, paclitaxel, analogs and derivatives of paclitaxel. The formulation of one or more drugs may further include or comprise one or more excipients, one or more plasticizers, one or more contrast agents (such as iopromide), one or more polymeric materials (such as PLLA or PLGA or PCL), tributyl acetyl citrate, one or more cationic surfactants (such as urea, polyethyleneimine), tri-n-hexyl butyryl citrate, UV curable materials (such as PVP hydrogel), nonionic surfactants (such as polysorbate / sorbitol), amphiphilic polymers (such as PEG), encapsulated drugs (such as encapsulated nanoparticle drugs), micelle encapsulated drugs, and phospholipid encapsulated drugs, PLGA microspheres, and combinations thereof.

[0221] In yet other aspects, the present invention provides a method for treating calcified deposits on the wall in a body cavity of a patient, wherein the method comprises: positioning an expandable structure at a treatment site near the calcified deposit to be treated, and radially expanding the expandable structure outwardly to radially press a plurality of stress applying features against the calcified deposit. The stress applying features are distributed on the outer surface of the expandable structure, and at least some of the stress applying features are independently attached to the outer surface of the expandable structure and have a convex rounded upper surface, and wherein radially pressing the plurality of stress applying features against the calcified deposit causes the calcified deposit to rupture while reducing damage to the wall.

[0222] In yet other aspects, the present invention provides a method for treating calcified deposits on a valve of a patient having calcified leaflets, wherein the method comprises: positioning an expandable structure at a treatment site near the calcified deposit to be treated (such as within or through the calcified leaflets), and radially expanding the expandable structure outwardly such that the stress applying features press against the wall of the valve annulus to press the calcified leaflets, thereby causing the calcified leaflets to rupture. The stress applying features are distributed on the outer surface of the expandable structure, and at least some of the stress applying features are independently attached to the outer surface of the expandable structure and have a convex rounded upper surface.

[0223] In another aspect of the present invention, a device for treating a patient's valve with 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 expand on opposing surfaces of the calcified leaflets in a manner that disrupts calcification sites on the calcified valve leaflets. In one example, when the balloon expands, the inner wall (or axially facing wall) of the segmented balloon is flat or axially outwardly protruding to press against the surface of the calcified leaflet from the opposite side, thereby disrupting the calcification sites on the calcified valve. In another example, at least one of the inner walls of the segmented balloon includes one or more stress application features coupled to the side walls and configured to engage the calcified valve leaflets upon balloon expansion to disrupt the calcification sites, wherein the features press the calcification sites against the opposing inner walls of the segmented balloon. In another example, the inner wall of the segmented balloon includes one or more stress application features coupled to the wall and configured to engage the calcified valve leaflets from the opposite side upon balloon expansion to disrupt the calcification sites. In another example, the number of stress application features ranges from 0.1 feature per square millimeter of inner wall surface to 100 features per square millimeter, preferably, in the range of 0.1 feature / mm 2 to 30 features / mm 2 and more preferably, in the range of 1 feature / mm 2 to 20 features / mm 2 In another example, the stress application features can be arranged on the side surface of the expandable structure in various configurations such as a circular pattern, a concentric circles pattern, a spiral pattern, a pattern that conforms to or matches the contour of the valve leaflets, or other patterns. In another example, at least some of the stress application features on one side of the inner wall of the segmented balloon are configured (or arranged) to be opposite other stress application features on the opposing inner wall. In another example, at least some of the stress application features have a blunt contact area on one side of the inner wall of the segmented balloon and are configured (or arranged) to be opposite the blunt contact areas of other stress application features on the opposing inner wall upon balloon expansion, thereby disrupting the calcification sites between the opposing blunt contact areas. In another example, the contact area of at least some of the stress application features is configured to have a convex shape on one side of the inner wall of the segmented balloon and is configured (or arranged) to be opposite the contact area of other stress application features on the opposing inner wall, the contact area of the stress application features on the opposing inner wall being configured to have a concave shape to fit into the opposing convex features upon balloon expansion, thereby disrupting the calcification sites between the opposing blunt contact areas.

[0224] In yet another example, when the balloon is inflated, at least some of the features on one side of the inner wall are configured to indent or at least partially indent into the space between two, three, four, or more features on the opposing inner sidewall of the segmented balloon, thereby disrupting calcified deposits in the valve leaflets. In another example, the sidewall and / or inner wall may be covered by an elastomeric member covering at least some of the features, and optionally, the elastomeric member is attached to the balloon segment or other segment of the balloon catheter and is configured to expand upon balloon dilation.

[0225] In another example, when the balloon is inflated (or fully inflated), the inner sidewall and / or the elastomeric member are configured to expand radially and / or axially to press against the calcified valve leaflets and disrupt the calcified deposits in the leaflets. In an alternative example, the segments of the balloon structure are slidably attached to or mounted on the shaft of the catheter and are configured to bring the inner sidewalls together after inflation. Optionally, the segments of the balloon structure are configured to nest with each other when the balloon structure expands. Typically, the segments of the balloon structure have conical surfaces that nest with each other.

[0226] In yet some other examples, the opposing inner walls may include flat surfaces that are configured to close against each other when the balloon structure is inflated and / or expanded. For example, the segmented balloon structure may include a pair of opposing conical balloons that have flat bottoms that include flat surfaces.

[0227] In some examples, when the balloon segments come together, the calcification disruption features on the opposing inner wall surfaces are axially aligned, which exerts a force on the opposing surfaces of the valve leaflets. In other cases, the calcification disruption features on the opposing surfaces are laterally offset such that they are not axially aligned when the balloon segments come together. In yet other cases, the calcification disruption features may be on only one of the two opposing inner wall surfaces.

[0228] In yet another example, at least one region of the sidewall of the inner segmented balloon and / or at least one region of the covering of the elastomeric member and / or at least some of the features are coated with one or more coatings that include a polymeric material, an adhesive material, an anti-proliferative agent, a factor Xa inhibitor, and a factor IIa inhibitor, where the coating material is configured to deliver a drug, fix fragments of the disrupted calcified deposits to the leaflets or the inner wall of the segmented balloon, or repair perforated leaflets. In another example, 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 perforations in the leaflet surface, or hold the leaflets together.

[0229] In another example, at least some of the features on opposite sides of the inner wall of the segmented balloon (such as concave contact surface areas and convex contact surface areas, spherical contact surface areas and slot contact surface areas, etc.) mate with each other. In some examples, calcification disruption features on an expandable structure (such as an expandable balloon) may be disposed on one or more of the surfaces of the expandable structure, the surfaces of the expandable structure including side surfaces, inner surfaces, or axially oriented surfaces. In some examples, an expandable structure such as an expandable balloon includes one or more shapes, including tubular shapes, annular shapes, hourglass shapes, conical shapes, rectangular shapes, square shapes, and the like. In yet another example, the axially oriented regions of the expandable structure may have various shapes, including one or more of flat, convex, concave, annular, and the like.

[0230] In another example of the present invention, a device for treating a patient's valve having calcified leaflets includes a catheter body having at least two expandable structures, where in one example, the at least two expandable structures are configured to expand together, such as a dual balloon configuration, where the dual balloons share the same inflation lumen and the same guidewire lumen. In another example, the at least two expandable structures are configured to expand independently, such as at least two balloon structures having separate inflation lumens, and the at least two balloon structures having the same or separate guidewire lumens. In a preferred example, the dual expandable structures are axially movable on a common axial tubular structure.

[0231] In certain cases, the valve calcification treatment device further includes a plurality of calcification disruption features distributed on at least one of the opposing inner walls of the segmented balloon structure, preferably on both of the opposing inner walls (and / or axially oriented walls). The calcification disruption features may include any of the stress-applying features and calcification disruption features described in this application, typically including circular features, including those hemispherical features, spherical features, and globular features described herein.

[0232] Preferred disruption features typically have a convex rounded leaflet engagement surface configured to rupture calcified deposits while minimizing damage to the leaflets when the balloon structure is expanded within a patient's valve. Typically, the convex upper surface of the stress application feature will be configured to extend from the opposing inner walls so as to engage the leaflet when the leaflet is captured between the walls. When the balloon is fully inflated, the rounded surface of the feature engaging the leaflet will typically have a height or width in the range of 0.01 mm to 3 mm, 0.1 mm to 3 mm, and typically 0.5 mm to 2 mm. Most commonly, the convex upper surface of the calcified deposit disruption feature will not have edges and irregularities that could damage the leaflets when the balloon structure is inflated within the patient's valve.

[0233] However, in some cases, the calcified deposit disruption feature may be provided with sharp elements protruding outwardly from the convex upper surface, where the sharp elements are configured to concentrate stress when the balloon surface bears against the surface of the valve leaflet during engagement with a calcified deposit on the valve leaflet. The sharp features will have a very small height or depth such that they will engage and disrupt the calcified deposit while substantially avoiding any damage to the valve leaflets. Each balloon segment may be fixed to the catheter body such that when the balloon structure is inflated, each balloon segment engages and captures the leaflet without any further manipulation. However, in other cases, the balloon segments may be configured to axially translate relative to each other on the catheter body to provide a variable spacing between the inner walls. In such cases, a first segment of the segments may be inflated and engaged on the valve leaflet, and a second segment is inflated and then pulled towards the opposing surface of the valve leaflet in order to effect disruption.

[0234] In yet another aspect, the present invention provides a method for disrupting a calcified deposit or plaque at a lesion, the method comprising: advancing a cannula over a guidewire and through the lesion, advancing an expandable member over the guidewire and into the interior of the cannula, and expanding the expandable member within the cannula to cause a feature to radially outwardly displace against the lesion both internally and externally of the cannula, thereby disrupting the calcified deposit or plaque.

[0235] In some examples, the method further comprises removing the expandable member from the cannula and removing the expandable member and the cannula from the guidewire, where the expandable structure may include any one of a balloon or other expandable member or a cardiac stent, and where after the cardiac stent is expanded, the cannula remains in place between the cardiac stent and the lesion. When the expandable structure causes the stress application feature to radially outwardly displace during expansion, the stress application feature may radially outwardly protrude from the cannula into the vessel wall.

[0236] In yet another aspect, the present invention provides a method for disrupting calcified deposits or plaques at a lesion site, the method comprising: advancing a cage structure or a basket structure over a guide wire and past the lesion site, and expanding the cage structure or the basket structure such that stress applying features are radially displaced on the cage structure or the basket structure against the lesion site, thereby disrupting the calcified deposits or plaques.

[0237] In some examples, expanding the cage structure or the basket structure includes mechanically reorienting structural components of the cage structure or the basket structure. In other examples, expanding the cage structure or the basket structure includes inflating a balloon within the cage structure or the basket structure, wherein the balloon may be advanced with the cage structure or the basket structure to the lesion site, or advanced together behind the cage structure or the basket structure to the lesion site.

[0238] In yet another aspect of the present invention, an apparatus for treating calcified deposits on a wall in a body cavity of a patient includes a catheter, the catheter including a catheter body having a proximal end and a distal segment. An expandable structure is disposed at the distal segment of the catheter body and has an outer surface configured to be radially displaced outwardly toward an inner surface of the body cavity wall. A plurality of stress applying features are distributed on at least a portion of the outer surface of the expandable structure, wherein at least some of the stress applying features are disposed on the outer surface of the expandable structure and have convex rounded tops configured to rupture the calcified deposits while minimizing damage to the body cavity when the expandable structure expands within the body cavity.

[0239] In certain instances, the convex rounded tops of at least some of the stress applying features have a radial height above the outer surface of the expandable structure that ranges from 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 when the expandable structure expands, the distribution density of the stress applying features ranges from 0.1 feature / mm 2 to 5 features / mm 2 , preferably from 0.2 feature / mm 2 to 4 features / mm 2 , more preferably from 0.25 feature / mm 2 to 3 features / mm 2 .

[0240] In yet some other specific instances, the stress applying features may have a coverage area, the maximum width, diameter, or other lateral dimension of which is 4 mm or less, often 3 mm or less, more commonly not exceeding 1 mm, and generally not exceeding 0.75 mm, and sometimes not exceeding 0.5 mm.

[0241] The stress - applying feature may have any one of the following features or a combination of the following features: The stress - applying feature includes, for example, any one or more of spherical balls, spheres, hemispheres, partial spheres, domes, and ellipsoidal geometries; The stress - applying feature is solid, hollow, coated, uncoated, has a textured surface, or has a smooth surface; The stress - applying feature may be a discrete body; The stress - applying feature may include a metal, a polymer, or a combination thereof.

[0242] In a preferred aspect, the encapsulation layer may cover part or all of the outer surface of the expandable structure and / or the stress - applying feature to fix the stress - applying feature on the outer surface of the expandable structure in a desired pattern.

[0243] In a specific example, the stress - applying feature may be fixed only by the encapsulation layer, or in addition to the encapsulation layer, it may also be fixed by an adhesive between the feature and the outer surface. The encapsulation layer may encapsulate the entire stress - applying feature including the convex - rounded top, or the encapsulation layer may only encapsulate the lower part of the stress - applying feature that does not include the convex - rounded top.

[0244] In a preferred example, the stress - applying feature may be held by a notch, cavity, groove, socket, or other recess in the outer surface of the expandable structure. This way of holding helps to fix and stabilize the stress - applying feature during introduction and use.

[0245] The encapsulation layer may include one or more polymers selected from thermoplastic fluoropolymers (PVDF), butyl methacrylate (PBMA), and thermoplastic polyesters (PLLA), etc.

[0246] The encapsulation layer is applied to the outer surface and the stress - applying feature by any one of coating, direct fluid application, lamination, and fusion.

[0247] The encapsulation layer may have a thickness in the range of 0.01 mm to 0.1 mm (0.5 mil to 5 mil), often in the range of 0.01 mm to 0.05 mm (0.4 mil to 2 mil), and more commonly in the range of 0.01 mm to 0.02 mm (0.4 mil to 0.8 mil).

[0248] The stress - applying feature may be constrained on the outer surface of the expandable structure by an elastic sleeve.

[0249] Typically, the stress - applying feature is attached to the outer surface of the expandable structure, but in some cases, it may be attached to the inner surface of the elastic sleeve. In some cases, the stress - applying feature is hollow and mounted on a cylinder that projects radially outward from the outer surface of the expandable structure.

[0250] In another aspect, a device for treating calcified lesions on the walls in a body cavity of a patient includes a catheter having a catheter body with a proximal end and a distal segment. An expandable structure is disposed at the distal segment of the catheter body and has an outer surface configured to radially outwardly displace towards the inner surface of the body cavity wall. A plurality of stress application features are distributed on the outer surface of the expandable structure, wherein at least some of the stress application features are present on the outer surface of the expandable structure and have an upper surface configured to rupture the calcified lesion while minimizing damage to the body cavity when the expandable structure expands within the body cavity. A encapsulation layer covers at least a portion of the outer surface of the expandable structure and the stress application features to fix the stress application features in a desired pattern on the outer surface of the expandable structure.

[0251] In some cases, at least some of the upper surfaces of the stress application features include convex rounded tops, and the encapsulation layer may cover the entire outer surface of at least some of the stress application features including the upper surface. Alternatively, the encapsulation layer may only cover the lower portion of the outer surface of at least some of the stress application features. Often, the stress application features will be disposed in notches, grooves, sockets or other recesses on the outer surface of the expandable structure. Alternatively, the stress application features may include hemispheres having flat bottoms adhered to the outer surface of the expandable structure.

[0252] In yet another aspect, the present invention provides a method for treating lesions on the walls in a body cavity of a patient, the method comprising providing a catheter having an expandable structure disposed at its distal end, wherein the expandable structure has an outer surface configured to radially outwardly displace towards the inner surface of the body cavity wall, and an outer wall having a plurality of spaced-apart "spacing" features distributed on the outer surface of the expandable structure. The expandable structure is expanded within the body cavity of the patient such that the outer surface and the features apply a radially outward force to the wall while the features maintain a gap between the outer surface of the expandable structure and the inner wall.

[0253] Typically, the spacing features are configured to form and / or maintain one or more gaps by separating the lesion from the outer surface of adjacent features of the expandable structure when the structure is in the expanded configuration. Typically, the spacing features include a plurality of features positioned around the circumferential length and / or axial length of the expandable structure to provide, form or maintain the gap.

[0254] In one case, the spacer feature has axially aligned through-holes that permit the passage of fluids such as contrast agents, blood, and / or pharmaceutical (drug) solutions therethrough. Typically, while the expandable structure is expanding, the gaps allow fluids to pass through them and perfuse through the expandable structure. For example, while the expandable structure is expanding, a drug can be perfused into the gaps. For example, the expandable structure includes a balloon and the drug is perfused through the wall of the balloon. In an alternative case, at least some of the spaced-apart features include a drug released into the gaps.

[0255] In certain cases, expanding the expandable structure creates one or more gaps between the outer surface and the inner wall of the expandable structure under physiological pressure to allow fluid perfusion through the one or more gaps.

[0256] In a preferred case, the spacer feature may include a convex rounded top as described previously with respect to the stress-applying feature and plaque-disrupting feature of the present invention.

[0257] The spacer feature may have a radial height above the outer surface of the expandable structure, with the radial height ranging from 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 when the expandable structure is expanded, the distribution density of the spacer features ranges from 0.1 feature / mm 2 to 5 features / mm 2 , preferably from 0.2 features / mm 2 to 4 features / mm 2 , more preferably from 0.25 features / mm 2 to 3 features / mm 2 .

[0258] In this perfusion method, typically, the expandable structure is expanded with a force sufficient to form and / or maintain one or more gaps against a physiological pressure of 0.5 psi to 5 psi, preferably 1 psi to 3 psi.

[0259] In yet another aspect, the present invention provides a method of securing a stress application feature to the outer surface of a balloon (such as an angioplasty balloon, a valvuloplasty balloon, etc.). The method includes providing a balloon having an outer surface and optionally forming a plurality of notches on at least a portion of the outer surface of the balloon. Optionally, the outer surface of at least the cylindrical working length or other working length of the balloon and / or the side surface of the balloon is coated with an elastomeric polymer base layer. An elastomeric adhesive is dispensed onto the outer surface of the balloon or into the respective notches on the base layer, and the stress application feature is placed onto the elastomeric adhesive dispensed onto the outer surface of the balloon or into the respective notches, causing a portion of the elastomeric adhesive to shift onto the outer surface of the balloon to surround each plaque disruption feature. Optionally, each stress application feature is covered with a dot layer of elastomeric adhesive, wherein the dot layer forms a seal with the elastomeric adhesive that has shifted onto the outer surface of the balloon to surround each plaque disruption feature. Optionally, an elastomeric polymer overcoat is then formed on the outer surface of at least the working length of the balloon and / or the side surface of the balloon. Generally, one or more of the elastomeric polymer, the elastomeric adhesive, the plaque disruption feature, the dot adhesive, and the overcoat are applied, dispensed, or placed after the balloon is expanded to an expanded configuration.

[0260] In some preferred embodiments, at least one of the base layer and the overcoat will be formed as part of the manufacturing method. In other preferred embodiments, both the base layer and the overcoat will be formed as part of the manufacturing method.

[0261] In a particular aspect, coating the outer surface of the balloon with an elastomeric polymer base layer includes: coating the outer surface with a curable elastomeric adhesive and curing the elastomeric adhesive.

[0262] In a particular aspect, the elastomeric adhesive dispensed onto the outer surface of the balloon and / or into the notches includes a photocurable acrylic adhesive.

[0263] In a particular aspect, the dot layer includes a photocurable acrylic adhesive. Generally, the elastomeric adhesive dispensed onto the outer surface of the balloon or into the notches and the dot layer include chemically similar photocurable acrylic adhesives, wherein the two adhesives fuse together upon curing.

[0264] In yet another aspect, the present invention provides a device for treating a patient valve having calcified leaflets, wherein the device includes a catheter body having a proximal end and a distal end and a segmented balloon structure. The segmented balloon structure is disposed at the distal end of the catheter body and has opposing inner walls that are configured to deploy on opposing surfaces of the leaflets to disrupt calcified deposits on the calcified valve. Features on one or both of the opposing inner walls are configured to disrupt calcified plaques on the valve leaflets when the opposing inner walls are deployed.

[0265] In some cases, the opposing inner walls are configured to close together when the balloon structure is expanded. In other cases, the segments are configured to converge after the balloon structure is expanded to capture the calcified valve leaflets between the segments.

[0266] In some cases, the feature includes a plate. In other cases, the feature includes a protrusion and a cavity, the protrusion being on one of the opposing inner walls and the cavity being on the other of the opposing inner walls, wherein the protrusion is configured to fit into the cavity when the opposing surfaces are deployed.

[0267] In yet another aspect, the present invention provides a method for securing a stress application feature to the outer surface of a balloon (such as an angioplasty balloon, a valvuloplasty balloon, etc.). The method includes providing a balloon having an outer surface and optionally forming a plurality of notches on at least a portion of the outer surface of the balloon. An elastic adhesive is dispensed onto the outer surface of the balloon and / or into each of the notches, and the stress application feature is placed onto the elastic adhesive dispensed onto the outer surface of the balloon and / or into each of the notches, causing a portion of the elastic adhesive to shift onto the outer surface of the balloon to surround each plaque disruption feature. Optionally, each stress application feature is covered with a dot layer of elastic adhesive, wherein the dot layer forms a seal with the elastic adhesive that has shifted onto the outer surface of the balloon to surround each plaque disruption feature. Then, an elastic polymer overcoat is formed on the outer surface of at least the working length of the balloon and / or on the side surface of the balloon. Typically, after expanding the balloon to an expanded configuration, one or more of the overcoat, the elastic adhesive, the plaque disruption feature, and the dot adhesive are applied, dispensed, or placed.

[0268] In a particular aspect, coating the outer surface of the balloon with an elastic polymer overcoat includes: coating the outer surface with a curable elastic adhesive and curing the elastic adhesive.

[0269] In a particular aspect, the elastic adhesive dispensed onto the outer surface or into the notches includes a photo-curable acrylic adhesive.

[0270] In a particular aspect, the dot layer includes a photo-curable acrylic adhesive. Typically, the elastic adhesive dispensed onto the outer surface or into the notches and the dot layer include chemically similar photo-curable acrylic adhesives, wherein the two adhesives fuse together upon curing.

[0271] In yet another aspect, the present invention provides a method for preventing rupture of a balloon in a calcified blood vessel, the balloon including an outer surface of a balloon (such as an angioplasty balloon, a valvuloplasty balloon, etc.). The method includes providing a balloon having an outer surface. Coating at least a working length of the outer surface of the balloon and / or a side surface of the balloon with one or more elastomeric polymer base layers, the elastomeric layer preventing rupture of the balloon when the balloon is expanded in a calcified and / or stiffened blood vessel or body cavity. In a particular aspect, coating the outer surface of the balloon with an elastomeric polymer base layer includes: coating the outer surface with a curable elastomeric adhesive and curing the elastomeric adhesive.

[0272] In yet another aspect, the present invention provides an apparatus for treating a patient's valve having calcified leaflets, wherein the apparatus includes a catheter body having a proximal end and a distal end and a segmented expandable or non-expandable structure. The structure is disposed at the distal end of the catheter body and has opposing inner walls configured to deploy or be positioned on opposing surfaces of the leaflets to disrupt calcification sites on the calcified valve upon expansion and / or axial convergence. When the opposing inner walls are deployed and / or axially converged, features on one or both of the opposing inner walls are configured to disrupt calcified plaque on the valve leaflets.

[0273] In some cases, the opposing inner walls are configured to close together upon expansion of the structure. In other cases, the segments are configured to converge to capture the calcified valve leaflets between the segments.

[0274] In yet another aspect, the present invention provides an apparatus for treating a patient's valve having calcified leaflets. The apparatus includes a catheter body having a proximal end and a distal end and a segmented balloon structure disposed at the distal end of the catheter body. The segmented balloon structure has opposing inner walls configured to deploy on opposing surfaces of the leaflets to disrupt calcification sites on the calcified valve. The two balloon segments are initially spaced apart on the catheter body and are configured to deploy such that the opposing inner walls converge upon inflation of the balloon segments to capture the calcified leaflets between the opposing inner walls.

[0275] In yet another aspect of the present invention, the stress application feature may be attached to an inflatable balloon or other expandable structure (such as a cylindrical expandable structure or a conical expandable structure), or the stress application feature may be attached to a non-expandable structure using a "carrier" template. The carrier template may be manufactured by, for example, rolling or otherwise forming a thin cylindrical base layer, which is sized to be placed in its deployed configuration (i.e., for an expandable structure, inflated or otherwise expanded) on the balloon or other cylindrical expandable or non-expandable structure. Typically, the base layer may be formed of a polymeric material (usually an elastic acrylic adhesive material as described elsewhere herein). Alternatively, for non-expandable stress application features, the carrier template may be formed of a non-elastic structure (including metals, ceramics, non-inflatable polymers, etc.). The stress application feature is attached to the outer surface of the carrier template, for example, by applying or dispensing an adhesive at the locations where the stress application feature is to be positioned and pressing the feature into the adhesive at these locations to attach the stress application feature to the outer surface of the carrier template. Then, the carrier template is placed on the outer surface of the structure, and the template is fixed to the outer surface, typically using an adhesive to fix the template to the outer surface, but alternatively by heat welding, ultrasonic fusion, or other conventional techniques to fix the template to the outer surface.

[0276] In another aspect, the present invention provides an apparatus for treating an aortic valve having calcified leaflets extending between the sinotubular junction and the valve annulus. The apparatus includes a cannula deployment catheter having a proximal end, a distal end, and a lumen extending through at least a distal region of the cannula deployment catheter. A leaflet capture cannula is coupled to the distal end of the deployment catheter, and the leaflet capture cannula has a distal edge configured to engage the aortic side (i.e., the side located at the sinotubular junction) of the calcified valve leaflets. The lumen of the cannula deployment catheter is configured to receive a valvuloplasty catheter, and a balloon or other expandable valvuloplasty element on the cannula deployment catheter is configured to expand against the ventricular side of the calcified valve leaflets while the distal edge of the leaflet capture cannula remains engaged with the aortic side of the calcified valve leaflets.

[0277] In certain instances, the distal edge of the leaflet capture cannula may be rounded.

[0278] In certain instances, the distal edge of the leaflet capture cannula may be corrugated.

[0279] In certain instances, the distal edge of the leaflet capture cannula may have a protrusion configured to advance past the sinotubular junction toward the valve annulus between the commissures on the aortic side of the calcified valve leaflets.

[0280] In certain circumstances, the region of the leaflet capture cannula or cannula deployment catheter adjacent the leaflet capture cannula may include an embolization filter configured to permit blood from the aortic valve to flow out of the lumen while intercepting potentially harmful embolization material released upon dilation of the valvuloplasty element.

[0281] In certain circumstances, the filter element may include a mesh structure formed as at least a portion of the leaflet capture cannula.

[0282] In certain circumstances, the filter element may include a fenestrated structure formed in the wall of the catheter.

[0283] In certain circumstances, the filter element may include a mesh structure formed in the wall of the catheter.

[0284] In certain circumstances, the cannula deployment catheter may include a stress application feature formed on at least a portion of the inner surface of the leaflet capture cannula.

[0285] In another aspect, the device of the present invention may include a system that includes any one of the cannula deployment catheters described and claimed herein, and a valvuloplasty catheter having a valvuloplasty element.

[0286] In certain circumstances, the valvuloplasty element includes a balloon structure disposed at the distal end of the catheter.

[0287] In other circumstances, the valvuloplasty element includes a mechanically expandable cage structure disposed at the distal end of the catheter.

[0288] In certain circumstances, the valvuloplasty catheter further includes a stress application feature on the outer surface of the valvuloplasty element.

[0289] In another aspect, the present invention provides a method for treating an aortic valve having calcified leaflets extending between the sinotubular junction and the valve annulus. The distal edge of the leaflet capture cannula is advanced from the aortic arch toward the sinotubular junction to engage the aortic side of at least some of the calcified valve leaflets. The valvuloplasty element is advanced through the lumen of the leaflet capture cannula, and the valvuloplasty element on the valvuloplasty catheter is expanded against the ventricular side of at least some of the calcified valve leaflets while the distal edge of the leaflet capture cannula remains engaged with the aortic side of at least some of the calcified valve leaflets.

[0290] In certain aspects, advancing the distal edge of the leaflet capture cannula includes advancing a deployment catheter having a proximal end, a distal end, and a lumen extending through at least the distal region of the deployment catheter, wherein the leaflet capture cannula is coupled to the distal end of the deployment catheter.

[0291] In certain circumstances, the distal edge can be circular.

[0292] In certain circumstances, the distal edge can be corrugated.

[0293] In certain circumstances, the distal edge can have a protrusion that extends from the aortic arch toward the sinotubular junction as the distal edge of the leaflet capture cannula advances, and that passes through the sinotubular junction and extends between commissures on the aortic side of the calcified valve leaflets to the valve annulus.

[0294] In certain circumstances, the method of the present invention can further include providing an embolization filter on the aortic side of the leaflet capture cannula to permit blood from the aortic valve to flow out of the lumen while intercepting potentially harmful embolization material released upon expansion of the valvuloplasty element.

[0295] In certain circumstances, the filter element can include a reticular structure formed as at least a portion of the leaflet capture cannula.

[0296] In certain circumstances, such a filter can include a fenestrated structure formed in the wall of the catheter.

[0297] In certain circumstances, such a filter can include a reticular structure formed in the wall of the catheter.

[0298] In certain circumstances, the method of the present invention can further include providing stress application features on the inner surface of the leaflet capture cannula.

[0299] In certain circumstances, expanding the valvuloplasty element can include inflating a balloon structure.

[0300] In other circumstances, expanding the valvuloplasty element can include mechanically expanding a cage structure.

[0301] In certain circumstances, the method of the present invention can further include providing stress application features on the outer surface of the valvuloplasty element.

[0302] In another aspect, the present invention provides an apparatus for treating wall calcifications in a body cavity of a patient, the apparatus including a catheter, an expandable structure, and a plurality of needle-like stress application features disposed on at least a portion of the outer surface of the expandable structure, wherein at least a distal portion of at least some of the needle-like stress application features has an atraumatic covering on its distal tip. Typically, the catheter includes a catheter body having a proximal end and a distal segment. The expandable structure is disposed at the distal segment of the catheter body and has an outer surface configured to radially outwardly displace toward the inner surface of the body cavity wall.

[0303] In certain circumstances, the expandable structure includes an inflatable balloon.

[0304] In certain instances, at least some of the needle-like stress application features have sharp distal tips.

[0305] In certain instances, the anti-trauma covering is compressible to expose the sharp distal tips when the covering is pressed against the calcified plaque.

[0306] In another aspect, the present invention provides an apparatus for treating calcified lesions on the wall in a patient's body cavity. The apparatus includes a catheter, an expandable structure, and a plurality of elongated blade-like stress application features. The catheter includes a catheter body having a proximal end and a distal segment, and the expandable structure is disposed at the distal segment of the catheter body. The expandable structure has an outer surface configured to radially outwardly displace towards the inner surface of the body cavity wall, and the plurality of elongated blade-like stress application features are distributed on at least a portion of the outer surface of the expandable structure. At least some of the blade-like stress application features have a compressible anti-trauma covering thereon.

[0307] In certain instances, the expandable structure includes an inflatable balloon.

[0308] In certain instances, the anti-trauma covering covers the entire blade-like stress application feature including the sharp edge before the covering is compressed.

[0309] In other instances, the sharp edge is exposed on the surface of the anti-trauma covering before the covering is compressed.

[0310] The described illustrative aspects, examples, or embodiments are not meant to be limiting. For example, the examples provided for an implantable stent can also be applied to other devices described in this application, such as sheaths, balloons, cage structures, etc., where the implantable stent includes a stent structure having a surface configured to expand within a patient's body.

[0311] In still other aspects of the present invention, an apparatus for treating calcified lesions on the wall in a patient's body cavity includes a catheter, an inflatable polymer balloon, and a plurality of discrete stress application features distributed on at least a portion of the outer surface of the balloon. The catheter body has a proximal end and a distal end, and the inflatable polymer balloon is attached to the distal end of the catheter body. The inflatable polymer balloon has a hardness and an outer surface, and each of the plurality of discrete stress application features has a hardness, a bottom, and a rounded convex upper surface, where the discrete stress application features are distributed on at least a portion of the outer surface. At least a first polymer adhesive layer is disposed between the bottom of the discrete stress application features and the outer surface of the inflatable polymer balloon.

[0312] In certain circumstances, the first polymeric adhesive layer includes a base layer configured to cover a continuous surface area of the outer balloon surface, where the continuous surface area is large enough to be located beneath at least a plurality of the discrete stress-applying features, and preferably, at least a plurality of the discrete stress-applying features are distributed over the continuous surface area in both the axial and circumferential directions.

[0313] Generally, the continuous surface area is large enough to be located beneath at least a majority of the discrete stress-applying features, and preferably, the continuous surface area is large enough to be located beneath all of the discrete stress-applying features.

[0314] In some cases, the continuous surface area includes at least a cylindrical region (sometimes referred to as the working length surface or working surface) of the outer surface of the balloon. For example, the cylindrical region of the continuous surface area can be located between the tapered or conical end regions of the outer surface of the balloon and / or between the curved transition regions of the outer surface of the balloon.

[0315] In some cases, the continuous surface area can include at least one helical strip disposed on the cylindrical region and / or the tapered or conical regions of the balloon.

[0316] In some cases, the continuous surface area can include at least one axial strip disposed on the cylindrical region and / or the tapered or conical regions of the balloon.

[0317] In some cases, the continuous surface area includes at least one circumferential band disposed on one or more of the cylindrical region and / or the tapered or conical regions of the balloon.

[0318] In some cases, the continuous surface area includes a random two-dimensional pattern.

[0319] In some cases, the device further includes a continuous surface of the balloon that includes a cylindrical surface, and the plurality of discrete stress-applying features are arranged as a plurality of circumferentially adjacent bands that are axially spaced apart along the cylindrical surface.

[0320] In some cases, the device further includes at least one second polymeric adhesive layer disposed between the bottom of the discrete stress-applying features and the outer surface of the expandable polymeric balloon. For example, the first polymeric adhesive layer and the second polymeric adhesive layer can both cover the same continuous surface area of the outer balloon surface. Alternatively or additionally, the first polymeric adhesive layer and the second polymeric adhesive layer can cover different continuous surface areas of the outer balloon surface.

[0321] In some cases, the thickness of each of the first adhesive layer and the second adhesive layer is not greater than 50% of the wall thickness of the expandable polymeric balloon.

[0322] In some cases, the second adhesive layer may include a plurality of adhesive points. For example, each adhesive point may be located beneath a respective, discrete stress application feature and on the outer surface of the balloon.

[0323] In other cases, the adhesive points may be located on the first polymeric adhesive layer and beneath the discrete stress application features.

[0324] In still other cases, the adhesive points may be located beneath the first polymeric adhesive layer and the discrete stress application features and on the outer surface of the balloon.

[0325] In some cases, the first polymeric adhesive layer and the second polymeric adhesive layer comprise the same adhesive polymeric material.

[0326] In some cases, the first polymeric adhesive layer and the second polymeric adhesive layer comprise different adhesive polymeric materials.

[0327] In some cases, the adhesive layer directly attached to the outer surface of the balloon is softer than the adhesive layer directly attached to the bottom of the stress application feature.

[0328] In some cases, the first polymeric adhesive layer and / or the second polymeric adhesive layer comprises one or more adhesive materials.

[0329] In some cases, the device of the present invention may further include a first polymeric overcoat. For example, the first polymeric overcoat may cover the outer surface of the balloon. For example, the first polymeric overcoat may cover at least some of the plurality of discrete stress application features. For example, the first polymeric overcoat may cover at least a portion of the first polymeric adhesive layer. For example, the first polymeric overcoat covers at least a portion of the first polymeric adhesive layer.

[0330] In some cases, the first polymeric overcoat comprises a polymeric adhesive.

[0331] In some cases, the hardness of the first polymeric adhesive layer upon curing may be less than the hardness of the wall of the expandable polymeric balloon and less than the hardness of the discrete stress application features, wherein the first polymeric adhesive is configured to accommodate the different expansions between the bottom of the discrete stress application features and the outer surface of the expandable polymeric balloon when the balloon expands. For example, the hardness of the discrete stress application features is at least 4 Mohs, the Shore hardness of the polymeric balloon wall is in the range of 60D to 90D, and the Shore hardness of the first polymeric adhesive is in the range of 50D to 70D.

[0332] In some cases, the discrete stress-applying feature may include at least one of a metal, a metal alloy, a mineral, a ceramic, and a hardened polymer. For example, the discrete stress-applying feature may include a metal or a metal alloy that includes at least one of iron, platinum, cobalt, chromium, rhodium, titanium, tungsten, and nickel.

[0333] In some cases, the polymeric balloon may include at least one of nylon, a polyamide block copolymer, and polyethylene terephthalate (PET).

[0334] In some cases, any one or more of the first polymeric adhesive layer, the second polymeric adhesive layer, and the first polymeric covering layer may include at least one of a polymethacrylate, a polyurethane-methacrylate, an isobornyl acrylate, an acrylate urethane methacrylate, a methacrylate acrylate, a modified methacrylate, a polyester, an epoxy adhesive, a phenolic adhesive, a polyvinyl acetate, a polyethylene-vinyl acetate, a polyethylene-methacrylate, a polyethylene, an acrylic acid, a cyanoacrylate, a hybrid cyanoacrylate / epoxy adhesive, a urea formaldehyde, a polyimide, a natural or synthetic rubber modified with a tackifying resin, a styrene-butadiene rubber latex, a silicone rubber, an anaerobic adhesive, a mussel adhesion protein, a polydopamine-clay-polyacrylamide, Caulobacter crescentus, Delo Monopox, or a combination thereof.

[0335] In some cases, the device of the present invention may further include at least a second polymeric adhesive layer disposed between the bottom of the stress-applying feature and the outer surface of the expandable polymeric balloon, wherein the at least second polymeric adhesive layer has a hardness greater than or equal to the hardness of the first polymeric adhesive layer upon curing. Typically, the at least second polymeric adhesive layer has a Shore hardness in the range of 50D to 70D upon curing.

[0336] In some cases, the first polymeric adhesive layer and the second polymeric adhesive layer may have the same hardness.

[0337] In other cases, the first polymeric adhesive layer and the second polymeric adhesive layer may have different hardnesses.

[0338] In some cases, the second polymeric adhesive may include a dot adhesive. For example, the dot adhesive may be formed on the first polymeric adhesive layer. Alternatively or additionally, the dot adhesive may be formed under the first polymeric adhesive layer.

[0339] In some cases, the Shore hardness of the first polymeric covering layer may be in the range of 50D to 70D.

[0340] In some cases, the device of the present invention may further include a second polymer covering layer that is formed on the outer surface of the balloon and covers a plurality of discrete stress application features. For example, the second polymer covering layer includes a polymer adhesive.

[0341] In this case, typically, the thickness of each of the first polymer covering layer and the second polymer covering layer is not greater than 50% of the wall thickness of the expandable polymer balloon.

[0342] In this case, typically, the Shore hardness of the second polymer covering layer is in the range of 50D to 70D.

[0343] In a preferred case, the balloon wall is composed of a single layer of polymer material. For example, the balloon wall is composed of a single polymer material with a hardness in the range of 55D to 90D.

[0344] In some cases, the polymer material of the balloon is a material with a homogeneous composition, that is, it has a uniform composition in most or the entire structure of the balloon structure.

[0345] In some cases, at least some of the plurality of discrete stress application features are formed as an integral structure.

[0346] In other cases, at least some of the plurality of discrete stress application features are formed as a multi-piece structure.

[0347] In some cases, at least one of the first polymer adhesive layer, the second polymer adhesive layer, the first polymer covering layer, and the second polymer adhesive covering layer includes a homogeneous polymer material, that is, it has a uniform composition in most of the structure of the balloon structure.

[0348] In some cases, at least one of the first polymer adhesive layer, the second polymer adhesive layer, the first polymer covering layer, and the second polymer adhesive covering layer includes a reinforcement, a filler, a crosslinking agent, or an additive.

[0349] In some cases, the first polymer adhesive layer and / or the second polymer adhesive layer attach the bottom of the discrete stress application feature to the outer surface of the expandable polymer balloon.

[0350] In some cases, the first polymer adhesive layer, the second polymer adhesive layer, the first polymer adhesive overlay, and / or the second polymer adhesive overlay each comprise at least one polymer selected from polymethacrylate, polyurethane-methacrylate, isobornyl acrylate, amino carbamate methacrylate, acrylate methacrylate, modified methacrylate, polyester, epoxy adhesive, phenolic adhesive, polyvinyl acetate, ethylene-vinyl acetate, ethylene-methacrylate, polyethylene, acrylic acid, cyanoacrylate, hybrid cyanoacrylate / epoxy adhesive, urea-formaldehyde, polyimide, natural or synthetic rubber modified with tackifying resin, styrene-butadiene rubber latex, silicone rubber, anaerobic adhesive, mussel adhesive protein, polydopamine-clay-polyacrylamide, Caulobacter crescentus, DeloMonopox, and combinations thereof.

[0351] In yet another aspect, the present invention provides an apparatus for treating calcified deposits on a wall in a body cavity of a patient. The apparatus includes a catheter, an expandable polymeric balloon, a plurality of discrete stress-applying features disposed on at least a portion of the outer surface, and a polymeric layer disposed on the outer surface of the expandable polymeric balloon. The catheter body has a proximal end and a distal end, and the expandable polymeric balloon is attached to the distal end of the catheter body. The expandable polymeric balloon has a stiffness and an outer surface configured to radially outwardly displace toward the inner surface of the body cavity wall, and each of the plurality of discrete stress-applying features has a stiffness, a bottom, and a rounded convex upper surface. The polymeric layer is disposed between the bottom of the discrete stress-applying features and the outer surface of the expandable polymeric balloon, and the polymeric layer covers a continuous surface area of the outer balloon surface and is large enough to be located beneath at least a plurality of the plurality of discrete stress-applying features, at least a plurality of which are distributed over the continuous surface area in both the axial direction and the circumferential direction. A plurality of adhesive points are deposited on the polymeric layer to enhance the attachment of the bottom of each of the plurality of discrete stress-applying features to the polymeric layer.

[0352] In some cases, the polymeric layer is configured to (a) adhere to the outer balloon surface and is configured to (b) accommodate different expansions between the bottom of the discrete stress-applying features and the outer surface of the expandable polymeric balloon when the balloon is inflated.

[0353] In some cases, the adhesive points are configured to adhere to the outer surface of the balloon and the bottom of the stress-applying features.

[0354] In some cases, the adhesive points are configured to (a) adhere to the polymer layer and attach the stress application feature to the outer balloon surface and are configured to (b) further accommodate the different expansions between the bottom of the discrete stress application feature and the outer surface of the expandable polymer balloon when the balloon is inflated.

[0355] In some cases, the adhesive points are configured to adhere to the outer surface of the balloon and are configured to cover the stress application feature.

[0356] In some cases, a polymer layer is disposed between the bottom of the discrete stress application feature and the outer surface of the expandable polymer balloon, and a plurality of stress application features are distributed over a continuous surface area in both the axial direction and the circumferential direction.

[0357] For example, the plurality of stress application features can be arranged in one or more axial strips, one or more circumferential bands, two or more helical lines, two or more axial strips, two or more circumferential bands, two or more helical lines, and / or a random two-dimensional grid over the continuous surface area.

[0358] In a specific example, the stress application features can be arranged in a grid pattern that has circumferential bands and axial strips and has spacing or gaps between the features in both the circumferential direction and the axial direction. Such spacing can be uniform or different, regular or random.

[0359] In some cases, the continuous surface area is large enough to be located beneath at least a majority of the plurality of discrete stress application features.

[0360] In some cases, the continuous surface area is large enough to be located beneath all of the plurality of discrete stress application features.

[0361] In some cases, the polymer layer is inseparable from the balloon outer surface.

[0362] In some cases, the polymer layer is attached to the balloon outer surface by one or more of heating, fusing, welding, depositing, gluing, and using an adhesive.

[0363] In some cases, the polymer layer can include a polymer adhesive material, consist essentially of a polymer adhesive material, or consist of a polymer adhesive material.

[0364] In some cases, the polymer layer can include a combination of an adhesive polymer material and a non-adhesive polymer material.

[0365] In some cases, the adhesive points can include an adhesive polymer material, consist of an adhesive polymer material, or consist essentially of an adhesive polymer material.

[0366] In some cases, the adhesive points include a combination of a polymeric adhesive material and a non-adhesive polymeric material.

[0367] In yet another aspect, the present invention provides an apparatus for treating calcified deposits on the wall in a body cavity of a patient, the apparatus comprising a catheter, an inflatable polymeric balloon, a plurality of discrete stress-applying features disposed on at least a portion of the outer surface of the inflatable polymeric balloon, a first polymeric layer, and a second polymeric material. The catheter includes a catheter body having a proximal end and a distal end, and the inflatable polymeric balloon is attached to the distal end of the catheter body. The inflatable polymeric balloon has a stiffness, and the outer surface is configured to radially outwardly displace toward the inner surface of the body cavity wall when the balloon is inflated. Each of the plurality of discrete stress-applying features has a stiffness, a bottom, and a rounded convex upper surface, wherein the discrete stress-applying features are distributed on at least a portion of the outer surface area in both the axial direction and the circumferential direction. The first polymeric layer is disposed between the bottom of the discrete stress-applying features and the outer surface of the inflatable polymeric balloon, and the first polymeric layer covers a continuous surface area of the outer balloon surface and is large enough to be located beneath at least a plurality of the plurality of discrete stress-applying features. The second polymeric material encapsulates at least the bottom of each of the plurality of stress-applying features and is attached to the first polymeric layer.

[0368] In some cases, the second polymeric material is attached to the first polymeric material by one or more of heating, adhesion, fusion, welding, or a combination thereof.

[0369] In some cases, the first polymeric layer and the second polymeric material comprise the same material.

[0370] In some cases, the first polymeric layer and the second polymeric material comprise different materials.

[0371] In yet another aspect, the present invention provides an apparatus for treating calcified deposits on the walls in a patient's body cavity. The apparatus includes a catheter, an inflatable polymeric balloon, a plurality of discrete stress-applying features distributed on at least a portion of the outer surface of the inflatable polymeric balloon, at least one layer including a plurality of discrete polymeric adhesive points, a first polymeric layer, and a second polymeric material. The catheter includes a catheter body having a proximal end and a distal end, and the inflatable polymeric balloon is attached to the distal end of the catheter body. The inflatable polymeric balloon has a hardness, and the outer surface is configured to radially outwardly displace towards the inner surface of the body cavity wall when the balloon is inflated. Each of the plurality of discrete stress-applying features has a hardness, a bottom, and a rounded convex upper surface, and the discrete stress-applying features are distributed on at least a portion of the outer surface. Discrete polymeric adhesive points are provided between the bottom of the discrete stress-applying features and the outer surface of the inflatable polymeric balloon, and at least a first polymeric adhesive layer is provided on the outer surface of the inflatable polymeric balloon, and the at least first polymeric adhesive layer at least partially overlaps at least a portion of the plurality of discrete polymeric adhesives of the at least one layer. The discrete polymeric adhesive points and the first polymeric adhesive are configured to accommodate different expansions between the bottom of the discrete stress-applying features and the outer surface of the inflatable polymeric balloon when the balloon is inflated.

[0372] In some cases, the plurality of discrete adhesive points extend beyond the periphery of the bottom of the plurality of stress-applying features.

[0373] In some cases, the first polymeric adhesive layer covers at least a portion of the plurality of discrete polymeric adhesive points of the at least one layer.

[0374] In some cases, the first polymeric adhesive layer covers at least a portion of the surface of the plurality of discrete stress-applying features.

[0375] In some cases, the plurality of discrete adhesive points and the first polymeric adhesive layer include the same polymeric adhesive.

[0376] In some cases, the plurality of discrete adhesive points and the first polymeric adhesive layer include different polymeric adhesives.

[0377] In some cases, at least the first polymeric adhesive covering layer covers at least a portion of the surface of the plurality of discrete stress-applying features.

[0378] In some cases, the first polymeric adhesive covering layer covers at least a portion of the first polymeric adhesive layer.

[0379] In some cases, the first polymeric adhesive covering layer covers at least a portion of the surface of the plurality of discrete stress-applying features and at least a portion of the first polymeric adhesive layer.

[0380] In some cases, at least a first adhesive polymer layer covers some or all of the outer surface of a single-layer, compositionally uniform polymeric balloon, where a plurality of stress application features are attached to the outer balloon surface through the adhesive polymer layer and / or an adhesive dot layer. Typically, at least the first adhesive polymer layer and one or more adhesive dot layers are softer than the balloon, and preferably, there are no reinforcing members or other stiffeners attached to or embedded in the balloon. The balloon itself will also not have any parts or regions that are harder than or otherwise different from the rest of the balloon. Optionally, as described herein, the balloon is modified by adding an adhesive polymer layer and / or adhesive dots and stress application features.

[0381] In some cases, the balloon consists of a single-layer composition or material structure, which may consist of a single polymer, copolymer, or homogeneous mixture of polymers, where metallic or other hard, rigid stress application features are attached to the balloon through an adhesive polymer, such as through the adhesive polymer layer and / or adhesive polymer dots described herein. There are no reinforcing members attached to or embedded in the balloon, and the balloon itself has no parts that are different from or harder than the rest of the balloon.

[0382] Typically, the stress application features will be discrete metallic structures having a circular upper surface and bottom, generally but not always flat, and the stress application features are adhesively attached directly to the outer surface of the single-layer balloon, which is not modified by a reinforcing member or an additional layer of balloon material. The polymeric adhesive used to attach the stress application features is typically softer than the polymer of the polymeric balloon.

[0383] In some cases, discrete stress application features can be adhesively attached directly to the outer surface of a single-layer polymeric balloon.

[0384] In some cases, at least one polymer layer can be formed on the surface of the polymeric balloon under the dot adhesives attaching the discrete stress application features to the balloon. Each of these polymer layers is softer than the balloon, and these polymer layers, individually or together, seal the interface between the stress application features and the balloon, thereby creating a cushion between the hard, discrete stress application features and the balloon. One or more polymer layers applied to the balloon form an adaptation layer or barrier, thereby allowing the balloon to be flexible when passing through a body cavity and reducing the likelihood of moisture entering under the stress application features. These single- or multi-layer intermediate layers maintain the flexibility of the balloon, conform the balloon to the passage of the body cavity, and stabilize the structure, thereby keeping the discrete features in their positions on the balloon during use in a physiological environment.

[0385] While polymer balloons will typically consist of a single unmodified homogeneous polymer layer without reinforcements, stiffeners, and other non-homogeneities, in some cases, regions of the balloon wall that are not under the stress-applying features may have multiple layers, stiffeners, or other non-homogeneous structures. However, in a preferred embodiment, those regions of the balloon under the stress-applying features will preferably be free of all such non-homogeneous structures.

[0386] In yet other aspects, the present invention provides an apparatus for treating calcified lesions on the walls in a patient's body cavity, the apparatus comprising a catheter, an expandable polymer balloon, and a plurality of discrete rigid stress-applying features. The catheter includes a catheter body having a proximal end and a distal end, and the expandable polymer balloon is attached to the distal end of the catheter body and has an outer balloon surface. Each of the plurality of discrete rigid stress-applying features is attached to the outer balloon surface, and the plurality of discrete rigid stress-applying features are arranged along the length of the outer surface of the polymer balloon as a first plurality of circumferential bands spaced apart in the axial direction. Each stress-applying feature within a band is circumferentially spaced apart, and when the polymer balloon is expanded, at least some of the stress-applying features are axially offset from at least one (and typically two) adjacent stress-applying features within the same band.

[0387] In some cases, the plurality of discrete rigid stress-applying features are also arranged as a second plurality of axially oriented strips disposed along the length of the outer surface of the balloon, wherein when the balloon is expanded, at least some of the stress-applying features within some or all of the axially oriented strips may be axially offset from the stress-applying features in circumferentially adjacent axially oriented strips.

[0388] In some cases, when the balloon is expanded, at least some of the stress-applying features within some or all of the axially oriented strips may be axially offset from the stress-applying features in circumferentially adjacent axially oriented strips.

[0389] In some cases, the stress-applying features within at least some of the axially oriented strips have the same axial spacing.

[0390] In some cases, the stress-applying features within all of the axially oriented strips have the same axial spacing.

[0391] In some cases, at least some of the stress - applying features within at least some of the circumferential bands may be axially offset from other stress - applying features within the same circumferential band to enhance the destructive force of each stress - applying feature and / or to avoid the stress - applying features from stacking when the balloon deflates. Often, all of the stress - applying features within at least some of the circumferential bands are axially offset from other stress - applying features within the same circumferential band. For example, each stress - applying feature within each circumferential band may be axially offset from other stress - applying features within the same circumferential band.

[0392] In some cases, the circumferential spacing between the respective stress - applying features within the same circumferential band is the same.

[0393] In some cases, the circumferential spacing between at least some of the stress - applying features within at least some of the circumferential bands is the same.

[0394] In some cases, at least some of the stress - applying features within at least one axial strip are axially offset from at least one stress - applying feature within an axially adjacent circumferential strip.

[0395] In some cases, all of the stress - applying features are axially offset from at least some of the stress - applying features within at least one axially adjacent circumferential strip. Often, all of the stress - applying features are axially offset from the circumferentially adjacent stress - applying features within the same circumferential band.

[0396] In some cases, all of the stress - applying features within each axial strip are axially offset from the stress - applying features within an axially adjacent circumferential strip.

[0397] In some cases, the stress - applying features are spaced from other stress - applying features on the balloon in both the axial and circumferential directions. The spacing may be the same or different in either or both directions.

[0398] In some cases, multiple stress - applying features attached to the balloon in the form of circumferential bands and axial strips may form a regular, irregular, random, spiral, or a combination thereof pattern. The spacing between the stress - applying features may be uniform throughout the length of the balloon and the offset distance is uniform, or the spacing may vary along the length of the balloon and the offset distance varies.

[0399] Discrete stress applying features can be attached to the balloon in the form of a grid having various patterns. The axial strips of the stress applying features can be straight and / or can be parallel to each other along the length of the balloon, or the axial strips of the stress applying features can have some features that are not in a straight line along the longitudinal length of the balloon. Slightly axially offsetting the discrete stress applying features of the axial strips or the discrete stress applying features of the axial rows from the stress applying features in the circumferentially adjacent axial strips improves the effect of the features in breaking or crushing an occluder in a body cavity because, compared to positioning the discrete stress applying features in circumferentially aligned bands, the offset of the discrete stress applying features enables better distribution of the force of the features. The offset of the features provides greater force, better force distribution, and a smaller profile of the features, thereby reducing the overlap of the features when the balloon deflates. However, if the offset is too large, the ability to crack the occluder is diminished or eliminated. Ideally, the spacing of the features is from 0.05 mm to 0.5 mm to optimize the performance of the balloon in breaking calcified deposits in a body cavity.

[0400] In some cases, at least some of the stress applying features have a convex rounded upper surface and a circular base around a center.

[0401] In some cases, the width or diameter of the stress applying features can be in the range of 0.15 mm to 1 mm, preferably in the range of 0.2 mm to 1 mm, and typically in the range of 0.3 mm to 0.6 mm.

[0402] In some cases, the distance of the axial offset of the stress applying features can be in the range of 0.3 mm to 2 mm, preferably in the range of 0.4 mm to 1.5 mm, and typically in the range of 0.5 mm to 1 mm.

[0403] In some cases, the circumferentially adjacent stress applying features are axially spaced far enough apart such that the peripheral edges of the circumferentially adjacent stress applying features do not axially overlap, wherein the gap between the peripheral edges of the circumferentially adjacent stress applying features will be in the range of 0 to 3 mm, typically in the range of 0 to 2 mm, and preferably in the range of 0.05 mm to 0.4 mm.

[0404] In some cases, all of the stress-applying features are spaced far enough apart such that when the expandable polymeric balloon is deflated, the peripheral edges of the stress-applying features do not axially overlap, and the gap between the peripheral edges of the stress-applying features is in the range of 0 to 3 mm, typically in the range of 0 to 2 mm, and preferably in the range of 0.05 mm to 0.4 mm. For example, for all of the stress-applying features, when the expandable polymeric balloon is inflated, the width or diameter of each stress-applying feature, the axial offset between circumferentially adjacent stress-applying features, and the circumferential offset between axially adjacent stress-applying features are constant.

[0405] In some cases, the center of the stress-applying feature includes the center of the bottom surface of the stress-applying feature.

[0406] In some cases, the center of the stress-applying feature includes the center of the upper surface of the stress-applying feature.

[0407] In some cases, the axial offset and the circumferential offset are measured relative to the centers of adjacent stress-applying features.

[0408] In some cases, the density of the circumferential bands along the axial length ranges from 0.2 bands per millimeter of axial balloon length to 2 bands per millimeter of axial balloon length, preferably from 0.3 bands per millimeter of axial balloon length to 1 band per millimeter of axial balloon length, and most preferably from 0.4 bands per millimeter of axial balloon length to 1 band per millimeter of axial balloon length.

[0409] In some cases, the distance of the bottom axial spacing of axially adjacent stress-applying features within at least some of the axially oriented bands is in the range of 0.5 mm to 3 mm, typically in the range of 1 mm to 2.5 mm, and preferably in the range of 1.5 mm to 2.5 mm.

[0410] In some cases, at least some of the discrete stress-applying features are formed as spheres, hemispheres, partial spheres, ellipsoids, or other shapes having a convex circular upper surface.

[0411] In yet another aspect, the present invention provides an apparatus for treating calcified lesions on the walls in a patient's body cavity, the apparatus comprising a catheter, an expandable polymeric balloon, and a plurality of discrete rigid stress-applying features. The catheter includes a catheter body having a proximal end and a distal end, and the expandable polymeric balloon is attached to the distal end of the catheter body and has an outer balloon surface. The rigid stress-applying features are each attached to the outer balloon surface, wherein at least some of the stress-applying features have a convex circular upper surface and a base directly or indirectly attached to the balloon surface. When the balloon is deflated, most (preferably all) of the peripheral edges of the stress-applying features do not overlap.

[0412] In some cases, when the polymeric balloon is deflated, the gap between the peripheral edges of adjacent stress-applying features will be in the range of 0 to 3 mm, typically in the range of 0 to 2 mm, and preferably in the range of 0.05 mm to 0.4 mm.

[0413] In yet another aspect, the present invention provides an apparatus for treating calcified lesions on the wall in a body cavity of a patient, the apparatus comprising a catheter, an inflatable polymeric balloon, and a plurality of discrete rigid stress-applying features. The catheter includes a catheter body having a proximal end and a distal end, and the inflatable polymeric balloon is attached to the distal end of the catheter body and has an outer surface. The plurality of stress-applying features are attached to the outer surface of a polymeric base layer, and when the inflatable polymeric balloon is fully inflated, the distribution density of the stress-applying features on at least the expanded region of the inflatable polymeric balloon is in the range of 0.1 feature per square millimeter of outer surface area or per square millimeter of a partial outer surface area (such as the cylindrical central region of the balloon), preferably in the range of 0.2 features / mm 2 to 4 features / mm 2 and more preferably in the range of 0.25 features / mm 2 to 3 features / mm 2 of the range.

[0414] In yet another aspect, the present invention provides an apparatus for treating calcified lesions on the wall in a body cavity of a patient, the apparatus comprising a catheter, an inflatable polymeric balloon, and a plurality of discrete rigid stress-applying features. The catheter includes a catheter body having a proximal end and a distal end, and the inflatable polymeric balloon is attached to the distal end of the catheter body. The inflatable polymeric balloon has an outer surface, and the plurality of stress-applying features are attached to the outer surface of the inflatable polymeric balloon, wherein when the inflatable polymeric balloon is fully inflated, the distribution density of the stress-applying features on at least the expanded region of the inflatable polymeric balloon is in the range of 0.1 feature / mm 2 to 5 features / mm 2 and preferably in the range of 0.2 features / mm 2 to 4 features / mm 2 and more preferably in the range of 0.25 features / mm 2 to 3 features / mm 2 of the range.

[0415] In some cases, the expanded region of the inflatable polymeric balloon includes the entire expandable surface area of the balloon.

[0416] In some cases, the expansion region of the inflatable polymeric balloon includes the central region of the balloon and excludes the tapered end regions of the balloon.

[0417] In yet another aspect, the present invention provides an apparatus for treating wall calcifications in a body cavity of a patient, the apparatus comprising a catheter, an inflatable polymeric balloon, and a plurality of discrete rigid stress application features. The catheter includes a catheter body having a proximal end and a distal end. The inflatable polymeric balloon is attached to the distal end of the catheter body and the inflatable polymeric balloon has an outer surface. The plurality of stress application features are attached to the outer surface of the polymeric balloon and each stress application feature has a base region that contacts the outer surface of the inflatable polymeric balloon. The ratio of (1) the cumulative area of all base regions that contact the outer surface of the inflatable polymeric balloon to (2) the total surface area of the outer surface of the inflatable polymeric balloon is in the range of 1:100 to 5:100, typically in the range of 2:100 to 5:100, and preferably in the range of 3:100 to 4:100.

[0418] In some cases, the outer surface of the inflatable polymeric balloon may include the entire expandable surface area of the balloon.

[0419] In other cases, the outer surface of the inflatable polymeric balloon includes the central region of the balloon and excludes the tapered end regions of the balloon.

[0420] In some cases, the stress application feature has a convex rounded upper surface and a circular base region that contacts the outer balloon surface.

[0421] In some cases, all of the stress application features have the same size.

[0422] In some cases, the stress application features are uniformly distributed on the outer surface of the inflatable polymeric balloon.

[0423] In yet another additional aspect, the present invention provides an apparatus for treating calcified lesions on the walls in a patient's body cavity, the apparatus comprising a catheter, an inflatable polymeric balloon, and a plurality of discrete rigid stress-applying features. The catheter includes a catheter body having a proximal end and a distal end. The inflatable polymeric balloon is attached to the distal end of the catheter body, and the inflatable polymeric balloon has an outer surface. The plurality of stress-applying features are attached to the outer surface of the polymeric balloon. The catheter includes a catheter body having a proximal end and a distal end, and the inflatable polymeric balloon has an outer surface that has a central region, a tapered distal region, a tapered proximal region, a distal transition region between the distal tapered region and the central region, and a proximal transition region between the proximal tapered region and the central region. Each rigid feature is attached to the outer surface of the inflatable polymeric balloon, wherein at least some of the rigid features are distributed over at least a portion of one of (a) the distal transition region, (b) the proximal transition region, (c) the distal tapered region, (d) the proximal tapered region, (e) the distal 2 mm length of the central region, and (f) the proximal 2 mm length of the central region of the outer surface of the inflatable polymeric balloon.

[0424] In some cases, at least some of the rigid features have a convex rounded upper surface.

[0425] In some cases, the width or diameter of the rigid features is in the range of 0.15 mm to 1 mm, preferably in the range of 0.2 mm to 1 mm, and typically in the range of 0.3 mm to 0.6 mm.

[0426] In some cases, the discrete rigid features comprise a metal or metal alloy that includes at least one of iron, platinum, cobalt, chromium, rhodium, titanium, tungsten, and nickel.

[0427] In some cases, the inflatable polymeric balloon comprises a semi-compliant balloon having a nominal inflation pressure and a rated burst pressure, wherein when the balloon is inflated from its nominal inflation pressure to its rated burst pressure, the diameter of the central region of the balloon increases by a percentage in the range of 1% to 20%, typically by a percentage in the range of 5% to 20%, and preferably by a percentage in the range of 5% to 15%.

[0428] In some cases, the polymeric balloon comprises at least one of nylon, polyamide block copolymer, and polyethylene terephthalate (PET).

[0429] In some cases, the inflatable polymeric balloon comprises a non-compliant balloon having a nominal inflation pressure and a rated burst pressure, wherein when the balloon is inflated from its nominal inflation pressure to its rated burst pressure, the diameter of the central region of the balloon increases by a percentage less than or equal to 5%.

[0430] In some cases, at least some of the rigid features are distributed over at least a portion of each of a distal transition region and a proximal transition region of an outer surface of an expandable polymeric balloon.

[0431] In some cases, at least some of the rigid features are also distributed over at least a portion of each of a tapered distal region and a tapered proximal region of the outer surface of the expandable polymeric balloon.

[0432] In some cases, at least some of the rigid features are distributed over at least a portion of each of a proximal end 1 mm length and a distal end 1 mm length of a central region of the outer surface of the expandable polymeric balloon.

[0433] In some cases, the rigid features are arranged on the outer surface of the expandable polymeric balloon as circumferential bands. For example, the circumferential bands can each include from 2 to 8 rigid features, typically each include from 2 to 6 rigid features, and preferably, each include from 3 to 5 rigid features.

[0434] In some cases, some of the rigid features are distributed over the central region of the outer surface of the expandable polymeric balloon, and additional features are distributed over one or more of (a) the distal transition region, (b) the proximal transition region, (c) the distal tapered region, (d) the proximal tapered region. Distributing the stress-applying features over the transition regions and / or tapered regions of the balloon allows the stress-applying features to break or fragment calcified deposits while preventing (eliminating or minimizing) damage to adjacent blood vessels by reducing, decreasing or eliminating the "dog bone" effect of the balloon near the calcified deposits. The presence of stress-applying features in regions where the circumference of the balloon is less than the circumference of the remainder of the balloon allows the balloon to bend around the calcified deposit without causing portions of the balloon to bulge or "balloon" to a larger size and potentially causing the stress-applying features to be angled with respect to the vessel wall. The stress-applying features on the transition regions and tapered regions can still provide sufficient force to fragment the calcified deposit and reduce damage to the vessel wall.

[0435] In some cases, all of the rigid features have the same shape and size.

[0436] In some cases, the shape of the rigid features on the central region is different from the shape of the rigid features on one or more of (a) the distal transition region, (b) the proximal transition region, (c) the distal tapered region, (d) the proximal tapered region, and / or the size of the rigid features on the central region is different from the size of the rigid features on one or more of (a) the distal transition region, (b) the proximal transition region, (c) the distal tapered region, (d) the proximal tapered region.

[0437] In some cases, the rigid features are arranged as axial strips and circumferential bands in any one or all of the regions.

[0438] In some cases, each axial strip consists of 2 to 8 rigid features.

[0439] In some cases, each circumferential band consists of 2 to 8 rigid features.

[0440] These and other embodiments are described in further detail in the following clauses and the description related to the accompanying drawings.

[0441] Clause 1. An endoprosthesis, comprising:

[0442] A stent, at least partially composed of a non-degradable material and configured to expand from a crimped configuration to an expanded configuration; and

[0443] A plurality of stress-applying features coupled to an outer surface of the stent;

[0444] Wherein at least some of the stress-applying features include blunt contact regions having contact surfaces that are spaced outwardly from the outer surface of the stent and configured to rupture occlusive material in the wall of the blood vessel lumen when the stent expands from the crimped configuration to the expanded configuration in the blood vessel lumen.

[0445] Clause 2. The endoprosthesis according to Clause 1, wherein the stent has a tubular geometry.

[0446] Clause 3. The endoprosthesis according to Clause 2, wherein the tubular stent has a cylindrical shape, an ellipsoidal shape, a tapered profile, an hourglass shape, or a dogbone shape.

[0447] Clause 4. The endoprosthesis according to Clauses 1 to 3, wherein at least some of the blunt contact regions include a peripheral edge that defines the contact surface and is configured to concentrate stress when the stent expands from the crimped configuration to the expanded configuration in the blood vessel lumen and engages the occlusive material on the wall of the blood vessel lumen.

[0448] Clause 5. The endoprosthesis according to Clause 4, wherein the peripheral edge is formed by the junction between the blunt contact region and a peripheral wall that at least partially surrounds the blunt contact region.

[0449] Clause 6. The endoprosthesis according to Clauses 1 to 5, wherein the contact surface of the blunt contact region is flat, convex, circular, or concave.

[0450] Clause 7. The endoprosthesis according to clause 6, wherein the contact surface of the blunt contact region is parallel to the outer surface of the stent.

[0451] Clause 8. The endoprosthesis according to clause 6, wherein the contact surface of the blunt contact region is inclined with respect to the outer surface of the stent.

[0452] Clause 9. The endoprosthesis according to clause 8, wherein the inclination angle of the contact surface of the blunt contact region is in the range of 5° to 45°, preferably in the range of 10° to 30°.

[0453] Clause 10. The endoprosthesis according to clauses 1 to 10, wherein the peripheral wall is oriented at an angle in the range of 75° to 105° with respect to the contact surface of the blunt contact region.

[0454] Clause 11. The endoprosthesis according to clauses 4 to 10, wherein the peripheral edge completely extends around the contact surface of the blunt contact region, and the width of the peripheral edge is in the range of 10 μm to 200 μm.

[0455] Clause 12. The endoprosthesis according to clause 11, wherein the peripheral edge is circular, and the width includes the diameter.

[0456] Clause 13. The endoprosthesis according to clauses 1 to 12, wherein at least some of the plurality of stress applying features include one or more plates, the total thickness of the one or more plates is in the range of 0.25 mm to 1 mm, and the width of the one or more plates at the attachment to the surface of the tubular stent is in the range of 0.1 mm to 2 mm.

[0457] Clause 14. The endoprosthesis according to clause 13, wherein at least some of the plates are configured as disks, stacked disks, frustum cones, stacked disks and frustum cones, ellipsoidal disks and asymmetric cones.

[0458] Clause 15. The endoprosthesis according to clauses 1 to 12, wherein the stent includes a plurality of struts connected by crowns.

[0459] Clause 16. The endoprosthesis according to clause 15, wherein the plurality of struts connected by crowns are connected into a plurality of circumferential rings.

[0460] Clause 17. The endoprosthesis according to clause 15, wherein the plurality of struts connected by crowns are connected into a helical pattern.

[0461] Clause 18. The endoprosthesis according to Clauses 13 to 17, wherein at least some of the stress applying features are located at or adjacent to the crown portion.

[0462] Clause 19. The endoprosthesis according to Clause 18, wherein at least some of the crown portions with stress applying features are not connected to adjacent rings.

[0463] Clause 20. The endoprosthesis according to Clause 18 or 19, wherein each of the stress applying features is located at or adjacent to the crown portion.

[0464] Clause 21. The endoprosthesis according to Clauses 13 to 17, wherein at least some of the stress applying features are located on the struts between the crown portions or on one or more connecting members connecting adjacent rings.

[0465] Clause 22. The endoprosthesis according to Clauses 1 to 21, wherein at least some of the stress applying features are arranged as diametrically opposed pairs of stress applying features.

[0466] Clause 23. The endoprosthesis according to Clause 22, wherein successive diametrically opposed pairs of crown portions are circumferentially offset.

[0467] Clause 24. The endoprosthesis according to Clause 23, wherein successive diametrically opposed pairs of crown portions are circumferentially offset by an angle of 45° to 90°.

[0468] Clause 25. The endoprosthesis according to Clauses 1 to 21, wherein at least some of the stress applying features are arranged as triplets of stress applying features that are circumferentially spaced apart by approximately 120° around a circle on the surface of the tubular stent.

[0469] Clause 26. The endoprosthesis according to Clauses 1 to 20, wherein at least some consecutive axially spaced stress applying features are circumferentially offset by an angle within the range of 5° to 15°.

[0470] Clause 27. The endoprosthesis according to Clause 26, wherein at least some consecutive circumferentially spaced stress applying features are axially offset by an angle within the range of 5° to 15°.

[0471] Clause 28. The endoprosthesis according to Clauses 1 to 27, wherein the stent is formed by patterning a tubular substrate, laser cutting the tubular substrate, rolling the cut substrate, bending wires, or three-dimensional printing.

[0472] Clause 29. The endoprosthesis according to Clauses 1 to 28, wherein the stress-applying feature is preformed and attached by gluing, soldering, welding, threaded attachment, riveting, or crimping.

[0473] Clause 30. The endoprosthesis according to Clause 29, wherein the stress-applying feature includes a preformed plate glued to the stent with an adhesive.

[0474] Clause 31. The endoprosthesis according to Clauses 1 to 28, wherein the stress-applying feature is formed in situ by three-dimensional printing, chemical vapor deposition, electrostatic deposition, molding, or folding of components of the stent.

[0475] Clause 32. The endoprosthesis according to Clauses 1 to 28, wherein the stress-applying feature includes tabs attached to the stent and folded onto the outer surface of the stent.

[0476] Clause 33. The endoprosthesis according to Clauses 1 to 32, wherein the stent includes a vascular stent or a stent-graft.

[0477] Clause 34. The endoprosthesis according to Clauses 1 to 32, wherein the stent includes an artificial valve.

[0478] Clause 35. The endoprosthesis according to Clauses 1 to 32, wherein the stent includes a valvuloplasty device.

[0479] Clause 36. The endoprosthesis according to Clauses 1 to 35, wherein the stent is balloon-expandable.

[0480] Clause 37. The endoprosthesis according to Clauses 1 to 35, wherein the stent is self-expanding.

[0481] Clause 38. The endoprosthesis according to Clauses 1 to 37, wherein the stress-applying feature is configured to preferentially contact the occlusive material in the wall.

[0482] Clause 39. The endoprosthesis according to Clauses 1 to 38, wherein the stent includes a cannula configured to be placed on a cardiac stent or a balloon or configured to be self-expanding.

[0483] Clause 40. The endoprosthesis according to Clauses 1 to 39, wherein the stress-applying feature includes sharp elements protruding outward from the blunt contact area, and wherein the sharp elements are configured to concentrate stress when the blunt contact area presses against the surface of the occlusive material and engages the occlusive material on the wall of the blood vessel lumen.

[0484] Clause 41. The endoprosthesis according to Clause 40, wherein the blunt surface extends a first distance above the surface of the stent, and the sharp element projects a second distance from the surface of the blunt contact area, and the second distance is equal to the first distance (0.05 mm to 0.1 mm).

[0485] Clause 42. The endoprosthesis according to Clause 41, wherein the second distance ranges from 0.01 mm to 0.2 mm or from 0.01 mm to 0.1 mm.

[0486] Clause 43. The endoprosthesis according to Clauses 40 to 42, wherein the sharp element includes a tip.

[0487] Clause 44. The endoprosthesis according to Clauses 40 to 42, wherein the sharp element includes an edge.

[0488] Clause 45. A method for rupturing calcified plaque in a patient's vascular system, the method comprising:

[0489] expanding a stent at least partially composed of non-degradable material from a crimped configuration to an expanded configuration in a calcified body vascular lumen;

[0490] wherein the stent includes a plurality of stress-applying features fixed to its outer surface;

[0491] wherein at least some of the stress-applying features include a blunt contact area that is spaced outwardly from the outer surface and has a peripheral edge configured to rupture occlusive material on the wall of the vascular lumen when the tubular stent expands from the crimped configuration to the expanded configuration in the vascular lumen; and

[0492] wherein when the stent expands, the stress-applying features rupture the occlusive material.

[0493] Clause 46. The method according to Clause 45, wherein the occlusive material includes a hardened plaque or a calcified lesion.

[0494] Clause 47. The method according to Clause 45 or 46, wherein expanding the stent includes expanding a balloon within the stent or allowing the stent to self-expand.

[0495] Clause 48. The method according to Clause 45, wherein expanding the stent includes expanding an artificial heart valve in a heart valve annulus, wherein the stent includes a structural support for the heart valve annulus.

[0496] Clause 49. The method according to Clause 48, wherein expanding the artificial heart valve comprises expanding a balloon to expand the artificial heart valve in the heart valve annulus.

[0497] Clause 50. The method according to Clause 45, wherein expanding the stent comprises expanding a valvuloplasty device in the heart valve annulus.

[0498] Clause 51. The method according to Clause 50, wherein the stent of the valvuloplasty device comprises an expandable cage structure, and expanding the valvuloplasty device comprises expanding the cage structure in the heart valve annulus.

[0499] Clause 52. The method according to Clauses 45 to 51, wherein the tubular stent has a cylindrical shape, an ellipsoidal shape, a tapered profile, an hourglass shape, or a dogbone shape.

[0500] Clause 53. The method according to Clauses 45 to 52, wherein the peripheral edge is formed by the junction between the blunt contact region and a peripheral wall at least partially surrounding the blunt contact region.

[0501] Clause 54. The method according to Clauses 45 to 53, wherein the blunt contact region is flat.

[0502] Clause 55. The method according to Clause 54, wherein the blunt contact region is parallel to the outer surface of the tubular stent.

[0503] Clause 56. The method according to Clause 55, wherein the blunt contact region is inclined with respect to the outer surface of the tubular stent.

[0504] Clause 57. The method according to Clauses 45 to 56, wherein the peripheral edge is formed by the junction between the blunt contact region and a peripheral wall at least partially surrounding the blunt contact region.

[0505] Clause 58. The method according to Clause 57, wherein the blunt contact region is planar.

[0506] Clause 59. The method according to Clause 57, wherein the peripheral wall is oriented at an angle in the range of 75° to 105° with respect to the blunt contact region.

[0507] Clause 60. The method according to Clauses 57 to 59, wherein the width of the peripheral edge is in the range of 10 μm to 200 μm.

[0508] Clause 61. The method according to Clauses 57 to 60, wherein at least some of the plurality of stress applying features include one or more plates, the total thickness of the one or more plates being in the range of 0.5 mm to 1 mm, and the width of the surface of the one or more plates attached to the surface of the tubular stent being in the range of 0.01 mm to 2 mm.

[0509] Clause 62. The method according to Clause 61, wherein at least some of the plates are configured as disks, stacked disks, frustum cones, stacked disks and frustum cones, ellipsoidal disks and asymmetric cones.

[0510] Clause 63. The method according to Clauses 45 to 57, wherein the stent includes a plurality of struts connected by a crown.

[0511] Clause 64. The method according to Clause 63, wherein the plurality of struts connected by the crown are connected into a plurality of circumferential rings.

[0512] Clause 65. The method according to Clause 63, wherein the plurality of struts connected by the crown are connected into a helical pattern.

[0513] Clause 66. The method according to Clauses 63 to 65, wherein at least some of the stress applying features are located at or adjacent to the crown.

[0514] Clause 67. The method according to Clause 66, wherein each of the stress applying features is located at or adjacent to the crown.

[0515] Clause 68. The method according to Clauses 63 to 65, wherein at least some of the stress applying features are located on the struts between the crowns.

[0516] Clause 69. The method according to Clauses 63 to 68, wherein at least some of the stress applying features are arranged as diametrically opposed pairs of stress applying features.

[0517] Clause 70. The method according to Clauses 63 to 69, wherein successive diametrically opposed pairs of crowns are rotationally offset with respect to the longitudinal axis of the stent.

[0518] Clause 71. The method according to Clause 70, wherein the successive diametrically opposed pairs of crowns are rotationally offset by an angle of 75° to 105° with respect to the longitudinal axis of the stent.

[0519] Clause 72. A method for manufacturing a vascular stent, the method comprising:

[0520] Pattern the tubular stent, the tubular stent including a plurality of struts connected by a crown within a tubular sheath, the tubular stent having a plurality of tabs extending outwardly from the struts and / or the crown within the tubular sheath; and

[0521] Fold the plurality of tabs onto the outer surface of the tubular sheath to form a plurality of stress application features on the outer surface of the tubular stent.

[0522] Clause 73. The method according to clause 72, wherein pairs of adjacent tabs form stacked stress application features by one tab being folded over the other.

[0523] Clause 74. The method according to clause 73, wherein, prior to folding, the pairs of adjacent tabs are arranged side by side on the stent.

[0524] Clause 75. The method according to clause 73, wherein, prior to folding, the pairs of adjacent tabs are arranged one in front of the other on the stent.

[0525] Clause 76. The method according to clause 73, wherein, prior to folding, the pairs of adjacent tabs are arranged on opposite sides of a strut.

[0526] Clause 77. An apparatus for treating calcified deposits on a wall in a body cavity of a patient, the system comprising:

[0527] A catheter including a catheter body having a proximal end and a distal segment;

[0528] An expandable structure disposed at the distal segment of the catheter, the expandable structure having an outer surface configured to radially outwardly displace towards the inner surface of the body cavity wall; and

[0529] A plurality of stress application features distributed on the outer surface of the expandable structure, wherein at least some of the stress application features are present on the outer surface of the expandable structure and have a convex rounded upper surface configured to rupture the calcified deposit when the expandable structure expands within the body cavity while minimizing damage to the body cavity.

[0530] Clause 78. The apparatus according to clause 77, wherein the body cavity includes a blood vessel, a valve annulus, a venous valve or an AV shunt.

[0531] Clause 79. The apparatus according to clause 77 or 78, wherein the calcified deposit is located within an inner wall, an intimal layer, a medial layer, an adventitial layer, valve leaflets, a valve annulus, a venous filter or an implant.

[0532] Clause 80. The device according to any one of Clauses 77 to 79, wherein the expandable structure has a relatively low rigidity when not expanded and a relatively high rigidity when fully expanded.

[0533] Clause 81. The device according to any one of Clauses 77 to 80, wherein the outer surface of the expandable structure when fully expanded is substantially cylindrical.

[0534] Clause 82. The device according to any one of Clauses 77 to 81, wherein the convex rounded upper surface of the plurality of stress applying features extends radially outward beyond the outer surface of the expandable structure when fully expanded.

[0535] Clause 83. The device according to Clause 82, wherein the convex rounded upper surface of the plurality of stress applying features extends radially outward beyond the outer surface of the expandable structure when fully expanded by a distance within the range of 0.15 mm to 3 mm, preferably within the range of 0.25 mm to 3 mm, and more preferably within the range of 0.5 mm to 3 mm.

[0536] Clause 84. The device according to any one of Clauses 77 to 83, wherein the convex rounded upper surface of the stress applying feature does not have edges and irregularities that may damage the wall when the expandable structure expands within the body cavity.

[0537] Clause 85. The device according to any one of Clauses 77 to 84, wherein at least some of the stress applying features have a single convex rounded upper surface and a lower base independently attached to the outer surface of the expandable structure.

[0538] Clause 86. The device according to any one of Clauses 77 to 85, wherein at least some of the stress applying features include a sphere, a hemisphere, a frustum of a sphere, or an ellipsoid.

[0539] Clause 87. The device according to any one of Clauses 77 to 86, wherein at least some of the stress applying features are independently attached to the outer surface of the expandable structure.

[0540] Clause 88. The device according to any one of Clauses 77 to 87, wherein at least some of the stress applying features include a hemisphere having a lower surface attached to the outer surface of the expandable structure.

[0541] Clause 89. The device according to Clause 88, wherein the lower surface is flat.

[0542] Clause 90. The device according to Clause 88, wherein the lower surface has a wavy profile.

[0543] Clause 91. The device according to any one of Clauses 77 to 88, wherein at least some of the stress applying features include cylinders having a hemispherical upper surface and a lower surface attached to the outer surface of the expandable structure.

[0544] Clause 92. The device according to any one of Clauses 77 to 91, wherein the stress applying features include sharp elements protruding outward from the convex rounded upper surface, and wherein the sharp elements are configured to concentrate stress when the convex rounded upper surface bears against the surface of the calcified lesion and engages the calcified lesion on the wall of the blood vessel lumen.

[0545] Clause 93. The device according to Clause 92, wherein the convex rounded upper surface extends a first distance above the surface of the stent, and the sharp elements protrude a second distance from the surface of the convex rounded upper surface, the second distance being equal to the first distance (0.05 mm to 0.1 mm).

[0546] Clause 94. The device according to Clause 92 or 93, wherein the second distance ranges from 0.01 mm to 0.2 mm or from 0.01 mm to 0.1 mm.

[0547] Clause 95. The device according to Clauses 92 to 94, wherein the sharp elements include tips.

[0548] Clause 96. The device according to Clauses 92 to 94, wherein the sharp elements include edges.

[0549] Clause 97. The device according to any one of Clauses 77 to 96, wherein the expandable structure includes an inflatable balloon.

[0550] Clause 98. The device according to Clause 97, wherein the inflatable balloon has a central region, a distal tapered region, and a proximal tapered region, and wherein the stress applying features are present on one or more of these regions.

[0551] Clause 99. The device according to Clause 97 or 98, wherein the stress applying features are present on at least the central region.

[0552] Clause 100. The device according to Clauses 97 to 99, wherein the stress applying features are present on at least one of the distal tapered region and the proximal tapered region.

[0553] Clause 101. The device according to Clause 100, wherein the stress applying features are present on both the distal tapered region and the proximal tapered region.

[0554] Clause 102. The device according to clauses 97 to 101, wherein when the expandable balloon is expanded 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, the expandable balloon has a expansibility of less than 10%.

[0555] Clause 103. The device according to any one of clauses 77 to 102, wherein the stress application feature is attached to the outer surface of the expandable structure by at least one of adhesive bonding, ultrasonic welding, fusion welding, thermal welding, press fitting, solvent bonding, bonding with a polymeric material, using fasteners, and combinations thereof.

[0556] Clause 104. The device according to any one of clauses 77 to 103, further comprising an outer sleeve positioned over the stress application feature on the outer surface of the expandable structure.

[0557] Clause 105. The device according to clause 104, wherein the outer sleeve includes a telescoping sheath configured to protect the stress application feature when the device is advanced and / or retracted within the body cavity.

[0558] Clause 106. The device according to clause 105, wherein the outer sleeve includes an elastomeric tubular member positioned on the outer surface of the expandable structure and conforming to the stress application feature when the expandable structure expands, wherein the elastomeric tubular member is configured to expand and contract with the expandable structure.

[0559] Clause 107. The device according to clause 104, wherein the elastomeric tubular member is laminated or attached to at least a portion of the outer surface of the expandable structure.

[0560] Clause 108. The device according to clause 104, wherein the outer sleeve includes a non-expandable or semi-compliant sheath that is folded over the balloon prior to balloon expansion.

[0561] Clause 109. The device according to clauses 104 to 108, wherein the outer sleeve completely covers the clot disruption feature on the outer surface of the expandable structure.

[0562] Clause 110. The device according to any one of clauses 104 to 109, wherein the outer sleeve includes a polymer.

[0563] Clause 111. The device according to Clauses 106 to 110, wherein at least some of the stress applying features are attached to the inner surface of the elastomeric tubular member.

[0564] Clause 112. The device according to Clause 111, wherein at least some of the stress applying features are formed as protrusions protruding from the inner surface of the elastomeric tubular member.

[0565] Clause 113. The device according to any one of Clauses 77 to 112, wherein at least some of the stress applying features have a base attached to the outer surface of the expandable structure, the base having a width (Wa) in the axial direction and a width (Wc) in the circumferential direction, where the width ratio Wa:Wc is in the range of 1:0.5 to 1:5; typically in the range of 1:1 to 1:5; more commonly in the range of 1:1 to 3:1.

[0566] Clause 114. The device according to Clause 113, wherein at least some of the bases have a circular periphery.

[0567] Clause 115. The device according to Clause 113, wherein at least some of the bases have an oval periphery.

[0568] Clause 116. The device according to any one of Clauses 77 to 115, wherein at least some of the stress applying features are arranged as diametrically opposed pairs of stress applying features.

[0569] Clause 117. The device according to Clause 116, wherein successive, diametrically opposed pairs of stress applying features are circumferentially offset.

[0570] Clause 118. The device according to Clause 117, wherein the successive, diametrically opposed pairs of stress applying features are circumferentially offset by an angle of 45° to 90°.

[0571] Clause 119. The device according to any one of Clauses 77 to 115, wherein at least some of the stress applying features are arranged as triplets of stress applying features, the triplets of stress applying features being circumferentially spaced apart by approximately 120° around a circle on the surface of the expandable structure.

[0572] Clause 120. The device according to any one of Clauses 77 to 119, wherein the inflatable balloon is configured to release an inflation medium comprising a medicament in response to an inflation pressure above a minimum threshold.

[0573] Clause 121. The device according to Clause 120, wherein the minimum threshold is above 3 atm, 5 atm or 7 atm.

[0574] Clause 122. The device according to any one of Clauses 120 to 121, wherein the expandable balloon includes a plurality of ports that open in response to the inflation pressure being higher than the minimum threshold.

[0575] Clause 123. A method for treating calcified lesions on the wall in a body cavity of a patient, the method comprising:

[0576] Positioning an expandable structure at a treatment site near the calcified lesion to be treated;

[0577] Radially expanding the expandable structure outwardly to radially press a plurality of stress-applying features against the calcified lesion, wherein the stress-applying features are distributed on an outer surface of the expandable structure, and at least some of the stress-applying features have a convex rounded upper surface, and wherein radially pressing the plurality of stress-applying features against the calcified lesion causes the calcified lesion to rupture while reducing damage to the wall.

[0578] Clause 124. The method according to Clause 123, wherein the body cavity includes a blood vessel, a valve annulus, a venous valve, or an AV shunt.

[0579] Clause 125. The method according to Clause 123 or 124, wherein the calcified lesion is located within an inner wall, an intima layer, a media layer, an adventitia layer, a valve leaflet, a valve annulus, a venous filter, or an implant.

[0580] Clause 126. The method according to any one of Clauses 123 to 125, wherein the convex rounded upper surface of the stress-applying feature has no edges and irregularities that may damage the blood vessel wall when the expandable structure expands within the body cavity.

[0581] Clause 127. The method according to Clauses 123 to 126, wherein the stress-applying feature includes a sharp element protruding outward from the convex rounded upper surface, and wherein the sharp element is configured to concentrate stress when the convex rounded upper surface presses against the surface of the calcified lesion and engages the calcified lesion on the wall of the blood vessel lumen.

[0582] Clause 128. The method according to Clause 127, wherein the convex rounded upper surface extends a first distance above the surface of the stent, and the sharp element protrudes a second distance from the surface of the convex rounded upper surface, the second distance being equal to the first distance (0.05 mm to 0.1 mm).

[0583] Clause 129. The method according to Clause 127 or 128, wherein the second distance ranges from 0.01 mm to 0.2 mm or from 0.01 mm to 0.1 mm.

[0584] Clause 130. The method according to Clauses 127 to 129, wherein the sharp element includes a tip.

[0585] Clause 131. The method according to Clauses 127 to 129, wherein the sharp element includes an edge.

[0586] Clause 132. The method according to any one of Clauses 123 to 131, wherein the expansion includes inflating a balloon having the plurality of stress applying features independently attached to an outer surface of the balloon.

[0587] Clause 133. The method according to any one of Clauses 123 to 132, wherein at least some of the stress applying features include a sphere or an ellipsoid having a lower surface attached to the outer surface of the expandable structure.

[0588] Clause 134. The method according to any one of Clauses 123 to 132, wherein at least some of the stress applying features include a hemisphere having a lower surface attached to the outer surface of the expandable structure.

[0589] Clause 135. The method according to any one of Clauses 123 to 132, wherein at least some of the stress applying features include a cylinder having a hemispherical upper surface and a lower surface attached to the outer surface of the expandable structure.

[0590] Clause 136. The method according to any one of Clauses 123 to 135, wherein the lower surface is directly attached to the outer surface of the expandable structure.

[0591] Clause 137. The method according to any one of Clauses 123 to 135, wherein the lower surface includes a base directly attached to the outer surface of the expandable structure.

[0592] Clause 138. The method according to any one of Clauses 123 to 137, wherein at least some of the stress applying features have a base attached to the outer surface of the expandable structure, the base having a width (Wa) in the axial direction and a width (Wc) in the circumferential direction, wherein the width ratio Wa:Wc ranges from 1:0.5 to 1:5; typically ranges from 1:1 to 1:5; more commonly ranges from 1:1 to 3:1.

[0593] Clause 139. The method according to Clause 138, wherein at least some of the bases have a circular periphery.

[0594] Clause 140. The method according to Clause 138, wherein at least some of the bases have an oval periphery.

[0595] Clause 141. The method according to any one of Clauses 123 to 140, wherein at least some of the stress application features are arranged as diametrically opposed pairs of stress application features.

[0596] Clause 142. The method according to Clause 141, wherein successive diametrically opposed pairs of stress application features are circumferentially offset.

[0597] Clause 143. The method according to Clause 142, wherein the successive diametrically opposed pairs of stress application features are circumferentially offset by an angle of 45° to 90°.

[0598] Clause 144. The method according to any one of Clauses 123 to 140, wherein at least some of the stress application features are arranged as triplets of stress application features, the triplets of stress application features being circumferentially spaced apart by approximately 120° around a circle on the surface of the expandable structure.

[0599] Clause 145. The method according to any one of Clauses 123 to 144, wherein radially expanding the expandable scoring structure includes inflating an inflatable balloon.

[0600] Clause 146. The method according to Clause 145, wherein when the inflatable balloon is 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, the inflatable balloon has an expansibility of less than 10%.

[0601] Clause 147. The method according to any one of Clauses 145 to 146, wherein the inflatable balloon is inflated to a pressure that presses the convex rounded upper surface of the stress application feature against the inner wall of the body cavity, while the pressure does not engage the outer surface of the inflatable balloon against the inner wall of the body cavity.

[0602] Clause 148. The method according to any one of Clauses 145 to 147, wherein the inflatable balloon retains sufficient flexibility before inflation to advance within the body cavity.

[0603] Clause 149. The method according to any one of Clauses 123 to 148, wherein the stress application feature is attached to the outer surface of the expandable structure by at least one of adhesive, ultrasonic welding, thermal welding, fasteners, solvent bonding, bonding with a polymeric material, or a combination thereof.

[0604] Clause 150. The method according to any one of Clauses 123 to 149, further comprising an outer sleeve positioned over the stress application feature on the outer surface of the expandable structure.

[0605] Clause 151. The method according to Clause 150, wherein the outer sleeve includes a retractable sheath configured to protect the stress application feature when the expandable member advances and / or retracts within the body cavity.

[0606] Clause 152. The method according to Clause 150, wherein the outer sleeve includes an elastomeric tubular member positioned on the outer surface of the expandable structure and aligned with the stress application feature, wherein the elastomeric tubular member is configured to expand and contract with the expandable structure, and the stress application feature is still configured to disrupt plaque when expanded against the plaque.

[0607] Clause 153. The method according to Clause 152, wherein the elastomeric tubular member is laminated to at least a portion of the outer surface of the expandable structure.

[0608] Clause 154. The method according to Clause 150, wherein the outer sleeve includes a non-expandable or semi-compliant sheath folded over the balloon prior to balloon inflation.

[0609] Clause 155. The method according to any one of Clauses 123 to 154, wherein the outer sleeve completely covers the clot disruption feature on the outer surface of the expandable structure.

[0610] Clause 156. The method according to any one of Clauses 153 to 155, wherein at least some of the stress application features are attached to the inner surface of the elastomeric tubular member.

[0611] Clause 157. The method according to Clause 156, wherein at least some of the stress application features are formed as protrusions projecting from the inner surface of the elastomeric tubular member.

[0612] Clause 158. The method according to any one of Clauses 123 to 155, wherein at least some of the stress applying features have a base attached to the outer surface of the expandable structure, the base having a width (Wa) in the axial direction and a width (Wc) in the circumferential direction, where the width ratio Wa:Wc is in the range of 1:0.5 to 1:5; typically in the range of 1:1 to 1:5; more commonly in the range of 1:1 to 3:1.

[0613] Clause 159. The method according to Clause 158, wherein at least some of the bases have a circular periphery.

[0614] Clause 160. The method according to Clause 158, wherein at least some of the bases have an oval periphery.

[0615] Clause 161. The method according to any one of Clauses 123 to 160, wherein at least some of the stress applying features are arranged as diametrically opposed pairs of stress applying features.

[0616] Clause 162. The method according to Clause 161, wherein successive diametrically opposed pairs of stress applying features are circumferentially offset.

[0617] Clause 163. The method according to Clause 162, wherein the successive diametrically opposed pairs of stress applying features are circumferentially offset by an angle of 45° to 90°.

[0618] Clause 164. The method according to any one of Clauses 123 to 160, wherein at least some of the stress applying features are arranged as triplets of stress applying features, the triplets of stress applying features being circumferentially spaced apart by approximately 120° around a circle on the surface of the expandable structure.

[0619] Clause 165. The method according to any one of Clauses 123 to 164, wherein the stress applying features are arranged in a plurality of circumferential ring patterns, where each ring pattern includes from 1 to 10 features, preferably from 2 to 5 features, and more preferably from 3 to 4 features.

[0620] Clause 166. The method according to Clause 165, wherein the circumferential ring patterns are axially spaced apart along the length of the expandable structure, and the spacing gap is in the range of 0.1 mm to 3 mm.

[0621] Clause 167. The method according to Clause 165 or 166, wherein the number of features ranges from 2 to 200 per millimeter of axial length.

[0622] Clause 168. The method according to any one of Clauses 123 to 167 further includes releasing an inflation medium including a medicament through the inflatable balloon in response to an inflation pressure above a minimum threshold.

[0623] Clause 169. The method according to Clause 168, wherein the minimum threshold is above 3 atm, 5 atm or 7 atm.

[0624] Clause 170. The method according to Clause 168 or 169, wherein the inflatable balloon includes a plurality of ports that open in response to the inflation pressure above the minimum threshold.

[0625] Clause 171. An apparatus for treating a patient's valve having calcified leaflets, the apparatus comprising:

[0626] a catheter body having a proximal end and a distal end; and

[0627] a segmented balloon structure disposed at the distal end of the catheter body, the segmented balloon structure having opposing inner walls configured to expand on opposing surfaces of the leaflets to disrupt calcification sites on the calcified valve.

[0628] Clause 172. The apparatus according to Clause 171, wherein the opposing inner walls are configured to close together when the balloon structure expands.

[0629] Clause 173. The apparatus according to Clause 172, wherein the opposing inner walls are configured to nest with each other when the balloon structure expands.

[0630] Clause 174. The apparatus according to Clause 173, wherein the opposing inner walls that nest with each other include conical surfaces that nest with each other.

[0631] Clause 175. The apparatus according to Clause 172, wherein the opposing inner walls include flat surfaces configured to close against each other when the balloon structure expands.

[0632] Clause 176. The apparatus according to Clause 175, wherein the segmented balloon structure includes a pair of opposing conical balloons having flat bottoms that include the flat surfaces.

[0633] Clause 177. The apparatus according to Clauses 171 to 176 further includes a plurality of calcification site disruption features distributed on at least one of the opposing inner walls of the segmented balloon structure.

[0634] Clause 178. The device according to Clause 177, wherein the calcification lesion disrupting features are distributed on two of the opposite inner walls of the segmented balloon structure.

[0635] Clause 179. The device according to Clause 177 or 178, wherein at least some of the calcification lesion disrupting features have a convex rounded leaflet engaging surface configured to rupture the calcification lesions when the balloon structure is expanded in the patient's valve while minimizing damage to the leaflets.

[0636] Clause 180. The device according to any one of Clauses 177 to 179, wherein the convex rounded upper surfaces of the plurality of stress applying features are configured to extend from the opposite inner walls of the balloon when the expandable balloon is inflated.

[0637] Clause 181. The device according to Clause 180, wherein when the balloon is fully inflated, the distance by which the convex rounded upper surfaces extend from the opposite inner walls is in the range of 0.1 mm to 3 mm, preferably in the range of 0.25 mm to 3 mm, more preferably in the range of 0.5 mm to 3 mm.

[0638] Clause 182. The device according to any one of Clauses 204 to 206, wherein the convex rounded upper surfaces of the calcification lesion disrupting features do not have edges and irregularities that may damage the leaflets when the balloon structure is inflated within the patient's valve.

[0639] Clause 183. The device according to Clauses 179 to 182, wherein the calcification lesion disrupting features include sharp elements protruding outwardly from the convex rounded upper surfaces, and wherein the sharp elements are configured to concentrate stress when pressed against the surface of the valve leaflets upon engagement with the calcification lesions on the valve leaflets.

[0640] Clause 184. The device according to any one of Clauses 171 to 183, wherein the balloon segments are fixedly attached to the catheter body with a fixed spacing between the opposite inner walls.

[0641] Clause 185. The device according to any one of Clauses 171 to 183, wherein the balloon segments are configured to translate axially relative to each other on the catheter body with a variable spacing between the opposite inner walls.

[0642] Clause 186. The device according to any one of Clauses 171 to 185, wherein when the balloon segments are brought together, the calcification lesion disrupting features on the opposing surfaces are axially aligned.

[0643] Clause 187. The device according to any one of Clauses 171 to 186, wherein the calcification lesion disrupting feature on the opposing surfaces is laterally offset such that the calcification lesion disrupting features do not axially align when the balloon segments are brought together.

[0644] Clause 188. A method for treating a patient's valve having calcified leaflets, the method comprising:

[0645] providing a catheter body having segments disposed at its distal end

[0646] a balloon structure;

[0647] advancing the segmented balloon structure intravascularly towards the patient's valve; and

[0648] expanding opposing inner walls of the segmented balloon against opposing surfaces of the leaflets

[0649] to disrupt calcification lesions on the calcified valve.

[0650] Clause 189. The method according to Clause 188, wherein the opposing inner walls are configured to close together when the balloon structure expands.

[0651] Clause 190. The method according to Clause 189, wherein the opposing inner walls are configured to nest with each other when the balloon structure expands.

[0652] Clause 191. The method according to Clause 189, wherein the nesting opposing inner walls include nested conical surfaces.

[0653] Clause 192. The method according to Clause 189, wherein the opposing inner walls include flat surfaces configured to close against each other when the balloon structure expands.

[0654] Clause 193. The method according to Clause 192, wherein the segmented balloon structure includes a pair of opposing conical balloons having flat bottoms that include the flat surfaces.

[0655] Clause 194. The method according to Clauses 188 to 193, wherein a plurality of calcification lesion disrupting features are distributed on at least one of the opposing inner walls of the segmented balloon structure.

[0656] Clause 195. The method according to Clause 194, wherein the calcification lesion disrupting features are distributed on both of the opposing inner walls of the segmented balloon structure.

[0657] Clause 196. The method according to Clauses 188 to 195, wherein at least some of the calcification lesion disrupting features have convex rounded leaflet engagement surfaces configured to rupture the calcification lesions when the balloon structure is expanded within the patient's valve while minimizing damage to the leaflets.

[0658] Clause 197. The method according to any one of Clauses 194 to 196, wherein the convex rounded upper surfaces of the plurality of stress applying features are configured to extend from the opposing inner walls of the balloon when the expandable balloon is inflated.

[0659] Clause 198. The method according to Clause 197, wherein when the balloon is fully inflated, the distance that the convex rounded upper surfaces extend from the opposing inner walls is in the range of 0.25 mm to 3 mm, preferably in the range of 0.5 mm to 3 mm.

[0660] Clause 199. The method according to any one of Clauses 196 to 198, wherein the convex rounded upper surfaces of the calcification lesion disrupting features do not have edges and irregularities that may damage the leaflets when the balloon structure is inflated within the patient's valve.

[0661] Clause 200. The method according to Clauses 196 to 198, wherein the calcification lesion disrupting features include sharp elements protruding outward from the convex rounded upper surfaces, and wherein the sharp elements are configured to concentrate stress when pressed against the surface of the valve leaflets upon engagement with the calcification lesions on the valve leaflets.

[0662] Clause 201. The method according to any one of Clauses 188 to 200, wherein the balloon is segmented and fixed to the catheter body with a fixed spacing between the opposing inner walls.

[0663] Clause 202. The method according to any one of Clauses 188 to 200, wherein the balloon segments are configured to translate axially relative to each other on the catheter body, the method further comprising moving the balloon segments together to compress the wall surface against the valve leaflets after the balloon structure is inflated.

[0664] Clause 203. A method for disrupting calcification lesions or plaques at a lesion site, the method comprising:

[0665] Advancing a cannula over a guide wire and through the lesion;

[0666] Advancing an expandable member over the guide wire and into the interior of the cannula; and

[0667] Expand the expandable member within the cannula to radially outwardly displace the feature against the lesion on the inside and / or outside of the cannula, thereby disrupting the calcified lesion or plaque.

[0668] Clause 204. The method according to clause 203 further includes removing the expandable member from the cannula and removing the expandable member and the cannula from the guide wire.

[0669] Clause 205. The method according to clause 204, wherein the expandable structure is a balloon or other expandable member.

[0670] Clause 206. The method according to clause 203, wherein the expandable structure includes a cardiac stent, and wherein after the cardiac stent is expanded, the cannula remains in place between the cardiac stent and the lesion.

[0671] Clause 207. The method according to any one of clauses 203 to 206, wherein when the expandable structure radially outwardly displaces the stress-applying feature during expansion, the stress-applying feature radially outwardly protrudes from the cannula into the vessel wall.

[0672] Clause 208. A method for disrupting a calcified lesion or plaque at a lesion, the method comprising:

[0673] Advance a cage structure or a basket structure on a guide wire and past the lesion; and

[0674] Expand the cage structure or the basket structure to radially displace a stress-applying feature against the lesion on the cage structure or the basket structure, thereby disrupting the calcified lesion or plaque.

[0675] Clause 209. The method according to clause 208, wherein expanding the cage structure or the basket structure includes mechanically reorienting the structural components of the cage structure or the basket structure.

[0676] Clause 210. The method according to clause 208, wherein expanding the cage structure or the basket structure includes inflating a balloon within the cage structure or the basket structure.

[0677] Clause 211. The method according to clause 210, wherein the balloon is advanced to the lesion together with the cage structure or the basket structure.

[0678] Clause 212. The method according to clause 210, wherein the balloon is advanced to the lesion together behind the cage structure or the basket structure.

[0679] Clause 213. An apparatus for treating calcified lesions on the wall in a body cavity of a patient, the apparatus comprising:

[0680] A catheter including a catheter body having a proximal end and a distal segment;

[0681] An expandable structure disposed at the distal segment of the catheter body, the expandable structure having an outer surface configured to radially outwardly displace toward the inner surface of the body cavity wall; and

[0682] A plurality of stress applying features distributed on the outer surface of the expandable structure, wherein at least some of the stress applying features are disposed on the outer surface of the expandable structure and have a convex rounded top configured to rupture the calcified lesion while minimizing damage to the body cavity when the expandable structure expands within the body cavity;

[0683] wherein the convex rounded top of the stress applying feature has a radial height above the outer surface of the expandable structure, the radial height ranging from 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 when the expandable structure expands, the distribution density of the stress applying features ranges from 0.1 feature / mm 2 to 5 features / mm 2 , preferably from 0.2 feature / mm 2 to 4 features / mm 2 , more preferably from 0.25 feature / mm 2 to 3 features / mm 2 .

[0684] Clause 214. The apparatus according to Clause 213, wherein the stress applying feature has a coverage area, and the maximum width, diameter or other lateral dimension of the coverage area is 4 mm or less, often 3 mm or less, more commonly not exceeding 1 mm, and generally not exceeding 0.75 mm, and sometimes not exceeding 0.5 mm.

[0685] Clause 215. The apparatus according to Clause 213 or 214, wherein the stress applying feature includes any one or more of a sphere, a ball, a hemisphere, a partial sphere, a dome and an ellipsoidal solid.

[0686] Clause 216. The apparatus according to Clauses 213 to 215, wherein the stress applying feature is solid.

[0687] Clause 217. The device according to Clauses 213 to 215, wherein the stress application feature is hollow.

[0688] Clause 218. The device according to Clauses 213 to 217, further comprising an encapsulation layer that covers the outer surface of the expandable structure and the stress application feature to fix the stress application feature on the outer surface of the expandable structure in a desired pattern.

[0689] Clause 219. The device according to Clause 218, wherein the stress application feature comprises discrete bodies.

[0690] Clause 220. The device according to Clause 219, wherein the discrete bodies comprise metal.

[0691] Clause 221. The device according to Clauses 218 to 220, wherein the stress application feature is fixed only by the encapsulation layer.

[0692] Clause 222. The device according to Clauses 218 to 220, wherein, in addition to the encapsulation layer, the stress application feature is also fixed by an adhesive between the feature and the outer surface.

[0693] Clause 223. The device according to Clauses 218 to 222, wherein the encapsulation layer encapsulates the entire stress application feature including the convex top.

[0694] Clause 224. The device according to Clauses 218 to 222, wherein the encapsulation layer only encapsulates the lower part of the stress application feature that does not include the convex top.

[0695] Clause 225. The device according to Clauses 213 to 224, wherein the stress application feature is held by a notch in the outer surface of the expandable structure.

[0696] Clause 226. The device according to Clauses 213 to 225, wherein the encapsulation layer comprises a polymer selected from thermoplastic fluoropolymer (PVDF), butyl methacrylate (PBMA), and thermoplastic polyester (PLLA).

[0697] Clause 227. The device according to Clauses 218 to 226, wherein the encapsulation layer is applied to the outer surface and the stress application feature by any one of coating, direct fluid application, lamination, and fusion.

[0698] Clause 228. The device according to Clauses 218 to 227, wherein the thickness of the encapsulation layer ranges from 0.01 mm to 0.1 mm (0.4 mil to 4 mil), often ranges from 0.01 mm to 0.05 mm (0.4 mil to 2 mil), and more commonly ranges from 0.01 mm to 0.02 mm (0.4 mil to 0.8 mil).

[0699] Clause 229. The device according to Clauses 213 to 228, wherein the stress application feature is disposed in a groove formed in the outer surface of the expandable structure.

[0700] Clause 230. The device according to Clauses 213 to 229, wherein the stress application feature is constrained on the outer surface of the expandable structure by an elastic sleeve.

[0701] Clause 231. The device according to Clause 230, wherein the stress application feature is further attached to the outer surface of the expandable structure.

[0702] Clause 232. The device according to Clause 230, wherein the stress application feature is attached to the inner surface of the elastic sleeve.

[0703] Clause 233. The device according to Clauses 213 to 228, wherein the stress application feature is hollow and mounted on a cylinder radially protruding outward from the outer surface of the expandable structure.

[0704] Clause 234. A device for treating calcified lesions on the wall in a body cavity of a patient, the device comprising:

[0705] A catheter including a catheter body having a proximal end and a distal segment;

[0706] An expandable structure disposed at the distal segment of the catheter body, the expandable structure having an outer surface configured to radially displace outwardly towards the inner surface of the body cavity wall;

[0707] A plurality of stress application features distributed on the outer surface of the expandable structure, wherein at least some of the stress application features are present on the outer surface of the expandable structure and have an upper surface configured to rupture the calcified lesion while minimizing damage to the body cavity when the expandable structure expands within the body cavity; and

[0708] An encapsulation layer that covers at least a portion of the outer surface of the expandable structure and the stress applying feature to fix the stress applying feature on the outer surface of the expandable structure in a desired pattern.

[0709] Clause 235. The device according to clause 234, wherein at least some of the upper surfaces of the stress applying features include convex rounded tops.

[0710] Clause 236. The device according to clause 234 or 235, wherein the encapsulation layer covers the entire outer surface including the upper surface of at least some of the stress applying features.

[0711] Clause 237. The device according to clause 234 or 235, wherein the encapsulation layer only covers the lower portion of the outer surface of at least some of the stress applying features.

[0712] Clause 238. The device according to clause 234 or 237, wherein the stress applying features are disposed in recesses on the outer surface of the expandable structure.

[0713] Clause 239. The device according to clause 234, wherein the stress applying feature includes a hemisphere having a flat bottom that adheres to the outer surface of the expandable structure.

[0714] Clause 240. The device according to clauses 234 to 239, wherein the stress applying features include discrete bodies.

[0715] Clause 241. The device according to clause 240, wherein the discrete bodies include metal.

[0716] Clause 242. The device according to clause 234 or 240, wherein the stress applying features include any one or more of spheres, spherical bodies, hemispheres, partial spheres, ellipsoidal solid bodies, and domes.

[0717] Clause 243. The device according to clauses 234 to 242, wherein the stress applying features are fixed only by the encapsulation layer.

[0718] Clause 244. The device according to clauses 234 to 243, wherein in addition to the encapsulation layer, the stress applying features are also fixed by an adhesive between the features and the outer surface.

[0719] Clause 245. The device according to clauses 234 to 244, wherein the encapsulation layer includes a polymer selected from thermoplastic fluoropolymers (PVDF), butyl methacrylate (PBMA), and thermoplastic polyesters (PLLA).

[0720] Clause 246. The device according to Clauses 234 to 245, wherein the encapsulation layer is applied to the outer surface and the stress application feature by any one of coating, direct fluid application, lamination, and fusion.

[0721] Clause 247. The device according to Clauses 234 to 246, wherein the thickness of the encapsulation layer ranges from 0.01 mm to 0.1 mm (0.4 mil to 4 mil), often ranges from 0.01 mm to 0.05 mm (0.4 mil to 2 mil), and more commonly ranges from 0.01 mm to 0.02 mm (0.4 mil to 0.8 mil).

[0722] Clause 248. The device according to Clauses 234 to 247, wherein the convex rounded top of the stress application feature has a radial height above the outer surface of the expandable structure, and the radial height ranges from a minimum value of 0.05 mm, 0.1 mm, 0.15 mm, 0.2 mm, or 0.25 mm to a maximum value of 1 mm, 0.5 mm, 0.4 mm, 0.3 mm, or 0.25 mm, and when the expandable structure expands, the distribution density of the stress application features ranges from 0.1 feature / mm 2 to 5 features / mm 2 , preferably 0.2 features / mm 2 to 4 features / mm 2 , more preferably 0.25 features / mm 2 to 3 features / mm 2 .

[0723] Clause 249. The device according to Clause 248, wherein the plaque disruption feature has a coverage area, and the maximum width, diameter, or other lateral dimension of the coverage area is 4 mm or less, often 3 mm or less, more commonly not exceeding 1 mm, and generally not exceeding 0.75 mm, and sometimes not exceeding 0.5 mm.

[0724] Clause 250. A method for treating a lesion on the wall in a body cavity of a patient, the device comprising:

[0725] providing a catheter having an expandable structure disposed at its distal end, the expandable structure having an outer surface configured to radially outwardly displace towards the inner surface of the body cavity wall, wherein the outer wall has a plurality of spaced-apart features distributed on the outer surface of the expandable structure; and

[0726] Expand the expandable structure in a patient's body cavity such that the outer surface and the feature apply a radially outward force to the wall while the feature maintains a gap between the outer surface and the inner wall of the expandable structure.

[0727] Clause 251. The method according to clause 250, wherein the spacer feature has axially aligned through-holes that permit a contrast agent to pass therethrough.

[0728] Clause 252. The method according to clause 277 or 278, wherein while the expandable structure is expanding, the gap permits fluid to pass therethrough and through the expandable structure for perfusion.

[0729] Clause 253. The method according to clause 277 or 278, further comprising perfusing a drug into the gap while the expandable structure is expanding.

[0730] Clause 254. The method according to clause 253, wherein the expandable structure comprises a balloon and the drug is perfused through the wall of the balloon.

[0731] Clause 255. The method according to clause 254, wherein at least some of the space spacer features comprise a drug released into the gap.

[0732] Clause 256. The method according to clauses 250 to 255, wherein expanding the expandable structure forms one or more gaps between the outer surface and the inner wall of the expandable structure under physiological pressure to permit fluid to be perfused through the one or more gaps.

[0733] Clause 257. The method according to clauses 250 to 256, wherein the body cavity comprises a blood vessel and the in vivo fluid perfusion comprises blood.

[0734] Clause 258. The method according to clause 257, wherein the in vivo fluid perfusion further comprises at least one of a contrast agent and a drug.

[0735] Clause 259. The method according to clauses 250 to 258, wherein at least some of the features have a convex rounded top.

[0736] Clause 260. The method according to Clauses 250 to 259, wherein the feature has a radial height above the outer surface of the expandable structure, and the radial height ranges from a minimum value of 0.05 mm, 0.1 mm, 0.15 mm, 0.2 mm or 0.25 mm to a maximum value of 1 mm, 0.5 mm, 0.4 mm, 0.3 mm or 0.25 mm, and when the expandable structure expands, the distribution density of the features ra...

Claims

1. An apparatus for treating calcified deposits on the wall in a patient's body cavity, the apparatus comprising: a catheter including a catheter body having a proximal end and a distal segment; an expandable structure located at the distal segment of the catheter body, the expandable structure having an outer surface configured to radially outwardly displace towards the inner surface of the body cavity wall; and a plurality of stress application features distributed on at least a portion of the outer surface of the expandable structure, wherein the outer surface of the expandable structure has a plurality of preformed notches, and wherein at least some of the stress application features are cradled and fixed in respective ones of the notches.

2. The device according to claim 1, wherein The expandable structure includes an inflatable balloon.

3. The device according to claim 1 or 2, wherein When the expandable structure expands, the distribution density of the stress application features on at least a portion of the outer surface of the expandable structure is in the range of 0.1 feature / mm 2 to 5 features / mm 2 Preferably, it is in the range of 0.2 feature / mm 2 to 4 features / mm 2 More preferably, it is in the range of 0.25 feature / mm 2 to 3 features / mm 2 within the range.

4. The device according to any one of claims 1 to 3, wherein At least some of the stress application features have a convex rounded top protruding above the outer surface, the convex rounded top being configured to rupture the calcified deposit while minimizing damage to the body cavity when the expandable structure expands within the body cavity.

5. The device according to claim 4, wherein, The convex rounded top of the stress application feature has a radial height above the outer surface of the expandable structure, the radial height ranging from a minimum of 0.05 mm, 0.1 mm, 0.15 mm, 0.2 mm, 0.25 mm, 0.5 mm, and 0.75 mm to a maximum of 1 mm, 0.5 mm, 0.4 mm, 0.3 mm, or 0.25 mm.

6. The device according to any one of claims 1 to 5, wherein, At least some of the stress application features have an upper surface flush with the outer surface.

7. The apparatus according to any one of claims 1 to 6, wherein, At least some of the stress application features have an upper surface flush with the outer surface and are fixed in the notches by adhesion, press fit, encapsulation, ultrasonic welding, and / or a combination thereof.

8. The apparatus according to any one of claims 1 to 7, wherein At least a portion of the outer surface of the expandable structure and the stress application features have no covering structure.

9. The apparatus according to any one of claims 1 to 8, wherein An encapsulation layer covers at least a portion of the outer surface of the expandable structure and the stress application features to fix the stress application features on the outer surface of the expandable structure in a desired pattern.

10. The device according to any one of claims 1 to 8, wherein, The average width and / or depth of the notches is in the range of 0.05 mm to 1 mm, preferably in the range of 0.1 mm to 0.5 mm, more preferably in the range of 0.1 mm to 0.25 mm.

11. The apparatus according to any one of claims 1 to 10, wherein, The inflatable balloon includes an inflatable wall.

12. The device according to any one of claims 1 to 10, wherein The inflatable balloon includes a non-inflatable wall.

13. The device according to any one of claims 1 to 12, wherein, At least some of the notches in the balloon wall are configured to inhibit dimensional change when the balloon expands.

14. The device according to claim 13, wherein, At least some of the notches in the balloon wall are reinforced.

15. The device according to any one of claims 1 to 12, wherein, At least some of the notches in the balloon wall are configured to cause the neck of the notch to contract when the balloon expands to a nominal diameter.

16. The device according to any one of claims 1 to 15, wherein The notches are staggered or patterned along the length and / or circumference of the balloon.

17. The device according to any one of claims 1 to 16, wherein, The balloon has one or more of a cylindrical surface, a conical surface, and opposing surfaces, and the stress application features are provided on some or all of these surfaces.

18. The device according to any one of claims 1 to 17, wherein, The stress application features are harder than the outer surface of the expandable structure.

19. The device according to any one of claims 1 to 18, wherein, The stress applying feature includes at least one of a metallic material, a polymeric material, or a ceramic material.

20. The device according to any one of claims 1 to 19, wherein The stress applying feature is trauma resistant, trauma resistant and coated, non-sharp, blunt.

21. The apparatus according to any one of claims 1 to 20, wherein, The stress applying feature is roughened by sandblasting or other means to enhance rupture or enhance adhesion or enhance encapsulation of the material.

22. The apparatus according to any one of claims 1 to 21, wherein, The stress applying feature includes a magnet or a magnetizable material.

23. The device according to any one of claims 1 to 22, wherein, The stress applying feature includes one or more of a sphere, a hemisphere, a portion of a sphere, a disc, a cylinder, and a cone.

24. The device according to any one of claims 1 to 23, wherein, At least some of the stress applying features have a base and a crown, wherein the base of at least some of the stress applying features is disposed in at least some of the plurality of preformed recesses.

25. The device according to claim 24, wherein, At least some of the stress applying features include a core material encapsulated in a hardened material.

26. The device according to claim 24 or 25, wherein, At least a portion of the base of at least some of the stress applying features is encapsulated in the hardened material.

27. The device according to claim 24 or 25, wherein, At least a portion of the crown of at least some of the stress applying features is encapsulated in the hardened material.

28. The device according to any one of claims 24 to 27, wherein At least a portion of each of the base and the crown of at least some of the stress applying features is encapsulated in the hardened material.

29. The device according to any one of claims 24 to 28, wherein The entire outer surface of at least some of the stress applying features is encapsulated in the hardened material.

30. The device according to any one of claims 24 to 29, wherein, The core material includes at least one of a polymeric material and a ceramic material, and the hardened material includes at least one of a metallic material, a polymeric material, and a ceramic material having a hardness greater than the hardness of the core material.

31. The device according to any one of claims 1 to 30, wherein, The stress applying features are partially or fully distributed on the surface of at least one portion of the expandable balloon, the at least one portion being selected from the group consisting of a central cylindrical portion, a central depression, a central waist portion, a flat end portion, a tapered end portion, and a conical end portion.

32. The device according to claim 31, wherein, At least one surface of at least one portion of the expandable balloon has no stress applying features distributed thereon, the at least one portion being selected from the group consisting of a central cylindrical portion, a central depression, a central waist portion, a flat end portion, a tapered end portion, and a conical end portion.

33. The device according to claim 31 or 32, wherein, The expandable balloon includes a segmented balloon structure disposed at the distal end of the catheter body, the segmented balloon structure having opposing inner walls configured to expand against opposing surfaces of the valve leaflets of a calcified valve to disrupt calcified deposits on the calcified valve.

34. An apparatus for treating calcified deposits on a wall in a body cavity of a patient, the apparatus comprising: a catheter including a catheter body having a proximal end and a distal segment; an expandable structure disposed at the distal segment of the catheter body, the expandable structure having an outer surface configured to radially outwardly displace toward the inner surface of the body cavity wall; and a plurality of stress applying features distributed on the outer surface of the expandable structure; and An energy source, the energy source being within the interior of the expandable structure, the energy source being configured to deliver energy to the plaque disruption feature to enhance the plaque disruption effect.

35. An apparatus for treating a calcification on a wall in a body cavity of a patient, the apparatus comprising: A catheter, the catheter including a catheter body having a proximal end and a distal segment; An expandable structure disposed at the distal segment of the catheter, the expandable structure having an outer surface configured to radially outwardly displace toward the inner surface of the body cavity wall; And A plurality of stress application features distributed on the outer surface of the expandable structure, wherein at least some of the stress application features are harder than the outer surface of the expandable structure.

36. The apparatus according to claim 35, wherein, The stress application features include at least one of a metallic material, a polymeric material, or a ceramic material.

37. The device according to claims 35 and 36, wherein, The stress application features are trauma - resistant, coated, non - sharp, or blunt.

38. The device according to any one of claims 35 to 37, wherein The stress application features are roughened by sandblasting or other means to enhance one or more of the cracking ability, surface adhesion, and encapsulation ability.

39. The apparatus according to any one of claims 35 to 38, wherein The stress application features include magnets or magnetizable materials.

40. The apparatus according to any one of claims 35 to 39, wherein, The stress application features are shaped as spheres, hemispheres, spherical portions, partial spheres, disks, cylinders, or cones.

41. The device according to any one of claims 35 to 40, wherein, The stress application features include a core covered by a hardened shell.

42. An apparatus, comprising: A catheter, the catheter including a catheter body having a proximal end and a distal segment; A balloon having a surface, wherein the surface has a plurality of pre - formed notches formed on at least a portion of the surface, the surface being attached to or attached to the distal segment of the catheter body; And A plurality of stress application features, each stress application feature having a base, a crown, and an outer surface, wherein the base of at least some of the stress application features is disposed in at least some of the plurality of pre - formed notches.

43. The apparatus according to claim 42, wherein, At least some of the stress application features include a core material encapsulated in a hardened material.

44. The apparatus according to claim 43, wherein, At least a portion of the base of at least some of the stress application features is encapsulated in the hardened material.

45. The apparatus according to claims 43 and 44, wherein, At least a portion of the crown of at least some of the stress application features is encapsulated in the hardened material.

46. The apparatus according to any one of claims 43 to 45, wherein, At least a portion of each of the base and the crown of at least some of the stress application features is encapsulated in the hardened material.

47. The device according to any one of claims 43 to 46, wherein, The entire outer surface of at least some of the stress application features is encapsulated in the hardened material.

48. The device according to any one of claims 42 to 47, wherein, The core material includes at least one of a polymeric material and a ceramic material, and the hardened material includes at least one of a metallic material, a polymeric material, and a ceramic material having a hardness greater than the hardness of the core material.

49. A method, comprising: Providing a balloon having an outer surface; Forming a plurality of notches on at least a portion of the outer surface of the balloon; Dispensing a first adhesive into each of the notches; placing a stress applying feature into each of the recesses to displace a portion of the adhesive onto the outer surface of the balloon to surround each plaque disrupting feature; as well as Each stress applying feature is covered with a dot layer of a second adhesive, wherein the dot layer forms a seal with the first adhesive displaced onto the outer surface of the balloon to surround each plaque disrupting feature.

50. The method according to claim 49, wherein, The first adhesive and the second adhesive include the same material.

51. The method according to claim 49, wherein, The first adhesive and the second adhesive include different materials.

52. The method according to claims 49 to 51 further includes at least one of the following steps: (a) coating the outer surface of at least the working length of the balloon with an elastic polymer base layer; and (2) forming an elastic polymer covering layer on the outer surface of at least the working length of the balloon.

53. The method according to claim 52 also includes two of the following steps: (a) coating the outer surface of at least the working length of the balloon with an elastic polymer base layer; and (2) forming an elastic polymer covering layer on the outer surface of at least the working length of the balloon.

54. The method according to claim 52 or 53, wherein, Coating the outer surface of the balloon with an elastic polymer base layer includes coating the outer surface with a curable elastic adhesive and curing the elastic adhesive.

55. The method according to any one of claims 49 to 54, wherein, The elastomeric adhesive dispensed into the recess comprises a light curing acrylic adhesive.

56. The method according to claim 55, wherein, The dot layer includes a light-curing acrylic adhesive.

57. The method according to claim 56, wherein The elastomeric adhesive dispensed into the recess and the dot layer comprise chemically similar light-curing acrylic adhesives that fuse together when cured.

58. An apparatus for treating a valve in a patient having calcified leaflets, the apparatus comprising: a catheter body having a proximal end and a distal end; a segmented balloon structure disposed at the distal end of the catheter body, the segmented balloon structure having opposing inner walls configured to be deployed on opposing surfaces of the calcified leaflets to destroy calcifications on the calcified valve; and Features are provided on one or both of the opposing inner walls, the features being configured to disrupt calcified plaque on the valve leaflets when the opposing inner walls are deployed.

59. The device according to claim 58, wherein, The opposing inner walls are configured to close together when the balloon structure is expanded.

60. The apparatus according to claim 58, wherein, The segments are configured to gather upon expansion of the balloon structure to capture the calcified valve leaflets between the segments.

61. The apparatus according to any one of claims 58 to 60, wherein, The feature includes a plate.

62. The apparatus according to any one of claims 58 to 60, wherein, The feature includes a protrusion on one of the opposing inner walls and a cavity on the other of the opposing inner walls, wherein the protrusion is configured to fit into the cavity when the opposing surfaces are unfolded.

63. An apparatus for treating a valve in a patient having calcified leaflets, the apparatus comprising: a catheter body having a proximal end and a distal end; and A segmented structure, the segmented structure being disposed at the distal end of the catheter body, the segmented structure having opposing inner walls configured to deploy on opposing surfaces of the leaflets to disrupt calcification sites on a calcified valve; wherein the opposing inner walls are configured to open to receive the leaflets and close to capture the leaflets, thereby applying stress to calcification sites on the leaflets.

64. The apparatus according to claim 63, wherein, The segmented structure includes two elements, each of the two elements including one of the opposing inner walls, wherein the elements are configured to close together to capture the leaflets and apply stress to the leaflets.

65. The apparatus according to claim 64, wherein, The elements are expandable.

66. The apparatus according to claim 64, wherein, The elements are non-expandable.

67. The apparatus according to any one of claims 63 to 66, wherein, At least one of the opposing inner walls includes stress-applying features.

68. An apparatus for treating a patient's valve having calcified leaflets, the apparatus comprising: A catheter body having a proximal end and a distal end; and A segmented balloon structure disposed at the distal end of the catheter body, the segmented balloon structure having opposing inner walls configured to deploy on opposing surfaces of the leaflets to disrupt calcification sites on a calcified valve; and wherein two balloon segments are initially spaced apart on the catheter body, and wherein the two balloon segments are configured to deploy such that the opposing inner walls converge to capture a calcified leaflet between the opposing inner walls.

69. A method for attaching stress-applying features to an outer surface of a cylindrical support structure, the method comprising: Providing a cylindrical carrier template having an outer surface; Marking a pattern of attachment locations on at least a portion of the outer surface of the carrier template; Securing stress-applying features to the outer surface of the carrier template at at least some of the attachment locations; Placing the carrier template on the outer surface of the cylindrical support structure; and Securing an inner surface of the carrier template to the outer surface of the support structure.

70. The method according to claim 69, wherein, Marking the pattern of attachment locations on at least a portion of the outer surface of the carrier template includes: forming notches at the attachment locations.

71. The method according to claim 69 or 70, wherein, Securing the stress-applying features to the outer surface of the carrier template includes: dispensing an adhesive into at least some of the attachment locations.

72. An apparatus for treating a heart valve having calcified leaflets, the apparatus comprising: A catheter body having a proximal end and a distal end; and A balloon structure disposed at the distal end of the catheter body, the balloon structure having an outer surface configured to deploy within the heart valve when the calcified leaflets are everted; A cannula configured to be positioned above the annulus of the heart valve and between the heart valve leaflets and the aortic wall; wherein the balloon structure is configured to capture the valve leaflets between the outer surface of the balloon and the inner surface of the cannula when the balloon is inflated.

73. The device for treating a heart valve with calcified leaflets according to claim 72, wherein, At least one of the outer surface of the balloon and the inner surface of the cannula includes stress-applying features.

74. The device for treating a heart valve with calcified leaflets according to claim 73, wherein, Each of the outer surface of the balloon and the inner surface of the cannula includes a stress application feature.

75. The device for treating a heart valve having calcified leaflets according to claims 72 to 74, further comprising an elongate deployment member having the cannula at its distal end.

76. A device for treating calcified lesions on a wall in a body cavity of a patient, the device comprising: a catheter including a catheter body having a proximal end and a distal segment; an expandable structure disposed at the distal segment of the catheter body, the expandable structure having an outer surface configured to radially outwardly displace toward the inner surface of the body cavity wall; and a plurality of needle-shaped stress application features distributed on at least a portion of the outer surface of the expandable structure; wherein at least a distal portion of at least some of the needle-shaped stress application features has a trauma protection covering at its distal tip.

77. The apparatus according to claim 76, wherein, The expandable structure includes an inflatable balloon.

78. The apparatus according to claims 76 and 77, wherein, At least some of the needle-shaped stress application features have sharp distal tips.

79. The device according to claim 78, wherein, The trauma protection covering is compressible to expose the sharp distal tip when the covering is pressed against a calcified plaque.

80. A device for treating calcified lesions on a wall in a body cavity of a patient, the device comprising: a catheter including a catheter body having a proximal end and a distal segment; an expandable structure disposed at the distal segment of the catheter body, the expandable structure having an outer surface configured to radially outwardly displace toward the inner surface of the body cavity wall; and a plurality of elongate blade-shaped stress application features distributed on at least a portion of the outer surface of the expandable structure; wherein at least some of the blade-shaped stress application features have a compressible trauma protection covering thereon.

81. The apparatus according to claim 80, wherein, The expandable structure includes an inflatable balloon.

82. The apparatus according to claims 80 and 81, wherein, Before the trauma protection covering is compressed, the covering covers the entire blade-shaped stress application feature including a sharp edge.

83. The apparatus according to claim 82, wherein, Before the trauma protection covering is compressed, the sharp edge is exposed on the surface of the covering.

84. A device for treating calcified lesions on a wall in a body cavity of a patient, the device comprising: a catheter including a catheter body having a proximal end and a distal end; an inflatable polymer balloon attached to the distal end of the catheter body, the inflatable polymer balloon including a balloon wall and an outer surface composed of a single polymer layer, the outer surface configured to radially outwardly displace toward the inner surface of the body cavity wall when the balloon is inflated; and A plurality of rigid stress - applying features distributed over at least a portion of the outer surface of the expandable polymeric balloon, wherein each of the rigid stress - applying features has a bottom that is directly adhered to the outer surface of the single polymeric layer by one or more layers of adhesive polymer, and the compliance of the adhesive polymer is equal to or greater than the compliance of the single polymeric layer.

85. The apparatus according to claim 84, wherein, The compliance of the single polymeric layer of the balloon is in the range of 0% to 25%, in the range of 1% to 25%, preferably in the range of 5% to 20%, and more preferably in the range of 5% to 15%.

86. The apparatus according to claims 84 and 85, wherein, The compliance of the adhesive polymer is in the range of 1% to 30%, in the range of 2% to 30%, preferably in the range of 5% to 25%, and more preferably in the range of 5% to 20%.

87. The apparatus according to any one of claims 84 to 86, wherein, The single polymeric layer has a uniform wall thickness over at least a portion of the balloon wall.

88. The device according to claim 87, wherein, At least on the cylindrical wall portion, the variation in the balloon wall thickness does not exceed ±20%, and typically does not exceed ±10%.

89. The device according to claims 84 to 88, further comprising a polymeric adhesive base layer formed on the outer balloon surface under the bottom of the rigid stress - applying feature, and the compliance of the polymeric adhesive base layer is equal to or greater than the compliance of the single polymeric layer.

90. The device according to claims 84 to 89, further comprising a plurality of polymeric adhesive dot layers between the outer surface of the balloon and the bottom of the rigid stress - applying feature, and the compliance of the plurality of polymeric adhesive dot layers is equal to or greater than the compliance of the single polymeric layer.

91. The device according to claim 90, comprising the polymeric adhesive base layer and the plurality of polymeric adhesive dot layers.

92. The apparatus according to claim 91, wherein, The polymeric adhesive base layer and the plurality of polymeric adhesive dot layers comprise the same polymeric adhesive.

93. The apparatus according to claim 91, wherein, The polymeric adhesive base layer and the plurality of polymeric adhesive dot layers comprise different polymeric adhesives.

94. The device according to claims 84 to 93, further comprising a polymeric adhesive covering layer formed on at least a portion of the rigid stress - applying feature and the outer balloon surface of the rigid stress - applying feature, and the compliance of the polymeric adhesive covering layer is equal to or greater than the compliance of the single polymeric layer.

95. The apparatus according to claim 94, wherein, The compliance of the polymeric adhesive covering layer is in the range of 1% to 30%, in the range of 2% to 30%, preferably in the range of 5% to 25%, and more preferably in the range of 5% to 20%.

96. The device according to claims 94 and 95, wherein, A plurality of polymeric adhesive dot covering layers cover the rigid stress - applying feature and the region of the outer balloon surface adjacent to the bottom of the rigid stress - applying feature at the periphery.

97. The apparatus according to claims 94 and 95, wherein, A polymeric adhesive continuous covering layer covers all of the rigid stress - applying features and at least a portion of the outer balloon surface.

98. The device according to claim 97, wherein, The polymeric adhesive continuous covering layer covers the entire outer balloon surface.

99. The device according to claim 97, comprising the polymer adhesive dot covering layer and the polymer adhesive continuous covering layer, wherein the continuous covering layer covers the dot covering layer.

100. The apparatus according to claim 99, wherein, The polymer adhesive continuous covering layer and the plurality of polymer adhesive dot covering layers comprise the same polymer adhesive.

101. The apparatus according to claim 99, wherein, The polymer adhesive base layer and the plurality of polymer adhesive dot layers comprise different polymer adhesives.

102. The apparatus according to any one of claims 84 to 101, wherein, The rigid stress applying feature comprises metal.

103. The apparatus according to any one of claims 84 to 102, wherein The rigid stress applying feature has a convex circular upper surface configured to break the calcified deposit when the expandable structure expands within the body cavity.

104. The apparatus according to claim 103, wherein, The rigid stress applying feature is shaped as a sphere, hemisphere, spherical portion, partial sphere, disc, cylinder or cone.

105. The apparatus according to claims 103 and 104, wherein, The rigid stress applying feature has a flat or wavy profiled bottom adhesively bonded to the outer balloon surface.

106. The apparatus according to any one of claims 84 to 105, wherein, The rigid stress applying feature is disposed in a recess formed in the outer surface of the balloon.

107. A device for treating calcified deposits on the wall in a body cavity of a patient, the device comprising: a catheter, the catheter comprising a catheter body having a proximal end and a distal end; an inflatable polymer balloon attached to the distal end of the catheter body, the inflatable polymer balloon comprising a polymer balloon wall having a hardness; and a plurality of rigid stress applying features distributed on at least a portion of the outer surface of the polymer balloon wall, wherein the hardness of the rigid stress applying feature is greater than the hardness of the inflatable polymer balloon, and the rigid stress applying feature has a bottom directly attached to the outer surface of the polymer layer by one or more layers of an adhesive polymer, wherein the hardness of the adhesive polymer when cured is not greater than the hardness of the balloon.

108. The apparatus according to claim 107, wherein, The hardness of the one or more adhesive polymers when cured is less than the hardness of the balloon.

109. The device according to claim 108, wherein the Shore hardness of the inflatable balloon is in the range of 60D to 80D, wherein the Shore hardness of the one or more polymer adhesives when cured is in the range of 50D to 65D, and wherein the Mohs hardness of the rigid stress applying feature is greater than 4, preferably 8.

110. The device according to claims 107 to 109, wherein one of the layers is a dot adhesive located above the first adhesive polymer layer and below the stress applying feature.

111. The device according to any one of claims 107 to 110, wherein There are two adhesive polymer layers on the outer surface of the balloon and a dot adhesive attaching the stress applying feature.

112. The device according to any one of claims 107 to 111, wherein, The hardness of the dot adhesive is less than the hardness of the balloon but greater than the hardness of either of the two adhesive layers.

113. A device for treating calcified deposits on the wall in a body cavity of a patient, the device comprising: a catheter, the catheter comprising a catheter body having a proximal end and a distal end; An inflatable polymer balloon attached to the distal end of the catheter body, the inflatable polymer balloon comprising a polymer balloon wall consisting of a single polymer layer having a wall thickness; A polymer base layer formed on the outer surface of the inflatable polymer balloon; And A plurality of rigid stress applying features distributed on at least a portion of the outer surface of the polymer base layer.

114. The apparatus according to claim 113, wherein, The polymer base layer covers at least the working length of the outer surface of the inflatable polymer balloon.

115. The apparatus according to claim 114, wherein, The polymer base layer covers the entire outer surface of the inflatable polymer balloon.

116. The apparatus according to claim 113, wherein, The polymer base layer includes axial strips located on the balloon surface.

117. The apparatus according to claim 113, wherein, The polymer base layer includes circumferential strips located on the balloon surface.

118. The device according to any one of claims 113 to 117, wherein, The hardness of the polymer base layer is less than the hardness of the inflatable polymer balloon.

119. The device according to any one of claims 113 to 117, wherein, The hardness of the polymer base layer is greater than the hardness of the inflatable polymer balloon.

120. The device according to claims 113 to 119, further comprising a polymer covering layer formed on the plurality of rigid stress applying features and the polymer base layer, wherein the thickness of the polymer base layer is not greater than 50% of the wall thickness of the inflatable polymer balloon.

121. The apparatus according to any one of claims 113 to 120, wherein, The Shore D hardness of the polymer balloon wall is in the range of 60D to 80D, and the Shore D hardness of the polymer base layer is in the range of 50D to 65D.

122. A device for treating calcified lesions on the wall in a patient's body cavity, the device comprising: A catheter including a catheter body having a proximal end and a distal end; An inflatable polymer balloon attached to the distal end of the catheter body, the inflatable polymer balloon comprising a polymer balloon wall consisting of a single polymer layer having a wall thickness; A plurality of rigid stress applying features distributed on at least a portion of the outer surface of the polymer balloon wall; And A polymer covering layer formed on the plurality of rigid stress applying features and the outer surface of the polymer balloon wall.

123. The apparatus according to claim 122, wherein, The thickness of the polymer covering layer is not greater than 50% of the wall thickness of the inflatable polymer balloon.

124. The apparatus according to claim 122 or 123, wherein, The polymer covering layer covers at least the working length of the outer surface of the inflatable polymer balloon.

125. The apparatus according to claim 124, wherein, The polymer covering layer covers the entire outer surface of the inflatable polymer balloon.

126. The apparatus according to claim 122, wherein, The polymer covering layer includes axial strips located on the balloon surface.

127. The apparatus according to claim 122, wherein, The polymer covering layer includes circumferential strips located on the balloon surface.

128. The apparatus according to any one of claims 122 to 127, wherein The hardness of the polymer covering layer is less than the hardness of the inflatable polymer balloon.

129. The apparatus according to any one of claims 122 to 127, wherein The hardness of the polymer covering layer is greater than the hardness of the inflatable polymer balloon. The device according to any one of claims 122 to 129 further comprises a polymeric base layer formed on the outer surface of the expandable polymeric balloon and located beneath at least some of the plurality of rigid stress applying features, wherein the thickness of the polymeric base layer is not greater than 50% of the wall thickness of the expandable polymeric balloon.

131. The apparatus according to any one of claims 122 to 130, wherein, The Shore D hardness of the polymeric balloon wall is in the range of 60D to 80D, and the Shore D hardness of the polymeric covering layer is in the range of 50D to 65D.

132. A device for treating calcified lesions on the wall in a body cavity of a patient, the device comprising: a catheter including a catheter body having a proximal end and a distal end; an expandable polymeric balloon attached to the distal end of the catheter body, the expandable polymeric balloon having a hardness and an outer surface configured to radially outwardly displace towards the inner surface of the body cavity wall; a plurality of discrete stress applying features, each of the plurality of discrete stress applying features having a hardness, a bottom, and a rounded convex upper surface, wherein the discrete stress applying features are distributed on at least a portion of the outer surface; at least a first polymeric adhesive layer disposed between the bottom of the discrete stress applying features and the outer surface of the expandable polymeric balloon.

133. The apparatus according to claim 132, wherein, The first polymeric adhesive layer includes a base layer configured to cover a continuous surface area of the outer balloon surface, wherein the continuous surface area is large enough to be located beneath at least a plurality of the plurality of discrete stress applying features, and the at least a plurality of the plurality of discrete stress applying features are distributed on the continuous surface area in both the axial direction and the circumferential direction.

134. The apparatus according to claim 133, wherein, The continuous surface area is large enough to be located beneath at least a majority of the plurality of discrete stress applying features.

135. The device according to claim 134, wherein, The continuous surface area is large enough to be located beneath all of the plurality of discrete stress applying features.

136. The apparatus according to any one of claims 133 to 135, wherein, The first adhesive layer is softer than the polymeric balloon.

137. The apparatus according to any one of claims 133 to 136, wherein, The continuous surface area includes at least a cylindrical region of the outer surface of the balloon.

138. The device according to any one of claims 133 to 137, wherein, The continuous surface area includes at least a portion of a tapered end region or a conical end region of the outer surface of the balloon.

139. The apparatus according to any one of claims 133 to 136, wherein, The continuous surface area includes at least one helical strip disposed on the cylindrical region and / or the tapered or conical region of the balloon. The device according to any one of claims 133 to 136, wherein The continuous surface area includes at least one axial strip disposed on the cylindrical region and / or the tapered or conical region of the balloon.

141. The apparatus according to any one of claims 133 to 136, wherein, The continuous surface area includes at least one circumferential band disposed on the cylindrical region and / or the tapered or conical region of the balloon.

142. The apparatus according to any one of claims 133 to 136, wherein The continuous surface area includes a random two-dimensional pattern.

143. The apparatus according to any one of claims 133 to 136, wherein, The continuous surface of the balloon includes a cylindrical surface, and the plurality of discrete stress applying features are arranged in a plurality of circumferentially adjacent bands axially spaced apart along the cylindrical surface. The device according to any one of claims 133 to 143 further comprises at least a second polymeric adhesive layer disposed between the bottom of the discrete stress applying feature and the outer surface of the expandable polymeric balloon.

145. The device according to claim 144, wherein, Both the first polymeric adhesive layer and the second polymeric adhesive layer cover the same continuous surface area of the outer balloon surface.

146. The apparatus according to claim 144, wherein, The first polymeric adhesive layer and the second polymeric adhesive layer each cover a different continuous surface area of the outer balloon surface.

147. The apparatus according to any one of claims 144 to 146, wherein, The thickness of each of the first polymeric adhesive layer and the second polymeric adhesive layer is not greater than 50% of the wall thickness of the expandable polymeric balloon.

148. The apparatus according to claim 144, wherein, The second adhesive layer comprises a plurality of adhesive dots.

149. The device according to claim 148, wherein, Each adhesive dot is located beneath a respective, discrete stress applying feature and on the outer surface of the balloon. The apparatus according to claims 148 and 149, wherein, The adhesive dots are located on the first polymeric adhesive layer and beneath the discrete stress applying features.

151. The device according to claims 148 and 149, wherein, The adhesive dots are located beneath the first polymeric adhesive layer and the discrete stress applying features and on the outer surface of the balloon.

152. The device according to any one of claims 144 to 151, wherein, The first polymeric adhesive layer and the second polymeric adhesive layer comprise the same adhesive polymeric material.

153. The apparatus according to any one of claims 144 to 151, wherein, The first polymeric adhesive layer and the second polymeric adhesive layer comprise different adhesive polymeric materials.

154. The apparatus according to any one of claims 144 to 153, wherein, The adhesive layer directly attached to the outer surface of the balloon is softer than the adhesive layer directly attached to the bottom of the stress applying feature. The apparatus according to any one of claims 144 to 153, wherein The first polymeric adhesive layer and / or the second polymeric adhesive layer comprises one or more adhesive materials.

156. The device according to any one of claims 133 to 155 further comprises a first polymeric covering layer.

157. The apparatus according to claim 156, wherein, The first polymeric covering layer covers the outer surface of the balloon.

158. The apparatus according to claims 156 and 157, wherein, The first polymeric covering layer covers at least some of the plurality of discrete stress applying features.

159. The apparatus according to any one of claims 156 to 158, wherein, The first polymeric covering layer covers at least a portion of the first polymeric adhesive layer.

160. The apparatus according to any one of claims 156 to 159, wherein The first polymeric covering layer covers at least a portion of the first polymeric adhesive layer.

161. The apparatus according to any one of claims 156 to 160, wherein, The first polymeric covering layer comprises a polymeric adhesive.

162. The apparatus according to any one of claims 156 to 161, wherein The first polymeric adhesive layer has a hardness upon curing that is less than the hardness of the wall of the expandable polymeric balloon and less than the hardness of the discrete stress applying feature, and wherein the first polymeric adhesive is configured to accommodate the different expansions between the bottom of the discrete stress applying feature and the outer surface of the expandable polymeric balloon when the balloon expands.

163. The apparatus according to claim 162, wherein, The discrete stress applying feature has a hardness of at least 4 Mohs, the Shore hardness of the polymeric balloon wall is in the range of 60D to 90D, and the Shore hardness of the first polymeric adhesive is in the range of 50D to 70D.

164. The apparatus according to claims 162 and 163, wherein, The discrete stress applying feature comprises at least one of a metal, a metal alloy, a mineral, a ceramic, and a hardened polymer.

165. The apparatus according to claim 164, wherein, The discrete stress applying feature comprises a metal or a metal alloy, the metal or metal alloy comprising at least one of iron, platinum, cobalt, chromium, rhodium, titanium, tungsten, and nickel.

166. The device according to any one of claims 162 to 165, wherein The polymer balloon comprises at least one of nylon, polyamide block copolymer, and polyethylene terephthalate (PET).

167. The apparatus according to any one of claims 132 to 166, wherein, Any one or more of the first polymer adhesive layer, the second polymer adhesive layer, and the first polymer covering layer comprises at least one of polymethacrylate, polyurethane-methacrylate, isobornyl acrylate, acrylate urethane methacrylate, methacrylate acrylate, modified methacrylate, polyester, epoxy adhesive, phenolic adhesive, polyvinyl acetate, polyethylene-vinyl acetate, polyethylene-methacrylate, polyethylene, acrylic acid, cyanoacrylate, mixed cyanoacrylate / epoxy adhesive, urea formaldehyde, polyimide, natural or synthetic rubber modified with tackifying resin, styrene-butadiene rubber latex, silicone rubber, anaerobic adhesive, mussel adhesive protein, polydopamine-clay-polyacrylamide, Caulobacter crescentus, Delo Monopox, or a combination thereof.

168. The device according to any one of claims 132 to 167 further comprises at least a second polymer adhesive layer disposed between the bottom of the stress application feature and the outer surface of the expandable polymer balloon, wherein the hardness of the at least second polymer adhesive layer upon curing is greater than or equal to the hardness of the first polymer adhesive layer. Typically, the at least second polymer adhesive layer has a Shore hardness in the range of 50D to 70D upon curing.

169. The apparatus according to claim 168, wherein, The first polymer adhesive layer and the second polymer adhesive layer have the same hardness.

170. The apparatus according to claim 168, wherein, The first polymer adhesive layer and the second polymer adhesive layer have different hardnesses.

171. The apparatus according to any one of claims 168 to 170, wherein, The second polymer adhesive comprises dot adhesives.

172. The apparatus according to claim 171, wherein, The dot adhesives are formed on the first polymer adhesive layer. The apparatus according to claim 171, wherein, The dot adhesives are formed below the first polymer adhesive layer.

174. The apparatus according to claim 173, wherein, The Shore hardness of the first polymer covering layer is in the range of 50D to 70D.

175. The device according to any one of claims 156 to 174 further comprises a second polymer covering layer formed on the outer surface of the balloon and covering the plurality of discrete stress application features.

176. The device according to claim 175, wherein, The second polymer covering layer comprises a polymer adhesive.

177. The apparatus according to claims 175 and 176, wherein, The thickness of each of the first polymer covering layer and the second polymer covering layer is not greater than 50% of the wall thickness of the expandable polymer balloon. The device according to any one of claims 175 to 177, wherein The Shore hardness of the second polymer covering layer is in the range of 50D to 70D. The apparatus according to any one of claims 132 to 178, wherein The balloon wall is composed of a single layer of polymer material. The apparatus according to any one of claims 132 to 179, wherein The balloon wall is composed of a single material having a hardness in the range of 55D to 90D.

181. The apparatus according to claims 179 and 180, wherein, The polymer material comprises a homogeneous polymer composition.

182. The apparatus according to any one of claims 132 to 181, wherein, At least some of the plurality of discrete stress application features are formed as an integral structure.

183. The apparatus according to any one of claims 132 to 181, wherein, At least some of the plurality of discrete stress application features are formed as a multi-piece structure.

184. The device according to any one of claims 175 to 183, wherein, At least one of the first polymer adhesive layer, the second polymer adhesive layer, the first polymer covering layer, and the second polymer adhesive covering layer comprises a homogeneous polymer material.

185. The device according to any one of claims 175 to 183, wherein At least one of the first polymer adhesive layer, the second polymer adhesive layer, the first polymer covering layer, and the second polymer adhesive covering layer includes a reinforcement, a filler, a crosslinking agent, or an additive.

186. The device according to any one of claims 144 to 185, wherein, The first polymer adhesive layer and / or the second polymer adhesive layer attach the bottom of the discrete stress applying feature to the outer surface of the expandable polymer balloon.

187. The device according to any one of claims 175 to 185, wherein, The first polymer adhesive layer, the second polymer adhesive layer, the first polymer adhesive covering, and / or the second polymer adhesive covering each include at least one polymer selected from polymethacrylate, polyurethane-methacrylate, isobornyl acrylate, acrylate urethane methacrylate, methacrylate acrylate, modified methacrylate, polyester, epoxy adhesive, phenolic adhesive, polyvinyl acetate, polyethylene-vinyl acetate, polyethylene-methacrylate, polyethylene, acrylic acid, cyanoacrylate, hybrid cyanoacrylate / epoxy adhesive, urea formaldehyde, polyimide, natural or synthetic rubber modified with tackifying resin, styrene-butadiene rubber latex, silicone rubber, anaerobic adhesive, mussel adhesion protein, polydopamine-clay-polyacrylamide, Caulobacter crescentus, Delo Monopox, and combinations thereof.

188. A device for treating calcified lesions on the wall in a body cavity of a patient, the device comprising: A catheter including a catheter body having a proximal end and a distal end; An expandable polymer balloon attached to the distal end of the catheter body, the expandable polymer balloon having a hardness and an outer surface configured to radially outwardly displace toward the inner surface of the body cavity wall; A plurality of discrete stress applying features, each having a hardness, a bottom, and a rounded convex upper surface, wherein the discrete stress applying features are distributed on at least a portion of the outer surface; A polymer layer disposed between the bottom of the discrete stress applying feature and the outer surface of the expandable polymer balloon; Wherein the polymer layer covers a continuous surface area of the outer balloon surface and is large enough to be located beneath at least a plurality of the plurality of discrete stress applying features, the at least a plurality of the plurality of discrete stress applying features being distributed on the continuous surface area in both the axial direction and the circumferential direction; And A plurality of adhesive points deposited on the polymer layer to enhance the attachment of the bottom of each of the plurality of discrete stress applying features to the polymer layer.

189. The apparatus according to claim 188, wherein, The polymer layer is softer than the polymer balloon. The apparatus according to claim 188, wherein, The adhesive points are softer than the polymer balloon.

191. The device according to any one of claims 188 to 190, wherein, The polymer layer is configured to (a) adhere to the outer balloon surface and is configured to (b) accommodate different expansions between the bottom of the discrete stress applying feature and the outer surface of the expandable polymer balloon when the balloon expands. The apparatus according to any one of claims 188 to 191, wherein The plurality of adhesive points are configured to (a) adhere to the polymer layer and attach the stress applying feature to the outer balloon surface, and are configured to (b) further accommodate the different expansions between the bottom of the discrete stress applying feature and the outer surface of the expandable polymer balloon when the balloon is inflated. The apparatus according to any one of claims 188 to 192, wherein The plurality of stress applying features are distributed over the continuous surface area in both the axial direction and the circumferential direction. The apparatus according to claim 193, wherein, The plurality of stress applying features are arranged on the continuous surface area as one or more axial strips, one or more circumferential bands, two or more helical lines. The apparatus according to claim 193, wherein, The plurality of stress applying features are arranged on the continuous surface area as two or more axial strips, two or more circumferential bands, one or more helical lines. The apparatus according to claim 193, wherein, The plurality of stress applying features are arranged on the continuous surface area as a random two-dimensional grid. The device according to any one of claims 188 to 196, wherein, The continuous surface area is large enough to be located beneath at least a majority of the plurality of discrete stress applying features. The apparatus according to any one of claims 188 to 196, wherein The continuous surface area is large enough to be located beneath all of the plurality of discrete stress applying features. The device according to any one of claims 188 to 198, wherein The polymer layer is inseparable from the outer balloon surface. The apparatus according to any one of claims 188 to 199, wherein, The polymer layer is attached to the outer balloon surface by one or more of heating, fusing, welding, depositing, gluing, and using an adhesive. The device according to any one of claims 188 to 200, wherein, The polymer layer includes a polymeric adhesive material. The apparatus according to claim 201, wherein, The polymer layer consists of or consists essentially of a polymeric adhesive material. The apparatus according to claim 201, wherein, The polymer layer includes a combination of an adhesive polymeric material and a non-adhesive polymeric material. The apparatus according to any one of claims 188 to 203, wherein The adhesive points include a polymeric adhesive material. The device according to any one of claims 188 to 203, wherein, The adhesive points consist of or consist essentially of a polymeric adhesive material. The apparatus according to any one of claims 188 to 203, wherein, The adhesive points include a combination of a polymeric adhesive material and a non-adhesive polymeric material.

207. An apparatus for treating calcified deposits on the wall in a patient's body cavity, the apparatus comprising: A catheter including a catheter body having a proximal end and a distal end; An expandable polymer balloon attached to the distal end of the catheter body, the expandable polymer balloon having a stiffness and an outer surface configured to radially outwardly displace towards the inner surface of the body cavity wall; A plurality of discrete stress applying features, each of the plurality of discrete stress applying features having a stiffness, a bottom, and a rounded convex upper surface, wherein the discrete stress applying features are distributed over at least a portion of the outer surface; A first polymer layer disposed between the bottom of the discrete stress applying features and the outer surface of the expandable polymer balloon; Wherein the polymer layer covers a continuous surface area of the outer balloon surface, and the polymer layer is large enough to be located beneath at least a plurality of the plurality of discrete stress applying features, and the at least plurality of the plurality of discrete stress applying features are distributed over the continuous surface area in both the axial direction and the circumferential direction; And A plurality of second polymer materials that encapsulate at least the bottom of each of the plurality of stress applying features and are attached to the first polymer layer. The device according to claim 207, wherein The second polymer material is attached to the first polymer material by one or more of heating, adhesion, fusion, welding, or combination. The apparatus according to claims 207 and 208, wherein The first polymer material and the second polymer material are the same material. The apparatus according to claims 207 and 208, wherein, The first polymer material and the second polymer material are different materials. The apparatus according to any one of claims 207 to 210, wherein The first polymer material is softer than the polymeric balloon. The apparatus according to any one of claims 207 to 211, wherein The second polymer material is softer than the polymeric balloon and harder than the first polymer material.

213. An apparatus for treating calcified lesions on the wall in a body cavity of a patient, the apparatus comprising: A catheter including a catheter body having a proximal end and a distal end; An inflatable polymeric balloon attached to the distal end of the catheter body, the inflatable polymeric balloon having a hardness and an outer surface configured to radially outwardly displace toward the inner surface of the body cavity wall; A plurality of discrete stress applying features, each having a hardness, a bottom, and a rounded convex upper surface, wherein the discrete stress applying features are distributed on at least a portion of the outer surface; A plurality of discrete polymeric adhesive points formed as at least one layer and disposed between the bottom of the discrete stress applying features and the outer surface of the inflatable polymeric balloon; And At least a first polymeric adhesive layer disposed on the outer surface of the inflatable polymeric balloon, the at least first polymeric adhesive layer overlapping at least a portion of the at least one layer of the plurality of discrete polymeric adhesive points; Wherein the discrete polymeric adhesive points and the first polymeric adhesive layer are configured to accommodate different expansions between the bottom of the discrete stress applying features and the outer surface of the inflatable polymeric balloon when the balloon is inflated.

214. The device according to claim 213, wherein, The plurality of discrete adhesive points extend beyond the periphery of the bottom of the plurality of stress applying features. The apparatus according to claims 213 and 214, wherein, The first polymeric adhesive layer covers the at least one layer of the plurality of discrete polymeric adhesive points.

216. The apparatus according to any one of claims 213 to 215, wherein, The first polymeric adhesive layer covers at least a portion of the surface of the plurality of discrete stress applying features.

217. The device according to any one of claims 213 to 216, wherein The plurality of discrete adhesive points and the first polymeric adhesive layer are the same polymeric adhesive. The apparatus according to any one of claims 213 to 216, wherein The plurality of discrete adhesive points and the first polymeric adhesive layer are different polymeric adhesives. The device according to any one of claims 213 to 218, wherein At least a first polymeric adhesive covering layer covers at least a portion of the surface of the plurality of discrete stress applying features. The apparatus according to any one of claims 213 to 219, wherein The first polymeric adhesive covering layer covers at least a portion of the first polymeric adhesive layer.

221. The apparatus according to any one of claims 213 to 220, wherein, At least a first polymeric adhesive covering layer covers at least a portion of the surface of the plurality of discrete stress applying features and at least a portion of the first polymeric adhesive layer. The device according to any one of claims 213 to 220, wherein The first polymeric adhesive overlay covers all surfaces of all of the plurality of discrete stress applying features and all of the first polymeric adhesive layer.

223. An apparatus for treating calcified deposits on a wall in a body cavity of a patient, the apparatus comprising: a catheter including a catheter body having a proximal end and a distal end; an expandable polymeric balloon attached to the distal end of the catheter body and having an outer balloon surface; and a plurality of discrete rigid stress applying features attached to the outer balloon surface; wherein the discrete rigid stress applying features are arranged on the outer surface of the polymeric balloon as a first plurality of circumferential bands; wherein when the polymeric balloon is expanded, each stress applying feature within a circumferential band is axially offset from at least one circumferentially adjacent stress applying feature within the same band.

224. The apparatus according to claim 223, wherein, The plurality of discrete rigid stress applying features are also arranged as a second plurality of axially oriented strips disposed along the length of the outer surface of the balloon.

225. The apparatus according to claim 224, wherein, When the balloon is expanded, the stress applying features in some or all of the axially oriented strips are axially offset from the stress applying features in circumferentially adjacent axially oriented strips. The apparatus according to claims 224 and 225, wherein, The stress applying features in at least some of the axially oriented strips have the same axial spacing. The apparatus according to claims 224 and 225, wherein The stress applying features within all of the axially oriented strips have the same axial spacing. The device according to any one of claims 223 to 227, wherein, At least some of the stress applying features within at least some of the circumferential bands are axially offset from other stress applying features within the circumferential band to enhance the destructive force of each stress applying feature and / or to prevent the stress applying features from stacking when the balloon deflates.

229. The device according to claim 228, wherein, All of the stress applying features within at least some of the circumferential bands are axially offset from other stress applying features within the circumferential band. The apparatus according to claim 228, wherein, All of the stress applying features within each circumferential band are axially offset from other stress applying features within the circumferential band. The apparatus according to any one of claims 223 to 230, wherein All of the stress applying features within the same circumferential band have the same circumferential spacing. The apparatus according to any one of claims 223 to 231, wherein, The stress applying features within at least some of the circumferential bands have the same circumferential spacing. The apparatus according to any one of claims 223 to 232, wherein, At least some of the stress applying features have a convex rounded upper surface and a circular base about a center. The device according to claims 223 to 233, wherein, The width or diameter of the stress applying features ranges from 0.15 mm to 1 mm, preferably from 0.2 mm to 1 mm, and typically from 0.3 mm to 0.6 mm. The device according to any one of claims 223 to 234, wherein The distance by which the stress applying features are axially offset ranges from 0.3 mm to 2 mm, preferably from 0.4 mm to 1.5 mm, and typically from 0.5 mm to 1 mm. The apparatus according to any one of claims 223 to 235, wherein The circumferentially adjacent stress applying features are axially spaced far enough apart such that the peripheral edges of the circumferentially adjacent stress applying features do not axially overlap, where the gap between the peripheral edges of the circumferentially adjacent stress applying features will be in the range of 0 to 3 mm, typically in the range of 0 to 2 mm, and preferably, in the range of 0.05 mm to 0.4 mm. The apparatus according to any one of claims 223 to 236, wherein All of the stress applying features are spaced far enough apart such that when the inflatable polymeric balloon is deflated, the peripheral edges of the stress applying features do not axially overlap, and the gap between the peripheral edges of the stress applying features is in the range of 0 to 3 mm, typically in the range of 0 to 2 mm, and preferably, in the range of 0.05 mm to 0.4 mm. The apparatus according to claim 237, wherein, For all of the stress applying features, when the inflatable polymeric balloon is inflated, the width or diameter of each stress applying feature, the axial offset between circumferentially adjacent stress applying features, and the circumferential offset between axially adjacent stress applying features are constant. The device according to any one of claims 223 to 238, wherein The center of the stress applying feature includes the center of the bottom surface of the stress applying feature. The device according to any one of claims 223 to 239, wherein The center of the stress applying feature includes the center of the upper surface of the stress applying feature.

241. The device according to any one of claims 238 to 240, wherein The axial offset and the circumferential offset are measured with respect to the center of an adjacent stress applying feature.

242. The apparatus according to any one of claims 223 to 241, wherein The density of the circumferential bands along the axial length ranges from 0.2 bands per millimeter of axial balloon length to 2 bands per millimeter of axial balloon length, preferably from 0.3 bands per millimeter of axial balloon length to 1 band per millimeter of axial balloon length, and most preferably from 0.4 bands per millimeter of axial balloon length to 1 band per millimeter of axial balloon length.

243. The device according to any one of claims 223 to 242, wherein The bottom of the axially adjacent stress applying features within at least some of the axially oriented bands are axially spaced a distance in the range of 0.5 mm to 3 mm, typically in the range of 1 mm to 2.5 mm, and preferably, in the range of 1.5 mm to 2.5 mm. The apparatus according to any one of claims 223 to 243, wherein At least some of the discrete stress applying features are formed as spheres, hemispheres, partial spheres, ellipsoids, or other shapes having a convex rounded upper surface.

245. An apparatus for treating calcified deposits on the walls of a body cavity of a patient, the apparatus comprising: a catheter including a catheter body having a proximal end and a distal end; an inflatable polymeric balloon attached to the distal end of the catheter body and having an outer balloon surface; and a plurality of rigid stress applying features attached to the outer balloon surface; wherein at least some of the stress applying features have a convex rounded upper surface and a base directly or indirectly attached to the balloon surface; and wherein when the balloon is deflated, the peripheral edges of the stress applying features do not overlap.

246. The apparatus according to claim 245, wherein, When the polymeric balloon is deflated, the gap between the peripheral edges of adjacent stress applying features will be in the range of 0 to 3 mm, typically in the range of 0 to 2 mm, and preferably, in the range of 0.05 mm to 0.4 mm.

247. A device for treating calcified lesions on the wall in a patient's body cavity, the device comprising: A catheter, the catheter comprising a catheter body having a proximal end and a distal end; An inflatable polymeric balloon, the inflatable polymeric balloon attached to the distal end of the catheter body, the inflatable polymeric balloon having an outer surface; And A plurality of stress-applying features, the plurality of stress-applying features attached to the outer surface of the inflatable balloon; Wherein when the expandable polymeric balloon is fully expanded, the distribution density of the stress application feature on at least the expansion region of the expandable polymeric balloon is in the range of 0.1 feature / mm 2 to 5 features / mm 2 Preferably, in the range of 0.2 feature / mm 2 to 4 features / mm 2 More preferably, in the range of 0.25 feature / mm 2 to 3 features / mm 2 and within the range.

248. A device for treating calcified lesions on the wall in a patient's body cavity, the device comprising: A catheter, the catheter comprising a catheter body having a proximal end and a distal end; An inflatable polymeric balloon, the inflatable polymeric balloon attached to the distal end of the catheter body, the inflatable polymeric balloon having an outer surface; And A plurality of stress-applying features, the plurality of stress-applying features attached to the outer surface of the inflatable polymeric balloon; Wherein when the expandable polymeric balloon is fully expanded, the distribution density of the stress applying features on at least the expansion region of the expandable polymeric balloon is in the range of 0.1 feature / mm 2 to 5 features / mm 2 Preferably, in the range of 0.2 feature / mm 2 to 4 features / mm 2 More preferably, in the range of 0.25 feature / mm 2 to 3 features / mm 2 In the range.

249. The device according to claim 248, wherein, The expansion region of the inflatable polymeric balloon includes the entire expandable surface area of the balloon. The apparatus according to claim 248, wherein, The expansion region of the inflatable polymeric balloon includes the central region of the balloon and excludes the tapered end regions of the balloon.

251. A device for treating calcified lesions on the wall in a patient's body cavity, the device comprising: A catheter, the catheter comprising a catheter body having a proximal end and a distal end; An inflatable polymeric balloon, the inflatable polymeric balloon attached to the distal end of the catheter body, the inflatable polymeric balloon having an outer surface; And A plurality of stress-applying features, the plurality of stress-applying features attached to the outer surface of the polymeric balloon; Wherein each of the stress-applying features has a base region in contact with the outer surface of the inflatable polymeric balloon; And Wherein the ratio of (1) the cumulative area of all the base regions in contact with the outer surface of the inflatable polymeric balloon and (2) the total surface area of the outer surface of the inflatable polymeric balloon is in the range of 1:100 to 5:100, typically in the range of 2:100 to 5:100, and preferably, in the range of 3:100 to 4:

100.

252. The apparatus according to claim 251, wherein, The outer surface of the inflatable polymeric balloon includes the entire expandable surface area of the balloon.

253. The apparatus according to claim 251, wherein, The outer surface of the inflatable polymeric balloon includes the central region of the balloon and excludes the tapered end regions of the balloon. The device according to any one of claims 251 to 253, wherein, The stress-applying feature has a convex rounded upper surface and a circular base region in contact with the outer balloon surface. The apparatus according to any one of claims 251 to 254, wherein, All of the stress-applying features have the same dimensions.

256. The device according to any one of claims 251 to 255, wherein, The stress-applying features are uniformly distributed on the outer surface of the inflatable polymeric balloon.

257. A device for treating calcified lesions on the wall in a patient's body cavity, the device comprising: A catheter, the catheter comprising a catheter body having a proximal end and a distal end; An inflatable polymeric balloon attached to the distal end of the catheter body, the inflatable polymeric balloon having an outer surface with a central region, a tapered distal region, a tapered proximal region, a distal transition region between the distal tapered region and the central region, and a proximal transition region between the proximal tapered region and the central region; and A plurality of rigid features attached to the outer surface of the inflatable polymeric balloon, wherein at least some of the rigid features are distributed over at least a portion of one of (a) the distal transition region, (b) the proximal transition region, (c) the distal tapered region, (d) the proximal tapered region, (e) a 2 - mm length at the distal end of the central region, and (f) a 2 - mm length at the proximal end of the central region of the outer surface of the inflatable polymeric balloon.

258. The device according to claim 257, wherein, At least some of the rigid features have a convex rounded upper surface. The apparatus according to claims 257 and 258, wherein, The width or diameter of the rigid features ranges from 0.15 mm to 1 mm, preferably from 0.2 mm to 1 mm, and typically from 0.3 mm to 0.6 mm. The device according to any one of claims 257 to 259, wherein, The discrete rigid features comprise a metal or metal alloy including at least one of iron, platinum, cobalt, chromium, rhodium, titanium, tungsten, and nickel. The device according to any one of claims 257 to 260, wherein The inflatable polymeric balloon comprises a semi - compliant balloon having a nominal inflation pressure and a rated burst pressure, wherein when the balloon is inflated from its nominal inflation pressure to its rated burst pressure, the diameter of the central region of the balloon increases by a percentage in the range of 1% to 20%, typically in the range of 5% to 20%, and preferably in the range of 5% to 15%.

262. The apparatus according to claim 261, wherein, The polymeric balloon comprises at least one of nylon, polyamide block copolymer, and polyethylene terephthalate (PET).

263. The device according to any one of claims 257 to 262, wherein, The inflatable polymeric balloon comprises a non - compliant balloon having a nominal inflation pressure and a rated burst pressure, wherein when the balloon is inflated from its nominal inflation pressure to its rated burst pressure, the diameter of the central region of the balloon increases by a percentage less than or equal to 20%, preferably less than or equal to 15%, and less than or equal to 10%.

264. The apparatus according to claim 263, wherein, The polymeric balloon comprises at least one of nylon, polyamide block copolymer, and polyethylene terephthalate (PET). The apparatus according to any one of claims 257 to 264, wherein At least some of the rigid features are distributed over at least a portion of each of the distal transition region and the proximal transition region of the outer surface of the inflatable polymeric balloon.

266. The device according to any one of claims 257 to 265, wherein At least some of the rigid features are also distributed over at least a portion of each of the tapered distal region and the tapered proximal region of the outer surface of the inflatable polymeric balloon.

267. The device according to any one of claims 257 to 266, wherein, At least some of the rigid features are distributed over at least a portion of each of a 1 - mm length at the proximal end and a 1 - mm length at the distal end of the central region of the outer surface of the inflatable polymeric balloon.

268. The device according to any one of claims 257 to 267, wherein, The rigid features are arranged as a circumferential band on the outer surface of the expandable polymeric balloon.

269. The apparatus according to claim 268, wherein, Each circumferential band includes from 2 to 8 rigid features, typically from 2 to 6 rigid features each, and preferably from 3 to 5 rigid features each. The apparatus according to any one of claims 257 to 269, wherein Some of the rigid features are distributed on the central region of the outer surface of the expandable polymeric balloon, and additional features are distributed on one or more of (a) the distal transition region, (b) the proximal transition region, (c) the distal tapering region, (d) the proximal tapering region. The apparatus according to claim 270, wherein, All of the rigid features have the same shape and size. The apparatus according to claim 270, wherein, The shape of the rigid features on the central region is different from the shape of the rigid features on one or more of (a) the distal transition region, (b) the proximal transition region, (c) the distal tapering region, (d) the proximal tapering region, and / or the size of the rigid features on the central region is different from the size of the rigid features on one or more of (a) the distal transition region, (b) the proximal transition region, (c) the distal tapering region, (d) the proximal tapering region. The device according to any one of claims 257 to 272, wherein, The rigid features are arranged as axial bands and circumferential bands in any one or all of the regions.

274. The apparatus according to claim 273, wherein, Each axial band consists of from 2 to 8 rigid features. The device according to claims 273 and 274, wherein Each axial band consists of from 2 to 8 rigid features.

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